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[109 Senate Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:27036.wais]
S. Hrg. 109-286, Pt. 6
Senate Hearings
Before the Committee on Appropriations
_______________________________________________________________________
Departments of Labor,
Health and Human Services,
Education, and Related
Agencies Appropriations
Fiscal Year 2007
109th CONGRESS, SECOND SESSION
H.R. 5647/S. 3807
PART 6
DEPARTMENT OF EDUCATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NONDEPARTMENTAL WITNESSES
S. Hrg. 109-286, Pt. 6
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, EDUCATION, AND RELATED
AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2007
=======================================================================
HEARINGS
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED NINTH CONGRESS
SECOND SESSION
on
H.R. 5647/S. 3807
AN ACT MAKING APPROPRIATIONS FOR THE DEPARTMENTS OF LABOR, HEALTH AND
HUMAN SERVICES, AND EDUCATION, AND RELATED AGENCIES FOR THE FISCAL YEAR
ENDING SEPTEMBER 30, 2007, AND FOR OTHER PURPOSES
__________
PART 6 (Pages 000)
Department of Education
Department of Health and Human Services
Nondepartmental Witnesses
__________
Printed for the use of the Committee on Appropriations
Available via the World Wide Web: http://www.gpoaccess.gov/
congress/index.html
__________
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COMMITTEE ON APPROPRIATIONS
THAD COCHRAN, Mississippi, Chairman
TED STEVENS, Alaska ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico PATRICK J. LEAHY, Vermont
CHRISTOPHER S. BOND, Missouri TOM HARKIN, Iowa
MITCH McCONNELL, Kentucky BARBARA A. MIKULSKI, Maryland
CONRAD BURNS, Montana HARRY REID, Nevada
RICHARD C. SHELBY, Alabama HERB KOHL, Wisconsin
JUDD GREGG, New Hampshire PATTY MURRAY, Washington
ROBERT F. BENNETT, Utah BYRON L. DORGAN, North Dakota
LARRY CRAIG, Idaho DIANNE FEINSTEIN, California
KAY BAILEY HUTCHISON, Texas RICHARD J. DURBIN, Illinois
MIKE DeWINE, Ohio TIM JOHNSON, South Dakota
SAM BROWNBACK, Kansas MARY L. LANDRIEU, Louisiana
WAYNE ALLARD, Colorado
J. Keith Kennedy, Staff Director
Terrence E. Sauvain, Minority Staff Director
------
Subcommittee on Departments of Labor, Health and Human Services,
Education, and Related Agencies
ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi TOM HARKIN, Iowa
JUDD GREGG, New Hampshire DANIEL K. INOUYE, Hawaii
LARRY CRAIG, Idaho HARRY REID, Nevada
KAY BAILEY HUTCHISON, Texas HERB KOHL, Wisconsin
TED STEVENS, Alaska PATTY MURRAY, Washington
MIKE DeWINE, Ohio MARY L. LANDRIEU, Louisiana
RICHARD C. SHELBY, Alabama RICHARD J. DURBIN, Illinois
ROBERT C. BYRD, West Virginia (Ex
officio)
Professional Staff
Bettilou Taylor
Jim Sourwine
Mark Laisch
Sudip Shrikant Parikh
Candice Ngo
Lisa Bernhardt
Ellen Murray (Minority)
Erik Fatemi (Minority)
Adrienne Hallett (Minority)
C O N T E N T S
----------
Wednesday, March 1, 2006
Page
Department of Education: Office of the Secretary................. 1
Wednesday, May 3, 2006
Department of Health and Human Services: Office of the Secretary. 61
Friday, May 19, 2006
Department of Health and Human Services: National Institutes of
Health......................................................... 105
Nondepartmental Witnesses
Department of Labor.............................................. 301
Department of Health and Human Services.......................... 315
National Institutes of Health.................................... 384
Department of Education.......................................... 538
Related Agencies................................................. 575
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, EDUCATION, AND RELATED
AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2007
----------
WEDNESDAY, MARCH 1, 2006
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10:45 a.m., in room SD-124, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Craig, Harkin, Kohl, Murray, and
Landrieu.
DEPARTMENT OF EDUCATION
Office of the Secretary
STATEMENT OF HON. MARGARET SPELLINGS, SECRETARY
ACCOMPANIED BY: THOMAS SKELLY, DIRECTOR, BUDGET SERVICE
opening statement of senator arlen specter
Senator Specter. Good morning Ladies, and Gentlemen, the
subcommittee on Labor, Health and Human Services, and Education
will now proceed with our hearing on the budget from the
Department of Education. I regret our delayed start, but we
just finished a vote on the PATRIOT Act, and Senator Harkin was
on the floor and should be here I think, shortly. Scheduling
has been complicated because of this vote. As you know we had
moved the time from 9:30 to 11:00 and then back to 10:30 and we
don't like to keep people waiting, especially the Secretary of
Education. But we welcome you here, Madam Secretary.
You were confirmed on January 20, 2005. You have extensive
experience working for the President when he had been a
Governor; you were Assistant to the Secretary for Domestic
Policy. You were Senior Advisor to then Governor Bush with
responsibilities for developing and implementing the Governor's
education policy. You are a graduate of the University of
Houston, with a bachelor's degree in political science and
journalism.
prepared statement
Madam Secretary, I shall be relatively brief because of our
time here, our late start. Without objection, my written
statement will be included in the record. As you and I have
talked briefly earlier this week, I'm concerned about the
overall budget. We had a budget for this subcommittee, which
has in addition to the Department of Education, Health and
Human Services and Labor, which fell about $8 billion short
when you figure the cuts and take into account, inflation. I
know that it is difficult as a loyal member of the
administration when you have the policies working up through
the Office of Management and Budget. But as I said to you in
our telephone conversation, and as I've said repeatedly, I
think there's a real need for someone in your position to be a
tough advocate for your Department. Education is simply under
funded. When I took a look at the President's budget, we're
always asked for comment and I wanted to be definitive and
brief and chose the word scandalous which I think it is. I know
the President, the administration have tremendous problems in
many, many areas but when you have so much money for the
National Institutes for Health, and the Centers for Disease
Control and Prevention, and Worker Safety, and Mine Safety, and
important education programs, it's simply insufficient to have
continual cuts on discretionary programs. We're regrettably
moving to a system where there will be no discretionary funding
at all. We'll all be out of jobs. The Appropriations Committee,
which used to be--was once a powerful committee.
[The statement follows:]
Prepared Statement of Senator Arlen Specter
This morning, the Subcommittee on Labor, Health and Human Services,
and Education will discuss the President's $54.410 billion 2007 budget
request for the Department of Education. We are delighted to have
before us the distinguished Secretary of Education, the Honorable
Margaret Spellings, our Nation's 8th Secretary of Education.
Madam Secretary, your impressive biography clearly illustrates your
abilities and potential for leading this important Department. Being a
mother of two school-age daughters gives you important insights into
your other job as Secretary of Education.
This subcommittee is pleased to see several shared priorities
funded in the fiscal year 2007 budget including the $200 million
request for school improvement grants, $380 million for the American
Competitiveness Initiative, and additional funding for foreign language
instruction and the Advanced Placement Program.
However, I am concerned that the budget is $2.1 billion below the
fiscal year 2006 level and that there are 42 program eliminations. For
example, $303 million currently available for Gear-Up, which provides
for the transition from seventh grade to college; $1.2 billion for
State grants for vocational and technical education programs; and $23
million for correctional education programs all are proposed for
elimination. The Pell Grant maximum award is frozen at $4,050 for the
fifth year in a row.
I know, Madam Secretary, that you can appreciate the difficult
tradeoffs that this subcommittee will need to negotiate in the coming
months as we balance the competing pressures of biomedical research,
worker protection programs and continued investment in our Nation's
youth. Madam Secretary, I look forward to working with you to craft an
appropriations bill that maintains our commitment to fiscal restraint
while preserving funding for high priority programs.
Senator Specter. Senator Landrieu, would you care to be
acting ranking and make an opening statement?
STATEMENT OF SENATOR MARY L. LANDRIEU
Senator Landrieu. Thank you, Mr. Chairman.
Senator Specter. Or not be acting, just make an opening
statement.
DEPARTMENT LAUDED FOR HURRICANE RESPONSE
Senator Landrieu. It's hard shoes to fill, but I will make
an opening statement. Just very briefly because I appreciate
that we want to hear our witness. But I wanted, Mr. Chairman,
to be here this morning to give compliments to this
Department--being mindful of what you said and agreeing with
the level of funding which I'll get back to in a minute. Which
I fully agree is scandalous. But Madam Secretary, your
Department has been really a model of partnership for the State
of Louisiana through the most difficult time that our State has
experienced. I spoke to the Secretary, Mr. Chairman, privately
before to let her know that if every Department of the Federal
Government had worked this honestly, this reliably, with us we
would not be experiencing the problems that we're experiencing
now. In all of the calls, and I had thousands of calls about
Katrina and Rita and the devastation that occurred, not one
call did my office receive from any school or university in the
country or from any parent saying they couldn't find a place
for their child, or their young person to go to school. Number
one, because the word went out across the country, please take
the 330,000 children that showed up for school on Friday; the
hurricane hit on Sunday, and they had no school to go to on
Monday.
Mr. Chairman, it's a credit to the education establishment
in this country that almost to my knowledge, every high school
student, every elementary school student, and every college
student that wanted to, found a place to continue their
education of the last 6 months, and Madam Secretary, I think
you deserve a lot of credit for that.
Second, the quickness in which we were able in a bipartisan
way, we were able to implement with the chairman's help and
assistance the special funding for getting our schools back up
and started also is a great model. Having said that, we still
have many problems as you know. We're hoping the new school
system that emerges in New Orleans can be a model for the
Nation as it emerges as a network of public charter schools and
we're going to need your ongoing help and commitment to that
end.
We do have problems with FEMA in terms of reimbursing and
not reimbursing for school construction, we've lost over 100
school buildings, Mr. Chairman, which is a great strain on any
system, to have to try to build the physical plants as well as
the internal operations. But I did want to start with that and
then finally say, having said that, the overall budget for the
Nation is just not sufficient to meet the new standards and
challenges that we have set for our schools as we struggle to
provide excellence, opportunity, no guarantee Madam Secretary,
but an opportunity.
TITLE I FUNDING
Title I funding, is the only Title that helps poor and
lower middle-income children get the resources they need; to
have the kinds of schools they need to be excellent. With that
funding decreasing I don't know how our poor counties and
middle-income counties that are struggling can meet the targets
of No Child Left Behind, which means closing that achievement
gap. So that's what I'm going to focus on in the committee and,
Mr. Chairman, I thank you very much.
Senator Specter. Well thank you very much, Senator
Landrieu. Well welcome again, Madam Secretary, the floor is
yours, and we look forward to your testimony.
SUMMARY STATEMENT OF HON. MARGARET SPELLINGS
Secretary Spellings. Thank you very much, Mr. Chairman. It
does seem like all roads lead to you today, and so I'm at your
service, and thank you for all your work that you're doing, not
only in this arena, but in many others.
EDUCATION FUNDS DISBURSED FOR HURRICANE RECOVERY
Senator Landrieu, thank you for your very generous
comments. I appreciate the opportunity to be here and your
support. Let me begin first, by thanking all of you for your
work on behalf of the victims of hurricanes Rita and Katrina.
As Senator Landrieu has talked about, we've worked a lot on
that. After you passed the Hurricane Education Recovery Act in
December, we sent immediately $250 million to Louisiana,
Mississippi, Texas, and Alabama to help re-open schools in the
region. That was in addition to $20 million that we sent to
help open, or re-open, charter schools for affected students in
Louisiana, and more than $200 million that we sent to help
college students in the region. We'll be sending another $500
million in aid to these States in the coming days, and we've
been consulting with experts at the Federal, State, and local
levels, reviewing records from tax data, property loss data,
and insurance claims, to make sure that this money is allocated
fairly.
We'll also be providing $645 million to reimburse districts
all over the country for the cost of educating displaced
students, as they've done so welcomingly, and so well. We've
been working with States to help accelerate this process and to
identify the number of displaced students so we can begin
sending this money to schools.
FISCAL YEAR 2007 EDUCATION BUDGET REQUEST
But today I'm here to talk about the President's budget,
and it's more important than ever that we spend taxpayer
dollars wisely and well. Since taking office in 2001, the
President has worked with you to increase funding for education
by about 30 percent. The new budget increases education
spending in key areas, but, as you've observed, not across the
board. I know together we have a very tough job ahead. The
programs you make funding decisions for are discretionary and
you don't have much room to maneuver. It's only getting harder
to fund priorities and reduce the deficit, because of the
rising cost of entitlement spending.
AMERICAN COMPETITIVENESS INITIATIVE
At the same time, as policymakers we must focus on results.
We've looked at data to see what policies are working for
students, and where we can save taxpayers money or work more
efficiently and effectively by eliminating and consolidating
less effective programs. Raising student achievement is always
our watch word. The President's new American Competitiveness
Initiative would devote $380 million to strengthen K-12 math
and science education. Overall the Department of Education will
increase funding for its programs in these critical fields by
51 percent. The President has asked me to form a national math
panel of experts to help us bring together the best research on
proven strategies for teaching math; just as we've done in
reading. His budget includes $250 million for a new program
called Math Now, that will help elementary and middle school
students develop the academic foundation to eventually take
higher-level classes in high school, such as Advanced Placement
courses. The trouble today is that more than a third of our
high schools offer no AP classes and that needs to change,
especially when we know that students are going to need these
skills in a world where 90 percent of the fastest growing jobs
require postsecondary education.
The President has also called for $122 million to prepare
an additional 70,000 teachers to lead Advanced Placement and
International Baccalaureate classes in math, science, and
critical foreign languages. The budget includes $25 million to
help recruit 30,000 math and science professionals to become
adjunct high school teachers in these critical areas.
I know there are concerns about resources, but in reality
we have resources available around these priorities. Currently
13 different government agencies spend about $2.8 billion on
207 different programs for math and science. The problem is
that these programs are in their own silos with little or no
coordination with No Child Left Behind and its goals for
raising student achievement. It's a 1,000 flowers blooming and
maybe even a few weeds throughout the Government.
We should align these efforts with the principles of No
Child Left Behind by continuing to hold schools accountable for
getting students to grade-level proficiency by 2014, and by
giving local policymakers and educators resources, authority,
and the research base to do what's best.
SCHOOL IMPROVEMENT AND HIGH SCHOOL REFORM
Thanks to No Child Left Behind, we've reached a point where
we have the data to see what's working in our schools and what
needs to work better. We're proposing a new $200 million School
Improvement program to help States use what we've learned to
turn around schools in need of improvement. Now we must build
on the foundations of the NCLB law, which is working in grades
three through eight, to extend the benefits of assessment and
accountability for results into our high schools, with the
President's $1.5 billion high school reform proposal. There's a
wide and growing consensus that we have a problem in our high
schools and we must work together to address these issues. A
high school diploma must be a record of achievement and not
just a certificate of attendance. If we raise the bar, our
students will rise to the challenge just as they always have,
but we must give them the skills to compete.
PREPARED STATEMENT
Thank you. I'd be glad to answer any questions. With me
today is Tom Skelly, our Budget Director, who tells me he's
been doing this since 1976. So he knows what he's doing by now.
[The statement follows:]
Prepared Statement of Hon. Margaret Spellings
Mr. Chairman and Members of the Committee. Thank you for this
opportunity to testify on behalf of the President's 2007 budget for
education. I know you have received our Congressional justifications
and other background materials laying out the details of our request,
so I will concentrate on a few key highlights.
President Bush is requesting $54.4 billion in discretionary
appropriations for the Department of Education in fiscal year 2007. We
are proposing significant increases in key areas, as well as
substantial savings from reductions in lower priorities. The result
would be a discretionary total that is up more than $12 billion, or 29
percent, since fiscal year 2001.
We know the 2007 budget process will involve difficult trade-offs
among existing programs, just as was the case with the 2006
appropriations bill. In 2006, we saw that this Subcommittee was willing
to balance funding for priority programs with reductions and
eliminations in other activities, and we hope you will take the same
approach in 2007.
For example, our budget would save $3.5 billion by eliminating
funding for 42 programs. These reductions and terminations reflect the
Administration's longstanding goal of providing local control,
streamlining government to avoid unnecessary duplication, and targeting
taxpayer dollars to those programs with the greatest promise of
improving student outcomes. Let me add that we very much appreciate the
efforts of this Subcommittee last year in eliminating five Department
programs, and making significant reductions in several others, in order
to better target existing resources. We look forward to working with
you on this goal again this year.
a broad emphasis on competitiveness
President Bush has made ensuring American competitiveness in the
global economy a strong priority in his overall 2007 budget, primarily
through his American Competitiveness Initiative. Several of the
increases in the Department's request are part of that Initiative, and
I'll say more about them in a minute, but I think most of you would
agree that we need to address the competitiveness issue in America's
schools now, this year. This is why most of our major increases for
2007--not just those included in the President's Initiative--are aimed
at keeping our students, and our workforce, competitive for the 21st
century.
In that context, a key proposal for 2007 is a renewed request for
High School Reform, a $1.5 billion initiative to support a wide range
of locally determined reforms aimed at ensuring that every student not
only graduates from high school, but graduates with the skills to
succeed in either college or the workforce. The High School Reform
proposal also would require States to assess students, in reading or
language arts and math, at two additional grades in high school. NCLB
currently requires assessments in these subjects for just one high
school grade. We believe the additional assessments are needed to
increase accountability and give parents and teachers the information
they need to keep all students on track toward graduation. And more
generally, these assessments will help researchers and policymakers
understand more about what works and what doesn't work in our high
schools, a key goal when about 1 million high school students a year
drop out, at great cost to our economy and society. Too many students
drop out, and too many of them are minorities.
We also are seeking $100 million for the Striving Readers program,
which is applying the lessons of the successful Reading First model,
which translates research into practice to improve reading instruction
for young children, at the secondary school level. The $70 million
increase for this program would expand support for the development and
implementation of research-based methods for improving the skills of
teenage students who are reading below grade level, and who otherwise
might end up dropping out of school. It's hard to compete with anyone
if you don't finish high school.
math and science
A critical new focus for 2007 is on improving student achievement
in math and science from the early grades through high school, and the
President is seeking $380 million in new funding to support this goal
through his American Competitiveness Initiative (ACI). That total
includes $250 million for two proposed programs we call Math Now, one
focused on developing and implementing proven instructional practices
for students in grades K-6, and one to support research-based
interventions for middle school students. Both initiatives would be
guided by the recommendations of a National Mathematics Panel that I
will appoint soon, and that will be charged with identifying essential
math content and sound instructional principles, just as the National
Reading Panel did for reading instruction.
Another key ACI request is a $90 million increase for the Advanced
Placement program, to expand incentives for training teachers and
encouraging students, particularly in high-poverty schools, to take
high-level Advanced Placement and International Baccalaureate courses
in math, science, and critical foreign languages. We also are proposing
a new requirement for State or private-sector matching funds to expand
the reach of the AP program, so that we can train an estimated 70,000
teachers over the next five years. Over the long term, this proposal
would increase the number of students taking AP-IB exams in math,
science, and critical foreign languages from 380,000 today to 1.5
million in 2012, and triple the number of students passing these tests
to 700,000 by 2012.
I believe that increasing the number of American students studying
and gaining fluency in critical foreign languages is essential not only
for our national security, as suggested by the President's National
Security Language Initiative, but also to maintain our economic
competitiveness. That's why I'm very pleased that our request includes
$35 million in new funds for a package of proposals that would
encourage more students to master a critical foreign language. The
largest proposal is $24 million for Advancing America Through Foreign
Language Partnerships, a new program that would link postsecondary
institutions with school districts to support language learning from
kindergarten through high school, as well as advanced language study at
the postsecondary level.
building state capacity for school improvement
We continue to make good progress in implementing No Child Left
Behind, with scores on State assessments up significantly across the
country, and the National Assessment of Educational Progress showing
real improvements in closing achievement gaps, especially in the early
grades addressed by key NCLB programs like Title I and Reading First.
Our 2007 request would help maintain that positive momentum, while
providing a new push in the area of school improvement. Our budget
would provide $12.7 billion for Title I Grants to Local Educational
Agencies, which is the foundation of NCLB, while funding a $200 million
School Improvement Grants program. This initiative would help States to
establish and expand the statewide systems of improvement and support
that are essential to the long-term success of NCLB. If we're going to
reach the 100-percent proficiency goal by 2013-14, we need to make
continuous improvement our watchword, and our request would help States
do just that.
Our request also would support additional options for students
enrolled in schools that have been identified for restructuring--these
are chronically low-performing schools that have not made adequate
yearly progress under NCLB for at least 5 years. The $100 million
America's Opportunity Scholarships for Kids program would permit the
parents of such students to transfer their children to a private school
or to obtain intensive tutoring or other supplemental services,
including after-school and summer-school instruction. The President
believes that for accountability to be meaningful, there must be real
consequences for schools and real options for students and parents.
other programs
The 2007 budget would provide a $100 million increase for the
reauthorized Special Education Grants to States program, for a total
increase of $4.3 billion, or 69 percent, over the past five years. We
also would maintain a $4,050 Pell Grant maximum award with a $12.7
billion request for that program, while continuing to support the new
Academic Competitiveness Grants and National SMART Grants program. I
want to thank the Members of this Subcommittee, along with your
colleagues in the House, for supporting these critical new grant
programs. In particular, SMART Grants complement the President's
American Competitiveness Initiative by awarding up to $4,000 annually
to third- and fourth-year postsecondary students majoring in physical,
life, or computer sciences, mathematics, technology, engineering, or a
critical foreign language.
conclusion
These highlights of our 2007 request show that within the very
tight constraints required by the need to reduce the Federal budget
deficit in a time of war, we are proposing a strong education budget,
one that will maintain and even accelerate progress under No Child Left
Behind, while making key new investments in critical areas designed to
ensure our future competitiveness in the 21st century global economy.
I will be happy to answer any questions you may have.
FISCAL YEAR 2007 EDUCATION BUDGET PRIORITIES
Senator Specter. Thank you very much, Madam Secretary. I
begin with the questions which I posed in the letter which I
sent to you, last month. I focus at the outset on the proposed
budget for the Department of Education, being $2.1 billion
below last year. The Department has highlighted rising test
scores, a narrowing of the achievement gaps since the passage
of No Child Left Behind, and the increase in Federal funding
that has accomplished those results. What are the prospects for
continued progress with the budget cuts which are in your
proposal?
Secretary Spellings. Well Senator, I think there are a
couple of answers to that. One is that the priorities of No
Child Left Behind are indeed funded in the President's budget--
the emphasis on reading, the emphasis on teacher development,
the emphasis on Title I. Then there are the additional
resources that we are requesting for school improvement--the
$200 million that we need as the No Child Left Behind law
matures--as well as the investment in competitiveness, and in
high schools, and in math and science. So I think that where we
have resources we've focused them on the goals of No Child Left
Behind. Second, I would say that a lot of the infrastructure
that was needed to be put in place to do No Child Left Behind,
such as assessments, and reading curriculum reform and those
sorts of things, has been done, and now we're turning our
attention to the maturing of No Child Left Behind and these
other priorities.
Senator Specter. The difficulty, Madam Secretary, is that
there are cuts in a lot of programs which impact the students
whom you're trying to deal with in No Child Left Behind. You're
robbing Peter to pay Paul, really. When you have a net decrease
of $2.1 billion and you have the inflation factor as well, it
just seems to me that it's impossible to make it up with the
shuffling that you're suggesting.
PUBLIC SCHOOL CHOICE AND SUPPLEMENTAL SERVICES
What is the situation with the repeated public comments
about the difficulty of moving students from one school which
is not satisfactory to other schools? We see constant
complaints that the recipient school districts are unable to
accommodate the students, that that has not really been a
practical or realistic program?
Secretary Spellings. Let me make a couple of comments about
that, Senator. First, I've observed that also. We have about a
10 percent take-up, if you will: 2 million students are
eligible for supplemental services, and about 200,000 students
are seeking those options. So we must do a better job of making
sure those options for parents are real. But one of the things
I think I've learned, and we're piloting strategies in various
places around the country, is, does it make more sense--and we
ought to get some data about this--to allow students to get
extra intervention and supplemental services before the public
school choice options are used. So we're testing that theory in
Chicago, Los Angeles, New York, and some districts in Virginia
will also test that out. Does it make more sense, before we
ship them off to other schools, to get them additional
remediation. That's why the President's call for an additional
$100 million for either choice, or ramped up supplemental
services, makes a lot of sense.
Senator Specter. But you still are letting them choose to
go to another district, aren't you?
Secretary Spellings. The public school choice options, yes,
are still in place. But what I'm saying is, perhaps parents
would be equally satisfied or more satisfied to receive
supplemental services first.
Senator Specter. Well, are you saying that in all
situations where children want to move from an inferior school
to a better school that there are remedial programs to
discourage their moving?
Secretary Spellings. Well, I'm saying that perhaps in the
meantime, as we address these choice issues, that getting
remediation in a particular skill or subject, quickly and
readily available, convenient----
Senator Specter. Well, are you talking about something
which is realistic, so that we have inferior schools in those
situations, all of those situations, or almost all of those
situations, or most of those situations, you have remedial
programs to discourage going to another school?
Secretary Spellings. Well, I think it's a range of
fallibility if you will. I mean, some of these schools are
chronically low performing and that's why we need to spend $200
million to make sure that real school restructuring takes
place.
EFFECTIVENESS OF SUPPLEMENTAL SERVICES
Senator Specter. Madam Secretary, my time is almost up and
I'm going to observe the time. But the question really is, is
that a palliative and a fig leaf, or does it really work?
Secretary Spellings. I think supplemental services can work
very well educationally for kids.
Senator Specter. Can. But do they, are they? Are there
sufficient supplemental services to pick up on this very
critical program problem?
Secretary Spellings. In some places there are, and in some
places there are not, Senator. Clearly, I agree.
Senator Specter. Well, that's not satisfactory. My red
light went on, so I'm going to yield at this point to
distinguished ranking member Senator Harkin.
Senator Harkin. Thank you very much Mr. Chairman, I
apologize for being late, I'll just forgo my opening statement
and ask that it be made a part of the record, if that's okay.
Senator Specter. Without objection, it will be made part of
the record.
[The statement follows:]
Prepared Statement of Senator Tom Harkin
Good morning, Madam Secretary. I don't get to see you that often in
person, so I want to take this opportunity to commend you for the steps
you've taken to make the No Child Left Behind Act more flexible.
There's still room for improvement, but you're responding to the
concerns that many people have with this law, and you deserve credit
for that.
Today, however, our focus is on the President's proposed budget for
education. And I must speak frankly: I don't see how anyone in this
administration can defend it.
This budget would cut federal education spending by $2.1 billion.
That's the largest cut, in dollars, in the 26-year history of the
Education Department. And it comes on the heels of a $600 million cut
in fiscal year 2006--the first cut in a decade.
It looks to me as if this administration has basically given up on
the three programs that matter most to the Nation's students--Title I,
IDEA, and Pell.
Title I is the cornerstone program for the No Child Left Behind
Act. It's the program that targets aid to the students who are most at
risk of failing. That's why NCLB calls for a $2.2 billion increase for
Title I this year. But how much more does the President ask for? Zero.
It's flat funded.
This administration has also given up on funding for students with
disabilities. In fact, it's moving in the wrong direction. In fiscal
year 2005, the federal government provided 19 percent of the average
per-pupil expenditure toward the costs of special education. This year,
fiscal year 2006, it went down to 18 percent. Next year, under this
budget, it would go down again, to 17 percent. As the federal share
goes down, states and local districts have to pick up more of the tab.
And we all know what that means--higher property taxes.
This administration has also given up on student aid. Under this
budget, the maximum Pell Grant award would be frozen at $4,050, the
same level as four years ago. I wonder if there are any colleges in
America that charge the same amount for tuition that they did four
years ago. I doubt it. It gets tougher and tougher all the time for
low- and middle-income families to afford college, but this
administration doesn't seem to care.
It's as if the President said, ``Well, I spent a little money on
education during the first couple years of my administration. So much
for that. I'm done.''
So if there's nothing in this budget for Title I, Pell, and IDEA,
what is there? Unfortunately, a lot of the ``same old, same old.''
Once again, the President proposes a high school reform initiative.
But as far as I'm concerned, it's dead on arrival. The President asked
for it last year, Congress rejected it, and the same thing will happen
again this year, as long as it's contingent on eliminating the Perkins
vocational ed program.
And speaking of eliminations, the budget zeroes out 42 programs in
all. Forty-one of them are programs you tried, unsuccessfully, to
eliminate in the past. Congress restored the funding for them last
year, and I can tell you right now, we'll restore funding for almost
all of them again this year.
Like I said, more of the ``same old, same old.''
There are really only two new initiatives in this budget of any
significance: the Math Now programs, which cost a total of $250
million, and the Title I School Improvement Grants, which are budgeted
for $200 million.
I happen to like both of these ideas. In fact, I was the first
Member of Congress to include funding for School Improvement Grants in
an appropriations bill. In fiscal year 2003, when I was chairman of
this subcommittee, I included $100 million for this program in the
Senate Labor-HHS bill. It didn't end up getting funded, but I'd like to
see it happen.
But where will the money come from to fund these new initiatives? I
guarantee you: We're going to restore the TRIO programs that this
budget would eliminate. There's enormous bipartisan support for TRIO.
So that's $456 million that we've got to find from somewhere. We're
going to restore GEAR-UP, at $303 million. We're going to restore the
Robert C. Byrd Scholarships, at $41 million. We're going to restore the
counseling programs, at $35 million. I created that program, so I can
assure you that Congress will save it.
I could go on and on, program after program. But here's the bottom
line: Unless the President helps up find more money overall for
education, his new initiatives are simply not going to get funded, at
least not anywhere close to the levels he wants.
I've served on this subcommittee as ranking member or chairman
since 1989, so I know what I'm talking about. If you want us to fund
these presidential initiatives, you're going to have to work with us to
get our congressional priorities funded as well.
Again, Madam Secretary, I want to welcome you to the subcommittee.
I look orward to hearing your testimony.
NO CHILD LEFT BEHIND FLEXIBILITY PROVISIONS
Senator Harkin. Madam Secretary, welcome. First a
compliment before I get into the other stuff, if you don't
mind; I don't see you that often, I just want to take the
opportunity to commend you for the steps that you've taken to
make the No Child Left Behind Act more flexible. That has
always been a sore point, and I appreciate that. There's I
think, still some room for improvement. But I think you were
responding to the concerns that many people have with this law,
and I think you deserve credit for that--to get that
flexibility in there. But that's aside from today.
FISCAL YEAR 2007 EDUCATION DEPARTMENT BUDGET REQUEST
We're talking about the budget. I guess my first question
was, the budget that you've sent up for our subcommittee on
education, would you Madam Secretary, like to see it passed
exactly as you sent it up?
Secretary Spellings. Well, Senator, as you know, we propose
and you dispose. It's a process between the two of us, we
seldom end up--you know, you all seldom enact exactly what the
President sends up. I mean obviously----
Senator Harkin. I'm just asking you. Do you back it? Do you
back it as you sent it up?
Secretary Spellings. Certainly. I support the President's
budget.
Senator Harkin. Does your boss the President back it as it
was sent up.
Secretary Spellings. Yes, he does.
Senator Harkin. So he wants it enacted just like that?
Secretary Spellings. Well, I think he believes that this is
the smartest, best allocation of resources, given all the
various priorities in the Government.
PROPOSED EDUCATION BUDGET CUTS
Senator Harkin. I just want to get that clear for the
record. That this isn't just some little game, that this is a
budget that your boss the President of the United States,
proposed to us, and this is how he'd like to see it enacted and
so would you, Madam Secretary. Here is the biggest cut in
Federal education spending, $2.1 billion in the 26 year history
of the Education Department. Do you disagree with that?
Secretary Spellings. Well, Senator----
Senator Harkin. Is that figure correct, or not?
Secretary Spellings. I can't remember the exact figure, the
$2.1----
Senator Harkin. That's what I have; I just want to make
sure we're on the same page.
Mr. Skelly. It's the biggest since 1988. So not 26 years.
Senator Harkin. So what year was the bigger cut?
Mr. Skelly. 1988.
Senator Harkin. 1988 was a bigger cut?
Mr. Skelly. In dollars and in percentage.
Senator Harkin. In dollars and in percentage, in 1988.
Mr. Skelly. Yes sir.
Senator Harkin. Okay, so I was off a few years. Then we had
a $600 million cut in fiscal year 2006. Right?
Mr. Skelly. That's right, Senator.
[Clerk's Note.--Senator Harkin was correct. The proposed
cut of $2.1 billion would be the largest reduction in the 26-
year history of the Education Department. The cut in 1988 was
larger as a percentage of the total budget, but not in
dollars.]
TITLE I GRANTS TO LEAS
Senator Harkin. Okay. I just want to make sure we're on the
same page. Now let's turn to Title I, cornerstone program of
the No Child Left Behind Act. Madam Secretary, I read your
testimony, you said it was the cornerstone.
Secretary Spellings. I do.
Senator Harkin. No Child Left Behind calls for a $2.2
billion increase for Title I this year, how much did the
President ask for? Zero. Flat funded.
Secretary Spellings. As well----
Senator Harkin. That's quite a cornerstone.
Secretary Spellings. As well as some additional resources
that attach to No Child Left Behind, like $200 million for
school improvement.
Senator Harkin. But Title I is the cornerstone, you say
that. When it's flat funded and when No Child Left Behind Act
calls for a $2.21 billion increase for Title I this year,
something's wrong with the cornerstone.
SPECIAL EDUCATION
Special education, Republicans and Democrats for years have
been saying we've got to get it to the 40 percent level, you
know what I'm talking about.
Secretary Spellings. Right, I do.
Senator Harkin. We've talked about it; we've had votes on
it, Senate Resolutions that are 100 to nothing, or 99 to 1 or
something like that, about doing this. Well, we've been inching
up the last few years, under the leadership of Senator Specter.
We've been getting it up; we've gone up to 19 percent. An all
time high. Last year we went back to 18, under this budget we
go back to 17 percent.
I don't know how you can see this as any kind of progress
at all on how the administration can support this.
PELL GRANTS
Student aid Pell Grants are now frozen at $4,050, the same
as 4 years ago. Can you name me one college in the United
States where the tuition is the same this year as it was 4
years ago? There isn't such a place. Yet the Pell Grant's
frozen at that. These are for the poorest of kids. I mean you
know what you have to do to qualify for a Pell Grant?
Secretary Spellings. I do.
Senator Harkin. You just about have to have nothing to
qualify for a Pell Grant. But yet, the President talks about
his competitiveness initiative. Sounds great, we all believe in
that, but is it just competitiveness just for the kids of
wealthy families, or families who can get loans and stuff like
that; how about competitiveness for the kids that qualify for
Pell Grants. What about them? What about their competitiveness?
Where do they fit into this picture? Well--I just don't see how
you can support that. I'm not saying it's all bad. There are
some things that you got in there that are good. Some of the
math and science stuff is okay. That's fine. Little bits and
pieces here and there. But in total, I just can't imagine your
support for that. I see my time is up now, and I didn't really
get a question in, but I wanted to make sure that we were
talking about apples and apples, and not oranges and apples and
that kind of stuff, and maybe on the second round I can have a
question about that. Thank you very much.
Senator Specter. Thank you, Senator Harkin. Senator
Landrieu.
EDUCATION RESPONSE FOR HURRICANE RECOVERY
Senator Landrieu. As the ranking member is here--before you
came in Senator, I was complimentary of the Department, of the
great work that they have done for the Hurricane Katrina and
Rita victims, and said what a reliable partner they've been. I
want to thank you also, Senator Harkin, because without you and
Senator Specter our education aid bill would not have passed
the way it did, and I want to say how much we appreciate that.
FISCAL YEAR 2007 BUDGET REQUEST
Having said that, I want to agree with what both the
chairman and ranking member said; not only do I think this
budget is scandalous in terms of short changing our goals,
Madam Secretary, for No Child Left Behind, but it's
disheartening and wholly inadequate. Disheartening for the army
of people out there trying to close these achievement gaps,
making the changes, pushing themselves to achieve excellence,
only to find their budget is being cut. While Title I is flat
funded dollar for dollar for last year, because it does not
have an inflation factor and it's not taking into consideration
the extra efforts being made to move these poor and low-income,
and moderate-income children up, it really is short changing
their ability.
Last night I got to attend a function in Washington, the
Youth National Guard Youth Challenge Program, that tries to
focus on reaching the 33 million Americans between the ages of
16 and 24 that do not have a high school diploma--33 million
Americans between the ages of 16 and 24. Those numbers don't
just pop, they are created by budgets like this that do not
provide the support of children in those early grades so that
they could get a diploma of achievement--they can read, and
calculate at grade level.
I know that as the Department's Secretary you're
responsible for carrying out the President's budget. But I want
to say as a Senator who is given choices between extending
dividend tax cuts, reducing capital gains taxes, this is what
is paying for those tax cuts. The short changing in education
for children in Louisiana, Mississippi, the Gulf Coast,
Arizona, in Pennsylvania, in Wisconsin, and in places in Iowa,
and all places are paying for those tax cuts. I think it's too
heavy of a price. I just want to go on record. It's too heavy
of a price to pay. We end up paying for it, in you know,
criminal justice systems. We end up paying it in mental health
services. The taxpayer's don't get a break. The taxpayers just
pick it up in a more painful, more expensive way. I don't know
when we're going to learn that investment in early childhood
education is giving children a fighting chance. There's no
guarantee of success, but I want to say for the record and my
time, and I'd like to ask you this question because only our
Federal portion represents about 8 to 10 percent of the total.
The States are picking up about 70 percent, is that correct
Madam Secretary of Education, expenses at the State level?
Secretary Spellings. It varies around the country.
EQUITABLE DISTRIBUTION OF EDUCATION RESOURCES
Senator Landrieu. What is the Department doing to try to
equalize or make more equitable the funding in the country,
from our wealthier counties, to our poor counties? If you could
just focus a minute of your answer. I know we haven't directed
you as such. Title I attempts to try to equal--it's Congress'
best attempt to try to give poor and middle income children the
same resources available. But is this Department at all focused
on that resource gap? There's an achievement gap, but there's a
resource gap. Do you know what it is, can you just tell us, and
give us a minute of what you're doing to try to close that gap?
DISTRIBUTION OF HIGHLY QUALIFIED PERSONNEL
Secretary Spellings. Well, that's a great question and I
think it manifests itself in a lot of ways. Highly qualified
teachers: one of the dirty little secrets in education is that
our most qualified people are in our least challenging
environments and vice versa, and so as we implement No Child
Left Behind we ought to look at how States and school districts
allocate highly qualified personnel. The President's budget
proposal on Advanced Placement (AP)--I talked about the 40
percent of the high schools that offer no AP at all. I use the
example in my speeches that in Fairfax County, Virginia, you
can find schools with 20 plus AP classes, whereas in the
District of Columbia, Ballou High School has just 3 or 4. Those
are exactly the kinds of things that we need to address as part
of either implementing No Child Left Behind or the resources
that the President has asked for.
No Child Left Behind--whether it's for special education
students or limited English speakers--has focused educators on
bottom line results for all kids and resources. Obviously, our
Federal commitment has always been to our Nation's neediest
students, and that's why we invest so much money in IDEA and
Title I, to help level out those educational opportunities
around the country. With respect to Title I, obviously the
formula reflects the numbers of poor kids as they migrate
around our country.
PER PUPIL EXPENDITURES ACROSS THE NATION
Senator Landrieu. Just to conclude though, Mr. Chairman, we
focus on the neediest. But I can say from--there are a lot of
middle-income families now that would classify themselves as
middle-income that are stretched and need help and as we
continue to cut these programs back, we're touching the bottom
5 or 7 percent, when we should be trying to help the bottom 40
or 50 percent. Tom, I would like you just to submit for the
record, the difference in resources from the poorest counties,
to the wealthiest counties to give us an update for the record
of this committee. I understand in some places it's like $3,000
or $4,000 a child, and then in some counties we're spending
$12,000-$14,000 a child. I know that we don't direct that
funding, but we can you know recognize that while there's an
achievement gap, there's a resource gap that this committee has
an obligation to fix, or try to fix. Thank you.
[The information follows:]
Education Funding in High-Poverty and Low-Poverty Districts
Average expenditures per student vary across local educational
agencies (LEAs) from about $3,300 to over $20,000 per student,
according to the 2003 Public Elementary-Secondary Education Finance
Data compiled by the Census Bureau. Most of the largest and smallest
figures are for very small school districts with limited enrollment.
For example, of the 10 LEAs with expenditures per student between
$3,000 and $4,000, only 1 had an enrollment of over 100 students. They
are mostly small, rural school districts, including 5 in Nebraska and 3
in Montana. However, even excluding the very small and rural school
outliers, there is a significant difference in the per-student averages
among the poorest and wealthiest LEAs (with ``poor'' and ``wealthy''
defined on the basis of the percentage of school-aged children living
in poverty). The 100 LEAs with the lowest poverty rates and enrollment
of at least 1,000 had average expenditures of $9,585 per student, while
the 100 LEAs with the highest poverty rates and enrollment of at least
1,000 had average expenditures of $7,897 per student.
Among the poorest LEAs, defined as those with poverty above 40
percent, there are many sizable school districts with average
expenditures well below the national average of about $8,100. For
example, Roosevelt Elementary School District in Arizona, with a
poverty rate over 45 percent and enrollment of 11,000, had an average
expenditure per student of $5,900. Laredo Independent School District
in Texas (45 percent poverty; enrollment of 24,000) had an average
expenditure per student of $6,900. Greenville Public School District in
Mississippi (42 percent poverty; enrollment of 7,400) had an average
expenditure per student of $5,900. But there are also many poor
districts with larger than average expenditures per student. These
include Muskegon Heights School District in Michigan (44 percent
poverty; $10,300 per student), Todd County, South Dakota (40 percent
poverty; $11,500 per student) and Rochester City School District in New
York (40 percent poverty; $12,711 per student).
The same can be said for the wealthier school districts. There are
examples of high per-student expenditures, such as Fairfax County,
Virginia (6 percent poverty; $9,500 per student), Montgomery County,
Maryland (7 percent poverty; $10,580 per student), and Cherry Hill, New
Jersey (3 percent poverty; $11,300 per student) as well as examples of
low per-student expenditures, such as Clay County, Florida (9 percent
poverty; $5,600 per student), Scottsdale School District, Arizona (7
percent poverty; $5,600 per student), and Alpine School District in
Utah (9 percent poverty; $4,400 per student).
While the spread is significant between the poorest and wealthiest
districts, there is a more noticeable pattern among States. The 142
LEAs with an average expenditure per-student below $5,000 are in only
17 States, with the majority in Arizona, Oklahoma, Utah, Montana, and
Nebraska. At the other end of the spectrum, half of the 200 LEAs with
the highest average expenditure per student are in three States:
California, New York, and New Jersey.
VOCATIONAL EDUCATION FUNDS
Senator Specter. Thank you, Senator Landrieu. Senator Kohl.
Senator Kohl. Thank you very much Mr. Chairman.
Secretary Spellings; you'll recall that we spoke at last
year's hearing about Perkins Vocational Education program.
Perkins is very important to every State, but particularly my
State. Wisconsin received almost $25 million in Perkins funds
last year, and over 23,000 students benefit in my State from
Perkins services. The vast majority of Perkins recipients in
Wisconsin have gone on to graduate and obtain high skill, high
wage jobs. Last year the President proposed to eliminate
Perkins funding but the Congress refused to go along, as you
know. The Senate voted to reauthorize Perkins by a vote of 99
to nothing. We also worked to restore most of the funding cut
by the President. One would think that these actions would have
sent a very strong message to the President, and Senators in
both parties feel strongly about Perkins. Yet once again, as
you know, the President's proposed elimination of this vital
program in 2007. Would you explain how he apparently is so out
of touch with we here who live and work with the problem
everyday in our States? Not just to reduce Perkins, which is
unacceptable, but to eliminate Perkins, which seems to me to be
incomprehensible.
INVESTMENT IN SECONDARY EDUCATION
Secretary Spellings. Senator, yes I will. The President
believes that we ought to gather up the resources that we spend
in vocational education, TRIO, and GEAR UP and a number of our
secondary school investments and create a high school reform
program; a $1.5 billion high school initiative for States to
use as they see fit, around graduation rates and enhanced
achievement for all high school students, including additional
accountability and the like. When and where vocational
education programs, GEAR UP, TRIO, any of those programs work
well, then States can and should--and I'm confident will--
continue to invest in those. But I think we also have to look
at our results of secondary education, and that is about half
of the African American and Hispanic kids who start high school
do not complete high school. When these resources and these
programs are targeted to them I think we have to ask ourselves,
are they working as well as they can be in the aggregate.
Senator Kohl. Well, I don't think you've really answered
the question, he still proposes eliminating Perkins and
aggregating it all really in the final analysis results in
cuts. But it's just done in a way that we don't really see how
these cuts occur, but that's I believe pretty clear to most of
us who look at this closely that aggregating really involves
cutting. Madam Secretary, I supported the No Child Left Behind
because it guaranteed flexibility and accountability would come
with more Federal funding to make it work. Instead, funding
levels have fallen billions of dollars short of what was
authorized and these cuts as you know cause real hardships.
Schools are being forced to cut staff and important programs
like summer school, class size reductions, arts, physical
education, and languages. Last year almost 11,000 schools
failed to make adequately yearly progress under No Child Left
Behind thus facing Federal sanctions. These schools will face
even greater challenges as testing and teacher quality
requirements go into full effect.
So isn't it time to provide the funding that was promised
so that we can give schools and students a real chance to
succeed which was the premise behind No Child Left Behind, that
there would be funding which is by all accounts not what was
promised. Where do we go from here?
ALLOCATION OF BUDGET RESOURCES
Secretary Spellings. I think what you'll find in the
President's budget, and it is a tough budget no doubt about it,
is that the resources are allocated around the core principles
of No Child Left Behind, such as our sustained investments in
Title I, in reading, in teacher quality, and the accountability
features and achievement. That those are our most--that's our
most urgent calling, and our highest priority for resources.
PELL GRANTS
Senator Kohl. Madam Secretary, the President's budget
proposal also targets student aid programs for harmful cuts
including a $4.6 billion reduction in funding for Pell Grants.
The maximum Pell Grant award is again frozen at $4,050 for the
fifth year in a row, despite rising tuition costs. These may
just seem like numbers but they also have a real impact on
students who are struggling to go to college. The University of
Wisconsin in Madison alone dispersed $9.2 million in Pell
Grants to 3,751 low-income students last year. In 1975 the Pell
Grant recovered 80 percent of the costs of a 4-year public
education in college and today that number is down to about 40
percent. So my question is, how can this administration claim
to want to make higher education a reality for low-income
students while at the same time cut the very programs that
would help them achieve that goal.
Secretary Spellings. Well, let me respond in a couple of
ways. One, while as you said the Pell Grant itself is still
$4,050, the actual grant has not been cut. There will be about
59,000 more students who will be taking advantage of Pell
Grants. In addition to that, as part of the reconciliation that
you all passed, there are additional resources for students who
are studying in the critical areas of science, technology,
engineering and math. Starting with about an additional $750
for year one of their studies, going up to $4,000 by the fourth
year if they pursue those particular fields. As you know, the
Congress finally has eliminated the Pell shortfall that has
vexed us for so long, which is most of that $4 billion that you
spoke of, but I think what we know is that the community
colleges, in particular, continue to be able to offer a full
and complete education at the Pell Grant level. So it's a
matter of students frequently starting there at community
college as opposed to a State university. But the Pell Grant
does remain stable at $4,050.
PREPARED STATEMENT
Senator Kohl. Thank you, and before I turn it back to the
chairman, my time has expired. When you keep a program like
Pell Grants at the same level for 5 years, you are reducing its
value, obviously. When I pointed out that the Pell Grant
covered in 1975, 80 percent of your public education and today
it's 40 percent, that describes the erosion of keeping the
number at a constant level. Thank you so much, and thank you
Mr. Chairman.
[The statement follows:]
Prepared Statement of Senator Herb Kohl
Thank you, Mr. Chairman. Secretary Spellings, I join my colleagues
in welcoming you here today. You face a significant and challenging
task in managing the Department of Education and I hope that we can
work together to improve access to education for all Americans.
I appreciate the difficult task you face in funding the many
education priorities of our country. That job is more challenging, in
our view, because this Administration has chosen budget and tax
policies that have led to rising deficits and diminishing resources
available for essential education programs.
This budget is abysmal for the education community. It proposes the
largest cut to federal education funding in the 26-year history of the
Department. Students, educators, parents, and administrators all lose
out under this budget. Funding for No Child Left Behind and Special
Education, the main federal funding streams for our local school
districts, are a far cry from their authorized levels. More
specifically, funding for No Child Left Behind is $12.3 billion dollars
below the authorization level, and IDEA is $6.3 billion short in 2007.
In addition, over forty programs are slated for elimination, including
funding for Career and Technical Education, Safe and Drug Free Schools,
and TRIO programs.
The President's budget should reflect our nation's priorities--but
these are just a few examples of this budget being out of step with our
values. I will continue to work with my colleagues to improve upon this
budget. Madame Secretary, I hope that you will work with us to better
meet our nation's education needs.
Senator Specter. Thank you Senator Kohl, Senator Craig.
AMERICAN COMPETITIVENESS INITIATIVE
Senator Craig. Mr. Chairman, thank you very much. Madam
Secretary, I'm pleased you're with us this morning. First and
foremost, I want to commend you and the President for including
the American Competitiveness Initiative in his State of the
Union. I thought that was critically important, and I'm looking
forward to working with the Department of Education and in this
instance the Department of Energy will have a fair chunk of
that, and my colleagues in the implementation of many of those
proposals. I think it's important. I think we can convince the
American people it's important, that we remain competitive and
that we design a system that allows us to do that. When we were
holding hearings on that recently in the Energy committee I was
likening it to our reaction to Sputnik. The Defense Education
Act of the 1960s that followed and the tremendous--and the
fallout, the positive fallout of that down through the decades,
as we trained a generation of mathematicians, and scientists,
all because we found ourselves not competitive in the real
world in a cold war environment and out of that space
initiative and everything else. Of course because the--what I
believe is a national crisis we're in today as it relates to
energy, we take that a lot easier because the lights are still
on, and even though gas is more expensive at the pump, it's
still there and we're adjusting accordingly even though it's
costing us, you know, lots of jobs out there in the industrial
sector today, and all that. The new world that we compete in is
going to be ever demanding.
We all know those stories, they are real and I'm glad to
see the President out on the edge of that, pushing it. That's
extremely important for us. In the context of doing that
although, I think we have to shape budgets that begin to fit
that and move us in those directions, and they are bits and
pieces of all that we're talking about in order to meet the
challenges laid out by the President in the Competitiveness
Initiative. I believe that bringing professionals into the
classrooms will be tremendous assets to our students. Yet the
system is so rigid to allowing that to happen today that it
almost, at the very beginning unless we break down some of
those barriers towards the very initiative that's underway.
What programs have been or are being implemented to ensure that
professionals interested in teaching have the training they
require, and do you believe the President's budget provides
adequate funding to bring these professionals ultimately into
the classroom to work alongside the educator in inspiring these
young people into these different areas that are within the
Competitiveness Initiative?
ADJUNCT TEACHERS PROGRAM
Secretary Spellings. Thank you for that question. The
President's budget calls for $25 million to start to seed some
of this kind of activity, which we call Adjunct Teachers. We
use this all the time in higher education, especially in
community colleges, and it's very effective. Typically, people
who are engaged in their own profession teach part time in
higher education. Many of these students now, high school
students, enjoy dual enrollment programs between community
colleges and high schools, and they are already being served by
the kind of professionals that you talk about. IBM has
committed 1,200 engineers and other highly skilled
professionals to make transitions into the teaching profession,
so I do think there's an appetite and a willingness out there
and a need--a dramatic need--for those sorts of competencies.
We have some models to build on through Troops-to-Teachers,
Teach for America, and some other programs that have taken mid-
career professionals and helped them become effective teachers.
But I think the notion is, let's be able to get some of our
expertise and resources from the broad community around some of
these 185 day, 10-month contract sort of structures, that we're
so used to dealing with in education.
INNOVATIVE HIGH SCHOOL RESTRUCTURING IN IDAHO
Senator Craig. I had the privilege, Mr. Chairman, of
walking through a new high school in Idaho during this last
recess. The largest building in our State from the standpoint
of an educational institution, 2,200 students. I thought, oh my
goodness, how can they possibly handle 2,200; surely they must
be lost in the system, because I was thinking of the old
models. But I walked into a school with academies, and the
allowance to actually begin shaping from your freshman year on,
some core competencies that move you then into community
colleges, or into University settings. In the junior senior
year, that nexus with the community college that you had--I
spent a couple of hours there, spoke with the senior class, and
walked out with a total different opinion. Or a sense of
understanding as to these new structures, and in this
particular school district which is the fastest growing in our
State, they're building a new high school about every 2 years
now, they're moving to this concept. They feel they can go to
larger schools but they allow the student to actually identify
with a much smaller unit within the school. It's impressive.
It's happening at other places in the county. Idaho is not
alone in it certainly, and it makes some very real sense, tied
to this competitive initiative, and being able to move young
people out earlier. Those who chose to, to get into that higher
learning, frankly, can break through the rigidity of the
current system that says, no, no this is the way we've always
done it, we control it, so this is the way you're going to do
it. If it isn't providing us with that level of training and
talent, then we've got to break through it, and if you can't
live within it, you get outside of it, I guess, and that's
starting to happen in parts of Idaho where we have community
college settings in which they can cooperate. That's a pretty
exciting concept. But in doing so--and then transitioning them
forward, there was concern about the Pell Grants and other
tools to make sure that those students can carry on, and I'm
looking at this budget concerned about obviously areas like the
Federal Direct Student Loans and the Federal Family Education
Loans, and all of those kind of things. Those tools are going
to be in part a necessary component of any kind of
competitiveness initiative to move these young people forward.
Secretary Spellings. I agree with that.
Senator Craig. Thank you.
Secretary Spellings. Absolutely, Senator. I think I'd love
to visit that school, I mean these are places as you said----
Senator Craig. You want to visit it?
Secretary Spellings. I would like to.
Senator Craig. Fine, you'll get an invitation today.
Secretary Spellings. Good.
Senator Craig. We'd love to have you out.
ADJUNCT TEACHERS
Secretary Spellings. Establishing the nexus between higher
education and high school, that can be more efficient and more
effective as we get these professionals who are working in the
field, and who have this expertise, because we're frankly going
to be very challenged to do it other ways.
Senator Craig. Well, it's an exciting model, and as I say,
there are many large schools across the country that are
recognizing that high schools of 2,000, if not restructured,
lose children.
Secretary Spellings. Exactly.
Senator Specter. Thank you very much, Senator Craig.
Senator Murray.
SCHOOLS-WITHIN-SCHOOLS
Senator Murray. Well, thank you very much Mr. Chairman, and
Senator Craig, I'm delighted to hear that you went to that
school. The Gates Foundation has been focusing on schools-
within-schools, with some real successful programs.
Senator Craig. If you'll let me interrupt. I'm not
absolutely sure, but it's very possible they're participating
in this one. Yes.
ACADEMIC COMPETITIVENESS AND NATIONAL SMART GRANTS
Senator Murray. Yeah. I agree with the focus on high
schools. I think it's absolutely critical that we as a Nation
really find out why we're losing kids at such dramatic rates.
Those kinds of programs really make a difference. But let me,
Madam Secretary, talk with you a minute about some of the
academic competitive grants in the national science and
mathematics act says to retain talent, the SMART grants. To
receive those American competitive grants, students have to
have completed what is called the rigorous secondary school
program of study. Now I agree, as I said that we have to do
everything we can to prepare students for the global economy
they're going to be in. Whether--but I think a student's luck
in where they attend high school, whether it's Senator Craig's
or another one, shouldn't determine whether or not the Federal
Government helps them attend college. CBO estimated that only
9.9 percent of the Pell eligible students are going to be able
to take advantage of those academic competitiveness and SMART
grants in 2007. Now the maximum Pell Grant has not increased
for 4 years despite as we all know tuition rising at our
Nation's public colleges by over 7 percent last year. So if the
$850 billion that those grants cost in 2007 were spent on Pell
Grants, students would actually receive an additional $200 in
aid that would have made a tremendous difference. I would like
to find out from you, how you anticipate judging what
constitutes a rigorous secondary school curriculum?
RIGOROUS HIGH SCHOOL CURRICULUM
Secretary Spellings. That's a great question and we're
struggling with that at the Department now. About a week ago,
we had folks in from the Gates Foundation, from the National
Governors Association, and from the Council of Chief State
School Officers to look at and talk about what's the most
appropriate way to do that while being very respectful of our
prohibition at the Department of Education for prescribing
curriculum. I certainly don't want to sit up here and look at
high school course syllabi and so forth. So we're working on
that right now. I mean, I think we know things that are widely
accepted, like Advanced Placement, International Baccalaureate,
and the State Scholar's program--that 14 States have already
bought into place, i.e. their determination of a college-ready
curriculum. For State Scholars this is 4 years of English, 3
years of math and science, and 2 years of foreign language.
We'll be announcing another 8 to 12 States that will be joining
the State Scholars program soon. So States have come to terms
largely, or are beginning to, with what they believe to be
college-ready, so that, I hope, will be informative as we look
at the Academic Competitiveness Grants.
Senator Murray. Well, I appreciate the goal, but here we
are in 2007 where less than 10 percent of the students are
going to be eligible for these grants, and in tight budget
times it seems to me that using those dollars to help all kids
get $200 in aid, not just those who are lucky enough to attend
a high school that works out to have a ``rigorous schedule.'' I
just think it's something we have to manage. So I'm very
concerned about a large amount of money funneling to a few kids
who happen to be in the right high school, with the right
curriculum, versus us being able to help all students with an
additional $200 with the same pot of money. So it's just a
budget issue in my mind. Obviously you've got a program you
love, and you want to go down that road. But in tight budget
times we have to say, are we going to help all kids out there,
or just the ones who are lucky enough to have that somehow
undefined yet rigorous curriculum.
Secretary Spellings. Well, it's also obviously our
responsibility to make sure that we have a college-ready
curriculum, and this is why we need more Advanced Placement in
more places, and so forth, making such a curriculum available
to all kids everywhere.
Senator Murray. Well, I think it's good to provide
incentives to high schools to move towards a rigorous
curriculum, I'm with you on that. But I don't want to see us
use the kids as a tool. Because in the end they are the ones
who are not going to be able to go to college based on where
they went to school. I think it's so important that we provide
that opportunity, but it's a philosophical debate.
HEA TITLE IX
I have limited time. I wanted to ask you about Title IX. On
March 17, the Department released a new guidance on the
interest prong of the three-part test which schools are using
to show their compliance with Title IX. As you are aware, I
have some really grave concerns about this new guidance,
because I believe it sets a new low bar for compliance with the
Federal Civil Rights Law. Schools would now be allowed to use
an email survey to show their compliance with Title IX. The
school would only have to send that survey to women. So, a lack
of response at our universities where kids already have a lot
to do, and may just say to heck with that, seems to me a very
poor way to be determining compliance with Title IX. Now I know
that it's used--surveys are used as part of compliance, but
it's the sole means to making sure whether a school complies or
not, to me seems really wrong headed.
Now as you know there's a lot of concern over this new
guidance, and there's a bipartisan group of Senators on the
subcommittee who have asked for a report on the guidance and
the use of surveys and I wanted to find out from you this
morning what the status is of that?
Secretary Spellings. We'll be completing that next month. I
believe you all gave us a deadline for March sort of timeframe
there. We will be completing it then. I do want to note that
we've not had any complaints about the survey aspect yet, and
frankly as you know it is a legitimate prong to ascertain
interest. This is prong three.
Senator Murray. But the sole prong is a problem.
Secretary Spellings. We have about 116 schools around the
country that do that now. But your report is due March 17, and
we intend to meet that deadline.
Senator Murray. Okay, well there's a lot of confusion on
behalf of schools about the guidance. I want to know what your
department is doing regarding technical assistance to schools
on the guidance of that?
Secretary Spellings. You have recently confirmed Stephanie
Monroe as AS for OCR. I've had a vacancy in that job for a long
time, and we are providing technical guidance around that
issue. I'm a mother of two daughters, I'm very committed to
their opportunities as well, and so----
PREPARED STATEMENT
Senator Murray. Well, we all are. But if we base compliance
on an e-mail survey to women in college expecting that their
response back as students is going to decide whether or not a
school is compliant, I think that is just not a very smart way
to go. I'm going to continue to work with other likeminded
Senators to make sure we don't somehow use that information to
take away the ability of many young women in this country to be
able to access sports in colleges.
[The statement follows:]
Prepared Statement of Senator Patty Murray
Secretary Spellings, thank you for coming today to talk with us
about the President's fiscal year 2007 budget request for the
Department of Education. I want to take this opportunity to say that I
have always believed that the federal budget is more than just a
compilation of numbers. Rather, it is a collective statement of the
values and priorities of our nation. Looking at the figures included in
the President's fiscal year 2007 budget request for the Department of
Education--which is the largest cut in federal education funding in 26
years--I have to say that I question the value that the President is
placing on educating our nation's youth this year.
As a country, we are required to articulate and defend our values
and priorities, particularly as we undergo the annual budget process.
While I share the President's stated commitment to preparing our nation
and workforce for the competition of the 21st century, I am
disheartened to see that his rhetoric about the importance of leaving
no child behind is not matched by the budget numbers this
administration put forward in its fiscal year 2007 request.
I want to remind my colleagues that what we do in the next few
weeks will affect us--and the American people--for a long time. The
budget decisions we make now will either empower us--or tie our hands--
when we turn to determining funding levels in this appropriations
committee later this year. That is why I must say I strenuously object
to the request put forward by the President.
While it's true that the President's budget includes increased
dollars for math and science education, these funds come at the expense
of cuts or elimination to other important programs. I view new
initiatives in math and science as complements to, but in no way
substitutions for, the other federal education investments we have made
over the past 40 years. While science and math competence are
undoubtedly a critical piece of what our students need to compete
globally, it cannot come at the expense of helping disadvantaged
students succeed academically, investing in our high schools, and
ensuring our college students have the financial means to attend
postsecondary education.
I am particularly disheartened that the administration continues to
fall behind in meeting its commitments under the No Child Left Behind
Act. The President's fiscal year 2007 request does not include any
increases in NCLB's cornerstone program, Title I. The administration's
decision to recommend level funding--at a time when requirements and
accountability provisions for our schools continue to grow--essentially
asks our schools to do more with less resources. This inconsistent
messaging is disingenuous and unfair. What's worse, our students,
parents, teachers and schools suffer as a result.
I also want to express my concern about the High School Reform
package the President is promoting. As you know, I have been an
advocate for focusing federal education resources to our nation's high
schools. That is why last year I introduced my Pathways for All
Students to Succeed (PASS) Act, to provide targeted resources to our
nation's high schools. The PASS Act would help America's teenagers
graduate from high school, go on to college, and enter the working
world with the skills they need to succeed.
While I appreciate the President's interest in high school reform,
the reality is that he elected to pay for these reforms by cutting
important programs. The $1.475 billion he is proposing for his high
school package doesn't come close to replacing the money we currently
spend on the 42 programs, including vocational and technical education,
GEAR UP and TRIO, proposed for elimination. At a time when 3,000
students drop out of high school each and every school day and when
half of our nation's African American and Latino students do not
complete high school, we need to be doing more, not less, to make our
high schools places where all students can learn.
In addition to stemming the tide of high school dropouts, we must
assist students in the transition from high school to college by
providing financial resources to facilitate access to higher education.
Yet recently the federal government cut $12.7 billion from student
loans that help low- and middle-income families pay for college. This
decision, during a year in which tuition and fees increased by 7.1
percent for four-year public universities and 5.9 percent for private
universities, does not reflect our national priorities. In the same
vein, the value the President purports to place on higher education is
not reflected in his budget, which level-funds the Pell Grant program
for the fourth year in a row.
As we work together in the next few weeks to prepare the budget
resolution, I will do my best to ensure that the values and priorities
of our nation and my state of Washington are reflected in the numbers
to which we will hold ourselves. As a policymaker and parent, I know
that American competitiveness demands a more comprehensive approach to
education. We must match our rhetoric with the necessary resources to
support all of our students, at all grade levels, in all subject areas.
Our children--and our country--deserve nothing less.
Thank you.
PROPOSED GEAR UP PROGRAM ELIMINATION
Senator Specter. Thank you, Senator Murray. Madam
Secretary, what participation did you have in the elimination
of the program known as ``GEAR UP'' that's been in existence
for about 7 years? On the ratings by OMB, they say ``GEAR UP''
is based on successful models for increasing the college
enrollment rate of at-risk students. Initial program results
suggest that grantees have been more successful in increasing
the percentage of students taking a more challenging course
load, better preparing these students for future college
enrollment.
It was an idea advocated by Congressman Chaka Fattah, who
has had a lot of experience in government in Philadelphia,
where there are tough schools with a lot of dropouts and a lot
of students with problems. It has been a program which has been
funded principally out of the Senate that I have spoken about
repeatedly. Let me ask you a two-part question. What do you
think the chances are that ``GEAR UP'' is going to be dropped
by the Congress? Second, what did you have to do with dropping
it, if anything?
Secretary Spellings. Well, Senator, first let me say that
you know ``GEAR UP'' was invented in Houston, Texas, I mean
when President Bush was Governor, we were strong supporters of
it.
Senator Specter. Does President Bush know that?
Secretary Spellings. Yes. President Bush, then Governor
Bush.
Senator Specter. Does President Bush know it's being
dropped?
Secretary Spellings. I presume he does.
Senator Specter. I'm going to tell him.
Secretary Spellings. I presume he does.
Senator Specter. Have you told him?
Secretary Spellings. Yes, sir. But let me tell you what
his----
Senator Specter. No, no. Have you--well you can tell me,
but first tell me, have you told him?
Secretary Spellings. Have I told him specifically ``GEAR
UP'' is not in the budget?
Senator Specter. Yes, ma'am, specifically. Have you told
him that ``GEAR UP'' has been dropped?
Secretary Spellings. I don't believe that I have told him
that specifically.
Senator Specter. Do you know if anybody has told him that
specifically?
Secretary Spellings. I do not.
Senator Specter. Get the President on the phone.
Secretary Spellings. I certainly will tell him.
START OF GEAR UP PROGRAM
Senator Specter. He calls me with some frequency when he
wants Supreme Court Justices confirmed. Next time he calls, I'm
going to parry him with this question about ``GEAR UP''; I
didn't know it was started in Houston.
Secretary Spellings. By Jim Ketelsen. The former CEO of
Tenneco.
Senator Specter. The first question I'm going to ask him
is, Mr. President, do you know ``GEAR UP'' was started in
Houston? Second question I'm going to ask him is, do you know
that ``GEAR UP'' has been dropped? The third question is, do
you know the Secretary of Education didn't personally tell you
that it was being dropped?
Secretary Spellings. You can tell him that.
Senator Specter. Okay. It's your turn.
HIGH SCHOOL REFORM INITIATIVE
Secretary Spellings. But let me say this, the President's
philosophy here around this high school reform issue is that
you need a block grant kind of program. That we ought to gather
secondary school resources into a $1.5 billion title that we're
saying would get results. That we shouldn't sit up here and
say, here's how you should get results. Now I fully believe
that in Houston, Texas, in Philadelphia, and places where these
programs are working well, and effectively, they will continue
to do those. I can't say that that's necessarily true in the
aggregate. Where they're going to be effective they'll be
maintained. I'm confident of that. The President's philosophy--
--
Senator Specter. How will they be maintained without
funding?
Secretary Spellings. They will be paid for then out of the
high school initiative.
Senator Specter. So you rob Peter to pay Paul, which is
what I said on my last round of questions, I'll probably say it
in my fourth round, too.
Secretary Spellings. I mean, I guess you could look at it
that way. We're gathering resources out of silos, out of
specific prescribed programs.
Senator Specter. So you think really, you ought to keep
``GEAR UP'' but under another name?
Secretary Spellings. No. I'm saying that States and local
school districts ought to have the opportunity to design and
choose programs as they see fit, including GEAR UP, Vocational
Education, or others.
Senator Specter. But, when it's been a successful Federal
program, and has all the backing from the Members of the House
and Senate, why submit a budget which cuts it?
Secretary Spellings. Well, I think the President believes
that successful programs will be invested in with Federal
dollars and maintained and enhanced at the State and local
level.
Senator Specter. Federal programs will be invested with
Federal dollars and maintained, and enhanced at the State and
local level?
Secretary Spellings. That where--in Philadelphia where this
is working well, they will use their high school resources to
invest in ``GEAR UP'' and they'll probably use State and
local----
Senator Specter. What resources? They're strapped to the
edge now.
Secretary Spellings. Under the high school reform block
grant, if you will, the $1.5 billion in Federal funds that
would be invested in high school reform, this program would
absolutely be an allowable purpose.
FISCAL YEAR 2006 FUNDING LEVEL OF PROPOSED TERMINATIONS
Senator Specter. Well, since that will happen I can rest
easy seeing it cut, I guess. Except that I won't. Senator
Harkin, why don't you do that on your time. Harkin wisely
points out. What was it you wisely pointed out?
Senator Harkin. That their reform package is $1.5 billion,
but the total amount that gets cut out of all these other
programs is $2.1 billion.
Senator Specter. How about that, Madam Secretary?
Secretary Spellings. Well, I think it's more like the $1.5
billion that we have gathered up. I don't know what all the
elements are that are in the $2 billion estimate that you have,
Senator Harkin, but it depends on what's on the list, I guess,
is the short answer.
Senator Specter. Madam Secretary, you can see the smooth
coordination. I frequently use the expression that when we
change chairman and ranking member that it's a seamless passage
of the gavel, which I now undertake to do, so that he can
follow up on his Charlie McCarthy, Edgar Bergen question that I
asked on his behalf. Senator Harkin.
Senator Harkin. Wait a minute. Which one am I?
Senator Specter. You're Edgar Bergen, I can tell you that.
Senator Harkin. Okay, well, to follow up on this.
Senator Specter. Secretary Spellings is too young to really
know who either is.
Secretary Spellings. I was just going to say you're dating
yourselves. But I wasn't going to say anything.
Senator Harkin. But to follow up on it, Madam Secretary. I
understand the High School Initiative program is at $1.475
billion. But there are 40 some programs that were eliminated.
All the TRIO programs, Talent Search, Upward Bound, Smaller
Learning Communities, that's $2.1 billion. So you've taken away
$2.1 billion that goes out to these high schools, and saying
now, here's $1.5 billion.
HIGH SCHOOL REFORM INITIATIVE
Secretary Spellings. Here's the difference. Part of the
Perkins Vocational Education Program goes into community
colleges and is in the postsecondary education environment, if
you will, and so the high school reform proposal at $1.5
billion reflects the investments that are currently going to K-
12 schools. The difference, the additional funds, can be found
in community colleges, which is obviously higher education.
Senator Harkin. Oh, so you're saying that Talent Search,
Upward Bound and all those programs are now shifted somehow to
community colleges?
Secretary Spellings. No, sir. I'm saying that the Perkins
Voc Ed Program, some of those resources end up in community
colleges, some end up in high schools. Trio, GEAR UP, those
sorts of programs that are high school programs, would, could
be funded from the $1.5 billion high school side of it.
Senator Harkin. Okay. I understand what you're saying now.
Please understand what I'm saying, that you add up all those
cuts in those programs, it's $2.1 billion. You replace that
with $1.475 billion for your high school initiative. So when
you say that schools, well, if they want to continue the
successful programs, they could. Well, I guess what I would ask
you to submit to this committee is which of these, is it 42
programs, 40 some, I forget what it was, that you're asking to
be eliminated--I mean, which of those are you saying are not
successful?
Secretary Spellings. Well----
Senator Harkin. Which of them are not successful? Please.
Secretary Spellings. We have a PART process that rates the
programs. I certainly could give that PART list for the 42
programs and will. The difference I want to say on the $2
billion worth is that, in the Perkins Program, part of those
resources go to community colleges, so the high school
initiative at $1.5 billion is, it reflects the resources that
are spent in K-12 schools.
[The information follows:]
OMB PART Ratings for Programs Proposed for Termination in the Fiscal
Year 2007 Budget Request
OMB developed the Program Assessment Rating Tool (PART) in order to
assess and improve program performance so that the Federal Government
can achieve better results. Ratings are based on questions in four
critical areas--purpose and design, strategic planning, management, and
results and accountability. The answers to questions in each of the
four areas result in numeric scores, which are combined to achieve an
overall qualitative rating that ranges from Effective, to Moderately
Effective, to Adequate, to Ineffective. Programs for which we have
insufficient evidence from either performance data or rigorous program
evaluations cannot be assessed and receive a PART rating of Results Not
Demonstrated. PART assessments help our Department and OMB improve the
performance of Federal programs by identifying flaws in program design,
management, or implementation that undermine effectiveness. PART
assessments also help inform funding decisions, but a program's PART
rating would not dictate budget policy. For example, the Administration
might not request funding for a program for which there is not a clear
Federal role or which is duplicative of other programs, even if it is
rated Effective or Moderately Effective.
The following chart shows whether programs proposed for termination
in the fiscal year 2007 budget request have been assessed using the
PART, and if assessed, the year of the assessment and the rating the
program received.
OMB PART FINDINGS FOR EDUCATION DEPARTMENT DISCRETIONARY PROGRAMS
PROPOSED FOR TERMINATION IN FISCAL YEAR 2007
------------------------------------------------------------------------
Program Year assessed Rating \1\
------------------------------------------------------------------------
TRIO Talent Search.............. 2003/2005........ Moderately
Effective
Comprehensive School Reform..... 2002............. Adequate
GEAR UP......................... 2003............. Adequate
Projects with Industry.......... 2004............. Adequate
Even Start...................... 2002............. Ineffective
Safe and Drug-Free Schools State 2002............. Ineffective
Grants.
TRIO Upward Bound............... 2002............. Ineffective
Vocational Education State 2002............. Ineffective
Grants.
B.J. Stupak Olympic Scholarships 2004............. Results Not
Demonstrated
Byrd Honors Scholarships........ 2004............. Results Not
Demonstrated
Educational Technology State 2005............. Results Not
Grants. Demonstrated
Leveraging Educational 2004............. Results Not
Assistance Partnership. Demonstrated
National Writing Project........ 2004............. Results Not
Demonstrated
Parental Information and 2004............. Results Not
Resource Centers. Demonstrated
Smaller Learning Communities.... 2005............. Results Not
Demonstrated
Teacher Quality Enhancement..... 2003............. Results Not
Demonstrated
Tech-Prep State Grants.......... 2002............. Results Not
Demonstrated
Academies for American History ................ Not Assessed
and Civics.
Arts in Education............... ................ Not Assessed
Civic Education................. ............... Not Assessed
Close Up Fellowships............ ............... Not Assessed
Demonstration Projects for ............... Not Assessed
Students with Disabilities.
Elementary School Counseling.... ............... Not Assessed
Excellence in Economic Education ............... Not Assessed
Exchanges with Historic Whaling ................ Not Assessed
and Trading Partners.
Federal Perkins Loans ............... Not Assessed
Cancellations.
Foundations for Learning........ ............... Not Assessed
Javits Gifted and Talented...... ............... Not Assessed
Mental Health Integration in ............... Not Assessed
Schools.
Ready to Teach.................. ............... Not Assessed
Safe Drug-Free Schools Alcohol ............... Not Assessed
Abuse Reduction.
School Dropout Prevention....... ............... Not Assessed
School Leadership............... ............... Not Assessed
Star Schools.................... ............... Not Assessed
State Grants for Incarcerated ............... Not Assessed
Youth Offenders.
Thurgood Marshall Legal ............... Not Assessed
Educational Opportunity Program.
Underground Railroad Program.... ............... Not Assessed
Vocational Education National ................ Not Assessed
Programs.
VR Migrant and Seasonal ................ Not Assessed
Farmworkers.
VR Recreational Programs........ ................ Not Assessed
VR Supported Employment State ................ Not Assessed
Grants.
Women's Educational Equity...... ................ Not Assessed
------------------------------------------------------------------------
\1\ Reflects the most recent rating for programs that were reassessed.
NOTE: A total of 74 ED programs have been assessed since 2002 using the
Program Assessment Rating Tool (PART); additional programs will be
rated in the future.
Senator Harkin. So in your opinion the $2.1 billion and
$1.5 billion that's just money that normally goes to community
colleges, is that right?
Secretary Spellings. Yes, sir.
Senator Harkin. Well, I'll have to take a look at that. I'm
not certain about that one but give me some documents on that
and I'll----
Secretary Spellings. I'll definitely do that.
Senator Harkin. Let me ask you, but one thing I did want to
cover is this what's happening with special education. I said
earlier it goes from 19 percent to 18 percent, now down to 17
percent and, right, but here's the real problem, as bad as that
is, there's another hit coming to these schools outside your
jurisdiction but you should be cognizant of it, Medicaid pays
for the cost of coverage services for eligible children with
disabilities. School districts can be reimbursed by Medicaid
for transportation costs they incur in providing services if
this works. The administration wants to prohibit schools from
getting reimbursed for transportation and in fiscal year 2007
schools are expected to receive $615 million from Medicaid for
that purpose. If this change goes through then they're going to
have to pay the $615 million in transportation costs
themselves. So while you might say that there's been a slight
increase in IDEA funding from $10.583 to $10.683, a $100
million increase, still not keeping up with inflation or
anything, there's going to be another cut from Medicaid
reimbursement for these kids. Where are these schools going to
get that $615 million, $650 million, $615 million, can't read
it, $615 million for transportation? Did I make myself clear?
Secretary Spellings. You did. Senator, as you know, those
are reimbursements through HHS and I'm sure you'll discuss that
with Secretary Leavitt. My understanding is, those are places
where they found a lot of fraud and abuse with respect to those
reimbursements and, you know, with respect to IDEA funding
overall we've had a 68.5 percent increase in funding since 2001
and, you know, we continue investments on the education side
for special education. With respect to the transportation
funding, my understanding is that it's been a place where
there's been some fraud and abuse and that that needs to be
curtailed.
Senator Harkin. I'm all for cutting fraud and abuse but
when you disallow the whole thing, I mean, you're saying that
every dollar's being abused. I mean, you're not saying it----
Secretary Spelling. I'm just not very familiar with the
particulars, since we don't run that program.
Senator Harkin. You're not saying that but OMB or the
administration's saying that and since there's a close
correlation here between the two, between you and HHS on this,
I mean, somehow we've got to bring that together because if we
cut the $615 million COLA, that's going to be a big hit.
ESEA TITLE I PROPOSED FUNDING DECREASE
Title I, let me just say one thing about Title I. Right now
29 States will get less Title I funds under the budget, than
they did last year. My State, Iowa, was one of 15 States that
will get less Title I funding than they did 3 years ago in
fiscal year 2004. On the district level it's even bleaker. This
fiscal year was the third year in a row that most districts got
less Title I funding than they did the year before. Fiscal year
2007 will be the fourth straight year. In my State, two-thirds
of Iowa districts got less Title I funding this year than they
did 3 years ago. So how can you say you're giving schools
enough money for No Child Left Behind when our budget once
again cuts Title I funds the most to the districts?
Secretary Spelling. Well, as you know, under Title I the
distribution formulas follow the kids and the poorest kids as
they move around and as those populations shift. There are also
obviously States who are getting additional Title I resources
owing to the distributional mechanics of Title I funds
following those poorest, neediest kids.
SCHOOLS CATEGORIZED AS NEEDING IMPROVEMENT
Senator Harkin. I'm told there are about 11,000 schools in
this country that have been designated in need of improvement,
is that about right?
Secretary Spellings. That's sounds about right----
Senator Harkin. 11,000.
Secretary Spellings [continuing]. That sometimes gets
characterized as failing schools. I think, you know, we all
know that there are schools that need improvement when half the
minority kids aren't getting out of high school. We have work
to do with special ed students and limited English speakers and
so on and so forth, so, it doesn't surprise me that 11,000
schools need improvement.
ESEA TITLE I FUNDING
Senator Harkin. Yeah, but again how are we going to help
these schools when we're cutting Title I funding? I mean, you
say it follows the kids around and I know poverty's gone up in
some areas but I can tell you we still have, I suppose, kids in
Iowa and rural areas and places like that that are getting cut
out, because it's almost like you're assuming there's a static
level of poor kids just goes to this level and they shift
around but it always stays static, I mean the total number
stays static. That's not true. I don't think there's any
figures that show that. The number of poor kids in this country
has gone up.
Secretary Spellings. Right. That's why we supported
increases in Title I for the poor through the course of the
present administration.
Senator Harkin. Well, we're getting less Title I money.
Secretary Spellings. I'm talking about in the entirety of
the President's term, Title I funding is up about 45 percent.
Senator Harkin. Oh, I see. So it went up a couple of years
in a row. Now we can sit back and we don't have to increase it
any more.
Secretary Spellings. Well, I'm not suggesting that we can
sit back by any stretch but----
Senator Harkin. We hear that when we double the funding for
NIH and we got it up there, now we say, well they did that, now
we don't have to worry any more and we just sit back. I think
what we were doing in the first couple of years is trying to
play catch-up ball in funding these kids in Title I. That
doesn't mean it's remained static and I just think the program
funds Title I.
Secretary Spellings. Well, we've also called for $200
million for School Improvement. You talked about the 11,000
schools.
Senator Harkin. I know about the $200 million. I just
divide that out to 11,000, it's about $20,000 per district.
Secretary Spellings. Well, I think we can learn from each
other. I think States will be doing more systematic and
systemic work at a State level that will leverage some of those
resources.
Senator Harkin. Our time is up. Madam Secretary, you said
quite frankly in your opening statement that the Federal
Government's role is providing help to States for under-
privileged, poor kids and kids with disabilities. Well, this is
it, right here, and I think we're shirking our responsibility
in that area to provide that kind of help to the States. Thank
you.
HIGH SCHOOL DROPOUTS--THE SILENT EPIDEMIC
Senator Specter. Thank you, Senator Harkin. One final
inquiry and, Madam Secretary, we're having votes about to
begin, force back votes on the PATRIOT Act. The publication of
The Silent Epidemic is out on dropouts--I see you nodding in
the affirmative--thanks to the Gates Foundation on funding it,
and it shows that about 3.5 million young people between the
ages of 16 and 25 have dropped out of high school, were not in
school in the year 2003, the most recent year in which such an
estimate is available. What in the budget is being directed to
that major problem?
ADDRESSING THE HIGH SCHOOL DROPOUT PROBLEM
Secretary Spellings. Well, Senator, a few things. One, as
that study observes, and I'm meeting with one of those authors
of the report this afternoon, I think, of the things we know is
that kids drop out because they don't have the necessary
reading and deciphering skills, particularly reading skills, to
do high-school-level work. That's why we support the Striving
Readers Initiative for a $100 million, so we can take some of
our reading research and extend it in the middle schools and
get these kids caught up so that they can do more rigorous
work. The other thing, as the report observes, and I think it
speaks to boredom and a lack of rigor sometimes in high school,
is that many of the students that drop out, you know, are
passing. They are kids that are effective in attending school
and they're just completely disengaged and tend not to find it
very satisfying. So I think if we expand Advanced Placement, if
we expand dual enrollment, and provide some of these things
that are more engaging and more interesting and more rigorous,
and more relevant to kids--I think those are some things we can
do to guard against dropouts.
Senator Specter. What do you think the prospects are of
ameliorating that problem?
Secretary Spellings. Well, I think it's, you know,
obviously going to be a journey. I don't think this is
something that happens overnight. I think we need to know more.
This is why the President has called for enhanced
accountability in high schools. We don't know very specifically
as policy-makers what is it about high school that's working
and not working and for whom. Is it reading? Is it rigor? Is
it, you know, disengagement? Is it a lack of vocational----
Senator Specter. How do you propose to find out?
Secretary Spellings. Well, what the President has called
for is additional accountability, more measurement in high
school. We only test in one grade in high school. Typically
States have elected to do that in the 10th or the 11th grade.
So after 8th grade we lack information about what the state of
high schools really is and an ability to parse that down for a
policy tool.
Senator Specter. Where the President has called for it,
what has the response been?
Secretary Spellings. Many States have put high school
assessments in place. I would say half or so have a full
complement of assessment through high school. That's the
Governor's----
DEPARTMENT'S COMMENTS ON THE SILENT EPIDEMIC
Senator Specter. Madam Secretary, we're going to have to
recess here in a moment but what I would ask you to do is to
give us your evaluation, your Department's evaluation of this
report on dropouts and what is currently being done and what
you think ought to be done. That's a gigantic problem which we
really ought to address.
Secretary Spellings. I agree.
[The information follows:]
School Dropouts
"The Silent Epidemic: Perspectives of High School Dropouts,'' a
March 2006 report by Civic Enterprises in association with Peter D.
Hart Research Associates for the Bill and Melinda Gates Foundation, is
based on a series of focus group interviews conducted with young people
aged 16-25 who identified themselves as high school dropouts from
public schools in large cities, suburbs, and small towns. As the report
notes, the study's purpose was to approach the dropout problem from the
perspectives of the former students themselves, to better understand
the lives and circumstances of students who drop out of high school and
to help ground the research in the stories and their reflections.
Though the study is primarily anecdotal and was not designed to be
nationally representative, its findings are consistent with the
Administration's emphasis on the need for high school reform in the
2006 and 2007 President's Budget proposals, as well as the effort to
bring more rigor to the high school curriculum through such initiatives
as the expansion of support for Advanced Placement courses.
For example, fully one-third of those surveyed said that they
dropped out of high school because they were ``failing in school,'' and
45 percent said they lacked academic preparation for the challenges of
high school. In response, The Silent Epidemic recommended the
development of ``early warning systems'' to help identify students at
risk of failing in school, the provision of intensive assistance to
struggling students, and research on what works in high school. The
Administration's $1.5 billion High School Reform initiative, first
proposed in the President's 2006 Budget, would address each of these
recommendations. Grantees would use test scores of incoming high school
students to identify those most at risk of not meeting State standards
and potentially dropping out, develop individualized performance plans
to meet student needs, and support research on specific interventions
and strategies for improving student achievement in high school.
The 2007 request also includes two other proposals specifically
targeted to the needs of students like those discussed in The Silent
Epidemic. First, a $70 million increase for the Striving Readers
program would significantly expand the development and implementation
of research-based interventions to improve the skills of teenage
students who are reading significantly below grade level. And a new,
$125 million Math Now for Middle School Students initiative would
support research-based math interventions in middle schools.
In addition, the proposed $90 million increase to expand the
availability of Advanced Placement and International Baccalaureate
programs in schools with large populations of low-income students would
help ensure that such students are able to prepare for and successfully
complete challenging, college-level curricula.
Finally, the Department already has played a key leadership role in
working with the National Governors Association (NGA) to reach a common
definition for calculating high school graduation rates. In particular,
the National Governors Association also agreed on the use, while States
ramp up their own capacity for a long-term solution, of an Average
Freshman Graduation Rate, an interim calculation developed by the
Department to provide comparable State-level graduation data.
The Department believes that momentum is building for a serious,
nationwide effort to improve the performance of our high schools.
President Bush has provided strong leadership in this area for the past
two years, and The Silent Epidemic should contribute to that momentum
and help persuade Congress that the time for action is now.
STATEMENT OF SENATOR THAD COCHRAN
Senator Specter. We have received the prepared statement of
Senator Thad Cochran which will be placed in the record.
[The statement follows:]
Prepared Statement of Senator Thad Cochran
Mr. Chairman, I welcome Secretary Spellings to the subcommittee and
look forward to her testimony about the fiscal year 2007 Budget
proposal for the Department of Education.
I first want to thank the Secretary for her extraordinary efforts
and those of her staff following Hurricane Katrina. The first questions
our school superintendents in Mississippi had as they began recovering
were about being able to comply with the No Child Left Behind standards
and regulations. The Secretary showed understanding and compassion for
the difficulties faced by these administrators who still are simply
trying to get schools back in operation and students back in their
classrooms. Her actions to waive and provide flexibility under these
trying circumstances are greatly appreciated. Her visits to Southaven,
Pass Christian, and Jackson and those of the Assistant Secretary for
Elementary and Secondary Education, Henry Johnson to Biloxi and others
to my State have been well received and again, appreciated. An
especially helpful gesture to my staff was detailing Beverly Ward, a
Department employee here in Washington, to my Mississippi Gulf Coast
office. She is still there, and has helped to provide coordination,
communication, and a sense of comfort to those in both K-12 and higher
education. Thank you very much for that assistance, Madam Secretary.
While the overall budget for the Department of Education is $2.2
billion less than last year, I am happy to see the budget proposal
includes continuation and even some increases in important programs
such as, Title I grants to schools for disadvantaged students this is
especially important in my State; an increase of $100 million for
Special Education grants; continuation of Ready to Learn Television;
and a $2 million increase in the Foreign Language Assistance Program
grants to schools.
The budget is challenging again this year, and the President has
proposed a number of reductions and eliminations that include programs
that have proven to be popular and successful, so we will work to find
a consensus agreement on what and at what amounts programs should be
funded. I note for example, the National Writing Project, Arts
Education, Gifted Education, and Civic Education are among the proposed
program eliminations. I'll be working with you, Mr. Chairman, in an
effort to ensure those programs are continued.
We will discuss the details of these programs over the next few
months. As always, we begin the process of the appropriations cycle
with a number of competing interests: those from the administration,
members of this Committee, other Senators, and the members of the
House. We will work to accommodate as many of those priorities as
possible, and come to decisions as a committee that will reflect what
we ascertain as the best course of action.
ADDITIONAL COMMITTEE QUESTIONS
Senator Specter. There will be some additional questions
which will be submitted for your response in the record.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted by Senator Arlen Specter
american competitiveness initiative
Question. The budget proposes to strengthen math and science
achievement of K-12 students through a new $380 million American
Competitiveness Initiative. I am a co-sponsor of S. 2198, which
addresses many of the same issues identified in this Initiative. My
concern is that this worthwhile Initiative is funded through reductions
in programs that many members of Congress support. Can you explain how
this budget will accommodate both this new initiative and the other
priority programs of various members of Congress?
Answer. We very much appreciate the strong support that you and
other Members of the Senate have shown for our efforts to improve math
and science education, as shown by the very similar goals of S. 2198
and the ACI. As for your concerns about funding the ACI proposals, I
would point out that at seven-tenths of 1 percent of our discretionary
budget, the $380 million request for the ACI represents a modest,
targeted approach to improving math and science education. The Congress
should be able to finance this initiative by reducing funding for less
needed or less effective programs. I understand very well that trade-
offs will be required by the Congress to fund the ACI, because we made
those very same trade-offs in preparing our 2007 request. At the same
time, we know that in negotiating the 2006 appropriations bill, your
Subcommittee demonstrated a willingness to balance funding for priority
programs with reductions and eliminations in other activities. We hope
to work with you to achieve that same kind of funding discipline for
2007, and our request includes many examples of programs that could be
reduced or eliminated to pay for new initiatives like the ACI.
federal perkins loans
Question. Your budget includes $664 million in spending that is
offset by the recall of the Federal contribution to the Perkins Loan
program. During last year's session, the House and Senate Authorizing
Committees agreed to extend the Perkins Loan program, not phase it out,
as your budget assumes. Can you tell me how my subcommittee should
make-up for the fact that this $664 million offset is not a viable
mechanism for additional spending proposed in your budget request?
Answer. The administration continues to believe needy students
would be better served by redirecting Perkins Loan funds to more
broadly available student aid programs, such as the Pell Grant, Federal
Family Education Loan (FFEL), and Direct Loan programs. With the number
of Perkins Loan institutions declining from 3,338 in academic year
1983-84 to 1,796 in 2003-04 and with only 3 percent of students
enrolled in postsecondary education receiving Perkins Loans each year,
the Administration believes the Federal share of funds held by this
small group of institutions would be more effective if used in a way
that serves all eligible students regardless of institution.
use of title i school improvement funds for comprehensive school reform
Question. In the last two Department of Education Appropriations
Acts, the conferees have included language in the statement of the
managers which encourages the Secretary to notify States of a priority
that they should place on the awarding of funds from the 4 percent
school improvement. Can you explain what actions your Department has
taken to comply with this language?
Answer. On March 9, 2005, the Department sent an e-mail to Title I
State directors to notify them of the provision in the fiscal year 2005
appropriations report language and to inform them of the conditions
that must be met for a State educational agency to use Title I school
improvement funds for comprehensive school reform (CSR) projects. A
Department official also discussed the directive at the Title I State
directors' meeting last year.
In addition, the Department has hosted three regional meetings of
State Title I directors and State CSR directors to talk about capturing
the lessons learned from CSR, building bridges between Title I and CSR,
and leveraging statewide systems of support to disseminate information
learned through CSR.
The Department will hold a meeting this spring focused on building
State capacity to improve schools using CSR and Title I to
institutionalize what has been learned about working with high-
performing, high-poverty schools. At the meeting Department staff will
discuss the fiscal year 2006 report language about using Title I school
improvement funds to support CSR projects.
comprehensive school reform as school improvement strategy
Question. Given that one rationale for the elimination of the
Comprehensive School Reform program was that States could use funds
under their 4 percent set asides for the same activities, do you have
any evidence that States have made or will make subgrants that support
comprehensive school reform activities in school districts, and if not,
why not?
Answer. We do not yet have any evidence, either from evaluation
data or other reports, that States or school districts are using
comprehensive school reform as part of their school improvement
strategy. In part, this may reflect the progressive nature of the No
Child Left Behind Act's (NCLB) school improvement requirements, which
gradually move from school improvement plans in the first 2 years to
replacement of curricula or staff under corrective action to
alternative governance during restructuring. Comprehensive school
reform generally represents the kind of thoroughgoing, fundamental
change called for under corrective action and restructuring and, thus,
may be adopted more frequently as increasing numbers of schools are
subjected to these more stringent improvement measures.
Also, while the school improvement requirements in NCLB are fairly
prescriptive, they do not specifically mention comprehensive school
reform as an improvement strategy. States and districts naturally look
to the statute for guidance as to what they must do to support schools
in the various stages of improvement, and will tend to adopt the
specific remedies found there.
Finally, comprehensive school reform is intensive and time-
consuming and requires considerable technical assistance from States
and school districts that have been focused in recent years on overall
implementation of NCLB. As States establish and strengthen their
statewide systems of support for LEA and school improvement, they are
likely to gain greater capacity to support activities like
comprehensive school reform. The President's School Improvement Grants
proposal would support this kind of evolution in State-level
improvement capabilities.
title i school improvement set-aside
Question. In the fiscal year 2007 budget request, you have proposed
overriding a provision in the No Child Left Behind Act to allow States
to reduce the grants to local educational agencies below the amount
they received in the 2006-2007 school year to generate sufficient funds
under the 4 percent school improvement provision of the law. Could a
State reduce the Title I grant funds of a school district identified
for improvement and subgrant those funds to another district?
Answer. Yes, that would be possible, but any such reduction would
be very small. Under the Administration's proposal, all districts would
contribute proportionately to the pool of funds available to support
State and local school improvement, not just those districts receiving
increased allocations under the Title I formulas. States would then
subgrant 95 percent of those funds to school districts with schools
identified for improvement, with priority on those districts with the
greatest need for such funds and the strongest commitment to using them
to raise the performance of the lowest-achieving schools. By the way,
the hold-harmless also leads States to reduce allocations to districts
identified for improvement and redirect funds to other districts; it
simply does so by disproportionately taking funds from districts that
otherwise qualify for more Title I funds.
limitation on reduction of title i grants for school improvement
purposes
Question. Would this proposal establish any limit to the amount by
which a State could reduce a school district's Title I grant?
Answer. Yes, unlike current law, our proposal actually would limit
any reduction for school improvement purposes to 4 percent. Under
current law, districts that receive increased Title I funding often see
their allocations reduced by more than 4 percent to make up for those
districts protected by the hold-harmless.
Question. If not, why do you believe that is unnecessary?
Answer. As I said, our proposal actually would restore a meaningful
limit to the State reservation for school improvement.
title i school improvement funding generated by 4 percent set-aside
Question. With more than 9,000 schools identified for improvement
in the 2004-2005 school year, effective interventions that reduce this
number and lead to improved student outcomes would help States and
local school districts meet the goals of No Child Left Behind. How much
funding has been generated and allocated under the 4 percent set-aside
for each of the past 3 fiscal years?
Answer. We do not have actual data on the amounts reserved and
allocated by the States during this period. We estimate that States
reserved and allocated for school improvement purposes approximately
$484 million in fiscal year 2004 and $500 million in fiscal year 2005,
and will reserve and allocate roughly $499 million in fiscal year 2006.
Question. Is there any information about the reach of this funding
and the number of schools identified for improvement, or on watch
lists, that have not been assisted?
Answer. Earlier this year, the Department published a report,
``Title I Accountability and School Improvement from 2001 to 2004,''
which found that about 90 percent of school districts with schools
identified for improvement reported that they provided at least some
kinds of the assistance required by NCLB. At the same time, more than
half of ``continuously identified schools'' (those identified for
improvement throughout the period studied) reported that they did not
receive more intensive assistance, such as assistance from a school
support team or a school-based staff developer. The Department study
also found, however, that State practices for allocating school
improvement funds varied widely, partly because the study began prior
to the implementation of No Child Left Behind, which brought
significant changes to school improvement funding that were not fully
implemented when the study was completed.
The recently released report, ``National Assessment of Title I:
Interim Report,'' found that less than three-quarters of districts with
identified schools reported having the staff, expertise, time, or money
to improve the performance of those schools.
Question. Is there any information on how the 4 percent set-aside
for school improvement funds have been used to remove schools from
school improvement lists?
Answer. We currently do not have data directly linking school
improvement funding with success in exiting improvement status.
title i school improvement monitoring
Question. Has the Department done any monitoring of the types of
activities funded with the 4 percent school improvement set-aside
established under the No Child Left Behind Act?
Answer. Yes. The monitoring indicators used by ED's Title I
monitoring team include a focus on whether SEAs have (1) reserved and
allocated Title I Part A funds for school improvement activities, and
(2) created and sustained a statewide system of support that provides
technical assistance to schools identified for improvement. The SEA
must provide documentation that it has established effective school
support teams with members who are knowledgeable about scientifically
based research and practices related to school improvement. Likewise,
the SEA must provide documentation that the teams provide support to
schools on such topics as the design and operation of the instructional
program and strategies for improving student performance. Monitors also
seek evidence that SEAs are ensuring that LEAs carry out their own
school improvement activities.
Another area reviewed is how the SEA distributes the 4 percent
school improvement funds. Of the amount it reserves, the SEA must
allocate not less than 95 percent directly to LEAs that operate schools
identified for improvement to support improvement activities. In most
cases, States are using these funds to provide special grants to
support improvement in those schools. In a few instances, States, with
the approval of the LEAs, directly provide improvement activities or
arrange to provide them through regional educational centers.
At the local level, ED's Title I monitors review how LEAs and
schools are using the funds for improvement activities. This
information is gleaned through interviews with LEA and school staffs.
Question. In particular, has the Department monitored the use of
funds for implementing required 2-year improvement plans incorporating
strategies based on scientifically based research and addressing the
specific issues that led to schools being identified for improvement?
Answer. Yes. The monitoring indicators used by ED's Title I
monitoring team seek information and evidence that the SEA has assisted
LEAs in developing or identifying effective curricula aligned with
State academic achievement standards and disseminated the curricula to
each LEA and school within the State. Additionally, monitors review and
discuss school improvement plans with LEA and school staffs to discern
how these plans address the 10 required components under NCLB,
including how the improvement plans incorporate strategies that are
research based and strategies that address the specific issues that led
to the school being identified for improvement.
school improvement grants program and effective school improvement
activities
Question. What are your plans for using any knowledge generated
through research on effective school improvement activities; and how
will the fiscal year 2007 budget request support this goal?
Answer. The new $200 million request for School Improvement Grants
recognizes the critical need for State leadership and support in LEA
and school improvement. While States currently reserve 4 percent of
Title I, Part A allocations for school improvement activities--an
amount totaling more than $500 million annually, they must subgrant 95
percent of these funds to LEAs, leaving just $25 million available for
State-level school improvement activities. The request would provide
substantial new support for State-led LEA and school improvement
efforts and would help build State capacity to carry out statutory
improvement responsibilities.
One research based approach that the Department is considering for
the proposed School Improvement Grants program is requiring each State
to use diagnostic assessments in schools that repeatedly fail to make
adequate yearly progress. Such tests would help LEAs and schools
clearly identify student strengths and weaknesses in a particular
subject and develop appropriate instruction.
supplemental educational services
Question. Budget documents supporting the budget request note that
``While many students attending schools identified for restructuring
receive SES, the services tend to be of limited duration.'' How does
the amount of funding generated from the appropriations for Title I
Grants to LEAs under the 20 percent SES/choice requirement relate to
this finding?
Answer. The statement in the budget request simply reflects the
reality that the duration and intensity of current supplemental
educational services (SES) are limited by the statutory cap on per-
pupil payments, with the current cap averaging about $1,500 nationally.
There are other factors that affect the duration of services, such as
the structure of SES programs and the actual costs charged by various
providers, but the general point is that the America's Opportunity
Scholarships for Kids proposal would roughly double the funding
available for SES, from $1,500 to $3,000 and, therefore, greatly
increase the intensity and duration of available services.
Question. If limited funding is not the reason for such limited
intensity, what are the primary causes of it?
Answer. The premise of our budget request was to enable parents to
purchase more extensive services with greater resources, and that
students in schools identified for restructuring are likely to be those
students who would most benefit from more extensive services than are
available under current law.
Question. What is the impact of this finding of limited intensity
on the effectiveness of the SES activity?
Answer. The SES program is still in its early years and we do not
yet have meaningful impact data.
Question. How is the Department monitoring the requirement in NCLB
that requires low-achieving students to receive priority for services
under choice and supplemental services options?
Answer. ED's Title I monitors review documentation to show that the
SEA has developed and disseminated guidance to LEAs outlining
requirements for implementing public school choice and supplemental
education services and that this guidance includes the requirement that
low-achieving students receive priority for these services. At the LEA
level, ED's Title I monitors review parent notification letters,
guidance documents, LEA contracts with SES providers, and other
documentation to determine if the LEA has complied with the required
priority for providing the choice and SES options.
supplemental educational services pilot program
Question. You announced a number of pilots last year giving a
select number of districts in need of improvement the flexibility to
serve as supplemental educational service (SES) providers in exchange
for greater student participation and achievement data. All of your
other pilots invited interested States to ``apply'' before being
offered this sort of flexibility. Can you explain how you selected the
handful of districts that are in the SES pilot and why you circumvented
States altogether and negotiated with districts directly?
Answer. For each of the pilots that we started last year (allowing
Chicago and Boston to be providers although they are districts in need
of improvement and allowing four districts in Virginia to reverse the
order of choice and SES), the Department discussed and sought approval
from each of the States before the pilots began. In the case of the
Virginia pilots, we negotiated directly with the State throughout the
entire process. For Chicago and Boston, we sought and received approval
from their respective States for participation in the pilot. As for
selection of these particular districts for the pilots, in the case of
Chicago and Boston we worked with the Council of the Great City Schools
to help us identify districts that were willing and able to participate
in the pilot. Virginia had been in communication with the Department
about ways to strengthen SES in the State, and came to the Department
with a formal request to reverse the order of choice and SES. It was
the first State to do so, and we granted this flexibility on a trial
basis.
selection of districts for ses pilot program
Question. Why was Chicago selected as opposed to districts such as
Pittsburgh or Philadelphia, for instance?
Answer. As I mentioned, the Department worked with the Council of
the Great City Schools to identify districts that had the ability to
provide high-quality SES services and would meet the terms of the
pilots. Pittsburgh and Philadelphia were not identified at the time as
districts meeting these conditions.
student participation and achievement under the ses pilot program
Question. How many additional students are benefiting from each of
the 3 pilots, which waive your regulation around prohibiting districts
in need of improvement from serving as an SES provider?
Answer. Chicago and Boston are the two districts participating in
this pilot. New York City was invited to participate but declined for
this year. In Chicago, approximately 55,000 students are participating
in SES through Chicago's program and private providers' programs; this
compares to about 40,000 last year. In Boston, about 3,700 are
participating, compared to about 2,000 last year.
Question. When will we be able to see the data on the benefits of
SES on student achievement from these pilots?
Answer. We anticipate that this summer, after the spring State
assessment results are in, we should be able to collect data on student
achievement.
Question. How are you assuring high-quality tutoring programs in
SES?
Answer. As a condition of participation in these pilots, each
district had to meet a set of guiding principles that the Department
identified as key elements of high quality SES programs. These included
communicating to parents about SES through multiple venues and in
languages that parents could understand, holding extended windows for
enrollment, and allowing providers to serve students at school
facilities for a reasonable fee.
expansion of the ses pilot program
Question. Do you plan to expand this pilot to additional districts
in the next school year?
Answer. We have monitored each of the pilot districts and collected
data on their implementation this year. We are now in the process of
reviewing these data and making determinations as to whether the
Chicago, Boston, and Virginia pilots will continue, and whether
additional sites will be added.
Question. If you do plan to expand the pilot program, what will be
the selection process and how many do you anticipate selecting?
Answer. In the near future, we will be making determinations as to
whether these pilots continue and the criteria we will use to select
sites for participation.
Question. Do you plan to put any additional requirements on school
districts serving as SES providers and, if so, what changes might there
be next year?
Answer. We are considering whether to add any additional criteria
to sites that participate in the pilots next year. We are using the
information we have gained from this year's pilot sites to consider
ways to strengthen the agreements with districts and help ensure that
more students are receiving quality SES services.
america's opportunity scholarships for kids
Question. The Department's budget includes $100 million for a
proposed voucher program that could be used by students in schools
identified for restructuring so that they can transfer to a private
school or receive intensive tutoring services. Why does the budget
request $100 million for vouchers for an estimated 2 percent of Title I
schools and request no increase in the amount of funds available for
the Title I grant program, the cornerstone of Federal assistance for
helping disadvantaged students?
Answer. Congress has invested nearly $200 billion in Title I Grants
to LEAs over the past 40 years, including $12.7 billion in the current
fiscal year. While we agree that Title I is the cornerstone of our
efforts to improve the quality of elementary and secondary education,
particularly for low-income and minority students in high-poverty
schools, the size of the program limits the impact of additional
funding available under current budget constraints. For example, the
$100 million proposed by President Bush for the America's Opportunity
Scholarships for Kids program represents less than one-tenth of one
percent of the funding provided for Title I Grants to LEAs, and would
have little or no impact when spread across 14,000 school districts.
However, this amount is sufficient to permit a meaningful demonstration
of the potential for expanded choice and tutoring options to improve
the achievement of students attending chronically low-performing
schools. Moreover, these funds would be targeted to the same students
who are the focus of the Title I program and, in the case of students
who select the tutoring option, would help improve the performance of
Title I schools undergoing restructuring.
Also, the President is requesting first-time funding for School
Improvement Grants, which would provide an additional $200 million for
State-led efforts to turn around low-performing school districts and
schools. These funds would directly benefit participating Title I
districts and schools that have been identified for improvement. For
this reason, it is not entirely accurate to say that the President's
2007 budget includes no increase in the amount of funds available for
Title I.
measuring performance of the impact aid program
Question. The Administration has been undertaking an examination of
how to measure performance under the Impact Aid program and has
identified a model for estimating unmet need of eligible school
districts. Please provide information on the findings of unmet need for
various types of Impact Aid districts.
Answer. In 2005, the Department created a simplified model to
analyze the effectiveness of the Impact Aid formulas and, more
specifically, address the question of whether or not funds are
adequately compensating for a Federal presence and the associated tax
burden. The Department sent a review and analysis of the model to the
House and Senate Committees on Appropriations in January 2006.
The report applied the simplified model to calculate the gap
between available revenues to the LEA and the amount needed to fund
schools at the State average per-pupil expenditure for Florida,
Alabama, and Wyoming, three States for which adequate data were
available. Comparing this gap to the actual payments made to Impact Aid
districts revealed that there was very little correlation between the
computation of local need from the simplified model and actual
payments.
The model incorporates tax data into the analysis and, while it
brings us closer to being able to compute valid economic analyses of
the program, because of data limitations the model has not yielded the
desired results. In order to answer these questions properly, more
sophisticated analysis with better data will likely be needed.
improving teacher quality programs
Question. In November 2005, the Government Accountability Office
released report GAO-06-25, which relates to State implementation of
teacher qualification requirements of the No Child Left Behind Act.
This report noted that some teachers who provide instruction in more
than one core academic subject-such as special education teachers and
those in rural schools-and secondary math and science teachers might
not meet the teacher qualification requirement by the current deadline.
What activities are funded currently and proposed in the fiscal year
2007 budget to help States and districts ensure that all students are
taught by a highly qualified teacher?
Answer. In 2007, the administration is requesting funds for several
programs that focus on improving teacher quality to help ensure that
all teachers are highly qualified. These include: Improving Teacher
Quality State Grants ($2.9 billion), Title I Grants to Local
Educational Agencies ($624 million--the estimated professional
development portion), Mathematics and Science Partnerships ($182.2
million), Transition to Teaching ($44.5 million), Teaching of American
History ($50 million), Troops-to-Teachers ($14.6 million), and Advanced
Placement ($122.2 million).
highly qualified teachers
Question. What specific steps will be taken to ensure that the
disparity between the proportion of highly qualified teachers in lower
income school districts and higher income schools is eliminated?
Answer. The Elementary and Secondary Education Act (ESEA), as
amended by the No Child Left Behind Act, establishes the important goal
that all students be taught by a ``highly qualified teacher'' (HQT) who
holds at least a bachelor's degree, has obtained full State
certification, and has demonstrated knowledge in the core academic
subjects he or she teaches. Further, the ESEA requires States and LEAs
to include, in their annual report cards, information on the percentage
of classes not taught by highly qualified teachers, disaggregated by
high- and low-poverty schools. In addition, the Individuals with
Disabilities Education Improvement Act of 2004 reinforced the NCLB goal
by aligning the requirements for special education teachers with the
NCLB requirements.
The Department has been requiring States to submit data as part of
their Consolidated State Performance Reports on the percentage of core
academic classes taught by highly qualified teachers in high- and low-
poverty schools, as well as the reasons why, for classes taught by
teachers who are not highly qualified, the teacher is not highly
qualified. In addition, States must have an equity plan in place to
ensure that poor or minority children are not taught by inexperienced,
unqualified, or out-of-field teachers at higher rates than are other
children. The Department will be looking at States' progress in both of
these areas this spring and summer. Although States and school
districts are making significant progress in meeting the HQT
requirement, there is still a lot of work to do to ensure that each
State can meet the goal that every child is taught by a highly
qualified teacher by the end of the 2005-2006 school year.
Meeting the NCLB Highly Qualified Teacher Requirement
In the Department's ongoing visits and communications with State
and local officials, we are often asked what will happen if, despite
their best efforts, districts cannot hire a highly qualified teacher
for every class in a core academic subject by the end of the 2005-2006
school year. Personnel decisions are made at the State and local
levels, and the law relies on education leaders in the States to make
the best educational decisions for improving student achievement. Last
fall, I sent a letter to the chief State school officers to assure them
that States that did not quite reach the 100 percent goal by the end of
the 2005-2006 school year would not lose Federal funds if they were
implementing the law and making a good-faith effort to reach the HQT
goal in NCLB as soon as possible.
The letter also stated that the Department will determine whether
or not a State is implementing the law and making a good-faith effort
to reach the HQT goal by examining four elements of implementation of
the HQT requirements: (1) the State's definition of a ``highly
qualified teacher,'' (2) how the State reports to parents and the
public on classes taught by highly qualified teachers, (3) the
completeness and accuracy of HQT data reported to the Department, and
(4) the steps the State has taken to ensure that experienced and
qualified teachers are equitably distributed among classrooms with poor
and minority children and those with their peers. In addition, the
Department will look at States' efforts to recruit, retain, and improve
the quality of the teaching force. If States meet the law's
requirements and the Department's expectations in these areas but fall
short of having highly qualified teachers in every classroom, they will
have the opportunity to negotiate and implement a revised plan for
meeting the HQT goal by the end of the 2006-2007 school year. However,
for States that either are not in compliance with the statutory HQT
requirements or are not making a good-faith effort to meet the goal of
having all teachers highly qualified, the Department reserves the right
to take appropriate action, such as the withholding of funds.
Departmental Review of States' Efforts to Meet the NCLB Highly
Qualified Teacher Requirements
In March 2006, I sent a follow-up letter to the chief State school
officers with timelines and additional information about the
Department's review of States' efforts to meet the HQT requirement. By
the middle of May, the Department will assess States' Consolidated
State Performance Report data for the 2004-2005 school year, HQT data
for previous years, and supporting information that we have obtained
through State monitoring visits and the review of publicly available
records. The Department will then make determinations about whether the
State is on track to meet the highly qualified teacher requirement.
Using the protocol ``Assessing State Progress in Meeting the Highly
Qualified Teacher Goal,'' the Department will determine whether each
State's 2004-2005 data indicate that the State has a reasonable
expectation of meeting the 100 percent HQT goal by the end of the 2005-
06 school year and is faithfully implementing the law. If this is the
case, the State may not be required to submit a revised plan, though it
certainly may.
It is likely, however, that the Department will request most States
to submit a revised plan detailing the new steps they will take to
reach the 100 percent HQT goal by the end of the 2006-2007 school year.
As part of the plan, each State will explain how and when the SEA will
complete the High Objective Uniform State Standard of Evaluation
(HOUSSE) process for those teachers not new to the profession who were
hired prior to the end of the 2005-2006 school year, and how the SEA
will limit the use of HOUSSE procedures for teachers hired after the
end of the 2005-2006 school year to those secondary school teachers
teaching multiple subjects in eligible rural schools (who, if highly
qualified in at least one subject at the time of hire, may use HOUSSE
to demonstrate competence in additional subjects within 3 years), and
those special education teachers teaching multiple subjects (who, if
they are new to the profession and highly qualified in language arts,
mathematics, or science at the time of hire, may use HOUSSE to
demonstrate competence in additional subjects within 2 years). Peers
and teacher-quality experts will review the State's revised plan and
evaluate how effectively the plan addresses the State's challenges in
reaching the 100 percent HQT goal.
Corrective Steps for Districts not Meeting Highly Qualified Teacher
Requirements
Finally, if the Department determines that a State has not
fulfilled its obligations under the statute and is not on track to have
all teachers highly qualified by the end of the 2005-2006 school year,
the Department will take corrective actions in addition to requiring
the State to submit a revised plan.
By the middle of May, the Department will notify States, in
writing, of the results of the assessment of their HQT progress and
will request the States, as appropriate, to submit revised plans.
States will have until July 7 to submit their revised plans to the
Department, and the Department then will determine whether a revised
State plan is sufficient to attain the HQT goal in 2006-2007 and
beyond. In August, the Department will begin a new cycle of State
monitoring visits to ensure that States are implementing their revised
plans.
information dissemination on highly qualified teacher requirements
Question. The report also identified some information dissemination
challenges. What actions has the Department taken or planned for making
helpful information available?
Answer. The GAO report recommended that the Department ``explore
ways to make the Web-based information on teacher qualification
requirements more accessible to users of its Web site. Specifically,
the Secretary may want to more prominently display the link to state
teacher initiatives, as well as consider enhancing the capability of
the search function.''
As noted in the GAO report, the Department agrees with the
recommendation and has been working to improve the Department's website
so that it is more user friendly for teachers and officials who are
trying to find information about the highly qualified teacher
requirements. For example, the website now directs students, teachers,
parents, and administrators to specific pages for materials of interest
to them. The teacher page has a section that describes State and local
initiatives to improve teacher quality, and both the teacher and
administrator web pages have direct links to information about the
highly qualified teacher provisions.
states' reporting of highly qualified teacher data
Question. The Congressional Justification states, ``The Department
is not entirely confident that all States are reporting accurately on
the highly qualified status of their teachers, particularly special
education teachers.'' This statement is consistent with the Government
Accountability Office's recent report regarding teacher quality issues.
What actions are you taking to specifically address this issue and what
plans do you have for future actions?
Answer. Under the Improving Teacher Quality State Grants section of
the congressional justification, we did report that the Department is
not entirely confident that all States are reporting accurately on the
highly qualified status of their teachers, particularly special
education teachers. To address this concern, the Department has been
working closely with States, especially through monitoring visits, to
help them improve the quality of the data that they report. As of late
March 2006, the Department has monitored all but three States
concerning their highly qualified teacher status and will monitor the
remaining States this spring.
We will also be looking very carefully at States' efforts to report
accurately HQT data this spring and summer when we review their
progress in meeting the requirement that all teachers of core academic
subjects be highly qualified by the end of the 2005-2006 school year.
After that review, we will likely require many States to submit revised
State plans, and we may take corrective actions against any States that
are not making a good-faith effort to improve their data collection and
reporting. The Department also plans to begin a new round of State
monitoring visits late this summer.
Question. How does your budget support your current and planned
actions?
Answer. The Department is planning to use Salaries and Expenses
funds to review States' HQT data and their efforts towards meeting the
goal of having all teachers of core academic subjects highly qualified.
enforcement of highly qualified teachers requirement
Question. In your October 21, 2005 policy letter regarding the
``highly qualified teacher'' issue, you assured States they would not
lose Federal funds if they failed to meet the 100 percent requirement
and were making a good faith effort to implement the law. One of the
ways you will make such a determination is by evaluating whether States
take action to ensure that inexperienced, unqualified, or out-of-field
teachers do not teach poor or minority children at higher rates than
other children. How are highly qualified teachers distributed currently
between low-income and high-income school districts?
Answer. States are reporting steady improvement towards meeting the
goal of having all teachers of core academic subjects highly qualified
by the end of the 2005-2006 school year. Data for the 2005-2006 school
year will be reported in 2007. For 2003-2004, the data indicate that 81
percent of core academic classes in high-poverty schools were taught by
highly qualified teachers, an increase of 7 percentage points over the
baseline of 74 in 2003. 2004 data for the percentage of core academic
classes taught by highly qualified teachers in low-poverty, elementary,
and secondary schools was 89 percent, 89 percent, and 84 percent,
respectively.
ensuring highly qualified teachers for students of all socioeconomic
status
Question. What steps is the Department taking to ensure
socioeconomic status does not determine whether a student has access to
a qualified teacher or not?
Answer. For the Improving Teacher Quality State Grants program, the
Department requires States to report on teachers' highly qualified
status at the classroom level. For example, in the 2003-2004 school
year, 81 percent of core academic classes in high-poverty schools were
taught by highly qualified teachers. We believe that, by requiring
States to report on all classrooms, we are sending the message that we
expect all core academic teachers to be highly qualified, whether they
are teaching in a high- or low-poverty school, or whether at the
elementary- or secondary-school levels.
As mentioned earlier, the Department will closely evaluate States'
progress in meeting the HQT requirement this spring and summer as part
of our determination of whether they are making a good-faith effort to
meet the 100 percent objective. This will include a review of their
Title I equity plans, which are meant to ensure that poor or minority
children are not taught by inexperienced, unqualified, or out-of-field
teachers at higher rates than are other children.
federal efforts to address inequitable distribution of highly qualified
and unqualified teachers
Question. How have States used Federal funds to address this issue?
Answer. The Department sponsored a 2-day meeting for State
coordinators in March 2006 that focused on the inequitable distribution
of teachers who are unqualified, inexperienced, or out-of-field.
Working with experts and researchers from the National Comprehensive
Center for Teacher Quality (at Learning Point, Inc.), the Educational
Testing Service, and the Council of Chief State School Officers, the
Department provided the State coordinators with a series of written
tools they can use to examine the inequity issue and begin to prepare
State plans to address the issue. The Department also provided all of
the States with a protocol that will be used to examine whether revised
State plans, which must be provided to the Department this summer, will
satisfactorily address this issue.
For most States, this is the first time they will be preparing
formal, written equity plans. In previous years, States had difficulty
determining if there was an equity distribution problem, so they were
unsure how to best address concerns about the unequal distribution of
highly qualified teachers. The availability of valid data about the
distribution of highly qualified teachers is now helping States to
think about the problem and develop equity plans.
Although States are just now developing their equity plans, many
States already have incentive programs and strategies to encourage
teachers to take on more challenging assignments. The Department is
highlighting some of these strategies at the following weblink: http://
www.teacherquality.us/Public/PublicHome.asp.
teacher quality enhancement program and teacher recruitment and
retention
Question. In recent years, Congress has tried to affect teacher
recruitment and retention through a number of legislative efforts,
including scholarships for those who commit to teaching in certain
geographic or content areas, loan forgiveness programs, and other
efforts. In addition, there are new requirements that districts and
States are trying ardently to meet as required by No Child Left
Behind's ``highly qualified teacher'' provisions. Why is the Department
acknowledging the crucial role teachers play in maintaining the
country's competitiveness, while at the same time it is proposing
elimination of the Higher Education Act's Teacher Quality Enhancement
program? Can you explain these seemingly conflicting efforts?
Answer. We do not believe that there is any conflict in the
Department's efforts to improve teacher recruitment and retention and
the Department's proposal to terminate duplicative programs, such as
the Teacher Quality Enhancement program. The Department continues to
recognize that the quality of the teacher is one of the most critical
components in how well students achieve and that improving efforts to
recruit and retain top quality teachers, especially in geographic and
academic areas of high need, is critical to improving the overall
quality of the Nation's teachers. The Department's proposal to
terminate the Teacher Quality Enhancement program is based, in part, on
the fact that State and local entities may already use funds they
receive under a number of other Department programs to carry out the
activities supported through the Teacher Quality Enhancement program.
Both the Improving Teacher Quality State Grants program and the
Transition to Teaching program include provisions designed to improve
teacher recruitment and retention, including all of the activities that
are allowable under the Teacher Quality Enhancement program. The
Department's proposal to eliminate funding for the Teacher Quality
Enhancement program would reduce unnecessary duplication, improve
programmatic efficiency, and simplify the grant process for potential
recipients.
data management initiative
Question. The Government Accountability Office report (GAO), GAO-
06-06, released in October 2005, included an assessment of the
Department's efforts to identify performance-related data items that
could be collected and reported by States that would promote the
evaluation of the effectiveness of Federal programs. This report
identified several challenges with respect to the participation of and
perceived benefit for States and quality and consistency of data
collected through the system. What is the Department's plan for
addressing the challenges identified in the GAO report and how much
funding is being allocated in fiscal year 2006 and requested in fiscal
year 2007 for this initiative?
Answer. The GAO report recommended that the Department develop a
strategy to help States improve their ability to provide quality data.
As described in the Corrective Action Plan we submitted to the GAO in
response to their report, we have taken several steps to improve the
quality of the data the Department collects. By the end of this fiscal
year, we will have awarded nearly $50 million in grants to States under
the Statewide Data Systems program to develop and implement statewide
longitudinal data systems. The President's 2007 budget requests a $30
million increase for this program.
The National Center for Education Statistics is working with the
staff of the Department's central database, the Education Data Exchange
Network (EDEN), to provide technical support and oversight for our
grantees. The Department provides additional technical assistance to
States through the Data Quality and Standards Contract with the Council
of Chief State School Officers. The Department is also a contributing
partner in the Data Quality Campaign, a partnership of more than 10
national organizations that helps States implement high-quality
statewide information management systems. Finally, the Department has
established a Partner Support Center that provides expert technical
assistance to States on data submission processes and quality issues
related to EDEN.
The Department is conducting a rigorous assessment of the quality
of our data collection and reporting. As part of this process, the
Department recently announced the launch of EDFacts, a new reporting
and analysis tool for data collected and compiled through sources such
as EDEN. In 2006, $5.705 million is being allocated for enhancements to
the EDFacts and EDEN systems, and $6.244 million is requested for 2007.
Question. Specifically, how will these funds be utilized?
Answer. These funds will be used to support the operation of the
Partner Support Center, development of new enhancements for the EDEN
and EDFacts systems (including this year's successful online collection
of the Consolidated State Performance Report), maintenance of these
systems, and development of new reports and tools that enhance program
offices' efficient use of collected K-12 performance data.
foreign language assistance program
Question. The budget proposes a $2 million increase for the Foreign
Language Assistance program. Budget documents supporting this request
state that beginning with the 2006 competition, the Department will
focus this program on providing incentives for States and districts to
provide instruction in critical needs language, especially those
programs using technology. Please explain how the 2006 competition will
be structured to address the issues raised in the fiscal year 2006
Senate Committee Report and the Statement of the Managers accompanying
the fiscal year 2006 Conference Report. Specifically, what type of
priority are you proposing for the 2006 competition, and what is the
complete list of foreign languages that will be eligible for such a
priority?
Answer. The Department is committed to ensuring that all school
districts that demonstrate the capacity to successfully implement a
program receive consideration for competitive grant funds. In response
to the concerns raised both in the Senate Committee Report and the
Statement of Managers that the poorest districts may be shut out of
Foreign Language Assistance grants due to their inability provide the
required 50 percent match, the Department has taken active steps to
increase awareness of waiver availability for eligible grant
applicants. The application package for grants includes detailed
information about what resources may contribute to a grantee's matching
requirement, and the Department considers waivers for any district that
can demonstrate financial hardship. The program office also has
expanded its outreach efforts to include details about the waiver
process and eligibility on the Department's web page, at professional
workshops, and in fact sheets about the program. The combination of
improved grant application materials and increased public awareness
about waivers will help ensure that disadvantaged districts are not
precluded from participating in the program.
Foreign Language Assistance Program--Critical Need Languages Priorty
In addition to giving increased attention to grantees that may be
eligible for waivers, the Department established a priority relating to
critical need languages for the 2006 grant competition. In conjunction
with the President's National Security Language Initiative, the
Department will give preference to grant applicants that demonstrate
the ability to build programs and courses in languages that have
significant political or economic importance. The specific languages
that have been identified as critical are Arabic, Chinese, Korean,
Japanese, Russian, and the languages in the Indic, Iranian, and Turkic
language families.
arts education
Question. The No Child Left Behind Act recognizes the arts as a
core academic subject and studies show that the arts are proven to help
close the achievement gap and improve essential academic skills. You
have stated previously that a ``well-rounded curriculum that includes
the arts and music contributes to higher academic achievement.'' If
arts have been proven to be essential to the learning process, why has
the President proposed the elimination of arts education in the fiscal
year 2007 budget?
Answer. Our request to zero-fund Arts in Education reflects the
Administration's policy of increasing resources for high-priority
programs by eliminating categorical programs that have narrow or
limited effect. These categorical programs siphon off Federal resources
that could be used by State and local educational agencies to improve
the academic performance of all students.
Districts desiring to implement arts education activities may use
funds provided under other Federal programs. The Elementary and
Secondary Education Act also provides LEAs with flexibility to
consolidate certain Federal funds to carry out activities, including
arts education programs, that best meet the needs of their district.
For example, under the State and Local Transferability Act, most LEAs
may transfer up to 50 percent of their formula allocations under
various State formula grant programs to their allocations under: (1)
any of the other authorized programs; or (2) Part A of Title I.
Activities to support arts education are an allowable use of funds
under the State Grants for Innovative Programs authority. Therefore, an
LEA that wants to implement an arts education program may transfer
funds from its allocations received under the authorized programs to
its State Grants for Innovative Programs allocation, without having to
go through a separate grant application process.
In addition, under the Improving Teacher Quality State Grants
program, local educational agencies can use their funds to implement
professional development activities that improve the knowledge of
teachers and principals in core academic subjects, including the arts.
The flexibility that is available under these Federal programs provides
additional justification for the Administration's policy of eliminating
discrete categorical grant programs such as Arts in Education.
Question. As a ``core academic subject,'' the arts should be
included in all research and data collection. The No Child Left Behind
Act and current Department of Education policy make it clear that
decisions regarding education are made on the basis of research. The
FRSS report, ``Arts in Education in Public Elementary and Secondary
Schools,'' is the only research report produced by the Department on
the status of how arts education is delivered in America's public
schools. The last report was for data collected in the 1999-2000 school
year and the fiscal year 2006 statement of the managers urges IES to
repeat this comprehensive data collection and report. When is the
Department planning on another round of data collection for an updated
report, which will help study and improve access to the arts as a core
academic subject?
Answer. We agree that having periodic information about arts
education is important. The next National Assessment of Educational
Progress (NAEP) arts assessment is scheduled for 2008. It will be an
8th-grade assessment that will include components for music, theater,
and the visual arts, as was the case with the last arts assessment in
1997. Work on the 2008 assessment began last year with item
development, and we will conduct a field test this year.
The Department has not budgeted for an arts education survey in the
National Center for Education Statistics (NCES) Fast Response Survey
program for fiscal year 2007. The expense of replicating a survey
involving multiple samples of teachers in the visual arts, music, and
dramatic arts is too great, given competing demands for funds and the
costs of the ongoing data collection programs of NCES. The National
Endowment for the Arts requested the earlier 1999-2000 arts education
survey and paid for it in part.
ready to teach program and math and science education
Question. Madam Secretary, the fiscal year 2007 budget allocates
$380 million for new or increased funding for math and science programs
aimed at giving students the skills they need to become competitive
workers in the global economy of the 21st century. Specifically, part
of this funding is targeted to address the critical shortage of
qualified teachers for math and science education, particularly in
high-concentration areas for low-income students.
The Ready To Teach program funds the development of digital
educational content and online professional development in partnerships
with the public television community. Congress has invested in this
program over several years to ensure that it is easily accessible,
flexible and tailored to local, State, and national standards. The most
recent grant competition recognized the continued success of PBS
TeacherLine service, and technology-based programs that offer a cost-
effective complement to off-campus training. In a difficult budget
environment, the Department should work to utilize the assets of
programs such as Ready to Teach in its effort to strengthen math and
science education, especially in the area of teacher training. How will
the Department utilize this investment in advancing math and science
education?
Answer. The Department has no plans to utilize the Ready to Teach
program to advance math and science education. There is limited
information on the effectiveness of professional development activities
supported through this small technology program. It's also not at all
clear that nonprofit telecommunications entities, like Ready to Teach
program grantees, are very well equipped to address the critical
training and professional development and training needs of current and
future math and science teachers.
In past years, Ready to Teach has played a very limited role in
helping schools and districts address professional development needs,
and next to no role in actually providing teacher training. In light of
recent research findings on the critical influence of highly qualified
teachers on student learning, and the seriousness of the on-going
teacher shortage crisis, the Administration believes that funds should
not be provided for small categorical programs like this one that have
limited impact and that siphon off Federal resources that could be used
by States and districts to pursue more important goals.
ready to learn program
Question. Madam Secretary, last year the Department restructured
the Ready to Learn educational television program to focus solely on
programming that teaches literacy, and eliminated much of the
widespread community outreach portion of the program. We all agree that
literacy proficiency is central to fulfilling the goals of No Child
Left Behind, and we applaud the Administration's including funds for
Ready to Learn in the Administration's budget request. However, the
elimination of the outreach activities concerns many of us here in
Congress. How does the Department plan to build upon the successes of
the local outreach activities by public television stations across the
country?
Answer. Over the current 5-year budget period, the Department
intends to dedicate approximately $20 million to support on-going Ready
to Learn (RTL) community outreach activities. While it's true that the
Department restructured the Ready to Learn educational television
competition, it's not true that ``much of the widespread community
outreach portion of the program'' was eliminated. In fiscal year 2005,
the Department made three new awards under the Ready to Learn program,
including one 5-year outreach award to the Corporation for Public
Broadcasting (CPB). Under this outreach award, CPB will continue to
work strategically with public television stations across the country
to support a variety of local outreach activities.
workshop approach to outreach and impact on student learning outcomes
Question. A recent evaluation of ``the workshop approach'' to
outreach supported by previous RTL grantees (entitled ``Using
Television as a Teaching Tool: The Impacts of Ready to Learn Workshops
on Parents, Educators, and the Children in Their Care'') suggests that
RTL has yet to achieve intended results in key areas of outreach
implementation. Although a link between RTL workshops and adults' self-
reported behaviors at 3 and 6 months after the workshops was
established, the effect sizes were small and the impacts on adult
behaviors did not translate into impacts on children. This study
concluded that the workshop approach to outreach had no measurable
effects on student learning outcomes and only moderate impacts on
parent/caregiver behaviors. As the study pointed out, enhancing
children's school readiness to the point of significant, measurable
improvement usually requires large investments in child-focused
interventions over extended periods of time. Thus, it's not surprising
that the workshops, which necessarily cannot be implemented at the
level of intensity usually associated with most interventions that
improve student-learning outcomes, showed no measurable effects on
student behaviors and learning outcomes. Based on the findings of this
rigorous 5-year evaluation, we believe that RTL outreach activities can
be targeted far more effectively, to the end of ensuring that all
children read on grade level by the third grade.
Because outreach is such a critical component of the RTL program,
under the new outreach award CPB plans to use the latest evidence from
social marketing research to target their efforts more effectively. CPB
will continue to rely heavily on community partnerships, and will
strategically partner with public broadcasting stations as local
community hubs. However, unlike in past outreach work, CPB will partner
with PBS to promote public awareness of RTL at the national and local
levels through press and media outlets such as newspapers, television,
and radio, emphasizing those most likely to reach the target audience
of low-income parents and caregivers.
More specifically, isn't there a way to combine the educational
television programming on PBS funded by Ready to Learn, with local
workshops for parents and teachers and other outreach activities by
local public stations, such as free book distribution.
Answer. As indicated in our response to the previous question, a
recent evaluation of ``the workshop approach'' to outreach supported by
previous RTL grantees (entitled ``Using Television as a Teaching Tool:
The Impacts of Ready to Learn Workshops on Parents, Educators, and the
Children in Their Care'') suggests that RTL has yet to achieve intended
results in key areas of outreach implementation. Based on this
evaluation, we believe that RTL outreach activities can be targeted far
more effectively, to the end of ensuring that all children read on
grade level by the third grade.
Under the new outreach award, CPB plans to change its outreach
strategy by using the latest evidence from social marketing research to
inform its work. CPB will continue to rely heavily on community
partnerships, and will strategically partner with public broadcasting
stations as local community hubs. However, unlike in past outreach
work, CPB will partner with PBS to promote public awareness of RTL at
the national and local levels through press and media outlets such as
newspapers, television, and radio, emphasizing those most likely to
reach the target audience of low-income parents and caregivers.
ready to learn continuation projects
Question. Additionally, given the President's emerging initiative
in math and science education, would you support a proposal to expand
the focus of Ready to Learn to include, in addition to literacy, math
and science education programming?
Answer. All of the Ready To Learn funds requested for fiscal year
2007 are needed to cover the continuation costs of current grantees,
which were awarded 5-year grants in 2005. Both programming awards must
focus on utilizing the principles of scientifically based reading
research to improve literacy outcomes for young children, consistent
with the priority established for last year's competition and the
cooperative agreements. By 2010, however, when the awards under this
program will be re-competed, it is possible that the research base on
how children acquire math and science knowledge will be sufficiently
well-developed to support the development of new children's educational
programming in these areas.
math and science education--math now program and math and science
partnerships
Question. The fiscal year 2007 budget proposes to establish Math
Now for Elementary and Secondary School programs, which are intended to
improve math instruction for elementary and middle school students.
What is the potential overlap between the proposed math programs and
the existing Math and Science Partnerships program?
Answer. The administration believes that Mathematics and Science
Partnerships, a formula-grant program that promotes strong teaching
skills for elementary and secondary school teachers, is important for
ensuring that all States have high-quality mathematics and science
professional development programs that focus on implementing
scientifically based research and technology into the curriculum.
The Math Now programs, which will implement proven practices in
mathematics instruction, including those recommended by the National
Mathematics Panel, will go one step further by helping to ensure that
American students are prepared to take and pass algebra courses in
middle school, which will encourage them to take and pass higher-level
mathematics and science courses in high school. They will focus more
precisely than does Mathematics and Science Partnerships on the need to
ensure that elementary-school students receive what the best research
indicates is the most effective math instruction and for middle-school
students who are struggling in math to receive the interventions they
need.
mathematics and science partnerships and math now program activities
Question. The States have some flexibility on how they target those
funds through their sub-granting process. Is there any information
about the extent to which States have targeted funding to the same
issues proposed to be addressed by these new programs?
Answer. The Department began collecting data from States and
partnerships this year that will describe how Mathematics and Science
Partnerships (MSP) subgrantees are implementing the program. These data
will include information about the kinds of activities MSP subgrantees
are conducting with program funds, and the information should be
available this summer.
Although we do not have a better sense of the activities MSP
grantees are conducting, it is possible that there may be some overlap
between the MSP and Math Now programs. However, we expect that it will
be minimal. For example, the MSP program focuses on providing
professional development for mathematics and science teachers, while
the Math Now programs would have several allowable uses of funds,
including professional development, but focusing more on improving
elementary-school math instruction and helping middle-school students
who are significantly below grade level in math. The Math Now grantees
would also implement instructional principles and promising practices
developed by the National Mathematics Panel, which is not a requirement
of MSP subgrantees.
national mathematics panel
Question. The fiscal year 2007 President's budget proposes to
establish a National Mathematics Panel to identify approaches and
interventions that meet either the scientifically based research
standard, as defined in the No Child Left Behind Act, or ``promising
practices.'' How will the selections for the National Mathematics Panel
be made, so that individuals with diverse backgrounds are represented
on the panel?
Answer. In order to ensure a diverse pool of expertise, the
Secretary will appoint no more than 20 members from the public and
private sectors, as well as no more than 10 members from the Department
of Education and other Federal agencies to the National Mathematics
Panel. Panel members may include researchers who study mathematics,
professors of mathematics and mathematics education, professors of
psychology and/or cognitive development, practicing teachers,
principals, State or local education officials, parents, business
leaders, foundation representatives, members of education associations,
and other individuals selected on the basis of their expertise and
experiences as appropriate.
Question. How will ``promising practices'' be defined for purposes
of identifying approaches and interventions?
Answer. Once it has been convened, members of the National
Mathematics Panel will meet and determine the appropriate definitions
and methodology for their review and synthesis of the evidence base on
mathematics education. One of their charges will be to recommend, based
on the best available scientific evidence, instructional practices,
programs, and materials that are effective for improving mathematics
learning. Since the scientific evidence base in mathematics education
is inadequate in many areas, we anticipate that the Panel will also
provide guidance that will help States and districts determine which
approaches and interventions have some evidence-even through it does
not yet meet the standards for scientifically based research-that
indicate that the interventions will improve student outcomes.
mathematics and science education
Question. The President's Academic Competitiveness Initiative (ACI)
clearly emphasizes the need for improved science, technology,
engineering and mathematics (STEM) education. The Department of
Education's 2007 budget request makes substantial improved mathematics
education via the Math Now program, but does not make a comparable
investment in science education. What is the Department's plan for
investing in science education?
Answer. Both mathematics and science are important subjects for our
students to learn well if we are to remain competitive in the global
economy. Because we need to set priorities within our budget, we are
focusing on mathematics first through the Math Now programs.
Mathematics is a ``gateway'' course for upper-level mathematics and
science learning, so we believe that it is crucial for students to
first have a firm foundation in mathematics. In addition, because Title
I mathematics assessments are already in place (while the science
assessments will not come on line until 2007-2008), we have an
immediate source of information for measuring the effectiveness of new
strategies in teaching mathematics, but not in science.
Science Education Support
Finally, the budget request includes either increases or level
funding for a number of programs that focus on science, including
Mathematics and Science Partnerships and Graduate Assistance in Areas
of National Need. The new Advanced Placement and Adjunct Teacher Corps
proposals would target science, in addition to mathematics and critical
foreign languages. Other Department programs that allow grantees to
focus on science include Transition to Teaching, Troop-to-Teachers, and
Improving Teacher Quality State Grants.
investments in advanced placement
Question. The fiscal year 2007 budget proposes to expand the reach
of the Advanced Placement program by requiring grantees to offer
incentives for teachers to become qualified to teach Advanced Placement
and International Baccalaureate Organization classes in mathematics,
science, and foreign languages and to teachers whose students pass
tests in those subjects. The budget also proposes to require grantees
to secure public and private matching funds to leverage the Federal
investment. How much money does the Department expect the private
sector to contribute toward the matching requirement for the Advanced
Placement (AP) program?
Answer. The Department expects the private sector to invest roughly
$114 million in the AP program, which matches the Department's funding
request for AP Incentive Grants. Based on conversations with potential
donors, who are very excited about this initiative, we believe this
assumption is realistic.
Question. What is the basis for that projection?
Answer. Conversations between Department officials and
representatives of private companies indicate that very substantial
non-governmental support will be forthcoming. Senior officials are
encouraging supporters of the proposal to publicize their commitment,
and we hope to provide more information in the coming weeks.
Question. Please provide the same information for State
contributions.
Answer. The Department is aware that many States are already
committed to investing in the AP program, and believe that States will
contribute their support and resources to increasing low-income
students' access to challenging coursework. Our expectation is that
State and local funds will amount to approximately $114 million,
resulting in roughly a one-third/one-third/one-third split in Federal,
State and local, and private-sector contributions.
Question. Also, does the Department plan to institute a
maintenance-of-effort requirement for States; why or why not?
Answer. No, because the statute already includes a ``supplement,
not supplant'' provision, which will prevent the Federal funds from
merely supplanting existing State and local efforts.
advanced placement incentive program
Question. How will the Department ensure that the proposed
incentive for teachers whose students pass AP/IB tests will not lead to
the unintended consequence of discouraging students from taking these
tests?
Answer. Providing a bonus to teachers for each student who passes
an AP test should be an incentive for teachers to get more students to
take and pass AP exams. According to ``Do What Works: How Proven
Practices Can Improve America's High Schools,'' written by Tom Luce,
now our Assistant Secretary for Planning, Evaluation, and Policy
Development, and Lee Thompson, the AP incentive program increased the
number of students taking AP courses and passing AP exams in Texas. The
Department's proposal would extend the opportunities granted to
students in Texas to young people across America.
federal student aid
Question. Budget documents supporting the recall of the Federal
portion of repayments made under the Federal Perkins Loans program
indicate that, ``the Administration believes the Federal share of funds
held by this small group of institutions might more effectively help
students if used in a way that serves all eligible students regardless
of institution.'' In addition to the $664 million proposed recall of
Perkins proceeds, the proposed budget includes a reduction of $436
million in funding from the Student Financial Assistance account. How
does the proposed budget more effectively serve all eligible students
by recalling $664 million from the Perkins loans program and reducing
the Student Financial Assistance account by $436 million?
Answer. It is important to look at the Federal investment in
student aid from a broad perspective. Overall, the President's Budget
would build on student benefits included in the Higher Education
Reconciliation Act (HERA) to provide a record $82 billion in new
student grant and loan assistance in fiscal year 2007. The HERA created
Academic Competitiveness Grants, a new need-based program supported
with mandatory funding that will award annual grants of up to $1,300 to
high-achieving first- and second-year students who have completed a
rigorous high school curriculum or up to $4,000 for third- and fourth-
year students majoring in mathematics, science, technology,
engineering, or critical foreign languages. In 2007, the program would
provide $850 million in grants to 600,000 low-income postsecondary
students. Over 2006-2010, grant awards would total more than $4.5
billion.
In addition, the HERA makes student loans more affordable by
phasing out student origination fees and fixing student interest rates
at 6.8 percent, reducing the maximum rate from the previous 8.25
percent. (If calculated today, the current variable rate formula--which
will continue to apply for loans originated prior to July 1, 2006--
would be 7.11 percent; if recent trends continue through June, the
actual rate may be even higher.) The HERA also expands loan limits for
first- and second-year students and graduate students and permanently
expands loan forgiveness from $5,000 to $17,500 for math, science and
special education teacher serving low-income communities.
Within the Student Financial Assistance account itself, most of the
$436 million reduction you mention reflects the effect of the new
scoring rule for the Pell Grant program, which reduces the need for
current year budget authority by allowing the use of excess funds from
the previous fiscal year. The balance of the reduction reflects
revised, lower estimates of fiscal year 2007 Pell Grant program costs
and the elimination of two redundant, ineffective, or unnecessary
programs: Federal Perkins Loans and Leveraging Education Assistance
Partnerships.
commission on the future of higher education
Question. Specifically, how will low- and middle-income students
achieve the same access to postsecondary education as high-income
students have, which is an objective of the Department of Education?
Answer. In today's highly competitive global economy it is vital
that no American student be denied access to effective postsecondary
education due to high costs. Accordingly, in September 2005 the
Secretary's Commission on the Future of Higher Education was created to
examine how we as a Nation can keep higher education affordable and
accessible. The Commission, made up of experienced leaders from
education, business, and government, is holding a series of meetings
around the country and gathering data from respected experts on higher
education. A final report with the commission's findings is expected by
August.
funding for higher education
Question. In ``Cracks in the Education Pipeline: A Business
Leader's Guide to Higher Education Reform,'' it is stated that low-
income families, those with incomes in the bottom 40 percent of the
earnings distribution, spend one-third of their income to send a child
to community college and 43 percent to enroll in a public 4-year
school. Further, the document states that, ``Student aid has the
greatest impact when targeted on low-income students who otherwise
would not enroll in college.'' What is proposed in this budget to help
such families finance their goals for postsecondary education?
Answer. The President's 2007 Budget for student aid builds on a
number of significant accomplishments in 2006 to provide a record $82
billion in assistance to more than 10 million students and parents.
Adopting a proposal from the 2006 President's Budget, Congress
appropriated $4.3 billion in mandatory funding in 2006 to eliminate a
long-standing funding shortfall in the Pell Grant program, putting this
vital program--the foundation of Federal need-based aid--on a firm
financial footing after years of growing fiscal instability. Congress
also adopted new budget rules proposed by the President to prevent
shortfalls from occurring in the future. In addition, the Higher
Education Reconciliation Act, signed by the President in February,
would further help the neediest students by phasing out origination
fees for Stafford Loans and providing over $4.5 billion over 5 years in
new need-based Academic Competitiveness and SMART Grants.
advancing america through foreign language partnerships
Question. The fiscal year 2007 budget proposes a new program,
through appropriations language, to establish partnerships between
institutions of higher education and school districts that support
programs of study in grades K-16 in critical need languages.
Specifically, how will this proposed program complement existing
Department programs, such as those authorized and funded under title VI
of the Higher Education Act and the Fulbright-Hays Act?
Answer. The Advancing America Through Foreign Language Partnerships
program is intended to complement, not duplicate, existing Department
programs that provide support for foreign language and areas studies
education. Distinctive elements of the Advancing America Through
Foreign Language Partnerships program, compared to the Title VI of the
Higher Education Act and those authorized by the Mutual Educational and
Cultural Exchange Act (Fulbright-Hays), include partnerships between
institutions of higher education and school districts; the degree of
focus on ``critical need languages'' such as Arabic, Chinese, Russian,
Hindi, Farsi, and others; and unique language programs of study that
enable successful students to advance from early learning in elementary
school through advanced proficiency levels in high school to superior
levels in college. The Title VI and Fulbright-Hays programs support 14
distinct yet interrelated programs designed to strengthen the
capability and performance of American education in foreign languages
and in area and international studies in a number of world regions.
These programs do not establish articulated programs of study in grades
K-16 in critical need foreign languages.
In addition, the objectives of this proposed program that relate to
establishing fully articulated K-16 programs that produce college
students who achieve a superior level of proficiency cannot be
accomplished through grants to local and State educational agencies
under the Department's Foreign Language Assistance program (FLAP). FLAP
is focused on improving the quality of foreign language instruction in
elementary and secondary schools. Institutions of higher education are
not eligible to apply for funding under the FLAP program. Moreover,
FLAP is not an appropriate vehicle for establishing the kind of
partnerships needed between school districts and institutions of higher
education to ensure an articulated curriculum and consistent goals and
continual progress toward the required outcomes at all educational
levels, including the postsecondary level.
The Advancing America Through Foreign Language Partnerships program
fits within the Department's mission and complements Title VI and other
Department activities relating to the teaching and learning of foreign
languages.
advancing america through foreign language partnerships and dod
national flagship language initiative
Question. How will this new program complement related programs
administered by other Federal agencies?
Answer. The Advancing America Through Foreign Language Partnerships
program would operate following the model created under the National
Flagship Language Initiative at the Department of Defense. The
Administration seeks to expand on DOD's pilot K-16 Mandarin Chinese
program by awarding an additional 24 grants to institutions of higher
education for partnerships with school districts for programs of
language study in a variety of languages critical to national security
such as Arabic, Chinese, Russian, Hindi, Farsi, and others. The
Administration is proposing that ED (and not DOD) undertake the
expansion of this program because the goals of the program fit within
the Department's mission and the program complements other ED
activities relating to the teaching and learning of foreign languages.
requirements of advancing america through foreign language partnerships
grantees
Question. Supporting budget documents note that applicants would
have to demonstrate the long-term success of their project, as well as
commit to a significant amount of cost sharing. Would you please
provide more information about each of these proposed requirements?
Answer. To address the need for skilled professionals with superior
competency in foreign languages critical to U.S. national security,
such as Arabic, Chinese, Russian, Hindi, Farsi, and others,
participants in the Advancing America Through Foreign Language
Partnerships program would be expected to make significant commitments.
We would expect that institutions of higher education applying for
grants would be able to identify each local educational agency partner
and describe each partner's responsibilities (including how they would
be involved in planning and implementing program curriculum, what
resources they would provide, and how they would ensure continuity of
student progress from elementary school to the postsecondary level).
Participating institutions of higher education would be expected to
work with partner school districts to develop and implement an
articulated curriculum with consistent pedagogical philosophy and goals
throughout all educational levels of the program. To ensure long-term
success of the project, we would expect applicants to be able to
describe in their applications how they would support and continue the
program after the grant has expired, including how they would seek
support from other sources, such as State and local government,
foundations, and the private sector. We would also expect grantees to
provide a non-Federal contribution, in cash or in kind, that would help
carry out the activities supported by the grant.
statewide data systems program
Question. The fiscal year 2007 budget requests $54.6 million for
the Statewide Data Systems program, an increase of $30 million over the
fiscal year 2006 amount. Budget documents supporting this request
indicate that 14 States are receiving funds from this program, although
all States need assistance to develop or refine and fully implement
systems that allow them to track the progress of individual students
statewide. Budget documents also state that the requested increase for
fiscal year 2007 would focus on the issue accelerating the capacity of
high schools to report and use accurate high school graduation and
dropout data. How are States utilizing funds from fiscal year 2005 and
fiscal year 2006?
Answer. The Statewide Longitudinal Data Systems (SLDS) grant
program is supporting State educational agencies in designing,
developing, implementing, and using longitudinal individual student
data and linking the student data to other contextual and management
data, such as program, staffing, facilities, financial, early
childhood, or post-secondary data. The resulting data systems will
allow States to evaluate learning of all students and track the
effectiveness of schools, programs, or interventions. Under the grant
program, States are required to provide data and meaningful analyses
back to local stakeholders, including teachers, principals, and
districts. States are also required to develop ongoing evaluation
procedures to ensure that the data collected are: (1) of high quality,
(2) responsive to local information needs, and (3) useful for improving
instruction and student learning.
States receiving SLDS grant money are required to incorporate data
from kindergarten to 12th grade in their data systems. Most have also
proposed to incorporate preschool and even birth-to-preschool data.
Similarly, most grantees propose to incorporate postsecondary data in
their systems, spanning prekindergarten-16 and even prekindergarten-20.
Some States will also link their data to those from non-education
agencies, such health or labor. These longitudinal student data,
especially with links to rich contextual data, will for the first time
allow States and districts to reliably link student outcomes to
different variables, including curricula, educational environment,
funding, socioeconomic background, and other factors that affect
student learning.
statewide longitudinal data systems
Question. How does this proposed priority fit with the basic needs
of States for developing longitudinal data systems?
Answer. Statewide longitudinal data systems (SLDS) grants enable
States to have more informative and reliable data on what is happening
and what works in high schools, including the ability to evaluate and
track how students' pre-high school experience affects how well they do
in high school. These funds also enable States to understand how what
happens in high school affects students' success in postsecondary
education and/or employment. Grant funds support data system
development and enhancements that enable States to conduct a wide range
of rigorous longitudinal analyses, including computations of a standard
four-year adjusted cohort graduation rate, as adopted by the National
Governors Association (NGA). Most of the first cohort of grantee States
have not collected and compiled these data before. Some States in the
first cohort of grants can currently compute the NGA graduation rate,
but these States still depend upon their grant funding to ensure the
quality of their data collection.
The requested increase in funding for this program will enable more
States that do not currently have this capacity to collect data
necessary for the computation of accurate high school graduation and
dropout rates necessary data on high school. For States that already
collect these data, the requested funding will enable them to connect
all relevant data in one longitudinal data system with better and more
efficient verification of data over time and across different
educational and other data systems. In these States, the SLDS grant
will result in better data faster.
national assessment of educational progress
Question. The budget requests an additional $4 million to allow the
Department to begin work on essential activities for implementing in
2009 State-level assessments at the 12th grade level. What activities
will be funded by this requested increase?
Answer. The funds requested for fiscal year 2007 would be used to
conduct validation studies to ensure that the assessment has predictive
validity and is an appropriate measure of readiness for work,
postsecondary education, or military service. The funds would also be
used for the development and pilot testing of new mathematics and
reading frameworks.
12th grade naep initiative--reading and math assessments
Question. What is the total cost of the 12th grade NAEP initiative,
and what is the range of options being considered for implementing this
new policy?
Answer. Assuming that State participation is mandatory, the
estimated total cost of the 12th grade State-level assessments in
Reading and Math for 2009 would be $45 million above the current NAEP
appropriation.
The following chart presents estimated costs for an assessment in
the 50 States, the District of Columbia, and Puerto Rico; as well as
for a non-mandated assessment, with 45 States volunteering to
participate; and for a pilot State assessment, with 10 States selected
to participate. Once the development and phase-in of the 12th grade
State-level assessments are complete, we estimate that the annual cost,
beginning in 2010, of conducting State-level assessments in Reading and
Mathematics would be $22.5 million for the mandatory scenario and $20.5
million for the voluntary scenario.
[Estimated cost, in millions of dollars]
----------------------------------------------------------------------------------------------------------------
12th Grade State-Level Reading and Math Assessments
--------------------------------------------------------------------------
Year Mandatory (52 Voluntary (45 Pilot (10
jurisdictions) jurisdictions) jurisdictions)
----------------------------------------------------------------------------------------------------------------
2007................................. 4.0 4.0 4.0
2008................................. 18.5 18.5 4.0
2009................................. 22.5 18.5 3.6
--------------------------------------------------------------------------
Total.......................... 45.0 41.0 11.6
----------------------------------------------------------------------------------------------------------------
office of communications and outreach
Question. Budget documents supporting your fiscal year 2007 budget
request indicate that staffing for communications and outreach will
change from 14 FTE in 2005 to 140 in fiscal year 2006. Will you explain
the need for 140 FTE's in this office, instead of utilizing these staff
in grants monitoring and other program administration capacities?
Answer. Staffing for communications and outreach did not increase
from 14 to 140. The reason there appears to be an increase is that we
took staff from other areas and consolidated them under a new
centralized communications office. In an effort to better coordinate
the communication functions of the Department to ensure clear,
consistent communications, a new Office of Communications and Outreach
(OCO) was created. It now includes the former Office of Public Affairs
(OPA), most of the functions of the former Office of Intergovernmental
and Interagency Affairs (OIIA) and the function of internal
communications. The new Office of Communications and Outreach
encompasses speechwriting, public affairs, web site, publications,
event services, external affairs and the Secretary's 10 regional
offices. The Office of Communications and Outreach is responsible for
creating and distributing appropriate education materials to inform the
work and decision-making of educators, policymakers, government
officials, parents and students.
department expenditures for public relations and outreach
Question. How much did your Department spend on public relations
and outreach in fiscal year 2005?
Answer. In fiscal year 2005, the Department spent $1,132,246 on
public relations and outreach, in procurement of items and services
such as speeches and editing for senior staff, logistical outreach
event support, webcasting, and the monthly ``Education News Parents Can
Use'' satellite broadcasts.
Question. How much do you plan to spend in fiscal year 2006 and
fiscal year 2007, and what are the primary outcomes intended to be
achieved by these expenditures?
Answer. The Department plans on spending $1,025,000 in fiscal year
2006 and $1,100,000 in fiscal year 2007 on public relations and
outreach events which are designed to inform members of the public
about No Child Left Behind and other Department programs, the monthly
``Education News Parents Can Use'' satellite broadcast, and technical
support for webcasting.
Each ``Education News Parents Can Us'' broadcast explains U.S.
Department of Education programs to parents using practical, plain-
language discussions of topics such as ensuring safe and drug free
schools, teaching reading, serving students with disabilities, and
using new education technology. Each broadcast offers this information
in a format that features short segments, including one-on-one
interviews, ``how-to'' demonstrations, and brief conversations with
parents, educators, education experts, and community, business and
religious leaders.
Technical and production support is needed for the creation of high
quality, live, or previously videotaped multi-media programs that can
be broadcast over the Internet. These productions are for the purpose
of raising the general public's awareness of and encouraging
participation in programs associated with ED's education reform
initiatives.
______
Questions Submitted by Senator Daniel K. Inouye
native hawaiian education
Question. First and foremost, I'd like to express my sincere
appreciation for the continued funding of Native Hawaiian Education.
This funding facilitated uninterrupted curricula development, teacher
training and recruitment programs as well as scholarship offerings.
Programs such as these allowed many young Hawaiians' the opportunity to
fully realize their dreams. Through continued support of Native
Hawaiian Vocational Education, countless individuals can now
successfully enter, compete and advance in the ever-changing and
competitive technological workplace.
I would also like to extend my personal thanks to your Department
administrators who have traveled to Hawaii to meet our local program
coordinators and provide technical assistance to our remote
communities. No doubt, your staff has seen first hand the tremendous
impact and success these funded programs have had on the people of
Hawaii.
Madam Secretary, what are the indicators or measures your
Department uses to manage existing competitive grantees under the
Native Hawaiian Education Act?
Answer. The Department has established three performance measures
for the Native Hawaiian Education program authorized under Title VII of
the ESEA. The measures are:
--The percentage of teachers involved with professional development
activities that address the unique educational needs of program
participants.
--The percentage of Native Hawaiian children participating in early
education programs who improve on measures of school readiness
and literacy.
--The percentage of students participating in the program who meet or
exceed proficiency standards in mathematics, science, or
reading.
The Department collects data on these measures through the annual
performance reports submitted by grantees.
Question. Please also describe the process by which these
indicators were selected.
Answer. The development of the performance indicators for the
Native Hawaiian Education program was based on an analysis of the
program's purpose, priorities and authorized activities, and how those
align with the overall priorities and purpose of the No Child Left
Behind Act. As the program authorizes a wide number of project
activities, we also had to narrow somewhat the areas for performance
measurement for the program, in order to minimize the burden of data
collection and reporting. Since we were unable to arrive at one
performance indicator that would be appropriate for all projects
possible or allowed under the program, we conducted an analysis of
grantee activities and goals. The analysis showed that most grantees
are implementing projects around a small number of areas (early
childhood, teacher professional development, and math and science
education) and, thus, we developed indicators to track program
performance in those areas.
women in technology
Question. The Women in Technology (WIT) program originated in Maui
5 years ago as a workforce development project initially funded through
a grant from the U.S. Department of Labor. A core mission component of
the program was to partner with educators and industry to create a
pipeline from education to employment in science, technology,
engineering and math. This concept was first introduced in our local
middle and high schools, to increase the confidence and interest of
under represented populations in math and science studies and expose
them to educational and professional opportunities in high-tech
professions. This was accomplished at no cost to the students.
Elementary school is a critical time to begin outreach efforts to
attract students into the science, technology, engineering and math
pipeline. National research indicates that gender identities and
stereotyping about career roles are set by age seven. One of the goals
of Women in Technology includes training elementary school teachers in
``inquiry-based learning'' methods. In this method, teachers learn how
to harness the natural inquisitive nature of their students and nurture
it into scientific questions/hypothesis and self-directed activities to
prove/disprove the students' questions. The inquiry-based activities
are integrated into the teaching curriculum and align with grade level
and standards. This method of teaching is well suited to children of
both genders and stimulates all styles of learning. A pilot program,
recently launched in Maui, included a professional development workshop
for one dozen elementary teachers.
Madam Secretary, Women In Technology is a critically important
program to securing a more prosperous future for many young Hawaiians.
So strong is my belief in the value of this program, that in years
past, I sought funding for it via my earmarks. As such are no longer
available, will the Department of Education provide funds for the
expansion of science, technology, engineering and math ``inquiry-based
learning'' curriculum and training to all elementary school teachers
throughout the State of Hawaii?
Answer. The agency operating the Women in Technology (WIT) program
may pursue discretionary funding opportunities under a number of
Department of Education programs that support activities such as the
ones you describe. WIT may apply, for example, for funding under the
Native Hawaiian Education program, which supports innovative projects
to provide supplemental services that address the educational needs of
Native Hawaiian children and adults. Authorized activities under that
program include development and implementation of professional
development programs to prepare teachers to address the unique needs of
Native Hawaiian students.
WIT may also be eligible for funding under the Mathematics and
Science Partnerships program. Funds for the program are distributed to
States based on a formula, and each State then administers a grant
competition for the funds. The program supports State and local efforts
to improve students' academic achievement in mathematics and science by
promoting strong teaching skills for elementary and secondary school
teachers, including integrating teaching methods based on
scientifically based research and technology into the curriculum.
Grantees may also use program funds to develop more rigorous
mathematics and science curricula that are aligned with challenging
State and local content standards; establish distance learning programs
for mathematics and science teachers; and recruit individuals with
mathematics, science, and engineering majors into the teaching
profession through the use of signing and performance incentives,
stipends, and scholarships. Professional development can include summer
workshops, or institutes and programs, that bring mathematics and
science teachers into contact with working scientists, mathematicians,
and engineers in order to expand teachers' subject-matter knowledge.
WIT administrators should contact the Hawaii Department of Education
for information on applying for this program.
______
Questions Submitted by Senator Herb Kohl
special education full funding
Question. Many of us here have worked hard every year to increase
funding for Special Education. Year after year, school districts in
Wisconsin tell me that this is one of their top concerns. But this
year's budget is especially worrisome. It proposes to cut the Federal
share of IDEA costs from 18 percent to 17 percent--that is less than
half of the 40 percent ``full funding'' level that Congress committed
to paying when IDEA was first adopted 31 years ago. This deliberate
step backward begs the question: does this Administration plan to ever
fully fund IDEA?
Answer. Under the President's leadership, funding for the Grants to
States program has increased by 67 percent since 2001. The President's
2007 request for the Special Education--Grants to States program of
$10.7 billion, which includes an increase of $100 million, would
provide about 17 percent of the national average per pupil expenditure
(APPE) for 6.9 million children with disabilities receiving special
education, compared to about 14 percent of the APPE in 2001. No
Administration has come close to requesting 40 percent of APPE, but
this Administration has proposed record-high increases in funding for
the program and has achieved record-high levels of the Federal
contribution.
early childhood education funding
Question. While I support the President's proposals to increase
resources to support math and science education at the high school
level, I am concerned about the decrease in funding for programs that
support early childhood education. Research shows that 80 percent of
brain development takes place during the first 3 years of a child's
life. In light of this research, please explain the Administration's
rationale for funneling resources away from programs that support our
youngest learners--like the Foundations for Learning and Even Start
programs--and putting those funds into our high school age programs.
Answer. The Department remains dedicated to the goal of promoting
cognitive development for all children, and the President's budget
request reflects a strong commitment to programs that have a proven
record of success in serving our Nation's youngest citizens. Neither
Even Start nor Foundations for Learning has a track record of
demonstrated effectiveness. While some local Even Start programs are
successful at supporting the development of children's early academic
skills, the program's overall reliance on the family literacy model has
not been shown to be effective. In addition, the Foundations for
Learning program is duplicative of other programs that serve very young
children and its size precludes any large impact on the populations to
which it is targeted. Other programs, such as Early Reading First and
the Early Childhood Educator Professional Development program, focus on
proven methods of addressing the cognitive development and school
readiness needs of young children
perkins loans and other student aid programs
Question. Not only does this budget cut Pell Grants, but it also
calls for the elimination of the Federal Perkins loan program. This
academic year, the University of Madison-Wisconsin served 5,202
students with $13.2 million in Federal Perkins Loans. These loans
helped students cover the gap between other financial aid and the
actual cost of attendance. They are also a good option for low-income
students because they are not dependent on credit history. Secretary
Spellings, if Congress were to agree to the President's recommendation
and eliminate Perkins loans, what do you suggest these students do to
pay for higher education?
Answer. First, to clarify, the President's Budget does not cut Pell
Grants; current estimates indicate every eligible student would receive
his or her full award under our proposal. The reduction in budget
authority compared with fiscal year 2006 reflects the new scoring rule
under which an estimated $273 million in unused funds from fiscal year
2006 can be used to reduce the need for new appropriations, as well as
a slight reduction in the estimated cost of the Pell Grant program.
More broadly, even with the Perkins Loan proposal, student aid
would increase under the President's Budget by more than $4.6 billion
in fiscal year 2007 over the previous year, including $790 million in
new need-based Academic Competitiveness and SMART Grants. In addition,
student loans under the Federal Family Education Loan and Direct Loan
programs will be a better bargain for borrowers due to lower interest
rates and reduced origination fees.
elementary and secondary school counseling program
Question. School counselors play a vital role in the lives of
American youths by providing guidance on issues both academic and
personal. During times of war and the ongoing fear of terrorism, the
need for effective school counseling is clearer than ever. In addition,
counselors continue to guide students in career, academic and social
development. That's why I am very concerned that the President's budget
again eliminates funding for the School Counseling Program. In
Wisconsin, each public school counselor oversees 461 students--a
caseload that already leaves many students underserved.
School counselors play an important role in helping students meet
the goals of No Child Left Behind. Why would the Administration cut a
program that is helping to make its signature education policy work?
Answer. The budget request to eliminate funding for the Elementary
and Secondary School Counseling program is part of an overall budget
strategy to discontinue programs that duplicate other programs that may
be carried out with flexible State formula grant funds, or that involve
activities that are better or more appropriately supported through
State, local, or private resources. Specifically, the 2007 budget
proposes termination of 42 programs in order to free up almost $3.5
billion (based on 2006 levels) for reallocation to higher-priority
activities within the Department. These higher-priority activities
include the Administration's $1.5 billion High School Reform
Initiative. Under this Initiative, local educational agencies will be
able to include student counseling services as part of the
comprehensive strategies they adopt to raise high school achievement
and eliminate gaps in achievement among subgroups of students.
In addition, if school districts choose to do so, they may support
counseling programs with the funds they receive under the State Grants
for Innovative Programs authority, which allows them to implement
programs that best meet their needs. Furthermore, the Elementary and
Secondary Education Act (ESEA) provides school districts with
additional flexibility to meet their own priorities by consolidating a
sizable portion of their Federal funds from their allocations under
certain State formula grant programs and using those funds under any
other of these authorized programs. A school district that seeks to
implement a school counseling program in some or all of its schools may
use funds from those programs to do so.
______
Questions Submitted by Senator Patty Murray
academic competitiveness/smart grants
Question. The fiscal year 2006 Budget Reconciliation bill created
Academic Competitiveness grants and the National Science and
Mathematics Access to Retain Talent (SMART) grants. To receive the
Academic Competitiveness grants, students must have completed a
rigorous secondary-school program of study. While I agree that we need
to be doing all we can prepare students for a job in a global economy,
a student's luck in where they attend high school shouldn't determine
whether or not the Federal Government helps them attend college. The
Congressional Budget Office has estimated that only 9.9 percent of Pell
eligible students will be able to take advantage of the Academic
Competitiveness and SMART grants in 2007.
The maximum Pell grant has not increased for years despite tuition
rising at our Nation's public colleges rising by over 7 percent last
year. If the $850 million that these grants cost in fiscal year 2007
were spent on Pell grants, students would receive an additional $200 in
aid.
How do you anticipate judging what constitutes a rigorous
secondary-school curriculum?
Answer. The Department of Education is working with all States to
help them identify high school programs of study they can submit to the
Secretary of Education for recognition as rigorous secondary programs
of study. In addition, there will be alternative eligibility provisions
for students from States that have not yet submitted designated
programs to the Secretary. These State-identified, eligible rigorous
secondary school programs or acceptable alternatives will soon be
posted on a Department web site.
Question. Particularly in such tight budget times, shouldn't we be
spending our resources on helping all students attend college
regardless of their circumstance, not benefiting the few who are lucky
enough to attend the ``right'' high school?
Answer. Taken together, the Federal student aid programs under the
President's fiscal year 2007 budget request would provide over $82
billion to students and families, much of it focused on the neediest
Americans. Within this larger investment, we believe it is appropriate
to target a portion of need-based aid--Academic Competitiveness/SMART
Grant recipients must be eligible for a Pell Grant--to encourage the
type of rigorous high school study and challenging college coursework
that is linked to success both for individuals and, ultimately, for our
Nation.
title ix report
Question. On March 17, 2005, the Department of Education released
new guidance on the interest prong of the three-part test which schools
use to show compliance with Title IX in athletics. As you are aware, I
have grave concerns about the new guidance because I believe it sets a
new low bar for compliance with a Federal civil rights law. Schools
would now be allowed to use an email survey to show compliance with
Title IX. Further, the school would only have to send that survey to
women and a lack of response could be determined as lack of interest in
sports. Surveys have been used in the past to show compliance with
Title IX, but not as a sole means and other factors such as emerging
sports had to be taken into consideration.
Because of concern over this new guidance, a bipartisan group of
Senators on this subcommittee asked for a report on the guidance and
use of surveys due March 17. What is the status of the requested
report?
Answer. The report in response to guidance and the use of surveys
for Title IX was submitted to the Committee on March 17, 2006.
title ix technical assistance
Question. Clearly, there is a lot of confusion on behalf of schools
about this new guidance. What is the Department doing regarding
technical assistance on the guidance?
Answer. The Office for Civil Rights (OCR) regularly provides
technical assistance on a variety of issues to interested parties,
including elementary and secondary schools and colleges and
universities. Assistance is an important method to help educational
institutions achieve voluntary compliance with the civil rights laws
and assist in preventing civil rights violations by educating schools
about their responsibilities. OCR provides guidance through a variety
of methods, including responses to thousands of requests for
individualized technical assistance, via phone, email, or mail, each
year from individuals, recipients, and groups representing recipients
and beneficiaries. Our technical assistance also includes on-site
consultations, conferences, training, community outreach, publishing
and disseminating materials, through the Department's website and
direct mailings, and issuing guidance.
With respect to Title IX of the Education Amendments of 1972 (Title
IX), the Department issued the Additional Clarification of
Intercollegiate Athletics Policy (Additional Clarification) to clarify
one method schools may choose to use to assess athletic interests and
to provide a practical tool they may choose to use to conduct that
assessment.
To further assist schools, OCR has been and continues to actively
seek out opportunities to provide technical assistance on a continuous
basis. In the year since the Additional Clarification was issued, OCR
has provided technical assistance on the Additional Clarification to
more than a thousand coaches, athletic directors, Title IX coordinators
and legal advisors, in addition to regularly providing individualized
technical assistance. These presentations have included secondary
schools, 2- and 4-year colleges and universities, and conferences
sponsored by umbrella organizations responsible for developing and
implementing the governing rules and procedures for national and
regional athletics at the secondary, junior college, and 4-year college
levels. We will continue to proactively seek out opportunities to
educate recipients, educational and athletic organizations,
administrators, parents and students regarding nondiscriminatory
implementation of Title IX and the Additional Clarification.
america's opportunity scholarships for kids
Question. The President's budget again proposes school vouchers
through the America's Opportunity Scholarships for Kids program. The
President's education budget also eliminates 42 programs. We often hear
that the programs are proposed for elimination because they are
ineffective. However, there is no evidence that private school vouchers
do anything to improve achievement for any students. Further, we still
have yet to see any real evaluation of achievement under the D.C.
voucher program.
In such a tight budget, how does the Administration justify
spending $100 million on a program that has yet to be found effective?
Answer. To offer the opportunity of a high-quality education to
more students who attend schools in restructuring around the country,
the Department proposes the creation of a national school choice
program that gives parents the choice to send their children to any
public or private schools that they believe would better serve their
student's needs. Though it is too early to know the potential effects
on academic achievement of the D.C. School Choice Incentive Program, we
do know that the program has generated significant support among
parents of students in low-performing schools in Washington, DC. The
America's Opportunity Scholarships program would extend that option to
parents whose children attend low-performing schools across the Nation.
In addition, several research studies, such as ``Private School
Vouchers and Student Achievement: An Evaluation of the Milwaukee
Parental Choice Program'' by Cecilia Rouse, and Jay Greene's ``The
Effect of School Choice: an Evaluation of the Charlotte Children's
Scholarship Fund,'' suggest that participation in the private school
choice programs leads to improvements in student achievement.
impact of medicaid change on children with disabilities
Question. The Department of Health and Human Services reflects a
change in how Medicaid is dealt with at schools. While I understand
this change is proposed in the HHS budget and not the Department of
Education, the impact will be felt by students and schools. The HHS
budget says that certain costs associated with services provided to
special education students who are also on Medicaid will no longer be
reimbursed to the schools through Medicaid. The estimated savings to
HHS is over $600 million for fiscal year 2007 and the 10-year savings
is over $9 billion. The President's budget proposes only a $100 million
increase to IDEA. While we will certainly fight for increasing funding
for IDEA and other education programs, given these tight budget times,
I have a feeling IDEA won't receive $9 billion in the next 10 years.
I am concerned that students will feel the impact of this change.
The Federal Government has yet to live up to the promise of funding 40
percent of the cost of educating a special education student and
schools will not be able to absorb the costs associated with this
change. Students will be told to get such services outside of school
hours.
How do you propose ensuring that students get all the necessary
service they receive now if this change happens at HHS?
Answer. The President's 2007 Budget includes a proposal that would
prohibit Federal Medicaid reimbursement for Medicaid administrative
activities performed in schools. It additionally provides that Federal
Medicaid funds will no longer be available to pay for transportation
required to be provided to children with disabilities by the
Individuals with Disabilities Education Act. HHS has had long-standing
concerns about improper billing by school districts for administrative
costs and transportation services. Both the HHS Inspector General and
the Government Accountability Office have identified these categories
of expenses as susceptible to fraud and abuse. Schools would continue
to be reimbursed for direct Medicaid services identified in an
Individualized Education Program (IEP) or Individualized Family Service
Plan (IFSP) and provided to Medicaid-eligible children, such as
physical therapy, that are important to meeting the needs of Medicaid-
eligible students with disabilities.
A shift in funding responsibility for administrative and
transportation costs associated with Medicaid eligible children with
disabilities should not affect services for these children. State and
local governments are responsible for ensuring that needed services are
provided for all children with disabilities, regardless of whether they
are Medicaid eligible. The change in policy would treat Medicaid
eligible children with disabilities the same as other children with
disabilities with regard to administrative and transportation costs.
The Department of Education and HHS intend to work together to ensure
that implementation of this change in policy is done in an orderly and
sensible fashion.
21st century community learning centers
Question. The President's budget would freeze funding for the 21st
Century Community Learning Centers Program for the fifth year in a row.
Furthermore, NCLB's fiscal year 2007 authorization level for the
program is $2.5 billion. This is a program that enjoys extraordinary
public and bipartisan congressional support. All of us hear from
constituents who want and need more funding to develop more afterschool
programs in their communities. These programs help working families,
provide vital additional academic support to students and provide safe,
supervised environments for kids afterschool--priorities that appear to
match many of the President's major goals.
With such diverse, bipartisan support, why has the Department
continued to propose only $981 million for the program? That gap leaves
the States, communities, families and students--as many as 1.4 million
children--behind and more than 25 States unable to offer new grant
opportunities in fiscal year 2005.
Answer. The program does, indeed, enjoy bipartisan support in
Congress, and we do receive many letters from Members asking us to
increase funding. However, in a tight budget environment, we need to
target the limited available funding on programs that show evidence of
success or that have a strong potential to fill major unmet needs. The
results of the only national evaluation of 21st Century Community
Learning Centers were not very positive and did not present a case for
increasing the funding. However, the Department's Institute of
Education Sciences has launched a study of specific math and reading
interventions that will determine after-school programs' potential
impact on academic achievement. We will review the results of that
study, and also the program performance results that States submit, in
determining whether to request increases in future years.
civic education
Question. As you know, we face a crisis today with young people who
are disenchanted with politics; they are apathetic and cynical about
Government and its institutions. I was disappointed to discover the
elimination of the Education for Democracy Act in the President's
budget request. This program funds domestic civic and international
civic and economic education programs. The Civic Education program is
successful in helping American students understand and appreciate
fundamental values and principles of our Government.
Can you comment on why a program that is consistent with the
Administration's desire for American students to have a basic
understanding and appreciation of the workings of our Nation's
Government and politics along with its values and principles was
eliminated in the President's budget?
Answer. The Administration agrees that there is a critical need for
education programs that effectively promote basic understanding and
appreciation of the workings of our Nation's Government and politics,
along with it values and principles. However, we question the efficacy
and wisdom of statutorily mandating that 100 percent of funds available
for domestic civic education activities must go to a single
organization, particularly when so little is known about the efficacy
of civic education interventions developed and supported by this
organization. The Administration believes that a more effective
approach to addressing the issue is to invest in programs that make
competitive awards to local schools districts and other eligible
entities to help create safe learning environments where students
understand, care about, and act on core ethical and citizenship values,
such as Character Education (which would receive $24.2 million under
the President's request) and Safe Schools/Healthy Students (which would
receive $79.2 million under the President's request).
While the Civic Education program, as currently authorized,
supports some worthwhile activities, there are no reliable measures of
overall effectiveness of interventions supported using program funds.
Studies and evaluations conducted by the Center for Civic Education
provide limited information on program performance, but none are
sufficiently rigorous to yield reliable information on the overall
effectiveness or impact(s) of the various interventions supported
through this program.
The administration does not believe additional funding is necessary
for the implementation of activities currently supported by the Center
for Civic Education--an established non-profit organization with a
broad network of program participants, alumni, volunteers, and
financial supporters at the local, State, and national levels. The
Center also has a long history of success raising additional support
through such vehicles as selling program-related curricular materials,
training and workshops, partnering with non-profit groups on core
activities, lobbying, and seeking support from foundations.
SUBCOMMITTEE RECESS
Senator Specter. Thank you very much. The subcommittee will
stand in recess to reconvene at 10 a.m., Wednesday, May 3, in
room SD-226. At that time we will hear testimony from the
Honorable Michael Leavitt, Secretary, Department of Health and
Human Services.
[Whereupon, at 12 noon, Wednesday, March 1, the
subcommittee was recessed, to reconvene at 10 a.m., Wednesday,
May 3.]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, EDUCATION, AND RELATED
AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2007
----------
WEDNESDAY, MAY 3, 2006
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10:15 a.m., in room SD-226, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Craig, Harkin, Kohl, Murray, and
Durbin.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
STATEMENT OF HON. MICHAEL O. LEAVITT, SECRETARY
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. Good morning, ladies and gentlemen. The
hearing for the Appropriations Subcommittee on Labor, Health
and Human Services, Education, and Related Agencies will now
proceed. I regret a little late start here, but we have been
conferring with the distinguished Secretary of Health and Human
Services, and we wanted to get some background information
before coming into the public hearing. This is a very important
hearing because it involves the budget for the Department of
Health and Human Services, and health is our number one capital
asset. Without health, none of us can function.
I could give an extensive testimonial to that over the past
year, but I'll save that for another day and instead focus on
the proposals for Federal expenditures. I say at the outset, as
I have said privately to the Secretary, that I am very
disturbed at the reduction in funds for his Department. There
is a $1.6 billion reduction in funding for the Department of
Health and Human Services, and that follows a pattern of
reductions for--the other departments which are within the
purview of this subcommittee. There have been reductions of
some $2.2 billion for the Department of Education, reductions
for the Department of Labor so that effectively, from the
year--fiscal year 2005 until the present time, we have a
reduction of $15.7 billion, and that means that there are vital
programs for health, vital programs for human services which
are inadequately funded to start with and are now really
effectively starved.
The National Institutes of Health (NIH), which is the crown
jewel of the Federal Government, is level funded, and that
means taking into account inflation, there will be fewer grants
made, and there have been enormous advances made by NIH. The
leadership's been provided really from this subcommittee long
before you became Secretary, Mr. Secretary. When we took the
NIH budget from $12 to $29 billion, there have been remarkable
advances in the research on Alzheimer's and Parkinson's and
heart disease and cancer, but not enough.
As we speak, a very distinguished Federal jurist who has
been named the 101st Senator as suffering from prostate cancer,
and I lost my Chief of Staff, Carey Lackman, a beautiful young
woman of 48 recently from breast cancer. In 1970, President
Nixon declared war on cancer. If we had devoted the resources
to the war on cancer which we devote toward other wars, we
would have conquered cancer. In the past year, I have made the
Kleenex industry wealthy, Mr. Secretary. This is a lingering
aspect of chemotherapy treatment, and that brings me back to
personalizing it just for a paragraph or two, but had the war
on cancer been fought vigorously, I wouldn't have gotten
Hodgkin's, I believe. The chances are good I wouldn't have.
Well, that's the backdrop of these hearings and my views.
As I told you privately a few moments ago and I think it's
worth repeating publicly, the President called in a number of
committee chairmen last week for our views on what ought to be
done, and when I had the opportunity to talk to the President,
and I have had the opportunity to get to know President Bush
rather well, he was in Pennsylvania 44 times in 2004 when he
ran for reelection and I was up too, and I was with him on most
of those occasions, and I have a very high regard for the
President and the job he is doing notwithstanding the poll
figures. Up close, he is very much engaged, very much on top of
the job. The persona that comes through the news media is very
very different. But at any rate, he is prepared to hear candid
views even if they don't agree with his, and I told him about
the $15.7 billion reduction in spending and told him what was
happening in the National Institutes of Health. I know that you
are not the President, and as you reminded me, you are not even
the Director of the Office of Management and Budget (OMB), but
you are the Secretary of Health and Human Services. What I am
calling upon all of the candid officers where I have a
chairmanship and can make a constructive suggestion is to carry
this fight to the Director of OMB and carry this fight to the
President, and no department is more important than yours. To
have level funding for NIH and to have cuts in the Centers for
Disease Control and Prevention (CDC) with all the work CDC has
to undertake is just unacceptable.
Well, I appreciate your being here, Mr. Secretary, and I
genuinely appreciate the job you are doing--leaving the
Governorship of Utah, coming to Washington, tackling really big
issues, and this matter of pandemic flu is of gigantic
importance. Senator Harkin has been the leader, and I have
worked with him as his partner, and we have moved ahead against
some problems to produce $6.6 billion in funding. The potential
for the pandemic flu if it strikes could be calamitous. When it
has struck this country and the world in the past, millions of
people have died. That's a real danger, and I am pleased to see
what you are doing and what you plan to do even with major
announcements to come tomorrow. Senator Murray has a time
conflict, and I will yield to her at this time.
STATEMENT OF SENATOR PATTY MURRAY
Senator Murray. Well, thank you very much, Mr. Chairman. I
am managing the floor for the Democrats in the supplemental and
need to get back to the floor, and I appreciate the chairman
yielding. I would second his statement and thank him for being
the champion of NIH research, but also education and healthcare
and all of the things that fall under the purview of this
budget that you are presenting on behalf of the administration
and echo his comments that investments in these diseases,
investments in our future are absolutely critical to our Nation
and the strength of our Nation in the future. I want to thank
the chairman for his tremendous work on behalf of this and echo
his sentiments that I am deeply concerned about the cuts that
are coming. I can't stay for the questioning. I did want to
submit some for the record and tell you personally that I have
been out in the state talking to many seniors about the new
Medicare Part D prescription drug benefit.
MEDICARE PART D DEADLINE EXTENSION
Although I voted against it, I want it to work. I want our
seniors to be able to sign up for this and make it work. I am
very concerned about what I am hearing from seniors as this May
15 deadline looms from seniors who can't get access or think
they have signed up for something find out several weeks later
they haven't. Many seniors are holding back signing up for it
because they are worried about whether or not it's going to
cover their drugs. I mean, you have heard all of it as well,
and I hope that we can be thoughtful in our approach, and I
would encourage you to look at extending the deadline--at least
for those whose benefits don't begin until January of next year
at the very minimum so that we don't cause a lot of seniors
harm in the process. What I see is people signing up for these
plans out of fear rather than out of knowledge. I think in the
long run, we will all be hurt if that occurs, and I wanted to
encourage you to work with us and continue to work with us. I
know you are hearing some of the same things we are and really
would like to see this--and to talk with you about that, but I
specifically wanted to ask because we are now seeing seniors
who signed up January 1 fall into the donut hole.
There is tremendous concern about those seniors who had
pharmacy assistance plans who had drugs before who signed up
for a drug are now falling into that donut hole. Are they
considered uninsured, or are they considered insured for the
purposes of being covered under the pharmacy assistance plans--
and would like to get you or your staff to work with us as we
try to help those seniors through that challenge right now. But
Mr. Chairman, I will submit questions for the record, but I
would like you and all of us to seriously look at this May 15
deadline and try and accommodate many of these seniors who are
really having challenges who I think we don't want to lose in
this process, and we want to make sure that we have given them
a benefit and not given them some dire circumstances. So I
appreciate the opportunity to throw that out there and look
forward to working with you, Mr. Secretary.
Senator Specter. Thank you, Senator Murray. Before yielding
to Senator Craig, let me call upon our current distinguished
ranking member for an opening statement. Before you walked in,
Senator Harkin, I was praising you behind your back for your
leadership--the number one leader on the funding for pandemic
flu, and I said I was your partner, and the floor is yours.
STATEMENT OF SENATOR TOM HARKIN
Senator Harkin. Well, that's kind of you, Mr. Chairman, but
I just follow your lead--that's all. If some of the reflective
glory comes up, I am--that's all right, that's fine with me.
Mr. Chairman, first of all, I want to thank you for your great
leadership in so many areas--of course in this area of health.
There is no stronger champion for the National Institutes of
Health than the Senator from Pennsylvania.
I have been by his side in--well, it's now going on about
16 years now. If it weren't for Senator Specter's great
leadership, we would never have doubled the funding for NIH
that we did in the late 1990s and put it up where it is. Now,
of course, we have some problems now in making sure we continue
that funding, and of course that's one of the problems that I
have with the President's budget, and I am sure the chairman
does also.
Welcome the Secretary, and then we'll just get to some
questions in at that time.
Senator Specter. Okay. Thank you very much, Senator Harkin.
Senator Craig?
STATEMENT OF SENATOR LARRY CRAIG
Senator Craig. Well, Mr. Chairman, I want to welcome the
Secretary, and I must say that these two gentlemen struggle
mightily with a very tough budget that Congress and this Senate
have always supported, but your environment and our environment
is one that we are being increasingly squeezed out of
discretionary monies by mandatory spending. Someday, we'll get
brave enough to take it on in a responsible way. But until that
time, the struggle of the chairman and the ranking member and
this member will continue to go on because there has to be a
sense of fiscal responsibility. I just came from the floor
suggesting that the supplemental that we have got out there
deserved to be vetoed by a President who had sent a message
because it was about $10 billion out of line, and that's
because we can't quit spending around here without a collective
pressure being brought upon us. At the same time, there are
priorities of spending that we get squeezed away from. I will
say, Mr. Secretary, when I was home in the last recess, the
good news--even though the Senator from Washington expresses
continued concern about prescription drugs--is that you are
having a phenomenal success, and I hope you will speak about it
today. To stand up and bring on line a massive new program that
this one is and to already be able to register the kinds of
successes--someone said to me well, gee, it must have been
pushed off the front page by the price of oil. I said no, it
was pushed off the front page because there was less criticism
today and more praise as the results come in. I hope you will
share those with us. Deadlines are important to cause people to
react and to analyze and to decide on decisions that are
necessary for them to make in a confused world. I will lastly
say a couple of weeks ago, I am walking through the security
line at the Boise Airport, and the fellow checking my ID said
Senator, there are too many decisions, too many choices in
prescription drugs, and I said well, then you would have
preferred that we would have mandated a single program for you?
Oh no, not at all.
Then I said you need to get with it. He said I am and
laughed. I said you saving money? He said, a lot of money, but
it was a tough choice. He said I really had to force myself to
do a little studying. Thank you. I yield the floor.
Senator Specter. Thank you very much, Senator Craig.
Senator Durbin, would you care to make an opening statement?
STATEMENT OF SENATOR RICHARD DURBIN
MEDICARE PART D FORMULARY PRICES
Senator Durbin. Mr. Chairman, thank you very much. I would
just say briefly thank you, Mr. Secretary, for being here. I
think you have an awesome responsibility and some very
important programs that are under your control and leadership.
I would say on Medicare Part D that I will not quarrel with the
premise that offering senior citizens coverage for prescription
drugs is a good thing. It keeps them healthy and independent,
strong, and out of hospitals and nursing homes longer. That's
what they need. I do believe, though, that in my State there
are still over 300,000 people who haven't made that choice. I
don't know if that number has come down significantly in the
last few days, but they only have 2 weeks left before they face
a penalty for not making a choice. It is also a fact that those
who have made a choice in terms of their prescription drug plan
are going to be somewhat surprised to learn that the prices are
not locked in. The prices of the drugs--in fact, the
formulary--the available drugs that you can purchase under a
plan can change on a daily basis, which leads to some
uncertainty about their future. Many of us felt that it would
have been a better approach to allow Medicare to offer one
universal plan which consumers could choose if they like, allow
Medicare to bargain for deep discounts in drugs and to offer
them nationwide. Then if private insurers wanted to compete,
they would be allowed to. That position did not prevail. So, in
Illinois, it meant some 45 different choices for prescription
drug plans, and some seniors struggled with them. Many
pharmacists continue to struggle with them as of today.
NIH BUDGET CUTS
I would also want to echo what I know was said earlier by
Senator Harkin. The pride that we have taken in Congress in the
fact that the research money for the National Institutes of
Health was doubled over a period of time. A former congressman
from my State, John Porter, was the chairman of the
Appropriations subcommittee that led that effort. He couldn't
have made it without the cooperation and enthusiastic help from
the Senate side, and I think that Senators Specter and Harkin
are justifiably proud of that as well. But I am troubled that
we have seen that growth in NIH research stall in last year's
budget and this year's budget continues. It's hard for me to
believe that we are now at full capacity in terms of research
for new drugs in America. I do believe that we need to expand
the horizons, expand the opportunities to find cures for
diseases, and this budget does not reflect that, and I hope
that you will address that issue.
MEDICAL PROFESSIONAL AVAILABILITY
One other issue that troubles me is the availability of
medical professionals. With an aging American population, with
increased demands for medical help for all of us, we want to
make certain that when we push the button in our room, a nurse
will show up, that a good doctor will be there to tend to our
needs, and I am worried that we are not keeping up with that
demand for our society. Sadly, one of the ways that we
supplement our need for medical professionals is to go
overseas, and I have done it myself--to go to other countries
that will send us these medical professionals. In most cases,
these countries cannot afford to give up their own, but they do
because of the lure of living in the United States and the
attractive salaries that might be available for these medical
professionals. The only morally responsible thing that we can
do is to increase the number of medical professionals in
America. When it came to the Nurse Reinvestment Act, which
Senator Mikulski and others pushed forward, we have not
adequately funded it, and I think we are going to pay a price
for it in terms of medical professionals and this continuing
brain drain on the poorest countries in the world that are
sending us their medical professionals they desperately need.
As tough as it may be to practice medicine in the inner
city of Chicago, it could not compare to practicing it in the
Congo where there is one doctor for every 160,000 people, one
surgeon for every 3 million. That is an impossible situation,
and we make it worse because we bring those medical
professionals to the United States--many times at the expense
of these countries. The responsible thing for us to do is to
develop our own medical professionals to meet the needs in the
future. I hope that you will be able to tell us that your
budget addresses that. I look forward to your testimony, and
thank you for joining us today.
Senator Specter. Well, thank you, Senator Durbin. Well, we
welcome you here, Secretary Leavitt, notwithstanding the
opening statements of the Senators. You come to this position
with a very distinguished record in public service--elected
three times as Governor of the State of Utah, having served as
Administrator for the Environmental Protection Agency and
having taken over this very important job at the very beginning
of the President's second term in late January 2005. We give
you the floor, Mr. Secretary. Take as long as you like. Do not
run the clock on the Secretary.
SUMMARY STATEMENT OF HON. MICHAEL O. LEAVITT
Secretary Leavitt. Thank you, Senator. I will submit a
formal statement for the record.
Senator Specter. Your statement will be made a part of the
record and any other prepared statement.
FISCAL YEAR 2007 HHS BUDGET
Secretary Leavitt. You acknowledged in a very kind way my
service--previously as Governor. I will tell you that I value
every day I had that opportunity. However, I will also confess
to you that earlier this week, I spoke with my colleagues at
HHS and told them that I am among the few people I suspect in
the world who can honestly say I can think of nothing that I
would rather do in my life right now than exactly what I am
doing. The issues here are demanding, but they are
extraordinarily important to the people of this country and,
may I say, the world. I say that with a sense of gratitude and
humility with being in a position to have some impact on
delivering on the most noble of aspirations that our country
has--our desire to see cancer cured, to see other diseases
cured as well, to find ways in which we can prepare ourselves
for a pandemic influenza and to do the other things that are
currently my responsibility. I just want you to know that these
are difficult issues, but I am grateful for the opportunity to
serve the American people. The budget that I'll reflect today
is a big budget. It's $700 billion. $75.5 billion of that we
refer to as discretionary. Senator Craig referenced the fact
that that number is being squeezed by the fact that the rest of
the budget continues to grow at an alarming rate. I have a new
grandson. He is now 8 months old. When he turns 35, Medicare
alone--one of the programs that I am responsible to manage--
will be 8 percent of our gross domestic product. By the time he
retires at age 65, it will be 11 percent. I think everyone in
this room knows that any nation that has one program that pays
for the healthcare of those who have concluded their careers
will likely not be on the economic leader board. I am deeply
concerned about that as others are. It is having the impact of
constraining our discretionary budgets. The budget I am here
today to discuss is a deficit reduction budget. It is $1.5
billion less than the budget that I was here a year ago to
discuss. You mentioned my 11 years as Governor. During that
period of time, I was responsible as the chief executive of my
State to balance that budget, and I know that any time you are
doing a deficit reduction budget, you are dealing with programs
that have been on the budget for a very good reason and you are
having to basically offset good programs against good programs.
There are no easy choices here. There will be disagreement on
what the priorities should be. I acknowledge that, and my
purpose today is only to tell you the basis on which I made
decisions given the need for this deficit reduction budget. You
will find new initiatives here, things that I believe are
extraordinarily important and that are important to the
President, things that you have talked about.
One of the things I am concerned about is our investments.
At NIH, for example, we are seeking level funding at NIH, but
there are new initiatives at HHS--for example, what we call
critical path. Despite the fact that we have doubled the NIH
budget, the number of molecules that we are able to actually
take into the marketplace has been cut almost in half during
that period of time. What that tells me is that we have to
change the regulatory process and find new tools. So, one of
the new initiatives we call critical path is essentially 76
science projects, if you will, to find new ways of measuring
the efficacy and the safety of drugs that will allow us to
dramatically improve that rather dismal statistic. You will see
some Presidential initiatives here that will be familiar to
you, such as a continued expansion of the community health
centers. You will also see bioterrorism emphasized and pandemic
influenza preparedness. I hope we'll have a chance to talk at
some length about our preparation. It is a very important
matter, and we are giving it the highest level of priority at
HHS. I have laid out the discretionary budget and asked those
who helped me prepare it to use a set of principles--some
things you will see follow through this entire budget. Some of
those would be a pause in construction of new buildings, for
example. Another thing you will see is that there are programs
whose purposes have been addressed in other areas. I have
discovered, like in many departments of the Federal Government,
there are silos. There are places that deal in one silo with a
problem and places that deal with it in another, and I have
done my best to try to bring them together, and what that has
allowed me to do is to find a way to be more efficient. You
will see some programs with carryover funds where I have taken
those funds and put them into some other purpose.
PREPARED STATEMENT
Those are the means by which I have done it. I laid out a
group of principles. I have tried to target as opposed to
looking at general problems. I have tried to work at prevention
as opposed to just ongoing funding of dilemmas. I have tried to
look for places where there was new innovation. We'll get a
chance to talk about all of them. I won't take more time. I am
anxious to get directly to your questions, but I do want to
tell you how appreciative I am of the chance to serve the
American people and to be here today to work with you to
accomplish that same purpose.
[The statement follows:]
Prepared Statement of Hon. Michael O. Leavitt
Good morning, Mr. Chairman, Senator Harkin, and Members of the
Committee. I am honored to be here today to present to you the
President's fiscal year 2007 Budget for the Department of Health and
Human Services (HHS).
Over the past 5 years, the Department of Health and Human Services
has worked to make America healthier and safer. Today, we look forward
to building on that record of achievement. For that is what budgets
are--investments in the future. The President and I are setting out a
hopeful agenda for the upcoming fiscal year, one that strengthens
America against potential threats, heeds the call of compassion,
follows wise fiscal stewardship and advances our Nation's health.
In his January 31 State of the Union Address, the President
stressed that keeping America competitive requires us to be good
stewards of tax dollars. I believe that the President's fiscal year
2007 Budget takes important strides forward on national priorities
while keeping us on track to cut the deficit in half by 2009. It
protects the health of Americans against the threats of both
bioterrorism and a possible influenza pandemic; provides care for those
most in need; protects life, family and human dignity; enhances the
long-term health of our citizens; and improves the human condition
around the world. I would like to quickly highlight some key points of
this budget.
We are proposing new initiatives, such as expanded Health
Information Technology and domestic HIV/AIDS testing and treatment that
hold the promise for improving health care for all Americans. We are
continuing funding for Presidential initiatives, including Health
Centers, Access to Recovery, bioterrorism and pandemic influenza; and
we are also maintaining effective programs such as the Indian Health
Service, Head Start, and the National Institutes of Health.
We are a Nation at war. That must not be forgotten. We have seen
the harm that can be caused by a single anthrax-laced letter and we
must be ready to respond to a similar emergency--or something even
worse. To this end, the President's Budget calls for a four percent
increase in bioterrorism spending in fiscal year 2007. That will bring
the total budget up to $4.4 billion, an increase of $178 million over
last year's level.
This increase will enable us to accomplish a number of important
tasks. We will improve our medical surge capacity; increase the
medicines and supplies in the Strategic National Stockpile; support a
mass casualty care initiative; and promote the advanced development of
biodefense countermeasures to a stage of development so they can be
considered for procurement under Project BioShield.
We must also continue to prepare against a possible pandemic
influenza outbreak. We appreciate your support of $2.3 billion for the
second year of the President's Pandemic Influenza plan in the fiscal
year 2006 Emergency Supplemental Appropriations Act for Defense, the
Global War on Terror, and Hurricane Recovery. It is vital that this
funding be allocated in the most effective manner possible to achieve
our preparedness goals, including providing pandemic influenza vaccine
to every man, woman and child within six months of detection of
sustained human-to-human transmission of a bird flu virus; ensuring
access to enough antiviral treatment courses sufficient for 25 percent
of the U.S. population; and enhancing Federal, state and local as well
as international public health infrastructure and preparedness. We also
want to work with you to ensure that this funding is appropriated prior
to October 1, 2006.
The President's fiscal year 2007 budget also provides more than
$350 million for important ongoing pandemic influenza activities such
as safeguarding the Nation's food supply (FDA), global disease
surveillance (CDC), and accelerating the development of vaccines, drugs
and diagnostics (NIH).
The budget includes a new initiative of $188 million to fight HIV/
AIDS. These funds support the objective of testing for three million
additional Americans for HIV/AIDS and providing treatment for those
people who are on state waiting lists for AIDS medicine. This
initiative will enhance ongoing efforts through HHS that total $16.7
billion for HIV/AIDS research, prevention, and treatment this year.
The budget maintains the NIH, and includes important increases for
important crosscutting initiatives that will move us forward in our
battle to treat and prevent disease--$49 million for the Genes,
Environment and Health Initiative and $113 million for the Director's
Roadmap. In addition, it contains an additional $10 million for the
Food and Drug Administration to lead the way forward in the area of
personalized medicine and improved drug safety.
One of the most important themes in our budget is that it increases
funding for initiatives that are designed to enhance the health of
Americans for a long time to come. For instance, the President's Budget
calls for an increase of nearly $60 million in the Health Information
Technology Initiative. Among other things, these funds support the
development of electronic health records (to help meet President Bush's
goal for most Americans to have interoperable electronic health records
by 2014); consumer empowerment; chronic care management; and
Biosurveillance.
The Budget also includes several initiatives to protect life,
family and human dignity. These include, for example, $100 million in
competitive matching grants to States for family formation and healthy
marriage activities in TANF. The President's budget also promotes
independence and choice for individuals through vouchers that increase
access to substance abuse treatment.
In the area of entitlement programs, I want to begin by
congratulating you and other Members of Congress for having
successfully enacted many needed reforms by passing the Deficit
Reduction Act (DRA). DRA supports our commitment to sustainable growth
rates in our important Medicare and Medicaid programs. It also
strengthens the Child Support Enforcement program. The Deficit
Reduction Act also achieves the notable accomplishment of reauthorizing
Temporary Assistance for Needy Families (TANF), which has operated
under a series of short-term extensions since the program expired in
September 2002.
Medicaid has a compassionate goal to which we are committed. Part
of our obligation to the beneficiaries of this program is ensuring it
remains available well into the future to provide the high-quality care
they deserve. With its action on many of our proposals from last year
in the Deficit Reduction Act, the Congress has made Medicaid a more
sustainable program while improving care for beneficiaries. The
President's Budget proposals build on the DRA and include a modest
number of legislative proposals, which improve care and will save $1.5
billion over 5 years in Medicaid and S-CHIP and several administrative
proposals saving $12.2 billion over 5 years.
This Administration has also pursued a steady course toward
Medicare modernization. In just the past 3 years, we have brought
Medicare into the 21st century by adding a prescription drug benefit
and offering beneficiaries more health plan choices.
Medicare's new prescription drug benefit represents the most
significant improvement to senior health care benefits in 40 years. CMS
has already exceeded the enrollment target with more than 30 million
beneficiaries with drug coverage as of April 18, 2006. In addition,
almost 6 million Medicare beneficiaries get drug coverage from other
sources such as the Department of Veterans Affairs. This brings the
total to approximately 35.8 million Medicare beneficiaries who are now
receiving prescription drug coverage. In most cases, their coverage is
either completely new or much better and much more secure than it was
before.
Savings from the prescription drug benefit have been greater than
expected. CMS' Office of the Actuary initially estimated beneficiary
premiums averaging $37 per month. Today, however, the average monthly
premium is $25 a month. And in some parts of the country, beneficiaries
are seeing premiums of less than $2 per month. In 2006, the Federal
government is projected to spend about 20 percent less per person than
first estimated, and over the next 5 years, payments are projected to
be more than ten percent lower than first estimated. So taxpayers will
see significant savings and State contributions will be about 25
percent lower over the next decade for beneficiaries who are in both
Medicaid and Medicare. All these savings result from the lower expected
costs per beneficiary.
Our work to modernize Medicare is not done. Rapid growth in
Medicare spending over the long-term will place a substantial burden on
future budgets and the economy. The President's fiscal year 2007 Budget
includes a package of proposals that will save $36 billion over 5 years
and continue Medicare's steady course toward financial security, higher
quality, and greater efficiency.
The bulk of these Medicare savings will come from proposals to
adjust yearly payment updates for providers in an effort to recognize
and encourage greater productivity. These proposals are consistent with
the most recent recommendations of the Medicare Payment Advisory
Commission. To ensure more appropriate Medicare payments, the Budget
proposes changes to wheelchair and oxygen reimbursement, phase-out of
bad debt payments, enhancing Medicare Secondary Payer provisions, and
expanding competitive bidding to laboratory services. Building on
initial steps in the Medicare Modernization Act, the Budget proposes to
broaden the application of reduced premium subsidies for higher income
beneficiaries. Finally, the President's Budget proposes to strengthen
the Medicare Modernization Act provision that requires Trustees to
issue a warning if the share of Medicare funded by general revenue
exceeds 45 percent. The Budget would add a failsafe mechanism to
protect Medicare's finances in the event that action is not taken to
address the Trustees' warning. If legislation to address the Trustees'
warning is not enacted, the Budget proposes to require automatic
across-the-board cuts in Medicare payments. The Administration's
proposal would ensure that action is taken to improve Medicare's
sustainability.
President Bush proposes total outlays of nearly $700 billion for
Health and Human Services. That is an increase of more than $58 billion
from 2006, or more than 9.1 percent.
While overall spending will increase, HHS will also make its
contribution to keeping America competitive. To meet the President's
goal of cutting the deficit in half by 2009, we are decreasing HHS
discretionary spending. Our non-emergency request for discretionary
budget authority for programs under the jurisdiction of this
Subcommittee totals $61.1 billion, a decrease of $1.6 billion below
fiscal year 2006. The $2.3 billion for the cost of the next phase of
the President's plan to prepare against an influenza pandemic that I
discussed earlier is in addition to this amount.
I recognize that every program is important to someone. But we had
to make hard choices about well-intentioned programs. I understand that
reasonable people can come to different conclusions about which
programs are essential and which ones are not. That has been true with
every budget I've ever been involved with. It remains true today. There
is a tendency to assume that any reduction reflects a lack of caring.
But cutting a program does not imply an absence of compassion. When
there are fewer resources available, someone has to decide that it is
better to do one thing rather than another, or to put more resources
toward one goal instead of another.
Government is very good at working toward some goals, but it is
less efficient at pursuing others. Our budget reflects the areas that
have the highest pay-off potential.
To meet our goals, we have reduced or eliminated funding for
programs whose purposes are duplicative of those addressed in other
agencies. One example of this is Rural Health where we have proposed to
reduce this program in the Health Resources and Services
Administration. The Medicare Modernization Act contained several
provisions to support rural health, including increased spending in
rural America by $25 billion over 10 years. For example, it increases
Medicare Critical Access Hospitals (CAH) payments to 101 percent of
costs and broadens eligibility criteria for CAHs. Moreover, recognizing
that Congress adopted many of our saving proposals last year, we are
continuing to make performance-based reductions.
Our programs can work even more effectively than they do today. We
expect to be held accountable for spending the taxpayers' money more
efficiently and effectively every year. To assist you, the
Administration launched ExpectMore.gov, a website that provides candid
information about programs that are successful and programs that fall
short, and in both situations, what they are doing to improve their
performance next year. I encourage the Members of this Committee and
those interested in our programs to visit ExpectMore.gov, see how we
are doing, and hold us accountable for improving.
President Bush and I believe that America's best days are still
before her. We are confident that we can continue to help Americans
become healthier and more hopeful, live longer and better lives. Our
fiscal year 2007 budget is forward-looking and reflects that hopeful
outlook.
Thank you for the opportunity to testify. I will be happy to answer
your questions.
HISTORICAL PANDEMICS
Senator Specter. Thank you very much, Mr. Secretary. We'll
now go to the questioning by the Senators with 5-minute rounds.
In the second round, Mr. Secretary, I intend to go into the
budget cuts on the Centers for Disease Control and the National
Institutes of Health and others which, as I have outlined
earlier, I think totally unacceptable, but let me begin with
the issue of the threat of the pandemic flu. There is a draft
report, which has appeared publicly, where you are stockpiling
75 million doses of antiviral drugs and 20 million doses of
vaccines. There are projections that there could be as much as
40 percent of the workforce absent. There are guidelines to
keep people from congregating together. There is even a note
about local police departments and National Guard would have
the primary responsibility for keeping order, but the military
would be available to assist. This sounds like a very, very
stark situation. We know that when such disasters have occurred
in the past, there have been millions who have been killed. One
of the really important matters to be covered is to acquaint
the public with what the problems are--that it may be difficult
or dangerous to go to the grocery store, that it is important
to have a supply of water, that there ought to be provisions
made for a worst-case scenario. There have been articles, but
they are buried in the newspapers, and I do not think that
there is a real public understanding of the seriousness of this
program. Now, what you are saying here today is going to be
carried in the news media, and this hearing is being covered
live on C-SPAN, so it is reaching people as we speak. Stark as
it is, I think we ought to be very candid, very frank--brutally
frank with the potential nature of the problem. Now, Mr.
Secretary, what is the worst-case scenario? If it's as bad as
it can be, how bad would that be?
Secretary Leavitt. Mr. Chairman, pandemics happen. They
have happened through all-time. You can date back to ancient
Athens--25 percent of that city was wiped out because of
disease. You can roll forward, and virtually every century, you
will see two or three pandemics. In the 14th century--Black
Death, perhaps the best known, killed 25 million people across
Europe.
Senator Specter. How many people died in the pandemic in
the United States not long into the 20th century?
Secretary Leavitt. Your point is a very good one. We have
had 10 pandemics in the last 300 years. We have had three
pandemics in the last 100 years. In 1968 and 1957--a lot of
people got sick. Not many people died. In 1918, however, many
people got sick and regrettably, millions died. If we were to
have a pandemic of equal proportion to that which occurred in
1918, roughly 90 million people in the United States would
become ill. About half of those--45 million would become sick
enough that they would require some form of serious medical
attention, and about 2 million people, regrettably, would die.
Senator Specter. Well, those are pretty stark figures--90
million, about one-third--almost one-third of the population,
and you say millions would die. What basic precautions should
people take?
PANDEMIC INFLUENZA PREPAREDNESS
Secretary Leavitt. Well, for that reason, the President has
asked that we mobilize the country. I have committed that we
would hold pandemic summits in all 50 States. So far, we have
had 46 of them. We are mobilizing State and local governments.
We are also working to develop a global monitoring system.
Senator Specter. What should individual citizens do? Should
individual citizens stock up on water? Should individual
citizens stock up on food?
Secretary Leavitt. Mr. Chairman, the preparation for a
pandemic is essentially the same preparation that needs to
occur in any disaster. It's a good idea to have some
nonperishable food stored at your home. That would be true for
a hurricane or a tornado. It would be a good idea for a
bioterrorism event or a nuclear event. It would be true as well
for a pandemic. It's a good idea to have a first aid kit and to
have prescription drugs stocked up in a way that if you were to
need your supply and couldn't get to the drug store that you
would have it. It's a good idea to have thought through how you
would deal with your children--if you had to alternate going to
work with your spouse or if they both needed to stay home and
you had to have some kind of caregiving process. It's a good
idea to take the same precautions as in any other emergency
situation.
Senator Specter. The red light went on in the middle of
your answer, and I intend to observe the red light meticulously
because I ask all the members of the panel to do the same, and
now I yield to Senator Harkin.
PANDEMIC INFLUENZA VACCINE STOCKPILE
Senator Harkin. Thank you very much, Mr. Chairman. Again,
welcome Mr. Secretary. Again, I just want to point out that
this committee--the Senate went on record 73 to 27 on an
amendment offered by Senator Specter on the budget to increase
our budget allocation by $7 billion for health and education
programs, much of which would go to this Department to make up
for a lot of the cuts that we see in this budget. Of course, we
don't have a budget yet. The House can't seem to pass one. So,
I don't know what's going to happen on that later on down the
pipe, but I am hopeful that that $7 billion that Senator
Specter and 72 other Senators voted to support stays in there.
If that's the case, then we can make up for some of the cuts
that are in your budget that I think are just devastating--the
cuts to Social Services Block Grants by $500 million,
eliminating the Community Services Block Grant programs, the
cuts--as you said, the level funding for NIH, which translates
into cuts for some of NIH and for the Centers for Disease
Control, the cuts on rural health programs, poison control
centers, health professions trainings programs--all of these
things all got cuts--all got cuts. Quite frankly, with the
needs that we have out there, these cuts cannot stand, and
that's why I am hopeful that we can get that $7 billion. Now, I
want to follow up a little bit on the Avian Flu. I want to see
if we can clarify the issue of stockpiling of antivirals. The
World Health Organization recommended that countries stockpile
sufficient antivirals to treat 25 percent of their populations.
In your written statement, you concur with that goal. That
would equate to about 80 million Americans. I understand that
your Department has ordered or has on hand enough antivirals to
treat about 26 million individuals, so that leaves about 50
million--60 million short. I understand that you anticipate
States will order 30 million courses of antivirals. The
Government will subsidize that at 25 percent of the cost.
States have been asked to place their orders with you by July--
by this July. The final course of treatment will be ordered
using pending funds--2007--next year funds. Well now, again, I
laid that groundwork to say that--are there any States that
have indicated that they will not be able to order these
medications because they have a lack of funds or a lack of
legislative authority to do so?
Secretary Leavitt. No State has made that statement to us
at this point.
Senator Harkin. Okay. What is your plan if States don't
order these treatments by July?
Secretary Leavitt. We intend to acquire 50 million courses
of antivirals.
Senator Harkin. You mean 50 million over the 20 you have?
Secretary Leavitt. Let me reconcile the entire amount and
then give you the timeframes. We will have by the end of 2006
the 26 million that you have spoken of. We will have by 2008,
50 million that will have been purchased by Federal money and
that will be available for distribution.
Senator Harkin. Okay.
PANDEMIC INFLUENZA VACCINE DISTRIBUTION
Secretary Leavitt. We will make a distribution of that 50
million among the States on essentially a proportionate basis.
So they will have that available to them in its entirety by the
end of 2007. Each of the States then has an opportunity to
supplement that--their proportionate share of that 50 million,
and we will subsidize it by 25 percent up to their
proportionate share of the remaining 31 million. We anticipated
originally that we would ask States to make that decision by
July. Since that information was provided to you, we have made
a decision that we will allow them to buy off of our order and
at the same time, deal directly with the manufacturer so that
they could be more efficient rather than go through us.
Senator Harkin. My time is running out. Mr. Secretary, in
the case of a pandemic, State, and local health departments
will have to distribute the vaccines. Are you encouraging
States to organize mass vaccination exercises during this next
flu season to get ready for that?
Secretary Leavitt. We are.
Senator Harkin. If so, will you allow the States to use a
portion of the $350 million that we allocated for that to
purchase annual flu vaccine?
Secretary Leavitt. Actually, we would prefer that they
utilize the $350 million to build up the public health
infrastructure and to reach deep into the community to be able
to do the kinds of things that Senator Specter was talking
about.
Senator Harkin. But isn't one way to do that is to purchase
annual flu vaccine and put in place an infrastructure----
Secretary Leavitt. Oh.
Senator Harkin [continuing]. To distribute it? That's what
I am saying.
That's what I am talking about.
Secretary Leavitt. I misunderstood your question.
Senator Harkin. Yeah.
Secretary Leavitt. At this point, we have not begun to
distribute the stockpile of vaccine that we have. It is
relatively small, but we will not release it until such time as
we have seen person-to-person transmission.
Senator Harkin. No, now we're--my time is running out, and
that's not what I am talking about. What I am talking about is
the annual flu vaccine.
Secretary Leavitt. Oh.
Senator Harkin. Is we put $350 million for--to build up
State and local structures in case of a pandemic. One of the
ways to test that to see if it works, to do it is to buy the
annual flu vaccine and say okay, we are going to set up
processes and methodologies to get that annual flu vaccine out.
Secretary Leavitt. Third time is the charm, Senator. You
got it.
Senator Harkin. Okay.
Secretary Leavitt. I think you finally reached me.
Senator Harkin. So, my question--would they be allowed to
use some of that $350 million to purchase the annual flu
vaccine to test modalities out there to--how to get it out?
Secretary Leavitt. I hadn't thought of that.
Senator Harkin. Oh.
Secretary Leavitt. It's a really interesting idea----
Senator Harkin. Okay.
Secretary Leavitt [continuing]. I'd be happy to give it
some thought and respond back to you.
Senator Harkin. I appreciate that. Thanks, Mr. Secretary.
All right.
[The information follows:]
Pandemic Influenza Infrastructure
A major component of the $350 million allocated to States for
pandemic influenza planning is for States to exercise their plans.
States are permitted to use Public Health Emergency Preparedness
cooperative agreement funds to purchase vaccine in limited quantities
for the purpose of conducting drills and exercises. At this time, they
are not permitted to purchase annual vaccine with the emergency
supplemental funding for pandemic influenza preparedness. However, they
may use some of these emergency supplemental funds during the influenza
season as an opportunity to exercise mass vaccination plans.
Senator Specter. Thank you, Senator Harkin. Senator Craig?
COMMUNITY HEALTH CENTERS
Senator Craig. Thank you very much, Mr. Chairman. Mr.
Secretary, during the Easter recess when I was back in Idaho, I
visited a community health center, and I do that on a regular
basis to see how it's working, who they are serving, how they
are serving, and it is really one of those kind of unsung
success stories out there that some of us fail to recognize.
Obviously, this present--President hasn't failed to recognize
that to lower income Americans, one way to serve them is making
sure the door is open, and community health centers do that
very well. This particular community health center in Nampa,
Idaho told me that in the year, they had served over 25,000
people, and the place was full, the parking lot was full, and
the doctors and nurses there were very pleased with the work
they were doing. Should this committee be concerned that
expansion of new facilities coupled with a reduction in funds
for training personnel to work in those facilities will slow
the service--access to service in communities that need these
facilities or worse--exacerbate shortages in medical personnel
across the country?
Secretary Leavitt. Mr. Senator, as I indicated earlier,
this is one of the President's high priorities, and this budget
includes funds to continue forward in his goal of providing
1,200 new or expanded community health center sites. This
includes enough for 300, 80 of which will be in the highest
poverty counties. This is a passion for the President and for
me, and we are working with every asset we have to continue
moving it forward.
Senator Craig. Okay. So as I said, funds as it relates to
the training of personnel, we don't--you don't see that as a
problem in relation to standing these up and facilitating them
for service?
Secretary Leavitt. As I speak with those who run and
operate these in the same way that you have, there are always
needs there.
Senator Craig. Yeah.
Secretary Leavitt. I would not want to say that we will
have quenched that, but we do recognize that training is a
component of it and want to meet those needs.
WELLNESS AND DISEASE PREVENTION
Senator Craig. Okay. Mr. Secretary, myself and other
Senators consistently over time have introduced legislation to
authorize Medicare to cover medical nutritional therapy
services for some beneficiaries. However, there is generally a
cost associated with any legislation, and that usually gives us
problems in this area. I am one who believes that good health
oftentimes brings down costs as it relates to healthcare and
that we ought to be increasing advocates of that instead of
repairs of broken bodies, if you will, after the fact. Can you
give me your general views based on your experience in
implementing programs designed for health and wellness as
opposed to programs designed to intervene or respond to long
after diseases and ailments have onset?
Secretary Leavitt. I believe, Senator, it should become our
entire focus. When I say entire focus--until we begin to view
wellness with the same passion we do treatment, not only will
we not see improvement in our health, we will not see
improvement in our fiscal health. I believe that is one of the
reasons--in fact, one of the primary reasons, why the new Part
D prescription drug benefit is such a historic point in time.
For the first time, we have begun to provide for seniors the
prescription drugs they need to stay healthy as opposed to
simply treating them after they are sick. Over and over again,
as I have traveled the country meeting with seniors, I have
heard stories of people who have had heart operations, ulcer
operations, and osteoporosis treatments that could have been
prevented with a small amount of prescription drugs at the
onset as opposed to the treatment at the end.
MEDICARE PART D ENROLLMENT
Senator Craig. Well, my time is up, but you segued nicely
from my request for a response as it relates to medical
nutritional therapy and to prescription drugs. Could you for a
moment give us some of the current figures as to where we are
with participation as to where we thought we would be and some
of the savings that are now already appearing on the scene?
Secretary Leavitt. We anticipated that in the first year,
we would see 28 to 30 million people enroll. We have now
exceeded 30 million. We anticipate between now and the 15 of
May that we will have--I don't know exactly of course, but
another couple million. If you assume that that's 32 million,
there are 42 million in total who are eligible. There are 6
million who are getting coverage from either a private employer
or some other source. If you add that 6 to the 32, you get 38.
That would mean we have a shot at being able to have enrolled
90 percent of every senior who is eligible for this benefit
during the first year. That is a remarkable achievement in my
mind, and it's a tribute not just to the Centers for Medicare
and Medicaid Services (CMS), but to the thousands of
pharmacists, the thousands of volunteers, the tens of thousands
of people all over this country who have been involved in
reaching out to seniors in their homes, in their places of
worship, in their senior centers. The other good news is the
cost is coming down. The program is getting better everyday.
The cost is coming down, and we are getting people enrolled.
Senator Craig. Thank you. It is a success story. We
appreciate it.
Senator Specter. Thank you very much, Senator Craig. Under
the early bird rule, we turn to Senator Durbin.
MEDICARE PART D ENROLLMENT DEADLINE
Senator Durbin. So, Mr. Secretary, there is more to the
story, and here is the rest of the story. The Bush
administration says that 35.8 million Medicare beneficiaries
will have drug coverage as of mid-April. The truth is 75
percent of those people--more than 26 million--already had
prescription drug coverage before January 1 of this year
through their employer, the VA or Medicaid. So there were 16
million Medicare beneficiaries who previously did not have drug
coverage. Only half or about 9 million have signed up for the
benefit. Millions need more time. In my State of Illinois,
606,000 people have not signed up for Part D, and the clock is
ticking. It's less than 2 weeks away. Forty-five different plan
choices, people--some of whom are flat on their back in nursing
homes and in no position to make these choices--I think we have
to acknowledge the obvious. Come May 15, the law will impose a
penalty on a lot of people who did their best and just couldn't
get this done, and I want to ask you point-blank do you think
we ought to extend the signup deadline beyond May 15? Number
two--should you allow senior citizens a do-over if they picked
a bad plan that dropped the formulary, increased the cost? Do
you think that that will be a reasonable way to deal with
clearly a challenge that has not been met?
Secretary Leavitt. Senator, millions of people--tens of
millions of people--have prescription drug coverage who did not
have it before. That is a great step forward, something I
believe you would concur with. Let me again say that I believe
that when May 15 comes, we will have reached roughly 90 percent
of those who are eligible. Of the remaining 10 percent, about
half of them will be a population that, granted, is very
difficult to reach.
Senator Durbin. But----
Secretary Leavitt. We have had that problem--I want to
answer your question. About half of them are in a low-income
status, and we have granted them the ability if they qualify
for the extra help--the people that you are most concerned
about--we will not require that they wait until the next
enrollment period. They will have no penalty, and they will
have no wait.
Senator Durbin. So increasing monthly premiums of 1 percent
for every month past the deadline--are you going to waive that?
Secretary Leavitt. If you are in fact a low-income eligible
person, you will not have a penalty, and you will not be
required to wait until the next enrollment period.
Senator Durbin. Will the administration support extending
the deadline beyond May 15?
Secretary Leavitt. We believe that a deadline is necessary
and that it is working. The Government actuary told us if we
did not have a deadline, we would have substantially fewer
people. We believe that the plan requires the time to mature.
We think that the--that half of the people who are--who have
yet to enroll will be eligible to enroll during that period
once they have qualified for extra help.
Senator Durbin. I think that we are missing the point here.
Of the universe of people who did not have prescription drug
coverage on January 1, some 25--let me get the figure correct
here--25 percent of the Medicare beneficiaries, about 15
percent of that number will have signed up by May 15, and 10
percent will have not. So 60 percent of our goal will have been
reached, but 40 percent not. You are shaking your head, but
those are the numbers, and we get the report from your agency
county by county. 606,000 people in my State, and we have done
our best. What I say to you is I hope that you will understand
their predicament, that the administration will relent and give
these seniors a second chance to sign up without penalty.
Second, if they have made a bad choice, I hope you will give
them a chance to have a do-over, a makeover, support
legislation that we have introduced. They can pick a plan that
really is better for them. If I might ask one other question--
I'm going to run out of time. I am worried about whether or not
we are doing what we need to do for our children on our watch.
I go to schools across my State, and I ask a simple question--
how many here have someone in your family with asthma? You will
see more than half the hands go up. You can tell by looking at
the children we are dealing with obesity. We know that one out
of every 160 children in America have autism at this point. How
can we deal with these issues when we are facing a budget that
is going to make such significant cuts in the Centers for
Disease Control and Prevention, in the National Institutes of
Health and that eliminates the NIH National Children's Study?
How can we find out what's happening out there and really
protect our children against what appears to be an onset of
some terrible health challenges?
MEDICARE PART D PLAN CHOICE
Secretary Leavitt. Senator, we do have an epidemic of
obesity, particularly among our young people, and the Centers
for Disease Control and Prevention does have a role as would
many other agencies at HHS, and we are prepared to join with
you in every way we can to assure that that occurs. It is a
very serious problem. I would like to just mention one other
thing on the choice of plans. A statistic I learned that I
think you will find interesting--we did develop a standard plan
that was recommended by the Congress. Only 10 percent of the
more than 30 million people now have chosen that plan, which
tells me that it was very important to people that they have a
choice and that they are able to choose a plan that fits their
situation. I know from signing a lot of people up that if they
had just had to deal with the standard plan, no matter what it
was, it would not have served them well. The plan will be
simplified in the next version in the same way that the market
has allowed for it to become better. We are all going to get
better at this as time goes on. In 1965, Medicare became law.
It got better in 1966. It got better in 1967. The plans are now
maturing. The pharmacies are learning how to use the system.
The consumers are now better informed. We are getting better at
what we do. This is a very important milestone--undoubtedly the
most important thing that's happened in healthcare in the last
40 years.
Senator Durbin. Thank you.
Senator Specter. Thank you, Senator Durbin. Senator Kohl?
FDA GENERIC DRUG APPLICATIONS
Senator Kohl. Thank you, Mr. Chairman. Mr. Secretary, the
FDA currently has a backlog of more than 800 generic drug
applications, which is an all-time high, and FDA officials
expect a record number of generic applications this year and an
even larger backlog. The Congressional Budget Office estimates
the use of generics provides a savings of $8 to $10 billion to
consumers every year, and that doesn't include the billions of
dollars more of savings to hospitals, Medicare, and Medicaid. I
believe it's now more important than ever that we speed less
expensive generic drugs to market, and I would think that you
agree. So do you support an increase in the FDA budget to help
reduce this backlog, and how much do you believe the FDA needs
to efficiently reduce the backlog and pass along the savings to
our people and also to the Federal Government?
Secretary Leavitt. Senator Kohl, I concur with you that
there is a need to speed generic drugs to market. It is a good
thing for consumers. It's a good thing for healthcare. We are
taking steps to do just that--not only to speed them, but to
prioritize them. The budget that I have proposed is the budget
we have proposed. We think we can accomplish that within the
budget that we have suggested.
Senator Kohl. So you are not proposing any increase in the
budget to help reduce this backlog?
Secretary Leavitt. We are putting substantial focus on it,
however, I will tell you, at FDA.
Senator Kohl. I'd like to hope that's going to happen, that
in fact we will get the kinds of numbers--increases that we
need, that I think you believe we need, and you are saying that
it's going to happen?
Secretary Leavitt. Let me suggest one piece of information
that might at least give you some insight into this. Of the 800
applications, some of them are essentially for the same
chemical or same molecule. So, we have begun to focus on those
on in which there is not one generic or two generics. In other
words, we want to get new generics into the market as opposed
to a repeat of existing molecules that have been made available
in some generic form. Now, we think we can do this better, and
I think we have to.
ADMINISTRATION ON AGING (AOA) BUDGET CUTS
Senator Kohl. Mr. Secretary, some of the most painful cuts
in the budget are programs under the Administration on Aging,
which takes a $28 million hit in programs like Meals On Wheels
and family caregiver support services. That means that--well,
in my State, Wisconsin senior population continues to grow from
705,000 senior citizens in 2000 all the way up to 1.2 million
senior citizens estimated for 2025. The budget does not account
for the growth and the need for services. In addition, this
budget proposes to eliminate Alzheimer's demonstration grants.
In Wisconsin, the Alzheimer's Association is in its first year
of a 3-year grant where they are working in Jefferson County on
a program to open a dementia care clinic at a hospital in Fort
Atkinson in Jefferson County. It is the first of its kind and
the only one in the area, and they would lose their funding
after this year should this budget prevail. So how do you
explain your plan to cut these vital programs while at the same
time our aging population is growing?
Secretary Leavitt. Senator, you have listed a number of
different areas, so let me do my best to respond to them and to
give you a sense of what was going on in here when I made these
decisions. I asked my budget team to essentially use a series
of principles. One of them I asked them is to look for one-time
funds. So part of that may be one-time funds where the project
was completed and hence wasn't repeated. Another principle was
looking for programs where purposes were involved in a number
of different places at HHS. So, it's possible that some of
those were there. There were also some funds that were carried
over from existing programs that I didn't repeat. Now, I can't
respond directly. If you'd like me to get to you specifically
with those, I'd be happy to respond, but my guess is that we'll
find that those principles are the ones that were involved in
helping to make the decisions we did.
Senator Kohl. I would like some more information on those
particular programs.
Secretary Leavitt. We'll be happy to respond to that.
[The information follows:]
Alzheimer's Demonstration Grants
For 14 years under the Alzheimer's Disease Demonstration Grant to
States Program (ADDGS), demonstrations in almost every State have
highlighted successful, effective approaches for serving people with
Alzheimer's. Similar to Preventive Health Services, it is time to put
these models and the lessons that have been learned to work by moving
them in AoA's core services programs--especially the National Family
Caregiver Support Progam--as a number of States have already done.
The fiscal year 2007 President's budget includes the elimination of
ADDGS. This reflects that demonstration projects for individual with
Alzheimer's and their caregivers are ready to be incorporated into the
core activities of the National Aging Services Network.
RURAL HEALTHCARE
Senator Kohl. There are a number of programs in your
Department aimed at bolstering rural health. Wisconsin, one of
the biggest beneficiaries in the country, received over
$600,000 from the Rural Hospital Flexibility Grant Program just
last year. This funding is used at over 60 rural hospitals that
serve anywhere from 10,000 to 12,000 patients every year. The
President's budget proposes to eliminate the Rural Hospital
Flexibility Grant Program, the rural and community access to
emergency devices and area health education centers. So how are
rural communities expected to meet their unique healthcare
challenges when these very important resources are being
severely diminished?
Secretary Leavitt. I, like you, come from a State where
rural medicine is a very important part of the social fabric of
our State, and so I have become quite sensitive to this. We
have adopted a slightly different strategy and that is to try
to bolster the reimbursement rates for providers in those
areas. I have also begun to look for places, frankly, where I
wasn't able to justify or I wasn't able to see a result. We
have invested about $25 billion through higher reimbursements
in rural areas, and that's the way we are intending for many of
those funds to be replaced.
Senator Kohl. Thank you, Mr. Chairman.
CDC BUDGET CUTS
Senator Specter. Thank you very much, Senator Kohl. On
round two, we begin now with Mr. Secretary. With respect to the
budget cuts, the Centers for Disease Control and Prevention has
been cut by $67 million this year. They have enormous
responsibilities in many many areas which I shall not
enumerate, and now we are looking to give them even greater
responsibilities if there should be a pandemic flu. Dr. Julie
Gerberding, a very distinguished Director of CDC, has sat at
your side testifying, preparing on this item. The physical
plant of CDC was a shambles when I visited it several years
ago. Prize-winning scientists were sitting in hallways, toxic
materials were not under lock and key, and we have carved out
funds within our existing budget to fund almost a billion and a
half dollars. Immediately, Senator Harkin and I found $137
million. Now, the budget has been cut from $159 million to $30
million--a $129 million cut. I have been lobbied very heavily
by people in the Atlanta community to find the funds, but I
can't find money out of thin air. How can CDC be realistically
cut and their physical plant not improved given the increased
responsibilities that you as Secretary are calling on them to
perform?
Secretary Leavitt. Senator, may I acknowledge that the work
that this committee has done to be supportive of CDC is not
just noticeable, but revered, and I also acknowledge that the
budget that we are presenting to you is reduced by $179
million. Within that total reduction, the buildings and
facilities as far as new construction does make up $129 million
of that. We have felt in a budget with a reduction or a deficit
that we have made substantial progress in this area.
Senator Specter. Should we stop the rebuilding?
Secretary Leavitt. Well, we believe that we are capable of
pausing on what will be a long-term strategy to continue to
improve the facilities. We have made substantial progress. They
are remarkable facilities, and I want to express my enthusiasm
for how much the campus has been improved, and I want to
acknowledge as well the role of you and Senator Harkin in
accomplishing that.
Senator Specter. Let me ask you to submit the balance of
your answer in writing so I can go onto NIH.
[The information follows:]
CDC Physical Plant
CDC has made remarkable progress on its Master Plan with $1.2
billion invested to date to upgrade their facilities. Since 2000, CDC
has initiated or completed the construction of more than 2.7 million
gross square feet (gsf) of laboratory and facility space. For fiscal
year 2007, we have included $30 million for repairs and improvements of
CDC facilities.
Consistent across HHS, our request focuses on finishing projects
that are near completion and maintaining existing facilities. No funds
are requested to initiate new construction.
NIH RESEARCH GRANTS
Senator Specter. NIH tells us that there are going to be
more than 800 applications--no, 656 fewer applications, fewer
ideas submitted. I am worried that there may be some for breast
cancer in that group or prostate cancer or Hodgkin's. How can
the crown jewel of the Federal Government--perhaps the only
jewel of the Federal Government be cut in funds?
Secretary Leavitt. Senator, I want to tell you again I
agree with you that funding new research ideas is a vital,
important priority and that the fiscal year 2007 budget
finances 275 more new grants. Now, one of the things you will
see is that the actual number doesn't reflect it because a lot
of expiring noncompeting grants diminish the number. When we
implemented the effort that you instigated in this committee to
double the amount of funding, there was a huge amount of new
grants. So, what we are in is the first year where there are
not as many non-competing continuation grants.
Senator Specter. Well, there will be a lot of grant
applications denied and a lot of existing grant applications
denied. I get lots of letters, and one illustrates it from
Pittsburgh--what am I going to do, Senator Specter, on the
tremendous progress I am making if they are going to cut off
the funding and the grant's going to be withdrawn? Really, Mr.
Secretary, this--these are not issues that can be handled
within the purview of the funds which you are allocated. We are
going to have to have a fundamental reassessment as to
priorities.
My red light just went on, but you--the red light doesn't
apply to you, Mr. Secretary, just to my questions.
Secretary Leavitt. I'd like to acknowledge that we are
working to find opportunities for new investigators and for new
innovations, and one of the things we are doing, frankly, is
reevaluating the grants. After they have been concluded, then
people must recompete. In some cases, there are research
projects that simply don't stack up to the opportunities
because we have essentially been able to get the value from
them that the peer review process believes would be to our
advantage. So, we have begun to redeploy that into new grants.
So, the actual number of new projects is higher than it appears
because of the decline in the number of noncompeting grants.
The red light's on, and I am sensitive to it.
Senator Specter. Well, I turn now to the second round for
Senator Harkin, and I am anxious to see if he follows his
customary pattern of having really tough questions in the
second round.
Secretary Leavitt. I am going to watch that too.
NIH FUNDING LEVELS
Senator Harkin. You're putting me on the spot here. Just to
follow up on the distinguished chairman's line of questioning
on NIH--when we worked hard in a bipartisan fashion with so
many others to double the funding for NIH, it was not meant to
just double it and then reach a plateau and plateau off. We did
this because for years, it had been underfunded, and we wanted
to get it back up to where it had been maybe 25 years ago and
continue the funding up. It was not meant to get it up and say
oh, now we can level off. That's what I see happening, and we
are falling into the same pattern that we did 30 years ago when
NIH all of a sudden had--it was getting out maybe 4 or 5 peer-
reviewed grants per every 10 that came in--30 percent--40
percent--50 percent. Now, we are getting down to 10 percent
again. So it's like we're plateauing off again. So we are going
to do this, and 10 years from now when we are probably gone,
somebody will be kind of like well, we're going to have to
double the funding again--not a good way to run things. So, I
kind of plead with you use your counsels within the executive
branch to tell them this is just not--this is not good. We--and
I think that's why we had so much support for the amendment
that Senator Specter offered on the $7 billion. A lot of it had
to do with we are not going to let NIH fall into that same rut
again. Well, that's a statement, and that's not a question--
darn it. Well, I had another statement too.
PANDEMIC INFLUENZA VACCINE
I won't get into that, but on the flu vaccine, I do want to
follow up a little bit on that. I have legislation in that
would provide for a free flu shot for everyone every year--free
flu--the Federal Government just provides a free flu shot. Now,
why is that? Well, I am thinking about the vaccines and the--we
have to get the infrastructure up for the pandemic flu that
may--a lot of signs say is coming. As you point out, we have
pandemics every so often. The infrastructure is not there to
deliver it. So, if you had a free flu shot for everyone every
year, not only do you save 35,000 lives a year perhaps or at
least a good portion of those, you save a lot of
hospitalizations, you save a lot of money if everyone got a
free flu shot every year. Plus you get the States in to think
about how you get it out there. You know, how do we start
inoculating people in Wal-Marts and sporting centers, high
schools, maybe even churches--after church or synagogue, they
could get inoculated. In other words, to set up a system so
that if a pandemic hits--bang, you have got it there and you
can get it out. So I hope that you will take a look at that and
see if there is any merit to getting a free flu shot for
everyone out there, and I don't know if you want to respond to
that or not.
Secretary Leavitt. I'd love to respond just briefly. I
believe one of the side benefits of our pandemic preparedness
is the ability to take the annual flu vaccine dilemma off the
table forever.
Senator Harkin. Yeah.
Secretary Leavitt. We will have to have new capacity
developed and have it operating continually to keep our
capacity warm----
Senator Harkin. That's right.
Secretary Leavitt [continuing]. The best thing to develop--
--
Senator Harkin. That's right.
Secretary Leavitt [continuing]. Would be new annual flu
vaccine.
Senator Harkin. That's right.
Secretary Leavitt. So, I fully believe that we will see
substantial increases in the availability of annual flu
vaccine. How we distribute it, what the cost is and so forth
will be a matter of policy, but we do need to increase it.
DISEASE PREVENTION
Senator Harkin. Well, I appreciate that. I will continue to
push that idea that we ought to just provide a free flu shot.
It's about--I estimated about--well, if you figure the flu
shot's about $10 for 200 million people, that's about $2
billion a year, but then the lives you save, the decrease in
hospitalizations--maybe won't cost that much, so you get a win
on the other side. Let me follow up on Senator Craig's
comments. I told him when he walked out I was going to follow
up on that, and I think I heard you say this was--your primary
concern is to get prevention out there. When you mentioned the
Medicare, that 8 percent GDP now going to 11 percent, the
answer is not just to provide more drugs for the elderly Part
D, and I don't mean to get into that contest there, but the
answer is just to start getting prevention earlier in life to
our kids as they go through life. Now, you know I have been
very concerned about child obesity, diet-related chronic
diseases, and one of the areas I am particularly interested in
is the junk food marketing that targets kids--its impact. Last
December, the IOM report, ``Food Marketing to Children: Threat
or Opportunity?'' was released in December. It outlined a
series of policy recommendations for government, the food and
beverage industry, schools, parents--designed to limit junk
food marketing and instead to utilize the power of marketing to
promote healthier diets. What's that got to do with you? Well,
the final recommendation of IOM was for the Secretary of Health
and Human Services to designate a responsible agency to
formally monitor and report regularly on the progress of all of
the recommendations in the report. On March 3 of this year, 14
Members of the Senate wrote to you urging you to implement this
final recommendation so that Congress can monitor the progress
made or not made toward the goal to see whether we need to do
something in that regard. Now again, I am not--don't want to
put you on the spot. We have not heard back from you, but that
was only March--that was March 3. But again, Mr. Secretary,
does HHS have any plans to take the action recommended by the
Institute of Medicine to appoint a monitoring body on food
marketing to children? If you don't have that answer, just----
Secretary Leavitt. I think I best respond to you----
Senator Harkin. Respond to me.
Secretary Leavitt [continuing]. In writing. I have read
about your concern about this, and I have begun to make
inquiries as to what the current status is.
[The information follows:]
Institute of Medicine Policy Recommendations
Obesity prevention is one of my top priorities. I have asked
Assistant Secretary for Health, Dr. John Q. Agwunobi, to work with all
of the HHS agencies and offices to explore this issue in depth, and
consider appropriate actions consistent with existing authorities and
available resources.
In addition, last year HHS and the Federal Trade Commission (FTC)
sponsored a joint workshop on the effects of food marketing on
children. On May 2, HHS and the Federal Trade Commission released a
report titled ``Perspectives on Marketing, Self-Regulation and
Childhood Obesity'' that recognizes that advertising and marketing can
play a positive role in encouraging sound nutrition and physical
activity.
The report includes a series of recommendations for food companies
and the entertainment industry to assist Americans in identifying more
nutritious, lower-calorie foods; increase efforts to educate parents
and children about nutrition and fitness; and to bolster the self-
regulatory strategies that are currently employed to monitor the
marketing of food and beverages to youth. In addition, the Council of
Better Business Bureaus and the National Advertising Review Council
recently announced the formation of a working group effort to review
and propose changes to the Children's Advertising Review Unit and its
self-regulatory guidelines.
Secretary Leavitt. Senator, could I just make one other
quick statement on a previous matter?
Senator Harkin. Sure.
NIH RESEARCH
Secretary Leavitt. I'd just like to acknowledge that--the
commitment that I feel to maintain the momentum of the research
we have going at NIH. I'll probably be the only one who will
say this is a good performance, but I have worked hard in a
deficit reduction budget to make sure that we kept it at least
flat. That is maybe good news only to me, but I wanted to tell
you I have worked hard on it and will continue to. I also
believe that what Dr. Zerhouni is doing with respect to trans-
institute projects with his Roadmap is a very important part of
the future. I would like to see a greater percentage of the $30
billion that we spend there every year for research on inter-
institute projects on basic science where all of the Institutes
will benefit. I think that's a more efficient way than simply
allocating to whatever disease or body part institute it is to
have their own project, and I would like at some point to work
with this committee to create a means by which that could be
accelerated. We need more cross-institute work. We need to have
less siloed research, multidisciplined research is clearly
where we will find success in the future.
Senator Harkin. I appreciate that. That's good.
COMPASSION CAPITAL FUND
Senator Specter. Thank you very much, Senator Harkin. Just
one final question before we conclude the hearing--Mr.
Secretary, I note that you and First Lady Laura Bush were in
Pittsburgh to talk about the progress on the initiative in
relating to gang control, a Capital Fund--Compassion Capital
Fund program--antigang efforts through a community and faith-
based organization back on March 7, 2005, and I would be
interested to know what your thinking is on any progress there.
The problem of gang warfare and shootings is epidemic and
endemic. Just this morning, two teenagers were shot straight
across from a high school in Philadelphia. The shootings are
virtually a daily occurrence. Recently, there was a gunfight.
Last week, two men were sentenced to life imprisonment for a
massive gunfight outside an elementary school in February 2004
which killed a 10-year-old. Are the funds made available
through this new program that you and First Lady Laura Bush
announced having any significant impact?
Secretary Leavitt. We are nearing the point in our process
of soliciting proposals. We have an obligation to come up and
review it with the committee, and we intend to do that. I think
at that point, we'll be in a position to evaluate together the
kinds of things those funds are being used for. We are quite
optimistic about it and hopeful that we can continue the
momentum of the program.
Senator Specter. Well, the announcement was sometime ago--
March 7, 2005. Have any grants been made under the program in
the intervening 15 months?
Secretary Leavitt. We have not yet received proposals. We
have an obligation to come to the committee to review them with
you before we do that, and we will do so.
Senator Specter. Well, we have put up a fair amount of
money last year, and you are asking for $35 million more this
year in a budget where there are cuts on some very vital
programs, so we don't want to keep those funds held in
abeyance. If they can be directed effectively to juvenile gang
problems, we want to do that.
Secretary Leavitt. Thank you.
Senator Specter. But if the money is not going to be
awarded so that we can see some positive results from those
funds, we want to use them elsewhere. Mr. Secretary, thank you.
Senator Harkin?
AGING SERVICES PROGRAMS
Senator Harkin. There was one thing I just--thank you, Mr.
Chairman--that I wanted to bring up before you left, Mr.
Secretary. When we first met when you came into my office when
your appointment was scheduled, one of the things I remember we
talked about was Systems Change Grants. Shortly after the
Olmstead decision by the Supreme Court, Senator Specter and I
started working to provide funds to help States get
deinstitutionalized or to prevent institutionalization, but get
people to deinstitutionalize. The Olmstead decision said you
know, we had to provide the least restrictive environment. So
we started this program called Real Systems Change Grants, and
we started putting money in it to implement these programs. I
believe, from all that I have known about it, it has been a
success year after year. But every year, we have to fight to
put the money into it. Again this year, the budget eliminates
funding for the grants again--once again, so we fight again to
put it in. Now, I now read that you have a new program in the
area--in the administration on aging called Choices for
Independence. Your budget's notes say, ``It seeks to reduce the
current systemic bias in favor of institutional care.'' Well,
that's what we were doing under Systems Change Grants. So
again, what's the difference? Is this new program meant to
replace it, to supplement it? I don't understand, and what's
the difference between the two programs? Why would you
eliminate the Systemic Change programs that we have been
funding and now come up with this new program?
Secretary Leavitt. Our purpose is to continue a portion of
it in the Administration on Aging. We do believe, as you have
stated, the need for us to deinstitutionalize and to have
people served in the communities and homes, and that's the
purpose. Perhaps we could provide you with more detail.
Senator Harkin. Well, provide me with more details because
it's not just aging. I mean, these are people with--a lot of
the time physical disabilities, sometimes with mental
disabilities, sometimes with both, but which has been proven
that in many cases can live in a community setting. But a lot
of times, it takes an initial expenditure made to get that
done. After they get out, they're fine. As you know, there is a
bias in Medicaid. Medicaid will pay for someone to be in an
institution, but that institution wants to live in a community,
they don't get that Medicaid support.
Secretary Leavitt. Something we'd like to change.
Senator Harkin. Well, I would like to change that too.
That's why we had this program. So I wish you would really look
at that. We are mandated--Supreme Court mandated. We got to--
they have got to deinstitutionalize. So, we need to change that
bias in Medicaid, and I hope we can work with you to do that
also to provide that, but I would like to know why this is
different. You put it in aging, but it doesn't just cover
aging, it covers everybody else. If you don't have it now----
Secretary Leavitt. I have asked my staff to respond as
quickly as possible.
Senator Harkin. I'd appreciate that. Thank you very much,
Mr. Secretary.
Secretary Leavitt. Thank you.
[The information follows:]
Aging Services Programs
Thank you for this opportunity to clarify my remarks at the recent
hearing. The Choices for Independence program ``complements'' the Real
Choice Systems Change initiative. This is a very important distinction.
Allow me to explain further how the two initiatives fit together.
Since fiscal year fiscal year 2001, Congress has appropriated over
$245 million for the Real Choice Systems Change (RCSC) Grants for
Community Living. In implementing the RCSC program, the Centers for
Medicare & Medicaid Services (CMS) has awarded over 297 grants to all
50 States, the District of Columbia (DC), and two territories. In
fiscal year 2006, Congress appropriated an additional $25 million to
fund a new round of RCSC grants. States and other eligible
organizations, in partnership with their disability and aging
communities, have the opportunity through RCSC to submit proposals to
design and construct systems infrastructure that will result in
effective and enduring improvements in community long-term support
systems. These system changes are designed to enable children and
adults of any age who have a disability or long-term illness to:
--Live in the most integrated community setting appropriate to their
individual support requirements and preferences;
--Exercise meaningful choices about their living environment, the
providers of services they receive, the types of supports they
use, and the manner by which services are provided; and
--Obtain quality services in a manner as consistent as possible with
their community living preferences and priorities.
As one component of their RCSC efforts, beginning in fiscal year
2003, CMS began partnering with the Administration on Aging (AoA) to
fund States to develop Aging and Disability Resource Centers (ADRC) to
streamline access to long-term supports for people with disabilities of
all ages. Simplified access to services, as represented through the
ADRC initiative, is a key element of a State's overall systems change
efforts. AoA resources for the ADRC initiative have come from the Older
Americans Act Title IV Discretionary funding.
Choices for Independence builds on the Older American's Act unique
mission, to help our Nation prepare for the aging of the baby boom
generation. Like the Real Choice grants, Choices addresses issues
facing Americans who need comprehensive home and community-based
systems of long-term care to delay or avoid nursing home placement.
Choices for Independence, like RCSC, is designed to promote home and
community-based care. Choices will focus mainly on linking Older
Americans with available services, improving consumer-directed care,
promoting evidence-based disease prevention, and targeting individuals
not yet eligible for Medicaid to help prevent them from spending down
to eligibility. In this way, Choices will complement the work that Real
Choice grants have so effectively begun to improve long-term care (LTC)
service delivery systems at the State level. In fiscal year 2007, as
CMS works to implement the Deficit Reduction Act of 2005 (DRA), they
will continue working with States to reform their LTC delivery systems
by building on the successful aspects of Real Choice Systems Change
grants.
The fiscal year 2007 budget for AoA essentially folds ADRCs into
the Choices for Independence initiative. The fiscal year 2007 budget
includes $28 million for Choices for Independence, including an
estimated $12.5 million for ADRCs; at the same time, CMS is requesting
no new funding for Real Choice Systems Change grants. After 5 years,
these grants have made great strides in helping States make
improvements to their home- and community-based health care delivery
service systems. The initiative provided useful lessons that led to the
development and implementation of the Money Follows the Person
demonstration (focus is consumer-directed care) as well as the State
plan options for home- and community-based services in the Deficit
Reduction Act (DRA). While Choices for Independence does not currently
assume funding from other agencies, AoA will continue to work closely
on this initiative with CMS and the other HHS agencies that have been
involved in the activities that led to its development.
Senator Specter. Thank you very much, Secretary Leavitt.
Thank you for what you are doing on the pandemic problem, and I
urge you to do more on acquainting America with the nature of
the worst-case scenario--how serious it could be and what
people ought to be doing individually--and your efforts to stir
up activity by state and local agencies to deal with the
problem. I would appreciate your assistance, your thought on
what we can do about these budget shortfalls and about what can
be done on advocacy within the administration, within the
Office of Management and Budget which has the final word here
and really with the President himself. I think that there is
not a recognition as to what this means on a lot of very
difficult very important agencies like the Centers for Disease
Control and Prevention. These cuts on so many of the health
agencies are just unacceptable. We can't solve that this
morning, and you can't solve it, and there may be--have to be
some action on Congress somewhere to find something that can
give so these cuts are not implemented. Thank you.
ADDITIONAL COMMITTEE QUESTIONS
Senator Specter. There will be some additional questions
which will be submitted for your response in the record.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted by Senator Arlen Specter
health professionals training
Question. Mr. Secretary, I am disappointed that the budget proposal
again eliminates funding for health professions training at HRSA,
particularly those programs focused on diversity. Why does the
administration continue to neglect these programs which play such a
vital role in the education of young minority students in the health
professions? What do we need to do to get the administration to match
the support for these programs that exists in the Congress?
Answer. The administration prioritizes the distribution of health
professionals by maintaining funding for the Nation Health Services
Corps, which places physicians in underserved areas, at $126 million.
There is no longer a supply problem for physicians. Improving access to
health care takes a commitment to improve the distribution of health
care providers so that they are serving in areas where there are unmet
or under-met healthcare needs. Programs that place people in the
communities that need them is the best investment. In fiscal year 2005,
only 16 percent of health professionals supported by the Health
Professions program entered practice in underserved areas.
medicare electronic payments
Question. The President's budget includes a proposal to save $133
million in Medicare by requiring all providers to accept electronic
payments, submit electronic claims, and accept more electronic
remittance advices. These savings are dependent upon virtually all
providers doing this by October 1, 2006. While I laud the goal of
increasing Medicare electronic transactions, I question how realistic
this is given that the majority of providers in our Nation are in small
practices or are solo practitioners. Many of these providers may not
have computers in their office or may be reluctant to give up paper. If
the savings are not realized, Medicare claims processing contractor
budgets will be shortchanged in fiscal year 2007. Given that CMS
recently instructed its claims processing contractors to institute a
hiring freeze on both new and replacement hires, which I understand
could last through the remainder of this year, and possibly into 2007
in order to address current budget shortfalls, I am concerned with any
proposal which could put their funding situation in further jeopardy.
How does CMS intend to implement this proposal and achieve the
estimated Medicare savings? What will the Agency do if the goal is not
realized and the savings are not achieved?
Answer. Senator, I appreciate your interest in our administrative
processes. This proposal to save $133 million is part of an overall
effort to modernize Medicare operations and administer this program
more efficiently. We are working as expeditiously as possible to
implement the proposal in 2006. It builds on laws that have already
been in effect for several years including the Debt Collection
Improvement Act (Public Law 104-134) which requires the government to
issue payments electronically, and the Administrative Simplification
Compliance Act or ASCA (Public Law 107-105) which requires most
providers to submit Medicare claims electronically.
CMS acknowledges that certain providers are exempt from the
requirement to submit electronic claims and will continue to allow
these providers to submit paper claims. However, CMS has asked the
Medicare contractors to review providers submitting paper claims to see
if they are actually entitled to the ASCA exemption. We expect that
these reviews will contribute to the savings that CMS expects to
realize next year. In addition, CMS has been taking a broad look at the
full range of claims-related activities to see which could be
streamlined or consolidated. For example, the Medicare contractors
currently send beneficiaries a monthly Medicare Summary Notice (MSN)
listing services provided. A few of these MSNs include a check to the
beneficiary but most do not involve payment. CMS believes it could save
between $15 and $30 million by sending these ``no pay'' MSNs quarterly,
or maybe semi-annually, instead of monthly. Another potential area for
saving resources without placing additional burdens on providers or the
Medicare contractors is to require those providers who already bill
electronically to receive other claims-related Medicare information and
outputs electronically as well. CMS believes that it may be able to
save $10 million from this initiative. While there are substantial
amounts at stake, CMS is confident that it can become more efficient
without jeopardizing the Medicare contractors' operations or burdening
the providers.
medicare integrity program
Question. CMS partners with private entities to administer the
Medicare fee-for-service program. In addition to paying Medicare
claims, handling appeals and answering beneficiary and provider
inquiries, these contractors are the first line of defense against
Medicare fraud and abuse. Unfortunately, the Medicare Integrity Program
(MIP)--which is the portion of the budget that funds these critical
anti-fraud activities--has been capped by statute since fiscal year
2003. I am pleased the President's fiscal year 2007 proposal supports
an increase for Medicare Part A and B Program Integrity efforts.
However, I am concerned with funding for these activities this year.
While I understanding there are no new dollars right now, I believe it
is important to find ways for these contractors to operate more
efficiently and effectively. One way to do this is for CMS to give
these contractors greater flexibility to manage their MIP budgets.
Currently, the Agency does not allow its contractors to transfer funds
among MIP program lines if the total funds to be transferred exceed 5
percent of the total funding. In these cases, the contractors must
request approval from CMS, which can take months and exacerbate funding
problems. This Committee included report language in our fiscal year
2006 spending bill urging CMS to give its contractors this much needed
budget flexibility. While CMS has granted its contractors flexibility
to manage their program management budgets, they have not done so for
MIP. Given the tight budgets contractors are currently facing with MIP
dollars, will you consider giving these contractors greater flexibility
so they can best manage their budgets to match programmatic needs?
Answer. Although you are correct that the Health Insurance
Portability and Accountability Act of 1996 (HIP AA) capped MIP funding
at fiscal year 2003 levels, Congress provided an additional $100
million in 1-year mandatory funding for fiscal year 2006 in the Deficit
Reduction Act of 2005 (DRA) for the new Parts C and D workloads. As you
stated, the fiscal year 2007 President's budget includes a proposal to
increase MIP funding over the fiscal year 2003 capped level by
$85,634,000 in discretionary funding.
CMS requires all five major MIP functions (Medical Review, Benefit
Integrity, Provider Education & Training, Provider Audit, and Medicare
Secondary Payer) in order to have a robust arsenal in the fight against
fraud, waste, and abuse. As you have noted, CMS is limited in its
ability to shift MIP funds since we must ensure that a multi-faceted
approach is maintained. In the last couple of years, CMS has increased
this flexibility somewhat for the MIP contractors. For example,
workload levels in Medical Review and Local Provider Education &
Training (LPET) are scalable to a certain extent. During the budget
formulation process, contractors determine the type and level of effort
they will be able to provide given the available resources. As problem
areas/issues surrounding their respective providers change, the
contractors can revise their Medical Review and LPET strategies and
shift the funding between the two functions as necessary.
As a matter of routine, CMS expects the contractors to keep the
agency informed of their changing resource requirements before they are
in a deficit situation. CMS is then able to work with the contractors
to identify workloads that can be altered or areas with surplus funding
that can be shifted while still achieving CMS' goals and objectives. In
limited cases, CMS is even able to provide additional funding.
office of minority health
Question. Mr. Secretary, I am concerned that the budget proposal
reduces funding for the Office of Minority Health by $10 million. In
the face of a widening health status gap, how does the administration
justify significantly reducing the budget of an office who's mission is
to lead the Department in the elimination of health disparities.
Also, in the fiscal year 2006 bill, the legislation calls for a
renewed focus on OMH's support for historically black medical schools.
Can you tell me the status of this effort?
Answer. The Office of Minority Health (OMH), part of the Office of
Public Health and Science (OPHS) in the Office of the Secretary,
advises both the Secretary and OPHS on public health program activities
affecting racial and ethnic minority populations. The fiscal year 2006
appropriation for OMH included a one-time congressional earmark in the
amount of $10 million, which was not continued in the fiscal year 2007
President's budget.
OMH recognizes the important role that historically black medical
schools play in increasing minority representation in the healthcare
workforce, and in providing needed services to minority communities.
Therefore, OMH encourages minority serving institutions of higher
education (including historically black medical schools) to apply for
grant programs supported by the Department of Health and Human Services
(HHS). In fiscal year 2006, OMH has received proposals from three
historically black medical schools; these proposals are currently under
review for funding consideration. In addition to its own support, OMH
is also working with other HHS Operating Divisions to enhance
Departmental opportunities to support these institutions.
nih sleep disorders conference report
Question. Mr. Secretary, during the National Institutes of Health's
Frontiers of Knowledge in Sleep and Sleep Disorders conference in March
2004, Surgeon General Carmona gave remarks on the profound impact that
chronic sleep loss and untreated sleep disorders have on all Americans
and that dissemination of the existing body of medical knowledge
regarding sleep and sleep disorders is critically important. What are
the prospects for development of a Surgeon General's Report on Sleep
and Sleep Disorders?
Answer. The Office of the Surgeon General (OSG) is studying this
topic as a potential subject for a Surgeon General's Workshop or
Surgeon General's Conference. In addition to the comments he made at
the March 2004 NIH conference on Sleep and Sleep Disorders, Surgeon
General Carmona also provided information regarding healthy sleep
habits in a December 29, 2005, press release, ``Tips for Parents of
Teenagers,'' as part of The Year of the Healthy Child. In March 2006,
OSG staff attended a scientific workshop on ``Sleep Loss and Obesity:
Interacting Epidemics'' to gather more information and identify leaders
in this field. In addition, OSG staff members have met with medical
intern and resident advocates to discuss their prolonged work hours,
and the potential impact on patient safety brought about by sleep loss
in this population.
underage drinking prevention
Question. In February, the Interagency Coordinating Committee on
the Prevention of Underage Drinking (ICCPUD), led by SAMHSA, released
``A Comprehensive Plan for Preventing and Reducing Underage Drinking.''
The plan sets three performance targets for 2009: reducing the
prevalence of past month alcohol use by those aged 12-20 by 10 percent;
reducing the prevalence of those aged 12-20 reporting binge alcohol use
in the past 30 days by 10 percent; and increasing the average age of
first use from 15.6 to 16.5. These are modest goals, and they expire in
just 3 years. It is well recognized, however, that reducing underage
drinking will take a concerted effort over many years--certainly more
than 3--and no one should be satisfied with 10 percent reductions. Why
didn't ICCPUD set more ambitious, longer-term targets? Would you
consider doing so in your next annual report?
Answer. The targets set forth in the Comprehensive Plan for
Preventing and Reducing Underage Drinking are ambitious, yet
achievable, particularly considering underage drinking rates have
remained essentially unchanged for over a decade. The targets in the
plan, which are to be measured over the 5 year period from 2004 to
2009, represent an ambitious first step in addressing what has been a
serious and persistent problem in our country. It is relevant to note
that Mothers Against Drunk. Driving (MADD) has recently adopted targets
that are in the same range, including a 3-year goal of reducing the
proportion of 16 to 20 year olds who drink alcohol and/or engage in
high risk drinking by 5 percent by 2008.
While the Interagency Coordinating Committee on the Prevention of
Underage Drinking (ICCPUD) and SAMHSA believe that the current 5-year
performance targets set forth in the plan are ambitious, these targets
will be revisited during the development of the next annual report.
Question. One of the expected benefits of forming the ICCPUD was
that it would result in fewer duplicative efforts in the area of
underage drinking. The idea was that as the many Federal agencies with
a stake in this problem learned about each other's efforts, they would
discover where their efforts overlap and, as a result, eliminate
redundancies. Has this occurred? Can you provide concrete examples in
which agencies have streamlined their anti-drinking activities?
Answer. Since the Interagency Coordinating Committee on the
Prevention of Underage Drinking (ICCPUD) was created in 2004, the
member agencies have worked together to conduct an inventory of Federal
underage drinking programs, develop the Comprehensive Plan for
Preventing and Reducing Underage Drinking and annual report, support a
national meeting of the States, support town hall meetings across the
country, and create a government-wide website. Through these
activities, the member agencies have gained a greater understanding of
the science related to underage drinking, as brought to the group by
the National Institute on Alcohol Abuse and Alcoholism (NIAAA), and
have enhanced their understanding of each other's activities.
The ICCPUD agencies are using this .knowledge to support each
other's activities, as exemplified by the recent town hall meetings
funded by SAMHSA. These meetings were used to distribute research
developed by NIAAA, and were strongly supported by a number of key
ICCPUD partners, including the Office of Juvenile Justice and
Delinquency Prevention (OJJDP), the Office of Safe and Drug Free
Schools (OSDFS), and the National Highway Traffic Safety Administration
(NHTSA). Several of these agencies encouraged their regional and State
counterparts to support and participate in the Town Hall meetings.
NHTSA used the meetings broadly to encourage the use of the HBO
documentary, SMASHED: Toxic Tales of Teens and Alcohol and its
accompanying educational package to facilitate and stimulate dialogue
about future evidence-based underage drinking prevention action in
local communities.
The Centers for Disease Control and Prevention (CDC) and SAMHSA
Center for Substance Abuse Prevention (CSAP) were both considering
alcohol epidemiological activities in the States. As a result of work
with ICCPUD, each agency became aware of the others' plans and avoided
duplication of effort. CDC contributed to the development of the
request for proposals issued by CSAP. This collaboration ensured that
the CSAP funded program will be consistent with CDC's efforts.
Question. It is my understanding that the Surgeon General intends
to issue a first-ever ``Call to Action'' on underage drinking
prevention sometime this spring. What is the status of the ``Call to
Action'' and its expected release date?
Answer. A Call to Action working group has developed a draft Call
to Action, which will be reviewed by the Interagency Coordinating
Committee on the Prevention of Underage Drinking (ICCPUD) member
agencies in addition to the Department of Health and Human Services.
The Surgeon General is committed to releasing the Call to Action at the
earliest possible time.
pandemic influenza preparedness
Question. Congress has appropriated $350 million for assistance to
the States and localities for pandemic preparedness. The goal of that
program is to assure that all localities meet a minimal level of
preparedness. Is the Department planning to create a single, core set
of performance standards that all jurisdictions must strive to achieve
with these funds?
Answer. As part of the Public Health Emergency Preparedness
Cooperative Agreement, CDC in conjunction with State and local public
health agencies and laboratories, national partner organizations, and
Federal agencies, developed performance measures for overall public
health preparedness. These measures are for all-hazards, including
pandemic influenza.
Question. As part of the initial ($100 million) funding that the
Department is allocating to localities for preparedness, grantees are
expected to perform some kind of preparedness exercise. Will the
Department be reviewing the after action reports from these exercises?
And if so, what resources (financial and personnel) has the Department
set aside to provide technical assistance to the States to help them
mitigate the deficiencies found in these exercises?
Answer. All States submitted draft pandemic influenza preparedness
and response plans to CDC in July 2005. As part of the $100 million
emergency supplemental funding, the Department, primarily through CDC
project officers and Subject Matter Experts, will assist in developing,
conducting, and evaluating various aspects of the pandemic influenza
plans through the use of exercises. As part of the award of the
remaining $250 million in pandemic influenza supplemental funding,
States will receive funds to ``fill gaps'' identified during the
initial round of support. ``Gaps'' will be identified through two
processes: first, by analyzing a comprehensive assessment conducted by
local health departments measuring the many components of comprehensive
influenza preparedness, and second, by analyzing results of exercises.
Ongoing technical assistance will by provided by CDC.
Question. How much of the $350 million has been released to the
States and localities? By when does the Department expect these
jurisdictions to have spent the funds? When will the remaining $250
million be made available to the States and localities? Is there an
expectation that the total $350 million must be obligated or expended
by the end of fiscal year 2006? If so, is this a realistic expectation?
Answer. States were awarded $100 million on March 7, 2006 to
conduct planning for pandemic influenza preparedness. Eighty percent of
those funds were restricted pending receipt of their supplemental
applications. The applications have been received and evaluated and CDC
is in the process of releasing many of the restrictions. We anticipate
releasing most of the remaining restrictions by May 17, 2006. The
remaining $250 million will be awarded later this summer. CDC does not
anticipate that all funds will be expended by the end of the budget
period. Recipients of funding may request for consideration that
carryover funds to be awarded the next budget year.
Question. Given that one of the most critical aspects of
preparedness will be the ability of local jurisdictions to rapidly
distribute a pandemic vaccine, will the Department encourage States to
organize mass vaccination exercises during the next flu season to test
their distribution plans? If so, will the Department allow the States
to use a portion of the $350 million to purchase annual flu vaccine?
Answer. States are permitted to use Public Health Emergency
Preparedness cooperative agreement funds to purchase vaccine in limited
quantities for conducting drills and exercises. They are not permitted
to purchase vaccine with the emergency supplemental funding for
pandemic influenza preparedness. However, they may use some of these
emergency supplemental funds during the influenza season as an
opportunity to exercise mass vaccination plans.
pandemic influenza vaccine
Question. The U.S. Government will be contributing to the expanded
production capacity of several manufacturing companies, who will use
that capacity to produce and market seasonal flu vaccine in the absence
of a pandemic. Given this unprecedented public investment in private
corporations, is the Department taking steps to assure that the price
charged public programs (e.g., Medicaid, Medicare) for seasonal flu
vaccine is reflective of this investment?
Answer. Our goal is to be able to produce enough vaccine for every
American within 6 months of a pandemic outbreak. To accomplish this
goal, we have focused our efforts on developing a cell-based vaccine
for influenza. Without this investment in new technologies, we will not
be able to produce enough vaccine in the event of a pandemic. Another
key element of our plan is to ensure that manufacturers expand capacity
in the United States. It is our hope that these manufacturers will
produce seasonal influenza vaccine in the absence of a pandemic,
allowing us to provide coverage to more Americans.
pandemic influenza surge capacity
Question. Which HHS agency is in charge of assuring States and
localities create the surge capacity for treating people who become ill
during a pandemic?
Answer. The Office of Public Health and Emergency Preparedness
(OPHEP) is the lead office in HHS for ensuring that States and
localities create the surge capacity for treating people who become ill
during a pandemic. OPHEP works closely with both HRSA and CDC to ensure
that funding through the State and local cooperative agreements enhance
surge capacity and pandemic influenza preparedness.
Question. Is the Department providing specific guidance and
performance measures with respect to creating surge capacity? Has the
Department estimated the cost of creating a minimum level of surge
capacity?
Answer. An influenza pandemic in a large number of communities
simultaneously would make the need for expanded medical surge capacity
critical. The 2005 cooperative agreement guidance for the Health
Resources and Services Administration (HRSA) National Bioterrorism
Hospital Preparedness Program provided performance benchmarks on surge
capacity, including influenza. Specifically, grantees are required to
establish systems that, at a minimum, can provide triage treatment and
initial stabilization, above the current daily staffed bed capacity,
for the following classes of adult and pediatric patients requiring
hospitalization within 3 hours in the wake of a terrorism incident or
other public health emergency--500 cases per million population for
patients with symptoms of acute infectious disease--especially
smallpox, anthrax, plague, tularemia, and influenza.
In addition, the National Strategy for Pandemic Influenza
Implementation Plan released on May 3, 2006, includes guidance to
Federal departments and agencies, State and local government, the
private sector, and the public about how to prepare for a pandemic.
With respect to surge capacity, the plan includes a number of actions
(with performance measures) on which HHS will collaborate with our
partners at the Federal, State, local, and tribal levels and in the
private sector. These include developing protocols for changing
clinical care algorithms in settings of severe medical surge (action
6.3.4.1), strategies for and protocols for expanding hospital and home
health care delivery capacity (action 6.3.4.2), policies and protocols
for emergency reimbursement or enrollment in Medicaid and State
Children's Health Insurance Program that are appropriate for a pandemic
(action 6.3.4.3), and ensuring that Federal medical assets are prepared
to deploy to augment State and local capacity (actions 6.3.4.3 to
6.3.4.7). The Department is currently preparing the plan to implement
these actions within the timelines specified in the National Strategy
for Pandemic Influenza Implementation Plan.
pandemic influenza preparedness plan implemention
Question. While significant funds are being invested in
preparedness, when a pandemic hits the costs for Federal, State, and
local governments will be significantly higher. Has the Department made
an estimate of what the cost would be to implement its pandemic
preparedness plans? For example, is there an estimate for what the
actual pandemic flu vaccine will cost once it is available? Has the
Department asked States and localities to estimate the costs of
responding to the pandemic, as opposed to planning for one?
Answer. It will be difficult to estimate with certainty the costs
of implementing our pandemic influenza plans because each State and
local preparedness plan is unique and because we do not know if we will
be responding to a mild or severe pandemic. We are currently focusing
our efforts on preparing for a pandemic to mitigate costs during an
outbreak by ensuring enough vaccine for every American six months after
human-to-human transmission, enough antivirals for 25 percent of the
population, and. a stockpile of 20 million courses of pre-pandemic
vaccine: We are also enhancing domestic and international surveillance
to quickly detect a pandemic to slow its spread. We are working closely
with States and local communities as they plan for a pandemic and to
exercise those plans.
uninsured access to pandemic influenza treatment
Question. Hospitals and other health care providers will bear the
brunt of costs associated with a pandemic. During a pandemic we need to
make sure that those who are uninsured are not deterred from seeking
necessary care as early as possible. At the same time we don't want
hospitals to have even higher levels of uncompensated care that could
threaten their long-term financial viability. Has the Department
considered what policies and funding might be needed to address this
problem?
Answer. As described in the National Strategy for Pandemic
Influenza Implementation Plan, HHS will work with State Medicaid and
SCHIP programs to ensure that Federal standards and requirements for
reimbursement or enrollment are applied with the flexibilities
appropriate to a pandemic, consistent with applicable law. In addition,
we are also examining the recommendations of Federal Response to
Hurricane Katrina: Lessons Learned report to determine what policies
might be needed to respond to public health emergencies, including a
pandemic.
pandemic influenza respirator masks
Question. Last week the Institute of Medicine issued a report
saying the respirator masks and surgical masks should not be re-used.
The report also suggested that, as part of a larger strategy of
infection control, N-95 respirator masks would offer some protection of
health care workers. The WHO recommends use of these masks in a health
care setting. How many N-95 masks does the United States now have
stockpiled? How many N-95 masks are on order for the stockpile? Does
the Department have an estimate of how many masks would be needed in
the healthcare system during a pandemic, when manufacturing and
distribution of such masks may be hard to accomplish?
Answer. The Strategic National Stockpile has approximately 9.1
million N-95 masks on hand and 98.4 million N-95 masks on order. The
Centers for Disease Control and Prevention estimates that up to 1.5
billion surgical masks and over 90 million N-95 respirators would be
needed for the healthcare sector in the event of a severe pandemic. HHS
purchased 150 million surgical masks and N-95 respirators in fiscal
year 2006. The Federal Government, States, and the private sector share
responsibility in ensuring an adequate level of preparedness. States
have access to funding from Health Resources and Services
Administration's (HRSA) National Bioterrorism Hospital Preparedness
Program to address these surge capacity needs.
medicare integrity program
Question. The Congress has provided significant funding, both
mandatory and discretionary, to help CMS combat the unacceptably high
payment error rate in the Medicare and Medicaid programs--literally
hundreds of millions of dollars even after you have made some progress
in reducing the error rate. Reportedly, over 90 percent of the Medicare
Integrity Program funds, $720 million per year have been diverted to
fiscal intermediaries and carriers doing routine claims processing,
leaving about $50 million per year for the targeted error rate
reduction contracts. What is the rationale for this diversion of
resources from fraud and abuse activities?
Answer. MIP funds are not used by fiscal intermediaries and
carriers in the performance of routine claims processing. Separate
funding under the Program Management account is set aside for that
purpose. These contractors, however, have historically been the first
line of defense in the fight against fraud and abuse. Under the MIP,
they have conducted medical review, fraud review, cost report audit,
provider education and other activities identified in the statute. All
of these activities are intended to insure that payments are made
properly and that inappropriate payments are recovered. Under the
medical review/local provider education program, FIs and Carriers are
evaluated on their ability to reduce the improper error rate.
Additionally, a significant portion of the $720 million in MIP
funding is used by a host of specialty contractors, most notably the
Program Safeguard Contractors, whose sole focus is fraud and abuse
activities.
medicare improper payments
Question. The Congress just appropriated $100 million this year for
fraud and abuse activities in the new Part D prescription drug program.
What are the Department's plans for using this money to address payment
errors in the Part D program? When do you intend to commit funds this
fiscal year?
Answer. The $100 million appropriated in the Deficit Reduction Act
(DRA) will be used for many different purposes to maintain the
integrity of the prescription drug benefit and fight against fraud and
abuse from all sources. CMS is in the process of committing the funds
provided in the DRA and plans on using all of the funds by the end of
the fiscal year.
CMS has developed a comprehensive plan for a Part D oversight
program building off the approach that has worked successfully for Part
A and Part B. CMS has established this plan in an effort to ensure that
the funding provided in the DRA will help to combat fraud, waste, and
abuse associated with the new prescription drug benefit. We have
included strong safeguards in areas where we identified
vulnerabilities, including eligibility, the bidding process,
beneficiary plan, and retail pharmacy fraud, incentives to reduce cost
and cost sharing, formulary development (kickbacks), and misuse of Part
D beneficiary lists. This program will ensure that Part D contractors
and other program stakeholders meet all applicable statutory,
regulatory and program requirements.
CMS is expanding its efforts in fighting fraud and abuse in
Medicare by using State of the art systems designed to prevent problems
and maintain integrity for the new Medicare prescription benefit. A
portion of the funding appropriated in the DRA will be used to develop
and/or maintain the following program integrity systems:
--Risk Adjustment System (RAS).--The system intended to vary the
Federal share of premiums based on factors that are beyond the
control of the drug plan;
--Medicare Advantage Prescription Drug (MARx) System.--A stand alone
system that will include the processing of all enrollment/
disenrollment transactions associated with the Part D Program;
--The Drug Data Processing System (DDPS).--The system that collects,
maintains, and processes information on all Medicare covered
and non-covered drug events for Medicare beneficiaries
participating in Part D; and
--The Medicare Beneficiary Database (MBD).--The database that houses
Medicare beneficiary enrollment information.
CMS has contracted with program integrity contractors, known as
Medicare Drug Integrity Contractors (MEDICs), to assist the Agency in
overseeing the Medicare Part D program. Part of the $100 million will
be used to establish and support three MEDICs in the regions, in
addition to the Eligibility and Enrollment MEDIC that began on November
15, 2005. The MEDIC contractors will:
--Analyze data to find trends that may indicate fraud or abuse;
--Begin to investigate potential fraudulent activities surrounding
enrollment, the determination of eligibility, or the delivery
of prescription drugs;
--Investigate unusual activities that could be considered fraudulent
as reported by CMS, contractors, or beneficiaries;
--Conduct fraud complaint investigations; and
--Develop and refer cases to the appropriate law enforcement agency
as needed.
In addition, CMS will support compliance activities to combat
fraud, waste, and abuse in association with the drug benefit. These
efforts will include the following strategies: (1) Part D compliance
monitoring; (2) accreditation organization validation studies for
Medicare Advantage plans; (3) Part D auditing; (4) other compliance and
monitoring strategies; and (5) compliance and oversight training for
Medicare Advantage plans.
CMS continues to work to ensure the integrity and validity of the
data for the prescription drug benefit. The funding provided in the DRA
will be used to monitor and evaluate prescription drug plans and
Medicare Advantage plans to maintain data integrity. CMS' monitoring
activities will include reviewing the plans' pricing and formulary to
ensure that they follow the guidelines that have been established. In
addition, CMS will review the data by performing payment validation of
the plans.
CMS will also use part of the $100 million to comply with the
improper Payments Information Act of 2002 (IPIA). CMS is building on
its current program integrity efforts by implementing new steps to
analyze program data to detect improper payments and potential areas of
fraud and abuse in the Medicare and Medicaid programs more quickly and
accurately. CMS is using these analyses to more effectively educate
providers and beneficiaries about ways to prevent and minimize waste,
fraud, and abuse. CMS' program integrity efforts are being expanded
beyond fee-for-service Medicare to encompass oversight of Part D
prescription drug benefit and the new Medicare Advantage plans.
The last activity that will be supported by the funding provided in
the DRA are audits. These audits will include financial audits of at
least one-third of all Part D organizations' financial records
including bids, data relating to Medicare utilization and allowable
costs as mandated in the MMA. In addition, CMS will use the funding to
audit one-third of the Medicare Advantage plans for adjusted community
rates and perform various cost plan audits.
Question. The fiscal year 2006 Senate bill and conference report
encouraged CMS to move forward on a $3 million demonstration of the use
of data fusion technology to detect payment error and fraud and abuse
in the Medicare program. We understand that the agency is moving
forward with a data fusion and analysis project to identify improper
payments to providers from Medicare using data sources outside of
current fraud recovery efforts. What can you do to get this program
moving forward more quickly?
Answer. CMS will be competing contracts among the MEDICs to support
and develop the Integrated Data Repository and an overall data
infrastructure to support CMS fraud, waste and abuse efforts. This
effort requires significant resources and will be funded with the $3
million referenced in the Senate and conference reports and through the
1 year MIP funding provided in the DRA. We anticipate that this effort
will integrate Medicare fee-for-service data, prescription drug data,
and Medicaid data into one central repository.
cms--status of quality demonstration project
Question. Mr. Secretary, last year alone there were over 1.3
million new cases of cancer diagnosed in America--I can't think of a
single family who hasn't had a friend or family member affected by this
terrible disease. The status quo is simply not acceptable. The last 2
years your department has taken targeted regulatory action to prevent
any access disruption through a demonstration project to support the
development of quality-based payment policy. I strongly urge you to
continue this important program and begin to move towards a permanent
funding solution that will preserve patient access to community cancer
care. Do you have any updates for the committee as to the status of the
quality demonstration project?
Answer. CMS is very focused on creating a payment system that
offers better support for the delivery of high-quality, low-cost care
as well as improving the benefits available to America's seniors to
prevent disease complications and live longer healthier lives. CMS has
worked closely with the AMA, AQA, and MedP AC among others to develop
consistent and effective ways to measure the quality of care.
We believe the oncology community is pleased with the improvements
made in this year's oncology demonstration project. This project will
enable us to capture more specific information about cancer patients
including their treatments and whether current cancer care represents
best practices and is provided in accordance with accepted practice
guidelines.
After reviewing this year's data, we will be able to make decisions
about the continuation of the demonstration project and what additional
improvements or modifications are necessary for 2007.
cms--adequate provider reimbursement
Question. Mr. Secretary, when it enacted MMA, Congress established
ASP as the reimbursement metric for prescription drugs covered under
Part B of Medicare. My concern is that CMS has continued to resist
using its administrative discretion to correct an ASP calculation
problem that thwarts the clear legislative intent underlying the shift
to ASP-based reimbursement. I am referring to CMS's insistence that it
cannot exclude the prompt pay discounts that manufacturers give
wholesalers from the calculation of ASP because the term ``prompt pay
discounts'' appears in the list of price concessions that the statute
says are to be netted out when ASP is calculated.
Wholesaler prompt pay discounts reward the timely completion of the
wholesaler's product purchase from the manufacturer, constitute an
integral part of the revenues received by wholesalers for their
services, and, in my experience, are not passed on to the wholesalers'
customers. By insisting that wholesaler prompt pay discounts be netted
out of ASP, CMS has undermined Congress' intent that payment at ASP+6
percent should cover physicians' drug acquisition costs, allow for a
reasonable level of pricing variability in the nationwide drug market,
and provide compensation for drug-related costs that are not separately
reimbursed. In essence, by requiring the inclusion of wholesaler prompt
pay discounts in the ASP calculation, CMS has converted physician
payments for Part B drugs from the congressionally mandated level of
ASP+6 percent to the lesser amount of ASP+4 percent.
Based on the statute and congressional language offered at the time
of its adoption, what is CMS' interpretation of congressional intent
with regard to adequate provider reimbursement for drug reimbursement,
and the application of the prompt pay discount to that reimbursement
for oncology services?
Answer. The Congress defined the ASP to be an average measure of
sale prices across a broad range of classes of trade and, therefore,
established that payments to providers represent average drug
acquisition costs and not the actual cost experienced by a particular
provider or specific class of trade. Further, in establishing that the
payment rates are 106 percent of the ASP, Congress established a
corridor above the average acquisition cost to address variations in
actual costs.
CMS interprets section 1847A(c)(3) to require manufacturers to
deduct prompt pay discounts given on sales included in the ASP
calculation from the ASP numerator (ASP=sales in dollars/units sold).
The language in section 1847A(c)(3) is plain, ``In calculating the
manufacturer's average sales price under this subsection, such price
shall include volume discounts, prompt pay discounts, cash discounts,
free goods that are contingent on any purchase requirement,
chargebacks, and rebates (other than rebates under section 1927). For
years after 2004, the Secretary may include in such price other price
concessions, which may be based on recommendations of the Inspector
General that would result in a reduction of the cost to the
purchaser.''
In the preamble to the CY 2006 Physician Fee Schedule final rule
(70 FR 70224), we stated that we lack the statutory authority to permit
manufacturers to exclude prompt pay discounts from the calculation of
the ASP. We continue to believe the use of ``shall'' and the
limitations on the discretion to include other price concessions in the
statutory language do not provide administrative discretion to exclude
a statutorily named price concession from the ASP calculation.
cms--prompt pay discount
Question. What evidence is available to CMS that the prompt pay
discount is being passed along to the provider of oncology services? If
the prompt pay discount is not being passed along to providers, how
does CMS achieve the congressional intent to rationalize provider
payments with actual costs?
Answer. CMS does not have evidence that prompt pay discounts are or
are not being passed along to the providers of oncology services. CMS
achieves the congressional intent by implementing the ASP methodology
cited in section 1847A(c)(3).
cms--regulatory authority for reimbursement
Question. Congress believes that CMS clearly has the administrative
authority to put forward a regulation on provider reimbursement to
resolve this issue. Does CMS share this view or is additional
legislation necessary?
Answer. CMS does not believe it has the regulatory authority to
exclude prompt pay discounts from the ASP calculation. The ASP
statutory language is plain and provides limitations on modifying price
concessions. We believe the section l847A(c)(3) authority to adjust the
price concessions is limited to those price concessions that would
ultimately lower the ASP, whereas removing prompt pay discounts from
the ASP calculation would increase Medicare expenditures.
______
Questions Submitted by Senator Tom Harkin
medicare fraud
Question. Mr. Secretary, as you know, I have a long record of
fighting fraud, waste, and abuse in the Medicare and Medicaid programs.
I know that CMS has addressed the issue of fraud in payments to
suppliers for power wheelchairs. However, there is still concerns among
legitimate suppliers that CMS is not doing enough to root out suppliers
that are not legitimate.
I understand that CMS is developing tougher quality and
accreditation standards for suppliers. When will these standards be
released? And what is CMS doing to make sure that they only issue
supplier numbers to legitimate providers? Are CMS's efforts to root out
fraud and abuse in this area being hampered by a lack of resources?
Answer. CMS plans on issuing new draft quality standards for
suppliers on its website this summer. CMS will then solicit accrediting
organizations to review suppliers and assure that they meet the new
quality standards. We anticipate that accreditation activities will
start before the end of calendar year 2006. Currently, to ensure that
only qualified suppliers are issued supplier numbers, we perform site
visits prior to enrollment and re-enrollment (which is required every 3
years). We also perform additional reviews of potentially questionable
suppliers. These reviews focus on questionable suppliers located in
geographic areas where there is a high concentration of fraud and
suppliers who have questionable patterns of billing and/or high claims
error rates.
cms--power wheelchairs
Question. On April 6 of this year, CMS published a new final rule
that requires that power wheelchairs suppliers review a beneficiary's
medical records and determine if a physician's prescription is
supported by medical evidence before a power mobility device will be
prescribed. What documentation are suppliers required to verify before
filling a prescription for a power mobility device? Will CMS issue
guidance for suppliers on documentation requirements--including the
level of specificity of the documentation--in order to clarify any
ambiguities regarding filling a legitimate prescription?
Answer. CMS would like to note that during the comment period of
the interim rule, some suppliers noted that they were already
experiencing a significant improvement in the timeliness, completeness
and substantive content of medical record documentation submitted by
physicians since the interim rule became effective. Along with the
positive feedback from suppliers, CMS has not received any significant
concerns from physician groups or other treating practitioners on this
topic. In fact, one professional organization representing over 94,000
physicians and medical students expressed support for the elimination
of the certificates of medical necessity (CMNs) for power mobility
devices (PMDs).
As you are aware, the CMN for PMDs was eliminated. The CMN was
originally designed to improve claims submission by allowing electronic
transmission of certain data. Unfortunately, some in the industry saw
the CMN as a substitute for evidence of a physician's independent
comprehensive examination and analysis of whether a PMD was medically
necessary. Despite CMS' and its contractors' statements to the
contrary, these suppliers treated the CMN as the ultimate instrument in
determining coverage. Some suppliers went so far as to hire physicians
to fraudulently complete CMNs. Furthermore, our analysis of claims has
found that in approximately 45 percent of cases, statements claimed in
the CMNs were not supported by the source information in the patient's
medical chart.
Instead of a CMN, the Durable Medical Equipment Regional Carriers
(DMERCs) will rely on the patient's medical chart to determine medical
necessity. We are concerned that a one-page scripted form would not
protect the Medicare program or its beneficiaries in the same way that
source information culled directly from a patient's medical record
would. The CMN did not help physicians or treating practitioners better
document their patients' clinical needs for a PMD, it did not ensure
that beneficiaries always received appropriate equipment, and it did
not serve as an effective deterrent to fraud and abuse. We believe the
beneficiary's physician or treating practitioner is in the best
position to evaluate and document the beneficiary's clinical condition
and PMD medical needs, and good medical practice requires that this
evaluation be adequately documented. Thus, to minimize the
documentation requirements for providers while assuring that
documentation is adequate, physicians and treating practitioners will
now prepare written prescriptions (as required by MMA section 302 and
the final rule) and submit copies of relevant existing documentation
from the beneficiary's medical record, rather than having to transcribe
medical record information onto a separate form such as a CMN.
The rule describes the information that must be included in the
written prescription: beneficiary's name, date of the face-to-face
examination, diagnoses and condition that the PMD is expected to
modify, a description of the item being prescribed, the length of need,
the prescribing physician's signature and date of signature. This model
provides structure while maintaining appropriate flexibility for the
prescribing physician or treating practitioner. Only about 10 percent
of physicians and treating practitioners prescribe a PMD for a Medicare
beneficiary in any given year, and the majority of those physicians and
treating practitioners only prescribe one or two PMDs a year. Given the
myriad of forms, brochures, requisitions and similar items in a typical
physician's office, a requirement to have a specific prescription form
handy in the event that it might be needed would impose an unnecessary
burden on the physician and other treating practitioners when that form
would only be needed once or twice a year for most prescribers, and
never actually needed for the vast majority.
Finally, the physician or treating practitioner must sign the
prescription for the PMD and is, therefore, accountable for
documentation of the medical need for the device. We believe that this
required signature and source documents in the patient's chart
effectively document the physician's attestation that the medical need
for the device is legitimate.
CMS and the DMERCs have provided extensive educational outreach to
both suppliers and the medical community pertaining to the
documentation requirements for PMDs. Examples of formal communication
include CMS program instructions, Medlearn Matter articles, and DMERC
supplier articles explaining the new responsibilities of suppliers. In
addition, medical review activities vary depending on the situation
under review. CMS cannot develop an all inclusive list of documents or
information that Medicare contractors may request during audits. When
requesting additional documentation, the DMERCs write to suppliers and
ask for the specific documentation or information needed for a review.
CMS has defined the circumstances under which contractors request
additional information in the Program Integrity Manual. Local Coverage
Determinations are issued by our contractors to describe in more detail
the conditions under which Medicare payment is made. This additional
documentation is only collected during the course of medical review
audits and does not need to be collected for all claims.
medicaid/special education benefits
Question. This question concerns Medicaid and special education. I
asked Education Secretary Spellings about it at our hearing with her in
March, but she said I needed to ask you, so I'd like to do that now.
Under current law, Medicaid pays for the cost of covered services
for eligible children with disabilities. School districts can also be
reimbursed by Medicaid for the transportation and administrative costs
they incur in providing these services. But now the administration
wants to prohibit schools from getting reimbursed for those costs. In
fiscal year 2007, schools are expected to receive $615 million from
Medicaid for transportation and administrative costs. If this change
goes through, they'll have to pay the $615 million themselves, and many
will have great difficulty doing so. I'm concerned about this, because
if schools can't pay the transportation costs to children with
disabilities, the children won't end up getting the services.
Does CMS plan to implement this cut? If so, where do you recommend
that schools find the money to make up the difference?''
Answer. Appropriate Medicaid services will continue to be
reimbursed as allowed under current law. However, claiming for certain
Medicaid services in school settings has proven to be prone to abuse
and overpayments. Schools provide a wide range of medical services to
students, which mayor may not be reimbursable under the Medicaid
program. Problem areas include but are not limited to school bus
transportation and administrative claiming, as well as direct medical
services. The fiscal year 2007 budget proposes administrative actions
to phase out Medicaid reimbursement for some services, including school
bus transportation and administrative claiming related to Medicaid
services provided in schools.
According to section 1903(a)(7) of the Social Security Act (the
Act), for the costs of any activities to be allowable and reimbursable
under Medicaid, these activities must be ``found necessary by the
Secretary for the proper and efficient administration of the plan''
(referring to the Medicaid State Plan). Additional authority derives
from section 1902(a)(17) of the Act, which requires that States take
into consideration available resources. Through the authority of these
statutes, the administration proposes to prohibit Federal reimbursement
for transportation provided by or through schools to providers.
HHS has had long-standing concerns about improper billing by school
districts for administrative costs and transportation services. Both
the Department's Inspector General and the General Accountability
Office (GAO) have identified these categories of expenses as
susceptible to fraud and abuse. GAO found weak and inconsistent
controls over the review and approval of claims for school-based
administrative activities that create an environment in which
inappropriate claims generated excessive Medicaid reimbursements. Audit
findings from States where the OIG conducted administrative claiming
audits have shown egregious violations. Proper and accurate claiming
for administrative services has not been carried out in compliance with
applicable Medicaid regulations. Overall, the leading conclusions from
these audits are that most States use an improper allocation
methodology and insufficient attention is paid to the details of the
claiming process.
The fiscal year 2007 President's budget includes a regulatory
proposal that would prohibit Federal Medicaid reimbursement for
Medicaid administrative activities performed in schools. It
additionally proposes that Federal Medicaid funds will no longer be
available to pay for the transportation to and from school related to
medical services provided through an Individualized Education Program
(IEP) or Individualized Family Service Plan (IFSP).
Schools would continue to be reimbursed for direct Medicaid
services identified in an IEP or IFSP provided to Medicaid eligible
children, such as physical therapy and occupational therapy that are
important to meet the needs of Medicaid-eligible students with
disabilities, as long as the providers meet Medicaid provider
qualifications. CMS estimates that these proposals will save $0.6
billion in fiscal year 2007 and $3.6 over 5 years.
special exposure cohorts
Question. The Labor HHS Appropriations Act of 2006 (Public Law 109-
149) requires NIOSH to prepare a report within 180 days of enactment
evaluating whether there are additional radiosensitive cancers not
already on the list of 22 cancers eligible for compensation under the
Special Exposure Cohort provision of EEOICPA and RECA that should be
eligible for compensation. Will NIOSH deliver this report to Congress
on schedule?
Will NIOSH solicit comments from experts in radiation epidemiology
before submitting this report?
Answer. NIOSH is currently working on finalizing this report and is
seeking comments from a set of experts with diverse expertise and
perspective, including experts in radiation epidemiology. The report
will be peer-reviewed prior to submission. We are working as quickly as
possible to obtain comments/edits from the outside reviewers to
expedite the process.
Question. The Office of Management and Budget recently issued a
``Passback'' memo to the Department of Labor, which called for options
to ``contain the growth in benefits'' from new Special Exposure Cohorts
under the Energy Employee Compensation law. To accomplish this, the
memo outlines options including administration clearance of all Special
Exposure Cohorts before a decision is made by you as Secretary of
Health and Human Services. Has your Department formulated a legal and
policy response to the OMB memo and if so, could you please share that
response with the Committee?
Answer. The National Institute for Occupational Safety and Health
(NIOSH) is responsible for receiving and scientifically evaluating
petitions from classes of workers seeking inclusion in EEOICP A's
Special Exposure Cohort. NIOSH carries out this responsibility under
regulations promulgated in May 2004, and amended in December 2005, to
make the rule consistent with the amendments to EEOICPA contained in
the Ronald W. Reagan National Defense Authorization Act for fiscal year
2005. In fulfilling this duty, NIOSH evaluates the feasibility of
scientifically estimating radiation dose for workers in the class that
is petitioning for inclusion in the SEC. If a dose estimate is not
feasible, NIOSH evaluates whether or not the health of the workers in
the proposed SEC class was potentially endangered by their radiation
exposure.
NIOSH presents its scientific and technical evaluation findings and
recommendations to the Presidentially appointed Advisory Board on
Radiation and Worker Health (the Board), a chartered Federal Advisory
Committee. The Board considers the NIOSH evaluation and then makes a
recommendation to me to either add or not add the class of workers to
the SEC. My decision about whether or not to add the class members to
the SEC is based on the following: the requirements of the law and the
above-mentioned regulations, the NIOSH findings and its recommendation
to the Board, and the recommendation of the Board.
______
Questions Submitted by Senator Daniel K. Inouye
health centers program
Question. I would like to express my sincere appreciation to Dr.
Elizabeth Duke for her continued support and interest in the extension
of health care service delivery networks to the underserved residents
in some of the most geographically isolated communities in Hawaii. In
particular, I am pleased with consideration to the future establishment
of a health center on Lana'i. Through the establishment of these health
centers, significant improvements have been noted in access, quality,
and continuity of care. All of which are integral to the early
detection, diagnosis and intervention in a myriad of potentially
debilitating diseases.
Answer. Thank you for your support of our work in the Health
Centers program. This program is integral to our mission to enhance the
health and well-being of Americans by providing for effective health
and human services
emergency medical services for children
Question. As expressed last year, I am very concerned that once
again the Emergency Medical Services for Children (EMSC) program has
not been included in your budget. It can not be stressed often enough
that the emergency care and resuscitation of children is uniquely
different from adult resuscitation. One size does not fit all in the
emergency care of children. There is great disparity in the quality and
availability of emergency services for children across this country.
While other programs are directed at ensuring the adequacy of adult
emergency care services, this is the only program specifically directed
at saving the lives of children. How does the Department plan to ensure
that America's children receive the emergency care they deserve with no
targeted funding?
Answer. States, through the Maternal and Child Health Block Grant
program, can continue to fund these specialized services.
baccalaureate to doctoral programs
Question. A long-standing supporter of the National Institute for
Nursing Research, I am pleased that the administration has continued
funding of this program. However, what impact will the $1 million
reduction have on the National Institute of Nursing Research's
development of initiative that supports fast-track baccalaureate-to-
doctoral programs? These programs were proposed to help increase the
number of nursing faculty and in turn decrease the number of qualified
nursing school candidates who were turned away in prior years.
Answer. The overall reduction of $792,000 in the fiscal year 2007
budget request of $136.6 million for the National Institute of Nursing
Research (NINR) will have no impact on its programs that fast-track
baccalaureate-to-doctoral nurses to increase the number of nursing
investigators. These programs are supported within the Research
Training mechanism in NINR, and the fiscal year 2007 President's budget
maintains the current level of support of this activity. NINR remains
committed to developing the next generation of nurse scientists. NINR
encourages and supports strategies to change the career trajectory of
nurse scientists. The Institute emphasizes early entry into research
careers, including fast-track baccalaureate-to-doctoral programs, and
supports pre-doctoral and postdoctoral nurses who are the future
researchers and nursing faculty.
______
Questions Submitted by Senator Herb Kohl
generic drugs/fda
Question. The FDA currently has a backlog of more than 800 generic
drug applications--an all-time high--and FDA officials expect a record
number of generic applications this year and an even larger backlog.
The congressional Budget Office estimates the use of generics provides
a savings of $8 to $10 billion to consumers every year, and that
doesn't include the billions of dollars of savings to hospitals,
Medicaid and Medicare. It is now more important than ever that we speed
less expensive generic drugs to market.
Secretary Leavitt, do you support an increase in the FDA budget to
help reduce the backlog? How much do you believe the FDA needs to
efficiently reduce the backlog and pass along the savings to Americans
and the Federal Government?
Answer. First, let me state that I understand that Congress and the
public are concerned about the high cost of prescription drug products.
I believe that generic drugs play a very important role in granting
access to products that will benefit the health of consumers and the
government. Prompt approval of generic drug product applications, also
known as abbreviated new drug applications, or ANDAs, is imperative to
making generic products available to American consumers at the earliest
possible date. This has been a high priority for FDA as it has been for
me during my time here at HHS. I believe that the process improvements
that FDA is currently implementing along with the investments we
continue to make in generic drugs offer the best promise for reducing
ANDA review time.
FDA has made significant investments to improve the generic drug
review process with the funds appropriated by Congress. In fiscal year
2007, FDA plans to spend $64.6 million relating to generic drugs,
including $29 million in the Office of Generic Drugs, or OGD. This
level represents an increase of more than 66 percent from the
comparable fiscal year 2001 amount, which has resulted in a lower
median review of 2 months.
FDA has made significant process improvements to increase the
efficiency of the ANDA review process. In fiscal year 2005, OGD focused
on streamlining efforts and took steps to decrease the likelihood that
applications will face multiple review cycles. OGD instituted
additional enhancements to the review process such as early review of
the drug master file as innovator patent and exclusivity periods come
to an end, cluster reviews of multiple applications, and the early
review of drug dissolution data.
In fiscal year 2006, FDA is building on these process improvements.
FDA began a major initiative to implement Question-based Review for
assessment of chemistry, manufacturing, and controls data in ANDAs.
This mechanism of assessment is consistent with the International
Conference on Harmonization Common Technical Document and will enhance
the quality of evaluation, accelerate the approval of generic drug
applications, and reduce the need for supplemental applications for
manufacturing changes.
FDA's OGD will continue to institute efficiencies in the review
process to facilitate the review and approval of ANDAs in fiscal year
2007 and beyond. FDA will also continue to work closely with generic
manufacturers and the generic drug trade association to educate the
industry on how to submit applications that can be reviewed more
efficiently and that take advantage of electronic efficiencies that
speed application review. FDA will also work with new foreign firms
entering the generic drug industry. It will take time for these new
firms to understand the requirements for generic drug product
applications. However, in the long-term, these efforts will shorten
overall approval time and increase the number of ANDAs approved during
the first cycle of review.
With the process improvements stated above and the investments we
continue to make in generic drugs, FDA will continue to reduce ANDA
review time and deliver safe and effective generic drug products to the
American public.
programs serving older americans
Question. Some of the most painful cuts in this budget are programs
under the administration on Aging, which takes a $28 million hit in
programs like Meals on Wheels and Family Caregiver Support Services.
That means that while Wisconsin's senior population continues to grow--
from 705,000 senior citizens in 2000 to 730,000 seniors this year and
1.2 million seniors by 2025--this budget does not account for the
growth in the need for services.
In addition, this budget proposes to eliminate Alzheimer
Demonstration grants. The Wisconsin Alzheimer Association is in its
first year of a 3-year grant, where they are working with Jefferson
County to open a dementia care clinic at a hospital in Fort Atkinson.
It is the first of its kind and the only one in the area. They would
lose their funding after this year should this budget prevail.
How do you explain the administration's plan to cut these vital
programs when our aging population is growing?
Answer. The fiscal year 2007 President's budget includes the
elimination of the Alzheimer's Disease Demonstration Grant to States
Program (ADDGS), Preventive Health Services program, and small cuts to
other AoA programs including a reduction of $906,000 to Home-Delivered
Nutrition Services and $1,980,000 to Family Caregiver Support Services.
These reductions reflect an effort to reduce the deficit while focusing
on programs that provide needed services most efficiently.
For 14 years under ADDGS, demonstrations in almost every State have
highlighted successful, effective approaches for serving people with
Alzheimer's. Now, it is time to put these models and the lessons that
have been learned to work by moving them into AoA's core services
programs--especially the National Family Caregiver Support Program--as
a number of States have already done.
Preventive Health Services is a limited, formula-grant funding
stream intended to foster the provision of health promotion/disease
prevention services in the context of the core community-based long-
term care services of the National Aging Services Network. AoA's
proposal under the Choices for Independence initiative supports the
same type of evidence-based health promotion and disease prevention.
The Home-Delivered Nutrition Services and Caregiver Support
Services programs have demonstrated efficiencies in leveraging Federal
dollars. In addition, demonstrations such as Choices for Independence
are aimed at increasing even further the efficiency of these programs.
While reductions in Nutrition and Caregiver services reflect an effort
to reduce the deficit, they also reflect an effort to target reductions
in programs that have the greatest potential to maintain service
delivery with fewer dollars.
rural health
Question. Secretary Leavitt, there are a number of programs within
your Department aimed at bolstering rural health. Wisconsin, one of the
biggest beneficiaries in the country, received over $600,000 from the
Rural Hospital Flexibility Grant program last year. This funding is
used at over 60 rural hospitals that serve anywhere from 10,000 to
20,000 patients per year. The President's budget proposes to eliminate
the Rural Hospital Flexibility Grant program, the Rural and Community
Access to Emergency Devices, and Area Health Education Centers.
How are rural communities expected to meet their unique health care
challenges when their resources are being slashed?
Answer. The Medicare Prescription Drug, Improvement and
Modernization Act (MMA) will increase Medicare spending in rural
America by $25 billion over the 10 years following MMA enactment,
substantially increasing funding for hospitals and other rural health
providers. This Act serves as a catalyst in rural communities by
increasing payments to hospitals, health professionals and other
services. In addition, the budget includes an additional $181 million
to provide added direct health services to underserved communities
through 302 new and expanded health center sites--about half of which
are likely to be in rural areas.
medicare drug benefit enrollment deadline
Question. Less than 2 weeks remain for most Medicare beneficiaries
to sign up for prescription-drug coverage without penalty. Yet last
week a Kaiser Family Foundation poll found that only 55 percent of
seniors realize the deadline is May 15, and only 53 percent know
enrolling after the deadline will cost 1 percent more per month.
Earlier this year, the Senate voted to give you authority to extend the
enrollment deadline, but the House has not yet acted. Do you support
Congress passing legislation to extend the deadline?
Answer. We are focused on enrolling people now, while the resources
are in place to help beneficiaries get the savings and security of
prescription drug coverage. According to the Office of the Actuary at
CMS, keeping the current May 15th deadline encourages beneficiaries to
take action and enroll. The actuaries believe that extending the
deadline would likely decrease overall enrollment in 2006 as pressure
on beneficiaries to enroll would be diminished. However, in light of
the cost effects on our vulnerable populations, we have recently waived
late-enrollment penalties for beneficiaries approved for low-income
subsides if they enroll in a drug plan by the end of 2006.
Proposals to extend the enrollment deadline beyond May 15 include
no funding for Medicare to maintain the high level of enrollment
support that is available right now. Beneficiaries should be encouraged
to take advantage of outreach resources like the 1-800 MEDICARE
telephone line. There are short waiting times now and individual, one-
on-one counseling is available to help people select a coverage plan.
Tens of thousands of beneficiaries are currently enrolling every
day, and there is still time to enroll in a plan.
national institutes of health funding
Question. The President's American Competitiveness Initiative
states that sustained scientific advancement is the key to maintaining
our competitive edge--and I agree with that. The President's fiscal
year 2007 budget proposal commits $5.9 billion to research and
education in basic science, that is the physical sciences--and I agree
with that as well. What I don't understand is why the President would,
in the same budget proposal, flat fund the National Institutes of
Health and its research into health sciences and biotechnology. Other
industrialized countries are making investments to make sure they get a
piece of the growing biotech and health care sectors of the world
economy--why aren't we?
Answer. In fiscal year 2003, President Bush fulfilled his
commitment to complete the historic doubling of the NIH budget, which
grew from $13.6 billion in fiscal year 1998 to $27.2 billion in fiscal
year 2003. During this 5-year period, NIH was able to fund nearly
11,600 more research grants than it did before the doubling began,
representing research ideas that are leading to vaccines, cures,
treatments, and other fundamental scientific breakthroughs helping to
open up even more new opportunities for improving human health.
With the fiscal year 2007 budget request of $28.6 billion, the NIH
budget will have grown by +$8.1 billion, or +40 percent, during this
administration. While the fiscal year 2007 request for NIH is a
straight-line from the fiscal year 2006 level, NIH plans to continue to
make strategic investments in trans-NIH initiatives and priorities
within its available funds. These include increased support for new
investigators, new research project grants, and the NIH Roadmap for
Medical Research, a new initiative on Genes, Health and the
Environment, and expansion of the Clinical and Translational Science
Award program launched in fiscal year 2006. The NIH budget also
includes increased investments in national priorities related to
developing biodefense countermeasures and pandemic influenza
diagnostics, vaccines, and therapeutics. These initiatives will
preserve our investment in biomedical research and support medical
advancements that will make healthcare more predictive, personalized,
and preemptive and thus, improve the length and quality of human life.
NIH welcomes the proposed increase in funding for the physical
sciences. Biomedical research is becoming increasingly multi-
disciplinary, requiring both science and mathematics to conduct
projects in emerging areas of great scientific promise, such as
bioinformatics, computational biology, nanotechnology, tissue
engineering, and biomedical diagnostic imaging, to name just a few.
SUBCOMMITTEE RECESS
Senator Specter. Thank you all very much. The subcommittee
will stand in recess to reconvene at 8:30 a.m., Friday, May 19,
in room SD-192. At that time we will hear testimony from the
Hon. Elias A. Zerhouni, M.D., Director, Department of Health
and Human Services.
[Whereupon, at 11:30 a.m., Wednesday, May 3, the
subcommittee was recessed, to reconvene at 8:30 a.m., Friday,
May 19.]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, EDUCATION, AND RELATED
AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2007
----------
FRIDAY, MAY 19, 2006
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met, at 8:31 a.m., in room SD-192, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Shelby, and Harkin.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
STATEMENT OF ELIAS A. ZERHOUNI, M.D., DIRECTOR
ACCOMPANIED BY:
JOHN E. NIEDERHUBER, M.D., ACTING DIRECTOR, NATIONAL CANCER
INSTITUTE
FRANCIS S. COLLINS, M.D., DIRECTOR, NATIONAL HUMAN GENOME
RESEARCH INSTITUTE
ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE OF ALLERGY
AND INFECTIOUS DISEASES
ELIZABETH G. NABEL, M.D., DIRECTOR, NATIONAL HEART, LUNG, AND
BLOOD INSTITUTE
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. Good morning, ladies and gentlemen. The
Appropriations Subcommittee on Labor, Health, Human Services,
Education, and Related Agencies will proceed with this hearing
on the National Institutes of Health, and the funding for these
institutes. We have a rather unusual hearing this morning
because we have asked representatives of groups advocating
research on the major illnesses--heart, cancer, Alzheimer's,
Parkinson's--some 20 in total, to underscore the difficulties
facing medical research in the United States today.
As it is well known, this subcommittee, Senator Harkin and
I, have taken the lead on NIH funding, which has grown from $12
billion to $29 billion over the past 10 years. Now we have seen
the increases which we had structured by, candidly, robbing
Peter to pay Paul. We have a very complex budget on this
subcommittee which has to fund not only health but education,
labor, worker safety, Head Start, the bulk of the social
programs.
Those programs have been cut in the last 2 fiscal years,
taking into account actual cuts and inflation, cut by some
$15.7 billion. The NIH, which I frequently say is the crown
jewel of the Federal Government, if not the only jewel of the
Federal Government, has been cut 10.4 percent in the last 2
years. We find that in fiscal year 2006 there was an actual cut
of almost $66 million.
The funding for fiscal year 2007 is level by the
administration. That means with the inflationary increase there
is a decrease in the actual dollars which are available. That
is just unacceptable in a country with an $11 trillion gross
national product and a Federal budget of $2.8 trillion.
The advances that have been made by medical science are
really remarkable, but it takes funding to accomplish that.
Something personal to me is the lack of adequate funding for
the National Cancer Institute. In 1970 President Nixon declared
war on cancer and if that war had been pursued with the same
intensity as our other wars cancer would have been cured long
ago.
My chief of staff, Carey Lackman, a beautiful young woman
of 48, died of cancer, breast cancer, recently. My son's
partner's wife, a beautiful young woman, died of breast cancer.
One of my best friends, Judge Edward Becker, one of the most
distinguished jurists in America, is suffering great anguish
and great pain as we speak from prostate cancer. I had a bout
with Hodgkin's last year myself and if you see me dabbing my
eyes that is one of the remnants of chemotherapy. Had the Nixon
war on cancer been pursued, I think I would not have gotten
Hodgkin's and Carey Lackman would not have died, Paula Klein
would not have died, Ed Becker would not be in the dire straits
he is today.
It is just unconscionable that we are not doing more. That
is tied to stem cell research. Again, Senator Harkin and I have
taken the lead there with our legislation which would enable,
authorize, take the bar away from the Federal Government
supporting embryonic stem cell research. We had a meeting
yesterday with Senator Frist, the Majority Leader. I believe we
are going to have a vote very soon on our issue. It is doubtful
that we have 67 to override a presidential veto and we are
talking about organizing a march on The Mall. We would like to
put 1 million people on The Mall in September, enough people on
The Mall to be heard in the living quarters of the White House
just a few blocks away, because the estimate of 110 million
people being affected directly or indirectly by these ailments
is enough to produce two-thirds to override a presidential veto
if in fact the President carries out his statement that he will
veto the bill.
Well, we have a very long hearing today. We moved the
hearing from 9:30 to 9:00 and then we moved it from 9:00 to
8:30 because Senator Harkin has commitments in Iowa. I am a
little more flexible. I only have to travel to Pennsylvania.
But we have a hearing this afternoon in Philadelphia on campus
safety. It is a very, very busy Congress and I think you have
seen that from the activities on the confirmation of the
Supreme Court justices and the immigration bill, the Patriot
Act, and so many other things we are doing.
But I do not believe there is any subject as important as
this one. You keep hearing ``nothing more important.'' Well, we
may be tied for first place. I do not think that it is true
that there is no subject more important than this one. I do not
think there is any subject as important as this one. This is
number one. Without health there is nothing.
Senator Harkin.
STATEMENT OF SENATOR TOM HARKIN
Senator Harkin. Mr. Chairman, thank you very much for your
very eloquent opening statement. I would ask that all my
statement be made a part of the record. I will just comment on
it here.
First, let me thank you, Mr. Chairman, for your courageous
leadership in this area of always fighting for the funding we
need for NIH. You led the way on building the funding over
those years. I was happy to backstop you and support you in
that. It was a very courageous effort that you led on that.
I thank you also for your courage in speaking out on the
budget earlier this year and your continuing to speak out
against the budget as it affects NIH.
Let me also thank you for your own personal courage in
battling Hodgkin's lymphoma last year and the example that you
set in coming to work every day and holding the hearings in the
Judiciary Committee and the Supreme Court nominees and taking
it to the floor even while you were undergoing some pretty
severe chemotherapy. So it was a great example, I think, of
personal courage and we thank you for that.
I would just remind everyone of what Senator Hatfield said.
When Senator Hatfield left the Senate, he gave his final speech
on the Senate floor. I will never forget. I was over there to
listen to it. He said at the time, he said: It is not that the
Russians are coming. He said: It is the viruses are coming, the
viruses are coming. How prophetic, how prophetic.
We did not work hard to double the funding of NIH to then
have it plateau off for another 20 years. The idea was to get
it back up where it had been in the 70s, where we had some 40-
some percent of our peer reviewed grants approved and funded.
That had fallen down and now I think it is down to about--I do
not have it in front of me. I think it is down to about 19
percent right now, the lowest ever, the lowest ever.
The problem--not only is it a problem this year in terms of
the budget--yes, it is 19 percent right now. About one out of
every five is accepted for funding. I think that is having a
ripple effect on researchers, it is having an effect on young
people who are thinking about research as a lifetime avocation.
But the problem is also looking ahead. As bad as this
year's budget is, next year's could be worse. According to OMB
projections, the administration will cut NIH by $800 million in
2008 and make more cuts in 2009 and fiscal year 2010.
Something has got to be done about this. Again, Senator
Specter, you have been tremendously courageous in speaking out
and trying to get a better deal for us on the budget. But we
need to hear from you at NIH, but we also need to hear from the
groups that are coming later, to tell the human side and give
the human face as to what is happening to so many people in our
society.
PREPARED STATEMENT
I have a friend of mine who at this very moment is in the
final stages of ALS disease. It is one of the worst things you
can imagine. Yet we dither around and we cannot get stem cell
research going in this country?
Well, again, Mr. Chairman, thank you. It has been an honor
to work with you.
[The statement follows:]
Prepared Statement of Senator Tom Harkin
Thank you, Mr. Chairman. You've led the way on NIH funding, and
it's been a real honor working with you on this issue.
Good morning, Dr. Zerhouni, and welcome. We're glad to have you
back with us today.
We need a strong NIH now more than ever, for so many reasons.
First, our security as a Nation depends on it. We often think about
security only in military terms. But in today's world, we need to be
just as worried about the threats we face from a bioterrorism attack or
pandemic flu. NIH research is critically important for protecting us in
both of those areas.
We also need NIH to help us through our health care crisis.
Consider just one disease--Alzheimer's. It's been estimated that
delaying the onset of Alzheimer's by just 5 years could save $50
billion a year in medical costs. That would go a long way to solving
our Medicare problems all by itself.
We need NIH now, because we're on the cusp of so many exciting
breakthroughs. Researchers are learning how to match drugs to
individual patients, based on their genetic code. They're learning more
about stem cell research. They're making discoveries about the
interplay between our genes and the environment.
What a shame, then, to get a budget like the one the President has
sent us.
His budget would level-fund NIH, one year after the first cut to
this agency since 1970. Eighteen of the 19 institutes would get less
funding than they did last year. The number of research project grants
would drop by about 640. And the success rate for grant applications
would remain at a record low of just 19 percent.
We're at a point now where only 1 out of every 5 grant applications
is accepted for funding. I'm sure there are a lot of young researchers
out there who are wondering, ``Why bother applying to NIH? Why bother
going into research at all?''
Senator Specter and I didn't work so hard to double NIH funding
just so we could watch the President cut it to the bone from then on
out. But that seems to be the President's plan. As bad as this year's
budget is, next year's will probably be even worse. According to OMB
projections, the Administration will cut NIH by $800 million in fiscal
year 2008, and make more cuts in fiscal year 2009 and fiscal year 2010.
We're going to hear firsthand what the President's budget will mean
for many diseases from our second group of speakers. I want to thank
the representatives of the 20 advocacy groups that are with us today
for taking the time to be here.
Mr. Chairman, I look forward to the testimony.
Senator Specter. Thank you very much, Senator Harkin. Thank
you for your leadership on these issues and the partnership
which I think has been very productive for our country.
Senator Shelby.
STATEMENT OF SENATOR RICHARD C. SHELBY
Senator Shelby. Thank you, Mr. Chairman. Mr. Chairman, I
ask that my written statement be made part of the record and I
will be brief.
This is a very important hearing and I am here this morning
to help you. I think the President, George W. Bush, is going to
have to speak out on this issue, that is properly funding NIH
medical research. We are falling behind and we cannot, because
we have led the world. We continue to lead the world, although
we are struggling as far as finances are concerned.
Mr. Chairman, you and Senator Harkin, who are the leaders
of this committee, I can tell you I am going to do everything I
can. We are challenged in the research everywhere in
biomedical, but in autoimmune areas there is a lot of hope
there. I am particularly interested in the lupus area. We are
challenged there. I am going to do everything I can as a member
of the Appropriations Committee to help fund, properly fund,
medical research through NIH. You have made a difference and
you will make a tremendous difference in the future.
PREPARED STATEMENT
But, as Senators Specter and Harkin both know, it is not
going to be easy, but we cannot go backward. We cannot cede
this to anybody else in the world. We are the leaders. We have
got to stay there.
Thank you, Mr. Chairman.
[The statement follows:]
Prepared Statement of Senator Richard C. Shelby
Mr. Chairman, thank you for holding this important hearing today. I
want to thank all of you for taking the time to be here today. It is
vitally important for me to hear directly from you on what your
agency's needs are, and the challenges you might face in the coming
months. We as a Nation are facing a integral moment in funding critical
research. Finding viable treatments and possible cures for many of our
common afflictions is our most important goal, but I think early
detection of disease is fundamentally important to containing costs in
the long-term.
As we begin to move forward in the appropriations process it is of
the utmost importance that we ensure adequate funding for these
indispensable research institutions. Millions of Americans rely on the
life saving work they perform and it is imperative that we as
appropriators fully support them.
Federal funding for medical research is critical and while we have
worked diligently to increase funding, more is left to do.
I am hopeful that this hearing today will provide a forum to
discuss the issues that must be addressed by researchers.
Thank you for your time and I look forward to your testimony.
Senator Specter. Thank you very much, Senator Shelby.
We now welcome Dr. Elias Zerhouni, the Director of the
National Institutes of Health. He had an illustrious career
before coming to be the 15 Director of NIH. He had been
executive vice dean at Johns Hopkins University School of
Medicine, chair of the Department of Radiology and Radiological
Science. He received his medical degree from the University of
Algiers School of Medicine and completed his residency in
diagnostic radiology at Johns Hopkins.
Thank you for your leadership in this very vital area, Dr.
Zerhouni, and we look forward to your testimony.
SUMMARY STATEMENT OF DR. ELIAS A. ZERHOUNI
Dr. Zerhouni. Thank you, Mr. Chairman. Thank you, Senator
Harkin, Senator Shelby. I submitted a written testimony. What I
would like to do really is just summarize the salient points of
the testimony, to allow as much time as possible for questions.
Senator Specter. Thank you, Dr. Zerhouni.
Dr. Zerhouni. What I would like to do is really direct your
attention to the screens.
RETURN ON INVESTMENT ON NIH FUNDING
What I would like to address are the fundamental questions
that I think all of us would like to have an answer to, to be
able to set policy for the future. First and foremost, what is
the return on the American people's investment at the National
Institutes of Health? Second, what has this NIH budget doubling
delivered for the American people? Third, what is our future
strategy? Where is NIH heading? When you talk about medical
research it is important to understand that it is not a 100-
meter dash, it is a marathon, and we have to sustain the effort
over time.
First, let me just remind everyone that biomedical research
has delivered enormous returns to the American people. I am
just going to give two examples here. Many more are in the
testimony. In coronary heart disease, if you look at the
progress over the past 30 years, there has been a 63 percent
decrease in mortality. Over a million early deaths are averted
every year because of the research of the past 30 years.
Economists tell us that this is worth $2.6 trillion in economic
return because a cohort of individuals who would have died in
their 50s now do not and then can produce economic return. We
have enormously exciting, effective strategies for not only
curing, but preventing and ultimately eliminating coronary
heart disease.
Now, you may ask yourself, what was the investment that the
American people, that each one of us made to achieve that?
Well, over the past 30 years each one of us has spent about
$3.70 per year for medical research related to coronary heart
disease. If you look at the total cumulative total over 30
years for heart research, it is $110 per person. I submit to
you that medical research has delivered, for an investment that
I think is extremely effective in its return.
Cancer is another example. If you look at cancer--and you
mentioned the war on cancer, Senator--for the first time in
recorded history, this year we have a lower number of deaths
from cancer in the United States, despite an increasing
population and an increasing average age of the population. We
have 10 million survivors. This is due to the advent of early
screening, early detection, new therapies.
What has this cost us? $8.60 per person per year over the
past 30 years. The total investment for each one of us is $260
over 30 years. I do not think there is an investment that I can
describe that any agency can be as proud of as the National
Institutes of Health is of its effectiveness. We have delivered
not only better cures, but also a healthier life for Americans,
who live now longer and healthier lives, with a disability rate
that has dropped by 30 percent over the past 22 years because
of improvements in bone health, in heart health, and many other
advances.
Since 1982 the disability rates have dropped by 30 percent
and in the past 30 years American life expectancy has increased
by over 6 years, from a total investment cumulative over 30
years, of about $1,300 per American.
This is not just what we have done in the past. We continue
to deliver. If you look at just the advances of the past year--
I am just going to take a few examples. If you look at the
impact of the human genome and genomics, we identified over 20
genes just in the past 12 months that relate to prostate cancer
and the causes of prostate cancer, in mental health about
obsessive compulsive disorder, and one of the most exciting
ones is in vision disease, where we have found genes that may
explain over 70 percent of cases of what we call age-related
macular degeneration, the fastest rising cause of blindness in
American seniors.
Vaccines: We have the first global candidate vaccine on
HIV/AIDS, that Dr. Fauci and his team developed. Yesterday the
FDA approved the first preemptive cancer vaccine against
cervical cancer. We have expanded the Avian Flu trials. We have
one vaccine in trial and a second one in development. This
would not have been possible without the support of Congress
and your support here on this committee.
But we realize that biomedical research must continue to
deliver and we have a challenge in front of us. We all know
that the rising cost of health care and the burden of disease
is going to be a challenge for all of us. We see the curve. We
see that it is not sustainable. Society spends about $7,100 per
American per year on health care costs. The total NIH spending,
$95 per American per year, has to do something, must do
something, to change that picture.
This is the vision of NIH. Our vision, all of us as
scientists at NIH, is to use our investment and deliver a
complete transformation of medicine, because if we keep
practicing medicine the way we know it today, 25 years from now
it just will not be sustainable. So discoveries and new ways of
not only curing disease, but preventing disease, preempting
disease altogether, is the key.
We will do this through what we call the four P's of
medicine. It will be more predictive because of our
understanding of molecular events. It will be more personalized
because we know that every one of us reacts differently to
different diseases. It will have to be increasingly preemptive
because this is where it is the least costly. But we cannot do
this without the participation of everyone, and this is why we
say the fourth P is, in the context of chronic diseases like
diabetes or obesity, it will require us to include the patients
as partners in this new medicine.
PREPARED STATEMENTS
So my message is very simple. We have delivered, we
continue to deliver, and we will deliver, and the return on
investment is in my view one of the most remarkable returns
that anyone can describe, and we will continue to do so. I am
happy to take any questions.
[The statements follow:]
Prepared Statement of Dr. Elias A. Zerhouni
Mr. Chairman and distinguished members of the subcommittee, it is
an honor and a privilege to appear before you today to present the
National Institutes of Health (NIH) budget request for fiscal year 2007
and discuss the priorities of NIH for this year and beyond.
budget request
The request for NIH is $28.4 billion in fiscal year 2007, the same
as the fiscal year 2006 level for the Agency. The budget request will
support the research programs managed by NIH's Institutes and Centers.
At this budget level, NIH will increase the biodefense research program
by $110 million for Advanced Development. Support for the Pandemic
Influenza Preparedness Plan will increase by $17 million. We have also
chosen to carefully invest in several trans-NIH strategic initiatives.
The NIH Roadmap, an incubator for new ideas and initiatives that will
accelerate the pace of discovery, increases by $113 million. We
allocated $40 million to the Institutes and Centers to launch the
Genes, Environment and Health Initiative to accelerate discovery of the
major genetic and environmental factors for diseases that have a
substantial public health impact. We have also directed $15 million to
the new ``Pathway to Independence'' program to increase our support of
new investigators.
I will focus my testimony on the return of the investment in NIH
for the American people. In particular, I will discuss how discoveries
fueled by this investment are transforming the practice of medicine. We
can now clearly envision an era when the treatment paradigm of medicine
will increasingly become more predictive, personalized and preemptive.
We will strike disease before it strikes us with the hope of greatly
reducing overall costs to society. We expect to move away from the
costly and predominantly curative model of today, which requires us to
wait for the disease to occur before intervening. I will share with you
the strategic vision of NIH and discuss the many management innovations
we have implemented to ensure optimal stewardship of taxpayers'
resources.
selected accomplishments of nih and their impact on health
The achievements of NIH and our private sector partners in medical
research are difficult to overstate. According to the latest report on
the Nation's health from the Centers for Disease Control and Prevention
(CDC), life expectancy continues to rise, now at an unprecedented 78
years for the total U.S. population. Since 1950, the age-adjusted death
rate for the total population declined by a remarkable 43 percent. Life
expectancy has increased by one year in every five for the past 30
years. Americans are not only living longer, they are healthier. For
instance, the disability rate of American seniors dropped by almost 30
percent in the past 20 years, owing to a range of scientific advances.
The following are samples of the many advances driven by the
investment in NIH.
advances in cardiovascular disease and stroke
Thirty years ago, it was common for a man or woman to suddenly die
of a heart attack or stroke between the ages of 50 and 60. Had this
trend continued unabated, today more than 1.6 million lives would have
been lost per year. Fortunately, today the toll is much less. The death
rates from cardiovascular disease have declined by 63 percent and by 70
percent for stroke. Were it not for the ground-breaking research on the
causes and treatment of heart disease, supported in large part by NIH,
including recent developments such as drug coated stents, safe levels
of blood pressure and cholesterol lowering therapies, heart attacks
would still account for 1.2 to 1.3 million deaths per year instead of
the actual 515,000 deaths experienced today. The estimated total
cumulative investment in cardiovascular research at the NIH per
American over the past 30 years, including the doubling period, is
about $110, or about $4 for each American per year over the entire
period.
advances in cancer
The mortality rates of cancer, the second leading cause of death in
the United States, have been falling for several years, and this year,
for the first time in history, the absolute number of cancer deaths in
the United States has decreased. More effective therapies have led to
improved outcomes for more than 10 million American cancer survivors.
With the increase in budgets between 1999 and 2003, the National Cancer
Institute has stimulated a paradigm shift in cancer therapy. We are
seeing the emergence of targeted therapies, with the unprecedented
ability to use specific molecular targeting to treat tumors with novel
agents. We can also detect and treat cancer at earlier stages. The
National Cancer Institute's (NCI) Early Detection Research Network
(EDRN), launched in 1999, has identified a number of biomarkers that
allow for the earlier detection of breast, prostate, colon, lung and
other cancers. This year, NCI, in collaboration with the Human Genome
Research Institute, has launched a cancer genome pilot project to help
further our understanding of the basic biology of cancer and identify
additional treatment targets. The estimated total cumulative investment
at the NCI per American over the past 30 years, including the doubling
period, is about $258, or about $9 per American per year over the
entire period.
advances in hiv/aids
Without the development and testing of antiretroviral drugs, there
would be no hope for patients with HIV/AIDS. The development of Highly
Active Antiretroviral Therapies primarily resulted from the work of a
large cadre of NIH-supported scientists and their counterparts in the
pharmaceutical industry. Their discoveries about the cellular
mechanisms of the disease have transformed AIDS into a manageable
disease, preventing hundreds of thousands of hospitalizations and early
deaths. To date, 21 antiretroviral drugs and 4 combination formulations
have been approved by the FDA. Many more less toxic AIDS drugs are
currently in development. Today, fewer than 50 HIV-infected babies are
born each year in the United States, sparing 16,000 to 20,000 children
from AIDS through the use of antiretroviral drugs to prevent mother-to-
child transmission. Mother-to-child transmission rates in developing
countries have declined by 40 percent with the use of drug therapy.
With the introduction of these new drugs, economists estimate the
aggregate potential value of improved survival has been nearly $400
billion for those infected through 2000. They estimate the aggregate
potential value for all past and future cohorts of individuals infected
with HIV is almost $1.4 trillion.
With the additional resources provided during the doubling of the
NIH budget, we launched the Vaccine Production Program (VPP) Laboratory
to efficiently translate candidate research vaccines, including HIV
vaccines, into useable products. Since its inception in 2001, this
program has overseen the manufacture of over 29 bulk pharmaceutical
compounds formulated into 14 different vaccine products for HIV, as
well as West Nile, SARS and Ebola Virus, and expanded our network of
clinical trial sites across the globe. This program is enabling NIH to
serve the needs of the American people in an age of global risks of
infectious diseases.
advances against the threat of pandemic influenza
Thanks to fundamental advances in viral genomics and genetic
engineering, NIH has been able to help in the development of
countermeasures against both seasonal and pandemic influenza viruses.
We now have a vaccine against the H5N1 virus and will develop a second
one in conjunction with CDC. Without such a vaccine, and others under
development and testing, we would be completely defenseless against the
potential pandemic that threatens the entire world. We are investing in
research and development to hasten the production process by converting
from egg-based to cell culture-based vaccines. We are developing novel
vaccine approaches using a variety of molecular biological techniques,
and we launched discovery efforts for new anti-viral compounds against
pandemic flu. We initiated a project to identify the genomes of
thousands of human and avian influenza viruses, and, to date, 831
influenza genome sequences from human isolates have been deposited in
NIH's GenBank, allowing researchers across the world to better
understand influenza viruses and develop countermeasures.
development of biodefense research
Since 2001, NIH has directed more than $10 billion toward
protecting the American public from bioterrorism. The 2001 intentional
release of anthrax underscored the reality of a bioterrorism threat
posed by other Category A agents such as smallpox, plague, tularemia,
hemorrhagic fevers, and botulinum toxin. NIH responded swiftly.
Promising vaccine candidates for Ebola and smallpox are currently in
clinical trials. Identification of the three-dimensional structure of
the anthrax toxin complex is fueling the search for compounds that
block the toxin's effects, and the discovery of the key mechanism of
Ebola virus cell entry prompted experiments demonstrating that Ebola
infection could be blocked in laboratory tests. We continue to build a
national biodefense research infrastructure that will position the
Nation to respond even more quickly and precisely to bioterrorism.
advances in diabetes and related illnesses
Nearly 21 million Americans have diabetes, a disease that can cause
damage to multiple organs and lead to death. Without NIH research, the
improvements of the past two decades in the therapies for diabetes
would not have occurred. Through large prospective trials, made
possible by the doubling of our budget, we have assessed the relative
value of drug based approaches versus weight loss and physical
activity, and showed it is possible to reduce the risk of type 2
diabetes by 58 percent with lifestyle modifications alone.
Diabetes can also result in vision loss. Four million American
adults suffer from diabetic retinopathy, the outcome of damage to the
tiny blood vessels in the light-sensitive retina lining the inside of
the eye. Nearly a million have the advanced vision-threatening stage of
the disease. The National Eye Institute completed a series of landmark
clinical trials to develop novel treatments for diabetic retinopathy.
Without these new treatments, 450,000 patients who have advanced
disease today would otherwise likely be blind in 5 years. As a
consequence, of those currently at risk, only 27,000 would progress to
legal blindness, and only 9,000 would become blind today. In addition
to reduced suffering and disability, the economic savings from these
treatments will reach as much as $1.6 billion per year.
As another example of payoff from recent NIH research, end-stage
renal disease (ESRD)--kidney failure requiring dialysis or
transplantation, a complication of diabetes and high blood pressure--
results in direct federal expenditures of approximately $20 billion per
year. Through the 1980s and 1990s, the incidence of ESRD nearly doubled
each decade, but in the last five years overall rates have stabilized--
and even declined in certain population groups. This improvement has
been driven by monitoring for proteins in urine to prevent kidney
disease or detect it in its early stages. Compared with earlier
projections, the savings in federal health care expenditures are
approximately $1 billion dollars per year.
Without the investment in medical research, people with diabetes
would be living shorter, less productive, and less hopeful lives.
advances in image-guided microsurgery
Increases in the NIH budget allowed new investments in the use of
imaging technologies like CAT scanning, MRI or ultrasonography for the
development of new microsurgical techniques. These minimally invasive
therapies are changing the fate of many patients, including patients
with Parkinson's disease, through deep brain stimulation. These new
techniques are also promising to revolutionize the treatment of
epilepsy, a disease that affects over 2.7 million Americans. As we move
forward with such research, we expect that surgery will become less
invasive, more precise and less dangerous, with far less operative
complications.
advances in health information for scientists and the public
The National Library of Medicine of the NIH provides the American
public with high quality, reliable information. The NIH web sites
(www.nih.gov) are now recognized by independent organizations as the
most successful health related web sites, with over 2 million queries
per day. Millions of patients and their families regularly consult NIH
web sites for up to date information in English and Spanish, a
capability made entirely possible by the doubling of the NIH budget.
The web-based ClinicalTrials.gov represents a landmark effort to
provide information to patients and physicians across the country on
NIH-funded clinical trials.
NIH also leads the research field in developing information
technology for biomedical research. No biomedical scientist develops a
project without first consulting the suite of powerful informational
research tools available through the NIH National Library of Medicine's
PubMed, a growing digital archive of peer-reviewed research articles
and scientific databases.
new research tools
NIH researchers have pioneered powerful new research tools and
methods such as high throughput DNA sequencing, protein identification
with mass spectrometry, gene expression arrays, the determination of
thousands of new protein structures, and imaging technologies which
were simply unavailable before the doubling of the NIH budget. A great
illustration of the impact of these advances has been the
identification of the cause of the SARS virus in less than a month and
the current tracking of pandemic flu viruses. These tools have greatly
accelerated the research process itself, spurred progress and spawned
new discoveries in all areas of biomedical research. Perhaps nowhere
else have these technological advances in imaging and genotyping
elicited more excitement than in the field of mental and behavioral
health, elucidating genes linked to schizophrenia, depression, bipolar
disorder and anxiety. These discoveries are allowing for the first time
direct visualization of brain structure and function to study the brain
circuitry involved in thinking and a range of behaviors.
new diagnostic and therapeutic technologies
Some of NIH's successes can be measured in new medical
technologies. Advances in research are driving an increase in the
number of technologies being licensed to companies for
commercialization. In fiscal year 2004, there were thousands of active
licenses between federally funded research institutions and companies
worldwide. Out of these technologies, several thousand companies are
making many new products that have an immeasurable impact on public
health. Today, from NIH funded research, more than 300 new drug
products and vaccines targeting more than 200 diseases--including
various cancers, Alzheimer's disease, heart disease, diabetes, multiple
sclerosis, AIDS and arthritis--are in clinical trials. These outcomes
are accomplished through the on-going network of successful
collaborations with our colleagues in private industry.
changing landscape of disease
Disease and injury are constant threats to humankind and are never
static. New diseases can emerge at any time, such as HIV/AIDS, SARS,
Pandemic Flu, obesity or many other conditions. Bioterrorism did not
figure significantly in the NIH agenda in 2001, but is now a top
priority of the agency. Twenty years ago the impact of Alzheimer's
disease was not fully appreciated, nor were its causes known.
As the result of our success in preventing and treating acute and
short term conditions such as heart attacks, stroke, cancer and many
infectious diseases, we are living longer. Our increasingly older
population faces the new challenge of multiple chronic conditions which
now consume about 75 percent of healthcare expenditures. This shifting
burden of health care from acute to chronic diseases is perhaps the
greatest challenge we face.
Health care costs in the United States have risen to more than $2
trillion. The amount spent on health care per person has doubled, from
$3,461 in 1993 to $7,110 today. The causes of health care inflation are
varied and complex, requiring different, nation-wide solutions.
We are in a race against the overwhelming human and economic
consequences of disease. We can win this race, but only if we use
research discoveries to transform medicine as we know it. Thanks to
recent research advances, we can foresee a future of more effective
medical treatment that might be less expensive than current practices.
strategic vision for nih: from curative to preemptive care
We are in an era of great scientific opportunity. Advances in our
understanding of basic human biology allowed NIH to sequence the human
genome by 2003, two years ahead of schedule, and to complete the
Haplotype Map, showing the variation between individual humans, in
October 2005, also ahead of plans. One of the greatest scientific
achievements in history, the genome blueprint, along with work in
systems biology and proteomics, are driving a revolutionary period in
the life sciences. We are on the brink of transforming medical
treatment in the 21st Century. Our hope is to usher in an era where
medicine will be predictive, personalized and preemptive.
Toward this goal, NIH is strategically investing in research to
further our understanding of the fundamental causes of diseases at
their earliest molecular stages so that we can reliably predict how and
when a disease will develop and in whom. Because we now know that
individuals respond differently to environmental changes according to
their genetic endowment and their own behavioral responses, we can
envision the ability to precisely target treatment on a personalized
basis. Ultimately, this individualized approach, completely different
than how we treat patients today, will allow us to preempt disease
before it occurs.
Consider, for instance, how better predictive and personalized
treatments could improve the safety and effectiveness of drugs. As we
know, drugs do not fall into the ``one size fits all'' category. The
same drug can help one patient and harm another. Recent research shows
that we will be increasingly able to know which patients will benefit
from treatment and which patients might be harmed. This field of study
is known as pharmacogenetics. Using the latest genomic data, enabled by
the doubling of the NIH budget, the NIH established a Pharmacogenetic
Research Network which is studying the interactions of drugs and
molecules as well as the biological processes that eliminate compounds
from the body. In the first five years of this program, the researchers
in this network made numerous discoveries.
For example, they learned that 10 percent of the North American
population exhibits a genetic variation that puts them at high risk for
life-threatening reactions to irinotecan, a cancer drug. We now know
that patients with this variation should be given lower than prescribed
doses of this successful drug, thus potentially saving their lives.
NIH researchers also discovered variations in a gene involved in
the body's response to more than half of all medications. Understanding
these differences could explain critical individual as well as racial
and ethnic differences in drug responses. Other genetic variations
discovered by the NIH network will have an impact on asthma treatment,
the risk of sudden death from irregular heartbeats and the proper use
of blood thinning medications to avoid deadly bleeding complications.
In another example of emerging personalized medicine, cancer
researchers have developed a test that helps determine the risk of
recurrence for women who were treated for early stage, estrogen-
dependent breast cancer. This information can help a woman and her
doctor decide whether she should receive chemotherapy in addition to
standard hormonal therapy. This test has the potential to change
medical practice by sparing tens of thousands of women each year the
unnecessary and harmful side effects associated with chemotherapy at
large potential cost savings.
rapid advances in the genomic era
Because of a hundred fold reduction in the cost of genomic
technology, we can now study, at affordable costs, the differences
between patients who have a disease and their normal counterparts.
Recently, this revolutionary approach led to the discovery of two
previously unsuspected factors that can identify who is at risk and how
to protect patients from age-related macular degeneration, an
increasing cause of blindness in our aging population, with over 7
million Americans at risk. Last month, a key transcription factor that
may be responsible for a large percentage of cases of diabetes was
discovered.
These breakthroughs form the basis of our budget request for the
Genes and Environment Initiative, supported by Secretary of Health and
Human Services Michael Leavitt, because it will give us the
unprecedented ability to discover, over the next three years, the
potential causes of the 10 most common diseases afflicting the U.S.
population. With this funding, if approved, we will also launch a
technology development effort for enabling scientists to measure many
types of environmental exposures at the individual level. Taken
together, these efforts will lead to better understanding of the
environmental and genetic factors in the development of many diseases.
Imagine a world where we will be able to tell each patient whether
they need to take action to preempt altogether the development of
costly and painful diseases. Imagine telling them that they do not need
to take expensive medications for life because they are not at risk of
disease. A more predictive, personalized and preemptive form of
medicine is no longer just a dream, but a vision to strive for as
rapidly as we can.
management innovations
NIH has an enormous and growing scope of mission. We conduct or
support research on over 6,600 diseases and conditions, from the most
common to the rarest. In 2005, more than 43,000 research grant
applications went through our rigorous two-tiered review process, with
about 22 percent of applications ultimately receiving funding.
More than 80 percent of the NIH budget supports extramural research
at 3,100 institutions around the world, employing about 200,000
scientists and other research personnel. Another 10 percent of the
budget goes into the NIH intramural program, consisting of
approximately 6,000 scientists, where work is focused on public health
priorities and cutting edge research. The hub of the intramural
program, the NIH Clinical Center on the Bethesda campus, is the world's
largest dedicated clinical research complex.
NIH is spending $95 per American this year on medical research, and
we need to make every dollar count. With the growth and increasing
complexity of the agency, NIH has aggressively moved to transform its
management strategies and decision-making processes. To streamline,
harmonize and better coordinate decisions that affect the entire
agency, in 2003, I established the NIH Steering Committee, composed of
nine Institute Directors who serve on a rotating basis. Six working
groups support the Steering Committee. This new governance structure
has enabled greater coordination and harmonization between the 27
Institutes and Centers at NIH.
NIH has addressed the need for more robust means to oversee the
vast NIH research portfolio, and plan and launch trans-NIH initiatives.
While the NIH successfully developed important trans-NIH initiatives
such as the Roadmap for Medical Research, the Strategic Plan for
Obesity Research, and the Neuroscience Blueprint, the agency is now
implementing even more rigorous and transparent processes and
developing cutting-edge tools to analyze, assess and manage the array
of research it supports. This will provide better information to
support planning and priority-setting in areas of shared Institute and
Center interests. To reinforce these accomplishments, NIH is
establishing a new office within the Office of the Director--the Office
of Portfolio Analysis and Strategic Initiatives (OPASI).
Review of our programs by the Office of Management and Budget under
the congressionally mandated Government Performance and Results Act
(GPRA) provides evidence that our programs are effective. We have been
rated in the top 15 percent of federal organizations.
NIH's effective performance is reflected in recent scores as
measured by the OMB Program Assessment Rating Tool (PART). In the
fiscal year 2007 PART, the Buildings and Facilities Program and the
Intramural Research Program both received the highest possible rating
of effective, with scores of 96 percent and 90 percent, respectively.
On the fiscal year 2006 PART, the NIH Extramural Research Program
achieved a similarly high 89 percent. These high scores demonstrate
exemplary management and substantial progress toward meeting NIH
performance measures. To date, approximately 90 percent of NIH's budget
has been PARTed and rated effective.
translating discoveries into better medical treatment
Rapidly translating our discoveries from the bench to the bedside
is a top priority of the NIH. The opportunities have never been greater
to use modern research methodologies such as genomics, proteomics,
metabolomics, high sensitivity biochemical methods and other novel
strategies to bring new insights to the study of human populations and
more rapidly achieve the goal of making medicine predictive,
personalized and preemptive.
To accelerate progress, NIH recently introduced the institutional
Clinical and Translational Science Award (CTSA). The CTSA program will
stimulate institutions across the country in transforming Clinical and
Translational Science in the U.S.A. to (1) captivate, advance, and
nurture a cadre of well-trained multi- and inter-disciplinary
investigators and research teams; (2) create an incubator for
innovative research tools and information technologies; (3) synergize
multi- and inter-disciplinary clinical and translational research; and
(4) accelerate the application of new knowledge and techniques to
clinical practice at the front lines of patient care.
training a new generation of scientists
New visions require new talent. In times of constrained budgets the
most important action NIH needs to take is to preserve the ability of
young scientists with fresh ideas to enter the competitive world of NIH
funding. To that effect, NIH has launched the new ``Pathway to
Independence'' program which will support, for each of the next five
years, 150 to 200 recently trained scientists conducting independent,
innovative research.
in summary
Our Nation's investment in biomedical research has dramatically
improved health outcomes. The return on the investment of the American
people at NIH is nothing short of spectacular. Thanks to the support of
Congress, we are able, through our science, to respond in record time
to emerging threats such as SARS, Pandemic Flu and biodefense needs. We
have learned how to decrease the incidence of many diseases and other
disabilities for old and young Americans. The estimated total
cumulative investment at the NIH per American over the past 30 years
including the doubling period is about $1,334 or about $44 per American
per year over the entire period. In return, Americans have gained over
six years of life expectancy and are aging healthier than ever before.
The President and Congress have wisely invested in biomedical
research. We are acutely aware that NIH research is often the only hope
for millions of people afflicted by disease. In the battle for health,
NIH also believes that it needs to accelerate the pace of progress, as
it is only through a fundamental transformation of medicine that
solutions to the rising burden of healthcare will be found.
I will be happy to answer any questions you may have.
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Prepared Statement of Dr. John E. Niederhuber
Mr. Chairman and Members of the Committee: I am please to present
the fiscal year 2007 President's budget request for the National Cancer
Institute (NCI). The fiscal year fiscal year 2007 budget includes
$4,753,609,000, a decrease of $39,747,000 below the fiscal year 2006
enacted level of $4,793,356,000 comparable for transfers proposed in
the President's request.
our goal remains the same
Four years ago, we put the NCI on a trajectory towards the
Challenge Goal of eliminating suffering and death due to cancer as
early as the year 2015. Since that time, we have vigorously and
aggressively managed NCI's portfolio of investments in cancer research
across that entire continuum of the process of cancer, whether we've
been focusing on understanding genetic mutations that were responsible
for susceptibility to cancer or focusing on issues that have to do with
survivorship and living with, rather than dying from, cancer.
NCI has been a major leader in the molecular metamorphosis of
biomedical medicine that has benefited all fields of medical research.
Without the Nation's support of NCI's pioneering role in funding
research--including basic science, clinical trials, and translational
investigations--into the molecular and genetic processes that underlie
all disease and the training of new cancer researchers, it is unlikely
that the advances we are seeing today in many health areas--from AIDS
to macular degeneration--would have occurred at the pace they have.
These leadership efforts must be sustained going forward.
The Nation's past commitment to cancer research has proven its
worth: mortality rates have declined for all cancers combined while
incidence rates have stabilized or increased slightly, detection and
treatments have improved, new therapeutic options offer startling
promise. Today there are nearly 10 million cancer survivors in the
United States compared to approximately 3 million cancer survivors in
1971 when the National Cancer Act was established. Also, in 1971 fewer
than half of those found to have cancer lived 5 years beyond their
diagnosis; today the 5 year survival rate is 64 percent for adults and
79 percent for children aged 14 or younger. The latter figure is truly
remarkable given how few children survived even a couple of years after
being diagnosed in the early 1970s. NCI's continued commitment is
manifested today in far-reaching programs that have advanced our basic
understanding of the genetic changes responsible for this dreaded
disease. The Nation's investment and the actions of Congress are
directly responsible for the development of a nation-wide network of 61
NCI-designated cancer centers and a highly successful Community
Clinical Oncology Program (CCOP), founded in 1983. Through the network
of 64 CCOP grantees, community investigators participate actively in
NCI-sponsored cancer prevention, control, and treatment clinical
trials. These programs place cutting-edge research directly in
communities and put access to cancer clinical trials into the hands of
local physicians. Because of their participation in NCI trials,
community clinicians more readily adopt new regimens, ensuring that
these advances are rapidly made part of the standard of care.
Recently, NCI's leadership team has initiated a series of site
visits to innovative community-based cancer centers as potential models
for a new NCI initiative, the Community Cancer Centers Program (CCCP).
The CCCP would help foster replication of successful community models
across the country, set the standards for multi-specialty state-of-the-
art care, provide access to early phase clinical trials, and ultimately
improve cancer care and outcomes. This program is especially designed
to bring academic standards of care and clinical trials directly to the
segments of our population who either through age or resources cannot
leave their community.
a record of real success
The past year in cancer research shows a record of substantial and
heartening achievement. We are expanding our foundation of knowledge
and the technical tools with which rapid advances can be made in
understanding the mechanisms of cancer. We are exponentially increasing
the opportunities to manage this lethal disease. Building on NCI-funded
research, large-scale clinical trials in 2005 yielded results that will
have profound effects in preventing and treating many cancers.
For example, three different clinical trials showed that adding
trastuzumab (Herceptin) to standard adjuvant chemotherapy
significantly reduced the risk of recurrence in women with the early-
stage breast cancer, HER-2/neu positive, which has an over expression
of protein in the gene. Approximately 50,000 women in the United States
are diagnosed with HER-2/neu positive breast cancer each year,
representing about 20 percent of invasive breast cancers.
Equally stunning results were seen in the trial of a vaccine that
protects against two strains of human papillomavirus (HPV) that cause
over 70 percent of cervical cancers, a disease that kills more than
200,000 women each year, including many in developing countries. Study
results concluded that women who received the vaccine during a 2-year
study were protected against precancerous lesions caused by HPV. NCI
made the initial discoveries linking HPV to cervical cancer, which led
to creation and testing of HPV vaccines that are based on technology
also developed at the Institute. It is an outstanding exemplar in this
era of molecular medicine of how NCI's knowledge about the etiology of
the disease enabled creation of a vaccine against a specific cancer.
In January, an NCI-sponsored trial reported that women who received
chemotherapy directly in their abdomens as part of treatment for
advanced ovarian cancer lived more than a year longer than women who
received the same chemotherapy intravenously. The findings confirm and
expand recent research showing that intraperitoneal (IP) chemotherapy,
which delivers drugs directly to the abdominal cavity through a
catheter, can significantly increase survival for some women with the
disease. As the results were made public, NCI issued a rare clinical
announcement to raise awareness about IP chemotherapy for ovarian
cancer among physicians and patients. The NCI announcement--the first
since 1999--was warranted because IP chemotherapy is widely regarded as
an old technology and previous trials have generated little interest
among physicians. Ovarian cancer causes the most deaths of any
gynecological cancer in the United States and frequently goes
undetected until tumors spread beyond the ovaries.
Another notable advance came last September with the announcement
of results from the NCI-sponsored Digital Mammographic Imaging
Screening Trial (DMIST). The study found that digital mammography is
more accurate than film mammography for women with dense breasts, as
well as for several other groups of women, including women under 50 and
pre- and perimenopausal women. Overall, DMIST offers a model case study
of how NCI can be an agent of change, pursuing new approaches to
research, partnering with the private and public sectors, and fueling
the development of technologies to achieve an important advance. It is
particularly noteworthy that NCI and the American College of Radiology
Imaging Network (ACRIN) secured the involvement in DMIST of four
companies that developed and manufactured digital mammography machines
for our use in clinical trials: Fischer Medical, Fuji Medical, General
Electric Medical Systems, and Hologic.
Finally, NCI has made strides to address the widespread disparities
in cancer screening, treatment, and care for disadvantaged, mostly
minority populations. One approach to closing this access gap is NCI's
Patient Navigator Research Program, which relies on personal guides to
shepherd disadvantaged cancer patients into standard care. NCI supports
a number of Patient Navigator Program pilot projects in minority
communities and about $24 million in grants will be awarded over the
next 5 years as part of the program.
advanced technologies accelerate progress
The technology revolution is speeding up and enabling the discovery
process. Nanotechnology has emerged as a key strategy for imaging
molecular features of cancer and will ultimately lead to personalized
medicine. NCI's investment in nanotechnology is a powerful example of
leveraging resources from the private sector through our Centers of
Cancer Nanotechnology Excellence.
Of equal significance, in December 2005 NCI and the National Human
Genome Research Institute (NHGRI) launched The Cancer Genome Atlas
(TCGA) Pilot Project, a comprehensive effort to accelerate
understanding of the molecular basis of cancer and which evolved from
the Human Genome Project (HGP). The TCGA Pilot Project will develop and
test the science and technology needed to systematically identify the
genetic changes in a small number of cancers.
Additionally, NCI's cancer Biomedical Informatics Grid
(caBIG<SUP>TM</SUP>) is creating a unifying technology platform or
``world-wide web'' for cancer research. caBIG<SUP>TM</SUP> is well on
the way to its goal to create a network of interconnected data,
applications, individuals, and institutions that will redefine how
cancer research is conducted and care is provided. This initiative has
also whetted considerable commercial interest.
interagency collaborations
Addressing the cancer problem requires that NCI work across
institutional and sector boundaries, share knowledge, and bring
together the diverse members of the Department of Health and Human
Services (DHHS) family of agencies, as well as other federal offices,
that can help develop systems-based solutions to the cancer problem.
The NCI and FDA Interagency Oncology Task Force (IOTF) continues to
remove bottlenecks in the process of developing and approving safe,
more effective cancer interventions. During 2005, IOTF helped foster
the creation of two important initiatives: the Exploratory
Investigational New Drug (IND) process to streamline the early clinical
development of new drugs and biologics; and the NCI Regulatory Affairs
Liaison position to help NCI-funded researchers navigate through FDA's
IND application process. Both will help eliminate obstacles to the
rapid development of promising new anticancer agents.
DHHS Secretary Mike Leavitt announced last month the Oncology
Biomarker Qualification Initiative (OBQI)--an unprecedented interagency
agreement among NCI, FDA, and the Centers for Medicare and Medicaid
Services (CMS) to collaborate on improving the development of cancer
therapies and the outcomes for cancer patients through biomarker
development and evaluation.
conclusion
We must do more to continue the acceleration of discovery,
development, and delivery of the interventions that will hasten the
transformation of our traditional view of cancer as a death sentence
into a disease that we can prevent, eliminate, or control. This will be
the legacy we leave our children.
While progress is evident, there is much that remains to be
accomplished. We are committed to face the challenge of making
difficult choices between those programs that we will continue to grow
and nurture and those that have already advanced our knowledge. The
decisions will be science driven. This is an unprecedented era of
discovery. The opportunities to apply powerful new technologies to
advance our knowledge and the opportunities to change the course of
cancer have never been greater.
______
Prepared Statement of Dr. Francis S. Collins
Mr. Chairman and Members of the Committee: I am pleased to present
the fiscal year 2007 President's budget request for the National Human
Genome Research Institute (NHGRI). The fiscal year 2007 budget includes
$482,942,000, a decrease of $3,107,000 from the fiscal year 2006
enacted level of $486,049,000 comparable for transfers proposed in the
President's request.
On October 26, 2005, an international consortium of dedicated
scientists from six countries, led by the NHGRI, published a new map of
the human genome called ``HapMap'' that may prove even more powerful
than the human genome sequence because of its medical applications.
The Human Genome Project (HGP) spelled out the letters of the 99.9
percent of the DNA code that we all share. The haplotype map, or HapMap
for short, provides detailed knowledge of the 0.1 percent that
represents variation in the genome. The HapMap reveals the way in which
this genetic variation is organized into chromosomal neighborhoods and
provides a powerful tool to uncover those spelling differences in the
human instruction book that predispose some people to diabetes,
Alzheimer's disease, heart disease, or cancer. As with the HGP, all of
the data has been placed in the public domain.
Since early deliberations about the HGP 20 years ago, scientists
and physicians have dreamed of the day when we would be able to apply
the tools of genomics to the diagnosis, treatment, and prevention of
those common diseases that fill up our hospitals and clinics, causing
untold suffering, misery, and premature death. The completion of the
HapMap brings us a major step closer to the realization of that dream.
The HapMap project could not have succeeded without the support of
multiple NIH institutes, the U.S. Congress, and the dedication of more
than 2,000 scientists across the world who delivered on every promise
of the project. In fact, in its brief three-year life, this project
produced a map three times more detailed than originally thought
possible. The NHGRI and other NIH institutes can now move quickly to
build on this success to discover the genetic and environmental factors
that cause disease, and to utilize this information to develop better
means of individualized prevention and treatment.
ongoing nhgri initiatives
Use of Comparative Genomics to Understand the Human Genome
The NHGRI continues to support the sequencing of the genomes of
non-human species such as the chimpanzee, dog, and mouse because of
what they tell us about the human genome. The first comprehensive
comparison of the genetic blueprints of humans and chimpanzees,
published in Nature to wide acclaim in September 2005, shows our
closest living non-human relatives share identity with 96 percent of
the human DNA sequence. The sequence of the dog genome was published in
December 2005, revealing many interesting details about the remarkable
diversity of man's best friend, and greatly empowering the ability to
track down the genes involved in many chronic illnesses (like cancer)
where dogs are excellent models for human disease.
Sequencing technology advances, on the way to the $1,000 genome
DNA sequencing enables a detailed description of the order of the
chemical building blocks, or bases, in a given stretch of DNA, and is a
powerful engine for biomedical research. Though DNA sequencing costs
have dropped by three orders of magnitude since the start of the HGP,
sequencing an individual's complete genome for medical purposes is
still prohibitively expensive. Two bold new advances in sequencing
technology recently developed by NHGRI-funded researchers promise to
greatly reduce this cost. Ultimately, the NHGRI's vision is to cut the
cost of whole-genome sequencing to $1,000 or less. If achieved, this
would enable the sequencing of individual genomes as part of routine
medical care, providing health care professionals with a more accurate
means to predict disease, personalize treatment, and preempt the
occurrence of illness.
Knockout Mouse Project
The technology to ``knockout'' or inactivate genes in mouse
embryonic stem cells has led to many insights into human biology and
disease. However, information about knockout mice have only been
published and made available to the research community for about 10
percent of the estimated 20,000 mouse genes. Recognizing the wealth of
information that mouse knockouts can provide, the NHGRI coordinated an
international meeting in 2003 to discuss the feasibility of a
comprehensive project. These discussions have now resulted in a trans-
NIH, coordinated, five-year cooperative research plan that will produce
knockout mice for every mouse gene and make these mice available as a
community resource.
Chemical Genomics--Roadmap--Molecular Libraries and PubChem
The NHGRI has taken a lead role in developing a trans-NIH chemical
genomics initiative. This is part of the NIH Roadmap, and now offers
public-sector researchers access to high throughput screening of
libraries of small organic compounds that can be used as chemical
probes to study the functions of genes, cells, and biochemical
pathways. This powerful technology provides novel approaches to explore
the functions of major components of the cells in health and disease.
All the data generated for this project is stored in the new PubChem
database at the National Library of Medicine.
Bench-to-Bedside in Intramural Research--The Example of Progeria
As just one example of the focus of the NHGRI intramural program on
translational research, rapid advances have recently been achieved in
the study of progeria, a rare genetic disease of childhood
characterized by dramatic acceleration of aging. In 2003, NHGRI
researchers discovered that progeria is caused by a single letter
misspelling in a gene known as lamin A. The lamin A protein undergoes a
particular modification known as farnesylation. That same modification
activates the protein product of the famous ras oncogene; ten years of
hard work has made available a class of cancer drugs that blocks this
step. Remarkably, cell culture and mouse model experiments suggest
these drugs may also have benefits for children with progeria. Serious
consideration of a clinical trial is now underway, just three years
after gene discovery.
The Surgeon General's Family History Initiative
Family medical history is a source of genetic information that can
help more accurately determine an individual's risk for specific
diseases. However, to date, this resource has been underutilized in
health. To address this, Surgeon General Richard Carmona established
the U.S. Surgeon General's Family History Initiative, a collaborative
effort between a number of Department of Health and Human Services
agencies, with leadership from NHGRI. The second annual National Family
History Day was celebrated on Thanksgiving Day 2005, when a new and
improved version of the software tool called ``My Family Health
Portrait'' was released to help individuals compile their own family
history information. This initiative should have an impact on patient-
healthcare provider interaction, facilitating the development of more
accurate family history information for patient medical records, and
leading to more personalized and effective disease prevention and
treatment strategies.
new nhgri initiatives
The Genes and Environment Initiative (GEI) and the Genetic Association
Information Network (GAIN).
Just this February, the Department of Health and Human Services
announced the creation of two related groundbreaking initiatives in
which NHGRI will play a leading role, to speed up research on the
causes of common diseases such as asthma, arthritis, the common
cancers, diabetes, and Alzheimer's disease.
The Genes and Environment Initiative (GEI) is a trans-NIH research
effort to combine comprehensive genetic analysis and environmental
technology development to understand the causes of common diseases. NIH
will invest $68 million in GEI in fiscal year 2007. Using the newly
derived HapMap, GEI will search for the specific DNA variations that
are associated with an increased risk of common illnesses. For the more
than a dozen disorders chosen for investigation under GEI, NIH will
study roughly 1,000 cases and 1,000 controls will be studied. Finding
the variants that predispose a person to common disease is one of the
highest priorities of current biomedical research, as this will enable
developing personalized medicine and identifying new drug targets.
To ensure that GEI takes advantage of the wide breadth of expertise
that is available on DNA variations for common disorders, NIH has begun
partnering under the Genetic Association Information Network with the
Foundation for the NIH, Pfizer, and Affymetrix to begin research on
seven diseases during this fiscal year.
But genes alone do not tell the whole story. Recent increases in
chronic diseases like diabetes, childhood asthma, obesity or autism
cannot be due to major shifts in the human gene pool as those changes
take much more time to occur. They must be due to changes in the
environment, including diet and physical activity, which may produce
disease in genetically predisposed persons. Therefore, GEI will also
invest in innovative new technologies/sensors to measure environmental
toxins, dietary intake and physical activity, and using new tools of
genomics, proteomics, and understanding metabolism rates to determine
an individual's biological response to those influences.
The Cancer Genome Atlas (TCGA)
In December, the National Cancer Institute (NCI) and the National
Human Genome Research Institute (NHGRI) jointly launched a very
important new effort to accelerate our understanding of the molecular
basis of cancer through the application of genome analysis
technologies, including large-scale genome sequencing. Thanks to the
tools and technologies developed by the Human Genome Project and recent
advances in using genetic information to improve cancer diagnosis and
treatment, it is now possible to envision a comprehensive effort to map
the changes in the human genetic blueprint associated with all known
forms of cancer. The overall effort, called The Cancer Genome Atlas,
will begin in 2006 with a three year, pilot project totaling $100
million to determine the feasibility of a full-scale effort to explore
the universe of genomic changes involved in all types of human cancer.
This atlas of genomic changes will provide: (1) new insights into the
biological basis of cancer which in turn will lead to new tests to
detect cancer in its early, most treatable stages; (2) new ways to
predict which cancers will respond to which treatments; (3) new
therapies to target cancer at its most vulnerable points; and (4)
ultimately, new strategies to prevent cancer altogether.
other areas of interest
Education of Health Care Professionals
To enable the translation of basic genetic discoveries into health
care practice, the NHGRI has developed numerous educational programs to
prepare health care professionals for this revolution. Specifically,
the NHGRI continues to play a lead role in the National Coalition for
Health Professional Education in Genetics (NCHPEG), which is leading a
national effort to achieve genetic literacy amongst health
professionals. NHGRI also worked closely with the American Academy of
Family Physicians, who featured genomic medicine as their educational
focus for 2005.
Minority Outreach Activities
The NHGRI has been at the forefront of ensuring that minority
scientists and students are equipped to meet the new challenges of
genome research for the 21st century. The institute has sponsored new
initiatives to reach out to diverse populations including research,
education, and outreach collaborations on the role of genetic factors
in health disparities. In conjunction with the National Council of La
Raza, NHGRI has developed a community-based model education program for
provision of genetics information to underserved Latino communities.
NHGRI is also working with Alaska Native communities and the University
of Washington to expand community-based education programs in Alaska
Native communities.
Genetic Nondiscrimination
The NHGRI remains very concerned about the impact of potential
genetic discrimination on research and clinical practice. Through many
surveys and research projects funded by the Ethical, Legal, and Social
Implication (ELSI) program of the Institute, it is clear many Americans
remain concerned about the possible misuse of their genetic information
by insurers or employers. In February 2005, the Senate unanimously
passed the Genetic Information Nondiscrimination Act of 2005 (S. 306),
which would address these concerns; the companion bill H.R. 1227 is now
pending in the House. The Bush Administration has issued a Statement of
Administrative Policy in support of the legislation. This issue remains
a high priority for the Institute.
______
Prepared Statement of Dr. Anthony S. Fauci
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Institute of Allergy
and Infectious Diseases (NIAID) of the National Institutes of Health
(NIH). The fiscal year 2007 budget of $4,395,496,000 includes an
increase of $12,195,000 over the fiscal year 2006 appropriated level of
$4,383,301,000, comparable for transfers proposed in the President's
request.
The mission of NIAID is to conduct and support research to
understand, treat, and prevent infectious and immune-related diseases.
Infectious diseases include well-known killers such as HIV/AIDS,
malaria, and tuberculosis; emerging or re-emerging threats such as
influenza; and ``deliberately emerging'' threats from potential agents
of bioterrorism. Immune-related disorders include autoimmune diseases
such as type 1 diabetes and rheumatoid arthritis as well as asthma,
allergies, and problems associated with transplanted tissues and
organs.
NIAID has a two-fold mandate. First, NIAID must plan and execute a
comprehensive and long-term basic and clinical research program on
well-recognized endemic infectious and immune-mediated diseases.
Second, and in this case it is unique among the NIH Institutes, it must
respond quickly with targeted research to meet new and unexpected
infectious disease threats as they arise, often in the form of public
health emergencies. Part of the expansion of the NIAID research
portfolio in recent years has been driven by unprecedented scientific
opportunities in the core NIAID scientific disciplines of microbiology
and immunology. Advances in these key fields have led to a better
understanding of the human immune system and the mechanisms of
infectious and immune-mediated diseases. But the scope of NIAID
programs also has grown because of a growing realization that
biomedical research is a key component of a successful response to new
challenges posed by emerging and re-emerging infectious diseases such
as pandemic influenza and HIV/AIDS, the threat of bioterrorism, and the
increase in asthma prevalence among children.
emerging and re-emerging infectious diseases
Despite advances in medicine and public health such as antibiotics,
vaccines, and improved sanitation, the World Health Organization (WHO)
estimates that infectious diseases still account for approximately 26
percent of all deaths worldwide, including about two-thirds of all
deaths among children younger than five years of age. Moreover, the
pathogens we face are not static, but change dramatically over time as
new microbes emerge and familiar ones re-emerge with new properties or
in unusual settings.
Influenza is perhaps the most pertinent example of a re-emerging
disease. Influenza viruses continually accumulate small changes such
that a new vaccine must be made for each influenza season. When a
totally new influenza virus against which the global population has no
natural immunity emerges, a worldwide pandemic can result if the new
viruses are able to transmit efficiently between people. Three such
pandemics occurred in the 20th century, in 1918, 1957, and 1968. The
pandemics of 1957 and 1968 were severe infectious disease events that
killed approximately two million and 700,000 people worldwide,
respectively. The 1918-1919 pandemic, however, was catastrophic. Public
health experts estimate that the 1918 pandemic killed more than 500,000
people in the United States and more than 50 million people worldwide.
The highly pathogenic H5N1 avian influenza virus currently found in
domestic and migratory birds in Asia, Africa, the Middle East, and
Europe is of great concern. Although H5N1 is primarily an animal
pathogen, it nonetheless has infected more than 170 people; more than
half of all confirmed H5N1 patients have died. At this time, the virus
is not able to spread efficiently from animals to humans and is
extremely inefficient in spreading from person to person, but the
feared human influenza pandemic could become a reality if the H5N1
virus mutates further or mixes its genes with human influenza viruses,
remains highly virulent, and acquires the capability to spread
efficiently from person to person.
It is imperative that we prepare for the possibility that a new
influenza virus will emerge to cause a 1918-like pandemic among human
beings. It is important to note, however, that our ability to cope with
a pandemic--with a sufficient supply of effective vaccines and
antiviral drugs, effective infection control, and clear public
communication--will to a large extent depend on how well we cope with
seasonal influenza. It is clear that we have not yet optimized our
preparedness and responsiveness to this recurring disease, which,
according to estimates of the Centers for Disease Control and
Prevention (CDC), kills an average of about 36,000 people in the United
States each year. The serious vaccine shortage that occurred in the
2004/05 influenza season underscored the difficulties we face in
annually renewing the influenza vaccine supply, and highlights the
pressing need to move toward adoption of newer vaccine manufacturing
techniques and other strategies that can improve the surge capacity,
flexibility and speed with which vaccines are made.
NIAID supports numerous research projects that lay the foundation
for improved influenza vaccine manufacturing methods, new categories of
vaccines that work against multiple influenza strains, as well as the
next generation of anti-influenza drugs. Some of these are basic
research projects intended to increase our understanding of how animal
and human influenza viruses replicate, interact with their hosts,
stimulate immune responses, and evolve into new strains. Other projects
are more targeted, such as a program to screen compounds for antiviral
activity against influenza viruses. One particularly important effort
is to develop a vaccine that raises immunity to parts of the influenza
virus that do not vary from season to season. Not only would such a
vaccine provide continued protection over multiple influenza seasons,
it might also offer considerable protection against a newly-emerged
pandemic influenza virus and thereby substantially improve our
preparedness for pandemic threats.
The Department of Health and Human Services (DHHS) Pandemic
Influenza Response and Preparedness Plan designates NIAID as the lead
agency for research and development efforts related to pandemic
influenza. In this capacity, NIAID has developed and is clinically
evaluating several candidate H5N1 vaccines, including inactivated and
live-attenuated vaccines, as well as other strategies such as
recombinant subunit and DNA vaccines. The potential benefits of NIAID
research to the American public have been clear and immediate. The pre-
pandemic H5N1 vaccine that is currently being stockpiled by DHHS was
shown in clinical trials by NIAID to be safe and capable of inducing an
immune response that would be predictive of being protective against
the H5N1 virus. The dose of vaccine required for this protection,
however, is high; and current NIAID studies are aimed at enhancing the
response to lower doses of the H5N1 vaccine, particularly with the use
of adjuvants, which are compounds that have been shown to enhance the
immune response to vaccines. NIAID also conducts surveillance for the
molecular evolution of influenza viruses among animals and humans in
Asia and elsewhere, and tracks changes in the virus that might allow it
to be transmitted more easily among people. The Institute also is
evaluating new antiviral drugs against H5N1 influenza as well as
combinations and varied doses of existing drugs. In addition, NIAID is
working to establish a clinical trials network in Southeast Asia to
conduct research on emerging infectious diseases, with an initial
emphasis on influenza.
Influenza is by no means the only emerging and re-emerging
infectious disease threat that the world faces. For example, malaria is
a substantial and growing problem compounded by the emergence of drug-
resistant malaria parasites and insecticide-resistant mosquito vectors.
NIAID supports a large malaria research portfolio; one recent study
identified a specific parasite gene that is essential for full
maturation of the parasites in mice. Disrupting this gene not only
prevented the onset of disease in mice, but injection of the modified
parasites stimulated an immune response that protected them from
subsequent infection with unmodified, fully-virulent malaria parasites.
This indicated that genetically attenuated parasites might be useful as
a malaria vaccine in the future.
Tuberculosis (TB) is an example of a microbial disease that has
reemerged in recent years. Infection with Mycobacterium tuberculosis is
estimated to be prevalent in one-third of the world's population and is
especially common among persons infected with HIV. NIAID supports a
large portfolio of research to develop new drugs, vaccines, and
diagnostics for TB and to evaluate improved treatment and preventive
regimens. Recently, two novel, engineered TB vaccines developed with
NIAID support entered Phase I clinical trials in the United States.
These promising candidates are the first new TB vaccines to be tested
in people in more than 60 years. In addition, the Global Alliance for
TB Drug Development and NIAID have collaborated to develop a promising
new TB drug candidate, which is now being tested in clinical trials.
NIAID also has made substantial research progress on West Nile Virus,
multi-drug resistant tuberculosis (MDR-TB), SARS, and other new or re-
emerging infections.
hiv/aids research
HIV/AIDS was first recognized as an emerging disease only 25 years
ago. Today it is a global catastrophe. According to the Joint United
Nations Program on HIV/AIDS (UNAIDS), approximately 40 million people
worldwide are living with HIV/AIDS, and their number is increasing by
more than 5 million people every year--about 14,000 each day. In the
United States, more than one million people are living with HIV/AIDS,
and approximately 40,000 new infections occur annually. Worldwide, more
than 25 million people with HIV have died since the pandemic began,
including more than 520,000 in the United States. In 2004, there were 3
million deaths worldwide due to HIV/AIDS. These statistics are grim
reminders of the physical and emotional devastation to individuals,
families, and communities coping with HIV/AIDS, and of the terrible
impact of HIV/AIDS on regional and global security and the global
economy.
Development of a vaccine that protects against HIV/AIDS is one of
the highest priorities of the NIAID. The scientific challenges that
must be overcome, however, are extraordinary. Because the immune
system, with rare exceptions, has not been shown to contain HIV on its
own, an HIV vaccine will have to elicit an even stronger immune
response than elicited by natural HIV infection if it is to prevent
infection. To help meet these challenges, NIAID established the Center
for HIV/AIDS Vaccine Immunology (CHAVI) in June 2005. CHAVI's mission
is to tackle the fundamental immunological obstacles in HIV vaccine
research and to design, develop, and test novel HIV vaccine candidates.
The establishment of CHAVI complements NIAID's continued support of
other innovative research projects conducted through a highly
cooperative and collaborative global research and development program.
Among many HIV vaccine research efforts, NIAID scientists have
developed a two-part vaccination strategy, consisting of an initial
(prime) vaccination followed by a later (boost) vaccination. The
priming dose is a ``naked'' DNA vaccine, and the boost is a recombinant
adenovirus vaccine, which is based on a highly attenuated version of a
common cold virus. Both components contain genes from three different
subtypes of HIV that together cause about 85 percent of all HIV
infections around the world. An initial Phase I clinical trial showed
that the pair of vaccines was well-tolerated and induced substantial
immune responses. Building on these promising findings, NIAID recently
launched a second phase of testing of this ``prime-boost'' strategy.
This project is a collaboration between three international clinical
trial networks--NIAID's HIV Vaccine Trials Network, the non-profit
International AIDS Vaccine Initiative, and the U.S. Military HIV
Research Program--and expands the safety and immunogenicity testing of
the prime-boost strategy in the Americas, South Africa, and Eastern
Africa. Also underway and slated to complete enrollment this year is
the evaluation of a candidate adenoviral vaccine administered without a
DNA vaccine to determine whether it may be useful alone in preventing
HIV infection or disease.
The use of potent combinations of anti-HIV drugs, many of which
were developed with NIAID support, has dramatically reduced the numbers
of AIDS deaths in industrialized countries. Most recently these drugs
have had a major impact on several developing countries in sub-Saharan
Africa, the Caribbean, South America and Asia, as drugs have become
available to them. Indeed, these drug regimens have transformed the
complexion of HIV/AIDS throughout the world, saving the lives of
millions of people. These results are some of the most cogent examples
of the practical benefits of NIH-supported research. But we cannot be
complacent in our success. Anti-HIV drug regimens often cause serious
side effects and frequently lose their effectiveness due to the
emergence of resistant forms of HIV within a patient. Clinical research
is moving new classes of AIDS drugs closer to market and defining how
to optimally use currently licensed medications. Basic HIV research
continues to uncover additional viral and cellular targets for therapy.
For example, several potential drug targets have been identified by
determining the mechanisms that HIV uses to gain entry into host cells.
These include fusion inhibitors, the first of which was recently
approved by the Food and Drug Administration (FDA). In addition,
several inhibitors of the HIV enzyme that allows the virus to enter and
integrate into an infected cell's genes have shown great promise in
clinical trials.
biodefense research
The potential use of biological agents in a terrorist attack is a
serious threat to the citizens of our nation and the world. Research to
mitigate this threat is a key focus of NIAID. The NIAID Strategic Plan
for Biodefense Research, developed shortly after the terrorist attacks
of 2001, outlines three essential pillars of the NIAID biodefense
research program: infrastructure needed to safely conduct research on
dangerous pathogens; basic research on microbes and host immune
defenses that serves as the foundation for applied research; and
targeted, milestone-driven development of medical countermeasures to
create the vaccines, therapeutics and diagnostics that we would need in
the event of a bioterror attack. Implementation of this plan enhances
not only our preparedness for bioterrorism, but also for naturally
occurring endemic and emerging infectious diseases. In addition, NIAID
was recently given the role of coordinating and facilitating NIH
research into countermeasures to mitigate harm to civilians from
chemical and radiological/nuclear weapons. Other NIH Institutes and
Centers will also contribute substantially to these efforts. The NIH
Strategic Plan and Research Agenda for Medical Countermeasures against
Radiological and Nuclear Threats was released in June 2005, and the NIH
Strategic Plan and Research Agenda for Medical Countermeasures against
Chemical Threats is scheduled to be released in mid-2006.
Perhaps the most tangible signs of NIAID's biodefense research
progress are the biocontainment research facilities now under
construction, which will be capable of safely containing dangerous
pathogens, enabling scientists to study such agents. For example,
through its extramural program, NIAID is supporting the construction of
two National Biocontainment Laboratories--capable of safely containing
the most deadly pathogens--as well as thirteen Regional Biocontainment
Laboratories nationwide. In addition, three intramural biocontainment
labs--on the NIH campus, on the National Interagency Biodefense Campus
at Fort Detrick in Fredrick, MD, and at the NIAID Rocky Mountain
Laboratories in Hamilton, MT--are either complete or under
construction. NIAID also has established a nationwide network of
Regional Centers of Excellence (RCEs) for Biodefense and Emerging
Infectious Diseases Research; two new RCE awards were announced on June
1, 2005, bringing the total number of RCEs nationwide to ten.
The investment in biodefense research has already yielded
substantial dividends, some of which are of immediate benefit while
others provide considerable promise for the future. Our basic research
and clinical trials have already greatly increased our ability to
respond to the threats of smallpox, anthrax, and Ebola with new and
improved vaccines. For example, in November 2004, DHHS awarded a
contract for the acquisition of 75 million doses of a new anthrax
vaccine to be held in the Strategic National Stockpile. NIAID's support
of the development of this vaccine was instrumental in making this
initiative possible. In addition, NIAID-supported scientists recently
discovered that a poxvirus infection may be halted by a cancer drug
aimed not at the virus, but at the host cellular machinery that the
virus needs to spread from cell to cell. Although much work remains,
this research provides a lead to not only a new therapeutic approach to
poxviruses such as smallpox, but also a means of circumventing
antiviral drug resistance for other viruses. In another example of
critical new discoveries, NIAID-supported scientists demonstrated that
host cell proteins called cathepsins play an essential role in the
Ebola virus' ability to enter and infect cells, and that inhibitors of
cathepsin activity block viral entry and reduce the production of
infectious Ebola viruses. This suggests that drugs that inhibit the
activity of cathepsins might be useful as anti-Ebola therapies.
NIAID's implementation of its Strategic Plan for Biodefense
Research has been aided by the enactment of the Project BioShield Act
of 2004. Project BioShield provides NIH additional flexibility in
awarding contracts, cooperative agreements, and grants for research and
development of critical medical countermeasures. The BioShield Act also
provides NIH with streamlined personnel authority, which has allowed
NIAID to hire highly-qualified individuals to fill key positions
related to product development. Lastly, Project BioShield provides
NIAID with additional authority for the construction of research
facilities, which NIAID used to award grants in fiscal year 2005 for
the construction of four Regional Biocontainment Laboratories.
research on immune-mediated diseases
Autoimmune diseases, allergic diseases, asthma and other
immunologic diseases are significant causes of chronic disease and
disability in the United States and throughout the world. Autoimmune
diseases affect 5 to 8 percent of the U.S. population; asthma and
allergic diseases together are the sixth leading cause of chronic
disease and disability in this country; and asthma is the leading cause
of hospitalizations and school absences among children. A promising
strategy to treat and prevent immune-mediated diseases is known as
immune tolerance. Immune tolerance therapies are designed to preprogram
immune cells in a highly specific fashion to eliminate injurious immune
responses, such as those seen in autoimmune diseases, while preserving
protective responses needed to fight infection. The NIAID has
established a comprehensive program in immune tolerance research,
including basic research, preclinical testing of promising strategies
in nonhuman primates, and clinical evaluation through the Immune
Tolerance Network (ITN), a consortium of more than 80 investigators in
the United States, Canada, Western Europe, and Australia. Currently,
NIAID is supporting more than 40 clinical trials of immune tolerance
strategies to treat autoimmune diseases, allergic diseases, and
transplant rejection.
NIAID-supported research in immune-mediated diseases has led to
significant advances in our understanding of how to manage these
diseases. For example, NIAID-supported scientists recently identified
novel ways to non-invasively assess the risk of kidney graft rejection
by using immunologic and genetic biomarkers present in urine. If
validated in larger studies, these biomarkers would allow physicians a
non-invasive way to monitor transplant recipients for organ rejection,
and intervene before organ injury, a significant advance in the
clinical management of transplant patients.
NIAID also remains committed to improving the health of children
with asthma, particularly those who live in our Nation's inner cities.
For example, NIAID-supported researchers recently published the results
of a study on the effect of home-based interventions that reduce
exposure to common allergens such as cockroaches, house dust mites, and
tobacco smoke. The study found that the interventions resulted in 20
percent fewer days with asthma symptoms and 14 percent fewer
unscheduled clinic visits through the intervention year. We anticipate
that our extensive research portfolio will continue to illuminate the
causes of asthma and other immune-mediated conditions, and lead to new
interventions to reduce the burden of these serious diseases.
conclusion
The research conducted at NIAID and at NIAID-sponsored laboratories
encompasses a broad array of basic, applied and clinical studies. This
research has resulted in tangible benefits to the American public and
to individuals throughout the world. By supporting talented researchers
and emphasizing a balance of basic studies and targeted research, we
hope to continue to develop innovative technologies and treatments to
combat a wide range of important diseases that afflict humanity.
______
Prepared Statement of Dr. Elizabeth G. Nabel
Mr. Chairman and Members of the Committee: I am pleased to present
the fiscal year 2007 President's Budget request for the National Heart,
Lung, and Blood Institute (NHLBI). The fiscal year 2007 budget includes
$2,901,012,000, a decrease of $20,745,000 over the fiscal year 2006
enacted level of $2,921,757,000.
The NHLBI was established as the National Heart Institute in 1948
with a mandate ``to improve the health of the people of the United
States'' through research on diseases of the heart and circulation. And
that is exactly what we have done. I believe it is no exaggeration to
claim that, over the past decades, biomedical research has made more
progress in cardiovascular disease than in any other major chronic
health problem. The impact on death rates alone constitutes a
monumental validation of this country's public investment in the NIH
and the NHLBI.
The United States experienced an epidemic of coronary heart disease
(CHD) during the twentieth century and, had the trend continued
unabated, more than 1.6 million lives would be lost to CHD this year.
In actuality, the toll will be less than 500,000 deaths, reflecting a
63 percent decline in age-adjusted mortality since 1950.\1\ Mortality
from stroke, the third most common cause of death in the United States,
declined 70 percent over that time. The effect on longevity has been
remarkable--looking just at recent data, we can see that between 1970
and 2000 the life expectancy of the average American increased by 6
years, and nearly 4 years of that gain was due to reductions in deaths
from cardiovascular disease.
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\1\ Data in this statement regarding mortality and life expectancy
are from U.S. Vital Statistics.
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Much of the reduction in death rates has come from improved
treatments for CHD. Not so long ago, atherosclerosis followed an
inexorable course and, once an artery became occluded, blood flow could
not be restored. Increasingly sophisticated technological developments
in revascularization--coronary artery bypass surgery (1968), balloon
angioplasty (1977), stents (1994), and now ``drug-eluting'' stents--
coupled with vastly improved diagnostic procedures and new medications,
have literally given many patients a new lease on life. NHLBI-supported
basic and applied research studies, as well as carefully designed
clinical trials, have enabled scientists to develop these
interventions, to assess their utility and safety, and to determine the
characteristics of patients most likely to benefit from them. Millions
of Americans suffer from cardiovascular disease, and this research has
contributed enormously to our ability to help them live longer and
healthier lives.
We are equally pleased to reflect on improvements that have
occurred in our ability to treat acute heart attacks. In past
generations, doctors could only stand by while a heart attack ran its
course and they had little to offer the patient but bed rest and a
prognosis of rapid death or severely restricted life as a ``cardiac
cripple.'' All that changed in the 1980s when scientists determined
that most heart attacks occur because of a blood clot in an artery that
feeds the heart. The development of thrombolytic--``clot-busting''--
therapy followed. NHLBI-sponsored clinical trials of thrombolysis
demonstrated that the procedure could limit the area of damaged heart
muscle and decrease mortality. This was revolutionary, and it rapidly
influenced how heart attack is treated.
The greatest benefit of thrombolysis, however, accrues in the
initial minutes and hours after onset of the attack and, unfortunately,
many patients do not reach the emergency room in time. In the 1990s the
NHLBI initiated a successful trial of community-based interventions to
reduce delays in seeking and receiving treatment for heart attack
symptoms. The knowledge gained was used to develop Act in Time to Heart
Attack Signs, a far-reaching public education campaign launched by the
NHLBI during the NIH budget doubling. Also during the doubling, the
Institute began a pilot program at Suburban Hospital to test a new
approach to diagnosing heart attack patients who may be candidates for
thrombolytic therapy. For many patients arriving at the emergency room
with chest pain, diagnosis requires measurement of enzymes that appear
in the bloodstream only hours after the heart attack has occurred--too
late for effective thrombolysis. The experimental program is having
great success in using MRI (magnetic resonance imaging) technology to
provide a diagnosis in about 35 minutes, and we believe it may form the
basis for a better approach to delivering prompt therapy to patients
who are likely to benefit from it. In light of recent evidence that
thrombolytic therapy may benefit patients who experience a clot-based
stroke, we have also teamed up with the National Institute of
Neurological Disorders and Stroke to use MRI in evaluating patients who
come to the emergency room with stroke symptoms.
Let me mention some special efforts to improve treatment of
coronary heart disease in a highly vulnerable population--patients with
obesity and type II diabetes. Although there is near-universal optimism
that a cure for diabetes will ultimately be found, in the meantime the
majority of patients are suffering and dying from cardiovascular
disease. We are working to identify approaches to prevent and treat
these complications, and I am happy to note that the budget doubling
enabled us to move forward with full funding of two major new clinical
trials in this area. The ACCORD trial is testing the extent to which
control of blood pressure, cholesterol, and glucose levels to
thresholds beyond those that are currently recommended will reduce the
occurrence of cardiovascular problems. The BARI-2D trial, focused on
diabetic patients who already have coronary heart disease, is weighing
the merits of revascularization versus medical treatment and, in
addition, studying two different approaches to controlling blood sugar.
These trials are effortful and expensive because they involve multiple
complex issues in diabetes management. However, they address a critical
public health need, given the escalating prevalence of obesity and
diabetes in the United States, and many among us are likely to benefit
from their findings.
Much as we celebrate these advances in treatment, let me assure you
that we have never lost sight of our ultimate objective--prevention.
Indeed, we have had considerable success in identifying risk factors
such as high blood pressure and cholesterol, developing and evaluating
methods to control them, and translating the research findings into
messages for health-care professionals, patients, and the general
public. During the budget doubling, we launched The Heart Truth, an
education campaign to raise awareness that heart disease is the leading
cause of death in American women and call women to take action to
reduce their risk of developing heart disease. Already we have evidence
that the campaign's message, ``Heart disease doesn't care what you
wear--it's the #1 killer of women,'' has raised awareness throughout
the nation. Last June we launched We Can! (Ways to Enhance Children's
Activity and Nutrition), a national education program to help children
8-13 years of age stay at a healthy weight. We Can! offers parents and
families tips and activities to encourage healthy eating, increase
physical activity, and reduce sedentary or screen time. It also
provides resources to help community groups and health professionals
work toward these goals.
Much of what we know about factors that put people at risk of
developing cardiovascular diseases has come from the multigenerational
Framingham Heart Study, begun in 1948. I am delighted to announce that
the NHLBI, in conjunction with Boston University, recently unveiled a
plan to take this study to the next level. Our new Framingham Genetic
Research Study will entail up to 500,000 analyses of the DNA of 9,000
study participants. By identifying genetic variations that relate
strongly to participant characteristics (e.g., blood pressure and
cholesterol levels, overweight and obesity) and to outcomes (e.g.,
stroke, congestive heart failure, diabetes), we hope to refine our
understanding of individual risk and identify carefully focused new
strategies for treatment and prevention. We at the NHLBI share Dr.
Zerhouni's vision of an approach to medical care that is predictive,
personalized, and preemptive and we believe this new endeavor
constitutes a major step toward realizing that goal.
pediatric heart and lung disorders
Tremendous progress has been made in treating congenital
cardiovascular malformations, the most common type of birth defect in
the United States. Many of us remember when these conditions
constituted a death sentence, but today we have an array of surgical
and medical treatments, as well as reliable and effective methods for
providing monitoring and support. As a result, more than 90 percent of
these babies live to celebrate a first birthday. Indeed, the prognosis
has improved so much that there are now more adults than children
living with congenital heart defects, according to data from the Adult
Congenital Heart Association. Nonetheless, congenital heart disease is
still a major contributor to infant mortality and many challenges
remain. Thanks to the budget doubling, we have been able to expand
significantly our efforts in this area by funding two additional
Specialized Centers of Research in Pediatric Cardiovascular Disease,
establishing a clinical research network to enable rapid evaluation of
new treatment approaches, and soliciting research proposals to develop
devices for infants and children who experience cardiopulmonary failure
and circulatory collapse.
As recently as 35 years ago, many premature infants died within
hours of birth from neonatal respiratory distress syndrome (RDS), a
condition caused by lack of a substance called surfactant that keeps
the lung's air sacs open for breathing. The NHLBI's long-term
investment in basic, applied, and clinical research has nearly
relegated neonatal RDS to history. With development of special
ventilation techniques to sustain babies until their lungs matured,
introduction of a prenatal test for lung maturity, and demonstration
that antenatal corticosteroid treatment could accelerate lung
maturation, U.S. deaths from this disorder fell 60 percent between 1970
and 1984--from 10,000 to 4,000 per year. Then, in the 1980s, NHLBI-
supported studies of surfactant structure, function, and regulation and
efforts to identify the genes for surfactant proteins culminated in
development of surfactant replacement products for testing in clinical
trials. Since 1990, when two surfactant treatments were approved for
widespread clinical use, neonatal RDS mortality has fallen more than 75
percent, to about 1,000 deaths per year.
asthma
For centuries, asthma was viewed a bronchial spasm problem and
treated--with limited success--as such. Our intensive research effort
in recent years led to the realization that asthma is a manifestation
of chronic inflammation and immune dysfunction. This insight
revolutionized treatment, the mainstay of which now is anti-
inflammatory medications to treat the underlying disease, with
bronchodilators used chiefly for quick relief of symptoms. The NHLBI
has also been a pioneer in development of self-management strategies
and their application, especially for inner-city minority children;
evidence indicates favorable effects on emergency room visits and
school absences in this vulnerable population. Results of all these
efforts are rapidly incorporated into national guidelines that set the
standard for modern asthma management. Clinical research networks have
proven invaluable for rapidly assessing new treatment strategies, and
during the budget doubling we were able to renew our highly productive
adult Asthma Clinical Research Network and initiate the Childhood
Asthma Research and Education Network, which addresses pediatric
asthma. We also began a program focused on severe asthma. These efforts
are enabling us to make good on our promise to patients, ``Your asthma
can be controlled--expect nothing less.'' And we are now talking with
increasing confidence about curing asthma, going beyond the initial
promise of asthma control.
sickle cell disease
As recently as 1970, the average patient with sickle cell disease
died in childhood. Today, life expectancy is about 45 years. NHLBI
research has led to a standard of care that begins with screening of
newborns, provides prophylaxis for potentially lethal childhood
infections, and offers transfusion therapy to prevent stroke in high-
risk children. A clinical trial demonstrated the value of the drug
hydroxyurea in preventing painful crises, acute chest syndrome (a life-
threatening respiratory complication), and need for transfusions in
adult patients. With the budget doubling, we have been able to
undertake a hydroxyurea trial in children, and also to assess the value
of stem cell transplantation as a possible cure. Our hope and
expectation is that further gains in longevity and quality of life will
be achieved.
I would be pleased to respond to any questions that the Committee
may have.
______
Prepared Statement of Dr. Duane Alexander, Director, National Institute
of Child Health and Human Development
Mr. Chairman and Members of the Committee: I am pleased to present
the fiscal year 2007 President's budget request for the National
Institute of Child Health and Human Development (NICHD). The fiscal
year 2007 budget includes $1,257,418,000, a decrease of $7,351,000 over
the fiscal year 2006 enacted level of $1,264,769,000 comparable for
transfers proposed in the President's request.
The mission of the NICHD is vital to the NIH goal of ensuring the
overall health and well-being of the American people. Our research
focuses on both child health and human development. Increasingly,
researchers are confirming that lifelong health and well-being are
strongly influenced by events occurring early in life.
Understanding human development evolves from understanding normal
growth and change processes before birth through adulthood. It begins
at the most basic molecular and cellular levels and encompasses
cognitive, behavioral, physical and social development. By
understanding what goes ``right,'' NICHD research provides clues as to
what may go ``wrong,'' laying the critical scientific foundation not
only for understanding many disease processes, but also for preventing
them altogether.
fetal development: jump start on life
We now know that both undernourished and obese mothers have
children with increased risk of chronic disease later in life. This is
a problem world wide and it is an increasing problem in the United
States.
To understand and reverse the epidemic of type 2 diabetes among
young people, we need to look beyond their diet. The health and
nutrition of the mother during fetal development influences not only
how children function but also the later development of diabetes, high
blood pressure, heart disease and other conditions. To better
understand fetal origins of adult disease, researchers recently
discovered links between birth weight and stress hormone (cortisol)
levels in boys and girls who were small at birth, but healthy term
babies. Cortisol helps to regulate blood pressure, energy production,
and response to stress. The researchers found that the lower birth
weight boys had higher levels of cortisol under stressful conditions
compared to the higher birth weight boys. They found that the lower
birth weight girls had higher cortisol levels at the beginning of the
day. This discovery demonstrates how low birth weight can have lasting,
yet different, effects on stress hormone levels in girls and boys.
These alterations in cortisol may predispose children to obesity,
hypertension, and glucose intolerance later in life.
predicting preeclampsia
Preeclampsia is a sudden, dangerously high increase in high blood
pressure that threatens the health of a pregnant woman and her fetus.
Preeclampsia strikes without warning and can result in maternal
seizures and even death. The researchers studying this condition found
that women who, in mid-pregnancy, have a lower level of a substance
known as placental growth factor were more likely to develop
preeclampsia. This advance may lead to a screening test for
preeclampsia and a treatment to help women avoid the condition.
obstetric pharmacology--treatment for pregnant women
Most drugs used to treat pregnant women are prescribed without full
knowledge about safety and efficacy. In many cases, no data exists to
predict how the drug's dynamics may interfere with a woman's pregnancy.
To fill this knowledge gap, the NICHD has established the Obstetric-
Fetal Pharmacology Research Units (OFPRU) Network to develop improved
safety and efficacy drug information for pregnant women. One drug
currently being studied is used to control gestational diabetes.
Gestational diabetes affects up to 15 percent of all pregnancies
according to the March of Dimes. The condition results from a sudden
inability of the body to remove sugar from the blood. Untreated,
gestational diabetes results in large, stocky babies who may cease
breathing unexpectedly, have difficulty feeding, and must eat
frequently to avoid seizures. Children of mothers with gestational
diabetes are also likely to become obese during childhood and
adulthood.
For many years, physicians treated gestational diabetes with
injections of insulin. Recently, however, physicians began treating
pregnant women with glyburide, which stimulates the pancreas to
gradually release small quantities of insulin. Many patients preferred
the convenience of taking a pill to giving themselves an injection.
Although many pregnant women have taken glyburide, no studies have ever
tested the drug's effectiveness in treating gestational diabetes. A new
study is examining the use of glyburide in pregnancy, to determine if
the current dosing schedule is the most effective means to treat the
disorder.
premature birth research
Reducing preterm birth (PTB) is a major public health priority and
a major research priority for this Institute. One out of eight infants
in the United States is born preterm. This amounts to about 476,000
infants a year. The March of Dimes estimates that babies born too soon
or too small cost the U.S. health system $18.1 billion a year. Preterm
infants face a number of serious health problems and life-threatening
conditions. PTB accounts for nearly half of the neurological problems
among newborns who are at risk of having learning disabilities and
mental retardation. When preterm infants reach adulthood, they also
face much higher risks of cardiovascular disease and diabetes.
The NIH investment in preterm birth research is paying dividends.
For the first time, we now have a method to reduce the risk of PTB for
some women. One of our studies found that weekly injections of a
synthetic form of progesterone reduces the chances of preterm delivery
in women who had already given birth prematurely. For the first time,
this research gives doctors an intervention that has been shown to be
both safe and effective in reducing the risks of preterm birth. This
discovery also illustrates how quickly research can be turned into
practice. Shortly after this research was published, The American
College of Obstetricians and Gynecologists recommended that all of
their members use progesterone to prevent PTB for women with previous
PTB. Another study found that pregnant women who have a condition known
as bacterial vaginosis have a greater likelihood of delivering
prematurely. For many years, these women have been treated with
antibiotics. Contrary to existing clinical thinking, treating the
infection with an antibiotic during pregnancy did not reduce the
incidence of preterm birth. Still another NICHD study found that women
with a condition known as trichomoniasis are also at increased risk for
preterm delivery. The study found that giving antibiotics does not
reduce the risk of preterm birth associated with infection; moreover,
this treatment actually increased the preterm birth rate.
The new knowledge gained from each of these three studies was
created by one of the multidisciplinary clinical research networks
supported by the NICHD. With these networks in place, NICHD scientists
working with researchers around the country can answer important
scientific questions quickly, and work through professional
organizations to help clinicians translate the new knowledge into
practice.
The NICHD recently established the Genomics and Proteomics Network
for Premature Birth Research. This new network will focus on the
hereditary information in DNA and the structure and function of
proteins to understand the underlying processes that lead to preterm
birth.
genes may hold the key to treating uterine fibroids
Each year, more than 200,000 women in the United States undergo a
hysterectomy to treat the chronic pain and abnormal bleeding caused by
fibroids. Scientists are exploring alternative ways to treat fibroids
without surgery. Previously, these researchers identified a molecule
called transforming growth factor beta (TGF-b) that helps to regulate
several processes including the growth of uterine fibroids. Using a
powerful new technology, the researchers identified the different genes
influenced by the growth factor in both normal and fibroid cells. The
researchers then tested a gene therapy that appeared to block
production and action of TGF-b. This insight may lead to novel, non-
surgical therapeutic approaches, not only to prevent uterine fibroid
growth, but also to treat other reproductive conditions.
buffergel shown to be safe contraceptive
Researchers have made a major step forward in developing
contraceptives that protect women against HIV. One product, BufferGel,
can be used with a diaphragm, much like a conventional spermicide. The
results of a recent study demonstrate that BufferGel is as effective at
preventing pregnancy as is currently available spermicides. A study is
now in progress to determine if BufferGel can reduce transmission of
the AIDS virus.
gene programs early development and neural migration
NICHD researchers made a significant advance in understanding
dyslexia. In an article that Science Magazine called one of the 10
major breakthroughs in 2005, the researchers linked the developmental
gene DCDC2 to dyslexia. This gene functions to control nerve cell
migration in early brain development. This work suggests that genetic
miscues alter brain biology in the womb in a way that predisposes
people to problems later in life.
future research: newborn screening
The NICHD Newborn Screening Initiative is moving forward in its
effort to develop and employ the latest technology for improving the
availability, accessibility, and quality of genetic and other
diagnostic laboratory testing for rare diseases and conditions
affecting newborns. Ultimately, this research could help identify at-
risk infants as early as possible and provide the data needed to
develop therapies for many of these conditions. As a cornerstone
activity, the NICHD funded a major grant for developing and refining a
newborn screening test for spinal muscular atrophy (SMA), a common
fatal neuromuscular disease in children. The NICHD will soon be funding
additional grants to increase understanding of conditions such as SMA
or other genetic conditions.
mathematics and science cognition and learning
The NICHD is enhancing its program to better understand the
underlying developmental processes that allow children to learn math
and science. One goal is to help researchers understand the
developmental and cognitive processes needed to help children
transition successfully from arithmetic to algebraic reasoning, a
fundamental skill needed to allow children to advance their
understanding of mathematical concepts. In turn, mastering math-related
concepts such as recognizing patterns, representing relationships, and
making generalizations is key to learning and understanding science.
These critical program activities fill a major research need to clarify
the cognitive factors needed for scientific thinking and learning.
community-based rehabilitation intervention
The aging of the baby-boom generation and expected pressures on the
U.S. health care system make research into effective therapies in
community settings a high priority. Clinical trials of rehabilitation
therapies have demonstrated the efficacy of novel interventions in
preventing or significantly lessening disabling conditions associated
with stroke, traumatic brain injury, and other disorders and
conditions. Little is known, however, about whether and how well such
therapies will work in less-controlled community practice settings.
Scientists do not know whether--or how--efficacious rehabilitative
therapies and even clinical trial design may need to be modified for
community settings. To address these critical questions, the NICHD will
solicit applications for clinical trials by scientists partnering with
persons with disabilities, practitioners, and others in the community.
Mr. Chairman and members of the Committee, the support you have
shown for medical research has allowed scientists in research centers
around the country to make discoveries that advance the health of
women, children and families. I will be pleased to answer any
questions.
______
Prepared Statement of Dr. Barbara M. Alving, Acting Director, National
Center for Research Resources
Mr. Chairman and Members of the Committee: It is a privilege to
present to you, for the first time, as the Acting Director of the
National Center for Research Resources (NCRR), the President's budget
request for NCRR for fiscal year 2007, a sum of $1,098,242,000,
including support for AIDS research, which reflects a net decrease of
$859,000 over the comparable fiscal year 2006 appropriation.
By developing and funding essential research resources, NCRR
connects scientists with one another, as well as with patients and
communities across the nation. These connections bring together
innovative research teams and the power of shared resources,
multiplying the opportunities to improve human health.
These connections can be seen in the new institutional Clinical and
Translational Science Awards program, launched in fiscal year 2006,
which enables researchers to train and collaborate in new ways to move
findings in the laboratory more quickly to patients. NCRR also is
bringing patients, advocacy groups, and researchers together to fight
rare diseases--a unique opportunity to combine patient information and
support with research knowledge. Other programs are helping
investigators to create technologies that will make research
information more accessible and precise through various software tools
and Internet connections.
In addition, NCRR-supported technologies help researchers--located
in isolated regions--share information that benefits underserved
populations across the country. And at NCRR-supported primate research
centers, investigators come together to study AIDS vaccines,
Parkinson's, Alzheimer's, and many other diseases. Perhaps our most
wide-ranging connections are made through science education--programs
that reach young and old--on a diverse range of health-related issues.
These are just a few of the programs that comprise NCRR's
portfolio, but they illustrate how we are investing research dollars in
order to bring the power of shared resources to communities and
researchers across the nation and ultimately improve the health of
Americans. I would now like to provide you with additional details
about each of these exciting programs.
integrating clinical and translational science
Recognizing that a well-integrated collaborative effort is needed
to transform basic discoveries into improved medical care, NCRR has
launched an important new initiative--the Clinical and Translational
Science Awards (CTSAs)--on behalf of the NIH Roadmap for Medical
Research. The CTSA Program was initiated to break existing barriers
between basic and clinical sciences and, above all, to get people to
work together to speed the delivery of improved health care to the
public. Developed with extensive input from the scientific community,
the CTSAs will help research institutions nationwide create an academic
home for clinical and translational research, essentially generating
what NIH Director Dr. Elias Zerhouni calls the ``glue'' that fills the
gaps among scientists in multiple disciplines and thus forms a bridge
between basic and clinical research.
In ongoing dialogues with the scientific community, researchers
also have told us that the CTSA initiative will allow them to
strengthen the career development pipeline for clinical and
translational researchers. At the same time, it will build partnerships
with communities that will ensure that diverse populations, and
clinical practitioners serving those populations, play an integral part
in addressing the unique health challenges that they face. With the
community's participation, the CTSAs will help to deliver improved
medical care that meets the needs of these diverse patients and their
communities.
creating partnerships: rare diseases network
Another NCRR initiative--the Rare Diseases Clinical Research
Network--illustrates the importance of bringing patients and
researchers together. Headed by NCRR in partnership with the NIH Office
of Rare Diseases, the network is truly a trans-NIH activity, with
funding coming from five additional NIH institutes. The need for such a
network is best appreciated when one considers the emotional toll a
family faces when they find out that their child has a rare disease and
the desperation they face when they search for medical resources. For
example, Trish Hertzog, a mother from Philadelphia who agreed that we
could tell her story to help others, can vividly recall the day her son
Mathew was born more than a decade ago. Unbeknownst to anyone,
including his doctors, this seemingly healthy newborn lacked a critical
gene that helps to remove toxic substances from the body. Within two
days of his birth, Mathew fell into a coma, as lethal levels of ammonia
built up in his brain, and died within hours.
Mathew Hertzog had inherited a rare condition known as a urea cycle
disorder, which affects only about 1 in 30,000 children. Collectively,
rare diseases affect about 25 million Americans, according to the
National Organization for Rare Diseases. Research on rare diseases is
especially challenging since few patients with the same condition can
be recruited from any one clinical site.
To improve outcomes and outreach, the Rare Diseases Clinical
Research Network unites the efforts of researchers from multiple
institutions and their patients nationwide. The Network's web site has
become a source of information for the public, physicians, patients,
and investigators about rare diseases. The site also contains a unique
web-based contact registry for patients who wish to learn about
clinical studies. With this Network now available, parents like Trish
can obtain information about rare diseases and learn about
participating in one of the initial clinical trials.
widening the net: under-represented populations and areas
NCRR is using the latest advances in technology to promote greater
inclusion of under-represented minority and rural populations in
research by boosting capacity in institutions and regions of the
country that lack high-capacity, broad-bandwidth Internet connections.
Some states--including Montana, Wyoming, Alaska, Idaho, Nevada, and
Hawaii--lack access to advanced Internet applications, such as virtual
laboratories, digital libraries, distance education, as well as
advanced networking capabilities. This lack of resources hinders the
ability of the institutions in these states to conduct collaborative,
data-intensive biomedical studies. In the first phase of a national
effort called IDeANet, NCRR is enhancing high-speed network
connectivity in these five rural Western states and Hawaii, which will
bring these areas on par with connectivity in the other parts of the
country.
This effort is part of the Institutional Development Award (IDeA)
Program, which broadens the geographical distribution of NIH funding
for biomedical research. Ultimately, IDeANet will expand to include
NCRR's Research Centers in Minority Institutions Program, which
enhances the research capacity and infrastructure at minority colleges
and universities that offer doctorates in health sciences.
spurring advances through data sharing
Through the Biomedical Informatics Research Network (BIRN), NCRR
supports the integration of data, expertise, and unique technologies to
spur scientific advances that would be difficult or impossible in the
context of individual laboratories. To illustrate this point, five
volunteer research participants traveled across the country to nine
different sites to have their brains imaged via magnetic resonance
imaging (MRI). The data that was collected contributed to a first-of-
its-kind neuroimaging dataset that will enhance large-scale, multisite
imaging studies for years to come. Scientists found that brain images
from a single individual appeared surprisingly different when collected
at different MRI centers--such variance would greatly hamper multi-site
imaging studies. Through BIRN, scientists have recently developed
software tools to standardize data and reduce this type of inter-site
variability in brain scans. This collaboration is just one example of
how BIRN contributes to solving complex health-related problems. While
initial efforts are focusing on neuroimaging data, the tools and
technologies developed by BIRN ultimately may be applied to other
disciplines.
providing critical links: nonhuman primate research
Studies of nonhuman primates are indispensable to translational
research, providing a critical link between small laboratory animals
and human subjects. Many of today's life-saving interventions--
including polio vaccines, AIDS-fighting drugs, and heart surgery
techniques--depended on preliminary evaluation in nonhuman primates
like the rhesus macaque. To support such studies, NCRR funds eight
highly specialized research facilities known as the National Primate
Research Centers, which bring together researchers with a variety of
expertise, thereby contributing to studies of major human health
issues, including cancer and neurodegenerative disorders.
Because the nation currently lacks a sufficient number of
clinically trained primate veterinarians, NCRR plans to support an
initiative to attract and train graduate-level veterinarians in the
procedures for conducting primate research. A well-trained veterinary
research corps will enhance the country's capacity to respond to the
emergence and spread of potentially deadly human diseases, such as
severe acute respiratory syndrome (SARS), influenza, and hepatitis.
promoting science and health literacy
By supporting collaborations among educators, researchers,
community groups, museums, and other organizations, NCRR's Science
Education Partnership Award program increases the public's
understanding of medical research and delivers information about
healthy living and career opportunities in science to children and the
general public. For instance, a novel project at the University of
Maryland is infusing physical education classes in grades 3-5 with
science-enriched curriculum to enhance children's knowledge of the
heart and other muscles and the importance of physical fitness. Another
project, a partnership involving the University of Hawaii and
culturally diverse local communities, is designed to enhance biomedical
education and mentoring for children and their teachers on isolated
Hawaiian islands. By providing students with opportunities to
participate in hands-on, inquiry-based research projects, NCRR hopes to
demystify science and make it more accessible to individuals throughout
the nation.
conclusion
The future of medical care will depend on our commitment to bring
together scientists with diverse expertise and to support research
institutions with varying strengths and research capacities. At the
same time, we must ensure the participation of researchers and patients
who are from ethnically and geographically diverse communities and
share the importance of medical research with educators and students.
Our goal in the coming year is to enhance these collaborations,
partnerships, and networks in order to bring the power of shared
resources to researchers across the nation and maximize our research
investments.
______
Prepared Statement of Dr. Jeremy Berg, Director, National Institute of
General Medical Sciences
Mr. Chairman and Members of the Committee: I am pleased to present
the fiscal year 2007 President's budget request for the National
Institute of General Medical Sciences (NIGMS). The fiscal year 2007
budget includes $1,923,481,000, a decrease of $12,137,000 from the
fiscal year 2006 enacted level of $1,935,618,000 comparable for
transfers proposed in the President's request.
NIGMS supports a broad spectrum of research central to the National
Institutes of Health's mission of improving the nation's health. Over
the years, this foundational work has led to important breakthroughs
and treatments. Biophysical studies sparked the development of life-
saving drugs for AIDS. Inventive burn and trauma research yielded the
first artificial skin to treat severely burned patients. Most recently,
research in pharmacogenetics led the Food and Drug Administration (FDA)
to change the label of irinotecan, a drug approved in 1996 for
colorectal, lung, and other cancers. The label now indicates that
people with a certain genetic variation are at a greater risk for life-
threatening reactions to the drug and encourages doctors to use a lower
starting dose for those patients.
In other areas, such as chemistry, groundbreaking basic research
helped support drug development by the pharmaceutical industry. NIGMS'
investment in this area was recognized with the 2005 Nobel Prize in
chemistry, bringing the number of laureates whose research we have
funded to 57. Long-time grantees Robert H. Grubbs, Ph.D., of the
California Institute of Technology and Richard R. Schrock, Ph.D., of
the Massachusetts Institute of Technology were honored for developing a
revolutionary way of synthesizing new molecules. Their discoveries
transformed a seemingly esoteric process into a practical tool that is
now routinely used in the pharmaceutical industry and in other areas of
the economy, including the plastics industry.
strengthening the pipeline
In addition to providing stable research support to these chemists,
NIGMS provided funds to support their transition from trainees to
independent researchers. The Institute has a number of structured
programs that offer thousands of trainees access to state-of-the-art
resources, rigorous curricula, and high-quality ethics training. Each
year, many scientists receiving NIGMS support launch independent
careers and join the ranks of top-notch researchers in a wide range of
scientific disciplines.
Many creative contributions like the few I have highlighted above
are the work of individual bright minds. However, as biomedical
research converges and scientific fields meld together in new ways,
researchers working in different areas need to combine their talent and
expertise. Recognizing the dual need for teamwork and individual
intellectual contribution, NIGMS has invested its resources wisely. In
addition to funding a substantial number of individual investigators,
we have broadened our investment by funding large, multidisciplinary
scientific teams. These programs have served a truly catalytic role in
tackling issues of great importance to public health, and I would like
to describe some of their recent advances.
dawn of personalized medicine
The NIGMS-led Pharmacogenetics Research Network (PGRN), a trans-NIH
project consisting of 12 scientific teams, has just completed its first
5 years of work with an impressive track record. For example, the
treatment of childhood leukemia is improving due to the discovery that
variations in two genes can predict which patients with the most common
form of the disease have a higher risk of relapse. On the horizon is
safer dosing of the widely used blood-thinning medicine Coumadin (also
known as warfarin) due to the discovery that normal variation in two
genes can put some patients at risk for excessive bleeding or for heart
attacks and strokes. PGRN researchers have also made important strides
in unraveling disparities in response to treatments for asthma, a
disease that affects roughly 20 million Americans, according to the
American Lung Association. Recent findings show that variation in just
a few genes affects responses to two mainstay asthma therapies, inhaled
steroids and beta-agonists. Genetic tests to detect these variations
may be available within a year.
Other payoffs from NIGMS investments in pharmacogenetics extend
beyond implications for individual drug dosing. PGRN research has
unexpectedly uncovered knowledge that can predict disease risk in
subsets of patients, including those taking tamoxifen for breast cancer
and beta-blockers for heart disease. Finally, NIGMS-sponsored research
in pharmacogenetics is having an impact on policy. PGRN studies have
played a role in the FDA's recent decision to develop new guidelines
for personalized medicines. For example, an FDA program that allows
manufacturers to submit pharmacogenetic data for review has seen a jump
from six submissions to 25 in the space of 1 year.
teaming science for public health gains
NIGMS' innovative ``glue grant'' program is a novel approach that
brings together scientists from different disciplines to attack
problems beyond the scope of an individual investigator but crucial to
the future of the public health enterprise. One example of a recent
glue grant advance is the discovery that genes can help explain why
patients can have dramatically different reactions to traumatic injury.
The NIGMS-funded Inflammation and the Host Response to Injury research
group, which performed this study, will also release this year a set of
standard operating procedures for the care of critically injured
patients. This work, while still in the early stages, is moving ahead
rapidly and will likely improve standards for treatment across the
nation as well as facilitate the conduct of high-quality research in
this important field.
Many areas of basic biomedical research require an incubation
period before results emerge and new knowledge is translated into the
clinic. Both pharmacogenetics and much of the complex biology being
investigated with glue grants are good examples, and the recent
achievements I've described offer evidence that the wait has been worth
it. However, in other circumstances NIGMS has invested basic research
expertise in areas quite ripe for practical development. A case in
point is the Models of Infectious Disease Agent Study (MIDAS), not yet
2 years old, which has already made an important mark on the public
health policy landscape. Several key papers have emerged from this
highly interdisciplinary effort, and the program continues to be fluid,
evolving to match public health needs. The MIDAS network is focusing on
modeling the spread of influenza, and its models are providing key
inputs to policy makers and health officials engaged in preparing for
possible influenza pandemics.
value of a systems approach
The ready application of MIDAS research to current flu preparedness
efforts is apparent, but I'd like to point out that this research is a
shining example of what may seem a more esoteric concept: systems
biology. In fact, systems biology is a powerful and promising approach
for investigating how to control the progression of diseases worldwide.
Systems biology addresses how the parts of a complex network work
together to produce the behavior of the overall system. The threads of
systems biology are apparent in pharmacogenetics, which goes beyond the
consideration of a drug and its target to examine other molecules that
affect drug action and determine how apparently subtle variations in
these molecules can affect drug efficacy and safety. In infectious
disease modeling, the properties of an infectious agent are
superimposed on the structure of society, from transportation networks
to human behavior. Systems biological approaches require
interdisciplinary teams of scientists working together toward a common
goal that is often closer to practical applications than are the
powerful, ``one component at a time'' approaches that have driven
biomedical research so successfully over the past decades.
power of the mind
Let me finish by returning to the contributions of individual
minds. I'll highlight two relatively young scientists who have been
recognized by the NIH Director's Pioneer Award program for their
exceptional potential to make major breakthroughs.
The first is Sunney Xie, Ph.D., of Harvard University. He is a
pioneer in the development of methods that can see single biological
molecules in action. Most biomedical experiments examine millions or
more molecules, revealing the average behavior of all of them. While
this information can be highly useful, many details are lost. Dr. Xie's
methods, developed through an inspired application of techniques from
physics and chemistry, look at the behavior of one molecule at a time.
This is like being able to hear one conversation clearly rather than
hearing the din of a room full of people all talking at once. As these
methods mature, they have the potential to transform our understanding
of how gene expression is controlled in normal and diseased cells.
The second NIH Director's Pioneer Award winner I will mention is
neurobiologist Erich Jarvis, Ph.D., of Duke University. Dr. Jarvis, an
African American who grew up amid poverty, drugs, and violence in
Harlem, seeks to unravel the mysteries of vocal learning. He is
investigating this question using songbirds as a model system, and he
has already made important strides in unlocking some of the complexity
of one of biology's unexplored frontiers: the brain. Although his
research falls outside the realm of the NIGMS mission and Dr. Jarvis is
not currently an Institute grantee, I tell you his story for a
different, very important reason. He is a terrific example of what we
stand to lose if we do not continue to invest in the creative
individual sparks of young scientists in our diverse society. At least
part of Dr. Jarvis's rise to success can be attributed to chances he
got in school. He participated in the NIGMS Minority Biomedical
Research Support and Minority Access to Research Careers programs as an
undergraduate at the City University of New York, Hunter College, where
he received a bachelor's degree in biology and mathematics. He later
earned a Ph.D. in molecular neurobiology and animal behavior from the
Rockefeller University and today works at the forefront of an exciting
discipline at the intersection of biomedical and behavioral research.
The creative energies of potential biomedical researchers--not just
those in fields traditionally related to biomedicine but also those in
associated fields in the physical, mathematical, behavioral, and social
sciences--will drive advances leading to improvements in human health
for many years to come. Nurturing a diverse scientific workforce will
enhance the vitality of our nation and improve the health of our
children and their children.
Thank you, Mr. Chairman. I would be pleased to answer any questions
that the Committee may have.
______
Prepared Statement of Dr. Patricia A. Grady, Director, National
Institute of Nursing Research
Mr. Chairman and Members of the Committee: I appreciate the
opportunity to present the fiscal year 2007 President's budget request
for the National Institute of Nursing Research (NINR). The fiscal year
2007 budget includes $136,550,000, a decrease of $792,000 over the
fiscal year 2006 enacted level of $137,342,000 comparable for transfers
proposed in the President's request.
I am pleased to describe some of the exciting research of the
National Institute of Nursing Research (NINR). NINR is charged with
supporting research that establishes the scientific basis of quality
patient care regardless of disease or health status. We fund research
that affects individuals across the lifespan and all health care
settings, especially the underserved.
NINR is currently celebrating the 20th anniversary of its
establishment at NIH. We have used this occasion not only to take stock
of our accomplishments, but more importantly, to look toward the future
role of NINR's research in today's increasingly complex health care
environment. We are faced with an aging population at a time when our
Nation is experiencing a shortage of nurses. We are also in an era of
new technologies, which demands that nurses be technologically-savvy
and able to adapt these new methods to a variety of patient populations
and settings. This dynamic health care environment provides many
opportunities for nursing research to address a variety of challenges
and improve health care for all patients.
Let me give you a few examples of how our research has improved
lives and the promise it holds for the future.
healthy mothers and healthy children
Sleep and Healthy Pregnancies.--Women often complain of fatigue and
difficulty sleeping during pregnancy, especially as they approach
delivery. Researchers studied women who slept less than 6 hours per
night or who experienced frequent sleep disturbances during their
pregnancy. These women had significantly longer labors and were 3-4
times more likely to have a cesarean delivery than women who slept 7-8
hours a night with fewer disruptions. These results highlight the
importance of adequate sleep during pregnancy, and suggest a need for
care providers to stress better sleeping habits to their pregnant
patients.
Children and Health Disparities.--In fiscal year 2007, NINR will
solicit new intervention research proposals aimed at reducing health
disparities among children. NINR is committed to reducing disparities
in health care, but current research in this area often targets adults.
Children who live in poverty have little access to health care, and
these children are disproportionately from minority populations. NINR's
effort to reduce disparities in child health will target such areas as:
developing culturally-sensitive interventions to promote physical
activity and healthy diets in children, reducing health risk factors in
children that lead to poor health outcomes, and studying how gender and
immigrant status affect child health and access to health care.
staying healthy throughout adulthood
Culturally-sensitive Diet Intervention.--Diabetes is prevalent
among rural African-Americans, and compliance with dietary self-
management guidelines is often poor. In one study, NINR researchers
tested a dietary intervention for diabetic African-Americans living in
rural South Carolina. Through culturally-tailored classes that taught
healthy food choices and low-fat cooking techniques, participants
successfully lowered their body weight and fat intake. Other community-
based interventions that include culturally-relevant components show
similar successes. These types of programs may be important tools in
promoting health and reducing health disparities.
Heart Disease in Women.--Heart disease, the number one cause of
death in the United States, is sometimes more difficult to diagnose in
women than in men, because women can exhibit different symptoms of
heart disease than men. Better ways of detecting heart disease are
therefore needed. NINR investigators are currently developing and
testing a new screening tool that could predict whether or not certain
women are at risk for serious heart disease. The test takes into
account the different symptoms that women with heart disease
experience, and it factors in the diverse symptoms experienced by women
of different races.
understanding aging and caring for the elderly
Improving Self-management for the Elderly.--The aging American
population has tremendous implications for our health care system.
Better tools are needed to prevent and treat the health problems
experienced by the elderly in a cost-effective manner. Improving self-
management strategies is one way to decrease hospital and long-term
care costs. Health professionals have developed telehealth programs
that allow elderly patients to monitor and manage their symptoms at
home by communicating with their providers over the phone or the
internet. However, the effectiveness of telehealth interventions has
not been well-studied. NINR investigators are currently testing a self-
management telehealth intervention for patients with heart failure. The
investigators will study questions such as: Is the intervention more
effective than traditional methods of treatment? Are elderly patients
willing to use the new technology? Do these techniques save money?
Findings from these studies may help providers better use technology in
self-management. This could ultimately lead to a higher quality of life
for patients, and lower health care costs for consumers.
Caregivers and Depression.--An aging population also means that an
increasing number of spouses and children will be caring for their
infirm partners or parents. In addition to significant economic and
societal costs,\1\ caregiving may also have serious negative health
impacts. Caregiving can often be a stressful and time-consuming
experience for those who take on the responsibility. NINR has funded a
wide range of studies to analyze the burdens experienced by caregivers
and develop methods to alleviate these burdens. One group of NINR
researchers surveyed over 2,000 female caregivers of elderly veterans
with dementia and found that over one-third of the caregivers exhibited
symptoms of depression. However, less than one in five of those with
depression were using antidepressants; Caucasians were twice as likely
as African-Americans to be taking such medications. These results
suggest that caregivers should be routinely screened for depression and
that better efforts may be needed to educate informal caregivers about
the potential benefits of antidepressant therapy.
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\1\ Langa KM, Chernew ME, Kabeto MU, Herzon AR, Ofstedal MB, Willis
RJ, Wallace RB, Mucha LM, Straus WL, Fendrick AM, National Estimates of
the Quantity and Cost of Informal Caregiving for the Elderly with
Dementia. J Gen Intern Med 16: 770-778, 2001.
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patients and families at the end of life
The final stage of life is a challenging time for everyone
involved, from the patient, to attending physicians and nurses, and to
bereaved family and friends. NINR is the lead NIH institute for end-of-
life research. We are charged with finding ways to improve end-of-life
care for all involved and ensure that patients experience death with as
much dignity and comfort as possible. We fund research on such topics
as: better management of symptoms prior to death; improving
communication between doctors, patients, and family members; and
examining factors that influence end-of-life decision-making. NINR
researchers continue to make important findings in these areas.
Communicating with Families at the End of Life.--One study found
that physicians in intensive care units often fail in communicating
with family members when discussing the withholding or withdrawal of
care from a dying patient. Problems included failures to listen to the
concerns or address the emotions of the family members. Physicians also
failed to properly explain the uses and purpose of palliative care or
the ethical basis for deciding to remove life-prolonging therapies. A
better awareness of these gaps can help physicians and nurses improve
their communication skills for talking to families in difficult times.
nursing shortages and training nurse researchers
The current aging of our population comes at a time when the supply
of nurses in the United States cannot meet the demand. In addition, new
advances in medical technology require a more technologically-savvy
nursing workforce. There was a shortage of approximately 168,000
registered nurses in the United States in 2003, and this shortage is
expected to top 1 million by 2020. The field of nursing research is
experiencing the effects of this shortage. Fewer nurses mean fewer
nurse researchers, and that means fewer nursing faculty.
NINR continues to fund innovative initiatives to train new nurse
researchers. Our Nursing Partnership Centers to Reduce Health
Disparities partner research-intensive universities with minority-
serving institutions to increase the number of researchers from
underserved populations. We also continue to collaborate with
universities on training students in fast-track baccalaureate-to-
doctoral programs to speed the process of developing new nurse
scientists and faculty.
ninr and the nih roadmap
NINR has incorporated two key themes of the NIH Roadmap into its
research agenda: Interdisciplinary Research Teams of the Future and Re-
engineering the Clinical Research Enterprise. Historically, NINR has
maintained a focus on interdisciplinary research, but increased
collaborations made possible by the Roadmap have fully introduced
nursing science to the rest of the scientific community. They have also
enabled nurse scientists to expand the breadth of their own work.
Because of the strongly clinical emphasis of the NINR research
portfolio, the Roadmap's clinical research initiatives are ideally
suited to NINR. We will actively pursue Roadmap initiatives that seek
to develop new technologies to measure patient symptoms and quality of
life, and others that strive to develop skilled clinical investigators
with strong multidisciplinary backgrounds.
conclusion
In conclusion, NINR continues to discover effective approaches to
meeting the challenges of today's dynamic health care environment,
while looking ahead to meet the health care needs of tomorrow. We will
strive to improve the quality of care and quality of life for all
individuals, especially the underserved, regardless of age or disease.
We will also train the next generation of leaders in nursing research.
The past twenty years have demonstrated the power of nursing research.
The future holds endless opportunities.
Thank you, Mr. Chairman. I will be happy to answer any questions
that the Committee might have.
______
Prepared Statement of Dr. Richard J. Hodes, Director, National
Institute on Aging
Mr. Chairman and Members of the Committee: The NIA is requesting an
fiscal year 2007 budget of $1,039,828,000, a decrease of $6,803,000, or
.6 percent below the fiscal year 2006 enacted level.
Thank you for this opportunity to participate in today's hearing. I
am Dr. Richard Hodes, Director of the National Institute on Aging, and
I am pleased to be here today to tell you about our progress making and
communicating scientific discoveries that will improve the health and
well-being of older Americans.
There are today approximately 35 million Americans ages 65 and
over, according to the U.S. Bureau of the Census, and this number is
expected to rise dramatically in the coming decades as members of the
Baby Boom generation reach retirement age. These older Americans are
more likely than at any other time in history to enjoy good health and
an active lifestyle: Data from the National Long Term Care Survey
(NLTCS) indicate that the rate of disability among older Americans
dramatically declined from the 1980s through the mid 1990s, even among
the ``oldest old,'' people age 85 and older. At the same time, however,
the downward trend in disability among the elderly may be in danger of
reversal. Data from the National Health Interview Survey show that,
over the same period, the disability rate actually rose significantly
for people ages 18-59, with the growing prevalence of obesity an
important factor in this trend. Now, in fact, some demographers are
forecasting a complete leveling-off of the disability decline in the
coming decade.\1\
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\1\ Goldman DP et al. Consequences of Health Trends and Medical
Innovations for the Future Elderly. Health Affairs online special issue
``Health and Spending of the Future Elderly.'' R5-R17, 2005.
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The mission of the National Institute on Aging (NIA) is to improve
the health and well-being of older Americans through research. In
support of its mission, the Institute conducts and supports an
extensive program of research on all aspects of aging, from the basic
cellular and molecular changes that occur as we age, to the prevention
and treatment of common age-related conditions, to the behavioral and
social aspects of growing older, including the demographic and economic
implications of an aging society. In addition, the NIA is the lead
Federal agency for research related to the all-important effort to
prevent and treat Alzheimer's disease (AD). Finally, our education and
outreach programs provide vital information to older people across the
Nation on a wide variety of topics, including living with chronic
conditions, maintaining optimal health, and caregiving.
alzheimer's disease and the neuroscience of aging
Alzheimer's disease is a devastating condition with a profound
impact on individuals, families, the health care system, and society as
a whole. Approximately 4.5 million Americans are currently battling AD,
with annual costs for the disease estimated to exceed $100 billion.\2\
Moreover, the rapid aging of the American population threatens to
increase this burden significantly in the coming decades: By 2050, the
number of Americans with AD could rise to some 13.2 million, an almost
three-fold increase.\3\
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\2\ Data from the Alzheimer's Association. See also Ernst, RL; Hay,
JW. ``The U.S. Economic and Social Costs of Alzheimer's Disease
Revisited.'' American Journal of Public Health 1994; 84(8): 1261--1264.
This study cites figures based on 1991 data, which were updated in the
journal's press release to 1994 figures.
\3\ Hebert, LE et al. ``Alzheimer Disease in the U.S. Population:
Prevalence Estimates Using the 2000 Census.'' Archives of Neurology
August 2003; 60 (8): 1119-1122.
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Dr. Zerhouni has told this Committee about the NIH's new paradigm
for biomedical research that is ``predictive, personalized, and
preemptive.'' This vision greatly informs the NIA's comprehensive
program of Alzheimer's disease research. NIA-supported investigators
conduct research on topics across the spectrum of AD-related inquiry,
from basic brain biology to clinical trials of potential interventions.
Through these studies, we are uncovering new predictors of individual
risk for AD, and using this information, along with a greater
understanding of specific pathways mediating disease processes, we are
developing new approaches to prevention and treatment.
Risk Factors and Early Diagnosis.--Population studies suggest that
conditions affecting the circulatory system may be associated with
higher risk for dementia, or that the presence of vascular disease may
influence the progression of AD. One recent report indicated that AD
dementia may be exacerbated by other cerebrovascular problems such as
small strokes, while another linked untreated high blood pressure in
mid-life with increased risk of dementia in later life. The possible
association of diabetes, insulin resistance, and AD is garnering
increased attention as well; recent findings from at least four long-
term studies link diabetes with decline in cognitive function. The NIA
recently funded two clinical trials to examine directly whether
diabetes-related interventions might be effective in preventing or
delaying cognitive decline or development of Alzheimer's disease.
Research suggests that the earliest AD pathology begins to develop
in the brain long before clinical symptoms yield a diagnosis; the
ability to make an accurate early diagnosis of AD would be highly
beneficial. Improvements in brain imaging, coupled with the development
of more sensitive cognitive tests, are enabling us to diagnose AD in
the research setting with greater precision than ever before. Imaging
techniques may become important for a number of other reasons,
particularly in helping investigators understand events unfolding in
specific regions of the brain in the very early stages of Alzheimer's
disease and in assessing the effectiveness of potential therapeutic
strategies. To speed both the development of imaging techniques and the
discovery of biological markers to detect Alzheimer's disease, the
National Institute on Aging and other Federal partners, in conjunction
with nine pharmaceutical/biotech companies, the Institute for the Study
of Aging, and the Alzheimer's Association, announced the Alzheimer's
Disease Neuroimaging Initiative in October 2004. The study will test
whether serial MRI, PET, or other biological markers can be used in
conjunction with clinical and neuropsychological assessment to measure
earlier and with greater sensitivity the development and progression of
mild cognitive impairment (MCI) and early Alzheimer's disease. This
major public-private partnership could help researchers and clinicians
develop new treatments and monitor their effectiveness as well as
lessen the time and cost of clinical trials. The study, which is taking
place at approximately 50 sites across the United States and Canada,
began recruitment in late 2005; approximately 800 people ages 55 to 90
will participate over the five years of the study.
Prevention and Treatment.--Results of a growing number of studies
are suggesting that diet and exercise may have significant benefits on
not only physical but also cognitive health. For example, in one recent
study, researchers related fruit and vegetable consumption among 13,388
older women over a 10-16 year period to subsequent cognitive
performance and found that women consuming the most green leafy
vegetables experienced slower decline than women consuming the least
amount. Long-term epidemiologic studies now also suggest that exercise
may have a specific influence on aspects of cognitive decline, and
researchers are hoping that clinical trials will be able to directly
test the therapeutic value of exercise and diet for improved cognitive
performance and, eventually, for reduced risk of AD. Small clinical
trials currently are ongoing to test the effects of exercise on
cognitive decline, both in older adults with normal cognition and in
persons with mild cognitive impairment with memory decline; a larger
trial that would include a cognitive component is in the planning
stages. In addition, the planned Lifestyle Interventions and
Independence for Elders (LIFE) study, which has been designed to
determine whether physical exercise is effective for preventing major
mobility disability or death, will include a cognitive component.
Clinical trials are also ongoing to test the effects of a variety of
dietary supplements, including antioxidants and alpha-lipoic acid, on
cognition.
Investigators are also searching for drugs that will be effective
in stopping the progression of AD or, ultimately, preventing the
disease altogether. Recently, investigators announced the discovery of
the first agent shown to delay the clinical diagnosis of Alzheimer's in
people with amnestic mild cognitive impairment, an MCI subtype strongly
correlated with the later development of AD. The investigators found
that individuals who took the drug donepezil (Aricept) were at reduced
risk of progressing to a diagnosis of Alzheimer's disease during the
first year of the trial, but by the end of the three-year study there
was no benefit from the drug. Although donepezil's effects were
limited, the results are nonetheless encouraging. And although too
little is known about donepezil's long-term effects to support a
recommendation for its routine use to forestall the diagnosis of AD in
people with mild cognitive impairment, these findings do suggest that
chemoprevention of AD is possible and support our hope that future
clinical studies will lead to more significant progress.
other aging-related research
Diseases of aging continue to affect many older men and women,
seriously compromising their quality of life. Diseases and conditions
currently under study at the NIA include:
Obesity.--Overweight and obesity are widespread in the United
States and are associated with an array of health problems, including
heart disease, stroke, osteoarthritis, adult-onset diabetes, certain
types of cancer and physical disability. NIH has assigned a high
priority to research on obesity.
These activities range from basic research on the genetic and
biological mechanisms of overweight and obesity to human intervention
studies. For example, recent studies of C. elegans, tiny worms
frequently used for genetic studies, are providing important insights
about fat regulation and storage that may that may be applicable in
humans. NIA-supported researchers used RNA interference (RNAi), a
technique in which genes are inactivated one at a time to determine
their function, to screen the worm's genome and found some 417 genes
involved with fat regulation and storage. Many of the genes they found
have human counterparts, a number of which had not been previously
implicated in the regulation of fat storage. The genes identified in C.
elegans may ultimately suggest new targets for treating human obesity
and its associated diseases.
Research has also shown that many of the disabling conditions
affecting older people could be diminished through regular exercise and
that fitness affects mortality risk regardless of an individual's body
fat. One study, which followed men 30-83 years of age for an average of
eight years, found that within each category of body fatness, ``fit''
men--as measured by exercise testing--were at a lower risk of death. In
addition, among fit men, obesity was not significantly related to risk
of death. In another study, low fitness increased mortality risk in men
approximately fivefold for cardiovascular disease and threefold for
all-cause mortality. Low fitness was associated with higher mortality
in all weight groups.
At a 2004 NIA and Centers for Medicare and Medicaid Services (CMS)
sponsored workshop, researchers used published findings and trends to
postulate that if the United States were able to prevent obesity until
a person reaches 65 years of age by adjusting the body mass index for
all cohorts entering Medicare, we could realize a significant decline
in the percent with heart disease and diabetes, a significant increase
in the percent without disability, and a cost savings to Medicare on
the order of $10 billion annually over the subsequent 30 years.\4\
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\4\ Lakdawalla, DN et al. The Health and Cost Consequences of
Obesity Among the Future Elderly. Health Affairs on line special issue
``Health and Spending of the Future Elderly.'' R30-41.
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Heart disease.--Each year over 1 million Americans undergo
angioplasty,\5\ Aa procedure in which a long, thin tube attached to a
tiny balloon is used to access and widen a blood vessel at the site of
narrowing or blockage. However, a significant number of these
individuals go on to experience restenosis, or gradual narrowing of the
artery at the site of the blockage; this condition is aggravated by the
implanting of stents (tiny metal scaffolds placed inside the artery to
hold it open). Restenosis usually occurs within six months of
angioplasty and results from the migration of cells from the middle of
the arterial wall into the inner layer of the artery, where they
multiply and block normal blood flow. Recognizing that cell division is
crucial to the development of restenosis, NIA scientists tested the
anticancer drug paclitaxel (Taxol), which arrests cell division, as a
means of preventing the tissue growth that leads to vessel narrowing,
and found that stents coated with paclitaxel can delay restenosis both
safely and effectively. The investigators obtained a patent for these
paclitaxel-coated stents, and a cooperative research and development
agreement was established with private industry partners to begin
clinical testing. Today, paclitaxel is one of only two drugs that, when
applied to stents, have been shown to safely reduce the incidence of
restenosis in humans. FDA approval of paclitaxel-coated stents was
granted in March 2004, and currently over 70 percent of the drug-
eluting stents used worldwide are paclitaxel-coated. Approximately 1.8
million patients worldwide have received paclitaxel-coated stents to
date.
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\5\ Data from the National Heart, Lung, and Blood Institute.
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Diabetes.--NIH investigators searching for potential treatments for
type 2 diabetes conducted a study of the compound exendin-4, an analog
of a hormone that is naturally released after eating and that can lower
blood sugar in people with diabetes. The investigators found that
exendin-4 is safe and effective, and in April 2004, the Food and Drug
Administration approved exenatide (Byetta<SUP>TM</SUP>), a synthetic
derivation of exendin-4, for the treatment of type 2 diabetes.
health communications and promotion
The NIHSeniorHealth website continues to be a major initiative that
enables the growing number of ``wired seniors'' to find credible aging-
related health information in an online format that is compatible with
their cognitive and visual needs, as evidenced by NIH-supported
research. Conceived by NIA and jointly developed with the National
Library of Medicine (NLM), the website now includes 26 health topics
developed by eleven NIH Institutes. Each month, 52,000 unique visitors
browse over a half a million pages. NIHSeniorHealth serves as a model
for web designers seeking to make sites accessible to older adults. To
increase the number of older adults skilled in searching for health
information online, NIA has developed and is evaluating a senior-
friendly Internet training curriculum geared around NIHSeniorHealth and
NLM's MedlinePlus web site for those who train older individuals to use
computers.
Changes in public health policy may necessitate the development of
new communications strategies and techniques targeted at older
Americans, as was demonstrated with the passage of Medicare Part D, the
``prescription drug benefit'' for U.S. seniors. NIA-supported
researchers are currently using established datasets to rapidly collect
information and analyze patterns of use under Medicare Part D; their
findings have been communicated to the CMS on an ongoing basis and will
inform the creation of new strategies for tailored communications that
will assist older Americans in understanding and maximizing use of this
important new program.
Thank you for the opportunity to testify before this Subcommittee.
I would be happy to answer any questions you may have.
______
Prepared Statement of Dr. Sharon Hrynkow, Acting Director, Fogarty
International Center
Mr. Chairman and Members of the Committee: I am pleased to present
the fiscal year 2007 President's Budget for the Fogarty International
Center (FIC). The fiscal year 2007 budget includes $66,681,000, which
reflects an increase of $303,000 over the fiscal year 2006 enacted
level of $66,378,000 comparable for transfers proposed in the
President's request.
Forty-seven years ago, Congressman John E. Fogarty noted, ``Time
and time again, it has been demonstrated that the goal of better health
has the capacity to demolish geographic and political boundaries and to
enter the hearts and minds of men, women, and children in the four
corners of the earth. It is an issue which serves as a forceful
reminder of the oneness, the essential brotherhood of man.''
Congressman Fogarty, the visionary namesake of the National Institutes
of Health's (NIH's) John E. Fogarty International Center for Advanced
Study in the Health Sciences (Fogarty), recognized that when it comes
to disease, we are truly one world. His words and those of his
Congressional colleagues implored us to work for ``a healthy America,
in a healthier world.''
Today, Fogarty works to meet this goal in two ways: by supporting
the whole of the NIH mission via international partnerships, and
through the support of global health research and training programs
aimed at improving the health of citizens in the United States and
around the globe. As a nation, our interest in global health stems not
only from humanitarian concerns, but also from an enlightened self-
interest. Such interests involve protecting our nation from imported
diseases, and political and economic considerations--healthy, stable
countries make strong allies and trading partners. In addition, through
partnerships with scientists from around the world, we are able to
identify new strategies and new understandings of disease processes,
including HIV/AIDS, tuberculosis, and chronic diseases such as heart
disease, that affect us all. I welcome this opportunity to relate
Fogarty's progress over the past year and proposed plans for fiscal
year 2007. While Fogarty's programs span over 20 topical areas, I will
focus on three exemplars in this summary.
battle against hiv/aids
Fogarty continues to place a high priority on combating HIV/AIDS
the deadliest pandemic of modern times. According to UNAIDS, an
estimated 4.9 million people worldwide became newly infected with HIV
in 2004--the highest number of new cases reported in any single year
since the beginning of the pandemic. As the United States works to
combat the spread of AIDS domestically and globally, trained scientists
in countries hard-hit by AIDS are crucial allies in our fight. In the
18-year history of Fogarty's flagship AIDS program, the AIDS
International Research and Training Program (AITRP), Fogarty has helped
train 2,000 health scientists, including Ph.D. and Masters level
researchers from developing countries working on AIDS. More than 50,000
have received short-course training in their home countries through
this program. These scientists represent a substantial increase in the
global capacity to fight AIDS and provide a wealth of allies in our
international struggle.
Haiti has the largest number of people living with AIDS in the
Caribbean. For almost two decades, Fogarty has invested in research and
public health infrastructure to combat the HIV/AIDS crisis there. Haiti
has now begun to ``turn the corner on AIDS,'' according to Dr. Jean
Pape, Haiti's leading AIDS researcher and long-standing Fogarty
collaborator. As a result of Fogarty's work and that of partner
agencies, HIV seroprevalence at a key sentinel site in Haiti dropped
from 6.3 percent in 1993 to 2.9 percent in 2003.
Due to this strong research base, Dr. Pape's institution received a
grant from the President's Emergency Plan for AIDS Relief (PEPFAR),
allowing 2,000 patients to receive antiretroviral therapy. An analysis
of the first 1,000 patients at the one-year follow-up indicates
outcomes comparable to those achieved in the United States in terms of
survival; other indicators show reduced amounts of HIV in the blood of
AIDS patients, as well as increased amounts of cells that are critical
to staving off the impacts of HIV. None of this would have been
possible without the vision and foresight of Fogarty, working hand in
glove with NIH partners, including the National Institute of Allergy
and Infectious Diseases.
In fiscal year 2007, Fogarty plans to expand both major AIDS
programs in its portfolio. The AITRP expansion would involve new U.S.
universities, including minority institutions, important partners as we
work to address global health challenges and the range of U.S.
challenges on AIDS. In addition, Fogarty's new training program in
clinical, operational and health services research would be expanded to
build much needed expertise in monitoring and evaluating AIDS programs
abroad.
addressing the threat of emerging and re-emerging infectious diseases:
prediction and preemption
Little is known about the ecological factors that lead to the
emergence or re-emergence of infectious diseases, including potentially
pandemic diseases such as avian flu. We do know that most new diseases
come from animals, both wild and domesticated. But beyond that we have
little ability to predict the emergence of new diseases, or how new or
existing diseases spread among animals, and from animals to humans. To
better understand the relationships between ecological factors that
drive emergence and transmission of infectious agents, and to develop
predictive models that would suggest practical modes to interrupt
disease spread, Fogarty led the development of a unique interagency
program on the Ecology of Infectious Diseases (EID). The EID program
fills a critical gap in our national effort to protect the health of
the public--both in the United States and globally--against the threat
of epidemic and emerging infectious diseases. The program links
microbiologists, veterinarians, physicians, ecologists, geospatial
scientists, and mathematical modelers together into transdisciplinary
teams to create new knowledge and new methods to predict and prevent
the spread of infectious disease. In its first years of operation, the
EID program has already linked experts from 23 countries and has
supported publication of over 200 scientific articles on dozens of
human and wildlife diseases, including schistosomiasis, Hanta virus,
cholera, and severe acute respiratory syndrome (SARS).
SARS was first reported in southern China in the winter of 2002-
2003, and within a few months it had spread to over two dozen
countries. Within a month of its discovery, SARS was recognized as a
viral respiratory illness caused by a newly identified coronavirus
(CoV), yet the origin of the virus and how it was initially transmitted
to humans remained a mystery. Preliminary evidence suggested that the
palm civet (a raccoon-like mammal common in live animal markets in
southern China) might have spread the virus to humans. However, the
occurrence of related viruses in bats led some to think these animals
may have been involved. A team of Fogarty-funded researchers from the
United States, China, and Australia collected and analyzed specimens
from nine species of bats in their native habitats in southern China.
The team studied the presence of antibodies to the SARS virus and
performed genome sequencing of viral isolates from positive tissues,
comparing these genome sequences to that of the SARS virus. Study
results indicate that bats are the natural reservoir of the SARS virus,
suggesting that palm civets played an intermediary role in human
infections. These findings have major implications for development of
public health strategies to combat the spread of SARS. In fiscal year
2007, FIC expects to expand the EID program in terms of the number of
projects supported and their scope, simultaneously increasing the focus
on supporting translation of research findings and predictions into
action.
As we consider the daunting challenge of pandemic avian influenza,
programs such as the EID can provide a critical component in our
ability to predict and prevent emergence and transmission of this and
other disease threats. The United States and its global partners will
be better poised to make effective interventions to prevent the spread
of avian flu through understanding of migration patterns of reservoir
bird species, the interactions between humans, domestic animals and
birds, and the pathogen dynamics in and among these hosts. We cannot
predict the spread of this disease, in its current zoonotic form, using
mathematical or statistical models if we do not support the fieldwork
necessary to sample wild and domesticated birds (work done by
ornithologists, veterinarians, and ecologists). The field data are
useful only for post field analysis if we integrate them into
predictive models. The interagency EID program is unique in its
integration of these methods into interdisciplinary teams to understand
the biology and predict disease emergence and transmission.
global burden of trauma and injury
According to the World Health Organization (WHO), the numbers and
the global burden due to trauma and injury are on the rise: more than
1.2 million people are killed in traffic accidents annually, and up to
50 million more are injured or disabled. If current trends continue,
the number of people killed and injured on the world's roads will rise
by more than 60 percent between 2000 and 2020. Almost 90 percent of
deaths due to injuries take place in poorer countries--this is true for
all forms of such trauma including road accidents, war, homicides, and
suicides. And, according to the Association for Safe International Road
Travel, road traffic accidents are the second leading cause of death
for Americans abroad.
To address this growing challenge, Fogarty, working closely with
the Centers for Disease Control and Prevention, WHO, the Pan American
Health Organization, and eight other NIH institutes, initiated a
research training program to build the capacity of developing country
investigators and institutions to conduct human trauma and injury
research. The International Collaborative Trauma and Injury Research
Training (ICTIRT) program involves collaborators from United States and
developing country institutions to train the next generation in basic
and applied science, the epidemiology of risk factors, acute care and
survival, rehabilitation, and the long-term mental health consequences
of trauma and injury, including civil strife. Benefits of this program
will accrue not only to developing countries but, as low-cost and
effective strategies are identified, to communities around the world.
This program was initiated with awards in fiscal year 2005 and fiscal
year 2006. We anticipate new awards in fiscal year 2006 and fiscal year
2007.
conclusion
The programs and international initiatives of the Fogarty
International Center are a living testament to the vision of
Congressman John E. Fogarty. As we consider the daunting global
challenges of AIDS, avian influenza and chronic problems, including
obesity and mental health disorders, we understand the
interconnectedness of the United States and the global community. These
challenges require us to move forward with efficiency and diplomacy,
for the benefit of the American people and the global community.
______
Prepared Statement of Dr. Thomas R. Insel, Director, National Institute
of Mental Health
Mr. Chairman and members of the Committee: I am pleased to present
the fiscal year 2007 President's budget request for the National
Institute of Mental Health (NIMH). The fiscal year 2007 budget includes
$1,394,806,000, which reflects a decrease of $8,709,000 under the 2006
enacted level of $1,403,515,000 comparable for transfers proposed in
the President's request. In my statement, I will call to your attention
our Nation's most prevalent mental and behavioral disorders and include
a brief review of our research activities and accomplishments.
burden and cost of mental illness
Mental disorders are common, chronic, and disabling. They cause
more disability than any other class of communicable medical illness in
American adults under age 45, according to the World Health
Organization's Global Burden of Disease report. The National
Comorbidity Survey Replication (NCS-R), funded by NIMH and released in
May 2005, documents the prevalence and severity of specific mental
disorders in the United States. The study shows that half of all
lifetime cases of mental illness begin by age 14, making these the
chronic diseases of the young. About 6 percent of the U.S. population
is afflicted with a severely disabling mental disorder in a given year.
Most troubling, this landmark study has demonstrated that despite
effective treatments, there are long delays--sometimes decades--between
first onset of symptoms and when people seek and receive treatment.
The cost in human suffering from these mental diseases is
compounded further by their economic burden. According to the
President's New Freedom Commission on Mental Health (2003), individuals
with serious mental illnesses represent the single largest diagnostic
group (35 percent) on the Supplemental Security Income (SSI) rolls.
Medicaid is the largest single payer of mental health services, with
more than 50 percent of all mental health expenditures paid for by the
public sector (including Medicaid, Medicare, state and local
governments.
The good news is that there now are some extraordinary new tools
and technologies, such as neuroimaging and genomics, with which to
address these urgent public health needs. Our major challenge is to
integrate and translate basic research discoveries and technological
advances into practical strategies that can help all communities,
including children, the socioeconomically disadvantaged, and others
facing barriers to mental health care.
envisioning personalized care
Research efforts stemming from former President George Bush's
proclamation of the 1990s as the Decade of the Brain established that
mental disorders (autism, bipolar, depression, schizophrenia, and
others) are brain disorders. The current decade is one in which many
major candidate molecules, cells, and circuits for normal and abnormal
brain function are being identified for the first time. Through these
discoveries research will definitively identify the specific brain
pathways that underlie each of the major mental disorders. By
identifying the features of the brain that go awry in mental illnesses,
we will have clear new targets to test how biological, behavioral, and
environmental factors affect illness and to develop more effective
interventions with the ultimate vision of delivering personalized care
through pre-emptive treatments and strategic preventions.
Currently, there are effective treatments for many mental disorders
such as depression and anxiety disorders. Studies show that even from a
business standpoint, treating these disorders is highly cost-effective;
national business groups are encouraging employers to support such
treatments in order to reduce healthcare costs while also improving
productivity and reducing absenteeism.
Not all treatments work for everyone, however, and clearly there
remains room for improvement in both diagnosis and treatment. In mental
disorders, just as in the rest of medicine, diagnosis should rely on
detection of biomarkers of the specific disease, and treatments should
be based on medication and/or behavioral interventions targeting
specific brain regions and processes. For a person with mental illness,
one can imagine that a future clinician would use a cognitive task
together with neuroimaging and genetics to diagnose and select a
specific treatment, just as a contemporary cardiologist uses a stress
test and echocardiogram to diagnose ischemic heart disease and select
the proper intervention.
It is critical to realize that this vision does not mean designing
exotic technologies for a few privileged patients. The ultimate goal is
personalized or individualized care for a broad spectrum of people with
mental disorders. Now, specific treatments for any given patient are
largely developed through trial and error. As researchers learn more
about the brain pathophysiology of mental disorders and related
behavioral and environmental factors, treatments will become more
specific. Early detection of mental illnesses will require a thorough
understanding of the range of risks that affect brain processes, which
in turn is based on a comprehensive understanding of genetics and
experience.
practical clinical trials
As noted above, we have treatments that are helpful for nearly all
of the mental disorders. But these treatments are not optimal; recovery
is often slow, incomplete, and compromised by adverse effects. Since we
do not know who will respond completely and who will develop adverse
effects, each clinician depends on trial and error with each patient.
The Institute has developed practical clinical trials in more than
10,000 patients to help clinicians individualize treatments. Practical
clinical trials, or ``effectiveness studies,'' are designed to examine
changes in symptoms and functioning, changes which are vital to
determining whether a treatment improves quality of life, caregiving
burden, or health service use. The designs of practical clinical trials
help increase relevancy to real-world clinical practice to help
clinicians answer the question: what is the best treatment for my
patient? Each of the following NIMH-funded practical clinical trials
provides results from the largest and longest studies of their kind.
In the Clinical Antipsychotic Trials of Intervention Effectiveness
(CATIE) Study, 1,432 schizophrenia patients from 56 sites, including
private practices, community health care centers, and state facilities,
were randomly assigned to treatment with one of five medications for 18
months. In the first phase of analysis the study found that newer,
``atypical'' antipsychotics are not much more effective than older,
conventional antipsychotics; however all the medications studied have
unique side effect profiles, some of which include significant weight
gain and metabolic side effects, thus increasing risk for diseases such
as diabetes. Later phases of this study will examine crucial issues
including effects of switching from one treatment to another, use of
health services, and cost-effectiveness.
Another example is the Treatment for Adolescents with Depression
Study (TADS), which compared short- and longer-term effectiveness of
medication and psychotherapy for depression in 439 adolescents. TADS
was designed to test best-practice care for depression and was carried
out by 13 academic and community clinics across the country.
Researchers found that fluoxetine (a selective serotonin reuptake
inhibitor) in combination with cognitive behavioral therapy was more
effective against adolescent depression than either one alone. In
addition, clinically significant suicidal thinking was greatly reduced
in all four treatment groups, with those receiving medication combined
with cognitive therapy showing the greatest reduction. This is an
especially important finding, considering recent concerns that the use
of antidepressant medications themselves may induce suicidal behavior
in youths. This study shows that treatment leads to a significant
improvement of depression overall. It is vital that all patients being
treated for depression be closely monitored.
The Sequenced Treatment Alternatives to Relieve Depression Trial
(STAR-D) examines 4,041 adults with major depression, particularly
those who previously showed poor outcomes to treatment, to see if
switching medications or augmenting the initial drug be more likely to
achieve a remission. The study, conducted at 41 sites coordinated by 14
regional centers, will also answer how the side effects of the various
medications compare and how psychotherapy compares with medication for
treatment-resistant depression.
In the Systematic Treatment Enhancement Program for Bipolar
Disorder (STEP-BD) trial, 4,360 participants with bipolar disorder from
20 private, state, and community practice sites underwent various
treatment pathways to find the most effective long-term and acute
treatments and ways to prevent relapse. In the first phase, slightly
more than half of the first group of 1,469 participants (58 percent)
achieved recovery. In addition, almost half of the recovery group had a
recurrence during the follow-up period, and the majority (70 percent)
of recurrences was characterized by a return to a depressive state. In
the following phases of the trial, not yet published, various
treatments will be tried such as mood-stabilizing medications,
antidepressants, atypical antipsychotics, and various ``talk''
therapies, to see which is best for acute treatment, long-term
treatment, and prevention of relapse.
nimh initatives for fiscal year 2007
To further advance the vision of personalized mental health care,
NIMH will pursue two collaborative initiatives in fiscal year 2007. The
first is the Autism Phenome Project, in collaboration with the NIH
Autism Coordinating Committee, the Centers for Disease Control and
Prevention, and the Department of Energy. Just as the Human Genome
Project identified the sequence and organization of human DNA, the
phenome project seeks to identify the various clinical characteristics
(phenotypes) and subtypes of autism and autism spectrum disorders.
Identifying specific phenotypic subtypes will aid research on genetic
and other potential causes and suggest more specific approaches to
treatment.
The second collaborative initiative is with the Department of
Defense (DOD) and the Department of Veterans Affairs (VA) to study the
mental health needs of active duty, National Guard, and Reserve
personnel including their transition to VA health services. In
particular, representative groups of men and women will be studied over
time to assess post-deployment adjustment difficulties (including post-
traumatic mood and anxiety disorders, and substance use and abuse
disorders), the development and effectiveness of early detection and
intervention methods, and the possibility of decreasing the risk of
developing chronic conditions, disability, and death in those with
adjustment difficulties.
These initiatives, in conjunction with the exciting research
already underway, will enable NIMH to make significant gains in the
upcoming years. We intend to realize our vision of translating basic
research and technologies to improved diagnosis, treatment, and
preventive strategies that will allow development of personalized
mental health care for the millions of Americans affected by mental
illnesses.
______
Prepared Statement of Dr. Stephen I. Katz, Director, National Institute
of Arthritis and Musculoskeletal and Skin Diseases
Mr. Chairman and Members of the Committee: I am pleased to present
the fiscal year 2007 President's budget request for the National
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
The fiscal year 2007 budget includes $504,533,000, a decrease of
$3,399,000 below the fiscal year 2006 enacted level of $507,932,000.
The NIAMS was created by an Act of Congress nearly 20 years ago,
and since its inception, the Institute has contributed to significant
research progress in areas of public health importance across diseases
that are common, costly, and have a major impact on quality of life,
disability, and mortality. Research milestones in the history of the
Institute include the development of life-saving treatments for kidney
failure in patients with lupus, and ground-breaking work to uncover the
genetic bases of periodic fever syndromes that affect both children and
adults, among many others.
Most recently, investments that NIAMS made as a result of the NIH
budget doubling are bringing results that will directly benefit
patients. These include support for large-scale clinical trials in
areas of high public health impact, such as osteoporosis and back pain;
efforts in biomarkers research and epidemiology studies for common
conditions such as osteoarthritis, as well as uncommon, but often
devastating, disorders such as scleroderma; and new initiatives in
translational research for diseases such as muscular dystrophy. Looking
to the future, NIAMS will continue its commitment to fund outstanding
science across a broad spectrum to enable us to better understand,
treat, and, ultimately, prevent diseases of the bones, joints, muscles,
and skin.
preventive medicine
The NIAMS has made significant investments in studies to identify
risk factors and biomarkers of disease, in an effort to facilitate the
early identification of signs and symptoms, and to develop
interventions that are more effective. This is particularly important
from a public health perspective for common conditions such as
osteoporosis and osteoarthritis that already afflict tens of millions
of Americans, and will affect even more as the U.S. population ages in
the coming decades.
In the area of osteoporosis, the NIAMS, along with the National
Institute on Aging, has provided steady support for the Study of
Osteoporotic Fractures (SOF), a multi-site clinical investigation to
determine the risk factors for osteoporotic fractures in older women.
Begun in 1986, SOF scientists recruited 9,704 white women aged 65 and
older from 4 metropolitan areas for this study. In 1997, an additional
662 African American women who are now seen with the original cohort
were enrolled. Major contributions from this long-term study include
the findings that bone mineral density (BMD) of the hip is the best
predictor of all types of fractures, and that weight loss and parental
history of hip fractures are among the most important risk factors for
this condition. SOF investigators have also learned that the
relationship of BMD and fracture risk is similar in white and African
American women, but that at every level of BMD, fracture rates are 30
to 40 percent lower in African American women. These insights are
providing clinicians with important information about which women are
at most risk for this debilitating disease, so that prevention
strategies may be used more effectively. Similar epidemiological
studies have now been launched to learn about risk factors for
osteoporosis in men.
With respect to osteoarthritis, the NIAMS partnered with the
National Institute on Aging, several other NIH components, and four
pharmaceutical companies in establishing the Osteoarthritis Initiative,
a public-private partnership aimed at developing clinical research
resources that support the discovery and evaluation of biomarkers and
surrogate endpoints for osteoarthritis clinical trials. For the first
time, a public-private partnership is bringing together new resources
and commitments to help find biological markers for the onset and
progression of osteoarthritis. Recruitment of participants is actively
underway, and by the end of fiscal year 2005, more than 3,800
participants have been recruited. One year follow-up measurements have
been carried out on over 1,000 participants, and will continue for the
next 4 years. All data and images collected will be available to
researchers worldwide to help quicken the pace of scientific studies
and biomarker identification. This consortium serves as a model for
future endeavors that link the public and private sectors.
complex genetics
The NIAMS is taking full advantage of the explosion of information
related to genetics, genomics, and proteomics to pursue the causes of
complex diseases, and how best to treat them. This includes recent work
which identified a genetic variation that doubles the risk of
developing rheumatoid arthritis. Scientists have long suspected that
autoimmune diseases such as rheumatoid arthritis result from a
combination of genetic and environmental factors. Now, a NIAMS-funded
research team has identified a specific genetic variation, called a
single nucleotide polymorphism or SNP, that increases rheumatoid
arthritis risk twofold. The SNP is located within a gene that codes for
a particular enzyme that is known to be involved in controlling the
activation of white blood cells, called T cells, that play an important
role in the body's immune system. Under normal conditions, the enzyme
works as a negative regulator: it inactivates a specific signaling
molecule which, in turn, interrupts the communications and keeps immune
cells from becoming overactive. However, in cases where the SNP is
present in one or both copies of a person's genes for this enzyme, the
team found that the negative regulation by the enzyme appears to be
inefficient, allowing T cells and other immune cells to respond too
vigorously, causing increased inflammation and tissue damage. The
implications of this finding go beyond a better understanding of
rheumatoid arthritis risk. It may also help explain why different
autoimmune diseases tend to run in families, since this gene variant is
also found in diabetes and lupus.
In other efforts, researchers have recently made breakthroughs in
understanding the genetics underlying psoriasis, a chronic skin disease
characterized by scaling and inflammation. This disorder occurs when
skin cells rapidly pass from their origin below the surface of the skin
and pile up on the surface before they have a chance to mature. Usually
this movement (also called turnover) takes about a month, but in
psoriasis it may occur in only a few days. Recent studies funded by the
NIAMS are helping scientists and doctors to understand the disease
process at the molecular level, and what role genes play in
predisposing people toward psoriasis. In one such project, researchers
investigated the role of both genes and the environment in psoriasis,
psoriatic arthritis, and atopic dermatitis, another inflammatory skin
condition. The researchers found similarities in genetic susceptibility
for psoriasis and atopic dermatitis. As for psoriatic arthritis--a
condition in which inflamed joints produce symptoms of arthritis for
patients who have or will develop psoriasis--they found that the
presence of modifier genes can indicate which people with psoriasis are
also at risk for psoriatic arthritis.
translational research
A key ingredient in research success is translation: work to bring
insights from the laboratory bench to the patient bedside, and back
again, with the ultimate goal of improving patient care and public
health. In this vein, NIAMS has recently launched a new program to
bring together basic and clinical scientists in a targeted and
organized way. The Centers of Research Translation (CORT) program
emphasizes the translation of results from basic to clinical studies,
as well as translating findings from clinical research to enhance and
focus the approaches used in basic studies--all with the goal of
improving public health.
This commitment to translational research is bringing results in
many areas, including the field of muscular dystrophy research. NIAMS
supports two of the six Senator Paul D. Wellstone Muscular Dystrophy
Cooperative Research Centers: the first, at the University of
Pittsburgh, focuses on gene and stem cell therapies to treat muscle
disease; and the second, located at the University of Pennsylvania, is
examining strategies to inhibit muscle degeneration and promote muscle
growth. These centers promote side-by-side basic, translational, and
clinical research; provide resources that can be used by the national
muscular dystrophy and neuromuscular communities; and provide training
and advice about muscle diseases for researchers and clinicians.
The Institute has also launched new initiatives to encourage
translational research in all forms of muscular dystrophy, and to
stimulate career development opportunities for muscle disease
researchers. These efforts are designed to facilitate the development
of new and more effective treatments for muscular dystrophy, and to
increase the number and quality of investigators in basic,
translational, and clinical research focused on this disease.
regenerative medicine
Regenerative medicine--a multidisciplinary field that involves the
life, physical, and engineering sciences--is an emerging area of
research that cuts across several NIAMS programs. For example,
important advances have been made recently in the development of
promising new polymers for cartilage repair. Cartilage is a tissue that
lacks capacity for self-repair. However, multidisciplinary studies by
biologists, engineers, physicians, and other are providing new
strategies for treating degenerative cartilage that may result in
treatments for articular cartilage lesions. Researchers funded by the
NIAMS have developed a class of injectable materials based on a
biodegradable polymer, OPF (oligo-polyethylene glycol fumarate), for
cartilage tissue engineering. Short-term studies in experimental
animals demonstrated excellent tissue filling and integration resulting
from implantation of these materials into cartilage defects. The
polymers were also designed to deliver bioactive molecules (such as
growth factors) as well as cells (such as chondrocytes or progenitor
cells) to cartilage lesions to enhance tissue repair. Early results
show that chondrocytes remain viable, proliferate, and synthesize
cartilage matrix components in these polymer gels. Taken together,
these results indicate that OPF gels are promising materials for cell
delivery in cartilage repair strategies.
conclusion
The scientific advances and innovative initiatives highlighted
above paint a picture of research progress that has benefited millions
of American children and adults. In the coming fiscal years, NIAMS will
focus on strategic collaborations by building partnerships to pursue
shared goals across public, academic, and private research entities. A
primary example of such a coordinated effort is the Collaborative
Initiative on Bone Strength. NIAMS--in conjunction with other NIH
components, the Food and Drug Administration, and industry partners--is
exploring a potential public-private collaboration on bone strength.
The main goals of such an initiative would be to provide data
supporting the use of new bone strength markers as surrogate endpoints
for fractures in clinical trials, and to find measurements that predict
risk of fracture more accurately than does bone density. This would
facilitate the continued development and approval of new treatment
alternatives to prevent fractures through the support of clinical
trials that are smaller, shorter, and less expensive than current
studies.
Finally, NIAMS is placing a high priority on strengthening the
pipeline of well-trained investigators across the Institute's areas of
research interest. This commitment includes funding for the new NIH
award program, ``Pathway to Independence,'' to support young
investigators, as well as an enhanced emphasis on basic, translational,
and clinical training at the major research centers supported by NIAMS.
All of these activities are driven by our dedication to fulfill the
mandate that Congress gave the Institute when it created NIAMS; namely,
to reduce the burden of illness and to enrich the quality of life for
all Americans affected by diseases within our mission.
______
Prepared Statement of Raynard Kington, Deputy Director, Office of the
Director
Mr. Chairman, Members of the Committee: I am pleased to present the
fiscal year 2007 President's budget request for the Office of the
Director (OD). The fiscal year 2007 budget includes, $667,825,000, an
increase of $140,259,000 over the fiscal year 2006 appropriation of
$527,566,000 comparable for transfers proposed in the President's
request. The OD provides leadership, coordination, and guidance in the
formulation of policy and procedures related to biomedical research and
research training programs. The OD also is responsible for a number of
special programs and for management of centralized support services to
the operations of the entire NIH.
The OD guides and supports research by setting priorities;
allocating funding among these priorities; developing policies based on
scientific opportunities and ethical and legal considerations;
maintaining peer review processes; providing oversight of grant and
contract award functions and of intramural research; communicating
health information to the public; facilitating the transfer of
technology to the private sector; and providing fundamental management
and administrative services such as budget and financial accounting,
and personnel, property, and procurement management, administration of
equal employment practices, and plant management services, including
the implementation of environmental and public safety regulation. The
principal OD offices providing these activities include the Office of
Extramural Research (OER), the Office of Intramural Research (OIR), and
the Offices of: Science Policy; Communications and Public Liaison;
Legislative Policy and Analysis; Equal Opportunity; Budget; and
Management. This request contains funds to support the functions of
these offices. In addition, the OD also maintains several trans-NIH
offices and programs to foster and encourage research on specific,
important health needs. I will now discuss the budget request for the
OD in greater detail.
nih roadmap for medical research
Responding to 21st Century biomedical challenges, the NIH Roadmap
for Medical Research serves as a test bed for trans-NIH programs
designed to accelerate the pace and translation of biomedical
discovery. Derived from stakeholder input, Roadmap initiatives are
bearing fruit with infrastructure, tools and training programs that
serve and intersect the needs of NIH research disciplines and missions.
Several large initiatives follow a ``hub-and-spoke'' model that
connects projects and research centers to one another and to the
research community at large. For example, the National Centers of
Biomedical Computing have created a networking `hub' to cooperatively
develop a number of computing resources that are being followed quickly
by investigator-initiated projects (spokes) that will use and assess
these resources. Recognizing that gaps in scientific knowledge can be
filled in many types of ways, the Roadmap invests in people with
innovative, high-risk ideas and in programs and training to foster the
development of new research teams and disciplines. Re-engineering of
clinical research is also underway with efforts to harmonize research
policies, develop tools to examine patient-reported outcomes, integrate
clinical research networks, and accelerate multidisciplinary and
translational research training. The NIH Roadmap for Medical Research
is lowering barriers to biomedical research and harnessing the
collective knowledge from multiple disciplines to make the next great
leap forward in biomedical discovery. The fiscal year 2007 budget
request for NIH Roadmap for Medical Research is $110,700,000, an
increase of $28,530,000 over the fiscal year 2006 level.
office of aids research
The Office of AIDS Research (OAR) plays a unique role at NIH,
establishing a roadmap for the AIDS research program. OAR coordinates
the scientific, budgetary, legislative, and policy elements of the NIH
AIDS research program. Our response to the AIDS epidemic requires a
unique and complex multi-institute, multi-disciplinary, global research
program. Perhaps no other disease so thoroughly transcends every area
of clinical medicine and basic scientific investigation, crossing the
boundaries of the NIH Institutes and Centers. This diverse research
portfolio demands an unprecedented level of scientific coordination and
management of research funds to identify the highest priority areas of
scientific opportunity, enhance collaboration, minimize duplication,
and ensure that precious research dollars are invested effectively and
efficiently, allowing NIH to pursue a united research front against the
global AIDS epidemic. OAR oversees the development of the annual
comprehensive trans-NIH AIDS-related research plan and budget, based on
scientific consensus about the most compelling scientific priorities
and opportunities that will lead to better therapies and prevention
strategies for HIV disease. The Plan serves as the framework for
developing the annual trans-AIDS research budget; for determining the
use of AIDS-designated dollars; and for tracking and monitoring those
expenditures. OAR also identifies and facilitates multi-institute
participation in priority areas of research and facilitates NIH
involvement in international AIDS research activities. The fiscal year
2007 budget request for OAR is $59,290,000, which is a decrease if
$1,000,000 below the fiscal year 2006 level.
office of research on women's health
The Office of Research on Women's Health (ORWH), the focal point
for women's health research for the Office of the Director,
strengthens, enhances and supports research related to diseases,
disorders, and conditions that affect women, and sex/gender studies on
differences/similarities between men and women; ensures that women are
appropriately represented in biomedical and biobehavioral research
studies supported by the NIH to facilitate analyses by sex/gender; and
develops opportunities for the advancement of women in biomedical
careers and investigators in women's health research. ORWH is
developing a novel initiative, entitled Advancing Novel Science in
Women's Health Research (ANSWHR), with the NIH ICs to support
innovative research in women's health and sex/gender issues. ORWH will
continue funding for new or continuing programs through new RFAs for
its highly successful interdisciplinary programs: Specialized Centers
on Research (SCORs) Affecting Women's Health and Building
Interdisciplinary Research Careers in Women's Health (BIRCWH).
Reissuance of these interdisciplinary programs will insure the
continuation of advances in sex and gender factors in women's health
research and the mentored development of junior faculty by bridging
advanced training with research independence resulting in more clinical
researchers performing in women's health research. The fiscal year 2007
budget request is $$40,949,000, which is the same as the fiscal year
2006 level.
office of behavioral and social sciences research
The NIH's long history of funding behavioral and social sciences
research has contributed significantly to our understanding, treatment,
and prevention of disease and to the promotion of health and well-
being. To further NIH's ability to capitalize on such opportunities,
Congress established the Office of Behavioral and Social Sciences
Research (OBSSR) to provide leadership in developing research programs
that are likely to improve our understanding of processes underlying
health and disease and to provide directions for intervention. OBSSR
works to ensure that behavioral and social sciences research is
integrated into the greater NIH health research enterprise.
As Secretary Leavitt's announcement of the Genes, Environment and
Health Initiative (GEHI) made clear, very little is known about how
various characteristics of the environment interact with genetics to
influence susceptibility to illness. The GEI's focus is interactions
among genetics, environmental toxins and individual behaviors (dietary
intake and physical activity) that influence the risk of developing a
number of common diseases. Based on recommendations from an OBSSR-
supported Institute of Medicine study examining the state of the
science on gene-social environment interactions, OBSSR is collaborating
with ICs to develop research initiatives at the interface of social and
genetic factors and health. Moreover, the office is initiating training
institutes in genetics for behavioral and social scientists to provide
them with the expertise they need to function in interdisciplinary
research teams working in this area.
Another area of trans-NIH emphasis has been effective design,
communication and implementation of health and clinical information to
ensure optimal outcomes across groups of diverse stakeholders. OBSSR's
participation in the ``Dissemination and Implementation Research in
Health'' program will help identify and overcome many barriers to the
widespread adoption of evidence-based social and behavioral
interventions to treat and prevent illness. The promise of these
efforts lies in their potential to improve treatment and prevention of
illness, the use of these tools to address disparities in health
outcomes, and the possibility of demonstrating opportunities for more
cost-effective health policy and practice.
To continue such groundbreaking work in the behavioral and social
sciences, the fiscal year 2007 budget request for OBSSR is $26,121,000,
the same amount as the fiscal year 2006 level.
office of disease prevention
The primary mission of the Office of Disease Prevention (ODP) is to
stimulate disease prevention research across the NIH and to coordinate
and collaborate on related activities with other federal agencies as
well as the private sector. There are several other offices within the
ODP organizational structure.
The Office of Medical Applications of Research (OMAR) has as its
mission to work with NIH Institutes, Centers, and Offices to assess,
translate and disseminate the results of biomedical research that can
be used in the delivery of important health interventions to the
public. The ODP has two additional specific programs/offices that place
emphasis on particular aspects of the prevention and treatment of
disease the Office of Dietary Supplements (ODS) and the Office of Rare
Diseases (ORD).
In fiscal year 2007, the ODS requests a budget of $26,807,000, the
same amount as the fiscal year 2006 level. ODS promotes the scientific
study of the use of dietary supplements by supporting investigator-
initiated research, and stimulating research through the conduct of
conferences and presentations at national and international meetings.
Other current ODS efforts include:
--Sponsorship of systematic reviews on the efficacy and safety of
dietary supplements in reducing the risk of chronic diseases
such as cancer and heart disease.
--Collaborations for the development, validation, and dissemination
of analytical methods and reference materials for dietary
supplements.
--Support for and development of databases of dietary supplement
information including:
--National Health and Nutrition Examination Survey (NHANES);
--Collaboration with USDA to develop an analytically-based database
of dietary supplement ingredients;
--Plan to develop a dietary supplement label database;
--International Bibliographic Information on Dietary Supplements
(IBIDS);
--CARDS, a database of federally funded research on dietary
supplements.
--Collaboration with other federal agencies to develop a coordinated
approach to assessment of the health effects of bioactive
factors in food and dietary supplements.
--Publishing Fact Sheets on dietary supplements for consumers.
Another component of ODP, the ORD, was formally established through
the Rare Diseases Act of 2002, Public Law 107-280. The budget request
for fiscal year 2007 for ORD is $15,548,000, the same amount as the
fiscal year 2006 level. The following are highlights of ORD activities:
(1) An Extramural Rare Diseases Clinical Research Network that involves
10 consortia with 70 sites, and 30 patient support organizations for
almost 50 rare diseases. Twenty-two clinical protocols have been
approved and another 25 will be developed during 2006. (2) ORD provides
support for 20 Bench-to-Bedside research projects in the NIH Intramural
Research Program and supports collaborative research efforts with the
National Human Genome Research Institute. (3) ORD also co-funds with
the NIH institutes and centers approximately 80 to 100 scientific
conferences per year to identify scientific opportunities or stimulate
research where it is lagging or lacking. (4) To assist the rare
diseases research community and patients with rare diseases, ORD
initiated a pilot program to develop genetic tests from gene
discoveries in the research laboratories to the clinic. (5) ORD is
developing a Web-based database of rare diseases bio-specimen
repositories in the United States to facilitate access to human
biomaterials for research.
office of science education
The Office of Science Education (OSE), within the Office of Science
Policy, develops science education programs to enhance efforts to
attract young people to biomedical and behavioral science careers and
to improve science literacy in both adults and children. The OSE
creates programs to improve science education in schools (the NIH
Curriculum Supplement Series); creates programs that stimulate interest
in health and medical science careers (LifeWorks Web site); creates
programs to advance public understanding of medical science, research,
and careers; and advises NIH leadership about science education issues.
Programs target diverse populations including under-served communities,
women, and minorities, with a special emphasis on the teachers of
students from Kindergarten through grade 12. The OSE Web site is a
central source of information about available education resources and
programs, http://science.education.nih.gov. The fiscal year 2007 budget
request for OSE is $3,839,000, the same as the fiscal year 2006 level.
loan repayment and scholarship program
The NIH, through the Office of Loan Repayment and Scholarship
(OLRS), administers the Loan Repayment and Undergraduate Scholarship
Programs. The NIH Loan Repayment Programs (LRPs) seek to recruit and
retain highly qualified physicians, dentists, and other health
professionals with doctoral-level degrees to biomedical and behavioral
research careers by countering the growing economic disincentives to
embark on such careers, using as an incentive the repayment of
educational loans. There are loan repayment programs designed to
attract individuals to clinical research, pediatric research, health
disparities research, and contraception and infertility research, and
to attract individuals from disadvantaged backgrounds into clinical
research. The AIDS, intramural Clinical, and General Research Loan
Repayment Programs are designed to attract investigators and physicians
to the NIH's intramural research and research training programs. The
NIH Undergraduate Scholarship Program (UGSP) is a scholarship program
designed to support and enhance the training of undergraduate students
from disadvantaged backgrounds in biomedical research careers and
employment at the NIH. For fiscal year 2006, the UGSP plans to award
scholarships and provide funding for summer internship service pay-back
for twenty (20) individuals and provide funding for twenty-one (21)
individuals performing one-year service payback at a cost of $768,000.
In fiscal year 2006, the Loan Repayment Program for Research Generally
(GR-LRP) plans to award contracts to fifty-one (51) individuals
entering into initial three-years contracts, and forty (40) contracts
to individuals entering into one-year renewal contracts at a cost of
$5,286,000. Lastly, the NIH Clinical Research Loan Repayment Program
for Inidividuals from Disadvantaged Backgrounds (CR-LRP) plans to award
contracts to two (2) individuals entering into initial two-year
contracts, and ten (10) contracts to individuals entering into one-year
renewal contracts at a cost of $483,000 in fiscal year 2006. The fiscal
year 2007 budget request for OLRS is $7,141,000, the same as the fiscal
year 2006 level.
office of portfolio analysis and strategic initiatives
In fiscal year 2005, the NIH established a new office within the
Office of the Director, the Office of Portfolio Analysis and Strategic
Initiatives (OPASI). The OPASI is made up of three divisions, focused
on (1) resource development and analysis (including the development and
deployment of knowledge management; (2) strategic coordination; and (3)
evaluation and systematic assessments. Collectively, these three
divisions identify and integrate information to support the planning
and implementation of trans-NIH initiatives that address exceptional
scientific opportunities and emerging public health needs. More
specifically, OPASI is facilitating a ``functional integration'' of
strategic planning and evaluation activities across the agency. The
fiscal year 2007 budget request for OPASI is $3,000,000, an increase of
$1,020,000 over the fiscal year 2006 level.
When fully staffed by fiscal year 2008, OPASI will have
approximately 72 FTEs. Thirteen existing FTEs transferred to OPASI in
fiscal year 2006, and approximately 16 FTEs will be recruited during
fiscal year 2006. The NIH is in the process of recruiting for a
Director, OPASI and expects to fill this position in 2006. Funding for
fiscal year 2007 will cover additional recruitments and Office
operations in an amount consistent with OPASI's structure and
responsibilities. In addition to salaries to support the FTEs, funding
will be used to pay for contractual services, supplies, equipment,
office rent and other services.
Through these efforts, the NIH Director and the IC Directors will
have access to more consistent information to improve coordination and
facilitate collaboration across the agency, and to inform priority
setting and budget decisions. The governance process for OPASI will
likely be carried out by a new working group of the NIH Steering
Committee, as described above. The group will be charged with
monitoring the overall effectiveness of the office, advising on policy
and planning issues, and forecasting the need for changes in OPASI's
activities, among other areas.
Thank you, Mr. Chairman for giving me the opportunity to present
this statement; I will be pleased to answer questions that the
Committee may have.
______
Prepared Statement of Dr. Story C. Landis, Director, National Institute
of Neurological Disorders and Stroke
Mr. Chairman and Members of the Committee, I am Story Landis,
Director of the National Institute of Neurological Disorders and Stroke
(NINDS). I am pleased to present the fiscal year 2007 President's
budget request for NINDS.
The mission of the NINDS is to reduce the burden of neurological
disorders by developing ways to prevent or to treat these diseases.
Epilepsy, autism, cerebral palsy, muscular dystrophy, spinal muscular
atrophy (SMA), and hundreds of other disorders are first evident in
infancy or childhood. Multiple sclerosis, spinal cord injury, migraine,
and traumatic brain injury are among the many nervous system diseases
that are prevalent in young adults. Stroke, dementias, chronic pain,
and Parkinson's disease will increase, if unchecked, with the aging of
our population. The impact of neurological disorders on people, on
their families, and on our economy is immense.
clinical research
The NINDS currently supports more than 1,000 clinical research
projects, of which more than 125 are clinical trials of interventions
to prevent or treat disease. Ongoing clinical trials are testing drugs,
natural biological molecules, surgery, deep brain stimulation,
hypothermia, radiation, immunotherapy, and behavioral therapies for
disorders including amyotrophic lateral sclerosis (ALS), brain tumor,
cerebral palsy, epilepsy, headache, Huntington's disease, multiple
sclerosis, muscular dystrophy, myasthenia gravis, pain, Parkinson's
disease, spinal muscular atrophy, stroke, Tourette syndrome, and
traumatic brain injury.
Last year an NINDS clinical trial showed that aspirin prevents
stroke effectively for the many people with partially blocked arteries
in the brain who have had a previous stroke or TIA (mini stroke).
Aspirin works as well as warfarin, a drug that requires monthly
monitoring and carries the risk of major hemorrhage and heart attack.
This trial is another step in a long march of advances that guide
physicians in preventing stroke in particular risk groups. The U.S.
Centers for Disease Control and Prevention estimated that the death
rate from stroke declined by 18.5 percent for the U.S. population from
1993 to 2003, and progress is continuing with results like these.
Each year also brings results from several NINDS preliminary
clinical trials. Current drugs for Parkinson's disease ultimately fail
because they do not halt the progressive death of brain cells that
causes this disease. The Neuroprotection Exploratory Trials in
Parkinson's Disease (NET-PD) is a network of 50 clinical centers
throughout the United States that efficiently tests drugs to slow the
underlying disease. NET-PD has completed phase II trials of four drugs
that had been rigorously selected for testing from candidates suggested
by scientists around the world, and just published the results of the
first two. NET-PD will move quickly to a large, definitive clinical
trial to test the safety and effectiveness of at least one of these
drugs in preventing Parkinson's disease.
In addition to clinical trials, other types of clinical studies
lead to new treatment or prevention strategies. An epidemiological
study this year found that men who exercised vigorously as young adults
had a 50 percent lower risk of developing Parkinson's disease in later
life than men who had low levels of physical activity. Other studies
determined how to predict which patients with glioblastoma, a common
and deadly brain tumor, will respond to a new class of anti-cancer
drugs, and discovered why infant seizures do not respond to drugs that
are effective in adults and what other drugs might work better.
The NINDS Clinical Research Collaboration (CRC), now under
development, will extend the reach of clinical research into more
communities across the United States. The CRC engages community
practice and academic neurologists to speed clinical studies; minimize
costs; make clinical trials more accessible to diverse participants;
facilitate trials of rare diseases; and improve transfer of research
results to clinical practice in the community. Complementing the CRC,
the NINDS is building a network to develop emergency treatments for
neurological disorders. Stroke, seizures, traumatic brain and spinal
cord injury, and other neurological disorders account for perhaps 5 to
10 percent of all medical emergencies. This program brings together
specialists in emergency medicine, neurological disease and clinical
trials.
genes and neurological disorders
In December, the journal Science chose the discovery of a gene
defect that can cause Tourette syndrome as one of the 10 most important
scientific advances of the year. Since the NIH budget doubling began,
scientists have identified more than 100 genes associated with
neurological diseases including ALS, ataxias, Batten disease, dyslexia,
dystonia, epilepsy, muscular dystrophies, Parkinson's disease,
peripheral nerve diseases, and spinal muscular atrophies.
Gene discoveries often have a rapid impact on patients and
families. They yield definitive DNA diagnostic tests that are faster,
cheaper, and more accurate, and allow genetic counseling and attention
to special risks of people with particular inherited disorders. For
example, patients with ataxia used to undergo MRI brain scans,
withdrawal of spinal fluid for analysis, tests for amino acids and
organic acids, lipoprotein electrophoresis, urine heavy metal screens,
thyroid function tests, and sometimes painful nerve or muscle biopsies
to get a diagnosis, costing thousands of dollars over several months.
Today, a commercially available DNA test can often give a definitive
diagnosis of a genetic neurological disorder within a week for a few
hundred dollars.
Gene findings also jumpstart therapy development. Over the last
year, studies of therapies in animal models, another benefit from gene
discoveries, have shown promise for neurofibromatosis, muscular
dystrophy, Fragile X syndrome, Huntington's disease, hereditary
ataxias, and several other disorders. Therapies are already moving from
animal models into NIH or private sector clinical trials, including
ceftriaxone for ALS, anti-oxidants for ataxia-telangiectasia, myostain
inhibitors and gentamicin for muscular dystrophy, and coenzyme Q10 for
Huntington's disease. The pace is remarkable after decades without
progress for many of these diseases.
Knowing where and when genes are active is key to understanding the
nervous system in health and disease. Most genes are active at some
time and place in the brain, yet only a small fraction of these have
been well characterized, so the NINDS initiated the GENSAT (Gene
Expression Nervous System Atlas) to map gene activity in the brain
across development. GENSAT also generates valuable research tools
including strains of mice in which a visible marker is turned on where
and when the gene of interest is active. Using these mice, scientists
this year found new insights into Parkinson's disease that could not
have been revealed without this resource. The studies showed that one
of two previously undistinguishable types of nerve cells is selectively
affected in Parkinson's disease, helped explain why brain movement
control circuits malfunction, revealed the molecular mechanism that
kills those cells, and identified a potential new target for drugs to
slow Parkinson's disease.
translational research
With the budget increases, the NINDS implemented major programs to
move insights from basic research to practical therapies ready for
testing in clinical trials, that is, translational research. The
Cooperative Program for Translational Research supports research teams
in academia and small companies. These milestone-driven, investigator-
initiated projects are developing drug, stem cell, or gene therapies
for Batten disease, Parkinson's disease, Huntington's disease, tuberous
sclerosis, Duchenne muscular dystrophy, traumatic brain injury, and
stroke, among other disorders.
In another translational effort, the NINDS developed the SMA
Project as a model program to expedite therapy development. The
contract-based project is making encouraging progress towards its
ambitious goal--having a drug for SMA ready for clinical trials by the
end of 2007. A steering committee, with drug development expertise from
industry, the FDA, academia, and the NIH, first developed a detailed
drug development plan. To carry out the plan, the project then created
a virtual drug development company with the tools and facilities for
identifying ``lead compounds,'' chemically modifying leads into
potentially improved compounds, testing drug candidates in cell and
animal models, and coordinating the overall drug development scheme.
More than 300 compounds have been prepared and are in testing. In 2007,
the NINDS will address a major barrier in the development of drugs for
other neurological diseases by extending the contract-based medicinal
chemistry resource from the SMA Project. Medicinal chemists modify
weakly active compounds so that drug development teams can test the new
drugs for improved safety and effectiveness.
NIH basic science stimulates therapy development in the private
sector, as well as by the NIH. In the past year, private sector
clinical studies of clotting Factors VII and VIIa have shown promise
for serious and hard to treat strokes caused by bleeding in the brain.
NIH research motivated those studies by showing that these strokes are
followed by continued expansion of blood filled pockets in the brain,
called hematomas, which contribute profoundly to disability and death.
Private sector clinical trials in gene and cell therapies for
Parkinson's disease begun this year also build upon NINDS research.
Longstanding NINDS targeted therapy development programs also
catalyze private sector efforts. For three decades, the Anticonvulsant
Screening Program (ASP) has fostered industry development of drugs for
epilepsy, including six drugs in widespread use and several more now in
clinical testing. Drugs that emerged from the ASP testing program are
also among the most effective treatments for chronic pain. NINDS
initiatives begun last year and to begin in 2007 focus on animal models
for testing drugs that block the development of epilepsy, work for
treatment resistant epilepsy, and meet the special needs of pediatric
and geriatric populations.
collaborative research
The NINDS strongly encourages cooperative efforts among scientists
and physicians from diverse disciplines, and works closely with other
parts of the NIH, other government agencies, and non-governmental
organizations, as well as with companies. As may be evident from the
discussions of the Clinical Research Consortium, NET-PD, GENSAT, the
Cooperative Program in Translational Research, and the SMA Project,
most NINDS programs, whether focused on a particular disease or a
scientific problem, emphasize collaboration. Other examples include
research centers on muscular dystrophy, Parkinson's, autism, spinal
cord injury, stroke and heath disparities, and resources including the
Human Genetics Repository and the Microarray Consortium.
The NIH Neurosciences Blueprint, begun in 2005, presents a
framework to enhance cooperation across the NIH institutes that share
an interest in diseases of the nervous system. Blueprint initiatives
have focused on neuroscience tools, training in the neurobiology of
disease for basic scientists, genome analysis, neuroimaging, genetic
mouse models, core research facilities, and clinical assessment tools.
In 2007, the Blueprint will focus on neurodegeneration, which
contributes to many diseases.
Among government agencies, the NINDS is working closely with the
U.S. Army Medical Research Institute of Chemical Defense (USAMRICD)
because many potential chemical terrorist agents affect the nervous
system. Cooperative projects with the Veterans Administration include a
major clinical trial of deep brain stimulation for Parkinson's disease.
The NINDS also meets regularly with the FDA on stem cells and other
biological therapies and works with the National Science Foundation on
common interests including computational neuroscience and informatics.
More than 300 non-governmental organizations (NGOs) focus on
diseases within the mission of the NINDS. The World Parkinson
Conference, held for the first time this February, and a major
conference on epilepsy planned for March 2007 are two of many recent
examples of cooperative efforts between NGOs and the NINDS. In June
2005, the Institute brought together 75 representatives of NGOs at the
NIH for a day of presentations, informal interaction, and group
discussions. Based on the strong positive feedback from participants,
the NINDS will hold similar meetings in the future to explore how we
can work together in the future.
Thank you, Mr. Chairman. I would be pleased answer questions from
the Committee.
______
Prepared Statement of Dr. Ting-Kai Li, Director, National Institute on
Alcohol Abuse and Alcoholism
Mr. Chairman and members of the Committee: I am pleased to present
the fiscal year 2007 President's budget request for the National
Institute on Alcohol Abuse and Alcoholism (NIAAA). The fiscal year 2007
budget includes $433,318,000, which reflects a decrease of $2,612,000
over the fiscal year 2006 enacted level of $435,930,000 comparable for
transfers proposed in the President's request.
Alcohol consumption kills or disables thousands of Americans each
year. The Centers for Disease Control and Prevention (CDC) reported in
2005 that, in the mid-1990s, alcohol use and abuse were among the top
ten causes of death and disability in the United States. CDC also
ranked excessive alcohol consumption as the third leading preventable
cause of death in 2001. Motor vehicle crashes are among the most
visible consequences of alcohol use; CDC estimates that in 2003, 40
percent of traffic deaths were alcohol-related. However, death and
disability also result from alcohol-related diseases, such as liver
cirrhosis, heart disease, stroke, dementia, and certain cancers.
Despite these consequences, the majority of people who drink are
able to do so without harm to themselves or others. One of the
fundamental goals of alcohol research is to determine why some
individuals cannot limit their drinking. Research has shown clearly
that half of the risk for developing alcohol use disorders is a
function of genes, while the other half can be traced to factors in the
environment, such as family, friends, and culture. The measure of risk
is not an either/or situation; genes and environmental factors interact
and influence one another, even at the molecular level.
Investigating the interplay of genes and environment is an
important focus across the NIH, with implications for many of the most
widespread, life-threatening, and costly health conditions affecting
Americans. One of the exciting areas of research I would like to
describe today has to do with how new tools we are developing to
investigate this interaction between genes and environment can
contribute to an understanding of alcohol dependence.
As a starting point, we have already identified several genes that
can raise or lower the risk of developing alcohol dependence. Variants
in two families of genes that are involved directly in alcohol
metabolism, for example, can lower risk. These genes encode enzymes
that break down alcohol. Some people inherit enzyme variants that will
result, if a person drinks, in especially high levels of a toxic
byproduct of alcohol metabolism. These individuals feel sick when they
drink; as a result, they are at lower risk of developing alcohol use
disorders.
Other genes that play a role in alcoholism risk encode the
communication circuitry of brain messenger molecules, the receptors of
neurotransmitters, a number of which have been linked to alcoholism and
psychiatric disorders that co-occur frequently with alcoholism.
Research suggests, for example, that genes for neurotransmitters
involved in depression and anxiety are also, in some groups, related to
alcoholism risk. Among the neurotransmitter systems for which research
has reported a relationship between genes and alcoholism risk: GABA, a
neurotransmitter that slows the pace of brain signaling and is known to
be involved in the alcohol response; NPY, a brain protein involved in
stress responses and memory; serotonin, a neurotransmitter involved in
the regulation of mood; and brain opioids, which play a role in the
sensation of pleasure.
Variants in these neurotransmitter genes influence alcoholism risk
by shaping how the brain responds to alcohol, regulating how pleasant
the experience is, or how sedating. An important new direction of
research has to do with investigating how the opposite can occur:
alcohol can make lasting changes in genes in ways that can have
profound effects on health.
Epigenetics refers to heritable and long-term changes in gene
function that occur without a change in DNA sequence. Such changes
could be caused, for example, by elements in the environment, such as
alcohol, changing how genes are translated into proteins, in other
words, how the genes are expressed. Epigenetics can help us understand
how alcohol has lasting effects on health.
One of the ways alcohol and its metabolites can change gene
expression is by modifying histones--proteins that intertwine with DNA.
Stable modification of DNA can also occur. Both of these reactions can
activate or silence the expression of genes. Alcohol through its
metabolism contributes to or alters the level of at least two specific
metabolites that are required for these chemical modifications.
Epigenetic modifications may be transmitted as the cell divides.
Thus, these modifications may persist throughout the lifespan.
Epigenetic changes also have the potential to be passed on to the next
generation, producing abnormalities in offspring. This research, at the
forefront of progress in genetics and molecular biology, gives us an
opportunity to understand the complex mechanisms by which an external
environmental factor like alcohol interacts with biology. It promises
to help explain why repeated exposure to alcohol can change permanently
how a person responds thereafter to the substance, setting the stage
for dependence. It can help explain why drinking during pregnancy can
cause irreversible damage to the brain of a fetus. And it may help
explain what underlies alcohol's destructive effects on such organs as
the liver, pancreas, and brain, as well as its role in cancers
associated with heavy alcohol exposure.
Epigenetics research may also provide a means for investigating the
long-term effects of alcohol consumption on adolescents. Alcohol is the
drug most commonly used by youth. Adolescents who drink tend to do so
intensively; according to 2005 data from the Monitoring the Future
study, 11 percent of 8th graders, 21 percent of 10th graders, and 28
percent of 12th graders report drinking 5 or more drinks in a row in
the past two weeks. This ``binge'' drinking is a particularly hazardous
pattern of drinking at any age. But during adolescence, when the brain
is still undergoing developmental change, binge drinking may have
particular dangers.
Preliminary studies suggest that alcohol has the potential to
disturb normal brain development in adolescence and young adulthood.
NIAAA research has established that youth who begin to drink in their
early teens are at greater risk later of developing alcohol dependence.
This increased risk can be explained only partly by inherited
biological risk factors, suggesting that early drinking itself causes
changes that manifest themselves in future behavior. Data from NIAAA's
National Epidemiologic Survey on Alcohol and Related Conditions has
shown that most cases of alcoholism are established by age 25. This
suggests that alcoholism, rather than being a disease of middle age, is
a developmental disorder that has its roots in youth.
An important NIAAA initiative is aimed at investigating the effects
of alcohol, including epigenetic effects, on developing brain
structures and systems that regulate behavior. It will address the
mechanisms that underlie alcohol-related changes during brain
development, the dosage and drinking patterns that result in changes,
and the factors that promote or protect against these changes. An
important aim of this research is to determine whether and how
alterations in brain function influence lifetime risk for alcohol use
disorders, particularly in vulnerable individuals.
Improving our fundamental understanding of how the environment
interacts with genes has many potential benefits. For example,
knowledge of the genes that are related to risk for alcohol problems--
and how variants of these genes might be manifest in physical or
behavioral traits--can be used to assist in the identification of
individuals at risk or, in other words, predict who is vulnerable.
Understanding how alcohol interacts with genes will help define how an
individual makes the transition from casual drinking to dependence; and
how long term heavy drinking causes disease.
Our growing body of knowledge about genes and the cellular
processes they encode is providing targets for medications development.
Genetics research is helping to show why no one medication will work in
every person. The ultimate goal will be to personalize treatment--
similar to the approach in diseases like hypertension or depression--by
choosing from an array of medications the agent that is most effective
for a given individual.
Finally, among its most important potential benefits, the
investigation of genes and environment will give us a clear picture of
the impact of alcohol on the long-term health and behavior of
adolescents. Understanding the mechanisms behind these persistent
effects will make even more compelling the imperative to identify
effective ways of preventing adolescents from consuming alcohol, not
only to safeguard their health and well-being in youth, but to preempt
the development of alcohol use problems in adulthood.
Thank you Mr. Chairman. I would be pleased to answer any questions
that the Committee may have.
______
Prepared Statement of Dr. Donald A.B. Lindberg, Director, National
Library of Medicine
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Library of Medicine
(NLM) for fiscal year 2007, a sum of $313,269,000, which is $1,641,623
less than the comparable fiscal year 2006 appropriation.
Only a few years ago we frequently described the role of the
National Library of Medicine almost entirely in the context of the
medical literature--NLM collected and organized the books and journals
that were then used in the process of making new discoveries that would
be reported in yet more books and journals. That paradigm, although
accurate as far as it goes, is no longer sufficient to describe the
Library's role. Today, the NLM is at the hub of an interconnected world
of an amazing amount of information, ranging from the published
literature, to molecular sequence and genomic data, to descriptions of
clinical trials, to still and moving medical images, to maps of
chemical spills and other information used for emergency preparedness,
and to authoritative research-based information prepared especially for
the general public--for patients and their families and caregivers.
The range of persons and institutions with which the Library
interacts is staggering. A National Network of Libraries of Medicine,
with more than five thousand members, extends the reach of NLM's
services. Many medical organizations, publishers, academic
institutions, government agencies, and libraries make data available to
the world through the National Library of Medicine. The NLM, with a
staff of experienced medical librarians, scientists, and health
professionals, creates databases and other Web resources to ensure that
high quality information is available to all, easily and without
restriction. The bottom line of all this is that the Library operates
the most-consulted scientific medical Web site in the world: two
million people come to the Library's Web site--to learn about diseases,
search the literature, connect with other information providers, and to
download terabytes of data--every day.
As a key member of the NIH research team, the Library works closely
with scientists on the Bethesda campus and around the country. A prime
example of this is the work of NLM's National Center for Biotechnology
Information (NCBI) and the panoply of databases with genomic
information contributed by NIH and NIH-supported scientists. This
collaboration extends around the world, with partners at institutions
in other nations contributing sequence and other data to the NCBI's
databases. Another example of extensive collaboration is that several
thousand public and private organizations have agreements with NLM to
use the Visible Human Project datasets of anatomical information to
create techniques and software used in teaching and research.
But the Library is also a bricks and mortar facility on the campus
of the National Institutes of Health. NLM has two reading rooms that
are open to the public--one that serves the Library's remarkable
collection of historical materials and a main reading room. An
exhibition, ``Visible Proofs: Forensic Views of the Body,'' has just
been opened in the Library's public area and will be visited by many
thousands, including students from grade school up. Previous
exhibitions are now touring the country, extending greatly the work of
our history of medicine curators.
A basic function of the National Library of Medicine is to serve as
a ``court of last resort'' for seekers of medical information. With the
world's largest collection--eight million items--the NLM is relied on
by institutions and individuals around the globe.
information services for the public
The Library's main portal for consumer health information is
MedlinePlus, available in both English and Spanish. Much of this
material is based on research done or sponsored by the NIH Institutes.
MedlinePlus has more than 700 ``health topics,'' containing, for
example, overview information, pertinent clinical trials, alternative
medicine, prevention, management, therapies, current research, and the
latest news from the print media. In addition to the health topics,
there are medical dictionaries, a medical encyclopedia, directories of
hospitals and providers, and interactive ``tutorials'' with images and
sound. The newest addition to MedlinePlus is a series of surgical
videos that show actual operations of common surgical procedures.
Another new aspect of MedlinePlus is ``Go Local,'' that is, a service
to link users from the MedlinePlus health topics to the health and
social services in their community that are related to that topic.
There are other popular NLM Web sites for the public.
ClinicalTrials.gov was created to give everyone easy access to
information about human research studies. The site contains information
on more than 25,000 federally and privately supported trials. It
includes summaries of the purpose of each study, the recruiting status,
criteria for patient participation, location(s) of the trial and
specific contact information. NIHSeniorHealth.gov is maintained by the
Library in collaboration with the National Institute on Aging and other
NIH Institutes. At present there are 22 topics of interest to seniors,
including, for example, Alzheimer's Disease, balance problems, macular
degeneration, shingles, and stroke. NIHSeniorHealth.gov contains
information in a format that is especially usable by seniors, with, for
example, large type, and it also has a ``talking'' function that allows
users to listen as the text is read to them.
NLM's Genetics Home Reference provides consumer-friendly summaries
of genetic conditions and related genes and chromosomes. This
information resource bridges consumer health information and scientific
bioinformatics data, and it links to many existing resources, both at
NLM and at other reliable sites. The Household Products Database
provides easy-to-understand data in consumer-friendly language on the
potential health effects of more than 2,000 ingredients contained in
more than 6,000 common household products. The Household Products
Database has proved to be popular with the media, and there have been a
number of newspaper and magazine articles about it. Another consumer
health site is the colorful Tox Town, which looks at an ordinary town
and points out many harmful substances and environmental hazards that
might exist there. Users can click on a town location, like a school,
office, factory, or park and find information about the toxic chemicals
that may be encountered there. Other versions are available for a big
city, a farm, and the U.S.-Mexico border area. There is also a new
special section with information on toxic chemicals and disaster health
concerns in the wake of Hurricane Katrina and Hurricane Rita.
information services for the scientific community
The most frequently consulted online medical resource in the world
is PubMed/Medline, an easily searchable database of more than 15
million references and abstracts for medical journal articles from the
1950s to the present. Usage of PubMed/Medline by the scientific and lay
communities has grown considerably since it became free on the Web in
1997, to over two million searches per day. PubMed also links to the
sites of participating publishers so that users can retrieve full-text
articles from 5,000 journals. Where links to electronic full text are
not available, the user may use PubMed to place an online order for an
article directly from a library in the National Network of Libraries of
Medicine.
PubMedCentral (PMC) is a Web-based repository of biomedical journal
literature providing free and unrestricted access to the full-text of
articles. This repository is based on a natural integration with the
existing PubMed/Medline biomedical literature database of references
and abstracts. Currently, PMC contains nearly 600,000 full-text
articles. Recent additions have come from newly published material as
well as from digitizing back issues that previously were only available
in printed form. NIH's Public Access policy encourages scientists whose
work is funded by the NIH to submit their manuscripts to PubMed
Central. NLM's National Center for Biotechnology Information designed
and implemented the NIH Manuscript Submission system, a quick and easy-
to-use system for scientists to submit their manuscripts. Creating such
digital archives as PubMedCentral to ensure that the world's biomedical
literature is properly recorded and available for future generations,
is an important NLM responsibility.
Another heavily used scientific resource is a database of all
publicly available DNA sequences, called GenBank. The NCBI, which
maintains GenBank, has also created integrated retrieval tools that
allow seamless searching of the sequence data and provide links to
related sequences, bibliographic citations, and other resources. Such
features allow GenBank to serve as a critical research tool in the
analysis and discovery of gene function as well as discoveries that
lead to identification and cures for a number of diseases. One recent
example of the use of NCBI sequence databases was to identify the first
polio case in the United States since 1999. The state health laboratory
in Minnesota had isolated an unknown virus from a hospitalized child
from an Amish community. The laboratory staff went to the Web, searched
against the 55 million DNA sequences at NCBI, and found a match to the
polio virus used in the Sabin oral vaccine. ``Bingo,'' said the
laboratory's director, ``It was a 98 percent match. We knew we had
nailed it.''
A critical need in biomedical research, as identified in the NIH
Roadmap Initiative, is a repository for what are called ``small
molecules'' that are crucial in drug development. Small molecules are
responsible for the most basic chemical processes that are essential
for life and they often play an essential role in the attack of a
pathogen, or in the cell's response to the attack. The new PubChem
database, developed by the NCBI, links the small molecules to their
biological functions and to the macromolecules with which they
interact. At present, PubChem includes over 7.5 million records for
small molecules with over 5 million molecular structures. These data
have been contributed by public, academic, and commercial resources.
The NCBI is also doing important work on other issues of current
public concern. One of these is to provide an Influenza Virus Resource
that links researchers working on vaccines to genomic data about the
influenza virus. As the data accumulate and the analyses progress, the
discoveries made will ultimately lead to better prediction of large-
scale outbreaks, more effective vaccine design, and the saving of many
human lives. Another area of NCBI work of topical interest is their
development, in the aftermath of 9/11, of sophisticated software called
OSIRIS. The software is now being tested within five collaborating
forensic DNA laboratories to assist in the analysis and validation of
forensic data and help identify victims from the Gulf Coast states in
the aftermath of Katrina.
A recently announced series of initiatives by several NIH
Institutes directed at understanding the genetic factors underlying
human disease will require the NCBI to play a key role. Several large-
scale, long-term studies, such as the Framingham Heart Study, will be
adding genetic information from participants to the clinical data
already collected. NCBI has been selected by the Institutes to build
the databases that will incorporate the clinical and genetic data, link
them to the molecular and bibliographic resources at the NCBI and, for
the first time, make these data available to the scientific and
clinical research community.
NLM remains the principal source of support nationally for research
training in the field of biomedical informatics. This support is
especially important as rapidly moving technology in health care and
biomedical research requires investigators who understand biomedicine
as well as fundamental problems of knowledge representation, decision
support, and human-computer interface. Five-year institutional training
grants from NLM support some 300 pre-doctoral, post-doctoral, and
short-term trainees across the country.
other areas of interest
The Library has an important role in developing standards for
Electronic Health Records. As part of its Unified Medical Language
System (UMLS) project, NLM creates vocabulary databases and software
tools to assist informatics researchers and system developers in
automated interpretation and integration of medical knowledge and
health data. Chief among the UMLS resources is the Metathesaurus, which
links and provides 4.7 million concept names for 1.2 million concepts
from 114 vocabularies in a single database format. The UMLS serves as a
common distribution vehicle for standard code sets and vocabularies
needed for administrative transactions and electronic health records,
as well as a resource for advanced natural language processing,
automated indexing, and enhanced information retrieval. Building on its
two decades of UMLS experience, the Library also serves as an HHS
coordinating center for standard clinical vocabularies, such as the
SNOMED CT clinical terminology. The Library works closely with the
Office of the National Coordinator for Health Information Technology
and other organizations to align health data standards into an
effective interlocking set and to promote more rapid adoption of
standards-based electronic health records to facilitate patient care,
public health surveillance, and clinical research.
Twenty years ago the National Library of Medicine published a long
range plan that has proved to be of enormous benefit to the
institution. Out of it grew such initiatives as the Visible Human
Project, the National Center for Biotechnology Information, and the
recommendation that the Library engage in an outreach campaign to reach
minority and other underserved health professionals. The Library is now
engaged in a similar planning exercise for the next decade. Leaders
from across the spectrum of health and medicine are meeting at the
Library to consider four major themes relating to resources and
infrastructure, outreach to the underserved, support for clinical and
public health systems, and support for genomics. The plan, which will
be issued by the NLM Board of Regents and published later in 2006, will
point the Library in the direction in which it can make its maximum
contribution to society.
______
Prepared Statement of Juanita M. Mildenberg, Acting Director, Office of
Research Facilities Development and Operations
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the Buildings and Facilities (B&F)
Program for fiscal year 2007, a sum of $81,081,000.
role in the research mission
State-of-the-art facilities for scientific research and research
support facilities are a vital part of the research enterprise. The
National Institutes of Health's (NIH) Buildings and Facilities (B&F)
program designs, constructs, repairs and improves the agency's
portfolio of laboratory, clinical, animal, administrative and support
facilities at its six installations in four states. These facilities
house researchers from the NIH Institutes' and Centers' (ICs)
intramural basic, translational, and clinical research programs;
science administrators who oversee NIH's grants; the NIH leadership,
and various programs that support agency operations. The fiscal year
2007 B&F budget request focuses on the need for responsible utilization
and stewardship of NIH's past and recent investments in the ``bricks
and mortar'' of the research enterprise. In order to stay abreast of
the changing needs of the NIH programs, it is imperative that we
provide reliable, safe and secure research support facilities that are
appropriately equipped, operated and maintained.
The B&F budget request is the product of a comprehensive, corporate
capital facilities planning process. This process begins with extensive
consultation across the research community and the NIH's professional
facilities staff. It works through the Facilities Working Group, an
advisory committee to the NIH Steering Committee, and the HHS Capital
Investment Review Board. Through this process, the program demand for
more effective and efficient facilities designed to support current and
emerging investigative techniques, technologies, and tools is
integrated with, and balanced against, the need to repair, renovate,
and improve the existing building stock to keep it in service and to
optimize its utility.
The fiscal year 2007 request provides the necessary funding support
for the ongoing safety, renovation and repair, and related projects
that are vital to proper stewardship of the entire portfolio.
The fiscal year 2007 B&F budget request is organized among three
broad Program Activities: Essential Safety and Regulatory Compliance,
Repairs and Improvements and Construction. The fiscal year 2007 request
provides funds for specific projects in each of the program areas. The
projects and programs enumerated are the end result of the
aforementioned NIH facilities planning process and are the NIH's
capital facility priorities for fiscal year 2007.
fiscal year 2007 budget summary
The fiscal year 2007 budget request for Buildings and Facilities is
$81.1 million. The B&F request contains a total of $14.5 million for
Essential Safety and Regulatory Compliance programs composed of $2
million for the phased removal of asbestos from NIH buildings; $5
million for the continuing upgrade of fire and life safety deficiencies
of NIH buildings; $1.5 million to systematically remove existing
barriers to persons with disabilities from the interior of NIH
buildings; $1 million to allow for environmental remediation activities
at NIH sites; and $5 million for the continued support of the
rehabilitation of animal research facilities. In addition, the fiscal
year 2007 request includes $65.9 million in Repairs and Improvements
for the continuing program of repairs, improvements, and maintenance
that is the vital means of maintaining the complex research facilities
infrastructure of the NIH; and $700,000 in Construction for pre-project
planning including concept development studies and analyses of NIH-wide
facility projects proposed in the facilities plan.
My colleagues and I will be happy to respond to any questions you
may have.
______
Prepared Statement of Dr. Roderic I. Pettigrew, Director, National
Institute of Biomedical Imaging and Bioengineering
Mr. Chairman and Members of the Committee: I am pleased to present
the fiscal year 2007 President's budget request for the National
Institute of Biomedical Imaging and Bioengineering (NIBIB). The fiscal
year 2007 budget includes $294,850,000; a decrease of $1,960,000 over
the fiscal year 2006 enacted level of $296,810,000 comparable for
transfers proposed in the President's request.
bridging the physical and life sciences
The mission of the NIBIB is to improve human health by leading the
development and accelerating the application of biomedical
technologies. The Institute is committed to integrating the engineering
and physical sciences with the life sciences to advance basic research
and medical care. To demonstrate our commitment, the NIBIB gives
special consideration for funding to research grant applications that
bridge and integrate the life and physical sciences.
translating technology into clinical practice
Ultimately, the NIBIB seeks to translate research findings made in
the laboratory into solutions that advance human health by reducing
disease burden and improving quality of life. One highly successful
example of a research and commercialization effort supported in part by
the NIBIB is an automated, digital-imaging device called the ``array
microscope.'' The system utilizes an array of 100 miniaturized
objectives to produce a single, seamless sweep of a microscope slide of
a histopathology sample. The result is a microscopic-level resolution,
multi-colored digitized image of the pathology sample. The most
immediate impact of this technology is expected to be in medical
pathology. These ``virtual slides'' can be easily stored in a patient's
record and can also be viewed over the Internet, providing immediate
on-line access to expert second opinions.
The recently released ``Quantum Project'' initiative is another
example of how the NIBIB strives to support a more integrated and
focused research agenda using multidisciplinary approaches to develop
innovative and marketable technologies. The goal of this unique program
is to make a ``quantum'' advance in healthcare by funding research on a
specific project or projects that will translate into new technologies
and modalities for the treatment, prevention and cure of disease or
resolve a major health care problem within a reasonable time frame. In
these ``bench to bedside'' partnerships, a team of interdisciplinary
scientists will conduct collaborative research that will result in a
prototype product that can be translated into clinical practice.
technologies to improve health care delivery
With the advent of miniaturized devices and wireless communication,
the way in which doctors care for patients has changed dramatically.
Empowering clinicians to make decisions at the bedside, or the ``point-
of-care,'' has the potential to significantly impact health care
delivery and help address the challenges of health disparities. The
success of such a shift relies on the development of portable
diagnostic and monitoring devices for near-patient testing. The NIBIB
has contributed to advances in this area by funding the development of
sensor and microsystem technologies for point-of-care testing. These
instruments combine multiple analytical functions into self-contained,
portable devices that can be used by non-specialists to detect and
diagnose disease, and can enable the selection and monitoring of
optimal therapies. These advances limit the reliance on submission of
samples to centralized laboratories and will make results more readily
available within minutes as opposed to several hours or days, enabling
clinicians to make decisions regarding treatment when these decisions
can have the greatest impact. An example under development at the NIBIB
is a handheld system for the rapid detection and identification of
bacteria which cause urinary tract infections. The research team
anticipates this test could become available in the next two to three
years. To further capitalize on these advances, the NIBIB is planning
an initiative to support research on critical areas for the development
of other hand-held, diagnostic devices. These systems could reduce the
cost of health care, much as integrated electronics have reduced the
cost of computing, and greatly simplify and improve patient delivery of
care.
next generation minimally-invasive technologies
Advances in imaging technologies have spurred new minimally-
invasive procedures to accurately identify the site of disease and
injury, provide tissue for a definitive diagnosis, administer treatment
with minimal trauma, and monitor treatment responses. Image-guided
interventions are not only more efficient in terms of time and cost,
but their less invasive nature may result in fewer complications and
less damage to tissue. For example, NIBIB investigators are developing
new magnetic resonance imaging (MRI) techniques to detect and treat
organ rejection non-invasively. The current standard for diagnosing and
staging rejection is the biopsy, which is invasive, painful, and prone
to sampling errors that can yield false negative results. The
development of a non-invasive imaging-based method that can replace the
biopsy is highly desirable.
Over the next year, the NIBIB intends to expand its image-guided
interventions program by supporting research on the development of
technologies that allow the surgeon to visualize the patient
seamlessly, in three-dimensional preoperative images; track
intraoperative changes with real-time imaging; and restore a normal
sense of touch through robotic tools with sensors for touch feedback,
or haptics. This research may lead to new minimally-invasive surgical
procedures with fewer complications, shorter hospital stays, and
reduced costs. To plan for future initiatives in this area, the NIBIB
recently organized an interagency retreat to identify high priority
challenges that can serve as short- and long-term goals. Eight Federal
agencies and nine NIH Institutes and Centers (ICs) participated in this
retreat.
smedical robotic
First generation surgical robots are already being installed in a
number of operating rooms around the country. Although these robots
can't perform surgery on their own, they are certainly lending a
mechanical hand. Robots are being used in medicine because they allow
for unprecedented control and precision of surgical instruments and
reduce trauma to the patient, dramatically improving surgical outcomes
and lowering health care costs. Robots are also being used in
rehabilitation as they provide considerable opportunities to improve
the quality of life for physically disabled people. For example, one of
the most common stroke disabilities is a paralyzed arm. The NIBIB and
the National Institute of Child Health and Human Development are
jointly funding the development of two robotic devices that could
accelerate rehabilitation of patients with paralyzed arms and reduce
the cost of physical therapy. These devices can also treat people who
have experienced catastrophic events, such as war injuries resulting in
limb loss. Testing with stroke patients is expected to begin this year
using one device.
Traumatic injury or neurological diseases can also significantly
alter or impair the lifestyle of an individual. To help patients lead
more productive lives, NIBIB scientists are developing a non-invasive
brain-computer interface to provide both communication and control
functions. By recording brain waves from the scalp and then decoding
them, this system allows people to move a cursor to spell words, and
even to control a robotic arm. Initial efforts to test this new
technology in the field are underway.
nanotechnology for disease detection and drug delivery
Detection of dormant metastatic tumor cells is a critical but
elusive goal in cancer treatment. To find these cells, NIBIB
researchers are developing non-invasive optical imaging techniques that
are less costly and more accessible than MRI-based techniques and are
free of the side effects associated with radioactive imaging agents.
Microscopic or nanoscale ``bubbles,'' called polymerosomes, containing
embedded fluorescent materials are the key to this new approach. These
labeled bubbles are injected directly into a tumor and then imaged.
Also in development are polymersomes that would deliver chemotherapy
agents directly to a tumor. The surface of the bubble can carry a
molecule that would bind to tumor cells, and its membrane would also
hold fluorescent molecules for detection by optical imaging, with the
chemotherapy ``payload' carried in the interior. One investigator has
developed a special device which improves drug release by ultrasonic
fragmentation of the bubble.
enhanced support for new investigators
New investigators are the innovators of the future--they bring
fresh ideas and technologies to existing biomedical research programs,
and they pioneer new areas of investigation. Entry of new investigators
into the ranks of independent, NIBIB-funded research is essential to
the health of the biomedical imaging and bioengineering research
enterprise. The NIBIB is specifically targeting new investigators for
special funding consideration. This proved to be quite successful in
the first year of this policy, and a continuation of this program is
planned.
training for the future
An important goal of the NIBIB is to train a new generation of
researchers equipped to meet the modern needs of interdisciplinary and
transdisciplinary research. Researchers trained in biomedical imaging
and bioengineering must be able to demonstrate technical competency in
multiple fields as well as the ability to think independently,
communicate ideas effectively, work in teams, and contribute to a
strong vision that transcends a narrow discipline. To this end, the
NIBIB will work with the community to develop new programs that cross-
train research scientists in the biological and quantitative sciences.
For example, the NIBIB's Research Supplements to Promote Clinical
Resident Research Experiences program has been very successful. This
novel training mechanism is designed to serve as a ``first step'' in
attracting outstanding clinicians into research careers related to the
mission of the NIBIB by providing a one to two-year research
opportunity during residency training.
The NIBIB has also developed several public and private
collaborations to catalyze research at this interface. For example, the
NIBIB and the Howard Hughes Medical Institute partnered in a novel
public-private partnership to stimulate the development of new
interdisciplinary graduate training programs that integrate the
physical, quantitative, and engineering sciences with the life
sciences. This program will train a new generation of researchers,
equipped to meet the challenges of the 21st Century.
nih roadmap for biomedical research
An overarching goal of the NIH Roadmap is to facilitate the
development of broad-based innovative, novel and multidisciplinary
science and technology that has the potential to further advances in
health care. This goal is well aligned with the NIBIB mission and is
actively supported on a number of fronts. For example, over the last
year NIBIB has been the lead Institute in a Roadmap initiative entitled
``Innovation in Molecular Imaging Probes.'' Molecular imaging
approaches can be used to study cellular events and biochemical
abnormalities. The major roadblocks to in vivo clinical applications of
molecular imaging are the poor sensitivity and potential toxicity of
the current probes. This initiative supports research programs that
will circumvent these roadblocks.
nih blueprint
The Neuroscience Blueprint is a framework designed to enhance
cooperative activities among the NIH ICs that support research on the
nervous system. During the last year, NIBIB contributed to the
development of a number of initiatives, leading or participating in
three project teams. These initiatives aim to support research and
development of imaging technology for high resolution imaging of neural
activity that is reflected in electrophysiological signals; and to
develop a framework to address the critical need for neuroimaging data
and software tools sharing and integration. The NIBIB also participated
in the development of neuroscience training initiatives.
______
Prepared Statement of Dr. Griffin P. Rodgers, Acting Director, National
Institute of Diabetes and Digestive and Kidney Diseases
Mr. Chairman and Members of the Committee: I am pleased to present
the fiscal year 2007 President's budget request for the National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) a sum
of $1,844,298,000, which includes $150,000,000 for the Special
Appropriation for Research on Type 1 Diabetes through Sec. 330B of the
Public Health Service Act. The NIDDK transfers some of these funds to
other institutes of the NIH and to the Centers for Disease Control and
Prevention (CDC). Adjusted for mandatory funds, this is an decrease of
$10,627,000 from the fiscal year 2006 enacted level of $1,854,925,000
comparable for transfers proposed in the President's request.
The NIDDK supports research to combat a wide range of chronic
health problems, including diabetes and other endocrine and metabolic
diseases; diseases of the digestive system, kidneys, urinary tract; and
blood; nutritional disorders; and obesity. Through vigorous research,
initiated both by investigators and by the Institute, the NIDDK will
continue to elucidate the fundamental biology underlying health and
disease. We are pursuing new strategies for disease diagnosis,
treatment, and ultimately, prevention and cure.
preempting chronic diseases and their complications
Chronic diseases pose some of the greatest health challenges to the
Nation today. These diseases and their symptoms range in severity, but
are often debilitating and sometimes fatal. Some impair fundamental
body processes, such as metabolism, while others target the kidneys,
liver, and other vital organs and systems. Though their causes and
ultimate effects on health may differ, chronic diseases share the grim
features of constant affliction and impaired quality-of-life. The
burden of chronic diseases within NIDDK's research purview is immense.
Recent estimates using national health survey data reveal that diabetes
(type 1 and type 2) affects nearly 21 million Americans.\1\ About 20
million Americans have chronically impaired kidney function, which
places them at increased risk for irreversible kidney failure (end
stage renal disease) and death.\2\ Digestive diseases, such as
irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), and
liver and biliary diseases, wreak havoc with people's lives. ``Benign''
diseases of the bladder and lower urinary tract, including urinary
incontinence and prostate diseases, can be devastating. These chronic
diseases also exact a heavy economic toll. For example, the healthcare
and indirect costs of diabetes and its complications totaled $132
billion in 2002.\3\ The painful, debilitating symptoms of IBS and the
bladder disease interstitial cystitis (IC) result in loss of work and
increased medical costs. Costs of chronic diseases that strike the
digestive system, kidneys, and bladder run into the tens of billions of
dollars.
---------------------------------------------------------------------------
\1\ National Institute of Diabetes and Digestive and Kidney
Diseases. National Diabetes Statistics fact sheet: general information
and national estimates on diabetes in the United States, 2005.
Bethesda, MD: U.S. Department of Health and Human Services, National
Institute of Health, 2005
\2\ The National Kidney Foundation http://www.kidney.org/
kidneyDisease/. Accessed February 14, 2006.
\3\ Hogan P, et al, Diabetes Care 26:917-932, 2003.
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The tremendous human and monetary costs of chronic disease are
matched only by the extraordinary interventions often needed just to
preserve life. Organ transplantation and kidney dialysis are but two
examples. Although these are extreme measures for the sickest patients,
they represent some of the victories achieved by biomedical research in
reducing morbidity and mortality from advanced chronic disease. Our
goal is to improve these treatments, while we simultaneously seek
prevention strategies. For example, whole liver transplantation from
deceased donors is a successful treatment for liver failure, but is
limited by a shortage of donor organs. A new NIDDK clinical network
(A2ALL) is maximizing this treatment option in adults by assessing the
safety and outcomes, for both patients and donors, of new procedures
that use partial liver transplants from living donors--thereby
increasing the potential donor pool. Similarly, we are addressing the
diminished quality-of-life and low five-year survival rates under
current dialysis treatment, which is typically administered three times
weekly. A new clinical trial will evaluate the effectiveness of daily
dialysis.
importance of early intervention
For persons already suffering from chronic disease, improved
treatments will have great benefits. However, it is imperative that
researchers find ways to intervene at the earliest possible stage of a
disease. The goals for such research are to: (1) identify and use
biological information, such as ``biomarkers,'' that can predict an
individual's susceptibility to disease, disease progression, or disease
complications--thereby enabling more tailored use of interventions; (2)
find the most effective interventions to preempt the onset or course of
disease; and (3) ensure that these predictive tools and interventions
can be precisely targeted for the benefit of patients. New advances in
science, technology, and public health research are making these goals
realizable, with the prospect of significant improvements in public
health. Examples of potential research payoffs include hepatitis C and
diabetes complications. In the United States, hepatitis C infection
affects an estimated 4 million people and is the leading cause of both
liver cancer and liver failure due to end-stage cirrhosis. Patients who
do not respond to standard medical therapy with interferon and
ribavirin are at high risk of developing these severe health problems.
Ideally, physicians should be able to predict likely ``non-responders''
to current therapy and those at risk for disease progression, and then
tailor interventions to them. While this is not yet possible, ongoing
studies will help to move the field forward, including a major clinical
trial (HALT-C) aimed at preventing end-stage cirrhosis and lowering
risk of liver cancer in ``non-responders'' with advanced disease.
Likewise, physicians would welcome new, precise methods for
tailoring interventions to individuals with diabetes so as to reduce
complications in those at greatest risk, while also lessening treatment
burden. Landmark clinical trials have demonstrated that tight control
of blood sugar levels in type 1 diabetes patients significantly reduces
their overall risk of eye, kidney, nerve, and cardiovascular disease.
Unfortunately, current therapies to achieve tight control also increase
the risk of potentially life-threatening bouts of low blood sugar. If a
simple method existed to identify patients who could tolerate
``looser'' control of blood sugar levels without an increased risk of
complications, then therapy could be tailored accordingly. Pinpointing
the underlying causes of diabetes complications will pave the way to
such targeted interventions.
Developing a more personalized approach to medical therapy requires
a robust toolkit forged from research advances. Therefore, the NIDDK is
continuing with new initiatives to accelerate translation of
fundamental research into clinically useful applications. For example,
we want to be able to stop early scarring of the liver and kidney--
known as fibrosis--before it ignites a series of events leading to
irreversible organ failure. The NIDDK is fostering new, non-invasive
imaging methods to reveal fibrosis. Such techniques will enable
physicians to diagnose, monitor and treat liver and kidney disease more
effectively. For diseases within the NIDDK mission, we are also
committed to the discovery of biomarkers--factors, such as molecules,
that can be measured and used to monitor a patient's disease or
response to therapy. A new translational initiative encourages research
to develop and validate these biomarkers for clinical use.
Critically important for predicting and preempting chronic
diseases--such as polycystic kidney disease (PKD), focal segmental
glomerulosclerosis (FSGS), kidney stones, IC, IBD, IBS, non-alcoholic
steatohepatitis (NASH), and hepatitis B and C--is a thorough
understanding of their natural history. For example, discovery of PKD
genes has led to insights into the molecular defect underlying most
cases of this disease. Promising new medical therapies are being
explored to prevent or reduce cyst formation, and new trials (HALT-PKD)
will now test approaches for preventing progressive kidney damage. In
the kidney disease FSGS, we do yet know all the causative factors, but
a better understanding of FSGS progression has enabled the NIDDK to
undertake a trial of therapies to prevent or delay kidney failure in
patients. A new international patient registry should increase our
understanding of inherited causes of calcium oxalate kidney stones. The
cause(s) of the bladder disease IC remains unknown, but studies of a
promising biomarker from urine may lead to improved diagnosis and
treatment for patients, as well as to new therapeutic options.
Our efforts in digestive diseases will be guided by a long-range
strategic research plan to be developed by a new National Commission,
as well as by a recently completed Liver Disease Action Plan. We are
already making progress on several fronts. In IBD, studies of a
recently identified Crohn's disease susceptibility gene are pointing
the way to new therapeutic options. Researchers are exploring the
multiple physical and cognitive factors that appear to play a role in
IBS. A new clinical research network is studying the biological basis
of progression from a less serious form of non-alcoholic fatty liver
disease to the fatty liver, liver inflammation and scarring of NASH,
and will test strategies to prevent disease progression in both adults
and children. Studies of the hepatitis B virus continue in order to
optimize treatment options. A new system to replicate (``grow'')
hepatitis C virus in the laboratory will significantly enhance research
to test potential therapeutic targets and open the door to vaccine
development--complementing ongoing trials such as HALT-C.
Strikingly, research has revealed that obesity, with its
comorbidities, is at the nexus of many chronic diseases. The high
prevalence of obesity in the U.S. population, with nearly 31 percent of
adults affected,\4\ bears directly on the millions affected with
chronic diseases. Obese individuals are at increased risk of type 2
diabetes, and obesity is linked to increased risk of NASH, as well as
of ESRD via type 2 diabetes and high blood pressure. However, not all
overweight and obese individuals will develop obesity-associated
diseases. Age, gender, race, ethnicity, socio-economic status, and
individual genetics are among the many factors that may influence risk.
Through initiatives developed by the NIH Obesity Task Force and through
NIDDK-led efforts, we are encouraging research studies to promote
prevention and to identify which subsets of obese individuals are at
risk for developing particular comorbidities, and, in turn, to tailor
interventions accordingly.
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\4\ Flegal KM et al, JAMA 2002;288:1723-1727.
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Recent data offer promise that we may be able to stem the tide of
obesity-related health problems. For example, analyses by the United
States Renal Data System (USRDS) indicate that overall incidence rates
of ESRD have stabilized in the United States, following a 20 year
period of annual increases. This finding suggests that there has been a
successful translation into medical practice of research-based
knowledge important to preventing ESRD--the use of medications (ACE
inhibitors) and the benefits of controlling blood sugar and blood
pressure levels. Unfortunately, this positive result has not yet been
seen across the entire U.S. population, in that ESRD continues to
affect minority groups disproportionately. The National Kidney Disease
Education Program (NKDEP) has a major campaign aimed at reducing the
burden of kidney disease in African Americans, for whom the risk
factors of high blood pressure, diabetes, and a family history are
dangerous red flags. Through its working groups, the program is also
promoting the standardized, routine reporting of serum creatinine--an
indicator of kidney function. Use of this simple approach can
facilitate early detection and treatment of impending or active chronic
kidney disease in patients. Along the same lines, the National Diabetes
Education Program (NDEP) has translated into a multi-faceted campaign
for multiple audiences the impressive results of the Diabetes
Prevention Program (DPP) clinical trial. This trial demonstrated that
lifestyle changes--relatively moderate weight loss and increased
physical activity--can reduce the risk of type 2 diabetes by 58 percent
in persons at risk for the disease.
Such hopeful results spur our efforts to further reduce the health
burden of these chronic conditions through interventions to prevent
obesity as early as possible. Prevention research needs to address the
alarming rise in rates of pediatric overweight and obesity nationwide
over the past three decades. A recent study indicates that
approximately two million American adolescents have a prediabetic
condition (IFG) strongly linked to obesity and overweight. Children and
adolescents are being increasingly diagnosed with type 2 diabetes,
NASH, and other obesity-associated conditions once found mainly in
adults. To address key points of vulnerability early in life, the NIDDK
is spearheading several initiatives, such as defining mechanisms by
which maternal obesity and diabetes during pregnancy affect the future
risk of obesity and other chronic diseases in offspring. Another
initiative is focused on finding ways to prevent or manage weight gain
in children. Moreover, the new ``HEALTHY'' trial will investigate
whether a concerted, integrated program in middle schools will help
reduce the prevalence of obesity-related harbingers of type 2 diabetes
by improving cafeteria lunches, vending machine offerings, and physical
education and promoting behavioral change. The tremendous success of
the intensive lifestyle intervention for adults in the Diabetes
Prevention Program provides hope that the HEALTHY trial may do the same
for children.
The Nation's investment in NIH-funded research offers enormous
benefits, particularly the opportunity to preempt disease and reduce
its lifelong costs, both human and economic. To this end, the NIDDK is
harnessing new technologies, maximizing research investments, and
capitalizing on new opportunities to achieve early, effective
intervention for the many chronic diseases within its mission. Thank
you, Mr. Chairman. I would be pleased to answer any questions that the
Committee may have.
______
Prepared Statement of Dr. John Ruffin, Director, National Center on
Minority Health and Health Disparities
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Center on Minority
Health and Health Disparities (NCMHD) for fiscal year 2007, a sum of
$194,299,000, which represents a decrease of $1,106,000 over the
comparable fiscal year 2006 appropriation.
The overall health of the general American population has improved;
yet as a Nation we continue to be challenged by disparities in health
among racial and ethnic minority and other health disparity
populations. There continues to be a disproportionate burden of
illness, disability and premature death resulting from diseases and
health conditions such as cancer, cardiovascular disease, HIV/AIDS,
stroke, obesity, mental illness and diabetes, in these communities.
The cause of health disparities is multi-factorial in nature. The
complexity of health disparities merits a strategic, innovative, and
multi-faceted attack. Genes, biology, culture, race environment,
socioeconomics, and health behaviors all contribute to this complex
public health crisis. Biomedical research is essential in transforming
the health of this Nation. In order to have the greatest impact on
improving the health of America's underserved populations, at NIH, we
believe a new biomedical research paradigm is needed--one that is
predictive, personalized and preemptive. We need a well-coordinated,
interdisciplinary effort involving traditional as well as non-
traditional partners to get to the crux of the health disparities
crisis.
The National Center on Minority Health and Health Disparities was
established in 2000 to lead the Federal effort in health disparities
research, research capacity building, and outreach. The NCMHD has
always recognized the significance of partnerships in resolving health
disparities. Our programs embody a strategy that emphasizes our efforts
to build a biomedical research enterprise that is diverse, predictive,
personalized, and preemptive.
The NCMHD is committed to training a diverse biomedical research
workforce to examine issues relevant to the disparities in health of
America's rapidly increasing racial and ethnic minority populations.
More than 600 promising research scientists across the country have
received NCMHD loan repayment awards to conduct health disparities
research and clinical research. Institutional capacity building has
been an important area of focus. Through our endowments and research
infrastructure program, we have funded almost 40 academic
institutions--ore than half being minority-serving institutions. The
funding is helping to equip the institutions, their faculty and
students to engage in avant-garde biomedical research and training.
Another integral element of our strategy is community participation.
Our aim is to empower the community to address its own health problems.
Our communities should include individuals other than patients, who
must be actively engaged in research intervention and ultimately the
translation and dissemination of research results into practical
community tools.
Advancements in science and technology offer hope for the future.
The NCMHD has supplied more than 100 individuals, institutions, and
small businesses with resources to conduct research to help answer some
of the perplexing issues in health disparities. NCMHD is one of the few
NIH Institutes or Centers (IC) that focuses on populations and not
specific diseases or health conditions. Consequently, we have had the
unique opportunity of partnering with all of the ICs over the past five
years in our quest to eliminate health disparities. Our partnerships
and our programs have allowed us to support research into many of the
diseases and health conditions affecting racial/ethnic minority and
other health disparity populations. It is through these programs and
partnerships, that the NCMHD has been able to have far reaching effect
in improving the health of the Nation's health disparity populations.
We have made progress, but there is much more to be achieved.
health disparities research agenda
A national health disparities research agenda is fundamental in
eliminating health disparities. Healthy People 2010, the prevention
strategy for the Nation, identified a number of health objectives to be
achieved over a 10-year period. The elimination of health disparities
among different segments of the population in the United States is one
of the goals. We have five years left as a Nation to demonstrate how
far we have come in attaining that goal. The NIH through the leadership
of the NCMHD has been a principal player in advancing the goals of
Healthy People 2010. The NCMHD coordinates the development of the
evolving NIH health disparities research agenda--the NIH Health
Disparities Strategic Plan. The Plan represents the trans-NIH health
disparities vision and strategy. Through the Strategic Plan, the NIH
can aggressively address health disparities by fostering pioneering
partnerships and initiatives. The NCMHD, through the Institute of
Medicine (IOM), initiated the five-year evaluation of the NIH Health
Disparities Strategic Plan. The NCMHD, in collaboration with NIH
leadership and the Secretary of Health and Human Services will address
the recommendations of the IOM report in implementing and reshaping the
NIH health disparities research agenda.
ncmhd health disparities efforts
At the NCMHD, we are working to build an inclusive, collaborative,
and adaptive biomedical and behavioral research enterprise to identify
innovative diagnostics, treatments, and preventive strategies that will
eliminate health disparities. NMCHD activities have been numerous and
far-reaching. The newest NCMHD initiative is the Community-Based
Participatory Research (CBPR) Program, which supports 25 institutions
nationwide. The CBPR exemplifies a predictive, personalized and
preemptive approach to eliminating health disparities. It is a three-
part program that engages the community in all phases of the research
process and is directed to a specific disease/health condition in a
particular minority population. It starts with a three-year planning
grant, followed by a five-year grant to conduct intervention research,
and concludes with a three-year grant to disseminate the research
information. The CBPR is a novel approach for the biomedical research
enterprise, and we anticipate its potential in addressing health
disparities through projects such as: Project GRACE: A Participatory
Approach to Address Health Disparities in HIV/AIDS among African
American Population; Partnership to Overcome Obesity in Hawaii; Project
AsPIRE (Asian American Partnership in Research); The Healing of the
Canoe (is aimed at planning, implementing and evaluating a community-
based and culturally competent intervention to reduce health
disparities and promote health in the Suquamish Tribe reservation
community); and Partnership for a Hispanic Diabetes Prevention Program
in Washington.
The Centers of Excellence Program, ``Project EXPORT'' has been key
in leading our effort in supporting the advancement of medical research
and the transformation of the health care system. The program is
creating new partnerships to enable institutions at all levels of
capability to maximize their health disparities research, research
training and community outreach efforts. The 73 Project EXPORT grantees
have had a tremendous influence on creating more than 100 unique
partnerships focused on health disparities. We have created an array of
partnerships with entities such as hospitals; tribal groups; health
plans; health centers; community and faith-based organizations; civic
and non-profit health organizations; and local, city, and state
governments. Biomedical research is important in understanding the
underlying causes of health disparities, and how to prevent, diagnose
and treat disease and disability. The research conducted by our Centers
of Excellence will help to increase that understanding through projects
such as: Perceived Discrimination in Healthcare among American Indian/
Alaska Natives; Religious Outlook on Organ and Tissue Sharing;
Inflammation and Asthma; Impact of Coronary Heart Disease Risk
Perception on Health Behaviors and Physical Activity Assessment in
Multi-Ethnic Women.
The NCMHD Loan Repayment Programs support the goals of the new NIH
Pathway to Independence Program by increasing the number of qualified
health care professionals who conduct health disparities and clinical
research. The programs promote a diverse and strong scientific
workforce. Since its establishment, the Loan Repayment Program has made
more than 600 new awards to researchers in research disciplines such as
epidemiology, pharmacology, linguistics, etiology, health policy, and
behavioral science. The program is fulfilling its Congressional intent
with the majority of award recipients being from a health disparity
population. The NCMHD is training research scientists and health
professionals not only to deal with health disparities on the domestic
level, but also globally. Through the Minority Health and Health
Disparities International Research Training Program (MHIRT), 24
academic institutions have developed international training
opportunities in health disparities research for faculty and students.
MHIRT participants will be exposed to research areas including cancer
epidemiology, reproductive biology, parasitology, and ethnopharmacology
in countries such as Ethiopia, Ghana, Jamaica, Dominican Republic,
Australia, and Spain.
The NCMHD commitment to enhancing research capacity at academic
institutions is best demonstrated through its Research Endowment
Program and its Research Infrastructure in Minority Institutions (RIMI)
Program. The RIMI program is building research capacity in 21
predominantly minority-serving academic institutions. The NCMHD
provides endowment grants to eligible institutions to build minority
health and other health disparities research and training capacity. The
Endowment program has funded 16 institutions to strengthen teaching
programs in the biomedical and behavioral sciences; establish endowed
chairs and programs; obtain state-of-the-art equipment for instruction
and research; and enhance the recruitment and retention of student and
faculty from health disparity populations.
research collaborations
The health disparities phenomenon is almost incomprehensible until
it is humanized. Hurricane Katrina demonstrated the underlying national
health crisis that continues to plague America's racial and ethnic
minority and low-socio economic communities. In some cases, evacuees
received medical treatment for the first time for chronic and life-
threatening diseases, such as hypertension, cardiovascular diseases,
diabetes, and mental health disorders.
Community involvement and partnerships are critical to redress the
devastation experienced by individuals caught in the path of Hurricane
Katrina. The NCMHD is collaborating with the HHS Office of Minority
Health on a HHS $12 million initiative to bring desperately needed
health care services, information, and hope to racial and ethnic
minority populations in the Gulf Coast region. The NCMHD provided $5.2
million in funding to support that initiative. Our Centers of
Excellence have also been mobilized to participate in the initiative to
create a Regional Coordinating Center to build a research
infrastructure for on-going efforts to eliminate health disparities in
the hurricane-ravaged communities. Such an infrastructure would
integrate research-based academic facilities, public health, primary
care, and specialty care officials to engage in innovative approaches
to relief activities, including developing and testing culturally
relevant telemedicine response to mental health needs, and other acute
and chronic diseases; instituting electronic health records for
individuals in the region through partnerships with academic experts in
practice-based research; and establishing effective community-based
screening and surveillance systems to monitor health needs of
individuals evacuated from hurricane-ravaged communities, as well as
those returning to communities as they are re-built, with a special
focus on exacerbations of existing health disparities.
The NCMHD Visiting Faculty Program is a new program that is
assisting researchers displaced by the hurricane. The program will help
to bring displaced scientists who were employed at institutions in the
Gulf Coast states to the NIH, so that they can continue their research
efforts.
conclusion
During its initial five years the NCMHD has strived to be
inclusive, creative, and adaptable to changing circumstances. The
programs highlighted are but some examples of what is being done to
eliminate health disparities. We need to build on these successes and
further our activities. Toward this end, the NCMHD will sustain and
expand its primary strategies. Research capacity building will continue
to extend beyond academia to involve community and faith-based
organizations, individuals, and businesses at the local and grassroots
level. Training and the diversification of the health, scientific, and
technological workforce will remain key areas of focus in developing
innovative projects. Prevention, treatment, cultural competency, and
healthcare delivery for urban and rural communities will continue to be
approached aggressively.
Through our vision of the future embodied in the NIH Health
Disparities Strategic Plan, the NCMHD renews its commitment to build a
solid and diverse national biomedical research enterprise of
individuals and institutions dedicated to eliminating health
disparities. With our NIH Institute and Center collaborations and our
partnerships with scientific institutions and community-based
organizations across the Nation, the NCMHD will advance scientific
discovery to ensure the health of all Americans. All citizens should
have an equal opportunity to live long, healthy and productive lives.
______
Prepared Statement of Dr. David A. Schwartz, Director, National
Institute of Environmental Health Sciences
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget for the National Institute of Environmental
Health Sciences (NIEHS) for fiscal year 2007, a sum of $637,323,000
which reflects a decrease of $3,809,000 from the fiscal year 2006
appropriation.
introduction
As the Director of NIEHS, I am grateful for this opportunity to
present our vision for the Institute and environmental health sciences.
Our vision at NIEHS is to prevent disease and improve human health by
using environmental sciences to understand human biology and human
disease. Environmental agents contribute to many conditions of public
importance, including cancer, neurodevelopmental disorders, autoimmune
diseases, and chronic lung disease. While many of our investigators are
focused on understanding the causes of disease, we are also involved in
studies of susceptibility, basic mechanisms of disease, and identifying
novel approaches to intervention and disease prevention.
Recent NIEHS-supported research illustrates the range of our
Institute's science. In studying asthma, NIEHS scientists examined the
mechanisms controlling the body's own system for achieving balance
between airway constriction and airway relaxation. They discovered a
natural bronchodilator, deficient in asthmatics, that relaxes the
airway; absence of this enzyme in mice increases the development of
allergen-induced asthma. In other work, investigators studied the role
of supplements in preventing birth defects. While folate has been shown
to prevent spina bifida, a defect in the spinal column, epidemiologists
have now discovered that women who take folate supplements during
pregnancy are at reduced risk of giving birth to a child with cleft lip
and palate birth defects. Finally, NIEHS-supported studies have shown
that short-term exposure to ozone can increase mortality rates. These
studies demonstrated that a 10-part per billion (ppb) increase in the
previous week's ozone was associated with a significant increase in
cardiovascular and respiratory mortality.
current challenges
Today, we find ourselves at a critical junction where new tools and
opportunities for substantial scientific achievement intersect with our
growing understanding of cellular and molecular mechanisms by which
environmental exposures exert their effects. Our challenge is to take
advantage of these advances and to forge new frontiers to improve our
nation's health. To help ensure that the best opportunities are
identified and funded, we have made several programmatic and scientific
changes at the Institute since last April. Importantly, these changes
are consistent with our strategic plan that we initiated ten months ago
and have involved the efforts of many talented individuals across the
country. Concurrently, we are engaged in developing critical
partnerships to address areas of public health concern that involve the
missions of multiple organizations.
integrative research on human disease
Environmental health science is not limited to an organ system,
disease or population, but spans the full spectrum of human health and
disease. The interdisciplinary nature of our work requires the right
mix of specialists. As NIEHS increases its focus on common human
diseases, interdisciplinary teams of scientists will be needed to
integrate clinical, epidemiological, and toxicological research with
basic mechanistic studies. To optimize the creation of these
interdisciplinary research teams, I have begun a number of programmatic
changes. I have created an Office of Translational Biomedicine that
will re-focus the NIEHS intramural and extramural programs so that our
basic research discoveries can be rapidly applied to improvements in
human health. In our division of extramural research, I have initiated
a new program, DISCOVER (Disease Investigation for Specialized
Clinically Oriented Ventures in Environmental Research), that brings
together extramural scientists with expertise in basic, clinical, and
population-based research to focus on a disease related to
environmental exposures. Among intramural investigators, I have
developed a new program, the Director's Challenge, that also supports
multidisciplinary research teams to attack basic problems, like
inflammation and oxidative stress, that can be induced by environmental
exposures and can influence the development of many different diseases.
I am re-engineering our Environmental Health Science Research Centers
so that they include a clinical component in their research, thus
enhancing the disease focus and relevance of these centers. I have also
directed funds to build a new clinical research unit on campus so that
our intramural research program can be integrated into human biology
and human disease.
recruit and train the next generation
A more integrative approach to understanding complex human diseases
will require innovative scientists with the type of training that can
take advantage of new technologies and research opportunities. NIEHS
has initiated a number of changes that address our future workforce
needs. We have re-engineered our existing training programs so that we
can better identify and encourage promising students at all levels to
pursue careers in environmental health research. The existing T32
training grants program will be broadened to include other training
opportunities in interdisciplinary research and genetics and genomics.
We will also train physician-scientists by expanding our MD, PhD
training program and by supporting young investigators in their
transition to early faculty positions (developed a K12 training
program. We have also instituted the Outstanding New Environmental
Scientist, or ONES, award to help young, talented investigators make
the transition from mentored to independent research. These grants will
assist young scientists in launching innovative research programs
focusing on problems of environmental exposures and human biology,
human pathophysiology, and human disease by providing support for both
the research and the start-up costs that are needed to establish a
laboratory.
expand community-linked research
The likelihood of exposure to environmental agents increases in
economically disadvantaged communities and is associated with an excess
disease burden in these communities. The NIEHS traditionally supports
research relevant to understanding those health disparities and
community concerns. We will continue to support research, both
domestically and globally, that can offer insights into how to reduce
exposures and disease in these settings. We will also be involved in
developing quick responses to emerging environmental health issues,
such as arose in the aftermath of Hurricane Katrina, when NIEHS
launched a website that used a Global Information System to assess
environmental hazards caused by the storm, as well as coordinated a
local team of physicians and support staff to deliver medical care.
Beginning in fiscal year 2006, NIEHS is planning to support a research
program to investigate the health consequences of Hurricane Katrina.
This project will examine the role of genes, the environment, and gene-
environment interaction in the exacerbation of airway disease from
exposure to mold and microbial toxins in New Orleans following
Hurricane Katrina.
re-evaluate programmatic investments
We have decided that investigator-initiated research needs to be
prioritized at NIEHS and are rigorously re-evaluating other existing
programs and approaches to determine if we need to re-conceptualize or
eliminate some of these efforts. We have developed two new programs
aimed at using environmental agents to understand basic mechanisms in
human biology. One is the Epigenetics Initiative which explores
intrauterine environmental and nutritional factors that can alter gene
expression and generate developmental abnormalities or functional
changes. The other is the Comparative Biology of Environmental Disease
which uses novel ``-omics'' technologies and comparative biology
approaches to study environmentally-relevant disease pathways. These
studies will help us understand why people exposed to the same
environmental stressors respond differently. Finally, we have
reorganized the National Center for Toxicogenomics to insure a more
timely and relevant product. In order to achieve these new programs and
priorities, I have decided that the Comparative Mouse Genomics Centers
Consortium has fulfilled its mission of infrastructure development and
will not be re-competed.
gene, environment and health initiative--a novel partnership
Currently, we have inadequate techniques to precisely measure
environmental exposures. This situation is in marked contrast to the
robust tools that have been recently developed for the fields of
genetics and genomics. To be able to assess the role that environmental
exposures and genetic variation play in the risk of developing disease,
we simply need more robust tools to measure the environmental exposures
and the biological responses to these agents. While these tools are
absolutely vital in moving the field of environmental health sciences
forward, these tools will be invaluable to investigators in all areas
of biomedical research. To further this goal, the NIH, with the support
of the Secretary, has developed the Gene, Environment and Health
Initiative. Our goal in this initiative is to develop tools to
precisely measure individual biological responses to changes in our
environment, diet, and activity level so that we can understand the
relationship between various environmental exposures and human health
and disease.
niehs strategic plan--a new outlook
The NIEHS recently embarked on a strategic planning exercise, the
final version of which can be viewed on our website and will soon be
distributed in hardcopy. This document represents the efforts of many
scientists and advocacy groups. I have been gratified by the intense
interest and involvement from citizens and scientists throughout the
country. This document is truly a national plan that represents our
collective wisdom of where environmental health sciences needs to go in
order to reap full benefit of our investments and opportunities. Many
of the suggestions have already been incorporated into our new programs
and we will continue to design programs that are responsive to this
plan.
summary
The opportunities within environmental health sciences are greater
than they have ever been. With our recent nationally supported
strategic plan and the exciting partnerships that we are developing, it
is my belief that environmental health sciences will continue to
strengthen. With an improved relevance to major public health concerns,
better technology for teasing out important environmental contributors
to disease, an integrated approach to research, and a re-energized
workforce, I expect the NIEHS to provide many of the important
scientific advances of the future. Ultimately, this knowledge will be
used to reduce the burden of many important diseases both in this
country and abroad. I would be happy to answer any questions you might
have.
______
Prepared Statement of Dr. Paul A. Sieving, Director, National Eye
Institute
Mr. Chairman and Members of the Committee: I am pleased to present
the fiscal year 2007 President's budget request for the National Eye
Institute (NEI). The fiscal year 2007 budget includes $661,358,000,
which reflects a decrease of $5,398,000 under the fiscal year 2006
enacted level of $666,756,000 comparable for transfers proposed in the
President's request.
As the Director of the NEI it is my privilege to report on the
progress laboratory and clinical scientists are making in combating
blindness and visual impairment and about the unique opportunities that
exist in the field of vision research.
retinal diseases
Retinal diseases are a diverse set of sight-threatening conditions
that include age-related macular degeneration (AMD), diabetic
retinopathy, retinopathy of prematurity, retinitis pigmentosa, Usher's
syndrome, ocular albinism, retinal detachment, uveitis (inflammation)
and cancer (choroidal melanoma and retinoblastoma).
Of these diseases, AMD is the most frequent cause of vision loss
and legal blindness in older-age Americans, making it a research
priority for the NEI. AMD causes degeneration of the macula, the
central part of the retina that gives us fine, sharp visual detail. AMD
is thought to result from the confluence of genetic predisposition and
chronic exposure to environmental risk factors.
On the genetic side of the equation, identifying subtle alterations
in a gene or genes in AMD and other late onset diseases has been
complicated by the fact that traditional genetic research strategies
and tools are either inadequate or too cumbersome in their application.
The development of more sophisticated genetic tools has enabled
scientists to scan the entire human genome more quickly and
efficiently. Using data from the Human Genome Project and the
International HapMap Project, four different NEI supported laboratories
identified a common variation in a gene called complement factor H
(CFH) that accounts for an estimated 50 percent of the risk of
developing AMD.
The CFH protein regulates an inflammatory response that is
typically triggered by infectious microbes. Alterations in the CFH gene
are postulated to poorly regulate this response, leading to chronic,
localized inflammation and ensuing damage to cells in the center of the
retina, the macula, and its neighboring tissues. Inflammation is
thought to play a role in many other common diseases such as
Alzheimer's disease, Parkinson's disease, multiple sclerosis, kidney
disease, stroke, and atherosclerosis. Although the cells, tissues, and
molecular events in these diseases are diverse, they may share some
common disease mechanisms that present an opportunity to cross
pollinate findings from diverse research areas.
The discovery of the CFH gene will allow researchers to create
animal models and evaluate therapies that control chronic inflammation.
The CFH gene also illustrates the potential of a new paradigm for
medicine in the 21st century. This new paradigm holds that the practice
of medicine should be preemptive, personal and predictive. The CFH gene
presents the possibility to one day identify at-risk patients and
intervene well before pathology is clinically detectable.
strabismus, amblyopia and visual processing
Developmental disorders such as strabismus (misalignment of the
eyes) and amblyopia (commonly known as ``lazy eye'') are among the most
common eye conditions that affect the vision of children. It is
estimated that 20 percent of preschool children ages 3-4 have these and
other treatable eye conditions.\1\
---------------------------------------------------------------------------
\1\ Comparison of preschool vision screening tests as administered
by licensed eye are professionals in the Vision in Preschoolers Study.
Ophthalmology 111(4):637-50, 2004.
---------------------------------------------------------------------------
In an effort to identify children with treatable eye conditions,
many states are developing guidelines for preschool screening programs.
However, none of the commonly used vision tests have been evaluated in
a research-based environment to establish their effectiveness. To
address this issue, the NEI supported a large, multi-center study
called the Vision in Preschoolers (VIP) Study to determine which tests
and test conditions can effectively identify preschoolers in need of a
comprehensive eye exam. Previously VIP Study researchers found that in
the hands of licensed eye care professionals, the best performing tests
were able to detect 90 percent of children with the most severe visual
impairments. This year, VIP Study investigators found that specially
trained nurses and lay people can achieve results that are comparable
to screenings performed by licensed eye care professionals. Given that
most eye screening programs rely on lay people and nurses, this finding
validates the effectiveness of this approach.
glaucoma and optic neuropathies
Glaucoma is a group of eye disorders that causes optic nerve damage
that can lead to severe visual impairment or blindness. Elevated
intraocular pressure (IOP) is frequently, but not always, associated
with glaucoma. Glaucoma is a major public health problem and published
studies find that the disease is three times higher in African
Americans than in non-Hispanic whites.\2\
---------------------------------------------------------------------------
\2\ The Eye Diseases Prevalence Research Group: Prevalence of open-
angle glaucoma among adults in the United States. Arch Ophthalmol
122:532-538, 2004.
---------------------------------------------------------------------------
The defining event that leads to vision loss in all forms of
glaucoma is the degeneration of retinal ganglion cells (RGC) in the
back of the eye. These cells relay visual information to the brain
through the optic nerve and their loss effectively severs the neural
network that allows us to process visual information. However, little
is known about the molecular events that result in RGC degeneration.
Using high dose radiation and bone marrow rescue to explore
inflammatory responses in an animal model of glaucoma, researchers
unexpectedly discovered that this procedure prevents the loss of RGCs.
The neuroprotection offered by this procedure was complete, highly
reproducible, and lasting. Normally, by 12-14 months, these glaucoma
susceptible mice have complete RGC loss. At 14 months, treated mice had
no detectable signs of disease. Although the mechanism that offers
neuroprotection is not yet known, researchers speculate that it is due
to radiation, because the transferred bone marrow was genetically
identical to the original bone marrow the mice were born with. This
highly novel treatment protocol offers a tool to understand
neurodegeneration and, with refinement, could have important
implications for the treatment and prevention of neurodegenerative
diseases.
corneal diseases
The cornea is the transparent tissue at the front of the eye.
Corneal disease and injuries are the leading cause of visits to eye
care professionals, and are some of the most painful ocular disorders.
In addition, approximately 25 percent of Americans have a refractive
error known as myopia or nearsightedness that requires correction to
achieve sharp vision; many others are far-sighted or have
astigmatism.\3\
---------------------------------------------------------------------------
\3\ The Eye Diseases Prevalence Research Group: The prevalence of
refractive errors among adults in the United States, Western Europe,
and Australia. Arch Ophthalmol. 122:495-505, 2004.
---------------------------------------------------------------------------
Inflammation is a common immune response to injury and infection in
the body. In the cornea, however, inflammation can cause extreme
discomfort and result in vision loss. Nonetheless, the cornea retains a
remarkable capacity for wound repair while actively suppressing an
inflammatory response. Scientists have recently discovered that two
lipids, lipoxin A<INF>4</INF> (LXA<INF>4</INF>) and docosahexaenoic
acid-derived neuroprotectin D1 (NPD1), are formed in the cornea and act
as anti-inflammatory agents during corneal infection and wound healing.
Topical treatment with LXA<INF>4</INF> and NPD1 in mice with corneal
injuries increased the rate of tissue repair and inhibited inflammation
without impairing the recruitment of key immune leukocytes, which are
normally associated with inflammation, into the wounded tissue.
Moreover, a transgenic mouse that lacks these lipids exhibited delayed
wound healing and attenuated leukocyte recruitment. The identification
of these anti-inflammatory lipids in the cornea and their enhancement
of wound healing by topical application suggest their use as
therapeutic agents to overcome aberrant and damaging inflammatory
responses in the eye.
cataract
Cataract, an opacity of the lens of the eye, interferes with vision
and is the leading cause of blindness in developing countries. In the
United States, cataract is also a major public health problem. The
enormous economic burden of cataract will worsen significantly in
coming decades as the American population ages.
The lens is a dense, compact structure containing two cell types:
metabolically active epithelial cells and quiescent fiber cells.
Throughout the life-time of an individual, the lens carries out a
process of continued growth with epithelial cells dividing and
differentiating into fiber cells. During this process, the emerging
fiber cells become denuded of organelles such as the nucleus and
mitochondria. This process in part helps the lens achieve the high
transparency needed for clear vision. Scientists have previously found
that the lens uses proteins involved in a biological process called
programmed cell death or apoptosis to rid lens fiber cells of their
organelles. This past year, vision researchers have discovered the
biologic process that regulates apoptosis such that it allows for the
elimination of organelles without resulting in cell death.
The process is termed Apoptosis-related Bcl-2 and Caspase-dependent
(ABC) differentiation. In this process, a number of proteins that
normally lead to cell death such as caspases--proteins that break-down
internal cellular structures--are expressed to denude organelles. The
caspase proteins are balanced by the simultaneous induction of pro-
survival molecules such as bcl-2, a protein that binds to cell death
proteins and inhibits further damage or death to fiber cells. The
discovery of ABC differentiation in the lens will allow researchers to
better understand lens cell renewal and determine whether faulty
mechanisms in this process might lead to cataract formation.
nih roadmap
A goal of the NIH Roadmap Nanomedicine Initiative is to
characterize quantitatively the molecular scale components or
nanomachinery of cells and to precisely control and manipulate these
molecules and supramolecular assemblies in living cells to improve
human health. The NEI has a leadership role in implementing the NIH
Roadmap Nanomedicine Initiative. Under this initiative, a Request for
Applications (RFA) was prepared to award Nanomedicine Center Concept
Development Awards. These concept development awards were created to
allow applicants time and resources to develop the concept for a
Nanomedicine Center that would address various issues in nanomedicine
including, biomolecular dynamics, intracellular transport, and protein-
protein interactions. Understanding these fundamental biologic
processes at the nanoscale level will allow scientists to engineer
molecular structures, assemblies, and organelles for treating diseased
or damaged cells and tissues. Of the applications, four Nanomedicine
Centers were awarded in fiscal year 2005. The Centers will be dedicated
to understanding the nanobiology that underlies protein folding
machinery; ion channels and ion transport proteins; synthetic signaling
and motility systems; and mechanical biology. The NIH expects to fund
additional Nanomedicine Centers in fiscal year 2006. The Nanomedicine
Initiative will also benefit eye research in a more direct way. Current
NEI grantees are exploring the use of nanotechnology to assist in
corneal wound healing and drug delivery to the retina. Increased
support of nanomedicine through the NIH Roadmap will undoubtedly speed
progress in these areas.
nih neuroscience blueprint
The NIH Neuroscience Blueprint is a collaborative effort among 15
NIH institutes and centers to accelerate the pace of discovery and
understanding in neurosciences research. In an effort to better
understand all elements of the nervous system, the Blueprint will focus
on the development of tools and resources that will facilitate research
on the processes of development, neurodegeneration, and plasticity that
underlie the health and disorders of the nervous system. One of the
approaches to develop these tools and resources is a cellular level
approach to discovering the key molecules involved in nervous system
function. There is still a need to identify the location, the
developmental timing, and the cellular function of most of the genes
and proteins expressed in the brain. Mapping of the neurogenome is
being conducted by creating and analyzing transgenic mice to map gene
expression and activity to different cell types and regions of the
mouse central nervous system. The NEI component of this effort will be
to ensure that the genes involved in neurons of the complete visual
system are included in the neurogenome map.
Mr. Chairman, this concludes my prepared statement. I would be
pleased to respond to any questions you or other members of the
committee may have.
______
Prepared Statement of Dr. Stephen E. Straus, Director, National Center
For Complementary And Alternative Medicine
Mr. Chairman and Members of the Committee: I am pleased to present
the President's fiscal year 2007 budget request for the National Center
For Complementary And Alternative Medicine (NCCAM). The fiscal year
2007 budget includes $120,554,000, a decrease of $911,000 over the
comparable fiscal year 2006 appropriation of $121,465,000.
NCCAM has made significant progress in discovering the potential of
complementary and alternative medicine (CAM) to prevent and treat
disease. During NCCAM's first 7 years, the Center has formed a research
enterprise that addresses the challenges of conducting CAM research as
well as training investigators, conducting outreach, and facilitating
the integration of proven CAM therapies into the health care that
Americans receive.
setting the course
Through national surveys, we know that two-thirds of Americans are
using some form of CAM each year. We are gaining understanding of which
Americans use the various CAM modalities and for which health purposes.
These patterns of CAM use will inform NCCAM's research priority setting
in fiscal year 2007, along with guidance from two key documents:
--The NCCAM Strategic Plan for 2005-2009 (developed with input from
the public and scientific and medical communities nationwide);
and
--The Institute of Medicine's 2005 report, ``Complementary and
Alternative Medicine in the United States.''
In fiscal year 2007, NCCAM will again collaborate with the Centers
for Disease Control and Prevention to support the National Health
Interview Survey to capture changes in trends of the American public's
use of CAM.
furthering the research mission
Seven years of NCCAM investments in CAM research translate to the
support of more than 1,200 projects (in research, training, and career
development) at over 260 U.S. institutions. There has been a 20-fold
increase in the number of CAM papers published in leading scientific
journals by NCCAM grantees. In fiscal year 2007, building upon this
strong foundation, NCCAM plans to further enhance CAM research in the
following areas.
A Flourishing Centers Program
NCCAM has expanded and refined its approach to research centers. As
a result, the Center now has a diverse cadre of multidisciplinary
research centers at conventional and CAM institutions nationwide.
--Centers of Excellence for Research on CAM.--Six centers with
outstanding research records direct teams of CAM and
conventional investigators to explore, using cutting-edge
technologies, how CAM therapies may work.
--Developmental Centers for Research on CAM.--Scientists and
practitioners at 18 CAM and conventional institutions have
forged research partnerships. In fiscal year 2007 there will be
new Phase I developmental centers for CAM institutions just
launching programs of research, and Phase II developmental
centers for CAM institutions prepared to undertake more
sophisticated research studies.
--International Centers for Research on CAM.--Two centers support
U.S. investigators who collaborate with experts in the
traditional medical systems of their own countries, building
research expertise and capacity abroad and providing foreign
researchers with valuable experience in navigating the NIH
grants system.
--Botanical Research Centers.--Seven dietary supplement research
centers focusing on studies of botanical products are funded by
NCCAM and the NIH Office of Dietary Supplements. Research
conducted by these centers will advance the scientific base of
knowledge about the safety, effectiveness, and mechanisms of
action of botanicals.
Studies of Herbals and Other Dietary Supplements
Herbals and other dietary supplements are widely used by the
American public and they are a research priority for NCCAM. Studying
botanicals, however, has presented special research challenges related
to product characterization, standardization, and dosage. With the
advice of experts in herbal medicine and leaders of the dietary
supplement industry, NCCAM is improving product consistency for
research studies and thus increasing the probability that the studies
NCCAM funds will yield accurate findings.
In this regard, the Center has developed research-quality cranberry
products to use in studies of urinary tract infections and standardized
an extract of milk thistle (silymarin), for study in patients with
chronic viral hepatitis and non-alcohol-related steatohepatitis, a
collaborative project with the National Institute of Diabetes and
Digestive and Kidney Diseases.
NCCAM has worked with several NIH partners to design, conduct, and
fund large clinical trials of dietary supplements. The largest of these
was reported in February 2006 in the New England Journal of Medicine: a
4-year study (co-funded by the National Institute of Arthritis and
Musculoskeletal and Skin Diseases) of glucosamine and chondroitin
sulfate, two dietary supplements widely used by people with knee
osteoarthritis. In this study, the two supplements combined did not
provide statistically significant pain relief for all the participants,
compared to placebo. However, a small subset of participants with
moderate-to-severe pain had significant pain relief. An ancillary study
is continuing to determine whether the combination of these supplements
can prevent or delay further joint deterioration, a common long-term
outcome for people with osteoarthritis.
A Broad Research Portfolio
There are hundreds of different practices, products, and approaches
that comprise CAM. Thus, the research that NCCAM funds is wide-ranging.
Areas that NCCAM will emphasize further in fiscal year 2007 include:
--Manual therapies.--The mechanisms of action underlying the effects
of manipulative and body-based therapies such as chiropractic
and massage are little understood. Therefore, NCCAM is
launching an initiative in fiscal year 2007 on the biology of
manual therapies to better understand the effects of these
techniques on the body.
--Mind-body medicine.--One recent NCCAM-funded study found that tai
chi combined with standard medical care benefits patients with
chronic heart failure. Studies of meditation and mindfulness-
based stress reduction in various health conditions are under
way. NCCAM is also redirecting the focus of its intramural
research program to emphasize studies of mind-body medicine.
--Echinacea.--Research on echinacea is being done both because of the
public health burden of the common cold and the public's
widespread use of this natural product. A study of a single
dosage of Echinacea purpurea to treat viral colds in healthy
children was recently completed by an NCCAM grantee. A larger
study is being undertaken in which a range of doses of this
popular herb will be assessed for its ability to prevent colds
in children.
--Immune responses.--Many CAM interventions are believed to affect
the immune system, either by enhancing its ability to thwart
infection or by suppressing an overactive response, as occurs
in autoimmune diseases. NCCAM is exploring the immune effects
and basic mechanisms of action of various CAM modalities such
as traditional Chinese herbal mixtures, ginseng, green tea, and
Ginkgo biloba.
expanding training and career development
There can be no significant CAM research progress without a
sufficient cadre of investigators who are both skilled in rigorous
research and knowledgeable about CAM practices. NCCAM has increased the
number, quality, and diversity of the CAM research community using a
variety of approaches and grant mechanisms. In fiscal year 2007, NCCAM
will offer three new training opportunities: supplements to existing
research grants, in order to attract more CAM practitioners into
research endeavors; the CAM Practitioner Research Career Development
Award, for CAM practitioners interested in research; and the NCCAM
Career Transition Award, to help outstanding postdoctoral research
fellows in their transition to an independent career in CAM research.
disseminating information
From the outset, NCCAM has made it a priority to help
practitioners, patients, and the public make informed decisions about
CAM. The Center conducts outreach to public and professional audiences
through a variety of channels: information clearinghouse, website,
quarterly newsletter, conferences, Distinguished Lecture Series, and
online continuing education. With the National Library of Medicine, the
Center publishes CAM on PubMed, an online database of more than 400,000
research papers on CAM.
facilitating integration
NCCAM is committed to facilitating the integration of safe and
effective CAM therapies into conventional medicine. One example of this
effort is within the NIH itself. The Center is establishing a new
Integrative Medicine Consult Service at the NIH Clinical Center, to
provide integrative medical consultations and enrich patient care. In
addition, NCCAM continues to provide CAM curriculum development grants
to conventional medical, dental, and nursing schools.
collaborating across nih
NCCAM continues its collaborations with other NIH Institutes and
Centers, as a contributing member of the biomedical research community.
For example, NCCAM is a partner in several of the NIH Roadmap for
Medical Research initiatives, including the Exploratory Centers for
Interdisciplinary Research. Also, by participating in efforts like the
NIH Neuroscience Blueprint, the NIH Pain Consortium, and the Trans-NIH
Obesity Initiative, NCCAM can accelerate efforts to unlock the
potential of CAM therapies through these multidisciplinary research
initiatives.
looking toward the future
Mindful of the lessons learned in our first 7 years as an NIH
Center, and with growing understanding of the scientific opportunities
and public health priorities to be addressed with CAM approaches, NCCAM
will continue to explore options to sustain and improve the health and
well-being of the American people.
Thank you, Mr. Chairman. I would be pleased to answer any questions
that the Committee may have.
______
Prepared Statement of Dr. Lawrence A. Tabak, Director, National
Institute of Dental and Craniofacial Research
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Institute of Dental and
Craniofacial Research (NIDCR) for fiscal year 2007. The fiscal year
2007 budget includes $386,095,000, a decrease of $3,241,000 from the
fiscal year 2006 level of $389,336,000, comparable for transfers
proposed in the President's Request.
strengthening the evidence base in dental care
Health care decisions should be guided by the preponderance of
clinical research data, or evidence, whenever possible. This approach
is known as ``evidence-based medicine'', a concept that has evolved
into a driving force in healthcare.
Recognizing the concept's value, dentistry also has embraced an
evidence-based approach. Yet, having sufficient clinical data from
which to build that base can be challenging. For some oral health
problems, evidence-based approaches are possible; for many others,
knowledge gaps must be filled before an evidence-based approach can
take root. As the nation's leading supporter of oral, dental, and
craniofacial research, the NIDCR is uniquely positioned to fill those
gaps while continuing its efforts in the laboratory to develop new and
even more effective ways to prevent, diagnose, and treat dental
diseases. I would like to highlight over the next few minutes how the
NIDCR is sowing the clinical seeds of progress to advance evidence-
based dentistry in America and, above all, improve the nation's oral
health.
practice-based research networks
Healthcare providers sometimes comment that too often they are not
included as participants in research, noting that their clinical
experience and insight are significant assets to understand and address
patients' most pressing health concerns. I believe that there is much
to be gained from engaging clinical practitioners in research. That is
why the NIDCR recently established three regional practice-based
research networks (PBRNs) to investigate everyday issues in oral
healthcare.
Each PBRN involves 100 or more oral health practitioners who will
propose and conduct studies of common dental procedures across a range
of patient and clinical conditions. For example, some of the early
investigations will gather data on methods dentists use to restore
teeth with deep decay, and to assess caries risk. Each network will
conduct 15 to 20 clinical studies over the next seven years. The PBRNs
also will collect information to generate data on disease, treatment
trends, and the prevalence of less common oral conditions.
While the PBRNs aim high, their success will be rooted in their
focus on real-world clinical issues and their ability to generate
information that will be of immediate value to practitioners and
patients alike. The studies will involve topics and procedures that
clinicians themselves identify as relevant and in need of systematic
research to help guide clinical decisions. I believe the PBRNs have the
potential to generate a body of high quality clinical research data in
a relatively short period of time. Most importantly, their research
will substantially enhance the base of evidence clinicians can use to
inform treatment decisions, translate newer information into daily
practice, and directly affect and improve routine dental care.
greater emphasis on large clinical studies
The nation's progress against heart disease, cancer, and infectious
diseases has been accelerated by large clinical studies yielding
results that can be generalized and can clarify the interplay of many
variables. In dentistry, clinical research traditionally has involved
smaller studies with fewer participants. The NIDCR is changing this
trend by supporting larger clinical studies whose outcomes have the
potential to fundamentally change dental practice and improve public
health. I would like to tell you about some examples.
periodontal disease and preterm birth
In the United States, about one in eight babies is born
prematurely.\1\ Preterm babies can be so small and underdeveloped that
they must remain hospitalized for months and, if they survive, spend
years battling chronic health problems. This heartbreaking situation
has spurred scientists to identify risk factors associated with
premature births. Risk factors such as smoking, hypertension, and
diabetes allow doctors to identify women who are more likely to deliver
prematurely and to tailor their prenatal care. However, identification
of risk factors is a work in progress. One in four of preterm births
(more than 125,000 per year) occurs without any known explanation.\2\
Scientists have assembled an intriguing body of preliminary evidence to
suggest that women who have severe gum, or periodontal, disease during
pregnancy are at increased risk of preterm delivery. This raises the
question: Does treatment for periodontal disease during pregnancy help
women reach full term and give birth to healthy babies?
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\1\ Martin JA, Hamilton BE, et al. Births: Final data for 2003.
National vital statistics reports; vol. 54 no 2. Hyattsville, MD:
National Center for Health Statistics. 2005.
\2\ Offenbacher S, Katz V, et al. Periodontal infection as a
possible risk factor for preterm low birth weight. J Periodontol, vol.
67(10) p. 1103-13.
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The NIDCR is supporting the first large, controlled Phase III
clinical trials to answer this important public health question. Two
studies involve over 2,600 women of various racial, ethnic, and
economic backgrounds. The first, called the Obstetrics and Periodontal
Therapy (OPT) trial, will soon report its findings, providing for the
first time the clinical data needed to offer sound scientific advice on
this issue. The results of the second study, called the Maternal Oral
Therapy to Reduce Obstetric Risk (MOTOR) trial, should be forthcoming
next year.
better pain treatments for jaw condition
Temporomandibular joint and muscle disorder (TMJMD) is an umbrella
term for conditions affecting the area in and around the
temporomandibular joint, or TMJ. The TMJs connect the jaw to the skull.
Common symptoms of TMJMD include persistent pain in the jaw muscles,
restricted jaw movement, and jaw locking.
Although TMJ disorders vary in their duration and severity, for
some people the pain becomes severe and permanent. NIDCR recently
launched a large, seven-year clinical study to accelerate research on
better pain-control treatments for TMJMDs. The study, called Orofacial
Pain: Prospective Evaluation and Risk Assessment (OPPERA) will collect
data on 3,200 healthy volunteers for three to five years to see how
many develop TMJMD, opening a largely unexplored window from which to
observe the early stages of the disorder. With this unique vantage
point, they can gather data on key genetic, physiologic, and
psychological variables involved in TMJMD pain, ultimately weaving the
information into more effective treatments.
Only a decade ago, a large study tracking the development of TMJMD
over time would have been scientifically problematic, because little
was known about the basic mechanisms of human pain. However, because
progress in the basic sciences has fed the knowledge pipeline, pain
researchers have now better defined the molecular circuitry involved in
pain transmission, thereby providing the conceptual framework for this
important clinical study.
molecular medicine and oral cancer
In the fight against cancer, future weapons of choice likely will
fall within the therapeutic category of molecular medicine. The concept
builds on world-wide efforts to design cancer treatments targeting the
precise molecules that drive the tumor process, leaving normal cells
unscathed. As envisioned, molecular medicine will increase the benefits
of treatment and limit greatly the unwanted side effects that now
afflict cancer patients. For the vision to become reality, scientists
first must learn to correctly identify distinctive features of the
genetic and/or protein profiles of developing tumors. Much progress has
been made in the laboratory, but the promise of molecular diagnostics
remains largely unready for translation to patient care.
An NIDCR-supported project that has successfully taken that
critical step is a partnership between scientists, dental educators,
and a community clinic in British Columbia. The partners have
integrated molecular techniques with existing screening tools by
combining certain molecular discoveries with clinical use of toluidine
blue, a chemical dye used to determine whether or not to biopsy an
abnormal growth. The technique hinges on laboratory work that showed an
association in early oral lesions between toluidine blue retention and
the presence of cells with distinct, cancer-predisposing chromosomal
abnormalities. The program already has identified several people
requiring treatment for oral cancer and pre-cancerous lesions.
dry mouth and radiation therapy
Persistent dry mouth often occurs in head and neck cancer patients
because radiation from the therapy damages the salivary glands. This
irreversible, chronic dryness makes normal chewing and swallowing
difficult, and leads to a range of painful oral diseases. Recently,
NIDCR scientists teamed with researchers at the National Cancer
Institute to develop an important new lead in protecting the salivary
glands during radiation therapy to the head and neck. Their work
involves a synthetic chemical called Tempol, which possesses a unique
ability to protect cells against radiation. In mice, administration of
Tempol 10 minutes prior to radiation therapy to the head and neck
provided significant protection to the salivary glands. Critically,
Tempol did not protect tumors from radiation, and thus did not diminish
the beneficial effects of the radiation therapy. Future clinical trials
in people are likely.
reducing disparities in the nation's oral health
Although the Nation's oral health has improved greatly over the
past several decades, this progress has not been equally shared by
millions of low income and underserved Americans. To help reverse this
trend, the NIDCR supports five Centers for Research to Reduce Oral
Health Disparities. The centers are designed to explore, understand,
and improve the oral health of those who reside in underserved
communities. The researchers seek creative but practical approaches
that are inexpensive, can be easily applied, and are exportable to
other underserved communities.
This year, the Disparities Centers reported several noteworthy
findings. For example, after a two-year clinical study, San Francisco
researchers found that infants and small children who receive at least
one fluoride varnish treatment per year can cut their dental caries
rate in half. Fluoride varnish is a concentrated fluoride in a resin or
synthetic base that is applied directly onto the teeth. The treatment
is inexpensive and is more easily used with very small children than
other preventive measures, such as dental sealants and mouth rinses.
Meanwhile, the Disparities Center at the University of Washington
is evaluating the oral health benefits of gum and candy sweetened with
xylitol rather than caries-promoting sugars. Xylitol, a natural
substance found in certain fruits, has been shown to fight tooth decay.
The team is refining the optimal dose to satisfy taste and fight decay.
Xylitol use exemplifies an easily adopted, self-administered,
scientifically validated approach that may be useful in underserved
populations.
improving the nation's oral health
As these highlights demonstrate, the NIDCR has made a strong
commitment to expand clinical research and to build the evidence base
that will inform better clinical practice. At the same time, progress
in basic science continues to provide new and exciting leads that can
translate into large clinical trials, yielding results with the
potential to transform dentistry and public health. Above all, the
NIDCR seeks to find practical solutions to intractable problems and, in
so doing, improve the Nation's oral health.
______
Prepared Statement of Dr. Nora Volkow, Director, National Institute on
Drug Abuse
Mr. Chairman and Members of the Committee: I am pleased to present
the fiscal year 2007 President's budget request for the National
Institute on Drug Abuse (NIDA). The fiscal year 2007 budget estimate is
$994,829,000, a decrease of $5,200,000 from the fiscal year 2006
enacted level of $1,000,029,000, comparable for transfers proposed in
the President's request.
introduction
The National Institute on Drug Abuse, within the National
Institutes of Health (NIH), is once again pleased to report continuing
declines in overall drug use among our Nation's youth. NIDA has focused
much of its research on the vulnerable adolescent period of
development, since this is when drug abuse typically takes hold and can
bend a young life toward long-term drug abuse problems or addiction.
Research findings elucidating the mechanisms of action and destructive
consequences of drugs of abuse on the brain and body appear to be
getting through to this population. For example, the 2005 Monitoring
the Future (MTF) Survey of 8th, 10th, and 12th graders shows a dramatic
19 percent reduction in use since 2001. However, areas of significant
concern remain, including the alarmingly high rates of non-medical use
of painkillers among 12th graders, the high rates of stimulant abuse
among 12th graders, and the spread of methamphetamine abuse to new
geographic areas of the country.
Therefore, while we can acknowledge and appreciate the positive
effects of evidence-based prevention and treatment efforts, we also
recognize the need to keep pace with emergent problems. To this end,
ongoing support of leading edge research by NIDA scientists continues
to enhance innovative prevention and treatment interventions, while
collaborations with other Institutes and public and private partners
make optimal use of our research infrastructure.
prescription drug abuse--the problem with painkillers
According to the 2004 National Survey on Drug Use and Health,
nearly three-fourths of the estimated 6 million people aged 12 and
older who reported non-medical use of prescription psychoactive drugs
said they abuse pain relievers in particular, with young adults (18-25)
showing the greatest increases in lifetime use from 2002-2004. Even
younger populations are involved, revealed by findings from NIDA's 2005
MTF Survey.
NIDA is tackling this growing problem from multiple angles, seeking
to understand the factors that have brought us to this point so that we
may reverse negative trends and stop new ones from emerging. Underlying
factors include the fact that opioids are now among the most commonly
prescribed medications, that society is more accepting of using
medications to treat all kinds of health problems, and that the
Internet provides greater access to prescription drugs.
In response to these concerns, NIDA's new initiative on
prescription opioids and treatment of pain is soliciting a broad range
of preclinical and clinical studies from across the sciences. We will
examine the basic mechanisms involved in pain and how their interaction
with prescription painkillers influences addiction potential--for
example, whether opiates are equally addictive to an individual in pain
versus one who is not in pain. Research on the basic interactions
between pain and opioid systems is needed to inform physicians about
associated abuse risks and to guide their prescribing practices.
Other strategies for reducing prescription painkiller abuse include
developing alternative pain medications and promoting better delivery
systems for painkillers to minimize abuse potential. Recent studies
have identified a subset of cannabinoid receptors (i.e., CB2 receptors)
as promising new targets for treating chronic pain from nervous system
injury. In addition, because of their lack of activity in brain reward
centers and diminished abuse liability, novel CB2-based medications
present an attractive alternative for treating chronic pain.
Buprenorphine/naloxone, a recently approved medication for the
treatment of opioid addiction, represents another approach. Acting on
the same brain receptors as drugs like heroin and morphine,
buprenorphine does not produce the same high, physical dependence,
harsh withdrawal symptoms, or dangerous side effects. Further, its
unique formulation with naloxone, an opioid antagonist, produces severe
withdrawal symptoms in addicts who inject it to get high, thereby
lessening the likelihood of diversion while maintaining desired
therapeutic properties. NIDA is planning a multiple trial study to
evaluate the effectiveness of buprenorphine in the treatment of the
pain patient who is addicted to his/her pain medication and to help
develop guidelines on how to treat these types of patients.
genes, environment, and behavior
A person's individual genome, or genetic makeup, plays an important
role in determining his or her vulnerability to or protection against
addiction. Studies of heredity have shown that about 40-60 percent of
predisposition to substance abuse can be attributed to genetics, with
environment impacting how those genes function or are expressed.
Addiction is a quintessential gene-x-environment interaction disease:
that is, a person must be exposed to drugs (environment) to become
addicted, yet exposure alone is not determinative--genes interact with
this environment to create a vulnerability to addiction. Growing
knowledge about the dynamic interactions of genes with the environment
confirm addiction as a complex and chronic disease of the brain with
many contributors to its expression in individuals.
NIDA is studying these interactions to see what they reveal about
vulnerability to addiction and to other adverse effects of abused
drugs. For example, one recent study found that carriers of a common
variant of the COMT gene were more likely to exhibit psychotic symptoms
and to develop schizophreniform disorder if they used marijuana.
Thus, people with particular genes may suffer more harmful effects
from drugs of abuse.
To expedite the translation of findings that could help identify
the location of genes that confer vulnerability or protection, NIDA is
supporting innovative research to help design, develop, and market
technology to conduct rapid behavioral throughput screens for
identifying genetic vulnerability using animal models of drug abuse and
addiction. This information could then become part of a database of
candidate genes for drug abuse, for eventual mapping and for targeted
therapeutic application. Advances in genetics research in addiction are
already suggesting ways to tailor our interventions to have the
greatest impact. For example, a recent study showed that distinct
alleles of the dopamine receptor gene led to different outcomes
according to the type of smoking cessation therapy used--bupropion or
nicotine replacement therapy. Such findings provide a glimpse of a
future in which a patient's genetic background will be a major factor
in selecting the most appropriate therapeutic course of action.
Other NIDA studies are also helping to unravel the ways in which
environmental factors, such as stress, induce brain changes that
interact with drugs of abuse and alter behavior. It is well known that
stress is a major cause of relapse to drug abuse in recovering addicts
and can prompt the release of a neurochemical, corticotrophin releasing
factor (CRF). Recent research showed that in cocaine-exposed animals,
stress-induced CRF triggered drug-seeking behavior, even as long as 3
weeks after exposure. This research highlights the concept of
persistent brain changes leaving individuals vulnerable to certain
relapse triggers like stress. Moreover, stress may be common to a
variety of conditions, including depression, anxiety, and some forms of
overeating and obesity. By revealing the precise brain mechanisms
involved in stress, our research can lead to treatments that for these
conditions.
We are also learning how environmental factors not only alter the
expression but the structure of genes involved in brain function, which
then influences an individual's behavior. Known as ``epigenetics,''
this field gives researchers an opportunity to investigate gene-
environment interactions, including the deleterious changes to brain
circuits resulting from drug abuse. Understanding how drugs of abuse
effect epigenetic changes may help in developing interventions to
counter or prevent such changes. A recent study of demonstrated that
cocaine caused significant structural changes to the DNA in regions
containing genes implicated in shaping the brain's response to drugs of
abuse; furthermore, in animals genetically engineered to minimize those
changes, the rewarding effects of cocaine were dramatically reduced.
These results show how gene-environment interactions can change the
brain and drive behaviors associated with drug addiction. NIDA is
supporting innovative research to help design, develop, and market
technology to conduct rapid behavioral throughput screens for
identifying gene/environment interactions.
social neuroscience
NIDA is targeting the influence of social factors both in
individual and group decision-making. This focus is critical not just
to understanding drugs of abuse but other health behaviors as well. For
instance, a social neurobiological perspective is being applied in NIDA
studies investigating the mechanisms underlying adolescents' increased
sensitivity to social influences (i.e., peers) and decreased
sensitivity to negative consequences of their behavior that together
make them particularly vulnerable to drug abuse.
A recent NIDA request for research in the emerging field of social
neuroscience is soliciting studies from basic to clinical science as we
work to examine how neurobiology and the social environment interact in
abuse and addiction processes (e.g., initiation, maintenance, relapse,
and treatment). We now have the tools to see how genetics, epigenetics,
and brain chemistry can change social behavior and how the social
interactions of an individual can change his or her brain. For example,
studies of early maternal behavior in animals demonstrated that
offspring receiving low levels of care during their first week of life
developed an over-responsive stress system that lasted a lifetime. In
this case, genes responsible for regulating stress responses were
``silenced'' by environmental manipulation. Some of these changes can
be reversed in adulthood by targeted intervention, making this research
area ripe for developing approaches to counteract the effects of
adverse environmental impacts, which in the case of stress are known to
increase the risks for substance abuse.
We are also committed to efforts to better characterize
``phenotypes'' of social environments and to understand their
interaction with other vulnerabilities, such as genetics. One approach
could include strategies such as mapping community risk factors for
drug use (e.g., parental practices, family structure, school systems,
socio-economic status, neighborhood characteristics, and drug
availability) and to use that knowledge to inform us about mediators of
the social stressors that elevate risk for drug abuse. A better
understanding of this relationship is relevant both for the treatment
of drug addiction and for psychotherapeutic interventions for mental
illnesses, which also involve social aspects of human behavior.
drug addiction treatment works
NIDA's research findings have demonstrated that drug addiction
treatment works. Moreover, comprehensive treatments (i.e., those that
include a combination of available medications, behavioral treatments,
and job training and referral services) tailored to the needs of the
individual patient have the highest success rates. We continue to work
with the private sector to develop medications to use with behavioral
therapies to treat drug addiction, and are pursuing collaborations with
pharmaceutical companies to move novel and promising compounds forward
to clinical evaluation. In addition, NIDA's initiative focusing on
pilot clinical trials of new addiction medications will invigorate the
field by helping investigators generate sufficient safety and efficacy
data to support full-scale clinical trials and expedite the possible
progression of novel medications to real-world use.
Over the past year, we have made great progress in identifying
potential medications for treating drug addiction, including addiction
to stimulants such as cocaine and methamphetamine. Several promising
compounds have been identified in animal studies, and initial clinical
efficacy for drug abuse has been demonstrated for medications marketed
for other uses: disulfiram, prescribed for alcoholism; modafinil, for
treatment of narcolepsy; and gamma-vinyl GABA (not marketed in the
United States) and topiramate, both used to treat seizure disorders.
Progress is also being made in the area of vaccine development for
cocaine and nicotine addiction, and Rimonabant, a cannabinoid receptor
blocker is a promising candidate for treating marijuana addiction.
Close to being approved for marketing by the pharmaceutical industry as
a weight loss aid, Rimonabant may also have the potential to prevent
relapse to cocaine, heroin, and methamphetamine abuse, and nicotine
addiction. Marinol, another cannabinoid receptor agonist, may also show
promise as a treatment for marijuana withdrawal symptoms.
Interventions are also needed to treat comorbid mental disorders
and addiction. For example, given that an estimated 15-30 percent of
patients with substance abuse problems also suffer from comorbid ADHD,
as found in research studies, NIDA has launched a large clinical study
in our Clinical Trials Network (CTN) to test whether treatment of ADHD
with methylphenidate, in parallel with treatment for substance abuse,
will improve outcomes in those who suffer from both conditions.
We are also developing drug abuse treatments for use in the
criminal justice system. Our research findings show that drug treatment
works even for people who enter it under legal mandate, with outcomes
as favorable as for those who enter treatment voluntarily. To
illustrate, in a Delaware Work Release study sponsored by NIDA, those
who participated in prison-based treatment followed by aftercare were
seven times more likely to be free of drugs after 3 years than those
who received no treatment. Moreover, nearly 70 percent of those in the
comprehensive drug treatment group remained arrest-free after 3 years--
compared to only 30 percent in the no-treatment group. We are helping
to integrate drug treatment into the criminal justice system and
improve outcomes for offenders through our comprehensive Criminal
Justice Drug Abuse Treatment Studies (CJ-DATS) initiative, undertaken
in collaboration with Federal, state, and local criminal justice
partners.
NIDA research has demonstrated the value of drug addiction
treatment programs in helping patients recover from the complex disease
of addiction. Faith-based and community-centered programs are often
part of long-term recovery, yet their effectiveness and role in
delivering treatment needs to be studied more extensively. NIDA is
conducting research to examine this role.
hiv/aids and minority disparities
The latest data from the Centers for Disease Control and Prevention
(CDC) suggest that the HIV/AIDS epidemic is evolving, with drug abuse
still a major vector in its spread. Progress in treating injection drug
abuse has helped to decrease HIV transmission among this highly
vulnerable population, influenced by a multi-pronged approach including
community-based outreach to reduce risky behaviors and development of
medications such as methadone and buprenorphine to treat injecting drug
users. But while this approach has helped reduce U.S. cases from this
route of transmission, other countries, such as Russia and Southeast
Asia, continue to report that injection drug abuse accounts for a large
proportion of their HIV/AIDS cases. Thus NIDA is supporting
international studies to promote HIV prevention practices and use of
medications to treat drug addiction. Depot-Naltrexone is one such
possibility, since it is a long-acting opioid antagonist medication
expected to soon receive approval for treatment of alcohol addiction.
Because efforts to decrease drug abuse also modify the behaviors that
can lead to HIV transmission, we believe strongly that drug abuse
treatment is HIV prevention.
Early detection of HIV helps prevent HIV transmission and increase
health and longevity. NIDA-supported research indicates that routine
HIV screening, even among populations with prevalence rates as low as 1
percent, is as cost effective as screening for other conditions such as
breast cancer and high blood pressure. These findings have important
public health implications, but require efforts to increase HIV
screening acceptability (similar to mammography) in order to be
effective.
We are also deeply concerned about the disproportionate impact of
HIV/AIDS on African Americans. For while they represent just 13 percent
of the U.S. population, African Americans account for 42 percent of
AIDS cases diagnosed since the start of the epidemic, according to CDC.
In fact, data from the CDC's National Vital Statistics Report published
in 2003 show that HIV/AIDS is the leading cause of death among all
African Americans 25-44 years old, ahead of heart disease, accidents,
cancer, and homicide.
To address these disparities, NIDA is encouraging research on the
nexus of drug abuse and HIV/AIDS among African Americans to understand
the risk factors and the pathways between them and to develop
culturally sensitive prevention and treatment programs for drug abuse
and HIV/AIDS. We are committed to making sure this research is
translated in a meaningful way.
from bench to bedside to community
NIDA is proud of our myriad efforts to translate the results of our
basic and clinical research on the brain and body effects, getting new
treatments into the hands of providers who will use them, disseminating
prevention messages to people who will hear them, and raising the
awareness of people who can help change the course of drug abuse
treatment in this country. Our audiences are many and include
physicians, teens, teachers, judges, parents, and others.
Through our physician outreach initiative, we are funding efforts
to develop strategies for primary care physicians to better identify
and serve drug abusing patients through use of science-based screening
and brief interventions. We are also supporting development of a pilot
judicial training curriculum in Cook County, Illinois, to help criminal
court judges understand the neurobiology of addiction and the
effectiveness of treatment. The goal of this program is to better
inform judicial decision-making with regard to substance-abusing
offenders. These efforts will be applied to the Federal court system as
well. We also support grants to evaluate results from drug courts to
achieve optimal dissemination and improve outcomes, and we will soon
publish a book of treatment principles for application with individuals
involved in the criminal justice system.
Our education portfolio continues to grow and includes a wealth of
materials, such as our NIDA Goes Back to School Initiative, a science
education campaign to provide middle school students with information
about how drugs work in the brain. An interactive website complements
this effort, allowing students and teachers to easily obtain additional
information about drugs of abuse. To help young people understand the
risks of drug abuse leading to HIV infection, NIDA and our partnering
organizations--including the American Academy of Child and Adolescent
Psychiatry, the AIDS Alliance for Children, Youth, and Families, and
the United Negro College Fund Special Programs Corporation--recently
launched a multimedia educational campaign, including a public service
announcement and website, to help young people ``learn the link''
between drug abuse and HIV infection. We are translating these
materials into Spanish and making them culturally relevant for
different populations.
We are also collaborating with our sister agency, the Substance
Abuse and Mental Health Services Administration (SAMHSA) and with the
National Institute of Mental Health on a new initiative to enhance the
capacity of community-based providers of drug abuse treatment services.
We continue to work with SAMHSA, supporting the development and
dissemination of research-based products through their Addiction
Technology Transfer Centers across the country, applying findings from
our Clinical Trials Network and other research. And because addictive,
psychiatric, and neurological disorders emerge from common neural
substrates, a tremendous amount of inter-Institute collaboration has
taken place--an approach we will continue to emphasize, given its
ability to produce sharable findings and cost efficiencies.
conclusion
Our investment in basic and clinical research has changed the way
people view drug abuse and addiction in this country. We now know how
drugs work in the brain, their health consequences, how to treat people
already addicted, and what constitutes effective prevention strategies.
As science advances, NIDA's comprehensive research portfolio is
strategically positioned to capitalize on new opportunities. We
continue to make great strides in translating and disseminating the
products of our research, so they can be used in real communities by
people who need them, providing front-line clinicians around the
country with the tools needed to reduce drug abuse and addiction in our
Nation. To make the most of scarce resources, we depend on a rigorous
planning and priority-setting process that not only supports our strong
commitment to reducing drug abuse and HIV transmission in this country,
but extends to other health fields represented by NIH. Sustaining the
momentum of our efforts will lead to even more discoveries that will
improve the health and safety of all Americans.
Thank you, Mr. Chairman. I will be pleased to answer any questions
the Committee may have.
IMPACT OF BUDGET CUTS
Senator Specter. We will now proceed with questioning by
the Senators, 5 minutes each.
Dr. Zerhouni, you say you will continue to deliver. How is
that possible when you have had more than a 10 percent
decrease, considering inflation, which amounts to about $3
billion? The comments that I hear relate to there being a
panic, panic among the applicants for NIH research. How can you
continue to deliver with that kind of a budget?
Dr. Zerhouni. It is very important to realize that medical
research cannot be funded through ups and down. We have to
sustain the investment over time, and it is clear that medical
research requires support for scientists. What is happening
right now is that through the doubling we have generated a new
generation of scientists. We have over a 50 percent increase in
the number of scientists.
Senator Specter. What is the consequence of the cut?
Dr. Zerhouni. The consequence of the cut is very simple. If
you keep investing below and lose purchasing power, the most
important impact on research is loss of scientists. This is
what we have seen in the past and this is what may happen again
if we do not sustain our investment in medical research.
PREPAREDNESS FOR PANDEMIC INFLUENZA
Senator Specter. Dr. Fauci, there is a great concern, as we
all know, about pandemic influenza. This subcommittee has held
a series of hearings on the subject. How are we doing? What are
the prospects for being prepared if that wave should strike us
in the United States?
Dr. Fauci. From the standpoint of the scientific
preparation for developing vaccines and drugs, from the last
time I testified before you, Mr. Chairman, which was just a
couple of months ago, we have made even more progress. We have,
as you know, as Dr. Zerhouni alluded to, we have a vaccine that
is currently in clinical trial in different age groups and
demographic groups. We have tested it and published the results
in healthy young adults. We have tested it in the elderly and
in children. As I mentioned to you at the last hearing, the
vaccine appears to be very well tolerated and induces an immune
response that would be predictive of being protective.
There is a big problem with it, though. The problem relates
to the fact that the dose that is required to induce the level
of immunity that you would predict would be protective is
prohibitively high, which is leading us to the studies that are
ongoing now, namely the use of what we call adjuvants, or
compounds which expand the capability of the immune system to
respond. Those studies are ongoing right now.
FUNDING FOR PANDEMIC INFLUENZA
Senator Specter. Is the funding adequate?
Dr. Fauci. We could do more with more funding, there is no
doubt about that. I would be----
Senator Specter. How much do you need?
Dr. Fauci. It is difficult to put a number on it, except to
say that----
Senator Specter. Well, if you cannot put a number on it, we
cannot.
Dr. Fauci. Well, we need--for example, if I could bring one
component up that I think would be of interest to this
committee, is that we are currently pursuing rather
aggressively the concept of what we call a universal influenza
vaccine, namely a vaccine that cross-reacts from season to
season and would also be protective against the pandemic flu.
Senator Specter. Dr. Fauci, I am reluctant to cut off a
witness with your distinctive record. Give us in writing what
funding you need.
Dr. Fauci. Okay, I could do that for you.
[The information follows:]
Funding for Pandemic Influenza
The National Institute of Allergy and Infectious Diseases (NIAID)
supports a robust and diverse portfolio of research on influenza,
including pandemic influenza. Many opportunities to accelerate the
research and development of medical countermeasures against influenza
as well as to advance our understanding of influenza viruses could be
pursued in fiscal year 2007 and fiscal year 2008 should additional
funds become available. In its professional judgment that is outside
the context of other competing priorities, NIAID estimates that it
could obligate an additional $212 million in influenza research in
fiscal year 2007 above the budget request and an additional $458
million in fiscal year 2008.
NIAID could use such funds to accelerate research and development
of antiviral drugs, vaccines, adjuvants, and diagnostics for influenza.
For example, NIAID could accelerate the development and clinical
testing of promising universal vaccine candidates, which could offer
protection against multiple influenza virus strains, and the
development of new and improved vaccine strategies for influenza such
as recombinant subunit vaccines and gene-based vaccines that may allow
for more rapid production of a vaccine against a pandemic strain of
influenza, should one emerge. These additional funds also could
facilitate the expansion of critical research resources, such as animal
models and clinical trials infrastructure that are essential for the
development of medical countermeasures against influenza.
Underpinning efforts to develop medical interventions against
pandemic influenza is research into the basic biology and disease-
causing mechanisms of influenza viruses. With additional funding, NIAID
could expand basic research in the areas of influenza virology,
pathogenesis, epidemiology, immunology, genomics, proteomics, and
systems biology as well as to expand international animal surveillance
activities. This research is crucial to the development of antiviral
drugs, vaccines, and diagnostics for influenza.
CANCER GENOME ATLAS
Senator Specter. Let me turn now to Dr. Niederhuber with
respect to the cancer-genomics initiative. Can that be
implemented with the current funding? What do we need to
successfully prosecute the war against cancer?
Dr. Niederhuber. Well, Senator Specter, thank you. We are
very committed, the National Cancer Institute, with our
partner, the National Human Genome Research Institute, to
initiate a pilot project on the Cancer Genome Atlas. Each
Institute has committed $50 million from our existing resources
to do that. This will be a pilot project which is helping us
understand the technology needs, the technology advancements,
and our ability to do this project.
Senator Specter. Dr. Niederhuber, would you supplement your
testimony today with a memorandum as to what you need as to
that program and as to the war on cancer overall?
Dr. Niederhuber. Absolutely, sir.
Senator Specter. Give us a winning strategy for that war?
Dr. Niederhuber. Absolutely.
[The information follows:]
Cancer Genome Atlas
The Cancer Genome Atlas program is the product of several years of
investment by the NCI in the Cancer Genome Anatomy Project (C-GAP) and
other large scale genomics programs, some of which were performed in
collaboration with the NHGRI. These efforts culminated in 2003 with a
report from the NCI's National Cancer Advisory Board (NCAB) which
recommended that the two Institutes undertake a pilot program to
determine the feasibility of systematically developing an ``atlas'' of
all genetic alterations involved in cancer.
Active planning for The Cancer Genome Atlas, or TCGA, began in the
latter half of 2002 as a consequence of progress and convergence of
science and advanced technologies in three distinct areas. First, the
completion of the sequencing of the human genome provided for the first
time in history a benchmark to begin to understand the effect of
genetic changes on the etiology and progression of diseases such as
cancer. Second, our years of investment in understanding cancer at the
molecular level resulted in the discovery of some very important
genetic changes in cancer cells that led to the development of targeted
drugs such as Gleevec and Herceptin. Based on an understanding of the
specific genetic alterations driving specific tumors, these targeted
drugs allowed oncologists for the first time to target specific genetic
alterations in patients with chronic myelogenous leukemia (CML) and
breast cancer, respectively. Finally, the pace of technology
development in analyzing all aspects of genes and their products is
accelerating--setting the stage for large scale interrogation of the
genome to understand the role of genetic mutation in diseases such as
cancer. Interestingly, one of the major requirements for this project
is the development of an unprecedented data management system and
ultimately an accompanying database; NCI's investment in the Cancer
Bioinformatics Grid (caBIG) over the past several years provides the
advanced technology platform needed to meet this need.
Cancer is a disease of changes in genes that occur over an
individual's lifetime. Three kinds of genetic alterations contribute to
cancer--those that occur in the DNA of egg or sperm and are passed from
a parent to offspring (germline mutations), those that occur as a
result of exposure to the environment (somatic mutations) and changes
in DNA that lead to changes in genes that control proteins involved in
transcription and translation. Additionally, changes in gene function
can occur without a change in the sequence of DNA (epigenetic changes).
TCGA will finally facilitate an in-depth understanding of how these
types of genetic changes differ in terms of their role in an
individual's inherited risk vs. those changes that arise from
environmental exposure. It is the latter category of mutations that
will allow scientists to obtain a clear picture of the impact of these
somatic mutations on the major pathways that appear to drive many of
the major hallmarks of cancer cells. Overall, the TCGA pilot project,
much like the Human Genome Project, has the potential to create an
unparalleled knowledge base, drive a new era of discovery by scientists
from all fields of biomedical research and ultimately provide a new
paradigm for the prevention, detection and treatment of chronic
diseases such a cancer.
The NCI and NHGRI believe strongly that TCGA is one of the most
important projects undertaken in medicine to date. It leverages all
that has gone before and for the first time will allow scientists to
apply our understanding of the human genome sequence to cancer--a
disease that will strike over 1.4 million Americans this year and kill
over 560,000 at a cost of well over $190 billion. We are committed to
getting this project underway within current budget constraints. The
NCI has identified funds for redeployment from other projects, and the
NHGRI will dedicate a large portion of its sequencing capacity to
performing this first-ever large scale effort in medical sequencing.
The information generated by the TCGA pilot project will provide
the necessary scientific data by which the Institutes and the
scientific community can evaluate the preliminary outcomes of the
research.
The convergence of our understanding of cancer at the molecular
level, advanced genome analysis technologies, especially
bioinformatics, and experience gained in the Human Genome Project,
allow us to now undertake TCGA, a project that promises to contribute
significantly to the development of 21st century medicine. Both the NCI
and the NHGRI are committed to leveraging these strengths to ensure
that we move forward toward our goal of personalized medicine for
cancer and all diseases.
a winning strategy against cancer
NCI has developed a Strategic Plan to reduce and eliminate the
suffering and death due to cancer with the help of the scientific
community. The Plan sets forth a framework within which NCI can use its
funding, infrastructure, tools, and intellectual resources to lead and
work with others. We set forth eight strategic objectives in the Plan
and these will be instrumental in guiding our operational level plans
and serve as an organizer for measuring and reporting progress. A
complete description of the Strategic Plan can be found on NCI's web
site at http://www.cancer.gov/aboutnci/2015.
There are two basic tactics--preempting cancer and ensuring the
best outcomes for all--embodied in the Plan's objectives.
To preempt cancer at every opportunity, there are four strategic
objectives:
--Understand the causes and mechanisms of cancer;
--Accelerate progress in cancer prevention;
--Improve early detection and diagnosis; and
--Develop effective and efficient treatments.
To ensure the best outcomes for all, there are four strategic
objectives:
--Understand the factors that influence cancer outcomes;
--Improve the quality of cancer care;
--Improve the quality of life for cancer patients, survivors, and
their families; and
--Overcome cancer health disparities.
To achieve these objectives requires numerous funding vehicles and
support mechanisms throughout the cancer research community. The steps
we could take in order to accelerate progress to eliminate the
suffering and death due to cancer include:
--Rapid development of an integrated technology initiative;
--Deployment of a modern integrated clinical trials infrastructure;
--Expansion and integration of the Cancer Centers program; and
--Mechanisms and Flexibilities--streamlined procurement and review
processes to acquire materials and services and coordination of
licensing and patenting activities.
An integrated advanced technology initiative for cancer could
provide a linkage between the National Cancer Program and R&D
initiatives being developed in selected national laboratories and
advanced technology facilities located in more than 40 states and
regions. Connected in real-time through a common bioinformatics grid,
forming a ``network of networks'' of science, technology, and
treatment, such an initiative could serve to accelerate the emerging
discipline of molecular oncology. This would create a pipeline of new
personalized cancer diagnostics and therapeutics from bench concept to
bedside and community delivery. In the next few years, such an
initiative could:
--Accelerate the implementation of a nationwide high-end information
technology grid for bioinformatics that could be uniquely
adapted for real-time data sharing. NCI's pilot version, called
caBIG, is slated for full-scale implementation this year and,
during the pilot phase, was implemented among 50 Cancer
Centers, FDA, and other organizations.
--Develop a comprehensive biomarker discovery and validation program.
--Foster the application of emerging technologies, such as
nanotechnology, and integrate molecular agents with advanced
imaging devices.
--Accelerate a nationwide real-time medical information electronic
system for research and medical data sharing using technologies
and devices currently employed by the banking industry and
large-scale commercial enterprises.
--Enhance the discovery and validation of new targets of genes and
proteins critical to cancer development.
NCI could deploy a more modern and integrated infrastructure for
cancer clinical trials. This clinical research infrastructure could:
--Strengthen collaborations with industry, FDA, Centers for Medicare
and Medicaid Services, and other public, private, academic, and
patient advocacy organizations to oversee the conduct of cancer
clinical trials.
--Develop new infrastructure and procedures to standardize,
coordinate, and track clinical trials development and accrual
across all NCI-supported clinical trials.
--Increase utilization of imaging tools in screening and therapy
trials, evaluate new imaging probes and methodologies, enable
access to the imaging data from trials in an electronic format,
and facilitate evaluation of image-guided interventions.
--Expand access and improve the timeliness for completion of the
highest priority clinical studies.
--Foster the development of a cadre of established clinical
investigators who could work between bench and bedside.
--Pilot new approaches and develop prototypes for clinical trials
networks that could improve the efficiency, coordination, and
integration of our national efforts.
--Develop a common clinical trials informatics platform that could be
made available to the full range of investigators working
within the cancer clinical trials system.
NCI plans to accelerate the expansion and integration of the NCI-
designated Cancer Centers program, including the addition of 14 new
Cancer Centers, increasing the number of centers to 75. The Cancer
Centers program could:
--Implement progressive bioinformatics and communication systems to
achieve horizontal integration.
--Fund additive programs in collaborative, multidisciplinary
research, and require integration and sharing of results.
--Broaden the geographic impact of the centers, networks, and
consortia and vertically integrate them with community and
regional health care delivery systems.
--Improve the access of minority and underserved populations to
state-of-the-art research and resources.
--Create and strengthen partnerships with government agencies and
community organizations.
--Broadly provide expertise and other resources to caregivers,
patients and families, and appropriate health agencies.
In addition to appropriations, flexible legislative authorities
related to exemptions from specific parts of current procurement, grant
review and processing, and licensing and patenting rules could also
help accelerate progress. A streamlined procurement process could
facilitate the acquisition of materials and services to support the R&D
activities. Technology development could also be enhanced by sufficient
flexibility and integration to enable interactions among a wide array
of laboratories and other entities. Expedited review procedures and
workflow processing could help to award funds in sequence as needed.
Coordination of the licensing and patenting activities among grantees,
contractors, and the intramural program could also be useful for many
of the multicomponent technology platforms that could be created
through an advanced technology effort.
WOMEN'S HEART DISEASE
Senator Specter. Let me turn now to Dr. Nabel. What have
the results been with the Women's Health Study? With respect to
heart disease, we know that women are affected differently. I
want the record to note that my question ends with no red
light, but you can proceed.
Dr. Nabel. Thank you, Mr. Chairman.
The women's health initiative was an important study
conducted over 15 years with 161,000 women in this country ages
50 to 79 participating. We gathered important information about
heart disease, the number one killer of women in this country.
From other studies, we realize that heart disease often
manifests itself in women differently than men. We have come to
recognize what those symptoms are. We have come to recognize
that some of the diagnostic tests have to be different and we
have come to recognize that some of the treatments have to be
specifically focused towards women.
These studies have given us a tremendous amount of
information. We now have engaged in a very large public
awareness education campaign and we are in the midst of helping
women to understand what their risks are for heart disease and
how to seek help when they need it.
Senator Specter. Thank you.
Senator Harkin.
NATIONAL CHILDREN'S STUDY
Senator Harkin. Thank you, Mr. Chairman.
Dr. Zerhouni, of all the proposed cuts in the budget there
is one that I think may be discouraging than all the rest, and
that is the planned elimination of the National Children's
Study. We passed this legislation back in 2000. It was going to
be the largest long-term study of children's health ever
conducted in the United States. It was going to involve 100,000
children from before birth to adulthood. The idea was to better
understand the link between the environments where the children
are raised and their physical and emotional health and
development.
We have already spent about $50 million planning the study,
4 to 5 years of planning on it. Now I understand that the study
is going to stop. Why is that?
Dr. Zerhouni. Well, the study has had a pilot phase to
evaluate feasibility. The issue really is, you are talking
about a very long study with a large budgetary impact, and at
the end it was just a matter of budgetary priorities which led
to the decision of not completing the pilots at this time, but
to look at other times when the budgets will be easier.
Senator Harkin. I understand that the budgetary impact was
$70 million. Is that correct or not?
Dr. Zerhouni. If you look at--the $70 million is not just a
1-year expenditure. In fact, you have to continue that
expenditure. If you committed to that expenditure, Senator,
then you have committed to the $3.2 billion or thereabouts
total over the total study. Why? Because once you launch the
study you have to continue recruitment of the 100,000 children,
the parents, and so on.
So if you look on the screen that tries to describe the
evolution, it is $69 million in 2007, $111 million in 2008,
$192 million, $194 million, and so on. So this is what led to
the budgetary conclusion for these tight fiscal times.
Committing to 2007 meant not just 2007, but a whole series of
budgetary commitments, and in the context of projections it was
very hard to see how it would fit in.
WOMEN'S HEALTH INITIATIVE
Senator Harkin. Well, as you know, it was supposed to start
by the end of this fiscal year.
Dr. Nabel, how long was the women's health initiative
study?
Dr. Nabel. 15 years, Mr. Senator.
Senator Harkin. 15 years.
Dr. Nabel. Yes.
Senator Harkin. Obviously, we got a lot of good information
out of it.
Dr. Nabel. We sure did.
Senator Harkin. What did that cost, do you know?
Dr. Nabel. In total, about $710 million.
Senator Harkin. For the 15 years. How many women did it
cover?
Dr. Nabel. 161,000 women.
Senator Harkin. This is 100,000 children and it was
supposed to be how many years study? About 20----
Dr. Zerhouni. 21 plus 4, so about 25 years, and about $3.2
billion is the number I remember, but upwards of that.
Senator Harkin. Well, it seems to me from the women's
health initiative we learned the benefits of long-term studies,
long-term longitudinal studies. It seems to me with everything
that is impacting on obesity, to diabetes to mental health,
kids and how they grow up, there is just a lot of things that
need to be taken into account. If you do these studies, then
you would be able to factor some of these things in after a
longer period of time.
I just find this very disturbing that we are cutting this
program. I am hopeful that we can put this back in the budget.
Maybe this is another result of the President's budget. I do
not know. Is that what it is? I am just asking it rhetorically.
I do not expect an answer, but I am just asking this
rhetorically. If that is what it is, then we have got to find
the money to put back in there.
This did not just come up. This is something that we had
talked about for a long time with your predecessor and others,
about getting this very long-term study done. We just assumed,
at least I did anyway, that it was on track and that we were
going to do it, and all of a sudden this year it pops up and it
is going to be eliminated. EPA was coming in on the study, I
think, also CDC was also going to partner in the study, if I am
not mistaken.
Dr. Zerhouni. No, you are not mistaken, Senator. It was a
trans-governmental study. It was not just an NIH study. It
really involved 14 different departments. Environmental health
was important, genetic health was important. Education was
involved as well. So 14 Federal agencies were involved.
Senator Harkin. Well, I am just wondering what kind of a
priority would this be in the scheme of things. Is this just
something that we can just drop out the bottom, or is this
really an important study to be done? Is it important or not?
Dr. Zerhouni. So the issue is really an issue of
prioritization, and you have a pilot phase study so we can
evaluate whether or not to go forward. But you mentioned
yourself the critical factor of sustaining success rates, and
so in the context of those decisions you can see where, in a
constant sum budget, studies like this will have a large impact
on success rates across the board. Therefore, when you look at
the investments that medical schools and others have made over
the doubling period, what we are seeing is a large increase in
demand for grants at the time when the supply for grants is
sort of flattening.
So the real tension right now is, how do you sustain a
vibrant research enterprise across the board and at the same
time look at issues like this one, which is a very valid issue
to look at? That is what the tension is and that is where the
budgetary decisions came up.
Senator Harkin. Thank you, Dr. Zerhouni.
Thank you, Mr. Chairman.
Senator Specter. Thank you very much, Senator Harkin.
Senator Shelby.
AUTOIMMUNE DISEASES
Senator Shelby. Thank you, Mr. Chairman.
I want to, doctor, focus on the area of autoimmune,
specifically lupus. It is estimated that 1.5 million Americans
suffer from lupus. Ninety percent of those being diagnosed are
women. This is a terribly painful disease, as you well know. It
has been about 40 years, it is my understanding, since a new
drug has been developed and approved for treatment of lupus. Is
there any hope in sight for new treatment, because this is in
the area, as I understand it, of autoimmune, in which you do a
lot of research?
So how do we--first, what do you see down the road there?
Dr. Zerhouni. This is an excellent, excellent question, in
a field of research, autoimmune disease, that affects 5 to 8
percent of Americans. It is not just lupus, Senator.
Senator Shelby. It is all autoimmune, is it not?
Dr. Zerhouni. Right, it is all autoimmune. It is a whole
category of diseases that we are now beginning to understand.
Breakthroughs over the past year indicate that we may have
actually developed technologies where we could develop--we
could detect years before the disease really starts the markers
of the disease and maybe intervene earlier.
What I would like to do is ask my colleague Dr. Fauci, who
is the Director of the National Institute of Allergy and
Infectious Diseases, who has a lot of knowledge in autoimmune
diseases, to perhaps address some of that.
Senator Shelby. That would be good. Thank you, doctor.
Dr. Fauci. Thank you, Dr. Zerhouni.
Senator Shelby, there are some very promising areas in the
whole arena of autoimmune diseases. There is still a long way
to go, but, very briefly, as Dr. Zerhouni mentioned in his
opening statement, it falls within that area of predictive and
ultimately preemptive and preventive, in the sense that we now
are developing rapidly, not only with lupus, much more
sensitive diagnostic tests that can give you a feel for the
ultimate evolution of an autoimmune disease.
One among many therapeutic modalities that I would just
submit for your consideration that we are very excited about is
the whole area of what is called immune tolerance. Immune
tolerance means that you manipulate the immune system to get it
to not respond to a particular antigen. In other words, you
tolerize it to it.
This has been something that has been very exciting in
animal studies. Now, with a network involving multiple
institutes within the NIH, the immune tolerance network, we
have been able to tolerize the body against rejecting
transplanted organs. We found very rapidly that that can be
applied to diseases of autoimmunity.
PREDNISONE
Senator Shelby. Is that what Prednisone does?
Dr. Fauci. Well, Prednisone is a drug that dampens globally
the immune system. But we are talking about when we talk about
tolerance, specifically training the body either not to reject
an organ that is transplanted or not to respond to tissues that
are self tissues. Patients should not respond to self antigens,
but for reasons that relate to genetic, environmental, and
other factors, they inappropriately react against their own
tissues.
So now we try to tolerize them and dampen the immune
response only specifically for the particular tissue that they
are attacking, not general immunosuppression, because one of
the real problems with treating any autoimmune disease, if you
induce a global immunosuppression you have a lot of
complications that relate to immunosuppressive therapy, much
the way cancer patients have complications related to
chemotherapy.
LUPUS
Senator Shelby. What could you say to the 1.5 million or
more lupus sufferers out there right now in the pipeline?
Dr. Zerhouni. Well, if I may, Dr. Fauci, I would like to
show you the evolution of our investments in lupus research.
What I want to tell you is that there is really hope
because, one, we have made advances in genomics that allow us
to now identify some genetic factors in patients with lupus.
Two, we really understand the immune response very specifically
and we believe that the T-cells that respond in lupus may be a
target for treatments. We also have research that suggests that
perhaps a viral connection exists as well.
So over the past 2 years, 3 years, there has been a
multiplication of new ideas thanks to the doubling and many
people looking at it. What we intend to do is sustain it. We
have ideas of how to in fact focus on autoimmune diseases
across NIH and do the basic research across all institutes that
will serve every one of these diseases.
So, Senator, it is a difficult disease. It is not an easy
disease. If you have known anyone with lupus----
Senator Shelby. My wife.
Dr. Zerhouni. I am sorry, Senator. I did not know about
that. It is something that we really care about.
Senator Shelby. Thank you very much.
Mr. Chairman, thank you.
PROGRAM FUNDING
Senator Specter. Thank you, Senator Shelby.
Obviously, we would like to have a lot more time to go into
greater detail on many subjects. But what we would appreciate
your doing is giving us a supplemental memorandum as to what
the cuts will mean for your ongoing programs. I would like to
share that with all of our colleagues in the House. Second,
what it would take to adequately fund the issues you are
working on and what you could accomplish with the figure you
put on as being adequate.
Dr. Zerhouni, your statistics are very impressive and the
showing of a trillion dollars in savings compared to a modest
investment, that is the kind of things Congress needs to hear.
That is the kind of things which impresses the Congress.
[The information follows:]
Program Funding
Within the context of a deficit-reduction budget, the President's
Budget request had to weigh many competing priorities, and still
proposed to hold spending for NIH at a straightlined level for fiscal
year 2007. In fiscal year 2006, NIH reduced all noncompeting Research
Project Grant (RPG) awards by -2.35 percent, and the average cost of
competing RPGs was held at the fiscal year 2005 level. The fiscal year
2007 President's Budget Request provides no inflationary increases for
noncompeting continuation awards and holds the average cost of
competing RPGs to the fiscal year 2006 level, which could lead to an
erosion of the research buying power of NIH research projects. Within
its available funds, however, NIH is supporting the highest priority
research activities, including making strategic investments in
biodefense, the NIH Roadmap, a new program for new investigators, and
the Clinical and Translational Sciences Award program.
If additional funds were available above these priorities, such as
an increase for fiscal year 2007 above the Biomedical Research and
Development Price Index inflator of 3.8 percent, NIH would be able
restore the buying power of its research program, and fund additional
projects, from basic, translational, and clinical research to
therapeutic development and advanced technologies. All of these
activities could serve to advance our understanding of the mechanisms
underlying human health and disease and contribute to improving human
health. Examples of projects that were not funded in the President's
Budget Request, but could be undertaken are as follows:
Large-scale Genome Study for Serious Mental Disorders.--This study
could speed development of new effective treatments for the 13 million
Americans suffering from seriously debilitating mental disorders that
prevent people from participating in daily life at home, work, or
social settings for over 80 days per year and results in early death or
suicide for 30,000 individuals each year.
Schizophrenia Treatment Research.--This proposed study could build
on recent advances in schizophrenia treatment to determine whether an
early intervention of aggressive pharmacotherapy, combined with focused
rehabilitative efforts, can prevent long-term disability and suffering
of schizophrenia, devastating mental illness affecting 2.4 million
adult Americans.
Protocols for Treating Autism Spectrum Disorders Early.--These
studies could bolster efforts to determine the most effective treatment
regimens to improve outcomes for children and families struggling with
the life-long disability and pain of autism spectrum disorders.
The Atherosclerosis Prevention Trial.--Although drugs to lower low-
density lipoprotein (LDL) cholesterol levels are known to reduce the
risk of major adverse cardiovascular events, it is not yet known
whether additional benefits can be realized by lowering LDL cholesterol
beyond current treatment guidelines. A multi-center, randomized
clinical trial could determine whether aggressive lowering of low-
density lipoprotein cholesterol beyond current treatment guidelines
further reduces major adverse cardiovascular events.
Program to Reduce Cardiovascular Disease Risk in Young Adults by
Preventing Weight Gain.--Studies could develop and evaluate promising
intervention approaches for preventing weight gain in young adults,
which is a major risk factor for cardiovascular disease (CVD) and
associated CVD risk factors including elevated cholesterol, high blood
pressure, and diabetes.
Systolic Blood Pressure Intervention Trial.--Although drug
treatment to lower blood pressure, both systolic and diastolic, is
known to reduce CVD mortality, it is not yet known whether additional
benefits can be realized by lowering systolic pressures beyond current
treatment guidelines. A multi-center trial could determine whether
treating systolic blood pressure to a lower goal than currently
recommended further reduces cardiovascular disease mortality and
morbidity, particularly for those aged 50 years and older in whom
systolic blood pressure is more strongly associated with CVD risk than
diastolic blood pressure.
PREPAREDNESS FOR PANDEMIC INFLUENZA
Senator Specter. Dr. Fauci, if you would supplement what
you have testified to on pandemic flu. There is enormous
concern in this country today and we would like to know to what
extent are we prepared. Being prepared is a tough subject to
answer, but to what extent are we prepared. When you say that
more funding would be of material assistance, I think there is
something that we are prepared to fund.
Senator Harkin took the lead and put a figure of $7
billion. We came close to $6 billion, and contracts have been
let for five big companies for a billion dollars. It is scary.
It could be devastating. So let us know, and this subcommittee
is prepared to take the lead again.
[The information follows:]
Preparedness for Pandemic Influenza
The Department has made great strides to improve the Nation's
preparedness for a pandemic influenza outbreak. For example, HHS has
stockpiled roughly 8 million doses of vaccine against one H5N1 virus
strain. Given, a two-dose vaccination schedule, this would allow
vaccination of 4 million people. The Department also recently invested
more than $1 billion in the development of cell-based vaccine
technology; shifting from the current egg-based technology is critical
to quickly producing vast quantities of vaccine should a pandemic
develop. Our goal is to build the capacity to vaccinate all 300 million
Americans within 6 months of a pandemic outbreak. The Strategic
National Stockpile now contains sufficient antivirals to treat nearly 7
million people, and with another 19 million courses on order, it should
contain 26 million courses by the end of 2006. HHS is also enabling
States and other entities to purchase up to 31 million antiviral
treatment courses off of the Federal contract. Our goal is to have
enough antivirals on hand for 25 percent of the population, or
approximately 75 million individuals. In addition, we have purchased
150 million N95 respirators, surgical masks and other personal
protective equipment. Planning summits have been held in all but two
States, and almost every State has either a draft or final pandemic flu
plan in place. As Secretary Leavitt has stated, ``Preparation is a
continuum. Every day we prepare brings us closer to being ready. We are
better prepared than we were yesterday. And we must be better prepared
tomorrow than we are today.''
The National Institute of Allergy and Infectious Diseases (NIAID)
is a major component of these preparation efforts. For example, NIAID
has made progress in the development of an H5N1 influenza vaccine.
NIAID-supported researchers at St. Jude Children's Research Hospital
obtained a clinical isolate of a highly virulent H5N1 influenza virus
in Vietnam in early 2004, and used a technique called reverse genetics
to create a non-virulent vaccine reference strain from this isolate.
NIAID then contracted with sanofi pasteur and Chiron Corporation (now
Novartis) to manufacture pilot lots of the inactivated virus vaccine
for use in clinical trials. The sanofi pasteur vaccine has been tested
in healthy adults and is currently in clinical testing in healthy
elderly people and children. The Chiron vaccine is currently in
clinical testing in healthy adults.
Results from the trial of the sanofi pasteur vaccine in healthy
adults provide both good and sobering news. The good news is that the
vaccine is well-tolerated, and induces an immune response that augurs
well for protecting people against the H5N1 virus. The sobering news is
that larger doses of the H5N1 vaccine than typically used for yearly
influenza vaccine are needed to elicit immune responses in the majority
of people that would be predictive of protection. However, preliminary
results from a Phase I clinical trial of an H9N2 influenza vaccine
candidate made by Chiron suggest that addition of an adjuvant--a
vaccine component that increases the immune response--may help to
reduce the required dose. Clinical trials of H5N1 candidates using
adjuvants and other strategies to improve immune responses at lower
doses of vaccine are ongoing or imminent.
In addition, NIAID intramural researchers are working with
colleagues from MedImmune, Inc. under a Cooperative Research and
Development Agreement (CRADA) to produce and test multiple vaccine
candidates for potential pandemic influenza strains, including H5N1
strains. The researchers have developed three live-attenuated H5N1
vaccine candidates, designed for nasal spray delivery, that have been
shown to be protective in mice. The CRADA capitalizes on the long
history of NIAID research and development of respiratory virus
vaccines, including fundamental research that was key to the
development of FluMist, the licensed nasal spray influenza vaccine
manufactured by MedImmune. The researchers have produced a clinical lot
of a candidate H5N1 vaccine based on a strain isolated in Vietnam in
2004, and clinical trial of this vaccine is expected to begin later
this year.
NIAID also supports a number of basic and applied research projects
that could lead to significant advances in the development and
production of vaccines against potential pandemic strains of avian
influenza. This includes investigation of cell culture-based vaccine
production as an alternative to chicken egg-based vaccine production--
as noted above, an endeavor to which the Department of Health and Human
Services recently committed $1 billion that was awarded to several
pharmaceutical companies. In addition, NIAID conducts and supports
research into new vaccine platforms, including recombinant subunit
vaccines, in which cultured cells are induced to make various influenza
virus proteins that are then purified and used in a vaccine; gene-based
vaccines, in which influenza genetic sequences are injected directly
into a person to stimulate an immune response; and vector approaches
that insert the genes of influenza virus into another non-virulent
virus (the vector) and inject the vector vaccine as a carrier to
present the influenza proteins to the vaccine recipient. For example, a
gene-based influenza vaccine developed by researchers at the NIAID
Vaccine Research Center is expected to enter Phase I clinical trials
later in 2006.
In addition to efforts to develop vaccines against potential
pandemic influenza strains, NIAID is supporting basic and applied
research to develop improved antiviral drugs against influenza. These
efforts include a screening program for new drugs, as well as targeted
drug development and clinical trials. NIAID-supported researchers are
conducting studies of varying doses and combinations of existing
antiviral medications, developing and testing long-acting next-
generation antivirals, and evaluating novel drug targets for potential
prevention and treatment of influenza using in vitro and animal models.
Because a pandemic influenza virus could emerge anywhere in the
world, NIAID helps to conduct global surveillance and molecular
analysis of circulating influenza viruses. For example, NIAID funds a
long-standing program to detect the emergence of influenza viruses with
pandemic potential, in which researchers in Hong Kong and at St. Jude
Children's Research Hospital collect and analyze influenza viruses from
wild birds and other animals in Asia and North America and generate
candidate vaccines against them.
NIAID is also supporting a collaborative effort to release full
genomic sequence information for several thousand influenza viruses to
the public domain. More than 1,000 influenza viruses have been
sequenced. Readily available sequence data will allow researchers to
further study how influenza viruses evolve, spread, and cause disease,
which may ultimately lead to improved methods of treatment and
prevention; identify specific characteristics of previous pandemic
strains, which may help focus preparedness efforts; and identify genes
that are highly conserved among various strains, and therefore act as
possible targets for broadly protective therapeutics or vaccines.
Lastly, NIAID is collaborating with Oxford University, the Wellcome
Trust and the World Health Organization to establish a small network of
clinical sites in Southeast Asia to conduct clinical research on avian
influenza and other emerging infectious diseases. A key purpose of the
effort is to build an independent clinical research capacity in these
countries. Five sites in Vietnam, four sites in Thailand and two in
Jakarta will be established.
Senator Specter. I had thought it would be helpful if you
stayed to hear the other testimony, but now that we have given
you this homework your time is too valuable. So we will stay
and forge on alone.
Thank you very much for coming in. Thank you for what you
are doing for America and the world.
Senator Shelby. Mr. Chairman, can I just take 1 second?
Senator Specter. Certainly.
Senator Shelby. I just want to commend you for bringing all
these people together. This is a blue ribbon panel if I have
ever seen one and I have seen a lot of panels in the Congress,
as you have. We appreciate what NIH has done and we will be
ashamed of ourselves if we do not properly fund you for the
benefit of the American people.
Senator Specter. That is high praise coming from Senator
Shelby because he usually deals with bankers.
Senator Specter. Senator Harkin.
MULTI-BUG APPROACH ON VACCINES
Senator Harkin. Mr. Chairman, I want to thank the panel and
all the people from NIH for coming down here today.
Dr. Fauci, in your supplement that the chairman spoke to
you about, I wanted to delve a little bit into the multi-bug
approach on vaccines that I understand you are working on,
rather than just the one bug, one vaccine approach. So I would
like to know a little bit more about that and where that
stands.
Dr. Collins, in regards to--there is some interesting work
going on in terms of the relating of genes and environment. I
know you are doing some stuff on that and I would also like to
be kind of brought up to speed on that, too, if you could
submit that.
Thank you.
[The information follows:]
Multi-Bug Approach on Vaccines
The National Institute of Allergy and Infectious Diseases (NIAID)
is supporting research and development of alternate approaches to
dealing with the threat of emerging and re-emerging infectious diseases
such as influenza.
For example, NIAID is pursuing the development of a ``universal
vaccine'' that protects against multiple virus strains such as those
resulting from antigenic drift associated with seasonal influenza and
antigenic shift associated with pandemic influenza. As influenza
viruses circulate, the genes that determine the structure of their
surface proteins undergo small changes. Sometimes the change in the
genes results in a slight change in the antigenic properties of the
protein, a process commonly referred to as ``antigenic drift''.
Antigenic drift is the basis for the changes in seasonal influenza
observed during most years, and is the reason that we must update
influenza vaccines annually. Influenza viruses also can change more
dramatically. For example, viruses sometimes emerge that can jump
species from natural reservoirs, such as wild ducks, to infect domestic
poultry, farm animals, or humans. When an influenza virus jumps species
from an animal, such as a chicken, to infect a human, the result is
usually a ``dead-end'' infection that cannot readily spread further in
the human population. However, mutations in the virus could develop
that allow human-to-human transmission. Furthermore, if an avian
influenza virus and another human influenza virus were to
simultaneously co-infect a person or animal, the two viruses might swap
genes, possibly resulting in a virus that is readily transmissible
between humans, and against which the population would have no natural
immunity. These types of significant changes in influenza viruses are
referred to as ``antigenic shift.'' When an ``antigenic shift'' occurs,
a global influenza pandemic can result. Historically, pandemic
influenza is a proven threat. In the 20th century, influenza pandemics
occurred in 1918, 1957, and 1968.
The NIAID is supporting a number of research projects to develop a
vaccine that induces a potent immune response to the common elements of
the influenza virus that undergo very few changes from season to season
and from strain to strain. Although this is a difficult task, such a
``universal'' influenza vaccine would not only provide continued
protection over multiple seasons, it might also offer protection
against a newly emerged pandemic influenza virus and thus substantially
reduce the susceptibility of the population to infection by any
influenza virus--making the country far less vulnerable to influenza
viruses emerging from avian and other animal sources.
One relatively stable element of the influenza virus is a protein
called M2. The external portion of the M2 protein is very similar in
influenza viruses from year to year and from strain to strain. A
``universal'' influenza vaccine targeting the M2 protein, or other
conserved elements, could be protective against a range of influenza
strains. NIAID-supported researchers have demonstrated that vaccines
made with bioengineered versions of M2 can protect mice from lethal
influenza virus. The scientists now are testing cross-reactivity
between different species and strains of influenza, examining how long
the immunity provided by these vaccines lasts, and evaluating whether
the influenza viruses can evade these vaccines by developing mutations
in their M2 proteins.
In addition, researchers at the NIAID Vaccine Research Center (VRC)
are developing and testing gene-based influenza vaccines that will
protect against multiple strains of influenza. As a first step, initial
candidate vaccines, each containing the gene encoding the hemagglutinin
(H) surface protein of an influenza virus isolated from a recent human
outbreak of influenza (H1N1, H3N2 or H5N1), have already shown promise
in animal studies. VRC researchers plan to develop additional gene-
based vaccines for all common variants of hemagglutinin, as well as
other influenza viral proteins, such as nucleoprotein and the M2
protein. In future, the VRC will incorporate both conserved and
variable genes from multiple influenza strains into DNA and adenovirus
vectors that can readily be produced by existing manufacturing
processes.
A second approach, while not technically a vaccine, is an immune
enhancer which specifically targets a component of the immune system
and enhances one's ability to respond to a broad range of microbial
threats. Studies of the human innate immune system, which is comprised
of ``first responder'' cells and other defenses that provide a first
line of defense against a wide variety of pathogens, have been moving
forward rapidly. These advances suggest it may be possible to develop a
relatively small set of fast-acting, broad-spectrum countermeasures
that can boost innate immune responses to many pathogens or toxins,
including influenza. The capability to boost the innate immune system
also could lead to the development of more powerful vaccine additives,
called adjuvants, that can increase vaccine potency. The concept of
immune enhancers has been demonstrated in early stage clinical studies,
but requires further research and development to be applied to pandemic
influenza vaccination.
Genes, Environment, and Health Initiative
On February 8, 2006, HHS Secretary Leavitt announced that the
President's budget proposal for fiscal year 2007 included $68 million
for the Genes, Environment and Health Initiative (GEI), a research
effort by the National Institutes of Health (NIH) to combine a type of
genetic analysis and environmental technology development to understand
the causes of common diseases such as asthma, arthritis, many types of
cancer, diabetes, and Alzheimer's disease. This represents a $40
million increase above the $28 million already planned for such efforts
by the NIH for fiscal year 2007.
If approved by Congress, $26 million of the requested $40 million
increase in funding would go to genetic analysis and $14 million to the
development of new tools to measure environmental exposures that affect
health. The discoveries made through these efforts can potentially lead
to profound advances in disease prevention and treatment. By seizing
the historic opportunity provided by the Human Genome Project and the
International HapMap Project, this initiative would speed the discovery
of genetic risk factors for common diseases. But, as it has been said,
genetics loads the gun; environment pulls the trigger. GEI will also
provide markedly improved ways to measure and analyze the environmental
contribution to disease, so that we can understand the complex
interplay among genes and environment that is responsible for all human
health and disease.
The NIH has recently formed a Coordinating Committee of
representatives from 13 Institutes and Centers that would develop the
content, priorities, and implementation of the initiative, should it be
approved by the Congress. Similar to the management of NIH Roadmap
initiatives, specific functions of the Coordinating Committee include:
(a) identification of research priorities and opportunities relevant to
the program, (b) guidance and support of the development and
implementation of specific research initiatives related to the program,
(c) evaluation of proposals for specific activities to be conducted
under the auspices of the program, and (d) facilitation of appropriate
NIH-wide communication of program goals, initiatives, and findings. Two
subcommittees have been formed, one to focus on the genetics component
of GEI and the other to focus on its environmental component. These
subcommittees will do the necessary planning for the proposed program
during the current year and will be prepared to help administer the
initiative, provided fiscal year 2007 funds are made available.
Attached is a breakdown of the proposed budget for the initiative.
Since the initiative is so early in its planning stages, the number of
grants that would be awarded eventually is not known at this time.
Through initiatives such as GEI, we stand on the threshold of
creating a future that would revolutionize the practice of medicine by
allowing us to predict disease, identify environmental triggers,
develop more precise therapies and, ultimately, prevent the development
of disease in the first place.
Senator Specter. Thank you all very much.
We turn now to our next panel: Dr. Knapp, Dr. Auerbach, Dr.
Chao, Dr. Comstock, Dr. Emerson, Ms. Eng, and Dr. Fox.
We have taken the unusual step of inviting 20 witnesses to
this hearing to give us a bird's eye view or a thumbnail
sketch, to mix metaphors, as to what is happening in specific
lines of medical research. We have allocated as much time as we
can, consistent with the schedule. It is not enough.
Dr. Knapp represents the entire group on medical research
and there has been an allocation of 3 minutes for him and an
allocation for every other witness, regrettably, of only a
minute and a half. But that is the best we can do, and you have
submitted written statements, all of which will be made a part
of the record, and that will give us an opportunity to have
some insights on your views and what is happening in your
specific fields.
We are going to just indicate the group you are associated
with, as opposed to going over your curriculum vitae's, which
are all very, very impressive. Dr. Knapp, we start with you,
representing the Ad Hoc Group for Medical Research.
STATEMENT OF RICHARD M. KNAPP, M.D., CHAIR, AD HOC
GROUP FOR MEDICAL RESEARCH
Dr. Knapp. Good morning. My name is Dick Knapp and I chair
the Ad Hoc Group for Medical Research.
Mr. Chairman, all Americans owe you and Senator Harkin an
enormous debt of gratitude for your unwavering commitment to
medical research and your continued leadership in the support
of the NIH, and we applaud your efforts to add funds to the
2007 budget to permit a $2 billion increase in NIH funding.
The President's budget claims to freeze NIH at the 2006
level, but for almost all NIH institutes and centers this
budget represents a cut, not a freeze. This budget proposal
represents the fourth consecutive year that NIH funding has
failed to keep pace with inflation. In inflation-adjusted
dollars, as you pointed out, Mr. Chairman, this budget
represents a loss of almost 11 percent of purchasing power
since 2003.
Mr. Chairman, we are well on our way to undoubling the NIH
budget that you and your colleagues fought so hard to achieve.
As you heard from Dr. Zerhouni, NIH-funded research is driving
the transformation of the practice of medicine. At a time of
unparalleled scientific opportunities and unprecedented health
challenges, NIH should be positioned to support more research,
not less. Yet, under this President's budget NIH would fund 10
percent fewer competing research project grants in 2007 than 4
years ago.
Because new investigators are essential to NIH's future, as
Dr. Zerhouni pointed out, NIH-sponsored training should be
supported as a top priority. However, due to fiscal
constraints, the NIH has been unable to meet the stipend
recommendations it made in 2001, and the President's budget
proposes no stipend increases in 2007.
The flattening of the NIH budget also undermines the
Nation's biomedical research infrastructure. Mr. Chairman, and
you Senator Harkin have emphasized the need for increased
support for the renovation and construction of extramural
research facilities and the acquisition of state of the art
laboratory instrumentation. Yet this budget again fails to
request funds for the NIH extramural facilities program and the
budget proposes to cut funding for shared instrumentation
grants by nearly 8 percent below the level of 2005.
This morning's witnesses will describe how NIH research has
safeguarded and improved the lives of all Americans while at
the same time serving as a catalyst for new products and
technologies, creating skilled jobs and contributing to the
Nation's economic growth.
PREPARED STATEMENT
We share your concern that the continued flattening of the
NIH budget threatens further progress in all of these areas.
Thank you for the chance to be here.
[The statement follows:]
Prepared Statement of Richard M. Knapp
Mr. Chairman and members of the subcommittee, my name is Dick
Knapp, and I chair the Ad Hoc Group for Medical Research Funding, a
coalition of more than 300 patient and voluntary health groups, medical
and scientific societies, academic and research organizations, and
industry. The Ad Hoc Group is pleased to have the opportunity to
provide an overview of the President's fiscal year 2007 budget for the
National Institutes of Health (NIH).
Mr. Chairman, the members of the Ad Hoc Group, and indeed, all
Americans, owe you and Senator Harkin an enormous debt of gratitude for
your unwavering commitment to medical research and your continued
leadership in support for the NIH. We share your belief that much of
what has been accomplished in the past half century to help save lives
and improve the health of all Americans can be attributed, directly or
indirectly, to the NIH. And we applaud your efforts to add funds to the
fiscal year 2007 budget resolution to permit a $2 billion increase in
the NIH budget. In January, the Ad Hoc Group joined four other major
medical research advocacy groups in calling for the NIH budget to be
increased by a minimum of $1.4 billion (5 percent) in fiscal year 2007.
The President's budget for fiscal year 2007 proposes $28.35 billion
in budget authority through this subcommittee for the NIH, which is an
increase of less than $1 million over the current year's level. Much
has been made of this proposal for flat funding. But for most areas of
research, this budget represents a cut, not a freeze. Under the
President's proposal, the fiscal year 2007 budgets for almost all NIH
institutes and centers would be reduced below the fiscal year 2006
levels.
In addition, it is important to recognize that this year's budget
is not a one-year aberration. The President's overall request is $64.5
million less than what NIH received in fiscal year 2005, and the
proposed budgets for most institutes and centers are between 1 and 1.5
percent lower than two years ago. If adopted, the President's budget
would represent the fourth consecutive year that NIH funding has failed
to keep pace with inflation as measured by the Biomedical Research and
Development Price Index. In fact, in terms of inflation-adjusted
dollars, the President's budget represents a loss of 11 percent of
purchasing power since 2003, as shown in the attached graph. Mr.
Chairman, we are well on our way to ``undoubling'' the NIH budget that
you and your colleagues fought so hard to achieve.
It is the cumulative effect of this multi-year ``flattening'' of
the NIH budget that is cause for concern. The flattening has had and
would continue to have a severe impact across the pillars of NIH: basic
research, translational and clinical research, research training, and
the research infrastructure.
NIH-funded researchers have blazed new trails for medical research.
Basic research forms the knowledge foundation needed to achieve
continued scientific advancement. And as you have heard from Dr.
Zerhouni, the discoveries resulting from the investment in NIH-funded
research are driving the transformation of the practice of medicine
through the development of novel and personalized therapies, cures, and
prevention strategies.
According to the Congressional Justification accompanying the
President's budget, in fiscal year 2007 NIH will be able to support
37,671 total research project grants (RPGs). This is 1,570 fewer RPGs
than NIH funded in fiscal year 2004. What is more critical is the
reduction in the number of new and competing RPGs. Under the
President's budget, NIH will be able to award 9,337 competing RPGs in
fiscal year 2007, a decrease of 1,074 compared to fiscal year 2003.
This is 10 percent reduction in just four years. At a time of
unparalleled scientific opportunities and unprecedented health
challenges, NIH should be positioned to support more research, not
less.
In addition, a key function of NIH is to support training awards to
encourage new investigators into basic and clinical medical research
careers. Because an influx of new investigators is essential to NIH's
future, NIH-sponsored training opportunities should be supported as a
top priority, with realistic funding levels for stipends, tuition, and
benefits. Under the President's budget, the NIH will be able to support
17,499 full-time training positions (FTTPs) in the Ruth L. Kirschstein
National Research Service Award (NRSA) program. This is a reduction of
139 since fiscal year 2005. Furthermore, in 2001 the NIH recommended
increased stipend support for NRSA recipients; however, the agency has
been unable to meet these objectives due to fiscal constraints. For
example, stipends for pre-doctoral students and post-doctoral fellows
have fallen significantly short of NIH's targets, and the President's
budget provides no increases for stipends above the fiscal year 2006
levels. How are we to continue to attract the best and brightest
students with stipends that are unduly low in view of the high level of
education and professional skills involved in biomedical research?
The flattening of the NIH budget also undermines the nation's
biomedical research infrastructure. NIH extramural research
infrastructure grants are essential if research institutions are to
update or replace aging research laboratories. Senator Harkin
recognized the critical importance of the research infrastructure to
the continued leadership of the United States in medical research when
he championed the Twenty-First Century Research Laboratories Act, which
was enacted in 2000. This legislation emphasized the need for increased
support for the renovation and construction of extramural research
facilities and the acquisition of state-of-the-art laboratory
instrumentation. Yet once again, the President's budget fails to
request funds for the peer-reviewed, competitively awarded, extramural
research facilities grant program administered through NIH's National
Center for Research Resources.
Federal funding also is critical to equip core facilities at
biomedical research institutions with state-of-the-art technologies.
NIH administers two competitive grant programs that award funds to
institutions to purchase present and emerging technologies: the Shared
Instrumentation Grant Program for groups of NIH-supported investigators
to obtain commercially-available equipment that costs more than
$100,000; and the High-End Instrumentation Grant Program to acquire
more expensive equipment, such as structural and functional imaging
systems, electron microscopes, and supercomputers. These grants
maximize the utility of federal research funds by allowing a number of
scientists with similar instrumentation needs to share such equipment,
and promote interactions among scientists, frequently across scientific
disciplines, thereby catalyzing mutually rewarding new research
collaborations. Yet, the President's budget proposes to reduce funding
for these programs to $64.4 million, which is 7.7 percent below the
fiscal year 2005 level.
This morning's witnesses will give specific examples of how the
research supported and conducted by NIH has had a profound and far-
reaching impact on society in many important ways, serving as a
catalyst for new products and technologies, creating skilled jobs,
contributing to the nation's economic growth, and most importantly,
safeguarding and improving the lives of all our citizens. Mr. Chairman,
we share you concern that the continued flattening of the NIH budget as
proposed by the President threatens further progress in all of these
areas.
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
Senator Specter. Thank you, Dr. Knapp.
Dr. Judith Auerbach, representing the Foundation for AIDS
Research.
STATEMENT OF JUDITH AUERBACH, Ph.D., VICE PRESIDENT,
PUBLIC POLICY AND PROGRAM DEVELOPMENT,
AMFAR, THE FOUNDATION FOR AIDS RESEARCH
Dr. Auerbach. Good morning, Mr. Chairman, and thank you
very much. I am Judy Auerbach from amFAR and I will speak very
quickly since we have only 90 seconds.
There are now more than 1 million HIV-infected people in
the United States and the rates of HIV infection have risen
dramatically among vulnerable populations, including racial and
ethnic minority women and men. To make headway in the fight
against AIDS, we need a strong Federal commitment to research
leading to more effective treatment and prevention methods.
During the doubling of NIH's budget, the Agency was able to
expand the knowledge base in basic research focusing on human
immunology, macromolecular biology, structural biology, and
behavioral research. This led to a dramatic increase in the
number of vaccine and therapeutic candidates in the pipeline
and to the implementation of crucial HIV prevention trials in
populations most at risk of infection.
But much of this progress is in jeopardy with current and
proposed cuts. Factoring in the recent recalculation, AIDS
research at NIH was cut by about 2.4 percent between 2005 and
2006 and will be cut another 6 percent under the President's
2007 request. This has grave consequences for grants overall,
for expanded trials of promising prevention technologies and
therap eutics, and for new and seasoned investigators.
The number of R01's in AIDS research decreased by 5 percent
in both numbers and dollars from 2005 to 2006 and would
decrease even further in 2007. Under current budget
constraints, it is anticipated that the AIDS clinical trials
networks will be allocated only about 54 percent of what it is
estimated they will need over the next 7 years. This means
important effectiveness trials of new prevention technologies
and new therapeutics will not be launched. Research institutes
are losing potential new investigators and more experienced
ones are demoralized, knowing that the majority of submissions
are triaged and unscored and that funding is not likely until
resubmission, even if then.
So altogether this means that important AIDS research will
not be undertaken and people at risk for or living with HIV and
AIDS will not have access to lifesaving interventions.
My time is over, so I will stop there. Thank you.
Senator Specter. Thank you, Dr. Auerbach.
Dr. Moses Chao, Christopher Reeve Foundation.
STATEMENT OF MOSES CHAO, M.D., CHRISTOPHER REEVE
FOUNDATION
Dr. Chao. Thank you, Mr. Chairman.
In the past 10 years we have witnessed a remarkable
turnaround in neuroscience research. It used to be dogma that
the adult spinal cord could not regenerate or recover from
serious injury. But now through basic research we know of
specific genes, proteins, and cells that can stimulate the
repair of the spinal cord, and we are now ready to convert
these findings into new therapies.
But the United States is falling behind because of the
decrease in NIH funding. The decrease has affected many
scientists, including my own lab, because the level of funding
has actually dropped to 10 percent. What that means is 1 out of
10 grants is being funded and that has produced some drastic
consequences, because many innovative applications and
promising experiments are not supported or carried out.
More distressingly, there is a huge negative impact on the
recruitment of our next generation of young scientists because
of this discouraging situation. So we believe that this is the
time to invest in basic research to advance the progress that
we have made in this area. Christopher Reeve often argued that
what we learn about spinal cord regeneration has direct
implications to many diseases, including glaucoma, Alzheimer's
disease, and Parkinson's disease. Therefore, to put the brakes
on funding basic research will interfere with new scientific
discoveries that will be aimed at improving the health of all
Americans.
Thank you.
Senator Specter. Thank you, Dr. Chao.
Ms. Amy Comstock, Parkinson's Action Network.
STATEMENT OF AMY L. COMSTOCK, CHIEF EXECUTIVE OFFICER,
PARKINSON'S ACTION NETWORK
Ms. Comstock. Good morning. Thank you, Chairman Specter and
Senators Harkin and Shelby. I am Amy Comstock, the Chief
Executive Officer of the Parkinson's Action Network, and I am
here on behalf of Parkinson's patients, their families, and all
of the national Parkinson's organizations.
Parkinson's disease is now listed among the 15 leading
causes of death in this country. Yet there is still no cure and
no known treatments that even slow the progression of the
disease. In fact, since the introduction of dopaminergic
treatments nearly 50 years ago, our community is still
struggling with mere variations of that treatment for this
progressive disease.
Even with the introduction of deep brain stimulation for
Parkinson's disease, we are still only responding to the
symptoms of the disease and not doing that very well sometimes,
and certainly not for a long duration.
So I am here this morning, quite frankly, to use the word
that we are terrified of flat funding at NIH. Not only will
flat funding eat into all forms of research currently under way
at NIH, but we are particularly fearful that it will have a
disproportionate impact on clinical and translational research,
which is exactly the kind of research that we need the most.
Clinical research is very expensive to conduct, but it is
what we have to have in order for treatments to make it through
the drug development pipeline and become available to patients.
For example, there is a handful of drugs slated for clinical
trials right now at NIH that in fact may be what we need so
badly. They may be compounds that can slow the progression of
the disease.
PREPARED STATEMENT
We have to have these trials, but we cannot have them
without funding. With flat funding, even if those trials are
conducted--we have to do the math--other research would be cut
at NIH. Therefore, we strongly support a minimum of 5 percent
increase for NIH.
Thank you.
[The statement follows:]
Prepared Statement of Amy L. Comstock
Thank you Chairman Specter, Ranking Member Harkin, and
distinguished members of the Subcommittee for convening this hearing on
NIH appropriations. I am the Chief Executive Officer of the Parkinson's
Action Network (PAN). PAN represents the Parkinson's community,
including the more than one million Americans currently fighting
Parkinson's disease (PD), and their families, and the national
Parkinson's organizations, such as The Michael J. Fox Foundation for
Parkinson's Research, Parkinson's Disease Foundation, National
Parkinson Foundation, Parkinson Alliance, and American Parkinson
Disease Association.
As I am sure you all you know, PAN was instrumental in helping
garner Congressional support for this Subcommittee's doubling of the
NIH budget over five years during the late 1990's and early in this
decade. We continue to work in conjunction with so many to prevent the
proposed freeze in funding for NIH. Flat-funding would, in effect,
constitute a significant cut, as the Biomedical Research and
Development Price Index (BRDPI) is estimated to have increased by 5.5
percent for fiscal year 2005, and will likely increase by 4.1 percent
for fiscal year 2006, and 3.8 percent in fiscal year 2007. Accordingly,
in order to not lose ground in ongoing research, we support the medical
research advocacy community's recommendation for a 5 percent increase
above the fiscal year 2006 funding level for the National Institutes of
Health.
We cannot turn our backs on our most promising research, which may
happen if this funding is not provided. The Parkinson's community is
particularly concerned with several clinical trials that may be
eliminated without sufficient funding and direction.
These clinical trials are a part of a study going on at NIH right
now that embody the kind of translational research most promising to
the Parkinson's community and is desperately needed. NET-PD
(Neuroprotection Exploratory Trials in Parkinson's Disease) is a trial
to study compounds that may slow the progression of Parkinson's
disease. Research into treatments that might slow progression is
particularly important as current treatments for PD alleviate some
symptoms but do not slow progression of the disease. Despite the
potential value, this program may be halted or cut back if NIH does not
receive adequate funding. Yet, NET-PD is exactly the kind of
translational research that we strongly support NIH aggressively
pursuing.
We believe that there is hope for today's Parkinson's disease
patients and their families. There are emerging therapies that should
be pursued--even therapies that could potentially reverse the
progression of the disease. These are the neuro-restorative therapies,
such as neural growth factors, gene therapies, and tissue transplants
including stem cells, which ultimately may restore function in patients
suffering from Parkinson's disease as well as other neurodegenerative
disorders. However, if this important research is not aggressively
pursued it may take many more years than necessary to determine if this
hopeful research may become much-needed therapies for today and
tomorrow's Parkinson's patients.
On behalf of the Parkinson's community, I thank you for your
continued interest in Parkinson's disease issues and your support for
better treatments and a cure for Parkinson's. I would be happy to
answer any questions you may have.
Senator Specter. Thank you, Ms. Comstock.
We turn now to Dr. Steven Emerson on the cancer issue. Give
my regards and thanks to Dr. John Glick, my oncologist.
STATEMENT OF STEPHEN EMERSON, M.D., ASSOCIATE DIRECTOR
FOR CLINICAL RESEARCH, ABRAMSON CANCER
CENTER, UNIVERSITY OF PENNSYLVANIA HOSPITAL
Dr. Emerson. Good morning, Chairman Specter, Senators
Harkin and Shelby. My name is Steve Emerson. I am the associate
director for clinical research at the Abramson Cancer Center at
Penn. Our outgoing director, Dr. Glick, sends his regards. He
is no stranger to this committee.
First off, I want to thank you all for your continued
support for the health and welfare of this country by means of
health care research over the past several years. Without your
support, we could not have done what we have done. In the area
of cancer where I work, I have seen in the 25 years I have been
working a change where 25 years ago a cancer diagnosis was
uniformly and relatively quickly fatal, to now where over half
the patients who walk in my office know that they will live at
least 5 years, if not be cured of their cancer.
But still we are only partway there and at this point
cancer is still the largest cause of death in all Americans
under the age of 85. It is still a huge killer. We have a long
way to go.
Now, you have heard a lot about the issues with the
doubling of the budget and yet where we are with the flat
budgets going forward. I want to concentrate on just one part
of that. One of my roles at Penn is head of training and the
mentoring of the next generation of investigators. What you see
with the budget being flat is actually a reduction in all new
R01's being funded to this year the eleventh percentile, next
year much lower. This is one-third the level of funding in
terms of numbers of grants and chances of getting funded that
it was even 3 years ago, and that is going to get worse next
year.
Worse than that, the money per grant is being cut 30
percent off even the best grants. So the funds going in for new
research have plummeted. That is the source of the panic you
are talking about. So for new investigators that we have all
invested in, the outlook for them for careers, for taking care
of all of us and for finding new cures, it is hard to convince
them what the future is. If we do not correct this, all of the
goodwill and investment we have made in the infrastructure with
the road map, all the collaborative work, all the genomics and
cancer that we have put this investment into will go to waste
because we will not have a next generation of scientists to
take advantage of it.
PREPARED STATEMENT
So thank you all again in the past and in the future for
your efforts on preserving the NIH budget and its mission.
Thanks again.
[The statement follows:]
Prepared Statement of Dr. Stephen Emerson
Good Morning, Chairman Specter, Senator Harkin, and Members of the
Subcommittee. I am Stephen Emerson, Associate Director for Clinical
Research at the University of Pennsylvania's Abramson Cancer Center,
one of NIH's original comprehensive cancer centers funded by the
National Cancer Institute three decades ago. Our outgoing Director, Dr.
John Glick, no stranger to this Subcommittee, extends his regards and
regrets his schedule did not permit him to appear this morning.
Thank you for the opportunity to speak with you today about efforts
by scientists and clinicians in the ongoing fight against cancer, a
disease that is the leading cause of death for Americans 85 years of
age and younger. In the United States last year, 1 of every 4 deaths
was from cancer. This illness claimed the lives of about 563,700
Americans, with approximately 1.4 million new cancer cases diagnosed.
These staggering figures should not, however, diminish the hope
that exists for all those who fall victim to this disease from the
dramatic progress we have made in this fight. When the Abramson Center
opened its doors three decades ago, a cancer diagnosis was a near
certain, imminent death sentence. But through the efforts of millions
of people, and as a direct result of the steadfast support of this
Subcommittee in robust funding for cancer research over the years,
today about 60 percent of cancer patients can expect to live more than
five years after diagnosis. Working with our colleagues in partnership
with organizations like the American Cancer Society and the Friends of
Cancer Research, there is an aggressive, day-to-day battle to reverse
the devastating effect that cancer has on the lives of so many
individuals and families--through research, prevention efforts and
treatment.
That effort, however, is under assault, and at great risk, if the
President's fiscal year 2007 budget for the National Institutes of
Health, and its proposed allocation for the National Cancer Institute,
is not reversed. In the Bush 2007 budget proposal, the NCI is slated to
receive $4.75 billion--a cut of nearly $40 million, or almost 1
percent, below NCI's fiscal year 2006 level. That is a reduction of $70
million cut from the fiscal year 2005 level and approximately $186
million less than what the Congressional Budget Office estimates is
necessary to maintain current projects, infrastructure and spending
adjusted for inflation and other factors.
Within the proposed levels for the NCI, virtually every major
activity, other than activities for the NIH Roadmap initiative, would
be reduced. Cancer research activities would be cut $50 million below
the 2006 level, which itself was slightly reduced from the level
allocated for 2005. Cancer biology research would be cut nearly $41
million and research into the causes of cancer would be reduced more
than $6 million. Overall support for the cancer centers would be
reduced by more than $2 million, capping a two-year period of real
decline in the NIH investment for its cancer centers. Even cancer
control and prevention, one of the single most important areas in our
efforts to combat this disease, is scheduled to be hit with a nearly
$2.5 million reduction, reductions that amount to a cumulative decline
of nearly $17 million over two years.
These proposed reductions, which I know you oppose Mr. Chairman,
completely contradict the Administration's stated goal of ending
suffering and death from cancer by 2015. They fly in the face of the
spiraling cost of cancer treatment, pegged at more than $72 billion
annually in the United States, nearly five percent of all health care
expenditures. And they send the wrong message to the nation at a time
when the economic burden, excluding the costs for treatment, from
cancer morbidity and premature mortality is a staggering $120 billion
annually.
For the community of scientists and clinicians who have dedicated
their lives to the prevention, diagnosis and treatment of cancer, and
who are the members of the team working in every state in our nation to
meet that 2015 goal, these proposed cuts are both alarming and highly
discouraging. If enacted, these funding levels would drop success rates
for scientists proposing research project grants to the NCI to just 16
percent--that is a 1 in 6 chance of obtaining funding. Such a level
would mean a drop in the NCI grant success rate of more than 50 percent
since 1998, and a drop of 43 percent since 2002. For NCI's R01 grants,
the bread and butter mechanism for most NIH funded scientists, the
payline for last year is even worse--just 11 percent. Reductions in
2007 would only erode that level further.
While older, more established research scientists will likely find
a way to hold on to most of their core funds, the effect on young
investigators--the seed corn of our future in this battle--is nothing
short of devastating. The NIH New Investigators Committee presented
data last December that showed the average age of a typical new NIH R01
awardee with an M.D. degree had reached 44. At the same time, the
percentage of new investigators in competing R01 Awards across NIH
continues to decline to just 20 percent. For the NCI, the first-time
investigator success rate for all grant mechanism is worse--just 11
percent. For R01's, the success rate is again just 17 percent. The
message these proposed cuts send is that for promising young biomedical
professionals, a career focused on tackling cancer--whether in the
fundamental study of genomics, proteomics, and biomarkers, or the more
applied disciplines directed at generating new diagnostic or treatment
regimes and devices--is not worth pursuing. The President's budget runs
the risk of beginning the effective elimination of a whole generation
of cancer scientists--at the very time when we are turning the corner
on the fight against this disease.
Those of us who have spent our lives focused on ending the scourge
of this disease know that this Subcommittee--more so than any other in
the U.S. Congress--led the fight for funds to double the NIH budget.
And there has been tremendous progress against cancer as the number of
people who died from cancer between 2002 and 2003 decreased for the
first time, the year corresponding to the last of the large NIH budget
increases. The Director of the NCI, in his testimony to this Committee
last month, outlined a number of significant scientific breakthroughs
in the treatment and diagnosis of breast, ovarian and cervical cancers
in just the last year. These continue the remarkable success we have
had in fighting the number two cause of death in the United States.
The proposed 2007 budget cuts would help to unravel the progress
this Subcommittee fought so hard to achieve in the doubling of NIH from
1998-2003. We urge you to redouble your efforts to stop them, and
provide a modest increase--perhaps an additional $300 million for the
NCI in the coming year--to help offset declines enacted in 2006 and
provide for most increases to sustain the pool of young scientists
whose careers will hopefully be marked by the end of cancer as a
scourge on so much of our nation and our world.
Thank you for the chance to present my views to the Subcommittee.
We would be happy to prepare responses to any questions you might have
for the record.
Senator Specter. Thank you, Dr. Emerson.
Ms. Lauren A. Eng, Spinal Muscular Atrophy Foundation.
STATEMENT OF LAUREN A. ENG, PRESIDENT, SPINAL MUSCULAR
ATROPHY FOUNDATION
Ms. Eng. My daughter is one of the 33,000 American children
suffering from spinal muscular atrophy, the most common genetic
killer of young children. One missing gene causes nerves and
muscles to wither away and most children die by the age of 2.
But there are many terrible diseases. What makes SMA remarkable
is the imminence of treatment. SMA represents both the problem
and the opportunity of drug development for orphan diseases.
Half of Americans with illness suffer from rare diseases and
for the vast majority of rare diseases, especially pediatric
ones, money and scientific advances are wasted because
discoveries do not move from the bench to the bedside.
Because of scientific breakthroughs, NINDS chose SMA from
its 600 diseases for a groundbreaking drug discovery program.
The SMA project is a shining example that NIH can develop
treatments and invest in further and basic science that is ripe
and pays off. With less than $5 million a year, a group of
potential drugs have already been identified. NIH has been a
catalyst of advancing research and drug companies are
interested. It achieved in 3 years what might have otherwise
taken 10.
PREPARED STATEMENT
But running an astonishing race is useless if you stop
short of the finish line. Under the proposed budget,
continuation of the program is at risk. There is funding to
pursue one drug, but scientists believe at least three should
be advanced, each costing $15 million to bring to trials. If
NIH cannot fund this next step, it will have catastrophic
effect. Academic and industry research will stop. We will have
wasted the enormous investments and progress made in biomedical
research, and for my child all of this is the difference
between life and death.
[The statement follows:]
Prepared Statement of Loren A. Eng
I am Loren Eng, president of the Spinal Muscular Atrophy (SMA)
Foundation and am here on behalf of the SMA Coalition. Most
importantly, I am the mother of Arya Singh, who is one of the 30,000
children in America dying from Spinal Muscular Atrophy.
As you may know, SMA is a terrible disease. It is the most common
genetic killer of babies and young children in America, and it is
untreatable and fatal. It is often described as a genetic version of
polio, or the children's equivalent of ALS. In children with SMA, one
missing gene, and one missing protein causes motor neurons to die.
Muscles weaken and wither away, leaving the bright minds of its young
victims trapped by their failing bodies. Most children with SMA die
within the first few years of life. Some are ``lucky'' and live longer,
but face extreme disability and suffering.
But there are many terrible diseases. What makes SMA remarkable is
the ability to truly make a difference with a modest amount of money
and smart strategy.
SMA is a poster child for both the problem and the opportunity of
drug development for rare pediatric diseases.
For large diseases, the historical focus on basic science works
well--large drug companies take that basic science and translate it
into treatments that save lives.
However, half of Americans with illness have smaller diseases, and
for them the system has not worked. Breakthroughs are often achieved in
basic science, but there are no large drug companies waiting to turn
those breakthroughs into treatments. For a handful of smaller diseases,
drug companies will only get involved at later stages where perceived
risk is lower. But for most small diseases, the basic science is wasted
because of the challenges of advances research from the bench to the
bedside. This is especially true for rare pediatric diseases. Money is
spent, but children still die.
In the past decade, scientists studying SMA have achieved
incredible breakthroughs, creating a unique opportunity to develop
treatments. To its credit, NINDS has recognized the opportunity and
taken steps to advance basic science with a revolutionary translational
research effort.
Just three years ago, the NINDS designated SMA, from among 600
diseases, as the best candidate for a model new program to translate
basic science into actual drugs and treatments. The SMA Project
combined academic and industry expertise, and was a focused and
strategic effort to translate remarkable science into real solutions.
In just three years, and for less than $5 million per year, the SMA
Project has brought us within reach of an effective treatment.
Investigators have identified a group of potential drugs that may slow
the progression of the disease. Despite a miniscule budget for the
project, NINDS has made incredible strides in harnessing the
community's efforts toward a near term treatment.
Unfortunately, running a brilliant race is useless if you stop
before the finish line, and that is what we fear is at risk of
happening.
I am not an expert in the federal budget but I do know that:
--this model SMA program would never have been initiated under this
budget,
--the existing funding of just $5 million a year is at risk, and
--the very success of the program is at risk.
The next phase of the project is pre-IND studies but there is only
enough funding to study JUST one compound. Project scientists say we
need at least two to three, and each costs $2 million. For clinical
trials we will need $10 to $15 million each.
The leadership of the NIH has been a catalyst of incredible
progress--it expects to advance research to a point when they can be
``handed off'' to drug companies to fully develop. For a fraction of
the vast amounts spent on caring for SMA victims, we could develop
treatments that would save them. With a modest amount of money and
continued focus, we can save lives, and money.
If NIH can not provide for these critical next steps, it will have
a domino effect elsewhere:
--Young investigators will not focus on SMA,
--Existing non-government research will stall,
--Industry will surely not engage, and
--Other diseases like ALS and DMD will not reap the benefits of SMA
research.
The SMA Project has been a revolutionary effort and a shining
example of how NIH cannot only fund basic research but actually DEVELOP
TREATMENTS for deadly diseases.
Through a solution driven approach, the NIH has achieved in 3 years
what might have taken a decade. ``Smart investment'' could pay off in
treatments that save lives. This is an incredible example of finding
solutions, not just spending money. Of course, in this case, a
``solution'' means treatment that could save the lives and reduce the
suffering of 30,000 children.
We urge you not to stop short now when we are so close. Reducing
funding for NIH, and for projects like the SMA Project will have
devastating consequences--we will waste the enormous amounts of money
that have been spent and progress that has been made. For our daughter,
it could mean the difference between life and death.
Senator Specter. Thank you, Ms. Eng.
We turn now to Dr. Philip Fox, American Association for
Dental Research.
STATEMENT OF DR. PHILIP C. FOX, DIRECTOR OF CLINICAL
RESEARCH, DEPARTMENT OF ORAL MEDICINE,
CAROLINAS MEDICAL CENTER ON BEHALF OF THE
AMERICAN ASSOCIATION FOR DENTAL RESEARCH
Dr. Fox. Thank you, Mr. Chairman. I am Dr. Phil Fox and I
am really representing the dental research community.
I would like to highlight this morning some advances in
salivary diagnostics, an area you have not heard much about.
Diagnosis of most health conditions requires a blood or a urine
sample and that may be invasive or painful to obtain. But now,
after many years of research, saliva is poised to be used as a
noninvasive diagnostic fluid for a number of oral and systemic
conditions.
Dental researchers have been able to amplify molecular
signals that are present in saliva, heralding the advent of new
tests that allow for earlier diagnosis than is currently
possible. Saliva is already being used routinely for rapid
noninvasive HIV diagnosis and saliva-based tests will soon be
available to detect oral cancer. Further, saliva has the
potential to detect exposure to chemical and biological weapons
and is being looked at in autoimmune diseases as well.
Now, most of this research is funded by the National
Institute of Dental and Craniofacial Research, the NIDCR.
However, as you have heard, the investment that is made in the
NIH doubling is now at risk. I think that we have the research
equivalent now of being all dressed up and nowhere to go.
As a result of your past investment, there are many
unprecedented opportunities in dental research. But the austere
budget of the last 4 years has resulted in a steady decrease in
new research grants and many young investigators who are
leaving the field.
Imagine a future in which a saliva sample is used for
quick, painless and less expensive diagnostic tests and to
monitor many systemic health conditions and exposure to
chemical and biological weapons. Early diagnosis could save
thousands of lives. We need you to sustain your commitment to
NIH and to dental research in order to realize these
unprecedented scientific opportunities.
Thank you for your interest and support.
Senator Specter. Thank you very much, Dr. Fox.
Unless there is some question from the panel, we will turn
now to our next group of experts.
Thank you all very, very much.
Dr. Knapp. Thank you.
Dr. Emerson. Thank you.
Senator Specter. We now call on Ms. Patricia Furlong, Dr.
Sam Gandy, Ms. Ann Gibbons, Dr. Robert Goldstein, Dr. Lawrence
Holzman, and Dr. Steven Houser.
Thank you all very much for joining us. As is the situation
with all of the witnesses, your full statements will be made a
part of the record. We turn first to Ms. Patricia Furlong, who
represents the Project on Muscular Dystrophy. Ms. Furlong.
STATEMENT OF PATRICIA FURLONG, CO-FOUNDER AND CHIEF
EXECUTIVE OFFICER, PARENT PROJECT MUSCULAR
DYSTROPHY
Ms. Furlong. Thank you very much, Senator Specter, Senator
Harkin, and Senator Shelby. I so appreciate this opportunity to
talk about NIH funding.
I thought I would start by giving you three examples. In
1999 a scientist from the University of Pennsylvania with NIH
support looked at aminoglycosides to suppress premature stop
codons. Premature stop codons in a genetic sentence could be
interpreted as a period in the middle of a genetic sentence,
creating the loss of a significant protein. These
aminoglycosides are found to suppress a premature stop.
This particular scientist went to industry and, again with
his own NIH support, began high throughput screens. Today we
have a drug in trial called PTC-124. This drug has implications
for all genetic diseases in terms of a subset of the population
with premature stops. It is currently in trial and
demonstrating pharmacological activity in cystic fibrosis and
in Duchenne muscular dystrophy we do not have the data. But
this drug has sweeping potential results across the rare
genetic disease community.
In 2000 a scientist from Johns Hopkins University looked at
muscle regulators and found that inhibiting myostatin would
improve the bulk of the muscle and potentially the strength.
This drug is currently in trial in muscular dystrophies FSH,
Becker, and myotonic.
In the year 2001, the Bowman-Burke inhibitor compound was
looked at. It is a protease inhibitor that can slow or halt
muscle degeneration in muscular dystrophy. It had been in trial
in the National Cancer Institute and was halted, not because of
any risk to the patient, but primarily due to lack of material.
This drug is now going into trial through NIH funding in
muscular dystrophy in January.
PREPARED STATEMENT
It is these cures, potential treatments for all of us, that
make such a difference in our lives. We ask you to commit to
NIH funding to supply that NIH, that research enterprise, with
the funding it needs to help all of us, to give us time with
the people we love, and to help not only the American people
but people across the world.
Thank you.
[The statement follows:]
Prepared Statement of Pat Furlong
Good morning/afternoon Mr. Chairman and Members of the Committee,
and thank you for this opportunity to testify on the NIH budget.
My name is Pat Furlong, Co-Founder and CEO of Parent Project
Muscular Dystrophy and the mother of two sons who battled Duchenne
Muscular Dystrophy.
Thanks to the significant amount of basic research funded by NIH in
recent years, we are making encouraging progress in our quest to
develop effective treatments for this always-fatal disease. Right now,
we are in a Phase II clinical trial on a promising drug for a subset of
patients with Duchenne muscular dystrophy, and potentially a subset of
patients with many other genetic conditions.
It's basic NIH-funded research that served as a foundation and
provided the spark for this drug, and many other promising therapies
that are in the works. Without adequate NIH funding to support basic
research, the medical research tower will rise much lower before
eventually buckling due to the tremendous strain placed on too few
resources.
We are particularly concerned about the negative impact the budget
crunch will have on young investigators seeking to enter the field of
Duchenne MD research. The budget limitations we have seen over the past
few years have made it tremendously more difficult for young, first-
time investigators with meritorious submissions to secure an R01 grant.
I urge your panel and the entire Senate to continue to lead the way
in restoring critically needed dollars to support basic NIH research.
Senator Specter. Thank you very much, Ms. Furlong.
We now turn to Dr. Sam Gandy, representing the Alzheimer's
Association.
STATEMENT OF SAM GANDY, M.D., Ph.D., CHAIR, MEDICAL AND
SCIENTIFIC ADVISORY COUNCIL, ALZHEIMER'S
ASSOCIATION
Dr. Gandy. Mr. Chairman, members of the subcommittee: As a
direct result of this subcommittee's leadership and foresight,
scientists supported by the NIH have made enormous strides
towards understanding Alzheimer's, a disease that affects 4.5
million Americans today and will affect as many as 16 million
in a few decades.
For the first time in the history of medicine, we have
Alzheimer's genes in hand and we can now contemplate rational
therapy for Alzheimer's. With adequate resources, scientists
will be able to develop medications that modify Alzheimer's
pathology in as few as 3 years. Achieving that goal will
relieve a major bottleneck and attract every major
pharmaceutical company to begin bringing new drugs into human
clinical trials.
The current trajectory of NIH cuts threatens to arrest
progress and devastate the upcoming generation of scientists.
Current grants are now routinely cut by 18 percent. In my
institution this is already causing layoffs and I see my
students turning away from research careers. Budget cuts also
mean that some of the most promising drug targets will go
unstudied. An important new molecule was discovered just last
month. Where will we find the resources to study its potential
therapeutic value?
PREPARED STATEMENT
The inescapable conclusion is that Federal budget cuts are
killing more than programs. These cuts are killing the minds of
millions of Americans. The threat of Alzheimer's is staggering
in its scope. I urge you and your colleagues to act now to
reverse the disastrous path upon which we find ourselves.
Thank you very much for providing me with this opportunity
to testify.
[The statement follows:]
Prepared Statement of Sam Gandy
Mr. Chairman and members of the Subcommittee, I appreciate the
opportunity to be here to discuss Alzheimer's disease, a disease that,
as we speak today, is robbing 4.5 million Americans of their abilities
to form memories and thoughts. The disease will ultimately take the
life of every one of these 4.5 million. Within a few decades, as many
as 16 million Americans will have Alzheimer's, all of whom will
eventually succumb to the disease, unless we all, together, take up the
fight toward a cure or means of prevention.
As a direct result of the leadership and foresight of this
Subcommittee, the National Institutes of Health have played essential
roles in developing and maintaining a cadre of American scientists such
as myself who have made enormous strides toward understanding
Alzheimer's and, for the first time in the history of medicine,
contemplating rational interventions aimed at the underlying disease
process We now know that Alzheimer's is a disease and not an inevitable
consequence of aging. We have identified several key genetic mistakes
that are so malignant that one single mistake in the DNA is sufficient
to cause the complete picture of Alzheimer's. These DNA mistakes have
been both necessary and sufficient to supply us with essential
information that has eluded scientists for the century since Alois
Alzheimer presented his landmark paper in Munich in 1906. For the first
time in the history of medicine, we are now able mimic the earliest
steps in the disease using chemicals, cells, or, most valuably, the
lowly laboratory mouse. Human Alzheimer genes have enabled us not only
to create in the laboratory a living brain with Alzheimer's, but,
astoundingly, we are also now able to cure experimental Alzheimer's in
the laboratory. These experimental therapies are now entering human
trials so that we might translate these experimental cures into
practical medicines for humans.
To date, four drugs have been approved for treating the symptoms of
Alzheimer's, but these drugs only help a few patients, and even then,
only modestly and temporarily. Current Alzheimer drugs leave the basic
underlying disease untouched and the natural progression from amnesia
to death proceeds along the standard, predictable, inevitable, and
cruel path that we know all too well. Yet, from the laboratory, for the
first time, scientists and physicians see genuine, tangible,
quantifiable hope. Most experts agree that with adequate resources,
scientists will be able to develop medications that will modify
Alzheimer's pathology within the next three years. If the prevailing
wisdom about the root cause of the disease is validated, a major
bottleneck will be relieved, and every major pharmaceutical company
will begin bringing new drugs into human clinical trials.
But that can only happen if you and your colleagues sustain the
Alzheimer research enterprise. Alzheimer's drug development will
certainly be stymied if Congress adopts the President's proposal, where
for the fourth consecutive year the NIH budget fails to even keep pace
with inflation.
The NIH doubling process is directly responsible for the progress
of Alzheimer's research as a field of study: the field has moved from a
backwater of obscurity into perhaps the single most visible, most
competitive, and most exciting research field in experimental
neurology. Within three years after this Subcommittee first
appropriated funds for Alzheimer's, the number of scientists drawn into
this field of study increased three-fold. But because of budget cuts
over the past three years we are already seeing talented scientists
turning to other fields.
The current trajectory of cuts threatens to devastate the upcoming
generation of scientists. NIH funding of the scientists who populate
the faculties of our universities is not simply used to buy test tubes
and chemicals: those funds directly pay the salaries of scientists on
these faculties. Draconian cuts will render these scientists and
professors unemployable. And with the loss of this talent, we are
postponing the day that we can eradicate this deadly disease.
But perhaps most importantly, persistent budget cuts are shutting
out opportunities to find ways to cure or prevent Alzheimer's disease.
In 1998, NIH was funding 30 percent of top-rated grant applications.
Today, the percentage of Alzheimer projects that actually receive
funding is down to 18 percent. Some institutes are struggling to
maintain 10 percent funding. This means that most scientific
opportunities are being left on the table. It also means that some of
the most promising clinical trials--the tools we need to translate
basic research findings into effective clinical treatments--will be
delayed or scrapped altogether. The inescapable conclusion, for me, at
least, is that federal budget cuts are killing more than programs; they
are killing the minds of millions of Americans.
Mr. Chairman and Senator Harkin, I am certain that you both realize
that we cannot be a strong nation unless we are a healthy nation. In
fiscal year 2007, spending on all Medicare beneficiaries benefits will
total $449.2 billion. Unless we find a way to prevent or cure
Alzheimer's disease, in less than 25 years, the care of Medicare
beneficiaries that is attributed to Alzheimer's alone will cost over
$400 billion, roughly equivalent to today's entire Medicare budget. The
threat is so enormous that the temptation is to just give in to
nihilism and cynicism. I urge you and your colleagues to join us in
resisting this temptation and act now to reverse the disastrous path
upon which we find ourselves.
Thank you for the opportunity to testify.
Senator Specter. Thank you. Thank you, Dr. Gandy.
Our next witness is Ms. Ann Gibbons, representing Autism
Speaks.
STATEMENT OF ANN GIBBONS, MEMBER, BOARD OF DIRECTORS,
AUTISM SPEAKS
Ms. Gibbons. I am the mother of a 17-year-old boy with
autism and I am a member of the board of directors of Autism
Speaks, and I am here to speak for those who cannot.
Autism is our Nation's fastest growing developmental
disorder, affecting 1 in 166 children, up more than tenfold
from a decade ago and costing our Nation approximately $35
billion annually. Autism has no known cause, no known cure, and
few effective treatments. The incidence of autism has increased
at epidemic proportions, but NIH funding for autism research
has been frozen over the past 2 years and will remain so in the
President's 2007 budget.
Specifically, the first lost opportunity is developing new
treatment standards for autism. This would support research on
new or existing early interventions to establish common methods
of verifiably effective treatment. Early intervention provides
children with the best possible opportunity to develop in the
most normal way possible, but not with the President's budget,
where this critical research will not be funded.
Another lost opportunity is defining the core features of
autism, when it begins, its long-term course, and subtypes of
the disorder that may exist on the autism spectrum.
Understanding the common features of autism will lead to
identification of its causes, both genetic and environmental,
and identify better treatments or even prevention of the
disease. The President's proposed budget will not fund this
research.
PREPARED STATEMENT
The incidence of autism will continue to grow, but funding
for autism research will not. With the President's budget,
opportunities will be lost, but the pain and suffering of
autistic children and their families will continue to grow, as
will the cost to society.
I just want to thank you all for what you are doing for
biomedical research.
[The statement follows:]
Prepared Statement of Ann Gibbons
Mr. Chairman, I am Ann Gibbons, a resident of Bethesda, Maryland, a
member of the Board of Autism Speaks, and the mother of a 17-year-old
son with autism.
Autism Speaks was launched to help find a cure for autism by
raising the funds to facilitate and quicken the pace of research, to
raise public awareness of autism, and to give hope to all those who
suffer from this disorder. Autism Speaks' goal is to give a voice to an
entire community, to every family dealing with the hardships of autism.
With its mergers with the National Alliance for Autism Research and the
Autism Coalition for Research and Education, Autism Speaks now
represents our nation's largest autism advocacy organization.
In both of my roles, in my public capacity as an Autism Speaks
board member and in my private role as a mother of an autistic child, I
commend you, Mr. Chairman, for your leadership in promoting funding for
biomedical research and support you in your efforts to secure increased
funding for the National Institutes of Health this year.
Funding for understanding the causes of and finding treatments for
autism is sorely needed. Autism is our nation's fastest-growing
developmental disorder, now affecting 1 in 166 children in the United
States, up more than tenfold from just a decade ago. A Harvard School
of Public Health professor, in a recent book, estimates that it can
cost $3.2 million to care for an autistic person over the course of his
or her lifetime, and by conservative estimates autism costs our society
$35 billion annually in direct and indirect costs.
Autism has no known cause, no known cure, and few effective
treatments. And while NIH funding for autism may have tripled in the
past decade to $100 million, that amount pales in comparison to the
money spent for research on other diseases and disorders that affect
fewer individuals.
Autism research is poised at a turning point. While diagnoses are
skyrocketing at epidemic rates, many areas of autism research stand on
the verge of important findings. If adequately funded, this research
could yield real progress on the diagnosis, treatment and cure for this
disorder. The President's proposed freeze on NIH funding falls short on
all counts, and would seriously impede the progress and promise of
autism research.
One turning point is the development of new treatment standards for
autism spectrum disorder. This program would support research on new or
existing interventions with the goals of establishing common methods of
treatment and measurements of treatment efficacy. This study could
hasten the ability to use existing treatments early to improve outcomes
for children and families struggling with the disability of autism
spectrum disorders. When autistic children do receive evidence-based
early intervention service between ages 3 and 5, from 20 to 50 percent
of them are able to go onto mainstream kindergarten. Early intervention
is critical in order to provide children with autism the optimum
opportunity to develop in the most normal way possible.
Unfortunately, Mr. Chairman, the President's proposed budget for
fiscal year 2007 will freeze funding for autism, and research leading
to advances in autism intervention will not be possible.
Another turning point is the need to define core features of
autism, including when it begins, its long-term course, and subtypes of
the disorder that may exist on what is known as the autism spectrum.
Defining the features of autism could lead toward the long-term
goal of finding genetic and non-genetic causes of autism and offering
the possibility of providing better treatments or even prevention of
the disease. It's also urgent that we better understand the genetic
associations with autism so that research into the interaction of genes
with the environment can be understood.
With the budget proposed by President, this research will not be
funded, and these advances cannot be made.
With the President's budget, progress in understanding brain
development and autism, one of the most devastating disorders affecting
hundreds of thousands of children, will be slowed or halted. Scientists
will be unable to realize the full potential of the latest scientific
techniques, in neuroimaging and genetics technology.
Mr. Chairman, autism, which the Centers for Disease Control and
Prevention estimates now affects 300,000 American children between ages
4 and 17, will continue to grow, with 3 children now being diagnosed
ever hour. The pain and suffering of autistic children and their
families will continue, as will the costs to society. But research on
this devastating disorder will be stymied, progress on potential
treatments and cures will be stymied as a result of the President
proposed freeze on spending for biomedical research and on research on
autism.
Moreover, we will lose the opportunity to save an entire generation
of children from this devastating disorder, which can lock people in
their own worlds, unable to communicate with, and sometimes unable to
experience the affection of those who love them.
Mr. Chairman, thank you for giving me the opportunity to speak for
those with autism and their families.
Senator Specter. Thank you. Thank you very much, Ms.
Gibbons.
Our next witness is Dr. Robert Goldstein, representing the
Juvenile Diabetes Research Foundation.
STATEMENT OF ROBERT GOLDSTEIN, M.D., Ph.D., CHIEF
SCIENTIFIC OFFICER, JUVENILE DIABETES
RESEARCH FOUNDATION
Dr. Goldstein. Thank you, Senators Specter, Harkin, and
Shelby for this opportunity to testify. I am Robert Goldstein,
the chief scientific officer for the Juvenile Diabetes Research
Foundation.
Without an increase in Federal funding for diabetes
research, there will be a disproportionate impact on clinical
translation research. Islet cell transplantation, a procedure
that has been successfully done experimentally in nearly 600
diabetes patients, will delay the--the NIH-sponsored clinical
trials to expand this proven treatment out into the community
will be seriously delayed.
In the area of hypoglycemia, dangerously low blood sugar
can lead to convulsions, coma, or even death. The Diabetes
Research and Children's Network's efforts to assess new glucose
monitoring technology will impact on the management of type 1
diabetes in children.
Diabetic retinopathy. Anti-angiogenesis drugs that can
reverse diabetic retinopathy have been discovered, but clinical
trials to extend and expand these findings to test new classes
of drugs would be delayed or halted.
Treatment of new onset of type 1 diabetes. Clinical trials
using monoclonal antibodies have shown that insulin-secreting
cells can be protected for up to 2 years. Support studies to
determine how to prolong this effect, whether treatment prior
to the onset can prevent diabetes, and whether these therapies
can be given years after onset would be delayed or curtailed.
Since type 1 diabetes is an autoimmune disease, this will
impact understanding of other autoimmune diseases.
PREPARED STATEMENT
Causes of type 1 diabetes. NIH-supported efforts to
identify the genes responsible for susceptibility will be
curtailed and delay our ability to effectively prevent disease
in at-risk populations.
Thank you for the opportunity to testify.
[The statement follows:]
Prepared Statement of Robert Goldstein
Chairman Specter, Ranking Member Harkin and Members of the
Subcommittee, thank you for the opportunity to testify before you today
regarding the many opportunities that will be lost without an increase
in federal funding for diabetes research at the National Institutes of
Health. I am Robert Goldstein, the Chief Scientific Officer for the
Juvenile Diabetes Research Foundation International.
In the past 25 years, the number of people with diabetes has more
than doubled, so that today approximately 20.8 million Americans have
diabetes. Evidence suggests that 1 in 3 Americans born in 2000 will
develop diabetes during his or her lifetime. Diabetes is the 6th
leading cause of death in the United States. The disease cost this
country $132 billion in 2002, which is almost 5 times NIH's annual
budget. Only research to better prevent, treat and cure diabetes will
significantly impact these numbers.
The Diabetes Research Working Group recommended $1.6 billion in
fiscal year 2004--the last year of their study--to take advantage of
the many diabetes research opportunities. We have used appropriations
to build critical momentum for accelerating the delivery of therapies
to people with diabetes. There have been major advances (see attached)
and more importantly programs have been put in place that will insure
continued advances. Yet funding today is $600 million short of this
recommendation. Absent an increase in federal funding, this momentum
will be lost and progress and solutions will be delayed. Specifically,
the following areas of diabetes research will be seriously impacted:
Islet Cell Transplantation.--Nearly 600 diabetes patients worldwide
have now received islet transplants, and enough patients have been
transplanted that long-term benefits can be documented. Islet cell
transplants have resulted in significant benefits to people with very
complicated forms of type 1 diabetes: for instance, at least half of
the transplant recipients exhibit stabilization or reversal of their
diabetic eye and nerve diseases. Overall, islet transplant patients
report a significant improvement in their quality of life. However,
challenges remain, and we need additional funding for NIH programs and
NIH/CMS sponsored clinical trials to test new protocols and fully
understand how to maximize this proven treatment so it is an
appropriate therapy for all who suffer from type 1 diabetes.
Hypoglycemia.--Hypoglycemia--episodes of dangerously low blood
sugar--is the most feared acute complication of diabetes and can lead
to shaking, convulsions, coma, or even death in extreme cases. Young
diabetic children who may not be able to recognize or communicate the
signs of impending hypoglycemia are especially vulnerable. Technologies
coming onto the market in the near term have the ability to warn
patients of hypoglycemia, and it is critical that the technology is
suitable for use in children. The NIH has established the Diabetes
Research in Children Network (DirecNet) to provide independent
assessments of glucose monitoring technology and its impact on the
management of type 1 diabetes in children, and this important work
would be delayed without additional funds.
Diabetic Retinopathy.--Diabetes is the leading cause of new
blindness in working age adults; more than 8.5 million people in the
United States have diabetic retinopathy or eye disease. Significant
progress being made on the causes and pathogenesis of diabetic
retinopathy is generating renewed hope for the prevention or reversal
of eye disease. For the very first time anti-angiogenesis drugs that
can actually reverse diabetic retinopathy, as opposed to simply halting
further progression by means of laser treatment, have been discovered.
The NIH-supported Diabetes Retinopathy Clinical Research Network
(DRCR.Net) includes more than 150 collaborating physicians across the
United States, and provides an organized platform for rapidly
translating new therapeutic ideas from the research community into
clinical testing in human patients. Clinical trials to test the
pipeline of potential new drugs would be delayed, curtailed or halted
without continued funding.
Treatment of New Onset Type 1 diabetes.--By the time type 1
diabetes is diagnosed, patients have already suffered a devastating
autoimmune attack that has destroyed most of the insulin-producing beta
cells of the pancreas. Research has shown that a patient's level of
residual beta cell activity correlates with the ability to more easily
maintain glucose levels close to normal and reduces the amount of
insulin that must be injected. A prime research goal is to develop new
therapies that will help newly diagnosed type 1 diabetes patients
preserve remaining beta cells and possibly even dampen the immune
system enough to allow the pancreas to regenerate new beta cells.
Researchers have identified a drug that can effectively alter the
clinical course of the disease. A short 1-2 week course of treatment
with an antibody--named anti-CD3--helps patients maintain or increase
their ability to produce insulin naturally for up to 18 months after
diagnosis compared to a placebo. This treatment demonstrates the proof
of principle that the clinical source of an established autoimmune
disease can be significantly altered. This work could not have been
done without the major advances in clinical trial platforms from
several NIH sponsored programs, including:
--Immune Tolerance Network, whose goals are to develop new therapies
to treat/prevent autoimmune disease and to prevent or treat
graft rejection in transplantation by inducing immune
tolerance. Among the diseases under investigation by this
collaborative effort include type 1 diabetes and islet
transplantation; and
--TRIAL NET which also supports studies aimed at both preventing
further destruction of insulin secreting cells in new onset
type 1 diabetes, as well as developing the means to prevent
disease.
More extensive studies to determine how long this effect can be
maintained, and whether the addition of specific antigen therapy or
other drugs can prolong this effect, will not occur without continued
support. Similarly, large studies to determine whether early treatment
prior to disease onset can prevent diabetes or whether these therapies
can be given years after disease should be supported.
Genetics and Environmental Causes of Type 1 Diabetes.--The best way
to attack type 1 diabetes is to stop it before it ever starts, but this
requires sophisticated knowledge of the underlying causes of disease.
Ground breaking NIH efforts (T1DGC, TEDDY, TRIGR) to identify the genes
responsible for susceptibility to type 1 diabetes coupled with the
identification of environmental triggers (viruses, toxins, dietary
factors) will be curtailed or abandoned without continued funding, and
delay our ability to effectively prevent disease in at-risk
populations.
Diabetes research has demonstrated a strong return on the federal
investment. Continued strong federal commitment is needed.
Thank you again for the opportunity to appear before you today. I
am happy to answer any questions you may have.
NIH and Diabetes Research--A Strong Return on Federal Investment
Diabetes affects more than 20 million adults and children in the
United States, up to 7 percent of the population. In 2001,
approximately $3.8 billion was spent on inpatient care for diabetes;
two-thirds of those costs could have been saved with appropriate
primary care for complications. A 2002 study estimated that diabetes--
both type 1 and type 2--caused the U.S. economy $132 billion in direct
medical costs and indirect costs such as disability, work loss, and
premature mortality. The disease accounts for more than 30 percent of
Medicare expenditures. Total diabetes costs are predicted to climb to
as much as $192 billion per year by 2020.
Beyond the economic impact is the personal toll that diabetes
exacts. Individuals with diabetes have twice the prevalence of
disability as persons without diabetes. In 2002, more than 176,000
cases of permanent disability were attributed to diabetes at an
estimated cost of $7.5 billion. That same year diabetes accounted for
88 million disability days. Persons with diabetes are at greater risk
for stroke, heart attack, blindness, kidney failure, limb amputation,
nerve damage, severe dental disease, and complications of pregnancy.
Type 1 diabetes can reduce a person's expected lifespan by as much as
15 years.
The Diabetes Control and Complications Trial (DCCT), a clinical
trial of 1,441 people with type 1 diabetes, demonstrated that tight
control of blood glucose through intensive insulin therapy could
significantly reduce or delay many diabetic complications. This
landmark finding spurred a shift in the daily management of type 1
diabetes and energized research in the field. In 1996, at the
conclusion of the DCCT, it was estimated that implementation of
intensive insulin management in the entire U.S. diabetic population
would save 920,000 years of sight, 691,000 years free from end stage
kidney disease, 678,000 years free from amputation, and 611,000 years
of life.
Since the discovery of insulin more than 80 years ago, biomedical
research has continued to improve the health and lives of diabetes
patients. The research listed below demonstrates that the field of
juvenile diabetes research is making advances worthy of a continued
strong federal investment.
--Advances in Islet Cell Transplantation.--Since 1999, almost 600
diabetes patients worldwide have received islet transplants,
and enough patients have been transplanted that long-term
benefits are beginning to emerge. This procedure involves
isolating the insulin-producing cells, called islet cells, from
a donor pancreas, and injecting them into an adult who has
juvenile diabetes. Islet cell transplants have resulted in
significant benefits to people with very complicated forms of
type 1 diabetes: for example, at least half of patients exhibit
stabilization or reversal of their diabetic eye and nerve
diseases. Overall, islet transplant patients report a
significant improvement in their quality of life. Unfortunately
this procedure cannot be used in children because the
medications that need to be taken to prevent the body from
rejecting these donated cells can have many side effects.
Researchers are working to improve this procedure and to
develop new techniques so that one day the procedure can be
suitable for children with juvenile diabetes.
--Treatment in new Onset Type 1 Diabetes.--Researchers have
identified a drug, a monoclonal antibody, that can effectively
alter the clinical course of type 1 diabetes: a short 1-2 week
course of treatment with the antibody--named anti-CD3--helps
patients maintain or increase their ability to produce insulin
naturally for up to 18 months after diagnosis compared to a
placebo. Treated patients required reduced insulin dosage, and
better hemoglobin A1c levels. A larger phase II trial of this
procedure is underway. These findings are significant because
residual beta cell activity correlates with the ability to more
easily maintain glucose levels close to normal, and to prevent
the development of the devastating complications of diabetes.
Anti-CD3 is at the leading edge of a robust pipeline of
potential therapies for reversing new onset type 1 diabetes.
The Type 1 Diabetes TrialNet was established in 2001 to ``fast
track'' potential diabetes therapies into clinical trials.
--Advances in Preventing Hypoglycemia.--Significant advances in
glucose monitoring technology help patients to determine
whether their blood sugars are falling (signaling the need to
eat to avoid hypoglycemia) or rising (indicating the need for
an insulin dose). Researchers have evidence that patients who
use continuous glucose monitoring systems spend more time in
the normal glucose range; a critical finding because short term
variability in glucose levels may be as important as overall,
long-term glucose control in predicting the risk of
complications. In 2005, an NIH-funded study validated that
newer-generation home blood glucose meters demonstrated a high
degree of accuracy over a broad range of glucose concentrations
in children with type 1 diabetes. The study was conducted by
Diabetes Research in Children Network (DirecNet), a network of
clinical centers that provides an independent assessment of
glucose monitoring technology and its impact on the management
of type 1 diabetes in children. DirecNet is now testing the new
continuous glucose monitors, which will be the next wave in
diabetes care and represent an essential step toward an
artificial pancreas.
--Reversing of Diabetic Retinopathy.--Diabetes is the leading cause
of new blindness in working age adults. Laser treatment can
reduce the risk of severe vision loss by 20 to 50 percent and
saves up to $1.6 billion per year by preventing or treating
diabetic eye disease. New research has discovered anti-
angiogenesis drugs that can actually reverse diabetic
retinopathy, as opposed to simply halting further progression
by means of laser treatment. These and other new classes of
drugs make up a pipeline that must be tested in clinical
trials.
--Preventing Cardiovascular Disease.--Adults with diabetes are two to
four times more likely to have a stroke or to die from heart
disease than adults without diabetes. Indeed, heart disease or
stroke is the leading cause of death among patients with
diabetes, accounting for 65 percent of deaths in this
population. Blood pressure control reduces the risk of heart
attack and stroke by 33 to 50 percent and the risk of other
complications by as much as 33 percent. Nevertheless,
additional research is necessary to understand the factors that
contribute to increased cardiovascular risk. New findings to
design new diagnostic tools that predict or detect the early
onset of cardiovascular disease, develop new drugs or devices
to reverse cardiovascular damage due to diabetes, and
clinically test new therapies in large, randomized trials.
--Slowing Onset and Progression of Kidney Disease.--Diabetes is the
leading cause of kidney failure in the United States,
accounting for 44 percent of new cases in 2002. Based on NIH-
funded research, scientists have made great progress in
developing methods that slow the onset and progression of
kidney disease in people with diabetes. Drugs used to lower
blood pressure (antihypertensive drugs) can slow the
progression of kidney disease significantly. Two types of
drugs, angiotensin-converting enzyme (ACE) inhibitors and
angiotensin receptor blockers (ARBs), have proven effective in
slowing the progression of kidney disease. Drugs that lower
blood pressure, including ACE inhibitors or angiotensin
receptor blockers (ARBs), decrease the onset of kidney disease
by 30 to 70 percent.
--Gaining an Understanding of Kidney Disease Susceptibility.--Some
diabetic patients seem to be particularly susceptible to
developing diabetic nephropathy, while others show no signs of
kidney damage even after many years of living with diabetes.
Researchers are actively investigating the genetic factors that
influence an individual's susceptibility or resistance to
diabetic nephropathy. The Genetics of Kidneys in Diabetes
(GoKinD) Study has gathered more than 2,600 participants for
the study of the genetic risk factors for type 1 diabetes and
diabetic kidney disease. This sample and data collection will
provide a resource to facilitate investigator-driven research
into the genetic basis of diabetic kidney disease. Furthermore,
GoKinD participants form the core of a population registry that
could be recruited for future clinical trials.
--Reducing Incidence of Diabetic Neuropathy.--Two-thirds of all
diabetes patients suffer from some degree of nerve damage
affecting organs throughout the body. This condition--known as
diabetic neuropathy--results in loss of sensation, weakness, or
pain in hands or feet, carpal tunnel syndrome, pain in the eyes
or face, pain in the chest or abdomen, profuse sweating, loss
of balance or coordination, slowed digestion of food or related
gastrointestinal problems, urinary incontinence, erectile
dysfunction, and a variety of other nerve problems. The
inability to feel pain coupled with impaired wound healing
often leads to non-healing foot ulcers and, ultimately,
amputation of some part of the foot or leg. For this reason,
diabetic neuropathy is the most common cause of non-traumatic
lower limb amputation. Comprehensive foot care programs to
detect and treat skin ulcers before they progress can reduce
the rate of amputation by 45 to 85 percent.
--Understanding Susceptibility to Disease.--The Type 1 Diabetes
Genetics Consortium (T1DGC) will identify the genes responsible
for susceptibility to type 1 diabetes, leading to a better
understanding of pathways to disease. Researchers recently
confirmed the discovery of a new gene that contributes to
susceptibility to disease. The pathway controlled by this gene
implicates it in other autoimmune diseases, not just type 1
diabetes, underlining that common pathways may be involved in
the development of autoimmunity. This understanding may lead to
better diagnosis and new therapies to stop diabetes before it
ever starts.
--Identifying Environmental Causes of Type 1.--The Triggers and
Environmental Determinants of Diabetes in Youth (TEDDY) study
has screened more than 6,000 newborns to identify the
environmental causes of type 1 diabetes in genetically
susceptible individuals. Once completed, the TEDDY study will
have amassed the largest data set and samples on newborns at
risk autoimmunity and type 1 diabetes anywhere in the world.
--Investigating Vaccine to Prevent Type 1.--Recent studies in animal
models have raised the possibility that a ``vaccine'' may be
able to prevent type 1 diabetes.
--Monitoring Progression of Type 1 Onset.--Researchers have developed
a means to non-invasively monitor the start and progression of
insulitis, the inflammation of insulin producing cells, in
mice, which may allow researchers to prediction whether and
when individual people will develop type 1 diabetes in the
future.
--Regenerating of Insulin Producing Cells.--Replacement of the lost
beta cells through either transplantation of islets from an
external source or regeneration of islets within a patient's
own pancreas is required to restore physiological control of
glucose and cure type 1 diabetes. Development of regenerative
treatments to restore beta cells without transplantation will
require researchers to understand how beta cells are normally
formed in the adult pancreas, and then use that information to
identify molecular targets for drugs that can induce that
process in diabetic patients. Researchers supported by the NIH
Beta Cell Biology Consortium are now uncovering multiple
pathways by which new beta cells are formed in the body. The
work should help clarify how pancreatic beta cells develop, and
it could potentially lead to successful treatments for both
type 1 and type 2 diabetes.
--Identifying Animal Models for Complication Studies.--The Animal
Models of Diabetic Complications Consortium (AMDCC) has
identified more than 70 animal models for the study of diabetic
complications, including a number of promising models for type
1 diabetic cardiomyopathy, nephropathy and neuropathy.
Senator Specter. Thank you, Dr. Goldstein.
We now turn to Dr. Lawrence Holzman, representing the
NephCure Foundation.
STATEMENT OF LAWRENCE B. HOLZMAN, M.D., CHAIRMAN,
SCIENTIFIC ADVISORY BOARD, NEPHCURE
FOUNDATION
Dr. Holzman. Mr. Chairman and members of the subcommittee:
Despite advances in dialysis and kidney transplantation, kidney
failure remains a devastating diagnosis, carrying a survival
prognosis similar to patients diagnosed with cancer and
assuring a lifetime of severe medical complications.
NIH-sponsored investigators have been really remarkably
successful in advancing our understanding of kidney disease,
with the goal of preserving and preventing kidney functional
loss. For example, a recent revolution in our knowledge of the
biology of the kidney filter has allowed the identification of
several inherited diseases and promises to provide tools that
will better allow us to diagnose and treat kidney failure in
general.
However, cutting the NIH budget for kidney disease research
or even failing to keep up with inflationary costs threatens
present research momentum. As an investigator and as a member
of an NIH peer review committee that evaluates scientific
proposals, I can assure you that the effects of a restricted
NIH budget are already being felt. Threatened by a pay line at
which only 12 percent of grant applications are funded,
investigators are reluctant to take risks necessary to
dramatically advance the field. Delays in funding outstanding
proposals retard progress and result in loss of uniquely
trained research personnel.
PREPARED STATEMENT
Finally, despite NIH set-asides designed to protect junior
investigators, our next generation of talented young people
observe the anxiety created by funding uncertainty, make
rational economic decisions, and turn away from a career in
biomedical science.
Therefore, we ask you to provide an increase of 5 percent
in fiscal year 2007 to the NIDDK and to the NIH budget overall.
Thank you for your attention.
[The statement follows:]
Prepared Statement of Lawrence Holzman
Mr. Chairman, and members of the Subcommittee, thank you for giving
me this opportunity to come before you today. I am Dr. Lawrence
Holzman, Associate Professor of Internal Medicine and Director of the
NIH-sponsored Nephrology Training Program at the University of Michigan
Medical School. I also serve as Chairman of the Scientific Advisory
Board of the NephCure Foundation (NCF), a non-profit organization
dedicated to fighting idiopathic nephrotic syndrome and focal segmental
glomerulosclerosis (FSGS).
Fifteen million Americans have significantly impaired kidney
function and are at risk of loosing their kidney function entirely.
Another 400,000 have already lost their kidney function. Despite NIH-
sponsored advances in dialysis and kidney transplantation, kidney
failure--due to common diseases such as diabetic kidney disease or
hypertension, or due to relatively rare diseases such as focal
segmental glomerulosclerosis--remains a devastating diagnosis. Kidney
failure carries a shortened survival similar to that of many cancers
and assures a lifetime of severe medical complications. The American
people spend nearly $20 billion per year to provide medical care for
these individuals alone. Undeniably, there remains a critical need to
prevent patients from losing kidney function.
Recognizing this need, NIH-sponsored investigators have made great
strides in the basic science and clinical science of kidney disease,
progress that has begun to slow the incidence of kidney failure. For
example, during the past decade, a revolution in our understanding of
the biology of the kidney filter sparked by initial successes in
molecular genetics has allowed the identification of several inherited
diseases of the kidney filter and promises to provide tools that will
much better guide diagnosis and treatment of the patients who are
likely to lose their kidneys. Dramatic advances in our understanding of
the biology of cystic diseases of the kidney such as polycystic kidney
disease has led to promising clinical trials of medications that might
slow or prevent these diseases. For those patients that have already
lost their native kidneys to disease, NIH-sponsored research has
improved our understanding of the immune system, providing hope for
kidney transplant patients who suffer the dangerous side effects of
present day anti-rejection medications and who suffer from the
knowledge that the average kidney transplant lasts only 11 years.
Moreover, dialysis patients have improved quality of life because NIH
sponsored clinical research has taught nephrologists how to better care
for their patients.
Cutting the NIH-budget for kidney disease research, or even failing
to keep up with the inflation in costs for doing this research,
immediately threatens the research momentum that was attained by
doubling the NIH budget. As an independent investigator, and as member
of an NIH peer review committee that evaluates independent-investigator
initiated scientific proposals, I can assure you that the affects of a
restricted NIH budget are already being felt in a real but difficult to
quantify fashion. Threatened by a ``pay line'' at which only 12-14
percent of grant applications are funded (rather than 24 percent just
three years ago), investigators have become reluctant to take risks
that must be taken in their research that would dramatically advance a
field. Delays in funding outstanding proposals (because they must be
recycled through the application process several times before they are
funded) retard progress and result in the loss of talented and uniquely
trained research personnel that cannot be readily replaced. Finally,
despite NIH set asides designed to protect junior investigators, our
next generation of talented young people observe the anxiety created by
funding uncertainty, make rationale economic decisions, and turn away
from a career in biomedical science, leaving the future of this science
in jeopardy.
NIH sponsored biomedical research is an American treasure that
reaps multifold benefits; it is a treasure that must be nurtured and
protected. Therefore, we ask you to provide an increase of 5 percent in
fiscal year 2007 for the National Institute of Diabetes, Digestive, and
Kidney Diseases (NIDDK), and the NIH overall.
Thank you.
Senator Specter. Thank you, Dr. Holzman.
Our final witness on the panel is Dr. Steven Houser,
representing the American Heart Association.
STATEMENT OF STEVEN R. HOUSER, Ph.D., DIRECTOR,
CARDIOVASCULAR RESEARCH CENTER, TEMPLE
UNIVERSITY SCHOOL OF MEDICINE ON BEHALF OF
THE AMERICAN HEART ASSOCIATION
Dr. Houser. Thank you, Senator Specter and Senators Harkin
and Shelby. I am an American Heart Association volunteer for
the last 30 years. My day job is at a cardiovascular research
group at Temple University School of Medicine in North
Philadelphia. My NIH-funded research focuses on how we can fix
broken hearts so that people can live healthier, happier lives.
Thanks to your investments, I believe we are on the
threshold of making wonderful discoveries that can be
translated into novel therapies. My lab group works on a very
simple concept. We have found that in every one of your hearts
there are stem cells that are making new myocites and blood
vessels all the time. I believe that we have the opportunity to
figure out ways to take these cells from each of your hearts,
expand them, prime them to repair your heart, and save them in
case you ever need them if your heart becomes damaged.
PREPARED STATEMENT
Unfortunately, the NIH cuts are limiting my ability and the
ability of my collaborators in Pennsylvania, Iowa, which I just
visited last week, and Alabama, where I will visit in about a
month, to pursue these ideas. It is forcing me to cut my staff,
train fewer people, lay off local workers. I think this has
impact not just on science and medicine, but on the economies
of the communities and the States that we are charged to serve.
So thank you so much for all your hard work with respect to
these issues, and I would be happy to answer any questions.
[The statement follows:]
Prepared Statement of Steven R. Houser
SUMMARY OF RECOMMENDATIONS
------------------------------------------------------------------------
Agency Amount
------------------------------------------------------------------------
National Institutes of Health........................ $29,800,000,000
National Institutes of Health Heart Research..... 2,200,000,000
National Institutes of Health Stroke Research.... 357,000,000
National Heart, Lung, and Blood Institute.... 3,100,000,000
National Institute of Neurological Disorders 1,600,000,000
and Stroke..................................
Agency for Healthcare Research and Quality........... 440,000,000
Centers for Disease Control and Prevention (plus 8,500,000,000
funding for pandemic influenza preparedness)........
Heart Disease and Stroke Prevention Program...... 55,000,000
Health Resources and Services Administration: Rural 8,900,000
and Community Access to Emergency Devices Program...
Department of Education: Carol M. White Physical 100,000,000
Education Program...................................
------------------------------------------------------------------------
An estimated 71 million American adults suffer from heart disease,
stroke, and other forms of cardiovascular disease. Nearly 2,500
Americans die of cardiovascular disease each day--an average of one
death every 35 seconds. Heart disease and stroke remain the first and
third leading causes of death, respectively, for both men and women in
the United States today and more than half of men and nearly 40 percent
of women will develop cardiovascular disease during their lifetime. As
the baby boom generation ages, the prevalence of cardiovascular disease
will increase dramatically, because although this disease can strike at
any stage of life--the likelihood increases with age. Deaths from heart
disease alone are projected to increase by about 130 percent between
2000 and 2050, according to one report.
Cardiovascular disease also costs Americans an estimated $403
billion in medical expenses and lost productivity in 2006--more than
any other disease and more than the projected budget deficit for that
year. As the population ages, the combination of demographics and high
costs will result in a cardiovascular disease crisis with staggering
implications for health care costs and quality of care.
Although progress has been made in the treatment of cardiovascular
disease, there is no cure. In fact, studies suggest that increased
rates of diabetes, obesity and other risk factors may reverse four
decades of declining mortality. The most prudent way to address this
looming crisis is to simultaneously invest in prevention and in the
development of more cost-effective treatments. Regretfully, the funding
levels proposed by the President undermine efforts in both of these
areas.
When adjusted for biomedical research inflation, the proposed NIH
budget for cardiovascular disease research is estimated to be 15
percent lower in 2007 than in fiscal year 2003. Funding levels proposed
in the budget for the CDC's Heart Disease and Stroke Prevention Program
remain flat at a time when only 14 states receive the resources
necessary to implement prevention programs and strategies. In addition,
the Rural and Community Access to Emergency Devices Program,
administered by the Health Resources and Services Administration, is
terminated in the President's budget. This program provides grants to
rural areas and communities to purchase and place AEDs in schools,
churches, fire stations, and other locations to save the lives of
cardiac arrest victims.
Now is the wrong time to reduce our nation's investment in programs
that prevent and treat America's leading and most costly cause of
death. Solving a problem of this magnitude will require a significant
public investment in these fiscally challenging times, but if we fail
to take aggressive and deliberate action now--we will pay a terrible
cost later--both in terms of health care expenditures and human lives.
The following recommendations from the American Heart Association
address this problem in a comprehensive but fiscally responsible
manner.
increase funding for the national institutes of health (nih)
NIH-sponsored research has revolutionized patient care and holds
the key to an eventual cure for all forms of cardiovascular disease.
Research funded by the NIH also fuels innovation that generates
economic growth and preserves our nation's role as a world leader in
the biomedical and biotechnology industries. For fiscal year 2006, NIH
funding was cut below the previous year's level for the first time in
35 years. The President preserved this cut in his fiscal year 2007
budget and reduced NIH further over the next five years by nearly 20
percent. This five year cut reduces NIH resources in inflation adjusted
terms by more than one-third from its peak in fiscal year 2003--the end
of the historical five-year doubling of the NIH budget.
Recommendation.--The AHA joins the research and patient advocacy
community in recommending an fiscal year 2007 appropriation of $29.8
billion for the NIH. This level, which represents a 5 percent increase
over 2006, covers the increased costs of biomedical research inflation
and provides additional resources to investigate emerging research
opportunities.
increase funding for nih heart and stroke research
From 1993-2003, death rates from cardiovascular diseases have
fallen by 22 percent, death rates from coronary heart disease have
declined by 30 percent, and death rates from stroke have fallen by 19
percent. NIH sponsored heart and stroke research has improved health
outcomes and in some cases, lowered health care costs. Examples of
recent NIH-supported research follow.
Aspirin Prevents Another Type of Stroke.--Aspirin is as effective
as, and safer than, the blood thinning drug warfarin in preventing
intracranial arterial stenosis--which accounts for roughly 10 percent
of all strokes. Aspirin is a low cost therapy that does not require the
intricate and costly monitoring like the drug warfarin. Researchers
estimate that use of aspirin rather than warfarin could cut health care
costs by $20 million each year.
Blood Test to Screen for Stroke Wins FDA Approval.--A blood test to
screen for heart disease gained approval to predict stroke risk. The
test scans the blood for levels of the enzyme lipoprotein-associated
phospholipase A2, which are higher in potential stroke victims.
Diuretics Again Initial Therapy for High Blood Pressure.--
Continuing analyses of the Antihypertensive and Lipid-Lowering
Treatment to Prevent Heart Attack Trial (ALLHAT) for diabetics, blacks
and non-blacks with high blood pressure confirms, the initial
conclusion that diuretics should be the initial high blood pressure
treatment instead of newer, more costly drugs.
Antibiotics do not Prevent Second Cardiovascular Events.--Results
of clinical trials have shown that antibiotics are ineffective in
preventing second events like heart attack, unstable chest pain and
stroke in patients with existing heart disease. This finding was
unanticipated.
Slightly Elevated Blood Pressure Triples Heart Attack Risk.--
Examining data from the Framingham Heart Study, researchers found that
the 59 million Americans with prehypertension, blood pressures ranging
from 120-139 over 80-89 mm Hg, are three times more likely to suffer a
heart attack and nearly twice as likely to experience heart disease
than those with normal blood pressure. Scientists estimate that
aggressive treatment would prevent 47 percent of heart attacks.
Although cardiovascular disease is the leading cause of death in
the United States, the NIH heart and stroke research budget remains
disproportionately under-funded compared to the burden of these
diseases on society. Cardiovascular disease meets NIH's priority
setting criteria (public health needs, scientific quality of research,
scientific progress potential, portfolio diversification and adequate
infrastructure support), yet only 7 percent of the NIH budget is
invested in heart research and a mere 1 percent is dedicated to stroke.
Adjusted for medical research inflation, resources for cardiovascular
research will decline 15 percent since fiscal year 2003 if the
President's budget is enacted. These declining resources are
insufficient to support and expand current activities and to invest in
promising initiatives to aggressively advance the battle against heart
disease and stroke. Additional funds would be used in the following
areas:
Atherosclerosis Prevention Trial Network.--Atherosclerosis is a
major risk factor for heart disease and stroke. With increased funding,
the National Heart, Lung, and Blood Institute (NHLBI) could initiate a
clinical trial to determine whether reducing low-density lipoprotein
cholesterol, so-called ``bad'' cholesterol, to a level lower than
currently recommended, reduces major cardiovascular disease events in
healthy patients at high risk of heart disease and or stroke.
Systolic Blood Pressure Intervention Trial.--High blood pressure is
a major risk factor for heart disease, heart failure and stroke. More
funding would allow the NHLBI to conduct a multicenter clinical trial
to determine whether reducing systolic blood pressure to a lower level
than currently recommended could prevent heart attacks and strokes.
Preventing Weight Gain in Young Adults.--Young adults are at a high
risk for weight gain. With more resources, NHLBI could develop and test
innovative practical, cost-effective ways to prevent weight gain in
young adults to prevent cardiovascular disease.
Stroke is the No. 3 killer of Americans and a major cause of
permanent disability. In addition to the elderly, stroke also strikes
newborns, children and young adults. An estimated 700,000 Americans
will suffer a stroke this year, and nearly 158,000 will die. Many of
America's 5.5 million stroke survivors face debilitating physical and
mental impairment, emotional distress and huge medical costs; about 1
in 4 survivors are permanently disabled.
As a result of fiscal year 2001 Congressional report language, the
National Institute of Neurological Disorders and Stroke (NINDS)
convened a Stroke Progress Review Group. A report from this group
provides a long-range stroke strategic plan for stroke research that
includes 5 research priorities and 7 resource priorities. Multiple
scientific programs initiated since the report have made impressive
progress; however, additional funding is needed to implement the plan.
The fiscal year 2007 estimate for NINDS stroke research falls 50
percent short of the target for implementation of that year of the
plan. Additional funds would be used to conduct stroke research in the
following areas:
Stroke Translational Research.--Translational studies are vital to
providing cutting-edge stroke treatment and prevention. Due to budget
shortfalls, the NINDS has been forced to compress its Specialized
Programs of Translational Research in Acute Stroke (SPOTRIAS) from the
planned 10 extramural centers to the five currently funded. SPOTRIAS
researchers facilitate translation of basic research into patient care
and evaluate and treat victims rapidly after the onset of stroke
symptoms.
Neurological Emergencies Treatment Trials Network.--Limited
resources will also force the NINDS to scale back its Neurological
Emergencies Treatment Trials Network. This initiative is designed to
develop a clinical research network of emergency medicine physicians,
neurologists and neurosurgeons to develop more and improved treatments
for acute neurological emergencies, such as stroke, through clinical
trials.
Stroke Education.--As a member of the Brain Attack Coalition--a
group of organizations devoted to fighting stroke--the AHA works with
the NINDS to increase public awareness of stroke symptoms and the need
to call 9-1-1. Together, we initiated a public education campaign, Know
Stroke: Know the Signs, Act in Time, and we are striving to develop
systems to make tPA available to appropriate patients. In partnership
with the CDC, the NINDS extended this campaign to launch a grassroots
program called Know Stroke in the Community to enlist the aid of
``Stroke Champions'' who educate communities about stroke signs and
symptoms. When these measures are implemented, stroke treatment will
shift from supportive care to early brain-saving intervention.
Additional funds are needed to educate the public and health providers
about stroke.
Recommendation.--The AHA recommends an fiscal year 2007
appropriation of $2.2 billion for NIH heart research. We advocate for
an appropriation of $3.068 billion for the NHLBI. And, we recommend
$357 million for NIH stroke research. We advocate for an appropriation
of $1.612 billion for the NINDS. These appropriations represent a 5
percent increase over fiscal year 2006--commensurate with the
Association's overall recommended funding increase for the NIH.
increase funding at the centers for disease control (cdc)
Basic research must be translated into easy-to-understand guidance
so that people can apply it to their daily lives. Prevention is the
best way to protect Americans' health and ease the financial burden of
disease. Although the clinical literature indicates that increased and
improved cardiovascular disease interventions can be highly successful,
investigators have concluded that well-established strategies for
combating cardiovascular disease are often not being implemented.
Recent studies suggest that not smoking, maintaining a healthy weight,
and avoiding diabetes, high blood pressure and high cholesterol, may
add 10 years to life.
The AHA commends Congress for supporting CDC's new Division for
Heart Disease and Stroke Prevention, which provides funding to 33
states to create programs to educate and prevent first and second
instances of heart disease and stroke. These state-tailored programs
facilitate collaboration among public and private sector partners to
help individuals control high blood pressure, lower elevated
cholesterol, learn heart disease and stroke signs and symptoms, call 9-
1-1, improve emergency response and quality of care, and eliminate
treatment disparities. Many of these programs have been successful in
reducing risk factors--like high blood pressure.
In fiscal year 2006, only 14 states received funding to implement
these prevention programs. The remaining 19 states received funds for
planning; which is now largely complete. Because cardiovascular disease
remains the No. 1 killer in every state, each state needs basic
implementation money for this program. However, current funding levels
will not allow for the expansion of this program.
Recommendation.--For fiscal year 2007, the AHA recommends an
appropriation of $8.5 billion plus funding for pandemic influenza
preparedness for the CDC, including a 10 percent increase over current
funding to return chronic disease prevention to the same level as
fiscal year 2002. Within that total, we recommend $55 million to expand
the Heart Disease and Stroke Prevention Program. This funding level
would allow the CDC to add up to 4 states to the program, allowing them
to conduct a state-tailored plan, and elevate 4 more states from
planning to program implementation, maintain the Paul Coverdell
National Acute Stroke Registry, and start the development of a state-
based cardiac arrest registry.
restore funding for the rural and community access to emergency devices
program
The Rural and Community Access to Emergency Devices Program
provides grants to states to train lay rescuers and first responders to
use AEDs and buy and place them where cardiac arrests are likely to
occur. During the first year of the program, 6,400 AEDs were purchased
and 38,800 individuals were trained. AEDs have been placed in schools,
faith-based and recreation facilities, nursing homes, and other
locations in communities across our nation.
About 94 percent of cardiac arrest victims die outside of a
hospital. Immediate CPR and early defibrillation using an automated
external defibrillator (AED) can more than double a victim's chance of
survival. Small, easy-to-use AEDs can shock the heart back into normal
rhythm. Placing AEDs in more public settings could save thousands of
lives each year. Communities with comprehensive AED programs that
include training of anticipated rescuers have achieved survival rates
of 40 percent or higher.
The Rural and Community Access to Emergency Devices Program is
terminated in the President's fiscal year 2007 budget. The budget
justification asserts that much of the demand for AEDs has been met,
although between fiscal year 2002 and fiscal year 2004 less than half
of the grant dollars requested by states for this lifesaving program
were actually awarded.
Recommendation.--For fiscal year 2007, the AHA recommends that the
Subcommittee allocate $8.927 million for HRSA's Rural and Community
Access to Emergency Devices Program to restore funding to its fiscal
year 2005 level.
increase funding for the agency for healthcare research and quality
(ahrq)
The AHRQ is a critical partner with the public and private health
care sectors. This agency helps develop evidence-based information
needed by consumers, providers, health plans and policymakers to
improve health care decision making. Through its Effective Health Care
Program, AHRQ supports research focusing on outcomes, comparative
clinical effectiveness, and appropriateness of pharmaceuticals, devices
and healthcare services for a number of conditions, including ischemic
heart disease, stroke, and high blood pressure. The new research and
comparative effectiveness reviews conducted and funded under this
program will help address issues raised in the Institute of Medicine's
(IOM) report: Crossing the Quality Chasm.
The AHRQ's initiative on health information technology (HIT) is a
key element to the nation's strategy to bring health care into the 21st
century. This initiative includes more than $166 million in grants, and
through these and other projects, AHRQ and its partners will help to
identify challenges to HIT adoption and use, solutions and best
practices, and tools that will help hospitals and clinicians
successfully incorporate new HIT. To facilitate this effort, the AHRQ's
National Resource Center for HIT provides the health care community
with technical assistance and consulting services to HIT projects, and
particularly focus on addressing challenges to HIT implementation in
rural and small community settings.
Recommendation.--The AHA joins with the Friends of AHRQ in
advocating for an appropriation of $440 million for the AHRQ to advance
health care quality, cut medical errors and expand the availability of
health outcomes information.
increase funding for the carol m. white physical education program
(pep)
Physical inactivity is a key risk factor for heart disease and
stroke, but Youth Risk Behavior Surveillance data indicates that almost
half of 12-21 year olds do not participate in any vigorous physical
activity on a regular basis. Despite recent studies by Action for
Healthy Kids and the Robert Wood Johnson Foundation showing that almost
80 percent of parents support daily physical education (PE) in schools
to help combat physical inactivity and teach life long skills, only 6-8
percent of schools nationally offer daily PE. One of the primary
barriers to providing PE is adequate financial resources for equipment,
program development, and staff training. The Carol M. White Physical
Education Program helps schools overcome this barrier by providing
money for school-based physical education activities that teach life-
long physical activity habits. PEP is the only federal program that
directly supports PE in schools.
Recommendation.--For fiscal year 2007, the AHA recommends an
appropriation of $100 million for the Carol M. White Physical Education
Program. This level of funding will allow the Department of Education
to expand the program to more districts while maintaining funding for
the duration of previously awarded grants.
Although heart disease, stroke, and other cardiovascular disease
are largely preventable, these diseases continue to exact a deadly toll
on our nation. As baby boomers age, our nation faces an expanding
cardiovascular disease crisis unless significant steps are taken. We
urge the subcommittee to consider these recommendations for the fiscal
year 2007 budget. Adequate funding of research, treatment and
prevention programs will save lives and reduce rising health care
costs.
Senator Specter. Thank you very much, Dr. Houser.
Senator Harkin, do you have any comment or question?
Senator Harkin. Just one. I have a lot of questions for the
panel, but just one that I just want to ask Dr. Goldstein. Give
us just a few seconds on your view on the potential of stem
cell, embryonic stem cell research to benefit juvenile
diabetes, type 1 diabetes?
Dr. Goldstein. We are extremely bullish, Senator Harkin, on
the potential to create insulin-secreting cells that are fully
functional and respond to glucose. Work has already carried the
human embryonic stem cell work to the point of producing
endoderm, which is the tissue that then can create the
pancreas. Investigators in animal studies can instruct endoderm
to make pancreas. If we can make pancreas, that will give us
the precursor cells for beta cells and insulin-secreting cells.
So we are extremely, extremely optimistic and wish the work
could go forward with full speed.
Senator Harkin. Thank you.
Senator Specter. Senator Shelby, any comment or question?
Senator Shelby. Yes.
Is anyone on the panel dealing in the autoimmune area,
especially dealing with lupus or lupus-related? Dr. Holzman, do
you want to comment on where we are going? You heard the first
panel earlier.
Dr. Holzman. Actually, in this regard I am more the
clinician dealing with patients on the front lines.
Senator Shelby. That is very important, the clinical work.
Dr. Holzman. I am a nephrologist, a person who deals with
kidney disease, and see many of the most complicated patients
with lupus and kidney disease. I can tell you first that these
are patients who suffer dramatically, that their lives are
spent worrying about not only dealing with the current flare,
the current problem, but the probability that the disease will
recur.
I should say that, thanks to big investments by the NIH in
clinical trials, there actually have been some new drugs, drugs
that have actually been around for a while but now are proven
safer and actually as effective as earlier, more dangerous
drugs, such as cyclophosphamide. We are now using
microphenalate moftil as a first-line drug for kidney lupus and
with I think fairly good success.
Senator Shelby. So you see a lot of hope there?
Dr. Holzman. I see a lot of hope there. I think that we
need to further invest using the latest technology and
translational studies in this area.
Senator Shelby. Thank you.
Thank you, Mr. Chairman.
Senator Specter. Thank you, Senator Shelby.
Thank you very much, ladies and gentlemen.
Senator Shelby. I think Dr. Goldstein was going to say
something.
Dr. Goldstein. Real quickly, Senator Shelby. I would just
like to repeat something that Dr. Fauci said: the support of
the Immune Tolerance Network, which is a clinical trial
translation platform for autoimmune diseases, including lupus,
type 1 diabetes, and others. We learn from each other, from the
science. Choking that funding off is going to eliminate the
possibility to do those cutting edge clinical trials.
Senator Shelby. Thank you.
Thank you.
Senator Specter. Thank you very much, ladies and gentlemen.
We very much appreciate your coming in.
We now turn to panel three: Dr. Daniel Koo, Dr. Phil
Landrigan, Mr. Emeran Mayer, Dr. Peter McDonnell, Ms. Sandra
Raymond, Mr. Herman Taylor, Ms. Suzanne Vogel-Scibilia.
Our first witness is Dr. Daniel Koo, represent the Deaf and
Hard of Hearing Alliance, and Dr. Koo is accompanied by an
interpreter. Dr. Koo, we begin with you.
STATEMENT OF DANIEL KOO, M.D., ON BEHALF OF THE DEAF
AND HARD OF HEARING ALLIANCE
Dr. Koo [speaks through a sign language interpreter]. Mr.
Chairman, members of the Subcommittee of Senate Appropriations:
On behalf of the member organizations of the Deaf and Hard of
Hearing Alliance----
Senator Harkin. Excuse me. Could you speak into that just a
little bit louder. I am having a hard time.
Senator Specter. Senator Thurmond always would say: Bring
the machine a little closer.
Dr. Koo. Mr. Chairman and members of the Senate
Appropriations Subcommittee: On behalf of the member
organizations of the Deaf and Hard of Hearing Alliance, a
coalition of professional and consumer organizations serving
and representing people who are deaf and hard of hearing, it is
my pleasure to be here with you this morning to discuss the
President's budget request for NIH's National Institute on
Deafness and Other Communication Disorders.
My name is Dr. Koo. I am a postdoctoral fellow at
Georgetown University conducting neuroimaging studies on
language and literacy, supported by NIDCD.
Fiscal year 2007's budget request for NIDCD is $1.9 million
less compared to the fiscal year 2006 appropriation. The DHHA
strongly urges Congress not to impose further cuts in NIH or
NIDCD research funding and that Congress and the administration
work together to ensure appropriate funding that does not
compromise current and future research efforts. The DHHA
applauds current research being conducted related to people who
are deaf and hard of hearing, specifically the strategies to
protect hearing, diagnose and prevent hearing loss, and explore
genetic modifiers.
However, we urge the NIDCD to continue to pursue and
support studies that delve into the acquisition and learning of
oral and-or visual languages, the various communication modes
and educational settings.
Cutting the funding most assuredly will prevent the
expansion of research in this critical area of need. Funding
support for NIDCD to date has allowed many scientists, like
myself, to make significant advances in hearing research as
well as related sensory and cognitive areas. With congressional
support, the NIDCD can continue its important research that
aids in preventing hearing loss as well as assisting those who
are deaf or hard of hearing.
PREPARED STATEMENT
With hearing loss expected to reach 40 million Americans
within the next generation, scientific work taking place at NIH
and NIDCD is too critical to the human condition to take a step
backward at this time.
Thank you.
[The statement follows:]
Prepared Statement of Daniel Koo
On behalf of the member organizations of the Deaf and Hard of
Hearing Alliance, a coalition of professional and consumer
organizations serving and representing people who are deaf or hard of
hearing, it is my pleasure to be here with you this morning to discuss
the President's budget request for the National Institutes of Health,
specifically the National Institute on Deafness and Other Communication
Disorders (NIDCD).
My name is Daniel Koo. I am a post-doctoral fellow at Georgetown
University conducting neuron-imaging studies on language and literacy
supported by NIDCD.
The fiscal year 2007 budget request for NIDCD is $391,556,000, a
decrease of $1,902,000 compared to the fiscal year 2006 Appropriation.
The DHHA strongly urges Congress not to impose further cuts in NIH or
NIDCD research funding, and we ask that Congress and the Administration
work together to ensure appropriate funding to ensure that current and
future research efforts are not compromised. With hearing loss expected
to affect 40 million within one generation, there has never been a time
when research has been needed so much.
The DHHA applauds the current research being conducted related to
people who are deaf or hard of hearing, specifically the strategies to
protect hearing, diagnose and prevent hearing loss, and explore genetic
modifiers. However, we urge NIDCD to continue to pursue and support
studies that delve into the acquisition and learning of oral and/or
visual languages the necessary precursor to a variety of communication
modes and settings. Cutting the funding will most assuredly prevent the
expansion of research in this critical area of need.
Funding support for NIDCD to date has allowed many scientists like
myself to make significant advances in hearing research, as well as
related sensory and cognitive areas that impact the human condition.
With Congressional support the NIDCD can continue its important
research that aids in preventing hearing loss as well as assisting
those who are deaf or hard of hearing. The work taking place at NIH and
NIDCD is too critical to the human condition to take a step backward at
this time.
Members of the Deaf and Hard of Hearing Alliance include: Alexander
Graham Bell, Association for the Deaf & Hard of Hearing, American
Academy of Audiology, American Academy of Otolaryngology-Head and Neck
Surgery, American Speech-Language-Hearing Association, Conference of
Educational Administrators of Schools & Programs for the Deaf, Council
of American Instructors of the Deaf, Cued Language Network of America,
Deafness Research Foundation, Hearing Loss Association of America,
Media Access Group at WGBH, National Association of the Deaf, National
Cued Speech Association, Registry of Interpreters for the Deaf,
Testing, Evaluation, and Certification Unit, and Telecommunications for
the Deaf, Inc.
Senator Specter. Thank you very much, Dr. Koo.
We now turn to Dr. Philip Landrigan, representing the
Campaign for American Children's Health. Dr. Landrigan.
STATEMENT OF PHILIP J. LANDRIGAN, M.D., MSc, FAAP,
PRESIDENT, CAMPAIGN FOR AMERICAN CHILDREN'S
HEALTH
Dr. Landrigan. Good morning, Senator Specter, Senator
Harkin, Senator Shelby. I'm Philip Landrigan, pediatrician at
Mount Sinai Medical School in New York City, and I thank you
for inviting me here this morning to come to speak in support
of the National Children's Study.
I'd like first of all to thank all of you for the great
support that you've given the National Children's Study over
the past 6 years since its inception in 2000, and thanks most
particularly for the discussion that you had in support of the
study just a few minutes ago this morning.
The reason that this Nation needs the National Children's
Study is that the children's study will give us information on
the preventable environmental causes of the major diseases that
afflict American children today--asthma, which has more than
doubled; childhood brain cancer has gone up 40 percent; autism,
you heard a few minutes ago has gone up remarkably; other
learning disabilities.
It's been said that the study is expensive and it is. But
the diseases, the chronic diseases that the study will address,
cost this Nation more than $600 billion a year. The very same
logic that Dr. Zerhouni invoked this morning when he spoke of
the great declines that have been achieved in heart disease
because of the Framingham study, the women's health initiative,
that same logic applies to the National Children's Study, and
it's ironic that I chose to include the same image in my
testimony as he used in his screen presentation this morning.
PREPARED STATEMENT
If we fail to fund the National Children's Study it will be
a major opportunity lost. The National Children's Study is our
generation's best hope, indeed probably our only hope, to get
on top of the chronic diseases in America's children.
I thank you.
[The statement follows:]
Prepared Statement of Philip J. Landrigan
Good morning, Mr. Chairman and Members of the Subcommittee. I am
Dr. Philip J. Landrigan. I am a pediatrician, Professor and Chairman of
Community & Preventive Medicine, and Professor of Pediatrics at the
Mount Sinai School of Medicine. I am Principal Investigator for the
Queens, New York Vanguard Center of the National Children's Study. I am
also President of the Campaign for American Children's Health, a not-
for-profit organization committed to preserving the health of America's
children by sustaining the National Children's Study.
Why Do We Need the National Children's Study? The United States
needs the National Children's Study because we desperately need the
information the Study will provide on preventable causes of the major
diseases that confront America's children today. Information from the
National Children's Study will provide a blueprint for prevention. The
diseases of greatest current concern in American children are:
--Asthma, which has more than doubled in frequency since 1980 and
become theleading cause of pediatric hospitalization and school
absenteeism;
--Birth defects, which are now the leading cause of infant death.
Certain birthdefects, such as hypospadias, have doubled in
frequency;
--Neurodevelopmental disorders--autism, dyslexia, mental retardation,
and attention deficit/hyperactivity disorder (ADHD). These
conditions affect 5-10 percent of the 4 million babies born
each year in the United States. Reported rates ofautism are
increasing especially sharply--more than 20 percent per year;
--Leukemia and brain cancer in children and testicular cancer in
adolescents. Incidence rates of these malignancies have
increased since the 1970s, despite declining rates of
mortality. Testicular cancer has risen by 55 percent, and
primarybrain cancer by 40 percent. Cancer is now the second
leading cause of death in American children, surpassed only by
traumatic injuries;
--Preterm birth, which has increased in incidence by 27 percent since
1981;
--Obesity and its consequence, type 2 diabetes. Obesity has trebled
in prevalencein the United States. Obesity has become common in
even the youngest of our children, and for example, 41 percent
of 5-year-olds entering kindergarten in the five boroughs of
New York City in 2005 were overweight or frankly obese. The
future toll of disease and premature death in these
youngsters--from diabetes, heart disease, stroke and probably
cancer--will be fearsome.
We have a responsibility to safeguard our children. They are the
most vulnerable among us, our most precious resource, and the hope for
our future. But these rapidly rising rates of chronic disease threaten
the health of our children and the future security of our nation.
Indeed, concern is strong among the pediatric community that these
rapidly rising rates of disease may create a situation unprecedented in
the 200 years of our nation's history, in which our current generation
of children may be the first American children ever not to enjoy a
longer life span than the generation before them. In other words, if we
do not support the necessary research--especially the National
Children's Study--and if we fail to take needed preventive action, we
are actually at risk of losing hard-won ground in children's health.
What is the National Children's Study?--The National Children's
Study is a prospective multi-year epidemiological study that will
follow 100,000 American children, a nationally representative sample of
all children born in the United States, from conception to age 21. The
study will assess and evaluate the environmental exposures these
children experience in the womb, in their homes, in their schools and
in their communities. It will seek associations between environmental
exposures and disease in children. The diseases of interest include all
those listed above. The principal goal of the Study is to identify the
preventable environmental causes of pediatric disease and to translate
those findings into preventive action and improved health care.
The National Children's Study was mandated by Congress through the
Children's Health Act of 2000. The lead federal agency principally
responsible for the Study is the National Institute of Child Health and
Human Development. Other participating agencies include the National
Institute of Environmental Health Sciences, the Environmental
Protection Agency, and the Centers for Disease Control and Prevention.
By working with pregnant women and couples, the Study will gather
an unprecedented volume of high-quality data on how environmental
factors acting either alone, or in combination with genetic factors,
affect the health of infants and children. Examining a wide range of
environmental factors--from air, water, and dust to what children eat
and how often they see a doctor--the Study will help develop prevention
strategies and cures for a wide range of childhood diseases. By
collecting data nationwide the study can test theories and generate
hypotheses that will inform biomedical research and he care of young
patients for years to come. Simply put, this seminal effort will
provide the foundation for children's healthcare in the 21st Century.
The Unique Strengths of the National Children's Study.--Six aspects
of the architecture of the National Children's Study make it a uniquely
powerful tool for protecting the health of America's children:
1. The National Children's Study is prospective in its Design.--The
great strength of the prospective study design is that it permits
unbiased assessment of children's exposures in real time as they
actually occur, months or years before the onset of disease or
dysfunction. Most previous studies have been forced to rely on
inherently inaccurate retrospective reconstructions of past exposures
in children who were already affected with disease. The prospective
design obviates the need for recall. It is especially crucial for
studies that require assessments of fetal and infant exposures, because
these early exposures are typically very transitory and will be missed
unless they are captured as they occur.
2. The National Children's Study Will Employ the Very Latest Tools
of Molecular Epidemiology.--Molecular epidemiology is a cutting-edge
approach to population studies that incorporates highly specific
biological markers of exposure, of individual susceptibility and of the
precursor states of disease. Especially when it is embedded in a
prospective study, molecular epidemiology is an extremely powerful
instrument for assessing interactions between exposures and disease at
the level of the individual child.
3. The National Children's Study Will Incorporate State-of-the-Art
Analyses of Gene-Environment Interactions.--Recognition is now
widespread that gene-environment interactions are powerful determinants
of disease in children. These interactions between the human genome and
the environment start early in life, affect the health of our children,
and set the stage for adult disorders. The heroic work of decoding the
human genome has shown that only about 10-20 percent of disease in
children is purely the result of genetic inheritance. The rest is the
consequence of interplay between environmental exposures and
genetically determined variations in individual susceptibility.
Moreover, genetic inheritance by itself cannot account for the sharp
recent increases that we have seen in incidence of pediatric disease.
4. The National Children's Study Will Examine a Nationally
Representative Sample of American Children.--Because the 100,000
children to be enrolled in the Study will be statistically
representative of all babies born in the United States during the five
years of recruitment, findings from the Study can be directly
extrapolated to the entire American population. We will not need to
contend with enrollment that is skewed by geography, by socioeconomic
status, by the occurrence of disease or by other factors that could
blunt our ability to assess the links between environment and disease.
5. Environmental Analyses in the National Children's Study will be
conducted at the Centers for Disease Control and Prevention.--The CDC
laboratories in Atlanta are the premier laboratories in this nation and
the world for environmental analysis. Because the testing will be done
at CDC it will be the best available, and the results will be
unimpeachable.
6. Samples Collected in the National Children's Study Will be
Stored Securely and Will be Available for Analysis in the Future.--New
tests and new hypotheses will undoubtedly arise in the years ahead.
Previously unsuspected connections will be discovered between the
environment, the human genome and disease in children. The stored
specimens so painstakingly collected in the National Children's Study
will be available for these future analyses.
The Current State of the National Children's Study.--Congress has
already laid a firm foundation for the National Children's Study.
Between 2000 and 2005, the Congress invested more than $55 million to
design the study and begin building the nationwide network necessary
for its implementation.
Seven Vanguard Centers and a Coordinating Center were designated in
2005 at sites across the nation--in Pennsylvania, New York, North
Carolina, Wisconsin, Minnesota, South Dakota, Utah and California--to
test the necessary research guidelines--with plans to expand the
program to 38 states and 105 communities nationwide.
The tough job of designing and organizing is nearly complete.
Funding for the Study this year will permit researchers to begin
achieving the results that will make fundamental improvements in the
health of America's children.
To abandon the Study at this point would mean forgoing all of that
dedication, all of that incredible effort, and all of the logistical
preparation.
The Study Will More Than Pay for Itself.--The National Children's
Study will yield benefits that far outweigh its cost. It will be an
extraordinarily worthwhile investment for our nation, and it can be
justified even in a time of fiscal stress such as we face today.
Six of the diseases that are the focus of the Study (obesity,
injury, asthma, diabetes, autism and schizophrenia) cost America $642
billion each year. If the Study were to produce even a 1 percent
reduction in the cost of these diseases, it would save $6.4 billion
annually, 50 times the average yearly costs of the Study itself.
But in actuality, the benefits of the National Children's study
will likely be far greater than a mere 1 percent reduction in the
incidence of disease in children. The Framingham Heart Study, upon
which the National Children's Study is modeled, is the prototype for
longitudinal medical studies and the benefits that it has yielded have
been enormous.
The Framingham Study was launched in 1948, at a time when rates of
heart disease and stroke in American men were skyrocketing, and the
causes of those increases were poorly understood. The Framingham Study
used path-breaking methods to identify risk factors for heart disease.
It identified cigarette smoking, hypertension, diabetes, elevated
cholesterol and elevated triglyceride levels as powerful risk factors
for cardiovascular disease. These findings contributed powerfully to
the 42 percent reduction in mortality rates from cardiovascular disease
that we have achieved in this country over the past 5 decades (see
Figure, next page).
The data from Framingham have saved millions of lives--and billions
of dollars in health care costs. The National Children's Study, which
will focus on multiple childhood disorders, could be even more
valuable.
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
The National Children's Study will Yield Benefits in the Near-Term
Future.--We do not need to wait 21 years for benefits to materialize
from the National Children's Study. Valuable information will become
available in a few years' time, as soon as the first babies in the
Study are born.
Consider, for example, data on premature births. The rate of U.S.
premature births in 2003 was 12.3 percent, far higher than the 7
percent rate in most western European countries. Hospital costs
associated with a premature birth average $79,000, over 50 times more
than the average $1,500 cost for a term birth. Just a 5 percent
reduction in rates of prematurity would cut hospital costs by $1.6
billion annually. Within just two years, that savings would match the
full cost of the Study.
The Study Enjoys Broad Support.--The Study enjoys a broad group of
supporters, including The American Academy of Pediatrics; Easter Seals;
the March of Dimes; the National Hispanic Medical Association; the
National Association of County and City Health Officials; the National
Rural Health Association; the Association of Women's Health, Obstetric
and Neonatal Nurses; United Cerebral Palsy; the Spina Bifida
Association of America; and the United States Conference of Catholic
Bishops, just to name a few. This broad and diverse group recognizes
the overwhelming benefits this Study will produce for America's
children.
Congress Should Fully Fund the National Children's Study.--Congress
first authorized the National Children's Study in 2000, and has
appropriated $55 million since then to design the Study, complete
preparatory research, and designate the seven Vanguard sites that will
conduct preliminary testing.
This has been a wise investment that should not be abandoned just
as the Study is about to bear fruit. Unfortunately, the Administration
has not provided continued funding in the fiscal year 2007 budget, a
decision which threatens to squander the investment already made and to
throw away the multi-generational benefits the Study will yield.
Funding for the Study this year requires a commitment of $69
million. These funds will be used to begin enrolling children in the
study. They will enable the NIH to continue establishing the 105 study
sites around the country. We urge Congress to fully fund the National
Children's Study. It is an investment in our children--and in America's
future.
The National Children's Study will give our nation the ability to
understand the causes of chronic disease that cause so much suffering
and death in our children. It will give us the information that we need
on the environmental risk factors and the gene-environment interactions
that are responsible for rising rates of morbidity and mortality. It
will provide a blueprint for the prevention of disease and for the
enhancement of the health in America's children today and in the
future. It will be our legacy to the generations yet unborn.
Thank you. I shall be pleased to answer your questions.
Senator Specter. Thank you very much, Dr. Landrigan.
We now turn to Dr. Emeran Mayer, representing the Digestive
Disease National Coalition. Dr. Mayer.
STATEMENT OF EMERAN A. MAYER, M.D., ON BEHALF OF THE
DIGESTIVE DISEASE NATIONAL COALITION
Dr. Mayer. Thank you, Senators Specter, Harkin, and Shelby,
for this opportunity. I'm here on behalf of the Digestive
Disease National Coalition, representing the International
Foundation for Functional Gastrointestinal Disorders. I'm a
gastroenterologist and director of an NIH-funded research
center at UCLA dedicated to the study of functional
gastrointestinal disorders.
These disorders, specifically irritable bowel syndrome, or
IBS, are the most common GI disorders in society. They're
characterized by chronic abdominal pain and discomfort and
affect women disproportionally. IBS's health care costs are $2
billion annually and exceed $20 billion when indirect costs are
included. Yet the cause of this disorder remains incompletely
understood.
During the past 10 years, NIDDK has helped advance
biomedical research in the field, bringing us within reach for
the first time of several IBS treatments with great potential.
The NIDDK is embarking on a strategic planning process for
digestive diseases in which IBS will be a critical component.
This is essential to advance our understanding, improve
treatments, and recruit new investigators for the disease.
The President's proposed cuts to NIH will have a
detrimental impact on research advancements in digestive
diseases and specifically in IBS. Such cuts would slow our
understanding of pathophysiological mechanisms and effective
treatments, slow or eliminate pivotal clinical trials, and
prevent the pharmaceutical industry to develop new treatments,
and most importantly reduce the number of established
investigators and send a shock wave to young investigators
considering entering into this field.
PREPARED STATEMENT
It is therefore essential to continue our investment into
these programs that hold such promise at this point. I urge you
therefore to prevent the proposed NIH budget cuts and to
prevent the likely unraveling of all the progress that has been
made during the past decade.
Thank you for the opportunity to testify.
[The statement follows:]
Prepared Statement of Emeran A. Mayer
Chairman Specter and members of the Subcommittee, thank you for the
opportunity to present testimony before you today on the effect that
the President's fiscal year 2007 budget for the National Institutes of
Health (NIH) will have on functional gastrointestinal and motility
disorders research. My name is Dr. Emeran A. Mayer and I am here today
representing the International Foundation for Functional
Gastrointestinal Disorders' (IFFGD) Board of Directors and the IFFGD
Advisory Board on behalf of the Digestive Disease National Coalition
(DDNC). I am the Director of the UCLA Center for Neurovisceral Sciences
& Women's Health (CNS), a translational research program recently
funded by the NIH that is currently viewed as the leading integrated
research program in the world in the area of functional digestive
disorders.
Functional gastrointestinal disorders, specifically irritable bowel
syndrome or IBS, and motility disorders are the most common
gastrointestinal disorders experienced in society and are present in
about 25 percent of the U.S. population. The impact on the healthcare
system and society in general is substantial. These disorders comprise
about 40 percent of gastrointestinal problems for which patients seek
health care and the frequency of work absenteeism as a result of these
disorders is second only to the common cold. IBS health care costs to
society are $2 billion annually and exceed $19 billion when indirect
factors such as loss of work and productivity are considered. Although
the cause of IBS is incompletely understood, we do know that this
disorder needs a multidisciplinary approach in research and often
treatment, in order to help the millions of patients suffering across
the country.
New knowledge on the mechanisms of these disorders, in particular
in terms of dysregulation of the elaborate interactions between the
nervous system and the digestive system, has resulted in
neurophysiological and neuropharmacological investigations which have
the potential to produce new pharmaceutical agents as well as disease
management programs for treatment of these disorders.
The National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) has been supporting research into the basic and
translational mechanisms of functional GI disorders including IBS, in
terms of individual research grants (R-01), career development grants
to young investigators (K awards), and major support of two research
centers, including our own at UCLA. These efforts during the past 10
years have been essential in advancing biomedical research in the field
and, for the first time, bringing us within reach of several novel
pharmacological treatments with great potential for IBS. The NIDDK is
in the process of embarking on a strategic planning process for
digestive diseases, and IBS will be a critical component of this plan.
Strategic planning is essential to advancing our understanding of this
disease, determining improved treatment options for IBS sufferers, and
assisting in the recruitment of new investigators to conduct IBS
research.
Cutting the budget for the NIH, as is proposed in the President's
fiscal year 2007 budget, will have a detrimental impact on the research
advancements in this important disease area that have been accomplished
during the past several years. Specifically, such cuts would have an
immediate impact in the following areas:
--It will slow the elucidation of pathophysiological mechanisms and
identification of novel targets, which will have a ripple
effect on drug development by the pharmaceutical industry.
There will be no new drug development without NIH funded basic
and translational research.
--It will slow or eliminate the execution of pivotal clinical trials
of novel treatments for IBS.
--Most importantly, it will slow strategic planning and reduce the
number of young investigators dedicated to the field by
starting an exodus of such individuals into jobs in the
pharmaceutical industry and private practice. Such a reduction
in the research base will take years to undo.
Biomedical research, sponsored by the NIH, has advanced our
understanding of countless diseases and disorders. It is important to
continue our investment in these vital programs that hold such promise
for our nation's future. Therefore, we ask you to provide an increase
of 5 percent in fiscal year 2007 for the National Institute of Diabetes
and Digestive and Kidney Diseases and for the NIH overall.
Senator Specter. Thank you, Dr. Mayer.
Our next witness is Dr. Peter McDonnell, representing the
National Alliance for Eye and Vision Research. Dr. McDonnell.
STATEMENT OF PETER McDONNELL, M.D., ON BEHALF OF THE
NATIONAL ALLIANCE FOR EYE AND VISION
RESEARCH
Dr. McDonnell. Thank you, Chairman Specter, Senator Harkin,
Senator Shelby.
The President's proposed fiscal year 2007 budget would cut
National Eye Institute funding by 0.8 percent, or $5.3 million.
This will have a significant detrimental impact on the entire
NEI research portfolio, especially research programs into age-
related macular degeneration, AMD. As Dr. Zerhouni mentioned
this morning, this is the leading cause of blindness now in the
United States. It robs our seniors of their independence.
I offer three examples. The NEI has identified variants of
a gene associated with the body's inflammatory response
responsible for 50 percent of the risk of developing AMD.
Without adequate funding, NEI will not be able to develop
diagnostics for early detection of at-risk individuals and
conduct clinical studies with promising therapies, as well as
study the impact of the inflammatory response and other
degenerative eye diseases.
The NEI has demonstrated that dietary zinc and anti-oxidant
vitamins actually reduce vision loss in individuals at risk of
developing AMD. Without adequate funding, NEI will not be able
to proceed with follow-up clinical studies to identify
additional dietary supplements used singly or in combination to
demonstrate even greater protective effects against progression
to advanced disease.
NEI's research has resulted in the first generation of FDA-
approved drugs to treat abnormal blood vessel growth in the wet
form of AMD, halting further vision loss. NEI's ability to
conduct clinical studies of these therapies in patients with
macular edema associated with diabetes and diabetic retinopathy
would also be jeopardized.
Thank you, Mr. Chairman, and we appreciate the
subcommittee's efforts to increase NIH and NEI funding in the
fiscal year 2007 budget.
Senator Specter. Thank you very much, Dr. McDonnell.
We now turn to Ms. Sandra Raymond, representing the Lupus
Foundation of America.
STATEMENT OF SANDRA RAYMOND, ON BEHALF OF THE LUPUS
FOUNDATION OF AMERICA
Ms. Raymond. Good morning, Mr. Chairman, Senator Harkin,
Senator Shelby.
Lupus is the prototypical autoimmune disease, so an
investment in lupus research may in fact produce answers to
many other autoimmune diseases affecting more than 23 million
Americans. In recent years, NIH has had funded studies that
give us great hope that we are on the brink of major
breakthroughs in lupus research.
For example, one study, an adult stem cell transplantation
study, is carried out on only the most severely ill of lupus
patients, for whom all other treatments have failed. Fifty
percent of these patients having the procedure had disease-free
survival for 5 years.
In another NIH-funded study, researchers identified a gene
that plays a role in one of the immune system pathways meant to
fight infection. In people with lupus, this pathway turns on,
but never turns off.
Mr. Chairman, should NIH appropriations be curtailed there
may not be a future generation of scientists to do lupus
research. Already the hint that funding may be reduced has
caused leaders in our field to consider better funded areas.
Cuts in NIH funding could bring to a standstill support of
clinical trials and large observational studies in lupus and
could limit research on those at highest risk for lupus, women
of color.
PREPARED STATEMENT
NIH-funded research currently in progress will lead to new
and improved treatments for lupus. There has not been a new
FDA-approved drug for lupus in almost 40 years and the drugs
that our patients are currently taking are very harsh
chemotherapies, chemotherapies in lupus as well as in cancer.
Thank you.
[The statement follows:]
Prepared Statement of the Lupus Foundation of America, Inc.
I am Dr. Michael Madaio, Chief of Nephrology, Professor of
Medicine, Temple University School of Medicine and a lupus researcher.
The Lupus Foundation of America, Inc. (LFA) appreciates the opportunity
to submit written comments for the record regarding funding for lupus
related programs for fiscal year 2007. The LFA is the nation's leading
non-profit voluntary health organization dedicated to improving the
diagnosis and treatment of lupus, supporting individuals and families
affected by the disease, increasing awareness of lupus among health
professionals and the public, and finding the causes and cure. As you
may know, lupus is a debilitating, chronic autoimmune disease that
causes inflammation and tissue damage to virtually any organ system; it
can cause significant disability or even death. Lupus is the
prototypical autoimmune disease; therefore, finding answers to
questions about lupus may also provide understanding about other
autoimmune diseases that affect 22 million Americans. The leaders and
members of the LFA and the 1.5 to 2 million people suffering from lupus
respectfully request for fiscal year 2007 $29.7 billion for the
National Institutes of Health (NIH) to support lupus research.
Specifically, we urge Congress to direct NIH to support and bolster
lupus research across all relevant institutes, centers, and offices.
I have been funded for lupus research for over 20 years. I am proud
to be affiliated with the Lupus Foundation of America as a member of
the Medical Scientific Advisory Board and Chairman of the Medical
Advisory Board for the Southeastern Pennsylvania Chapter of the LFA.
While I am a nephrologist, since my research and clinical practice is
focused on lupus, I really work day-to-day within the realms of
nephrology and rheumatology as well as other medical specialties and
subspecialty areas. I understand the importance of biomedical research
funding and the impact that federal research funding has had, does
have, and can have on the lives of the 1.5 million people living with
lupus and the 22 million Americans with other autoimmune diseases.
After a tragic 40 year dearth of new treatments to manage this
often debilitating and devastating disease, the good news is that we
finally are on the brink of major breakthroughs, thanks to research
sponsored by the National Institutes of Health. Exciting research and
strides in treatments for people with lupus are on the horizon and a
sustained investment now in lupus research will speed the day to better
treatments and a cure. One exciting study, adult stem cell
transplantation, was carried out on only the most severely ill of lupus
patients for whom all other treatments have failed. Fifty percent of
the patients having the procedure had disease free survival at 5 years.
In another NIH funded study researchers identified a gene that plays a
role in one of the immune system pathways meant to fight infection. In
people with lupus this pathway turns on and never turns off. These
findings and others will lead to effective ways of treating lupus and
other autoimmune diseases affecting 23 million Americans.
Specifically, I am conducting extensive research on lupus
nephritis, which is kidney involvement in lupus disease. My field is
advancing rapidly, due in large part to factors directly dependent on
NIH funding:
--the burgeoning growth in the number of new animal models, including
a wealth of informative transgenic and gene-targeted mutants;
--increased access to improved powerful technologies such as gene and
protein arrays, now available at many institutions and to many
investigators through NIH core facilities;
--new technologies that permit successful query of the very small
amounts of human tissue typically available from patients and,
collaboration across disciplines and across institutions to
bring crucial expertise together;
--new insights into underlying biology and pathophysiology in
immunity and lupus are constantly emerging;
--technologies to identify biomarkers are improved and accessible;
and
--new approaches to therapy are being explored.
These endeavors are bearing fruit but they are highly dependent on
NIH funding.
If funding for the NIH is cut or level funded, it could cripple or
paralyze current lupus research efforts.
As lupus is a systemic disease that can affect any organ or tissue
elucidating pathogenesis (or cause) and treatments of lupus will have
direct impact on many other autoimmune diseases (e.g. results and
treatments translating to other diseases). Providing adequate resources
to support lupus research will help the nation turn the corner on
finding better treatments or a cure for lupus while also supporting
breakthroughs and progress for other disease states. It is important to
note that the corollary is true: cuts in lupus research funding also
will have an adverse effect on progress for lupus and for progress in
related diseases. Cuts in NIH funding could bring to a standstill
support of clinical trials and large observational studies, and could
curtail research on those at highest risk for lupus, women of color; it
also could negatively impact pediatric research at a time when
researchers have just begun to undertake studies in important new
areas. Furthermore, insufficient federal funding also could slow much-
needed genetic research when we are just discovering the critical
components that may contribute to lupus and its effects. Therefore, it
is critical that biomedical researchers be provided the necessary
resources to continue seeking answers to the questions that will lead
to better lupus treatments. Increased research funding will help
deliver much-needed breakthroughs from the laboratory to patients in
need.
The National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS), the institute most involved in lupus research, is one
of the smallest institutes at NIH. In the past 2 years there has been a
decrease in research funding for NIAMS overall, with a 10 percent
decrease in new research grants. Currently, only 12-15 percent of the
grant applications submitted to NIAMS receives funding. Further cuts
will cause this rate to drop precipitously to below 10 percent next
year. Just 2 or 3 years ago, funding levels were at 25-30 percent. Cuts
in research funding, coupled with the rate of biomedical research
inflation (3-4 percent per year), further erode NIAMS' ability to fund
lupus research grant applications at the rate necessary to begin making
real progress. As such, an increase above the rate of biomedical
research inflation is necessary to allow NIH to sustain and build on
its research progress resulting from the recent budget doubling while
avoiding the severe disruption to that progress that would result from
a lesser increase or cut.
Furthermore, in the proposed budget for NIAMS for 2007 there will
be a loss of 10 training grants; each grant funds training for four
physicians, mostly rheumatologists. Young and senior investigators
alike are moving into other fields because of the lost of funding.
Exacerbating the situation, medical schools are struggling financially
due to public funding cuts thus eliminating any safety net for
researchers that may have previously existed. As a result, young
investigators are not attracted to lupus research which means there
will be not be a future generation of lupus scientists and clinicians
to do research. Moreover, after having attracted scientists to
translational immunology in the last 5 to 10 years, when funding was
increasing, there is now a possibility we could lose both the current
and next generation of young investigators. Increased funding is
necessary to support an adequate number of training grants. Without
research and training funds lupus researchers might be forced to become
private practice physicians instead, leading to an imbalance in the
health care system: sufficient numbers of physicians to treat lupus
patients, but no new treatments with which to care for them, and no
researchers to develop the cures of tomorrow.
We recognize and appreciate that Congress and the nation face
unprecedented fiscal challenges; however, we cannot afford to lose
ground in biomedical research at such a promising time. The LFA looks
forward to working with the subcommittee and others in Congress to
reduce and prevent the suffering caused by lupus. We stand ready to
serve as a resource for any information you may need in this regard and
thank you for this opportunity to submit written testimony for the
record concerning fiscal year 2007 lupus related funding.
Senator Specter. Thank you very much, Ms. Raymond.
Our next witness is Dr. Herman Taylor, representing the
Jackson Heart Study. Dr. Taylor.
STATEMENT OF HERMAN A. TAYLOR, JR., M.D., ON BEHALF OF
THE JACKSON HEART STUDY
Dr. Taylor. Thank you, Mr. Chairman, and good morning,
Senator Harkin, Senator Shelby. I am Herman Taylor, professor
and cardiologist at the University of Mississippi Medical
Center and also with appointments at Jackson State and Talugu
College.
I am proud this morning to come to you on behalf of the
largest study of cardiovascular disease ever undertaken in the
African American population. It is called the Jackson Heart
Study. The NHLBI and the National Center for Minority Health
and Health Disparities are the NIH entities that fund this
groundbreaking work. We are not only doing research, but we are
actively involved in training young people to be scientific
leaders for tomorrow.
We are accomplishing much, but our challenges are huge. A
well documented and widening gap has opened up between blacks
and other citizens of this country with respect to
cardiovascular health. While most Americans have enjoyed a 40-
year decline in death rates from cardiovascular disease, there
has been virtually no change in the death rate from
cardiovascular disease for African Americans in the State of
Mississippi and certain other urban areas in other parts of the
country share these equally dismal statistics.
So while the Jackson Heart Study is a very heartening and
wonderful undertaking, if the intent is to approach these
disparities what we have done thus far can be compared to
throwing a 10-foot rope to a man at the bottom of a 40-foot
well. It is a great idea, it is a good intention, but it comes
up short.
PREPARED STATEMENT
If we consider the question of health disparities an
important national priority, you have to ask yourself what if
we were equal. Dr. David Satcher asked that question in a
recent publication and he concluded, looking at CDC statistics,
that last year 80,000 African Americans died unnecessary deaths
compared to their white counterparts. In our State 1,200, our
small southern State, 1,200 African Americans died
unnecessarily.
To reverse this trend, we must support research and extend
the work of the Jackson Heart Study. Thank you.
[The statement follows:]
Prepared Statement of Herman A. Taylor, Jr.
I am proud to come to you today on behalf of the largest and most
comprehensive study of CVD in the African American community ever
conducted--the JHS. Through the generous support of 2 NIH components--
NHLBI and the NCMHD--this ambitious and multifaceted project is
emerging as a leading study on CV disease among African Americans.
Besides its establishing a growing database of detailed health
information and test results ranging from advanced images of the heart
to genetics to measures of stress and psychological parameters, the JHS
is also an incubator for the scientific leaders of tomorrow through our
education and training programs that involve minority students in
didactic classroom sessions and practical research experiences. And
while we search for answers and train future leaders, we also are
taking action NOW--to serve the community with important health
information from our study as well as others.
We are relatively new, born during the period of NIH budget
doubling, and already we have accomplished much within the Jackson
community and beyond. However, despite the promise of the JHS and our
optimism over its impact, I come to you with a deep concern, summarized
in the arresting quotes below.
``It has been discovered that the health of [blacks] in [parts of]
Mississippi is deteriorating while the health standards for the nation
are improving . . . .''--The Wall Street Journal
``Cardiovascular deaths in MS seem to be rising while they have
fallen for the past 30 years for the rest of the country.''--
Circulation (the official organ of the American Heart Association)
These 2 quotes are distressing, whether you are African American or
not, whether you are Mississippian or not. However, the magnitude of
the problem they summarize becomes clearer when you consider that the
two statements were made 32 years--a full generation--apart. The notion
that in the richest country in the history of man, one location or
group within its borders can be so singularly and peculiarly burdened
from a largely preventable disease is barely credible. But it is true,
and it has the status quo for around forty years.
So while the JHS represents an inspired, timely effort of the NHLBI
and the NCMHD, to freeze research efforts at the current levels of
funding would be like throwing a 10 foot rope to a man at the bottom of
a 40 foot hole. We come up short, and despite the right idea and a
noble attempt, the problem of disparate CV health remains unsolved. To
extend the reach of the JHS to its full potential, our Study and other
complementary studies--and the investigators driving them--must thrive,
and have support for their approaches and new ideas.
The JHS contributes to extending the research lifeline in several
important ways. First there is the core JHS Study itself. Classically
designed in the pattern of the world famous Framingham Study, it offers
a chance to Study a wide list of possible causes for poorer
cardiovascular health among African Americans, to inform precise
interventions that will reduce disparities. Funded through 2013 by
NHLBI and NCMHD, it is a landmark undertaking. The JHS also is
innovative in its list of partnering institutions. Besides the guidance
and support of the NHLBI and the NCMHD, 3 local Jackson Institutions of
higher learning take active part in making the JHS work--Jackson State
University, University of Mississippi Medical Center, and Tougaloo
College all have unique and vital roles in the Study. Comprising a team
of 2 Historically Black institutions and a third predominantly
minority-serving institution, this combination has been ground-braking
and synergistic in the service of this population-based study of an
African American population. Training of promising young talent from
the affected population and participation of HBCU's in epidemiological
research at the highest level is bearing fruit for the Nation in terms
of a rising cadre of leaders in the relevant fields.
However, the potential impact of the JHS is bigger than even this
important core Study will provide. This is because not only is the JHS
a Study in its own right, it is a platform for critical spin-off
studies. These ``Ancillary Studies'' require secondary funding that is
NOT a part of the JHS contract funding. A flat or declining NIH budget
threatens these important studies, where much of the truly innovative
work on health disparities could occur. For instance, nearly all of the
genetics studies of heart disease in the JHS require this ancillary
funding. The genetics of CVD may be the key in the lock of our
understanding of much of the current epidemic. Implications of these
studies may be huge for not only African Americans, but all people
threatened by the nation's number one killer. Flat budget lines
severely limit the opportunities for such important studies. This is
especially devastating to new investigators, those who apply for the
career development (K) awards that NHLBI has been so committed to
funding. These young people are the cadre of scientists in whom we are
investing our future hopes of American world leadership in health
research, and the ultimate resolution of health disparities.
The future of innovative science from the JHS is therefore tied in
important ways to Ancillary studies (R01's) and career development (K)
awards for new investigators. Holding the line on the NIH budget is to
worsen a palpable threat scientists now feel--that of being squeezed
out of a zero-sum game where more and more scientists are fighting each
other and the rising cost of research in order to launch and sustain
promising careers. This is especially devastating to new investigators,
in whom we are investing our future hopes of American world leadership
in health research.
Therefore, the JHS at this point in its evolution can be thought of
as a major platform for scientific discovery--an incredible growing
database that is a national resource. If the growing brain trust of
scientists--in Jackson as well as Boston, Bethesda, Minneapolis,
Baltimore, New York, Chicago and elsewhere--who are showing active
interest, receive funding for meritorious ideas, the JHS stands to
produce important breakthroughs in our understanding of the CVD
patterns seen in AA and others. However, if flat pay lines prevent the
funding of new ideas for using this unparalleled resource, the
trajectory of discovery will be blunted, the pace of advance slowed,
and important scientific opportunity, squandered. And the wisdom shown
by NCMHD and NHLBI in building this platform for discovery will be in
many ways betrayed.
We cannot afford to squander any opportunities to improve health
overall and eliminate health disparities. I witness the impact of
failed promises everyday. Among my patients, I see the end result of
our incomplete understanding of heart disease: in young mothers whose
hearts fail after childbirth for no good reason--though we have a name
for it--peripartum cardiomyopathy--we don't understand it, and we don't
understand why it afflicts Blacks more than other Americans. I see it
in fathers with no known risk factors, but develop coronary disease
anyway. I see it in people suffering from morbid obesity who not only
are at increased risk for disease, but because of their size,
therapeutic and diagnostic interventions themselves are technically
much more difficult. Standard operations are often riskier, and
sometimes impossible to perform. With 1,200 unnecessary deaths from CVD
among AA in our small Southern state alone, deferring the dream of
health equality only adds to our regional tragedy of health
disparities. With 80,000 unnecessary deaths nationally among African
Americans in 2004 (most from CVD) research retrenchment in the form of
flat lining or cutting the research budget only defers finding answers
that were needed yesterday for our Nation's health. An act of national
compassion and strong resolve is necessary. I pray that this Congress
and President will engage this great threat to the dream of a healthy,
vigorous nation. It is in our compelling national interest to do so.
Thank you, Mr. Chairman. I would be pleased to answer any questions
that the Committee may have.
Senator Specter. Thank you very much, Dr. Taylor.
Our final witness is Dr. Suzanne Vogel-Scibilia,
representing the National Alliance for Mental Illness.
STATEMENT OF SUZANNE VOGEL-SCIBILIA, M.D., PRESIDENT,
NATIONAL ALLIANCE ON MENTAL ILLNESS
Dr. Vogel-Scibilia. Greetings from Beaver County,
Pennsylvania, Senator Specter.
I'm a volunteer with----
Senator Specter. Whereabouts? Where?
Dr. Vogel-Scibilia. Beaver.
Senator Specter. Thank you.
Dr. Vogel-Scibilia. I'm a volunteer at NAMI and the
president of the National Alliance on Mental Illness, and I
have been a practicing psychiatrist and a family member of
persons with mental illness as well as a consumer with bipolar
disorder myself. I have had periods of severe illness, but I
have had a good recovery.
Unfortunately, though, many people in our country have not
yet achieved recovery. If Congress cuts funding at the NIMH as
the President has suggested, we will have to continue to have
millions of people in this country with chronic disability and
a $40 billion loss in economic productivity each year alone for
schizophrenia, not to mention other illnesses.
Because of the past doubling of the research budget, NIMH
has brought forth vitally important real world trials to impact
the treatment of all persons with schizophrenia, bipolar
disorder, and depression. Unfortunately, though, the future
gains in medication and treatment options for this vital
research will not be realized unless further medical support is
given to these important studies. We will be unable to fund the
United States whole genome studies for serious mental illness,
which could transform the understanding of causes and risk
factors for these devastating illnesses and open up new avenues
of effective treatment.
Last, we will be unable to advance schizophrenia and
bipolar research progress. One example is in the understanding
if early intervention and medication therapy and rehabilitation
will prevent disability and morbidity for persons with new
onset schizophrenia. We will also be unable to address and
prevent the epidemic of suicide in this country, including a
substantial number of our young people who die or are disabled
before their life has truly started, and the elderly who are
cheated from their retirement years.
For myself, my children, and the people who belong to over
1,100 affiliates of NAMI in the United States of America, we
humbly thank you for all your reform to express our concerns
and hope that research dollars will be provided to help those
of us who suffer.
Thank you very much.
Senator Specter. Thank you very much, Dr. Vogel-Scibilia.
One question, Dr. Taylor. When you say ``unnecessary
deaths,'' how would you define that?
Dr. Taylor. Yes. The term, sir, refers to deaths that you
would not expect, given statistical projections, given the
current level of care and our understanding of risk factors for
cardiovascular disease. So these are people who--a certain
number of people are expected to die, of course, from certain
diseases, like heart disease, every year. Well, these are
people who you would not expect to have died. Dr. Satcher and
others have termed these ``unnecessary deaths.''
Senator Specter. You are saying in effect that that is
higher for blacks, African Americans, than others?
Dr. Taylor. Senator, it is substantially higher. Again, the
national prediction is that 80,000 of these deaths occur from a
variety of causes and the lion's share of those deaths are due
to cardiovascular causes.
Senator Specter. What is the reason for the higher
incidence of deaths among blacks?
Dr. Taylor. Well, this is the principal focus of the
Jackson Heart Study and studies like it, to figure that out.
Clearly there are higher levels of risk factors, such as
obesity, hypertension, diabetes. But one must ask the question,
why are those risk factors higher? We cannot simply say, well,
there is more hypertension, therefore we expect more deaths.
The question is why is there more hypertension and related
problems?
Also, access to care clearly is a major part of this. But
historically, African Americans as a group have been
understudied with regards to what are the true determinants of
poor health. Studies like the Jackson Heart Study and studies
related to it I think will help unravel these questions and
give us detail that we might not even suspect at this point.
The Jackson Heart Study, for instance, includes studies into
genetic underpinnings of various illnesses. But on the opposite
end perhaps of the spectrum, we look very carefully at
psychological determinants of ill health, at social and
behavioral parameters that may also impact how well people do
in terms of their overall health.
Senator Specter. Senator Shelby.
Senator Shelby. Thank you, Mr. Chairman.
Ms. Raymond, what funding do we really need to sustain
research into lupus at NIH in your judgment?
Ms. Raymond. Well, presently the amount of funding now
allocated is around $66 million. In order to really sustain and
break through, I think we need $200 million.
Senator Shelby. That is a lot of money.
Ms. Raymond. A lot of money.
Senator Shelby. But a lot of promise, too.
Ms. Raymond. I think so. We have many deaths due to lupus.
Senator Shelby. Absolutely.
Ms. Raymond. It is a fatal disease. It is prototypical
because it affects any organ system, any tissue system in the
body.
Senator Shelby. 90 percent of them are women, are they not?
Ms. Raymond. 90 percent are women and a majority are women
of color, African American, Hispanic, Asian, and Native
Americans.
Senator Shelby. Dr. McDonnell, macular degeneration. What
is the real promise once you are diagnosed in that area?
Dr. McDonnell. Well, Senator, this is now with the tidal
wave of aging Americans, this has taken over from diabetes as
the major cause of Americans to go blind. It is a progressive
disease involving--it is almost our Alzheimer's or
Parkinson's--a neuro- degenerative condition of the cells of
the retina, of the back of the eye. The eye is part of the
brain, and this progression occurs.
Now we believe we have some dietary supplements that may
slow the progression.
Senator Shelby. What are these?
Dr. McDonnell. Anti-oxidant vitamins and zinc have been
shown, thanks to an NEI-funded study, to delay the progression
to severe forms of the macular degeneration. Now, we have some
treatments that can treat severe forms with blood vessels that
are causing leakage and bleeding and scarring in the back of
the retina. We also hope to be able to begin and expand upon
studies of regenerative medicine using stem cells, such as
would be done in other fields, to restore the cells that are
lost or damaged from this disease.
Senator Shelby. So there is great promise everywhere in
biomedical research. It has just got to be properly funded. Is
that the bottom line?
Dr. McDonnell. I agree with that. As you heard, lupus also
damages the eye. The eye is part of the brain. Fortunately, not
all patients are afflicted in the eye, but we have patients go
blind and we need the same treatments that would improve the
kidney damage and brain damage of lupus also for our eye
patients.
Senator Shelby. Thank you.
Mr. Chairman, thank you.
Senator Specter. Thank you, Senator Shelby.
Senator Harkin.
Senator Harkin. Thank you, Mr. Chairman.
Dr. Landrigan, thank you for bringing up the children's
study. That is why I brought it up earlier. You talked about
the benefits to children, but would it not also benefit adults
also? I mean, obviously obese children have later complications
as they grow older. Many of the things that happen to you in
childhood you carry with you, especially mental health. If you
have mental health problems early in life and they are not
attended to, it can manifest itself later on.
So I just wanted to draw you out a little bit on that in
terms of the benefits of the children's study, not just to
kids, but I think across the spectrum.
Dr. Landrigan. Yes, Mr. Harkin, that is absolutely true.
There is an expanding body of research, called the early
origins of adult disease hypothesis. For example, slow fetal
growth of the baby still in the mother's womb is associated in
young adult life with an increased risk of diabetes,
hypertension, and heart disease. There are some intriguing
clues, more from animal studies than human at the moment, that
early exposures to toxic chemicals may cause brain damage that
does not become manifest in childhood, but shows up four, five,
six decades later in the form of dementia or Parkinson's
disease.
So I think it is both to protect America's kids as well as
future generations of adults that we are seeking the full
funding for the study to be restored in fiscal year 2007, which
would be $69 million, and also assurances that the study will
continue to be funded in the years ahead. It will not succeed
unless the funding for it is sustained.
Senator Harkin. Thank you very much.
Mr. Chairman, I do not have any further questions. I would
just again for the record state, Mr. Chairman, that you and I
and others on this committee had planned for this children's
study. It was passed in 2000. A lot of planning went into this
and forethought went into it to set up this long-term study,
and I just cannot believe that we are just going to just stop
it at this point in time.
So we have just got to do everything we can to mandate, if
we have to, mandate--I do not know if there is anyone here from
OMB, but mandate--that this funding go forward this next year.
Thank you very much.
Senator Specter. Thank you. Thank you, Senator Harkin.
I thank all of you. We are fighting. We put up a Specter-
Harkin amendment and added $7 billion to the budget in the
Senate. Unfortunately, that has not been accomplished in the
House. We have added from that $7 billion $2 billion for the
National Institutes of Health.
But this is a battle that really has to be engaged in by
110 million Americans who are suffering directly or indirectly
from the kinds of illness which we have heard about here today.
We thank you for coming in. This has been an impressive
hearing because it puts a face on these ailments. They are sort
of abstractions. They are not abstractions if your wife is
suffering from them or a close relative or a close friend or
you are suffering from them. They are not abstractions at all.
But there has to be a very intense advocacy effort. We call it
lobbying around here. It is really advocacy. Your organizations
are very, very important in this advocacy effort. We thank you
for what you are doing. But you have to contact your
counterparts everywhere.
The amendment which Senator Harkin and I sponsored won 73
to 27, but there were 27 Senators who voted no and you ought to
identify them and you ought to march on them in their cities,
in their States, seriously, very, very seriously. It is a
little hard, with all that Senator Harkin and I have to do--he
has got to bounce out of here and go to Iowa for a meeting
later today and I have got to conduct a hearing on campus
violence in Philadelphia at 2 o'clock. I have not been in my
office all week. I have been on the floor managing the
immigration bill. Before that I was fully occupied with the
Supreme Court nominations.
But your groups are advocates and I would like to see that
million person march. But it has got to be done. We are a
democracy and people in Washington pay attention to people in
their home States. If I get seven letters, I have got 12
million constituents, I think it is significant. You have
really got to be more politically active, not Democrat or
Republican active, but active for these issues, active for NIH,
active for stem cells.
I am convinced there are cures for all of these ailments
and we have the resources to do it. It is a question of how
many doctors and hospitals and research scientists and
dedicated people you have. It is not a matter of how many
dollars you have. It is a matter of what your resources are.
The money flow comes out of Washington to a large extent, also
out of your State capitals.
ADDITIONAL COMMITTEE QUESTIONS
There will be some additional questions which will be
submitted for your response in the record.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted by Senator Arlen Specter
liver disease research branch
Question. Dr. Zerhouni, 3 years ago, the NIDDK established a Liver
Diseases Research Branch within its Division of Digestive Diseases and
Nutrition. Please explain the benefits of having a Research Branch
dedicated to a specific area of research and describe how this Liver
Disease Research Branch has succeeded in its mission.
Answer. Research on diseases of the liver is a trans-NIH effort
involving 19 institutes, centers, and offices. The National Institute
of Diabetes and Digestive and Kidney Diseases (NIDDK) has lead
responsibility for liver disease research at the NIH. Within the NIDDK,
liver disease research is under the purview of the Division of
Digestive Diseases and Nutrition. The Federal liver disease research
effort has benefited greatly from the establishment in 2003 of an
organizational entity within the NIDDK--the Liver Disease Research
Branch--dedicated exclusively to this very important area. This new
Branch was formed to focus and coordinate research efforts on critical
areas relevant to liver and biliary disease, such as hepatitis and
liver transplantation.
Following a national search, Jay H. Hoofnagle, M.D., an
internationally recognized authority in liver disease research, was
appointed as Chief of this Branch. The NIDDK recruited an additional
scientific Program Director with expertise in liver diseases to further
support the efforts of the Branch. The Branch also includes scientific
experts in the areas of viral hepatitis, clinical trials, epidemiology
and data systems, genetics and genomics, and research training and
career development.
The Liver Disease Research Branch has accelerated research on liver
disease supported by the NIDDK and has helped to coordinate and
stimulate liver-related research efforts across the NIH and within
other Federal agencies, such as the Centers for Disease Control and
Prevention, the Department of Defense, the Bureau of Prisons, the Food
and Drug Administration, and the Department of Veterans Affairs. An
initial important task set for the Branch was to prepare the trans-NIH
Action Plan for Liver Disease Research. The Plan provides an overview
of the current burden of liver disease in the United States, the
current level of NIH research funding in liver disease, and recent
research advances. Importantly, the Plan also summarizes challenges to
advancing liver disease research and delineates the major goals for
future research. Specific goals for the next 10 years are defined for
each of 16 topic areas in liver disease research.
One mission of the Branch is to oversee the conduct of the Plan,
which includes annual Progress Reviews to aid in its implementation
through an ongoing assessment of progress and the need for further
efforts to promote liver and biliary disease research. The Progress
Review for 2005, the first year following release of the Action Plan,
is available at: http://www.niddk.nih.gov/fund/divisions/ddn/ldrb/
Progress_reviews.htm. The Branch also develops and coordinates future
NIH efforts in liver disease research aimed at reaching the goals
defined in the Plan.
Thus, the Branch is succeeding in its mission to plan and direct
the NIH program of liver research, as evidenced by an impressive array
of initiatives that include major clinical trials and special program
announcements in the areas of proteomics of the liver, biomarkers for
liver disease, non-invasive tests for diagnosis and staging of liver
disease, and ancillary studies linked to specific clinical trials,
databases and cohort studies on liver disease (http://
www.niddk.nih.gov/fund/program/DDN-list.htm#Liverprograms).
urology research strategic planning
Question. Our conference report last year ``urged the NIDDK to
continue to support and develop the `Urologic Diseases in America'
report and to include urological complications as well as diabetes and
obesity research initiatives.'' This language was included in response
to concern that the NIH-wide Obesity Strategic Plan did not address
urological issues such as, stress urinary incontinence or erectile
dysfunction (ED), two conditions highly associated with obesity. These
conditions severely affect quality of life and result in high medical
costs. How do you ensure that all disciplines are represented in
strategic planning?
Answer. The NIH acts to ensure that its strategic planning efforts
for research are comprehensive, inclusive, and evidence-based.
Currently, strategic planning is conducted by the individual
Institutes, Centers, and Offices of the NIH, as well as through trans-
NIH and interagency mechanisms, as appropriate. The NIH Office of
Portfolio Analysis and Strategic Initiatives, which I established
recently, will have an instrumental role in facilitating both
individual and trans-NIH strategic planning efforts through its planned
activities.
To ensure effective planning processes, the NIH seeks input from a
wide array of stakeholders, including scientific experts,
representatives from professional organizations, and patient advocates.
For example, most strategic planning for urologic diseases research is
conducted by the National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK). In two major planning efforts, the NIDDK
assembled large, multidisciplinary groups of scientists and medical
professionals prominent in their fields and active in patient and
professional societies related to bladder disease in 2002, and in
pediatric urology in 2006. These groups were thus able to bring
multiple perspectives to bear when reviewing progress in bladder
disease and pediatric urology research, and to provide broad-based
assessments of research needs and recommendations for future action,
including recommendations regarding the impact of obesity and diabetes
on certain urologic diseases. As a result, these groups' 2002 and 2006
reports have served as a model for NIH planning for urologic diseases
research and for trans-NIH collaborations in this area. Moreover, the
NIDDK has continued to gather multidisciplinary expert groups to assist
in more focused areas of research planning, such as prostate disease,
and urologic diseases in women. All of these efforts are bolstered by
the Urologic Diseases in America report, which has provided significant
information related to major urologic diseases. The NIDDK is strongly
committed to maintaining this program, and a research solicitation is
being developed for the next phase of Urologic Diseases in America that
will include assessment of the impact of diabetes and obesity on
urologic diseases. Additional, ongoing assessments of research progress
in urologic diseases through advisory group meetings, scientific
conferences, and stakeholder input allow flexibility, capitalization on
new research advances, and the opportunity to strategically address
research gaps and barriers that may emerge or become evident over time.
The Strategic Plan for NIH Obesity Research, developed by the NIH
Obesity Research Task Force, similarly drew upon a broad base of
scientific expertise within and external to NIH. The plan focuses, in
part, on goals and strategies to break the link between obesity and its
associated health conditions. Recommendations from this and other plans
and from ongoing strategic planning efforts are reflected in NIH
action. For example, the NIDDK has funded the Program to Reduce
Incontinence by Diet and Exercise (PRIDE) study, which is examining the
impact of weight loss on urinary incontinence in overweight and obese
women. The benefits of considering multiple disciplines in research
planning can be seen in research results. For example, the NIH-funded
Diabetes Prevention Program recently found that weight loss improves
bladder control in women with prediabetes. This new knowledge, that an
intervention proven to reduce risk of type 2 diabetes can also reduce
episodes of urinary incontinence, has the potential to improve health
and quality of life for the large number of older American women who
have both prediabetes and bladder control problems. The NIH has also
been supporting a similar study in patients with type 1 diabetes who
are participating in the Epidemiology of Diabetes Interventions and
Complications study, to determine whether intensive control of blood
sugar levels--an intervention proven to reduce risk of developing eye,
kidney, nerve, and cardiovascular complications of diabetes--also
reduces risk of urologic complications.
opasi trans-nih funding program
Question. Dr. Zerhouni, you have initiated a new trans-NIH funding
program, which requires each Institute and Center to contribute a fixed
portion of their appropriations for cross-cutting research initiatives.
Can this program move forward as planned in an environment of no real
increases in NIH funding?
Answer. The Administration has focused resources on our highest
priority: protecting the citizens and our homeland. This underscores
the importance of being as strategic as possible with NIH dollars to
catalyze high-impact research. The time is right for NIH to take a more
coordinated approach to the development and funding of trans-agency
initiatives by asking each IC to pool a very small proportion of their
appropriation in a Common Fund for shared needs. This is true not only
because of the difficult budgets, but also because many of the most
exciting scientific opportunities and pressing public health challenges
we now face cut across the mission areas of multiple institutes and
centers. Thus, the creation of this new trans-NIH funding stream will
actually enable the NIH to be more proactive in addressing emerging
scientific needs and opportunities; to fund high-risk, high-impact
science; and to incubate and launch pilot efforts that have
transforming potential for all of science.
the heart truth road show
Question. As a member of the Congressional Heart and Stroke
Coalition, I am concerned that heart disease remains the leading cause
of death of women in the United States, but many women do not realize
this fact. I know that for the past several years, the NIH has been
working with the fashion industry in your Heart Truth Campaign to
increase women's knowledge about their No. 1 killer and that the Heart
Truth Road Show stopped in Pittsburgh recently. Please explain to the
Committee about the progress of this initiative?
Answer. The National Heart, Lung, and Blood Institute's (NHLBI) The
Heart Truth campaign continues to flourish, extending the reach of the
campaign in a variety of ways.
--As the campaign ambassador, First Lady Laura Bush is leading the
federal effort to give women a personal and urgent wake-up call
about their risk of heart disease, participating in more than a
dozen Heart Truth events around the nation over the past 3
years.
--Corporate partners, including General Mills, Minute Maid, and
DermaDoctor, have featured the campaign's Red Dress (emblematic
of the message ``Heart disease doesn't care what you wear; it's
the killer of women'') on more than 60 million product
packages. Johnson & Johnson, L'eggs hosiery, Benecol, Starkist
Tuna, and Celestial Seasonings have promoted The Heart Truth
campaign and Red Dress logo in newspaper advertising inserts,
resulting in a combined circulation of 370 million.
--The Red Dress Collection 2006 Fashion Show took place on the third
annual National Wear Red Day--Friday, February 3, 2006. People
throughout the country participated in the day's celebration to
increase awareness of women's heart disease.
--The Heart Truth Road Show visited shopping malls in Pittsburgh,
Memphis, and Washington, DC, in the spring of 2006 to raise
awareness about women and heart disease by helping participants
learn about risk factors; providing free health screenings
including blood pressure, body mass index, total blood
cholesterol, and blood glucose; and disseminating educational
materials.
--The campaign launched ``Know The Heart Truth'' in April 2006, an
initiative that is recruiting and training health advocates and
educators in local communities to increase awareness about
women and heart disease. The Heart Truth has also formed
partnerships with leading organizations representing women of
color to engage in national and local activities, including a
faith-based initiative, to help women reduce their risk for
heart disease.
The impact of The Heart Truth campaign is already becoming
apparent. Awareness of heart disease as the leading cause of death
among American women increased from 34 percent in 2000 to 46 percent in
2003 to 55 percent in 2005. A 2005 survey commissioned by WomenHeart
found that 60 percent of U.S. women agreed that the Red Dress makes
them want to learn more about heart disease. Twenty-five percent of
women recalled the Red Dress as the national symbol for women and heart
disease awareness and 45 percent agreed that it would prompt them to
talk to their doctor and/or get a check-up. A Lifetime Television
Women's Pulse Poll released in February 2006 showed that women are
increasingly aware of the dangers of heart disease. Thirty-nine percent
of survey participants recognized the Red Dress as the national symbol
for women and heart disease awareness, up from 25 percent in 2005.
stroke
Question. Following up on language from last year's congressional
report, please provide this Committee with highlights of implementation
progress on the Stroke Progress Review Group report.
Answer. In 2001, the NINDS convened the first meeting of the Stroke
Progress Review Group (SPRG) to identify and prioritize scientific
opportunities and needs in stroke research. One hundred forty prominent
scientists, clinicians, patient advocates, and industry representatives
participated and developed a set of scientific and resource
recommendations that the NINDS assembled in a Report of the SPRG in
2002. In 2003, the chairs of the SPRG meeting reprioritized their
recommendations and identified a subset of high priorities for stroke
research in an Implementation Report. Many of the following research
activities address the scientific research and resource priorities
identified by the SPRG in its 2002 Report and 2004 Implementation
Report.
The NINDS is funding a wide range of studies on the basic biology
of stroke, including the role of the blood-brain barrier (BBB; the
cellular barrier that controls the exchange of substances between the
blood and the nervous system) and the neurovascular unit (NVU; the
functional ``unit'' comprised by brain blood vessels, glial support
cells, and neurons). Understanding the function of the NVU and the BBB
in stroke is critical to developing strategies for treating and
preventing stroke and related conditions such as vascular cognitive
impairment (VCI). NINDS is supporting a variety of stroke-related
studies focused on the roles of the NVU and the BBB under two recent
Program Announcements with set-aside funding. To more fully understand
the biological basis of VCI, the Institute held a workshop in June 2006
to discuss the cell biology of VCI and develop recommendations to
accelerate research in this area.
To facilitate the translation of basic research findings into the
clinical setting, NINDS is planning to expand its Specialized Programs
of Translational Research in Acute Stroke to include seven programs
across the country participating in clinical trials, training of
research fellows, and translational research on stroke. In addition,
NINDS released two new grant solicitations to address barriers to
translational research in stroke.
The NINDS also continues to fund many clinical trials involving
potential interventions and preventive strategies for stroke. To
improve outcomes for stroke patients in emergency-room settings, the
NINDS is developing a Neurological Emergencies Treatment Trials (NETT)
Network of emergency medicine physicians, neurologists, and
neurosurgeons, and plans to fund the clinical coordinating center
component of the NETT in fiscal year 2006. The Institute is also
supporting research on the causes of stroke among high risk groups,
improved methods for diagnosing stroke, and a range of educational
outreach programs to increase awareness of stroke risk factors and
symptoms.
In September 2006, the NINDS will sponsor another meeting of the
SPRG to assess research progress in stroke, evaluate current
priorities, and identify new opportunities for advancing stroke
research. Prior to the meeting, 16 working groups will assess progress
and develop recommendations for future priorities on topics ranging
from genetics of stroke to recovery and rehabilitation. NINDS solicited
information from the stroke research community on research progress and
remaining needs and research gaps, and will provide this feedback to
the SPRG participants prior to their deliberations. Following the
September meeting, the SPRG will produce a mid-course implementation
report that reflects the current status of stroke research and
identifies new priorities.
clinical and translational science awards
Question. You have announced that by the year 2010, the GCRC
program will have been phased out and the funding transferred to a new
program. How are you going to assure that the CTSAs maintain or enhance
services currently provided by the GCRCs including specialty nursing
care, patient facilities, laboratory testing, and specialized
monitoring and diagnostic capabilities?
Answer. Applicants for the Clinical and Translational Science
Awards (CTSAs) are asked to propose a center, department, or institute
for clinical research that will transform the clinical and
translational research environment at their institution. Up to $6
million additional funds may be requested in addition to certain
National Center for Research Resources (NCRR) and NIH Roadmap awards
held by the institution at the time of application. These additional
funds may be used to transform the local, regional, and national
environment for clinical and translational science, thereby increasing
the efficiency and speed of clinical and translational research. By
introducing CTSAs as an increase in support, NIH is allowing applicants
to retain such services as are currently provided by the General
Clinical Research Centers (GCRCs) that they deem needed for their
clinical research, such as inpatient and outpatient facilities,
laboratory testing, and specialized monitoring and diagnostic
capabilities.
Question. You have announced that by the year 2010, the GCRC
program will have been phased out and the funding transferred to a new
program. How will you monitor the impact on the vitally important
clinical research support currently provided to patients and
investigators through the GCRCs?
Answer. NIH staff review GCRC Annual Reports, communicate
frequently with grantees, and attend annual meetings with Center
grantees in Washington, DC. Clinical and Translational Science Awards
likewise will submit Annual Reports and will establish Steering
Committees on which NIH will be represented. These various tools and
forums provide opportunities to assess the impact of the Clinical and
Translational Science Awards and General Clinical Research Centers and
will assure NIH of the requisite monitoring for impact on clinical
research support.
Question. You have announced that by the year 2010, the GCRC
program will have been phased out and the funding transferred to a new
program. Will institutions that lose their existing GCRC funding and do
not receive CTSA awards be able to support patient-oriented research
facilities and services?
Answer. The 60 CTSAs that NIH plans to award could support over 90
percent of the institutions that currently have GCRCs. Researchers that
perform patient oriented research at institutions that do not receive
CTSAs may apply for investigator-initiated NIH research supported by a
variety of NIH grant mechanisms including Research Project and Research
Program Projects and Centers grants. Additional sources of research
support for investigators may come from Research Foundations,
partnerships with industrial sponsors and institutional funds.
Question. You have announced that by the year 2010, the GCRC
program will have been phased out and the funding transferred to a new
program. Will researchers in these institutions have to cancel planned
patient-oriented research projects because of inadequate facilities?
Certainly, the NIH budget is too constrained to provide this support
through other competitive mechanisms.
Answer. Researchers in the institutions that do not receive
Clinical and Translational Science Awards may apply for investigator
initiated NIH research supported by numerous NIH grant mechanisms
including Research Project and Research Program Projects and Centers
grants. Research Foundations, partnerships with industrial sponsors,
and institutional funds may also provide additional sources of research
support for investigators.
Question. The K12 training mechanism is required for the CTSA
award. Why isn't the GCRC M01 mechanism required? The RFA appears to
marginalize the GCRCs and their functions, and I am concerned about
that. Why not require the M01 mechanism in the CTSA award RFA in 2007?
Answer. Applicants for a CTSA are required to include a Mentored
Clinical Research Scholar Award (K12) component in their proposal so as
to promote clinical and translational research as a distinct
discipline. There is no requirement for applicants to be K12 awardees
for them to apply for a CTSA. NCRR has not made an M01 award an
eligibility requirement for a CTSA application in the expectation that
certain new affiliations amongst institutions that do not currently
hold an M01 award would be strong enough to compete successfully. CTSAs
will support the discipline of clinical and translational science and
the needs of its researchers, so applicants are encouraged to look
beyond the constraints of M01 awards and to propose novel concepts,
methodologies, and approaches that could be integrated into a
comprehensive, effective, and efficient researcher-, trainee-, and
participant-centered clinical research program.
Question. Could NIH maintain a GCRC or mini-GCRC program for
institutions that have had strong GCRCs, historically, but do not
receive CTSA awards.
Answer. NCRR has received wide support for the new CTSA program, so
we believe that the purposes of clinical research will best be served
by a smooth and uninterrupted transition. Several new consortia are
expected to apply for CTSAs and clinical research at those sites that
compete well in the peer review process should not be delayed by
prolongation of the GCRC program. Retaining the GCRC program would
limit the funding available for the CTSA program and NIH believes that
this would be detrimental to the needs and interests of the majority of
clinical investigators.
Question. Have you considered the possibility of a ``pause'' after
the second year of implementation to evaluate the effectiveness and
impact of the new CTSA program before proceeding with additional
awards?
Answer. The combination of Annual Reports with Clinical and
Translational Science Award Steering Committees will assure NIH of the
requisite evaluation opportunities during their implementation. In the
event that changes are required to optimize the award functionality,
they can be made without the delays that would be incurred through a
``pause'' in making awards.
Question. Do you have a fall-back plan if the budget is not
sufficient to accommodate the implementation of the CTSA program as you
envision it?
Answer. Transformation of Clinical Research infrastructure programs
from GCRCs to CTSAs will be funded principally by NCRR appropriated
funds, with additional funds from the NIH Roadmap for Medical Research.
The project period for CTSA grants is 5 years, and NIH is planning for
an additional 5-year competitive renewal of these awards. The fiscal
year 2006 funding level for the combined CTSA/GCRC program is
$322,740,000 and their estimated fiscal year 2007 funding level is
$361,200,000. NIH plans to award four to seven CTSAs in fiscal year
2006, to increase the number of awards annually, and to have 60 CTSAs
in place by 2012. While changes in Congressional Appropriations would
affect both the GCRC and CTSA programs in parallel, the transformation
of the GCRC program to CTSAs is occurring in response to user demand.
polycystic kidney disease
Question. The Food and Drug Administration has granted ``Fast
Track'' designation for Tolvaptan, a promising drug therapy designed to
retard disease progression in polycystic kidney disease (PKD) and thus
prevent kidney failure. What does the NIH plan to do to make the most
of this discovery and foster the development of further PKD therapies?
Answer. The NIH is committed to research that will pursue
opportunities to combat polycystic kidney disease (PKD)--a serious,
burdensome, and costly disease. Within the NIH, the National Institute
of Diabetes and Digestive and Kidney Diseases (NIDDK) supports a
diverse portfolio of basic and clinical research into the underlying
biology of and possible therapies for PKD. The Interdisciplinary
Centers for Polycystic Kidney Disease Research are important components
of this research portfolio. The NIDDK recently renewed funding for four
Centers for five additional years. Three of the Centers focus on the
more common autosomal dominant PKD (ADPKD), and will explore
extensively the basic and clinical functional changes seen in ADPKD.
The fourth is a Research and Translational Core that focuses on
autosomal recessive PKD (ARPKD) and will make available to
investigators in the field a broad range of model research systems and
reagents for the study of ARPKD.
The Institute also has two other major research projects related to
PKD--the HALT-PKD trial network, and the Consortium for Radiologic
Imaging Studies of PKD (CRISP) cohort study. CRISP was established to
develop innovative and standardized imaging techniques and analyses
that would allow clinicians to reliably follow disease progression of
ADPKD. This four-year study followed 240 PKD patients with annual
glomerular filtration rate evaluation (a measure of kidney function),
and magnetic resonance imaging to assess changes in kidney volume over
time. The first phase of CRISP was recently completed, and the primary
study results were published in the New England Journal of Medicine in
May 2006 (NEJM 354: 2122-2130, 2006). Although the preliminary findings
show promise for use of imaging methods and structural endpoints for
tracking progression of ADPKD, the NIDDK has extended the CRISP cohort
study for another five years, in order to collect additional structure
and function data on enrolled subjects. Additional data from CRISP II
will enable investigators to assess how reliably structural changes can
predict functional kidney changes over time in ADPKD. The CRISP II
investigators are currently developing the protocol for the next phase
of the study.
The Polycystic Kidney Disease Clinical Trials Network, co-funded by
the PKD Foundation, is conducting two phase III-type studies in the
HALT-PKD trial--one in patients with early kidney disease and another
in patients with more advanced disease. HALT-PKD is testing whether
blockade of the renin-aldosterone-angiotensin system, with angiotensin-
converting enzyme inhibitor monotherapy or combination angiotensin-
converting enzyme inhibitor and angiotensin receptor blocker, will slow
the progression of ADPKD. A partnership was also negotiated with
industry to provide medications for testing in these studies. The HALT-
PKD trial in subjects with early kidney disease is novel in that it is
implementing the CRISP imaging methods in order to determine how
reliable the methods are for interventional studies in ADPKD. The
ability to reliably implement imaging methods for trials of ADPKD will
have a significant impact on planning future interventional studies of
new therapeutics in this disease. The HALT-PKD studies began enrolling
patients in January 2006, and will be the largest interventional trial
ever conducted in ADPKD.
national primate research center
Question. The fiscal year 2006 Labor-HHS-Education Appropriations
bill provided the NIH Office of AIDS Research with up to $4 million to
spend for construction or renovation necessary to expand a breeding
colony for non-human primates for AIDS research, which is intended to
be collaborative effort amongst the National Primate Research Centers.
What progress has been made on that effort, and what is the expected
completion date?
Answer. Although the fiscal year 2006 bill allows the Office of
AIDS Research (OAR) to utilize funds for construction for the national
breeding resource facility, funds will not be used for that purpose in
fiscal year 2006. In late fiscal year 2005, the Tulane National Primate
Research Center successfully competed for the first phase of a national
breeding resource facility project. However, construction capability in
this region has been limited in the aftermath of Hurricane Katrina.
Thus the second phase of this project has not proceeded as scheduled.
Consequently, OAR cannot use this provision of the fiscal year 2006
appropriations bill this year. Instead, OAR provided funds to NCRR to
support AIDS-related research infrastructure needs and increased
operating expenses, such as unanticipated high energy costs, at the
National Primate Research Centers (NPRCs). A timeline for completing
the national breeding resource facility project is being reassessed.
______
Questions Submitted by Senator Tom Harkin
collaboration among institutes
Question. Dr. Zerhouni, one of the most common complaints I hear
from advocacy groups is that they can't get multiple NIH institutes and
centers (ICs) to work together on common goals. Consider diseases like
scleroderma, neurofibromatosis or epilepsy, all of which fall under the
jurisdictions of more than one IC. In each case, one IC might be
designated as taking the lead on the disease, but other ICs also share
the responsibility for conducting research on it. Too often,
unfortunately, patients complain that the ICs don't collaborate.
Sometimes the patients themselves practically have to drag a researcher
from one institute into a meeting with a researcher from another
institute, just to get them to talk.
I know you're well aware of this problem. It's an issue that the
National Academies addressed in its report on NIH's structure in 2003.
What are you doing to improve the situation?
Answer. In 2002, I began a process called the Roadmap for Medical
Research that was designed to identify major opportunities and gaps in
biomedical research that no single institute at NIH could tackle alone
to make the biggest impact on the progress of medical research. A
primary accomplishment of the Roadmap was internal ``functional
integration'' of the 27 institutes and centers (IC) to plan, implement
and fund initiatives that go beyond the mission of any one IC. These
accomplishments led to creation of the Office of Portfolio Analysis and
Strategic Initiatives (OPASI) which has begun to institutionalize these
processes. The establishment of OPASI represents a major organizational
change at NIH aimed primarily at addressing challenges in the
coordination of biomedical research of benefit to every IC. Using a
combination of approaches such as agency-encompassing portfolio
analysis and establishment of a common fund for shared needs, OPASI
will synergize diverse components of the NIH toward the attainment of
common goals more efficiently. Continuing the tradition of the NIH
Roadmap, this office will also support well-developed initiatives that
address areas of science which do not clearly fall within the mission
of any one IC or program office. This makes OPASI a natural space for
NIH ICs to work together on broad-reaching opportunities which will
impact multiple aspects of public health and disease intervention.
conflicts of interest
Question. Last August, NIH announced the final ethics rules on
conflicts of interest. What impact are they having on employee
retention and recruitment, and on interactions between NIH scientists
and outside associations, such as trade groups and scientific
associations?
Answer. Regarding Employee retention and recruitment. In the
preamble to the final rule (published in August 2005), we stated that
we would review the rule to ``evaluate continued adequacy and
effectiveness in relation to current agency responsibilities.'' We are
particularly interested in learning about any effects that the
prohibited holding and outside activities provisions of the rule have
had on hiring and retention. We are currently in the process of
conducting a survey of current NIH employees, collecting their feedback
related to the new regulations. In separate surveys in the coming
months, we intend to ask former employees (those who left the NIH after
January 1, 2005) and potential employees their opinions as well.
Interactions between NIH scientists and outside associations, such
as trade groups and scientific associations. The regulations do not
affect official duty interactions that scientists may have with trade
groups or scientific associations.
pandemic flu
Question. We are all concerned about how long it would take between
the time that we detected a pandemic flu virus in the United States and
when we could create a vaccine for it. Right now, if a pandemic were to
occur, I understand that it would take almost six months to produce a
vaccine, using our current egg-based methods.
HHS recently invested $1 billion in the development of new cell-
based technologies to produce a pandemic vaccine. We're all looking
forward to the results. But even if successful, a cell-based vaccine
would not be immediately available at the time of a pandemic.
The current methods of vaccine development are commonly referred to
as the ``one drug, one bug'' philosophy--develop a vaccine for each flu
strain or strains. But that means that you have to identify the ``bug''
or flu strain before you can begin to manufacture a vaccine. However, I
have heard that there is work being done to develop a vaccine that
would address all strains of the flu--a ``one drug, many bugs'' plan.
Is NIH supporting this type of research? Does it have promise?
Answer. The National Institute of Allergy and Infectious Diseases
(NIAID) is supporting research and development of alternate approaches
to dealing with the threat of emerging and re-emerging infectious
diseases such as influenza.
For example, NIAID is pursuing the development of a ``universal
vaccine'' that protects against multiple virus strains such as those
resulting from antigenic drift associated with seasonal influenza and
antigenic shift associated with pandemic influenza. As influenza
viruses circulate, the genes that determine the structure of their
surface proteins undergo small changes. Sometimes the change in the
genes results in a slight change in the antigenic properties of the
protein, a process commonly referred to as ``antigenic drift.''
Antigenic drift is the basis for the changes in seasonal influenza
observed during most years, and is the reason that we must update
influenza vaccines annually. Influenza viruses also can change more
dramatically. For example, viruses sometimes emerge that can jump
species from natural reservoirs, such as wild ducks, to infect domestic
poultry, farm animals, or humans. When an influenza virus jumps species
from an animal, such as a chicken, to infect a human, the result is
usually a ``dead-end'' infection that cannot readily spread further in
the human population. However, mutations in the virus could develop
that allow human-to-human transmission. Furthermore, if an avian
influenza virus and another human influenza virus were to
simultaneously co-infect a person or animal, the two viruses might swap
genes, possibly resulting in a virus that is readily transmissible
between humans, and against which the population would have no natural
immunity. These types of significant changes in influenza viruses are
referred to as ``antigenic shift.'' When an ``antigenic shift'' occurs,
a global influenza pandemic can result. Historically, pandemic
influenza is a proven threat. In the 20th century, influenza pandemics
occurred in 1918, 1957, and 1968.
The NIAID is supporting a number of research projects to develop a
vaccine that induces a potent immune response to the common elements of
the influenza virus that undergo very few changes from season to season
and from strain to strain. Although this is a difficult task, such a
``universal'' influenza vaccine would not only provide continued
protection over multiple seasons, it might also offer protection
against a newly emerged pandemic influenza virus and thus substantially
reduce the susceptibility of the population to infection by any
influenza virus--making the country far less vulnerable to influenza
viruses emerging from avian and other animal sources.
One relatively stable element of the influenza virus is a protein
called M2. The external portion of the M2 protein is very similar in
influenza viruses from year to year and from strain to strain. A
``universal'' influenza vaccine targeting the M2 protein, or other
conserved elements, could be protective against a range of influenza
strains. NIAID-supported researchers have demonstrated that vaccines
made with bioengineered versions of M2 can protect mice from lethal
influenza virus. The scientists now are testing cross-reactivity
between different species and strains of influenza, examining how long
the immunity provided by these vaccines lasts, and evaluating whether
the influenza viruses can evade these vaccines by developing mutations
in their M2 proteins.
In addition, researchers at the NIAID Vaccine Research Center (VRC)
are developing and testing gene-based influenza vaccines that will
protect against multiple strains of influenza. As a first step, initial
candidate vaccines, each containing the gene encoding the hemagglutinin
(H) surface protein of an influenza virus isolated from a recent human
outbreak of influenza (H1N1, H3N2 or H5N 1), have already shown promise
in animal studies. VRC researchers plan to develop additional gene-
based vaccines for all common variants of hemagglutinin, as well as
other influenza viral proteins, such as nucleoprotein and the M2
protein. In the future, the VRC will incorporate both conserved and
variable genes from multiple influenza strains into DNA and adenovirus
vectors that can readily be produced by existing manufacturing
processes.
A second approach, while not technically a vaccine, is an immune
enhancer which specifically targets a component of the immune system
and enhances one's ability to respond to a broad range of microbial
threats. Studies of the human innate immune system, which is comprised
of ``first responder'' cells and other defenses that provide a first
line of defense against a wide variety of pathogens, have been moving
forward rapidly. These advances suggest it may be possible to develop a
relatively small set of fast-acting, broad-spectrum countermeasures
that can boost innate immune responses to many pathogens or toxins,
including influenza. The capability to boost the innate immune system
also could lead to the development of more powerful vaccine additives,
called adjuvants, that can increase vaccine potency. The concept of
immune enhancers has been demonstrated in early. stage clinical
studies, but requires further research and development to be applied to
pandemic influenza vaccination.
______
Questions Submitted by Senator Daniel K. Inouye
traditional healing practices
Question. Last year, at my request, Dr. Donald Lindberg, Director
of the National Library of Medicine, visited one of our Native Hawaiian
Healing programs at Papa Ola Lokahi for the purpose of conducting
``listening circles'' to discuss the needs for preservation and
documentation of traditional cultural healing practices. I am very
interested in a report of his findings from this visit. I am most
appreciative of the National Library of Medicine's continued interest
and support of Native Hawaiian issues.
Answer. Early this year NLM convened a working group to examine
both the feasibility of an exhibition on Native health and healing, and
NLM's role in collecting and preserving information about traditional
medicine. As a result of this working group, NLM has reviewed its
collection to develop policies, as well as examined its collection in
these areas. Subsequently, the Library has made an effort to collect
modern publications such as all the items in the Bishop Museum's
(Honolulu, HI) current catalog as well as their out of print materials.
In addition to purchasing standard published materials, NLM is also
obtaining input from Native American (including Native Hawaiian)
healers, leaders, educators, and others, on appropriate collection and
preservation policies. Over the past year, since the series of
Listening Circles the NLM participated in with different Native
Peoples, NLM staff have met with many such individuals to gain insight
into the issues of collecting and preserving information about
traditional healing practices. For example, in February, NLM staff met
with librarians and curators from the Bishop Museum, Hawaiian
Historical Society, The Hawaiian Mission Children's Society Library,
and the University of Hawaii to gather information to planning a larger
follow-up meeting.
This meeting, to include NLM staff, occurred in July 2006, and a
report of findings from this visit will be prepared.
developing nurse researchers
Question. A long-standing supporter of the National Institute for
Nursing Research, I am pleased with the extensive array of research
initiatives that have been undertaken by the Institute. I am
particularly pleased with those endeavors that are directed at
developing the pool of nurse researchers who also become nurse faculty.
Another important initiative is training support for fast-track
baccalaureate to doctoral program participants. I welcome news of the
Institute's progress in facilitating research projects in rural areas
that serve minority students via community colleges.
Answer. NINR considers the development of nurse researchers and
nurse faculty to be a fundamental component of its research mission.
Indeed, developing nurse investigators will be an overarching goal in
the Institute's new strategic plan for 2006-2010.
Approximately 7 percent of NINR's budget supports the Institute's
Centers programs, which are used to develop the nursing research
infrastructure and train new investigators. In addition to our ten Core
and nine Exploratory Centers, we have co-sponsored a joint initiative
with the National Center on Minority Health and Health Disparities that
supports partnerships between established, research-intensive
institutions and growing, minority-serving institutions. These Nursing
Partnership Centers on Reducing Health Disparities, involving 17
schools of nursing, will increase health disparities research and
broaden the diversity of the nurse scientist pool. Several of these
Centers are located in rural areas or serve rural and other underserved
populations. These Centers represent a major investment aimed at
expanding the cadre of nurse scientists involved in health disparities
research.
baccalaureate to doctoral programs
Question. A long-standing supporter of the National Institute for
Nursing Research, I am pleased that the Administration has continued
funding of this program. However, what impact will the $1 million
reduction have on the National Institute of Nursing Research's
development of initiative that supports fast-track baccalaureate-to-
doctoral programs? These programs were proposed to help increase the
number of nursing faculty and in turn decrease the number of qualified
nursing school candidates who were turned away in prior years.
Answer. The overall reduction of $792,000 in the fiscal year 2007
budget request of $136.6 million for the National Institute of Nursing
Research (NINR) will have no impact on its programs that fast-track
baccalaureate-to-doctoral nurses to increase the number of nursing
investigators. These programs are supported within the Research
Training mechanism in NINR, and the fiscal year 2007 President's Budget
maintains the current level of support of this activity. NINR remains
committed to developing the next generation of nurse scientists. NINR
encourages and supports strategies to change the career trajectory of
nurse scientists. The Institute emphasizes early entry into research
careers, including fast-track baccalaureate-to-doctoral programs, and
supports pre-doctoral and postdoctoral nurses who are the future
researchers and nursing faculty.
cancer centers
Question. The National Cancer Institute has had great success and
demonstrated value in its system of cancer centers across the country.
When awarding core grants for cancer research, is attention paid to
geographic and ethnic diversity to ensure that results will capture the
often significant differences in outcomes among various ethnic groups
and lifestyles?
Answer. The NCI-designated Cancer Centers are vital parts of a
national strategy to reduce the suffering and death due to cancer. The
NCI Cancer Centers Program provides critical infrastructure for
academic and research institutions throughout the United States that
provide broad based, coordinated, interdisciplinary programs in cancer
research. These institutions are characterized by scientific excellence
and a capacity to integrate various research approaches focused on the
problem of cancer. Generally, in order to become an NCI-designated
Cancer Center, an institution must have a large cancer-relevant grant
funding base; substantial institutional commitment in the form of
space, resources, and authorities provided to the Center Director; a
synergistic organization of transdisciplinary research across all
scientific areas of the institution; and, specifically for
comprehensive centers, community outreach, education, and training
activities.
While the NCI designation is based solely on an evaluation of the
science, Centers deliver medical advances to patients and their
families; provide state-of-the-art care and access to clinical trials;
serve as the major training ground for new clinicians and researchers;
and have the strong links with national, state, and local agencies and
advocacy groups needed to address cancer issues most relevant to their
communities.
Examples of strategies focused on the geographic reach of Cancer
Center services include:
--Minority Institution/Cancer Center Partnership Programs (MI/CCP).--
The MI/CCP, which partner Minority-Serving Institutions (MSIs)
with existing NCI-designated Cancer Centers, was established in
2000 to take maximum advantage of their respective expertise
and experience. The program is designed to foster development
of independent cancer research programs and minority career
scientists in MSIs and to improve minority-focused outreach and
training efforts in NCI-designated Cancer Centers.
Participation in this program better positions MSIs to compete
for independent NCI designation and/or to form equal and
permanent research alliances with existing NCI-designated
Cancer Centers. These partnerships are expected to enable the
NCI-designated Cancer Centers to realize substantial progress
in their efforts to implement effective research, outreach, and
education programs that truly benefit minority populations.
--Affiliations and Consortia.--Realizing that many institutions
serving minorities may not have the research capability or the
desire to apply for NCI designation independently, NCI revised
the Cancer Center guidelines to encourage the development of
affiliations and consortia. We specifically encourage
consideration of partnerships that address cancer in minority
and other underserved populations.
--Emphasized Integration.--Through NCI's ``Discovery, Development,
Delivery'' continuum, we expect the continued development of
links between existing Cancer Centers, their affiliates and
partners in research; as well as state, municipal, and
community-based private organizations. NCI is actively seeking
mechanisms to foster both vertical integration (i.e., from the
Cancer Centers through the community layers they serve) and
horizontal integration (i.e., across Cancer Centers and a
nationwide network of public and private partners) of the
benefits of cancer research. This integration provides a more
unified approach to reducing cancer and cancer risk, and more
uniform delivery of the benefits of cancer research into all
communities.
NCI recognizes that the Cancer Research Center of Hawaii is unique
in the community it serves. NCI program staff regularly consults with
existing NCI-designated centers on approaches for enhancing
representation of underserved populations, and provides support and
direction to Center and institutional leadership on how to maintain NCI
designation; the latter activities are viewed as particularly critical
for Centers with. significant minority and other undeserved
populations.
NCI continues to pay close attention to the Cancer Centers
geographic placement. The latest planning grants for NCI Cancer
Research Centers (an initial step to gaining designation) have gone to
areas without an NCI-designated Center (University of Louisville,
University of Oklahoma, Emory University, Medical University of South
Carolina, and Howard University). The University of New Mexico, a
former planning grant recipient, received Cancer Center designation
last year. NCI also continues to advise emerging centers in a number of
other underrepresented areas around the country on an informal basis.
Additionally, the Cancer Centers themselves are increasingly
establishing their own networks with community hospitals and private
oncology practices and extending the benefits of care and clinical
trials further into communities not previously reached.
consultation protocol
Question. I am pleased that the National Library of Medicine and
the National Cancer Institute have made substantial efforts to
incorporate, within their program areas, resources to address Native
Hawaiian health issues and concerns. The Secretary's latest directive
on consultation directs the Intra-Department Council on Native American
Affairs to incorporate Native Hawaiian health needs and concerns within
the consultation framework for agencies within the Department of Health
and Human Services similar to that afforded American Indians and Alaska
Natives.
Would the National Institutes of Health be willing to engage in
discussions with Papa Ola Lokahi (Native Hawaiian Health Board) on how
best the lessons learned working with the National Library of Medicine
and the National Cancer Institute can be incorporated within all the
Institutes of the National Institutes of Health to develop an agency-
wide consultation protocol for the National Institutes of Health and
Native Hawaiians similar to that afforded to American Indians and
Alaska Natives?
Answer. The NCMHD has established a trans-NIH Committee to work on
the NIH implementation of the Department of Health and Human Services'
tribal consultation policy. As the committee prepares the NIH-wide
tribal consultation protocol, it will look at various best practice
models among the Institutes and Centers, including the National Library
of Medicine and National Cancer Institute's models for lessons learned
that could be incorporated into the protocol and be beneficial to Papa
Ola Lokahi and other Native Hawaiians. The NIH recognizes the
importance of listening, dialoguing, and developing relationships prior
to developing programs and services, and would be willing to hear the
suggestions of Papa Ola Lokahi.
______
Questions Submitted by Senator Harry Reid
chronic fatigue syndrome (cfs)
Question. How many Chronic Fatigue Syndrome (CFS) specific grant
applications were received, reviewed and funded for fiscal year 2004
and fiscal year 2005?
Answer. In fiscal year 2004, 17 CFS-specific grant applications
(R01) were received and reviewed; 2 were awarded. One P50, a
specialized center, was received and awarded. One R13, a conference
grant, was received and awarded. In fiscal year 2005, eight CFS-
specific grant applications (R01) were received and reviewed; one was
awarded. One K12, Physician Scientist Award, was received but not
awarded.
Question. Please provide a detailed list of the studies,
institutions, lead researchers and individual grant amounts for all CFS
studies funded in fiscal year 2004 and fiscal year 2005.
Answer. The information requested is included in the following
tables compiled by the OD Budget Office.
NATIONAL INSTITUTES FOR HEALTH--FUNDING FOR CHRONIC FATIGUE SYNDROME FISCAL YEAR 2004
[Whole dollars]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
IC Project number Principal investigator Institution State Project title Amount
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
NHLBI......................... 5 RO1 HL045462........ COLLINS, TUCKER O........... CHILDREN'S HOSPITAL (BOSTON).... MA..... TRANSCRIPTIONAL REGULATION OF E-SELECTIN............ $177,750
NHLBI......................... 5 R01 HL054926........ ISCHIROPOUL OS, HARRY....... CHILDREN'S HOSPITAL OF PA..... REACTIVE SPECIES IN VASCULAR DISEASE-INJURY 170,000
PHILADELPHIA. MECHANISMS.
NHLBI......................... 5 R01 HL055591........ LOMASNEY, JON W............. NORTHWESTERN UNIVERSITY......... IL..... MOLECULAR BASIS FOR PROTEIN-PHOSPHOLIPID INTERACTION 148,500
NHLBI......................... 5 R01 HL056850........ CLEMMONS, DAVID R........... UNIVERSITY OF NORTH CAROLINA NC..... MECHANISMS BY WHICH IGF-I STIMULATES SMOOTH MUSCLE 203,694
CHAPEL HILL. CELLS.
NHLBI......................... 5 R01 HL059459........ FREEMAN, ROY................ BETH ISRAEL DEACONESS MEDICAL MA..... ORTHOSTATIC INTOLERANCE IN CFS...................... 392,186
CENTER.
NHLBI......................... 2 R01 HL061388........ CRANDALL, CRAIG G........... UNIVERSITY OF TEXAS SW MED CTR/ TX..... HEAT STRESS AND CIRCULATORY CONTROL................. 61,066
DALLAS.
NHLBI......................... 5 R01 HL066007........ STEWART, JULIAN M........... NEW YORK MEDICAL COLLEGE........ NY..... CIRCULATORY DYSFUNCTION IN CHRONIC FATIGUE SYNDROME. 252,000
NHLBI......................... 5 R0l HL067422........ CRANDALL, CRAIG G........... UNIVERSITY OF TEXAS SW MED CTR/ TX..... SKIN COOLING TO IMPROVE ORTHOSTATIC TOLERANCE....... 131,500
DALLAS.
NHLBI......................... 5 RO1 HL070215........ CALDWELL, ROBERT W.......... MEDICAL COLLEGE OF GEORGIA...... GA..... ENDOTHELIAL CELL DYSFUNCTION IN OXIDATIVE STRESS 125,562
MODELS.
----------
TOTAL, NHLBI............ ...................... ............................ ................................ ....... .................................................... 1,662,258
==========
NINDS......................... 1R13NSO47105-01....... HORTOBAGYI, TIBOR........... EAST CAROLINA UNIVERSITY........ SC..... INTERNATIONAL SYMPOSIUM ON MOTOR CONTROL USING TMS.. 2,250
NINDS......................... 5Z01NS002979-06....... GOLDSTEIN, DAVID............ NINDS........................... MD..... CLINICAL NEUROCARDIOLOGY: CATECHOLAMINE SYSTEMS IN 531,506
STRESS AND DISEASE.
----------
TOTAL, NINDS............ ...................... ............................ ................................ ....... .................................................... 533,756
==========
NIAID......................... 1 R01 AI05601401A1.... SULLIVAN, PATRICK F......... UNIVERSITY OF NORTH CAROLINA NC..... MICROARRAYS & PROTEOMICS IN MZ TWINS DISCORDANT FOR 255,301
CHAPEL HILL. CFS.
NIAID......................... 5 RO1 AI042403-07..... BARANIUK, JAMES N........... GEORGETOWN UNIVERSITY........... DC..... MECHANISMS OF RHINITIS IN CFS....................... 232,800
NIAID......................... 5 R01 AI049720-05..... JASON, LEONARD.............. DE PAUL UNIVERSITY.............. IL..... ACTIVITY INTERVENTION FOR CHRONIC FATIGUE SYN- DROME 266,169
NIAID......................... 5 R01 AI051270-03..... TAM, PATRICIA E............. UNIVERSITY OF MINNESOTA TWIN MN..... VIRAL DSRNA AS A MEDIATOR OF CHRONIC MUSCLE DISEASES 334,125
CITIES.
NIAID......................... 2 RO1 AI054478-02..... NATELSON, BENJAMIN H........ UNIV OF MED/DENT NJ NEWARK...... NJ..... SLEEP AND CYTOKINES IN CHRONIC FATIGUE SYNDROME..... 334,904
----------
TOTAL, NIAID............ ...................... ............................ ................................ ....... .................................................... 1,423,299
==========
NICHD......................... R01HD043301-02........ TAYLOR,RENE E R............. UNIVERSITY OF ILLINOIS AT IL..... CHRONIC FATIGUE SYNDROME IN ADOLESCENTS............. 267,009
CHICAGO.
----------
TOTAL, NICHD............ ...................... ............................ ................................ ....... .................................................... 267,009
==========
NIAMS......................... 5-R01-AR-47678-03..... BUCHWALD DEDRA S............ UNIVERSITY OF WASHINGTON........ WA..... ARE FIBROMYALGIA AND CHIARI I MALFORMATION RELATED?. 146,712
----------
TOTAL, NIAMS............ ...................... ............................ ................................ ....... .................................................... 146,712
==========
NIMH.......................... 5K23MH001961-04....... FRIEDBERG, FRED............. STATE UNIVERSITY NEW YORK STONY NY..... PSYCHIATRIC COMORBIDITY IN CHRONIC FATIGUE SYN- 148,923
BROOK. DROME.
----------
TOTAL, NIMH............. ...................... ............................ ................................ ....... .................................................... 148,923
==========
NINR.......................... R01-AI049720-05....... LEONARD, JASON.............. DE PAUL UNIVERSITY.............. IL..... ACTIVITY INTERVENTION FOR CHRONIC FATIGUE SYN- 100,000
DROME.
----------
TOTAL, NINR............. ...................... ............................ ................................ ....... .................................................... 100,000
==========
NCRR.......................... 2M01RR000037-44....... SMITH, MARK................. UNIVERSITY OF WASHINGTON........ WA..... THE EFFECT OF PARENTAL CHRONIC FATIGUE SYNDROME ON 29,494
OFFSPRING.
NCRR.......................... 3P41RR002305-20S1..... MCCULLY, KEVIN.............. UNIVERSITY OF PENNSYLVANIA...... PA..... CHRONIC FATIGUE SYNDROME............................ 5,742
NCRR.......................... 5M01RR000039-44....... PAPANICOLA OU, DIMITRIS A... EMORY UNIVERSITY................ GA..... EFFECTS OF CORTICOTROPIN-RELEASING HORMONE INFUSION 179,251
IN NORMAL FEMALES.
NCRR.......................... 5M01RR000042-44....... WILLIAMS, DAVID A........... UNIVERSITY OF MICHIGAN AT ANN MI..... SUBJECT REGISTRY: INTERDISCIPLINARY STUDIES OF 9,149
ARBOR. CHRONIC MULTI-SYMPTOM ILLNESSES.
NCRR.......................... 5M01RR000046-44....... LIGHT, KATHLEEN C........... UNIVERSITY OF NORTH CAROLINA NC..... FACTORS IN ARTHRITIS, CFS, FIBROMYALGIA & 74,144
CHAPEL HILL. TEMPOROMANDIBULA R DISORDERS.
NCRR.......................... 5M01RR000052-43....... ROWE, PETER C............... JOHNS HOPKINS UNIVERSITY........ MD..... DISORDERED RESPONSES TO ORTHOSTATIC STRESS IN . . . 7,991
GULF WAR SYNDROME SYMPTOMS.
NCRR.......................... 5M01RR000052-43....... SCHWARTZ, CINDY............. JOHNS HOPKINS UNIVERSITY........ MD..... MOVEMENT RESTRICTION AND FATIGUE IN CANCER SURVIVORS 157
NCRR.......................... 5M01RR002635-20....... ADLER, GAIL................. BRIGHAM AND WOMEN'S HOS- PITAL.. MA..... IMMUNONEUROENDOC RINE RESPONSE TO TETANUS TOXOID... 4,821
NCRR.......................... 5MO1RR010710-07....... FRIEDBERG, FREDRICK......... STATE UNIVERSITY NEW YORK STONY NY..... PSYCHIATRIC COMORBIDITY IN CHRONIC FATIGUE SYNDROME. 159,869
BROOK.
NCRR.......................... 5M01RRO10710-07....... FRIEDBERG, FREDRICK......... STATE UNIVERSITY NEW YORK STONY NY..... WHY DO PEOPLE DROP OUT OF SUPPORT GROUPS FOR CHRONIC 6,401
BROOK. FATIGUE SYNDROME?.
NCRR.......................... 5M01RR016587-03....... HURWITZ, BARRY.............. UNIVERSITY OF MIAMI-MEDICAL..... FL..... RBC MASS/AUTONOMIC NERVOUS SYSTEM/INTEGRITY/SY NCOPE 142,237
IN CHRONIC FATIGUE SYNDROME.
NCRR.......................... 5P20RR011145-10....... FRIEDMAN, THEODORE C........ CHARLES R. DREW UNIVERSITY OF CA..... USE OF VIAGRA TO ALTER SYMPTOMS IN PTS WITH CFS..... 118,851
MED & SCI.
NCRR.......................... 5P41RR008119-12....... TARASOV, SERGEY G........... UNIVERSITY OF MARYLAND BALT PROF MD..... SPECT & DNA BINDING OF NAPHTYLIMIDO IMIDAZOACRIDONE 43,966
SCHOOL. WMC79 & RELATED COMPOUND.
NCRR.......................... 5P51RR000168-43....... MADRAS, BERTHA K............ HARVARD UNIVERSITY (MEDICAL MA..... MOLECULAR TARGETS OF THE ANTI-NARCOLEPTIC DRUG 14,843
SCHOOL). MODAFINIL.
NCRR.......................... 5R13RR017508-03....... LAKOWICZ, JOSEPH R.......... UNIVERSITY OF MARYLAND BALT PROF MD..... CFS COURSE ON FLUORESCENCE SPECTROSCOPY: MICROSCOPY, 4,084
SCHOOL. DATA ANALYSIS, FLUOROMETRY.
----------
TOTAL, NCRR............. ...................... ............................ ................................ ....... .................................................... 801,000
==========
OD............................ 1R01HD43301-02........ TAYLOR, RENEE............... UNIVERSITY OF ILLINOIS, CHI- IL..... CFS................................................. 400,000
CAGO.
----------
TOTAL, OD............... ...................... ............................ ................................ ....... .................................................... 400,000
----------
GRAND TOTAL............. ...................... ............................ ................................ ....... .................................................... 5,482,957
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
NATIONAL INSTITUTES FOR HEALTH--FUNDING FOR CHRONIC FATIGUE SYNDROME FISCAL YEAR 2005
[Whole dollars]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
IC Project number Principal investigator Institution State Project title Amount
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
NHLBI......................... 5 R01 HL045462........... COLLINS, TUCKER O........ CHILDREN'S HOSPITAL BOSTON...... MA..... TRANSCRIPTIONAL REGULATION OF E-SELECTIN............ $177,750
NHLBI......................... 5 R01 HL054926........... ISCHIROPOUL OS, HARRY.... CHILDREN'S HOSPITAL OF PA..... REACTIVE SPECIES IN VASCULAR DISEASE-INJURY 170,000
PHILADELPHIA. MECHANISMS.
NHLBI......................... 5 R01 HL055591........... LOMASNEY, JON W.......... NORTHWESTERN UNIVERSITY......... IL..... MOLECULAR BASIS FOR PROTEIN-PHOSPHOLIPID INTERACTION 148,500
NHLBI......................... 5 R01 HL056850........... CLEMMONS, DAVID R........ UNIVERSITY OF NORTH CAROLINA NC..... MECHANISMS BY WHICH IGF-I STIMULATES SMOOTH MUSCLE 209,541
CHAPEL. CELLS.
NHLBI......................... 5 R01 HL059459........... FREEMAN, ROY............. BETH ISRAEL DEACONESS MED- ICAL. MA..... ORTHOSTATIC INTOLERANCE IN CFS...................... 403,952
NHLBI......................... 5 RO1 HL061388........... CRANDALL, CRAIG G........ UNIVERSITY OF TEXAS SW MED...... TX..... HEAT STRESS AND CIRCULATORY CONTROL................. 47,164
NHLBI......................... 5 R01 HL067422........... CRANDALL, CRAIG G........ UNIVERSITY OF TEXAS SW MED...... TX..... SKIN COOLING TO IMPROVE ORTHOSTATIC TOLERANCE....... 131,500
NHLBI......................... 5 R01 HL070215........... CALDWELL, ROBERT W....... MEDICAL COLLEGE OF GEORGIA (MCG) GA..... ENDOTHELIAL CELL DYSFUNCTION IN OXIDATIVE STRESS 125,562
MODELS.
----------
TOTAL, NHLBI............ ......................... ......................... ................................ ....... .................................................... 1,413,969
==========
NINDS......................... 5Z01NS002979-07.......... DAVID, GOLDSTEIN......... NINDS INTRAMURAL RESEARCH MD..... CLINICAL NEUROCARDIOLOGY: CATECHOLAMINE SYSTEMS IN 559,424
PROGRAM. STRESS AND DISEASE.
NINDS......................... 9L30NS054198-02.......... FRANTOM, CATHERINE G..... LOAN REPAYMENT.................. ....... NEURO-REHAB MEASUREMENT............................. 3,058
----------
TOTAL, NINDS............ ......................... ......................... ................................ ....... .................................................... 562,482
==========
NIAID......................... 5 R0l AI051270-04........ TAM, PATRICIA E.......... UNIVERSITY OF MINNESOTA TWIN MN..... VIRAL DSRNA AS A MEDIATOR OF CHRONIC MUSCLE DISEASES 349,860
CITIES.
NIAID......................... 5 R01 AI054478-03........ NATELSON, BENJAMIN H..... UNIV OF MED/DENT OF NJ-NJ NJ..... SLEEP AND CYTOKINES IN CHRONIC FATIGUE SYNDROME..... 673,289
MEDICAL SCHOOL.
NIAID......................... 1 R01 A1055735-01A2...... JASON, LEONARD A......... DE PAUL UNIVERSITY.............. IL..... RISK FACTRORS ASSOCIATED WITH CFS AND CF PRO- 541,703
GNOSIS.
NIAID......................... 5 R01 AI056014-02........ SULLIVAN, PATRICK F...... UNIVERSITY OF NORTH CAROLINA NC..... MICROARRAYS & PROTEOMICS IN MZ TWINS DISCORDANT FOR 518,667
CHAPEL HILL. CFS.
----------
TOTAL, NIAID............ ......................... ......................... ................................ ....... .................................................... 2,083,519
==========
NICHD......................... R01HD043301-03........... TAYLOR, RENE E R......... UNIVERSITY OF ILLINOIS AT IL..... CHRONIC FATIGUE SYNDROME IN ADOLESCENTS............. 268,159
CHICAGO.
----------
TOTAL, NICHD............ ......................... ......................... ................................ ....... .................................................... 268,159
==========
NIAMS......................... 5-RO1-AR-47678-04........ BUCHWALD DEDRA S......... UNIVERSITY OF WASHINGTON........ WA..... ARE FIBROMYALGIA AND CHIARI I MALFORMATION RELATED?. 127,983
----------
TOTAL, NIAMS............ ......................... ......................... ................................ ....... .................................................... 127,983
==========
NIMH.......................... 5K23MH001961-05.......... FRIEDBERG, FRED.......... STATE UNIVERSITY NEW YORK STONY NY..... PSYCHIATRIC COMORBIDITY IN CHRONIC FATIGUE SYNDROME. 157,316
BROOK.
----------
TOTAL, NIMH............. ......................... ......................... ................................ ....... .................................................... 157,316
==========
NCRR.......................... 1M01RR020359-01.......... BARANIUK, JAMES N........ CHILDREN'S RESEARCH INSTI- TUTE DC..... RHINITIS IN CHRONIC FATIGUE SYNDROME (CFS).......... 3,236
NCRR.......................... 2M01RR000052-44.......... SCHWARTZ, CINDY.......... JOHNS HOPKINS UNIVERSITY........ MD..... MOVEMENT RESTRICTION AND FATIGUE IN CANCER SURVIVORS 1,246
NCRR.......................... 2P20RR011145-11.......... FRIEDMAN, THEODORE C..... CHARLES R. DREW UNIVERSITY OF CA..... USE OF VIAGRA TO ALTER SYMPTOMS IN PTS WITH CFS..... 19,782
MED & SCI.
NCRR.......................... 2P41RR002305-21A1........ MCCULLY, KEVIN........... UNIVERSITY OF PENNSYLVANIA...... PA..... CHRONIC FATIGUE SYNDROME............................ 16,453
NCRR.......................... 5M01RR000037-45.......... SMITH, MARK.............. UNIVERSITY OF WASHINGTON........ WA..... THE EFFECT OF PARENTAL CHRONIC FATIGUE SYNDROME ON 6,418
OFFSPRING.
NCRR.......................... 5M01RR000042-45.......... WILLIAMS, DAVID A........ UNIVERSITY OF MICHIGAN AT ANN MI..... SUBJECT REGISTRY: INTERDISCIPLINARY STUDIES OF 77,197
ARBOR. CHRONIC MULTI-SYMPTOM ILLNESSES.
NCRR.......................... 5M01RR000046-45.......... LIGHT, KATHLEEN C........ UNIVERSITY OF NORTH CAROLINA NC..... FACTORS IN ARTHRITIS, CFS, FIBROMYALGIA & 17,907
CHAPEL HILL. TEMPOROMANDIBUL AR DISORDERS.
NCRR.......................... 5M01RR000048-44.......... TAYLOR, RENEE............ NORTHWESTERN UNIVERSITY......... IL..... A PROSPECTIVE STUDY OF CHRONIC FATIGUE SYNDROME IN 26,247
ADOLESCENTS.
NCRR.......................... 5MO1RR000071-42.......... MATHEW, SANJAY........... MOUNT SINAI SCHOOL OF MEDICINE NY..... MRS NEUROMETABOLITE S IN CHRONIC FATIGUE SYNDROME, 10,871
OF NYU. GENERALIZED ANXIETY DISORDER.
NCRR.......................... 5MO1RRO10710-08.......... FRIEDBERG, FREDRICK...... STATE UNIVERSITY NEW YORK STONY NY..... PSYCHIATRIC COMORBIDITY IN CHRONIC FATIGUE SYNDROME. 48,251
BROOK.
NCRR.......................... 5MO1RRO10710-08.......... FRIEDBERG, FREDRICK...... STATE UNIVERSITY NEW YORK STONY NY..... WHY DO PEOPLE DROP OUT OF SUPPORT GROUPS FOR CHRONIC 42,683
BROOK. FATIGUE SYNDROME?.
NCRR.......................... 5M01RR016587-04.......... HURWITZ, BARRY........... UNIVERSITY OF MIAMI-MEDICAL..... FL..... RBC MASS/AUTONOMIC NERVOUS SYSTEM/INTEGRITY/SYNCOPE 28,827
IN CHRONIC FATIGUE SYNDROME.
NCRR.......................... 5P41RR008119-13.......... NOWACZYK, KAZIMIERZ...... UNIVERSITY OF MARYLAND BALT PROF MD..... CFS COMPUTERS....................................... 20,687
SCHOOL.
NCRR.......................... 5P51 RR000168-44......... MADRAS, BERTHA K......... HARVARD UNIVERSITY (MEDICAL MA..... MOLECULAR TARGETS OF THE ANTI-NARCOLEPTIC DRUG 120,481
SCHOOL). MODAFINIL.
NCRR.......................... 5R13RR017508-04.......... LAKOWICZ, JOSEPH R....... UNIVERSITY OF MARYLAND BALT PROF MD..... CFS COURSE ON FLUORESCENCE SPECTROSCOPY: MICROSCOPY, 4,207
SCHOOL. DATA ANALYSIS, FLUOROMETRY.
----------
TOTAL, NCRR............. ......................... ......................... ................................ ....... .................................................... 444,493
==========
OD............................ 1R01HD43301-03........... TAYLOR, RENEE............ UNIVERSITY OF ILLINOIS AT IL..... CFS................................................. 300,000
CHICAGO.
OD............................ 1R01AI055735-01A2........ JASON, LEONARD........... DE PAUL UNIVERSITY.............. IL..... CFS................................................. 100,000
----------
TOTAL, OD............... ......................... ......................... ................................ ....... .................................................... 400,000
----------
TOTAL, NIH.............. ......................... ......................... ................................ ....... .................................................... 5,457,921
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Question. NIH is expected to announce later this month the awards
made in response to the 7/14/05 RFA for CFS. Will the studies funded
under this RFA yield a true increase in the level of NIH research
funding for CFS?
Answer. Yes. The 7 new grants funded will infuse an additional
several million dollars into the bottom line for CFS funding that has
remained relatively constant in the $5.5-$6 million range over the past
years. A projected $2 million is derived from the redirected funds of
the ORWH budget to fund and co-fund studies through the ICs. The
remainder will be provided by the NIAAA, NIAMS, NIEHS, and NINDS.
Additionally, individual letters sent from the Tans-NIH Working Group
for Research on Chronic Fatigue Syndrome encouraged the unsuccessful
applicants to revise and submit their proposals under the standing CFS
Program Announcement. Many have been in touch for advice and plan to
resubmit. The announcement resulted in increased interest from many
researchers who had not previously conducted research on CFS. They are
now aware that NIH interest in CFS is broad based and that many
disciplines can contribute. It is expected that this RFA, information
on the new website, and contacts established with members of the CFSWG
will lead to. a further increase in investigator initiated submissions.
Question. You have been a strong advocate for more centralized
power and discretion within the NIH Office of the Director for the
Roadmap Initiative to identify major opportunities and gaps in research
that no single institute at NIH can tackle alone but that the agency as
a whole must address. CFS is a complex illness that affects the brain
and multiple body systems and thus is an example of a condition that
must be addressed by multiple institutes. The CDC is expected to
announce that CFS affects more than four million adults in the United
States. In 1999, responsibility for CFS was moved to the Office of the
Director. What progress in NIH's approach to the study of CFS has been
made since this move?
Answer. Tremendous progress has been and will continue to be made
in pursuing and further stimulating CFS research. This is accomplished
through a trans-NIH Working Group for Research on CFS (CFSWG) that is
chaired by the Office of Research on Women's Health (ORWH) in the
Office of the Director and includes members from 13 different ICs. The
CFSWG was established in April 2001 to develop an action plan to
enhance the status of CFS research at the NIH and among the external
scientific community. The Working Group first issued a program
announcement based on recommendations from the Chronic Fatigue
Syndrome, State of the Science Conference held in October 2000 that
encouraged innovative and interdisciplinary CFS research. The CFSWG
updated and reissued this announcement in 2005 based on the results of
a second NIH-sponsored scientific workshop. This workshop, Neuro-Immune
Mechanisms and Chronic Fatigue Syndrome: Will understanding central-
mechanisms enhance the search for the causes, consequences and
treatment of CFS?, was held in June 2003. Its proceedings were
published in 2004 (NIH Publication No. 04-5497) and disseminated widely
among the scientific community. The first issue of the new ORWH Science
Series for the Public, informational fact sheets, is also derived from
these proceedings. Also based on these proceedings, the ORWH and the
CFSWG developed a request for applications (RFA) to explicate how the
brain, as the mediator of the various body systems involved, fits into
the schema for understanding CFS (RFA OD-06-002). This RFA specifically
solicited proposals from multidisciplinary teams of scientists to
develop an interdisciplinary approach to the mechanisms involved in CFS
in men and women across the life span. Twenty-nine applications were
received and are in process. All documents mentioned above as well as
complete information about the NIH CFS program are available at http://
orwh.od.nih.gov/cfs.html. All of the above demonstrate concerted trans-
NIH efforts coordinated by an OD program office that is the focal point
for research on women's health, ORWH, to engage the scientific
community in addressing the many aspects of and increasing knowledge of
CFS.
Question. Has the move to the Office of the Director led to any
real progress in multidisciplinary research? If so, what specifics can
you point to?
Answer. Yes. Collaborative achievements that include the
development of an action plan to enhance the status of CFS research at
the NIH and the products of this plan, such as trans-NIH Program
Announcements, Requests for Applications, Scientific Workshops would
not have been possible without the formation of a trans-NIH CFSWG
chaired by the ORWH in the Office of the Director. The ORWH has had a
long and successful track record for developing and leading
interdisciplinary research and training initiatives on women's health
and sex and gender factors in human health through its Coordinating
Committee for Research on Women's Health (CCRWH), which brings together
representatives from every institute and center to facilitate
collaborative efforts. Similarly, the CFSWG, supported and led by the
ORWH, is composed of representatives from 13 NIH institutes and centers
with an interest in facilitating collaborative efforts to invigorate
CFS research at the NIH.
Question. How does the current status of CFS research within the
NIH serve as a model for progress, based on more centralized authority
within the Office of the Director or as a model for multidisciplinary
approaches and the Roadmap.
Answer. NIH has made steady progress towards an interdisciplinary
approach to CFS through the efforts and function of an OD program
office that was established to serve as the NIH focal point for the OD
on women's health research. Therefore, the OD, through ORWH, was able
to bring together diverse institutes to collaborate effectively in a
trans-NIH initiative to enhance research on CFS. The ORWH also
contributed staff and budget to these expanded research activities.
This ORWH effort for CFS serves as an example of how an office within
the OD can facilitate trans-NIH scientific initiatives that manifest
real progress in research.
______
Questions Submitted by Senator Herb Kohl
alzheimer's disease
Question. In April, the National Center for Health Statistics
reported that the life expectancy of Americans has risen to 78 years--
the highest it has ever been. However, they also reported that the
death rate from Alzheimer's disease is increasing among the top 10
causes of death in the United States. In light of the fact that the
Baby Boom generation is entering the age of highest risk for
Alzheimer's, shouldn't NIH be increasing, rather than reducing, its
investment in Alzheimer's research?
Answer. It should be noted that our fiscal year 2007 funding level
for Alzheimer's disease is an estimate and reflects a reduction that is
comparable to the reductions in the total budgets of the NIH ICs
supporting research in this important area. At this time, it is not
possible to be precise as to where available funding will be allocated.
Funding decisions will be based on public health need, scientific and
technological opportunity, and the peer review of research
applications.
As the Senator points out, with current trends, Alzheimer's disease
will become an increasingly critical public health concern over the
coming decades. To reverse this trend, it is critical that we explore
all promising avenues of discovery and promote the translation of
research results into interventions for the successful prevention,
detection, diagnosis, and treatment of Alzheimer's disease. Alzheimer's
disease research continues to be a high priority for NIH, and
scientific opportunities in this area will be actively pursued within
available resources.
epilepsy
Question. As you know, for years I have pushed NIH to work harder
to develop better treatments and a cure for epilepsy. I have supported
efforts by the National Institute of Neurological Disorders and Stroke
to fund epilepsy research. However, many experts think we need a
broader approach, with greater collaboration between NINDS and the
National Institute on Mental Health, the National Institute on Child
Health and Human Development, and other Institutes. What are you doing
to guarantee that multi-Institute studies on epilepsy are developed and
funded in the coming year?
Answer. As the lead NIH Institute for epilepsy research, the
National Institute of Neurological Disorders and Stroke (NINDS)
coordinates epilepsy research efforts through the InterAgency Epilepsy
Working Group. The Epilepsy Working Group is composed of scientific
program staff from the NINDS, eight other Institutes, including the
National Institute of Mental Health (NIMH) the National Institute of
Child Health and Human Development (NICHD), and staff members from the
Centers for Disease Control and Prevention. The Working Group
facilitates coordination and collaboration among NIH Institutes. For
example, NINDS and NIMH Epilepsy Working Group members collaborated
with the American Epilepsy Society to sponsor an international workshop
in May 2005 on treatment of nonepileptic seizures (NES), a
neuropsychiatric seizure disorder. As a result of this meeting, the
NIMH and the NINDS issued a request for applications on ``Collaborative
Research on Mental and Neurological Disorders.''
This initiative focused on co-morbidities between mental health and
neurological disorders, including epilepsy.
The NINDS and the NICHD have a long history of collaboration on
epilepsy research. The NICHD funds the Mental Retardation Research
Centers Program, a network of regional centers developed for research
on mental retardation and related aspects of human development,
including epilepsy. Many of the Centers also provide infrastructure for
NINDS-supported epilepsy research projects. Both Institutes fully
expect this successful collaboration to continue in the future.
The NIMH, NICHD, and NINDS also collaborate in funding the Autism
Research Network (ARN). The ARN is made up of eight collaborative
research centers that focus on the causes, diagnosis, early detection,
prevention, and treatment of autism. One of the network studies, ``A
Longitudinal Assessment of Behavior Problems, Puberty, and Epilepsy''
is designed to investigate which children with autism develop seizures
and whether there are changes in behavior that either precede or follow
the development of seizures.
Question. As you know, NINDS held a successful epilepsy conference
in 2000, where research benchmarks were developed and used to create a
research agenda in epilepsy. It's my understanding that NINDS is
planning a follow-up conference on Curing Epilepsy in March 2007. Will
you ensure that representatives from other Institutes participate in
the 2007 conference? What steps will you take after the conference to
ensure that collaborative research is pursued in order to have the
greatest impact for epilepsy patients?
Answer. The NINDS has invited all the organizations represented on
the InterAgency Epilepsy Working Group (IAEWG) to participate in
planning and co-sponsoring the Curing Epilepsy 2007 conference. Co-
morbidities, such as cognitive and psychological issues in children and
adults with epilepsy, will be one of the major themes of the
conference. Epilepsy co-morbidities often include behavioral problems,
learning and memory difficulties, and depression. The NINDS expects
that the conference will draw attention to the importance of these
issues and will stimulate interdisciplinary investigation into the
causes, treatment and prevention of epilepsy and its co-morbidities.
The IAEWG will also consider the potential for collaborative activities
in response to any recommendations that result from the Curing Epilepsy
2007 conference.
age-related macular degeneration
Question. You have publicly cited as an NIH ``breakthrough'' the
discovery of a gene strongly associated with age-related macular
degeneration (AMD). As you know, AMD is the leading cause of blindness
in the United States, especially among our seniors, robbing them of
their independence and quality of life. What does this finding mean for
new treatments to stop or reverse this blinding eye disease? How will
the National Eye Institute follow up on this exciting breakthrough when
the President's budget proposes to cut NEI funding?
Answer. National Eye Institute-sponsored investigators have made
considerable progress since the recent discovery of the complement
factor H (CFH) gene in age-related macular degeneration (AMD). NEI
intramural researchers are initiating a phase I clinical trial to
evaluate anti-inflammatory agents that may inhibit damaging immune
responses potentially resulting from alterations in the CFH gene. NEI
extramural and NIH intramural scientists discovered that alterations in
a second gene in the inflammatory pathway, complement factor B, are
also associated with AMD. Variations in these two genes can predict the
clinical outcome in 74 percent of individuals with AMD. In addition,
the NEI launched a new research initiative to further investigate the
role of inflammation in AMD and other common eye diseases such as
diabetic retinopathy and uveitis.
irritable bowel syndrome
Question. For the last several years, the Appropriations Committee
has asked the National Institute of Diabetes and Digestive and Kidney
Diseases to develop a strategic plan for research into Irritable Bowel
Syndrome. NIDDK has explained that the Institute [is] creating an
overall digestive disease action plan and that IBS will be a
significant part of it. Can you update us on NIDDK's progress on the
digestive disease plan and explain how much attention IBS will receive?
Answer. The NIH established a National Commission on Digestive
Diseases in August 2005, based on the shared interest of the NIH and
the Congress in advancing research on digestive diseases. One of the
Commission's primary purposes is to develop a Long-Range Research Plan
for Digestive Diseases, which will include plans for stimulating
research on functional gastrointestinal (GI) and motility disorders
such as irritable bowel syndrome (IBS). Within the NIH, the NIDDK has
lead responsibility for digestive diseases research and supports a
research portfolio in IBS and other types of functional GI and motility
disorders. The NIDDK is providing leadership and support for this
federally chartered Commission.
As NIH Director, I appointed members of the Commission after a
broad call for nominees with diverse scientific, professional, and
personal experiences related to digestive diseases from within the
academic and medical research and practice communities, patient and
patient advocacy community, and the NIH and other Federal health
agencies. The perspective of individuals with personal or professional
interest in IBS and other types of functional GI and motility disorders
is represented within the Commission.
Commission members recently convened for their first meeting on
June 12, 2006, and are currently finalizing topics for chapters of the
Research Plan, one of which is expected to focus on IBS and related GI
motility disorders research. The ultimate goal of the Commission's
Research Plan is to improve the nation's health through advancing
research on digestive diseases, such as IBS. The Research Plan will
include: (1) information on the burden of disease on individuals and
society; (2) examples of research advances that are generating new
knowledge vital to understanding, treatment, and prevention; and (3)
compelling opportunities for future NIH-funded research, which offer
promise for reducing the burden of disease. This Research Plan will
recommend promising research directions relevant to IBS and other types
of functional GI and motility disorders, which will help guide the
NIDDK, the NIH, and the investigative and lay community in the pursuit
of the most productive research avenues.
The Commission will rely on broad stakeholder input from members of
the digestive diseases community to inform the Research Plan throughout
its development. For example, Commission members are currently
establishing Working Groups composed of individuals with expertise
related to specific areas of digestive diseases research, who will
provide input necessary for crafting a well-informed Research Plan. One
of these Working Groups is expected to focus on functional GI and
motility disorders, such as IBS, in addition to potential overlapping
and synergistic efforts in this area on the part of other Working
Groups. Other opportunities for broad stakeholder input into the
Commission's activities will include public Commission meetings and an
open comment period for public input on the draft Research Plan.
Additional information on the Commission's ongoing activities can be
found on its website at: http://NCDD.niddk.nih.gov.
CONCLUSION OF HEARINGS
Senator Specter. So thank you for what you are doing. We
appreciate your thanks to us, and we are going to do more and
we ask you to do more. That concludes our hearings.
[Whereupon, at 10:14 a.m., Friday, May 19, the hearings
were concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, EDUCATION, AND RELATED
AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2007
----------
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
DEPARTMENT OF LABOR
Office of the Secretary
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
[The following questions were submitted to be answered for the
record:]
Questions Submitted by Senator Arlen Specter
mine safety
Question. Congress has now passed bi-partisan mine safety
legislation that contained many of the provisions in a bill I
introduced on February 16, 2006. Congress has also passed a pending
supplemental appropriations bill containing $35,600,000 to augment
inspections of coal mines and to expand research to develop mine safety
technology. How do you intend to implement these authorization and
appropriation measures? What additional appropriations are necessary to
fully implement the new authorization?
During the hearing this Subcommittee held on January 23, 2006, on
the Sago Mine disaster, I questioned the policy of the requiring mine
representatives to be present during accident investigation interviews
with miners. Although the legislation I introduced would prohibit this
practice, it was not included in the consensus bill reported last week.
Do you support such a provision?
Answer. $25.6 million of the $35.6 million contained in the
supplemental appropriation was appropriated to MSHA. The supplemental
appropriation contains a provision requiring MSHA to submit a spending
plan for these funds to the appropriations committees by July 15, 2006,
and MSHA will comply with this provision. The remaining $10 million in
supplemental funding was appropriated to NIOSH for expansion of
research and mine safety technology, therefore NIOSH is the appropriate
entity to answer questions regarding their plans for the use of those
funds. With regard to additional appropriations necessary to fully
implement the MINER Act, the MINER Act contains authorization for new
grant programs but no funding for these programs has been appropriated.
Many of the new MINER Act provisions do not require any additional
funding. For example, the increase of the maximum civil penalty for
flagrant violations and the implementation of minimum penalties for
unwarrantable citations and orders, as well as the provision requiring
every mine to have an Emergency Response Plan do not require any
increases in funding.
With regard to MSHA accident investigations, the Mine Act gives
MSHA discretion to determine who may be present during accident
investigation interviews with miners and other persons who may have
relevant information. As you are aware, MSHA's longstanding past
practice regarding interviews has generally included participation by
the mine operator and the representative of miners. However, we have
come to the conclusion that this process should be changed to conform
to the process used by virtually all other law enforcement
investigative agencies. We believe that witness interviews should be
conducted with only federal, and where applicable, state authorities.
Of course, witnesses would continue to have the option of having a
personal representative of their choosing present during the interview.
We believe that the time proven technique of interviewing witnesses
separately and without additional persons present is the best method of
eliciting useful information without fear of intimidation, and
minimizes the ability of witnesses to modify their testimony in light
of the knowledge gained from other witnesses. In fact, recent
experience has demonstrated that the presence of third-parties could
compromise the investigation, make witnesses less likely to cooperate,
and result in premature release of information before all witness
interviews are complete. Thus, we agree that participation in
interviews by non-government personnel should be limited to a personal
representative of the witness. Of course, MSHA will continue its
practice of releasing all witness transcripts, except those requested
under the Mine Act to be confidential, once the investigation has
reached a stage where release would not impede or interfere with the
investigation.
job corps funding
Question. It has been more than 45 calendar days of continuous
session of the Congress since the President proposed rescinding $75
million of Job Corps construction and renovation funds. Have these
funds now been released as required by the Congressional Budget and
Impoundment Control Act?
Answer. The $75 million in Construction, Rehabilitation, and
Acquisition funds were not withheld from obligation, as noted in our
May 30, 2006 letter to GAO on this matter, and remain available for
obligation by the Office of Job Corps.
Question. Your budget proposed to cut $62,578,000 from the Job
Corps budget for program year 2007, which would result in 3,614 fewer
students enrolled than in 2005. This would reduce funding, on
inflation-adjusted basis, 8.5 percent below the level in 2005. How far
below capacity would this put the 122 existing Job Corps centers?
Answer. With the requested 2007 operating budget of $1,401,602,000,
Job Corps will be able to maintain 42,863 year-around training slots,
which represents 95.5 percent of the peak level that could be
accommodated by our physical infrastructure.
reintegration of youthful offenders
Question. Your budget once again zeroes out the program I was
instrumental in creating, for training and employing of youthful
offenders. Even after last November's conference agreement restored $49
million for this program, the Administration immediately offered it up
as an offset to help pay for December's Katrina supplement. Do you
think this was an appropriate way to respond?
Answer. The impacts of the Katrina and Rita hurricanes were
unprecedented and the Administration carefully prioritized the use of
available resources across government to fund relief and recovery
efforts. The Youth Offender appropriation was only one of many offsets
the Administration presented to Congress, and this is consistent with
the Administration's proposal in the fiscal year 2007 and previous
budgets to replace the Responsible Reintegration of Young Offenders
program with the Prisoner Reentry Initiative, thereby increasing the
program's overall scope and reach.
elimination of migrant job training
Question. Both the House and the Senate appropriations committees
have repeatedly rejected your proposal to eliminate the Migrant and
Seasonal Farmworkers Program under the Workforce Investment Act. I
think it's fair to say that Congress recognizes that it is unrealistic
to expect states and localities to be responsible for a unique and
difficult-to-serve migratory population that, from their point of view,
is ``here today and gone tomorrow.'' It is also unfair to shift this
burden to states when you are proposing to reduce the already limited
job training resources that states have to serve their eligible local
residents. If Congress understands this, why doesn't the Department?
Answer. The Administration's fiscal year 2007 Budget proposal seeks
to tap the workforce investment system's potential to serve more
migrant and seasonal farmworkers by providing job training services to
them through the One-Stop Career Center system, and turning to other,
appropriate agencies to provide supportive services, housing, and other
related assistance. Currently, the section 167 program provides
employment and training services to only 10,000 of an estimated two
million farmworkers, which demonstrates the need for a wider system
approach.
The Administration believes that providing services to farmworkers
through the One-Stop system will increase the number served and have a
positive employment and earnings impact on those who receive services.
impact of job training cuts
Question. Your budget is based on the assumed enactment of a new
Workforce Investment Act reauthorization proposal calling for Career
Advancement Accounts, to be run through a consolidated workforce
system, cutting nearly $700 million. Until the authorization
legislation is changed, this Committee acts on the basis of extending
current law. In the absence of law change, what impact will your budget
proposals have on existing programs for youth, adults, dislocated
workers, and the Employment Service? For example, the Pennsylvania
Association of Workforce Investment Boards estimates the President's
Budget would result in a 17 percent cut from current levels for the
youth, adult and dislocated worker block grants. Do I have your
assurance that you will not proceed administratively to implement
proposals such as consolidated Career Accounts without Congressional
approval?
Answer. The President's Budget request does assume enactment of the
Career Advancement Account (CAA) proposal, which would reduce overhead
and administrative costs and focus more funding on training, thereby
tripling the number of individuals receiving job training through the
workforce investment system.
In the absence of any legislation passed by Congress, states will
continue to operate Workforce Investment Act programs and the
Employment Service as currently authorized. The appropriation level
provided by Congress is a separate issue from job training reform. We
feel that CAAs are a more effective approach than the current workforce
investment system, regardless of the funding level provided by
Congress.
Several states and local areas have expressed interest in piloting
CAAs. We will work with these areas to develop a limited pilot that can
be carried out under current law. However, statutory changes are
necessary to achieve all of the reforms envisioned under the CAA
proposal.
workforce training cuts
Question. Your budget for workforce programs contains cuts of $506
million for state grant programs, while increasing funding under
national control by $107 million. How does this square with your
legislative proposal to shift greater control of resources to the
States?
Answer. The President's fiscal year 2007 Budget proposes a minimal
increase for programs under ``national control.'' The only activity
that falls under this category that is proposed for additional funding
is Unemployment Insurance National Activities, whereby an increase of
$600,000 is requested to pay for activity related to processing
separation documents and unemployment claims of former military service
personnel.
Furthermore, the fiscal year 2007 Budget request proposes
initiatives that give greater control of funding to states and local
areas. The Career Advancement Account proposal promotes state and local
flexibility by streamlining and strengthening the One-Stop Career
Center system and removing or simplifying statutory requirements that
create rigidity and hinder flexibility in providing education and
training opportunities to American workers. Also, the Administration
included a streamlined program structure in its Older Americans Act
reauthorization proposal, which would give states greater control over
the Senior Community Service Employment Program (SCSEP) funds.
asbestos exposure
Question. Madame Secretary, the fiscal year 2006 appropriation
contained $2 million for the Employment Standards Administration to
facilitate the expeditious startup of a system to resolve the claims of
injury caused by asbestos exposure. How are these funds being used to
shorten the lead-time for implementation of pending asbestos
legislation?
Answer. If the Asbestos legislation is enacted as currently
written, the Department of Labor will be expected to manage a new and
very substantial national benefits program involving the disbursement
of billions of dollars in compensation to hundreds of thousands of
individual asbestos claimants. The proposed time frame for implementing
this legislation is extremely short, requiring immediate preparatory
work and the up-front expenditure of resources to ensure that payments
can begin being made to compensable claimants as quickly as possible.
Given the status of the pending legislation, the $2 million is
being used to analyze the proposed legislation and plan how to
implement it in the event that it is passed. In the next phase, funding
will be used for initial program start-up expenses in the areas of
program design, acquisition of specialized expertise, technology, and
infrastructure.
osha penalties for asbestos violations
Question. I have introduced legislation (S. 668) to subject
employers who willfully violate OSHA asbestos standards to fines at
levels set by the Uniform Criminal Code as well as imprisonment of up
to five years, or both. Currently OSHA provides for criminal penalties
only in those cases where a willful violation of standards results in
the death of a worker within six months after the violation is
discovered. Do you agree that stronger enforcement action is needed
against parties that violate OSHA asbestos enforcement rules?
Answer. Currently, the OSH Act provides for criminal fines and
imprisonment of up to six (6) months against an employer only where the
employer's willful violation of a standard caused the death of an
employee. In addition, criminal penalties exist against employers who
make false statements to OSHA investigators or who unlawfully interfere
with OSHA investigations. S. 668 provides that any willful violation of
a standard issued under OSH Act section 6 with respect to control of
occupational exposure to asbestos is punishable by fines under section
3571 of Title 18, United States Code, and imprisonment in the case of a
first offense, of up to five years. While we agree that occupational
exposure to asbestos is a very serious health issue, we believe the
current OSH Act and penalty structure provide the means and flexibility
to address instances where penalties are warranted.
immigration bill
Question. The Senate passed immigration legislation, S. 2611,
contains a provision requiring the Secretary of Labor to certify that
no United States workers are available for a specified position before
employers can hire an alien for the job. Do you support this provision,
and does your Department have sufficient resources to administer it?
Answer. The Department supports the need to enact comprehensive
immigration reform that creates a guest worker program and enhances the
security of our borders. In his various speeches on immigration reform,
the President has repeatedly noted that foreign workers should be
allowed to take only those jobs that no U.S. worker is willing or
available to perform. To implement this important program design
feature, the Department will need to either establish a labor market
test for domestic worker interest or create a mechanism whereby
employers can attest that they have tested the labor market and been
unable to find a U.S. worker to fill the job. If an attestation system
is created, the Department would randomly audit employer attestations
to ensure program integrity. We agree that the S. 2611 provision is
consistent with the President's position and we support it accordingly.
The administration will work with Congress as immigration legislation
moves forward to ensure that the need for resources is addressed.
Question. Your Department has the responsibility to prevent
employer exploitation of undocumented workers, by enforcing minimum
wage and overtime laws. To what extent is this effort discouraging
illegal immigration?
Answer. The strong enforcement of basic labor standards for all
employees weakens the incentive to hire undocumented workers. Although
it is difficult to quantify the extent to which labor standards
enforcement deters or dissuades employers from hiring undocumented
workers, most studies on the impact of illegal immigration acknowledge
the importance of such enforcement as a key component in an overall
strategy for addressing the problem.
Question. What actions do Labor Department inspectors take when
they come across evidence that a business unlawfully employs illegal
immigrants?
Answer. When the Wage and Hour Division (WHD) performs an
investigation a complaint-based investigation, it does not seek
evidence of the complainant's immigration status. WHD instituted this
policy to avoid discouraging complaints from undocumented workers who
might otherwise be reluctant to complain to WHD because of their
immigration status.
However, WHD investigators do perform directed investigations (non-
complaint cases) to determine employers' compliance with their
employment eligibility verification obligations (Forms I-9). In cases
where it appears that violations have been committed, WHD refers the
matter to DHS pursuant to a Memorandum of Understanding.
medical leave program
Question. At your last appearance before this Committee on March
15, 2005 you stated no final decision has been made with respect to
revising regulations implementing the Family and Medical leave Act.
What progress has been made addressing concerns of workers and
employers that have resulted in so many lawsuits on the interpretation
of when employers are eligible for leave under the law?
Answer. The Department continues to review the issues raised by the
Supreme Court's decision in Ragsdale v. Wolverine World Wide, Inc., as
well as other court decisions, and the possibility of revisions to the
FMLA regulations remains an item on the Department's regulatory agenda.
No final decisions have yet been reached as to what, if any, changes
might actually be proposed. If changes are proposed, the public will be
provided ample opportunity to comment through the formal notice and
comment rulemaking process.
re-allocation of unspent funds
Question. Your budget proposed bill language that would take money
away from states that have more than 30 percent unspent job training
funds, yet you do not propose applying this principle to Dislocated
Worker national reserve funds, which currently have unspent funds
exceeding 50 percent. What is your justification for this?
Answer. The Department always obligates all National Reserve monies
to states during the program year for which such money was
appropriated. Any unspent funds are unspent at the state and local
level, not at the national level. This indicates that even more funds
are available for expenditure by states and grantees.
rapid response funds
Question. Currently, states use rapid response funds to provide
immediate service to workers affected by a mass layoff, often before
the workers are even laid off. Under your legislative proposal, states
will need to apply to the Employment and Training Administration for
rapid response funds as events occur. What are the reasons for keeping
these funds at the national level, and having states apply for them
each time they are faced with mass layoffs?
Answer. The Department does not contemplate that a state would have
to apply for funds each time there is a mass layoff or to only
sporadically fund a state rapid response coordinator. Early
intervention to provide information and assistance to workers to
decrease the amount of time between actual layoff and re-employment is
a key principle of the dislocated worker program. Rapid response is a
key element of this early intervention strategy.
States could demonstrate need and apply for rapid response funds at
the beginning of the program year or throughout the program year. We
will not propose that a state be required to submit an application for
funding each time a dislocation event occurs.
In spite of all the good work that has been done over the past
fifteen years with dislocated worker rapid response funds, the
Department has found that most company executives do not know about the
type and quality of assistance available to them and their employees
when closures or layoffs are contemplated. They have also reported that
where they have layoffs in several states simultaneously, the levels
and quality of assistance varies dramatically. ETA, in collaboration
with state and local partners, has undertaken several initiatives in
the auto, textile and defense industries recently to try to integrate
services and develop more consistency. We believe a nationally-
coordinated approach to delivering rapid response assistance by states
can help bring the services to more workers and employers.
The proposed mechanism will assist both the Department and the
states to better manage scarce taxpayer resources by directing the bulk
of the funds to the areas of need. For example, not all states
experience major layoffs every year. Analyses of dislocated worker
program expenditures reported by states have shown that the funds
reserved for rapid response are consistently under-expended. In the
aggregate, the rapid response carry-in funds from program year 2003 to
2004, and from 2004 to 2005, was $136.7 million and $166 million,
respectively. Through March 31, 2006, states reported accrued
expenditures of just over $176 million of a total available of more
than $342.5 million, or 51.4 percent of the total funds available.
States are not required to retain the up to 25 percent authorized to be
reserved for rapid response activities. They may include a portion of
the funds in the amount allocated to local workforce investment boards
for core, intensive and training services for dislocated workers, or
they may award additional funds from the reserved amount to local areas
that experience disasters, mass layoffs, plant closings or other events
that precipitate substantial increases (defined by the state) in the
number of unemployed workers.
comments on cecil roberts testimony
Question. Mr. Cecil Roberts, President of the United Mine Workers
of America, testified to this Committee that the penalties assessed by
the Labor Department are designed to insure that mining remains
profitable, even if the conditions are so hazardous the mine should be
shut down. Do you believe that keeping a mine operating is more
important than the safety of the miners?
Answer. No, we do not believe that keeping a mine operating is more
important than the safety of the miners who work in that mine. The Mine
Act states in its opening section that ``the first priority of all in
the coal or other mining industry must be the health and safety of its
most precious resource--the miner.'' That is the premise on which the
Mine Act is based and the reason for the existence of MSHA. The Mine
Act contains provisions to withdraw miners until the hazard or
violation is abated when there is an imminent danger to the health and
safety of miners or an unwarrantable failure of an operator to comply
with a mandatory health and safety standard. MSHA uses its withdrawal
authority vigorously and appropriately.
Under the Mine Act, MSHA has the authority to propose penalties for
violations of the Act. MSHA does so in accordance with the six
statutory criteria enacted by Congress in the Mine Act, including
consideration of the effect of the proposed penalty on the operator's
ability to stay in business. Consistent with the Administration's last
three budget requests, Congress included a provision in the MINER Act
to increase the maximum civil penalty for flagrant violations of the
Mine Act to $220,000. Minimum penalties were also included for
unwarrantable failure violations. The Department has announced that
MSHA will be revising its regulations and proposing a new penalty
formula to raise penalties for mine safety and health violations across
the board. These higher penalties should provide a greater incentive to
mine operators to comply with MSHA's safety standards.
older worker employment program
Question. The Department has launched another national grant
competition process for the Senior Community Service Employment Program
despite not having the essential performance data that will not be
available for new performance goals until September 2006. Since the
current law directs that re-competition be conducted for non-
performance by a grantee, on what basis do you deem this new round of
competition to have sound data for assessing current or future grantee
performance or capacity?
Answer. The Department has been collecting performance data since
the inception of the program, and has been collecting additional data
on the new common performance measures since July 2004.
Furthermore, according to the Title V of the Older Americans Act,
competition is not limited to when grantees fail performance measures.
Section 514(a) limits the award of SCSEP grants to no more than three
years, thus requiring a selection of grantees within three years of the
first competition. The issue of whether the Department can compete the
SCSEP grants has also been addressed by the courts. The U.S. District
Court of the District of Columbia held recently in Experience Works v.
Chao, 267 F.Supp. 2d 93 (D.D.C. June 17, 2003), ``[t]he use of
competitive procedures is a time-honored method for obtaining the most
highly qualified awardees of government funds, for allowing new and
innovative ideas and organizations to receive those funds, and for
assuring public confidence in the integrity of the process to
distribute government funds.''
Finally, the current Solicitation for Grant Applications (SGA)
clearly identifies the criteria against which applicants are assessed.
All applicants will be rated using a ranking criterion based on points.
This SGA requires that responses be thoughtful and reflect a strategic
vision.
The SGA evaluation criteria are as follows:
1. Design and Governance--15 points
2. Program and Grant Management Systems--10 points
3. Financial Management System--10 points
4. Program Service Delivery--40 points
5. Performance Accountability--25 points
Question. When the program was competed in 2003, this whole
competition process--application, grading and transition--took almost 6
months--including over 6 weeks for transitioning the participants
affected. This time the new competition rules are much more complex,
yet the whole process has been shortened to 4 months, leaving barely 3
weeks for transition of these vulnerable participants--why the rush to
get this done this way this year?
Answer. This year's competition is not rushed. Applicants were
given nearly the same amount of time this year as in the 2003
competition to respond to the Solicitation for Grant Applications
(SGA). In 2003, grantees were given 90 days to respond to the SGA, a
time period which included Christmas. This year, the competition was
announced in the Federal Register on March 2, and grantees were given
until May 26 to respond, or 85 days.
Further, once grants are awarded, grantees have 2 months in which
to transition participants among grantees, a longer transition period
than in 2003. As specified in the SGA, the transition period follows a
1-month extension of current grants and will take place August 1-
September 30, 2006. This means that the period from publication of the
SGA (March 2) until the transition period ends (September 30) is
approximately 7 months, 1 month longer than the 2003 competition.
Question. The cost of transitioning thousands of participants
nationwide among old and new sponsors will be significant. Subsequent
to publication of the SGA in the Federal Register, the DOL website was
amended to say, ``Transition cost should be submitted as an integral
part of the budget and reflected on the other' cost category with a
narrative explanation. Can you assure the Committee that services to
enrollees will not be diminished as a result of incurred transitions
costs?
Answer. All current grantees were required to build transition
costs into their budgets in the 2003 competition, and all applicants
under the 2006 competition have also budgeted for transition costs.
Further, the Department is prepared to assist grantees with additional
costs associated with the transition, as it did following the
transition after the 2003 competition. Program Year 2004 recaptured
funds are available for this purpose.
At the time of the 2003 competition, many participants and grantees
were concerned about the transition effects upon participants. The
Department can say with authority that every single participant was
transitioned successfully. Competition does not need to cause any
disruption among services participants receive.
DOL has identified specific responsibilities for itself, national
grantees and state grantees to ensure a smooth transition. DOL will
provide orientation to all national grantees to provide information on
program administration and management. DOL will begin regular
conference calls between federal and regional DOL staff and national
grantees to quickly address any transition issues. DOL will also
provide assistance through a national call center, and provide on-site
technical assistance as needed.
Question. Your budget proposes to save $44 million in the Community
Service Employment for Older American program through ``efficiencies
related to program streamlining.'' What exactly is being proposed to
save this amount?
Answer. The Administration proposes that reauthorization of the
Title V SCSEP program be based on five key reform principles: (1)
helping meet employers' demands for skilled workers by attracting more
older workers into the labor force, encouraging others to remain in the
workforce, and by offering opportunities for older workers to update
their skills; (2) making the One-Stop Career Center system effective
for older individuals seeking to work or upgrade their skills,
including better integrating services for older workers and assisting
more older workers, regardless of income, to gain skills that are in
demand; (3) tailoring services to meet the needs of individual older
workers by providing a range of training experiences, including
community service employment, on-the-job training and classroom
training, depending on the individual's background and experience; (4)
targeting SCSEP resources to those older workers most in need
(primarily low-income older workers who lack the basic skills for
private sector employment), while ensuring that others receive services
through the One-Stop Career Center system; and (5) streamlining the
program to make it easier to administer in order to improve program
performance, serve more participants, and receive a return on
investment for the federal taxpayers' dollar.
In fiscal year 2007, savings from streamlining administration and
other reforms will amount to an estimated $44 million in the first year
of implementation. Specifically, we expect that savings will be
achieved from the following reforms:
--Revamping the SCSEP program structure so that states conduct a
competition every three years to run the program in the state,
which will simplify administration, eliminate duplication, and
create a more comprehensive program.
--Eliminating fringe benefits for program participants (except
accident insurance or benefits that may be required by law) to
reinforce the training aspect of the program.
--Allowing SCSEP funding to be used for training (as opposed to
wages) and allowing more flexible training options in addition
to community service work experience.
In addition to savings from reforms through reauthorization,
savings will also be realized through the current grant competition.
The current Solicitation for Grant Applications encourages a regional
service delivery architecture that will reduce redundancy and
fragmentation of service delivery areas by requiring that applicants
apply to serve an entire county instead of a portion, and generally
requiring that applicants apply to serve contiguous counties if
multiple counties are served.
It is important to note that the fiscal year 2007 request will
continue to support 92,300 low-income elderly individuals, the same
level as fiscal year 2006.
administration and management
Question. Provide appropriations and full time equivalent staff for
each of fiscal years 2003 through 2005 enacted, fiscal 2006 comparable,
and fiscal 2007 budget request, for each of the components of the
Administration and Management activity within the Departmental
Management account, including: Department Budget Center; Center for
Program Planning and Results; Human Resources Center; Information
Technology Center; Civil Rights Center; Office of Security and
Emergency Management and Business Operation Center. Provide the source,
by Department of Labor agency and activity, of the FTE and funding for
Working Capital Fund Programs, comparing fiscal year 2006 comparable
with the fiscal year 2007 request.
Answer. The information for Administration and Management follows:
ADMINISTRATION AND MANAGEMENT BUDGET ACTIVITY DEPARTMENTAL MANAGEMENT SALARIES AND EXPENSES
[Amount in thousands]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fiscal year 2003 Fiscal year 2004 Fiscal year 2005 Fiscal year 2006 Fiscal year 2007
enacted enacted enacted comparable request
Agency -------------------------------------------------------------------------------------------------------------
AMT FTE AMT FTE AMT FTE AMT FTE AMT FTE
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Program Planning and Results... $6,352 4 $6,076 9 $5,537 8 $5,438 8 $5,562 8
Human Resources Center.................... 3,650 23 3,473 23 3,502 24 3,445 24 3,573 24
Information Technology Center............. 12,414 60 12,954 56 11,624 50 9,346 37 9,755 37
Business Operation Center................. 2,652 16 2,026 14 1,959 11 1,778 11 1,825 11
Office of Security and Emergency Mgmt.\1\. ......... ......... ......... ......... 6,944 ......... 6,875 ......... 1,893 .........
Department Budget Center \2\.............. ......... ......... 1,776 15 2,362 19 2,056 18 2,116 18
Library................................... 714 2 719 2 754 1 754 1 782 1
Federal Executive Board................... 170 2 173 2 176 2 206 2 210 2
Assistant Secretary for Administration and 4,239 5 5,956 5 6,500 10 7,590 10 7,923 10
Management...............................
Civil Rights Center \3\................... 5,930 48 6,144 48 6,237 46 6,451 46 6,735 46
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Represents funding for Frances Perkins Building security enhancements. The fiscal year 2007 Request includes a comparative transfer of $5 million
from this budget activity to the Working Capital Fund for upgrading security and continuity of operations capabilities for the Department.
\2\ Department Budget Center was transferred to Administration and Management budget activity from the Chief Financial Officer budget activity in fiscal
year 2004.
\3\ CRC is funded from the Civil Rights Activity, rather than the Administration and Management Activity.
The information for Working Capital Fund follows:
DOL AGENCY WORKING CAPITAL FUND ASSESSMENTS
[In thousands of dollars]
------------------------------------------------------------------------
Fiscal year
-------------------------
2006 2007
estimate request
------------------------------------------------------------------------
ETA........................................... 14,987 17,942
ETA/TES....................................... 9,326 9,922
ESA........................................... 37,620 44,021
OSHA.......................................... 22,851 25,235
EBSA.......................................... 10,054 11,463
BLS........................................... 16,009 19,353
OIG........................................... 4,097 4,685
OSEC.......................................... 14,458 16,730
VETS.......................................... 2,832 3,207
SOL........................................... 6,396 6,646
ILAB.......................................... 1,984 2,228
MSHA.......................................... 11,237 13,564
ODEP.......................................... 1,250 1,305
FPB repairs................................... 915 833
-------------------------
Total................................... 154,016 177,134
------------------------------------------------------------------------
program direction
Question. Provide appropriations and full time equivalent staffing
for each of fiscal years 2003 through 2005 enacted, fiscal 2006
comparable, and fiscal 2007 budget request, for each of the following
components of the Program Direction and Support activity within the
Departmental Management account: Office of the Secretary; Office of the
Deputy Secretary; Office of Public Affairs; Office of the Assistant
Secretary for Policy; Office of Congressional and Intergovernmental
Affairs; Office of Small Business Programs; Office of Public Liaison;
Office of the 21st Century Workforce; and the Center for Faith-Based
and Community Initiatives.
Answer. The information for Program Direction follows:
PROGRAM DIRECTION AND SUPPORT
[Amount in thousands]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fiscal year 2003 Fiscal year 2004 Fiscal year 2005 Fiscal year 2006 \1\ Fiscal year 2007
enacted enacted enacted comparable request
PDS components -------------------------------------------------------------------------------------------------------------
AMT FTE AMT FTE AMT FTE AMT FTE AMT FTE
--------------------------------------------------------------------------------------------------------------------------------------------------------
Office of the Secretary................... $3,669 17 $3,015 12 $4,639 21 $4,859 17 $5,068 20
Office of the Deputy Secretary............ 1,173 8 1,270 8 1,260 9 1,234 8 1,293 9
Office of Small Business Programs......... 1,021 9 1,097 9 1,289 8 1,344 7 1,659 8
Office of Public Liaison.................. 840 8 895 7 949 6 1,004 6 1,072 6
Office of Congressional and 4,232 32 4,456 32 4,420 27 4,651 24 5,258 27
Intergovernmental Affairs................
Office of Public Affairs.................. 4,003 26 5,861 35 3,612 28 3,772 26 4,812 28
Office of the Assistant Secretary for 10,423 53 8,975 46 8,903 40 7,222 35 8,741 40
Policy \2\...............................
Office of the 21st Century Workforce...... 1,019 8 1,049 8 1,041 6 1,040 6 1,092 6
Center for Faith-Based & Community ......... ......... 593 5 605 6 633 6 800 6
Initiatives..............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ $28.5 million was appropriated in ETA Program Administration for Job Corps program salaries and expenses. These funds have been allotted to the
Office of the Secretary to be used for the Job Corps program in accordance with Section 102 of Public Law 109-149.
\2\ Includes ASP drug-free workplace funds.
built-in and program changes
Question. Provide a table for each discretionary appropriation
account, identifying by line-item, the built-in changes from the fiscal
year 2006 adjusted level, and each program increase, to arrive at the
fiscal year 2007 budget request level.
Answer. The attached table reflects built-in increases and
decreases, program increases and decreases, and finance changes,
affecting each discretionary appropriation account from the fiscal year
2006 adjusted level to the fiscal year 2007 budget request level.
DEPARTMENT OF LABOR
[In thousands of dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fiscal year Built-In Program Fiscal year
2006 ------------------------------------------------ Finance 2007 budget
Discretionary Appropriation Account adjusted Transfer changes request
level Increases Decreases Increases Decreases current Law
--------------------------------------------------------------------------------------------------------------------------------------------------------
EMPLOYMENT & TRAINING ADMIN:
TRAINING AND EMPLOYMENT SERVICES:
Adult Employment and Training Activities........ 857,079 ......... ........... ......... -145,079 ......... ......... 712,000
Dislocated Worker Employment and Training 1,337,553 ......... ........... ......... -222,971 ......... ......... 1,114,582
Activities.....................................
Youth Activities................................ 940,500 ......... ........... ......... -100,000 ......... ......... 840,500
===============================================================================================
Job Corps:
Operations...................................... 1,450,400 1,282 ........... ......... -50,080 ......... ......... 1,401,602
Construction and Renovation..................... 106,920 ......... ........... ......... -6,920 ......... ......... 100,000
-----------------------------------------------------------------------------------------------
Subtotal--Job Corps........................... 1,557,320 1,282 ........... ......... -57,000 ......... ......... 1,501,602
===============================================================================================
Responsible Reintegration for Young Offenders....... 49,104 ......... ........... ......... -49,104 ......... ......... ...........
Prisoner Re-entry................................... 19,642 ......... ........... ......... ........... ......... ......... 19,642
Native Americans.................................... 53,696 ......... ........... ......... -2,238 ......... ......... 51,458
Migrants and Seasonal Farmworkers................... 79,252 ......... ........... ......... -79,252 ......... ......... ...........
===============================================================================================
National Programs:
Pilots, Demonstrations and Research............. 29,700 ......... ........... ......... -12,000 ......... ......... 17,700
Evaluation...................................... 7,857 ......... ........... ......... -2,936 ......... ......... 4,921
Denali Commission............................... 6,875 ......... ........... ......... -6,875 ......... ......... ...........
Other........................................... 1,980 ......... ........... ......... -1,980 ......... ......... ...........
Community College Initiative.................... ........... ......... ........... 150,000 ........... ......... ......... 150,000
-----------------------------------------------------------------------------------------------
Subtotal--National Programs................... 46,412 ......... ........... 150,000 -23,791 ......... ......... 172,621
===============================================================================================
Job Corps Construction Balances Cancellation........ ........... ......... ........... ......... -75,000 ......... ......... -75,000
-----------------------------------------------------------------------------------------------
Total--Training and Employment Services........... 4,940,558 1,282 ........... 150,000 -754,435 ......... ......... 4,337,405
===============================================================================================
COMMUNITY SERVICE EMPLOYMENT........................ 432,311 ......... ........... ......... ........... ......... ......... 432,311
===============================================================================================
STATE UI & ES OPERATIONS:
Unemployment Compensation (Trust Funds):
State Operations................................ 2,497,770 101,905 ........... 40,000 ........... ......... ......... 2,639,675
AWIU........................................ 41,580 ......... -41,580 ......... ........... ......... ......... ...........
National Activities......................... 9,900 ......... ........... 600 ........... ......... ......... 10,500
-----------------------------------------------------------------------------------------------
Subtotal--Unemp Comp...................... 2,549,250 101,905 -41,580 40,600 ........... ......... ......... 2,650,175
===============================================================================================
Employment Service:
Grants to States:
Federal funds........................... 22,883 ......... ........... ......... -867 ......... ......... 22,016
Trust funds............................. 693,000 ......... ........... ......... -26,247 ......... ......... 666,753
National Activities (Trust Funds)........... 33,428 ......... ........... ......... -510 ......... ......... 32,918
-----------------------------------------------------------------------------------------------
Subtotal--Employment Service.............. 749,311 ......... ........... ......... -27,624 ......... ......... 721,687
===============================================================================================
One Stop Career Centers /ALMIS.............. 81,662 ......... ........... ......... -17,807 ......... ......... 63,855
Work Incentives Grants...................... 19,514 ......... ........... ......... -19,514 ......... ......... ...........
-----------------------------------------------------------------------------------------------
Total--State UI & ES Operations........... 3,399,737 101,905 -41,580 40,600 -64,945 ......... ......... 3,435,717
===============================================================================================
Program Administration:
Adult Services.................................. 43,360 1,716 ........... ......... ........... ......... -288 44,788
Trust Funds................................. 7,846 ......... ........... ......... ........... ......... 288 8,134
Youth Services.................................. 38,565 1,410 ........... ......... ........... ......... ......... 39,975
Workforce Security.............................. 6,225 2,616 ........... ......... ........... ......... -2,415 6,426
Trust Funds................................. 72,113 ......... ........... 6,000 ........... ......... 4,688 82,801
Apprenticeship Training, Employer and Labor 21,538 800 ........... ......... ........... ......... -923 21,415
Services.......................................
Executive Direction............................. 6,956 320 ........... ......... ........... ......... -1,120 6,156
Trust Funds................................. 2,090 ......... ........... ......... ........... ......... -231 1,859
-----------------------------------------------------------------------------------------------
Total--Program Administration............. 198,693 6,862 ........... 6,000 ........... ......... -1 211,554
-----------------------------------------------------------------------------------------------
Total--ETA................................ 8,971,299 110,049 -41,580 196,600 -819,380 ......... -1 8,416,987
===============================================================================================
EMPLOYEE BENEFITS SECURITY ADMINISTRATION:
Enforcement & Participant Assisstance............... 111,604 3,794 -98 5,000 ........... ......... ......... 120,300
Policy & Compliance Assistance...................... 17,358 642 ........... ......... ........... ......... ......... 18,000
Executive Leadership, Program Oversight & 5,044 229 ........... ......... ........... ......... ......... 5,273
Administration.....................................
-----------------------------------------------------------------------------------------------
Total--EBSA....................................... 134,006 4,665 -98 5,000 ........... ......... ......... 143,573
===============================================================================================
EMPLOYMENT STANDARDS ADMIN.:
Enforcement of Wage & Hour Standards................ 166,408 5,170 ........... 6,000 ........... ......... ......... 177,578
Office of Labor Management Standards................ 45,912 1,974 ........... 4,520 ........... ......... ......... 52,406
Federal Contractor EEO Standards.................... 81,645 3,012 ........... ......... -1,000 ......... ......... 83,657
Federal Programs for Workers' Comp.................. 99,593 4,581 ........... ......... ........... ......... ......... 104,174
Trust Funds......................................... 2,034 42 ........... ......... ........... ......... ......... 2,076
Program Direction & Support......................... 17,253 550 400 -677 ........... ......... ......... 17,526
-----------------------------------------------------------------------------------------------
Total--ESA........................................ 412,845 15,329 ........... 10,920 -1,677 ......... ......... 437,417
===============================================================================================
OCCUPATIONAL SAFETY & HEALTH:
Safety & Health Standards........................... 16,462 430 ........... ......... ........... ......... ......... 16,892
Federal Enforcement................................. 173,430 6,503 ........... ......... ........... ......... ......... 179,933
State Programs...................................... 91,093 ......... ........... ......... ........... ......... ......... 91,093
Technical Support................................... 21,435 957 ........... ......... ........... ......... ......... 22,392
Compliance Assistance:
Compliance Assistance--Federal.................. 72,545 1,396 ........... 2,616 ........... ......... ......... 76,557
Compliance Assistance--State.................... 53,357 ......... ........... ......... ........... ......... ......... 53,357
Training grants................................. 10,116 ......... ........... ......... -10,116 ......... ......... ...........
-----------------------------------------------------------------------------------------------
Subtotal--Compliance Assistance............... 136,018 1,396 ........... 2,616 -10,116 ......... ......... 129,914
===============================================================================================
Safety and Health Statistics........................ 24,253 521 ........... 7,500 ........... ......... ......... 32,274
Executive Direction................................. 10,591 578 ........... ......... ........... ......... ......... 11,169
-----------------------------------------------------------------------------------------------
Total--OSHA....................................... 473,282 10,385 ........... 10,116 -10,116 ......... ......... 483,667
===============================================================================================
MINE SAFETY & HEALTH ADMIN:
Coal................................................ 117,463 2,932 ........... ......... ........... ......... ......... 120,395
Metal/Nonmetal...................................... 68,227 1,879 ........... ......... ........... ......... ......... 70,106
Standards Development............................... 2,485 173 ........... ......... ........... ......... ......... 2,658
Assessments......................................... 5,405 161 ........... ......... ........... ......... ......... 5,566
Educational Policy and Development.................. 31,749 1,177 ........... ......... ........... ......... ......... 32,926
Technical Support................................... 25,609 804 ........... 1,000 ........... ......... ......... 27,413
Program Eval & Info Resources....................... 15,532 203 ........... ......... ........... ......... 1 5,735
Program Administration.............................. 11,938 1,099 ........... ......... ........... ......... ......... 13,037
-----------------------------------------------------------------------------------------------
Total--MSHA....................................... 278,408 8,428 ........... 1,000 ........... ......... ......... 287,836
===============================================================================================
BUREAU OF LABOR STATISTICS:
Employment & Unemployment Statistics................ 165,683 5,373 ........... ......... ........... ......... ......... 171,056
Labor Market Information (Trust Funds).............. 77,066 1,960 ........... ......... ........... ......... ......... 7,026
Prices and Cost of Living........................... 173,515 5,566 ........... 8,000 ........... ......... ......... 187,081
Compensation and Working Conditions................. 81,052 2,808 ........... ......... ........... ......... ......... 83,860
Productivity and Technology......................... 10,777 341 ........... ......... ........... ......... ......... 11,118
Executive Direction & Staff Services................ 30,235 912 ........... ......... ........... ......... ......... 31,147
-----------------------------------------------------------------------------------------------
Total--BLS........................................ 538,328 16,960 ........... 8,000 ........... ......... ......... 563,288
===============================================================================================
DEPARTMENTAL MANAGEMENT:
Program Direction and Support....................... 25,759 1,320 -152 2,868 ........... ......... ......... 29,795
Departmental IT Cross Cut........................... 29,462 ......... ........... ......... -57 ......... ......... 29,405
Departmental Management Cross Cut................... 1,683 ......... ........... ......... -575 ......... ......... 1,108
Legal Services...................................... 80,416 3,246 ........... 1,204 ........... ......... ......... 84,866
Trust Funds......................................... 308 14 ........... ......... ........... ......... ......... 322
International Labor Affairs......................... 72,567 651 -26 ......... -60,829 ......... ......... 12,363
Administration & Management......................... 30,613 1,237 -4 ......... -100 ......... ......... 31,746
FPB Security Enhancements........................... 1,875 18 ........... ......... ........... ......... ......... 1,893
Adjudication........................................ 27,243 1,700 -12 ......... ........... ......... ......... 28,931
Women's Bureau...................................... 9,763 456 -71 ......... -800 ......... ......... 9,348
Civil Rights Activities............................. 6,451 284 ........... ......... ........... ......... ......... 6,735
Chief Financial Officer............................. 5,340 239 ........... ......... ........... ......... ......... 5,579
-----------------------------------------------------------------------------------------------
Total--DM S&E..................................... 291,480 9,165 -265 4,072 -62,361 ......... ......... 242,091
===============================================================================================
OFFICE OF DISABILITY EMPLOYMENT POLICY.................. 27,695 558 ........... -7,934 ........... ......... ......... 20,319
VETERANS EMPLOYMENT AND TRAINING:
State Administration Grants......................... 160,791 427 ........... ......... ........... ......... ......... 161,218
Federal Administration.............................. 30,211 2,206 ........... ......... ........... ......... ......... 32,417
Nat'l Veterans Training Institute (NVTI)............ 1,964 5 ........... ......... ........... ......... ......... 1,969
Homeless Veterans Program........................... 21,780 58 ........... ......... ........... ......... ......... 21,838
Veterans Workforce Investment Program............... 7,425 20 ........... ......... ........... ......... ......... 7,445
-----------------------------------------------------------------------------------------------
Total--VETS....................................... 222,171 2,716 ........... ......... ........... ......... ......... 224,887
===============================================================================================
OFFICE OF INSPECTOR GENERAL:
Program Activities.................................. 65,744 2,329 ........... ......... ........... ......... ......... 68,073
Trust Funds......................................... 5,552 136 ........... ......... ........... ......... ......... 5,688
-----------------------------------------------------------------------------------------------
Total--OIG........................................ 71,296 2,465 ........... ......... ........... ......... ......... 73,761
===============================================================================================
Working Capital Fund.................................... 6,168 16 ........... 13,954 -6,184 ......... ......... 13,954
-----------------------------------------------------------------------------------------------
Total--DM......................................... 618,810 14,920 -265 10,092 -68,545 ......... ......... 575,012
-----------------------------------------------------------------------------------------------
Total--Department of Labor........................ 11,426,978 180,736 -41,943 241,728 -899,718 ......... -1 10,907,780
--------------------------------------------------------------------------------------------------------------------------------------------------------
women in apprenticeship
Question. The conference agreement on the fiscal year 2006 Labor
Department appropriations legislation specified $982,000 for carrying
out Public Law 102-530, the Women in Apprenticeship and Non-Traditional
Occupations Act.
What action is being taken to issue grants to community based
organizations to encourage employment of women in apprenticeable
occupations and nontraditional occupations?
Answer. The Employment and Training Administration and the Women's
Bureau have worked collaboratively to develop a Solicitation for Grant
Applications (SGA). The SGA is currently going through Departmental
clearance and we expect a notice announcing the SGA to be published in
the Federal Register in August 2006.
appalachian council/working for america institute
Question. This subcommittee held a hearing on July 22, 2004, on the
funding of the Appalachian Council and Working for America Institute.
Despite that hearing, the Labor Department did not renew the contracts
for these organizations, forcing Congress to earmark $2.2 million and
$1.5 million, respectively, for their continued operation. I understand
that funding has now run out, and I urge you to renew the contracts.
Will you take another look at the organizations, and see what can be
done to provide renewed funding?
Answer. On February 1, 2005, the Department of Labor executed a
$1,500,000 grant to the Working for America Institute (WAI). This grant
will remain active until February 3, 2007. The Department of Labor
continues to work closely with WAI to support the deliverables of their
grant, including developing resources to support a well-skilled
advanced manufacturing workforce.
Job Corps funded the Appalachian Council for $2.2 million in
February, 2005 and then renewed the funding in the amount of $2.2
million in April, 2006. That funding is through March 31, 2007. An
evaluation will be done to determine if additional funding will be
provided based upon performance and funding availability.
job training staff
Question. Your budget request for federal administration of
Employment and Training Administration programs provided for 1,158
direct full-time equivalent staff, compared to the current level of
1,194 staff.
Why are you requesting only a reduction of 14 federal staff when
you are proposing to consolidate several job training programs into a
single block grant to states?
Answer. The Employment and Training Administration (ETA) fiscal
year 2006 FTE level supported by appropriated funds is 1,180 (with an
additional 16 FTE supported by fees and reimbursements). The ETA fiscal
year 2007 Legislative Proposal FTE level (excluding FTE supported by
fees and reimbursements) is 1,158. Compared with fiscal year 2006
staffing, ETA's fiscal year 2007 Legislative Proposal represents a net
reduction of 22 FTE--an addition of 7 FTE within Youth Services to
support the proposed transfer of Youthbuild from the Department of
Housing and Urban Development to ETA, and a reduction of 29 FTE in
Workforce Security in anticipation of the enactment of a Foreign Labor
Certification Permanent Program fee.
ETA does not anticipate that the implementation of the Career
Advancement Accounts (CAA) will have an immediate impact on ETA
staffing levels. Assuming the passage of authorizing legislation in
fiscal year 2007, a significant amount of effort by ETA staff will be
required to transition from the current Workforce Investment Act (WIA)
structure to a new CAA structure. Moreover, during the transition and
until it is complete, the same or a similar level of effort that is
currently provided will be necessary to continue national and regional
Federal oversight required to administer WIA. The time necessary to
implement the transition to a new CAA structure will also provide ample
time for an orderly transition to an FTE level appropriate for the
level of Federal oversight required to administer CAAs.
safe places in mines
Question. The Commonwealth of Pennsylvania has begun an analysis of
locating safe places in the mines for workers to seek refuge in case
escape routes are blocked. These safe places could be permanent or
portable. Do you intend to conduct a similar analysis nationwide?
Answer. Section 13 of the MINER Act requires NIOSH to study various
refuge alternatives in an underground coal mine environment and issue a
report not later than 18 months after enactment of the Act. Not later
than 180 days after the receipt of this report, the Secretary of Labor
is required to provide a response to the two authorizing committees
describing what actions, if any, the Secretary intends to take based on
the report. The Department will comply with this statutory requirement.
competitiveness agenda
Question. You propose cutting $653 million from workforce
investment programs and another $27 million from the Employment
Service, despite the fact that funding for workforce programs is $1
billion below the funding level than when the President took over and
there are one million more unemployed workers than there were in 2001.
Isn't that approach inconsistent with a competitiveness agenda that is
supposedly going to help America, and its workers, compete in the
global economy?
Answer. Although the President's fiscal year 2007 Budget request
for the Employment and Training Administration is below the fiscal year
2006 appropriation, it is a responsible budget that reflects the
competitive demands for very limited resources for domestic programs
and the need to eliminate waste and redundancy. The proposed reforms
align with the competitiveness agenda by reforming the workforce
investment system so that many more workers are trained, equipping them
with the skills necessary to succeed in the 21st Century.
The public workforce investment system could be structured to
better meet the training challenges presented by the increased need for
skills and competencies by workers. There exists a lack of integration,
which causes too much money to be spent on competing bureaucracies,
overhead costs, and unnecessary infrastructure, and not enough on
meaningful skills training that leads to job growth and economic
prosperity.
Career Advancement Accounts, relative to the existing workforce
investment system, will be more effective and flexible in meeting the
demands of the global economy and in addressing the nation's workforce
challenges. Career Advancement Accounts would mean a streamlined
workforce investment system that gets more training dollars in the
hands of workers and reduces costs by eliminating duplication across
employment and training programs and lowering overhead costs. The
greater efficiency from this redesign of the system will result in cost
savings that account for much of the reduction in ETA's budget. More
than triple the number of workers currently being trained would be
trained under this proposal.
voucher proposal
Question. You have proposed a new WIA reauthorization proposal
calling for Career Advancement Accounts, i.e. vouchers, to be run
through a consolidated workforce system overseen by the Governor,
allowing him or her to choose to eliminate the local workforce system
and the One Stop network. This is the third different reauthorization
proposal you have made to the Congress, your previously two attempts to
create a block grant for the Governor have been resoundingly rejected
in both the House and Senate, which have consistently protected the
local workforce delivery system as essential to helping our workers
receiving training for jobs in the local economy. Knowing that this
approach has been rejected twice before, isn't your budget proposal jut
a smokescreen to provide a rationale for deep budget cuts to the
workforce system?
Answer. No. Under the Administration's proposal for Career
Advancement Accounts, states can maintain One-Stop Career Centers to
provide employment services to job seekers and employers, as well as
access to Career Advancement Accounts, at these sites. Career
Advancement Accounts are a more efficient and effective way to deliver
job training that will result in more workers getting the skills they
need with less overhead costs. We believe that with the constraints on
discretionary spending and the promise of more than tripling the number
of workers trained with this innovative new approach, Congress will
take this proposal seriously. This proposal is consistent with the
``innovation'' agenda that has bi-partisan support in Congress.
Workforce Investment Act (WIA) reauthorization has been pending in
Congress for three years. No proposals have been either formally
accepted or rejected. H.R. 27, which was passed by the House on March
2, 2005, does consolidate the WIA Adult, WIA Dislocated Worker, and
Employment Service funding streams, indicating interest on the part of
Congress in streamlining programs as the Administration proposed.
rational for workforce training
Question. You claim that only 200,000 are trained annually by the
workforce system; however your data provides the smallest data pool
possible to make your claim, as it only measures participants leaving
training during a fiscal year. GAO estimates that over double this
number, 416,000 receive training annually. Your own data provided in
the Budget Justifications shows that over 15 million participants
receive an array of training, intensive, or basic employment assistance
annually through the workforce system. Isn't your budget request
another example of using selective data to block grant and cut program
funding?
Answer. The important point is that 200,000 people complete and
exit training per year with a $4 billion investment, meaning that too
much money is being spent on low-cost services with little value to the
customer. ETA uses actual data collected from the states in referencing
number of people trained. The GAO study indicates that 40 percent of
funds are used for training adults and dislocated workers, whereas ETA
estimates this figure at 26 percent. This discrepancy occurs due to two
primary differences in the measurements: (1) ETA is measuring exiters,
or those that have actually completed training, while GAO is measuring
training costs of all participants receiving training (meaning that
people are ``double counted'' because their training may have occurred
over two program years); and (2) ETA includes expenditures, while GAO
includes both expenditures and obligations--obligations which may not
result in someone actually being trained. The estimates by ETA and GAO
are different because they look at distinctly different sets of cost
estimates and individuals included in the count.
The question also refers to the number of individuals served by the
workforce investment system. The large majority of these participants
are receiving only basic employment services, including self-services.
The Career Advancement Accounts proposal would increase the number of
individuals trained through the workforce investment system, while
still providing basic employment services to job seekers.
elimination of migrant programs
Question. For the third year in a row, you have proposed
eliminating the Migrant and Seasonal Farmworker program authorized
under WIA. You first proposed to work with states and local areas to
ensure that migrant and seasonal farmworkers could access services
through One-Stop Career Centers; despite the fact that your
Department's data show that the program met its performance goals. Now
you propose to give governors the flexibility to design how individuals
will access information and Career Advancement Accounts or vouchers.
How does the Administration propose to ensure that these individuals--
some of America's neediest adults and their families--will be able to
successfully navigate among service delivery systems that will differ
from state to state and secure the job training and employment services
that they need?
Answer. The Administration's fiscal year 2007 Budget proposal seeks
to tap the workforce investment system's potential to serve more
migrant and seasonal farmworkers by providing job training services to
them through the One-Stop Career Center system, and turning to other,
appropriate agencies to provide supportive services, housing, and other
related assistance. Currently, the section 167 program provides
employment and training services to only 10,000 of an estimated 2
million farmworkers, which demonstrates the need for a wider system
approach.
The Administration believes that providing services to farmworkers
through the One-Stop system will increase the number served and have a
positive employment and earnings impact on those who receive services.
The Administration's fiscal year 2007 budget proposal seeks to take
advantage of the One-Stop system's potential to better serve more
migrant and seasonal farmworkers by helping them access the full array
of employment and training services available from the seventeen
federal programs delivered through the One-Stop system. While the
proposal is to increase the amount of funding spent on training
utilizing Career Advancement Accounts as the vehicle, the proposal also
includes continued funding for core service delivery, including career
guidance and job referrals, to any job seeker. Career Advancement
Accounts can be used for a combination of remedial training leading to
a diploma or GED in addition to post secondary education. We believe
this combination of career guidance and training in the context of the
One-Stop delivery system that connects workers to a wide array of
services, including supportive services, can result in increased
services to farmworkers and more positive employment and earnings
impact on those farmworkers who receive services.
employment service cuts
Question. You propose to cut the Employment Service by about $27
million in fiscal year 2007 over and above a $96 million reduction in
fiscal year 2006. You would give states the flexibility to determine
how to provide basic employment services to America's workers and at
the same time, absorb other costs that you propose to divest from the
federal level--in labor market information products and services and
dedicated professionals to help the disabled obtain employment. Past
shortfalls in federal support have forced states to close local
offices. With these deep cuts, states will be forced to shut down many
more One Stop Career Centers that help match job seekers and employers
seeking workers. How do you expect governors to be able to help an
expected 14 million workers who need jobs and the thousands of
employers looking for workers?
Answer. The Department proposes to consolidate the Workforce
Investment Act (WIA) programs for adults, dislocated workers, and
youth, and the Wagner-Peyser funding stream into a single flexible
grant that enables governors to utilize these resources strategically
to both drive their economies and provide maximum training and
employment opportunities for their citizens.
The public workforce investment system, as currently constituted,
is ill-equipped to meet the workforce challenges presented by the
increased need for advanced skills and competencies in the 21st century
economy. As one researcher has noted, ``As it now stands, employment
services (and by extension the One-Stop system) is very far from being
an effective labor exchange capable of assisting people surmount the
challenges of today's job market.\1\ This is due, in part, to the lack
of integration, which causes too much money to be spent on competing
bureaucracies, overhead costs, and unnecessary infrastructure, and not
enough on meaningful skills training that leads to job growth and
economic prosperity. For example, while the Employment Service is
intended to be the cornerstone of the One-Stop system under WIA, many
states continue to have a separate network of Employment Service
offices that offer the same ``core services'' that are available under
WIA through One-Stop Career Centers.
---------------------------------------------------------------------------
\1\ Osterman, Paul. ``Employment and Training Policies: New
Directions for Less Skilled Adults.'' Paper prepared for the Urban
Institute. October 2005. p.16.
---------------------------------------------------------------------------
Furthermore, large amounts of state unexpended carryover funds
still remain. In fiscal year 2004, unexpended funds from the WIA Adult,
Dislocated Worker, and Youth programs totaled almost $1.2 billion and a
similar amount is projected for fiscal year 2005, which ends on June
30, 2006. Therefore, it is the Administration's position that through
more efficient administration, integration of existing funding, and the
effective use of currently available resources, states will not face
the need to reduce services to the citizens generally or to populations
with barriers to employment.
national reserve fund
Question. Your proposal indicates that the Department would retain
at the national level a portion of funds for a National Reserve Fund
for unexpected emergencies before allocating funds for Career
Advancement Accounts. What is the Department's estimate for this fund?
And how would we distinguish the uses of these funds from the pilot,
demonstration, and research account?
Answer. Under the Career Advancement Account (CAA) proposal, the
Department proposes to set aside funds for a National Reserve in a
manner similar to the current Dislocated Worker National Reserve
structure. The Department would reserve 7.5 percent of the
appropriation provided by Congress for Career Advancement Accounts for
the National Reserve. The Secretary would have the discretion to use
this funding to quickly address unanticipated events, such as natural
disasters, mass layoffs and plant closings, and the impacts of foreign
trade. The National Reserve would also be used to provide technical
assistance and for demonstration activities.
The proposed use of Career Advancement Account National Reserve
funds for demonstrations in addition to those carried out under pilots,
demonstration and research budget authority is no different than the
current structure. Under WIA section 171(d), up to ten percent of the
National Reserve is used for dislocated worker projects. These
demonstrations are in addition to the pilots, demonstrations and
research authorized under WIA section 171(b). As it does now, the
Department will maintain rigorous financial controls that track fund
sources for all programs and activities.
rapid response services
Question. Your consolidation proposal eliminates state resources
set aside specifically for states to respond rapidly with information
and services to workers who have received word of pending layoffs. You
would require states to apply for funds from the National Reserve
Account to provide such services. What justification do you provide
states about requiring them to go through extra steps to provide rapid
response services and gaining their confidence that the Department can
respond to such requests in a timely manner?
Answer. The Department does not contemplate that a state would have
to apply for funds each time there is a mass layoff or to only
sporadically fund a state rapid response coordinator. Early
intervention to provide information and assistance to workers to
decrease the amount of time between actual layoff and re-employment is
a key principle of the dislocated worker program. Rapid response is a
key element of this early intervention strategy.
States could demonstrate need and apply for rapid response funds at
the beginning of the program year or throughout the program year. We
will not propose that a state be required to submit an application for
funding each time a dislocation event occurs.
In spite of all the good work that has been done over the past
fifteen years with dislocated worker rapid response funds, the
Department has found that most company executives do not know about the
type and quality of assistance available to them and their employees
when closures or layoffs are contemplated. They have also reported that
where they have layoffs in several states simultaneously, the levels
and quality of assistance varies dramatically. ETA, in collaboration
with state and local partners, has undertaken several initiatives in
the auto, textile and defense industries recently to try to integrate
services and develop more consistency. We believe a nationally-
coordinated approach to delivering rapid response assistance by states
can help bring the services to more workers and employers.
The proposed mechanism will assist both the Department and the
states to better manage scarce taxpayer resources by directing the bulk
of the funds to the areas of need. For example, not all states
experience major layoffs every year. Analyses of dislocated worker
program expenditures reported by states have shown that the funds
reserved for rapid response are consistently under-expended. In the
aggregate, the rapid response carry-in funds from program year 2003 to
2004, and from 2004 to 2005, was $136.7 million and $166 million,
respectively. Through March 31, 2006, states reported accrued
expenditures of just over $176 million of a total available of more
than $342.5 million, or 51.4 percent of the total funds available.
States are not required to retain the up to 25 percent authorized to be
reserved for rapid response activities. They may include a portion of
the funds in the amount allocated to local workforce investment boards
for core, intensive and training services for dislocated workers, or
they may award additional funds from the reserved amount to local areas
that experience disasters, mass layoffs, plant closings or other events
that precipitate substantial increases (defined by the state) in the
number of unemployed workers.
adult training funds
Question. We need to upgrade the skills of our current workforce,
including the low skilled on a broad base to increase economic growth
and incomes. Recent data released from the National Assessment of Adult
Literacy indicates that 14 percent of American adults had less than
basic literacy skills--meaning they had a hard time locating easily
identifiable information on commonplace material or following written
instructions in simple documents. Your proposal would reduce adult
training funds and turn the funds that are left into Career Advancement
Accounts. It appears that low skilled adults who would compete with
other workers for these vouchers may require combinations of
assessment, career planning and developmental education services prior
to being able to benefit from technical training. How will these
individuals really fare under a system of capped vouchers and high
pressure sales from many training providers?
Answer. We agree there is a need to upgrade the skills of our
current workforce, including those with low skills and literacy. State
and local workforce systems set service priorities, and this will
continue to be the case under the CAA proposal. These priorities will
differ across the country, since demographics, labor markets and
regional economies differ. By combining funding streams, our proposal
will allow a more flexible response to these differences. Our proposal
will triple the number of workers who currently are being trained by
the workforce investment system.
Assessment, career planning and developmental education services
will continue to be accessed through One-Stop Career Centers, provided
either through Workforce Investment Act funding or One-Stop partner
programs. States will be responsible for determining eligible training
providers within the state, as well as determining policies that govern
those providers, such as policies to prevent false advertising and
other abuses.
economic growth efforts
Question. Your consolidation proposal, combined with sizable cuts
and program eliminations, ironically puts states in the position of not
being able to jump start or continue to nurture regional economic
growth planning and collaboration activities that integrates economic
development, workforce development and education systems. These
activities are similar to those you are promoting through your new
WIRED initiative. What do you say to states that want to move forward
with such integrated economic growth efforts if they don't qualify for
funds under federal rules?
Answer. The proposals for consolidation of workforce programs are
intended to provide maximum flexibility for states and regional
economies to implement the type of workforce investment services that
are needed in that specific region. We believe that our traditional
thinking about how individual programs are funded is contributing to
the persistent problem of siloed program services, with excessive funds
being spent on overhead and bureaucracy, rather than addressing the
workforce needs of a regional economy. If regional economic needs are
to be effectively and comprehensively addressed, it will take many
sources of funding, including funding from economic development
agencies and educational institutions, and coordination across these
funding streams. Therefore, the approach of making Federal funding for
workforce services more flexible will contribute to integrated economic
development efforts and the maximum leveraging of resources. Finally,
the transformation of a regional economy is not dependent on Federal
demonstration funding. What drives transformation is the collaborative
leadership and strategic planning of economic development, research and
development, capitalization, entrepreneurship and workforce development
visionaries.
elimination of youth training grants
Question. Your proposal to redesign the workforce delivery system
eliminates WIA training grants for disadvantaged youth that are aimed
at improving their education, employment, and earnings prospects. It is
difficult to reconcile your proposed request when the President and you
as well have focused on the need to raise the skills of young people in
order to maintain our competitive edge in this new global economy. And
from research--much funded by your Department, we know that an array of
services is necessary to help disadvantaged youth complete their
education, mature into solid citizens, and make the successful
transition to work. By making these young people compete with adults
for Career Advancement Accounts, aren't you really limiting their
changes for future success?
Answer. We agree that there should be an emphasis on raising the
skills of young people in order to maintain our competitive edge in the
global economy. Career Advancement Accounts will be available to out-
of-school youth. Furthermore, states and localities will still be able
to provide career counseling and other services to these out-of-school
youth, and workforce information will be available to assist them in
choosing careers in high growth industries and in determining
appropriate training for those careers.
Targeted programs and set-asides have led to multiple program
silos, excessive overhead and bureaucracy, lack of coordination and
integration, and only a modest number of people trained for the size of
the workforce system investment. States and local areas will still be
able to serve targeted groups, such as out-of-school youth, but will
have more flexibility in using resources and not be subject to the
often conflicting requirements of multiple programs or funding streams.
Furthermore, consolidating funding streams will enable states and
localities to better focus on the needs of their distinct populations,
since labor force demographics and labor markets vary considerably
across the country. The substantial number of requests for waivers to
allow transfer of funds between programs indicates the need for more
flexibility in this area than the current legislation allows.
career advancement accounts
Question. A recent ETR article on the fiscal year 2007 budget
request noted ``ETA officials said their legislative analysts believe
this program--the consolidated Career Accounts proposal--can be
implemented under current authorizing statues, but would be easier for
states to embrace with program consolidation that would occur under the
WIA reauthorization package put forward by House Republicans, HR 27.''
It's my understanding that HR 27 has passed the House and is awaiting
conference with the Senate. Please explain how, if the House already
has a bill that is not consistent with your Career Advancement Accounts
proposal, how you plan to accomplish this.
Answer. As you indicate, the House has passed H.R. 27 and the
Senate recently passed its version of Workforce Investment Act
reauthorization legislation. H.R. 27 would implement many key
components of the President's job training reform proposal, such as
merging funding streams. We believe CAAs can be built upon this piece
of legislation.
elimination of job bank program
Question. The elimination of America's Job Bank is particularly
troubling. It is the backbone for more than 20 state job banks as well
as the electronic version of a national employment service. Thousands
of job seekers get their work through AJB and thousands of employers
use it. By your own Department's last count, over 138 million job
searches were conducted on AJB for the year ending June 3, 2005 and
over 9 million resume searches were conducted by employers during the
same period. There were about 7.8 million job postings originated on
AJB during that year, over 700,000 new resumes posted, and 55,000 new
employer registrations. All of these activity counts are increases over
the prior year. How can the United States have a modern public
employment service without an electronic exchange?
Answer. The Department of Labor considered numerous factors in
coming to the decision to phase out America's Job Bank (AJB), which
included looking at the larger environment in which AJB is operating
and weighing the costs associated with running the system. Since the
launch of AJB, the number of private sector Internet-based job banks
(Career Builder, Monster, Yahoo! Hot Jobs, etc.) has proliferated,
calling into question the need for a Federal government-sponsored
national job bank. These private-sector electronic labor exchange
systems are continuously improving and most, if not all, of these sites
offer free services to job seekers. Current trends in the industry seem
to indicate that some level of free service will also be offered to
businesses/employers in the future and many employers who currently use
AJB are already using these other job banks simultaneously to advertise
their openings.
In addition, it has been increasingly difficult, if not impossible,
to keep America's Job Bank updated as technology has advanced. Also, as
Internet technology and technical resources have become widespread and
the costs associated with them have declined, state and local areas
that previously relied on AJB for their Internet self-service labor
exchange presence have built and operate job banks of their own that
are not based on AJB and promote them to their job seeker and business
customers rather than AJB.
AJB is not the backbone for 20 state job banks, nor is there any
evidence of widespread job gains as a result of using AJB. In fact, AJB
is not used in most One-Stop Career Centers across the country.
proposed workforce legislation
Question. The Administration plans to introduce legislation to
reform the workforce investment system and create the Career
Advancement Accounts (CAAs). If this legislation is not passed before
fiscal year 2007, what would be the impact on services of the proposed
15 percent funding reduction for workforce development programs?
Answer. The President's Budget request assumes enactment of the
Career Advancement Account (CAA) proposal, which would reduce overhead
and administrative costs and focus more funding on training, thereby
tripling the number of individuals receiving job training through the
workforce investment system. In the absence of CAA legislation passed
by Congress, the workforce investment system will continue to have
siloed funding streams that result in duplicative costs.
While states will be able to continue operating Workforce
Investment Act programs and the Employment Service at the lower funding
levels proposed by the Administration, these reduced levels, without
the accompanying reforms, may result in decreases in the number of
participants served through these programs, compared to the President's
proposal.
Question. States could administer the CAAs through ``community
career centers'' at community colleges, public libraries, senior
centers, and other locations, as well as through existing one-stop
centers. Could this approach lead to the creation of a parallel system
of job search and career assessment services, that duplicates what is
already available through the one-stop centers? Could it lead to
confusion among potential customers of the system, about where to go to
access services?
Answer. Under our proposal, states can maintain One-Stop Career
Centers to provide employment services to job seekers and employers, as
well as access to Career Advancement Accounts. States and localities
would have the option of making employment services and access to
Career Advancement Accounts available at additional sites in the
community.
Question. Will the existing state and local workforce boards have
any role in administering the new program, or will they be disbanded?
Similarly, will the programs that are currently mandatory partners in
the one-stop system have any role in administering the CAAs?
Answer. State and local Workforce Investment Boards will continue
to exist and retain roles and functions similar to what they have under
the current Workforce Investment Act. Similarly, the required partners
will continue to participate in the One-Stop service delivery system,
and have a role in setting local policy and providing oversight for the
service delivery system. The specific role of the partner programs in
administering Career Advancement Accounts (CAA) would be worked out
under policies set by the state in setting up the CAA system.
Question. How will the Labor Department calculate the amount of
funds each state will receive for CAAs? Will there be a formula?
Answer. There will be a formula for allotting Career Advancement
Account funds to states, similar to the formulas that have been used to
allot funds to states under current law. The specific formula proposal
has not been finalized, but the final formula would be worked out
between the Administration and Congress.
Question. The CAA proposal assumes that individuals need minimal
assessment and case management services to make good decisions about
whether and how to use training funds. However, in implementing reform
of the Trade Adjustment Assistance (TAA) program, you have emphasized
the need to co-enroll TAA participants in WIA for case management, so
that their training needs can be properly assessed. What is the basis
for your decision to provide training funds with minimal case
management funds, in the CAA proposal?
Answer. The Department's ongoing evaluation of the Individual
Training Account activity under the Workforce Investment Act shows that
when an individual is provided more choice in training and counseling
services, the individual is more likely to use an ITA for training and
to enter training more quickly. Further, the individual's training
selection tends to be similar to training programs selected by similar
individuals who are required to receive counseling services and
approval.
We believe that up-front assessment (as contrasted with ongoing and
costly case management) is what workers need, including those served
under the TAA program. Assessments can be provided under the CAA
proposal if needed, with over $700 million set aside for such services
to complement training (22 percent of the total consolidated resources
per state, roughly equivalent to the current Wagner-Peyser amount for
core services). The purpose of such assessments is to properly gauge
marketable skills and assist workers to reenter employment or identify
training to fill gaps in marketable skills. Our demonstrations show
that with this ``informed choice'' more people can receive actual
training for jobs in the local labor market.
Question. The new system would be designed based on lessons from
the implementation of the Individual Training Account and Personal
Reemployment Account (PRA) programs. What lessons specifically have
been drawn from the implementation of those programs? What evaluations
exist to support giving more control over training funds to
individuals?
Answer. CAAs provide individuals with increased customer choice and
flexibility for selecting training and other services that are
appropriate for them and are based in part on lessons learned from
Individual Training Account (ITA) and Personal Reemployment Account
(PRA) demonstrations.
The ongoing evaluation of the ITA Experiment explored the use of
increasing customer choice in the delivery of ITAs. Initial analysis
from eight local boards participating in the experiment showed that
when an individual was provided more customer choice in training and
counseling services, the individual was more likely to accept an ITA
for training, the individual's training selection tended to be similar
to training programs selected by individuals required to receive
counseling services and approval of programs, and the individual was
more likely to enter training quickly. The final report, to be
completed later this year, will provide a more in-depth analysis of the
impacts of the three different ITA service approaches.
The goals of PRAs are to provide individuals who are identified as
most likely to exhaust Unemployment Compensation with a quicker return
to work, direct access to training, greater customer choice and
control, and better economic outcomes. Initial observations from the
PRA Demonstration show that participating states were able to implement
the PRAs generally as planned, with the first accounts offered in March
2005. The evaluation of the PRA Demonstration is underway. An interim
report, to be completed this year, will provide a more in-depth
understanding of the implementation process. In the meantime, reports
from states on best practices show that account mechanisms can be
implemented, appropriate oversight can be maintained, and individual
choice can provide greater access to needed services.
Question. The CAA proposal includes performance measures that are
similar to those now used to assess the adult and dislocated worker
programs. However, with CAA funds going directly to individuals, who
would be held accountable for performance outcomes--states or the local
community career centers? Does it make sense to apply performance
measures designed for adults (that focus on employment outcomes) to
CAAs that are also used by youth? Currently, youth performance measures
also consider educational goals.
Answer. States will continue to negotiate performance targets and
report to the Department of Labor on three primary outcome measures:
(1) entered employment, (2) retention in employment, and (3) earnings.
In addition, attainment of a degree or certificate, entry into training
and education, and literacy and numeracy gains would be tracked as
intermediate outcomes.
rapid response funds
Question. Currently, states use rapid response funds to provide
immediate service to workers affected by a mass layoff, often before
the workers are even laid off. Under your legislative proposal, states
will need to apply to The Employment and Training Administration for
rapid response funds as events occur. What are the reasons for keeping
these funds at the national level, and having states apply for them
each time they are faced with a mass layoff? What effect will this
approach have on states' ability to provide immediate rapid response
services for mass layoffs?
Answer. The Department does not contemplate that a state would have
to apply for funds each time there is a mass layoff or to only
sporadically fund a state rapid response coordinator. Early
intervention to provide information and assistance to workers to
decrease the amount of time between actual layoff and re-employment is
a key principle of the dislocated worker program. Rapid response is a
key element of this early intervention strategy.
States could demonstrate need and apply for rapid response funds at
the beginning of the program year or through the program year. We will
not propose that a state be required to submit an application for
funding each time a dislocation event occurs.
In spite of all the good work that has been done over the past
fifteen years with dislocated worker rapid response funds, the
Department has found that most company executives do not know about the
type and quality of assistance available to them and their employees
when closures or layoffs are contemplated. They have also reported that
where they have layoffs in several states simultaneously, the levels
and quality of assistance varies dramatically. ETA, in collaboration
with state and local partners, has undertaken several initiatives in
the auto, textile and defense industries recently to try to integrate
services and develop more consistency. We believe a national approach
to delivering rapid response assistance by states can help bring the
services to more workers and employers.
The proposed mechanism will assist both the Department and the
states to better manage scarce taxpayer resources by directing the bulk
of the funds to the areas of need. For example, not all states
experience major layoffs every year. Analyses of dislocated worker
program expenditures reported by states have shown that the funds
reserved for rapid response are consistently under-expended. In the
aggregate, the rapid response carry-in funds from program year 2003 to
2004, and from 2004 to 2005, was $136.7 million and $166 million,
respectively. Through March 31, 2006, states reported accrued
expenditures of just over $176 million of a total available of more
than $342.5 million, or 51.4 percent of the total funds available.
States are not required to retain the up to 25 percent authorized to be
reserved for rapid response activities. They may include a portion of
the funds in the amount allocated to local workforce investment boards
for core, intensive and training services for dislocated workers, or
they may award additional funds from the reserved amount to local areas
that experience disasters, mass layoffs, plant closings or other events
that precipitate substantial increases (defined by the state) in the
number of unemployed workers.
foreign labor certification
Question. There is an inherent unfairness to having some employers'
applications from six years ago pending at the BEC and having new
applications adjudicated in two months. These inordinate delays have
caused and are causing serious prejudice to employers and employees
alike. With this as background, please address the following issues:
Answer. The Department published a final regulation implementing a
new re-engineered Permanent Labor Certification Program effective March
28, 2005. This regulation created a new faster and more efficient
method for employers to have their applications processed. The
regulation applies to all applications filed after its effective date.
However, for applications previously filed up until March 27, 2005,
those applications must be processed under the previous regulation. The
process prescribed by the previous regulation takes considerably more
time than the new one, despite efficiency measures we have introduced,
e.g., technology, to streamline it as much as possible.
Question. Congress has expressed a clear intention in the Child
Status Protection Act to prevent government delays from separating
families by having children turn 21 during the permanent residence
processing. At the time Congress passed the CSPA, the existing scope of
the DOL backlog was unanticipated. In light of the clear Congressional
intention, why has the Department of Labor refused to expedite long-
pending backlogged applications based upon a showing that the impact of
the delay will forever prevent a child from becoming a permanent
resident with his or her parents?
Answer. We understand the Child Status Protection Act applies only
to cases pending before the Department of Homeland Security. The
Department of Labor strongly supports efforts to keep families
together. The Department has determined this goal can best be
accomplished by minimizing the amount of time it takes to process
foreign labor certification applications. For this reason, the
Department has consistently applied a first in/first out (FIFO) policy
to cases in the Program Electronic Review Management (PERM) program.
The FIFO policy prevents the need to make subjective decisions
regarding which, if any, cases merit special consideration for
expedition, thereby conserving resources and substantially reducing the
amount of time that is required to process applications. It is ETA's
longstanding policy to also process cases in the permanent labor
certification program backlog on a ``First-In/First-Out'' basis within
that system's various processing categories; for example Reduction in
Recruitment (RIR) cases are in a separate processing queue from cases
being handled through the traditional recruitment process (TR), but
cases in each queue are processed on a ``First-In/First-Out'' basis. It
has been ETA's established policy never to expedite cases bases on the
specific circumstances of individual employers or aliens.
Question. In addition to children aging out, other significant
detriments to employers and employees exist in specific cases. Examples
include inability to promote employees, loss of tuition benefits,
inability to travel, inability for spouses to work, etc. Given that the
delays are through no fault of the employer or the employee, why has
the Department of Labor failed to establish a system for expediting
worthy cases?
Answer. The Department's policy of not expediting cases saves an
enormous amount of limited resources since we do not have to evaluate
the merits of each request to expedite across what potentially could be
tens of thousands of cases. Furthermore, we believe some of the
concerns you note arise from visa restrictions over which the
Departments of State and Homeland Security have jurisdiction and not
from any DOL permanent labor certification rules or requirements.
The most equitable response to this complicated issue is to require
strict adherence to our first-in/first-out policy under which all
applicants are treated consistently. For every case considered for
expedited consideration, an older case would be further delayed. Unlike
the Department of Homeland Security, the Department of Labor does not
have the legislative authority for a fee structure which allows for
``premium processing.''
Currently, employers do not pay a fee to DOL for the processing of
permanent foreign labor certification applications. Employers benefit
significantly from the admission of foreign workers, and the efficient
review of applications they receive under the new, streamlined process.
The backlog system is not fully automated and therefore continues to
function through a FIFO process. The Administration has included a
proposal in the fiscal year 2007 budget to create a fee structure for
the Permanent Labor Certification Program. We anticipate revenue from
such fees would permit the assignment of additional staff, such that
there should be no backlogs in the new PERM system.
Question. Why has the Department of Labor made it so difficult and
risky for employers to convert cases from the BEC to PERM? Seemingly,
DOL has created the most restrictive rules possible to discourage these
conversions, resulting in an unexpectedly low number of conversions and
an unexpectedly high number of cases remaining at the BECs? Will DOL
amend its rules to encourage conversions? Examples of improvements
include eliminating the risk of the loss of priority date if a case is
not eventually adjudicated to be ``identical''; eliminating the risk of
loss of the ability to obtain seventh year H-1B extension if the case
is not considered to be ``identical''; removing the ``identical''
standard entirely; changing present procedures which involve audits of
most or all of the conversion cases; eliminating the very extensive
delays in adjudicating PERM conversion cases; and allowing cases at the
BEC to remain pending until the approval of the PERM case (especially
since a mere typographical error could result in a PERM case being
denied).
Answer. The Department is in the process of reviewing the rate at
which cases have been converting from the old pre-PERM certification
system to PERM. Employers currently have the option of re-filing the
case if it meets the requirements of the PERM regulation. Those who
wish to have the benefit of the new efficient processing system must
meet the regulatory requirements of that rule. The Department does not
have the resources to process identical cases under two different
regulations implementing the permanent labor certification program,
i.e., pre-PERM and post-PERM. Removing the ``identical'' standard under
the PERM regulation would require a new rulemaking process and has the
potential for trading backlogs between the Backlog Elimination Centers
and the Department's National Processing Centers. We do not feel that
this would be in the interests of employers or foreign workers. The new
PERM system is much more efficient than the old system, but converting
all old cases into new PERM cases would result in backlogs in PERM.
Question. What is the plan for dealing with applications for which
no 45 day letter was received by June 30? Will provisions be made for
reconstructing lost files? When will employers be notified of these
procedures?
Answer. The BECs have taken extensive steps to ensure that all
applications identified for transfer to the BECs have been shipped and
received at their designated destination. However, because there may be
some applications that for various reasons were never identified by the
state agencies or ETA Regional Offices for shipment to the BECs, we are
developing a process by which to handle those cases. Within the past
two weeks, the Department posted a detailed set of Frequently Asked
Questions (FAQs) on the foreign labor certification website which
addresses procedures related to the 45-day letters http://
www.ows.doleta.gov/foreign/#whatsnew.
Due to the high demand for information and time and resource
constraints, we believe that posting the information on our website is
the best way for the entire public to have access to the information at
the same time. These FAQs will provide procedures for employers in the
event they have had a case closed through the non-receipt of a 45-day
letter. Additional FAQs to cover these situations may be posted if
appropriate at a later date.
Question. What are the realistic expectations for adjudicating all
BEC cases by September 30, 2007? How are these expectations impacted by
losses of the top level people at the BEC in Pennsylvania? How has DOL
factored into these expectations the lack of incentive for BEC
employees to complete the cases on a timely basis since doing so will
result in loss of their positions as of September 30, 2007?
Answer. The Department has plans underway to fill all vacancies,
both Federal and contractor staff, at the Philadelphia Backlog
Elimination Center. Since establishing the two (2) backlog centers in
July 2004, we have logged in all 360,000+ cases transferred to the
backlog centers from the states, sent 45-day letters to all employers,
and cleared over (157,473) cases from the centers. We intend to have
all backlog cases under processing by September 30, 2007.
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, EDUCATION, AND RELATED
AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2007
----------
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
NONDEPARTMENTAL WITNESSES
[Clerk's note.--The subcommittee was unable to hold
hearings on nondepartmental witnesses. The statements and
letters of those submitting written testimony are as follows:]
DEPARTMENT OF LABOR
Prepared Statement of the National Association of Workforce Boards
Chairman Specter, Ranking Member Harkin, and distinguished Members
of the subcommittee, my name is Stephanie Powers, Chief Executive
Officer of the National Association of Workforce Boards (NAWB). I am
submitting this testimony on behalf of Leonard Wilson, Chairman of the
Board of Directors of NAWB, and the Nation's workforce investment
boards regarding fiscal year 2007 funding for programs authorized under
the Workforce Investment Act (WIA). We appreciate this opportunity.
Workforce Investment Boards (WIBs).--The Nation's 589 local, and 52
State workforce boards provide strategic guidance and leadership for
the design and implementation of the Nation's workforce investment
system, which includes 2,000 comprehensive One-Stop Career Centers. The
boards have approximately 13,000 private sector members who volunteer
their time to insure that the workforce investment programs are
connected with community economic development priorities and employers'
needs.
The Workforce Challenge in the United States.--More than at any
time in our history, the American workplace demands a competitive and
responsive workforce. The complex interplay of technology and
globalization, coupled with profound demographic changes, have set in
motion a set of difficult challenges to our economic prosperity.
Business, political leaders, and policy experts often disagree as to
the proper mix of monetary, trade, taxation, and regulatory policy to
ensure prosperity in the years ahead. Nonetheless, virtually all the
experts, public and private, agree that a key ingredient to our
economic success lies in the capacity of the American workforce to
offer knowledge, skills and innovation to the economy. Yet, the
administration continues to propose potentially devastating reductions
in funding, and policy changes for the Nation's workforce investment
system that, if adopted, would virtually eliminate our workforce
preparation infrastructure, and decimate United States efforts to
maintain a skilled workforce.
As your Committee examines the President's fiscal year 2007 budget
proposal, and deliberates over workforce investment and employment
services funding, the National Association of Workforce Boards
respectfully asks that you: (1) Weigh the potentially devastating
impact of the administration's budget and policy recommendations for
WIA and the Wagner-Peyser Act; (2) Decide instead to enhance and build
on strengths of locally-based, private sector-led Workforce Investment
system and its successes; and (3) Invest, not disinvest in the Nation's
workforce development system, funding programs authorized under WIA and
the Wagner-Peyser Act at not less than the fiscal year 2005 funding
levels.
In 2006, we know that it is crucial for our workers to be ready,
willing, and able to respond to the pace of America's changing
workplace needs. On the demand side, employers must be ready to invest
in the capacity of all workers, not just those already skilled and
educated. Collectively, our Nation must commit resources at all levels,
to raise the performance of students and workers at the bottom, while
improving the performance of those in the middle and top. We must
ensure that all low wage and structurally unemployed workers have the
opportunity to gain new high-value skills, maintaining important
transitional income support and health insurance while upgrading skills
and changing careers. Our public policy investments need to embrace the
realities of a 21st Century workplace and develop a system that will
help our employers and workers compete successfully. Success for the
future will depend not just on educating all Americans to much higher
standards, but also to different standards.
We believe that the complexity of what we are facing requires our
Nation to maintain a strong Federal commitment to coherent and
consistent public investment policies that address the needs of workers
and employers alike. There will be a price to broad prosperity if we
ignore the sum of these growing realities:
--Broad Lack of Workforce Proficiency in Technology.--The Global
Affairs Director of the Microsoft Corporation, Pamela Passman,
in a recent speech at NAWB's annual conference, expressed her
company's concerns about the ``readiness of the American
workforce to embrace technology as an essential tool of the
knowledge economy.'' She stressed that there is no concern with
countries embracing technology, innovating, and investing in
education and skills training, as long as America is doing the
same. But she warned about the lack of proficiency of adults to
search, comprehend, and use information (13 percent) and to
perform computational tasks, despite the Nation's focus on
improving math and science skills (13 percent). These
deficiencies, if not quickly addressed, will hamper growth and
innovation expansion for ``employers who are demanding more
skills that revolve around knowledge creation, collaboration
and communication, and analysis.''
--A Growing Talent Shortage.--The well-regarded staffing company
manpower asserts, in a recently released white paper entitled
Confronting the Talent Crunch: What's Next States, ``There
already is a talent shortage in many areas of the global labor
force, a situation that will grow more widespread across more
jobs over the next 10 years--and could threaten the engines of
world economic growth and prosperity.'' The Bureau of Labor
Statistics predicts a shortfall of 10 million workers in the
United States by 2010, which may exert additional strain on the
talent pool availability.
--Demographic Reality #1: Aging Workforce.--The first of the baby
boomers has turned 60 this year. Older workers will be leaving
the workforce much faster than new workers are entering, and as
they leave the workforce they will take with them an incredible
wealth of education, talent, skills, experience, and
traditional work ethic. For example, more than 50 percent of
the current science and engineering workforce in the United
States is approaching retirement. Given this, should we be
concerned that China graduates four times as many engineers as
the United States? Or that out of the 1.1 million high school
seniors who took a college entrance exam, just under 6 percent
indicated plans to pursue a degree in engineering--nearly a 33
percent decrease in interest from the previous decade (Passman,
2/27/06).
--Demographic Reality #2.--Immigrants and Untapped Pools of Potential
Workers. The future workforce will be far from homogeneous. The
predicted growth in the American labor force will come largely
from immigrants who are less likely to quickly replace the
level of skills that will be departing with the boomers'
exodus. If these trends continue, and they are predicted to do
so, increasing workforce remedial interventions will be needed
to deal with English language deficiencies and to boost basic
education proficiencies. Employers will also need to be better
prepared to provide various accommodations for both an aging
workforce and people with disabilities who are likely to enter
the workforce in greater numbers as technology and civil rights
protections enable higher rates of their participation. The
continued growth of working women will require more flexible
working schedules and family leave policies as their child care
and elder care responsibilities require them to balance work
and family commitments.
So the question looms, how can workers be assisted in navigating
and managing their work lives in this complex global economy? Will
companies be competitive without access to a higher-skilled workforce?
And importantly, how should public policy respond to the realities of
the societal changes and the vagaries of the global economy? The
President acknowledged in his State of the Union message the increasing
concern about national competitive challenges, but we regret that his
budget proposal for workforce investment does not support his agenda in
this area; in fact, it misses the mark. It is baffling why the
administration would propose such deep cuts in the Nation's workforce
investment programs in the face of mounting evidence, and their call
for attention to American competitiveness. We should increase, not
decrease these investments.
The WIA system currently provides a wide range of vital services to
over 16 million U.S. jobseekers and employers through its One-Stop
delivery system, including labor market information, job search
assistance, guidance and counseling services to help workers find the
right jobs, and employers find the right employees. The system provides
essential rapid response and transition assistance to dislocated
workers; support services for individuals pursuing first time
employment; and assistance for low-wage workers in search of career
growth opportunities leading to self-sufficiency. It is designed to
help jobseekers access the education and training they need to succeed
in the new knowledge economy; to meet the skill needs of employers.
According to the U.S. GAO, the WIA system spent over 40 percent of
its funding in fiscal year 2003 on training for jobseekers in the
United States, and this estimate did not take into account funds used
to pay for computer lab workshops in software applications, basic
keyboarding, computer skills training, and even certain adult basic
education classes offered through the One-Stop delivery system. Nor did
it take into account training arranged by the One-stops but not paid
for with WIA funds.
As your Committee deliberates on funding for the U.S. workforce
investment system, and considers the President's 2007 budget proposal,
we respectfully ask that you:
(1) Enhance and Build on Workforce Investment Boards' Successes
The United States' Council on Competitiveness and the experts who
participated in its National Innovation Initiative identified
innovation as the single most important factor in determining America's
success through the 21st Century. They identified the key ingredients
for innovation as talent, investment, and infrastructure, and urged the
knitting together of these strands to foster new innovation ``hot
spots'' in regions across the United States than can sustain jobs and
wage growth. It is crucial to find ways bring businesses, workers,
researchers, economic developers, entrepreneurs, educational and
training institutions, and governments together, at the regional level,
to identify and develop their strengths and capacity for innovation.
In fact, the Workforce Investment Act is predicated on such a
collaborative model. Many Workforce Boards across the country are
already performing this convening/brokering role that is essential to
regional economic prosperity. To eliminate funding for this work as
proposed in the administration's fiscal year 2007 budget, would be to
put a stop to what hundreds of local workforce investment boards from
around the country have already begun--the building of collaborative
regional, knowledge-based economies. Let me share some examples with
you.
--The Finger Lakes Workforce Investment Board.--In New York
identified and developed career maps for photonics and
biotechnology as potential growth sectors for a region in
transition. The WIB with K-12 schools, the business community,
community colleges and the Syracuse University School of
Education identified the foundational skill standards for these
industries and recommended steps for secondary schools to
realign curricula in science, math and technology, as well as
ways to build awareness of the career opportunities and
pathways existing in these sectors.
--The South Florida Workforce Investment Board.--That serves the
Miami metro area served 7,648 employers and placed 69,634
clients in jobs this past year. They calculate the return on
investment to the community of $11.01 for every dollar of
workforce funds invested. In an area of historically high
unemployment, these results are the fruit of the partnerships
that the WIB has fostered with economic development agencies,
business and the community's public agencies.
--The Brevard Workforce Development Board.has created an extensive
menu of business services and targeted those growth industries
such as healthcare, manufacturing, and Aerospace that are
growing jobs in their community, which is one of the hottest
job growth areas in the country. Their ability to continue this
work would be diminished, if not eliminated, if the proposed
budget cuts and Career Advancement Account proposals are
enacted.
--The Northwest Wisconsin Workforce Investment Board.--Developed the
``Talent Profiling System'' (TPS), a soft skills matching tool,
to respond to the overwhelming requests of employers to find
people that fit their jobs. Since its implementation, TPS has
achieved results ranging from having the highest employer
penetration rate in the State's 11 Workforce Development Areas
to a decrease of $916.88 to $420.24 in cost-per-placement and
realized $4.22 Return On Investment (ROI) for each tax dollar
invested.
--The North Central Texas Workforce Development Board.--Serves a
fourteen county region with 1.6 million people that surrounds
the Dallas/Fort Worth area. This board supports small
businesses by serving as the HR department for small companies.
In this vital role they provide personalized attention for
recruiting and placement; applicant screening; and on-site
assistance with interviewing. Services to small business such
as these, the engine of economic growth, will be severely
limited by 15 percent + reductions in funding and the Career
Advancement Account proposal.
--The Greater Peninsula Workforce Development Consortium.--In Newport
News, Virginia created The Manufacturing Pipeline Partnership
for their local manufacturers. Participating manufacturers have
been able to significantly improve their hiring practices
through this collaborative effort. Northrop Grumman Newport
News was able to hire 922 workers in skilled trades' positions,
Siemens VDO Automotive, hired 100 plus workers for crucial
positions in their advanced technology production areas. The
WIB and the partnership it convened is directly contributing to
the long term economic vitality of the region. This would not
have been possible without the WIB's convening role, and WIBs
would effectively be eliminated by the administration's budget
cuts.
(2) Weigh the Potential Impact of Cuts on the Workforce Investment
System and its Customers
The administration's fiscal year 2007 budget proposes a new 15
percent cut in funding for WIA and Wagner-Peyser. These reductions
would be applied to a workforce investment system that has already
sustained funding reductions over the years, and is stretched very
thin. Simply put, our system cannot sustain any further cuts without
having to close numerous One-Stop Centers throughout the country, and
cut back on services provided to those in need (eg, dislocated workers,
the structurally unemployed, low wage workers in search of self-
sufficiency, at-risk youth, and employers).
These negative consequences of funding reductions do not even take
into account the potential devastation that would be caused by the
administration's policy recommendations contained in the fiscal year
2007 budget. In her testimony before your Committee, Secretary of Labor
Elaine Chao indicated that the One-Stop delivery system would be
preserved under the administration's fiscal year 2007 proposal. She
stated this despite the fact that 75 percent of the funding for States
under their consolidated proposal, would be required to be spent on
Career Advancement Accounts--leaving less funding for all other system
functions and services, than now provided for the Wagner-Peyser program
alone.
The real impact of the administration's proposal (in total) would
be the elimination of most of the local Workforce Investment Boards
around the country, and the closure of most of the One-Stop Centers.
With only 22 percent of WIA and Wagner-Peyser funding, States would be
forced to provide all remaining services other than training. Funds to
engage the private sector, both through the boards and through business
services would be immediately impacted. The loss of the private sector
engagement and focus would be diametrically opposed to the original
Congressional intent of WIA and to calls from the country's leaders on
U.S. competitiveness. Discussions with our colleagues around the
country indicate that the impact on the workforce system infrastructure
would be dramatic and would effectively dismantle much of the strategic
partnership work, employer outreach, and physical One-Stop
infrastructure that the WIBs have spent the last 5 years crafting.
Innovative programs developed in partnership with employers and
economic development, such as incumbent worker, industry sector, career
ladder, and layoff aversion programs would be abruptly halted. And
tragically, the private-sector leadership of the workforce boards, that
has taken us so long to build, would be dismantled and swept under the
rug. We believe this leadership and participation should be cultivated,
not marginalized, particularly at a time when business leadership and
employer engagement in the system is growing. It would be hard to find
many other Federal programs where the business community has such a
direct role in determining how Federal tax dollars are used in local
communities.
When WIA was enacted in 1998, it was clear that Congress intended a
significantly enhanced role for business vested in the Workforce
Investment Boards. As WIA has matured these past 5 years, we believe
that this strategic oversight has turned out to be a highly desirable
value proposition and we urge Congress to continue a strong endorsement
of the approach by maintaining and increasing WIA funding that insures
the private sector's engagement in the public workforce system.
(3) Invest, Not Disinvest
We applaud the efforts of the subcommittee to provide funding for
WIA at levels as close to constant as possible in these increasingly
difficult budgetary times. NAWB knows that there are many pressures on
the Federal budget and many legitimate requests for funding. However,
we submit the competitive posture of the Nation needs to be placed at
the top of the priority list, and urge you to fund WIA and Wagner-
Peyser at the fiscal year 2005 levels.
While the Department of Labor may claim there is excess unspent
money in the WIA system to justify their recommended budget cuts, they,
in fact, are not presenting the facts accurately. The GAO's 2002 study
clearly disputed this claim. And since the original claims of slow
expenditures and excessive carryover were made, the WIA system has
significantly diminished system carryover to less than 30 percent of
its accrued expenditures--the standard proposed by the administration
for WIA reauthorization, and included in both the House and Senate WIA
reauthorization bills.
In summary, when WIA was enacted, it was intended to ensure that
all Americans have access to the information, job search assistance,
and training they need to qualify for good jobs, and to successfully
manage their careers in the new economy of the 21st Century--we urge
you not to turn your backs on America's workforce investments. . . .
they are about our future prosperity, and ultimately our national
security in the purest sense.
Thank you for your support in the past, and for this opportunity to
submit testimony.
______
Prepared Statement of the National Job Corps Association
job corps worthy investment to america's youth
Six Million Youth Eligible to Participate
On behalf of the National Job Corps Association (NJCA), we want to
thank the Labor, Health and Human Services and Education Appropriations
Subcommittee for its unwavering dedication to Job Corps and the
vulnerable disadvantaged young Americans it serves. We appreciate the
Committee's strong support of Job Corps in fiscal year 2006. Not only
did the Committee provide a funding increase, but it established Job
Corps as an office reporting directly to the U.S. Secretary of Labor.
With strong bipartisan support, Congress acknowledged Job Corps' 40-
year track record of success by eliminating layers of bureaucracy and
ensuring department-wide attention on America's most disadvantaged
youth.
Job Corps is a voluntary program that serves more than 60,000 young
Americans each year, which is only about 1 percent of the nearly 6
million disadvantaged youth that are eligible for Job Corps' services.
Over the last four decades, Job Corps has built its reputation as the
Nation's largest and most successful residential educational and
vocational training program for economically disadvantaged youth, ages
16 through 24. With millions of youth eligible and in need of Job Corps
services, it is only with your help that Job Corps can remain a beacon
of hope for many young Americans and an excellent example of our
government's role in ensuring every American has a chance to succeed in
the 21 century economy. Tony Pusateri, a Senior Vice President of
Equity Residential in Plano, Texas and member of the National Apartment
Association Education Institute observed: ``I've been around Washington
and seen a lot of government programs that I didn't support, but Job
Corps is one program . that I am proud my tax dollars go to.''
Unfortunately, the administration's fiscal year 2007 budget request
cuts Job Corps by $72 million from the fiscal year 2006 enacted level.
We are deeply concerned that such a funding cut would force a drastic
reduction in the number of youth Job Corps will be able to serve. While
we encourage spending restraint by the U.S. Government, we also believe
it is imperative to provide adequate funding to support the young
Americans who are our Nation's future.
job corps operations funding
Administration's Fiscal Year 2007 Budget Proposal
The administration's proposal recommends funding Job Corps'
operations account at $1.401 billion, a decrease of $64 million
compared to the fiscal year 2006 appropriated levels. This level of
funding amounts to a 7.8 percent decrease in Job Corps' real-dollar
funding from fiscal year 2006.
If the operations account were to be cut by $64 million, more than
3,000 economically disadvantaged young Americans would be turned away
from Job Corps. These vulnerable youth, though they have the desire,
would not be able to enter Job Corps to complete their high school
education and place themselves on a career path. As one of the few
national job training programs that has shown consistent positive
results, Job Corps has the ability to preserve economic prosperity by
equipping thousands of high school dropouts, foster care youth, and
other vulnerable youth with job skills to enter gainful employment and
become responsible, productive citizens. This cut would limit the
opportunities of vulnerable youth who are seeking a way to put
themselves back on track for success.
NJCA Fiscal Year 2007 Request
The NJCA requests a total of $1.53 billion for Job Corps' fiscal
year 2007 operations account to support at least 44,000 training slots
and keep all Job Corps centers at full capacity. This amount is based
on the Office of Management and Budget's (OMB) projected 3.3 percent
rate of inflation between fiscal year 2006 and fiscal year 2007 as well
as additional appropriations to support efforts to improve educational
programs on Job Corps centers. The increase would (1) allow the 122 Job
Corps centers across the country to operate at full capacity to ensure
the programs serves as many eligible youth as possible; and (2) support
the U.S. Department of Labor's efforts to ensure the program has the
necessary resources to hire capable teachers and ensure the quality of
its educational courses.
job corps construction, rehabilitation and acquisition (cra) funds
Administration's Fiscal Year 2007 Budget Proposal
The administration's budget proposal recommends funding Job Corps'
CRA account at $100 million, an $8 million reduction from fiscal year
2006.
As you know, Job Corps gives young people the opportunity to focus
and learn in a safe, stable, and supportive environment. However, the
average building on a Job Corps center is 47 years-old--20 years older
than the construction industry's recommended lifespan. While the
program is committed to addressing the backlog of repairs by developing
a 10-year capital improvement plan to construct and repair facilities
based on priority, it needs more funding resources.
NJCA Fiscal Year 2007 Request
With respect to Job Corps' capital account, the NJCA requests $130
million in fiscal year 2007. These funds will be used to: repair dorms,
classrooms, and other student facilities on existing Job Corps centers;
replace deteriorated structures, especially those that threaten the
safety and health or violate minimum building codes, including
mechanical systems; continue to address the $700+ million backlog of
construction and/or repair needs; and provide third year funding for
incremental Job Corps expansion.
conclusion
As Job Corps looks to the future to train the next generation of
youth, we hope you agree that it remains a Federal program worthy of
America's attention and support. Seventy-four percent of Job Corps
enrollees are high school dropouts. The typical Job Corps student reads
slightly less than the 8th grade level. Most youth who attend Job Corps
have never held a full-time job. Thirty-two percent come from families
on public assistance. However, through targeted self paced learning and
dedicated counselors and teachers, these youth graduate from Job Corps
with well-documented improvements in their education and skill levels
and more than 90 percent transition into employment, higher education
or the military. Job Corps provides thousands of youth a second chance
to achieve the American dream.
The NJCA looks forward to working with the members of this
Committee to ensure that thousands of disadvantaged young Americans
will continue having the opportunity to lift themselves up through Job
Corps. We have been encouraged by the Committee's support that have
expanded and strengthened Job Corps over the years and hope that we
will enjoy that support and confidence in fiscal year 2007 and into the
future.
______
Prepared Statement of the National Youth Employment Coalition
The National Youth Employment Coalition (NYEC) is a network of over
270 youth employment, education, and workforce development
organizations dedicated to promoting policies and initiatives that help
young people succeed in becoming lifelong learners, productive workers
and self-sufficient citizens. NYEC works to improve the effectiveness
of youth-serving organizations by informing and tracking policy;
setting and promoting quality standards; promoting professional
development; and building organizational capacity. We thank you for
your previous support of programs that provide meaningful job training
and youth development opportunities for young people and for the
opportunity to submit this testimony.
Youth development/employment programs must be adequately funded
because our youth are facing a crisis that has profound implications
for their lives, their futures, and our society at large. There are 2.4
million low-income 16 to 24 year olds who left school without a diploma
or received a diploma but are unemployed.
Youth development/unemployment programs must be funded at a level
commensurate with the need to develop a globally competitive and highly
skilled workforce for the jobs of tomorrow and today. Youth face a
crisis that has profound implications for the lives, their futures, and
society at large. According to a report by Public/Private Ventures,
``nationwide, 15 million people between the ages of 16 and 24 are not
prepared for high-wage employment. Inadequate education or training is
a major reason.'' A report by the National Association of Manufacturers
identified three simultaneous phenomena that together are transforming
the American economy and its labor force: global pressures, relentless
advances in technology, and demographic shifts that will result in ``a
projected need for 10 million new skilled workers by 2020.''
In the face of persistent youth unemployment and changes in the
labor market which require more knowledge and skills, the
administration's proposed 2007 budget for WIA and Employment Services
programs, is a matter of serious concern. It calls for a 15 percent
reduction in these important programs and perpetuates the downward
trend that would leave employment and training programs $1 billion
below funding levels of 5 years ago.
Unless Congress rejects these proposals, many thousands of youth
will continue to lack the opportunities and supports necessary to
succeed in the 21st century workplace. NYEC urges you to increase
investment in programs under the Workforce Investment Act (WIA) and to
restore funds for Perkins Act programs, TRIO, and Gear-Up, and the
Reintegration for Young Offenders Program.
These programs are needed because unemployment among youth is
unacceptably high. While adult unemployment averaged 5 percent in the
last quarter of 2005, the unemployment rate among youth 16-19 was 16.1
percent; more than three times as high. A recent study from
Northeastern University's Center for Labor Market Studies found that
between 2000 and 2004, the number of employed teens declined by nearly
1.3 million.
Since fiscal year 2002, our Nation has been in the process of
disinvesting in youth employment and development programs. If this
current round of cuts is implemented, investment in the WIA youth
programs will have dropped by more than 38 percent from $1.4 billion in
fiscal year 2002 to $841 million in fiscal year 2007. This when
according to the National Center on Education and the Economy we need
``to invest in training on a scale that supports the well-being of the
Nation's economy and so that it is not just a privilege for the lucky
few.''
The administration's disinvestment runs counter to its own
philosophy of investing in programs that work and divesting from
programs that do not work. These programs work. According to the U.S.
Department of Labor's fiscal year 2005 Performance and Accountability
Report, in Program Year 2004 (July 2004-June 2005), WIA programs
exceeded the Department's target for Diploma Attainment among youth 14-
18 (65 percent v. 53 percent), entry to employment for youth 19-21 (72
percent v. 68 percent), and employment retention for youth 19-21 (82
percent v. 79 percent).
The only measure in which programs failed to meet or surpass the
Department's target was in cost per participant. According to the
Report (page 65), ``Average cost per participant was slightly higher
than expected--$2,822 vs. a target of $2,663. However, consistent with
ETA's vision for youth services, the program has served a higher
proportion of out-of-school youth. Out-of-school youth are a more
expensive population to serve, with a cost of $3,724 per participant,
therefore the overall cost per participant increased over prior years.
At the time the cost per participant target was estimated, DOL did not
anticipate the full extent of increased expenditures on out-of-school
youth.'' The Report also notes that ``Results for PY 2004 continue an
upward trend that began with WIA implementation in 1998. All three
outcome indicators have increased from PY 2003 and exceeded performance
targets. Most important is the continued increase in high school
diploma attainment, given the strong statistical correlation between
educational attainment and success in the labor market.''
It should be noted that even at $2,822 per participant, the cost is
below the $3,000 assumed in the administration's proposed Career
Advancement Accounts (CAA).
Further, a recent study of comprehensive youth workforce
development programs in 36 communities carried out by the Center for
Law and Social Policy confirms that Federal investment makes a
difference. It found that that between 2000 and 2005 these programs
successfully connected out-of-work youth to approximately 18, 456 long
term unsubsidized work opportunities; 23,652 internship opportunities;
28,302 short-term unsubsidized jobs; and 23,478 training opportunities.
The program reached 42 percent of the eligible target population and 62
percent of the eligible out-of-school population.
According to a 2004 report prepared by Northeastern University's
Center for Labor Market Studies, there are 5.4 million 16 to 24-year-
olds who left school without a diploma or received a diploma but are
unemployed. About 44 percent of them are low-income. With more than
540,000 students dropping out of high school each year the implications
of this phenomenon are staggering:
--The earnings gap widens with years of schooling and formal
training. In 2003, earnings of male dropouts fell to $21,447;
high school graduates earned an average of $32,266; and college
graduates earned about $63,000 or triple that of dropouts. As a
result, dropouts pay less taxes, are more likely to rely on
public assistance, and to be part of the criminal justice
system.
--One expert estimates that the United States would save $41.8
billion in health care costs if 2004's 600,000 dropouts were to
advance an additional year in educational attainment.
--Approximately 16 percent of all young men, ages 18-24, without a
high school degree or GED are either incarcerated or on parole
at any one point in time.
--Three quarters of State prison inmates are high school dropouts, as
are 59 percent of inmates in the Federal system.
--Increasing the high school completion rate by 1 percent for all men
aged 20-60 would save the United States $1.4 billion a year in
reduced costs from crime.
--The situation is even more dire in minority communities where as
few as 20 percent of black teens are employed at any time,
unemployment among young black men aged 16-24 not enrolled in
school is about 50 percent, and approximately one-third of all
young black men are involved with the criminal justice system
at any given time.
According to a paper by written by Professor Michael Wald and Tia
Martinez for the Hewlett Foundation, ``over the past 25 years the
situation for youth who fall off the ladder as they move to adulthood
has gotten considerably worse.'' Nevertheless, inflation-adjusted
spending for programs that target at-risk youth dropped by 63 percent
from 1985 to 2003.
Youth workforce development programs provide a wide range of
services to improve educational achievement, prevent youth from
dropping out of high school, and reengage youth who are out of school
and out of work. NYEC believes that we must reverse the trend of
disinvesting in youth employment and development and fund the WIA youth
formula at $1 billion. While we support new programs that help youth
prepare for jobs and careers and prevent them from leaving school,
funding for untested initiatives like the CAA's should not come at the
expense of successful programs that are already stretched to the
breaking point.
The administration's fiscal year 2007 budget also proposes to
eliminate the Reintegration of Young Offenders Program. According to
the Bureau of Justice Statistics, approximately 120,000 youth under the
age of 18 are currently incarcerated in juvenile detention centers,
State prisons, and local jails. Most will be released in the next few
years.
A 1998 study by Vanderbilt Professor Mark Cohen, estimated that
each teen prevented from adopting a life of crime could save the Nation
between $1.7 and $2.3 million. A report prepared in 2002 for the
California State Senate Joint Committee on Prison and Construction
Operations stated, ``Given the staggering cost of failure, it is hard
to imagine any justifiable argument against providing education and
services to this population.''
Finally, the cost per participant pales in comparison with the cost
of alternatives like incarceration. According to the Justice Policy
Institute, for example, ``incarceration, particularly for juveniles, is
an expensive proposition. Each year, capital costs to build new
facilities run in the range of $100,000 per cell and operating costs
typically exceed $60,000 per cell.'' The return on investment in the
Young Offenders program will be returned many times over.
While NYEC recognizes the administration's continuing commitment to
helping prisoners successfully return to society, we are concerned that
unless funds are specifically targeted to serving youth, the needs of
adults will most often take precedence. At a minimum, funds currently
targeted at court-involved youth under the Reintegration for Young
Offenders Program should be restored to fiscal year 2003 levels ($54
million).
We support the goals of the President's ``American Competitiveness
Initiative'' and his charge that ``We must continue to lead the world
in human talent and creativity. Our greatest advantage . . . has always
been our educated, hardworking, ambitious people--and we're going to
keep that edge.'' Realizing that goal, however, requires investment in
all our citizens.
NYEC has many concerns about the CAA's. We are particularly
concerned that the limit of $3,000 a year for up to 2 years will
function as a cap that will prevent workers from receiving the best and
most appropriate training. A June 2005 GAO Report on the Workforce
Investment Act (GAO-05-650) revealed that only 8 percent Workforce
Investment Boards cap their Individual Training Accounts at $3,000.
Fully 63 percent impose caps of $5,000 or more and 35 percent have caps
of $7,000 and up. Fifteen percent have no caps. While this could
achieve DOL's goal of increasing the number of people trained, it would
call the quality of much of that training into question.
Without Federal investment in effective programs such as those
supported by WIA youth formula funds, the Responsible Reintegration of
Young Offenders program, and the education programs that provide
meaningful pathways from high school to higher education, millions of
young people will not make the successful transition into productive
employment.
We thank the Committee for its commitment to these important
programs that prepare our youth to compete in the global marketplace of
the 21st century. We look forward to working with you to strengthen our
Nation's youth employment and youth development systems.
______
Prepared Statement of the Oregon Human Development Corporation
Honorable Chairman, Senator Arlen Specter, and Honorable Committee
Members: I want to thank you for the opportunity to share information
about the Workforce Investment Act, Section 167 (WIA 167) National
Farmworker Jobs Program.
My name is Ronald Hauge and I am the Executive Director of Oregon
Human Development Corporation (OHDC), a not-for-profit organization
that has provided education, training, and workforce development
services for Oregon's migrant and seasonal farmworkers for more than 27
years. Throughout this period Congress has supported focused workforce
development services for migrant and seasonal farmworkers within the
CETA, JTPA, and WIA Federal workforce initiatives. The underlying
reason for this support has been the recognition that migrant and
seasonal farmworkers have different characteristics and needs than
conventional job seekers who use the Nation's workforce system, and
that based on these differences specialized workforce services are
necessary to effectively serve this population.
The Department of Labor's own performance reports that show the WIA
167 National Farmworker Jobs Program consistently among the higher
performing workforce programs, yet the administration has tried to
eliminate the WIA 167 for the last several years. It is only by
congressional action that the WIA 167 program continues to exist. Each
year this Committee has demonstrated its wisdom and priorities by
supporting appropriations to preserve these effective workforce
services. Accordingly, I want to thank the Honorable Chairman and
Committee Members for your instrumental role in saving the program and
maintaining these valuable investments for our Nation's agricultural
workforce.
At this time I would like to point out a few features of the WIA
167 program that illustrate its importance.
program performance
According the Department of Labor's performance reports the WIA 167
program has achieved entered employment rates above 80 percent, job
retention rates of 75 percent, and earnings gains above $4,000. This is
unquestionably strong performance given that migrant and seasonal
farmworkers are among the most difficult to serve job seekers in the
workforce system, and that the program operates largely in rural areas
with limited labor markets.
integration of the wia 167 program into the one stop workforce system
The WIA 167 programs in each State are integrated into the One Stop
workforce system on a location-by-location basis. In Oregon, for
example, OHDC has six service delivery offices and each of the offices
is integrated into the local One Stop system by virtue of co-location
or other planned systemic integration. OHDC WIA 167 staff are members
of local Workforce Investment Boards in each service area.
In Oregon, this integration is acknowledged at the State level and
is well documented in the State of Oregon's Two-Year Plan for Title I
of the Workforce Investment Act and the Wagner-Peyser Act. The plan
states that ``strategies in Oregon to promote equal and effective
access and service delivery and to promote enhancement and integration
of services to MSFWs (migrant and seasonal farm workers) include Oregon
Human Development WIA 167 staff have workspace in WorkSource Oregon
centers and access rights to the MSFW customer base in each workforce
area they serve. With this, they are able to identify from a broader
base of MSFW customers those particularly interested in the intensive
and training services they can offer and where other staff are able to
understand more thoroughly the value added services offered by the WIA
167 for enhanced referral of their customers; they are seen as a
critical component to delivering workforce services to MSFWs.''
(emphasis added)
few alternative options for farmworkers
The mainstream One Stop workforce system is geared primarily toward
meeting the ``demand'' needs of high growth/high demand industries--as
part of larger economic development strategies. This leaves lower
skilled, hard working farmworkers with few or no options to improve
their skills and secure stable employment in the primary labor market.
Accordingly, the WIA 167 program becomes the only viable workforce
development option for most farmworkers, a place with culturally
sensitive, bilingual staff who are experienced in serving farmworkers
and who understand the needs of local employers. It is clear that
without the WIA 167 program few farmworkers would receive any
developmental benefit from the Nation's workforce system.
rural community asset
The WIA 167 program is a real asset to rural communities. The
program adds tangible service capacity and diversity to smaller rural
One Stop workforce systems. The program can provide agricultural
upgrade training to help agricultural employers enhance worker
productivity and stability, thus extending the workforce development
system's benefit into the agricultural industry. Also, the program can
serve as a foundation to attract other services for farmworkers such as
housing, literacy and language training, disaster services, and a
variety of emergency services that help stabilize the agricultural
labor force in local communities.
As you can see, the WIA 167 National Farmworker Jobs Program is an
effective, valuable, coordinated resource that not only benefits
farmworkers, but also strengthens the Nation's One Stop workforce
system and rural communities.
Before closing I would like to share, in the words of OHDC
workforce coordinators, the experience of two farmworkers who were
assisted in Oregon Human Development Corporation's WIA 167 program.
Jesus Ortiz \1\
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\1\ Editors Note.--Not real names.
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Worked with Glen Walters Nursery for a number of years but had been
unable to advance because he did not have any formal education on how
to supervise a crew. Most of his knowledge came from first hand
experience in the general operation of his department and observing
other supervisors. In November 2004 OHDC enrolled Jesus in the WIA 167
National Farmworker Jobs Program. OHDC met with the employer and
arranged to provide supervisory skills upgrade training to develop the
supervisory skills of Jesus, with the understanding that Jesus would be
promoted into a supervisory position following the training. Because
Jesus had limited English language skills, OHDC provided the training
in Spanish. Jesus completed the training, which was defined as ``a
success'' by the employer, who promoted Jesus into a supervisory
position. Jesus also received a wage increase that took his earnings
from $7.45 per hour to $11.00 per hour. Now, Jesus not only has the
knowledge foundation that makes him a more effective leader and
supervisor, but he also has a better income that will dramatically
improve his family's well being. It is important to note that this
success story would not have been possible if OHDC's WIA 167 program
had not been available to provide the training in Spanish--something
not available from any other partner in the local One Stop workforce
system.
Antonio Sanchez \1\
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\1\ Editors Note.--Not real names.
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Enrolled in the WIA 167 program in October 2005 at OHDC's Woodburn
office. Antonio is a married father of three children. Antonio had
worked primarily in agricultural work since he was 18 years old. He was
employed with a dairy since 2003, living in employer owned housing. At
the dairy Antonio worked long hours and weekends (65-75 hours per week)
earning a salary of $2,000 per month with no health or vacation
benefits. Antonio was eager to start attending training classes
available through the WIA 167 program--his primary goal was to obtain a
Commercial Drivers License (CDL) and to secure a commercial driving
job. Antonio completed job readiness, customer service, computer, CPR,
and CDL trainings within a 6 month period, even though English was not
his primary language. He was an active participant with a strong desire
to learn as much as he could so he could secure employment that would
offer him and his family health insurance benefits, a regular work
schedule, and a good living wage so his family could purchase their own
home. Upon obtaining his CDL, OHDC referred Antonio to a job interview
with Sysco Food Service. According to the Sysco supervisor, Antonio
made a great impression during his interview and was offered an entry
level position starting at $12.13 an hour--and he will be given the
opportunity to transition to a Truck Driver position earning more than
$16.00 per hour. The position provides vacation and excellent health
benefits, retirement and life insurance. The family is now in the
process of purchasing a home of their own.
These two examples illustrate how the WIA 167 program works for
both farmworkers and employers.
In closing, I want to thank you again for your ongoing concern for
the Nation's agricultural workforce. Although there are many priorities
the Committee must evaluate, this is not the time for the Nation to
turn its back on our hard working farmworkers who produce and harvest
much of the Nation's food and other agricultural products--and who
contribute so much for our collective benefit. Therefore, I strongly
urge the Committee to maintain or increase the appropriation for the
WIA 167 National Farmworker Jobs Program in the 2007 budget.
______
Prepared Statement of the Association of Farmworker Opportunity
Programs
Good morning Chairman Specter and members of the subcommittee. My
name is David Strauss and I represent the 48 nonprofit and public
agencies that provide job training and related services to our Nation's
migrant and seasonal farmworkers. They perform these tasks with grants
from the United States Department of Labor pursuant to Section 167 of
the Workforce Investment Act. As you know, the administration has tried
to eliminate this program for the last 5 years. You and the members of
your subcommittee have led the way in maintaining it each year, and we
thank you for your leadership.
About 2.5 million people labor in the fields and farms of America,
from Hawaii to Florida and Puerto Rico, from Maine to California.
Estimates are that 85 percent of the fruits and vegetables we eat are
hand harvested by farmworkers. The pay is extremely low: most
farmworkers earn less than $12,000 per year. Few farmworkers receive
the job-related benefits, such as health insurance and sick pay, which
we all take for granted. In most States, agricultural workers are not
even eligible for unemployment compensation. They live a tough life.
Many workers travel hundreds, sometimes thousands of miles in search of
work. They get paid only when they perform the work: if the weather is
bad or the crop is not as plentiful as the farmer had hoped, they
simply do not receive wages. They typically cannot afford decent
housing. Their children have to struggle mightily to even complete
their public school education. The dropout rate for farmworker youth,
especially those who migrate with their parents, is enormous.
For over 33 years the Federal Government has made and kept a
commitment to these hardworking people. Special Federal programs were
created to recognize the reality that farmworkers often cross State
lines to work and live. Thus, we have migrant head start, migrant
health, migrant education, and the job training effort called the
National Farmworker Jobs Program. These all are federally funded and
have guidelines that acknowledge that Governors should not be placed in
a position of deciding whether or not agricultural workers qualify for
these services under State residency or other localized requirements.
Today, I want to explain the way some of our program operators and
staff members helped farmworkers and other rural poor people during the
aftermath of the hurricanes of 2005.
When the winds and rains of Hurricanes Katrina and Rita ravaged the
gulf States many impoverished groups suffered. Among the hardest hit
were the area's migrant and seasonal farmworkers. Thousands lost their
jobs and many saw their homes damaged or destroyed. With incomes
typically far below the poverty line, most farmworkers have no safety
cushion when disaster strikes. To make matters worse, language barriers
and cultural isolation often prevent them from accessing emergency
services delivered by mainstream providers.
It is hard to picture the severe hardships created by the
hurricanes. Potable water could not be obtained, food and fuel were
unavailable, and electricity and telephone services interrupted. These
deprivations continued for weeks. For many, the migrant and seasonal
farmworker job-training agencies provided the only relief.
It must be noted that the four agencies mentioned below can only
use Federal migrant and seasonal farmworker job training and assistance
funds for eligible farmworkers and their dependents. The head of
household must demonstrate eligibility, which includes proof of work
authorization or citizenship and evidence of a recent history of
performing farmwork. For those ineligible for Federal services, the
agencies found other resources. The 167 WIA agencies in the four
States are funded solely through the DOL job training grants for
farmworkers. Without Congress's 2005 appropriation for migrant and
seasonal farmworker job training, those agencies' doors would have been
closed and none of the assistance described below would have happened.
Here is a summary of the 167 agencies' relief activities:
louisiana
Motivation, Education and Training, Inc. of Louisiana (MET) is the
167 agency in that State. MET was on the ground in the Hammond, LA area
a few days after the storm hit. That area had no electric power, or
telephone service, gasoline, or clean water. MET set up an intake
center in a trailer, powered by a generator. Staff provided emergency
services to people who could not be reached by FEMA. Red Cross trucks
brought water and ice. MET provided vouchers for food, clothing, rent
and other items to over 300 families (made up of over 1,200 people) who
otherwise might have starved or been rendered homeless. While much of
the community infrastructure, was poorly supplied, the local Wal-Mart
was well prepared for the needs of people affected by the storm, and
MET worked out arrangements for the vouchers to be used there. The
average voucher was about $370 per family. They continue to serve
eligible families months after the storm. These vouchers are funded
through the 167 program.
Ineligible families are referred to the Quad Area Community Action
Agency, which issues commodities and other goods.
mississippi
The Mississippi Delta Council for Farmworker Opportunities (MDC)
was one of the few statewide nonprofit organizations to have a nearly
intact network following the hurricane. Headquartered in Clarksdale,
MDC gave out vouchers and other help to hundreds of seasonal as well as
migrant farmworkers. Vouchers were issued to 330 eligible farmworkers
and families, and commodities and other supplies were given to 331
other people. Vouchers were provided through 167 WIA program funds.
The commodity donations were made possible through the efforts of
the 167 WIA agency in Tucson, Arizona: Portable Practical Educational
Programs (PPEP). PPEP gathered its own resources, those from the League
of United Latin American Citizens, and from World Care. PPEP led two
caravans consisting of a total of 14 trucks loaded with relief supplies
making the 1,200-mile journey from Tucson to Clarksdale. MDC located a
warehouse in Clarksdale, and the supplies continue to be distributed
from there to farmworkers and other rural poor families throughout
affected counties and in places where evacuees from the Gulf Coast and
the New Orleans area are sited. MDC is also shipping supplies to their
colleagues at Telamon Alabama for use in the Mobile area. As in
Louisiana, the people they are serving are mostly outside any area of
help provided by FEMA or the Red Cross.
MDC is currently assessing farmworker needs in the counties of
Scott, Simpson, Smith, Forrest, Greene, and George. There appears to be
a tremendous need for housing for farmworkers whose homes were
devastated by the storms.
alabama
Telamon Alabama is the 167 WIA agency in that State. It has
provided direct voucher services to at least 25 farmworker families
dislocated by the storm, primarily in Baldwin County. They have
assisted about 200 others. Very little presence of FEMA or the Red
Cross is reported for the farmworker areas of that county. A particular
problem is that the fishing industry on the coast was devastated.
Shrimp harvesting businesses operated by Vietnamese immigrants and
others were virtually wiped out by the storm. Telamon is limited by the
amount of help it can provide in two ways: its 167 WIA grant is about
half that of Mississippi and considerably less than Louisiana's. In
addition, there are large numbers of undocumented farmworkers, and
there are few resources for referral for them. Telamon is providing as
many persons as they can with commodities that have been shipped in
from Arizona.
florida
The counties in which farmworkers were most affected were not
declared disaster areas. That restricted FEMA's involvement. The
Florida Department of Education's Adult Migrant Programs (FDOE)
operates the farmworker job-training program in Florida. FDOE funds a
number of sites with 167 WIA subgrants. Those sites have assisted
over 400 farmworkers and their families, primarily obtaining resources
from the United Way agencies that use Community Services Block Grant
funds. A number of private funds were set up in the aftermath of the
2004 hurricanes, and these funds were used to alleviate suffering from
these storms. The 400 farmworkers they have already assisted were
working in nurseries that were wiped out by the storm. However, the
avocado orchards that were to be harvested were severely damaged, and
the planting season that farmworkers rely upon in late fall were
delayed because of the wet conditions.
summary
In Alabama, Louisiana, and Mississippi, the agencies that operate
the programs funded under 167 of the WIA served as primary relief
sources for migrant and seasonal farmworkers and their families in the
wake of Hurricanes Katrina and Rita. At least 1,800 farmworkers and
family members have received emergency services to date, either in the
form of vouchers or relief supplies. Hundreds of other people in those
States and in Florida were referred to agencies funded to help storm
victims. There are medium- and long-term problems that farmworkers will
experience that are not yet fully known. Much farm labor housing in
Mississippi and Alabama has been destroyed, and future prospects for
employment in agriculture are unclear.
It is crucial that these four organizations were in place when the
rural poor of the affected areas needed them. Had the funding for these
organizations ceased in 2005 as the Department of Labor recommended,
thousands of hard-working, low-paid farmworkers and their families
would face life-threatening deprivations. And the growers and farmers
that rely on them would be facing a much more uncertain future as they
try to rebuild their agricultural enterprises. Fortunately, despite
DOL's attempts to eliminate this program since 2002, Members of
Congress have had the foresight to sustain the migrant and seasonal
job-training program.
Without these grants, who would be there to serve the working poor
in rural Louisiana, Mississippi, Alabama, and Florida during this
terrible time?
______
Prepared Statement of the Central Valley Opportunity Center
Chairman Specter, and other members of the subcommittee, my name is
Ernie Flores and I am the executive director of Central Valley
Opportunity Center (CVOC). CVOC is the DOL WIA Title I Section 167
grantee, and also a Community Action Agency, in Madera, Merced and
Stanislaus counties in the central San Joaquin Valley of California. At
this time I submit my testimony for your consideration and in support
of continued funding for the WIA 167 program, operated as the National
Farmworker Jobs Program (NFJP) in the DOL. As you are aware, for the
past 5 years, the President's budget, and the DOL, have proposed to
eliminate the funding for NFJP. If this were to happen, it would
effectively end vital employment and training services, job
stabilization services, and various educational services that migrant
and seasonal farm workers require to either continue working in
agriculture, or to transition into year round employment outside of
agriculture. It should also be mentioned that the funding for the
entire NFJP program is approximately $80 million. Unfortunately, this
amount of funding only allows us to serve 3-5 percent of the eligible
farmworkers in need of our services.
Although the U.S. DOL has testified that farm workers could be
served through the local One-Stop Centers, all partners in the One Stop
system, including the One Stop operators and the 167 grantee One Stop
partners, are in agreement that the One Stop system is not prepared to
served farmworkers. The majority of farm workers have limited English
proficiency, possess very little formal education and generally have
very few marketable job skills. The only jobs program that is prepared
to help farm workers overcome those types of barriers, and become or
continue to be gainfully employed, is the WIA 167 NFJP.
The U.S. DOL has also testified before Congress that the NFJP is
ineffective and duplicates the work of other job training programs. As
to effectiveness, the DOL's own internal performance reports document
that the NFJP has attained the highest performance ratings, for all WIA
employment programs in the areas of entered employment, wage gains, and
retention in employment, during the past 4 quarters. As for
duplication, the NFJP generally serves over 95 percent of all migrant
and seasonal Farmworkers that are enrolled in any WIA programs during
any 12 month program period. Any Farmworkers that are enrolled in other
WIA programs are most likely co-enrolled into a NFJP WIA 167 program
also.
For the past 27 years CVOC has provided various employment,
training and social service programs to migrant and seasonal farm
workers and other low income persons in our three county service area
in Central California. As is the case with all NFJP grantees, our field
offices are easily accessible to Farmworkers since they are located in
their communities. CVOC offers the following services under the NFJP
grant:
employment and training
--Outreach, assessment and enrollment
--Case management/vocational guidance
--Vocational training
--Welding
--Auto Mechanics
--Cooking/Food preparation
--General/Advance Business Occupations
--Cashiering/Merchandising
--Commercial Drivers License
--English As a Second Language classes
--General Equivalency Diploma classes
--Supportive Services (child care, gas, food, housing)
--Job Readiness Training
--On the Job Training
--Direct Job Placement
--Indirect Job Placement
--Active follow-up services
--Retraining services
In addition to these services, CVOC has leveraged resources with
the help of the NFJP grant in order to provide farm workers with
services such as energy payment assistance, emergency housing, food
vouchers, medical & dental services and various other social services.
In should be understood that there are no other programs in the WIA
system that are prepared to meet the employment and training needs of
migrant and seasonal farmworkers except for programs like CVOC, and the
other grantees of the WIA NFJP. If these programs cease to operate as a
nationally administered program, and funding is seriously cut or
eliminated, there will literally be no employment and training services
for migrant and seasonal farm workers.
I sincerely implore you to continue the funding for the WIA 167
NFJP so that together we can continue to do for the least of our
brothers. So that farmworkers can also reap the harvest of the American
dream.
At this time I would like to share some of our ``success stories.''
The stories clearly show how the lives of farmworkers, or their
dependents, are forever changed for the better when they receive
services from the National Farmworkers Jobs Programs grantees.
Thank You.
Isaura Gonzalez
Before coming to CVOC, Isaura Gonzalez was a seasonal cannery
worker at Michael Angelo Gourmet, where she was making $9.50/hr. This
wage was not too bad considering she dropped out of school in the
seventh grade. However, this was a temporary job and offered no
benefits. Isaura came to CVOC with a dream. She wanted to obtain her
General Education Diploma (GED) and find a year-round job with fringe
benefits. Six months later, all her dreams became true! Isaura
successfully completed the CVOC 22-week General Business Occupations
course a month early and obtained her GED with an amazing score of
2,910. This score is the highest ever in CVOC's history! She is now
working for Hilmar Cheese Company as a Data Entry/Machine Operator
Manager making $14.95/hr. She has fringe benefits and a year-round job.
Recently, during her first quarter follow-up she said she was expecting
a raise soon.
Juan Hernandez
He had just graduated from high school when he came to CVOC to
register for the welding program in October of 2004. He was 18 years
old, the dependent of a farm worker. He was very eager to learn welding
because his uncle is a welder so he wanted to follow his uncle's
footsteps. While he was in training, he was very punctual and the
instructor was very happy to see how well he did and how eager he was
to learn. After completing training, the Job Developer placed him as a
welder at Gladden Equipment Erectors. His starting pay was $10.50 per
hour and soon after, he began to travel to different States to work for
the company. He sometimes spends a month traveling with the company.
Today, he still works for the same company and earns $14.00 per hour.
Hugo Sanchez
Hugo had not graduated from high school when he came to CVOC to
register for the Cashiering Program in March 2004. He was hoping to
obtain his GED, enroll in ESL classes, and obtain a Vocational Training
Certificate. While he was attending classroom training, he found the
cashiering class was too easy for him so he decided to transfer to
General Business Occupations (GBO) training. While in training, he
obtained his GED, improved his English skills, and completed GBO
training. After completing training, he started working as a temporary
data entry teller at E & J Gallo Winery in August of 2004 earning
$11.14 per hour. Since this job was temporary, he found another job. In
November 2004, he started working at Foster Farms Dairy where he
started earning $12.83 per hour. He continues to work for them and now
earns $16.97 per hour. In May 2006 he will be making $18.90 per hour as
the CAT supervisor
Julian Diaz
Before Julian Diaz came to CVOC, he was working as a farm worker
and at Wal-Mart. Julian was living with his parents in Modesto Housing
Authority's Public Housing. He wanted to become a welder and he
discovered that CVOC offered this training. He saw the CVOC ad in the
Modesto Bee and he decided to call. Julian began his 22-week training
in welding in September of 2005. He completed his training on February
24, 2006. Even though he finished all his exams in January, Julian
decided to stay until February to gain more skills. He was a great
student and attended class every day. His instructor was very pleased
with his hard work. The instructor even helped him find work.
Julian is now working as a welder at West-Mark in Atwater making
$11.00 per hour. He will soon be receiving health benefits and 401k.
Julian has achieved all the goals he hoped to achieve and is very happy
that he chose CVOC for his training. Julian even went as far as calling
the welding instructor in tears on his first day of work to express his
gratitude for the training, job skills, tools, and the opportunity that
was given to him.
______
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Prepared Statement of the AIDS Institute
The AIDS Institute, a national public policy research, advocacy,
and education organization, is pleased to submit written comments to
you in support of a number of critical HIV/AIDS and Hepatitis programs
as part of the fiscal year 2007 Labor, Health, and Education and
Related Services appropriation measure. We thank you for your
consistent support of these programs over the years, and trust you will
do your best to adequately fund them in the future in order to provide
for, and protect the health of, many Americans.
hiv/aids
HIV/AIDS remains one of the world's worst health pandemics in the
history of civilization. Worldwide, some 40 million people are infected
with this incurable infectious disease, and 14,000 new infections occur
each passing day. Tragically, AIDS has already claimed the lives of 25
million people. Here in the United States, according to the CDC,
944,305 people have been diagnosed with AIDS, and over 529,000 people
have died through 2004. It is estimated there are more than 40,000 new
infections in the United States each year. At the end of 2003, an
estimated 1,039,000 to 1,185,000 persons in the United States were
living with HIV/AIDS.
Persons of minority races and ethnicities are disproportionately
affected by HIV/AIDS. In 2003, African Americans, who make up
approximately 12 percent of the U.S. population, accounted for half of
the HIV/AIDS cases diagnosed. HIV/AIDS also disproportionately affects
the poor, and about 70 percent of those infected rely on public health
care financing.
The U.S. Government has played a leading role in fighting the AIDS
epidemic, both at home and abroad. The vast majority of the
discretionary programs supporting HIV/AIDS efforts domestically and a
portion of our Nation's contribution to the global AIDS effort are
funded through your subcommittee. The AIDS Institute, working in
coalition with other AIDS organizations, have developed realistic and
practical funding request numbers for each of these domestic and global
AIDS programs. The AIDS Institute asks that you do your best to
adequately fund these programs at the requested level.
We are keenly aware of the current budget constraints and competing
interests for limited Federal dollars. Unfortunately, despite the
growing need, almost all domestic HIV/AIDS programs in recent years
have experienced funding decreases.
This year, the President has proposed three new domestic HIV/AIDS
initiatives by providing $70 million for getting prescription drugs to
those who need them; $90 million for testing those who do not yet know
their status; and $25 million to help raise the awareness of those who
do not know they should be tested. The AIDS Institute applauds these
initiatives and encourages the subcommittee to fund these increases.
RYAN WHITE CARE ACT
[In millions of dollars]
------------------------------------------------------------------------
Fiscal year Amount
------------------------------------------------------------------------
2005....................................................... 2,048
2006....................................................... 2,038
2007 President's request................................... 2,133
2007 community request..................................... 2,631
------------------------------------------------------------------------
The centerpiece of the Federal Government's response to caring and
treating low-income individuals with HIV/AIDS are those programs funded
under the Ryan White CARE Act. CARE Act programs currently reach over
571,000 low-income, uninsured, and underinsured people each year, most
of who are from a racial or ethnic minority group. The majority of CARE
Act funds support primary medical care and essential support services.
Providing care and treatment for those who have HIV/AIDS is not
only the compassionate thing to do, but it is cost-effective in the
long run, and serves as a tool in prevention of HIV/AIDS.
In recent years, with the exception of minor increases for the AIDS
Drug Assistance Program (ADAP), CARE Act funding has decreased. Because
of across the board recessions, flat funding has actually resulted in
budget cuts for the past several years. We urge you to provide these
vitally important programs with the community requested level of
funding. Consider the following:
(1) The caseload is increasing. People are living longer with HIV/
AIDS due to lifesaving medications; there are 40,000 new infections
each year; and the Federal Government has initiated increased testing
programs to identify positive people-all of which will necessitate the
need for more medical services and medications.
(2) There is a greater financial burden on CARE Act programs. The
price of healthcare, including medications, is increasing; non-profit
organizations are struggling; Medicaid benefits are being scaled-back
at the State level and significant Medicaid reductions recently passed
the Congress.
(3) Level or decreased funding for the CARE Act is impacting State
and local governments grant awards. Because of reduced funding levels,
34 out of the 51 largest cities affected by HIV/AIDS experienced cuts
to their Title I awards this year. This is after 18 cities experienced
cuts last year. Additionally, 41 States and territories received less
money last year in their Title II base awards.
(4) ADAP funding shortfalls are causing States to place clients on
waiting lists, limiting drug formularies, and increasing eligibility
requirements. In February 2006, nine States reported having waiting
lists, totaling 791 people. Several ADAPs reported other cost
containment measures, including formulary reductions (4), eligibility
restrictions (2) and limiting annual client expenditures (2). Due to
the small increase the ADAP program was given last year, additional
severe restrictions are anticipated in many additional States across
the country.
(5) Two recent reports conclude there are a staggering number of
people in the United States who are not receiving life-saving AIDS
medications. The Institute of Medicine report ``Public Financing and
Delivery of HIV/AIDS Care, Securing the Legacy of Ryan White''
concluded that 233,069 people in the United States who know their HIV
status do not have continuous access to Highly Active Antiretroviral
Therapy (HAART). A study by the CDC titled, ``Estimated number of HIV-
infected persons eligible for and receiving antiretroviral therapy,
2003--United States'', reached similar conclusions. According to CDC's
estimates, 212,000, or 44 percent of eligible people living with HIV/
AIDS, aged 15-49 in the United States, are not receiving antiretroviral
therapy. The report concludes, ``there is a substantial unmet health
care need for antiretroviral therapy among HIV-infected persons in
care.''
This is a travesty in our own country. As we seek to provide
lifesaving medications to those abroad, we must ensure we are providing
medications to our own here in the United States.
Fiscal Year 2007 Administration Initiative.--The AIDS Institute is
in strong support of President Bush's proposed increase of $70 million
for ``States in need to bridge the existing gaps in coverage for
Americans waiting for life-saving medications. These funds would help
the States end current waiting lists and help support care for
additional patients.'' Since ADAP only received a funding increase of
$2 million in fiscal year 2006 and the need number for fiscal year 2007
is $197 million, the $70 million increase, while certainly not enough,
is a welcome increase. We urge the Committee to approve this long
overdue increase.
Additionally, President Bush proposed an increase of additional $25
million Title III Ryan White CARE Act funding ``to significantly
strengthen outreach by local community and faith-based organizations in
hardest hit areas. These grants would help raise awareness, increase
early detection, combat stigma, and facilitate access to treatment,
especially for African-American, Hispanic, Native American, and other
minority community groups whose need is often greatest.'' This
additional funding is also extremely worthy of funding, and the
administration should be commended for its proposal.
The AIDS Institute supports continued and increased funding for the
Minority HIV/AIDS Initiative (MHAI). MHAI funds services nationwide
that address the disproportionate impact that HIV has on communities of
color.
CENTERS FOR DISEASE CONTROL AND PREVENTION--HIV PREVENTION AND
SURVEILLANCE
[In millions of dollars]
------------------------------------------------------------------------
Fiscal year Amount
------------------------------------------------------------------------
2005....................................................... 662
2006....................................................... 651
2007 President's request................................... 740
2007 community request..................................... 1,049
------------------------------------------------------------------------
While the number of new HIV infections in the United States has
greatly decreased since the 1980's, there are still an estimated 40,000
new infections each year. Since AIDS is a preventable disease, these
are 40,000 new infections annually that could have been prevented.
Leading the Federal Government's campaign in AIDS prevention is the
CDC. As with other domestic AIDS programs, funding is severely lagging,
and the CDC is being asked to do more with fewer and fewer dollars. In
fact, CDC's AIDS funding has declined in the last 4 years in a row. It
is not surprising given the budget decreases, the administration's goal
of reducing the infection rate in half by 2005 did not occur.
Fiscal Year 2007 Administration Initiative.--The AIDS Institute is
in strong support of President Bush's proposed increase of $90 million
``to the purchase and distribution of rapid HIV test kits, facilitating
the testing of more than 3 million additional Americans. Test kits
would be distributed in areas of the country with the highest rates of
newly discovered HIV cases, and the highest suspected rates of
undetected cases.'' A large portion of the funds would be used for the
testing of prisoners and intravenous drug users, two groups with
extremely high levels of infections. Knowledge of one's HIV status,
particularly for high risk individuals, is an effective prevention
tool. Approximately one quarter of the over 1 million people living
with HIV in the United States (252,000 to 312,000 persons) are unaware
of their HIV status. This initiative, if funded by the Congress, should
help prevent future infections and bring additional people into
lifesaving treatment and care. The AIDS Institute urges the Committee
to fund this extremely worthy program.
While The AIDS Institute supports increased testing programs, we do
not support funding those efforts at the expense of prevention
intervention programs. Funding for these programs are already under
funded.
We are pleased to hear that the new leadership of CDC's HIV
prevention programs has pledged to make the CDC budget more
transparent, and will better detail where the funds are being spent,
and on what populations and programs. For far too long, this
information has not been made available.
Efforts to improve prevention methods and weed out non-effective
programs should be a constant undertaking and be guided by science and
fact based decision-making. It is for these reasons that The AIDS
Institute opposes funding of abstinence-only until marriage programs,
for which the President requested a $27 million increase. While we
support abstinence-based prevention programs as part of a comprehensive
prevention message, there is no scientific proof that abstinence-only
programs work. On the contrary, they reject proven prevention tools,
such as condoms, and fail to address the needs of homosexuals, who can
not marry, and who remain greatly impacted by HIV/AIDS. Given that
approximately one-half of all new infections in the United States are
among those under the age of 25, it is essential that our youth be
given the proper tools to prevent HIV infection.
NATIONAL INSTITUTES OF HEALTH-AIDS RESEARCH
[In million of dollars]
------------------------------------------------------------------------
Fiscal year Amount
------------------------------------------------------------------------
2005....................................................... 2,921
2006....................................................... 2,903
2007 President's request................................... 2,888
2007 community request..................................... 3,000
------------------------------------------------------------------------
Through the NIH, research is conducted to: understand the AIDS
virus and its complicated mutations; discover new drug treatments;
develop a vaccine and other prevention programs such as microbicides;
and ultimately, a cure. Much of this work at the NIH is done in
cooperation with private funding and ingenuity. The critically
important work performed by the NIH not only benefits those in the
United States, but the entire world.
This research has already helped in the development of many highly
effective new drug treatments, prolonging the lives of millions of
people. Undoubtedly, the commitment of the Congress and the
administration to double NIH funding over the past 5 years has led to
great advances. As neither a cure nor a vaccine exists, and patients
continue to build resistance to existing medications, additional
research in cooperation with private interests must continue. We are
disappointed the President's budget is proposing a decrease of $15
million in AIDS research for fiscal year 2007. We ask the Committee to
fund NIH, including critical AIDS research, at the community requested
level of $30 billion.
Substance Abuse and Mental Health Services Administration
It is widely known that many persons infected with HIV also
experience drug abuse and/or mental health problems, and require the
programs funded by SAMHSA. Given the growing need for services, we are
disappointed that overall funding requested for SAMHSA is down by $71
million, and the Center for Substance Abuse Treatment is being cut by
$24 million, the Center for Substance Abuse Prevention is cut by $12
million, and the Center for Mental Health Services is cut by $35
million. We ask the Committee to reject these cuts, and adequately fund
these programs.
viral hepatitis
Viral Hepatitis, whether A, B, or C, are infectious diseases that
also deserve special attention by the Federal Government and the
subcommittee. According to the CDC, there are an estimated 1.25 million
Americans chronically infected with Hepatitis B, and 73,000 new
infections each year. Although there is no cure, a vaccine has been
available since 1982, and there are a few treatment options available.
An estimated 3.9 million (1.8 percent) Americans have been infected
with Hepatitis C, of whom 2.7 million are chronically infected.
Currently, there is no vaccine or cure, and very few treatment options
available. It is believed that one-third of those infected with HIV are
co-infected with Hepatitis C.
Given these numbers, we are disappointed that the administration is
proposing to cut the 317 Immunization Grant Program funds that serve as
the major source in the public sector for at-risk adult immunizations.
Instead of facing cuts, since the vaccines are relatively inexpensive,
this cost-effective program should be significantly enhanced in order
to protect people from Hepatitis A and B. We recommend funding the 317
Program at $800 million for fiscal year 2007 in order to fully realize
the public health benefits of immunization.
The administration is also calling for decreased funding for Viral
Hepatitis at the CDC. The program is currently funded at a level less
than it was in fiscal year 2003, and falls way short of the $50 million
that is needed. These funds are needed to establish a program to lower
the incidence of Hepatitis C through education, outreach, and
surveillance, and to support such initiatives as the CDC National
Hepatitis C Prevention Strategy and the 2002 NIH Consensus Statement on
the Management of Hepatitis C and accompanying recommendations.
The AIDS Institute asks that you give great weight to our testimony
and remember it as you deliberate over the fiscal year 2007
appropriation bill. Should you have any questions or comments, feel
free to contact Carl Schmid, Director of Federal Affairs, The AIDS
Institute (202) 462-3042 or cschmid@theaidsinstitute.org. Thank you
very much.
______
Prepared Statement of the American Academy of Family Physicians
The 94,000-member American Academy of Family Physicians submits
this statement for the record to the Senate Appropriations Subcommittee
on Labor/Health and Human Services, Education and Related Agencies. Our
statement is made in support of the Section 747 Primary Care Medicine
and Dentistry Cluster. The Academy also supports the Agency for
Healthcare Research and Quality (AHRQ) and rural health programs.
brief background: training family physicians
Section 747 within the Public Health Service Act is the only
Federal program that funds training for family physicians. The law
requires the program to meet two goals: (1) increase the number of
primary care physicians (family physicians, general internists and
general pediatricians) and (2) boost the number of people to provide
care to the underserved. Regarding family medicine specifically,
Section 747 offers competitive grants for training programs in medical
school and in residency programs.
The fiscal year 2006 spending bill provided $41 million to Section
747, a figure that was a significant cut from the $88.8 million the
cluster received in fiscal year 2005. And, unfortunately, the
President's fiscal year 2007 budget proposed zero dollars for the
program. We urge Congress to fund Section 747 at fiscal year 2005
levels ($88.8 million).
who are family physicians?
Family physicians are the specialists trained to provide
comprehensive, coordinated and continuing care to patients of both
genders and all ages and ethnicities, regardless of medical condition.
These residency-trained, primary care physicians treat babies with ear
infections, adolescents who are obese, adults with depression and
seniors with multiple, chronic illnesses. And because they focus on
prevention, primary care, and integrating care for their patients, they
are able to treat illnesses early and cost-effectively. In addition,
when necessary, family physicians help patients navigate our complex
health system and find the right subspecialists. Finally, family
physicians are distributed throughout the country in approximately the
same proportion as the population: about one-quarter of all Americans
live in rural areas and about 25 percent of family physicians practice
there, as well.
community health centers: understaffed with shortages of family
physicians
Over the last few years, the administration has made increasing the
number of Community Health Centers (CHCs) a priority within its health
care budget. Specifically, the President's fiscal year 2007 blueprint
recommends an increase of $181 million for CHCs, which would increase
funding to nearly $2 billion. These dollars would complete the
administration's goal to create 1,200 health center sites around the
Nation. While a laudable objective, this funding does not take into
account staffing issues at these centers; the CHC dollars go primarily
to so-called ``bricks and mortar,'' i.e., construction of the health
care clinics.
The additional funding recommended in the President's budget to
build Community Health Centers, and the zero dollars proposed to train
family physicians under Section 747, are a serious disconnect: primary
care physicians make up nearly 90 percent of doctors working in CHCs--
and most are family physicians. In short, without more family
physicians, no one will be available to staff these new centers.
This point was brought home in a March 1, 2006 article in the
Journal of the American Medical Association (JAMA). The authors found
that in 2004, CHCs were understaffed and could not fill all clinical
positions (Rosenblatt, et al.). Rural health centers had more openings
that took longer to fill than those in urban areas. More alarmingly,
over 13 percent of family physician positions at CHCs were vacant.
As the only Federal program that trains family physicians, funding
for Section 747 is critical. Without Section 747 to train family
physicians, CHCs staffing problems will get worse.
section 747 produces doctors who work in chcs and serve in the nhsc
A second study buttresses the importance of family physicians to
CHCs and to the National Health Service Corps, which is another
administration priority. An unpublished 2006 study from the University
of California, San Francisco and the Robert Graham Center for Policy
Studies in Family Medicine and Primary Care shows that medical schools
that receive Section 747 dollars produce physicians who work in CHCs
and serve in the National Health Service Corps compared to schools
without this funding.
The finding is particularly true for family physicians.
Specifically, according to the study, nearly 4,000 family physicians
and general practitioners were exposed to Title VII funding during
medical school and subsequently chose to work in a CHC. Without this
exposure, at least 750 fewer family physicians would have been working
in a CHC in 2003. Coupled with the JAMA article, which shows that there
are 600 vacancies for family physicians, without Section 747 funding,
there would be twice as many vacancies in health centers.
lower health care costs and improved quality
Section 747 plays a role in lowering our Nation's health care costs
and increasing the quality of U.S. health care. For example, an article
in Health Affairs (April 2004) demonstrated that States that spent more
on Medicare had lower quality of care. While seemingly
counterintuitive, the authors found two reasons for this result.
The first reason was that expensive health care did not improve
patient satisfaction or outcomes. The second reason was that the makeup
of the health care workforce made a difference: more primary care
doctors in a State meant higher quality care and lower cost. In
contrast, more specialists and fewer generalists led to lower quality
and higher costs. And, just a small increase in the number of primary
care doctors in a State was associated with a large boost in that
State's quality ranking.
The first reason was that expensive health care did not improve
patient satisfaction or outcomes. The second reason was that the makeup
of the health care workforce made a difference: more primary care
doctors in a State meant higher quality care and lower cost. In
contrast, more specialists and fewer generalists led to lower quality
and higher costs. And, just a small increase in the number of primary
care doctors in a State was associated with a large boost in that
State's quality ranking.
An article in a March 2005 edition of Health Affairs, ``The Effects
of Specialist Supply on Populations' Health: Assessing the Evidence''
went even further. This piece stated that there was a ``negative
relationship between the supply of primary care physicians and death
from stroke, infant mortality and low-birthweight, and all-cause
mortality.'' The article went on to say that just one more primary care
physician per 10,000 people was associated with a decrease of 34.6
deaths per 100,000 people.
The article also cited breast cancer research for the State of
Florida, which indicated that ``each tenth-percentile increase in
primary care physician supply is associated with a statistically
significant 4 percent increase in odds of early-stage breast cancer.''
Statistics were similar for other types of cancers: there was a
relationship between early identification of cancer and the supply of
primary care physicians. Numerous other research was highlighted in the
Health Affairs article that indicated a higher ratio of primary care
physicians to populations led to better health outcomes. These data
support the need for additional funding for Section 747, the only
Federal program that produces primary care physicians.
the overspecialized u.s. physician workforce: a world anomaly
Unlike all other developed countries, the United States does not
have a primary care-based health care system. While other developed
countries have about equal numbers of primary care physicians and
subspecialists, in the United States, less than one-third of the
physician workforce is primary care.
More disturbingly, compared to developed countries, the United
States spends the most per capita on healthcare--but has some of the
worst healthcare outcomes. More than 20 years of evidence have shown
that a health system based on primary care produces greater health and
economic benefits. Boosting support for Section 747, which funds
training for family physicians and for other primary care disciplines,
could improve the health of patients in the United States.
agency for healthcare, research and quality
The Academy recommends $440 million for the Agency for Healthcare,
Research and Quality (AHRQ). A major purpose of AHRQ is to conduct
primary care and health services research geared to physician
practices, health plans and policymakers. What this means is that the
agency translates research findings from basic science entities like
the National Institutes of Health (NIH) into information that doctors
can use every day in their practices. Another key function of the
agency is to support research on the conditions that affect most
Americans.
More recently, AHRQ has become the lead Federal agency for research
on comparative clinical effectiveness; information technology; and
patient safety. For example, the Medicare Modernization Act asked AHRQ
to study the ``clinical effectiveness and appropriateness of specified
health services and treatments,'' and to use this information to
improve the quality and effectiveness of the costly Medicare, Medicaid
and SCHIP programs. In fiscal year 2006, $15 million was appropriated
by Congress for this purpose. This type of study on ``what works'' in
clinical therapies is crucial in an era of skyrocketing health care
costs and limited Federal dollars.
Historically, however, AHRQ has been the lead agency to translate
research into information for physicians and patients. Over the years,
Congress has provided billions of dollars to the National Institutes of
Health, which has resulted in important insights in preventing and
curing major diseases. However, AHRQ's role has been to take this basic
science and produce understandable, practical materials for the entire
healthcare system. In short, AHRQ is the link between research and the
patient care that Americans receive.
In addition, AHRQ has long-supported research on conditions that
affect most people. Most Americans get their medical care in doctors'
offices and clinics. However, most medical research comes from the
study of extremely ill patients in hospitals. AHRQ studies and supports
research on the types of illness that trouble most people. In brief,
AHRQ looks at the problems that bring people to their doctors every
day--not the problems that send them to the hospital.
rural health programs
Continued funding for rural programs is vital to provide adequate
health care services to America's rural citizens. We support the
Federal Office of Rural Health Policy; Area Health Education Centers;
the Community and Migrant Health Center Program; and the NHSC. State
rural health offices, funded through the National Health Services Corps
budget, help States implement these programs so that rural residents
benefit as much as urban patients.
conclusion
The Academy urges Congress to fund Section 747 at fiscal year 2005
levels ($88.8 million). We believe that the two recent studies showing
that Community Health Centers not only rely heavily on family
physicians, but cannot fill all of their positions, and the data
indicating the crucial role that primary care training plays in whether
physicians practice in CHCs or serve in the NHSC, make an irrefutable
case for funding Section 747. In addition, however, family physicians
are critical to the health and well-being of everyone in the country.
Finally, all of these studies, authored by different researchers, are
consistent: Section 747 works.
The AAFP also urges Congress to fund the Agency for Healthcare
Research and Quality at $440 million; and support rural health
programs. We thank you in advance for making these investments in
America's healthcare system.
______
Prepared Statement of the American Academy of Pediatrics
There can be no denying that there have been numerous and
significant successes in improving the health and well-being of
America's children and adolescents, from even just decades ago. Infant
and child mortality rates have been radically lowered. The number of 2-
year-olds who have received the recommended series of immunizations is
at an all-time high, while vaccine-preventable diseases such as
measles, pertussis, and diphtheria have decreased by over 98 percent
Teen pregnancy rates have declined by 27 percent over the last decade.
Still, despite these successes, far too many children in America
continue to suffer from disease, injury, abuse, racial and ethnic
health disparities, or lack of access to quality care. And more than 9
million children and adolescents through age 18 remain uninsured.
Clearly there remains much work to do.
As clinicians we not only diagnose and treat our patients, we must
also promote strong preventive interventions to improve the overall
health and well-being of all infants, children, adolescents and young
adults. Likewise, as policy-makers, you have an integral role to play
in improving the health of the next generation through adequate and
sustained funding of vital Federal programs.
The AAP, SAM and APA have identified three key priorities within
this Committee's jurisdiction that are at the heart of improving the
health and well-being of America's children and adolescents: access to
health care, quality of health care, and immunizations.
access
We believe that all children and adolescents should have full
access to comprehensive, age-appropriate, quality health care. From the
ability to receive primary care from a pediatrician trained in the
unique needs of children and adolescents, to timely access, to
pediatric medical subspecialists and pediatric surgical specialists,
America's children and adolescents deserve access to quality pediatric
care in a medical home. Given the recent cuts to the Medicaid program
and fiscal belt-tightening in the States, discretionary programs now
more than ever provide a vital health care safety net for America's
most vulnerable children and adolescents.
Maternal and Child Health Block Grant.--The Maternal and Child
Health (MCH) Block Grant Program at the Health Resources and Services
Administration (HRSA) is the only Federal program exclusively dedicated
to improving the health of all mothers and children. Nationwide, the
MCH Block Grant Program provides preventive and primary care services
to over 32 million women, infants, children, adolescents and children
with special health care needs. In addition, the MCH Block Grant
Program supports community programs around the country in their efforts
to reduce infant mortality, prevent injury and violence, expand access
to oral health care, and address racial and ethnic health disparities.
Moreover, the MCH Block Grant Program includes efforts dedicated to
addressing interdisciplinary training, services and research for
adolescents' physical and mental health care needs, and supports
programs for vulnerable adolescent populations, including health care
initiatives for incarcerated and minority adolescents, and violence and
suicide prevention. It also plays an important role in the
implementation of the State Children's Health Insurance Program
(SCHIP), which is critically important at a time when States are
struggling with ongoing deficits and shifting costs. One of the many
successful MCH Block Grant programs is the Healthy Tomorrows
Partnership for Children Program, a public/private collaboration
between the MCH Bureau and the American Academy of Pediatrics.
Established in 1989, Healthy Tomorrows has supported over 140 family-
centered, community-based initiatives in 44 States, including Ohio,
Wisconsin, Texas, California, Kentucky, Rhode Island, and Maryland.
These initiatives have addressed issues such as access to oral and
mental health care, abstinence, injury prevention, and enhanced
clinical services for chronic conditions such as asthma. To continue to
foster these and other community-based solutions for local health
problems, in fiscal year 2007 we strongly support an increase in
funding for the MCH Block Grant Program to $724 million.
Family Planning Services.--The family planning program, Title X of
the Public Health Services Act, ensures that all teens have
confidential access to valuable family planning resources. For every
dollar spent on family planning through Title X, $3 is saved in
pregnancy-related and newborn care costs to Medicaid. Title X--which
does not provide funding for abortion services--provides critically
needed preventive care services like pap tests, breast exams, and STI
tests to millions of adolescents and women. But funding for Title X
continues to fall well below the need. Over 9 million cases of STIs
(almost half the total number) are in 15- to 24-year-olds, and over 30
percent of women will become pregnant at least once before age 20. Teen
pregnancy rates continue to vary over racial and ethnic groups, and
nearly half (48 percent) of all teens say that they want more
information from--and increased access to--sexual health care services.
Responsible sexual decision-making, beginning with abstinence, is the
surest way to protect against sexually transmitted infections and
pregnancy. However, for adolescent patients who are already sexually
active, confidential contraceptive services, screening and prevention
strategies should be available. We therefore support a funding level in
fiscal year 2007 of $375 million for Title X of the Public Health
Service Act.
Mental Health.--It is estimated that over 13 million children and
adolescents have a mental health problem such as depression, ADHD, or
an eating disorder, and for as many as 6 million this problem may be
significant enough to disturb school attendance, interrupt social
interactions, and disrupt family life. Despite these statistics, the
National Institute of Mental Health (NIMH) estimates that 75-80 percent
of these children fail to receive mental health specialty services, due
to stigma and the lack of affordability of care and availability of
specialists. Grants through the Children's Mental Health Services
program have been instrumental in achieving decreased utilization of
inpatient services, improvement in school attendance and lower law
enforcement contact for children and adolescents. We recommend that
$109.7 million be allocated in fiscal year 2007 for the Mental Health
Services for Children program to continue these improvements for
children and adolescents with mental health problems.
Child Abuse and Neglect.--Health care providers play a crucial role
in the prevention, identification, and treatment of child abuse and
neglect. In spite of this fact, few Federal resources are dedicated to
bringing the medical profession into full partnership with law
enforcement, the judiciary, and social workers. We urge the
subcommittee to provide an increase of $10 million in fiscal year 2007
for the Center for Disease Control and Prevention's National Center for
Injury Prevention and Control to establish a network of consortia to
link and leverage health care professionals and resources to address--
and ultimately prevent--child abuse and neglect.
Health Professions Education and Training.--Critical to building a
pediatric workforce to care for tomorrow's children and adolescents are
the Training Grants in Primary Care Medicine and Dentistry, found in
Title VII of the Public Health Service Act. These grants are the only
Federal support targeted to the training of primary care professionals.
They provide funding for innovative pediatric residency training,
faculty development and post-doctoral programs throughout the country.
For example, the Montefiore Medical Center in the South Bronx of New
York City has used Title VII funds to support its Residency Training
Program in Social Pediatrics (RPSP). Initiated in response to local
needs to prepare physicians for the delivery of care to underserved
populations and to practice specifically at Community Health Centers in
the inner-city setting, RPSP simultaneously trains physicians in
neighborhood health centers and in an academic hospital. Since its
inception, RPSP has graduated over one hundred pediatricians, a large
number of whom are women and minority physicians. Additionally, 79
percent of all RPSP graduates report that they currently practice in
community-oriented primary care settings serving predominately poor and
minority inner-city populations. Another 10 percent of RPSP graduates
report that they are involved in professional activities such as health
administration and policy, including directing patient care in
community health centers.
Through the continuing efforts of this subcommittee, Title VII has
provided a vital source of funding for critically important programs
that educate and train tomorrow's generalist pediatricians in a variety
of settings to be culturally competent and to meet the special health
care needs of their communities. We recommend fiscal year 2007 funding
of at least $40 million for General Internal Medicine/General
Pediatrics. We also join with the Health Professions and Nursing
Education Coalition in supporting an appropriation of at least $550
million in total funding for Titles VII and VIII. We applaud the
administration's support for the National Health Service Corps and
Community Health Centers, key components with Title VII to ensuring an
adequate distribution of health care providers across the country; but
we emphasize the need for continued support of the training and
education opportunities through Title VII for health care professionals
who provide care for our Nation's communities.
Independent Children's Teaching Hospitals.--Equally important to
the future of pediatric education and research is the dilemma faced by
independent children's teaching hospitals. In addition to providing
critical care to the Nation's children, independent children's
hospitals play a significant role in training tomorrow's pediatricians
and pediatric subspecialists. Children's hospitals train 30 percent of
all pediatricians, half of all pediatric subspecialists, and the
majority of pediatric researchers. However, children's hospitals
qualify for very limited Medicare support, the primary source of
funding for graduate medical education in other inpatient environments.
As a bipartisan Congress has recognized in the last several years,
equitable funding for Children's Hospitals Graduate Medical Education
(CHGME) is needed to continue the education and research programs in
these child- and adolescent-centered settings. Since 2000, CHGME
hospitals accounted for nearly 87 percent of the growth in pediatric
subspecialty training programs and 68 percent of the growth in
pediatric subspecialty fellows trained. We are extremely disappointed
in the 67 percent reduction in funding for this vital program proposed
by the administration, and join with the National Association of
Children's Hospitals to restore funding of $303 million for the CHGME
program in fiscal year 2007. The support for independent children's
hospitals should not come, however, at the expense of valuable Title
VII and VIII programs, including grant support for primary care
training.
quality
Access to health care is only the first step in protecting the
health of all children and adolescents. We must ensure that the care
provided is of the highest quality. Robust Federal support for the wide
array of quality improvement initiatives, including research, is needed
if this goal is to be achieved.
Emergency Services for Children.--One program that assists local
communities in providing quality care to children in distress is the
Emergency Medical Services for Children (EMSC) grant program. There are
approximately 30 million child and adolescent visits to the Nation's
emergency departments every year. Children under the age of 3 years
account for most of these visits. Up to 20 percent of children needing
emergency care have underlying medical conditions such as asthma,
diabetes, sickle-cell disease, low birthweight, and bronchopulmonary
dysplasia. A CDC report issued in February of 2006 reaffirmed that more
hospitals must be properly equipped and clinicians must be educated and
trained to manage these special health care needs in emergency
situations. In addition, emergency systems must be equipped with the
resources needed to care for this especially vulnerable population. In
order to assist local communities in providing the best emergency care
to children, we once again reject the administration's proposed
elimination of the EMSC program and strongly urge that the EMSC program
be maintained and adequately funded at $25 million in fiscal year 2007.
Agency for Healthcare Research and Quality.--Quality of care rests
on quality research--for new detection methods, new treatments, new
technology and new applications of science. As the lead Federal agency
on quality of care research, the Agency for Healthcare Research and
Quality (AHRQ) provides the scientific basis to improve the quality of
care, supports emerging critical issues in health care delivery and
addresses the particular needs of priority populations, such as
children. Substantial gaps still remain in what we know about health
care needs for children and adolescents and how we can best address
those needs. Children are often excluded from research that could
address these issues. The AAP and endorsing organizations strongly
support AHRQ's objective to encourage researchers to include children
and adolescents as part of their research populations. We also support
increasing AHRQ's efforts to build pediatric health services research
capacity through career and faculty development awards and strong
practice-based research networks. Additionally, AHRQ is focusing on
initiatives in community and rural hospitals to reduce medical errors
and to improve patient safety through innovative use of information
technology--an initiative that we hope would include children's
hospitals as well. Through its research and quality agenda, AHRQ
continues to provide policymakers, health care providers, and patients
with critical information needed to improve health care; therefore, we
join with the Friends of AHRQ to recommend funding of $440 million for
AHRQ in fiscal year 2007.
National Institutes of Health.--Since its inception, the National
Institutes of Health (NIH) has been an integral part of the public
health continuum. NIH serves as a vital component in improving the
Nation's health through research, both on and off the NIH campus, and
in the training of researchers, including pediatric investigators. Over
the years, NIH has made dramatic strides that directly impact the
quality of life for infants, children and adolescents through
biomedical and behavioral research. For example, NIH research has led
to successfully decreasing infant death rates by over 70 percent,
increasing the survival rates from respiratory distress syndrome, and
dramatically reducing the transmission of HIV from infected mother to
fetus and infant from 25 percent to just 1.5 percent. NIH is engaged in
a comprehensive research initiative to address and explain the reasons
for a major public health dilemma--the increasing number of obese and
overweight children and adults in this country. Today U.S. teenagers
are more overweight than young people in many other developed
countries. And the Newborn Screening Initiative is moving forward to
improve availability, accessibility, and quality of genetic tests for
rare conditions that can be uncovered in newborns. The pediatric
community applauds the prior commitment of Congress to maintain
adequate funding for the NIH. We remain concerned, however, that the
cumulative effect of several years of flat funding will stall or even
set back the gains that were made under the years of the NIH's budget
doubling. We urge you to sustain the momentum of scientific discovery.
We support the recommendation of the Ad Hoc Group for Medical Research
for a funding level in fiscal year 2007 of $29.75 billion. In addition,
to ensure ongoing and adequate child and adolescent focused research,
such as the National Children's Study (NCS) led by the National
Institute for Child Health and Human Development (NICHD), we join with
the Friends of NICHD Coalition in requesting $1.35 billion in fiscal
year 2007. Moreover we recommend that the NCS be adequately funded in
fiscal year 2007 at $69 million to begin the implementation phase of
this important study. We are greatly disappointed by and reject the
administration's proposal to phase out the NCS in 2007. This large
longitudinal study, authorized in the Children's Health Act of 2000,
will provide critical research and information on major causes of
childhood illnesses such as premature birth, asthma, obesity,
preventable injury, autism, development delay, mental illness, and
learning disorders.
We commend this committee's ongoing efforts to make pediatric
research a priority at the highest level of the NIH. We urge continued
Federal support of NIH efforts to increase pediatric biomedical and
behavioral research, including such proven programs as targeted
training and education opportunities and loan repayment. We recommend
continued interest in and support for the Pediatric Research Initiative
in the Office of the NIH Director and sufficient funding to continue
the pediatric training grant and pediatric loan repayment programs both
enacted in the Children's Health Act of 2000. This would ensure that we
have adequately trained pediatric researchers in multiple disciplines
that will not come at the expense of other important programs.
Finally, as clinicians, we know first-hand the considerable
benefits for children and society in securing properly studied and
dosed medications. The benefits of pediatric drug testing are
undisputed. Proper pediatric safety and dosing information reduces
medical errors and adverse events, ultimately improving children's
health and reducing health care costs. In a very conservative estimate,
the FDA projects savings from pediatric testing of over $228 million a
year in reduced hospitalization expenses for just five diseases
affecting children. But until now there has been little incentive for
drug companies to study off-patent drugs--older drugs that are
critically needed therapies for children. The Research Fund for the
Study of Drugs, created as part of the Best Pharmaceuticals for
Children Act of 2002, provides support for these critical pediatric
testing needs, but unfortunately is currently funded at an amount
sufficient to test only a fraction of the NIH and FDA-designated
``priority'' drugs. Therefore, we urge the subcommittee to provide the
NIH with sufficient funding to fund the study of generic (off-patent)
and selected on-patent drugs for pediatric use.
We believe that these requests represent the best and most reliable
estimates of the level of funding needed to sustain the high standard
of scientific achievement embodied by the NIH. However, we encourage
Congress to explore all possible options to identify additional sources
of funding needed to support these increases if we are to reach these
funding goals while not weakening any other valuable component of the
Public Health Service.
immunization
Immunization remains one of the greatest public health achievements
of the last century, saving literally millions of lives. Thanks to the
widespread use of vaccines, millions of children have avoided serious
and often fatal diseases that previously devastated lives. Before
immunization, polio paralyzed 10,000-25,000 children and adults,
rubella (German measles) caused birth defects and mental retardation in
as many as 20,000 newborns, and measles infected millions of children,
killing 400-500 and leaving thousands with serious brain damage each
year. Immunizations have reduced by more than 95 percent the cases of
vaccine-preventable infectious diseases in this country. And some, like
rubella, are virtually eliminated from North America, thanks to
successful immunization programs.
Pediatricians, working alongside public health professionals and
other partners, have brought the United States its highest immunization
coverage levels in history--over 92 percent of children received all
vaccinations by school age in 2004-2005. We attribute this, in part, to
the Vaccines for Children (VFC) Program, and encourage Congress to
maintain its commitment to ensuring the program's viability. The VFC
program combines the efforts of public health and private pediatricians
and other health care professionals to accomplish and sustain vaccine
coverage goals for both today's and tomorrow's vaccines. It removes
vaccine cost as a barrier to immunization for some and reinforces the
concept of vaccine delivery in a ``medical home.'' However, we are
concerned that the administration's fiscal year 2007 budget once again
has proposed to reduce funding for the Section 317 program by
transferring funds from that program to expand VFC. This is
shortsighted. Additional section 317 funding is necessary to provide
the pneumococcal conjugate vaccine (PCV-7), a vaccine that prevents an
infection of the brain covering, blood infections and approximately 7
million ear infections a year, to those remaining States that currently
do not provide it. Increased Section 317 funding also is needed to
purchase the influenza vaccine--now recommended for children between
the ages of 6 months and 5 years of age. This age cohort is
increasingly susceptible to serious infection and the risk of
hospitalization. And an increase in funding is needed to purchase the
recently recommended rotavirus vaccine, tetanus-diptheria-pertussis
(Tdap) vaccine for adolescents and the meningococcal conjugate vaccine
(MCV). Meningococcal disease is a serious illness, caused by bacteria,
with 10-15 percent of cases fatal and another 10-15 percent of cases
resulting in permanent hearing loss, mental retardation, or loss of
limbs.
The public health infrastructure that now supports our national
immunization efforts must not be jeopardized with insufficient funding.
One of the conclusions of the 2000 Institute of Medicine report,
Calling the Shots, was that unstable funding for State immunization
programs threatens coverage levels for specific populations and age
groups and vaccine safety. This continues to be true today. A strong
and sufficient infrastructure is essential. For example, adolescents
continue to be adversely affected by vaccine-preventable diseases
(e.g., chicken pox, hepatitis B, measles and rubella). Comprehensive
adolescent immunization activities at the national, State and local
levels are needed to achieve national disease elimination goals. States
and communities continue to be financially strapped and therefore, many
continue to divert funds and health professionals from routine
immunization clinics in order to accommodate anti-bioterrorism
initiatives or now pandemic influenza. Moreover, continued investment
in the CDC's immunization activities must be made to avoid the
reoccurrence of childhood vaccine shortages by providing and adequately
funding a national 6 month stockpile for all routine childhood
vaccines--stockpiles of sufficient size to insure that significant and
unexpected interruptions in manufacturing do not result in shortages
for children.
While the ultimate goal of immunizations clearly is eradication of
disease, the immediate goal must be prevention of disease in
individuals or groups. To this end, we strongly believe that CDC's
efforts must be sustained. In fiscal year 2007, we recommend an overall
increase in funding above fiscal year 2006 of $282 million to ensure
that the CDC's National Immunization Program has the funding necessary
to accommodate vaccine price increases, new disease preventable
vaccines coming on the market, global immunization initiatives--
including funds for polio eradication and the elimination of measles
and rubella--and to continue to implement the recommendations developed
by the IOM.
conclusion
We appreciate the opportunity to provide our recommendations for
the coming fiscal year. As this subcommittee is once again faced with
difficult choices and multiple priorities we know that as in the past
years, you will not forget America's children and adolescents.
Other recommendations for fiscal year 2007:
DEPARTMENT OF HEALTH AND HUMAN SERVICES
------------------------------------------------------------------------
Agency Amount
------------------------------------------------------------------------
Centers for Disease Control and Prevention (total).... $8,500,000,000
Polio Eradication................................. 101,254,000
Birth Defects, Disability and Health.............. 135,000,000
Newborn Hearing Screening Technical Assistance.... 9,000,000
National Violent Death Reporting System........... 10,000,000
Folic Acid Education Campaign..................... 4,000,000
Health Resources and Services Administration (total).. 7,500,000,000
Newborn Hearing Screening Grants to States........ 10,000,000
Consolidated Community Health Centers............. 2,038,000,000
Substance Abuse and Mental Health Services 3,531,000,000
Administration (total)...............................
Indian Health Service (total)......................... 3,361,000,000
Food and Drug Administration (total).................. 1,566,000,000
------------------------------------------------------------------------
______
Prepared Statement of the American Association of Colleges of Nursing
The American Association of Colleges of Nursing (AACN) respectfully
submits this statement highlighting funding priorities for nursing
education and research programs in fiscal year 2007. AACN represents
over 590 senior colleges and universities with baccalaureate and
graduate nursing programs that include over 210,000 students and 11,000
faculty members. These institutions are responsible for educating
almost half of our Nation's registered nurses (RNs) and all of the
nurse faculty and researchers. Nursing represents the largest health
profession, with approximately 2.9 million dedicated, trusted
professionals delivering primary, acute, and chronic care to millions
of Americans.
the nationwide nursing shortage
Our country continues to be challenged by a shortage of registered
nurses that was first noted in 1998. This shortage is showing no signs
of diminishing and demographics reveal that, unlike shortages in the
past, it will affect health care delivery for the foreseeable future.
In 2005, the American College of Healthcare Executives reported that 85
percent of hospitals experienced a nursing shortage. The U.S. Bureau of
Labor Statistics (BLS) has projected that our country will require an
additional 1.2 million new and replacement registered nurses by 2014.
Nursing has been identified by BLS as the fastest growing professional
occupation in the country. However, according to the Health Resources
and Services Administration (HRSA), the supply of RNs will drop 29
percent below demand by 2020 unless deliberate action is taken to
increase the number of nurses graduating each year and entering the
workforce. Nursing vacancies exist throughout all health care sectors,
including long-term care, home care, and public health. Among the
Nation's 5,000 community health centers, the vacancy rate for RNs is 10
percent and 9 percent for nurse practitioners. Even the Department of
Veterans Affairs, the largest sole employer of RNs in the United
States, has a 10 percent RN vacancy rate.
Research clearly documents that patient safety is compromised
without a sufficient number of RNs. In 2002, the Joint Commission on
Accreditation of Healthcare Organizations (JCAHO) noted that the
nursing shortage contributed to nearly a quarter of all unexpected
incidents that adversely affect hospitalized patients. Since RNs
comprise the largest component of a hospital workforce, shortages
result in emergency room overcrowding and diversions, increased wait
time for or cancellation of surgeries, discontinued patient care
programs or reduced service hours, and delayed discharges.
The nursing shortage also threatens homeland security and disaster
preparedness efforts. The Government Accountability Office reported
that local and State health officials cited the nursing shortage as an
impediment to their preparedness efforts in 2003.
These alarming facts are coupled with little change in contributing
factors, such as the aging of America's population, the aging nurse
workforce, high rates of RN retirement, and the increasing demand for
high acuity health care services by chronically ill, medically complex
patients. To ensure that every patient receives the safest, highest
quality health care, Federal support must continue to play an integral
role in our Nation's efforts to address the nursing shortage.
current strategy: nursing workforce development programs
Acknowledging the severity of the Nation's nursing shortage,
Congress passed The Nurse Reinvestment Act of 2002. This legislation
created new programs and expanded existing Nursing Workforce
Development authorities. Administered by HRSA under Title VIII of the
Public Health Service Act, these programs focus on the supply and
distribution of RNs across the country. Programs support individual
students in their nursing studies through loans, scholarships, and loan
repayment programs. Title VIII programs stimulate innovation in nursing
practice and bolster nursing education throughout the continuum, from
entry-level preparation through graduate study. They are the largest
source of Federal funding for nursing education assisting students,
schools of nursing, and health systems in their efforts to educate,
recruit, and retain RNs. In fiscal year 2005, these programs helped to
educate 52,759 student nurses through individual and programmatic
support.
Funding for these authorities is insufficient to address the
severity of the nursing shortage. Currently, Nursing Workforce
Development Programs receive $149.68 million, down from $150.67 million
in fiscal year 2005. During the nursing shortage in 1974, Congress
appropriated $153 million for nursing education programs. Translated
into today's dollars, that appropriation would total $615 million, more
than four times the current level. However, it will take billions of
dollars to resolve today's nursing shortage.
AACN respectfully requests $175 million for Title VIII Nursing
Workforce Development in fiscal year 2007, an additional $25.32 million
over fiscal year 2006. New monies would expand nursing education,
recruitment, and retention efforts to help resolve the nursing
shortage.
Colleges of Nursing Respond
The approximately 1,500 schools of nursing nationwide have been
working diligently to expand enrollments. AACN's 2005-2006 annual
survey of 567 schools entitled, Enrollments and Graduations in
Baccalaureate and Graduate Programs in Nursing, reveals that
enrollments increased by 9.7 percent in entry-level baccalaureate
nursing programs. This makes the fifth consecutive year of enrollment
increases that can be attributed to a combination of Federal support
through Nursing Workforce Development Programs, private sector
marketing efforts, public-private partnerships providing additional
resources to expand capacity of nursing programs, and State legislation
targeting funds towards nursing scholarships and loan repayment.
While impressive, these increases still cannot meet the demand. In
the November 2003 issue of Health Affairs, Dr. Peter Buerhaus reported
that nursing school enrollments would have to increase by at least 40
percent annually just to replace those nurses who retire. Despite
intensive efforts nationwide, AACN found that enrollments increased by
a total of 57.2 percent, over the last 5 years in entry-level
baccalaureate programs. Moreover, only 8.1 percent of RNs are under the
age of 30, according to the 2004 National Sample Survey of Registered
Nurses.
Despite increasing enrollments and the escalating demand for RNs,
U.S. schools of nursing still are forced to turn away eligible
students. At least 41,683 qualified applications were turned away
despite the increase in enrollments. This is a 27 percent increase from
the over 32,797 denied admission in 2004, according to AACN data.
Reasons cited for this denial are insufficient numbers of faculty,
clinical sites, classroom space, clinical preceptors, and budget
constraints. Over 73 percent of the schools surveyed cited the faculty
shortage as the primary barrier to increasing enrollments. Some of
these qualified students are placed on waiting lists for 2 years or
more, but many good students are lost to the nursing profession.
Bottleneck: The Nurse Faculty Shortage
AACN believes that the most effective strategy to resolve the
nursing shortage is addressing the underlying faculty shortage. HRSA
reported in 2004 that just 13 percent of the RN workforce holds either
a master's or doctoral degree, credentials required to teach. In 2003,
there were 10,500 full-time masters and doctorally prepared faculty in
baccalaureate and graduate nursing programs. Projections through 2012
show that the faculty pool will shrink by at least 2,000 as compared to
2003, even after accounting for retirements, resignations, and
additional entrants. Note that these figures do not take into account
the need for faculty in new or expanded programs, but only represent
present staffing requirements. If the faculty vacancy rate holds
steady, the deficit of nurse faculty is expected to swell to over 2,600
unfilled positions in 2012.
This situation will only worsen with time. The number of productive
years for nurse educators will decrease as faculty age continues to
climb, averaging 52 years in 2004. As such, significant numbers of
faculty are expected to retire in the coming years, but there are not
enough candidates in the pipeline to take their places. An average of
410 individuals are awarded doctoral degrees in nursing each year, but
almost a quarter (23 percent) take jobs outside of academic nursing. In
2005, AACN found a faculty vacancy rate of 8.5 percent, which
translates into an average of approximately 2 faculty vacancies per
school of nursing. Of those vacancies, over half, (52.6 percent)
required a doctoral degree. Higher compensation in clinical and private
sector settings lures current and potential nurse educators away from
the classroom. For example, the average salary of a nurse practitioner
in an emergency department was $84,835, according to the 2005 National
Salary Survey of Nurse Practitioners. However, the average salary for a
nurse practitioner in academia was only $66,925, 26.8 percent less.
Without sufficient nurse faculty, schools of nursing cannot expand
enrollments.
Reversing the Trend: Nurse Faculty Loan Program (Sec. 846A).--This
trend can be reversed with additional appropriations for the Nurse
Faculty Loan Program. Designed to increase the number of nurse faculty,
schools of nursing receive grants to create a loan fund. To be eligible
for these loans, students must pursue full-time study for a masters or
doctoral degree. In exchange for teaching at a school of nursing, loan
recipients will have up to 85 percent of their educational loans
cancelled over a 4-year period. A student may receive a maximum loan
award of $30,000 per academic year for tuition, books, fees, laboratory
expenses, and other reasonable. educational costs. In fiscal year 2005,
66 new grants were made to schools of nursing, and 26 grants were
continued, totaling 92. These funds will support an estimated 475
future nurse faculty members. In fiscal year 2006, $4.77 million was
appropriated. However, if the current funding was doubled to almost $10
million, based on fiscal year 2005 projections, colleges of nursing
could educate over 900 future faculty. Further, with an average faculty
to student ratio of 1:10, those 900 faculty could teach an additional
9,000 nurses each year.
Advanced Education Nursing Program (Sec. 811).--These grants
support the majority of schools of nursing preparing graduate-level
nurses, some of whom become faculty. Receiving $57.06 million in fiscal
year 2006, this grant program helps schools of nursing, academic health
centers, and other nonprofit entities improve the education and
practice of nurse practitioners, nurse-midwives, nurse anesthetists,
nurse educators, nurse administrators, public health nurses, and
clinical nurse specialists. Out of the 88 applications reviewed for
this program in fiscal year 2005, 43 new grants were awarded, and 114
were continued. In addition, 422 schools of nursing received
traineeship grants, which in turn directly supported 9,000 individual
student nurses.
The health system's increasing demand for primary care, increased
utilization of case-management--particularly for chronic illnesses,
prevention and cost-efficiency, and a shortage of physicians are
driving the Nation's need for nurse practitioners, certified nurse-
midwives, and other RNs with graduate education and advanced clinical
skills, known as advanced practice registered nurses (APRNs). Mounting
studies demonstrate the quality and cost effectiveness of APRN care.
This is especially important for the 78 million aging Baby Boomers,
whose demand for health care services will skyrocket in the near
future. The rate of physician office visits by Medicare beneficiaries
jumped 20.5 percent from 1992 to 2001, according to the Federal report
Older Americans 2004: Key Indicators of Well-Being.
Workforce Diversity Program (Sec. 821).--These grants prepare
disadvantaged students to become nurses. As the United States becomes
ever more heterogeneous, it is imperative that the composition of our
nursing workforce mirrors this shift. According to the U.S. Census
Bureau, roughly 30 percent of the population was reported as a racial
or ethnic minority in 2000, but by 2050 that percentage will jump to
over 52 percent. This program awards grants to schools of nursing and
other entities seeking to increase access to nursing education for
disadvantaged students, including those racial and ethnic minorities
under-represented among RNs. Scholarships or stipends, pre-entry
preparation, and retention activities are provided to enable students
to complete their nursing education. In fiscal year 2005, 171
applications were reviewed, from those 11 new grants were awarded and
48 previously awarded grants were continued. These program funds
assisted at least 6,344 students. Workforce Diversity received $16.11
million in fiscal year 2006.
At Risk: Nursing Student Loan Program (Sec. 835).--This revolving
loan fund was established in 1964 to specifically target nursing
workforce shortages. The Nursing Student Loan (NSL) program provides
participating undergraduate or graduate nursing students with a maximum
of $13,000 in loans at 5 percent interest. Schools of nursing
participating in the NSL select recipients and determine the level of
assistance provided, with a preference for those with financial need.
New loans are made as existing loans are repaid. This program has not
received additional appropriations since 1983. However, in fiscal year
2005, the NSL provided financial assistance to 17,240 nursing students.
In fiscal year 2005, Sec. 222 of the Consolidated Appropriations Act of
2005 (Public Law 108-447) included language which stated: ``The
unobligated balance of the Nursing Student Loan program authorized by
section 835 of the Public Health Services Act is rescinded.'' As a
result, the NSL gave back $6.1 million to the U.S. Treasury in July
2005. In previous years, those funds were redistributed among
participating institutions, increasing the amount of possible loans. A
similar provision, in the fiscal year 2006 appropriations law will
force the NSL to return even more funds to the Treasury that instead
could have assisted nursing students in completing their education.
national institute of nursing research
One of the 27 Institutes and Centers at the National Institutes, of
Health (NIH), the efforts of the National Institute of Nursing Research
(NINR) improve patient care and foster advances in nursing and other
health professions' practice. These practices must be must constantly
updated and validated based on rigorous, peer-reviewed research. The
outcomes-based findings derived from NINR research are important to the
future of the health care system and its ability to deliver safe, cost-
effective, and high quality care. Through grants, research training,
and interdisciplinary collaborations, NINR addresses care management of
patients during illness and recovery, reduction of risks for disease
and disability, promotion of healthy lifestyles, enhancement of quality
of life in those with chronic illness, and care for individuals at the
end of life. To advance this research, AACN requests a funding level of
$150 million in fiscal year 2007, an additional $12.66 million over the
$137.34 million NINR received in fiscal year 2006.
NINR Addresses the Need for Translational and Clinical Research
NINR emphasizes translational research, the means by which basic
findings relating to behavior, molecules, and genes are tested in the
clinical setting and translated into innovative medical practices and
improvements in public health. Under the framework of the Roadmap
Initiative, NINR and nurse researchers are addressing the development
of new interdisciplinary research teams and enhanced clinical research
to move the overall NIH portfolio of social, behavioral, and medical
research forward in this coordinated and cohesive effort.
NINR Addresses the Shortage of Nurse Researchers and Faculty
NINR allocates 8 percent of its budget, a high proportion when
compared to other NIH institutes, to research training to help develop
the pool of nurse researchers. In fiscal year 2005, NINR training
dollars supported 80 individual researchers and provided 155
institutional awards, which in turn supported a number of nurse
researchers at each site. Since nurse researchers often serve as
faculty members for colleges of nursing, they are actively educating
our next generation of RNs.
agency for healthcare research and quality
While NIH supports biomedical research that improves health care by
focusing on the cause, cure, and prevention of disease, the Agency for
Healthcare Research and Quality (AHRQ) supports health systems
research, collecting evidence-based information on health care
outcomes. AHRQ research findings are used by patients, clinicians,
health system decision makers, and public policymakers to guide health
care delivery systems and patient care. The research supported by AHRQ
not only improves the quality of health care services, but also helps
people make more informed decisions about their health care. AACN joins
the Friends of AHRQ in recommending a funding level of $440 million for
fiscal year 2007, an additional $121.3 million over the fiscal year
2006 level of $318.7 million.
Health Systems Research at AHRQ Addresses Nurses' Role in Patient
Safety
AHRQ research has demonstrated that inefficient work processes,
overwhelming workloads, extended work hours, and poor workplace designs
create obstacles to providing patients safe, cost-effective, and high
quality health care. The New England Journal of Medicine published a
study of over 6 million patients in May 2002, that found hospitalized
patients had better outcomes when the majority of their nursing care
was provided by RNs. Decreased hours of RN care, stemming from the
nursing shortage, correlated with longer hospital stays, increased
incidence of urinary tract infections and gastrointestinal bleeding, as
well as higher rates of pneumonia, shock, and cardiac arrest. When
patients received additional hours of RN care, the death rates dropped
for pneumonia, shock or cardiac arrest, upper gastrointestinal
bleeding, sepsis, and deep venous thrombosis.
conclusion
AACN acknowledges the fiscal challenges that the subcommittee and
the entire Congress must work within. However, the health needs of our
Nation must be addressed by a dedicated, long-term vision for educating
the new nursing workforce. Today, nurses must evaluate research that
promotes evidence-based practice and utilize technical innovations in
providing safe, high quality patient care. Research shows that patient
care suffers and mortality rates increase in facilities without
sufficient numbers of RNs. Without highly educated nurses, who will
care for us when we must enter into our increasingly complex health
care system?
______
Prepared Statement of the American Association of Colleges of
Osteopathic Medicine
On behalf of the American Association of Colleges of Osteopathic
Medicine (AACOM) which represents the administrations, faculties and
students of all twenty colleges of osteopathic medicine in the United
States, I am pleased to present our views on the fiscal year 2007
appropriations for health professions education programs under Title
VII of the Public Health Service Act.
First, we must express our profound concern at the devastating cuts
proposed by the administration for Title VII programs in its fiscal
year 2007 budget. The Bureau of Health Professions received $342
million in cuts in the President's fiscal year 2007 proposal which is
fully 46 prepared of its entire budget. While we support the $181
million increase in the President's budget for Community Health
Centers, the large funding decreases to the Title VII programs raises
the question of whether there will be a sufficient number of health
care providers to staff these clinics. The fiscal year 2007 cuts are in
addition to the 12 programs that were eliminated in the fiscal year
2006 appropriations bills, as well as other programs that received
significant decreases in both years. Congress must not allow these
draconian slashes to cripple the programs that assist health
professions schools in training the workforce needed to care for our
citizens in the 21st century.
A study that recently appeared in the Journal of the American
Medical Association recommends increased Titles VII and VIII support to
alleviate provider shortages at Community Health Centers [Shortages of
Medical Personnel at Community Health Centers: Implications for Planned
Expansion, Roger A. Rosenblatt, C. Holly. A. Andrilla, Thomas Curtin;
L. Gary Hart, Journal of the American Medical Association, JAMA
2006;295:1042-1049]. The study found that Titles VII and VIII programs
help ameliorate these shortages and maldistribution by training
providers who are more likely to practice in rural and underserved
communities.
Health professions education programs under Title VII and nursing
education programs under Title VIII are essential components of
America's health care safety net. An adequate diverse, well-distributed
and culturally competent health workforce is indispensable to our
national readiness efforts. Colleges of osteopathic medicine have a
long tradition of training primary care physicians who practice in
rural and urban underserved areas.
The health professions education programs under Title VII and the
nursing education programs under Title VIII of the Public Health
Service Act have been valuable in our efforts to continue to ensure
this commitment. In Public Law 105-392, the Health Professions
Education Partnership Act of 1998, forty-four different Federal health
professions training programs were consolidated into seven clusters.
These clusters provide support for training of primary care and dental
providers; the establishment and operation of interdisciplinary
community-based training activities; health professions workforce
analysis; public health workforce development; nursing education; and
student financial assistance. These programs are designed to meet the
health care delivery needs of over 2,800 Health Professions Shortage
Areas in the country. Many rural and disadvantaged populations depend
on the health professionals trained by these programs at their only
source of health care. For example, without the practicing family
physicians who are currently in place, an additional 1,332 of the
United States' 1,082 urban and rural counties would qualify for
designation as primary care Health Professions Shortage Areas.
Title VII programs have had a significant impact in reducing the
Nation's Health Professions Shortage Areas. Indeed, a 1999 study
estimated that if funding for Title VII programs were doubled the
effect would be to eliminate the Nation's Health Professions Shortage
Areas in as little as 6 years. [Politzer, RM, Hardwick, KC, Cultice,
JM, Bazell, C. ``Eliminating Primary Care Health Professions Shortage
Areas: The Impact of Title VII Generalist Physician Education,'' The
Journal of Rural Health, 1999: 15(1): 11-19].
A study by the Robert Graham Center showed that receipt of Title
VII family medicine grants by medical schools produced more family
physicians and more primary care doctors serving rural areas and health
professions shortage areas. Over 69 percent of Title VII funded
internal medicine graduates practice primary care after graduation.
This rate is nearly twice that of programs not receiving Title VII
funding.
Among the programs within these clusters that have been especially
important to enhancing osteopathic medical schools' ability to train
the highest quality physicians are: General Internal Medicine
Residencies; General Pediatric Residencies; Family Medicine Training;
Preventive Medicine Residencies; Area Health Education Centers (AHECs);
Health Education and Training Centers (HETCs); Health Careers
Opportunities Programs (HCOP); and Centers of Excellence (COE)
programs.
In addition, three Title VII programs offer interdisciplinary
training for all health professions. The Geriatric Education Centers
(GEC) program provides grants to support collaborative arrangements
involving several health professions schools and health facilities that
provide training in the diagnosis, treatment and prevention of disease
and other health concerns of the elderly. The Geriatric Training
program for physicians, dentists, and mental health professionals (GT)
provides for these professionals who plan to become faculty members.
The Geriatric Academic Career Awards (GACA) support the career
development of geriatricians in junior faculty positions who are
committed to an academic career of teaching clinical geriatrics in
medical schools.
Accordingly, Mr. Chairman and Members of the subcommittee, AACOM
recommends that the fiscal year 2007 funding levels for Titles VII
Health Professions Education and VIII Nursing Education be
$299,552,000. You will note that this is the same level as the Congress
approved for fiscal year 2005.
AACOM also strongly urges continuation of funding for the Council
on Graduate Medical Education (COGME). Since its inception, COGME's
diverse membership has given the health policy community an opportunity
to discuss national workforce issues. The fifteen formal reports and
multiple ancillary materials provided by COGME have offered important
findings and observations in the rapidly changing health care
environment and have argued for a system of graduate medical education
that develops a physician workforce to meet the healthcare needs of the
American people.
Some of the more significant recommendations include:
--Community-based education with an emphasis on primary care;
--Continued progress toward a more representative participation of
minorities in medicine;
--The development and maintenance of a workforce planning
infrastructure to improve the understanding of supply, need and
demand forces;
--The development of Federal-State partnerships to further workforce
planning; and
--Encouragement and support for medical education and health care
delivery programs that increase the flow of physicians to rural
areas, with an emphasis on the smaller, more remote
communities.
In summary, Mr. Chairman and Members of the subcommittee, health
profession education programs under Title VII are an essential part of
the healthcare safety net for all Americans. We respectfully urge you
to restore funding for these programs at the fiscal year 2005 level.
Please contact me or Michael J. Dyer, AACOM's Vice President for
Government Relations at (301) 968-4152 if you have any questions.
______
Prepared Statement of the American Nurses Association
The American Nurses Association (ANA) appreciates this opportunity
to comment on fiscal year 2007 appropriations for nursing education,
workforce development, and research programs. Founded in 1896, ANA is
the only full-service national association representing registered
nurses (RNs). Through our 54 constituent member associations, ANA
represents RNs across the Nation in all practice settings.
The ANA gratefully acknowledges this subcommittee's history of
support for nursing education and research. We appreciate your
continued recognition of the important role nurses play in the delivery
of quality health care services. This testimony will give you an update
on the status of the nursing shortage, its impact on the Nation, and
the outlook for the future.
the nursing shortage today
The nursing shortage is far from solved. Here are a few quick
facts:
--According to American Hospital Association's 2005 Workforce Survey,
109,000 nurses are needed immediately to fill vacancies at our
Nation's hospitals. In addition, 40 percent of the hospitals
surveyed reported that RN recruitment was more difficult in
2004 than in 2003.
--The Bureau of Labor Statistics reported in February of this year
that registered nursing will have remarkable job growth in the
time period spanning 2004-2014. During this time decade, the
health care system will require more than 1.2 million new
nurses.
--The report issued by the Division of Nursing at the Health
Resources and Services Administration in 2002 projects that,
absent aggressive intervention, the supply of nurses in America
will fall 29 percent below requirements by the year 2020.
This growing nursing shortage is having a detrimental impact on the
entire health care system. Numerous studies have shown that nursing
shortages contribute to medical errors, poor patient outcomes, and
increased mortality rates. A study published in the January/February
2006 issue of Health Affairs showed that hospitals could avoid 6,700
deaths per year by increasing the amount of RN care provided to their
patients. This study, ``Nurse Staffing in Hospitals: Is There a
Business Case for Quality?'' by Jack Needleman, Peter Buerhaus, Maureen
Stewart, Katya Zelevinsky and Soeren Mattke, also revealed that
hospitals could avoid 4 million hours worth of inpatient care by
avoiding the complications associated with a shortage of RN care.
This study built upon research published in the New England Journal
of Medicine in May 2002. The 2002 research was based on a review of
more than 6 million patients. It found that increased hours of RN care
were associated with fewer ``failure-to-rescue'' deaths in hospitalized
patients resulting from pneumonia, shock or cardiac arrest, upper
gastrointestinal bleeding, sepsis and deep venous thrombosis.
Research published in the October 23, 2002 Journal of the American
Medical Association also demonstrated that more nurses at the bedside
could save thousands of patient lives each year. In reviewing more than
232,000 surgical patients at 168 hospitals, researchers from the
University of Pennsylvania concluded that a patient's overall risk of
death rose roughly 7 percent for each additional patient above four
added to a nurse's workload.
A Joint Commission on the Accreditation of Healthcare Organizations
(JCAHO) study published in 2002 shows that the shortage of nurses
contributes to nearly a quarter of all unexpected incidents that kill
or injure hospitalized patients.
the impact on preparedness and military health care
This growing nursing shortage has effects well beyond traditional
domestic health care. RNs are integral to everything from pandemic flu
management, to terrorism preparedness, to veterans' health delivery, to
disaster response. In the event of a terrorist attack or pandemic flu
outbreak, nurses will be needed to evaluate patients, administer
vaccines and medications, perform disease surveillance, and to train
non-licensed staff. The GAO has repeatedly reported that the nursing
shortage is complicating efforts at the State and local level to
implement pandemic flu and bioterrorism preparedness efforts (see: GAO:
03-654T, 03-769T, 04-458T, 05-760T, 05-863T). For instance, in May
2003, the GAO testified, ``Five of the [seven] States we visited
reported shortages of hospital medical staff, including nurses and
physicians, necessary to increase response capacity in an emergency.''
(GAO-03-769T).
The nursing shortage is also stressing military health care
delivery. The Army, Navy, and Air Force are offering new lucrative RN
recruitment packages that include large sign-on bonuses, generous
scholarships, and loan forgiveness packages. Yet, neither the Army nor
the Air Force has met their active service nurse recruitment goals
since the 1990s. On May 10, 2005, Army leaders warned the Senate
Appropriations Committee that they were experiencing a 30 percent
shortage of certified registered nurse anesthetists. In 2004, the Navy
Nurse Corps recruitment fell 32 percent below target. Because the
military holds the vast majority of its health care assets in the
reserves, the reserve activation has been particularly hard on nursing.
This ongoing nurse shortage is creating real concerns about the ability
to deliver needed health care to today's military.
nursing workforce development programs
Federal support for the Nursing Workforce Development Programs
contained in Title VIII of the Public Health Service Act is
unduplicated and essential. The 107th Congress recognized the
detrimental impact of the developing nursing shortage and passed the
Nurse Reinvestment Act (Public Law 107-205). This law improved the
programs of Title VIII to meet the unique characteristics of today's
shortage. This achievement holds the promise of recruiting new nurses
into the profession, promoting career advancement within nursing and
improving patient care delivery. This promise will not be met, however,
without a significant investment.
In fiscal year 2005, this subcommittee allocated $151 million in
funding for Title VIII which supported 52,795 individual grants. In
fiscal year 2006, you allocated $150 million for Title VIII. While ANA
applauds your ongoing recognition for these nursing workforce
development programs, we also recognize that these funding levels fail
to meet the challenges of the growing nursing shortage. For instance,
in fiscal year 2005, 4,465 RNs applied for the Nurse Education Loan
Repayment Program (described fully below). Due to lack of funding, a
mere 803 (18 percent) were approved.
ANA strongly urges you to increase funding for Title VIII programs
by at least $25 million to a total of $175 million in fiscal year 2007.
This funding amount has been supported by a bipartisan group of 54
Senators in a Dear Colleague sent to this subcommittee. The nursing
shortage and its impact on the health care of the Nation demand this
continued investment.
In 1974, this subcommittee invested $153.6 million Title VIII.
Inflated to today's dollars, this appropriation would equal $622.5
million, more than four times the current appropriation. Certainly,
today's shortage is more dire and systemic than that of the 1970's; it
deserves an equivalent response.
Title VIII includes the following program areas:
Nursing Education Loan Repayment Program & Scholarships.--This line
item is comprised of the Nurse Education Loan Repayment Program (NELRP)
and the Nursing Scholarship Program (NSP), the Secretary of HHS has the
authority to allocate funds between the two areas. In fiscal year 2006,
the Nurse Education Loan Repayment Program and Scholarships received
$31 million.
The NELRP repays up to 85 percent of a RN's student loans in return
for full-time practice in a facility with a critical nursing shortage.
The NELRP nurse is required to work for at least 2 years in a
designated facility during which time the NELRP repays 60 percent of
the RN's student loan balance. If the nurse applies and is accepted for
a third year, an additional 25 percent of the loan is repaid.
The NELRP boasts a proven track record of delivering nurses to
facilities hardest hit by the nursing shortage. HRSA has given NELRP
funding preference to RNs who work in disproportionate share hospitals,
skilled nursing facilities, federally-designated health centers, and
departments of public health. However, lack of funding has hindered the
full implementation of this program. As stated above, in fiscal year
2005, 82 percent of the nurses willing to immediately begin practicing
in facilities hardest hit by the shortage were turned away from this
program due to lack of funding.
The NSP offers funds to nursing students who, upon graduation,
agree to work for at least 2 years in a health care facility with a
critical shortage of nurses. Preference is given to students with the
greatest financial need. Like the loan repayment program, the NSP has
been stunted by a lack of funding. In fiscal year 2005, HRSA received
6,563 applications for the nursing scholarship. Due to lack of funding,
a mere 217 scholarships were awarded. Therefore, 97 percent of nursing
students willing to work in facilities with a critical shortage were
denied access to this program.
Nurse Faculty Loan Program.--This program establishes a loan
repayment fund within schools of nursing to increase the number of
qualified nurse faculty. Nurses may use these funds to pursue a
master's or doctoral degree. They must agree to teach at a school of
nursing in exchange for cancellation of up to 85 percent of their
educational loans, plus interest, over a 4-year period. Loans can cover
the costs of tuition, fees, books, laboratory expenses, and other
reasonable education expenses. In fiscal year 2006, this program
received $4.8 million.
This program is vital given the critical shortage of nursing
faculty. America's schools of nursing cannot increase their capacity
without an influx of new teaching staff. Last year, schools of nursing
were forced to turn away tens of thousands of qualified applicants due
largely to the lack of faculty. In fiscal year 2005, HRSA awarded 66
nurse faculty loan repayments.
Nurse Education, Practice, and Retention Grants.--This section is
comprised of many programs designed to support entry-level nursing
education and to enhance nursing practice. In fiscal year 2005, this
line item supported 10,490 nursing students. All together, the Nurse
Education, Practice, and Retention Grants received $37.3 million in
fiscal year 2006.
The education grants are designed to expand enrollments in
baccalaureate nursing programs; develop internship and residency
programs to enhance mentoring and specialty training, and; provide new
technologies in education including distance learning.
Practice grants currently support 18 Nurse Managed Clinics that
provide primary health care in medically underserved communities;
provide nursing students the skills necessary to practice in existing
and emerging health systems, and; develop cultural competencies.
Retention grant areas include career ladders and improved patient
care delivery systems. The career ladders program supports education
programs that assist individuals in obtaining the educational
foundation required to enter the profession, and to promote career
advancement within nursing. Enhancing patient care delivery system
grants are designed to improve the nursing work environment. These
grants help facilities to enhance collaboration and communication among
nurses and other health care professionals, and to promote nurse
involvement in the organizational and clinical decision-making
processes of a health care facility. These best practices for nurse
administration have been identified by the American Nurse Credentialing
Center's Magnet Recognition Program . These practices have been shown
to double nurse retention rates, increase nurse satisfaction, and
improve patient care.
Nursing Workforce Diversity.--This program provides funds to
enhance diversity in nursing education and practice. It supports
projects to increase nursing education opportunities for individuals
from disadvantaged backgrounds--including racial and ethnic minorities,
as well as individuals who are economically disadvantaged. In fiscal
year 2006, these programs received $16 million.
Racial and ethnic minorities currently comprise more than 25
percent of the Nation's population and will comprise nearly 40 percent
by the year 2020. However, only 10.6 percent of the RNs in the United
States are self-identified as one or more of the racial and ethnic
minority groups. Increasing cultural and ethnic diversity in nursing
helps to address the prevention, treatment, and rehabilitation needs of
an increasingly diverse population. For fiscal year 2005, HRSA received
191 submissions for nursing workforce diversity grants. HRSA was able
to fund 97 (50 percent of applications).
Advanced Nurse Education.--Advanced practice registered nurses
(APRNs) are nurses who have attained advanced expertise in the clinical
management of health conditions. Typically, an APRN holds a master's
degree with advanced didactic and clinical preparation beyond that of
the RN. Most have practice experience as RNs prior to entering graduate
school. Practice areas include, but are not limited to: anesthesiology,
family medicine, gerontology, pediatrics, psychiatry, midwifery,
neonatology, and women's & adult health. Title VIII grants have
supported the development of virtually all initial State and regional
outreach models using distance learning methodologies to provide
advanced study opportunities for nurses in rural and remote areas. In
fiscal year 2006, these programs received $57 million.
These grants also provide traineeships for masters and doctoral
students. Title VIII funds more than 60 percent of U.S. nurse
practitioner education programs and assists 83 percent of nurse
midwifery programs. Over 45 percent of the nurse anesthesia graduates
supported by this program go on to practice in medically underserved
communities. Many provide care to minority or disadvantaged patients.
In fiscal year 2005, HRSA funded 81 advanced education nursing grants
(89 percent of applications), 347 advanced education nursing
traineeships (every application), and 75 nurse anesthetist traineeships
(every application).
Comprehensive Geriatric Education Grants.--This authority awards
grants to train and educate nurses in providing health care to the
elderly. Funds are used to train individuals who provide direct care
for the elderly, to develop and disseminate geriatric nursing
curriculum, to train faculty members in geriatrics, and to provide
continuing education to nurses who provide geriatric care. In fiscal
year 2006, these grants received $3.4 million.
The growing number of elderly Americans and the impending health
care needs of the baby boom generation make this program critically
important. In fiscal year 2005, HRSA received 43 applications for
comprehensive geriatric education grants. HRSA continued 17 previously
awarded grants and awarded 11 new ones (65 percent of applications).
national institute of nursing research (ninr)
ANA also urges the subcommittee to increase funding for the NINR,
one of the institutes at the National Institutes of Health (NIH). This
research is integral to improving the effectiveness of nursing care.
Advances in nursing care arising from behavioral and biomedical
research have shown excellent progress in reducing health care costs.
Research programs supported by NINR address a number of critical public
health and patient care questions. The research is driven by real and
immediate problems currently facing patients and their families.
Recent studies have illuminated the impact of placing a patient in
long term care on the patient's family caregiver, the impact of
maternal obesity prior to pregnancy on childhood weight problems, the
difference in heart attack symptoms in women versus men, the most
effective means to prevent infectious diseases in inner city
households, and the incidence and risk factors for uterine rupture in
pregnancies following cesarean section. NINR is leading the NIH
research on end-of-life and palliative care. NINR is also the lowest
funded institute at NIH. In fiscal year 2006, NINR received $137.3
million. ANA recommends $150 million in fiscal year 2007 NINR funding.
conclusion
While ANA appreciates the continued support of this subcommittee,
we are concerned that Title VIII funding levels have not been
sufficient to address the growing nursing shortage. The nursing
shortage will continue to worsen if significant investments are not
made. Recent efforts have shown that aggressive and innovative
recruitment efforts can help avert the impending nursing shortage--if
they are adequately funded.
ANA asks you to meet today's shortage with a relatively modest
investment of $175 million in Title VIII programs. Additionally, an
investment of $150 million in the NINR will help assure that these
nurses are equipped with the information needed to provide the best
care possible.
______
Prepared Statement of Americans for Nursing Shortage Relief
The undersigned organizations of the ANSR (Americans for Nursing
Shortage Relief) Alliance greatly appreciate the opportunity to submit
written testimony regarding fiscal year 2007 appropriations for Title
VIII--Nursing Workforce Development Programs. The ANSR Alliance is
comprised of fifty-one national nursing organizations that united in
2001 to identify and promote creative strategies for addressing the
nursing and nurse faculty shortages, including passage of the Nurse
Reinvestment Act of 2002--an important first step in increasing the
number of qualified nurses in America.
ANSR stands ready to work with policymakers to advance programs and
policies that will sustain and strengthen our Nation's nursing
workforce. To ensure that our Nation has a sufficient and adequately
prepared nursing workforce to provide quality care to every American
well into the 21st century, ANSR advocates for the following:
--At least $175 million in funding for Nursing Workforce Development
Programs under Title VIII of the Public Health Service Act at
the Health Resources and Services Administration (HRSA) in
fiscal year 2007.
the nursing shortage
Nurses play a critical role in this Nation's health care system.
With an estimated 2.9 million licensed registered and advanced practice
registered nurses (RNs and APRNs), nurses represent the largest
occupational group of health care workers and provide patient care in
virtually all locations in which health care is delivered. This coupled
by their scope of practice areas make the nursing shortage an even more
interesting challenge. Some facts to consider:
--The nursing workforce is aging. In 1980, 26 percent of RNs were
under the age of 30. Today, approximately 8 percent of RNs are
under the age of 30 with the average nurse 46.8 years of age;
--Approximately half of the RN workforce is expected to reach
retirement age within the next 10 to 15 years. The average age
of new RN graduates is almost 30 years.
--The Bureau of Labor Statistics report (December, 2005) projected
that registered nursing would create the second largest number
of new jobs among all occupations within 9 years. In addition,
employment of registered nurses is expected to grow much faster
than average for all occupations through 2014. It is
anticipated that approximately 703,000 additional jobs, for a
total of 3,096,000, will be available for RNs by this date.
--The national nursing shortage also is affecting our Nation's 7.6
million veterans who receive care through the 1,300 Veterans
Administration (VA) health care facilities;
--Nearly 1,800 faculty members leave their positions every year due
to factors of retirement or higher wages earned as a staff
nurse. Fewer than 400 faculty candidates receive their doctoral
degrees each year; and,
--The number of full-time nurse faculty required to ``fill the
nursing gap'' is approximately 40,000. Currently, the National
League for Nursing estimates that there fewer than 10,000 full-
time faculty members in the system.
the nursing supply impacts america's emergency preparedness
Nurses play a critical role as front-line, first-responders. When
word of the devastation caused by Hurricanes Katrina and Rita spread,
nurses across the country immediately volunteered in American Red Cross
shelters, medical clinics, and hospitals throughout that area. Nurse
midwives delivered babies in airplane hangars, and nurses trained in
geriatric care assisted in caring for those evacuated from the comforts
of their homes, assisted living facilities or nursing homes. Nurse
practitioners diligently staffed temporary and permanent health care
clinics to provide needed primary care to hurricane victims. In
addition, many nurses realized their role in the comfort and support
they offered as they listened to survivors recount their stories of
pain and tragedy.
These stories seem particularly relevant in demonstrating the
contributions that nurses provide during tragedies, and should
illustrate the need to ensure an adequate supply of all types of nurses
in all parts of the country. Unless steps are taken now, the Nation's
ability to respond to disasters will be further hindered by the growing
nursing shortage. An investment in the nursing workforce is a step in
the right direction to bolster our public health infrastructure and
increase our Nation's health care readiness and emergency response
capabilities.
the desperate need for nurse faculty
After years of declining interest, the nursing profession is seeing
the opposite occur. Many Americans have come to find nursing an
attractive career because of job security, salary levels, and the
opportunity to help others. However, the common theme among prospective
nursing students is that due to a lack of a sufficient number of
faculty they can face waiting periods of up to 3 years before
matriculating. When all nursing programs are considered, the number of
qualified applications turned away during the 2004-2005 academic year
was estimated to be more than 147,000 by the National League for
Nursing. Without sufficient support for current nurse faculty and
adequate incentives to encourage more nurses to become faculty, nursing
schools will fail to have the teaching infrastructure necessary to
educate and train the next generation of nurses that the Nation so
desperately needs.
the funding reality
Enacted in 2002, the Nurse Reinvestment Act included new and
expanded initiatives, including loan forgiveness, scholarships, career
ladder opportunities, and public service announcements to advance
nursing as a career. Despite the enactment of this critical measure,
HRSA fails to have the resources necessary to meet the current and
growing demands for our Nation's nursing workforce. For example, in
fiscal year 2003, HRSA received 8,321 applications for the Nurse
Education Loan Repayment Program but only had the funds to award 7
percent (602) of all applications. Also in fiscal year 2003, HRSA
received 4,512 applications for the Nursing Scholarship Program but
only had funding to support a mere 2 percent (94) of all applications.
The ANSR Alliance strongly urges this subcommittee to provide a
minimum of $17,505 million in fiscal year 2007 to fund Title VIII--
Nursing Workforce Development Programs. This level of investment will
help leverage the HRSA resources to fund a higher rate of Nurse
Education Loan Repayment and Nursing Scholarship applications, as well
as implement other essential endeavors to sustain and boost our
Nation's nursing workforce.
summary
----------------------------------------------------------------------------------------------------------------
President's
Programmatic area Final fiscal year budget fiscal ANSR's request
2006 year 2007
----------------------------------------------------------------------------------------------------------------
Title VIII: Nurse Workforce Development Programs at $149,000,000 $150,000,000 $175,000,000
HRSA..................................................
----------------------------------------------------------------------------------------------------------------
ansr alliance organizations
Academy of Medical-Surgical Nurses; American Academy of Ambulatory
Care Nursing; American Academy of Nurse Practitioners; American
Association of Critical-Care Nurses; American Association of Nurse
Anesthetists; American Association of Occupational Health Nurses, Inc.;
American College of Nurse-Midwives; American Organization of Nurse
Executives; American Society for Pain Management Nursing; American
Society of PeriAnesthesia Nurses; American Society of Plastic Surgical
Nurses; Association of periOperative Registered Nurses; Association of
Rehabilitation Nurses; Association of State and Territorial Directors
of Nursing; Association of Women's Health, Obstetric and Neonatal
Nurses; Dermatology Nurses' Association; Developmental Disabilities
Nurses Association; Emergency Nurses Association; Infusion Nurses
Society; National Association of Clinical Nurse Specialists; National
Association of Nurse Massage Therapists; National Association of
Orthopaedic Nurses; National Association of Pediatric Nurse
Practitioners; National Association of School Nurses; National Black
Nurses Association; National Conference of Gerontological Nurse
Practitioners; National Council of State Boards of Nursing; National
League for Nursing; National Student Nurses' Association; National
Nursing Centers Consortium; National Organization of Nurse Practitioner
Faculties; Nurses Organization of Veterans Affairs; Oncology Nursing
Society; Society for Urologic Nurses and Associates; Society of Trauma
Nurses; and Wound Ostomy Continence Nurses Society.
______
Prepared Statement of the American Public Power Association
The American Public Power Association (APPA) is the national
service organization representing the interests of over 2,000 municipal
and other State and locally owned utilities throughout the United
States (all but Hawaii). Collectively, public power utilities deliver
electricity to one of every seven electricity consumers (approximately
43 million people), serving some of the Nation's largest cities.
However, the vast majority of APPA's members serve communities with
populations of 10,000 people or less.
We appreciate the opportunity to submit this statement supporting
funding for the Low-Income Home Energy Production Assistance Program
(LIHEAP).
APPA has consistently supported an increase in the authorization
level for LIHEAP and supports the full authorization level of $5.1
billion for fiscal year 2007 as enacted in the Energy Policy Act of
2005.
APPA is proud of the commitment that its members have made to their
low-income customers. Many public power systems have low-income energy
assistance programs based on community resources and needs. Our members
realize the importance of having in place a well-designed low-income
customer assistance program combined with energy efficiency and
weatherization programs in order to help consumers minimize their
energy bills and lower their requirements for assistance. While highly
successful, these local initiatives must be coupled with a strong
LIHEAP program to meet the growing needs of low-income customers. In
the last several years, volatile home-heating oil and natural gas
prices, severe winters, high utility bills as a result of dysfunctional
wholesale electricity markets and the effects of the economic downturn
have all contributed to an increased reliance on LIHEAP funds.
Also when considering LIHEAP appropriations this year, we encourage
the subcommittee to provide advanced funding for the program so that
shortfalls do not occur in the winter months during the transition from
one fiscal year to another. LIHEAP is one of the outstanding examples
of a State-operated program with minimal requirements imposed by the
Federal Government. Advanced funding for LIHEAP is critical to enabling
States to optimally administer the program.
Thank you again for this opportunity to relay our support for
increased LIHEAP funding for fiscal year 2007. We look forward to a
favorable outcome.
______
Prepared Statement of the Association of Maternal and Child Health
Programs
The Association of Maternal and Child Health Programs (AMCHP) is a
national, non-profit organization representing leaders of State public
health programs for maternal and child health, including children with
special health care needs, in all 50 States, the District of Columbia,
and eight additional jurisdictions. Our members administer Title V
Maternal and Child Health Services Block Grant funds to improve the
health of mothers and children. We strongly urge you to restore funding
for the MCH Block Grant to the fiscal year 2005 level of $724 million.
First authorized in 1935, the MCH Block Grant provides for a wide
range of health services and fosters prevention of disease and
disabling conditions for over 32 million women and children across the
country. Funds from the MCH Block Grant enable States to provide women
with prenatal and postnatal care, screen newborns for genetic and
hereditary conditions; support childhood immunizations; reduce infant
mortality and developmentally handicapping conditions; and prevent
childhood accidents and injuries. Block grant funding enables State
agencies to tailor vital programs for women, children and families to
the needs of each community, while ensuring that the programs meet
national goals.
Since the program's inception, it has evolved into a powerful
Federal-State partnership. Each year, $600 million Federal are matched
by over $5 billion in State funds for maternal and child health
programs. These funds have enabled States to reach more than 80 percent
of infants, 50 percent of pregnant women and 20 percent of children in
the United States. Since 2000, the number of women and children served
has increased by almost 5 million, an increase of 18 percent.
In fiscal year 2006, $693 million was appropriated for the MCH
Block Grant, $31 million below the fiscal year 2005 comparable
appropriation. This loss of funds, as the number of women and children
needing services continues to increase, will impact the ability of
States to address areas of critical need. While President Bush
recommended level funding for the MCH program in his budget request, he
also recommended that Federal support for the Traumatic Brain Injury
program, Universal Newborn Hearing Screening, Emergency Medical
Services for Children and the Sickle Cell Anemia Demonstration Project
be eliminated. If this recommendation were enacted without a
commensurate increase in the block grant, States would be forced to
shift MCH Block Grant funds away from other pressing health priorities
to meet those addressed by these programs. We recommend that funding
for these four valuable programs be restored, in addition to the
restoration of the MCH Block Grant funding to the fiscal year 2005
level.
The flexibility of the block grant has allowed States to respond to
emerging health issues that affect women and children, such as the
rising infant mortality rates, particularly among minority populations,
and the availability of newborn screening for a newly expanded range of
diseases and disorders. Reducing the infant mortality rate is a goal of
the MCH Block Grant program, which will be difficult to achieve if
funding continues to erode. State maternal and child health programs
coordinate newborn screening and follow-up services, activities to
ensure that every infant born in this country receives screening tests
that detect disorders that could result in death or permanent
disabilities. The money spent on these screening programs saves lives,
and preserves State and Federal Government dollars that would otherwise
be spent on expensive, lifelong treatment and rehabilitative services
for infants whose genetic disorders go undetected. Level funding of the
MCH Block Grant will not allow States to meet the increasing demand for
newborn screening services.
Last year's budget cut has already had a real impact on State
programs, threatening the quality and quantity of care these programs
provide. The MCH Block Grant can not continue to do more with less.
Consider the following descriptions of the impact these cuts are having
at the State level:
--In Iowa, the impact of the MCH Block Grant cut means that the State
will not have the resources to address emerging public health
issues, such as planning for a potential bird flu pandemic. It
will, instead, be necessary to direct Title V resources toward
continuing existing programs. Infant mental health, smoking
cessation during pregnancy and obesity prevention programs will
all be short-changed as a consequence.
--Funding has been pulled from a large Healthy Communities Access
Program project in Washoe County, Nevada because of this year's
cuts just as it was making great inroads in systems development
for access to care for low-income families in that county.
Nevada has a community-based prenatal program that reached 600
participants in its first year. Demand for services has tripled
this year. Further cuts to the MCH Block Grant would
necessitate cutting this program, so fewer pregnant women would
be served. The MCH program has had to drop all its contracts
with community coalitions to promote access to care, which has
hampered the success of these activities.
--Alabama lost $409,339 in block grant funding in fiscal year 2006.
The Alabama MCH program has reduced staffing by attrition at
both the central office and county office levels. Nursing and
nursing assistants, administrative support, and epidemiology
services and medical equipment and supplies have been affected.
--In Washington State, reductions in the MCH Block grant, impact
women and children by minimizing or eliminating local community
activities. Many activities will either be eliminated or
drastically scaled back, including early childhood programs,
adolescent health care, mental health services, the Healthy
Youth Survey, newborn hearing screening, and services for
children with special health care needs. Multiple Federal cuts
mean than many of the MCH partners will also be reducing
efforts. With this reduction, Washington State will be moving
back in time, not even maintaining the status quo.
--In Michigan, cut backs in medical care and treatment for children
with special health care needs will be necessary as a result of
the $656,000 reduction in its allocation.
The dramatic effects are not unique to Iowa, Nevada, Alabama,
Washington State or Michigan, but affect all States and jurisdictions.
AMCHP recognizes the fiscal restraints facing this subcommittee.
Nevertheless, we can not stress enough what a dire situation MCH Block
Grant cuts are creating, especially given the cuts in the Medicaid
program and the fact that other safety net programs also face
reductions. Title V programs play a valuable, complementary role to the
SCHIP and Medicaid programs. As more women and children are forced out
of the Medicaid program, they will turn to MCH programs to ensure that
their health care needs are met. With increased demand for MCH Block
Grant services, States will be forced to limit already stretched
services to vulnerable populations.
Our children are the future. Their needs should not be short-
changed by budget limitations, but addressed effectively with adequate
funding. The MCH Block Grant has a proven track record of effectiveness
and supports health services for over 32 million Americans. We strongly
urge you to restore funding for the MCH Block Grant to the fiscal year
2005 level of $724 million.
______
Prepared Statement of the Centers for Disease Control and Prevention
Coalition
The CDC Coalition is a nonpartisan coalition of more than 100
groups committed to strengthening our Nation's prevention programs. Our
mission is to ensure that health promotion and disease prevention are
given top priority in Federal funding, to support a funding level for
the Centers for Disease Control and Prevention (CDC) that enables it to
carry out its prevention mission, and to assure an adequate translation
of new research into effective State and local programs. Coalition
member groups represent millions of public health workers, researchers,
educators, and citizens served by CDC programs. We are grateful to be
able to present our views to the subcommittee.
The CDC Coalition continues to believe that Congress should support
CDC as an agency--not just the individual programs that it funds. In
the best judgment of the CDC Coalition--given the challenges and
burdens of chronic disease, a potential influenza pandemic, terrorism,
disaster preparedness, new and re-emerging infectious diseases and our
many unmet public health needs and missed prevention opportunities--we
believe the agency will require funding of at least $8.5 billion, plus
sufficient funding to prepare the Nation against a potential influenza
pandemic. This request reflects the support CDC will need to fulfill
its core missions for fiscal year 2007, as well as funding for the
Agency for Toxic Substances and Disease Registry and the Vaccines for
Children program.
The CDC Coalition appreciates the subcommittee's work over the
years, including your recognition of the need to fund chronic disease
prevention, infectious disease prevention and treatment, and
environmental health programs at CDC. By translating research findings
into effective intervention efforts, CDC has been a key source of
funding for many of our State and local programs that aim to improve
the health of communities. Perhaps more importantly, Federal funding
through CDC provides the foundation for our State and local public
health departments, supporting a trained workforce, laboratory capacity
and public health education communications systems.
CDC also serves as the command center for our Nation's public
health defense system against emerging and reemerging infectious
diseases. With the potential onset of a worldwide influenza pandemic,
in addition to the many other natural and man-made threats that exist
in the modern world, the CDC has become the Nation's--and the world's--
expert resource and response center, coordinating communications and
action and serving as the laboratory reference center. States and
communities rely on CDC for accurate information and direction in a
crisis or outbreak.
Unfortunately, Congress cut overall CDC funding in fiscal year 2006
for the first time in 25 years. And in fiscal year 2007, the President
has proposed cutting CDC funding even more--more than 2 percent
overall, and more than 4.5 percent to CDC's core programs. We are
moving in the wrong direction, especially in these challenging times
when public health is being asked to do more, not less. In light of the
current workload placed on the public health service--in addition to
the threat of emerging diseases such as the avian flu--it simply does
not make any sense to cut the budget for CDC at a time when the threats
to public health are so great. Funding public health outbreak by
outbreak is not an effective way to ensure either preparedness or
accountability. Until we are committed to a strong public health
system, every crisis will force trade offs.
CDC serves as the lead agency for bioterrorism preparedness and
must receive sustained support for its preparedness programs in order
for our Nation to meet future challenges. In the best judgment of CDC
Coalition members, given the challenges of terrorism and disaster
preparedness, and our many unmet public health needs and missed
prevention opportunities, we support the proposed increase for anti-
terrorism activities at CDC, including the increases for the Strategic
National Stockpile and the new Botulinum Toxin Research funding.
However, we strongly caution that the President's proposed level-
funding of the State and local capacity grants continues to reflect a
$95 million cut from fiscal year 2005 levels. We encourage the
subcommittee to restore these cuts to ensure that our States and local
communities can be prepared in the event of an act of terrorism.
Heart disease remains the Nation's number one killer. In 2003,
684,462 people died of heart disease (51 percent of them women),
accounting for 28 percent of all U.S. deaths. Stroke is the third
leading cause of death after heart disease and cancer, and is a leading
cause of serious, long-term disability. In 2003, stroke killed 157,800
people (61percent of them women), accounting for about 1 of every 15
deaths. In 1998, the U.S. Congress provided funding for CDC to initiate
a national, State-based heart disease and stroke prevention program
with funding for eight States. Currently, 32 States and the District of
Columbia are funded, 19 as capacity building programs and 14 as basic
implementation programs. The CDC Coalition recommends $55 million for
the Heart Disease and Stroke Prevention Program.
The CDC funds proven programs addressing cancer prevention, early
detection, and care. Cancer is the second most common cause of death in
the United States. In 2006, about 1.4 million new cases of cancer will
be diagnosed, and about 564,830 Americans--more than 1,500 people a
day--are expected to die of the disease. The financial cost of cancer
is also significant. According to the National Institutes of Health, in
2005, the overall cost for cancer in the United States was nearly $210
billion: $74 billion for direct medical costs, $17.5 billion for lost
worker productivity due to illness, and $118.4 billion for lost worker
productivity due to premature death.
Among the ways the CDC is fighting cancer, it funds the National
Breast and Cervical Cancer Early Detection Program that helps low-
income, uninsured and medically underserved women gain access to
lifesaving breast and cervical cancer screenings and provides a gateway
to treatment upon diagnosis. CDC also funds grants to States to develop
Comprehensive Cancer Control (CCC) plans, bringing together a broad
partnership of public and private stakeholders to jointly set
priorities and implement specific cancer prevention and control
activities customized to address each State's particular needs. CDC
also funds programs to raise awareness about colorectal, prostate,
lung, ovarian and skin cancers, and the National Program of Cancer
Registries, a critical registry for tracking cancer trends in all 50
States. The CDC coalition recommends $427.5 million for the Cancer
Prevention and Control activities of the CDC.
Although more than 18 million Americans have diabetes, 5.2 million
cases are undiagnosed. From 1980--2002, the number of people with
diabetes in the United States more than doubled, from 5.8 million to
13.3 million. Each year, 12,000--24,000 people with diabetes become
blind, more than 42,800 develop kidney failure, and about 82,000 have
leg, foot, or toe amputations. Preventive care such as routine eye and
foot examinations, self-monitoring of blood glucose, and glycemic
control could reduce these numbers. Without additional funds, most
States will not be able to create programs based on these new data.
States also will continue to need CDC funding for diabetes control
programs that seek to reduce the complications associated with
diabetes.
Over the last 25 years, obesity rates have doubled among adults and
children, and tripled in teens. Obesity, diet and inactivity are cross-
cutting risk factors that contribute significantly to heart disease,
cancer, stroke and diabetes. The CDC funds programs to encourage the
consumption of fruits and vegetables, to get sufficient exercise, and
to develop other habits of healthy nutrition and activity. The CDC
Coalition recommends $70 million for CDC's Division of Nutrition and
Physical Activity.
Arthritis and chronic joint symptoms affect nearly 66 million
Americans and they are the Nation's leading cause of disability. Early
diagnosis and appropriate management of the disease can prevent much of
the pain and disability associated it. The CDC Coalition recommends
$14.4 million for the arthritis programs of the CDC.
More than 400,000 people die prematurely every year due to tobacco
use. The CDC's tobacco control efforts seek to prevent tobacco addition
in the first place, as well as help those who want to quit. The CDC
Coalition recommends $145 million for the CDC's tobacco control
programs.
Each day more than 4,000 young people try their first cigarette. At
the same time, daily participation in high school physical education
classes dropped from 42 percent in 1991 to 32 percent in 2001. Almost
80 percent of young people do not eat the recommended number of
servings of fruits and vegetables, while nearly 30 percent of young
people are overweight or at risk of becoming overweight. And every
year, almost 800,000 adolescents become pregnant and about 3 million
become infected with a sexually transmitted disease. School health
programs are one of the most efficient means of correcting these
problems, shaping our Nation's future health, education, and social
well-being. The CDC Coalition requests $34 million for CDC's Division
of Adolescent and School Health (DASH) Coordinated School Health
Program and $41.8 million for DASH's HIV prevention education programs.
Public health programs delivered at the State and local level
should be flexible to respond to State and local needs. Within an
otherwise-categorical funding construct, the Preventive Health and
Health Services Block Grant is the only source of flexible dollars for
States and localities to address their unique public health needs. The
track record of positive public health outcomes from Prevention Block
Grant programs is strong, yet so many requests go unfunded. However,
the President's budget proposes the elimination of the Preventive
Health and Health Services Block Grant--again. We appreciate the work
of the subcommittee to at least partially restore the fiscal year 2006
elimination of the Block Grant. Nevertheless, the $20 million cut to
the Block Grant in fiscal year 2006 reduces the States' ability to
tailor Federal public health dollars to their specific needs. As States
use their Prevention Block Grant dollars to address high priority needs
such as emerging and chronic diseases, child safety seat programs,
suicide prevention, smoke detector distribution and fire safety
programs, adult immunization, oral health, worksite wellness,
infectious disease outbreaks, food safety, emergency medical services,
safe drinking water, and surveillance needs--we can scarcely understand
why the Prevention Block Grant should be eliminated. We encourage the
subcommittee to restore the cuts and fund the Prevention Block Grant at
$132 million.
Much of CDC's work in chronic disease prevention and health
promotion is guided by its prevention research activities. Prevention
research considers the factors associated with illness, disability, and
injury, such as lifestyles or exposure to environmental toxins, and the
best ways to address these factors and thereby promote health. By
answering these questions, prevention research links biomedical
research, which focuses on human physiology and disease treatment, to
policies and public health interventions that promote wellness and
reduce the need for treatment.
CDC provides national leadership in helping control the HIV
epidemic by working with community, State, national, and international
partners in surveillance, research, prevention and evaluation
activities. The CDC estimates that up to 1,185,000 Americans are living
with HIV, one-quarter of whom are unaware of their infection. Also, the
number of people living with HIV is increasing, as new drug therapies
are keeping HIV-infected persons healthy longer and dramatically
reducing the death rate. Prevention of HIV transmission is our best
defense against the AIDS epidemic that has already killed over 500,000
U.S. citizens and is devastating the populations of nations around the
globe, and CDC's HIV prevention efforts must be expanded. The CDC
Coalition recommends that a total of $1.05 billion be appropriated to
the Division of HIV Prevention.
The United States has the highest sexually transmitted diseases
(STD) rates in the industrialized world. More than 18 million people
contract STDs each year. In 1 year, our Nation spends over $8.4 billion
to treat the symptoms and consequences of STDs. Elimination of STDs,
especially syphilis, is now within our grasp. These welcome
opportunities, if adequately funded now, will save millions in annual
health care costs in the future. Untreated STDs contribute to infant
mortality, infertility, and cervical cancer. State and local STD
control programs depend heavily on CDC funding for their operational
support.
CDC conducts the National Health and Nutrition Examination Survey
(NHANES), the only national source of objective health data to provide
accurate estimates of diagnosed and undiagnosed medical conditions in
the population. NHANES is a unique collaboration between CDC, the
National Institutes of Health (NIH), and others to obtain data for
biomedical research, public health, tracking of health indicators, and
policy development. Through physical examinations, clinical and
laboratory tests, and interviews, NHANES assesses the health status of
adults and children in the United States. Mobile exam centers travel
throughout the country to collect data on chronic conditions,
nutritional status, medical risk factors (e.g., high cholesterol level,
obesity, high blood pressure), dental health, vision, illicit drug use,
blood lead levels, food safety, and other factors that are not possible
to assess by use of interviews alone. Findings from this survey are
essential for determining rates of major diseases and health conditions
and developing public health policies and prevention interventions.
We must address the growing disparity in the health of racial and
ethnic minorities. CDC's REACH 2010 Demonstration Program, Racial and
Ethnic Approaches to Community Health (REACH), helps States address
these serious disparities in infant mortality, breast and cervical
cancer, cardiovascular disease, diabetes, HIV/AIDS and immunizations.
We encourage the subcommittee to provide adequate funds for CDC's REACH
program.
The CDC Coalition is requesting an appropriation of $49.75 million
for Steps to a HealthierUS (STEPS) program. Additional resources will
allow for the creation of programs in more States. Furthermore, while
the President's budget request includes $1.5 million to support the
YMCA Pioneering Healthier Communities initiative, $3 million is needed
to continue to expand this important effort. This would enable
additional communities to participate in this initiative, to allow on-
going training for communities and to support a Center for Community
Health Advancement at the CDC to assist the YMCA and other communities
undertaking healthy lifestyle initiatives to prevent and control
obesity and chronic disease.
CDC oversees immunization programs for children, adolescents and
adults, and is a global partner in the ongoing effort to eradicate
polio worldwide. The value of adult immunization programs to improve
length and quality of life, and to save health care costs, is realized
through a number of CDC programs, but there is much work to be done and
a need for sound funding to achieve our goals. Influenza vaccination
levels remain low for adults. Levels are substantially lower for
pneumococcal vaccination and significant racial and ethnic disparities
in vaccination levels persist among the elderly. Childhood immunization
programs at CDC also need a funding boost, to ensure sufficient
purchase and delivery of the varicella and pneumococcal vaccines. In
addition, developing functional immunization registries in all States
will be less costly in the long run than maintaining the incomplete
systems currently in place. The CDC Coalition requests $802.4 million
for the National Immunization Program at CDC.
Injuries are the leading cause of death in the United States for
people ages 1-34. Of all injuries, those to the brain are most likely
to result in death or permanent disability. Each year more than 50,000
people die as a result of a brain injury and as many as 90,000 others
are left with a long-term disability. A traumatic brain injury (TBI) is
defined as a blow or jolt to the head or a penetrating head injury that
disrupts the function of the brain. The Traumatic Brain Injury Act is
the Nation's only law that was specifically designed to respond to this
public health crisis. The Institute of Medicine reported this month
that this law has been effective in addressing a wide variety of gaps
in service system development. The CDC Coalition requests that the
subcommittee restore $30 million in appropriations for TBI programs at
CDC and at HRSA, which President Bush zeroed out. The monies would be
allocated as follows: CDC--$9 million; HRSA State Grant Program--$15
million; and HRSA Protection and Advocacy program--$6 million.
Injury at work remains a leading cause of death and disability
among U.S. workers. During the period from 1980 through 1995, at least
93,338 workers in the United States died as a result of injuries
suffered on the job, for an average of about 16 deaths per day. The
Bureau of Labor Statistics (BLS) at the Department of Labor has
identified 5,915 workplace deaths from acute traumatic injury in 2000.
BLS also estimates that 5.7 million injuries to workers occurred in
1997 alone; while NIOSH estimates that about 3.6 million occupational
injuries were serious enough to be treated in hospital emergency rooms
in 1998. The injury prevention and workforce protection initiatives of
NIOSH need continued support.
Of the 4 million babies born each year in the United States, 3
percent are born with one or more birth defects. Birth defects are the
leading cause of infant mortality, accounting for more than 20 percent
of all infant deaths. Children with birth defects who survive often
experience lifelong physical and mental disabilities. An estimated 54
million people in the United States currently live with a disability,
and 17 percent of children under the age of 18 have a developmental
disability. Direct and indirect costs associated with disability exceed
$300 billion.
Created by the Children's Health Act of 2000 (Public Law 106-310),
the National Center on Birth Defects and Developmental Disabilities
(NCBDDD) at CDC conducts programs to protect and improve the health of
children and adults by preventing birth defects and developmental
disabilities; promoting optimal child development and health and
wellness among children and adults with disabilities. We encourage the
subcommittee to provide at least $135 million in fiscal year 2007
funding for the NCBDDD. This would be a modest increase of $10 million
and would further surveillance, research and prevention activities
related to birth defects and developmental disabilities and improve the
lives of those living with disabilities.
We also encourage the subcommittee to provide $10 million for CDC's
Environmental Public Health Services Branch to revitalize environmental
public health services at the national, State, and local level. As with
the public health workforce, the environmental health workforce is
declining. Furthermore, the agencies that carry out these services are
fragmented and their resources are stretched. These services are the
backbone of public health and are essential to protecting and ensuring
the health and well being of the American public from threats
associated with West Nile virus, terrorism, E. coli and lead in
drinking water.
We appreciate the subcommittee's hard work in advocating for CDC
programs in a climate of competing priorities. We encourage you to
consider our request for $8.5 billion, plus sufficient funding to
prepare for a possible influenza pandemic, for CDC in fiscal year 2007.
______
Prepared Statement of the College of New Rochelle, NY
Mr. Chairman and Members of the subcommittee, on behalf of The
College of New Rochelle (CNR), and the thousands of New York City
metropolitan area residents impacted by our programs each year, I am
grateful for the opportunity to submit testimony to your committee
regarding our Center for Wellness project.
the national health care crisis: a need for the project
Government sources report that one of the most important issues
currently facing American society is the health care crisis. Among the
reasons cited are the escalating costs of health care, an increasing
lack of access to health insurance among the poor and middle class, an
aging population and a growing national shortage of qualified nurses
and other health care providers.
Recent data shows the following:
--Out of some 40 million Americans who are informal care givers, an
estimated 72 percent are women;
--Women represent 71 percent of Americans age 85+, the fastest
growing segment of the population;
--Almost two-thirds of Americans are overweight or obese;
--One in three Americans born in the year 2000 will develop Type 2
diabetes;
--Surveys indicate that 28 percent of high school girls think they
are overweight; 60 percent report trying to lose weight; 8
percent suffer from anorexia or bulimia;
--More than half of all Americans get too little physical activity;
--Some 45 million Americans have no health insurance; and
--Over 1 million new and replacement nurses will be needed nationwide
by 2020.
One significant health care issue is the individual's lack of
attention to participation in self-care. Government experts emphasize
the importance of widespread public awareness of basic health habits
and preventative care, as well as support for those seeking
preventative assistance in making better health and lifestyle choices.
In order to keep the crisis from increasing, the U.S. Department of
Health and Human Services, through the Office of Disease Prevention and
Health Promotion, has launched a national initiative, Healthy People
2010. Through its School of Nursing, and programs such as Healthy
Campus 2010, CNR has been participating actively in HHS initiatives for
many years, developing local health education programs which benefit
students and New York City metropolitan area residents, and which help
address national goals.
The Office of Disease Prevention and Health Promotion has
identified ten major public health issues based on their causal
relationship to serious or chronic illnesses. These are: insufficient
physical activity, overweight and obesity, decreasing environmental
quality, tobacco use, substance abuse, irresponsible sexual behavior,
mental health disorders, injury and violence, immunization
deficiencies, and lack of access to health care. People of all socio-
economic backgrounds are susceptible; however, the risk factors are
even greater among the poor, the elderly and the uninsured.
Moreover, recent studies reveal that those most at risk for
developing chronic and life-threatening conditions are African
Americans, Hispanics, and Asians--populations largely represented in
the New York metropolitan area where CNR has six campus locations
serving 7,000 students and many local residents.
the national nursing shortage: cnr's school of nursing
Compounding the health care crisis is the critical and
unprecedented nationwide shortage of nurses--one that is uniquely
different from previous shortages. Among the causes cited for this
growing problem are an aging nursing workforce, increased job
opportunities for women in other fields, and fundamental changes in how
and in what setting patients are treated. A compelling statistic is the
average age of nurses which is now over 45. A significant percentage of
nurses currently employed will most likely retire just as the baby boom
generation reaches Medicare age.
According to a recent Federal survey an estimated 1 million new and
replacement nurses will be needed nationwide by 2020. Government
leaders are stressing the urgency of embarking on a national agenda to
encourage more students to choose nursing as a career. Among their
recommendations are the creation of incentives to recruit new
candidates to the profession, and the broad-scale development of
creative approaches for the continuing preparation and retention of
skilled nurses.
CNR's School of Nursing (SON), founded in 1976, belongs to the
National League for Nursing and is accredited by the Commission on
Collegiate Nursing Education. The School is ideally poised to assume a
leadership role in enacting the national recommendations cited above.
In recent years, the School has been especially successful in
recruiting students (including many from disadvantaged backgrounds) and
in fostering a lifelong commitment to nursing careers. Enrollment in
SON has increased by 25 percent over the past 2 years. At present,
there are 669 students enrolled in SON: 580 in the baccalaureate
program and 89 in the masters program. SON programs are addressing the
shortage by creating initial student access to the nursing profession
and also by providing a career ladder for nurses seeking to advance
their careers. Five separate programs are offered:
--Undergraduate program leading to a Bachelor of Science Degree in
Nursing (BSN);
--Programs of study for registered nurses seeking either a BSN or a
Master of Science Degree;
--BSN program for those holding degrees in other fields;
--Graduate program with several tracks leading to an MS Degree in
Nursing; and
--Several post-Master certificate programs.
A pivotal function of CNR's multi-faceted Center for Wellness
project includes the building of a new state-of-the-art facility on the
College's New Rochelle campus, providing space for nursing and health
education classes and events. This will heighten the visibility of
nurses as educators as a crucial part of the nursing profession
throughout the New York City area and beyond. The new facility and its
related health and wellness education programs also hold much promise
for drawing a greater number of students to SON as well as providing
expanded access and opportunity for nurses seeking to acquire
additional professional skills and/or further their careers.
the center for wellness at the college of new rochelle
The proposed Center for Wellness will be a state-of-the-art multi-
purpose facility at the College's main campus and will house Nursing
programs, Physical Education, Health Education and Health Services
programs. The faculty will create a comprehensive center for the
development and delivery of a broad range of integrated health and
wellness education programs. The program will include a variety of
health and educational activities in an intergenerational fashion to
involve students, employees, and members of the surrounding community.
Health seminars will cover a wide variety of issues including parenting
and women's issues, smoking, diabetes, heart disease, nutrition and
weight issues, sex education and assault issues, drug abuse prevention
and treatment, and wellness education. The School of Nursing will offer
courses and workshops in wellness and disease prevention, not only
through the curriculum in the School of Nursing, but also to the
students, staff and faculty in Westchester and at the branch campuses.
The integrated wellness program will be supplemented with fitness and
education programs targeted to specific populations such as the New
Rochelle School District, the Senior Center of New Rochelle and the
United Hebrew Home.
The programs at the Center for Wellness will provide access to
timely information and help foster lifelong healthy lifestyle choices
among students, faculty and staff at the main campus and throughout the
five metropolitan New York communities where CNR has city campus
locations. At these city campuses, CNR will give busy low-income adult
students access to wellness promotion, health maintenance and fitness
programs on campus. For example, the College is working with the New
York City health education program ``Take Care New York'' to educate
all of our students on the necessity of a healthy lifestyle. CNR will
also use distance learning technology so that faculty and staff at its
campuses can share their own expertise, as well as that of national
experts, with CNR students and community members.
The College of New Rochelle recognizes that preventative health
care is vital to our Nation's future. This Center will position CNR as
a model institution for the development and delivery of innovative
health and wellness education. CNR believes that this holistic approach
to wellness will serve as motivation for more students to enter the
field of nursing and thus begin to alleviate the nursing shortage. The
programs, adaptable to the needs of many different communities and
populations, will be able to be replicated at other institutions
regionally and nationally.
The total cost to establish the Center for Wellness is estimated at
$25 million. Through the support of the subcommittee, The College of
New Rochelle received funding through the Labor, HHS and Education
Appropriations Bill in the amount of $200,000 in 2005. CNR has utilized
this funding for the development of wellness education programs that
have benefited CNR students, middle school students, and senior
citizens from the area surrounding the New Rochelle Campus. In fiscal
year 2007, The College hopes that the subcommittee can fund our request
of $2.7 million to construct and equip the Center.
______
Prepared Statement of the Diabetes Care Coalition
Mr. Chairman and members of the Committee, thank you for the
invitation today to discuss how government, private industry and non-
governmental agencies can form innovative partnerships to address the
epidemic of uncontrolled diabetes in America. This raging epidemic is
simply too great a challenge for any but a collective effort.
I know this subcommittee has little ability to change the fiscal
reality that you must produce an appropriations bill that, for a second
consecutive year, must reduce spending under your jurisdiction by
multiple billions of dollars. This fiscal reality does not change the
fact that one out of every three people with diabetes will suffer a
heart attack by age 40, every day 144 Americans with diabetes will go
blind, every hour three people with diabetes will undergo an
amputation, and every minute 20 people with diabetes undergo kidney
dialysis. The sad fact is most of these and other complications of
diabetes are preventable through known interventions. But, not everyone
living with diabetes is aware of some of the simple things they can do
to monitor their disease and prevent some of these terrible
consequences.
My entire career has been dedicated to improving the care of people
with diabetes, through research into the causes of diabetes
complications, and how to improve diabetes care. I have been President
of the American Diabetes Association, a member of the Coalition I
represent today, and the founding Chairman of the private-public
partnership of the National Diabetes Education Program (NDEP), which
was funded by the National Institutes of Health and the Centers for
Disease Control and Prevention (CDC) to improve the care of Americans
with diabetes. I am also the Medical Advisor to the Diabetes Care
Coalition (DCC) on whose behalf I am speaking today.
As Dr. Gerberding told the House of Representatives Appropriations
Subcommittee on Labor, Health and Human Services, Education, and
Related Agencies in March 2006, ``where we invest, we can make a
difference''. I am here today to tell you that the DCC is committing
significant private sector resources to mount a critical public
awareness campaign aimed at improving the health of individuals with
diabetes. We are initiating discussions with experts at the CDC, and
are excited about the potential opportunity to develop an innovative
partnership with this world-renown agency to leverage scarce Federal
resources, and combine our efforts with theirs, to immediately begin to
reduce the burden of this rapidly growing disease.
In this difficult fiscal environment where we are seeing the CDC
budget cut this year by hundreds of millions of dollars, and the
President's proposal to cut it again by almost $200 million next year,
we believe it is imperative to encourage creative solutions to reach
the millions of Americans living with diabetes with information that
can ultimately prevent heart attacks, strokes, blindness, amputations,
and other complications of this disease. The DCC represents what is
truly a creative solution to combat the problem of uncontrolled
diabetes.
The DCC was born out of a recognition by its various participants
that Americans with diabetes lack a basic understanding of how best to
control their disease to reduce their risk of complications like heart
attacks and strokes. The DCC's pilot ``Know Your A1C'' campaign
represents a novel approach to empower people with diabetes to take
personal responsibility by working with their diabetes healthcare team
to manage the disease.
Personally, I am concerned that the Federal Government's commitment
to battling the epidemic of uncontrolled diabetes is under-funded and
potentially losing ground. Since 2003, the CDC estimates that the
prevalence of diabetes in America increased 14 percent. Over 20.8
million adult Americans live with diabetes today compared to 18.2
million in 2003. While I recognize the limitations on the Federal
budget and the tough choices that have to be made in this Committee
every day, now is not the time to approve declining budgets for our
Federal programs that aim to prevent and manage diabetes.
I do not want to overwhelm you with facts and figures, but it is
clear from even a brief review that diabetes is about to overwhelm
America's medical system. By providing you with perspective related to
the reach of diabetes, I trust you will appreciate the need to invest
in battling uncontrolled diabetes before its impact devastates our
health system. The place our Nation needs to make this investment is
here in your appropriations bill, in the CDC.
Diabetes strikes across age groups, economic status, and ethnicity.
Projections for the future are even more ominous. The Yale Schools of
Public Health and Medicine project the population of Americans living
with diabetes will increase two and a half times by 2025. Supporting
this projection, the CDC estimates that 33 percent of all children and
nearly one half of minority children born in the year 2000 will develop
diabetes by 2050.
The economic cost of diabetes is enormous. In 2002, the total
economic impact of diabetes was $132 billion. Put another way, 1 out of
every 10 health care dollars spent in the United States is spent on
diabetes care and its complications. CMS estimates that 32 percent of
the Medicare budget goes towards caring for Americans with diabetes--an
amazing one-third of the entire Medicare program that is struggling
with long-term solvency issues far more critical and a near-term fiscal
crisis than Social Security solvency.
The human costs of uncontrolled diabetes are more shocking:
--2 out of 3 people with diabetes in America will die of a heart
attack or stroke.
--Diabetes is the leading cause of blindness, causing 12,000 to
24,000 new cases each year.
--Diabetes is the leading cause of kidney failure, accounting for 43
percent of new cases in 2002.
--More than 60 percent of non-traumatic lower-limb amputations occur
in people with diabetes.
Unfortunately, most diabetes patients are not controlling the risk
factors that can keep them healthy. A1C is a compelling example of this
trend. A1C is the single most important measure of glucose control over
time and a proven risk factor for all major diabetes complications. A1C
is a test that shows glucose control over the previous 3 months; sort
of a diabetes batting average except that lower is better.
Diabetes patients should know their A1C number and work to keep it
in check--similar to blood pressure or cholesterol levels. The test is
paid for by managed care, Medicare, and most private insurance plans;
there are few financial barriers to being in the know.
However, a recent study by the New York State Department of Health
found that 89 percent of patients with diabetes did not know their A1C.
Worse, even among those who knew their A1C, 80 percent had A1C's above
the value deemed acceptable by all diabetes organizations. Nationally,
the CDC estimates that 65 percent of all diabetes patients are out of
control, defined by the CDC as ``an A1C level above 7.''
I urge this Committee to consider, based on the dire state of
diabetes in America, whether we can or should continue to overlook the
basic diabetes care needs of Americans. The answer to me seems obvious;
we must embark on an aggressive campaign to encourage Americans to
manage diabetes to control its staggering human and financial costs
that encompass all sectors of the American community.
The DCC works to bridge the diabetes management knowledge gap by
educating diabetes patients and their healthcare teams on ways to
battle uncontrolled diabetes primarily through A1C awareness and
management. Through public education in its initial test markets, the
DCC aims to help diabetes patients take control of their disease and
live longer, healthier lives--without the specter of heart attack,
stroke, amputation, or kidney failure.
The American Diabetes Association and the Juvenile Diabetes
Research Foundation International are jointly leading the DCC's ``Know
Your A1C'' campaign to battle uncontrolled diabetes in America.
Providing financial support to this novel non-branded, public-private
partnership are six of the world's leading pharmaceutical and medical
device companies: Abbott Diabetes Care Inc., Becton, Dickinson and
Company, LifeScan, Inc., Novo Nordisk Inc., Roche Diagnostics
Corporation, and sanofi-aventis U.S. Inc.
The ``Know Your A1C'' campaign is different from other public
service campaigns. It encourages Americans and their families to
control diabetes by focusing primarily on the message that patients
need to know and to manage their A1C. Prior to launching its campaign,
the DCC conducted research to determine the most effective way to
encourage patients to manage diabetes and the findings supported a sole
focus on A1C control.
The campaign utilizes television, radio and print placements to
reach families affected by diabetes in the pilot markets. While these
placements consist of paid advertising today, beginning in late 2006,
most of the effort will rely on public service announcements generated
under an agreement with the Ad Council.
The effort is enhanced by the sales teams of the corporate
supporters who distribute unbranded educational materials into medical
offices, clinical laboratories, pharmacies, diabetes educators' offices
and any other location likely to be frequented by a person with
diabetes in the pilot markets. The campaign also provides an order
fulfillment system via 800 number allowing people to request basic
materials associated with the campaign, a website and direct mail to
healthcare professionals to ensure campaign materials have the broadest
reach possible in the test markets.
In 2006, the DCC will expand upon its 2005 ``Know Your A1C'' pilot
program in Atlanta and Tampa. This year, the campaign will reach the
television and radio markets of Atlanta, GA, Lexington, KY, Little
Rock, AR and Memphis, TN.
The DCC is expanding its focused campaign simply because it is
proven to work. Consider some of these compelling highlights of the
campaign's achievements in 2005 in Atlanta and Tampa.
--An improvement in the number of patients with diabetes who report
obtaining an A1C test in the past 3 months from a low of 25
percent prior to campaign launch to an average of 52 percent
during the campaign.
--An increase in patient with diabetes understanding of A1C awareness
from a low of 38 percent among people with diabetes prior to
the launch of the campaign to an average of 54 percent by the
end of the campaign; and
--An increase in patient with diabetes understanding of what the A1C
test measures from a low of 17 percent prior to the campaign to
an average of 41 percent during the campaign.
Based upon these results, the Ad Council will join the DCC to
refine the ``Know Your A1C'' campaign and transform it from a regional
effort into a national public service campaign. This campaign is
expected to launch in late 2006. Plus, the campaign hopes to reach
English and Spanish speaking populations. I hope you share in my
enthusiasm for this program as it could potentially transform America's
ambivalence towards the uncontrolled diabetes epidemic into a national
call to action.
We would like to build on the current NIH and CDC patient awareness
campaigns and will soon talk to CDC about the best ways to work with it
to improve patient awareness of A1C levels. This may include CDC
support for needed patient and healthcare provider components that
inform Americans with diabetes how they can and should manage the
disease not presently part of the campaign. Components the DCC would
like to incorporate in the campaign include more aggressive healthcare
provider education tools, documents informing families how to help
manage a family member's diabetes, information detailing steps patients
can take for A1C control, components that speak more directly to multi-
cultural audiences and a more robust order fulfillment program.
While the Diabetes Care Coalition will provide an expanded national
``Know Your A1C'' campaign in late 2006 and the personnel necessary to
distribute the materials associated with the campaign, a partnership
with the Federal Government will enable us to expand and enhance our
campaign. A public-private partnership will give us the expertise and
funding needed to take the battle to all Americans and their healthcare
teams to eliminate uncontrolled diabetes. This makes economic and
humanitarian sense.
Today, the DCC joins the American Diabetes Association in
requesting an increase in the CDC diabetes prevention and control
program by $20.8 million in fiscal year 2007. Given the scope and reach
of diabetes, we believe this is a modest request even in this budget
climate.
We also encourage this Committee to urge the CDC to dedicate new
and existing resources for its diabetes control program to battling
uncontrolled diabetes. To best serve the American people, CDC must
equally address both aspects of controlling this disease--primary
prevention activities to stop new cases of diabetes, as well as
secondary prevention activities to improve the health of the 20.8
million people living with diabetes.
Members of the Committee, the time to battle the epidemic of
uncontrolled diabetes is now. If we miss this opportunity, America will
lose substantial ground and run the risk of never getting the diabetes
epidemic under control.
Unfortunately, the 20.8 million Americans living with diabetes
today represent ``the low water mark'' in the reach and scope of the
disease. It is time to realize that diabetes is here to stay in America
and to act in a way that accepts this truth. Please help empower
Americans living with diabetes, and the growing numbers who will live
with it tomorrow, to ``Know Your A1C'' by providing the CDC with the
resources needed to battle the epidemic of uncontrolled diabetes.
Thank you for your time and consideration.
______
Prepared Statement of the InterTribal Bison Cooperative
introduction and background
My name is Ervin Carlson, a Tribal Council member of the Blackfeet
Tribe of Montana and President of the InterTribal Bison Cooperative.
Please accept my sincere appreciation for this opportunity to submit
testimony to the honorable members of the Appropriations Sub-Committee
on Labor, Health and Human Services and Education. The InterTribal
Bison Cooperative (ITBC) is a Native American non-profit organization,
headquartered in Rapid City, South Dakota, comprised of 57 federally
recognized Indian Tribes located within 19 States across the United
States.
Buffalo thrived in abundance on the plains of the United States for
many centuries before they were hunted to near extinction in the 1800s.
During this period of history, buffalo were critical to survival of the
American Indian. Buffalo provided food, shelter, clothing and essential
tools for Indian people and insured continuance of their subsistence
way of life. Naturally, Indian people developed a strong spiritual and
cultural respect for buffalo that has not diminished with the passage
of time.
Numerous tribes that were committed to preserving the sacred
relationship between Indian people and buffalo established the ITBC as
an effort to restore buffalo to Indian lands. ITBC focused upon raising
buffalo on Indian Reservation lands that did not sustain other economic
or agricultural projects. Significant portions of Indian Reservations
consist of poor quality lands for farming or raising livestock.
However, these wholly unproductive Reservation lands were and still are
suitable for buffalo. ITBC began actively restoring buffalo to Indian
lands after receiving funding in 1992 as an initiative of the Bush
administration.
Upon the successful restoration of buffalo to Indian lands,
opportunities arose for Tribes to utilize buffalo for tribal economic
development efforts. ITBC is now focused on efforts to assure that
tribal buffalo projects are economically sustainable. Federal
appropriations have allowed ITBC to successfully restore buffalo the
tribal lands, thereby preserving the sacred relationship between Indian
people and buffalo. The respect that Indian tribes have maintained for
buffalo has fostered a serious commitment by ITBC member Tribes for
successful buffalo herd development. The successful promotion of
buffalo as a healthy food source will allow Tribes to utilize a
culturally relevant resource as a means to achieve self-sufficiency.
funding request for preventative health care initiative
The InterTribal Bison Cooperative respectfully requests an
appropriation for fiscal year 2007 in the amount of $2,000,000 in the
form of an earmark to the Department of Health and Human Service
Department's budget. ITBC intends to utilize the funds to conduct a
national demonstration project focused on the delivery of bison meat to
Native Americans suffering from diet related diseases.
The Native American population currently suffers from the highest
rates of Type 2 diabetes. The Indian population further suffers from
high rates of cardio vascular disease and various other diet related
diseases. Studies indicate that Type 2 diabetes commonly emerges when a
population undergoes radical diet changes. Native Americans have been
forced to abandon traditional diets rich in wild game, buffalo and
plants and now have diets similar in composition to average American
diets. More studies are needed on the traditional diets of Native
Americans versus their modern day diets in relation to diabetes rates.
However, based upon the current data available, it is safe to assume
that disease rates of Native Americans are directly impacted by a
genetic inability to effectively metabolize modern foods. More
specifically, it is well accepted that the changing diet of Indians is
a major factor in the diabetes epidemic in Indian Country.
Approximately 65-70 percent of Indians living on Indian
Reservations receive foods provided by the USDA Food Distribution
Program on Indian Reservation (FDPIR) or from the USDA Food Stamp
Program. The FDPIR food package is composed of approximately 58 percent
carbohydrates, 14 percent proteins and 28 percent fats. Studies have
shown that the FDPIR food package has not been compatible with the
genetic compositions of Native Americans and has been a major factor in
the high incidence of diet-related disease among Native Americans.
Indians utilizing Food Stamps generally select a grain based diet and
poorer quality protein sources such as high fat meats based upon
economic reasons and the unavailability of higher quality protein food
sources.
Buffalo meat is low in fat and cholesterol and is compatible to the
genetics of Indian people. ITBC intends to develop a health care
initiative that would educate Indian Reservation families of the
benefits of incorporating buffalo meat into their diets. In conjunction
with educating Reservation families on the benefits of buffalo meat,
ITBC intends to develop methods to make buffalo meat accessible for
Indian families and to promote incorporation of buffalo into their
diets. ITBC intends to coordinate with Reservation health care
providers in nutritional studies of Reservation populations that
incorporate buffalo meat into diet packages.
ITBC believes that incorporating buffalo meat will positively
impact the diets of Indian people living on Reservations. A healthy
diet for Indian people that results in a lower incidence of diabetes
and other diet related illnesses will reduce Indian Reservation health
care costs and result in a savings for taxpayers.
funding request for itbc training and labor program
The InterTribal Bison Cooperative respectfully requests an
appropriation for fiscal year 2007 in the amount of $500,000. This
amount is $400,000 above the fiscal year 2006 appropriation for ITBC
and is critical to maintain last years funding level and to develop
ITBC's training and labor program.
In fiscal year 2005, the ITBC and its member Tribes were funded at
$100,000, a decrease of $200,000 from the previous year. ITBC is now
requesting $500,000 for fiscal year 2007 for job training as part of
ITBC's labor initiative. To insure the success of ITBC' s buffalo
restoration efforts to Indian lands, training for the various jobs
related to the buffalo projects is essential. Most member Tribes of
ITBC have reservation unemployment rates of 72 percent. Jobs
opportunities on most Indian Reservations are limited, low-paying, and
often seasonal and temporary. The jobs created by buffalo restoration
to Indian lands will positively impact Tribal unemployment rates and
the overall Reservation poverty levels. Raising buffalo as an economic
development effort requires skilled labor in permanent employment. ITBC
has developed a job training program incorporating on-the-job training
and work experience for youth that specifically addresses the unique
needs of managing and maintaining buffalo. ITBC's training program
further focuses on strengthening the economic development opportunities
of buffalo restoration with training specific to meat processing,
veterinary science, wildlife and biological services, infrastructure
development, business and management training, and the overall
development of a skilled workforce.
Sufficient funding for job training is critical to the success of
the buffalo restoration projects. The increase in funding will ensure
that ITBC can provide job training, job growth training to ITBC member
tribes. Without funding at the requested level, the buffalo restoration
projects have less assurance of success.
itb goals and initiatives
In addition to developing a preventative health care initiative,
ITBC intends to continue with buffalo restoration efforts and the
Tribal buffalo marketing initiative.
In 1991, seven Indian Tribes had small buffalo herds, with a
combined total of 1,500 animals. The herds were not utilized for
economic development but were often maintained as wildlife only. During
ITBC's relatively short 10-year tenure, it has been highly successful
at developing existing buffalo herds and restoring buffalo to Indian
lands that had no buffalo prior to 1991. Today, through the efforts of
ITBC, over 35 Indian Tribes are engaged in raising over 15,000 buffalo.
All buffalo operations are owned and managed by Tribes and many
programs are close to achieving self-sufficiency and profit generation.
ITBC's technical assistance is critical to ensure that the current
Tribal buffalo projects gain self-sufficiency and become profit-
generating. Further, ITBC's assistance is critical to those Tribes
seeking to start a buffalo restoration effort.
Through the efforts of ITBC, a new industry has developed on Indian
reservations utilizing a culturally relevant resource. Hundreds of new
jobs directly and indirectly revolving around the buffalo industry have
been created. Tribal economies have benefited from the thousands of
dollars generated and circulated on Indian Reservations.
conclusion
ITBC has proven highly successful since its establishment to
restore buffalo to Indian Reservation lands to revive and protect the
sacred relationship between buffalo and Indian Tribes. Further, ITBC
has successfully promoted the utilization of a culturally significant
resource for viable economic development.
ITBC has assisted Tribes with the creation of new jobs, on-the-job
training and job growth in the buffalo industry resulting in the
generation of new money for tribal economies. ITBC is also actively
developing strategies for marketing Tribally owned buffalo. Finally,
and most critically for Tribal populations, ITBC is developing a
preventive health care initiative to utilize buffalo meat as a healthy
addition to Tribal family diets to reduce the incidence of diet-related
illnesses.
ITBC strongly urges you to support its request for a $2,000,000
earmark to the Department of Health and Human Service Department's
budget to develop the critically needed preventative health care
initiative utilizing Tribally produced buffalo.
______
Prepared Statement of the John B. Amos Cancer Center
Mr. Chairman and members of the subcommittee, I appreciate the
opportunity to submit testimony to the hearing record regarding the
John B. Amos Cancer Center (JBACC) in Columbus, Georgia. JBACC is a
comprehensive community cancer center designed to address the continuum
of the disease from prevention and early detection through treatment,
survivorship and palliation.
Accredited by the Commission on Cancer, American College of
Surgeons, JBACC's mission is to provide exceptional quality-driven
care. Accordingly, we have opened a (49,620 sq. ft.) hospital-based
cancer center located on its own campus and surrounded by meditation
gardens. This unique facility is designed to address cancer along a
disease management approach allowing patients, families, and the
community at large to enter our services at any point in the disease
process whether it is for education, diagnosis, treatment, or
psychosocial support. Our outreach programs are a significant component
of our action plan to improve the health of the region, as well.
Further development of these programs is the reason I address you
today.
As you are aware, the John B. Amos Cancer Center received fiscal
year 2005 Labor, HHS, and Education Appropriations. I would like to
thank the subcommittee for this support and elaborate on the success of
our programs thus far.
Leveraging community and government support, we have developed
extensive Breast and Cervical Cancer Screening Programs that allow us
to reach many underserved areas of the 14 county region encompassing
our service area. Community Health Advisors (CHAs) trained and educated
by JBACC in collaboration with the West Georgia Cancer Coalition to
address cancer education, prevention, and diagnostic care, assist in
the facilitation of community screenings to maximize the effect of the
screening events. These CHAs are native to the communities they serve
and therefore possess intuitive knowledge necessary for conducting
successful community screenings such as appropriate venues and
marketing techniques for the respective population. Other factors, such
as matching a bilingual CHA with Hispanic communities to increase
accessibility and comfort levels are also considered.
Screenings are conducted on a weekly basis in communities
throughout the region. Rural communities are specifically targeted as
screening sites at least once a month. A culturally diverse
multidisciplinary team extends a comprehensive approach to providing
care and access to services at these events. This is a level of service
previously unattainable in some areas. The team includes a bilingual
physician, a nurse practitioner, a nurse, a case manager, and clerical
personnel. Additionally, volunteers are often available to set up
educational materials. The CHAs often attend the events as well and may
sometimes act as liaisons between patients and the JBACC staff.
By the point at which many patients walk into the Amos Cancer
Center facility, the disease has advanced to a stage at which treatment
and cure is exceedingly difficult. Therefore, the primary goal of
community screenings is to promote and make available early detection
and treatment options. To this end, initial on-site exams are performed
free of charge, regardless of ability to pay, to increase service
accessibility. Abnormal exams are referred to care coordinators for
referral for additional screenings or diagnostic testing, as
applicable. Dependent upon the patient's schedule, this can usually be
achieved with the same week as the initial screening. A surgical
consult is provided 2 to 4 days after testing, if necessary. If further
investigation is warranted, coordinators access the system to see that
the patient's needs, including financial and psychological are met. The
target timeline objective is two weeks from exam to diagnosis and
treatment. Identification of cervical abnormalities is slightly more
involved and requires a timeline of approximately 3.5 to 4 weeks.
The outreach program is not limited to screenings. Educational
programs and cancer prevention programs are provided to organizations
throughout the region. These include breast health lectures provided to
churches, sororities, and healthcare groups, and providing educational
materials and interactive displays for cancer-themed events on local
college campuses. These events reinforce the importance of early
detection.
We have developed a successful early detection outreach program.
The requested funding of $2 million in fiscal year 2007 would allow us
to expand the program to be even more effective within the fourteen
county region in which 511,736 citizens reside. Expansion efforts would
allow us to reach traditionally underserved populations by scheduling
screenings in communities not yet familiar with our programs. This
includes rural and urban areas in both Georgia and Alabama, some of
which lie in the socio-economically deprived ``Black Belt''.
In addition to the community screenings, funding would provide for
the development of two permanent weekly cancer screening clinics. These
clinics would allow citizens the peace of mind of the availability of
set screening opportunities, rather than waiting for a local
opportunity to occur.
Funding from JBACC's fiscal year 2005 Labor, HHS, Education
Appropriation was limited to breast and cervical cancer screening.
However, we have identified a need and an opportunity within the
community to focus on men's health issues as well, through prostate
screenings. The requested funding would allow for the expansion of our
outreach program to include this component. Incorporation of prostate
screenings into our existing program could occur seamlessly. This would
allow us to expand our focus to include a population previously not
served in this capacity. Excluding skin cancers, prostate cancer is the
most common cancer in American men. While the statistics regarding
prostate cancer are staggering, early detection and more effective
treatment methods have led to lower death rates in recent years. This
further underscores the need for prostate screening programs in
underserved areas to improve the health status of the region.
The requested funding would also provide for colorectal screenings.
This year, nearly 150,000 men and women will be diagnosed with
colorectal cancer while approximately 56,000 will die from it. Once
again, however, early detection and treatment are essential to
increased survival rates. However, studies indicate that many people
are often uncomfortable talking about the disease. They are also
misguided on their risk factors and chance of getting the disease.
Overcoming these obstacles to diagnosis and treatment can be achieved
through community educational and screening opportunities.
Mr. Chairman, John B. Amos Cancer Center is committed to improving
the health of the region by addressing and embracing the Healthy People
2010 focus areas of overall cancer deaths. Recognizing that to reach
our goals we must design programs that engage the region in our early
detection and screening programs, we have taken great strides to do so.
We believe in the documented success of our outreach programs and hope
that the subcommittee will provide $2 million toward program expansion.
Through the expansion, we will reach underserved populations and reduce
cancer mortality and morbidity, thereby improving the health of the
region in accordance with the goals of the Department of Health and
Human Services as well as this subcommittee.
______
Prepared Statement of Matria Healthcare
summary of fiscal year 2007 recommendations
--Provide full funding in fiscal year 2007 for the Health and Human
Services (HHS) Health Information Technology Initiative,
including funding for the Office of the National Coordinator
for Health Information Technology (ONCHIT) and the Agency for
Healthcare Research and Quality (AHRQ).
--Provide a 5 percent increase for fiscal year 2007 to the National
Institutes of Health (NIH) budget. Within NIH, provide an
increase of 5 percent to the National Library of Medicine
(NLM).
--Urge the National Coordinator for the Office of the National
Coordinator for Health Information Technology (ONCHIT), the
National Library of Medicine (NLM) at the National Institutes
of Health (NIH), the Agency for Healthcare Research and Quality
(AHRQ), and the Centers for Medicare and Medicaid Services
(CMS) to conduct outreach activities to all public and private
sector organizations which have demonstrated capabilities in
health information technology, particularly to those who have
demonstrated capabilities in disease management technology as
it relates to saving health care dollars, and improving care
for chronically ill individuals and the workforce.
Chairman Specter and members of the subcommittee, thank you for the
opportunity to present this written statement regarding the importance
of health information technology, specifically as it relates to disease
management technology, saving health care dollars, and improving care
for chronically ill individuals and the workforce.
Matria Healthcare is a national leader in disease management. Our
disease management programs have been adopted by leading corporations,
health plans, and State governments as a proven solution for reducing
costs and improving health and productivity. Because 15 percent of the
population typically drives 85 percent of healthcare costs, Matria
believes the strongest, most effective healthcare solutions start with
a strong disease management program to begin curbing costs immediately.
The disease management component of Matria's health enhancement
offering provides management programs for the Nation's most costly
chronic diseases, episodic conditions, and issues affecting the
psychosocial well-being of patients and has produced outcomes like no
other provider. Matria's industry-leading TRAX technology platform
represents the state-of-the-art in healthcare data warehousing and
protocol-driven healthcare delivery. This platform is driving the
clinical and financial outcome success of Matria in over one hundred
Fortune 1000, health plan, and State government programs. Matria's
technology platform is being utilized by members of the National
Coordinator for Health Information Technology's Interoperability
Consortium to successfully improve clinical outcomes and reduce
healthcare expenditures amongst its employees.
In April 2004, President Bush revealed his vision for the future of
healthcare in the United States. The President's plan involves a health
care system that puts the needs of the patient first, is more
efficient, and is cost-effective. At this time, he established, within
the Office of the Secretary of Health and Human Services, an Office of
the National Coordinator for Health Information Technology (ONCHIT).
Among other things, this office is meant to ensure that appropriate
information is available to guide medical decisions, improve healthcare
quality, reduce healthcare costs resulting from inefficiency, medical
errors, inappropriate care, and incomplete information, promote a more
efficient marketplace, greater competition, and increase in choice, and
improve the coordination of care and information among hospitals,
laboratories, physician offices, and other ambulatory care providers.
Matria's health enhancement offerings are consistent with these
goals of the President and the ONCHIT. In the transition towards a
health care system where informed consumers will own their personal
health records, health savings accounts, and health insurance, it is
important for the Federal Government to partner with public and private
sector organizations which have demonstrated capabilities in this
arena.
Health information technology will improve the practice of medicine
and make it more efficient. The rapid implementation of secure and
interoperable electronic health records will, for example,
significantly improve the safety, quality, and cost-effectiveness of
health care. To implement this vision, Matria urges the subcommittee to
support the President's budget request of $116 million for the ONCHIT
to provide strategic direction for development of a national
interoperable health care system. Matria also encourages the
subcommittee to support the $50 million Health Information Technology
Initiative through the Agency for Healthcare Research and Quality
(AHRQ) to accelerate the development, adoption, and diffusion of
interoperable information technology in a range of health care
settings. Additionally, Matria urges the subcommittee to provide a 5
percent increase for fiscal year 2007 to the National Institutes of
Health (NIH) budget, and within NIH, provide a proportional increase of
5 percent to the National Library of Medicine (NLM).
Finally, Matria encourages the subcommittee to urge the National
Coordinator for the ONCHIT, NLM, AHRQ, and the Centers for Medicare and
Medicaid Services (CMS) to conduct outreach activities to all public
and private sector organizations which have demonstrated capabilities
in health information technology, particularly to those who have
demonstrated capabilities in disease management technology as it
relates to saving health care dollars, and improving care for
chronically ill individuals and the workforce.
By working together, the goal of creating an efficient national
healthcare system will be realized. Thank you for allowing me to submit
this testimony to you today.
______
Prepared Statement of the National Alliance to End Homelessness
The National Alliance to End Homelessness (the Alliance) is a
nonpartisan, nonprofit organization that has several thousand partner
agencies and organizations across the country. These partners are local
faith-based and community-based nonprofit organizations and public
sector agencies that provide homeless people with shelter, transitional
and permanent housing, and services such as substance abuse treatment,
job training, and health and mental health care. In addition, we have
supported over 220 State and local entities as they create 10 year
plans to end homelessness. The Alliance represents a united effort to
address the root causes of homelessness and challenge society's
acceptance of homelessness as an inevitable by-product of American
life.
Overview.--Adequate social services program funding is essential to
ending homelessness. Housing must be coupled with appropriate services
such as health care, employment preparation, mental health and
substance abuse treatment, child care, and youth directed programs to
be effective. These programs were put to the test as social service
agencies assisted Katrina evacuees. The Social Services Block Grant,
the Community Services Block Grant, Projects for Assistance in
Transition from Homelessness, Education for Homeless Children and Youth
funded school liaisons and Health Care for the Homeless clinics among
others were essential as the gulf coast residents overcame their
housing crisis. These lessons illustrate how HHS, Labor, and Education
programs can help those homeless due to other crises such as job loss
or catastrophic illness.
goals
1. Moving Forward to End Homelessness.--By implementing 10 year
plans to end homelessness, communities across America are ending
homelessness. Communities are using Federal, State, and local funds to
help homeless persons, some of whom have been homeless for years,
maintain housing. It is important that this progress not be undermined.
To this end, the Alliance recommends the following:
A. Allocate $55 million for services in permanent supportive
housing within SAMHSA's Center for Mental Health Services.
B. Reject cuts to the Grants for the Benefit of Homeless
Individuals/Treatment for Homeless Individuals (GBHI) and
insure that additional local programs can access these funds.
C. Increase funding to Projects for Assistance in Transition from
Homelessness (PATH) to $65 million.
D. Increase the Runaway and Homeless Youth Act Programs to $140
million and reject detrimental policy recommendations.
E. Fund Education for Homeless Children and Youth services at its
full authorized level of $70 million.
F. Increase funding for the Homeless Veterans Reintegration
Program to $50 million.
2. Connecting Homeless Families, Individuals, and Youth to
Mainstream Services.--The estimated 3.5 million people who are homeless
throughout a year depend on mainstream programs such as the ones below
to live day to day and once housed, remain housed. These programs help
address the complex situations persons experiencing homelessness are
trying to overcome. The Alliance recommends the following to meet this
goal:
A. Fund the Social Services Block Grant at $1.7 billion, the same
funding level as fiscal year 2006.
B. Reject elimination of the Community Services Block Grant.
C. Appropriate $171 million for the Health Care for the Homeless
programs within the Health Resource Services Administration's
Consolidated Health Centers program.
D. Appropriate $60 million in education and training vouchers for
youth exiting foster care under the Safe and Stable Families
Program.
Goal #1--Moving Forward to End Homelessness
Support Services for Permanent Supportive Housing Projects
The Alliance recommends allocating $55 million for services in
permanent supportive housing within SAMHSA's Center for Mental Health
Services. The administration has set a goal of ending chronic
homelessness by 2012. We know this goal is attainable based on evidence
based practices. For example, through the collaborative initiative
grants program, HHS, the Department of Veterans Affairs, and HUD have
funded programs and seen results. These eleven grants have ended
homelessness for 550 people who cumulatively had over 5,000 years of
homelessness. Unfortunately, funding for these grants will end in 2006.
The President has proposed an increase of $209 million for the
McKinney/Vento homelessness programs as part of the proposed fiscal
year 2007 HUD budget to primarily pay for housing for those who are
chronically homeless. No such investment has been included for HHS.
Treatment for Homeless Individuals
The Alliance recommends that Congress fully reject cuts in Grants
for the Benefit of Homeless Individuals (GBHI) funding and work to
strengthen the program for additional grantees. Maintaining programs
such as GBHI is essential to achieving the President's goal of ending
chronic homelessness by 2012. Mainstream health, welfare, addiction,
and mental health programs often do not adequately serve homeless
people. In 2003, the U.S. Department of Health and Human Services
studied mainstream programs and their ability to serve chronically
homeless populations. The report, entitled Ending Chronic Homelessness:
Strategies for Action, explained that no mainstream program is
comprehensive enough to adequately serve chronically homeless people.
Thus, HHS included in the recommendations that future program budgets
should focus on funding programs directed for chronic homelessness.
There are a variety of reasons mainstream programs fail to
adequately service people who are chronically homeless. Many programs
simply lack the ability to fund or coordinate the full range of health,
housing, and support services required to adequately help homeless
people. Grants through the Treatment for Homeless Individuals/Grants
for the Benefit of Homeless Individuals (GBHI) program help homeless
service providers assemble services that meet the complex needs of
their clients and maintain their housing.
Projects for Transition Assistance from Homelessness (PATH)
The Alliance recommends that Congress increase PATH funding to $65
million.
The PATH program provides homeless people with serious mental
illnesses access to mental health services. PATH focuses on outreach to
eligible consumers, followed by help in ensuring that those consumers
are connected with mainstream services. Under the PATH formula grant,
approximately 30 States share in the program's annual appropriations
increases. The remaining States and territories receive the minimum
grant of $300,000 for States and $50,000 for territories. These amounts
have not been raised since the program was authorized in 1991. To
account for inflation, the minimum allocation should be raised to
$600,000 for States and $100,000 for territories. Amending the minimum
allocation requires a legislative change. If the authorizing committees
do not have sufficient time to address this issue, we hope that
appropriators will explore ways to make the amendment through
appropriations bill language.
Runaway and Homeless Youth Programs
The Alliance recommends funding the Runaway and Homeless Youth Act
(RHYA) programs at $140 million. RHYA programs support cost-effective,
community and faith-based organizations that protect youth from the
harms of life on the streets. The problems of homeless and runaway
youth are addressed by the Administration for Children and Families
within HHS, which operates coordinated competitive grant programs like
RHYA. The RHYA programs can either reunify youth safely with family or
find alternative living arrangements. RHYA programs end homelessness
by: engaging youth living on the street with Street Outreach Programs,
quickly providing emergency shelter and family crisis counseling
through the Basic Centers, or providing supportive housing that helps
young people develop lifelong independent living skills through
Transitional Living Programs.
Education for Homeless Children and Youth
The Alliance recommends funding Education for Homeless Children and
Youth (EHCY) at its full authorized level of $70 million. The most
important potential source of stability for these children is school.
The mission of the Education for Homeless Children and Youth program is
to ensure that homeless children can continue to attend school and
thrive. A struggle for homeless service providers who serve families
with children is to maintain the children's stability during a time
when their lives are turned upside down. Even if new housing can be
found in a short time, the lasting effects of a spell of homelessness
can be devastating.
The Education for Homeless Children and Youth program, within the
Department of Education's Office of Elementary and Secondary Education,
removes obstacles to enrollment and retention by establishing liaisons
between schools and shelters and providing funding for transportation,
tutoring, school supplies, and the coordination of statewide efforts to
remove barriers.
Homeless Veterans Reintegration Program (HVRP)
The Alliance recommends that Congress increase HVRP funding to $50
million.
HVRP, within the Department of Labor's Veterans Employment and
Training Service (VETS), provides competitive grants to community-
based, faith-based, and public organizations to offer outreach, job
placement, and supportive services to homeless veterans. HVRP is the
primary employment services program accessible by homeless veterans and
the only targeted employment program for any homeless subpopulation.
The Department of Labor estimates that 8,750 homeless veterans will be
served through HVRP at the fiscal year 2006 appropriation level of $22
million. This figure represents just 2 percent of the overall homeless
veteran population, which the Department of Veterans Affairs estimates
numbers more than 400,000 over the course of a year. An appropriation
at the authorized level of $50 million would enable HVRP grantees to
reach approximately 19,866 homeless veterans.
Goal #2--Connecting Homeless Families, Individuals and Youth to
Mainstream Services
Social Services Block Grant (SSBG)
The Alliance recommends that Congress fully restore SSBG funding to
its fiscal year 2006 level of $1.7 billion. Cuts to programs like the
SSBG will create additional barriers for communities trying to achieve
the President's goal of ending chronic homelessness by 2012. SSBG funds
are essential for programs dedicated to ending homelessness. In
particular, youth housing programs and permanent supportive housing
providers often receive State, county, and local funds which originate
from the SSBG. As the U.S. Department of Housing and Urban Development
has focused its funding on housing, programs that provide both housing
and social services have struggled to fund the service component of
their programs. This gap is often closed using Federal programs such as
SSBG.
Community Services Block Grant (CSBG)
The Alliance recommends that Congress fully restore CSBG funding to
its fiscal year 2006 level of $630 million. Eliminating funding for the
CSBG will destabilize the progress communities have made toward ending
homelessness by not only ending services directly provided by CSBG
funds but limiting a community's ability to access other Federal
dollars such as those provided by HUD. This runs contrary to the
President's stated goal of ending chronic homelessness by 2012.
Community Action Agencies (CAAs) are directly involved in housing and
homelessness services. In several communities, CAAs lead the Continuum
of Care (CoC). CoCs coordinate local homeless service providers and the
community's McKinney-Vento Homeless Assistance Grant application
process with the Department of Housing and Urban Development.
In the fiscal year 2004 Community Services Block Grant Information
Systems report published by the U.S. Department of Health and Human
Services, CAAs reported administering $207.4 million in Section 8
vouchers, $30 million in Section 202 services \1\ and $271.1 million in
other Department of Housing and Urban Development (HUD) programs which
includes homeless program funding.\2\
---------------------------------------------------------------------------
\1\ Section 202 is dedicated to housing from elderly and disabled
individuals and families.
\2\ U.S. Department of Health and Human Services, Administration of
Children and Families. The Community Services Block Grant Fiscal Year
2004 Statistical Report. Prepared by the National Association for State
Community Services Programs.
---------------------------------------------------------------------------
Health Care for the Homeless (HCH)
The Alliance recommends $171 million, the amount recommended by the
President, for HCH (8.7 percent of the $1.963 billion requested for the
Consolidated Health Centers account). Persons living on the streets
suffer from health problems resulting from or exacerbated by the
conditions of being homeless, such as hypothermia, frostbite, and
heatstroke. In addition, they often have infections of the respiratory
and gastrointestinal systems, tuberculosis, vascular diseases such as
leg ulcers, and hypertension.\3\ Health care for the homeless programs
are vital to prevent these conditions from becoming fatal. Congress
allocates 8.7 percent of the Consolidated Health Centers account for
Health Care for the Homeless (HCH) projects. The HCH program has
achieved significant success since its inception in 1987, but the
health care needs Americans experiencing homelessness each year far
exceed the service capacity of Health Care for the Homeless grantees.
The President's fiscal year 2007 budget would create 15 to 20 new
projects, serving an additional 25,000 to 30,000 people experiencing
homelessness.
---------------------------------------------------------------------------
\3\ Harris, Shirley N, Carol T. Mowbray and Andrea Solarz. Physical
Health, Mental Health and Substance Abuse Problems of Shelter Users.
Health and Social Work, Vol. 19, 1994.
---------------------------------------------------------------------------
Foster Youth Education and Training Vouchers
The Alliance recommends that Congress appropriate $60 million in
education and training vouchers for youth exiting foster care under the
Safe and Stable Families Program. The Education and Training Voucher
Program offers funds to foster youth and former foster youth to enable
them to attend colleges, universities and vocational training
institutions. Students may receive up to $5,000 a year for college or
vocational training education. The funds may be used for tuition,
books, housing, or other qualified living expenses. Given the large
number of people experiencing homelessness who have a foster care
history, it is important to provide assistance such as these education
and training vouchers to stabilize youth, prevent economic crisis, and
prevent possible homelessness.
conclusion
Homelessness is not inevitable. As communities implement plans to
end homelessness, they are struggling to find funding for the services
homeless and formerly homeless clients need to maintain housing. The
Federal investments in mental health services, substance abuse
treatment, employment training, youth housing, and case management
discussed above will help communities create stable housing programs
and change social systems which will end homelessness for millions of
Americans.
______
Prepared Statement of the National Association of Community Health
Centers
On behalf of more than 1,000 health center grantees across the
country serving more than 15 million patients, the National Association
of Community Health Centers (NACHC) is pleased to submit this statement
for the record, and thank the subcommittee for its continued support
and investment in the Health Centers program.
about health centers
Over more than 40 years, the Health Centers program has grown from
a small demonstration project providing desperately needed primary care
services in underserved communities to one of the fundamental elements
of our Nation's health care safety net. Funding was approved in 1965
for the first two neighborhood health center demonstration projects,
one in Boston, Massachusetts, and the other in Mound Bayou,
Mississippi.
Today, America's health centers are helping communities meet
escalating health needs and address costly and devastating health
problems, from prenatal and infant health development to chronic
illness (like diabetes and asthma), to mental health, substance
addiction, domestic violence and HIV/AIDS. Health centers are the
family doctor for 1 in 8 uninsured individuals, and 1 in every 5 low-
income children. Health centers serve as the primary health care safety
net for many communities across the country and the Federal grant
program enables more low-income and uninsured patients to receive care
each year.
Every Federally Qualified Health Center (FQHC) is governed by a
community board with a patient majority--a true patient democracy.
Health centers are required to be located in a federally designated
Medically Underserved Area (or MUA), and must provide a package of
comprehensive primary care services to anyone who comes in the door,
regardless of their ability to pay. At the typical health center,
roughly one-quarter of the operating revenues are from the Federal
grant; and just over 40 percent are from reimbursement through Federal
insurance programs, principally Medicare and Medicaid. The balance of
the revenues are from State and community partnerships, privately
insured individuals, and patients ability to pay.
The Health Centers program is administered by the Bureau of Primary
Health Care (BPHC) at the Health Resources and Services Administration
(HRSA), within the U.S. Department of Health and Human Services (HHS).
funding background
The subcommittee has approved substantial funding increases for the
Consolidated Health Centers program over the past several years
resulting in a broad expansion effort to serve many of those that
remain underserved in our country. Most recently, the increase in
funding approved for fiscal year 2006 will help more than 600,000
additional Americans gain access to effective, affordable primary and
preventive care services offered by our Nation's Health Centers.
Since 2001, the subcommittee has increased funding for Health
Centers in order to stabilize existing centers and meet the goals of
the President's initiative--1,200 new or expanded centers and an
additional 6.1 million patients served by 2006. To date, the expansion
has brought high-quality services to an additional 4 million Americans
and has produced new or expanded facilities in over 800 communities
nationwide. Even with the increases provided over the past several
years, hundreds of communities submitted applications that received
high ratings but could not be funded, due to lack of funds. There is
clearly a tremendous need and a tremendous desire to expand health
center services to new communities.
The health centers program has succeeded in expanding access to
primary and preventive care services in underserved communities across
the country. The Office of Management and Budget rated the Health
Centers program as one of the top 10 Federal programs, and the best
competitive grant program within all of HHS. With additional resources,
health centers stand ready to provide low-cost, highly effective care
to millions more uninsured and underserved individuals and families.
fiscal year 2007
In his fiscal year 2007 budget proposal, President Bush requested
an increase for the Health Centers program of $181 million, for a total
funding level of $1.963 billion in fiscal year 2007. NACHC strongly
supports the President's requested increase for the program, which will
continue the historic expansion of the Health Centers program into
hundreds of additional communities nationwide.
In 2005, President Bush called for ``a community health center in
every poor county'' in America. NACHC strongly supports this goal and
urges Congress to provide funds to begin this critical expansion
effort. NACHC was encouraged that the administration did not recommend
waiving the statutorily designated proportionality requirements for
Migrant, Public Housing and Homeless Health Centers in order to
implement this second expansion initiative.
In addition to the expansion efforts, it is critical that Federal
funding for health centers keep pace with the growing cost of
delivering care. NACHC requests that the subcommittee designate $50
million of any increase in funding to be used to make base grant
adjustments for existing centers, allowing an average increase of 2.8
percent in current health center grants, equal to the Medicare Economic
Index. Under the subcommittee's leadership, Congress has provided base
grant adjustments for existing centers in 5 out of the 7 previous
fiscal years. A recent study by NACHC found that in the 2 years that
these adjustments were not included in the Health Centers
appropriation, the number of patient visits per grantee actually
decreased.
NACHC appreciates the subcommittee's leadership in stabilizing the
Federal Tort Claims Act (FTCA) judgment fund for health centers in past
years. For fiscal year 2007, the President has requested that
$44,500,000 be appropriated for this purpose. This is the same funding
level as last year, and NACHC expects it will be sufficient to cover
FTCA claims in 2007.
In 1997, Congress authorized and began funding the HRSA Loan
Guarantee Program (LGP) for the construction, renovation, and
modernization of health centers. Demand for this guarantee program has
accelerated significantly in the last year. NACHC expects that at the
current rate of usage, the remaining $5 million in credit subsidy will
be entirely used during fiscal year 2006. In response that the success
of this program, NACHC is requesting an additional $5 million be
provided until expended for additional loan guarantees. The LGP has
proven to be a vital resource for health centers across the country as
they seek financing to fund the facilities necessary to accommodate the
growth in patient visits resulting from recent expansion efforts.
Finally, Health Centers support funding for other Federal programs
that are integral to the continued expansion and strength of community
health centers. These include:
--$150 million for the National Health Service Corps, which is the
largest source of health professionals for health centers;
--$250 million for Title III of the Ryan White CARE Act, which
provides grants to health centers and other safety net
providers for outpatient early intervention services;
--$550 million for Title VII and Title VIII Health Professions
programs, particularly Area Health Education Centers, which
bring together academic and community partners to improve the
supply and distribution of health professionals in underserved
communities.
--$170 million for health information technology (HIT) resources
through various programs at the Department of Health and Human
Services. Health centers must have adequate resources through
HHS to facilitate the utilization of electronic health records
and other important HIT tools to promote health disparities
reduction.
conclusion
America's health centers are grateful to the subcommittee for its
ongoing efforts to support and stabilize the Health Centers program and
to expand health centers' reach into more than 5,000 communities
nationwide. As a result of those efforts, more than 15 million people
have access to the affordable, effective primary care services that our
Nation's health centers provide.
We respectfully ask that the subcommittee continue that investment,
as the work of caring for our uninsured and medically underserved is
far from complete. Some 36 million Americans are still without regular
access to medical services. America's health centers look forward to
meeting that need and rising to the challenge of providing a health
care system that works for all Americans. We look forward to working
with you over the coming year to move toward that goal.
If you need any additional information or have any questions
related to health centers or NACHC, please do not hesitate to contact
me or John Sawyer, Assistant Director of Federal Affairs, at (202) 331-
4603, or via email at jsawyer@nachc.com.
______
Prepared Statement of the National Association for State Community
Services Programs
The National Association for State Community Services Programs
(NASCSP) thanks this committee for its continued support of the
Community Services Block Grant (CSBG), and seeks an appropriation of
$650 million for the State grant portion of the CSBG, the same as its
fiscal year 2004 appropriation. We are requesting that the CSBG funding
be restored to the fiscal year 2004 level this year in order for the
CSBG Network to continue addressing the long-term needs of those
families affected by Hurricanes Katrina and Rita, those families
transitioning from welfare to work, and to assist low-income workers in
remaining at work through supportive services such as transportation
and child care. It is essential that the CSBG funding be restored in
full for fiscal year 2007. The across the board cuts the CSBG has
experienced the past several years have decreased the ability of the
CSBG Network to provide essential services to low-income Americans.
In addition, NASCSP urges this Committee to eliminate all
authorization language regarding the management of the CSBG from the
fiscal year 2007 appropriation bill. In fiscal year 2006, the
appropriations bill included authorization language regarding the use
of the block grant at the State level. Specifically, the fiscal year
2006 appropriations report included the following authorization
language which conflicted with ``SEC. 675C. USES OF FUNDS (A)(3) of the
Public Law 105-285: The Community Opportunities, Accountability, and
Training and Educational Services Act of 1998 (the CSBG authorization
law): ``That to the extent Community Services Block Grant funds are
distributed as grant funds by a State to an eligible entity as provided
under the Act, and have not been expended by such entity, they shall
remain with such entity for carryover into the next fiscal year for
expenditure by such entity consistent with program purposes.''
The 1998 CSBG Authorization allows CSBG eligible entities to carry
over up to 20 percent of funds but requires the State to recapture or
redistribute any funds that exceed 20 percent. According to the 1998
CSBG Authorization, once these funds are recaptured the State is to
redistribute the excess funds to other low-income communities in dire
need of additional funds. When language such as the above is placed in
the Appropriations document, it overrides the Authorization language.
The inclusion of such language in the appropriations report caused a
hardship on States as they managed the block grant. Passing national
legislation which contradicts the authorization language regarding the
distribution of funds preempts the prerogative of States. NASCSP urges
the committee to discourage the incorporation of authorization language
in the appropriations act.
NASCSP is the national association that represents State
administrators of the Community Services Block Grant (CSBG), and State
directors of the Department of Energy's Low-Income Weatherization
Assistance Program.
background
The States believe the Community Services Block Grant (CSBG) is a
unique block grant that has successfully devolved decision making to
the local level. Federally funded with oversight at the State level,
the CSBG has maintained a local network of nearly 1,100 agencies which
coordinate nearly $9.7 billion in Federal, State, local, and private
resources each year. Operating in 99 percent of counties in the Nation
and serving nearly 15.2 million low-income persons, local agencies,
known as Community Action Agencies (CAAs), provide services based on
the characteristics of poverty in their communities. For one town, this
might mean providing job placement and retention services; for another,
developing affordable housing; in rural areas it might mean providing
access to health services or developing a rural transportation system.
Since its inception, the CSBG has shown how partnerships between
States and local agencies benefit citizens in each State. We believe it
should be looked to as a model of how the Federal Government can best
promote self-sufficiency for low-income persons in a flexible,
decentralized, non-bureaucratic and accountable way.
Long before the creation of the Temporary Assistance for Needy
Families (TANF) block grant, the CSBG was setting the standard for
private-public partnerships that work to the betterment of local
communities and low-income residents. Family oriented, while promoting
economic development and individual self-sufficiency, the CSBG relies
on an existing and experienced community-based service delivery system
of CAAs and other non-profit organizations to produce results for its
clients.
major characteristics of the community services network
Emergency Response.--CAAs are utilized by Federal and State
emergency personnel as a frontline resource to deal with emergency
situations such as floods, hurricanes and economic downturns. They are
also relied on by citizens in their community to deal with individual
family hardships, such as house fires or other emergencies.
In fact, during and after Hurricane Katrina and Rita the State CSBG
offices and local CAAs quickly mobilized to provide immediate and long-
term assistance to over 355,000 evacuees. This immediate assistance
included, but was not limited to, transportation, food, medical check-
ups, housing, utility deposits, job placement, and clothing. State CSBG
offices and CAAs across the country coordinated their relief efforts
with other agencies providing disaster relief assistance such as FEMA,
Red Cross, and other faith-based and community-based organizations.
State CSBG offices through their local network of CAAs continue to
provide the long-term assistance evacuees will need as they relocate
and re-establish themselves through self-sufficiency and family
development programs. These programs offer comprehensive approaches to
selecting and offering supportive services that promote, empower and
nurture the individuals and families seeking economic self-sufficiency.
At a minimum, these approaches include:
--A comprehensive assessment of the issues facing the family or
family members and of the resources the family brings to
address these issues;
--A written plan for becoming more financially independent and self-
supporting;
--A comprehensive mix of services that are selected to help the
participant implement the plan;
--Professional staff members who are flexible and can establish
trusting, long-term relationships with program participants;
and
--A formal methodology used to track and evaluate progress as well as
to adjust the plan as needed.
Additional information on the CSBG Network's Hurricane Katrina
relief efforts may be found in the attached issue brief.
Accountable.--The Federal Office of Community Services, State CSBG
offices and CAAs have worked closely to develop a results-oriented
management and accountability (ROMA) system. Through this system,
individual agencies determine local priorities within six common
national goals for CSBG and report on the outcomes that they achieved
in their communities.
Leveraging Capacity.--For every CSBG dollar they receive, CAAs
leverage $4.87 in non-federal resources (State, local, and private) to
coordinate efforts that improve the self-sufficiency of low-income
persons and lead to the development of thriving communities.
Volunteer Mobilization.--CAAs mobilize volunteers in large numbers.
In fiscal year 2004, the most recent year for which data are available,
the CAAs elicited more than 44 million hours of volunteer efforts, the
equivalent of almost 21,182 full-time employees. Using just the minimum
wage, these volunteer hours are valued at nearly $227 million.
Locally Directed.--Tri-partite boards of directors guide CAAs.
These boards consist of one-third elected officials, one-third low-
income persons and one-third representatives from the private sector.
The boards are responsible for establishing policy and approving
business plans of the local agencies. Since these boards represent a
cross-section of the local community, they guarantee that CAAs will be
responsive to the needs of their community.
Adaptability.--CAAs provide a flexible local presence that
governors have mobilized to deal with emerging poverty issues.
The statutory goal of the CSBG is to ameliorate the effects of
poverty while at the same time working within the community to
eliminate the causes of poverty. The primary goal of every CAA is self-
sufficiency for its clients. Helping families become self-sufficient is
a long-term process that requires multiple resources. This is why the
partnership of Federal, State, local, and private enterprise has been
so vital to the successes of the CAAs.
who does the csbg serve?
National data compiled by NASCSP show that the CSBG serves a broad
segment of low-income persons, particularly those who are not being
reached by other programs and are not being served by welfare programs.
Based on the most recently reported data, from fiscal year 2004:
--More than 2.7 million customer families have incomes at or below
the poverty level; 1.1 million customer families have incomes
at or below 50 percent of the poverty guidelines. In 2004, the
poverty level for a family of three was $15,670.
--58 percent of adults have a high school diploma or equivalency
certificate.
--44 percent of all customer families are ``working poor'' and have
wages or unemployment benefits as income.
--23 percent depend on pensions and Social Security and are therefore
poor, former workers.
--Almost 430,000 families are TANF participants, 22 percent of the
average monthly TANF caseload.
--Nearly 60 percent of families assisted have children under 18 years
of age.
what do local csbg agencies do?
Since Community Action Agencies operate in rural areas as well as
in urban areas, it is difficult to describe a typical Community Action
Agency. However, one thing that is common to all is the goal of self-
sufficiency for all of their clients. Reaching this goal may mean
providing day care for a struggling single mother as she completes her
General Equivalency Diploma (GED) certificate, moves through a
community college course and finally is on her own supporting her
family without Federal assistance. It may mean assisting a recovering
substance abuser as he seeks employment. Many of the Community Action
Agencies' clients are persons who are experiencing a one-time
emergency. Others have lives of chaos brought about by many overlapping
forces--a divorce, sudden death of a wage earner, illness, lack of a
high school education, closing of a local factory or the loss of family
farms.
CAAs provide access to a variety of opportunities for their
clients. Although they are not identical, most will provide some if not
all of the services listed below:
--a variety of crisis and emergency safety net services;
--employment and training programs;
--transportation and child care for low-income workers;
--individual development accounts;
--micro business development help for low-income entrepreneurs;
--local community and economic development projects;
--housing and weatherization services;
--Head Start;
--energy assistance programs;
--nutrition programs;
--family development programs; and
--senior services.
CSBG funds many of these services directly. Even more importantly,
CSBG is the core funding which holds together a local delivery system
able to respond effectively and efficiently, without a lot of red tape,
to the needs of individual low-income households as well as to broader
community needs. Without the CSBG, local agencies would not have the
capacity to work in their communities developing local funding, private
donations and volunteer services and running programs of far greater
size and value than the actual CSBG dollars they receive.
CAAs manage a host of other Federal, State and local programs which
makes it possible to provide a one-stop location for persons whose
problems are usually multi-faceted. Over half (52 percent) of the CAAs
manage the Head Start program in their community. Using their unique
position in the community, CAAs recruit additional volunteers, bring in
local school department personnel, tap into religious groups for
additional help, coordinate child care and bring needed health care
services to Head Start centers. In many States they also manage the Low
Income Home Energy Assistance Program (LIHEAP), raising additional
funds from utilities for this vital program. CAAs may also administer
the Weatherization Assistance Program and are able to mobilize funds
for additional work on residences not directly related to energy
savings that, for example, may keep a low-income elderly couple in
their home. CAAs also coordinate the Weatherization Assistance Program
with the Community Development Block Grant program to stretch Federal
dollars and provide a greater return for tax dollars invested. They
also administer the Women, Infants and Children (WIC) nutrition program
as well as job training programs, substance abuse programs,
transportation programs, domestic violence and homeless shelters, as
well as food pantries.
examples of csbg at work
Since 1994, CSBG has implemented Results-Oriented Management and
Accountability practices whereby the effectiveness of programs is
captured through the use of goals and outcomes measures. Below you will
find the network's first nationally aggregated outcomes achieved by
individuals, families and communities as a result of their
participation in innovative CSBG programs during fiscal year 2004:
--103,057 participants gained employment with the help of community
action (49 States reporting);
--13,313 participants obtained ``living wage'' employment with
benefits (35 States reporting);
--88,187 low-income participants obtained safe and affordable housing
in support of employment stability (43 States reporting);
--510,322 low-income households achieved an increase in non-
employment financial assets, including tax credits, child
support payments, and utility savings, as a result of community
action ($133.5 million in aggregated savings);
--5,645 families achieved home ownership as a result of community
action assistance (41 States reporting);
--56,283 low-income people obtained pre-employment skills and
received training program certificates or diplomas (47 States
reporting);
--30,776 low-income people completed Adult Basic Education or GED
coursework and received certificates or diplomas (40 States
reporting);
--9,647 low-income people completed post-secondary education and
obtained a certificate or diploma (41 States reporting); and
--2,284,577 new community opportunities and resources were created
for low-income families as a result of community action work or
advocacy, including ``living wage'' jobs, affordable and
expanded public and private transportation, medical care, child
care and development, new community centers, youth programs,
increased business opportunity, food, and retail shopping in
low-income neighborhoods (46 States reporting).
All the above considered, NASCSP urges this committee to fund the
CSBG grant to the States at $650 million.
______
Prepared Statement of the National Consumer Law Center
The National Consumer Law Center (NCLC),\1\ on behalf of our low-
income clients,\2\ respectfully submits this testimony regarding the
appropriation of funds for the Low Income Home Energy Assistance
Program (LIHEAP) \3\ for fiscal year 2007. NCLC and our clients are
strong supporters of LIHEAP, the primary safety net between low-income
consumers and the disconnection of vital utility service. The high
energy prices that squeeze the budgets of low-income households to the
breaking point show no sign of abating. The recent National Energy
Assistance Directors' Association (NEADA) national study on LIHEAP
recipients documents the tremendous value of LIHEAP to low-income
families as well as the severe sacrifices made by the poor to pay their
home energy bills.\4\ Low-income families and fixed-income elderly
clients continue to fall further behind as energy prices have reached a
new, higher baseline. LIHEAP is essential for their safety and well
being. We thank the subcommittee for its strong support of the LIHEAP
program in the fiscal year 2006 appropriations process and, in light of
the forecasted continued high energy prices, urge the subcommittee to
consider fully appropriating LIHEAP at $5.1 billion in regular LIHEAP
funds for fiscal year 2007, the amount authorized under the Energy
Policy Act of 2005, with advance appropriations of the same amount for
fiscal year 2008.
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\1\ The National Consumer Law Center (NCLC) is a nonprofit
organization that represents the interests of low-income consumers on a
broad range of issues, including access to adequate and affordable
supplies of utility service for home heating and cooling. This
testimony was prepared by Olivia Wein, staff attorney in NCLC's
Washington, DC office.
\2\ The Appalachian People's Action Coalition (Ohio); Texas Legal
Services Center; Action, Inc. (Gloucester, MA); Action for Boston
Community Development, Inc.
\3\ 42 U.S.C. 8621 et seq.
\4\ National Energy Assistance Directors Association, National
Energy Assistance Survey (April 2004) (NEADA survey) available at
www.neada.org.
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Home Energy Prices Are At An All-Time High.--Residential energy
prices were expected to continue to rise this year, but the disruption
in the Gulf fuel refineries by the hurricanes sent them skyrocketing.
Consequently, paying home energy bills has been all the more difficult
for fixed income seniors and low-income households and has made LIHEAP
all the more important for these vulnerable families. The Center on
Budget and Policy Priorities has acknowledged that this year marks the
``largest 1-year jump in home heating prices in three decades.'' \5\
According to Guy Caruso, Administrator of the Energy Information
Administration at the U.S. Department of Energy, ``several factors are
driving up winter prices and expenditures: first, international factors
such as low spare crude oil capacity and political tensions contribute
to uncertainty and low supply growth for crude oil and high crude
prices; second, recent hurricanes and associated disruptions exacerbate
already tight markets in oil, petroleum products, and natural gas; and,
finally, winter weather affects consumption and consequently household
expenditures.'' \6\ The summer heat is also dangerous, especially for
the elderly, the very young and those with chronic diseases.
Unfortunately, the vast majority of newer electric generation plants
rely on natural gas, thus tying electricity prices to the volatile
natural gas prices. Taking all of these factors into account, it is
obvious how critical LIHEAP's heating and cooling assistance is to the
livelihood of so many families. The mounting increases in essential
residential energy prices as illustrated in the chart below are putting
more and more families' health and safety at risk.
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\5\ Center on Budget and Policy Priorities. ``Steep Spike in Energy
Costs Increases Low-Income Households' Need For Help Paying Heating
Bills This Winter'' (Oct. 6, 2005).
\6\ Statement of Guy Caruso, Administrator for the Energy
Information Administration, U.S. Department of Energy before the
Committee on Energy and Natural Resources, United States Senate. Full
Committee Hearing--Winter Fuels Outlook (Oct. 18, 2005).
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More Households Than Ever Cannot Keep Up With Costs Of Home
Energy.--Although the costs of home energy have been a burden to most
Americans, those with low incomes have been hurt the most. The salary
for low-income Americans has stayed relatively flat while the cost of
living has gone up, resulting in even more challenging struggles just
to make ends meet for many families. According to Dr. Meg Power of
Economic Opportunity Studies, families below 150 percent of the Federal
poverty guideline spend on average about $1,470 on energy costs, about
19 percent of their total yearly income. In 2005, however, low income
families were expected to pay more than $1,650.\7\ Those prices will
only go up for 2006. Having their heat switched off is a real
possibility for numerous low-income households, and although there are
winter utility shut-off moratoria in place for many States, not every
home is protected against energy shut-offs in the middle of winter. As
we approach the lifting of winter shut-off moratoria, we expect to see
a wave of disconnections as households are unable to afford the cost of
the energy bills. In the summer, the inability to keep the home cool
can be lethal, especially to seniors. According to the CDC, in 2001 300
deaths were caused by excessive heat exposure and seniors and young
children are particularly vulnerable to heat stress.\8\ The CDC also
notes that air-conditioning is the number one protective factor against
heat-related illness and death.\9\
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\7\ Meg Power, PhD. Economic Opportunity Studies. ``Energy Bills of
Low-Income Consumers in Fiscal Year 2005, The Resources Available to
Help Them Pay, and the Impact on Their Household Budgets'' (Nov. 23,
2004).
\8\ CDC, ``Extreme Heat: A Prevention Guide to Promote Your
Personal Health and Safety'' available at www.bt.cdc.gov/disasters/
extremeheat/heat_guide.asp.
\9\ Id.
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Iowa.--Despite milder winter temperatures this winter, the sharp
rise in natural gas prices has set back a record number of low-income
households in Iowa. The number of low-income households with past due
energy accounts as of January 2006 is 14.7 percent higher than the same
time last year and 162 percent higher than the number in January 1999.
The total amount of arrearages of LIHEAP households has also grown
sharply due to the increase in prices. By January 2006, the total
amount of LIHEAP household arrearages had increased 32 percent from the
same period in 2005 and 169 percent compared to the same period in
1999. The total number of LIHEAP households increased 8 percent from
this same period last year.\10\
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\10\ National Energy Assistance Directors, ``Est. Total Households
Receiving LIHEAP Heating Assistance by State--Projected Applications
for Fiscal Year 2006'' (2/13/06).
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Ohio.--In Ohio, the number of households entering into the State's
low-income energy affordability program, the Percentage of Income
Payment Program (PIPP), increased 23 percent from January 2005 to
January 2006. The increase is even more dramatic at 84 percent, when
comparing PIPP enrollment from January 2002 to January 2006. The total
dollar arrearage amounts for PIPP customers also increased 27 percent
from January 2005 to January 2006. Likewise, the total PIPP arrearages
have increased dramatically, 84 percent, from January 2002 to January
2006. Ohio's LIHEAP program expects to provide heating assistance to
almost 5 percent more households in fiscal year 2006 than in fiscal
year 2005 (and almost 30 percent more households when compared to Ohio
households that received heating assistance in fiscal year 2002).\11\
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\11\ Based on date from the National Energy Assistance Directors,
``Est. Total Households Receiving LIHEAP Heating Assistance by State--
Projected Applications for Fiscal Year 2006 (2/13/06)'' and ``Estimated
Total Households Receiving LIHEAP Heating Assistance by State Actuals
in 2002, 2003; Projected in 2004.'' Available at www.neada.org.
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Pennsylvania.--Utilities in Pennsylvania that are regulated by the
Pennsylvania Public Utility Commission (PA PUC) have established
universal service programs that assist utility customers in paying
bills and reducing energy usage. Even with these programs, electric and
natural gas utility customers find it difficult to keep pace with their
energy burdens. The PA PUC estimates that approximately 21,000
households entered the current heating season without heat-related
utility service--this number includes about 4,000 households who are
heating with potentially unsafe heating sources such as kerosene space
heaters. This is an increase of 68 percent when compared to the average
number entering the heating season without heat for the years 2000-
2003. An additional 17,500 residences where service was previously
terminated are now vacant.\12\ In 2005, the number of terminations
increased 52 percent compared with terminations in 2004.\13\ As of
January 2006, 17.48 percent of residential electric customers and 18.19
percent of natural gas customers are overdue on their energy bills. As
of February 2006, Pennsylvania projected serving 354,065 LIHEAP
applicants in fiscal year 2005, an 8.2 percent increase over the prior
year.\14\
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\12\ http://www.puc.state.pa.us/general/press_releases/
press_releases.aspx?ShowPR=1435.
\13\ http://www.puc.state.pa.us/general/pdf/Terminations_Table_Jan-
Dec04-05.pdf
\14\ http://www.neada.org/news/news060213_liheap06projections.pdf
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LIHEAP Helps These Vulnerable Households.--Growing utility
arrearages for low-income households will only place these fragile
households on a downward spiral towards disconnections. Adequate LIHEAP
assistance can help families facing terminations, but, even more
importantly, adequate LIHEAP appropriations can help struggling
families maintain vital energy services and protect the health and
safety of vulnerable seniors, families with young children or disabled
family members. The recent NEADA national energy assistance survey
found that 48 percent of LIHEAP recipients would have had their
electricity or home heating fuel discontinued if LIHEAP had not been
available.\15\
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\15\ NEADA Survey, Table 47.
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The Need For LIHEAP Is Greater Than Ever.--The continued sharp rise
in residential energy prices is expected for the near future. The data
from Iowa, Ohio and Pennsylvania, which are amongst the few States that
collect residential utility customer payment data, show that even in a
milder than normal winter, the prices have risen to such a degree that
an increasing number of low-income households is falling behind. This
year's dramatic rise in residential energy prices has yielded the
greatest number of LIHEAP applications in 12 years.\16\ Last year, the
number of eligible recipients for LIHEAP climbed to 32 million;
however, only around 5 million were able to benefit from it.
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\16\ http://www.neada.org/news/news060213_liheap06projections.pdf.
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The Consequences Of Unaffordable Energy Bills Are Dire.--When
people are unable to afford paying their home energy bills, many
dangerous and unhealthy actions are often taken. Common practices
include resorting to alternative heating sources, such as space
heaters, ovens and burners, all of which are huge fire hazards;
numerous deaths due to fires started by space heaters have already
occurred this year and are a recurring problem every year. According to
the U.S. Consumer Product Safety Commission, about 25,000 fires in
homes are caused by space heaters and 300 people are killed because of
them every year in the United States.\17\ Other dangerous practices
include illegal gas hookups that create dangerous gas leaks, keeping
the thermostat at unhealthy and sometimes hypothermic temperatures (and
hyperthermic temperatures in the summer). Those who cannot afford their
winter heating bill often face dire choices such as sacrificing food,
medical care or prescription medicine.\18\ In the summer, the inability
to afford cooling bills can result in heat-related deaths and illness.
The loss of essential utility services can be devastating, especially
for poor families that can find themselves facing the prospects of
hypothermia in the winter, hyperthermia in the summer,\19\ eviction,
property damage from frozen pipes, the use of dangerous alternative
sources of heat,\20\ and the potential threat of the intervention of
child welfare agencies.\21\ Studies have also demonstrated the clear
links between homelessness and utility disconnections, as well as the
connections between unaffordable utility service and the disruption to
families and children's education. LIHEAP works to bring fuel costs
within a manageable range for low-income households. There are other
societal benefits to a strong LIHEAP. A recent study documents an
association between receipt of LIHEAP assistance and a reduced
incidence of undernutrition in young children.\22\
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\17\ U.S. Department of Energy: A Consumer's Guide to Energy
Efficiency and Renewable Energy. http://www.eere.energy.gov/consumer/
your_home/space_heating_cooling/index.cfm/mytopic=12600.
\18\ NEADA Survey, Table 39. To pay their energy bills, 22 percent
of LIHEAP recipients went without food, 38 percent went without medical
or dental care, 30 percent did not fill or took less than the full dose
of a prescribed medicine.
\19\ From 2000 to 2003, approximately 50 percent-68 percent of
heat-related deaths were 60 years old or older. Office of Climate,
Water and Weather Services, Heat Related Fatalities by Age and Gender,
reports for 2000--2003.
\20\ In 1998 there were over 49,000 heating-equipment related home
fires resulting in 388 deaths and 1,445 injuries and $515 million in
property damage. National Fire Protection Association Fact Sheets on
Home Heating, in United States Home Heating Fire Patterns and Trends,
John H. Hall, Jr., NFPA, June 2001.
\21\ Robert B. Swift, Rising Costs for Home Heating Fuel Could
Spawn More Problems, Sunbury (PA) Item, Jan. 29, 2000.
\22\ Pediatric Academic Societies, Publication #921, Platform
Presentation, Epidemiology Session, May 6, 2003, Seattle, WA:
Children's Sentinel Nutrition Assessment Program: Heat or Eat: Low
Income Home Energy Assistance Program and Nutritional Risk Among
Children < 3.
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People are putting themselves at risk when they do not have
sufficient funds to pay their home energy bills, but LIHEAP can and
does come to their aid and does greatly alleviate some of the hardship
caused by high energy bills. With the assistance of LIHEAP, households
will not have to make such unconscionable, dangerous sacrifices.
The Need for Advance Appropriations is Critical.--The timing of the
release of the LIHEAP block grant to the States is critical for the
effective and efficient operation of the State programs. The normal
appropriations process leaves very little time between enactment of the
Labor-HHS-Education spending bill and the start of most States' heating
programs. An advance appropriation is essential for States to determine
income guidelines and benefit levels well ahead of time and for
properly planning the components of their program year (e.g., amounts
set aside for heating, cooling and emergency assistance,
weatherization, self sufficiency and leveraging activities). Without
advance appropriations, delayed passage of the spending bill can force
States to open their winter heating program without knowledge of their
final grant amount. Advance appropriations shield States from
disruption of the start-up of their winter heating programs if there is
a delay in the passage of the Labor-HHS-Education spending bill.
LIHEAP Works.--LIHEAP is a targeted block grant that assists
vulnerable low-income households with the costs of home energy.
According to the U.S. Department of Health and Human Services, one-
third of households receiving LIHEAP heating and cooling assistance had
an elderly member; over 30 percent of households receiving heating and
cooling assistance had a member with a disability; and almost one third
of households receiving heating assistance and around a fifth of
households receiving cooling assistance had young children. In fiscal
year 2001, LIHEAP recipient households had a mean individual energy
burden almost five times the energy burden for non-low income
households.\23\ A While there are broad Federal guidelines for LIHEAP,
States have the flexibility to tailor their programs to best meet their
needs. Administrative costs are minimal--capped at 10 percent. This
ensures that the vast majority of LIHEAP dollars are directed to energy
assistance for low-income families.
---------------------------------------------------------------------------
\23\ U.S. Department of Health and Human Services, Administration
for Children and Families, Office of Community Services, Division of
Family Assistance, LIHEAP Home Energy Notebook for Fiscal Year 2001
(February 2003), Table A-2b, p. 49.
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The National Association of Regulatory Utility Commissioners
(NARUC), the National Energy Assistance Directors Association and the
National Fuel Funds Network also support fully funding the regular
block grant LIHEAP program at $5.1 billion.
Conclusion.--In light of the continued projected increase in
residential energy costs and LIHEAP's continued demonstrated success in
helping low-income families maintain access to vital energy service, we
urge the subcommittee to appropriate $5.1 billion for the regular
LIHEAP program in fiscal year 2007 as well as advance appropriations
for fiscal year 2008 of $5.1 billion for the regular program. Thank you
for consideration of our testimony.
______
Prepared Statement of the National Kidney Foundation
The National Kidney Foundation (NKF), a voluntary health
organization whose membership includes patients and families; organ
transplant recipients; families who have donated the organs of loved
ones for transplantation and living organ donors; and health care
professionals, is pleased to submit public witness testimony for the
written record in support of fiscal year 2007 Appropriations.
We are very appreciative of the $1,800,000 in funding that Congress
provided in fiscal year 2006 to establish a Chronic Kidney Disease
(CKD) program within the Centers for Disease Control and Prevention
(CDC). As the subcommittee drafts the fiscal year 2007 Labor, Health
and Human Services, and Education Appropriations Bill, we respectfully
request your continued support for funding to expand these activities,
as outlined below. Unfortunately, the administration did not request
continued funding for this program in its 2007 Budget Request.
impact of chronic kidney disease
The implications of kidney disease for the public are considerable,
yet the average American is relatively unaware of its consequences.
Twenty million Americans have CKD, and another 20 million are at risk
of developing the disease, but most people with kidney disease do not
know they have it and will not be diagnosed until it has threatened
their health and even their lives. Individuals with diabetes or
hypertension are especially vulnerable.
Kidney disease is the 9th leading cause of death in the United
States, and death by cardiovascular disease is 10 to 30 times higher in
kidney dialysis patients than in the general population. Kidney disease
is associated with 25 percent of the Medicare budget and 7 percent of
the Medicare population has a diagnosis of kidney disease. Further, the
number of individuals with end stage renal disease (ESRD), irreversible
kidney failure requiring either dialysis or a transplant to remain
alive, is expected to increase from 382,000 patients in 2000 to 712,000
by 2015. Effective treatments are available to reduce morbidity and
mortality resulting from kidney disease and its complications and to
retard progression to kidney failure. However, CKD is not being
detected sufficiently early to initiate treatment regimens and reduce
death and disability. NKF believes a public health approach would
contribute toward early detection and treatment, thereby reducing
hardship and saving money and lives.
2006 cdc activities
NKF is working closely with CDC to implement this program and we
are very pleased with the progress to date. CDC intends to use the
current-year appropriation to identify and coordinate sources for CKD
data; propose solutions to fill data deficiencies; undertake a
surveillance system feasibility study; fund pilot projects in selected
States; and, organize an expert consensus conference to lay the
groundwork for a Public Health Kidney Disease Strategic Plan. Earlier
this year, CDC requested proposals to support the development of a
comprehensive CKD surveillance system. The agency expects to award two
grants in 2006 designed to identify sources of CKD data, as well as
gaps and deficiencies in existing data. The program will also propose
solutions to remedy deficiencies, including the execution of a
feasibility study and pilot test for a surveillance system. Additional
activities in 2006 will include studies of the economic benefit of CKD
intervention.
fiscal year 2007 request
A restoration of funding to the 2006 level would enable CDC to
continue planning for capacity and infrastructure for a kidney disease
epidemiology, research and health outcomes program and to institute a
CKD surveillance system. We are hopeful for a funding increase over
fiscal year 2006, which would enable the agency to expand the number
and scope of grants to support State-based community demonstration
projects for CKD detection and treatment, a core component of this CKD
initiative. We envision this would include tracking the progression of
CKD in patients who have been diagnosed, as well as identify the onset
of kidney disease among individuals who are members of high risk
groups.
We thank you for your past support of this initiative and
respectfully request your continued support, to enable CDC and the
public health community to move forward to address the growing concern
of Chronic Kidney Disease.
______
Prepared Statement of the National League for Nursing
The National League for Nursing (NLN)--representing more than 1,100
nursing schools and health care agencies, some 17,000 individual
members comprised of nurses, educators, administrators, public members,
and 18 constituent leagues--appreciates the subcommittee's past support
for nursing education and your continued recognition of the important
role nurses play in the delivery of health care services.
We, however, are concerned. Unless additional resources are
expended, the advancements made by Congress to help alleviate the
nursing shortage will be impeded owing to the currently proposed fiscal
year 2007 appropriations level. The NLN advocates your continued
support for Title VIII--Nursing Workforce Development Programs (Public
Health Services Act), housed in the Health Resources and Services
Administration (HRSA) with the congressionally prescribed mission of
ensuring a sufficient supply of nurses. We urge you to fund the Title
VIII programs at a minimum level of $175 million for fiscal year 2007.
Placing this minimal funding request in perspective, note that during
the last serious nursing shortage in 1974, Congress appropriated $153
million for nurse education programs. In today's dollars that
appropriation would equate to approximately $592 million, nearly four
times the amount the Federal Government is spending on nurse education
now.
Today's nursing shortage is very real and very different from any
experienced in the past. The existing shortage is evidenced by an aging
workforce and too few people entering the profession. A critical factor
exacerbating the national nurse-workforce deficiency is the declining
number of qualified nurses available to teach future generations of
registered nurses. The NLN's Faculty Survey conducted in 2002 concludes
that not enough qualified nurse educators exist to teach the number of
nurses necessary to ameliorate the nursing shortage.
The NLN Survey found three trends influencing the future of nursing
education over the next decade:
The aging of the nurse faculty population
An average of 1.3 full-time faculty members per program left their
positions in nursing education in 2002. About half the survey
respondents had at least one unfilled budgeted full-time faculty
position and some had as many as 15 such positions. 36.5 percent of
faculty who left their positions in the preceding year did so because
of retirement; 8.6 percent of faculty were 61 years of age or older;
and 75 percent of the current faculty population is expected to retire
by 2019.
Approximately 1,800 full-time faculty members leave their positions
each year. About 10,000 master's level nurses graduate per year, 15
percent of whom would have to enter teaching in order to maintain
today's production level for generating the Nation's nurse workforce.
Since this is highly unlikely, the gap between unfilled positions and
the candidate pool is widening significantly.
The increasing number of part-time faculty
The number of part-time faculty has increased notably since 1996--
nearly 17 percent in baccalaureate programs and 14 percent in associate
degree programs. Part-time faculty now provides approximately 23
percent of the estimated number of faculty FTEs.
Part-time employees often are not an integral part of the design,
implementation, and evaluation of the overall nursing education
program. Many may hold other positions that often limit their
availability to students. Further, many part-time faculty have not been
prepared for the faculty role.
The large number of nursing faculty who are not prepared at the
doctoral level
Approximately half the full-time faculties in baccalaureate and
higher-degree programs hold a doctoral degree. In associate degree
programs, doctorally-prepared faculty account for only 6.6 percent of
the total faculty and the number is slightly more than 5 percent in
diploma programs. Only 350 to 400 nursing students receive doctoral
degrees each year and the pool of doctorally-prepared candidates for
full-time nursing professorships is very limited.
Educators without doctoral degrees may lack credibility within a
university setting and have limited opportunities to assume leadership
positions. Institutions with low numbers of doctorally-prepared
educators may be less likely to obtain funds to support research or
educational innovations. As important as educational incentives are for
future practicing nurses, the scholarships for doctoral students who
will instruct the next generation of nurses are even more critical.
Since less than an adequate number of nurse educators currently
teach in the education pipeline, the situation appears to be growing
acute and is not expected to improve in the near future absent adequate
intervention. In a survey of the 2004-2005 academic year conducted by
the NLN, an estimated 147,000 qualified applications were turned away
from nursing programs at all degree levels owing in large part to the
lack of faculty necessary to teach this number of additional students.
This number represents a 17.6 percent increase from the 2003-2004
academic year. With an increasing application pool, a key priority in
tackling the nurse shortage has to be scaling up the capacity to accept
qualified applicants. Today's undersized supply of appropriately
prepared nurses and nurse faculty does not bode well for meeting the
needs of a diverse, aging population.
Congress made an important step in passing the Nurse Reinvestment
Act in 2002. The new monies used to fund loans and scholarships are
appreciated. Yet, it has become abundantly clear that significantly
more funding is required to even minimally meet the HRSA charge to
support nursing students and schools of nursing so as to meet the
existing and rising national needs for nurses. In fiscal year 2005,
HRSA was forced to turn away 82 percent of the applicants for the Nurse
Education Loan Repayment Program and more than 98 percent of the
applicants for the Nursing Scholarship Program due to lack of adequate
funding.
Please do not allow the Nation to lose ground in the effort to
remedy the nursing shortage. Fund Title VIII--Nursing Workforce
Development Programs at a level commensurate with the severity of the
health care crisis facing the Nation today. Your support will help
ensure that nurses exist in the future who are prepared and qualified
to take care of you, your family, and all those in this country who
will need our care.
______
Prepared Statement of the Oncology Nursing Society
The Oncology Nursing Society (ONS) appreciates the opportunity to
submit written comments for the record regarding fiscal year 2007
funding for cancer and nursing related programs. ONS, the largest
professional oncology group in the United States composed of more than
33,000 nurses and other health professionals, exists to promote
excellence in oncology nursing and the provision of quality care to
those individuals affected by cancer. As part of its mission, the
Society honors and maintains nursing's historical and essential
commitment to advocacy for the public good.
This year more than 1.4 million Americans will be diagnosed with
cancer and more than 565,000 will lose their battle with this terrible
disease. Despite these grim statistics, significant gains in the War
Against Cancer have been made through our Nation's investment in cancer
research and its application. Research holds the key to improved cancer
prevention, early detection, diagnosis, and treatment, but such
breakthroughs are meaningless unless we can deliver them to all
Americans in need. Recent studies have reported 126,000 registered
nurse vacancies in hospitals and 13,900 registered nurse vacancies in
nursing homes. Moreover, a recent survey of ONS members found that the
nursing shortage is having an adverse impact in oncology physician
offices and hospital outpatient departments. Some respondents indicated
that when a nurse leaves their practice that they are unable to hire a
replacement due to the shortage--leaving them short-staffed and posing
scheduling challenges for the practice and the patients. These
vacancies in all care settings create significant barriers to ensuring
access to quality care.
To ensure that all people with cancer have access to the
comprehensive, quality care they need and deserve, ONS advocates on-
going and significant Federal funding for cancer research and
application, as well as funding for programs that help ensure an
adequate oncology nursing workforce to care for people with cancer. The
Society stands ready to work with policymakers at the local, State, and
Federal levels to advance policies and programs that will reduce and
prevent suffering from cancer and sustain and strengthen the Nation's
nursing workforce.
securing and maintaining an adequate oncology nursing workforce
Oncology nurses are on the front lines in the provision of quality
cancer care for individuals with cancer--administering chemotherapy,
managing patient therapies and side-effects, working with insurance
companies to ensure that patients receive the appropriate treatment,
providing counseling to patients and family members, and engaging in
myriad other activities on behalf of people with cancer and their
families. Cancer is a complex, multifaceted chronic disease, and people
with cancer require specialty-nursing interventions at every step of
the cancer experience. People with cancer are best served by nurses
specialized in oncology care, who are certified in that specialty.
Overall, age is the number one risk factor for developing cancer.
Approximately 77 percent of all cancers are diagnosed at age 55 and
older. Currently, Medicare beneficiaries account for more than 50
percent of all cancer diagnoses and 64 percent of cancer deaths. Over
the next 10 to 15 years the number of Medicare beneficiaries with
cancer is estimated to double while, according to U.S. Department of
Labor estimates, more than 1.1 million registered nursing vacancies
will need to be filled by 2012 to meet growing patient demand and
replace retiring nurses.
As the overall number of nurses will drop precipitously in the
coming years, we likely will experience a commensurate decrease in
number of nurses trained in the specialty of oncology. With an
increasing number of people with cancer needing high quality health
care, coupled with an inadequate nursing workforce, our Nation could
quickly face a cancer care crisis of serious proportion with limited
access to quality cancer care, particularly in traditionally
underserved areas. A study in the New England Journal of Medicine found
that nursing shortages in hospitals are associated with a higher risk
of complications--such as urinary tract infections and pneumonia,
longer hospital stays, and even patient death. Without an adequate
supply of nurses, there will not be enough qualified oncology nurses to
provide the quality cancer care to a growing population of people in
need and patient health and well-being could suffer.
Further, of additional concern is that our Nation also will face a
shortage of nurses available and able to conduct cancer research and
clinical trials. With a shortage of cancer research nurses, progress
against cancer will take longer because of scarce human resources
coupled with the reality that some practices and cancer centers
resources could be funneled away from cancer research to pay for the
hiring and retention of oncology nurses to provide direct patient care.
Without a sufficient supply of trained, educated, and experienced
oncology nurses, our Nation may falter in its delivery and application
of the benefits from our Federal investment in research.
ONS has joined with others in the nursing community in advocating
$175 million as the fiscal year 2007 funding level necessary to support
implementation of the Nurse Reinvestment Act and the range of nursing
workforce programs housed at the U.S. Health Resources and Services
Administration (HRSA). Enacted in 2002, the Nurse Reinvestment Act
included new and expanded initiatives, including loan forgiveness,
scholarships, career ladder opportunities, and public service
announcements to advance nursing as a career. Despite the enactment of
this critical measure, HRSA fails to have the resources necessary to
meet the current and growing demands for our Nation's nursing
workforce. For example, in fiscal year 2005, HRSA was forced to turn
away 82 percent of the applicants for the Nurse Education Loan
Repayment Program and over 98 percent of the applicants for the Nursing
Scholarship Program due to lack of adequate funding.
While a number of years ago one of the biggest factors associated
with the shortage was a lack of interested and qualified applicants,
due to the efforts of the nursing community and other interested
stakeholders, the number of applicants is growing. As such, now one of
the greatest factors contributing to the shortage is that nursing
programs are turning away qualified applicants to entry-level
baccalaureate programs due to a shortage of nursing faculty. According
to the American Association of Colleges of Nursing (AACN), at least
32,617 of such qualified applicants were turned away in 2004 alone.
Many of these qualified students are being placed on waiting lists that
may be as long as 2 years or more. The National League for Nursing
(NLN) released a preliminary report in December 2005 that showed that
due to faculty shortages, in total schools of nursing were forced to
reject more that 147,000 qualified applications for 2005, an 18 percent
increase over 2004 figures. The number of full-time nursing faculty
required to ``fill the nursing gap'' is approximately 40,000 and
currently there are less than 20,000 full-time nursing faculty in the
system. The nurse faculty shortage is only expected to worsen with time
as faculty age continues to climb, averaging 52 years in 2004.
Significant numbers of faculty are expected to retire in the coming
years with insufficient numbers of candidates in the pipeline to take
their places. If funded sufficiently, the components and programs of
the Nurse Reinvestment Act will help address the multiple factors
contributing to the nursing shortage.
ONS strongly urges Congress to provide HRSA with a minimum of $175
million in fiscal year 2007 to ensure that the agency has the resources
necessary to fund a higher rate of nursing scholarships and loan
repayment applications and support other essential endeavors to sustain
and boost our Nation's nursing workforce. Nurses--along with patients,
family members, hospitals, and others--have joined together in calling
upon Congress to provide this essential level of funding. One Voice
Against Cancer (OVAC), a collaboration of more than 45 national
nonprofit organizations representing millions of Americans, also
advocates $175 million for the Nurse Reinvestment Act in fiscal year
2007. ONS and its allies have serious concerns that without full
funding, the Nurse Reinvestment Act will prove an empty promise and the
current and expected nursing shortage will worsen, and people will not
have access to the quality care they need and deserve.
boost our nation's investment in cancer prevention, early detection,
and awareness
Approximately two-thirds of cancer cases are preventable through
lifestyle and behavioral factors and improved practice of cancer
screening. Although the potential for reducing the human, economic, and
social costs of cancer by focusing on prevention and early detection
efforts remains great, our Nation does not invest sufficiently in these
strategies. While as a Nation we spend almost a trillion dollars a year
on our health care system, we only allocate approximately 1 percent of
that amount for population-based prevention efforts. By 2020, cancer
and other chronic disease expenditures will reach $1 trillion or 80
percent of health care costs. The Nation must make significant and
unprecedented Federal investments today to address the burden of cancer
and other chronic diseases, and to reduce the demand on the healthcare
system and diminish suffering in our Nation both for today and
tomorrow.
As the Nation's leading prevention agency, the Centers for Disease
Control and Prevention (CDC) plays an important role in translating and
delivering at the community level what is learned from research.
Therefore, ONS joins with our partners in the cancer community--
including OVAC--in calling on Congress to provide additional resources
for the CDC to support and expand much-needed and proven effective
cancer prevention, early detection, and risk reduction efforts.
Specifically, ONS advocates the appropriation of $427.5 million in
fiscal year 2007 for the CDC's comprehensive cancer, ovarian cancer,
breast and cervical cancer early detection, cancer registries, prostate
cancer, colorectal cancer, and skin cancer programs. ONS also urges a
funding increase for the CDC's physical activity, nutrition, and
tobacco-control programs to help reduce risk factors for developing
cancer and other chronic diseases. ONS advocates the following fiscal
year 2007 funding levels:
--$250 million for the National Breast and Cervical Cancer Early
Detection Program;
--$65 million for the National Cancer Registries Program;
--$25 million for the Colorectal Cancer Prevention and Control
Initiative;
--$50 million for the Comprehensive Cancer Control Initiative;
--$20 million for the Prostate Cancer Control Initiative;
--$5 million for the National Skin Cancer Prevention Education
Program;
--$7.5 million for the Ovarian Cancer Control Initiative;
--$5 million for the Geraldine Ferraro Blood Cancer Program;
--$145 million for the National Tobacco Control Program; and
--$70 million for the Nutrition, Physical Activity, and Obesity
Program.
sustain and seize cancer research opportunities
Our Nation has benefited immensely from past Federal investment in
biomedical research at the National Institutes of Health (NIH). ONS has
joined with the broader health community in advocating $29.7 billion
for NIH in fiscal year 2007. This will allow NIH to sustain and build
on its research progress resulting from the recent doubling of its
budget while avoiding the severe disruption to that progress that would
result from a minimal increase. Cancer research is producing
extraordinary breakthroughs--leading to new therapies that translate
into longer survival and improved quality of life for cancer patients.
We have seen extraordinary advances in cancer research resulting from
our national investment that have produced effective prevention, early
detection and treatment methods for many cancers. To that end, ONS
calls upon Congress to allocate $5.034 billion to the National Cancer
Institute (NCI) in fiscal year 2007 to continue our battle against
cancer.
The National Institute of Nursing Research (NINR) supports basic
and clinical research to establish a scientific basis for the care of
individuals across the life span--from management of patients during
illness and recovery to the reduction of risks for disease and
disability and the promotion of healthy lifestyles. These efforts are
crucial in translating scientific advances into cost-effective health
care that does not compromise quality of care for patients.
Additionally, NINR fosters collaborations with many other disciplines
in areas of mutual interest such as long-term care for older people,
the special needs of women across the life span, bioethical issues
associated with genetic testing and counseling, and the impact of
environmental influences on risk factors for chronic illnesses such as
cancer. ONS joins with the nursing community in advocating an
allocation of $150 million for NINR in fiscal year 2007.
conclusion
ONS stands ready to work with policymakers to advance policies and
support programs that will reduce and prevent suffering from cancer and
sustain and strengthen our Nation's nursing workforce. Moreover, ONS
maintains a strong commitment to working with Members of Congress,
other nursing societies, patient organizations, and other stakeholders
to ensure that the oncology nurses of today continue to practice
tomorrow and that we recruit and retain new oncology nurses to meet the
unfortunate growing demand that we will face in the coming years. Thank
you for this opportunity to discuss the fiscal year 2007 funding levels
necessary to ensure that our Nation has a sufficient nursing workforce
to care for the patients of today and tomorrow and that our Nation
continues to make gains in our fight against cancer.
______
Prepared Statement of the Pancreatic Cancer Action Network
On behalf of The Pancreatic Cancer Action Network (PanCAN), I thank
you for this opportunity to present written testimony to the Labor,
Health and Human Services, and Education subcommittee of the House
Appropriations Committee.
PanCAN was founded in 1999 to focus national attention on the need
to find the cure for pancreatic cancer. We provide public and
professional education that embraces the urgent need for more research,
effective treatments, prevention programs, and early detection methods.
PanCAN is the first and only national patient based advocacy
organization specifically focused on pancreatic cancer. We now have a
full time staff of 30 individuals, and 90 ``Team Hope'' affiliates in
communities across the country, comprised of thousands of volunteers
who seek to increase awareness about this disease, raise funds, and
voice their concern that there is a desperate need to find a cure for
pancreatic cancer.
background on pancreatic cancer
Every 17 minutes, someone in the United States dies form pancreatic
cancer. It is the 4th leading cause of cancer death in the Untied
States. The facts on pancreatic cancer are striking:
--Over 33,730 Americans will be diagnosed with pancreatic cancer in
2006, and 32,300 will die from this disease.
--The 99 percent mortality rate is the highest of any cancer.
--There are no early detection methods.
--The average life expectancy after diagnosis with metastatic disease
is just 3 to 6 months.
Yet, despite these statistics, pancreatic cancer receives the least
amount of research funding from the Federal Government of all major
cancers. Federal funding for pancreatic cancer research totaled roughly
$66 million in fiscal year 2005, a mere 1 percent of the National
Cancer Institute's (NCI's) $4.825 billion research budget. While good
progress is being made in early detection, research and treatment
programs for some cancers, this is clearly not the case for pancreatic
cancer.
Pancreatic cancer is the deadliest cancer for one reason: limited
Federal funding opportunities discourage researchers from pursuing
pancreatic cancer as a focus. There are less than 15 fully-funded
researchers nationwide who are specifically dedicated to this disease.
The combination of few dollars and few researchers means there has been
very little scientific progress.
PanCAN has outlined opportunities below for the Federal Government
to take specific actions to facilitate progress in combating this
disease.
Provide Adequate Funding Increases for Cancer Research, Prevention, and
Treatment Programs
Pancreatic cancer is the country's fourth leading cause of cancer
death, killing over 33,730 people annually, yet it remains severely
under-funded when comparing NCI funding levels for the top five cancers
based on mortality. The NCI spent a reported $66 million on pancreatic
cancer research in fiscal year 2005, yet the other four top cancers (in
mortality) are funded at levels at least four times this amount.
Further, the discrepancy in funding has existed for many years, only
compounding this inconsistency.
PanCAN supports the highest possible funding increase that Congress
can provide for the National Institute of Health (NIH) and the NCI in
fiscal year 2007. With additional funding for both the NIH and the NCI,
new research grants can be awarded to fulfill the research goals
identified by the NCI as essential to combating this disease. PanCAN is
a member of the ``One Voice Against Cancer'' (OVAC) coalition which is
comprised of more than 50 cancer advocacy organizations that have come
together to support our common goal: increased Federal funding for
cancer research, prevention and training programs that are funded
through the NIH, NCI and Centers for Disease Control and Prevention
(CDC).
PanCAN wholeheartedly endorses OVAC's proposed fiscal year 2007
funding requests that seek a 5 percent increase for both the NIH and
NCI. We urge you to provide a minimum of $29.7 billion for the NIH in
fiscal year 2007. Separate testimony submitted to the Committee by OVAC
reiterates the need for additional Federal funding for biomedical
research: ``The tremendous investment our Nation has made in the NIH
has reaped remarkable returns and set the table for a period of
unparalleled innovation in the fight against cancer and other diseases.
For fiscal year 2007, OVAC joins with the broader public health
community and urges Congress to provide $29.7 billion for the NIH. This
is the minimal level of funding that will allow the NIH to maintain the
current pace of discovery and innovation.''
PanCAN also supports the NCI Director's Professional Judgment
Budget, which calls for a total of $5.9 billion for the NCI in fiscal
year 2007. Those within the agency and very knowledgeable of the
research being conducted by the NCI have developed this plan and
accompanying budget that seeks to investigate the most promising
research available to the community at this time. We urge the Committee
to do all that it can to support investments in biomedical research
that will save lives. At a minimum, we urge the Committee to support a
funding increase of 5 percent above last year's level for the NCI,
which would bring the agency's fiscal year 2007 funding level to $5.034
billion. This funding level would provide an additional $240 million to
at least keep the existing level of research at the NCI moving forward
at a stable pace and thus protect the current number of investigator
grant awards from significant cuts.
Ensure that Pancreatic Cancer Research is Not Compromised as the NCI
Shifts its Focus from Disease Specific Research to More Global
Science Initiatives
Last year, PanCAN requested that the Committee oversee
implementation of the short, medium, and long-term strategies as
identified in the Pancreatic Cancer Progress Review (PRG). The PRG has
been in place since September 2002 and yet, 4 years later, few of these
strategies have been implemented. For this reason, PanCAN urges the
Committee to require the NCI to implement, in fiscal year 2007, all of
the outstanding strategies as identified in the NCI implementation plan
for pancreatic cancer PRG recommendations.
Through conversations and meetings with NCI leadership, we've
learned about the shift in the NCI's focus on research. Disease
specific science is being shelved in favor of sexier initiatives in the
areas of nanotechnology, genomics, and the development of a biospecimen
repository.
As the NCI moves its scientific agenda forward in these three
areas, PanCAN is concerned that critical resources will be taken away
from the significant investments that have been made in research
related to early detection, diagnosis and treatment protocols for
specific cancers. Other cancers have achieved significant declines in
their respective mortality rates after early detection protocols have
been developed. Since there is no such tool for diagnosing pancreatic
cancer early in its development, the mortality rates remain high, and
tens of thousands of patients are lost each year. As the advocacy
community for pancreatic cancer patients, we feel that the NCI cannot
justify any reductions in funding for pancreatic cancer research until
significant reductions are achieved in the mortality rate for this
cancer.
PanCAN urges the Committee to obtain assurance from the NCI that
the cornerstone research of the agency will not be diminished as these
new scientific initiatives are pursued. Further, PanCAN urges the
Committee to direct the NCI to develop a written report that
specifically details how these three major scientific initiatives will
specifically advance pancreatic cancer research and submit this report
to the Committee by April 1, 2007.
Support Selected Opportunities for Advancement of Pancreatic Cancer
Research to Capitalize on the Initial Investment of Disease
Specific Research
Identify genetic factors, environmental factors, and gene-
environment interactions that contribute to pancreatic cancer
development.
Achieve a more complete understanding of the biology of the normal
pancreas and the development of pancreatic adenocarcinoma and use this
knowledge to improve prevention, early detection, and treatment
interventions.
Develop nationwide tissue and data repositories, molecular
profiling resources, and bioinformatics tools for pancreatic cancer
research. Use these resources to develop prevention and early detection
interventions that are based on molecular features of pancreatic
cancer.
Establish models for the study of environmental factors, gene-
environment interactions, chemoprevention, chemotherapy, radiation
therapy, vaccines, and imaging to improve understanding of pancreatic
cancer risk, prevention, diagnosis, and treatment.
Identify and develop surveillance and diagnosis methods for early
detection of pancreatic cancer and its precursors.
Develop and establish sustained, expanded training and career
development efforts in pancreatic cancer research and care to build a
comprehensive, multidisciplinary research community focused on this
disease.
Mr. Chairman, the scientific community--through research--is making
great progress in combating cancer. More people are surviving cancer
today than any other time in history. Unfortunately, these achievements
are not extended to the vast majority of pancreatic cancer patients. We
urge you to provide America's world-renowned research enterprise with
the funding levels necessary for investigators to continue to work
their magic and develop screening protocols, effective treatments and
therapies that will one day lead to the eradiation of all cancers--
including pancreatic. To quote Congressman Clay Shaw (R-FL), a cancer
patient, ``When you approach the finish line, you don't walk . . . you
run!'' If the United States truly seeks to move forward with its
ambitious goal to stop pain and death from cancer by 2015, it is
imperative that Federal research programs be adequately funded to
achieve this goal. On behalf of the 33,730 patients diagnosed with
pancreatic cancer in 2006, I urge you to support increased funding for
cancer research, treatment and prevention programs in your fiscal year
2007 bill.
______
Prepared Statement of People for the Ethical Treatment of Animals
People for the Ethical Treatment of Animals (PETA) represents more
than 1.3 million Americans who support the Federal Government's ongoing
commitment to develop scientifically valid safety tests to protect
human health and the environment from chemical hazards while reducing,
and ultimately replacing, the use of animals. Thank you for the
opportunity to present testimony relevant to the fiscal year 2007
budget request for the National Institute of Environmental Health
Sciences in relation to the National Toxicology Program (NTP).
history of the ntp
The NTP was established in 1978 to provide information about
potentially toxic chemicals and to coordinate toxicity testing programs
within the Federal Government, strengthen the science of toxicology,
and develop and validate improved testing methods. Three agencies form
the core of the NTP: the National Institute of Environmental Health
Sciences of the National Institutes of Health (NIEHS/NIH), the National
Institute of Occupational Safety and Health of the Centers for Disease
Control and Prevention (NIOSH/CDC), and the National Center for
Toxicological Research of the Food and Drug Administration (NCTR/FDA).
The NTP's activities are funded through the NIEHS at an annual level of
approximately $500 to $600 million.\1\
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\1\ White House Office of Technology Assessment. Researching health
risks. Washington, DC: EOP (1993).
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ntp rodent cancer testing program
During the 1960s and 70s, as vast numbers of new chemicals were
being produced and used in agriculture, manufacturing, food
preparation, and virtually every other aspect of modern life, the
public became increasingly concerned that these chemicals were finding
their way into the environment and food supply. Since much of the
public anxiety regarding chemicals related to their potential to cause
cancer, the Federal Government instituted a program to assess the
cancer-causing potential of chemicals using rats and mice--on the
assumption that rodent carcinogens could also present a cancer risk to
humans. This rodent cancer-testing program began under the auspices of
the National Cancer Institute, but has been managed by the NTP since
its inception in 1968.
A conventional NTP rodent cancer study takes approximately 5 years
to design, conduct and interpret, consuming at least 860 animals and up
to $4 million per chemical tested.\2\ The study exposes three groups of
animals to three different doses of a test chemical, while a fourth
group (known as the ``control'' group) receives no chemical exposure.
The chemically exposed animals receive daily doses of a test substance
for their entire 18- to 24-month life span. If these animals develop
more tumors than the non-chemically exposed controls, this is taken as
evidence that a chemical causes cancer. To date, the NTP has tested
hundreds of substances in rodent cancer studies--including
pharmaceuticals, pesticides, plastics, industrial chemicals, and even
plant extracts--at a projected cost of more than 1 billion U.S.
taxpayer dollars.\3\
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\2\ NIEHS Fact Sheet: The National Toxicology Program. Research
Triangle Park, NC: NIEHS (1996).
\3\ 502 lifetime cancer studies in rats and mice <greek-e> $2-4
million/study = $1-2 billion.
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a history of controversy
The NTP recently celebrated the publication of its 500th rodent
cancer study as ``the gold standard in animal toxicology.'' \4\
However, in contrast to the fanfare with which this announcement was
made, the history of NTP rodent cancer studies is one of controversy
spanning several decades, with top Federal officials admitting:
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\4\ NIEHS News Release: NTP completes 500th two-year rodent study
and report; series is the gold standard of animal toxicology. 25 Jan
2001. <http://www.niehs.nih.gov/oc/news/ntp500.htm>.
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``The current 2-year rodent carcinogenicity study was never
validated and there is little evidence supporting the repeatability and
reproducibility of the current rodent carcinogenicity study.'' \5\
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\5\ Contrera JF, Jacobs AC, DeGeorge JJ. Carcinogenicity testing
and the evaluation of regulatory requirements for pharmaceuticals.
Regulatory Toxicology and Pharmacology 25, 130-145 (1997).
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--Drs. Joseph Contrera, Abigail Jacobs, and Joseph DeGeorge
Food and Drug Administration, Center for Drug Evaluation and
Research
``We have been concerned about the predictivity of 2-[year] [rodent
cancer studies] for the past 10 [years], as our experience and
knowledge have expanded.'' \6\
--Drs. Bernard Schwetz and David Gaylor
Food and Drug Administration, Office of the Director/National
Center for Toxicological Research
``The problem is we don't know what the findings really mean.'' \7\
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\7\ Brinkley J. Many say lab-animal tests fail to measure human
risk. The New York Times 1993 Mar 23;Sect A:1.
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--Dr. Robert Maronpot, chief, Laboratory of Experimental Pathology,
National Institute of Environmental Health Sciences (NIEHS)
``Even if a chemical is found to be nontoxic in animal studies, the
safety of the chemical cannot be assured.'' \8\
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\8\ Shane BS. Human reproductive hazards. Environmental Science and
Technology 30, 1193 (1989).
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--Dr. Barbara Shane, NTP executive secretary
``I have to say we don't serve the American people very well right
now.'' \6\
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\6\ Schwetz B, Gaylor D. New directions for predicting
carcinogenesis. Molecular Carcinogenesis 20, 2 75-279 (1997).
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--Dr. Kenneth Olden, director, NTP & NIEHS (1991-2005)
peta's analysis
PETA recently conducted an in-depth analysis of all 502 federally
funded and conducted lifetime rodent cancer studies published on the
NTP website as of January 2006.\9\ On the basis of this analysis,
together with more than 25 years of published scientific literature on
this subject, we have determined that:
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\9\ PETA's full report is available upon request or may be
downloaded from http://www.stopanimaltests.com/u-ntp.asp.
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--The great majority of the U.S. Government's more than $1 billion
investment in the NTP rodent cancer-testing program has
produced little or no actual benefit, having been used to
underwrite studies that:
--Have been judged by the NTP itself to be ``inadequate'' or to
produce ``equivocal'' (ambiguous) results, which are of no
use to health authorities ($121 million).
--Have produced such dubious and conflicting results that more than
75 percent of tested chemicals remain either unclassified
as to their cancer risk to humans, or are lumped into such
meaningless categories as ``possible'' human carcinogens or
``unclassifiable'' as to human cancer risk--designations
that do nothing to enhance public health or worker
protection ($460-720 million).
--Have been shown by other scientists to produce consistent and
reproducible results only 57 percent of the time when the
same chemicals are tested more than once using the same
method--a result that could be achieved by simply tossing a
coin.
--Critical public health and worker protection measures related to
cigarette smoke, asbestos, benzene, and other cancer-causing
substances were delayed for many years because of misplaced
trust in animal tests, which for years could not replicate
cancerous effects that had already been documented in
people.\10\ \11\ \12\ \13\ If standard animal tests failed to
readily identify these well-known human carcinogens, how many
other dangerous chemicals are Americans being exposed to today
as a result of misleading animal data?
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\10\ Laskin S, Sellakumar AR. Models in chemical respiratory
carcinogenesis. In: Karbe E, Park JF, eds. Experimental lung cancer:
carcinogenesis and bioassays. New York: Springer-Verlag (1974).
\11\ Rodelsperger K, Woitowitz H-J. Airborne fiber concentrations
and lung burden compared to the tumor response in rats and humans
exposed to asbestos. Annals of Occupational Hygiene 39, 715-725 (1995).
\12\ DeLore P, Borgomono C. Acute leukemia following benzene
poisoning. Journal de MAE1decin de Lyon 9, 227-236 (1928).
\13\ De Marini DM and others. Benchmarks: alternative methods in
toxicology. MA Mehlman, ed. Princeton, NJ: Princeton Scientific
Publishing (1989).
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--Conversely, substances such as saccharin and ethyl acrylate (used
in the manufacturing of latex paints and textiles) have been
branded as ``probable'' human carcinogens and stigmatized on
the basis of animal data later dismissed as irrelevant or
otherwise inapplicable to humans.\14\ False alarms such as
these can cost society billions in terms of loss of viable
products in commerce, decreased international competitiveness,
job loss, litigation, and unnecessary public anxiety.
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\14\ NIEHS Fact Sheet: The Report on Carcinogens--9th edition. 15
May 2000. <http://www.niehs.nih.gov/oc/news/9thROC.htm>.
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--Lifetime cancer studies in rats and mice are so costly and
inefficient that the NTP has only been able to conduct an
average of 12 such studies per year over the past several
decades. At this rate, it would take the NTP more than 32,000
years, 68 million animals, and $160 billion to test the more
than 80,000 environmental chemicals whose cancer-causing
potential has not yet been specifically assessed.\15\
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\15\ Ward EM, Schulte PA, Bayard S, et al. Priorities for
development of research methods in occupational cancer. Environmental
Health Perspectives 111, 1-12 (2003).
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These findings call into question the wisdom of continued Federal
appropriations to the NTP rodent cancer-testing program. Taxpayer
dollars would be better spent developing more reliable, relevant, and
cost-effective methods for assessing chemical safety.
ntp vision and roadmap for the 21st century
The NTP itself appears to recognize the limitations of relying upon
decades old and never validated toxicity studies. In 2003, the NTP
articulated its ``vision'' to move toxicology from an observational to
a predictive science with markedly reduced reliance on animal
testing.\16\ Among the methods that the NTP has identified for further
development are ``high throughput'' screens, which combine robotics and
in vitro (cell-based) toxicology to create a system capable of rapidly
and inexpensively screening tens of thousands of substances per year at
multiple concentrations relevant to real-world human exposure levels.
PETA believes that a ``battery'' of several in vitro tests--based on
human tissues and mechanisms of cancer induction that are relevant to
people (e.g., genetic damage, cell transformation, depression of the
immune system, hormone imbalance, etc.) represents the most credible
and viable approach to accurately identifying chemicals that pose a
cancer risk to humans.
request for appropriations
In order to more rapidly and effectively screen chemicals to detect
those that present a cancer risk to humans, we respectfully urge the
subcommittee to support increasing appropriations from within the
existing NIEHS budget for the development and validation of efficient
and economical non-animal test methods under the NTP's ``21st Century
Vision'' program.\16\ Given the dubious value of the NTP rodent cancer-
testing program, we respectfully recommend that funding of this program
be discontinued and redirected instead to the NTP Vision program.
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\16\ Toxicology in the 21st Century: The Role of the National
Toxicology Program. 24 Feb 2004. <http://ntp-server.niehs.nih.gov/
index.cfm?objectid=EE4AED80-F1F6-975E-7317D7CB17625A15>.
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request for committee report language
We also respectfully request that the subcommittee consider the
following report language for the Senate Labor, Health and Human
Services, Education and Related Agencies Appropriations bill:
``Not later than March 30, 2007, the Director of the NTP/NIEHS
shall provide Congress with a report detailing the number of rodent
lifetime cancer studies funded to date by the NTP/NCI which (i)
produced results deemed to be equivocal and/or inadequate for
classification as to human cancer risk, or (ii) have failed to provide
a clear answer as to whether the substance tested presents a cancer
risk to humans. The Director's report should detail the costs
associated with such studies, and explain the NTP's continued reliance
on rodent lifetime cancer studies in light of criticisms from senior
Federal officials regarding their dubious validity and utility.''
Thank you for the opportunity to submit this request on behalf of
our more than 1.3 million members and supporters.
______
Prepared Statement of Project R&R
Project R&R: Release and Restitution for Chimpanzees in U.S.
Laboratories, whose advisory board of chimpanzee experts includes 12
organizations with a combined membership of 500,000, respectfully
submits testimony on our funding priority.
We request that Federal funding for breeding chimpanzees for
research, or for projects that require breeding, be terminated. We do
so for the following reasons:
--A ``surplus'' of chimpanzees has resulted from over-breeding in the
1980s for HIV/AIDS research and later findings that they are a
poor HIV/AIDS model.\1\
---------------------------------------------------------------------------
\1\ National Research Council (1997) Chimpanzees in research:
strategies for their ethical care, management and use. National
Academies Press: Washington, D.C.
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--There are enough chimpanzees to address existing federally funded
research.\2\
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\2\ Report of the Chimpanzee Management Plan Working Group to the
National Advisory Research Resources Council; May 18, 2005.
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--As a result of the ``surplus,'' the government funds a national
sanctuary system.\3\
---------------------------------------------------------------------------
\3\ http://www.ncrr.nih.gov/compmed/cm_chimp.asp.
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--The current population costs about $11 million Federal per year.
--Breeding more chimpanzees increases taxpayers' financial burden.
--Expansion of the population compounds existing concerns about their
quality of care.
--While there is a breeding moratorium, NIH still funds research
projects requiring breeding.\4\
---------------------------------------------------------------------------
\4\ Ibid.
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--The public is concerned about the use of chimpanzees in research.
Background.--Of an estimated 1,300 chimpanzees in laboratories in
the United States today, approximately 850 are federally owned or
supported. In the mid-1990s, the National Research Council (NRC) made
recommendations to address the ``surplus'' that included a moratorium
on breeding federally-owned or supported chimpanzees for at least 5
years \5\ (implemented in 1995). The National Advisory Research
Resources Council, which advises NCRR on funding activities, policies,
and program, met on 09/15/05 and recommended that NCRR extend the
moratorium to 12/07. The recommendation was accepted \6\--reasons
included the high costs associated with care and the fact that
chimpanzees are a poor model for human HIV research.\7\ \8\
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\5\ National Research Council (1997) Chimpanzees in research:
strategies for their ethical care, management and use. National
Academies Press: Washington, D.C.
\6\ http://www.ncrr.nih.gov/compmed/cm_chimp.asp
\7\ Muchmore, E., (2001) Chimpanzee models for human disease and
immunobiology, Immunological Reviews, 183, 86-93.
\8\ Reynolds, V., (1995) Moral issues in relation to chimpanzee
field studies and experiments, Alternatives to Laboratory Animals, 23,
621-625.
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Circumventing the moratorium.--Despite the moratorium, NIH funds
research projects requiring breeding. For example, the National
Institute of Allergy and Infectious Diseases (NIAID) maintains a
contract with the New Iberia Research Center (NIRC) to provide 10 to 12
infants annually for research. The 10 year contract entitled ``Leasing
of chimpanzees for the conduct of research' was allotted over $22
million ($3.9 million has been spent since 2002).\9\
---------------------------------------------------------------------------
\9\ Source: http://dcis.hhs.gov/nih/nih_daily_active_web.html (See
contract No. 272022754).
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NIRC has also received $5.47 million from 09/00 to 08/05 for a
grant from NCRR to maintain 138 chimpanzees for breeding. NIH/NCRR
spends more than $1 million annually to maintain the NIRC breeding
colony.\10\ These grants result in $9 million going to breeding-related
activities at NIRC alone since 2000.
---------------------------------------------------------------------------
\10\ http://nirc.louisiana.edu/divisions/nihgrants.html
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Such expenditures circumvent the intent of the breeding moratorium,
compelling the need to prevent the growing financial burden of
increasing numbers of chimpanzees, particularly since, by the
government's own admission, a ``surplus'' already exists.
Costs for Chimpanzee Maintenance.--The cost of care for chimpanzees
is a major concern, particularly with NIH's tightening budget. In 1995,
the Institute for Laboratory Animal Research (ILAR) published a study
that projected the future costs of maintaining chimpanzees in U.S.
research.\11\ ILAR, a division of the National Academies of Science,
functions as ``an advisor to the Federal Government, the biomedical
research community, and the public.'' \12\
---------------------------------------------------------------------------
\11\ Dyke, B., Williams-Blangero, S. et al, 1995 ``Future costs of
chimpanzees in U.S. research institutions,'' ILAR Journal V37(4) http:/
/dels.nas.edu/ilar_/ilarjournal/37_4/37_Future.shtml
\12\ Institute for Laboratory Animal Research, website at http://
dels.nas.edu/ilar_n/ilarhome/about.shtml
---------------------------------------------------------------------------
The ILAR study examined the per diem costs of the existing
population of chimpanzees at six facilities. Taking into account a
variety of factors such as longevity, distribution of sex, and
complexity of care, it projected costs of maintaining the present
colony over the next 60 years. To account for inflation, an annual 4
percent increase was incorporated, corresponding approximately to the
Biomedical Research and Development Price Index.
The results of the study indicated that the lifetime cost of
maintaining chimpanzees over the next 60 years--the approximate
lifespan of chimpanzees in captivity--will exceed $3.14 billion. The
1995 projection, however, was based on a population of 1,447
chimpanzees. The present population of federally owned or supported
chimpanzees in 2006, due to implementation of the partial breeding
moratorium in 1995 and the close of the Coulston Foundation in 2002,
stands closer to 850. This represents approximately 59 percent of the
1,447 number used in ILAR's projection. Thus we can estimate the cost
of the existing colony to be $1.85 billion.
The ILAR projection also concluded that the current 2006 annual
costs would be approximately $18.8 million. Adjusting this number by 59
percent results in $11 million spent in 2006 alone to maintain
chimpanzees for research.
It is important to note that $11 million represents only a partial
estimate of the entire Federal expenditure for chimpanzee research. The
total population of U.S. chimpanzees available for research is
estimated at 1,300. Approximately 500 of these chimpanzees are
privately owned. Privately owned chimpanzees are also partially funded
by Federal research dollars. Therefore, the 2006 estimate of annual
expenditure actually exceeds $11 million by an undetermined amount.
Delivery of care.--USDA inspection reports indicate that facilities
housing chimpanzees for research are not adequately meeting basic
housing needs. Inspection reports for the NIRC 2004 showed some
chimpanzees being housed in less than the minimal space requirements.
The facility was given one year to correct the non-compliance, which
needed to be further extended as construction of new housing facilities
was still not completed. NIRC was also cited 7 times during its 12/04
inspection for improperly sanitizing cages and living quarters, as well
as for failing to provide adequate environment enhancement.
Inspection reports filed on the Southwest Foundation for Biomedical
Research and the Yerkes Primate Facility, both National Primate
Research Centers, also demonstrate multiple non-compliant items for
failing to keep chimpanzee areas in well-maintained condition, and
failing to maintain safe facilities free of dangers due to disrepair.
A poor model.--It is widely agreed within the scientific community
that chimpanzees are a poor model for HIV. Years of research
demonstrated that HIV-infected chimpanzees do not develop AIDS.
Similarly, while chimpanzees are used in current hepatitis C research,
they do not model the course of the human disease. The decoding of the
chimpanzee genome pointed out similarities as well as differences
between humans and chimpanzees. Some of those greatest differences
relate to the immune system.\13\ Such differences question the validity
of using chimpanzees in infectious disease research, further arguing
the need to curb populations and costs.
---------------------------------------------------------------------------
\13\ The Chimpanzee Sequencing and Analysis Consortium/Mikkelsen,
TS, et al.,(1 September 2005) Initial sequence of the chimpanzee genome
and comparison with the human genome, Nature 437, 69-87.
---------------------------------------------------------------------------
Ethical concerns.--The U.S. public is concerned about the use of
chimpanzees in research because of their intellectual, emotional and
social similarities to humans. A 2005 poll conducted by the Humane
Research Council revealed that 4 out of 5 (83 percent) of the U.S.
public recognize chimpanzees as highly intelligent, social individuals
who have an extensive capacity to communicate. A full 71 percent of
Americans support the release of chimpanzees if they have been used in
research for more than 10 years.\14\ A 2001 poll conducted by Zogby
International showed that 90 percent of Americans believe it is
unacceptable to confine chimpanzees in government-approved cages.\15\
---------------------------------------------------------------------------
\14\ U.S. Public Opinion of Chimpanzee Research, Support for a Ban,
and Related Issues, Prepared for the New England Anti-Vivisection
Society, by the Humane Research Council, 2005.
\15\ Public Opinion Poll, Prepared for the Chimpanzee
Collaboratory, by Zogby International, 2001.
---------------------------------------------------------------------------
Conclusion.--We respectfully request that the following language
appear in the House Labor, Health and Human Services, Education and
Related Agencies Appropriations Subcommittee Report for Fiscal Year
2007:
``None of these funds shall be used for the breeding of chimpanzees
or research projects that require the breeding of chimpanzees.''
We hope the committee will accommodate this modest request that
will save the government substantial money, benefit chimpanzees, and
allay some concerns of the public at large. Thank you for your
consideration.
______
Letter From Senator Pat Roberts, et al.
Washington, DC, April 5, 2006.
Hon. Arlen Specter, Chair,
Hon. Tom Harkin, Ranking Member,
Subcommittee on Labor, HHS, and Education, Senate Committee on
Appropriations, Washington, DC
Dear Chairman Specter and Ranking Member Harkin: As you begin your
work on the fiscal year 2007 Labor, Health and Human Services, and
Education Appropriations bill, we urge you to provide the same level of
funding for Title VII health professional as was appropriated in fiscal
year 2005 ($299,552,000). These programs provide direct financial
support for health care workforce development and education. In
addition, they are the only Federal programs designed to train
providers in interdisciplinary setting to respond to the needs of
special and underserved populations. They also work to increase
minority representation in the health care workforce.
The fiscal year 2006 Labor, Health and Human Services, Education
Appropriations bill dramatically reduced funding for Title VII health
professions programs, resulting in a 51 percent overall cut below
fiscal year 2005. At a time of serious health professions shortages,
this reduction has already had devastating effects on the country's
neediest communities. By restoring funding to these programs to fiscal
year 2005 levels, you will enable them to continue to improve the
distribution, quality, and diversity of the health professions
workforce.
We respectfully urge you to restore funding to the Title VII
programs in the fiscal year 2007 Labor, Health and Human Services, and
Education appropriations bill. We greatly appreciate your consideration
of the request.
Sincerely,
Senators Pat Roberts, Jack Reed, Elizabeth Dole,
Daniel K. Akaka, Susan M. Collins, Lamar
Alexander, Richard Durbin, Sam Brownback,
Blanche L. Lincoln, Richard G. Lugar, James
M. Jeffords, Paul S. Sarbanes, Norm
Coleman, Charles E. Schumer, Byron L.
Dorgan, Frank R. Lautenberg, Dianne
Feinstein, Mark L. Pryor, Hillary Rodham
Clinton, Evan Bayh, Christopher J. Dodd,
Patrick J. Leahy, John F. Kerry, Tim
Johnson, Debbie Stabenow, Jon Kyl, Ken
Salazar, Bill Nelson, Benjamin E. Nelson,
Edward M. Kennedy, Robert Menendez, Barbara
A. Mikulski, Russell D. Feingold, George V.
Voinovich, Mary L. Lanorieu, Maria
Cantwell, Barack Obama, Joseph I.
Lieberman, Jeff Bingaman, Harry Reid, John
D. Rockefeller, IV, Conrad Burns, Barbara
Boxer, Mark Dayton, Lincoln Chafee, Patty
Murray, Christopher S. Bond, Carl Levin,
Mike DeWine, Chuck Hagel, John Warner,
Lindsey Graham, Richard M. Burr, James M.
Talent, Jeff Sessions, and Ron Wyden.
______
Prepared Statement of the Spina Bifida Association
On behalf of the more than 70,000 individuals and their families
who are affected by Spina Bifida, the Spina Bifida Association (SBA)
appreciates the opportunity to submit written testimony for the record
regarding fiscal year 2007 funding for the National Spina Bifida
Program and other related Spina Bifida initiatives. SBA is the national
voluntary health agency working on behalf of people with Spina Bifida
and their families through education, advocacy, research and service.
The Association was founded in 1973 to address the needs of the Spina
Bifida community and today serves as the representative of 56 chapters
serving more than 125 communities nationwide. SBA stands ready to work
with Members of Congress and other stakeholders to ensure our Nation
takes all the steps necessary to reduce and prevent suffering from
Spina Bifida.
background on spina bifida
Spina Bifida, a neural tube defect (NTD), occurs when the spinal
cord fails to close properly during the early stages of pregnancy,
typically within the first few weeks of pregnancy and most often before
the mother knows that she is pregnant. Over the course of the
pregnancy--as the fetus grows--the spinal cord is exposed to the
amniotic fluid which increasingly becomes toxic. It is believed that
the exposure of the spinal cord to the toxic amniotic fluid erodes the
spine and results in Spina Bifida. There are varying forms of Spina
Bifida occurring from mild--with little or no noticeable disability--to
severe--with limited movement and function. In addition, within each
different form of Spina Bifida the effects can vary widely.
Unfortunately, the most severe form of Spina Bifida occurs in 96
percent of children born with this birth defect.
The result of this neural tube defect is that most children with it
suffer from a host of physical, psychological, and educational
challenges--including paralysis, developmental delay, numerous
surgeries, and living with a shunt in their skulls which seeks to
ameliorate their condition by helping to relieve cranial pressure
associated with spinal fluid that does not flow properly. As we have
testified previously, the good news is that after decades of poor
prognoses and short life expectancy, children with Spina Bifida are now
living long enough to become adults with Spina Bifida. These gains in
longevity principally are due to breakthroughs in research, combined
with improvements generally in health care and treatment. However, with
this extended life expectancy, our Nation and people with Spina Bifida
now face new challenges--education, job training, independent living,
health care for secondary conditions, aging concerns, among others.
Despite these gains, individuals and families affected by Spina Bifida
face many challenges--physical, emotional, and financial. Fortunately,
with the advent of the National Spina Bifida Program 4 years ago,
individuals and families affected by Spina Bifida now have a national
resource to provide them with the support, information, and assistance
they need and deserve.
While the consumption of 400 micrograms of folic acid daily prior
to becoming pregnant and throughout the first trimester of pregnancy,
can help reduce the incidence of Spina Bifida by up to 75 percent,
cases of Spina Bifida still occur and our Nation still must take steps
to ensure that the tens of thousands of individuals living with Spina
Bifida can live full, healthy, and productive lives. To ensure the
highest quality-of-life possible, prevention interventions and
treatment therapies must be identified, developed, and delivered to
those in need.
cost of spina bifida
It is important to note that the lifetime costs associated with a
typical case of Spina Bifida--including medical care, special
education, therapy services, and loss of earnings--are as much as $1
million. The total societal cost of Spina Bifida is estimated to exceed
$750 million per year, with just the Social Security Administration
payments to individuals with Spina Bifida exceeding $82 million per
year. Moreover, tens of millions of dollars are spent on medical care
paid for by the Medicaid and Medicare Programs. Our Nation must do more
to help reduce the emotional, financial, and physical toll of Spina
Bifida on the individuals and families affected. Efforts to reduce and
prevent suffering from Spina Bifida help to save money and save lives.
improving quality-of-life through the national spina bifida program
SBA has worked with Members of Congress to ensure that our Nation
is taking all the steps possible to prevent Spina Bifida and diminish
suffering for those currently living with this condition. With
appropriate, affordable, and high-quality medical, physical, and
emotional care, most people born with Spina Bifida likely will have a
normal or near normal life expectancy. Ensuring access to these
services is essential to improving the quality-of-life for those born
with this birth defect.
The National Spina Bifida Program at the National Center for Birth
Defects and Developmental Disabilities (NCBDDD) at the Centers for
Disease Control and Prevention (CDC) works on two critical levels--to
reduce and prevent Spina Bifida incidence and morbidity and to improve
quality-of-life for those living with Spina Bifida. The program seeks
to ensure that what is known by scientists is practiced and experienced
by the 70,000 individuals and families affected by Spina Bifida.
Moreover, the National Spina Bifida Program works to improve the
outlook for a life challenged by this complicated birth defect--
principally identifying valuable therapies from in-utero throughout the
lifespan and making them available and accessible to those in need.
The National Spina Bifida Program serves as a national center for
information and support to help ensure that individuals, families, and
other caregivers, such as health professionals, have the most up-to-
date information about effective interventions for the myriad primary
and secondary conditions associated with Spina Bifida. Among many other
activities, the program helps individuals with Spina Bifida and their
families learn how to treat and prevent secondary health problems, such
as bladder and bowel control difficulties, learning disabilities,
depression, latex allergy, obesity, skin breakdown and social and
sexual issues. Children with Spina Bifida often have learning
disabilities and may have difficulty with paying attention, expressing
or understanding language, and grasping reading and math. All of these
problems can be treated or prevented, but only if those affected by
Spina Bifida--and their caregivers--are properly educated and taught
what they need to know to maintain the highest level of health and
well-being possible. The National Spina Bifida Program's secondary
prevention activities represent a tangible quality-of-life difference
to the 70,000 individuals living with Spina Bifida with the goal being
living well with Spina Bifida.
In fiscal year 2006, Congress folded funding for a study on folic
acid (also known as the ``China Study'') into the National Spina Bifida
Program and provided $5.1 million in fiscal year 2006 (a final
allocation of $5 million after the one percent across-the-board cut)
for this new joint program. SBA appreciates Congressional interest and
intent in ensuring that the CDC's folic acid and Spina Bifida
activities are coordinated. SBA maintains a strong interest in working
with NCBDDD and Members of the subcommittee to ensure that this new
joint program fulfills Congressional intent and that the quality-of-
life components of the National Spina Bifida Program receive adequate
funding to support ongoing and expanded endeavors.
SBA advocates that the National Spina Bifida Program receive $6
million in fiscal year 2007 and that that sum be used to expand and
continue to promote quality-of-life programs that support people with
Spina Bifida so they can live fulfilling and productive lives. In its
first 3 years, this program already has made a difference for our
community and with additional resources it can expand its reach and
provide additional assistance and hope to those with an affected loved
one. Increasing funding for the National Spina Bifida Program will help
ensure that our Nation continues to mount a comprehensive effort to
prevent and reduce suffering from Spina Bifida.
preventing spina bifida
While the exact cause of Spina Bifida is unknown, over the last
decade, medical research has confirmed a link between a woman's folate
level before pregnancy and the occurrence of Spina Bifida. Sixty
million women are at-risk of having a child born with Spina Bifida and
each year approximately 3,000 pregnancies in this country are affected
by Spina Bifida, resulting in 1,500 births. As mentioned above, the
consumption of 400 micrograms of folic acid daily prior to becoming
pregnant and throughout the first trimester of pregnancy can help
reduce incidence of Spina Bifida up to 75 percent. There are few public
health challenges that our Nation can tackle and conquer by three-
fourths in such a straightforward fashion. However, we must still be
concerned with addressing the 25 percent of Spina Bifida cases that
cannot be prevented by folic acid consumption, as well as ensuring that
all women of childbearing age--particularly those most at-risk for a
Spina Bifida pregnancy--consume adequate amounts of folic acid.
The good news is that progress has been made in convincing women of
the importance of folic acid consumption and the need to maintain diet
rich in folic acid. Since 1968, the CDC has led the Nation in
monitoring birth defects and developmental disabilities, linking these
health outcomes with maternal and/or environmental factors that
increase risk, and identifying effective means of reducing such risks.
Former CDC Director Jeff Koplan has stated that the agency's folic acid
prevention campaign has reduced neural tube defect births by 20
percent. This public health success should be celebrated, but it is
only half of the equation as approximately 3,000 pregnancies still are
affected by this devastating birth defect. The Nation's public
education campaign around folic acid consumption must be enhanced and
broadened to reach segments of the population that have yet to heed
this call--such an investment will help ensure that as many cases of
Spina Bifida can be prevented as possible.
SBA works collaboratively with CDC and the March of Dimes to
increase awareness of the benefits of folic acid, particular for those
at elevated risk of having a baby with neural tube defects (those who
have Spina Bifida themselves or those who have already conceived a baby
with Spina Bifida). With additional funding in fiscal year 2007 these
activities could be expanded to reach the broader population in need of
these public health education, health promotion, and disease prevention
messages. SBA advocates that Congress provide additional funding to CDC
to allow for a particular public health education and awareness focus
on at-risk populations (e.g. Hispanic-Latino communities) and health
professionals who can help disseminate information about the importance
of folic acid consumption among women of childbearing age.
In addition to a $6 million fiscal year 2007 allocation for the
National Spina Bifida Program, SBA supports a fiscal year 2007
allocation of $135 million for the NCBDDD so the agency can enhance its
programs and initiatives to prevent birth defects and developmental
disabilities and promote health and wellness among people with
disabilities.
improving health care for individuals with spina bifida
The mission of the Agency for Healthcare Research and Quality
(AHRQ) is to improve the outcomes and quality of health care; reduce
its costs; improve patient safety; decrease medical errors; and broaden
access to essential health services. The work conducted by the agency
is vital to the evaluation of new treatments in order to ensure that
individuals and their families living with Spina Bifida continue to
receive the high quality health care that they need and deserve--SBA
recommends that AHRQ receive $443 million in fiscal year 2007 so that
it can continue to conduct follow-up efforts to evaluate Spina Bifida
treatments, promulgate associated standards of care, and further the
provision of evidence-based care stemming from the outcomes of the 2003
Spina Bifida Research Conference.
sustain and seize spina bifida research opportunities
SBA seeks to support individuals and families affected by Spina
Bifida, maximize the prevention of Spina Bifida, and ensure that all
babies born with Spina Bifida have the greatest chance of survival and
the highest quality-of-life--through the lifespan. When families
recently diagnosed with a Spina Bifida pregnancy contact SBA, the
organization puts them in touch with another family who has a child
with the condition so they can learn of the joys and challenges of
having a child with the birth defect. Unfortunately, traditionally when
families have faced a Spina Bifida diagnosis they have had two
difficult options. The first is to continue the pregnancy with the
expectation of multiple surgeries for the child after birth, uncertain
life expectancy, and many physical and developmental challenges and
complications. The second, unfortunately, is to terminate the
pregnancy. Fortunately, now there may be an important and effective
third option.
Since the late 1990s, doctors at three U.S. hospitals--Children's
Hospital of Philadelphia, Vanderbilt University Medical Center in
Nashville, and the University of California at San Francisco--have been
operating before birth on fetuses diagnosed with Spina Bifida. In 2004,
the University of North Carolina became the fourth hospital in the
Nation to perform the in-utero operations. By closing the spinal lesion
early in pregnancy, physicians believe they can minimize the damage
created by fluid leaking from the spine, as well as limit by the harm
done due to the spinal cord's contact with the amniotic fluid. Surgeons
have found that closing the hole in the spine in this fashion before
birth may correct breathing problems in 15 percent of the children
receiving the procedure and may reduce the need for a shunt to drain
fluid from the brain by between 33 percent and 50 percent.
To determine whether or not this new procedure is safer and more
effective than the traditional post-birth surgery to address the
condition, the National Institute of Child Health and Human Development
(NICHD) is conducting a large study involving the Children's Hospital
of Philadelphia, Vanderbilt University Medical Center, and the
University of California at San Francisco. While these three
institutions have undertaken preliminary studies of the in-utero
surgery technique, the overall and long-term effectiveness of this
approach as compared to traditional therapy remains unknown. Given the
potential for this surgery to ameliorate many of the conditions
associated with Spina Bifida, we must do a better job of studying and
evaluating this procedure, educating health care providers about this
surgery as a potential option, and making information about it
available to more families facing a Spina Bifida pregnancy.
Additionally, the National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK) is scheduled to host an interagency meeting in
spring 2006 on urological complications. We are also excited to report
that the National Institute of Neurological Disorders and Stroke
(NINDS) has formed a trans-agency Spina Bifida Working Group. SBA looks
forward to working with both agencies on these and other important
Spina Bifida related initiatives.
Our Nation has benefited immensely from our past Federal investment
in biomedical research at the National Institutes of Health (NIH). SBA
joins with the rest of the public health community in advocating that
NIH receive $29.7 billion in fiscal year 2007. This funding will
support applied and basic biomedical, psychosocial, educational, and
rehabilitative research to improve the understanding of the etiology,
prevention, cure and treatment of Spina Bifida and its related
conditions. In addition, SBA urges the NIH to explore the following as
they relate to individuals with Spina Bifida: assistive technology, in
utero surgery, cost of care, women's and men's health, tethered spinal
cord, hydrocephalus, latex allergies, and other related factors.
conclusion
SBA stands ready to work with policymakers to advance policies that
will reduce and prevent suffering from Spina Bifida. Again, we thank
you for the opportunity to present our views on funding for programs
that will improve the quality-of-life for the 70,000 Americans and
their families living with Spina Bifida and stand ready to answer any
questions you may have.
______
Prepared Statement of the Tuomey Healthcare System
Mr. Chairman, and Members of the subcommittee, thank you for the
opportunity to submit testimony regarding the need for a Bedside
Medication Verification System and subsequently a Computerized
Practitioner Order Entry and Clinical Decision Support System at Tuomey
Healthcare System.
For more than 90 years, Tuomey's growth and advancement have been
guided by professionals who care deeply about the Sumter community and
the individual healthcare needs of every person in it. From the small
20-bed Sumter Hospital born out of Timothy Tuomey's gift in 1913 to a
healthcare system of more than 1,600 employees and 266 beds, Tuomey's
history has been one of compassion and resolve. It is propelled by a
long-term vision for healthcare that's second to none and is enhanced
by a deeply philanthropic mission.
Since 2000, Tuomey has provided tens of millions of dollars in
community services. And each year, we absorb almost $20 million in
indigent care. Our employee base is tremendously dedicated to Sumter's
health as well, as evidenced by their gift of close to $1 million since
2000. Through all of this, Tuomey is committed to Sumter, and it shows
in everything we do. In the last year, Tuomey has ranked in the 97th
and 98th percentiles nationally in the Press Ganey customer
satisfaction scores in the inpatient and ambulatory surgery center
categories.
The demand for Tuomey services will be further increased with the
upcoming addition of approximately 850 service men and women to Shaw
Air Force Base and the closing of the base's inpatient hospital. This
equates to an approximate 3,000 person increase in total population to
the Sumter community. To handle Tuomey's additional patient volume and
to continue providing the quality care for which we are known, it is
imperative we increase our inpatient capacity. Likewise, we must expand
our women's and obstetrics service areas and our Emergency Department
to meet the growing needs of this community. It is an expensive
proposition, but one to which we are committed. It's the next step in
our path to safeguarding this community's health.
Plans are currently underway for the construction of a new 24-bed
women's complex called The Tuomey Women's Center, expansion and
enhancement of our nurseries, the addition of 22 general medical
inpatient rooms, and the expansion of the Emergency Department. The
total combined cost of these expansions and enhancements is $31.5
million.
High quality care and patient safety are the core elements of
everything we do at Tuomey, utilizing technology where appropriate and
cost effective. We have been a Meditech Information Systems customer
since 1988, with virtually every department in our facility
computerized, to include nursing documentation, radiology results,
laboratory results and all financials. In July 2005, we went live with
the McKesson Electronic Medical Record, which allows physicians to
access patient information from anywhere with an internet connection,
enhancing the timely delivery and continuity of care. However, even
with the benefits gained from our technology, we still deal with the
challenges of caring for sicker patients in a shorter period of time
with limited financial resources and shortages of skilled labor. Like
many other hospitals, a completely safe and accurate medication
management process remains one of our most difficult challenges. In
addition, the medication management process is one of the areas where
technology can offer the greatest number of improvements in terms of
patient safety and quality of care.
In its 1999 report, ``To Err is Human: Building a Safer Health
System,'' The Institute of Medicine (IOM) estimated that 44,000 to
98,000 patients die each year from medical errors, of which the largest
portion, up to one-third, has been linked to medication errors or
adverse drug events (ADEs). A medication error can lead to increased
charges and longer patient stays while adverse drug events can lead to
patient injury and death. While there is a difference between
medication errors and adverse drug events, Tuomey's goal is to avoid
both and to consistently offer the highest quality care in the safest
patient care environment possible.
Medication administration safety is dependent on five basic safety
checks: the correct patient, the correct drug, the correct dose, the
correct route of administration and the correct time of administration.
Any deviation from these five standards of medication administration
practice can lead to medication errors and Adverse Drug Events. Given
that there are now more than 17,000 brand and generic names for
pharmaceuticals in North America and nurses are caring for sicker
patients on shorter hospital stays, the implementation of automated
systems to safeguard against human errors in all aspects of the
medication administration process has reached a state of critical need
at Tuomey.
Currently, Tuomey is using an antiquated, yet not uncommon, system
of medication ordering in which providers handwrite orders that are
sent via pneumatic tube to a pharmacy location. The pharmacy staff
deciphers the handwritten orders to the best of their human ability and
sends the medications to the nursing staff that then rely on
handwritten orders and the five rights of medication administration. In
addition, the pharmacy charges the patient's account for the
medications at the point the medications are dispensed from the
pharmacy. The pharmacy is then responsible for crediting the patient's
account if the medications are never taken.
The failure rate for this type of system is staggering throughout
the healthcare community. Physicians, pharmacists, nurses and support
staff work long hours with fluctuating levels of stress. Experts have
estimated that at least 38 percent of all medication errors take place
at the bedside using manual handwritten systems like the one currently
in use at Tuomey. There are simply too many distractions and too many
chances for something to go wrong when completely relying on protocols
and procedures to assure safe and accurate medication administration.
It is important to note, though, that Tuomey has never been complacent
with a system that puts any patient at risk. Tuomey has remained
vigilant to the risks associated with its current medication
administration process and has made many improvements and changes to
the manual system to promote patient safety and accuracy.
Unfortunately, for many years, there has not been a feasible
alternative to the manual system. Technology and system availability
have only recently reached a State worth investigating for true process
improvement. Tuomey has investigated the currently available
technologies and has identified viable solutions to improve the
medication administration process. Bedside Medication Administration
systems using barcode verification (BMV) and Computerized Physician
Order Entry with Clinical Decision Support (CPOE/CDSS) have been
identified as two systems that can greatly minimize the chance of
errors and promote the highest quality care in the medication
administration process.
Bedside Medication Administration using barcode identification
systems have consistently been shown to improve patient safety and
patient billing in hospital sites throughout the country. The basic
process for bar code medication administration systems begins with an
initial positive identification of a patient by the nursing staff.
After the initial identification, the patient is given a wristband with
an identifying bar code. From that point forward, the patient will be
identified via a scan of the wristband's bar code. Before administering
any medication or performing a treatment, the patient must be
identified to the system via the scan. By first correctly identifying
the patient to the system, the nurse then allows the system to double
check the other four rights before the actual administration.
If a medication order has expired or been changed, the nurse is
immediately alerted to avoid a possible medication error or Adverse
Drug Event. The basic setup for the bar code medication administration
system involves a laptop computer with a scanner linked to a hospital
wireless network that runs the medication verification and patient
billing systems. Accurate identification and correct order association
assure patient safety and patient billing is accurately updated at the
point of administration.
Computerized Practitioner Order Entry (CPOE) and Clinical Decision
Support System (CDSS) implementation at Tuomey will virtually eliminate
the chance of error in the deciphering of handwritten orders and
eliminate any need for transcription all together since providers will
be entering all medication and treatment orders directly into the
information system with alerts and warnings regarding allergies,
duplications and dangerous interactions readily available. If the
orders are accurately entered and double checked for safety, then the
bedside point of administration system will accurately ensure the
correctly entered orders are carried out safely and accurately as
intended by the ordering clinicians. Nurses will ensure that all five
standards of medication administration are correct and accurate using
barcodes identifying both the medication and the patient.
While Bedside Medication Verification and Computerized Practitioner
Order Entry/Clinical Decision Support Systems are highly
interdependent, staging of the implementations are vital to success.
CPOE/CDSS cannot receive real-time feedback regarding medication
administration without a Bedside Medication Verification system
implemented and functioning. Likewise, Computerized Practitioner Order
Entry (CPOE) and Clinical Decision Support System (CDSS) maturity lags
behind Bedside Medication Verification due to the level of
sophistication and logic design required. Any implementation strategy
for Bedside Medication Verification and CPOE/CDSS at Tuomey Healthcare
System must include plans to implement Bedside Medication Verification
before moving to the other systems.
In fiscal year 2007, we hope that the subcommittee will support our
request for funding of $1.5 million in order to implement a Bedside
Medication Verification system that will be Phase I of this entire
project. It is our belief that we will be highly successful in this
project and could serve as a resource and site for other health care
organizations to learn from in enhancing the safety of all patients.
As healthcare continues to evolve, so does Tuomey Healthcare
System. We're here to anticipate the needs of the communities we serve,
responding with proactive healthcare initiatives, such as the systems
noted above. Our stable but consistent growth positions Tuomey as one
of South Carolina's largest healthcare systems. Tuomey is committed to
Sumter, and it shows in everything we do.
______
NATIONAL INSTITUTES OF HEALTH
Prepared Statement of the American Association for Cancer Research
(AACR)
The number of cancer deaths is falling and the number of cancer
survivors is increasing each year. This remarkable progress has
occurred because of the advances in cancer research, discovery,
detection, prevention, and treatment made possible, in part, by a
strong and steady level of funding and commitment by the Federal
Government.
The National Cancer Program supports an incredible array of cancer
research programs that shows great promise for benefit to patients with
cancer. To sustain the research momentum that has been so carefully
built up over the past decade--and to continue to give hope to those
with cancer--the Congress must provide sufficient resources to preserve
the scientific infrastructure and foster new discoveries.
The American Association for Cancer Research (AACR) stands ready to
contribute its share to accelerate our progress against this
devastating disease. The AACR joins with other leaders in the cancer
community to call upon the Congress to take the following actions to
enable these invaluable programs to continue their contributions to
improving the lives of patients with cancer and other life-threatening
diseases:
(1) Provide a 5 percent increase in funding for the National
Institutes of Health to $29.75 billion for fiscal year 2007; and
(2) Provide a 5 percent increase in funding for the National Cancer
Institute to $5.03 billion for fiscal year 2007.
Early this year, it was reported that the number of cancer deaths
every year in the United States fell for the first time in more than 70
years. Coupled with the fact that observed cancer death rates from all
cancers combined dropped 1.1 percent each year from 1993 to 2002, these
persistent declines in cancer mortality rates are evidence of the
success of the National Cancer Program and its research, prevention,
and treatment advances.
Among these advances are a series of new targeted cancer therapies
that have evolved from a process of rational drug design based upon our
expanded understanding of the genetic basis of disease. For example,
Herceptin became the first targeted therapy for breast cancer in 1997--
it is an injectable antibody that targets and blocks the function of
HER2 protein when it is overproduced in the body, which leads to
cancer. In 2001, Gleevec became the first approved kinase inhibitor for
cancer, shutting down the BCR-ABL kinase that causes chronic myeloid
leukemia. These discoveries have led to a half-dozen other more recent
drug approvals that are based upon these and other novel mechanisms of
action.
Exciting, life-saving scientific progress such as this will only
continue if it is nurtured and sustained by an adequate level of
Federal research investment. The American Association for Cancer
Research (AACR) calls upon the President and the United States Congress
to make the commitment to sustain this research momentum by increasing
the appropriations for the National Institutes of Health (NIH) to
$29.75 billion and the National Cancer Institute (NCI) to $5.03 billion
for fiscal year 2007. Without such a commitment, promising research
will be abandoned, new treatments may never come to fruition, and
patients with cancer will lose the hope of enjoying a life beyond
cancer.
The AACR stands ready to contribute its share to accelerate our
progress against this devastating disease. As AACR approaches its
Centennial Year in 2007, with more than 24,000 members, it is well
positioned to foster and facilitate the scientific developments that
will underpin our forward movement in basic, translational, and
clinical cancer research. Through its five prestigious scientific
journals--including Cancer Research, the most frequently cited cancer
journal in the world--AACR rapidly disseminates cutting-edge, peer-
reviewed findings throughout the medical research community. AACR's
Annual Meeting attracts more than 16,000 scientists worldwide to cross-
disciplinary sessions led by the world's leading experts. The AACR has
been at the forefront of the art of anticancer drug development and the
science of cancer prevention, and originated the annual International
Conference on Cancer Prevention Research. Through these high quality
scientific meetings, along with prestigious awards and research
training programs and grants, the AACR utilizes a multilayered approach
to stimulate and foster the best science that will lead to the conquest
of cancer.
No single sector or entity alone can successfully tackle the
complex set of diseases known as cancer. Academic scientists and
clinicians have a large role to play in discovery and the translation
of discoveries into standard clinical care. Biotechnology and
pharmaceutical companies, with their vast research and development and
manufacturing and distribution capabilities, are also essential for the
smooth, efficient, and effective delivery of cancer medicines to
hospitals and patients. Barriers or roadblocks in any aspect of the
research, discovery, development, or delivery path will have an adverse
impact on achieving the goal of conquering cancer and saving lives.
Central to this multisector effort is the National Cancer Program
and the fundamental and foundational work of the National Cancer
Institute. For 35 years, because of the National Cancer Act, the NCI
has spearheaded the research efforts that have led to the declining
mortality rates we are experiencing today. The strategies underlying
the National Cancer Program have been developed by the NCI in close
collaboration with the cancer community. Each year the Director of the
NCI engages in an open and transparent priority-setting process to
develop a plan and budget proposal for the following year. It is
reviewed by the cancer community and published each fall as The
Nation's Investment in Cancer Research: A Plan and Budget Proposal. It
is the definitive guide to how the NCI is using its funds and how it
plans to spend additional funds should they become available.
The scope and breadth of the activities in which the National
Cancer Institute is engaged are truly remarkable. As the leader of the
Nation's grand plan to attack cancer, the NCI must be provided with the
resources necessary to carry out its mission on many different fronts
and in many different ways. The five-year doubling of the budget of the
NIH enabled the National Cancer Institute to begin to expand its
activities into promising new areas that had been beyond its reach.
However, since the completion of the budget doubling in 2003,
negligible NCI budget increases (in the .5 to 2.6 percent range) and an
actual hard budget cut in fiscal year 2006, have forced retrenchment
and curtailing of some research.
Our Nation's current investment in the National Cancer Institute
supports a broad range of scientific research, infrastructure,
communications structure, and technological advances. The AACR strongly
supports continued and increased investments in these key areas as the
surest way to guarantee progress against cancer. In particular, the
AACR urges that the NCI maintain its focus on:
--Research to understand the causes and mechanisms of cancer,
including continued studies into the genetic, environmental,
and lifestyle factors that contribute to cancer causation. This
research includes population studies that identify cancer
risks, studies of normal as well as abnormal biological
functioning, and research on cellular and molecular mechanisms
of cancer initiation, progression, and metastasis.
--Research on new approaches to prevent or delay the onset of cancer,
including nutrition, vaccination, and chemoprevention. This
research should continue its emphasis on behavioral factors
that affect cancer risk--poor diet, lack of physical activity,
sun exposure, and tobacco use--and strategies to change these
behaviors.
--Research to improve early detection and diagnosis of cancer through
the discovery and development of biomarkers and imaging
techniques. This research includes using proteomic technologies
to develop biomarker panels and anatomical and molecular
imaging techniques to detect tumors and identify metastasis, as
well as studying how patients accept and comply with cancer
screening methods.
--Research to discover, develop, and evaluate therapeutics for
destroying or controlling cancer cells and metastasis. These
include localized therapies--such as surgery or radiotherapy;
systemic therapies--such as chemotherapy or vaccines;
molecularly targeted therapies (such as Herceptin and Gleevec)
directed at specific tumors or tissues; and combinations which
are often more effective than either therapy alone.
--Research to improve the quality of cancer care and the quality of
life of cancer patients, including the development of ways to
measure quality, the impact of aging on quality of care, health
and lifestyle issues of cancer survivors, and the development
and application of interventions to overcome cancer health
disparities.
The National Cancer Institute carries out this vast research
portfolio through a wide variety of different vehicles and mechanisms
in its research infrastructure. The AACR strongly favors continued and
increased support for these areas to optimize the return on research
dollars. In particular, the AACR recommends that the National Cancer
Institute continue to utilize the following successful multisector
approaches to implementing the National Cancer Program:
--Extramural program supports independent scientists conducting
research in universities, teaching hospitals, and other
organizations outside the NIH. The largest portion of NCI
research funds is devoted to this program. It supports a
balanced portfolio of more than 7,000 research and training
awards, as well as grants, cooperative agreements, and
contracts with individual investigators, professional
societies, and research institutions. Peer-reviewed research
under this program includes genetic, epidemiological,
behavioral, social, applied, and surveillance research, basic
prevention science, cancer biomarkers, chemopreventive agent
development, community oncology and prevention trials, early
detection, nutrition science, organ system research, cancer
diagnostics, imaging, drug development, and biometrics, among
others.
Thousands of AACR member scientists participate in and depend upon
support from the extramural program to advance their research goals.
Investigator-initiated scientific research is the engine driving new
discoveries and advances in cancer research and it must remain at the
forefront of efforts to conquer this disease. Funding for this aspect
of the National Cancer Program must be maintained at a sufficiently
high level to promote and advance research progress.
--Training and Career Development to increase the number of
scientists who specialize in the basic or clinical biomedical
fields is a critical NCI function. Such investments foster the
development of interdisciplinary teams and ensure a growing
core of well trained investigators to focus on cancer.
--Partnerships, including with other agencies, pharmaceutical
companies, academia, and a wide variety of other organizations,
are essential to leverage the limited resources of the NCI.
Interagency agreements with the Food and Drug Administration
and the Centers for Medicare and Medicaid Services have been
highly successful in expediting new drug development and
coverage for new treatments. The Academic Public Private
Partnership Program (AP4) supports a new way of accelerating
drug discovery and development through multiple partnerships.
--Additional important means used by the National Cancer Institute to
advance its cancer research agenda include Cancer Centers and
Centers of Research Excellence at major academic and research
institutions across the country; Networks and Consortia, such
as the Early Detection Research Network; NCI-Supported Clinical
Trials that involve more than 12,000 investigators; Cancer
Surveillance through the voluminous data collected by the NCI
Surveillance, Epidemiology, and End Results (SEER) program;
Technology Development, including the cancer Biomedical
Informatics Grid (caBIG) platform for sharing research data;
and Communication, Education, and Dissemination of research
progress directly to and for the benefit of the public and
public health professionals.
Through this wide array of effective mechanisms, the National
Cancer Institute seeks to implement the ambitious research goals of the
National Cancer Program. Each facet of the strategy is important and
generates synergies with other facets to accomplish more than the
apparent sum of the parts. Cuts to cancer research funding jeopardize
multiple facets of the strategy and have a direct adverse impact on
patients by delaying or halting development of promising treatments.
To sustain the research momentum that has been so painstakingly
built up over the past decade, the Congress must provide sufficient
resources to preserve the current infrastructure and prevent its
diminishment through inflation or other means. The American Association
for Cancer Research and the cancer community, recognizing the many
competing demands on the Federal budget, believe that, at a minimum, a
5 percent increase for the NIH and the NCI, to $29.75 billion and $5.03
billion respectively, will enable these valuable programs to continue
in a strong, if not robust, way.
To make a quantum push forward with our efforts against cancer, the
Director of the National Cancer Institute has identified, with
significant communitywide input, at least five additional areas and
opportunities that the NCI is poised to exploit if the resources become
available. By investing in these new strategic initiatives (at an
additional cost of less than $800 million) the Congress will clearly
demonstrate its strong commitment to making the conquest of cancer a
national priority and a goal that is within our reach. Several of these
areas for strategic new investments to accelerate our progress against
cancer include:
--Expand the Number of Cancer Centers to improve access for
underserved populations and extend their outreach and
collaboration capabilities.
--Reengineer Cancer Clinical Trials through implementation of the
recommendations of the Clinical Trials Working Group.
--Link Science and Technology using a variety of new mechanisms and
resources.
--Integrate Cancer Science and encourage interdisciplinary team
science across the biomedical research community.
This Nation has the most sophisticated and highly developed
biomedical research infrastructure in the world in the National
Institutes of Health. A significant portion of that research investment
is directed squarely at the cancer problem. Incredible progress has
been made in understanding this disease and in devising cutting-edge
approaches to preventing, controlling, and eliminating it. The pace of
this research must be maintained to continue our record of advances
that is leading to decreased mortality and improved patient care and
outcomes.
The American Association for Cancer Research respectfully requests
the Congress to support, at a minimum, a 5 percent funding increase for
the National Institutes of Health (to $29.75 billion) and the National
Cancer Institute (to $5.03 billion) to preserve the ability of these
successful institutions to continue their groundbreaking work toward
the conquest of cancer for the benefit of all of our citizens.
______
Prepared Statement of the American Association for Geriatric Psychiatry
The American Association for Geriatric Psychiatry (AAGP)
appreciates this opportunity to present its recommendations on issues
related to fiscal year 2007 appropriations for mental health research
and services. AAGP is a professional membership organization dedicated
to promoting the mental health and well being of older Americans and
improving the care of those with late-life mental disorders. AAGP's
membership consists of approximately 2,000 geriatric psychiatrists as
well as other health professionals who focus on the mental health
problems faced by senior citizens.
AAGP appreciates the work this subcommittee has done in recent
years in support of funding for research and services in the area of
mental health and aging through the National Institutes of Health (NIH)
and the Substance Abuse and Mental Health Services Administration
(SAMHSA). Although we generally agree with others in the mental health
community about the importance of sustained and adequate Federal
funding for mental health research and treatment, AAGP brings a unique
perspective to these issues because of the elderly patient population
served by our members.
AAGP recognizes the Federal budget constraints that the
subcommittee must consider in making allocations. At the same time, it
is important to note that research dollars and better trained
professionals can help avert a crisis in the delivery of mental health
care to the elderly in future generations when more efficient and
effective therapies are identified through research. In fact, the New
England Journal of Medicine has just published an important study,
funded by NIMH, that suggests we can significantly decrease relapse
rates in depression--which lead to more physician visits and
hospitalizations--by continuing these patients for longer periods on
antidepressant medication. In addition, studies of the IMPACT model for
treating late-life depression suggest that effective treatment of
depression in primary care reduces the cost of general health care in
those settings.
Even as we note the important research being doing in the field,
there are serious concerns, shared by AAGP and researchers, clinicians,
and consumers that there exists a critical disparity between
appropriations for research, training, and health services and the
projected mental health needs of older Americans. This disparity is
evident in the convergence of several key factors:
--demographic projections inform us that, with the aging of the U.S.
population, there will be an unprecedented increase in the
burden of mental illness among aging persons, especially among
the baby boom generation;
--this growth in the proportion of older adults and the prevalence of
mental illness is expected to have a major direct and indirect
impact on general health service use and costs;
--despite the fact that effective treatment exists, the current
mental health needs of many older adults remain unmet;
--the number of physicians being trained in geriatric mental health
research and clinical care is insufficient to meet current
needs, and this workforce shortfall is projected to become a
crisis as the U.S. population ages over the next decade;
--a major gap exists between research, mental health care policy, and
service delivery; and
--as funding for Federal health research has slowed across
disciplines, the allocation of funds for research that focuses
specifically on aging and mental health is disproportionately
low, and woefully inadequate to deal with the impending crisis
of mental health in older Americans.
In this context, it is important to note actions relating to late
life mental health addressed by the White House Conference on Aging,
which was convened by President Bush in December 2005. Recognizing the
current health and mental health needs of older Americans and the
challenges awaiting as the Baby Boom generation ages, delegates placed
mental health and geriatric health professional training issues at the
forefront by voting them among their top 10 resolutions.
demographic projections and the mental disorders of aging
With the baby boom generation nearing retirement, the number of
older Americans with mental disorders is certain to increase in the
future. By the year 2010, there will be approximately 40 million people
in the United States over the age of 65. Over 20 percent of those
people will experience mental health problems. A national crisis in
geriatric mental health care is emerging and has received recent
attention in the medical literature. Action must be taken now to avert
serious problems in the near future. While many different types of
mental and behavioral disorders can occur late in life, they are not an
inevitable part of the aging process, and continued research holds the
promise of improving the mental health and quality of life for older
Americans.
The current number of health care practitioners, including
physicians, who have training in geriatrics is inadequate. As the
population ages, the number of older Americans experiencing mental
problems will almost certainly increase. Since geriatric specialists
are already in short supply, these demographic trends portend an
intensifying shortage in the future. There must be a substantial public
and private sector investment in geriatric education and training, with
attention given to the importance of geriatric mental health needs. We
will never have, nor will we need, a geriatric specialist for every
older adult. However, without mainstreaming geriatrics into every
aspect of medical school education and residency training, broad-based
competence in geriatrics will never be achieved. There must be adequate
funding to provide incentives to increase the number of academic
geriatricians to train health professionals from a variety of
disciplines, including geriatric medicine and geriatric psychiatry.
This year's loss of all funding for geriatric health professions
programs under Title VII of the Public Health Service Act is a stunning
blow to this critical need, and AAGP urges the subcommittee to restore
these programs.
Current and projected economic costs of mental disorders alone are
staggering. It is estimated that total costs associated with the care
of patients with Alzheimer's disease is over $100 billion per year in
the United States. Psychiatric symptoms (including depression,
agitation, and psychotic symptoms) affect 30 to 40 percent of people
with Alzheimer's and are associated with increased hospitalization,
nursing home placement, and family burden. These psychiatric symptoms,
associated with Alzheimer's disease, can increase the cost of treating
these patients by more than 20 percent. Although NIA has supported
extensive research on the cause and treatment of Alzheimer's, treatment
of these behavioral and psychiatric symptoms has been neglected and
should be supported through NIMH.
Depression is another example of a common problem among older
persons. Of the approximately 32 million Americans who have attained
age 65, about 5 million suffer from depression, resulting in increased
disability, general health care utilization, and increased risk of
suicide. Depression is associated with poorer health outcomes and
higher health care costs. Co-morbid depression with other medical
conditions affects a greater use and cost of medications as well as
increased use of health services (e.g., medical outpatient visits,
emergency visits, and hospitalizations). For example, individuals with
depression are admitted to the emergency room for hypertension,
arthritis, and ulcers at nearly twice the rate of those without
depression. Those individuals with depression are more likely to be
hospitalized for hypertension, arthritis, and ulcers than those without
depression. And, those with depression experience almost twice the
number of medical visits for hypertension, arthritis and ulcers than
those without depression. Finally, the cost of prescriptions and number
of prescriptions for hypertension, arthritis, and ulcers were more than
twice than those without depression.
Older adults have the highest rate of suicide rate compared to any
other age group. Comprising only 13 percent of the U.S. population,
individuals age 65 and older account for 19 percent of all suicides.
The suicide rate for those 85 and older is twice the national average.
More than half of older persons who commit suicide visited their
primary care physician in the prior month--a truly stunning statistic.
national institute of mental health
In his fiscal year 2007 budget, the President proposed a decrease
in funding for the National Institutes of Health (NIH), for the first
time in 30 years. This decline in funding is likely to have a
devastating impact on the ability of NIH to sustain the ongoing, multi-
year research grants that have been initiated in recent years.
AAGP would like to call to the subcommittee's attention the fact
that, even in the years in which funding was increased for NIH and
NIMH, these increases did not always translate into comparable
increases in funding that specifically address problems of older
adults. Data supplied to AAGP by NIMH indicates that while extramural
research grants by NIMH increased 59 percent during the five-year
period from fiscal year 1995 through fiscal year 2000 (from
$485,140,000 in fiscal year 1995 to $771,765,000 in fiscal year 2000),
NIMH grants for aging research increased at less than half that rate:
only 27.2 percent during the same period (from $46,989,000 to
$59,771,000). Furthermore, despite the fact that over the past 5 years,
Congress, through committee report language, has specifically urged
NIMH to increase research grant funding devoted to older adults, this
has not occurred.
AAGP is pleased that NIMH has recently renewed its emphasis on
mental disorders among the elderly, and commends the recent creation of
a new Aging Treatment and Prevention Intervention Research Branch at
NIMH. AAGP would like the scope of this Branch increased into a
comprehensive aging Branch that is responsible for all facets of
clinical research, including translational, interventions, and disease-
based psychopathology. The Branch should also be given adequate
resources to fulfill its primary mission within NIMH.
In addition to supporting research activities at NIMH, AAGP
supports increased funding for research related to geriatric mental
health at the other institutes of NIH that address issues relevant to
mental health and aging, including the National Institute of Aging
(NIA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA),
the National Institute on Drug Abuse (NIDA), and the National Institute
of Neurological Disorders and Stroke.
center for mental health services
It is also critical that there be adequate funding for the mental
health initiatives under the jurisdiction of the Center for Mental
Health Services (CMHS) within SAMHSA. While research is of critical
importance to a better future, the patients of today must also receive
appropriate treatment for their mental health problems. SAMHSA provides
funding to State and local mental health departments, which in turn
provide community-based mental health services to Americans of all
ages, without regard to the ability to pay. AAGP was pleased that the
final budgets for the last 5 years have included $5 million for
evidence-based mental health outreach and treatment to the elderly.
AAGP worked with members of this subcommittee and its House counterpart
on this initiative, which is a very important program for addressing
the mental health needs of the Nation's senior citizens. Increasing
this mental health outreach and treatment program must be a top
priority, as it is the only Federally funded services program dedicated
specifically to the mental health care of older adults.
The greatest challenge for the future of mental health care for
older Americans is to bridge the gap between scientific knowledge and
clinical practice in the community, and to translate research into
patient care. Adequate funding for this geriatric mental health
services initiative is essential to disseminate and implement evidence-
based practices in routine clinical settings across the States.
Consequently, we would urge that the $5 million for mental health
outreach and treatment for the elderly included in the CMHS budget for
fiscal year 2005 be increased to $20 million for fiscal year 2006. Of
that $20 million appropriation, AAGP believes that $10 million should
be allocated to a National Evidence-Based Practices Program, which will
disseminate and implement evidence-based mental health practices for
older persons in usual care settings in the community. This program
will provide the foundation for a longer-term national effort that will
have a direct effect on the well-being and mental health of older
Americans.
The Community Mental Health Services Block Grant Program requires
States and territories to include an annual plan for providing
comprehensive community mental health services to adults with a serious
mental illness and children with a serious emotional disturbance.
Experience has demonstrated that States do not make adequate provisions
for older adults. AAGP recommends that SAMHSA require these plans to
include specific provisions for mental health services for older
adults.
health resources and services administration
Despite growing evidence of the need for more geriatric specialists
to care for the nation's elderly population, a critical shortage
persists. For fiscal year 2006, the Congress inexplicably eliminated
all funding for the geriatric health professions program under Title
VII of the Public Health Service Act. The loss of these programs could
have a disastrous impact on physician workforce development over the
next decade, with dangerous consequences for the growing population of
older adults who will not have access to appropriate specialized care.
The geriatric health professions program supports three important
initiatives. The Geriatric Faculty Fellowship trains faculty in
geriatric medicine, dentistry, and psychiatry. The Geriatric Academic
Career Award program encourages newly trained geriatric specialists to
move into academic medicine. The Geriatric Education Center (GEC)
program provides grants to support collaborative arrangements that
provide training in the diagnosis, treatment, and prevention of
disease. In fiscal year 2005, these programs were funded at $31.5
million, but, while they were funded in the Senate Appropriations bill
for fiscal year 2006, the final legislation followed the House version,
which eliminated funding for them. AAGP urges the subcommittee to
restore funding to this program at fiscal year 2005 levels.
The loss of these programs, just as the massive Baby Boomer
generation are entering late life, will have a devastating effect on
the Nation's ability to provide the kind of health care that will allow
these seniors to be independent and productive as they age.
conclusion
Based on AAGP's assessment of the current need and future
challenges of late life mental disorders, we submit the following
fiscal year 2007 funding recommendations:
1. The current rate of funding for aging grants at NIMH and CMHS is
inadequate and should be increased to at least three times their
current funding levels. In addition, the substantial projected increase
in mental disorders in our aging population should be reflected in the
budget process in terms of dollar amount of grants and absolute number
of new grants.
2. To help the country's elderly access necessary mental health
care, previous years' funding of $5 million for evidence-based mental
health outreach and treatment for the elderly within CMHS must be
increased to $20 million.
3. Funding for the geriatric health professions program under Title
VII of the Public Health Service Act should be restored to fiscal year
2005 levels.
4. Both NIMH and CMHS must support adequate infrastructure and
funding within both NIMH and CMHS to develop initiatives in aging
research, to monitor the number and quality of applicants for aging
research grants, to promote funding of meritorious projects, and to
manage those grant portfolios.
5. The scope of the recently formed Aging Treatment and Prevention
Intervention Research Branch at NIMH should be increased to include all
relevant clinical research, including translational, interventions, and
disease-based psychopathology, and must receive NIMH's full support so
it may fulfill its primary mission.
AAGP looks forward to working with the members of this subcommittee
and others in Congress to establish geriatric mental health research
and services as a priority at appropriate agencies within the
Department of Health and Human Services.
______
Prepared Statement of the American Association of Immunologists
The American Association of Immunologists (``AAI'') is pleased to
have this opportunity to submit its views on fiscal year 2007 funding
for the National Institutes of Health (NIH). AAI would like to thank
the members of the subcommittee for their strong support for biomedical
research, and in particular, express our great appreciation to the
chairman, Senator Specter, and Ranking Member, Senator Harkin, for
their extraordinary leadership and dedication to advancing biomedical
research.
The AAI is a not-for profit professional society representing more
than 6,500 research scientists and physicians who are the world's
leading experts on the immune system. While our members work in
academia, government, and industry, most are among the more than
200,000 research personnel affiliated with more than 3,000 institutions
who depend on NIH funding to support their work.\1\ With approximately
84 percent of NIH funds awarded to these individuals and institutions,
NIH's funding level has a huge impact both on the advancement of
biomedical research and on the local, State, and national economies.
---------------------------------------------------------------------------
\1\ National Institutes of Health Fiscal Year 2007 Performance
Budget Overview, pp.1-2. Many AAI members are medical school professors
and researchers who receive grants from NIH, and in particular from the
National Institute of Allergy and Infectious Diseases (NIAID) and the
National Cancer Institute (NCI) (as well as other NIH Institutes and
Centers), to support their research endeavors.
---------------------------------------------------------------------------
the importance of immunology
Immunological research is crucial in a world increasingly at risk
from infectious agents and chronic diseases.\2\ Basic research on the
immune system provides a foundation for the development of diagnostics,
vaccines, and therapeutics. Current efforts are focused on preventing
and treating diseases caused by natural infectious agents, including
influenza and avian flu, SARS, West Nile Virus, tuberculosis, and AIDS,
as well as those that may be modified for use as agents of
bioterrorism, including plague, smallpox, and anthrax. In addition,
basic immunological research continues to be crucial in the development
of increasingly effective approaches for treating chronic diseases,
including cancer, autoimmune diseases, inflammatory disorders, and
immunodeficiencies.
---------------------------------------------------------------------------
\2\ Immunologists depend heavily on the use of animal models in
their research. Without animal experimentation, theories about immune
system function and treatments that might cure or prevent disease would
have to be tested first on human subjects, something our society--and
our scientists--would never countenance. Despite the clear necessity
for animal research, we are experiencing both increasing regulatory
burden in animal experimentation (eroding the return on NIH's
investment), and threats from people and organizations that oppose such
research. The legal and illegal methods used by some groups to further
an animal-rights/anti-medical research agenda are diverting precious
resources from our work, threatening the personal safety and security
of scientists, and delaying the progress of important research now
underway.
---------------------------------------------------------------------------
The immune system works by recognizing and attacking ``foreign
invaders'' (i.e., bacteria and viruses) inside the body. It also plays
an important role in controlling the growth of tumor cells. The immune
system can protect its host (human or animal) from illness or disease
either entirely--by attacking and destroying the virus, bacterium, or
tumor cell--or partially, resulting in a less serious illness. But even
a healthy immune system cannot completely protect us from all threats
that might cause disease. Moreover, the immune system also has a ``dark
side'': it can lead to the rejection of transplanted organs or bone
marrow and--if it is working improperly--can allow the body to attack
itself instead of an invader, resulting in an ``auto-immune'' disease
(e.g., Type 1 diabetes, multiple sclerosis, rheumatoid arthritis).
Recent advances in immunology have allowed for revolutionary
treatments. For example, therapeutic substances called ``biologics''
have provided new, effective treatments for painful, debilitating and
life-threatening diseases such as rheumatoid arthritis, inflammatory
diseases, and cancer. Biologics that use modified human antibodies and
cell receptors specifically target the substance (TNF) that causes
joint destruction in rheumatoid arthritis, and the painful symptoms of
psoriasis, and ankylosing spondylitis. An engineered antibody
(herceptin) is being used to control the reoccurrence of breast cancer;
resulting in a two-fold reduction in reoccurrence. Another monoclonal
antibody and human protein--CTLA4Ig--has been dramatically effective in
clinical trials treating prostate cancer and melanoma as well as
showing promise as a treatment for lupus, arthritis, multiple
sclerosis, and organ transplant rejection.
Immunologists have also focused on improved approaches to vaccine
development, including a vaccine for Hemophilius influenza type b. This
vaccine has reduced the incidence of pediatric meningitis in the United
States from approximately 20,000 to 200 cases per year. Our
understanding of what makes an efficacious vaccine will be critical as
we face future pandemics, be they natural, like avian flu, or altered
pathogens that could be used for bioterrorism, like missilized anthrax.
None of these advances could have been made without substantial
public investment in basic immunological research. But even as we make
huge strides, new threats emerge: immunologists are working feverishly
to defend against bird flu and potential bioterrorism pathogens.
the nih budget: trouble in the post-doubling years
AAI is very grateful to this subcommittee and the Congress for
doubling the NIH budget from fiscal year 1998 to fiscal year 2003. This
``doubling'' represented an unprecedented commitment by the Federal
Government to preventing, treating, and curing disease, and has allowed
scientists to begin new, cutting edge research made possible by recent
advances in sequencing the genomes of humans, model organisms, and
microbial pathogens that cause human and animal diseases.
But scientific research takes time, and the doubling of the NIH
budget will have been for naught if we are unable to complete ongoing
studies or retain trained personnel. Indeed, the doubling has already
been eroded. Since 2003, the annual increases in the NIH budget have
not kept pace with biomedical research inflation.\3\ Moreover, the
President's fiscal year 2007 ``flat'' budget would result in an
effective decrease in the NIH budget, only the second time in 36 years
that the NIH budget has been reduced. This would have a devastating
effect:
---------------------------------------------------------------------------
\3\ NIH funding increases/decreases since the doubling period ended
[fiscal year 2004 (3.03 percent), fiscal year 2005 (2.18 percent) and
fiscal year 2006 (-.12 percent)] have all been below the Biomedical
Research and Development Price Index (``BRDPI''), a U.S. Department of
Commerce (``DOC'') estimate of the cost of inflation for biomedical
research. The BRDPI was developed by the DOC's Bureau of Economic
Analysis under an agreement with NIH and is updated annually. It
indicates how much the NIH budget must increase to maintain purchasing
power. Projections for future years are prepared by the NIH Office of
Science Policy.
---------------------------------------------------------------------------
1. Key NIH Institutes could be forced to drop paylines even lower
than the current, far too low 10-14 percent (significantly below the
approximately 22 percent funded during the doubling); \4\
---------------------------------------------------------------------------
\4\ AAI analyzed paylines of key NIH Institutes from fiscal year
2000-fiscal year 2002; see www.nih.gov.
---------------------------------------------------------------------------
2. There would be no inflationary increases for direct, recurring
costs in non-competing Research Project Grants (RPGs), undermining
NIH's fiscal year 2007 goal to ``preserve to the greatest extent
possible the ability of scientists to obtain individual support for
their research ideas.'' National Institutes of Health Summary of the
Fiscal Year 2007 President's Budget February 6, 2006, p.3;
3. It would have rapid, adverse repercussions on the future of the
research enterprise. Our brightest young people will be deterred from
pursuing biomedical research careers if their chances of receiving an
NIH grant become even lower. If we cannot attract and retain the best
young minds, the United States will lose its preeminence in science and
technology to nations--including India, Singapore, China, and Korea--
that are investing aggressively to compete.
4. It would not permit increases in already inadequate stipends to
pre- and post-doctoral fellows, and will undermine efforts to attract
excellent scientists to NIH and to academia.
pandemic influenza/influenza
Influenza leads to more than 200,000 hospitalizations and about
36,000 deaths nationwide in an average year. Pandemic influenza could
cause millions of deaths and hospitalizations. Despite these very real
threats, the President's fiscal year 2007 NIH Budget includes an
increase of only $17 million to support specific research initiatives
focused on pandemic influenza, bringing total NIH spending on influenza
to approximately $199 million (about $35 million over fiscal year
2006).
The vast majority of funds (more than $3 billion) appropriated to
date under the Department of Health and Human Services Pandemic
Influenza Preparedness Plan have been devoted to other pandemic
influenza related activities (including production/procurement of
vaccines/antivirals). While these public health efforts are extremely
important, it is essential to realize that any existing pathogen that
could cause influenza or pandemic influenza (e.g., bird flu) can
mutate, rendering existing countermeasures ineffective. Since new
influenza strains can quickly emerge, research to identify new
pathogens, understand the immune response, and develop tools for
protecting against the pathogen should never take a back seat to other
pandemic influenza-related activities. The need for this research
supports AAI's request for an increased budget for NIH.
biodefense research
AAI supports the President's request for $1.891 billion for
biodefense research, an increase of 6.2 percent over fiscal year 2006.
NIH's fiscal year 2007 biodefense research priorities include
continuing work on developing vaccines and treatments for anthrax,
smallpox, plague, tularemia, hemorrhagic fevers, and botulinum toxin.
NIH plans to direct $160 million to an Advanced Development Fund
(``ADF'') within the Office of the NIH Director to ``support efforts to
work with academia and industry to develop candidate countermeasures
from the point of Investigation New Drug Application (INDA) to the
level that these candidate countermeasures could be eligible for
acquisition by Project Bioshield.'' AAI urges that the NIH Director
work closely with the NIAID Director to ensure that the ADF focuses on
NIH's traditional expertise in basic and translational research and not
on activities relevant to commercial development or the manufacturing
of a product.
NIH also plans to spend $25 million to construct additional high
containment laboratories at biosafety level (BSL) 3 and to renovate
existing labs to meet current BSL-3 standards. (BSL-3 labs are
necessary for the safe conduct of research on dangerous and infectious
pathogens.) AAI recommends that these funds be used first for the
renovation of existing labs; the construction of new labs may not be
necessary with the limited research funding that may be available this
year.
administrative issues
1. Office of Portfolio Analysis and Strategic Initiatives
AAI supports the newly formed Office of Portfolio Analysis and
Strategic Initiatives (OPASI) as a way of better managing and analyzing
NIH's portfolio. While we understand the need for a ``Common Fund'' to
support OPASI, we believe that, in this difficult fiscal climate, such
a fund should be limited and should grow no faster than the overall NIH
budget.
2. Research, Management and Support (RM&S)
The President's fiscal year 2007 budget proposal for Research,
Management and Services (RM&S), which supports the management,
monitoring, and oversight of intramural and extramural research
activities (including NIH's highly regarded peer review process),
includes an increase of $14 million, or 1.3 percent. AAI supports an
appropriate increase in the RM&S budget to ensure that it is sufficient
(1) to enable NIH to supervise a portfolio of increasing size and
complexity and (2) to ensure that NIH funds are well and properly
spent.
3. Outsourcing
AAI continues to be concerned about the ``outsourcing'' of NIH
jobs. While certain NIH jobs may be appropriate for such an approach,
it should not be applied to program administration staff, many of whom
are highly experienced and have historical knowledge and understanding
of NIH programs and policies. Such outsourcing would result in the loss
of a dedicated and capable workforce and reduce efficiency in the long
run.
aai's recommended budget increase for fiscal year 2007: 5 percent (1.2
percent above projected inflation)
AAI strongly believes that we must increase the NIH budget now in
order to capitalize on important advances that have resulted from the
doubling. We urge this subcommittee to increase the NIH budget by 5
percent ($1.4 billion) in fiscal year 2007, for a total budget of
$29.75 billion. This increase, which is only 1.2 percent above the
projected rate of biomedical research inflation, would enable
researchers to capitalize on important advances that have resulted from
the doubling, leading to increased translational and clinical
applications. It would also assist efforts to attract and retain bright
young American scientists to research careers.
the effective use of nih funds
While AAI advocates a 5 percent increase in NIH funding, we agree
that NIH should use its existing funds as effectively as possible. To
that end, we recommend the following:
(1) The ``NIH Roadmap for Biomedical Research'' (``NIH Roadmap'')
AAI notes that the President's fiscal year 2007 budget request for
the NIH Roadmap has grown to $443 million, an increase of $113 million
over fiscal year 2006. While AAI supports this effort to fund
multidisciplinary, interdisciplinary research and agrees that such
research is an important part of biomedical research in the 21st
century, we recommend that funds allocated to the NIH Roadmap not grow
faster than the overall NIH budget and that all Roadmap funds,
including the Director's Pioneer Awards, be awarded through a rigorous
peer review process.
(2) NIH ``Enhanced Access to Scientific Publications'' Policy
AAI recommends that NIH partner with not-for-profit scientific
publishers to provide enhanced public access to NIH-funded research
results, rather than continuing an expensive effort to publish
manuscripts itself. In this era of limited funds, NIH should work with
these willing partners to ensure that its budget is used to support and
advance research and not to duplicate services already provided by the
private sector. AAI urges the subcommittee to support efforts underway
between NIH and the not-for-profit scientific publishing community to
develop a policy that will enhance public access while addressing the
concerns of publishers.
(3) Peer review and the independence of science
Millions of lives--as well as the prudent use of taxpayer dollars--
depend on government officials receiving--and taking--the very best and
most independent scientific advice available. We urge this subcommittee
to provide oversight which ensures that funds expended enhance the
ability of scientists to provide independent scientific advice
(particularly on government scientific advisory panels) and preserve
independent peer review (including ensuring the review of scientific
research results by peers through robust, independent scientific
journals).
conclusion
AAI greatly appreciates this opportunity to testify and thanks the
members of this subcommittee for your strong support for biomedical
research, the NIH, and the scientists who devote their lives to
preventing, treating, and curing disease. We look forward to working
with you and hope that you will contact me or AAI if you have any
questions or if we can be of assistance.
______
Prepared Statement of the American Association of Nurse Anesthetists
FISCAL YEAR 2007 APPROPRIATIONS REQUEST SUMMARY
----------------------------------------------------------------------------------------------------------------
Fiscal year 2006 Fiscal year 2007 AANA fiscal year 2007
actual budget request
----------------------------------------------------------------------------------------------------------------
HHS/HRSA/BHPr Title VIII Advanced Awaiting grant Grant allocations not $4 million for nurse
Education Nursing, Nurse Anesthetist allocations. specified. anesthesia education
Education Reserve. $3.5 million fiscal $65 million for
year 2005. advanced education
nursing
Title VIII HRSA BHPr Nursing $151,191,000 $150,000,000 $175,000,000
Education Programs.
----------------------------------------------------------------------------------------------------------------
The AANA is the professional association for more than 34,000
Certified Registered Nurse Anesthetists (CRNAs) and student nurse
anesthetists representing over 90 percent of the nurse anesthetists in
the United States. Today, CRNAs are directly involved in approximately
65 percent of all anesthetics given to patients each year in the United
States. CRNA services include administering the anesthetic, monitoring
the patient's vital signs, staying with the patient throughout the
surgery, as well as providing acute and chronic pain management
services. CRNAs provide anesthesia for a wide variety of surgical cases
and are the sole anesthesia providers in almost 70 percent of rural
hospitals, affording these medical facilities obstetrical, surgical,
and trauma stabilization, and pain management capabilities. CRNAs work
in every setting in which anesthesia is delivered including hospital
surgical suites and obstetrical delivery rooms, ambulatory surgical
centers (ASCs), pain management units and the offices of dentists,
podiatrists and plastic surgeons.
Nurse anesthetists are experienced and highly trained anesthesia
professionals whose record of patient safety in the field of anesthesia
was bolstered by the Institute of Medicine report that found in 2000,
that anesthesia is 50 times safer than 20 years previous. (Kohn L.,
Corrigan J., Donaldson M., ed. To Err is Human. Institute of Medicine,
National Academy Press, Washington DC, 2000.) Nurse anesthetists
continue to set for themselves the most rigorous continuing education
and re-certification requirements in the field of anesthesia. Relative
anesthesia patient safety outcomes are comparable among nurse
anesthetists and anesthesiologists, with Pine having recently
concluded, ``the type of anesthesia provider does not affect inpatient
surgical mortality.'' (Pine, Michael MD et al. Surgical mortality and
type of anesthesia provider. Journal of American Association of Nurse
Anesthetists. Vol. 71, No. 2, p. 109-116. April 2003.) In addition, a
recent AANA workforce study's data showed that CRNAs and
anesthesiologists are substitutes in the production of surgeries.
Through continual improvements in research, education, and practice,
nurse anesthetists are vigilant in their efforts to ensure patient
safety.
CRNAs provide the lion's share of the anesthesia care required by
our U.S. Armed Forces through active duty and the reserves, from here
at home to the leading edge of the field of battle. In May 2003, at the
beginning of ``Operation Iraqi Freedom'' 364 CRNAs were deployed to the
Middle East to ensure military medical readiness capabilities. For
decades, CRNAs have staffed ships, remote U.S. military bases, and
forward surgical teams without physician anesthesiologist support.
importance of title viii nurse anesthesia education funding
The nurse anesthesia profession's chief request of the subcommittee
is for $4 million to be reserved for nurse anesthesia education and $65
million for advanced education nursing from the Title VIII program.
This sustained funding is justified by two facts. First, there is a 12
percent vacancy rate of nurse anesthetists in the United States
impacting people's healthcare. And second, the Title VIII program,
which has been strongly supported by members of this subcommittee in
the past, is an effective means to help address the nurse anesthesia
workforce demand. This demand for CRNAs is something that the nurse
anesthesia profession addresses every day with success, and with the
critical assistance of Federal funding through HHS' Title VIII
appropriation.
The increase in funding for advanced education nursing from $58
million to $65 million is necessary to meet the continuing demand for
nursing faculty and other advanced education nursing services
throughout the United States. Only a limited number of new programs and
traineeships can be funded each year at the current funding levels. The
program provides for competitive grants and contracts to meet the costs
of projects that support the enhancement of advanced nursing education
and practice and traineeships for individuals in advanced nursing
education programs. This funding is critical to the efforts to meet the
nursing workforce needs of Americans who need healthcare.
In 2003, the AANA conducted a nurse anesthesia workforce study that
concluded a 12 percent vacancy rate in hospitals for CRNAs, and a lower
vacancy rate in ambulatory surgical centers. The supply has increased
in recent years, stimulated by increases in the number of CRNAs
trained. However, these increases had not been enough to offset the
number of retiring CRNAs. This trend, established in 2003, requires a
continuous growth in the number of nurse anesthesia graduates to fill
the vacancy rate. This is compounded by the rising number of Medicare-
eligible Americans, from about 34 million today to more than 40 million
in 2010, who will require the care that CRNAs provide.
The problem is not that our 99 accredited programs of nurse
anesthesia are failing to attract qualified applicants; it is that the
programs are full. Each CRNA program continues to turn away qualified
applicants--bachelor's educated registered nurses who had spent at
least 1 year serving in an acute care environment. These CRNA schools
are located all across the country including the following:
------------------------------------------------------------------------
Number of
accredited nurse
State anesthesia
programs
------------------------------------------------------------------------
PA................................................... 12
FL................................................... 6
OH................................................... 5
TX................................................... 5
IL................................................... 4
NY................................................... 4
CA................................................... 3
CT................................................... 3
MD................................................... 3
RI................................................... 2
WI................................................... 1
------------------------------------------------------------------------
Recognizing the importance of nurse anesthetists to quality
healthcare, the AANA has been working with the 99 accredited programs
of nurse anesthesia to increase the number of qualified graduates. In
addition, the AANA has worked with nursing and allied health deans to
develop new CRNA programs.
The Council on Certification of Nurse Anesthetists (CCNA) reports
that in 1999, our schools produced 948 new graduates. In 2005, that
number had increased to 1,790, an 89 percent increase in just 5 years.
This growth is expected to continue. The CCNA projects CRNA programs to
produce over 1,900 graduates in 2006.
To truly meet the nurse anesthesia workforce challenge, the
capacity and number of CRNA schools must continue to expand. With the
help of competitively awarded grants supported by Title VIII funding,
the nurse anesthesia profession is making significant progress,
expanding both the number of clinical practice sites and the number of
graduates.
The AANA is pleased to report that this progress is extremely cost-
effective from the standpoint of Federal funding. Anesthesia can be
provided by nurse anesthetists, physician anesthesiologists, or by
CRNAs and anesthesiologists working together. As mentioned earlier, it
has been confirmed, ``the type of anesthesia provider does not affect
inpatient surgical mortality.'' Yet, for what it costs to train just
one anesthesiologist, several CRNAs may be educated to provide the same
service with the same optimum level of safety. This represents a
significant educational cost/benefit for supporting CRNA educational
programs with Federal dollars vs. supporting other models of anesthesia
education.
To further demonstrate the effectiveness of the $3 million Title
VIII investment in nurse anesthesia education, the AANA surveyed its
CRNA program directors in 2003 to gauge the impact of the Title VIII
funding. Of the eleven schools that had reported receiving competitive
Title VIII Nurse Education and Practice Grants funding from 1998 to
2003, the programs indicated an average increase of at least 15 CRNAs
graduated per year. They also reported on average more than doubling
their number of graduates, who provide care to patients during and
following their education. Moreover, they reported producing additional
CRNAs that went to serve in rural or medically underserved areas. Under
both of these circumstances, an increased number of student nurse
anesthetists and CRNAs are providing healthcare to the people of
medically underserved America.
We believe it is important for the subcommittee to allocate $4
million for nurse anesthesia education for several reasons. First, as
this testimony has documented, the funding is cost-effective and well
needed. Second, the Title VIII authorization previously providing such
a reserve expired in September 2002. Third, this particular funding is
important because nurse anesthesia for rural and medically underserved
America is not affected by increases in the budget for the National
Health Service Corps and community health centers, since those
initiatives are for delivering primary and not surgical healthcare.
Lastly, this funding meets an overall objective to increase access to
quality healthcare in medically underserved America.
title viii funding for strengthening the nursing workforce
The AANA joins a growing coalition of nursing organizations and
others in support of the subcommittee providing a total of $175 million
in fiscal year 2007 for nursing shortage relief through Title VIII.
This amount is approximately $25 million over the fiscal year 2005
level and over the President's fiscal year 2007 budget.
Every district in America is familiar with the importance of
nursing. The AANA is appreciative of the leadership of the subcommittee
and the congressional support for the $5 million increase over the
President's request in fiscal year 2005 for nurse education funding.
America spends more than $2 trillion on healthcare this year, paid
by private and public sources. About $298 billion accounted for
Medicare outlays in 2005. Medicare directs about $8.7 billion of that
to fund direct and indirect GME, with some 99 percent of that funding
helping to educate physicians and allied health professionals, and
about 1 percent to help educate nurses. For every present and future
healthcare patient, Congress must put some focus on nurses and nurse
anesthesia care.
To ensure that America has access to nurse anesthesia care when
needed, a sustained investment from Congress is necessary especially
for the provision of services in rural and medically underserved
America. Quality anesthesia care provided by CRNAs saves lives,
promotes quality of life, and makes fiscal sense. This Federal support
for nurse education will improve patient access to quality services and
strengthen the Nation's healthcare delivery system.
Thank you.
______
Prepared Statement of the American College of Cardiology
The American College of Cardiology appreciates the opportunity to
provide the subcommittee with recommendations for fiscal year 2007
funding for life-saving cardiovascular research and education.
The ACC is a 33,000 member non-profit professional medical society
and teaching institution whose purpose is to foster optimal
cardiovascular care and disease prevention through professional
education, promotion of research, and leadership in the development of
standards and formulation of health care policy.
Heart disease is the leading cause of death for both women and men
in the United States, killing more than 900,000 Americans each year.
More than 70 million Americans live with some form of heart disease.
The economic impact of cardiovascular disease on the U.S. health care
system continues to grow as the population ages. In 2005, heart disease
and stroke were projected to cost the Nation $393 billion, including
health care services, medications, and lost productivity.
As the premier cardiovascular society, the ACC supports a strong
Federal investment in research and public education that addresses the
prevention, detection and treatment of cardiovascular disease. Current
Federal research is providing breakthrough advances that fundamentally
change our understanding of cardiovascular disease, leading to more
effective treatments, decreased costs and increased quality of life for
patients.
For instance, a study published in the February 2006 issue of the
Journal of the American College of Cardiology yielded important
findings for women with coronary heart disease. Part of the National
Heart, Lung, and Blood Institute (NHLBI)'s Women's Ischemia Syndrome
Evaluation (WISE) study, researchers found that women with a condition
called coronary microvascular syndrome often go undiagnosed for heart
disease because dysfunction occurs in very small arteries of the heart
and does not show up when physicians use standard tests. As a result of
the missed diagnosis, women are not treated for angina and high
cholesterol and remain at high risk for a heart attack. National
Institutes of Health (NIH) studies like WISE are helping to unravel the
mystery of cardiovascular disease in women and hold immediate
implications for the treatment of women at risk for heart disease.
The ACC is extremely concerned that the administration's budget
request proposes no increase in funding for the NIH and cuts funding
for many critical health programs. If instituted, the administration's
budget would force the research community to scale back and even halt
valuable initiatives. The ACC is encouraged that the Senate recently
approved an amendment to its budget resolution that provides an extra
$7 billion for key health and education programs.
funding recommendations
The ACC urges Congress to support the following fiscal year 2007
funding recommendations.
National Institutes of Health: $29.849 billion.--Research conducted
through the NIH has resulted in better diagnosis and treatment of
cardiovascular disease, improving the quality of life for those living
with the disease and lowering the number of deaths attributed to it.
National Heart Lung and Blood Institute: $3.068 billion.--The NIH
is doing critical research into the causes, treatment and prevention of
cardiovascular disease through the NHLBI.
Agency for Healthcare Research and Quality: $440 million.--The
Agency for Healthcare Research and Quality (AHRQ)'s health services
research complements the research of the NIH by helping cardiologists
make choices about what treatments work best, for whom and when.
CDC State Heart Disease and Stroke Prevention Program: $55
million.--The Centers for Disease Control and Prevention (CDC) State
Heart Disease and Stroke Prevention program's public education efforts
is making strides in the prevention and early intervention of
cardiovascular disease.
HRSA Rural and Community AED Program: $9 million.--The Health
Resources and Services Administration (HRSA) Rural and Community Access
to Emergency Defibrillation program is saving lives by placing external
defibrillators in public facilities.
summary
The ACC appreciates the subcommittee's past support for these
important programs. The ACC urges Congress to provide a strong fiscal
year 2007 investment in the cardiovascular research and education
programs described above to continue the great strides being made in
fighting cardiovascular disease. Should you have any questions, please
contact Jennifer Brunelle at jbrunell@acc.org or (301) 581-3477.
______
Prepared Statement of the American College of Obstetricians and
Gynecologists
The American College of Obstetricians and Gynecologists (ACOG),
representing 49,000 physicians and partners in women's health care, is
pleased to offer this statement to the House Committee on
Appropriations, Subcommittee on Labor, Health and Human Services, and
Education. We thank Chairman Regula, Ranking Member Obey, and the
entire subcommittee for their leadership to continually address
maternal and child health care services.
The Nation has made important strides to improve women and
children's health over the past several years, and ACOG is grateful to
this Committee for its commitment to research. We look forward to
working with the Members of this Committee to ensure that vital
research continues to eliminate disease and to ensure valuable new
treatment discoveries are implemented. The National Institutes of
Health (NIH) has examined and determined many disease pathways, while
the Health Resources and Services Administration (HRSA) and the Centers
for Disease Control and Prevention (CDC) have been successful in
translating research findings into valuable public health policy
solutions. This dedicated commitment to elevate, promote and implement
medical research faces an uncertain future at a time when scientists
are on the cusp of new cures.
It is essential that the Committee provide strong support for
current studies, and for future advances, as well. We urge the
Committee to support a an fiscal year 2007 appropriation of $29.75
billion for the NIH, and $1.328 billion for the National Institute of
Child Health and Human Development (NICHD), both a 5 percent increase
over fiscal year 2006 levels. We also continue to support efforts to
secure adequate funds for important public health programs at HRSA
($7.5 billion) and the CDC ($8.5 billion plus funding for pandemic
influenza preparedness).Continued appropriations to these agencies will
ensure ongoing and new research initiatives continue to yield positive
results for women and children's health.
national institutes of health--research leading the way
Research at the NICHD
The NICHD conducts research that holds great promise to improve
maternal and fetal health and safety. With the support of Congress, the
Institute has initiated research addressing the causes of cerebral
palsy, gestational diabetes and pre-term birth. However, much more
needs to be done to reduce the rates of maternal mortality and
morbidity in the United States. More research is needed on such
pregnancy-related issues as the impact of chronic conditions during
pregnancy, racial and ethnic disparities in maternal mortality and
morbidity, and drug safety with respect to pregnancy.
A commitment to research in maternal health sheds light on a
breadth of issues that save women's lives. Important research examining
the following issues must continue:
Reducing High Risk Pregnancies
NICHD's Maternal Fetal Medicine Unit Network, working at 14 sites
across the United States (University of Alabama, University of Texas-
Houston, University of Texas-Southwestern, Wake Forest University,
University of North Carolina, Brown University-Women and Infant's
Hospital, Columbia University, Drexel University, University of
Pittsburgh-Magee Women's Hospital, University of Utah, Northwestern
University, Wayne State University, Case Western University, and Ohio
State University), will help reduce the risks of cerebral palsy,
caesarean deliveries, and gestational diabetes. This Network discovered
that progesterone reduces preterm birth by one-third.
Reducing the Risk of Perinatal HIV Transmission
In the last 10 years, NICHD research has helped decrease the rate
of perinatal HIV transmission from 27 percent to 1.2 percent. This
advancement signals the near end to mother-to-child transmission of
this deadly disease.
Reducing the Effects of Pelvic Floor Disorders
The Institute has made recent advancements in the area of pelvic
floor disorders. The NICHD is investigating whether women that have
undergone cesarean sections have fewer incidences of pelvic floor
disorder than women who have delivered vaginally.
Reducing the Prevalence of Premature Births
NICHD is helping our Nation understand how adverse conditions and
health disparities increase the risks of premature birth in high-risk
racial groups.
Drug Safety During Pregnancy
The NICHD recently created the Obstetric and Pediatric Pharmacology
Branch to measure drug metabolism during pregnancy.
The Challenge of the Future: Attracting New Researchers
Despite the NICHD's critical advancements, reduced funding has made
it difficult for this research to continue, largely due to the lack of
new investigators. Congressional programs such as the loan repayment
program, the NIH Mentored Research Scientist Development Program for
reproductive health, and a small grant program, all attract new
researchers, but low pay lines make it difficult for the NICHD to
maintain them. Due to the structure of the peer review system, previous
grant recipients have an advantage because their grants require fewer
funds. This makes it more difficult for new investigators to get into
the system, jeopardizing the future of women's health research. We urge
the Committee to significantly increase funding at the NICHD to
maintain a high level of research innovation and excellence, in turn
reducing the incidence of maternal morbidity and mortality and
discovering cures for other chronic conditions.
hrsa and cdc: turning research into public health solutions
It is essential that we rapidly transform women's health research
findings into public health solutions. HRSA and the CDC have created
women and children's health outreach programs based on research
conducted on infant mortality, birth defects, gynecological cancers,
and a variety of other health issues.
For example, research shows tobacco abuse and health disparities
are risk factors for infant mortality. Healthy Start offers programs
for States, which fund provider and community education programs that
improve maternal health through tobacco cessation programs, and finds
ways to decrease the infant mortality rate by investigating cultural
and institutional health disparities. Research also shows that early
screening and detection of certain strands of the human papilloma virus
(HPV) may progress into cervical cancer. By screening thousands of low-
income women who would not otherwise receive access to care; this CDC
program has saved hundreds of lives.
National Fetal Infant Mortality Review
The Fetal and Infant Mortality Review (FIMR) is a cooperative
Federal agreement between ACOG and the Maternal Child Health Bureau at
HRSA. FIMR uses the expertise of ob-gyns and local health departments
to find solutions to problems related to infant mortality. In light of
the increase in the infant mortality rate for 2002, the FIMR program is
vital to develop community-specific, culturally appropriate
interventions. Today 220+ local programs in 42 States are implementing
FIMR and finding it is a powerful tool to bring communities together to
address the underlying problems that negatively affect the infant
mortality rate.
In order to meet the demand of the increasing number of FIMR
programs, NFIMR must be able to continue its activities at an adequate
funding level. A rigorous national evaluation of FIMR conducted by
Johns Hopkins University has concluded that the FIMR methodology is an
effective perinatal initiative. Based on that new research, FIMR can
now be called an evidence based MCH intervention. All Healthy Start
programs and every locality with disparities in infant outcomes should
be actively encouraged to implement this FIMR process. We urge this
Committee to recognize the many positive contributions of the FIMR
program and ensure it remains a fully funded program within HRSA.
Provider's Partnership
Through May 2003, HRSA funded the Provider's Partnership, a
cooperative agreement between the Federal Maternal and Child Health
Bureau and ACOG. This Partnership includes a series of State-level
projects initiated to address key women's health issues, while
simultaneously building partnerships between ACOG Members and public
health leadership.
The Partnership works specifically with psychosocial issues that
greatly impact the health and well-being of women. The morbidity and
mortality attributed to issues such as a woman's depression, tobacco
use, substance abuse and domestic violence are becoming increasingly
apparent as they weigh on both the woman and her entire family. Without
treatment, these psychosocial issues place a heavy financial burden on
State and Federal resources. Obstetrician-gynecologists play a critical
role in addressing these problems within their current practice;
however because of the complexity and the importance of promptly
linking at-risk women with appropriate services, responsibility for
full psychosocial assessment and treatment cannot fall solely on
obstetrician-gynecologists. Partnerships between women's health care
physicians and State and community programs are needed that allow for
integration of medical care with psychosocial services. Partnerships
increase coordination thereby minimizing demands on both the behavioral
health care system and individual providers. Provider's Partnership
enables stakeholders to improve prevention interventions, so that later
complications can be avoided.
There are currently 30 State-level Partnership teams focused on
depression in women, tobacco use, perinatal HIV transmission and oral
health. These teams have been successful at surveying obstetric
providers on their screening; counseling and referral practices for
perinatal depression and tobacco use, the results of which have been
the basis for the development of statewide legislative and practice
policy guidelines; establishing pilot screening and intervention
initiatives for depression in women; and instituting provider training
and technical assistance for depression and tobacco use screening and
intervention. Despite their successes, these teams still struggle for
funds to offset administrative and program costs. Representatives from
additional States have expressed an interest in developing an ACOG
Provider's Partnership; however, any new efforts are being postponed
until additional funding can be identified. We urge the committee to
restore funding for the Partnership to fiscal year 2003 levels.
The National Breast and Cervical Cancer Early Detection Program
(NBCCEDP)
The National Breast and Cervical Cancer Early Detection Program
(NBCCEDP) administered by the CDC is an indispensable health program in
helping underserved women gain access to screening programs for early
detection of breast and cervical cancers. The NBCCEDP has served over
2.5 million women and provided 5.8 million screening examinations.
Early detection and treatment of breast and cervical cancers greatly
increase a woman's odds of conquering these diseases. The President's
fiscal year 2007 Budget recommends decreasing funding by $1.4 million,
preventing access to these services for an estimated 4,000 women per
year. We strongly urge the Committee to continue saving women's lives
and prevent cuts to this vital program.
National Center on Birth Defects and Developmental Disabilities
(NCBDDD)
Birth defects affect about one in every 33 babies born in the
United States each year. Babies born with birth defects have a greater
chance of illness and long term disability than babies without birth
defects. According to the CDC, a great opportunity for further
improvement lies in prevention strategies that, if implemented prior to
conception, would result in additional improvement of pregnancy
outcomes. A cooperative agreement between the NCBDDD and ACOG has
resulted in increased provider knowledge of genetic screening and
diagnostic tests, technical guidance on routine preconception care and
prenatal genetic screening, and improved access to care for women with
disabilities.
Again, we would like to thank the Committee for its continued
support in addressing the multiple factors that affect maternal and
child health. We strongly urge this subcommittee to support increased
funding for the NICHD, and renewed appropriations for the maternal
child health programs at the CDC and HRSA. By continuing to translate
research done at the NICHD into positive outreach programs such as the
Provider's Partnership and the NBCCEDP, we can further improve our
Nation's overall health.
______
Prepared Statement of the American Diabetes Association
Thank you for the opportunity to submit testimony on the importance
of Federal funding for diabetes programs at the Centers for Disease
Control and Prevention (CDC) and diabetes research at the National
Institutes of Health (NIH).
As the Nation's leading nonprofit health organization providing
diabetes research, information and advocacy, the American Diabetes
Association feels strongly that Federal funding for diabetes prevention
and research efforts is critical not only for the 20.8 million
Americans who currently have diabetes, but also for the more than 40
million who have a condition known as ``pre-diabetes.''
Diabetes is a serious disease, and is a contributing and underlying
cause of many of the diseases on which the Federal Government spends
the most health care dollars. In addition to the $132 billion in 2002
dollars in direct and indirect costs spent solely on diabetes each
year, diabetes is a significant cause of heart disease (which costs our
Nation $258.5 billion each year), a significant cause of stroke ($57.9
billion each year), and the leading cause of kidney disease ($40.3
billion). Diabetes is also the leading cause of adult-onset blindness
and lower limb amputations.
Approximately 48,000 people suffering from diabetes live in each
congressional district and the number of people living with diabetes in
this country is growing at a shocking rate. In the last 2 years alone,
diabetes prevalence in the United States has increased by 14 percent.
The number of Americans with diabetes is now growing at a rate of 8
percent per year and is the single most prevalent chronic illness among
children. Because of the systemic havoc that diabetes wreaks throughout
the body, it is no surprise that the life expectancy of a person with
the disease averages 10-15 years less than that of the general
population.
As the statistics listed above illustrate, we are facing an
epidemic of diabetes in this country, which if left unchecked could
have significant implications for many future generations. A recent
study of the diabetes epidemic in New York City warns that diabetes-
caused heart attacks threatens to reverse the tremendous gains made in
preventing deaths from heart disease. One of the authors of the study
termed it ``a public health catastrophe.'' We know, for example, that
in every 24 hour period, there will be 4,100 people diagnosed with
diabetes, 230 amputations in people with diabetes, 120 people who enter
end-stage kidney disease programs and 55 people who go blind. All told,
there will be nearly 225,000 deaths from diabetes each year. That is
the ultimate cost of underfunding research and prevention programs.
While science continues to work towards finding a cure, we must
first adequately fund the diabetes prevention and outreach work being
done at the Centers for Disease Control and Prevention. Therefore, we
are requesting:
--At least a 10 percent increase over fiscal year 2006 levels for the
CDC's Center on Chronic Disease Prevention and Health,
including an additional $20.8 million increase for the CDC's
Division of Diabetes Translation (DDT), only $1 for each
American suffering from diabetes; and
--Restoration of the Preventive Health & Health Services Block Grant.
The CDC's Division of Diabetes Translation is critical to our
national efforts to prevent and manage diabetes because they translate
the research that has already been done to real programs at the
community level. Currently, for every $1 that diabetes costs this
country, the Federal Government invests less than $.01 to help
Americans prevent and manage this deadly disease. This dynamic must be
changed. While the Association strongly believes that significant
funding is needed to fully fund programs in all 50 States, our request
of $20.8 million will allow these critical programs to expand to an
additional 10 States.
In 2005 DDT provided support for more than 50 State- and
territorial-based Diabetes Prevention and Control Programs (DPCPs) to
increase outreach and education, and reduce the complications
associated with diabetes. However, funding constraints required DDT to
provide severely limited support to 22 States, 8 territories, and D.C.
This level of funding, referred to as ``capacity building,'' allows a
State to do surveillance, but is not enough for the State to do much--
or anything--in the way of intervention.
DDT was able to provide the higher level of support, ``basic
implementation,'' to the other 28 States. At the basic implementation
level, States are able to devise and execute community-level programs.
With an additional $20.8 million over fiscal year 2006 funding levels,
an additional 10 States could start to receive the substantial benefits
of basic implementation programs.
The basic implementation programs undoubtedly make a major impact
on local communities. For example, the West Virginia DPCP has developed
a model education training program in state-of-the-art diabetes care,
and has established a work-site health promotion program for State
employees. At the same time, by collaborating with the West Virginia
Association of Diabetes Educators, the State has almost doubled the
number of certified diabetes educators, and plans to expand that
success to underserved rural areas through satellite training programs.
Our goal is to make this a reality for the rest of the country, so that
communities have the ability to invest in their future by investing in
diabetes prevention and education.
Without fully-funded diabetes programs and projects in all parts of
the country, it will be exceedingly difficult--if not impossible--to
control the escalating costs associated with diabetic complications and
to stem the epidemic rise in diabetes rates. State DPCPs, when provided
with enough funding, are proven programs that have been extremely
successful in helping Americans prevent and manage their diabetes. In
the Division of Diabetes Translation Program Review fiscal year 2004,
the CDC stated, ``The Basic Implementation DPCPs serve as the backbone
for our growing primary prevention efforts. These State programs are
the key elements to our success in meeting the challenges of
controlling and preventing diabetes.'' For example, the Texas DPCP
contracts with local health departments, community health centers, and
local non-profits to serve counties throughout the State. These
programs have demonstrated success in promoting physical activity,
weight and blood pressure control, and smoking cessation for those with
diabetes. One of their programs, Coordinated Approach to Child Health
(CATCH), is an elementary school program to increase activity levels,
improve diets and reduce children's risk for obesity, a leading factor
in the development of diabetes in children. Americans in every State
should have access to such quality programs. Unfortunately, the
Division's fiscal year 2006 budget of just over $63 million, and the
President's request for a cut in fiscal year 2007 to $62.42 million,
will prevent more counties and States from implementing programs such
as the one described above.
In addition to DPCP, the CDC's Division of Diabetes Translation
also conducts other activities to help people currently living with
diabetes. To put research into action, CDC works with NIH to jointly
sponsor the National Diabetes Education Program (NDEP), which seeks to
improve the treatment and outcomes of people with diabetes, promote
early detection, and prevent the onset of diabetes. The CDC is also
currently working to develop a National Public Health Vision Loss
Prevention Program that will investigate the economic burden and
strengthen the surveillance and research of this all-to-common
complication of diabetes. In addition, CDC funds work at the National
Diabetes Laboratory to support scientific studies that will improve the
lives of people with diabetes. In fiscal year 2005, the Division of
Diabetes Translation alone published 53 manuscripts on the care,
prevention, and science of diabetes, including 17 abstracts.
The Association appreciates the increased attention by Congress to
diabetes research at the National Institutes of Health (NIH) in recent
years. While there is not yet a cure for diabetes, researchers at NIH
are working on a variety of projects that represent hope for the
millions of individuals with Type 1 and Type 2 diabetes. The
Association strongly encourages you to provide at least a 5 percent
increase to the NIH to fulfill this promise. Unfortunately, while the
death rate due to diabetes has increased by more than 40 percent in
recent years, diabetes research funding has not kept pace. Indeed, from
1987-2001, appropriated diabetes funding as a share of the overall NIH
budget has dropped by more than 20 percent (from 3.9 percent to 2.9
percent). While Congress had initially begun to address this
discrepancy, the fiscal year 2006 budget reduced funding at the
National Institutes of Diabetes, Digestive and Kidney Diseases (NIDDK)
by $9 million. This is unconscionable when diabetes deaths continue to
increase at such a rate. The Association believes that NIH research and
CDC translational programs go hand in hand in the effort to combat the
diabetes epidemic.
The Association is also supportive of restoration of the CDC's
Preventive Health & Health Services Block Grant (PBG). The PBG, which
allows States to develop innovative health programs at the community
level, received $99 million in fiscal year 2006, but is currently
slated for no funding for fiscal year 2007. These programs have been
very successful. In the State of Louisiana, the grants are used to
train school based health personnel on the diagnosis and management of
type 2 diabetes, and also to screen adolescents at significant risk for
type 2 diabetes. There are 53 school based health centers in Louisiana
that are directly assisted by this program. As the State continues to
rebuild following Hurricane Katrina, it would be tragic to remove this
small but critical piece of health infrastructure funding.
The Association, and the millions of individuals with diabetes we
represent, firmly believes that we could rapidly move toward curing,
preventing, and managing this disease by increasing funding for
diabetes programs and research both at CDC and NIH. Your leadership is
essential to accomplishing this goal. As you are considering fiscal
year 2007 funding, we ask you to remember that chronic diseases,
including diabetes, account for nearly 70 percent of all health care
costs as well as 70 percent of all deaths annually. Unfortunately, less
than $1.25 per person is directed toward public health interventions
focused on preventing the debilitating effects associated with chronic
diseases, demonstrating that Federal investment in chronic disease
prevention remains grossly inadequate. We cannot ignore those Americans
who are currently living with diabetes and other diseases.
In closing, the American Diabetes Association strongly urges the
subcommittee and Congress to provide a 10 percent increase for the
CDC's Center on Chronic Disease Prevention and Health, including a
$20.8 million increase for the CDC's Division of Diabetes Translation,
and to restore the Preventive Health & Health Services Block Grant.
Providing this funding would be an important step towards empowering
States to fight diabetes at the community level. Additionally, we urge
the subcommittee to increase NIH funding by 5 percent to allow for an
increased commitment to diabetes research.
On behalf of the 20.8 million Americans with diabetes--a disease
that crosses gender, race, ethnicity and political party; a disease
that is among the most costly, debilitating, deadly and prevalent in
our Nation; and a disease that is exploding throughout our Nation--
thank you for the opportunity to submit this testimony. The American
Diabetes Association is prepared to answer any questions you might have
on these important issues.
______
Prepared Statement of the American Foundation for the Blind
Mr. Chairman and members of the subcommittee, my name is Paul
Schroeder and I am the Vice President for Programs and Policy at the
American Foundation for the Blind. Thank you for giving the American
Foundation for the Blind (AFB) the opportunity to submit testimony to
the subcommittee as you begin to consider funding priorities for fiscal
year 2007. The AFB is a national non-profit organization with a
commitment to enhancing and promoting the health, education,
employment, and overall quality of life for people with vision loss.
For nearly a century AFB has been expanding possibilities for
people with vision loss by setting trends and devising innovative
programs. For example, AFB works with the corporate sector to get the
latest technologies that promote equal access into the hands of people
who have vision loss. AFB also promotes the development and
dissemination of new ideas and resources for service professionals, and
AFB assists consumers with vision loss to maintain independent and
healthy lives by providing them and their families with information
about services and advice on purchasing decisions. In these and many
other ways AFB continues to respond to the current needs of the vision
loss community.
The AFB, with headquarters in New York City, and a Public Policy
Center in Washington, DC, also operates the National Center on Vision
Loss in Dallas, TX, to help ensure that Americans with vision loss have
information and access to all technologies needed to maintain their
independence. This innovative resource center offers information,
education, technology, and training--all under one roof and through the
Internet--to create accessible living and work environments for people
who are visually impaired. The AFB has launched a $2.4 million
campaign--Project Independence--to expand and enhance the Dallas center
and ensure it has national reach through web-based and other
information dissemination programs. Also this year, the AFB has
enhanced its efforts to promote health maintenance and prevention of
secondary health conditions among those with vision loss. The testimony
that follows will speak in more detail to this issue.
recognizing the leadership of the subcommittee in support of americans
with disabilities
According to the Institute of Medicine's 1991 report Disability in
America: Toward a National Agenda for Prevention, ``disability is an
issue that affects every individual, community, neighborhood and family
in the United States.'' This statement remains equally true today. An
estimated 54 million people in the United States currently live with a
disability, including severe vision loss. There are approximately 10
million Americans that are blind or have vision impairment, 6.5 million
of whom are elderly. With the continued aging of the population, the
number of elderly Americans affected by vision loss will only increase.
Mr. Chairman, AFB commends the subcommittee's leadership and
commitment to programs of interest and benefit to citizens with
disabilities. Within the jurisdiction of the Labor, Health and Human
Services, and Education Subcommittee are the vast majority of the
Federal programs that support services to people with disabilities. The
main focus of our testimony, however, is to highlight for the
subcommittee the critically important work of the CDC's National Center
on Birth Defects and Developmental Disabilities.
the cdc's national center on birth defects and developmental
disabilities
Mr. Chairman, on behalf of the American Foundation for the Blind, I
would like to commend the leadership of the CDC's National Center on
Birth Defects and Developmental Disabilities (NCBDDD) for their hard
work and dedication to their mission to promote the health and wellness
of children and adults living with disabilities. We are particularly
pleased and supportive of the Center's new focused initiatives to
address the secondary health effects of people with vision loss and
other disabilities.
It has been widely documented that individuals with disabilities
experience negative health, social, emotional, family, and community
outcomes at higher rates than others. Sadly, 20.1 percent of people
with disabilities lack health insurance, as compared to 17.8 percent of
the general population. Moreover, secondary conditions such as heart
disease, diabetes and stroke, all of which are modifiable and
preventable, are also particularly acute among Americans with vision
loss. For example, elderly Americans with vision loss have higher rates
of depression, hypertension, heart disease, stroke, and physical
injuries than people without these sensory impairments. Unique to
individuals with vision loss is the risk of prescription errors
stemming from inaccessible print labeling and/or instructions about
safe administration of the drugs.
These disparities in health have multiple consequences including
the decreased ability to perform valued activities, participate in
social roles including employment, and ever-escalating costs associated
with deteriorating health conditions.
Many Americans with vision impairment, however, could substantially
improve their every day lives and prevent the onset of secondary
conditions with appropriate health interventions and information. To
ensure that this help is available, additional research to strengthen
the evidence base for effective public health interventions needs to be
conducted. In addition, substantially enhanced dissemination programs
of these interventions through a website and other means accessible to
people with vision loss is a vital component of such a program. Such a
dedicated program would be of significant benefit to those facing
vision loss and their families. The initiation of such a program at the
National Center on Birth Defects and Developmental Disabilities would
reduce health disparities and push forward the public health frontier
in assisting people with blindness and vision loss.
recommendations
Mr. Chairman, the administration's request for the National Center
on Birth Defects and Developmental Disabilities is $110,481,000, a
decrease of $14.28 million below fiscal year 2006 levels. If enacted,
this would be the second year in a row that the incredibly important
programs funded in this national Center received cuts. AFB strongly
encourages the subcommittee to reverse these reductions and to
specifically add $950,000 for a dedicated program to ameliorate and
prevent secondary health conditions that affect individuals with vision
loss. AFB would also encourage the subcommittee to support an expansion
of the proposed Center on Vision Loss in Dallas, Texas.
summary and conclusions
Mr. Chairman, again we wish to thank the subcommittee for its past
leadership and commitment to disability issues. With your leadership
much additional progress can be made to improve the lives and health of
Americans with vision loss.
Thank you for this opportunity to testify.
______
Prepared Statement of the American Physiological Society
The American Physiological Society (APS) thanks the subcommittee
for its sustained support for the National Institutes of Health (NIH).
The doubling of the agency budget that took place between fiscal years
1996 and 2002 allowed the NIH to expand its efforts to address old and
new challenges in biomedical science. Our Nation's investment in basic,
translational, and clinical research plays an important role in the
continued health and prosperity of our people. Increases in NIH funding
have allowed researchers to explore scientific opportunities on an
unprecedented scale. However, to build on existing knowledge and
explore new areas, NIH must be able to provide research support for
innovative ideas. In fiscal year 2006 the NIH budget was cut for the
first time since 1970, and the administration's fiscal year 2007 budget
proposal would keep the agency at the same level. Taking inflation into
account, the President's budget plan represents another budget cut that
will reduce the number of research grants funded. As funding falters,
the best and brightest minds will turn away from careers in medical
science. If NIH cannot fund new ideas, this will not only hamper
efforts to find cures, it will also discourage up and coming
researchers who could become the next generation of basic and clinical
scientists. The APS urges you to make every effort to provide the NIH
with a 5 percent funding increase so we can take advantage of more
scientific opportunities that will lead to ways to alleviate the
suffering and burdens of disease and strengthen the Nation's scientific
workforce to face future challenges.
The APS is a professional society dedicated to fostering research
and education as well as the dissemination of scientific knowledge
concerning how the organs and systems of the body work. The Society was
founded in 1887 and now has more than 10,000 member physiologists
across the United States. The APS offers these comments on the budget
recognizing both the enormous financial challenges facing our Nation
and the enormous opportunities before us to make progress against
disease.
NIH's task is both to cure specific diseases and to look broadly at
scientific opportunities that may help us expand our understanding of
biological problems that affect health. Basic research contributes to a
body of knowledge whose importance will only be determined over time.
Physiology, which is the study of biological function, provides the
foundation for much of the translational research that turns
discoveries into therapies and prevention strategies.
One example of this is the lung disease cystic fibrosis. Over the
last 20 years, the scientific community has made great leaps in
understanding the role that genes play in the development of various
diseases. The CFTR gene responsible for cystic fibrosis was identified
in 1989. Since then, researchers have worked to gain a better
understanding of what happens in the disease at the molecular level
with the hope of developing a gene therapy that would prolong and
improve patients' lives. One critical question was how much of the
normal gene is necessary to improve lung function. In late 2005, NIH
supported researchers at the University of Iowa published the results
of experiments in which they delivered healthy copies of the CFTR gene
to cultured lung cells taken from cystic fibrosis patients.\1\ They
were then able to measure whether function improved with increasing
amounts of gene product. Unexpectedly, delivery of low levels of the
CFTR gene was more effective than very high doses. This type of
experiment provides the foundation for designing safe and effective
clinical treatments.
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\1\ S. L. Farmen et al., Am J Physiol Lung Cell Mol Physiol 289,
L1123-30 (Dec. 2005).
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In addition to supporting research, the NIH must also address
workforce issues to be sure our Nation's researchers are ready to meet
the challenges they will face in the future. Last year the NIH
announced a new program to encourage clinical and translational
research at universities. The new Clinical and Translational Service
Awards (CTSAs) will provide a total of $30 million in fiscal year 2006
to develop new research and training programs at academic institutions
around the country. This will allow researchers to capitalize on
knowledge generated from basic research through the development of
clinical applications and treatments.
The NIH plays many critical roles in advancing biomedical research.
It provides opportunities for individual researchers at universities
and medical schools throughout the country to compete for research
funds based upon the scientific merit of their ideas. NIH also carries
out other functions including:
--Sponsoring research training opportunities for young scientists and
physicians;
--Funding major collaborative initiatives that bring together
multiple institutions with diverse resources;
--Providing the public with up-to-date information about the latest
research on various diseases and health conditions through
individual institutes and online resources such as ``MedLine
Plus'' and ClinicalTrials.gov;
--Supporting unique science education programs, particularly for
underserved minority students; and
--Funding innovative research through the NIH Roadmap initiative.
These activities are critical to moving science forward, and they
are unique to the NIH. Another example is the newly developed Genes and
Environment Initiative (GEI). The GEI is a multi-institute effort to
identify genetic and environmental risk factors that contribute to
common diseases such as asthma, diabetes, heart disease, cancer and
Alzheimer's disease. The planned research will build on the Human
Genome Project and take advantage of new technologies developed in the
pursuit of basic research. With its wide range of expertise, the NIH is
uniquely suited to undertake broad projects such as this.
The examples listed above represent a select few examples from the
NIH's extensive and outstanding portfolio. The APS joins the Federation
of American Societies for Experimental Biology (FASEB) and the Ad Hoc
Group for Medical Research Funding in urging that NIH be provided with
a 5 percent funding increase in fiscal year 2007 to permit the agency
to maintain its current wide-ranging and important research efforts.
This forward-looking approach to our Nation's biomedical research
efforts is much to be preferred over the administration's proposal to
fund the agency at last year's level, which would force the NIH to
contract its research portfolio, thus leaving many important projects
unfunded.
______
Prepared Statement of the Coalition of Northeastern Governors
The Coalition of Northeastern Governors (CONEG) is pleased to
provide this testimony for the record to the Senate Subcommittee on
Labor, Health and Human Services, Education, and Related Agencies
regarding fiscal year 2007 appropriations for the Low Income Home
Energy Assistance Program (LIHEAP). The Governors appreciate the
subcommittee's consistent support for the LIHEAP program. We also
welcome the additional fiscal year 2006 funds recently provided by the
Congress, even as we recognize the difficult challenges facing the
subcommittee in this time of severe fiscal constraints. However, in
light of sharply higher home energy prices, we request the subcommittee
to provide the full authorized amount of $5.1 billion in regular fiscal
year 2007 LIHEAP funding--to restore the purchasing power of the LIHEAP
program. In addition, we request that the subcommittee provide
contingency funds to address energy emergency situations.
The continuing trend in rising prices for natural gas and home
heating fuels is creating a growing home energy crisis for low-income
citizens across the Nation. Low-income households, whose percentage of
income spent on energy may be four times that of average households,
can amass significant home energy debt that makes it difficult to
purchase heating fuels or pay outstanding utility bills. High levels of
accumulated arrearages owed by low-income households raise the prospect
of hundreds of thousands of households cut off from utility service
this spring.
Particularly in the Northeast, which is heavily dependent on
deliverable home heating fuels such as home heating oil, kerosene, and
propane, price volatility has an especially perverse impact. These low-
income households, without the disposable income to purchase fuels off-
season, typically enter the market when both the demand for and price
of fuels are high. Without access to LIHEAP assistance during the
heating season, they may not be able to obtain any fuel at all, due to
the collect-on-delivery business policy commonly used by fuel dealers.
If LIHEAP benefit levels are too low, these households may not be able
to afford the cost of the required minimum delivery.
LIHEAP is a vital tool in making home energy more affordable for
almost 5 million of the Nation's very low-income households faced with
high energy burden--the elderly and disabled on fixed incomes and
families with young children. Over the past 5 years, as the average
price of home heating oil and natural gas more than doubled, the
purchasing power of the LIHEAP grant has plummeted--undercutting the
ability of the program to serve adequately these vulnerable households.
States across the country in recent years have seen significant
increases in their regular LIHEAP caseloads, as well as in requests for
emergency crisis from those households in imminent danger of a utility
or fuel service cut-off. The number of requests for LIHEAP assistance
has reached its highest level in more than a decade. In response to the
continually rising home energy costs and the growing crisis in this
recent heating season, States across the country have stepped in to
provide more than $450 million for low-income energy programs. In
addition to regulatory actions, such as extending shut-off moratoria
periods and limiting deposit and reconnection fees, many State public
utility commissions have provided more than $100 million in assistance
from funding sources such as public benefit funds or universal service
funds.
The LIHEAP program delivers maximum program dollars to households
in need--the consequence of its administrative costs being among the
lowest of human service programs. In the Northeast, States have
incorporated various administrative strategies designed to minimize the
amount of program funds used to operate the program. Innovative
administrative strategies include the use of uniform application forms
to determine program eligibility, establishment of a one-stop shopping
approach for the delivery of LIHEAP and related programs, sharing
administrative costs with other programs, and the use of mail
recertification.
The recent action by Congress to increase LIHEAP funding in fiscal
year 2006 is a welcome and important step to begin restoring some of
the lost LIHEAP purchasing power. However, the prospect of continued
high and potentially volatile prices for home energy means that the
projected need continues to outweigh available Federal and State
funding. Even with these additional Federal and State funds, the value
of the LIHEAP grant has been significantly reduced, defraying only a
modest amount of a low-income household's total heating bill; and it
reaches only a small percentage of the households that need assistance.
Increased Federal funding is vital for LIHEAP to assist the
Nation's vulnerable, low-income households faced with unaffordable home
energy bills. An increase in the regular LIHEAP appropriation to the
full authorized level of $5.1 billion for fiscal year 2007 in addition
to contingency funds, will enable our States to help mitigate the
potential life-threatening emergencies and economic hardship that
confront the Nation's most vulnerable citizens. With these additional
funds, States can provide assistance to more households in need, offer
benefit levels that can make a meaningful reduction in their home
energy burden, lessen the need for emergency crisis, plan and operate a
more efficient program, and again make optimal use of leveraging and
other cost-effective programs.
We thank the subcommittee for this opportunity to share the views
of the Coalition of Northeastern Governors, and we stand ready to
provide you with any additional information on the importance of the
Low Income Home Energy Assistance Program to the Northeast.
______
Prepared Statement of the American Lung Association
SUMMARY: FUNDING RECOMMENDATIONS
[In millions of dollars]
------------------------------------------------------------------------
Agency Amount
------------------------------------------------------------------------
National Institutes of Health.............................. 30,205
National Heart, Lung, and Blood Institute.............. 3,099
National Cancer Institute.............................. 5,030
National Institute of Allergy and Infectious Disease... 4,682
National Institute of Environmental Health Sciences.... 680
National Institute of Nursing Research................. 146
Fogarty International Center........................... 70
Centers for Disease Control and Prevention................. 8,500
National Institute for Occupational Safety and Health.. 285
Office on Smoking and Health........................... 145
Environmental Health: Asthma Activities................ 70
Tuberculosis Control Programs.......................... 252
Influenza Pandemic......................................... 2,652
------------------------------------------------------------------------
The American Lung Association is pleased to present our
recommendations for programs in the Labor Health and Human Services and
Education Appropriations Subcommittee purview. These appropriations
will make a difference in the lives of millions of Americans who suffer
from lung disease.
The American Lung Association is one of the oldest voluntary health
organizations in the United States, with a National Office and
constituent associations around the country. Founded in 1904 to fight
tuberculosis, the American Lung Association today fights lung disease
in all its forms, with special emphasis on funding research for cures,
promoting cleaner air and helping prevent kids from smoking. The Lung
Association is funded by contributions from the public, along with
gifts and grants from corporations, foundations and government
agencies, and achieves its many successes through the work of thousands
of committed volunteers and staff.
the toll of lung disease
Each year, an estimated 349,000 Americans die of lung disease. Lung
disease is America's number three killer, responsible for one in every
seven deaths. More than 35 million Americans suffer from a chronic lung
disease. Each year lung disease costs the economy an estimated $157.8
billion. Lung diseases represent a spectrum of chronic and acute
conditions that interfere with the lung's ability to extract oxygen
from the atmosphere, protect against environmental or biological
challenges and regulate a number of metabolic processes. Lung diseases
include: asthma, chronic obstructive pulmonary disease, lung cancer,
tuberculosis, pneumonia, influenza, sleep disordered breathing,
pediatric lung disorders, occupational lung disease and sarcoidosis.
chronic obstructive pulmonary disease
Chronic Obstructive Pulmonary Disease, or COPD, is a growing health
problem. Yet it remains relatively unknown to most Americans and much
of the research community. COPD refers to a group of largely
preventable diseases, including emphysema and chronic bronchitis, that
generally gradually limit the flow of air in the body. COPD is the
fourth leading cause of death in the United States and worldwide.
In 2004, the annual cost to the Nation for COPD was $37.2 billion.
This includes $20.9 billion in direct health care expenditures, $8.9
billion in indirect morbidity costs and $7.4 billion in indirect
mortality costs. Medicare expenses for COPD beneficiaries were nearly
2.5 times that of the expenditures for all other patients.
It has been estimated that 11.4 million patients have been
diagnosed with some form of COPD and as many as 24 million adults may
suffer from its consequences. In 2004, an estimated 9 million Americans
were diagnosed with chronic bronchitis by a health professional.
Further, an estimated 3.6 million Americans have been diagnosed with
emphysema in their lifetime. In 2002, 120,555 people in the United
States died of COPD. Women have exceeded men in the number of deaths
attributable to COPD since 2000. Over the past 30 years, the death rate
due to COPD has doubled while the death rates for heart disease, cancer
and stroke have decreased by over 50 percent.
Today, COPD is treatable but not curable. Fortunately, promising
research is on the horizon for COPD patients. Research on the genetic
susceptibility underlying COPD is making progress. Research is also
showing promise for reversing the damage to lung tissue caused by COPD.
Despite these promising research leads, the American Lung
Association believes that research resources committed to COPD are not
commensurate with the impact COPD has on the United States and the
world.
The American Lung Association strongly recommends that the NIH and
other Federal research programs commit additional resources to COPD
research programs. In addition, there is a need for improved
surveillance data on the disease. The Lung Association supports the CDC
in gathering more information about COPD as part of the National Health
and Nutrition Examination Survey, the Behavioral Risk Factor
Surveillance System and other health surveys. This information will
help public health professionals and researchers understand the disease
better and lead to possible control of the disease.
tobacco use
Tobacco use is the leading preventable cause of death in the United
States, killing more than 438,000 people every year. Smoking is
responsible for one in five U.S. deaths. The direct health care and
lost productivity costs of tobacco-caused disease and disability are
also staggering, an estimated $167 billion each year. Taxpayers pay
billions of dollars each year to treat tobacco-caused disease through
federally funded health programs including Medicare and Medicaid.
The CDC's Office on Smoking and Health provides significant
technical assistance to States that are using tobacco settlement
dollars to develop comprehensive and effective tobacco prevention
programs, in addition to providing a small, yet essential, amount of
Federal assistance directly to State tobacco control and prevention
programs. States that currently fund comprehensive programs, as well as
those seeking to develop programs, rely on CDC's expertise. Funds for
tobacco prevention at CDC also are used to maintain comprehensive
information on smoking and health and to support ongoing research on
tobacco-related issues.
We believe Congress should fund the type of youth tobacco
prevention programs that science tells us are essential to counter the
impact of tobacco company marketing to our kids. The American Lung
Association strongly supports a minimum level of $145 million in fiscal
year 2007 funding for the CDC's Office on Smoking and Health.
asthma
Asthma is a chronic lung disease in which the bronchial tubes
become swollen and narrowed, preventing air from getting into or out of
the lung. An estimated 30.2 million Americans have ever been diagnosed
with asthma by a health professional. Approximately 20.5 million
Americans currently have asthma, of which 11.7 million had an asthma
attack in 2004. Asthma prevalence rates are 39 percent higher among
African Americans than whites. Studies also suggest that Puerto Ricans
have higher asthma prevalence rates and age-adjusted death rates than
all other Hispanic subgroups.
Asthma is expensive. The growth in the prevalence of asthma will
have a significant impact on our Nation's health expenditures,
especially Medicaid. Asthma incurs an estimated annual economic cost of
$16.1 billion to our Nation. Asthma is the third leading cause of
hospitalization among children under the age of 15. It is also the
number one cause of school absences attributed to chronic conditions.
The Federal response to asthma has three components: research, programs
and planning. We are making progress on all three fronts but more must
be done:
Asthma Research
Researchers are developing better ways to treat and manage chronic
asthma. Two examples show why this should continue. Research supported
by National Heart, Lung and Blood Institute (NHLBI) has shown that
using corticosteroids to treat children with mild to moderate asthma is
safe and effective, answering a parent's question about whether these
effective drugs would stunt the growth of children who used them.
Genetic research is also providing insights into asthma.
Researchers in the NHLBI-supported Asthma Clinical Research Network
have discovered that a genetic variation determines how well asthma
patients will respond to the most common asthma medication, inhaled
beta-agonists. This discovery will help physicians better target the
drugs they proscribe.
Asthma Programs
Last year, Congress provided approximately $31.9 million for the
Centers for Disease Control and Prevention (CDC) to conduct asthma
programs. The American Lung Association recommends that CDC be provided
$70 million in fiscal year 2007 to expand its asthma programs. This
funding includes State asthma planning grants, which leverage small
amounts of funding into more comprehensive State programs.
Asthma Surveillance
In addition to public education programs, the CDC has been piloting
programs to determine how to establish a nationwide health-tracking
system. The pilots have shown how to integrate different data to
determine how pervasive asthma is in these communities. Congress needs
to increase funding to create a nationwide health-tracking system,
based on the localized pilots that are underway now.
lung cancer
An estimated 350,679 Americans are living with lung cancer. During
2005, an estimated 172,570 new cases of lung cancer will be diagnosed.
This year 163,510 Americans will die from lung cancer. Survival rates
for lung cancer tend to be much lower than those of most other cancers.
Men have higher rates of lung cancer than women. However, over the past
30 years, the lung cancer age-adjusted incidence rate has decreased 9
percent in males compared to an increase of 143 percent in females.
Further, African Americans are more likely to develop and die from lung
cancer than persons of any other racial group.
Given the magnitude of lung cancer and the enormity of the death
toll, the American Lung Association strongly recommends that the NIH
and other Federal research programs commit additional resources to lung
cancer research programs. We support increasing the National Cancer
Institute budget to $5.003 billion.
influenza
Influenza is a highly contagious viral infection and one of the
most severe illnesses of the winter season. It is responsible for an
average of 200,000 hospitalizations and 36,000 deaths each year.
Further, the emerging threat of a pandemic influenza is looming. Public
health experts warn that over half a million Americans could die and
over 2.3 million could be hospitalized if a moderately severe strain of
a pandemic flu virus hits the United States. To prepare for a potential
pandemic, the American Lung Association supports funding the Federal
Pandemic Influenza Plan at the recommended level of $2.652 billion.
tuberculosis
Tuberculosis is an airborne infection caused by a bacterium,
Mycobacterium tuberculosis (TB). TB primarily affects the lungs but can
also affect other parts of the body, such as the brain, kidneys or
spine. There are an estimated 10 million to 15 million Americans who
carry latent TB infection. Each has the potential to develop active TB
in the future. About 10 percent of these individuals will develop
active TB disease at some point in their lives. In 2005, there were
14,093 cases of active TB reported in the United States.
The American Lung Association has endorsed the Institute of
Medicine (IOM) report, Ending Neglect: The Elimination of Tuberculosis
in the United States, IOM report and its recommendations on how to
eliminate TB in the United States. While declining overall TB rates are
good news, the emergence and spread of multi-drug resistant TB pose a
significant threat to the public health of our Nation. Continued
support is needed if the United States is going to continue progress
toward the elimination of TB. We estimate it will cost $528 million for
the CDC Tuberculosis Elimination Program to implement the report
recommendations. We request that Congress increase funding for
tuberculosis programs to $252 million for fiscal year 2007.
The NIH also has a prominent role to play in the elimination of TB.
Currently there is no highly effective vaccine to prevent TB
transmission. However, the recent sequencing of the TB genome and other
research advances has put the goal of an effective TB vaccine within
reach. In addition, the American Lung Association encourages the
subcommittee to fully fund the TB vaccine blueprint development effort
at the National Institutes of Allergy and Infectious Disease (NIAID).
Fogarty International Center TB Training Programs
The Fogarty International Center (FIC) at NIH provides training
grants to U.S. universities to teach AIDS treatment and research
techniques to international physicians and researchers. Because of the
link between AIDS and TB infection, FIC has created supplemental TB
training grants for these institutions to train international health
care professionals in the area of TB treatment and research. However,
we believe TB training grants should not be offered exclusively to
institutions that have received AIDS training grants. The TB grants
program should be expanded and open to competition from all
institutions. The American Lung Association recommends Congress provide
$70 million for FIC to expand the TB training grant program from a
supplemental grant to an open competition grant.
environmental health
The National Institute of Environmental Health Sciences funds vital
research on the impact of environmental influence on disease. The
American Lung Association supports increasing the appropriation from
this subcommittee to $680 million.
researching and preventing occupational lung disease
The American Lung Association recommends that the subcommittee
provide $285 million for the National Institute for Occupational Safety
and Health (NIOSH) at the CDC.
conclusion
In conclusion, Mr. Chairman, lung disease is a continuing, growing
problem in the United States. It is America's number three killer,
responsible for one in seven deaths. The lung disease death rate
continues to climb. Mr. Chairman, the level of support this committee
approves for lung disease programs should reflect the urgency
illustrated by these numbers.
______
Prepared Statement of the American Nephrology Nurses' Association
The American Nephrology Nurses' Association (ANNA) appreciates the
opportunity to submit written comments for the record regarding fiscal
year 2007 funding to address the challenges that kidney disease and the
nursing shortage are posing to the Nation. ANNA exists to advance
nephrology nursing practice and positively influence outcomes for
patients with kidney or other disease processes requiring replacement
therapies through advocacy, scholarship, and excellence. ANNA consists
of more than 12,000 registered nurses and other health care
professionals with varying experience and expertise in such areas as
hemodialysis, peritoneal dialysis, conservative management, continuous
renal replacement therapies, chronic kidney disease, and renal
transplantation.
As part of our mission, we educate health professionals, the
public, and policymakers to increase public awareness and understanding
of the unique health care needs and challenges people with kidney
disease face. Moreover, ANNA maintains a strong commitment to securing
public policies and programs that help secure better treatments and
care for individuals with kidney disease. ANNA specifically seeks to
advance public and private efforts to improve treatment of kidney
disease, reduce and prevent the onset of end stage renal disease
(ESRD), and ensure that all people with kidney disease have access to
the medical care and treatment options they need to live the highest
quality of life possible.
To that end, ANNA respectfully requests that Congress reject the
President's proposed $11 million cut in funding for the National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and
instead support increased funding for diabetes and kidney disease
research to find better treatments, preventive interventions, and
develop a cure. NIDDK conducts and supports research on most of the
more serious diseases affecting public health. The Institute supports
much of the clinical research on the diseases of internal medicine and
related subspecialty fields, as well as many basic science disciplines.
Additional fiscal year 2007 funding for NIDDK will help advance our
Nation's understanding of the risk factors associated with kidney
disease, boost efforts to identify ways in which kidney disease can be
reduced and prevented, and increase initiatives to improve care and
treatment of individuals with chronic kidney disease as well as those
with ESRD.
The National Institute of Nursing Research (NINR) supports clinical
and basic research to establish a scientific basis for the care of
individuals across the life span-from management of patients during
illness and recovery to the reduction of risks for disease and
disability, the promotion of healthy lifestyles, promoting quality of
life in those with chronic illness, and care for individuals at the end
of life. NINR seeks to understand and ease the symptoms of acute and
chronic illness, to prevent or delay the onset of disease or disability
or slow its progression, to find effective approaches to achieving and
sustaining good health, and to improve the clinical settings in which
care is provided. Importantly, NINR research also focuses on the
special needs of at-risk and under-served populations, with an emphasis
on health disparities, such as those seen among the ESRD population.
These efforts are crucial in the creation of scientific advances and
their translation into cost-effective health care that does not
compromise quality. ANNA is pleased to join with others in the nursing
community in advocating a fiscal year 2007 allocation of $150 million
for NINR.
As you know, the Nation is facing a nursing shortage of
unprecedented proportion. At the same time the nursing shortage is
expected to worsen, the number of people with ESRD needing access to
state-of-the-art treatment and care is estimated to increase
significantly. More than 350,000 Americans have ESRD which gives the
United States the highest incidence rate. As the population continues
to grow and age and medical services advance, the need for nurses will
continue to increase. A report issued by the U.S. Health Resources and
Services Administration (HRSA), Projected Supply, Demand, and Shortages
of Registered Nurses: 2000-2020, predicted that the nursing shortage is
expected to grow to 29 percent by 2020, compared to a seven percent
shortage in 2005. Nurses are crucial to the health of our Nation and
those with ESRD.
According to the U.S. Department of Health and Human Services
(HHS), the nursing workforce programs housed at HRSA will support the
recruitment, education, and retention of an estimated 36,750 nurses and
nursing students and approximately 956 new loan repayments and
scholarships among other activities. With additional funding in fiscal
year 2007, the HRSA nursing workforce programs would have more
sufficient resources to bolster the Nation's nursing workforce at a
rate necessary to help stem the nursing shortage tide. To address this
current and growing challenge in the health care delivery system, ANNA
urges Congress to support the nursing community's request of $175
million for the HRSA nursing workforce programs. Moreover, please note
that ANNA supports the written testimony submitted by the Americans for
Nursing Shortage Relief (ANSR) Alliance and respectfully requests your
full and fair consideration of the funding allocations and issues
outlined by ANSR.
Please know that we understand that Congress has limited resources
to allocate. However, we are concerned that without adequate funding
for research and the Nation's nursing workforce, the Nation will falter
in its efforts to diminish suffering from kidney disease and to provide
quality nursing care to all in need. On behalf of ANNA's Board of
Directors and the hundreds of thousands of individuals with kidney
disease to whom we provide care, thank you for this opportunity to
submit written testimony regarding the fiscal year 2007 funding levels
necessary to ensure that our Nation adequately supports kidney disease
research and the Nation's nursing workforce. Please feel free to
contact us at any time; we are happy to be a resource to subcommittee
members and your staff.
______
Prepared Statement of the American Public Health Association
The American Public Health Association (APHA) is the Nation's
oldest, largest and most diverse organization of public health
professionals in the world, dedicated to protecting all Americans and
their communities from preventable, serious health threats and assuring
community-based health promotion and disease prevention activities and
preventive health services are universally accessible in the United
States. We are pleased to submit our views on Federal funding for
public health activities in fiscal year 2007.
recommendations for funding the public health service
The APHA's budget recommendation for overall funding for the Public
Health Service includes funding for the Centers for Disease Control and
Prevention (CDC), the Health Resources and Services Administration
(HRSA), the Substance Abuse and Mental Health Services Administration
(SAMHSA), the Agency for Healthcare Research and Quality (AHRQ), and
the National Institutes of Health (NIH), as well as agencies outside
the subcommittee's jurisdiction--the Food and Drug Administration (FDA)
and the Indian Health Service (IHS). We encourage the subcommittee to
restore $1 billion in funding cuts that occurred in fiscal year 2006,
and reject the President's proposal to cut an additional $600 million
from the Public Health Service.
centers for disease control and prevention (cdc)
The APHA believes that Congress should support CDC as an agency--
not just the individual programs that it funds. We support a funding
level for CDC that enables it to carry out its mission to protect and
promote good health and to assure that research findings are translated
into effective State and local programs.
In the best professional judgment of the APHA, in conjunction with
the CDC Coalition--given the challenges of terrorism and disaster
preparedness, new and re-emerging infectious diseases, the epidemic of
obesity, particularly among children, and our many unmet public health
needs and missed prevention opportunities--we believe the agency will
require funding of at least $8.5 billion, plus sufficient funding to
prepare the Nation against a potential influenza pandemic. This request
reflects the support CDC will need to fulfill its core missions for
fiscal year 2007, as well as funding for the Agency for Toxic
Substances and Disease Registry and the Vaccines for Children program.
The APHA appreciates the subcommittee's work over the years,
including your recognition of the need to fund chronic disease
prevention, infectious disease prevention and treatment, and
environmental health programs at CDC. By translating research findings
into effective intervention efforts, CDC has been a key source of
funding for many of our State and local programs that aim to improve
the health of communities. Perhaps more importantly, Federal funding
through CDC provides the foundation for our State and local public
health departments, supporting a trained workforce, laboratory capacity
and public health education communications systems.
CDC also serves as the command center for our Nation's public
health defense system against emerging and reemerging infectious
diseases. With the potential onset of an influenza pandemic, in
addition to the many other natural and man-made threats that exist in
the modern world, the CDC has become the Nation's--and the world's--
expert resource and response center, coordinating communications and
action and serving as the laboratory reference center. States and
communities rely on CDC for accurate information and direction in a
crisis or outbreak.
Unfortunately, Congress cut overall CDC funding in fiscal year 2006
for the first time in 25 years. And in fiscal year 2007, the President
has proposed cutting CDC funding even more--more than 2 percent
overall, and more than 4.5 percent to CDC's core programs. We are
moving in the wrong direction, especially in these challenging times
when public health is being asked to do more, not less. In light of the
current workload placed on the public health service--in addition to
the threat of emerging diseases such as the avian flu--it simply does
not make any sense to cut the budget for CDC at a time when the threats
to public health are so great. Funding public health outbreak by
outbreak is not an effective way to ensure either preparedness or
accountability. Until we are committed to a strong public health
system, every crisis will force trade offs.
CDC serves as the lead agency for bioterrorism preparedness and
must receive sustained support for its preparedness programs in order
for our Nation to meet future challenges. APHA supports the proposed
increase for anti-terrorism activities at CDC, including the increases
for the Strategic National Stockpile and the new Botulinum Toxin
Research funding. However, we strongly caution that the President's
proposed level-funding of the State and local capacity grants continues
to reflect a $95 million cut from fiscal year 2005 levels. We encourage
the subcommittee to restore these cuts to ensure that our States and
local communities can be prepared in the event of an act of terrorism.
Unfortunately, the President's budget proposes the elimination of
some very important CDC programs, like the Preventive Health and Health
Services Block Grant. Within an otherwise-categorical funding
construct, the Preventive Health and Health Services Block Grant is the
only source of flexible dollars for States and localities to address
their unique public health needs. The track record of positive public
health outcomes from Prevention Block Grant programs is strong, yet so
many requests go unfunded. However, the President's budget proposes the
elimination of the Preventive Health and Health Services Block Grant--
again. We appreciate the work of the subcommittee to at least partially
restore the fiscal year 2006 elimination of the Block Grant.
Nevertheless, the $20 million cut to the Block Grant in fiscal year
2006 reduces the States' ability to tailor Federal public health
dollars to their specific needs. As States use their Prevention Block
Grant dollars to address high priority needs such as emerging and
chronic diseases, child safety seat programs, suicide prevention, smoke
detector distribution and fire safety programs, adult immunization,
oral health, worksite wellness, infectious disease outbreaks, food
safety, emergency medical services, safe drinking water, and
surveillance needs--we can scarcely understand why the Prevention Block
Grant should be eliminated. We encourage the subcommittee to restore
the cuts and fund the Prevention Block Grant at $132 million.
We also encourage the subcommittee to provide $10 million for CDC's
Environmental Public Health Services Branch to revitalize environmental
public health services at the national, State, and local level. As with
the public health workforce, the environmental health workforce is
declining. Furthermore, the agencies that carry out these services are
fragmented and their resources are stretched. These services are the
backbone of public health and are essential to protecting and ensuring
the health and well being of the American public from threats
associated with West Nile virus, terrorism, E. coli and lead in
drinking water.
We appreciate the subcommittee's hard work in advocating for CDC
programs in a climate of competing priorities.
health resources and services administration (hrsa)
HRSA programs are designed to give all Americans access to the best
available health care services. Through its programs in thousands of
communities across the country, HRSA provides a health safety net for
medically underserved individuals and families, including more than 45
million Americans who lack health insurance; 50 million Americans who
live in neighborhoods where primary health care services are scarce;
African American infants, whose infant mortality rate is more than
double that of whites; and the estimated 1 to 1.2 million people living
with HIV/AIDS. Programs to support the underserved place HRSA on the
front lines in erasing our Nation's racial/ethnic and rural/urban
disparities in health status. HRSA funding goes where the need exists,
in communities all over America. We support a growing trend in HRSA
programs to increase flexibility of service delivery at the local
level, necessary to tailor programs to the unique needs of America's
many varied communities. The agency's overriding goal is to achieve 100
percent access to health care, with zero disparities. In the best
professional judgment of the APHA, to respond to this challenge, the
agency will require an overall funding level of at least $7.5 billion
for fiscal year 2007.
The APHA is gravely concerned about a number of programs that are
slated for deep cuts or elimination under the administration's budget
proposal. Building on the HRSA programs that were cut or eliminated in
the fiscal year 2006 appropriations bill, we strongly suggest that this
trend is moving our Nation in the wrong direction. We urge the
subcommittee to restore funding to HRSA programs that were cut last
year, as well as ensure adequate funding for fiscal year 2007 by
rejecting the proposed cuts contained in the President's budget.
We express our dismay at the eroding support from the subcommittee
for some of HRSA's programs over the last few years, including Health
Professions programs, Area Health Education Centers, and the Maternal
and Child Health block grant, among others. On top of the $250 million
cut to the agency for fiscal year 2006, the President has proposed
another $321 million overall cut from last year's appropriated level.
Under the President's proposal, total cuts to HRSA since fiscal year
2005 would reach more than $570 million, a devastating 8 percent cut in
2 years. We urge the subcommittee to restore the fiscal year 2006 cuts,
and reject the President's proposed cuts for fiscal year 2007.
One program that has received consistent support from the
subcommittee is the community-based health centers and National Health
Service Corps-supported clinics, which form the backbone of the
Nation's health safety net. More than 4,000 of these sites across the
Nation provide needed primary and preventive care to 15 million poor
and near-poor Americans. HRSA primary care centers include community
health centers, migrant health centers, health care for the homeless
programs, public housing primary care programs and school-based health
centers. Health centers provide access to high-quality, family-
oriented, culturally and linguistically competent primary care and
preventive services, including mental and behavioral health, dental and
support services. Nearly three-fourths of health center patients are
uninsured or on Medicaid, two-thirds are people of color, and more than
90 percent live below 200 percent of the poverty level. Additional
primary care is provided by 2,700 clinicians in the National Health
Service Corps. Corps members work in communities with a shortage of
health professionals in exchange for scholarships and loan repayments.
The APHA is pleased that the President has requested a significant
increase for Community Health Centers for a total of $1.918 billion.
Nevertheless, in the context of corresponding cuts to the Health
Professions programs, we are left with some doubt about who, exactly,
is going to staff all these new Community Health Centers. We are once
again very concerned that the HRSA health professions programs under
Title VII and VIII of the Public Health Service Act have landed on the
chopping block. Today our Nation faces a widening gap between
challenges to improve the health of Americans and the capacity of the
public health workforce to meet those challenges. An adequate, diverse,
well-distributed and culturally competent health workforce is
indispensable to our national readiness efforts and to address critical
health care needs. These programs help meet the health care delivery
needs of the areas in this country with severe health professions
shortages, at times serving as the only source of health care in many
rural and disadvantaged communities. Therefore, the elimination of most
funding for the Title VII health professions training programs and flat
funding for Title VIII nurse training will only make certain that the
needs of these medically underserved populations will not be met.
Furthermore, we believe the elimination of the Healthy Community
Access Program, universal newborn hearing screening programs, and the
Emergency Medical Services for Children Program, will further undermine
the availability of basic health services for some that are most in
need--especially children. The Healthy Community Access Program is an
example in which communities build partnerships among health care
providers to deliver a broader range of health services to their
neediest residents. This program of coordinated service delivery is
innovative, not duplicative of other available programs, and therefore
its elimination is of grave concern. Also, the proposed zero funding of
universal newborn hearing screening programs in the administration's
budget will likely cause many hearing impairments in infants to go
undetected, which can negatively impact speech and language
acquisition, academic achievement, and social and emotional
development. The proposed elimination of the Emergency Medical Services
for Children Program will likely halt the improvements made in recent
years to pediatric emergency care, which will disproportionately affect
children who are eligible for Medicaid and SCHIP, but not enrolled due
to State enrollment limits and budgetary pressures, and therefore
frequently use emergency health services.
The Maternal and Child Health (MCH) Block Grant is operating for a
second year with less funds than in fiscal year 2005, yet with greater
needs among more pregnant women, infants, and children, particularly
those with special health care needs. Furthermore, if programs like the
Traumatic Brain Injury program, Universal Newborn Hearing Screening,
and Emergency Medical Services for Children program are eliminated,
those costs will be borne by the MCH Block Grant.
We are pleased with the increases proposed by the President for
programs under the Ryan White CARE Act, administered by HRSA's HIV/AIDS
Bureau. The CARE Act programs are an important safety net, providing an
estimated 571,000 people access to services and treatments each year.
At a time when HIV/AIDS is the sixth leading cause of death for people
who are 25 to 44 years old in the United States, and the number of new
domestic HIV/AIDS cases is increasing, we support increased funding for
Ryan White Act programs.
Through its many programs and initiatives, HRSA helps countless
individuals live healthier, more productive lives. As leaders of our
Nation, this subcommittee decides what direction we will go in terms of
delivering health care to those who need it most. The APHA believes
that with adequate resources, HRSA is well positioned to meet these
challenges as it continues to provide needed health care to the
Nation's most vulnerable citizens. We encourage the subcommittee to
restore the funds to these important public health programs and reject
the proposed cuts in the President's budget.
agency for healthcare research and quality (ahrq)
We request a funding level of $440 million for the AHRQ for fiscal
year 2007, an increase of $121 million over the enacted fiscal year
2006 level. This level of funding is needed for the agency to fully
carry out its congressional mandate to improve health care quality,
including eliminating racial and ethnic disparities in health, reducing
medical errors, and improving access and quality of care for children
and persons with disabilities. The cuts proposed in the administration
budget will severely hamper these efforts.
substance abuse and mental health services administration (samhsa)
The APHA supports a funding level of $3.466 billion for SAMHSA for
fiscal year 2007, an increase of $107 million over the enacted fiscal
year 2006 level. This funding level would provide support for substance
abuse prevention and treatment programs, as well as continued efforts
to address emerging substance abuse problems in adolescents, the nexus
of substance abuse and mental health, and other serious threats to the
mental health of Americans.
national institutes of health (nih)
The APHA supports a funding level of $29.75 billion for the NIH for
fiscal year 2007, an increase of $1.1 billion over the enacted fiscal
year 2006 level. The translation of fundamental research conducted at
NIH provides the basis for community based public health programs that
help to prevent and treat disease.
department of health and human services
The budget of the Office of Minority Health faced several years of
decreasing budgets prior to last year. In fiscal year 2006, OMH
received $56 million; and the proposed budget in fiscal year 2007 is
$46 million. APHA is concerned that at a time when we have increasing
evidence of disparities in health care delivery, access and health
outcomes, the budget of OMH is getting cut. We support maintaining OMH
funding at the fiscal year 2006 level.
conclusion
In closing, we emphasize that the public health system requires
financial investments at every stage. Successes in biomedical research
must be translated into tangible prevention opportunities, screening
programs, lifestyle and behavior changes, and other interventions that
are effective and available for everyone. While we have said this
before, in the post-September 11th era, we need to apply this to our
spending growth in terrorism and influenza preparedness as well. We
must think in a broad and balanced way, leveraging homeland security
programs and funding whenever possible to provide public health
benefits as a matter of routine, rather than emergency.
We thank the subcommittee for the opportunity to present our views
on the fiscal year 2007 appropriations for public health service
programs.
______
Prepared Statement of the American Society for Clinical Pathology
demand for qualified laboratory personnel outstrips supply
On behalf of the American Society for Clinical Pathology (ASCP), a
non-profit organization representing 140,000 pathologists, medical
technologists, cytotechnologists and other medical laboratory
professionals, we are submitting this written testimony regarding the
Title VII Allied Health Professions program that is administered by the
Health Resources and Services Administration (HRSA).
Last year, funding for the Title VII Allied Health Professions
program was cut by 68 percent. Funding for these programs, which
provide seed money for the establishment and expansion of medical
laboratory education training programs, was reduced from $300 million
in fiscal 2005 to $94 million for the 2006 fiscal year. Funding for the
allied health and other disciplines program was reduced from $11.8
million to $4 million. Congress eliminated funding for the allied
health special project grants that fund medical laboratory education
programs under the Title VII of the Public Health Service Act. These
programs represent a small portion of the funding provided by the
Labor, Health and Humans Services, and Education Appropriations bill,
but their importance to developing the next cadre of laboratory
professionals can not be overstated.
Because few patients have direct contact with the people who work
in our Nation's medical laboratories, the important role these health
care practitioners play in patient care often goes unnoticed. Not only
is laboratory testing key to diagnosing patient health, but
laboratories also help identify appropriate patient treatments. In
fact, the results of diagnostic laboratory testing impact over 70
percent of all healthcare treatment decisions. So, ensuring that our
Nation's laboratories possess the laboratory professionals needed to
accurately process laboratory testing demands is critical to patient
health.
Unfortunately, the United States continues to face a severe
shortage of qualified laboratory personnel. The U.S. Department of
Labor projects that approximately 15,000 medical laboratory
professionals will be needed each year through 2014. Unfortunately,
fewer than 5,000 individuals are graduating each year from accredited
or approved educational training programs.
Hardest hit by the shortage are rural areas and areas served by
smaller hospitals. These areas are finding it increasingly difficult to
recruit and retain qualified laboratory personnel. According to data
gathered by the American Society for Clinical Pathology, half of all
medical laboratories are reporting substantial difficulties hiring new
testing personnel. It can often take a laboratory 6 to 12 months to
hire an employee.
Another cause for concern is the average age of the laboratory
workforce, which has been increasing steadily over the past few years,
reflecting the fact that the pace with which younger, newly trained
laboratorians have entered the laboratory workforce has not kept pace
with retirements. At 43.7, the average age of medical technologists is
essentially the same as that of nurses (43.3). An aging workforce can
be more vulnerable to the adverse health and safety risks associated
with shift work. Moreover, as our Nation ages, estimates project that
the demand for laboratory testing services may increase.
Personnel turnover is also an increasing problem. With competition
for laboratory personnel intensifying over the last year, turnover
rates for some categories of laboratory personnel exceed 20 percent.
Because of the difficulty in finding qualified staff, medical
laboratories are increasingly turning to temporary staff (many of whom
may already be working full- or part-time at another medical
laboratory) to handle the patient testing workload.
To make matters worse, our Nation's capacity to train new
laboratory personnel has declined substantially over the past 10 years.
According to the National Accrediting Agency for Clinical Laboratory
Sciences, school closings in the last 5 years have reduced the number
of medical technologists and medical laboratory technicians being
trained annually. The number of individuals graduating from these
educational programs has declined approximately 35 percent over the
last 10 years, from 6,783 graduates in 1994 to 4,390 in 2004. Over the
last 10 years, the number of educational programs for laboratory
professionals has declined more than 30 percent, from 637 programs in
1994 to 435 programs in 2004. For cytotechnologists, the number of
educational programs has been reduced 25 percent over the last 10
years, from 65 programs in 1994 to 49 programs in 2004. Only 260
cytotechnologists graduate from these educational programs each year.
Now with the devastating cuts to the Title VII programs, more programs
may close.
Besides reducing our ability to train new laboratorians quickly,
these losses have an especially profound impact on rural areas, where
prospective laboratory practitioners often seek training close to home.
Wyoming, for example, has no accredited or approved medical laboratory
educational programs. Not surprisingly, data provided by HRSA indicates
Wyoming has one of the lowest concentrations of laboratory
professionals per resident (66 per 100,000 residents) in the United
States.
ASCP believes that the Title VII Allied Health Education Programs
have helped make a difference. For example, the University of Nebraska
has for several years now offered a medical laboratory education
program that has received funding under the allied health and other
disciplines program. The University's program includes an effective
distance training program that has served other nearby States as well.
HRSA data indicates Nebraska has more than 128 laboratory professionals
per 100,000 residents--almost twice the number of Wyoming and one of
the highest concentrations of laboratory personnel in the United
States. Because of cuts to the Title VII programs, Federal funding for
the University of Nebraska's medical laboratory education program has
been eliminated.
Given that medical technologist and medical laboratory technician
jobs have often been ranked among the best jobs by the Jobs Rated
Almanac, we hope increasing funding for laboratory professionals
education programs will help encourage more individuals to pursue
rewarding careers in the medical laboratory. Your help in restoring
funding for these important educational programs will make our shared
goal of reversing the laboratory personnel shortage much more
obtainable. ASCP joins with our colleagues in the Health Professions
and Nursing Education Coalition to request that Congress appropriate
$550 million for the Title VII programs.
______
Prepared Statement of the American Society for Microbiology
The American Society for Microbiology (ASM) is pleased to submit
the following statement on the fiscal year 2007 appropriation for the
National Institutes of Health (NIH). The ASM is the largest single life
science Society with over 42,000 members who are involved in basic
biomedical research, research and development activities, and
diagnostic testing in university, industry, government and clinical
laboratories.
The ASM is deeply concerned that the President's proposed fiscal
year 2007 budget falls far short of adequately funding biomedical
research supported by the NIH. Under the President's fiscal year 2007
budget request, 18 of the 19 Institute budgets are reduced in real
dollars. These proposed reductions come at a time when more, not less,
research is needed to address pressing health problems. Funding for the
NIH in recent years has fallen substantially in constant dollars,
foreshadowing a troubling future for biomedical research and for
progress against health challenges from emerging and entrenched
infectious diseases and chronic diseases. The continued toll on human
life from chronic diseases, new threats from pandemic diseases and the
potential dangers from bioterrorism make the ASM firmly believe that
now is not the time to perpetuate the decline in funding of the past
three fiscal years for the NIH. Biomedical research supported by the
NIH is critical to the discovery of new knowledge and understanding
which underpins development of medical treatments and vaccines. As the
U.S. population ages and as global stability is threatened by
pandemics, basic research which can only be supported by the NIH is
essential to the well being of the world. However, basic biomedical
research and the recruitment and training of the next generation of
researchers will be weakened if funding for the NIH stagnates and does
not keep pace with inflation for a fourth year.
The ASM commends Congress for the past decades of substantial and
sustained funding for the NIH, an investment which is key to global
health and benefits all Americans medically and economically. The ASM
is pleased that the Senate recently has taken steps to increase the NIH
budget for fiscal year 2007. The ASM urges Congress to continue to
recognize the medical, economic, and strategic importance of adequately
funding the NIH and recommends at least a 5 percent increase for the
NIH in fiscal year 2007, an appropriation of $29.75 billion. This level
of funding is the minimum amount necessary to sustain the current rate
of research progress and offset biomedical research inflation.
biomedical research benefits public health preparedness and the economy
In the past year, there have been tragic reminders that being
unprepared protects neither the public health nor the economic and
strategic interests of the United States. Increased support for
biomedical research is needed because new knowledge and technology are
the pillars of preparedness against biological threats. Each day we
face local, national, and global threats to health, safety, and well-
being. To counter these threats, the NIH's resources are focused on
preserving and improving health in this country and elsewhere through
innovative, cutting-edge research. Declining cancer, heart disease and
stroke mortality, extended HIV/AIDS life expectancies, and massive
genome databanks are evidence of the power of biomedical research.
Research supported by the NIH is responding to the realities of 21st
century medicine, developing predictive and preemptive medical
capabilities to overcome expected health resource shortages and
unforeseen dangers like newly identified microbial pathogens.
Research funded by the NIH also contributes to the Nation's
competitiveness and economic strength, which is clearly rooted in basic
science that generates commercially viable products and technologies.
Biomedical research advances scientific knowledge, expands the high-
technology workforce of the Nation, and enhances innovation among the
country's private sector companies. Roughly 84 percent of the proposed
fiscal year 2007 NIH budget will support the extramural science
community through research grants and contracts. This funding will
sustain work by more than 200,000 research personnel affiliated with
approximately 3,000 hospitals, universities, private companies, and
other research facilities.
infectious disease research needs increased support
Inadequate increases in funding for biomedical research weakens our
national defenses against infectious diseases, which despite some
medical victories persist as the second leading cause of death
worldwide, accounting for 26 percent of all deaths. Infectious diseases
particularly affect years of healthy life lost because they cause
approximately two-thirds of deaths among children less than 5 years of
age. Our ability to combat infectious diseases depends on basic
research of how microbes spread, how they are harbored in the
environment, and how they cause disease. The National Institute of
Allergy and Infectious Diseases (NIAID) supports research that is
essential to developing strategies to prevent, diagnose and treat
infectious diseases here and abroad. NIAID funding supports both
intramural and extramural researchers in academia and the private
sector searching for new therapies, diagnostics, vaccines, and other
technologies that improve health care for infectious diseases. This
critical work also focuses on high-priority homeland security
initiatives, includes influenza preparedness and counter-bioterrorism.
Unfortunately, the proposed fiscal year 2007 budget leaves funding for
the NIAID flat, about $4.4 billion or 0.3 percent over the fiscal year
2006 appropriation. With additional resources the NIAID could fund more
promising initiatives and restore funding for research projects.
the threat of pandemic influenza
Biomedical research and preparedness save lives and, in the case of
pandemic influenza, the number of lives saved could be significant.
Anticipating dire possibilities if the H5N1 avian influenza virus
mutates sufficiently to move easily from human to human, the Department
of Health and Human Services (DHHS) and other Federal agencies recently
introduced the National Strategy for Pandemic Influenza. The ASM
commends this plan as a prudent response to what could become a lethal
global event. Fearsome pandemics have ravaged human populations three
times in the past century: the 1918-1919 Spanish influenza that took
more than 40 million lives worldwide, the 1957 Asian influenza, and the
1968 Hong Kong influenza. Those unusually virulent viral strains
contained genetic material from avian influenza viruses like the
current H5N1 virus. Confirmed reports of H5N1 related deaths in birds
and mammals are coming from an expanding list of nations, where
millions of domestic and wild fowl have died or been destroyed. In just
the 4 months since the introduction of the National Strategy for
Pandemic Influenza, H5N1 has spread to 37 nations. At present about 186
humans have contracted the disease, more than half of whom have died.
Feared for their facile ability to infect and kill, influenza viruses
are always with us. Every year, seasonal influenza causes 250,000 to
500,000 deaths worldwide. In the United States, this highly
communicable disease annually causes an average 36,000 deaths, more
than 200,000 hospitalizations, and, when calculated with pneumonia, an
estimated $37.5 billion in direct and indirect costs. Together
influenza and pneumonia are the leading infectious cause of deaths in
the United States, ranked seventh among all causes of death. The
Centers for Disease Control and Prevention has estimated that if
pandemic flu arrives in the United States, 90 million people will
become ill and almost 2 million people could die. The global potential
for profound loss, millions of human lives and billions in financial
costs, clearly demands that our public health institutions be ready
with the most effective preventive and therapeutic measures against
influenza.
The ASM strongly supports the critically important NIH influenza
initiatives. Researchers sponsored by the NIAID are focusing on
effective vaccines and antivirals as prioritized in the national
strategic plan, which calls for pandemic vaccine within 6 months of
detection, as well as enough antiviral treatment. Scientists supported
by the NIAID have completed a successful clinical trial of an
experimental inactivated H5N1 influenza vaccine. Research efforts in
the DHHS Plan also include the development of new vaccine delivery
systems and higher capacity cell-based production methods. Recent
advances supported by the NIAID include the institute's Influenza
Genome Project, collecting to date the full genomic sequences of more
than 830 influenza viral isolates from human patients and building a
repository databank for use by other scientists.
progress against infectious diseases
There are numerous research programs at the NIH that battle a long
and growing list of infectious diseases which deserve increased
support. Biomedical research consistently yields new ways to treat or
prevent diseases. The following are just a few examples of new science
advances:
Scientists supported by the NIAID have collaborated to develop a
tissue culture cell system in which the whole hepatitis C virus can be
grown, which will allow researchers to better understand how Hepatitis
C Virus (HCV) replicates and causes infection. HCV is a major cause of
chronic liver disease with over 170 million infected people worldwide
and can progress to cirrhosis of the liver, leading to liver cancer and
failure. Two studies by the NIAID have shown that anti-cancer drugs
show promise as potential antiviral drugs and merit further
exploration. A vaccine to protect adults and adolescents against
illness due to Bordetella pertussis infection, or whooping cough, has
proved more than 90 percent effective in a large-scale clinical trial,
which could help stem the increase in pertussis cases in the United
States. The NIAID has supported a clinical trial of a vaccine against
pneumococcal disease, which is a major cause of illness and death in
children worldwide.
Biomedical research must remain focused on major killers like HIV/
AIDS, tuberculosis and malaria, which together are responsible for more
than 5 million deaths each year. Despite extensive prevention programs,
an estimated 14,000 people are newly infected with HIV daily. Twenty-
five years after physicians first described AIDS as a new disease, more
than 40 million people are living with HIV. The bacterium that causes
TB currently infects about one-third of the world's population. Multi-
drug resistant (MDR) TB increased 13.3 percent in the United States
from 2003 to 2004, the largest single year increase in MDR TB since
l993, presenting significant challenges to treatment and control of TB
in the United States and abroad. Extensively drug-resistant (XDR) TB
has increased in the industrialized nations from 3 percent of MDR TB
cases in 2000 to 11 percent in 2004. Two new engineered TB vaccines
developed with support of the NIAID have entered clinical trials and a
number of TB drug candidates are ready for clinical testing. Scientists
continue to pursue a wealth of genomic data to understand malaria
pathogenesis and to uncover new molecular targets for both drugs and
vaccines for malaria which has an incidence of 300 to 500 million cases
a year.
The NIAID funds extensive, multifaceted programs focused on these
devastating diseases. In the past year, advances include: the new
Center for HIV/AIDS Vaccine Immunology to address what is proving to be
the very difficult task of finding HIV vaccines, with clinical sites in
England, Africa, and three U.S. States; a clinical trial of two topical
microbicides to assess effectiveness in stopping HIV transmission; and
detection of a cellular protein that helps the tuberculosis microbe
resist standard antimicrobials.
emerging diseases and biodefense research
A world influenced by rapid transit and global markets challenges
not just U.S. competitiveness, but also our public health networks and
our national sense of security. We no longer can view far-flung disease
outbreaks as remote or theoretical threats to our well-being. The
administration has requested $1.9 billion in fiscal year 2007 funding
for the NIH's biodefense efforts in recognition that the ability to
counter bioterrorism depends on progress in biomedical research and the
support of scientific capacity to respond to new biological threats. In
2005, the NIAID awarded two additional grants to research consortia
aimed at new vaccines, therapies, and diagnostics, completing a
national network of 10 Regional Centers of Excellence for the NIAID
Biodefense and Emerging Infectious Diseases Research program. Research
targets include anthrax, plague, smallpox, West Nile fever, botulism,
hantaviruses, viral hemorrhagic fevers and many other less-common
diseases. The NIAID also began clinical trials of an experimental DNA
vaccine against the West Nile virus, which first appeared in the United
States in 1999; two NIAID-supported teams identified how Nipah and
Hendra viruses attack human and animal cells, both emerging viruses
that cause serious respiratory and neurological disease; and NIAID
researchers and their university partners determined which host-cell
enzymes Ebola viruses can hijack to infect humans.
conclusion
To sustain the pace of research discovery, we must continue to
enhance the research capacity and productivity of the Nation's
biomedical research enterprise. We must be prepared for the predictable
diseases and build sufficient research capacity to detect and respond
quickly to unexpected health threats. The 2002-2003 outbreak of Severe
Acute Respiratory Syndrome (SARS) is a prime example of this balance, a
rapid international response occurred to the sudden reality of a novel
pathogen, which spread to more than two dozen countries. Biomedical
scientists drew upon vast reserves of earlier viral research and
quickly developed three distinct SARS vaccines now being evaluated,
with the first human clinical trial opening just 21 months after SARS
appeared as a new disease. Increased funding for biomedical research
will strengthen our public health preparedness, our technological
competitive edge and our ability to improve the quality and length of
life for people. We urge Congress to provide at least a 5 percent
increase for the NIH budget for fiscal year 2007 to help accomplish
these goals.
______
Prepared Statement of the American Society for Microbiology
The American Society for Microbiology (ASM) is submitting the
following statement in support of increased funding for the Centers for
Disease Control and Prevention (CDC) in fiscal year 2007. The ASM is
the largest single life science society with over 42,000 members who
are involved in research and diagnostic testing in university,
industry, government and clinical laboratories.
The fiscal year 2007 budget request would reduce funding for the
CDC for the second year in a row. Excluding one-time emergency funding
items, CDC core programs would be cut over 4 percent below the fiscal
year 2006 level of funding, which was 4 percent below the fiscal year
2005 budget. In view of the CDC's critical role in protecting the
health and safety of the public, the cumulative two year reduction of
funding of over 8 percent is cause for serious concern. The ASM
recommends that Congress provide $8.5 billion plus sufficient funding
for pandemic influenza preparedness for the CDC in fiscal year 2007.
This level of funding will sustain core programs crucial to improving
public health in the United States and overseas.
The CDC works with partners in the United States and across the
globe to monitor health status and trends, detect and investigate
health problems, conduct research to enhance prevention, develop and
advocate sound health policies, and foster safe and healthy
environments. CDC capabilities must expand, not contract, as increasing
worldwide connectivity brings global health concerns to the United
States. Among the CDC's health protection goals are ``people prepared
for emerging health threats'' and ``healthy people in a healthy
world.'' Both will require continued, extensive efforts here and abroad
and clearly need sustained funding to assure success.
cdc preparedness
CDC leadership in public health requires readiness to respond to
unexpected health crises, above and beyond the Agency's ability to
guard day-to-day wellness of people. In fiscal year 2005, the CDC's
Epidemic Intelligence Service (EIS) officers responded to 66 health
outbreaks, eight of them in other countries, and personnel from the CDC
assigned to State or local health departments conducted 367 field
investigations. After Hurricane Katrina struck the Gulf Coast, the CDC
quickly provided information critical to preserving health and created
the Katrina Information Network, later called the Emergency Response
Information Network. Within two weeks, the CDC posted nearly 200
pertinent documents on its website (on infection control, first
responder and volunteer safety, environmental issues and more). A
commercial test kit for mold contamination, developed in 2003 by
scientists of the CDC and a private biotech company, became a valuable
assessment tool post-Katrina. Calls to the agency for rapid response
generally involve infectious diseases, which persist as a principal
concern of the CDC.
pandemic influenza
Within the proposed fiscal year 2007 budget, pandemic influenza is
a top-priority for funding for the CDC. The requested $188 million for
pandemic preparedness would expand the CDC's participation in the
Federal interagency National Strategy for Pandemic Influenza, the
Federal agency plan to prevent, detect, and treat outbreaks of
influenza. Since mid-2005, a virulent avian influenza virus (strain
H5N1) has been moving more rapidly from nation to nation, killing
millions of wild and domestic birds and causing concern that viral
mutations might cause human-to-human transmission. Scientists recently
found that the human virus strains responsible for three major
pandemics in the 20th century contained genetic material derived from
avian viruses. Thus far, human deaths from H5N1 have been relatively
few, but those known to be infected suffer a high mortality rate.
Globally, traditional seasonal influenza already kills 250,000 to
500,000 each year; pandemic influenza could kill many millions.
Although the H5N1 virus has not reached the United States, many health
officials consider future outbreaks in this country to be inevitable.
If viral mutations provoke a human pandemic, 15-35 percent of the U.S.
population could be affected, exacting a large number of influenza
deaths and economic losses of $71.3-$166.5 billion, according to the
CDC's estimates.
The proposed fiscal year 2007 funding for pandemic preparedness
will continue fiscal year 2006 improvements in domestic disease
surveillance, upgrades of quarantine stations at major ports of entry,
and support of global surveillance and detection activities in endemic,
epidemic, and other high-risk countries. The proposed budget would fund
new resources to increase stocks of diagnostic reagents; establish
laboratory facilities with appropriate biocontainment capabilities;
develop models and risk-assessment tools to predict disease spread;
increase seasonal flu vaccine production; establish a viral-genome
reference library; and create an electronic registry to more
effectively track, distribute and administer vaccines to the public.
The CDC would conduct studies that examine human infections of animal
influenza A viruses; an additional $2.8 million would streamline
outbreak response in countries identified as needing special
assistance; and nearly $20 million would help States administer more
seasonal influenza vaccines and thus stimulate greater vaccine
production by manufacturers.
In the past year, Federal support for the CDC's influenza
preparedness activities yielded promising testing and vaccine
development innovations. Researchers developed a laboratory test to
diagnose currently circulating A/H5 (Asian lineage) strains of
influenza in patients, which was approved this February by the Food and
Drug Administration. Using advanced molecular technology, the test
gives preliminary results within four hours, compared to two to three
days with previous testing. To more rapidly detect U.S. influenza
outbreaks, the test is being distributed to laboratories within the
national Laboratory Response Network (LRN), facilities in all 50 States
with special training in molecular testing, biosafety, and containment
procedures. The CDC also shared the new testing technology with the
World Health Organization (WHO); the CDC is one of four WHO
Collaborating Centers worldwide providing technical and logistical
expertise on pandemic influenza. Using new genetic sequence
information, scientists from the CDC also collaborated last year with
Federal and academic researchers to reconstruct the virus responsible
for an estimated 20 to 50 million people during the 1918-19 pandemic.
The virus particles are being stored at the CDC, for use in expedited
vaccine and antiviral drug development.
infectious diseases
To protect public health, the CDC has a major responsibility for
preventing and controlling infectious diseases, still a leading cause
of death and disability in this country and worldwide. The ASM is
particularly aware of the important role of the CDC in protecting
against infectious diseases. The fiscal year 2007 budget request
includes $245 million for infectious disease programs, from laboratory
research and epidemic investigations to surveillance networks, public
education programs and specialized training. Increased funding for
infectious diseases is needed not only to maintain and expand funding
for existing infectious disease problems, but also to respond to new
infectious disease threats and emergencies. The CDC must be able and
ready to respond to shifting challenges, as it has done in the past for
emerging disease outbreaks. The public clearly expects and relies on
the CDC for rapid response to disease threats and for accurate,
science-based advice on health issues. After the agency consolidated
all of its more than 40 health information hotlines and clearinghouses
into one toll-free service last March, the consumer center handled
nearly 500,000 calls during its first 9 months and continues to expand.
Preventing and controlling serious infectious diseases in the
United States depends on the CDC's scientific expertise and education
outreach tailored for specific diseases. An example is the CDC program
to prevent HIV/AIDS, sexually transmitted diseases, and tuberculosis,
an ongoing multi-faceted effort that is allotted $1.0 billion in the
administration's fiscal year 2007 request ($86 million more than fiscal
year 2006). Tuberculosis continues to be a serious threat in the United
States and worldwide, with a 13.3 percent increase in multi-drug
resistant (MDR) TB in the United States from 2003 to 2004, the largest
single year increase in MDR TB since 1993. An estimated 40,000
individuals newly acquire HIV in the United States each year and far
more effort to prevent new infections is needed. The prevalence of
anti-retroviral resistance to therapy at the time of HIV diagnosis is
also increasing rapidly and will result in dramatically increased
morbidity and health care costs if more effective efforts at prevention
are not implemented. In contrast, new pediatric HIV infections are
decreasing in number and routine prenatal HIV testing planned by the
CDC for fiscal year 2007 should decrease pediatric cases even further.
The CDC's National Plan to Eliminate Syphilis, started in 1999,
requires further support with syphilis rates among U.S. men
unfortunately increasing in the United States.
Preventive health in the United States met a major milestone last
year, when government efforts finally eliminated rubella virus, the
highly contagious agent of childhood measles. The ASM agrees with the
CDC's fiscal year 2007 budgetary emphasis on vaccination, certainly one
of the most efficient and effective methods to fight infectious
diseases. The fiscal year 2007 $2.6 billion immunization program
continues two established components to protect the Nation's children,
the Vaccines for Children program that provides vaccines free to
children in financial need (40 percent of all childhood vaccines
purchased in the United States), and the Section 317 program,
supporting State-managed immunization programs. Researchers from the
CDC recently used computer modeling to evaluate economic benefits from
this country's standard childhood immunization schedule, comprising
seven vaccines for illnesses like diphtheria, mumps, and polio. They
concluded that collectively the immunizations not only save thousands
of lives each year, but also $10 billion in direct medical costs plus
more than $40 billion in indirect costs.
The CDC's protection of American health and safety reaches beyond
national borders, facing infections that can migrate from one afflicted
population to the next through global travel and commerce.
International collaboration against pandemic influenza is a large-scale
example, but one among many such responses. Last year, experts from the
CDC worked with officials from the WHO and the Angola government to
control an outbreak of Marburg hemorrhagic fever in that African
nation, posting traveler alerts on its website and providing on-site
laboratory and field investigative services.
The proposed fiscal year 2007 budget requests $381 million for the
CDC's global health activities, to improve detection and control of
diseases such as HIV/AIDS, malaria, polio, and measles. In fiscal year
2005, the CDC program Preventing Mother-and-Child HIV Transmission
collaborated with other nations to screen 2 million pregnant women in
15 countries, giving short-course antiretroviral prophylaxis to 125,000
who tested HIV-positive. The fiscal year 2007 budget includes $122
million in direct AIDS-related funding for ongoing prevention,
treatment, and surveillance in 25 countries. From 1988 to 2004, global
polio incidence declined by more than 99 percent, saving about 250,000
lives and avoiding 5 million cases of childhood paralysis. Global
deaths due to measles fell by 48 percent between 1999 and 2004.
The National Laboratory Training Network (NLTN) is a unique
training system sponsored by the CDC and the Association of Public
Health Laboratories. The NLTN is solely dedicated to ensuring quality
laboratory practice for testing of public health significance through
relevant and timely continuing education offered in a variety of
educational venues at a reasonable cost, often at no charge. The NLTN
Continuing Education programs offer laboratories critical insights into
public health needs while also ensuring high quality, cost-effective,
and clinically relevant direct patient testing needs are met. The ASM
strongly supports the continuation of the NLTN programs though the CDC.
bioterrorism
The possibility of bioterrorism persists as a principal focus for
the CDC, and the fiscal year 2007 budget requests $1.7 billion to
support ongoing programs, the Strategic National Stockpile (SNS),
surveillance and quarantine efforts, laboratory research on high-risk
pathogens like anthrax, and assistance to State and local governments.
Since its creation in 1999, the SNS has expanded its inventory of
vaccines, drugs, and other countermeasures, preparing for health crises
like influenza pandemics, natural catastrophes like Hurricane Katrina,
and biological, chemical, radiological, or nuclear terrorist attacks.
Supplies can be delivered anywhere in the United States within 12 hours
of an event. The SNS fiscal year 2007 request of $593 million increases
the fiscal year 2006 appropriation by $70 million, nearly $50 million
of which will finance portable hospital units under the Mass Casualty
Initiative, for rapid deployment to expand local hospital capacity. The
CDC's fiscal year 2007 bioterrorism strategy also includes funding to
utilize a recent invention, a new mass spectrometry method from the
CDC's Environmental Health Laboratory for detecting botulinum toxin in
people and the Nation's milk supply within 15 seconds. The additional
funds will improve the method to more rapidly detect anthrax lethal
factor, ricin and other toxins that can be used as bioweapons, as well
as fully exploit the method's ``fingerprinting'' of suspect toxins to
determine their source.
The ASM asks Congress to recognize and support the CDC's crucial
activities by providing increased support for the CDC's core programs
and pandemic influenza preparedness.
______
Prepared Statement of the American Society of Nephrology
introduction
The American Society of Nephrology (ASN) is pleased to submit this
statement for the record to the Senate Appropriations Subcommittee on
Labor, Health and Human Services, and Education in support of the ASN's
top funding and research priorities for fiscal year 2007.
The ASN is a professional society of more than 10,000 researchers,
physicians, and practitioners who are committed to the treatment,
prevention, and cure of kidney disease. Specifically, the ASN is
committed to enhance and assist the study and practice of nephrology,
to provide a forum for the promulgation of research, and to meet the
professional and continuing education needs of its members.
The ASN statement focuses on those issues and programs that most
immediately fall under the committee's jurisdiction and assist our
members to fulfill their missions. We want to express our strong
support for advancing programs supported by the National Institutes of
Health (NIH) and Agency for Healthcare Research and Quality (AHRQ). The
ASN thanks the subcommittee for its commitment and steadfast support of
these programs.
the face of kidney disease
Kidney disease is a major health problem in the United States, and
along with Alzheimer's disease, the fastest growing cause of death in
the United States. (CDC data). It is estimated that at least 15 million
people have lost 50 percent of their kidney function without even
knowing it and suffer from Chronic Kidney Disease (CKD). Another 20
million more Americans are at increased risk of developing kidney
disease. Sub clinical kidney disease has emerged recently as a major
risk factor for CVD. The culmination of unimpeded progression is end
stage renal disease (ESRD), a condition in which patients have
permanent kidney failure, affects almost 400,000 Americans, and
directly causes 50,000 deaths annually. In the past 10 years, the
number of patients in the United States with ESRD has almost doubled.
Although the largest age group having ESRD ranges from 45-64 years old,
rates increase steadily for those between the ages of 65-74 and are
disproportionately high in African-Americans. African-Americans
represent about 32.4 percent of all patients treated for kidney failure
in the United States and the risk of ESRD for middle-age African-
American males with high blood pressure is six times that of their
Caucasian counterparts.
economic costs
Although no dollar amount can be affixed to human suffering or the
loss of human life, economic data can help to identify and quantify the
current and projected future financial costs associated with ESRD. The
2000 report of the United States Renal Data System indicates that the
total Medicare ESRD program cost will more than double, surpassing $28
billion, by 2010, as the prevalence of kidney failure is projected to
double. The annual average cost per ESRD patient is approximately
$55,000. These escalating costs serve to magnify the need to
investigate new, and better apply, recently proven strategies for
preventing progressive kidney disease.
In short, we can treat and maintain patients who have lost their
kidney function but the critical need is to prevent the loss of kidney
function and its complications in the first place. Meeting this vital
goal can only be accomplished through more concerted research and
education.
major causes of end stage renal disease
Diabetes, a disease that affects 17 million Americans, is the most
common cause of ESRD in the United States. Nearly 34 percent of all
Americans being treated for kidney failure have diabetes. Moreover,
only 18 percent of people with diabetes survive 5 years after beginning
treatment for kidney failure. With current projections that the
epidemic of obesity-related diabetes mellitus will continue to soar, a
dramatic increase in kidney disease is anticipated in the next 10
years.
Hypertension, or high blood pressure, is the next leading cause of
ESRD, accounting for 23.6 percent of ESRD patients. Similar to
diabetes, higher rates of hypertension can be found among certain age
and ethnic groups. For example, hypertension is common among African-
Americans (35 percent). It is also a disease of the aged and accounts
for 37 percent of new ESRD cases in those 65 years old and above.
Despite recent progress and discoveries regarding the major causes
of ESRD, it is among many areas of disease research that remain under-
investigated. Researchers agree that significant inroads in previously
understudied sub-fields need to be made. Significant among them, more
focus and direction need to be introduced into the general field of
renal research and patient and physician education. These pressing
factors provided the impetus for an informal dialogue on the resulting
calls to action.
lack of public awareness
A major problem with kidney disease is that it is largely a
``Silent Disease''. In fact, of the 15 million Americans who have lost
at least half of their kidney function, the vast majority have no
knowledge of their condition. While people with chronic kidney disease
may not show any symptoms, this does not mean that they are not going
to have long-term damage to their kidney function, requiring dialysis
or a transplant. These people may also be especially vulnerable to
cardiovascular disease. If these 15 million people were identified
early, there are new therapies, particularly special blood pressure
drugs known as ACE inhibitors, which could be prescribed with
potentially significant benefits. In addition, vigorous treatment of
hypertension and other complications that cause illnesses and loss of
productivity could be administered to the patients.
Given the cost to human life and to the Federal Government caused
by ESRD specifically, as well as other forms of kidney disease, we urge
this subcommittee to provide funding increases for kidney disease
research.
kidney disease research
National Institutes of Health (NIH)
The ASN applauds Congress and members of the subcommittee for
leading the bipartisan effort to double our investment in promising
biomedical research supported and conducted by the NIH. NIH has served
as a vital component in improving the Nation's health through research,
both on and off the NIH campus, and in the training of research
investigators, including nephrology researchers. Strides in biomedical
discovery have had an impact on the quality of life for people with
kidney disease. If we are to sustain this momentum and translate the
promise of biomedical research into the reality of better health, this
Nation must maintain its commitment to medical research. We support the
recommendation of the Ad-Hoc Group for Medical Research Funding to add
5 percent in fiscal year 2007 to the NIH budget for a total of $29.750
billion.
In fiscal year 2007, the NIH budget must grow by 3.5 percent, or
nearly $1 billion, just to keep pace with inflation. Further, the NIH
has ambitious plans for new initiatives to combat the health challenges
of the future. To ensure that NIH's momentum is not further eroded, and
to continue the fight against the diseases and disabilities that affect
millions of Americans, the ASN will work with the administration and
the Congress to seek an NIH budget of at least $30 billion for fiscal
year 2007.
National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK)
Many recent advances have been made in our understanding into the
causes and progression of renal failure, such as: how diabetes and
hypertension affect the kidney and the mechanisms responsible for acute
renal failure.
Despite these advances, the number of people with renal failure and
the numbers who die of renal failure continue to increase each year.
Most alarming is the significant increase in diabetes, the most common
cause of chronic kidney failure, and its relationship to kidney
disease. The ASN believes the rising incidence and prevalence of
diabetes-related kidney disease warrants additional recourses to
improve our understanding of the relationship between kidney disease
and diabetes.
The NIDDK sponsors a number of activities that researchers hope
will lead to improved detection, treatment and prevention of kidney
disease and chronic kidney failure. To ensure ongoing kidney disease
and kidney disease related research and important clinical trials
infrastructure development we recommend a 5 percent increase for the
NIDDK over fiscal year 2006 levels.
asn research goals & recommendations for kidney disease
In the fall of 2004, the ASN conducted a series of research
retreats to develop priorities to combat the growing prevalence of
kidney disease in the United States. The ASN joined experts, both
within and outside the renal community, and identified five areas
requiring attention: acute renal failure, diabetic nephropathy,
hypertension, transplantation, and kidney-associated cardiovascular
disease.
The final research retreat report(s) highlighted priorities and
contained three overriding recommendations. Theses include:
1. Development of Core Centers for kidney disease research
Expansion of the kidney research infrastructure in the United
States can be achieved by vigorous funding of a program of kidney
research core centers. Specifically, we propose that the number of
kidney centers be increased with the goal of providing core facilities
to support collaborative research on a local, regional and national
level. It should be emphasized that such a program of competitively
reviewed kidney core centers would facilitate investigator-initiated
research in both laboratory and patient-oriented investigation. This
approach is highly compatible with the collaborative research
enterprise conceived in the NIH Road Map Initiative.
2. Support programs/research initiatives that impact the understanding
of the relationship between renal and cardiovascular disease
It is now well recognized that chronic kidney dysfunction is an
important risk factor for the development of cardiovascular disease. It
is recommended that the NIDDK and NHLBI work cooperatively to support
both basic and clinical science projects that will shed light on the
pathogenesis of this relationship and to support the exploration of
interventions that can decrease cardiovascular events in patients with
CKD. Thus, we specifically propose that NHLBI should support
investigator-initiated research grants in areas of kidney research with
a direct relationship to cardiovascular disease. Similarly, NHLBI
should work collaboratively with NIDDK to support the proposed program
of kidney core research centers.
3. Continued support and expansion of investigator initiated research
projects
In each of the five subjects there are areas of fundamental
investigation that require the support of investigator initiated
projects, if ultimately progress is to be made in the understanding of
the basic mechanisms that underlie the diseases processes. It is
recommended that there should be an expansion of support for research
in the areas that lend themselves to this mechanism of funding, by
encouraging applications with appropriate program announcements and
requests for proposals. In addition to vigorous support for RO1 grants,
continued funding of Concept Development and R21/R33 grants is
essential to support development of investigator-initiated clinical
studies in these areas of high priority. Such funding is critical to
accelerate the transfer of new knowledge from the bench to the bedside.
In summary, the ASN foresees the following important directions in
the future of kidney disease research:
--Continued research in acute renal failure, diabetic nephropathy,
hypertension, transplantation, and kidney-associated
cardiovascular disease;
--The establishment of core centers for kidney disease research;
--Persistent attention to the relationship between kidney disease and
hypertension and collaboration between NIDDK and NHLBI;
--Expansion of investigator initiated research projects.
The ASN will strive to fulfill its mission statement and research
recommendations (agenda). The ASN will remain active on Capitol Hill
and assist members of Congress and the administration in their
understanding of kidney disease and problems facing CKD and ESRD
patients and the health care providers who serve them.
Agency for Health Care Research and Quality (AHRQ)
Complementing the medical research conducted at NIH, the AHRQ
sponsors health services research designed to improve the quality of
health care, decrease health care costs, and provide access to
essential health care services by translating research into measurable
improvements in the health care system. The AHRQ supports emerging
critical issues in health care delivery and addresses the particular
needs of priority populations, such as people with chronic diseases.
The ASN firmly believes in the value of AHRQ's research and quality
agenda, which continues to provide health care providers, policymakers,
and patients with critical information needed to improve health care
and treatment of chronic conditions such as kidney disease. The ASN
supports the Friends of AHRQ recommendation of $440 million for AHRQ in
fiscal year 2007.
conclusion
Currently, there is no cure for kidney disease. The progression of
chronic renal failure can be slowed, but never reversed. Meanwhile,
millions of Americans face a gradual decline in their quality of life
because of kidney disease. In many cases, abnormalities associated with
early stage chronic renal failure remain undetected and are not
diagnosed until the late stages. In sum, chronic renal failure requires
our serious and immediate attention.
As practicing nephrologists, ASN members know firsthand the
devastating effects of renal disease. ASN respectfully requests the
subcommittees' continued support to enable the nephrology community to
continue with its efforts to find better ways to treat and prevent
kidney disease.
Thank you for your continued support for medical research and
kidney disease research. To obtain further information about ASN,
please go to http://www.asn-online.org or contact Paul Smedberg, ASN
Director of Policy & Public Affairs at 202-416-0646.
______
Prepared Statement of the Association of Academic Health Centers
The Association of Academic Health Centers (AAHC) is pleased to
submit this statement for the record with its fiscal year 2007
appropriations recommendations for a number of essential programs that
are critical to improving health and health care delivery in our
Nation.
The AAHC, the national organization representing almost 100
academic health centers, is dedicated to improving the Nation's health
care system by mobilizing and enhancing the strengths and resources of
the academic health center enterprise in health professions education,
patient care, and research. An academic health center consists of an
allopathic or osteopathic medical school, one or more other health
professions schools or programs, and one or more owned or affiliated
teaching hospitals, health systems, or other organized health care
services. Our member institutions have enormous impact on their
regions, the Nation, and the global economy.
the research enterprise
AAHC member institutions are the infrastructure of the Nation's
research enterprise. Academic health center researchers in both the
basic and clinical sciences are pushing the bounds of science to
advance progress in the diagnosis and treatment of myriad diseases and
chronic illnesses. In addition, our institutions are engaged in a broad
range of health services research contributing to improvements in the
organization, financing, and delivery of health services.
Our key partner in the nation's research achievements is the
National Institutes of Health (NIH), which throughout its history has
provided the necessary funding for basic science research and a wide
array of projects to test clinical applications. Maintaining NIH's
capabilities to carry out investigator-initiated research is absolutely
critical to ensure that the Nation advances in health care, sustains
the education and advancement of highly trained scientists, and builds
the infrastructure for the conduct of research across the country. We
believe that America's preeminence in science and its leading position
in our global economy are tied closely to the Nation's investment in
its research enterprise through the NIH.
Over the past 3 years, increases in appropriations for the NIH have
not kept pace with inflation. In fact, the administration's current
proposal to freeze the NIH budget at a level that is more than 11
percent below the 2003 funding level in constant dollars can only be
viewed as threatening to the Nation. The practical effect of such
funding is that NIH cannot sustain its ongoing efforts and at the same
time support promising new research. The opportunity costs in terms of
our capacity to reduce the burden of illness and improve patient
outcomes are enormous. Disrupting ongoing research projects or failing
to support promising new proposals is, in the long run, more costly
than any short-term budget savings. The cost will be counted by the
missed opportunities to mitigate or cure many conditions, reducing the
quality of life for people throughout the world.
We believe that the Congress must renew its commitment to the
research enterprise, even in these times of budgetary restraint.
Failure to do so means that with each passing year the NIH will support
less internal and extramural research. We are very pleased that the
Senate Budget Resolution for fiscal year 2007 provides for a $7 billion
increase in overall discretionary dollars for health and education
programs, including an assumption of at least $1 billion for the NIH.
We are very grateful for the leadership of Senators Specter and Harkin
who proposed an amendment to increase funding and argued persuasively
for making this investment in the future of biomedical research. We
strongly recommend that funding for the NIH in fiscal year 2007 be
increased at least 5 percent or no less than the funding provided in
fiscal year 2005 to prevent further erosion of its purchasing power.
the health professions workforce
The health workforce must be viewed as a cornerstone of our
Nation's well being. The health professions not only treat and care for
patients but also represent an economic engine for the country.
Unfortunately, the supply of health professionals is threatened. By
most estimates, there are an insufficient number of health
professionals to meet current and future demands. It has been estimated
that the Nation will need approximately 3.5 million health care workers
in addition to the 2 million workers to replace those who leave the
workforce.
Further, the geographic maldistribution of health professionals--
especially primary care physicians and other non-physician
practitioners--leaves large numbers of Americans without access to care
with as many as 50 million people living in communities officially
designated as health professions shortage areas. Of particular concern
are estimated shortages in dentistry, medicine, nursing, pharmacy, and
an array of allied health professionals that will likely increase with
an aging population and potentially less migration of health
professionals throughout the world.
The health and economic prosperity of the Nation depend on an
effective and well-trained health workforce. Key to ensuring an
adequate supply is investment in the educational programs and the
students who are pursing careers in the health professions. Moreover,
these educational programs need to increasingly attract students who
will practice in underserved areas--both during their training and
afterward. At the same time, continuing education and distance learning
programs must be maintained to connect practitioners with advances in
care and provide opportunities for consultation and referral.
Strengthening the health care delivery system in underserved areas is
key to our efforts to improve the health of the Nation and eliminate
the disparities in health outcomes that result from inadequate access
to care.
The cornerstone of efforts to address the maldistribution of health
professionals, to train a diverse health professions workforce, and to
promote access for elderly and other vulnerable populations has been
the programs authorized under Title VII of the Public Health Service
Act. These programs include targeted scholarships for disadvantaged
students; initiatives at the secondary school level to prepare students
for college-level programs in the allied health professions; direct
support for programs in pharmacy, dentistry, geriatrics, pediatrics,
and other primary care disciplines; and Area Health Education Centers
and Health Education and Training Centers. In addition, Title VIII
funds for nursing have been especially important in helping to address
widespread and persistent shortages and to develop programs for much
needed advanced practice nurses, including the faculty to direct these
programs. Support for health professions programs has been unstable
and, in the case of Title VII, was cut more than half this year--from
$252 million in fiscal year 2005 to $99 million in fiscal year 2006.
It is also important to note that cutting support for health
professions education is likely to undermine current efforts to
significantly expand community health centers. Staffing for these
centers relies on primary care practitioners in the disciplines that
are the focus of many of the programs in Titles VII and VIII. A recent
study published in The Journal of the American Medical Association
(March 1, 2006; Vol. 295, No. 9) found that workforce shortages ``may
impede the expansion of the U.S. community health center safety net,
particularly in rural areas.'' The study also recommends that funding
for Title VII be bolstered as this is ``the only Federal program that
exists to encourage the production of primary care clinicians likely to
practice in underserved areas . . .''
Reports from the member institutions of the AAHC confirm the
adverse impact of further reductions in funding for Title VII. For
example, at the University of Nebraska Medical Center, Title VII grants
totaling $3.2 million were received in fiscal year 2005. These grants
support the placement of behavioral health professionals in more than
140 rural and other underserved settings providing over 5,000 annual
behavioral health visits.
In addition, the Nebraska Geriatric Education Center, supported by
a Title VII grant, plays a key role in training professionals to meet
the needs of older patients while at the same time expanding access to
care for this population. Finally, the School of Allied Health and the
primary care medicine programs at the University of Nebraska Medical
Center depend on Title VII grants to increase the diversity of their
student population and to provide teaching opportunities in sites
serving rural and other underserved communities.
Without continuing support from Title VII grants, California health
professions training programs could lose approximately $18 million
annually. Statewide programs in California train physicians to work in
underserved areas such as rural and inner city clinics, teach medical
Spanish and cultural awareness skills to health professionals, and work
with community health workers in low-income neighborhoods to teach
self-help skills to patients with diabetes and asthma.
In North Carolina more than $12.5 million in Title VII grants were
distributed to the University of North Carolina at Chapel Hill, Duke
University, and Wake Forest University. These funds are used to train
primary care physicians, dentists, geriatric specialists, physician
assistants, and others. These programs have helped to recruit a diverse
cadre of students as well as support the work of Area Health Education
Centers which are linked to the universities and provide essential
access to care in underserved areas.
These are just a few examples of the valuable work that results
from the Federal funding of Title VII. The administration's
recommendations would virtually eliminate funding for these programs.
Leaders of academic health centers nationwide confirm that these
programs have made a difference in the nation's health. The Nation's
return on its investment is clear. Title VII has succeeded in (1)
supplying a workforce to serve populations in need, (2) enabling
institutions and communities to recruit a diverse workforce, and (3)
expanding access to care for many of the Nation's most vulnerable
individuals.
We strongly recommend that funding for Titles VII and VIII total
$550 million for fiscal year 2007. This would help to off-set the $155
million cut in place for this year and ensure that these critical
programs can continue to address the urgent need to improve the health
of our Nation.
hospital preparedness program
The continuing threats from natural and/or terrorist events require
our health system to be prepared to treat mass casualty events.
Critical emergency care and inpatient surge capacity must be available
across the country. Because of the financial condition of many public
and non-profit hospitals, the cost of capital to undertake the
necessary preparations for the treatment of large numbers of patients
is beyond their reach. These funds make it possible for hospitals to
build the infrastructure and surge capacity that is necessary to meet
unknown, but potentially large, public health emergencies.
We strongly support the administration's budget request for $474
million for the hospital preparedness program to continue progress
toward a more rapid and coherent response to these unpredictable
circumstances.
state high-risk insurance pools
The number of uninsured in America continues to grow as employers
curtail or drop group coverage and many workers are forced to forego
coverage. The AAHC has been at the forefront of efforts to address the
crisis of the Nation's uninsured. This is an urgent problem and we are
committed to supporting a range of approaches to make health coverage
more accessible and affordable.
One subset of the uninsured population involves individuals at risk
for health care coverage because of one or more pre-existing health
conditions. Some of these individuals have only been able to purchase
coverage under the auspices of State high-risk health insurance pools
because no other insurance product is available to them. State high-
risk insurance pools are a vital pathway for those who have been
excluded from the health insurance market because of their health
status.
Section 2745 of the Public Health Service Act authorizes a program
of grants to the States for the establishment and operation of
qualified high-risk health insurance pools. In the recently enacted
Deficit Reduction Act, Congress extended this program and authorized
$75 million for fiscal year 2007. Unfortunately, the President's budget
does not recommend any funding for this important program. We urge the
subcommittee to fund this grant program at the fully authorized amount
of $75 million.
We thank you for the opportunity to present our views and
recommendations regarding funding for discretionary health programs in
fiscal year 2007. Our member institutions are committed to improving
the Nation's health and well-being, and we look forward to working with
Chairman Specter and all members of the subcommittee. We are pleased to
be available to provide information and answer questions at any time.
______
Prepared Statement of the Association of American Cancer Institutes
The Association of American Cancer Institutes (AACI), representing
86 of the Nation's premier academic and free-standing cancer centers,
appreciates the opportunity to submit this statement for consideration
as the Labor-Health and Human Services Appropriations Subcommittee
plans the fiscal year 2007 appropriations for the National Institutes
of Health (NIH) and the National Cancer Institute (NCI).
america's investment in cancer research
Thirty-five years ago, a diagnosis of cancer was largely a death
sentence. Since then, our national investment in cancer research has
reaped remarkable returns, including potential cancer vaccines,
improved detection strategies, and targeted, less difficult therapies.
The last several years have been particularly exciting for science and
specifically for cancer research. Advances such as the sequencing of
the human genome and improved insights about the genetics of cancer
have led to promising new approaches to the prevention and treatment of
cancer. Today, many patients are benefiting from targeted drug
therapies, like Gleevec, Tarceva and Avastin that are more specific,
less toxic and more effective. It is the support of the Nation's cancer
research enterprise by the NCI, 80 percent \1\ of whose funds are spent
at academic research institutions across the country, that has led to
these discoveries.
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\1\ United States. Department of Health and Human Services. The
Nation's Investment in Cancer Research. 2006. (http://plan.cancer.gov/
pdf/nci_2007_plan.pdf)
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The President's 2007 budget proposal provides only level funding
for the NIH and a $40 million cut for the NCI. This is of great concern
to the Nation's cancer centers, which play a critical role in the
progress against cancer, and are major hubs of State of the art cancer
research, drug development, treatment, prevention and control. A
depleted budget for NCI directly impacts the pace of scientific
discovery and may mean that new ideas to combat cancer will go
unexplored, and the development of novel cancer therapies will be
seriously compromised. Reduced funding will also discourage the next
generation of cancer researchers leading some to choose other fields.
We are at a time of unprecedented opportunity to make a dramatic
assault on cancer, and the hard-won momentum that has been achieved in
recent years must be sustained. Otherwise, America risks losing an
entire generation of ideas that could produce possible cures for the
diseases we know as cancer.
cancer research: saving lives and money
At the Nation's cancer institutes, we have demonstrated that cancer
research saves lives. Cancer mortality rates decreased by 10 percent
between 1991 and 2001, translating to as many as 321,000 lives saved
\2\ and in 2003, the number of cancer deaths dropped for the first time
since the war on cancer began. The death rate for all cancers combined
is dropping about 1.1 percent per year, while the rate of new cancers
is holding steady.\2\ The five-year relative survival rate for all
cancers diagnosed between 1995 and 2000 is 64 percent, an increase from
just 50 percent in the mid-1970s. Thanks to prevention research and the
development of early detection technologies and new treatments, today,
nearly 10 million Americans are cancer survivors.\2\
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\2\ Statistics from the American Cancer Society.
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The financial cost of cancer is rising, but research advances help
to mitigate cancer's annual price tag, which in 2005 was estimated at
$210 billion, including $136 billion in lost productivity and over $70
billion in direct medical costs.\3\ Tamoxifen, used to treat breast
cancer, is saving $41,372 for each year of life gained in women 35 to
49 years old; $68,349 for women 50 to 59 years old; and $74,981 for
women 60 to 69 years old.\4\ The drug Cisplatin has translated to an
increase in the survival rate for testicular cancer patients. The drug
cost an estimated $56 million to develop and has already produced an
annual return of $166 million in treatment savings.\5\ That research
saves money is evident.
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\3\ Estimates from the National Heart, Lung and Blood Institute.
\4\ United States Senate. Joint Economic Committee, Office of the
Chairman, Connie Mack. The Benefits of Medical Research and the Role of
NIH. 2000. (http://jec.senate.gov)
\5\ Estimates from Lasker/Funding First. (www.fundingfirst.org)
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the nation's cancer centers: economic engines in their communities
In addition to training the future workforce for cancer care and
research, America's cancer centers themselves have direct economic
impact, both locally and nationally. It is estimated that every dollar
spent on research funding and patient activities at cancer centers
translates to $2.50 to $3 invested in the local economy.\6\ In
addition, the amount of research support and operating budgets that are
leveraged through NCI-designated cancer centers support grant (CCSG)
funding alone is striking. The total amount of research support is more
than ten times the amount generated by the CCSG grants themselves.\7\
By attracting patients from outside the community, constructing new
laboratories and clinical facilities, recruiting new faculty and staff
from outside the region who bring cutting-edge scientific, clinical and
public health expertise to work in communities, and developing
entrepreneurial opportunities in the biotech and pharmaceutical
industries, cancer research centers serve as an economic stimulus and
generate commerce in their communities.
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\6\ United States. Department of Commerce, Bureau of Economic
Analysis. Regional Multipliers: A User Handbook for the Regional Input-
Output Modeling System (RIMS II). 3rd ed. 1997.
\7\ United States. National Cancer Institute. Advancing
Translational Cancer Research: A Vision of the Cancer Center and SPORE
Programs of the Future. 2003. (http://deainfo.nci.nih.gov/advisory/
ncab/p30-p50/P30-P50final12feb03.pdf)
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united states: global leader in cancer research
The United States is a world leader in the battle against cancer
because of the Nation's past investment in cancer research, but our
competitive edge will quickly erode without continued commitment.
Sustained inquiry and scientific advancement are critical to
maintaining our competitive stature. Failure to appropriate new funds
for biomedical innovation and discovery threatens America's capacity to
compete with emerging global economies and other countries are eager to
take our place as the world's leader in biomedical research. The United
States must significantly enhance its research and technical capacity
to maintain our preeminent position.
conclusion
In summary, cancer research saves lives, saves money, stimulates
economic growth at home and enhances U.S. competitiveness abroad.
Federal investment in cancer research must remain a national priority.
America must commit to sustaining the pace of cancer-related science so
that new discoveries are translated into clinical benefit for all.
Congress has the opportunity now to take an important leadership role
in assuring that the NIH budget is increased in fiscal year 2007. We
urge your support to increase this critically important funding.
______
Prepared Statement of the Association of Independent Research
Institutes
The Association of Independent Research Institutes (AIRI)
respectfully submits this written statement for the record of the U.S.
Senate Appropriations Subcommittee on Labor, Health and Human Services,
and Education. AIRI appreciates the commitment that the members of this
Subcommittee have made to biomedical research through support for the
National Institutes of Health (NIH).
AIRI is a national organization of 86 independent, not-for-profit
research institutes that perform basic and clinical research in the
biological and behavioral sciences in 28 States. Our member institutes
are private, stand-alone research centers that set their sights on the
vast frontiers of medical science. AIRI institutes--many of which were
originally established by generous philanthropists or from spin-offs of
unique university research areas--tend to be relatively small in size,
with budgets ranging from a few million to hundreds of millions of
dollars. In addition, each AIRI institution is governed by its own
independent Board of Directors, which allows our members to be
structurally nimble and capable of adjusting their research programs to
emerging areas of inquiry. While the primary function of AIRI
institutes is research, most are also strongly involved in training the
next generation of biomedical researchers. In a testament to the
quality of research and innovative ideas that AIRI institutes bring to
the national biomedical enterprise--our institutions consistently
exceed the success rates of the overall NIH grantee pool, and receive
about 11 percent of NIH's peer reviewed, competitively awarded
extramural grants.
The doubling of the NIH budget allowed the biomedical research
community to accelerate solutions to human disease and disability. We
have blazed new trails for medical research, diving into the
intricacies of how the human body musters its defenses, and how those
responses can be evaluated, enhanced, and modified. In addition, it
helped us to realize new scientific management strategies such as
fostering interdisciplinary research and creating new robust teams of
scientists that, before the doubling, did not have scientific common
ground. These research teams navigate the fast progressing research
environment where there is an increasing need to integrate and
aggregate basic research, computational capabilities, and clinical
evidence into new cures more quickly. Further, the doubling has helped
us to redefine health and healthcare goals based on scientific
discoveries that were out of reach prior to the doubling. We now talk
about disease and health care in terms of predictive, preventative and
pre-emptive tactics.
With flexible structures that are friendly to change, AIRI
institutes are able to move amongst the new science partnerships that
will transform America's health and health care in the 21st century.
NIH has responded to the rapidly changing world by strategically
framing the next generation of biomedical research through cross-
cutting, interdisciplinary initiatives such as those supported in the
NIH Roadmap, the NIH Neuroscience Blueprint, the new Clinical and
Translational Science Award program and the new Genes, Environment and
Health Initiative. AIRI institutes are innovators poised to foster
partnerships that will nurture the collaborative environment necessary
to successfully and efficiently conduct research within these evolving
NIH frameworks.
AIRI endorses the fiscal year 2007 Ad Hoc Group for Medical
Research proposal to increase the NIH budget by five percent over the
fiscal year 2006 level. We recognize that the current budget
environment puts pressure on Congress to face difficult funding trade-
offs; however, as this subcommittee works to define priorities for the
year and set goals for the future, AIRI asks that you maintain your
long-term commitment of support for NIH and its mission. The
President's fiscal year 2007 budget would flat-fund NIH. The 5 percent
increase for NIH supported by AIRI would not only allow the agency to
sustain current programs but also invest in critical new initiatives.
This would prevent NIH from falling behind the ``Innovation Index''--
the rate of biomedical inflation as calculated in the Biomedical
Research and Development Price Index (BRDPI) plus a modest investment
in new initiatives.
Using the fiscal year 2007 BRDPI projection as a base, NIH would
require an increase of at least 3.8 percent over fiscal year 2006. AIRI
strongly believes that an increase for NIH above BRDPI is justified by
the health needs as well as current and burgeoning research
capabilities of the Nation. An increase above BRDPI would allow new
innovative ideas to be funded and would infuse existing programs to
evolve as their research findings push them to higher levels of basic
understanding, translation and clinical functionality.
AIRI also hopes that the subcommittee will support programs and
policies that foster a sustainable, biomedical research workforce. The
biomedical research community is dependent upon a knowledgeable and
skilled workforce to address current and future critical health
research challenges. The cultivation and preservation of this workforce
is dependent upon several factors, including the ability to: recruit
scientists and students globally; train researchers both in basic and
clinical biomedical research; focus on career development initiatives
to recruit and retain researchers at critical stages; support new and
young investigators; and maintain the NIH extramural investigator
salary cap at Executive Level I. By again maintaining the NIH
extramural investigator salary cap (the salary level that extramural
researchers may apply toward their NIH grants) at Executive Level I in
the fiscal year 2007 Appropriations bill, Congress will ensure that
extramural investigators' salaries are competitive with the salary
level for intramural researchers at NIH. As we work to enhance
biomedical research capabilities, we should not impose barriers that
would discourage talented people from committing to careers in
research.
In addition, AIRI urges Congress to support NIH-funded equipment
and infrastructure programs. As the investment in medical research and
the national biomedical research agenda have expanded, the need for
acquisition and modernization of laboratory equipment and
infrastructure has become critical. NIH equipment grants meet the
specific infrastructure needs of research institutions to maximize
productivity of their research grants.
Medical research is a long-term process and, in order to meet the
challenges of improving human health, we must not diminish our Federal
commitment and investment. It is essential to sustain the momentum of
NIH-funded research so that it continues to meet the goal of improving
the health of all Americans. AIRI would like to thank the subcommittee
for its important work to ensure the health of the Nation, and we
appreciate this opportunity to present recommendations concerning the
fiscal year 2007 Appropriations bill.
______
Prepared Statement of the Association of Women's Health, Obstetric and
Neonatal Nurses (AWHONN)
The Association of Women's Health, Obstetric and Neonatal Nurses
(AWHONN) appreciates the opportunity to provide comment on the fiscal
year 2007 appropriations for nursing education, research, and workforce
development programs as well as programs designed to improve maternal
and child health. AWHONN is a membership organization of 22,000 nurses,
and it is our mission to promote the health and well-being of all women
and newborns. AWHONN members are registered nurses, nurse
practitioners, certified nurse-midwives, and clinical nurse specialists
who work in hospitals, physicians' offices, universities, and community
clinics throughout the United States.
health resources and services administration (hrsa)
AWHONN recommends a minimum of $7.5 billion in funding for HRSA
AWHONN is deeply concerned by the President's budget request of a
$255 million cut in fiscal year 2007 to HRSA. Through its many programs
and new initiatives, HRSA helps countless individuals live healthier,
more productive lives. In this day and age, rapid advances in research
and technology promise unparalleled change in the Nation's health care
delivery system. HRSA could be well positioned to meet these new
challenges as it continues to provide for the Nation's most vulnerable
citizens. In order to respond to these challenges, AWHONN asserts that
HRSA will require an overall funding level of at least $7.5 billion for
fiscal year 2007.
title viii--nursing workforce development programs under hrsa
AWHONN recommends a minimum of $175 million in funding for Title VIII
Nursing workforce development programs are authorized under Title
VIII of the Public Health Service Act. These programs are essential
components of the American health care safety net, which brings
critical services to our entire Nation. In addition, Title VIII
programs are the only comprehensive Federal programs that provide
annual funds for nursing education that help nursing schools and
nursing students prepare to meet patient needs in a changing healthcare
delivery system. These programs are also in institutions that train
nurses for practice in medically underserved communities and Health
Professional Shortage Areas. While the President's budget recommends
level funding of Title VIII at $150 million for fiscal year 2007,
AWHONN supports a minimum of $175 million in funding for Title VIII
Nursing Workforce Development programs.
In 2002, Congress enacted the Nurse Reinvestment Act that provides
funding for new and expanded programs such as scholarship and repayment
programs like the Nurse Education Loan Repayment Program (NELRP),
career ladders, internships and residencies, retention programs, and
faculty loans designed to encourage students to consider nursing, keep
nurses in the field, and ensure that nurse educators are plentiful
enough to educate future nurses that we desperately need. These new
programs received an initial appropriation of $20 million in fiscal
year 2003, which was in addition to $93 million in funding provided for
existing Title VIII programming. Unfortunately, due to limited funding
in the first 2 years of the new authorization, the loan and scholarship
programs have not been as successful as they could be in providing
support to students in nursing schools. For example, NELRP is a
competitive program that repays 60 percent of the qualifying loan
balance of registered nurses selected for funding in exchange for 2
years of service at a critical shortage facility. In fiscal year 2005,
HRSA made a total of 599 awards of this nature with an obligation of
$19 million. These loans are imperative for continuing to bring nurses
into underserved communities in addition to bringing nurses through
their education and training years.
Nurses are essential health care providers, and the nursing
community seeks the support of this subcommittee for bolstering
existing nursing programs and creating new ones for recruiting students
into the nursing profession. In addition, AWHONN seeks development of
qualified faculty members for educating new nurses, and we need to
create career opportunities for retaining nurses as faculty. The entire
nursing workforce needs strengthening. As a result, it will take long-
term planning and innovative initiatives at the local, State, and
Federal level to assure an adequate supply of a qualified nurse
workforce for the Nation. Federal investment in nursing education and
retention programs is critical for meeting the health care needs of our
Nation.
Increased funding for Title VIII will make a positive
impact on the nursing shortage
Recent data from the Bureau of Health Professions, Division of
Nursing's National Sample Survey of Registered Nurses--February 2002,
confirm that of the approximately 2.9 million registered nurses in the
Nation only 82 percent of these nurses work full-time or part-time in
nursing. A dominant factor in this shortage is the impending retirement
of up to 40 percent of the workforce by 2010. This surge in retirement
will occur at the same time as the surging baby boomer population
retires, which will noticeably cause an increase in demand for health
care services and the services of registered nurses. In addition, the
U.S. Bureau of Labor and Statistics detailed in February 2004 that
registered nurses will have the largest projected 10-year job growth in
the United States, with about 1 million new job openings by 2010.
The shortage of registered nurses and the effect of this shortage
on staffing levels, patient safety and quality care demands attention
and a significant increase in funding to bolster and improve these
programs. Nursing is the largest health profession, yet only one-fifth
of one percent of Federal health funding is directed to nursing
education. A significant increase in funding for these programs can
help lay the groundwork for expanding the nursing workforce, through
education and clinical training and retention programs.
Increased funding for Title VIII will help fill the nursing
gap
The nursing shortage is not confined solely to care providers, and
this demand for providers is hindered by the growing shortage of
nursing faculties. Nursing faculty continues to decrease in number.
According to a 2005 survey on faculty vacancies from the American
Association College of Nursing, the number of full-time nursing faculty
required to ``fill the nursing gap'' is approximately 40,000.
Currently, there are less than 20,000 full-time nursing faculty in the
system. In 2004, nursing schools turned away more than 32,000 qualified
applicants to entry-level baccalaureate and graduate nursing programs
due to insufficient faculty, clinical sites, classroom space, clinical
preceptors, and budget constraints, including almost 3,000 students who
could potentially fill faculty roles. When all nursing programs are
considered, the number turned away during the 2003-2004 academic year
grows to more than 125,000 qualified applicants. Without sufficient
support for current nursing faculty and adequate incentives to
encourage more nurses to become faculty, nursing schools will fail to
have the teaching infrastructure necessary to educate and train our
next generation of nurses that we so desperately need.
While the capacity to implement faculty development is currently
available through Section 811 and Section 831, adequate funding and
direction is needed to ensure that these programs are fully
operational. Options to provide support for full-time doctoral study
are essential to rapidly prepare the nurse educators of the future.
AWHONN recommends that a portion of the funds be allocated for faculty
development and mentoring.
Increase funding for Title VIII will encourage advance
practice nursing.
AWHONN recognizes the importance of the investment in advanced
practice nursing programs. As in other professions, the advanced degree
has become a necessary achievement for career advancement, and
registered nurses who pursue the MSN degree are part of the cadre of
nurses who go on to become faculty. Our Nation needs more nurses with
basic training to enter the field, but focusing only on these nurses
addresses only half the problem. The nursing shortage encompasses
nursing faculty; both advanced practice nursing and basic nursing must
receive additional funding but not one at the expense of the other.
title v--maternal and child health bureau (mchb) under hrsa
AWHONN recommends $850 million in funding for MCHB
The Maternal and Child Health Bureau incorporates valuable programs
like the Traumatic Brain Injury program, Universal Newborn Hearing
Screening, Emergency Medical Services for Children and Healthy Start,
which were zeroed out, and the Maternal and Child Health Block Grant
(MCH) that was level funded. These programs provide comprehensive,
preventive care for mothers and young children, as well as an array of
coordinated services for children with special needs. In fact, MCH
serves over 80 percent of all infants in the United States, half of all
pregnant women, and 20 percent of all children.
Restore Funding to the Universal Newborn Hearing Screening
The Children's Health Act of 2000 authorized funding for grants and
programs to improve State-based newborn screening. Newborn screening is
a public health activity used for early identification of infants
affected by certain genetic, metabolic, hormonal or functional
conditions for which there are effective treatment or intervention.
Screening detects disorders in newborns that, left untreated, can cause
death, disability, mental retardation and other serious illnesses.
Screening programs coordinated through MCHB help to ensure that
every baby born in the United States receives, at a minimum, a
universal core group of screening tests regardless of the State in
which he or she is born. However, the administration again proposes
eliminating universal newborn screening programs. It goes without
saying that more disorders will go unnoticed if the affected newborns
are not screened. AWHONN encourages the subcommittee to restore funding
to the fiscal year 2006 level plus inflation for the newborn hearing
screening program.
national institutes of health (nih)
AWHONN recommends $29.75 billion in funding for the NIH
Multiple institutes housed under the National Institutes of Health
(NIH) serve valuable roles in helping promote the importance of nursing
in the health care industry along with the health and well-being of
women and newborns. While AWHONN applauds the doubling of NIH's budget
over the years, the President's Budget signals a level funding of NIH
programs for fiscal year 2007. By allowing level funding, America will
most certainly loose its edge in biomedical research.
national institute of nursing research (ninr) under nih
AWHONN recommends $160 million in funding for NINR
The National Institute of Nursing Research (NINR) engages in
significant research affecting areas such as health disparities among
ethnic groups, training opportunities for management of patient care
and recovery, and telehealth interventions in rural/underserved
populations. This research allows nurses to continually refine their
practice and provide quality patient care.
For example, NINR research is invaluable in contributing to
improved health outcomes for women. Recent public awareness campaigns
target differences in the manifestation of cardiovascular disease
between men and women. The differing symptoms are the source of many
missed diagnostic opportunities among women suffering from the disease,
which is the primary killer of American women. Because of the emphasis
on biomedical research in this country, there are few sources of funds
for high-quality behavioral research for nursing other than NINR. It is
critical that we increase funding in this area in an effort to optimize
patient outcomes and decrease the need for extended hospitalization.
While the President's budget recommended level funding for NINR at $137
million, AWHONN requests $160 million for fiscal year 2007.
national institute of child health and human development (nichd) under
nih
AWHONN recommends $1.328 billion in funding for NICHD
The National Institute of Child Health and Human Development
(NICHD) seeks to ensure that every baby is born healthy, that women
suffer no adverse consequences from pregnancy, and that all children
have the opportunity for a healthy and productive life unhampered by
disease or disability. For example, with increased funding, NICHD could
expand its use of the NICHD Maternal-Fetal Medicine Network to study
ways to reduce the incidence of low birth weight. Prematurity/low birth
weight is the second leading cause of infant mortality in the United
States and the leading cause of death among African American infants.
AWHONN, like many organizations directly involved in programs to
improve the health of women and newborns, looks to NICHD to provide
national initiatives, such as the Maternal-Fetal Medicine Network that
assists with the care of pregnant women and babies.
national institute of environmental health sciences (niehs) under nih
AWHONN recommends $680 million for NIEHS
Research conducted by the National Institute of Environmental
Health Sciences (NIEHS) plays a critical role in what we know about the
relationship between environmental exposures and the onset of diseases.
Through the research sponsored by this Institute, we know that
Parkinson's disease, breast cancer, birth defects, miscarriage, delayed
or diminished cognitive function, infertility, asthma and many other
diseases and ailments have confirmed environmental triggers. Our
expanded knowledge, as a result, allows both policymakers and the
general public to make important decisions about how to reduce toxin
exposure and reduce the risk of disease and other negative health
outcomes.
indian health service (ihs) under the department of health and humans
services (hhs)
AWHONN recommends $5.54 billion in funding for IHS
The Indian Health Service (IHS) is the principal Federal health
care provider and health advocate for the American Indian and Alaska
Native populations. The President's budget recognizes this importance
by requesting an increase to the IHS budget of $124 million over the
fiscal year 2006 level, bringing the total to $4 billion for fiscal
year 2007. While AWHONN applauds this increase, we recommend further
increased funding for IHS to fully achieve its goals.
A recent study of Federal health care spending per capita found
that the United States spends $3,803 per year per Federal prisoner,
while spending about half that amount for a Native American: $1,914.
Per capita health care spending for the U.S. general population is
$5,065 per year. A significant increase in funding over fiscal year
2006 spending levels is necessary for the Federal government to fulfill
its responsibility to Indian Country and achieve its stated goals.
While the nursing shortage continues nationwide, IHS has been
disproportionately affected by the lack of RNs. IHS nurses are older,
with an average age of 48, and nearly 80 percent of RNs are over the
age of 40. Further, the average vacancy rate for RNs is 14 percent. IHS
administers three interrelated scholarship programs designed to meet
the health professional staffing needs of IHS and other health programs
serving Indian people. These programs are severely under-funded.
Targeted resources need to be invested in the IHS health professions
programs in order to recruit and retain registered nurses in Indian
Country.
centers for disease control and prevention (cdc) under hhs
AWHONN recommends $8.65 billion in funding for CDC
The President's budget request funds the CDC at $8.2 billion for
fiscal year 2007, a $179 million decrease over fiscal year 2006. It is
critically important to increase funding for CDC. For example, CDC has
been deeply involved in the prevention of birth defects through
programs like the Folic Acid Education Campaign and the National Center
on Birth Defects and Developmental Disabilities (NCBDDD) for over 30
years. The public health impact of birth defects is tremendous. Of the
four million babies born each year in the United States, approximately
120,000 are born with a serious birth defect. CDC funds several
programs critical to reducing the number of children born with birth
defects, including funding to States for birth defects tracking
systems. Due to lack of funds, in fiscal year 2005 CDC was only able to
fund 15 States, which were down from 28 States in fiscal year 2004.
Additional funding for these grants is needed to fund all of the States
seeking CDC assistance for these critical surveillance programs.
Overall, AWHONN urges the Subcommittee to at a minimum restore all
cuts to programs from fiscal year 2006 and adjust for inflation.
Funding the aforementioned agencies and their programs at this minimum
level will at least allow them to effectively operate and achieve their
stated mission. AWHONN thanks you for your time, and we greatly
appreciate this opportunity submit testimony on these critical areas of
funding.
______
Prepared Statement of the Charles R. Drew University of Medicine and
Science
summary of recommendations for fiscal year 2007
--Provide a 5 percent increase for fiscal year 2007 to the National
Institutes of Health (NIH) and a proportional increase of 5
percent to the individual institutes and centers, specifically,
the National Cancer Institute (NCI), the National Center for
Research Resources (NCRR), and the National Center on Minority
Health and Health Disparities (NCMHD).
--Continue to urge NCI to support the establishment of a
collaborative minority health comprehensive research center at
a historically minority institution in collaboration with the
existing NCI Cancer Centers. Continue to urge NCRR and NCMHD to
collaborate on the establishment of a minority health
comprehensive research center.
--Urge the Department of Health and Human Service, particularly the
Office of Minority Health (OMH), to support a Health
Professions Leadership Development and Support Program at
Charles R. Drew University of Medicine and Science.
Mr. Chairman and members of the subcommittee, thank you for the
opportunity to present you with testimony. Charles R. Drew University
of Medicine and Science is one of four predominantly minority medical
schools in the country, and the only one located west of the
Mississippi River. It is also one of the Hispanic serving institutions
in California.
Charles R. Drew University of Medicine and Science is located in
the Watts-section of South Central Los Angeles, and has a mission of
rendering quality medical education to underrepresented minority
students, and, through its affiliation with the University of
California Los Angeles (UCLA) at the co-located King-Drew Medical
Center, Drew provides valuable health care services to the medically
underserved community. Through innovative basic science, clinical, and
health services research programs, Charles R. Drew University works to
address the health and social issues that strike hardest and deepest
among inner city and minority populations.
The population of this medically underserved community is
predominately African American and Hispanic. Many of these people would
be without health care if not for the services provided by Charles R.
Drew University of Medicine and Science. This record of service has led
Charles R. Drew University (in partnership with UCLA School of
Medicine) to be designated as a Health Resources and Services
Administration Minority Center of Excellence.
research: a response to health disparities
Racial and ethnic disparities in health outcomes for a multitude of
major diseases in minority and underserved communities continue to
plague this Nation that was built on a premise of equality. As
articulated in the Institute of Medicine report entitled ``Unequal
Treatment: Confronting Racial and Ethnic Disparities in Health Care'',
this problem is not getting better on its own. For example, African
American males develop cancer 15 percent more frequently than white
males. Similarly, African American women are not as likely as white
women to develop breast cancer, but are much more likely to die from
the disease once it is detected. In fact, according to the American
Cancer Society, those who are poor, lack health insurance, or otherwise
have inadequate access to high-quality cancer care, typically
experience high cancer incidence and mortality rates. Despite these
devastating statistics, we still do not have the resources to try to
combat cancer in our communities.
In response to these findings and the high cancer rate in our own
community, Charles R. Drew University of Medicine and Science has been
working to build a Life Sciences Research Facility on its campus. The
Center would specialize in providing not only medical treatment
services for the community, but would also serve as a research
facility, focusing on prevention and the development of new strategies
in the fight against cancer. These strategies will be disseminated
locally and nationally to communities at risk, as well as to others
engaged in comprehensive cancer prevention programs.
The Life Sciences Research Building will provide the additional
laboratory and support space necessary for further progress and
development of innovative research in the clinical, biological, and
life sciences. The new, three story building will provide Drew with
state-of-the-art, flexible, modern biomedical and bio-behavioral
research space. The proposed structure will provide 40,000 gross square
feet, which is a significant increase over existing facilities at the
University. Current research activities will be enhanced by additional
laboratory and support space. The facility will house the Life Sciences
Institute, building upon Drew's demonstrated strengths in clinical
research, health services research, and basic science research. The
Life Sciences Research Building will allow researchers in the College
of Medicine and in the College of Allied Health to capitalize on the
explosion of knowledge in genetics and biology, epidemiology, and
health care delivery while exploring the interface between health,
social, and economic infrastructure, cultural attitudes, and
legislative policy. The Institute will play a unifying role for the
life sciences across the University by bringing researchers from a wide
array of disciplines together under one roof to collaborate in forward-
looking research aimed at improving the health and quality of life of
medically underserved and low-income communities.
Mr. Chairman, the support that this subcommittee has given to the
National Institutes of Health (NIH) and its various institutes and
centers has and continues to be invaluable to our university and our
community. The dream of a state-of-the-art facility to aid in the fight
against cancer and other diseases in our underserved community would be
impossible without the resources of NIH.
To help facilitate the establishment of the Life Sciences Research
Building at Charles R. Drew University of Medicine and Science, the
University is seeking support from the National Institutes of Health's
National Center for Research Resources (NCRR), the National Center for
Minority Health and Health Disparities (NCMHD), and the National Cancer
Institute (NCI).
health professions leadership development and support program
A Health Professions Leadership Development & Support Program is
designed to: (1) enhance faculty recruitment and retention support for
academicians providing for the supervision, instruction, and guidance
of resident physicians-in-training in underserved communities; and (2)
provide financial stability for the Office of Graduate Medical
Education (GME) to ensure the sustainability of this national priority
area.
This is a critical program for improving the minority pipeline as
outlined in the recent report by a committee chaired by former
Secretary of DHHS, Dr. Louis Sullivan titled ``Missing Persons:
Minorities in the Health Professions September 20, 2004''. This report
highlights the critical role played by institutions such as Drew
University as a major training site for minority health care
professionals and biomedical scientists. Specifically, this program
will help to support the Drew University Graduate Medical Education
program.
The Program will be used by the University to augment and/or
recruit physician leaders in Family Medicine, Pediatrics, Psychiatry,
Surgery, Internal Medicine, and Obstetrics/Gynecology in response to
the need to develop external, non-County residency rotations. The
Surgery residency program was not renewed as of 2005, however, the
University plans to reapply for a new program as part of its faculty
recruitment plans. These actions coincide with the affiliated medical
center's anticipated efforts to secure institutional approval from the
Centers for Medicare and Medicaid Services (CMS) as well as the Joint
Commission on the Accreditation of Healthcare Organizations (JCAHO).
conclusion
Despite our knowledge about racial/ethnic, socio-cultural and
gender-based disparities in health outcomes, the ``gap'' continues to
widen in most instances. Not only are minority and underserved
communities burdened by higher disease rates, they are less likely to
have access to quality care upon diagnosis. As you are aware, in many
minority and underserved communities preventive care and/or research is
completely inaccessible either due to distance or lack of facilities
and expertise. This is a critical loss of untapped potential in both
physical and intellectual contributions to the entire society.
Even though institutions like Charles R. Drew are ideally situated
(by location, population, and institutional commitment) for the study
of conditions in which health disparities have been well documented,
research is limited by the paucity of appropriate research facilities.
With your help, the Life Sciences Research Facility will facilitate
translation of insights gained through research into greater
understanding of disparities.
We look forward to working with you to lessen the burden of health
disparities and working with the Department of Health and Human
Services to address the residency training program issues at Charles R.
Drew University.
Mr. Chairman, thank you for the opportunity to present testimony on
behalf of Charles R. Drew University of Medicine and Science.
______
Prepared Statement of the Cooley's Anemia Foundation
subject
Mr. Somma's testimony thanks the subcommittee for the past support
it has shown to the Cooley's Anemia Foundation and to the patients who
are afflicted with this fatal genetic blood disease, also known as
thalassemia. He urges the Committee to restore the funding cut in the
President's budget from the Thalassemia Blood Safety Surveillance
program at CDC. He discusses the importance of funding NIH research
into this disease, particularly through NHLBI and NIDDK. He challenges
the subcommittee to challenge the NIH to find the cure for thalassemia
and, with it, for other similar diseases through a strong commitment to
gene therapy. He urges continued support for the Thalassemia Clinical
Research Network.
Mr. Chairman and Members of the Subcommittee: Thank you for the
opportunity to present this testimony to the subcommittee today. My
name is Frank Somma. I live in Holmdel, New Jersey and I am honored to
serve as the National President of the Cooley's Anemia Foundation. I
speak to you in my capacity as a volunteer. As many members of this
subcommittee know, Cooley's anemia, or thalassemia, is a fatal genetic
blood disease.
I could bog you down in a detailed scientific explanation of what
happens physiologically when the human body cannot produce red blood
cells in adequate numbers and of adequate quality to sustain life. I am
not going to do that. The important thing for members of this
subcommittee to remember about Cooley's anemia is that it is an
incurable and fatal genetic blood disease. Period.
I also understand that I can present you with five pages of single-
spaced testimony. I am not going to do that either. Instead, I am
respectfully going to address the following three issues in a clear and
succinct manner.
--The first is the immediate need to restore $2.0 million to the CDC
to fund the thalassemia blood safety surveillance network.
--The second issue is the equally critical need for this subcommittee
to commit our government to the development of a focused gene
therapy program that is designed to cure something.
--The third issue is the urgent need to restore funding to NIH to
assure the continuation of desperately needed research at NIDDK
and for the Thalassemia Clinical Research Network at NHLBI.
Blood Safety Surveillance
Mr. Chairman, when a baby is diagnosed with Cooley's anemia, or
thalassemia major, the standard of treatment is to begin that child on
blood transfusions. I want to be very clear here that the treatment is
not to give the child a blood transfusion; it is to begin a lifetime
treatment regimen of such invasive and dangerous intervention. Our
patients receive a blood transfusion every two weeks for the rest of
their lives.
Because Cooley's anemia patients are transfused so regularly, they
are the early warning system for problems in the blood supply. If there
is an emerging infection or other problem with the blood supply, it is
our patients that will get it first.
Please understand that nearly every patient over the age of 18
today who has thalassemia major also has HIV or hepatitis C as a result
of their transfusions--or did have it while they were still alive.
Blood safety is a major national issue. Surgical and trauma
patients often have no choice but to be transfused. And, it is done an
emergency basis many times. Nothing is more important to the patient at
the time of transfusion than that they can be confident that the blood
being pumped into their veins is free from infectious agents.
Utilizing the status of our patient population, the CDC has been
monitoring the overall safety of the blood supply to this Nation and is
prepared to issue an alert if a new virus or threat emerges. The blood
safety surveillance program is currently operating very effectively
through the Office of Hereditary Blood Diseases in the National Center
for Birth Defects and Developmental Disability (NCBDDD) with about $2.0
million in funding. Inexplicably, the President's budget eliminates the
program, leaving the blood supply vulnerable to contamination by new
viruses or mutated versions of old viruses, putting all Americans not
just those with Cooley's Anemia at risk.
We are respectfully requesting that the subcommittee restore this
funding to the $2.0 million level that currently exists in order to
continue to protect Americans from unnecessary infections and diseases
that may occur in the blood supply.
Gene Therapy
Mr. Chairman, it has been a long time coming, but we are here to
bring you some very good news about gene therapy. After a lot of false
starts, we can now see a pathway for scientists to follow to help turn
the promise of gene therapy into cures for single gene disorders. The
problem to this point has not been one of science; it has been one of
expectations. As a society, we forgot that science requires trial and
error and that experiments are just that--experiments.
Today, gene therapy is advancing at a rapid pace in the rest of the
world. Exciting work is being undertaken in Japan and China, in the UK
and in France. Unfortunately, it is showing less progress the United
States of America . . . and that is not right. We are the international
leaders in scientific research and, in a field like this--fraught with
financial, scientific and ethical minefields--it is essential that
America be the world leaders. We set the highest ethical and moral
standards on every one of these issues. We protect human subjects best.
It is simply too important to leave it to anyone else.
For persons with a single cell mutation disorder like thalassemia
or sickle cell disease or severe combined immune deficiency (SCID),
gene therapy holds out great promise for a cure. In fact, the CAF has
recently launched the CURE Campaign: Citizens United for Research
Excellence. The theme of the campaign is ``It is Time to Cure
Something.'' We are now learning so much about how to deliver healthy
genes to unhealthy cells that we cannot turn back--nor can we as a
Nation afford to let our friends in Europe and Asia race ahead of us in
the areas of biomedical research and gene therapy.
We hope that this Congress--speaking through this subcommittee--
will do what we have done and dare the NIH and its grantees to ``cure
something.'' You are investing nearly $29 billion of taxpayer money in
this agency that houses the ``best and the brightest'' and that funds
``the best and the brightest.'' We as Americans must never stop
striving to reach previously unimaginable heights. If that means that
we have to shake up the status quo and create a new funding mechanism,
let's do it. But let's not continue to follow the slow going
incremental'' path of the past.
We need to spend our tax dollars in a coordinated and focused
manner that will maximize the chances that we will unlock the secrets
of how to correct single gene defects. We are very close now, with an
experiment currently being conducted--in France--that may be a
breakthrough. It is time for the United States to step up and lead the
world in this life-saving area of research.
NIH and the Thalassemia Clinical Research Network
Mr. Chairman, about 5 years ago, working closely with members of
this subcommittee, the CAF convinced the NHLBI of the need to create a
clinical research network that would allow the top researchers in the
field to collaborate on desperately needed research projects using
common protocols. Today, that network is up and running and is the
focal point for thalassemia research, most of which takes place in
academic medical centers throughout the country.
However, there is a cloud hanging over this, and all other,
research at NIH. As the Biomedical Research and Development Price Index
continues to escalate, the buying power of a flat-funded NIH continues
to decrease. There would be nothing wrong with this if we had cured
thalassemia, and hemophilia, and cystic fibrosis, and all other genetic
and non-genetic diseases. But that is not the case.
There is an enormous amount of work to be done. And there is no one
else to do it but our National Institutes of Health, with the support
of our Congress and President.
I urge the subcommittee to settle for nothing less than a 5 percent
increase in funding for NIH so that the critical life saving research
that is occurring there can continue. Some of our fellow citizens don't
have another year to wait.
conclusion
As I indicated at the outset, Mr. Chairman, I am not interested in
filling the air with words. Unfortunately, I don't have the luxury of
time to do that. The Cooley's Anemia Foundation has three priorities
this year:
--Funding the blood safety surveillance program at CDC at $2.0
million;
--An enhanced focus on gene therapy designed to cure something; and,
--A five percent increase in NIH funding to continue current vital
research programs.
Mr. Chairman, every night when I watch my beautiful, smart,
talented 21 year old daughter Alicia put a needle under her skin to
infuse a drug for 8-10 hours to remove the excess iron in her system
from her bi-weekly blood transfusions, I know we can do better.
Please excuse my passion, but this is the United States of America.
I know we can prevent this disease from happening in newborns. I know
we can improve the lives of those who currently have it. And, most
importantly, I am absolutely certain we can cure it once and for all.
You don't need five pages of testimony from me to do that. You just
need to demand the very best from the very best--our scientists, our
government, the patient advocacy community and ourselves.
Thank you for your very kind attention and for all the support this
committee has shown to our patients and their families over the years.
______
Prepared Statement of the Crohn's and Colitis Foundation of America
summary of fiscal year 2007 recommendations
(1) A 5 percent increase for the National Institute of Diabetes,
and Digestive and Kidney Diseases, and the National Institute of
Allergy and Infectious Diseases.
(2) $700,000 for the National Inflammatory Bowel Disease
Epidemiological Program at the Centers for Disease Control and
Prevention.
Mr. Chairman, thank you for the opportunity to submit testimony on
behalf of the Crohn's and Colitis Foundation of America (CCFA). We
greatly appreciate your leadership and the opportunity to work with you
to improve the quality of life for our patients and families.
My name is Kenneth Edmonds and I serve on the National Board of
Trustees for the CCFA, the Nation's oldest and largest voluntary
organization dedicated to finding a cure for and to seeking to prevent
Crohn's disease and ulcerative colitis.
Through research, education and support, CCFA is committed to
improving the quality of life of children and adults affected by these
diseases, collectively known as inflammatory bowel disease (IBD). I am
one of them.
IBD is a chronic disorder that causes inflammation of the digestive
tract. It affects approximately 1.4 million Americans, 30 percent of
whom are diagnosed in their childhood. IBD can cause persistent
diarrhea, severe abdominal pain, fever, and, at times, rectal bleeding.
If complications develop, it also can lead to, among other conditions,
anemia, liver disease and colorectal cancer.
Indeed, inflammatory bowel disease can be painful and debilitating.
And, its impact is perhaps most devastating for children and
adolescents, whose diagnoses often make them stand out at a time when
they most want to fit in. Their disease can make them not only feel
different, but look different as some adolescents with IBD may have
delays in physical growth and puberty, causing them to appear younger
and smaller than their peers. But, at any age, being diagnosed with IBD
can bring change and challenge.
The news of my diagnosis came not in one, sudden rush, but rather
in a long, gradual backslide--and into a hospital bed. In retrospect, I
exhibited typical signs of IBD as early as 1993 while a student in
college. But, unfortunately, I responded to those signals like too many
adolescents and young adults--I overlooked them.
At the time, I experienced acute abdominal pain so sharp and sudden
that I would double over. These cramps often came without warning,
creating an intense urge to use the nearest bathroom. On these
occasions and others, my stools had traces of blood.
But, because I was young and active, I didn't think that much about
it. And, I certainly didn't talk about it, to anyone. I chalked these
brief episodes up to my regimen, rather than my abdomen. I figured that
I just needed to add more greens to my diet and add more hours to my
sleep.
But, by 1996, after moving to Chicago, my symptoms had become too
persistent, too serious and too severe to ignore. By the summer of that
year, I had developed sores or ulcers on my tongue, making it difficult
and painful to eat. I lost appetite and lost weight.
In addition to the persistent diarrhea and acute cramps, I also had
developed a tear (a fissure) in the lining of my anus, which caused
excruciating pain and bleeding during bowel movements. I also suffered
from severe exhaustion.
As you can imagine, this was an agonizing predicament: I was losing
weight, but could not eat. I was fatigued, but could not sleep. I had
frequent, sudden bowel movements, but they caused sharp, piercing pain.
Indeed, I had deteriorated dramatically; my condition relegating me to
somewhere between bedridden and bathroom-bound.
A misdiagnosis, three, long, withering weeks, and a plane ride
later, I found myself in the Washington Hospital Center under the care
of my uncle, a gastroenterologist here in the District. After a series
of tests, x-rays and examinations, I was diagnosed with Crohn's colitis
and prescribed medications for my symptoms. Since my hospitalization 10
years ago, I am pleased to report that the disease has been in
remission and I have enjoyed relatively good health.
But, Mr. Chairman, IBD is a life-long disease. While there are drug
therapies to treat symptoms, there is no medical cure. And, its cause
is unknown.
That's why CCFA's work has been so critical and groundbreaking.
recommendations for fiscal year 2007
(1) National Institutes of Health
In fact, CCFA has developed incredibly successful research
partnerships with the NIH, forging longstanding collaborations with the
National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK), which sponsors the majority of IBD research, and the National
Institute of Allergy and Infectious Diseases (NIAID). CCFA provides
crucial ``seed-funding'' to researchers, helping investigators gather
preliminary findings, which in turn enables them to pursue advanced IBD
research projects through the NIH. This approach led to the
identification of the first gene associated with Crohn's--a landmark
breakthrough in understanding this disease.
Mr. Chairman, CCFA's scientific leaders, with significant
involvement from NIDDK, have developed an ambitious research agenda,
titled ``Challenges in Inflammatory Bowel Disease'' that outlines and
seeks to address the many opportunities that currently exist.
Fortunately, the field of IBD is widely viewed within the scientific
community as one of tremendous potential. To help capitalize on these
opportunities, CCFA recommends that the subcommittee provide a 5
percent increase in funding for NIDDK and NIAID in fiscal year 2007.
Moreover, CCFA requests that the subcommittee encourage these two
institutes to expand their IBD research portfolios at a similar rate.
(2) Centers for Disease Control and Prevention
IBD Epidemiology Program
Mr. Chairman, CCFA estimates that 1.4 million people in the United
States suffer from IBD, but there could be many more. We do not have an
exact number due to these diseases' complexity and the difficulty in
identifying them.
We are extremely grateful for your leadership in providing funding
over the past 2 years for an epidemiology program on IBD at the Centers
for Disease Control and Prevention. This program is yielding valuable
information about the prevalence of IBD in the United States and
increasing our knowledge of the demographic characteristics of the IBD
patient population. If we are able to generate an accurate analysis of
the geographic makeup of the IBD patient population, it will provide us
with invaluable clues about the potential causes of IBD.
Unfortunately Mr. Chairman, the President has eliminated funding
for this important program in his fiscal year 2007 budget for the CDC.
CCFA encourages the subcommittee to restore support for the IBD
Epidemiology Program at last year's level of $700,000.
Once again Mr. Chairman, thank you for the opportunity to submit
written testimony
______
Prepared Statement of the Digestive Disease National Coalition
summary of fiscal year 2007 recommendations
--Provide increased funding for the National Institutes of Health
(NIH) at an increase of 5 percent over fiscal year 2006.
Increase funding for the National Cancer Institute (NCI), the
National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) and the National Institute of Allergy and
Infectious Diseases (NIAID) by 5 percent.
--Continue focus on digestive disease research and education at NIH,
including the areas of Inflammatory Bowel Disease (IBD),
Hepatitis and other liver diseases, Irritable Bowel Syndrome
(IBS), Colorectal Cancer, Endoscopic Research, Pancreatic
Cancer, Celiac Disease, and Hemochromatosis.
--$30 million for the Centers for Disease Control and Prevention's
(CDC) Hepatitis Prevention and Control activities.
--$25 million for the Center for Disease Control and Prevention's
(CDC) Colorectal Cancer Screening and Prevention Program.
Chairman Specter, thank you for the opportunity to again submit
testimony to the subcommittee. Founded in 1978, the Digestive Disease
National Coalition (DDNC) is a voluntary health organization comprised
of 23 professional societies and patient organizations concerned with
the many diseases of the digestive tract. The Coalition has as its goal
a desire to improve the health and the quality of life of the millions
of Americans suffering from both acute and chronic digestive diseases.
The DDNC promotes a strong Federal investment in digestive disease
research, patient care, disease prevention, and public awareness. The
DDNC is a broad coalition of groups representing disorders such as
Inflammatory Bowel Disease (IBD), Hepatitis and other liver diseases,
Irritable Bowel Syndrome (IBS), Pancreatic Cancer, Ulcers, Pediatric
and Adult Gastroesophageal Reflux Disease, Colorectal Cancer, Celiac
Disease, and Hemochromatosis.
Mr. Chairman, the social and economic impact of digestive disease
is enormous and difficult to grasp. Digestive disorders afflict
approximately 65 million Americans. This results in 50 million visits
to physicians, over 10 million hospitalizations, collectively 230
million days of restricted activity. The total cost associated with
digestive diseases has been conservatively estimated at $60 billion a
year.
The DDNC would like to thank the subcommittee for its past support
of digestive disease research and prevention programs at the National
Institutes of Health (NIH) and the Centers for Disease Control and
Prevention (CDC). With respect to the coming fiscal year, the DDNC is
recommending an increase of 5 percent to $30.1 billion for the National
Institutes of Health (NIH) and all of its Institutes.
Specifically the DDNC recommends
--$5.35 billion for the National Cancer Institute (NCI).
--$2 billion for the National Institute of Diabetes and Digestive and
Kidney Disease (NIDDK).
--$4.89 billion for the National Institute of Allergy and Infectious
Diseases (NIAID).
We at the DDNC respectfully request that any increase for NIH does
not come at the expense of other Public Health Service agencies.
With the competing and the challenging budgetary constraints the
subcommittee currently operates under, the DDNC would like to highlight
the research being accomplished by NIDDK which warrants the increase
for NIH.
inflammatory bowel disease
In the United States today about 1 million people suffer from
Crohn's disease and ulcerative colitis, collectively known as
Inflammatory Bowel Disease (IBD). These are serious diseases that
affect the gastrointestinal tract causing bleeding, diarrhea, abdominal
pain, and fever. Complications arising from IBD can include anemia,
ulcers of the skin, eye disease, colon cancer, liver disease,
arthritis, and osteoporosis. Crohn's disease and ulcerative colitis are
not usually fatal but can be devastating. The cause of IBD is still
unknown, but research has led to great breakthroughs in therapy.
In recent years researchers have made significant progress in the
fight against IBD. In 1998, the FDA approved the first drug ever
specifically to fight Crohn's disease, a remarkable milestone. The DDNC
encourages the subcommittee to continue its support of IBD research at
NIDDK and NIAID at a level commensurate with the overall increase for
each institute. The DDNC would like to applaud the NIDDK for its strong
commitment to IBD research through the Inflammatory Bowel Disease
Genetics Research Consortium. The DDNC urges the Consortium to continue
its work in IBD research. Given the recent advancements in treatment
for these diseases and the increased risk that IBD patients have for
developing colorectal cancer, the DDNC strongly believes that
generating improved epidemiological information on the IBD population
is essential if we are to provide patients with the best possible care.
Therefore the DDNC and its member organization the Crohn's and Colitis
Foundation of America encourage the CDC to initiate a nationwide IBD
surveillance and epidemiological program in fiscal year 2007.
hepatitis c: a looming threat to health
It is estimated that there are over 4 million Americans who have
been infected with Hepatitis C of which over 2.7 million remain
chronically infected. About 10,000 die each year and the Centers for
Disease Control and Prevention (CDC) estimates that the death rate will
more than triple by 2010 unless there is additional research,
education, and more effective treatments and public health
interventions. Hepatitis C infection is the largest single cause for
liver transplantation and one of the principal causes of liver cancer
and cirrhosis. There is currently no vaccine for hepatitis C, and
treatment has limited success, making the infection among the most
costly diseases in terms of health care costs, lost wages, and reduced
productivity. Patients who are older at the time of infection, those
who continually ingest alcohol, and those co-infected with HIV
demonstrate accelerated progression to more advanced liver disease.
The DDNC applauds all the work NIH and CDC have accomplished over
the past year in the areas of hepatitis and liver disease. The DDNC
urges that funding be focused on expanding the capability of State
health departments, particularly to enhance resources available to the
hepatitis C State coordinators. The DDNC also urges that CDC increase
the number of cooperative agreements with coalition partners to develop
and distribute health education, communication, and training materials
about prevention, diagnosis and medical management for hepatitis A, B,
and C.
The DDNC supports $30 million for the CDC's Hepatitis Prevention
and Control activities. The hepatitis division at CDC supports the
hepatitis C prevention strategy and other cooperative nationwide
activities aimed at prevention and awareness of hepatitis A, B, and C.
The DDNC also urges the CDC's leadership and support for the National
Viral Hepatitis Roundtable to establish a comprehensive approach among
all stakeholders for viral hepatitis prevention, education, strategic
coordination, and advocacy.
colorectal cancer prevention
Colorectal cancer is the third most commonly diagnosed cancer for
both men and woman in the United States and the second leading cause of
cancer-related deaths. Colorectal cancer affects men and women equally.
According to the American Cancer Society, this year alone about 135,400
individuals will be diagnosed with colorectal cancer, and of those
diagnosed 56,700 patients will die. Although colorectal cancer is
preventable and curable when polyps are detected early, a General
Accounting Office report issued in March 2000 documented that less than
10 percent of Medicare beneficiaries have been screened for colorectal
cancer. This report revealed a tremendous need to inform the public
about the availability of screening and educate health care providers
about colorectal cancer screening guidelines. In 2003, the New York
City Department of Health has recommended colonoscopy for everyone over
age 50 to prevent colorectal cancer.
The DDNC recommends a funding level of $25 million for the CDC's
Colorectal Cancer Screening and Prevention Program. This important
program supports enhanced colorectal screening and public awareness
activities throughout the United States. The DDNC also supports the
continued development of the CDC-supported National Colorectal Cancer
Roundtable, which provides a forum among organizations concerned with
colorectal cancer to develop and implement consistent prevention,
screening, and awareness strategies.
pancreatic cancer
In 2006, an estimated 33,730 people in the United States will be
found to have pancreatic cancer and approximately 32,300 will die from
the disease. Pancreatic cancer is the fifth leading cause of cancer
death in men and women. Only 1 out of 4 patients will live 1 year after
the cancer is found and only 1 out of 25 will survive 5 or more years.
Although we do not know exactly what causes pancreatic cancer, several
risk factors linked to the disease have been identified:
(1) Age: Most people are over 60 years old when the cancer is
found;
(2) Sex: Men have pancreatic cancer more often than women;
(3) Race: African Americans are more likely to develop pancreatic
cancer than are white or Asian Americans;
(4) Smoking;
(5) Diet: Increased red meats and fats; and
(6) Diabetes.
The National Cancer Institute (NCI) has established a Pancreatic
Cancer Progress Review Group charged with developing a detailed
research agenda for the disease. The DDNC encourages the subcommittee
to provide an increase for pancreatic cancer research at a level
commensurate with the overall percentage increase for NCI and NIDDK.
irritable bowel syndrome (ibs)
IBS is a disorder that affects an estimated 35 million Americans.
The medical community has been slow in recognizing IBS as a legitimate
disease and the burden of illness associated with it. Patients often
see several doctors before they are given an accurate diagnosis. Once a
diagnosis of IBS is made, medical treatment is limited because the
medical community still does not understand the pathophysiology of the
underlying conditions.
Living with IBS is a challenge, patients face a life of learning to
manage a chronic illness that is accompanied by pain and unrelenting
gastrointestinal symptoms. Trying to learn how to manage the symptoms
is not easy. There is a loss of spontaneity when symptoms may intrude
at any time. IBS is an unpredictable disease. A patient can wake up in
the morning feeling fine and within a short time encounter abdominal
cramping to the point of being doubled over in pain and unable to
function.
The unpredictable bowel symptoms may make it next to impossible to
leave your home. It is difficult to ease the pain that may repeatedly
occur periodically throughout the day. A patient can become reluctant
to eat for fear that just eating a meal will trigger symptoms all over
again. IBS has a broad and significant impact on a person's quality of
life. It strikes individuals from all walks of life and results in a
significant toll of human suffering and disability.
While there is much we don' understand about the causes and
treatment of IBS, we do know that IBS is a chronic complex of systems
affecting as many as one in five adults. In addition:
(1) It is reported more by women than men;
(2) It is the most common gastrointestinal diagnosis among
gastroenterology practices in the United States;
(3) It is a leading cause of worker absenteeism in the United
States; and
(4) It costs the U.S. Health Care System an estimated $8 billion
annually.
Mr. Chairman, much more can still be done to address the needs of
the nearly 35 million Americans suffering from irritable bowel syndrome
and other functional gastrointestinal disorders. The DDNC recommends
that NIDDK increase its research portfolio on Functional
Gastrointestinal Disorders and Motility Disorders.
gastroparesis
Gastroparesis, or paralysis of the stomach, refers to a stomach
that empties slowly. Gastroparesis is characterized by symptoms from
the delayed emptying of food, namely: bloating, nausea, vomiting or
feeling full after eating only a small amount of food. Gastroparesis
can occur as a result of several conditions; it can occur in up to 30
percent to 50 percent of patients with diabetes mellitus. A person with
diabetic gastroparesis may have episodes of high and low blood sugar
levels due to the unpredictable emptying of food from the stomach,
leading to diabetic complications. Other causes of gastroparesis
include Parkinson's disease and some medications, especially narcotic
pain medications. In many patients a cause of the gastroparesis cannot
be found and the disorder is termed idiopathic gastroparesis. Over the
last several years, as more is being found out about gastroparesis, it
has become clear this condition affects many people and the condition
can cause a wide range of symptoms of differing severity.
celiac disease
Celiac Disease is a life-long condition in which the body develops
an allergy to gluten, a protein found in wheat, barley, and rye, which
can result in damage to the small intestine. Celiac disease affects as
many as 2 million Americans. Onset of the disease can occur at any age.
The common symptoms of Celiac Disease include fatigue, anemia, chronic
diarrhea or constipation, weight loss, and bone pain. The only
treatment for celiac disease is strict adherence to a gluten-free diet.
Undiagnosed and untreated celiac disease can lead to other disorders
such as osteoporosis, infertility, neurological conditions, and in rare
cases cancer. Persons with Celiac Disease often have other associated
autoimmune disorders as well.
digestive disease commission
In 1976, Congress enacted Public Law 94-562, which created a
National Commission on Digestive Diseases. The Commission was charged
with assessing the State of digestive diseases in the United States,
identifying areas in which improvement in the management of digestive
diseases can be accomplished and to create a long-range plan to
recommend resources to effectively deal with such diseases. The
Commission's subsequent report in 1979 laid the groundwork for
significant progress in the area of digestive disease research. After
almost 25 years, however, the burden of digestive diseases among the
U.S. population remains substantial.
The DDNC recognizes the creation of the National Commission on
Digestive Diseases, and looks forward to working with the National
Commission to address the numerous digestive disorders that remain in
today's diverse population.
conclusion
The DDNC understands the challenging budgetary constraints and
times we live in that this subcommittee is operating under, yet we hope
you will carefully consider the tremendous benefits to be gained by
supporting a strong research and education program at NIH and CDC.
Millions of Americans are pinning their hopes for a better life, or
even life itself, on digestive disease research conducted through the
National Institutes of Health.
Mr. Chairman, on behalf of the millions of digestive disease
sufferers, we appreciate your consideration of the views of the
Digestive Disease National Coalition. We look forward to working with
you and your staff.
digestive disease national coalition
The Digestive Disease National Coalition was founded 25 years ago.
Since its inception, the goals of the coalition have remained the same:
to work cooperatively to improve access to and the quality of digestive
disease health care in order to promote the best possible medical
outcome and quality of life for current and future patients with
digestive diseases.
______
Prepared Statement of the Doris Day Animal League
The Doris Day Animal League represents 350,000 members and
supporters nationwide who support a strong commitment by the Federal
Government to research, development, standardization, validation and
acceptance of non-animal and other alternative test methods. We are
also submitting our testimony on behalf of the Humane Society of the
United States and The Procter & Gamble Company. Thank you for the
opportunity to present testimony relevant for the fiscal year 2007
budget request for the National Institute of Environmental Health
Sciences (NIEHS) for the fiscal year 2007 activities of the National
Toxicology Program Center for the Evaluation of Alternative
Toxicological Test Methods (NICEATM), the support center for the
Interagency Coordinating Committee for the Validation of Alternative
Test Methods (ICCVAM).
In 2000, the passage of the ICCVAM Authorization Act into Public
Law 106-545, created a new paradigm for the field of toxicology. It
requires Federal regulatory agencies to ensure that new and revised
animal and alternative test methods be scientifically validated prior
to recommending or requiring use by industry. An internationally agreed
upon definition of validation is supported by the 15 Federal regulatory
and research agencies that compose the ICCVAM, including the EPA. The
definition is: ``the process by which the reliability and relevance of
a procedure are established for a specific use.''
function of the iccvam
The ICCVAM performs an invaluable function for regulatory agencies,
industry, public health and animal protection organizations by
assessing the validation of new, revised and alternative toxicological
test methods that have interagency application. After appropriate
independent peer review of the test method, the ICCVAM recommends the
test to the Federal regulatory agencies that regulate the particular
endpoint the test measures. In turn, the Federal agencies maintain
their authority to incorporate the validated test methods as
appropriate for the agencies' regulatory mandates. This streamlined
approach to assessment of validation of new, revised and alternative
test methods has reduced the regulator burden of individual agencies,
provided a ``one-stop shop'' for industry, animal protection, public
health and environmental advocates for consideration of methods and set
uniform criteria for what constitutes a validated test methods. In
addition, from the perspective of animal protection advocates, ICCVAM
can serve to appropriately assess test methods that can refine, reduce
and replace the use of animals in toxicological testing. This function
will provide credibility to the argument that scientifically validated
alternative test methods, which refine, reduce or replace animals,
should be expeditiously integrated into Federal toxicological
regulations, requirements and recommendations.
history of the iccvam
The ICCVAM is currently composed of representatives from the
relevant Federal regulatory and research agencies. It was created from
an initial mandate in the NIH Revitalization Act of 1993 for NIEHS to
``(a) establish criteria for the validation and regulatory acceptance
of alternative testing methods, and (b) recommend a process through
which scientifically validated alternative methods can be accepted for
regulatory use.'' In 1994, NIEHS established the ad hoc ICCVAM to write
a report that would recommend criteria and processes for validation and
regulatory acceptance of toxicological testing methods that would be
useful to Federal agencies and the scientific community. Through a
series of public meetings, interested stakeholders and agency
representatives from all 14 regulatory and research agencies, developed
the NIH Publication No. 97-3981, ``Validation and Regulatory Acceptance
of Toxicological Test Methods.'' This report, and subsequent revisions,
has become the sound science guide for consideration of new, revised
and alternative test methods by the Federal agencies and interested
stakeholders.
After publication of the report, the ad hoc ICCVAM moved to
standing status under the NIEHS' NICEATM. Representatives from Federal
regulatory and research agencies and their programs have continued to
meet, with advice from the NICEATM's Advisory Committee and independent
peer review committees, to assess the validation of new, revised and
alternative toxicological methods. Since then, several methods have
undergone rigorous assessment and are deemed scientifically valid and
acceptable. In addition, the ICCVAM is working to streamline assessment
of methods from the European Union (EU) that have already been
validated for use within the EU. The open public comment process, input
by interested stakeholders and the continued commitment by the Federal
agencies has led to ICCVAM's success. It has resulted in a more
coordinated review process for rigorous scientific assessment of the
validation of new, revised and alternative test methods.
request for appropriations
On December 19, 2000, the ``ICCVAM Authorization Act'' which makes
the entity a permanent standing committee, was signed into Public Law
No. 106-545. For several years, the NIEHS has provided financial
resources to the NICEATM for ICCVAM's activities. In order to ensure
that Federal regulatory agencies and their stakeholders benefit from
the work of the ICCVAM, it is important for NIEHS to provide funding at
an appropriate level. We respectfully request a fiscal year funding
level of $4 million.
request for committee report language
The NIEHS should support the NICEATM/ICCVAM in creating a five-year
roadmap for assertively setting goals to prioritize ending the use of
antiquated animal tests for specific endpoints. While the stream of
methods forwarded to the ICCVAM for assessment has remained relatively
steady, it is imperative that the ICCVAM take a more proactive role in
isolating areas where new methods development is on the verge of
replacing animal tests. These areas should form a collective call by
the Federal agencies that compose ICCVAM to fund any necessary
additional research, development, validation and validation assessment
that is required to eliminate the animal methods. We also strongly urge
the NICEATM/ICCVAM to closely coordinate research, development and
validation efforts with its European counterpart, the European Centre
for the Validation of Alternative Methods (ECVAM) to ensure the best
use of available funds and sound science. This coordination should also
reflect a willingness by the Federal agencies comprising ICCVAM to more
readily accept validated test methods proposed by the ECVAM to ensure
industry has a uniform approach to worldwide chemical safety
evaluation.
We also respectfully request the subcommittee consider the
following report language for the Senate Labor, Health and Human
Services, Education and Related Agencies Appropriations bill:
``The Committee commends the National Interagency Center for the
Evaluation of Alternative Methods/Interagency Coordinating Committee on
the Validation of Alternative Methods (NICEATM/ICCVAM) for its
leadership role in the assessment of new, revised and alternative
scientifically validated methods for the Federal government. The
Committee also commends the National Toxicology Program (NTP) for
finalizing its `Roadmap to Achieve the NTP Vision, A Toxicology Program
for the 21st Century', which commits to `develop and validate improved
testing methods and, where feasible, ensure that they reduce, refine or
replace the use of animals' as one of its top four goals.
``The Committee directs the NICEATM/ICCVAM, in partnership with the
relevant Federal agency program offices and the NTP, to build on the
NTP Roadmap to create a 5-year plan to research, develop, translate and
validate new and revised non-animal and other alternative assays for
integration of relevant and reliable methods into the Federal agency
testing programs. In this 5-year plan the Federal agency program
offices shall be directed to identify areas of high priority for new
and revised non-animal and alternative assays or batteries of those
assays to create a path forward for the replacement, reduction and
refinement of animal tests, when this is scientifically valid and
appropriate. The Committee directs a transparent, public process for
developing this plan and recommends the plan be presented to the
Committee by November 15, 2007. Funding for developing the plan shall
be from the NIEHS and the NTP, and shall not reduce the NICEATM/ICCVAM
funding base.''
______
Prepared Statement of the Dystonia Medical Research Foundation
summary of fiscal year 2007 recommendations
--Provide increased funding for the National Institute of Health at
an increase of 5 percent over fiscal year 2006. Increase
funding for the National Institute of Neurological Disorders
and Stroke (NINDS), the National Institute of Deafness and
other Communication Disorders (NIDCD), and the National Eye
Institute (NEI) by 5 percent.
--Fiscal Year 2007 Recommendations for NIH
--NIH: $30 billion
--NINDS: $1.61 billion
--NEI: $700.4 million
--NIDCD: $412.7 million
--Continue to accelerate funding for intramural and extramural
dystonia research at NINDS.
--Continue to expand NIDCD's intramural and extramural research on
dysphonia.
--Continue to expand NEI's intramural and extramural research on
dystonia.
Chairman Specter, thank you for the opportunity to submit testimony
to the subcommittee on behalf of the Dystonia Medical Research
Foundation (DMRF). Dystonia has affected the lives of many Americans
and we are thankful to be able to provide for you our recommendations
for fiscal year 2007 Federal funding with regards to dystonia research.
Dystonia is a neurological disorder characterized by powerful and
painful involuntary muscle spasms that causes the body to twist,
repetitive jerking movements, and sustained postural deformities. There
are several different variations of dystonia, including: focal
dystonias which affect specific parts of the body, such as the arms,
legs, neck, jaw, eyes, vocal cords; and generalized dystonia, affecting
many parts of the body at the same time. Some forms of dystonia are
genetic and others are caused by injury or illness. Dystonia does not
affect a person's consciousness or intellect, but is a chronic and
progressive movement disorder for which, at this time, there is no
known cure. The Foundation estimates that some form of dystonia affects
about 300,000 people in North America.
Even though there is no known cure for dystonia, there are
treatments to lessen the severity of the symptoms of the disease such
as oral medications, botulinum toxin injections, and in some cases
surgery. Having increased access to these medical therapies is becoming
an increasing larger issue for the community as a whole.
In the past few decades, dystonia researchers have made several
exciting scientific advancements and have been able to rapidly turn
laboratory and clinical research into diagnostic examinations and
treatment procedures, directly benefiting those affected. Genetics, in
particular, is opening up a new understanding into the cause and
pathophysiology of the disorder. Thus far, 13 dystonia related genes or
gene loci have been identified. In 1997, the DYT1 gene for childhood
early onset dystonia was identified, and we now have a genetic test
available to confirm diagnosis of this particular type of dystonia.
Most recently, in 2002, the gene for myoclonus dystonia was identified.
However the community is still without a diagnostic test and
misdiagnosis still occurs too frequently.
Deep brain stimulation is a surgical procedure that was originally
developed to treat Parkinson's disease but is now being applied to
severe cases of dystonia. Deep brain stimulation has drastically
improved the lives of dozens of dystonia patients during the past few
years. Individuals who were previously bedridden by muscle spasms and
pain are able to walk without assistance, to speak clearly, to dress
themselves, to get a driver's license, to date, to travel, and to live
the life of an able-bodied person. Deep brain stimulation is currently
used primarily to treat severe cases of generalized dystonia but its
promising role in treating focal dystonias is being explored. Surgical
interventions are a crucial and active area of dystonia research.
research, awareness, and support
Now is an exciting time to be involved in dystonia research and
awareness. Researchers are becoming more interested in movement
disorders and dystonia at the National Institutes of Health (NIH), and
research is yielding promising clues for better understanding and
management of this disorder.
One way the Dystonia Medical Research Foundation has advocated for
more research on dystonia, is by funding ``seed'' grants to
researchers. Thus far the Dystonia Foundation has funded over 415
grants and fellowships totaling more than $21 million. Due to our
advocacy there are a growing number of talented researchers dedicated
to understanding the biochemistry of dystonia, genetic causes, new
therapeutics and the necessity of an epidemiology study.
Another primary goal of the Dystonia Foundation is education of
both lay and medical audiences. The Foundation conducts regular medical
workshops and patient symposiums to present, discuss, and disseminate
comprehensive medical and research data on dystonia. In January 2001,
NINDS co-sponsored a genetics and animal models meeting, designed to
involve not only prominent researchers but inviting junior
investigators to participate in the discussions. In September, 2005 NIH
funded a workshop on ``Rehabilitation in Dystonia'' at which leading
experts from neurosurgeons and neurologists to physical therapists,
psychologists, and biomedial engineers argued for more aggressive
research and the use of new concepts and tools in the treatment of
dystonia and in 2006 NIH is funding a science workshop on the dystonia
protein torsinA/Nuclear envelope. On June 6 & 7 a NINDS Research Agenda
Workshop will take place.
The Young Investigators Award Program and the Residency Program are
in place to entice emerging medical professionals into the field of
dystonia research and cultivate future dystonia experts.
Since 1995, over 10,000 educational medical videos have been
distributed to hospitals, medical and nursing schools, and at medical
conventions. In addition to medical and coping publications, we have a
children's video to educate families and increase public awareness of
this devastating disorder in younger populations. Media awareness is
conducted throughout the year, and especially during Dystonia Awareness
Week, observed nationwide from June 4 through 11. Local volunteers have
been successful in securing news stories on dystonia in local venues as
well as national media shows such as Good Morning America, The Oprah
Winfrey Show, and Maury Povich. Through his friendship with the mother
of a dystonia patient, screen star Kirk Cameron has taken an interest
in promoting dystonia awareness, and the Dystonia Foundation is in the
process of investigating the possibility of a public service
announcement and several appearances at fundraising events. In the Fall
of 2006 the new dystonia documentary entitled TWISTED will be premiered
on PBS.
The Dystonia Foundation has over 100 chapters, support groups, and
area contacts across North America. In addition, there are chairpersons
whose mission is to promote awareness, children's advocacy,
development, extension, Internet resources, leadership, medical
education, and symposiums. Furthermore, patient symposiums are held
internationally and regionally to provide the latest medical and coping
information to dystonia patients and others interested in the disorder.
dystonia and the national institutes of health
The Dystonia Medical Research Foundation recommends an increase to
$31.6 billion or 5 percent for NIH overall, and a 5 percent increase
for NINDS, and NIDCD. We at DMRF request that this increase for NIH
does not come at the expense of other Public Health Service agencies.
We also urge the subcommittee to recommend that NINDS provide the
necessary funding for additional extramural research. There is also an
imperative need for NINDS to increase its efforts to educate the public
and medical community about dystonia through co-sponsorship of
workshops and seminars. We also encourage the subcommittee to support
NIDCD in its efforts to revamp its strategic planning process by
implementing a Strategic Planning Group which will help NIDCD as they:
consider applications for high program priority; develop program
announcements and requests for applications; and develop new research
areas in the Intramural Research Program.
The National Institute of Neurological Disorders and Stroke (NINDS)
awarded eleven grants for dystonia research in response to the Program
Announcement, ``Studies into the Causes and Mechanisms of Dystonia''
(August 2002). These awards covered a wide range of research areas,
which included gene discovery, the genetics and genomics of dystonia,
the development of animal models of primary and secondary dystonia,
molecular and cellular studies inherited forms of dystonia,
epidemiology studies, and brain imaging. In addition, the National
Institute on Deafness and Other Communication Disorders (NIDCD) funded
an eighth study on brainstem systems and their role in spasmodic
dysphonia.
DMRF also supports the many intramural researchers studying
dystonia. Research includes: exploring improved clinical rating scales
for dystonia, elevations of sensory motor training, utilizing Botox as
a possible treatment for focal hand dystonia, characterization of
abnormalities in sensory regions of the brain, treatments for spasmodic
dysphonia, deep brain stimulation (the direct electrical stimulation of
specific brain targets), non-invasive transcranial brain stimulation,
anatomy imaging of the affect of dystonia on brain activity, and
exploring the link between laryngitis and spasmodic dysphonia. The
public awareness impact of pianist Leon Fleisher's treatment through
the NIH intramural research program has had a tremendously positive
impact.
NINDS continues to work with dystonia research and voluntary
disease groups in the community. In June 2005, NINDS sponsored a
workshop on spasmodic dysphonia, which was held at the NIH and was
supported by the NINDS and the NIH Office of Rare Diseases. NIH staff
are currently drafting a white paper on the results of the meeting and
future research opportunities for improving the diagnosis,
understanding the pathogenesis, developing new treatments, and
preventing spasmodic dysphonia. Another NINDS laboratory is
investigating several neurodegenerative disorders, including a form of
hereditary dystonia known as the Mohr-Tranebjaerg deafness-dystonia
syndrome. This form of dystonia is inherited through the X chromosome.
The NINDS laboratory is investigating how abnormalities in a specific
protein lead to the death of affected cells.
Dystonia is the third most common movement disorder after
Parkinson's Disease and tremor, and effects many times more people than
better known disorders such as Huntington's Disease, muscular dystrophy
and ALS or Lou Gehrig's Disease. We ask that NINDS fund dystonia-
specific extramural research at the same level that it supports
research for other neurological movement disorders.
conclusion
The ultimate goal of the Dystonia Foundation is a cure for
dystonia. Until that goal is realized, we are hungry for knowledge
about the nature of dystonia and for more effective treatments with
fewer side effects. We have amassed many exceptional and diligent
researchers; who are committed to our goal, and our top priority is
funding their very important research. But the Foundation cannot do it
alone. We need Federal support through NIH to continue to fund quality
scientific research and eliminate this debilitating disease.
Combine the thwarting of scientific progress with the decreased
access to therapies and all the progress of the last few years could be
wiped away. We ask that you aggressively support medical research,
specifically for movement disorders and brain research. By doing so,
you are doing a tremendous service for my family and myself and to the
hundreds of thousands of people and families affected by dystonia.
Thank you very much.
______
Prepared Statement of the FSH Society
Chairman Specter, Senator Harkin and members of the subcommittee, I
am Daniel Perez, President & CEO of the FSH Society. The FSH Society is
a non-profit volunteer health agency organized by patients for patients
with facioscapulohumeral muscular dystrophy (FSHD). Our purpose is to
be a resource for individuals and families with FSH muscular dystrophy
(FSHD), represent them and advocate on their behalf. On behalf of the
FSH Society and its members, thank you for this opportunity to testify.
FSHD is the third most prevalent form of muscle disease and the
second most prevalent adult muscular dystrophy. It affects 1/20,000
people. For men, women, and children the major consequence of
inheriting FSHD is a lifelong progressive and severe loss of all
skeletal muscles. The FSH Society was created because of a need for a
comprehensive resource for FSHD individuals and families. A world
leader in combating muscular dystrophy it has provided well over a
million dollars in seed grants to pioneering researchers worldwide and
created an international collaborative network of patients and
researchers. The Society relies entirely on private grants, donations
and philanthropy. Since our establishment in 1991, our major focus has
been to help facilitate Federal research agencies such as the National
Institutes of Health (NIH) grow funding and programs for FSHD research.
The Society has submitted 28 written and five oral testimonies to
Senate and House Appropriations Subcommittees on Labor, Health, Human
Services and Education on the need for more NIH funding on FSHD.
The NIH often applauds the effort and dedication of the Society in
expanding research efforts in FSHD and bringing additional attention to
this dystrophy. We commend the Director of the NIH, Dr. Elias Zerhouni,
for the significant efforts made by his agency in muscular dystrophy.
Between 1987 and 2005, the overall NIH funding for dystrophy increased
from $4.6 million to $39.3 million. Since 2000, the FSHD budget has
increased from $400,000 to $2.1 million (fiscal year 2006 estimated).
We applaud Dr. Stephen I. Katz, Director, National Institute of
Arthritis and Musculoskeletal Disorders (NIAMS) and Chairman of the
Muscular Dystrophy Coordinating Committee (MDCC), and John D. Porter,
Program Director Muscular Dystrophy, National Institute of Neurological
Disorders and Stroke (NINDS) and Executive Secretary MDCC, for their
extraordinary comprehension, accuracy and for the speed in which the
NIH Action Plan for Muscular Dystrophy was researched, compiled,
written, and approved. The NIH is making significant investments to
understand muscular dystrophy research needs and has made excellent
choices in recruiting program staff with the ability to understand the
extremely complex nature of muscular dystrophy. However, to this day,
the NIH reports difficulty in growing and expanding its FSH muscular
dystrophy research portfolio and in receiving sufficient numbers of
investigator-submitted applications of high quality.
the md-care act, public law 107-84
Congress enacted The Muscular Dystrophy Community Assistance,
Research and Education Amendments of 2001 (the MD-CARE Act, Public Law
107-84) that was signed into law on December 18, 2001. Both the Senate
and House acted with force and clarity to mandate the NIH and other
applicable Federal agencies, to immediately expand and intensify
research on all forms of muscular dystrophy. The MD-CARE Act declared
that: (1) the Director of the NIH work with the Directors of NIAMS,
NINDS and NIH National Institute of Child Health and Human Development
(NICHD) to expand and intensify research on all nine types of dystrophy
described in the Act; (2) Centers of excellence for research should be
established for all nine types of dystrophy; (3) a MDCC with two-thirds
government and one-third public members be established to coordinate
activities across NIH and other national research agencies on all forms
of dystrophy; and; (4) the MDCC to submit a research action plan for
conducting, and supporting research and education for all nine types of
dystrophy. The MD-CARE Act also requires annual updates on research
funding amounts by the Department of Health and Human Services (DHHS)
for Duchenne, Myotonic, FSHD and other muscular dystrophies.
In August 2004, the MDCC submitted an initial report for the NIH
Muscular Dystrophy Research and Education Plan to Congress which was
put through a more intensive planning process that involved external
scientific experts in the field of muscular dystrophy and muscle
disease. This detailed version of the MDCC ``Action Plan for the
Muscular Dystrophies'' was submitted to Congress in December 2005.
FSHD is prominently and well represented in the five sections of
the NIH ``Action Plan for the Muscular Dystrophies.'' Three key
sections for FSHD research are: Mechanisms Section, Research Objective
3, ``Define the molecular pathogenetic mechanisms that lead to
facioscapulohumeral muscular dystrophy''; Mechanisms Section, Research
Objective 4, ``Establish mouse (and cellular) models for
facioscapulohumeral muscular dystrophy, specific to emerging candidate
genes and/or disease genomics, to understand the epigenetic mechanisms
and for the development of novel intervention strategies''; and, the
Infrastructure Section, Research Objective 13, ``Stimulate
international collaborations and infrastructure sharing to ensure that
opportunities are exploited and resources are used to maximum
advantage, particularly in cases of novel opportunity or for the rare
and/or understudied muscular dystrophies.'' The full description and
text of research objective three in the mechanisms section illustrates
that the NIH fully comprehends what needs to be done to achieve
progress in FSHD.\1\
---------------------------------------------------------------------------
\1\ NIH Action Plan for the Muscular Dystrophies, Mechanisms
Section, Research Objective 3: ``Define the molecular pathogenetic
mechanisms that lead to facioscapulohumeral muscular dystrophy,''
December 2005.
``Defining the molecular mechanisms by which a reduction in repeats
at the D4Z4 translates into the multi-system symptoms seen in
facioscapulohumeral muscular dystrophy has been difficult. Elucidation
of the function of the allelic variants (A and B) at D4Z4 may help
advance understanding of disease mechanisms. If perturbations of
chromatin structure and/or derepression of gene expression ultimately
figure into pathogenesis, there are some other diseases that could help
inform researchers in this field. A potentially important avenue of
research is the analysis of the chromatin structure at the D4Z4 locus,
including methylation and/or binding of specific repressors or
activators. Such chromatin conformational changes have been suggested
as a possible disease mechanism, presumably affecting the regulation of
expression of other genes. Since the issue of altered regulation of
genes in the vicinity of D4Z4 remains controversial, there is a need
for careful studies using microarrays or other techniques, to determine
if genes near the D4Z4 repeat units on chromosome 4q, or at more
distant locations on this chromosome, are up-regulated or down-
regulated in facioscapulohumeral muscular dystrophy. The expression and
function of the D4Z4 gene, DUX4, should be analyzed. The association of
4qter with the nuclear lamina and the potential role of this
association upon gene expression profiles should be explored. Genetic
causes for facioscapulohumeral muscular dystrophy, other than the D4Z4
contraction (such as non-chromosome 4 linked cases), should be
investigated in available patients.''
---------------------------------------------------------------------------
It is absolutely clear that muscular dystrophy is a high priority
for the NIH and it understands the research that needs be developed,
funded and contracted. However, the dystrophies such as FSHD with
complex etiology, low prevalence or that present unique scientific
opportunity are getting far less funding than they deserve. FSHD is
clearly deficient in projects and funding caused by it being a
complicated disease with complex etiology that requires mastery to
review grants or to undertake research. In the dystrophy area, the NIH
believes that insight gained from studying a specific type of dystrophy
will provide benefit for all of the muscular dystrophies. Sadly, that
is not the case for FSHD.
nih efforts on fsh muscular dystrophy (2000-present)
NIH has supported several initiatives in recent years in dystrophy
research and training. In response to the fiscal year 2000 report
language, the NINDS, NIAMS and the NIH Office of Rare Diseases (ORD)
held a research symposium in May 2000, in Bethesda, on the cause and
treatment of FSH muscular dystrophy. The international team of
researchers and NIH staff assembled research recommendations and
directions that called for enhancing the understanding of the mechanism
and molecular process associated with FSHD, strategies for exploring
potential treatments and therapies, strategies to promote establishment
of biomaterials registries and longitudinal and population based
studies of FSHD, and a listing of required infrastructure and research
resources.
The findings of the conference on FSHD were used to create NIH
solicitations. One request focused on exploratory and high risk
research applications on FSH muscular dystrophy, and several other
announcements were made for grant applications on therapeutic and
pathogenic approaches for muscular dystrophy in which FSHD was
mentioned.
In September 2000, the NINDS and NIAMS issued a contract to
establish and fund a National Registry for Myotonic and FSH Muscular
Dystrophy based at the University of Rochester. Patients join the
registry voluntarily by providing medical and family history data. The
registry brings together FSHD patients and families seeking to
participate in research with researchers seeking patients for research
on the disorder.
Several program announcements were issued to promote large scale
clinical and translational research in muscular dystrophy, as called
for in the MD-CARE Act, called the Senator Paul D. Wellstone Muscular
Dystrophy Research Centers. One of these centers, at the University of
Rochester, focuses on myotonic and FSH muscular dystrophy. One-quarter
of this Wellstone MD CRC center focuses on the molecular pathology of
FSHD and serves as a resource for cell lines, tissue biopsies,
antibodies and data about gene expression. This Wellstone MD CRC core
at Rochester is the only funding specific for FSHD in the six Wellstone
MD CRCs.
The MD-CARE Act provides that the Wellstone MD CRC centers are not
to replace funding and projects in existing basic research portfolios.
In addition to building national infrastructure for dystrophy research,
the NIH is expanding research resources for FSHD by funding several
basic research grants related to understanding the mechanism and
pathology of FSH muscular dystrophy.
One of these grantees, Rossella Tupler, supported by the FSH
Society, helped bring about a momentous breakthrough in FSHD research.
The prestigious scientific journal Nature made an advance online
publication of ``Facioscapulohumeral muscular dystrophy in mice over-
expressing FRG1'', by Davide Gabellini and Rossella Tupler, et al., on
December 11, 2005. The Nature paper is a breakthrough on multiple
levels, it: (1) creates an animal model for FSHD; (2) points to a gene,
called FRG1, that causes FSHD; (3) identifies other genetic processes
impacted by FRG1 over-expression involved in other major adult
dystrophies; (4) shows that both the FRG1 gene and mis-expressed pre-
mRNA intermediary products can be targeted and regulated by new and
novel gene therapy techniques to correct expression levels; and (5)
gives FSHD the hard target needed in order have better success in
securing major funding from large agencies. They have demonstrated that
transcriptional modulation of a gene from the region can produce an
interesting, potentially relevant phenotype. This model can now be used
to create conditional variants and ultimately move on to look for
transcriptional suppressors of the phenotype.
The NINDS, NIAMS and NICHD support career development and training
awards for muscle biology and neuroscience through three program
announcements for domestic and foreign investigators to help create a
cadre of new scientists and researchers working on muscular dystrophy.
The NINDS, NIAMS program officers in dystrophy are working diligently
trying to help extramural researchers submit the highest quality
applications.
The NIH assisted Dr. Melanie Ehrlich of Tulane University, who was
displaced by hurricane Katrina by offering a position in the NIAMS
intramural research laboratory of Dr. Kuan Wang and granting
supplemental relief funds to salvage her FSHD research.
nih muscular dystrophy funding
However, in the 6 years since the MD-CARE Act was signed the NIH
[NIAMS, NINDS, NICHD, NHGRI] funding for FSHD remains very small. Since
2000, the overall NIH wide muscular dystrophy budget has increased from
$12.6 million to $39.0 million in fiscal year 2007 estimated. Since
2000, the FSHD budget has increased from $400,000 to $2.1 million in
fiscal year 2007 estimated. In the past year, at least five basic
research grant applications (R01s) were submitted on FSHD and none were
chosen for funding! Though the international field of FSHD researcher
is small, the researchers are absolutely top-rate, world class and
certainly competitive with other NIH grant applicants. Five
applications represents about 25-30 percent of the entire field of FSHD
researchers with the standing and experience to submit a basic research
grant. A significant amount of FSHD researchers are submitting grant
applications!
NATIONAL INSTITUTES OF HEALTH (NIH) APPROPRIATIONS HISTORY
[Dollars in millions]
----------------------------------------------------------------------------------------------------------------
FSHD FSHD
Fiscal year NIH overall MD research MD percent FSHD percent of percent of
of NIH research MD NIH
----------------------------------------------------------------------------------------------------------------
2000.............................. $17,821 $12.60 0.071 $0.40 3.18 0.0022
2001.............................. 20,458 21.00 0.103 0.50 2.38 0.0024
2002.............................. 23,296 27.60 0.118 1.30 4.71 0.0056
2003.............................. 27,067 39.10 0.144 1.50 3.83 0.0055
2004.............................. 27,887 38.70 0.139 2.20 5.67 0.0079
2005.............................. 28,494 39.50 0.139 2.00 5.06 0.0070
2006.............................. 28,428 39.3E 0.138 2.1E 5.31 0.0074
2007E............................. 28,428 39.0E 0.137 2.1E 5.38 0.0074
----------------------------------------------------------------------------------------------------------------
Source: NIH/OD Budget Office & NIH OCPL.
NIAMS has one research contract for FSHD, the National Registry for
Myotonic and FSH muscular dystrophy for $295,888 (fiscal year 2005).
Its total muscular dystrophy portfolio for fiscal year 2005 was 57
projects, including two Wellstone MD CRC components for a total of
$17,136,343. FSHD was only 1.7 percent of NIAMS fiscal year 2005
muscular dystrophy funding.
NINDS reports three research grants, one intramural grant, one
research contract, and one-quarter of a Wellstone CRC for FSHD for a
total of $1,359,930 in fiscal year 2005. The total muscular dystrophy
fiscal year 2005 portfolio reported for fiscal year 2005 was 33
projects, including two Wellstone CRCs for a total of $11,987,219. FSHD
was only 11.4 percent of NINDS fiscal year 2005 muscular dystrophy
funding.
NICHD reports that approximately ten percent of its $4,762,321
fiscal year muscular dystrophy portfolio has some broad or general
application to FSHD, but does not identify specific projects. The NICHD
reports that $400,000 was spent on FSHD. The total muscular dystrophy
fiscal year 2005 portfolio reported was 17 projects, including three
Wellstone MD CRC components for a total of $4,762,321. FSHD was only
8.4 percent of NICHD fiscal year 2005 dystrophy funding.
The NIAMS, NINDS, NICHD, and NHGRI--the four lead institutes on
muscular dystrophy--reported a combined total of 108 projects on
muscular dystrophy totaling $34,285,883 in fiscal year 2005. Of that
total amount facioscapulohumeral muscular dystrophy (FSHD) received
$1,440,555 in directly titled funds for three grants, one contract and
one-quarter of a Wellstone MD CRC.
The NIH now has six Wellstone MD CRCs, which are approximately
equivalent to 27 basic research grants (R01). One-quarter of one
Wellstone, or one R01 equivalent, has direct relevance to FSHD. Only
3.7 percent of the total Wellstone MD CRC expenditure is being spent on
the second most prevalent adult muscular dystrophy or the third most
prevalent form of muscular dystrophy affecting men, women and children.
request
Mr. Chairman and Members of the Committee, we request an
appropriation of $10 million-$12.5 million to accomplish the FSH
muscular dystrophy research plan as outlined by the NIH and submitted
to the Congress. As a start, simply examining the scope of the work
outlined in the NIH Action Plan for Muscular Dystrophy ``Mechanisms
Section, Research Objective 3: Define the molecular pathogenetic
mechanisms that lead to FSH muscular dystrophy,'' illustrates a
requirement of at least 12 to 15 basic research grants (R01s) and/or
high risk innovative research grants (R21s) that require $5 million-$6
million to adequately fund them.
We also request that the umbrella area of muscular dystrophy
receive an appropriation commensurate with similar disease areas, and
we request equity by starting with a doubling of the current $39
million to $80 million to adequately fund the NIH research plan for
dystrophy. NIH Disease Funding, Special Areas of Interest table shows
that similar umbrella areas of health burden, scope, and impact such as
Multiple Sclerosis ($109 million), Motor Neuron Disease ($57 million),
Cystic Fibrosis ($89 million), Parkinson's ($223 million), and
Huntington's ($48 million) receiving average funding levels of $105
million. Muscular dystrophy affects hundreds of thousands of
individuals, including family and friends.
We understand that the NIH overall budget went down in fiscal year
2006 to $28,428M from $28,494M and that Congress is strapped with other
priorities. Chairman Specter, thank you for the constant and consistent
support of biomedical research and for the NIH programs that offer hope
for millions of sick and dying people. Mr. Chairman, members of the
committee and members of Congress, the opportunities for FSHD research
are greater than ever. The past year brought with it several major
breakthroughs and discoveries and we are on the cusp of understanding
FSHD and a never before seen class of disease. Now that we have a very
refined plan of attack and research direction by the NIH, the need for
funding is even greater. FSHD research needs to continue unabated and
we remind you that there is no treatment or therapy for this
devastating and crippling disease.
We ask the subcommittee to appropriate in fiscal year 2007 $12.5
million for FSH Muscular Dystrophy and $80 million for Muscular
Dystrophy either as new money towards the overall NIH budget or as a
requested allocation/re-allocation of resources internally within the
NIH, to support the NIH stated plan of action to work on dystrophy. We
thank the subcommittee for this opportunity to present our views.
______
Prepared Statement of the Foster Grandparent Program
Mr. Chairman and members of the subcommittee, thank you for the
opportunity to submit this testimony in support of fiscal year 2007
funding for the Foster Grandparent Program (FGP), the oldest and
largest of the three programs known collectively as the National Senior
Volunteer Corps, which are authorized by Title II of the Domestic
Volunteer Service Act (DVSA) of 1973, as amended and administered by
the Corporation for National and Community Service (CNS). NAFGPD is a
membership-supported professional organization whose roster includes
the majority of more than 350 directors, who administer Foster
Grandparent Programs nationwide, as well as local sponsoring agencies
and others who value and support the work of FGP.
Mr. Chairman, I would like to begin by thanking you and the
distinguished members of the subcommittee for your steadfast support of
the Foster Grandparent Program. No matter what the circumstances, this
subcommittee has always been there to protect the integrity and mission
of our programs. Our volunteers and the children they serve across the
country are the beneficiaries of your commitment to FGP, and for that
we thank you. I also want to acknowledge your outstanding staff for
their tireless work and very difficult job they have to ``make the
numbers fit.''--an increasingly difficult task in this budget
environment.
NAFGPD remains concerned that the Corporation's fiscal year 2007
request does not provide any new funding where it is needed most--in
the field. All of us recognize the spending constraints placed on the
President and, most importantly on you and the Appropriations
Committee. However, in a time of such scarce Federal resources, NAFGPD
believes strongly that any new funding should flow to our programs in
the field where it is most urgently needed, not CNCS headquarters.
This fiscal year 2007 budget request follows fiscal year 2006 in
which FGP experienced a nearly $500,000 funding cut. The last time FGPs
in the field realized any increases at all to cover the increased costs
of doing business--especially in the area of transportation costs--was
in fiscal year 2005; that increase amounted to a very small .84
percent, when inflationary price increases have been averaging 2-3
percent every year. FGP programs continue to face considerable stress
in covering the rising costs of administering programs and maintaining
program quality.
NAFGPD respectfully requests two things of the subcommittee:
(1) To provide $115.929 million for the Foster Grandparent Program
in fiscal year 2007, an increase of $4.992 million over the fiscal year
2006 level. This critical funding will ensure the continued viability
of the Foster Grandparent Program, and allow for important expansion of
this unique program. Specifically, this proposal would fund a 3 percent
cost of living increase for every Foster Grandparent Program and
expansion grants to existing programs that would add 370 new low-income
senior volunteers to serve children;
(2) To maintain current appropriations statutory language that
prohibits CNCS from using funds in the bill to pay non-taxable stipend
to volunteers whose incomes exceed 125 percent of the national poverty
level. In its budget narrative, CNCS has again requested that this
language be eliminated because it stifles innovation. In fact, CNCS has
the ability to test any innovations they wish through demonstration
activities--they just cannot pay a non-taxable stipend to volunteers
whose incomes exceed 125 percent of the national poverty level.
Congress has repeatedly over the last six years disavowed this practice
and re-affirmed that the non-taxable stipend must be reserved for low-
income volunteers. We ask that you again protect the mission of the
Foster Grandparent and Senior Companion Programs--to enable low-income
older people--to serve their communities by maintaining this important
statutory language.
fgp: an overview
Established in 1965, the Foster Grandparent Program was the first
federally funded, organized program to engage older volunteers in
significant service to others. From the 20 original programs based
totally in institutions for children with severe mental and physical
disabilities, FGP now comprises nearly 350 programs in every State and
the District of Columbia, Puerto Rico, and the Virgin Islands. These
programs are now primarily in community-based child caring agencies or
organizations--where most special needs children can be found today--
and are administered locally through a non-profit organization or
agency and Advisory Council comprised of community citizens dedicated
to FGP and its mission. FGP represents the best in the Federal
partnership with local communities, with Federal dollars flowing
directly to local sponsoring agencies, which in turn determine how the
funds are used. Through this partnership and the flexibility of the
program, FGP is able to meet the immediate needs of the local
communities. This was demonstrated by Foster Grandparent Programs in
communities that were impacted by the influx of Hurricane Katrina
evacuees. Foster Grandparents rallied to provide services to children
in shelters, child care centers, and schools.
There are currently 38,700 Foster Grandparent volunteers who give
over 36 million hours annually to more than 277,000 children. The
Foster Grandparent Program is unique for several reasons. The program
is one of only two volunteer programs in existence that enable seniors
living on very limited incomes to serve their communities as volunteers
by providing a small non-taxable stipend and other support which allow
volunteers to serve at little or no cost to themselves. FGP volunteers
provide intensive, consistent service--15 to 40 hours every week,
usually four hours every day. FGP provides intensive pre-service
orientation and at least 48 hours of ongoing training every year to
keep volunteers current and informed on how to work with children who
have special needs. And our volunteers provide one-to-one service to
their assigned children, exactly what is required to help prepare our
Nation's neediest children to become self-sufficient adults.
fgp: the volunteers
The Foster Grandparent Program is a versatile, dynamic, and
uniquely multi-purpose program. First, the program gives Americans 60
years of age or older who are living on incomes at or less than 125
percent of the poverty level the opportunity to serve 15 to 40 hours
every week and use the talents, skills and wisdom they have accumulated
over a lifetime to give back to the communities which nurtured them
throughout their lives. Seniors in general are not valued or respected
in today's society, and low-income seniors are particularly devalued
because of their economic status. They are rarely asked by their
communities to contribute through volunteering, because they are not
traditionally those who participate in community activities.
FGP actively seeks out these low-income seniors. We dare to ask
them to serve, to give something back. And we help them to develop the
additional skills they may need to function effectively in settings
unfamiliar to them, like public schools, hospitals, childcare centers,
and juvenile detention facilities. We also provide them with ongoing
training and support throughout their tenure as Foster Grandparents.
Through their service, our older volunteers say they feel and stay
healthier, that they feel needed and productive. Most importantly, they
leave to the next generation a legacy of skills, perspective and
knowledge that has been learned the hard way--through experience.
Within budgetary constraints, FGP is engaging older people who are
not usually asked to serve and those usually considered as needing
services rather than being able to serve: 86 percent are 65 or older
and 45 percent come from various ethnic groups.
fgp: the children
Through our volunteers, the Foster Grandparent Program also
provides person-to-person service to children and youth under the age
of 21 who have special or exceptional needs, many of whom face serious,
often life-threatening challenges. With the changing dynamics in family
life today, many children with disabilities and special needs lack a
consistent, stable adult role model in their lives. The Foster
Grandparent is very often the only person in a child's life who is
there every day, who accepts the child, encourages him no matter how
many mistakes the child makes, and focuses on the child's successes.
Special needs of children served by Foster Grandparents include
AIDS or addiction to crack or other drugs; abuse or neglect; physical,
mental, or learning disabilities; speech, or other sensory
disabilities; incarceration and terminal illness. Of the children
served, 7 percent are abused or neglected, 26 percent have learning
disabilities, and 11 percent have developmental delays. FGP focuses its
resources in areas where they will have the most impact: early
intervention services and literacy activities. Nationally, 85 percent
of the children served by Foster Grandparents are under the age of 12,
with 39 percent of these children age 5 or under. Foster Grandparents
work intensively with these very young children to address their
problems at as early an age as possible, before they enter school.
Nearly one-half of FGP volunteers serve nearly 12 million hours
annually addressing literacy and emergent-literacy problems with
special needs children.
Activities of the FGP volunteers with their assigned children
include teaching parenting skills to teen parents; providing physical
and emotional support to babies abandoned in hospitals; helping
children with developmental, speech, or physical disabilities develop
self-help skills; reinforcing reading and mathematics skills; and
giving guidance and serving as mentors to incarcerated or other youth.
fgp: the volunteer sites
The Foster Grandparent Program provides child-caring agencies and
organizations offering services to special-needs children with a
consistent, reliable, invaluable extra pair of hands 15 to 40 hours
every week to assist in providing these services. Seventy-one percent
of FGP volunteers serve in public and private schools as well as sites
that provide early childhood pre-literacy services to very young
children, including Head Start.
fgp: cost-effective service
The Foster Grandparent Program serves local communities in a high
quality, efficient and cost-effective manner, saving local communities
money by helping our older volunteers stay independent and healthy and
out of expensive in-home or institutional care. Using the Independent
Sector's 2003 valuation for one hour of volunteer service ($17.19/
hour), the value of the service given by Foster Grandparents annually
is over $618 million, and represents a 5-fold return on the Federal
dollars invested in FGP. The annual Federal cost for one Foster
Grandparent is $3,800--less than $4 per hour.
The value local communities place on FGP and its multifaceted
services is evidenced by the large amount of cash and in-kind donations
contributed by communities to support FGP. For example, FGP's fiscal
year 2001 Federal allocation was matched with $40 million in non-
Federal donations from States and local communities in which Foster
Grandparents volunteer. This represents a non-Federal match of 42
percent, or $.42 for every $1 in Federal funds invested--well over the
10 percent local match required by law.
nafgpd's fiscal year 2007 budget request
Given the dramatically expanding number of low-income seniors
eligible to serve and the staggering number of troubled and challenged
children in America today, we respectfully request that the
subcommittee provide $115.929 million for the Foster Grandparent
Program in fiscal year 2007, an increase of $4.992 million over fiscal
year 2006. This critical funding will ensure the continued viability of
the Foster Grandparent program, and allow for an expansion of this
important program.
The requested increase would be allocated for the following
purposes, in order of priority:
1. in accordance with the Domestic Volunteer Service Act (DVSA),
designate one-third of the increase over the fiscal year 2006 level to
fund Program of National Significance (PNS) expansion grants to allow
existing FGP programs to expand the number of volunteers serving in
areas of critical need as identified by Congress in the DVSA. This
expansion of FGP was overwhelmingly supported and endorsed by White
House Conference in Aging delegates at the recent 2005 Conference
convened by the President.
2. use all remaining funds to award an administrative cost increase
of at least 3 percent to each existing Foster Grandparent Program in
order to maintain quality, enable recruitment and sustain the work
already being done by programs.
This funding proposal will generate opportunities for approximately
370 new low-income senior volunteers to contribute 390,000 hours of
service annually to nearly 2,000 additional children with special needs
through PNS grants to existing FGPs.
We request that no funds be provided for Senior Demonstration.
Language in the Corporation for National and Community Service's Budget
Justification indicate that any demonstration funds awarded will again
be used for programming that allows the payment of a stipend to
individuals whose incomes exceed 125 percent of the national poverty
level. In recognition of the fact that this practice has nothing to do
with the true spirit of volunteerism, Congress has expressly prohibited
this practice for the last 6 years in appropriations language; we
request that this important language be maintained to protect the
purpose of FGP and SCP: to enable low-income elders to serve their
communities.
The message is clear: (1) the population of low-income seniors
available to volunteer 15 to 40 hours every week is increasing; (2)
communities need and want more Foster Grandparent volunteers and more
Foster Grandparent Programs. The subcommittee's continued investment in
FGP now will pay off in savings realized later, as more seniors stay
healthy and independent through volunteer service, as communities save
tax dollars, and as children with special needs are helped to become
contributing members of society.
Mr. Chairman, in closing I would like to again thank you for the
subcommittee's support and leadership for FGP over the years. NAFGPD
takes great comfort in knowing you and your colleagues in Congress
appreciate what our low-income senior volunteers accomplish every day
in communities across the country.
______
Prepared Statement of Friends of the National Institute on Aging
Chairman Specter and members of the subcommittee, thank you for
this opportunity to testify in support of increasing funding within the
National Institutes of Health (NIH), and in particular within the
National Institute on Aging (NIA).
The Friends of the NIA is a relatively new coalition comprised of
some 50 organizations from academia and the non-profit community. All
of the groups comprising the Friends of the NIA conduct, fund or
advocate for scientific efforts to improve the health and quality of
life for Americans as they grow older. All of our groups support the
continuation and expansion of biomedical, behavioral, and social
science research within the NIA. The Friends of the NIA seeks to raise
awareness about aging research and the important scientific progress
supported and guided by the NIA. Our testimony not only addresses
recent research advances funded by the NIA, but also points to missed
opportunities if there is not growth in the NIA appropriation from
Congress in fiscal year 2007.
The NIA is dedicated to conducting biomedical, behavioral, and
social science research in order to prevent disease and other problems
of the aged, and to maintain the health and independence of older
Americans. This research is all the more urgent because of the
explosive growth of the older population in the United States. This
year, the first wave of our largest generation--some 77 million members
of the postwar Baby Boom generation--began turning aging 60. Currently
there are some 36 million Americans aged 65 and older. That population
is expected to double in size within the next 25 years, at which time
nearly 20 percent of the American population will be older than age 65
and eligible for old age assistance for health care under the Federal
Medicare program (Federal Interagency Forum on Aging-Related Statistics
2004, Older Americans). Of particular interest is the dramatic growth
that is anticipated among those most at risk for disease and
disability, people age 85 and over whose numbers are expected to grow
from 4.3 million in 2000 to at least 19.4 million in 2050 (65+ in the
United States: 2005, U.S. Census, 2006).
This growing population presents many social and economic
challenges as increasing numbers of Americans reach retirement age.
This rapidly expanding population, many of whom will have multiple
medical needs, will require substantial changes in health care
delivery. Aging itself is not the cause of disease, disability, and
frailty, but these conditions are influenced by age-related changes,
lifestyle choices and rising risk factors. We also know that outside
influences, such as economic, physical, environmental, and caregiving
stresses increase vulnerability to disease, especially amongst the
elderly. NIA has a broad research portfolio and is the only Institute
that studies the normal changes associated with aging as well as
pathological conditions from an interdisciplinary perspective.
Understanding when and how changes occur as we age provides important
clues for developing interventions that will prevent and treat
diseases, and improve quality of life.
In addition to participating in NIH-wide initiatives, NIA has made
and supported many significant contributions of its own to the
biomedical and psycho-social understanding of the aging processes and,
through ongoing clinical trials, to the testing of promising
interventions for the detection, treatment and prevention of many age-
related conditions.
The NIA is the lead Federal research agency for Alzheimer's disease
(AD). AD is the most common cause of dementia and a serious threat to
the Nation's health and economic well-being. Today, an estimated 4.5
million Americans, 1 in 10 persons over age 65 and nearly one-half of
those over 85, suffer from this debilitating disease. That toll is
projected to increase to 5.1 million people by 2010 and 16 million by
2050 (Hebert et al. 2003, Alzheimer's Disease in the U.S. Population).
Over the next decade, Medicare spending on beneficiaries with AD will
more than triple to $189 billion. Our concern is that flattened budgets
for the NIH institutes are threatening major AD research initiatives.
One example is the Alzheimer's Disease Neuroimaging Initiative (ADNI),
launched in 2004 as a public/private partnership: the most
comprehensive effort to date to identify neuroimaging strategies and
biomarkers to identify the onset of mild cognitive impairment and early
AD with greater sensitivity. The project currently involves
approximately 50 sites across the United States and Canada and holds
the promise of early diagnosis and subsequent interventions that could
postpone or more effectively treat AD. The Genetics Initiative is
another multi-site collaboration that is collecting, sharing, and
analyzing data to complete the picture of genetic risk factors for AD.
These programs offer enormous potential to identify AD and intervene
early, but lack of adequate funding will prevent or slow realization of
the full potential of these programs. With aging baby boomers on the
horizon, we cannot afford this delay.
Great strides have been made in AD. Only a few years ago, this
disease could not be positively confirmed until autopsy. Now we can
diagnose the disease in life with a high degree of certainty; we
understand some of the basic mechanisms of the disease; and five
approved drugs for treating symptoms are now approved with many new
compounds being tested in publicly and industry-supported clinical
trials.
This is a critical time for investment not retrenchment. Scientists
are poised to find effective ways to prevent, delay onset, and even
treat this disease. If the onset of AD could be delayed by just two
years, the AD afflicted population would remain at current size, even
with the expected increases in senior population; a five-year delay of
onset would cut the projected AD population in half.
Other promising NIA biomedical research efforts into prominent
diseases include research programs to discover new Parkinson's
susceptibility genes; studies of age-related bone loss and
osteoporosis; development of programs to assess genetic and
environmental factors in racial and ethnic health differences
simultaneously; and bone marrow failure diseases, all of which occur in
higher incidence in people over 60.
NIA's behavioral and social science research programs have been
instrumental in providing crucial economic and demographic population
information. NIA's Centers on the Demography of Aging, particularly
their Health and Retirement Survey (HRS) and the National Long-Term
Care Survey (NLTCS), provide critical data on the health and economic
status of the older population. These data have been used by Congress
to better understand the budgetary impact of population aging, as
potential changes to public programs such as Social Security, Medicare,
and Medicaid are deliberated. By using NLTCS data, investigators
identified the declining rate of disability in older Americans first
observed in the mid-1990s--a trend that has continued. This trend, if
continued, could have momentous impact on reducing the need for costly
long-term care. The Social Security Administration recognizes and co-
funds the HRS as a ``Research Partner'' and posts the study on its home
page to improve its availability to the public and to policymakers. In
2005, the Center for Medicare and Medicaid Services (CMS) funded a
supplemental survey using the HRS to provide timely information on who
is likely to enroll in the new Medicare Part D prescription drug
program and how those decisions are related to knowledge of the
program, drug use and costs.
There is building evidence that continued engagement in productive
activities has a positive impact on health and life satisfaction. The
experience and expertise of the new 65+ population offers great
potential to help address workforce shortages as well as some of the
critical social needs of our country. The NIA is working to build a
research agenda that focuses on maximizing older workers' safety,
health, productivity and life satisfaction--knowledge that this will be
critical to developing sound national policies.
NIA provides critical support for the training of new
investigators. The reduction in funded proposals as a result of limited
NIA budget will impact the ability to recruit and sustain an
appropriate pool of qualified researchers in gerontology and
geriatrics. Numerous reports have cited the need for more geriatricians
and geriatric-trained professionals for our aging society. By 2030, the
United States will need up to 36,000 geriatricians and will fall far
short of that figure by as many as 25,000 unless effective steps are
taken to train new providers (Medical Never-Never Land, Alliance for
Aging Research, 2002). Further budget cuts will reduce funding
available for training, and may force some leading researchers and
practitioners to abandon gerontology as well as the mentoring of new
professionals in the field.
With bipartisan leadership in Congress, the NIH budget doubled
between 1998 and 2003 ($13.6 to $27.3 billion). However, since 2003,
funding for the NIH in real dollars has been on a downward trajectory.
Under the President's proposed fiscal year 2007 budget, the NIA is
slated to be decreased in real terms by $10 million. Further, in order
to preserve clinical trials already underway, NIA will fund only 18
percent of new grant proposals. This is down substantially from 28.5
percent in 2003, and will not come close to supporting the more than 50
percent of submitted applications that the NIA has determined to be
highly promising. At the same time that the acceptance rate of new
proposals is down, the funding levels of new grants has also dropped
from years past. Moreover, even those grantees receiving funding face
an average reduction from requested budgets by 18 percent across the
board. (Fiscal Year 2007, National Institutes on Aging, Justification
of Estimates for Appropriations Committees). Investigator-initiated
research projects provide new breakthroughs in knowledge and treatment
to benefit older Americans and their families. Declining budgets slow
momentum and impact future research programs. For example, continued
cuts will impact projects such as, the start up of new clinical trials
in caloric restriction, testosterone supplementation in men, and
lifestyle interventions and independence for elders, all of which have
shown great potential for significant public health outcomes.
The Friends of the National Institute on Aging recommend the
following directives:
(1) The time for research on aging is now if we are to achieve a
healthier and more productive aging America. To further this goal, the
Friends of the NIA endorse the recommendation issued by the Ad Hoc
Group for Medical Research in calling for a 5 percent overall increase
for the National Institutes of Health in fiscal year 2007.
(2) NIA needs additional resources to support individual
investigator awards, to avoid an 18 percent cut in its existing grants,
and to sustain training and research opportunities for new
investigators.
Mr. Chairman, the Friends of the NIA thanks you for this
opportunity to outline the challenges threats and opportunities that
lie ahead as you consider appropriate funding for the NIH and the
National Institute on Aging.
______
Prepared Statement of Friends of NIDA Coalition
The Friends of the National Institute on Drug Abuse (FoN), a
burgeoning coalition of scientific and professional societies, patient
groups, and other organizations committed to preventing and treating
substance use disorders as well as understanding the causes and public
health consequences of addiction, is pleased to provide testimony in
support of the NIDA's extraordinary work. Pursuant to clause 2(g)4 of
House Rule XI, the Coalition does not receive any Federal funds.
Drug abuse is costly--to individuals and to our society as a whole.
Smoking, alcohol abuse and illegal drugs cost this country more than
$500 billion a year, with illicit drug use alone accounting for about
$180 billion in health care, crime, productivity loss, incarceration,
and drug enforcement. Beyond its monetary impact, drug and alcohol
abuse tear at the very fabric of our society, often spreading
infectious diseases and bringing about family disintegration, loss of
employment, failure in school, domestic violence, child abuse, and
other crimes. The good news is that treatment for drug abuse is
effective and recovery from addiction is real for millions of Americans
across the country. Preventing drug abuse and addiction and reducing
these myriad adverse consequences in the ultimate aim of our Nation's
investment in drug abuse research. Over the past three decades,
scientific advances resulting from research have revolutionized our
understanding of and approach to drug abuse and addiction.
NODA supports a comprehensive research portfolio that spans the
continuum of basic neuroscience, behavior and genetics research through
applied health services research and epidemiology. While supporting
research on the positive effects of evidence-based prevention and
treatment efforts, NIDA also recognizes the need to keep pace with
emergent problems. Research shows encouraging trends that NIDA's public
education and awareness efforts are having an impact: For example, the
2005 Monitoring the Future Survey of 8th, 10th, and 12th graders shows
a dramatic 19 percent reduction in use since 2001. However, areas of
significant concern remain. Some of NIDA's current research priorities
include understanding more about methamphetamine and the brain,
addressing the growing problem of prescription drug abuse, using drug
abuse treatment to curtail the spread of HIV/AIDS, and encouraging
collaborations that address comorbidity.
Because of the critical importance of drug abuse research for the
health and economy of our Nation, we write to you today to request your
support for a 5 percent increase for NIDA in the fiscal 2007 Labor,
Health and Human Services, Education and Related Agencies
Appropriations bill. That would bring total funding for NIDA in fiscal
2007 to $1,050,030,450. Recognizing that so many health research issues
are inter-related, we also support a 5 percent increase for the
National Institutes of Health overall, which would bring its total to
$30 billion for fiscal 2007, This work deserves continuing, strong
support from Congress. Below is a short list of significant NIDA
accomplishments, challenges, and successes.
Adolescent Brain Development--How Understanding the Brain Can
Impact Prevention Efforts.--NIDA maintains a vigorous developmental
research portfolio focused on adolescent populations. NIDA working
collaboratively with other NIH Institutes has shown that the human
brain does not fully develop until about age 25. This adds to the
rationale for referring to addiction as a ``developmental disease;'' it
often starts during the early developmental stages in adolescence and
sometimes as early as childhood, a time when we know the brain is still
developing. Having insight into how the human brain works, and
understanding the biological underpinnings of risk taking among young
people will help in developing more effective prevention programs. FoN
believes NIDA should continue its emphasis on studying adolescent brain
development to better understand how developmental processes and
outcomes are affected by drug exposure, the environment and genetics.
Medications Development.--NIDA has demonstrated leadership in the
field of medications development by partnering with private industry to
develop anti-addiction medications resulting in a new medication,
buprenorphine, for opiate addiction. FoN recommends that NIDA continue
its work with the private sector to develop much needed anti-addiction
medications, for cocaine, methamphetamine, and marijuana dependence.
Co-Occurring Disorders.--NIDA recognizes the need to to adequately
address research questions related to co-occurring substance abuse and
mental health problems. In particular, NIDA has developed robust
collaborations with other agencies (such as NIAAA, NIMH and SAMHSA) to
stimulate new research to develop effective strategies and to ensure
the timely adoption and implementation of evidence-based practices for
the prevention and treatment of co-occurring disorders. Through these
initiatives, NIDA is supporting research to determine the most
effective models of clinically appropriate treatment and how to bring
them to communities with limited resources. FoN recognizes the
imperative for continued funding of essential research into the nature
of and improved treatment for these complex disorders and endorses
these efforts.
Drug Abuse and HIV/AIDS.--One of the most significant causes of HIV
virus acquisition and transmission involves drug taking practices and
related risk factors in different populations (e.g. criminal justice,
pregnant women, minorities, and youth). Drug abuse prevention and
treatment interventions have been shown to be effective in reducing HIV
risk. FoN congratulates NIDA on its ``Drug Abuse and HIV--Learn the
Link'' public awareness campaign, targeting young people, and believes
NIDA should continue to support research that focuses on developing and
testing drug-abuse related interventions designed to reduce the spread
of HIV/AIDS.
Emerging Drug Problems.--NIDA recognizes that drug use patterns are
constantly changing and expends considerable effort to monitor drug use
trends and to rapidly inform the public of emerging drug problems. FoN
believes NIDA should continue supporting research that provides
reliable data on emerging drug trends, particularly among youth and in
major cities across the country and will continue its leadership role
in alerting communities to new trends and creating awareness about
these drugs.
Reducing Prescription Drug Abuse.--NIDA research has documented
continued increases in the numbers of people, especially young people,
who use prescription drugs for non-medical purposes. Particular concern
revolves around the inappropriate use of opiod analgesics--very
powerful pain medications. FoN commends NIDA for its research focus in
this area, and for the new Prescription Opioid Use and Abuse in the
Treatment of Pain initiative. Research targeting a reduction in
prescription drug abuse, particularly among our Nation's youth, will
continue to be a priority for NIDA. Finally, FoN endorses NIDA's
programmatic research designed to further the development of
medications that are less likely to have abuse/addiction liability, and
to develop prevention and treatment interventions for adolescents and
adults who are abusing prescription drugs.
Reducing Methamphetamine Abuse.--NIDA continues to recognize the
epidemic abuse of methamphetamine across the United States.
Methamphetamine abuse not only affects the users, but also the
communities in which they live, especially due to the dangers
associated with its production. FoN believes NIDA should continue to
support research to address the broad medical consequences of
methamphetamine abuse, and is encouraged by the evidence of treatment
effectiveness in these populations. Topics of particular concern
include: understanding the effects of prenatal exposure to
methamphetamine, developing pharmacotherapies and behavioral therapies
to treat methamphetamine addiction and information dissemination
strategies to inform the public that treatment for methamphetamine
addiction is effective.
Reducing Inhalant Abuse.--FoN recognizes that inhalant use
continues to be a significant problem among our youth. Inhalants pose a
particularly significant problem since they are readily accessible,
legal, and inexpensive. They also tend to be abused by younger teens
and can be highly toxic and even lethal. FoN applauds NIDA's inhalant
research portfolio and believes NIDA should continue its support of
research on prevention and treatment of inhalant abuse, and to enhance
public awareness on this issue.
Long-Term Consequences of Marijuana Use.--NIDA research shows that
marijuana can be detrimental to educational attainment, work
performance, and cognitive function. However, more information is
needed in order to assess the full impact of long-term marijuana use.
Therefore, FoN recommends that NIDA continue to support efforts to
assess the long-term consequences of marijuana use on cognitive
abilities, achievement, and mental and physical health, as well as work
with the private sector to develop medications focusing on marijuana
addiction.
Translating Research Into Practice.--FoN commends NIDA for its
outreach and work with State substance abuse authorities to reduce the
current 15- to 20-year lag between the discovery of an effective
treatment intervention and its availability at the community level. In
particular, FoN applauds NIDA for continuing its work with SAMHSA to
strengthen State substance abuse agencies' capacity to support and
engage in research that will foster statewide adoption of meritorious
science-based policies and practices. FoN encourages NIDA to continue
collaborative work with State substance abuse agencies to ensure that
research findings are relevant and adaptable by State substance abuse
systems. NIDA is also to be congratulated for its broad and varied
information dissemination programs as part of an effort to ensure drug
abuse research is used in everyday practice. The Institute is focused
on stimulating and supporting innovative research to determine the
components necessary for adopting, adapting, delivering, and
maintaining effective research-supported policies, programs, and
practices. As evidence-based strategies are developed, FoN urges NIDA
to support research to determine how these practices can be best
implemented at the community level.
Primary Care Settings and Youth.--NIDA recognizes that primary care
settings, such as offices of pediatricians and general practitioners,
are potential key points of access to prevent and treat problem drug
use among young people; yet primary care and drug abuse services are
commonly delivered through separate systems. FoN encourages NIDA to
continue to support health services research on effective ways to
educate primary care providers about drug abuse; develop brief
behavioral interventions for preventing and treating drug use and
related health problems, particularly among adolescents; and develop
methods to integrate drug abuse screening, assessment, prevention and
treatment into primary health care settings.
Utilizing Knowledge of Genetics and New Technological Advances to
Curtail Addiction.--NIDA recognizes that not everyone who takes drugs
becomes addicted and that this is an important phenomenon worthy of
further exploration. Research has shown that genetics plays a critical
role in addiction, and that the interplay between genetics and
environment is crucial. The science of genetics is at a crucial phase--
technological advances are providing the tools to make significant
breakthroughs in disease research. For example, FoN believes NIDA
should take advantage of new high-resolution genetic technologies which
may help to develop new tailored treatments for smoking.
Reducing Health Disparities.--NIDA research demonstrates that the
consequences of drug abuse disproportionately impacts minorities,
especially African American populations. FoN believes that researchers
should be encouraged to conduct more studies in this population and to
target their studies in geographic areas where HIV/AIDS is high and or
growing among African Americans, including in criminal justice
settings.
The Clinical Trials Network--Using Infrastructure to Improve
Health.--FoN applauds the continued success of NIDA's National Drug
Abuse Treatment Clinical Trials Network (CTN), which was established in
1999 and has grown to include over 17 research centers or nodes spread
across the country. The CTN provides an infrastructure to test the
effectiveness of new and improved interventions in real-life community
settings with diverse populations, enabling an expansion of treatment
options for providers and patients. FoN suggests NIDA continue to
develop ways to use the CTN as a vehicle to address emerging public
health needs.
Behavioral Science.--NIDA has long demonstrated a strong commitment
to supporting behavioral science research. FoN encourages NIDA to
continue to determine the interplay of behavioral, biological, and
social factors that affect development and the onset of diseases like
drug addiction to understand common pathways that may underlie other
compulsive behaviors such as gambling and eating disorders.
Drug Treatment in Criminal Justice Settings.--NIDA is very
concerned about the well-known connections between drug use and crime.
Research continues to demonstrate that providing treatment to
individuals involved in the criminal justice system decreases future
drug use and criminal behavior, while improving social functioning.
Blending the functions of criminal justice supervision and drug abuse
treatment and support services create an opportunity to have an optimal
impact on behavior by addressing public health concerns while
maintaining public safety. FoN strongly supports NIDA's efforts in this
area, particularly the Criminal Justice Drug Abuse Treatment Studies
(CJ-DATS), a multi-site set of research studies designed to improve
outcomes for offenders with substance use disorders by improving the
integration of drug abuse treatment with other public health and public
safety systems.
Social Neuroscience.--Research-based knowledge about the dynamic
interactions of genes with environment confirm addiction as a complex
and chronic disease of the brain with many contributors to its
expression in individuals. FoN applauds NIDA's involvement in the
recently released ``social neuroscience'' request for applications, and
encourages the Institute to continue its focus on the interplay between
genes, environment, and social factors and their relevance to drug
abuse and addiction.
Translational Research: Ensuring Research is Adaptable and
Useable.--FoN commends NIDA for its broad and varied information
dissemination programs. FoN also understands that the Institute is
focused on stimulating and supporting innovative research to determine
the components necessary for adopting, adapting, delivering, and
maintaining effective research-supported policies, programs, and
practices. As evidence-based strategies are developed, FoN urges NIDA
to support research to determine how these practices can be best
implemented at the State and community level.
Blending Research and Practice.--FoN notes that it takes far too
long for clinical research results to be implemented as part of routine
patient care, and that this lag in diffusion of innovation is costly
for society, devastating for individuals and families, and wasteful of
knowledge and investments made to improve the health and quality of
people's lives. FoN applauds NIDA's collaborative approach aimed at
proactively involving all entities invested in changing the system and
making it work better. NIDA is leading efforts to make the best
substance abuse treatments available to those who need them, and this
effort requires working with many different contributors to assimilate
their feedback and create change at multiple levels.
conclusion
The Nation's investment in scientific research has changed the way
people view drug abuse and addiction in this country. We now know how
drugs work in the brain, their health consequences, how to treat people
already addicted, and what constitutes effective prevention strategies.
FoN asks you to provide an appropriation of $1,050,030,450 for NIDA, so
that it may continue to serve the public health of all Americans and
capitalize on new opportunities as science advances.
We understand that the fiscal year 2007 budget cycle will involve
setting priorities and accepting compromise. However, in the current
climate, we believe a focus on substance abuse and addiction, which
according to the World Health Organization account for nearly 20
percent of disabilities among 15-44 year olds, deserve to be
prioritized accordingly. We look forward to working with you to make
this a reality.
Thank you, Mr. Chairman, and the subcommittee, for your support for
the National Institute on Drug Abuse.
______
Prepared Statement of the Heart Rhythm Society
The Heart Rhythm Society (HRS) thanks you and the Subcommittee on
Labor, Health and Human Services and Education for your past and
continued support of the National Institute of Health, and specifically
the National Heart, Lung and Blood Institute (NHLBI).
The Heart Rhythm Society, founded in 1979 to address the scarcity
of information about the diagnosis and treatment of cardiac
arrhythmias, is the international leader in science, education and
advocacy for cardiac arrhythmia professionals and patients, and the
primary information resource on heart rhythm disorders. The Heart
Rhythm Society serves as an advocate for millions of American citizens
from all 50 States, since arrhythmias are the leading cause of heart-
disease related deaths. Other, less lethal forms of arrhythmias are
even more prevalent, account for 14 percent of all hospitalizations of
Medicare beneficiaries.\1\ Our mission is to improve the care of
patients by promoting research, education and optimal health care
policies and standards. We are the preeminent professional group,
representing more than 4,200 specialists in cardiac pacing and
electrophysiology.
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\1\ Heart Rhythm Foundation, Arrhythmia Key Facts, 2004 http://
www.heartrhythmfoundation.org/facts/arrhythmia.asp.
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The Heart Rhythm Society recommends the subcommittee renew its
commitment to supporting biomedical research in the United States and
recommends Congress provide NIH with a 5 percent increase for fiscal
year 2007. This translates into an appropriation of $29.849 billion for
NIH, with $3.068 billion designated to the National Heart, Lung, and
Blood Institute (NHLBI). This increase will enable NIH and NHLBI to
sustain the level of research that leads to research breakthroughs and
improved health outcomes. In particular, the Heart Rhythm Society
recommends Congress support research into abnormal rhythms of the
heart.
HRS appreciates the actions of Congress to double the budget of the
NIH in recent years. The doubling has directly promoted innovations
that have improved treatments and cures for a myriad of medical
problems facing our Nation. Medical research is a long-term process and
in order to continue to meet the evolving challenges of improving human
health we must not let our commitment wane. Furthermore, NIH research
fuels innovation that generates economic growth and preserves our
Nation's role as a world leader in the biomedical and biotech
industries. Healthier citizens are the key to robust economic growth
and greater productivity. Economists estimate that improvements in
health from 1970 to 2000 were worth $95 trillion. During the same time
period, the United States invested $200 billion in the NIH. If only 10
percent of the overall health savings resulted from NIH-funded
research, our investment in medical research has provided a 50-fold
return to the economy.\2\
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\2\ Murphy, KM and Topel, RH, The Value of Health and Longevity,
National Bureau of Economic Research Working Paper Series, Working
Paper 11405, June 2005.
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research accomplishments
In the field of cardiac arrhythmias, NIH-funded research has
advanced our ability to treat atrial fibrillation and thus prevent the
devastating complications of stroke. Atrial fibrillation is found in
about 2.2 million Americans and increases the risk for stroke about 5-
fold. About 15-20 percent of strokes occur in people with atrial
fibrillation. Stroke is a leading cause of serious, long-term
disability in the United States and people who have strokes caused by
AF have been reported as 2-3 times more likely to be bedridden compared
to those who have strokes from other causes. Each year about 700,000
people experience a new or recurrent stroke and in 2002 stroke
accounted for more than 1 of every 15 deaths in the United States.
Ablation therapy however is providing a cure for individuals whose
rapid heart rates had previously incapacitated them, giving them a new
lease on life.\3\
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\3\ American Stroke Association and American Heart Association,
Heart Disease and Stroke Statistics_2005 Update, 2005 http://
www.americanheart.org/downloadable/heart/
1105390918119HDSStats2005Update.pdf.
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Important advances have also been made in identifying patients with
heart failure and those who have suffered a heart attack and are at
risk for sudden death. The development, through initial NIH-sponsored
research, and implantation of sophisticated internal cardioverter
defibrillators (ICD's) in such patients has saved the lives of hundreds
of thousands and provides peace of mind for families everywhere,
including that of Vice-President Cheney's. A new generation of
pacemakers and ICDs is restoring the beat of the heart as we grow
older, permitting us to lead more normal and productive lives, reducing
the burden on our families, communities and the healthcare system.
Arrhythmias and sudden death affect all age groups and are not solely
diseases of the elderly.
Research advances in molecular genetics have provided us the root
basis for life-threatening abnormal rhythms of the heart associated
with of wide range of inherited syndromes including long and short QT,
Brugada syndromes, and hypertrophic cardiomyopathies. This knowledge
has provided guidance to physicians for better detection and treatment
of these sudden death syndromes reducing mortality and disability of
infants, children and young adults. Individuals who survive an instance
of sudden death often remain in vegetative states, resulting in a
devastating burden on their families and an enormous economic burden on
society. These advances have translated into sizeable savings to the
health care system in the United States. Researchers are also
developing a noninvasive imaging modality for cardiac arrhythmias.
Despite the fact that more than 325,000 Americans die every year from
heart rhythm disorders, a noninvasive imaging approach to diagnosis and
guided therapy of arrhythmias, the equivalent of CT or MRI, has
previously not been available.
The NIH-funded Public Access Defibrillation (PAD) Trial was also
able to determine that trained community volunteers increase survival
for victims of cardiac arrest. It had already been known that
defibrillation, utilizing an automated external defibrillator (AED), by
trained public safety and emergency medical services personnel is a
highly effective live-saving treatment for cardiac arrest. A NIH-funded
trial however was able to conclude that placing AED's in public places
and training lay persons to use them can prevent additional deaths and
disabilities.\4\
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\4\ National Heart Lung and Blood Institute, NIH, Public Access
Defibrillation by Trained Community Volunteers Increases Survival for
Victims of Cardiac Arrest, November 2003 http://www.nhlbi.nih.gov/new/
press/03_11_11.htm.
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Without NIH support, these life-saving findings may have taken a
decade to unravel. The highly focused approach utilizing basic and
clinical expertise, funded through Federal programs made these advances
a reality in a much shorter time-period.
budget justification
These impressive strides notwithstanding, cardiac arrhythmias
continue to plague our society and take the lives of loved ones at all
ages, nearly one every minute of every day, as well as straining an
already burdened health system. Sudden Cardiac Arrest is a leading
cause of death in the United States, claiming an estimated 325,000
lives every year, or one life every two minutes.\5\ The burden of
morbidity and mortality due to cardiac arrhythmias is predicted to grow
dramatically as the baby boomers age. Atrial fibrillation strikes 3-5
percent of people over the age of 65,\6\ presenting a skyrocketing
economic burden to our society in the form of healthcare treatment and
delivery. It is estimated in 2005 that the direct and indirect cost of
stroke will be $56.8 billion.\7\ Cardiac diseases of all forms increase
with advancing age, ultimately leading to the development of
arrhythmias. NIH research provides the basis for the medical advances
that hold the key to lowering health care costs.
---------------------------------------------------------------------------
\5\ Heart Rhythm Foundation, The Facts on Sudden Cardiac Arrest,
2004 http://www.heartrhythmfoundation.org/its_about_time/pdf/
provider_fact_sheet.pdf.
\6\ Heart Rhythm Society, Atrial Fibrillation & Flutter, 2005_ttp:/
/www.hrspatients.org/patients/heart_disorders/atrial_fibrillation/
default.asp.
\7\ American Stroke Association, Impact of Stroke, 2005 http://
www.strokeassociation.org/presenter.jhtml?identifier=1033.
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The above progress we have witnessed in recent years will provide
treatments for this illness, only if the resources continue to be
available to the academic scientific and medical community. However,
the budgets appropriated by Congress to the NIH in the past three years
were far below the level of scientific inflation. These vacillations in
funding cycles threaten the continuity of the research and the momentum
that has been gained over the years. While HRS recognizes that Congress
must balance other priorities, sustaining multi-year growth for the
biomedical research enterprise is critical. A central objective of the
doubling of the NIH budget was to accelerate solutions to human disease
and disability. NIH is now engaging in the next generation of
biomedical research to translate basic research and clinical evidence
into new cures. Our ability to bring together uniquely qualified and
devoted investigators and collaborators both at the basic science level
and in the clinical arena is a vital key to our to this success.
Funding models however show that a threshold exists, below which NIH
will not be able to maintain its current scope and number of grants,
let alone expand its programs to address new concerns and emerging
opportunities. Furthermore, the United States is in danger of losing
its leadership role in science and technology. The United States faces
growing competition from other nations, such as China and India, which
are working to invest more of their GDP's into building state-of-the-
art research institutes and universities to foster innovation and
compete directly for the world's top students and researchers.\8\
---------------------------------------------------------------------------
\8\ Task Force on the Future of American Innovation, The Knowledge
Economy: Is the United States Losing it's Competitive Edge?, February
16, 2005.
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It is for this reason that we are asking for your support to
increase NIH appropriations by 5 percent for a fiscal year 2007 budget
of $29.849 billion for NIH and $3.068 billion for NHLBI. The Heart
Rhythm Society recommends Congress specifically acknowledge the need
for cardiac arrhythmia research to prevent sudden cardiac arrest and
other life threatening conditions such as sudden infant death syndrome,
definitive therapeutic approaches for atrial fibrillation and the
prevention of stroke, and other genetic arrhythmia conditions. Thank
you very much for your consideration of our request.
If you have any questions or need additional information, please
contact Nevena Minor, Coordinator, Health Policy at the Heart Rhythm
Society (amelnick@hrsonline.org or 202-464-3434).
Thank you again for the opportunity to submit testimony.
______
Prepared Statement of the Hemophilia Federation of America
summary of fiscal year 2007 recommendations
--Continued support for Hemophilia Treatment Centers through the
Health Resources and Services Administration Maternal and Child
Health Block Grant.
--$10 million for hemophilia programs at the Centers for Disease
Control and Prevention and expansion of the program to allow
partnerships with additional patient-based organizations within
the hemophilia community.
--A 5 percent increase overall for the National Institutes of Health,
including a 5 percent increase for the National Heart, Lung,
and Blood Institute, and the National Institute for Allergy and
Infectious Diseases.
introduction
The Hemophilia Federation of America (HFA) is a national nonprofit
organization that assists and advocates for the blood clotting
disorders community. The vision of the HFA is that the blood clotting
disorders community will face no barriers to choice of treatment and
quality of life.
The programming of HFA is designed to be of assistance to the
consumer and their families and is structured to follow our mission and
vision. We at HFA consider ourselves the ``consumer organization.''
That was the purpose of our organization when we were established a
decade ago and it has remained constant in the structure and activities
of the organization. The following is a summary of some of the programs
that HFA offers to the hemophilia community:
``Helping Hands''
Helping Hands is a program that offers financial assistance to
patients and families in a crisis. The grant applicant requests funds
for emergency assistance with various needs such as: rent, utilities,
car repair, and quality of life issues. Over one half of the requests
funded in recent years were first time applicants. The requests are
comprised of referrals from member organizations and industry.
``Dads in Action''
Dads in Action is a new program launched in the fall of 2003 that
is designed to encourage dads to take a more active role in their
children's lives, to be more involved in the care of their child with
hemophilia and to strengthen communication throughout the family.
Participants return to their home chapters to start a ``Dads in
Action'' program where they carry the lessons learned to fellow Dads at
their local chapter. The program receives high reviews from
participants and is an integral part of our vision for the community.
The Annual HFA Symposium
HFA's annual Symposium is one of the brightest stars in our
programmatic agenda. This event has grown from a small gathering of 100
people in 1996 to over 500 in 2006. Are sole focus at this annual event
is the consumer. Our patients view that annual symposium as a big
family reunion where they learn how to cope with everyday situations.
There are also free programs for teens and children. The goal of the
Symposium is to address issues that impact the entire community.
Presenters are experts in their field and share their expertise with
the community.
fiscal year 2007 appropriations recommendations
Hemophilia Treatment Centers/Health Resources and Services
Administration
In 1974, Congress created a network of Hemophilia Treatment Centers
(HTCs) throughout the United States. This treatment centers remain
essential to ensuring that comprehensive and specialized care is
available for persons with bleeding disorders. There are currently over
140 HTCs in the United States. These centers abide by Federal
guidelines for the delivery of comprehensive hemophilia services as
developed by the Health Resources and Services Administration and the
Centers for Disease Control and Prevention.
HTC's provide family centered, state-of-the-art medical and
psychosocial services, as well as education and research to persons
with inherited bleeding disorders. The bleeding disorder community
utilizes many services through the Hemophilia Treatment Centers. These
services include diagnostic evaluations for hemophilia, von Willebrand
disease and other bleeding disorders. They also include annual
comprehensive evaluations, clinical trials on new blood clotting
therapies, coordination with the individual's primary care physician,
emergency consultations, hematological management for surgeries, dental
procedures and childbirth. HTC's educate patients and family members on
infusion training, encourage collaboration with clinicians throughout
the United States, participate in CDC research, and collaborate with
the hemophilia community.
At the Health Resources and Services Administration, funding is
provided to HTC's through the Maternal and Child Health Block Grant
program. For fiscal year 2007, HFA encourages the subcommittee to
reject the president's proposed $36 million cut to MCHBG, and restore
funding to the fiscal year 2006 level of $816 million.
Hemophilia Program at the Centers for Disease Control and Prevention
Mr. Chairman, HFA strongly supports the expansion of hemophilia
related programs within CDC's National Center on Birth Defects and
Developmental Disabilities' Hereditary Blood Disorders program. In
partnership with HRSA, this program provides vital support to
Hemophilia Treatment Centers, particularly in the areas of research,
education, disease management, blood safety and surveillance. For
fiscal year 2007, HFA encourages the subcommittee to provide an
increase of $3 million for hemophilia related activities at CDC. This
proposed increase would bring the total level of CDC funding for the
hemophilia treatment center network to $10 million. This increase is
important given the fact the program has been level funded for over 10
years.
HFA was very pleased that the fiscal year 2006 Senate Labor-HHS-
Education committee report encouraged CDC to expand opportunities for
additional patient-based organizations to participate in the agency's
hemophilia program. Under the current structure of the program, only
one hemophilia organization is eligible to receive support for the
purpose of providing much needed services to patients. In order to
maximize the effectiveness of the CDC program, we believe that
additional patient based organizations should be empowered to receive
funding on an annual basis. As referenced earlier, HFA offers a wide
variety of high quality, consumer focused, programs that no other
organization provides. If the CDC program were opened-up to allow
additional organizations to participate, we would be able to help a
much larger number of patients and families throughout the country. We
encourage the subcommittee to support our efforts in this regard in the
fiscal year 2007 bill.
Research at the National Institutes of Health
HFA applauds the National Heart, Lung and Blood Institute, the
National Institute of Diabetes and Digestive and Kidney Diseases, and
the National Institute of Allergy and Infectious Diseases for their
strong support of hemophilia related research. We are grateful to the
subcommittee for recognizing the growing problem of bleeding disorders
in women, which if untreated, can lead to serious medical conditions
including anemia, unnecessary hysterectomies, and menstrual
complications.
Patients and families in the hemophilia community are placing their
hopes for a better quality of life on treatment advances made through
biomedical research. For fiscal year 2007, we encourage the
subcommittee to provide a 5 percent increase overall for each institute
and center at the NIH.
Mr. Chairman, thank you for the opportunity to present the views of
the Hemophilia Federation of America.
______
Prepared Statement of Hepatitis Foundation International
summary of fiscal year 2007 recommendations
--Continue the great strides in research at the National Institutes
of Health (NIH) by providing a 5 percent budget increase for
fiscal year 2007. Increase funding for the National Institute
for Allergy and Infectious Diseases (NIAID), the National
Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK), the National Institute on Alcohol Abuse and Alcoholism
(NIAAA), and the National Institute on Drug Abuse (NIDA) by 5
percent.
--Continued support for the hepatitis B vaccination program for
adults at the Centers for Disease Control and Prevention (CDC)
as well as CDC's Prevention Research Centers by providing an 8
percent increase for CDC.
--Support for the Substance Abuse and Mental Health Services
Administration (SAMHSA) by providing an 8 percent increase in
fiscal year 2007.
--Urge CDC, NIAID, NIDDK, NIAAA, NIDA, and SAMHSA to work with
voluntary health organizations to promote liver wellness,
education, and prevention of both hepatitis and substance
abuse.
Mr. Chairman and members of the subcommittee, thank you for your
continued leadership in promoting better research, prevention,
education, and control of diseases affecting the health of our Nation.
I am Thelma King Thiel, Chairman and Chief Executive Officer of the
Hepatitis Foundation International (HFI).
Currently, five types of viral hepatitis have been identified,
ranging from type A to type E. All of these viruses cause acute, or
short-term, viral hepatitis. Hepatitis B, C, and D viruses can also
cause chronic hepatitis, in which the infection is prolonged, sometimes
lifelong. While treatment options are available for many patients,
individuals with chronic viral hepatitis B and C represent a
significant number of patients requiring a liver transplant. Current
treatments have limited success and there is no vaccine available for
hepatitis C, the most prevalent of these diseases.
hepatitis a
The hepatitis A virus (HAV) is contracted through fecal/oral
contact (i.e. fecal contamination of food, water, and diaper changing
tables if not cleaned properly), and sexual contact. In addition,
eating raw or partially cooked shellfish contaminated with HAV can
spread the virus. Children with HAV usually have no symptoms; however,
adults may become quite ill suddenly experiencing jaundice, fatigue,
nausea, vomiting, abdominal pain, dark urine/light stool, and fever.
There is no treatment for HAV; however, recovery occurs spontaneously
over a 3 to 6 month period. About 1 in 1,000 with HAV suffer from a
sudden and severe infection that may require a liver transplant. A
highly effective vaccine can prevent HAV. This vaccination is
recommended for all children and individuals who have chronic liver
disease or clotting factor disorders, in addition to those who travel
or work in developing countries.
hepatitis b
Hepatitis B (HBV) claims an estimated 5,000 lives every year in the
United States, even though therapies exist that slow the progression of
liver damage. Vaccines are available to prevent hepatitis B. This
disease is spread through contact with the blood and body fluids of an
infected individual and from an HBV infected mother to child at birth.
Unfortunately, due to both a lack in funding to vaccinate adults and
the absence of an integrated preventive education strategy,
transmission of hepatitis B continues to be problematic. Additionally,
there are significant disparities in the occurrence of chronic HBV-
infections. Asian Americans represent four percent of the population;
however, they account for over half of the 1.3 million chronic
hepatitis B cases in the United States. Current treatments do not cure
hepatitis B, but appropriate treatment can help to reduce the
progression to liver cancer and liver failure. Yet, many are not
treated. Preventive education and universal vaccination are the best
defenses against hepatitis B.
hepatitis c
Infection rates for hepatitis C (HCV) are at epidemic proportions.
Unfortunately, many individuals are not aware of their infection until
many years after they are infected. This creates a vicious cycle, as
individuals who are infected continue to spread the disease,
unknowingly. The Center for Disease Control and Prevention estimates
that there are over 4 million Americans who have been infected with
hepatitis C, of which over 2.7 million remain chronically infected,
with 8,000-10,000 deaths each year. Additionally, the death rate is
expected to triple by 2010 unless additional steps are taken to improve
outreach and education on the prevention of hepatitis C and scientists
identify more effective treatments and cures. As there is no vaccine
for HCV, prevention education and treatment of those who are infected
serve as the most effective approach in halting the spread of this
disease.
prevention is the key
The absence of information about the liver and hepatitis in
education programs over the years has been a major factor in the spread
of viral hepatitis through unknowing participation in liver damaging
activities. Adults and children need to understand the importance of
the liver and how viruses and drugs can damage its ability to keep them
alive and healthy. Many who are currently infected are unaware of the
risks they are taking that expose them to viral infections and ultimate
liver damage.
Knowledge is the key to prevention. Preventive education is
essential to motivate individuals to protect themselves and avoid
behaviors that can cause life-threatening diseases. Primary prevention
that encourages individuals to adopt healthful lifestyle behaviors must
begin in elementary schools when children are receptive to learning
about their bodies. Schools provide access to one-fifth of the American
population.
Individuals need to be motivated to assess their own risk
behaviors, to seek testing, to accept vaccination, to avoid spreading
their disease to others, and to understand the importance of
participating in their own health care and disease management. The NIH
needs to support education programs to train teachers and healthcare
providers in effective communication techniques, and to evaluate the
impact preventive education has on reducing the incidence of hepatitis
and substance abuse.
Therefore, HFI recommends that CDC, NIAID, NIDDK, NIAAA, NIDA, and
SAMHSA be urged to work with voluntary health organizations to promote
liver wellness, education, and prevention of viral hepatitis, sexually
transmitted diseases and substance abuse.
Only a major investment in immunization and preventive education
will bring these diseases under control. All newborns, young children,
young adults, and especially those who participate in high-risk
behaviors must be a priority for immunization, outreach initiatives,
and preventive education. We recommend that the following activities be
undertaken to prevent the further spread of all types of hepatitis:
--Provide effective preventive education in our elementary and
secondary schools so children can avoid the serious health
consequences of risky behaviors that can lead to viral
hepatitis.
--Train educators, health care professionals, and substance abuse
counselors in effective communication and counseling
techniques.
--Promote public awareness campaigns to alert individuals to assess
their own risk behaviors, motivate them to seek medical advice,
encourage immunization against hepatitis A and B, and to stop
the consumption of any alcohol if they have participated in
risky behaviors that may have exposed them to hepatitis C.
--Expand screening, referral services, medical management,
counseling, and prevention education for individuals who have
HCV, many of whom may be co-infected with HIV and Hepatitis C
and/or Hepatitis B.
centers for disease control and prevention (cdc)
HFI recommends an 8 percent increase in fiscal year 2007 for
further implementation of CDC's Hepatitis C Prevention Strategy. This
increase will support and expand the development of State-based
prevention programs by increasing the number of State health
departments with CDC funded hepatitis coordinators. The Strategy will
use the most cost-effective way to implement demonstration projects
evaluating how to integrate hepatitis C and hepatitis B prevention
efforts into existing public health programs.
CDC's Prevention Research Centers, an extramural research program,
plays a critical role in reducing the human and economic costs of
disease. Currently, CDC funds 26 prevention research centers at schools
of public health and schools of medicine across the country. HFI
encourages the subcommittee to increase core funding for these
prevention centers, as it has been decreasing since this program was
first funded in 1986. We recommend the subcommittee provide an 8
percent increase for the Prevention Research Centers program in fiscal
year 2007.
Also, HFI recommends that the CDC, particularly the Division of
Adolescent and School Health (DASH), work with voluntary health
organizations to promote liver wellness with increased attention toward
childhood education and prevention.
investments in research
Investment in the NIH has led to an explosion of knowledge that has
advanced understanding of the biological basis of disease and
development of strategies for disease prevention, diagnosis, treatment,
and cures. Countless medical advances have directly benefited the lives
of all Americans. NIH-supported scientists remain our best hope for
sustaining momentum in pursuit of scientific opportunities and new
health challenges. For example, research into why some HCV infected
individuals resolve their infection spontaneously may prove to be life
saving information for others currently infected. Other areas that need
to be addressed are:
--Reasons why African Americans do not respond as well as Caucasians
and Hispanics to antiviral agents in the treatment of chronic
hepatitis C.
--Pediatric liver diseases, including viral hepatitis.
--The outcomes and treatment of renal dialysis patients who are
infected with HCV and HBV.
--Co-infections of HIV/HCV and HIV/HBV positive patients.
--Hemophilia patients who are co-infected with HIV/HCV and HIV/HBV.
--The development of effective treatment programs to prevent
recurrence of HCV infection following liver transplantation.
--The development of effective vaccines to prevent HCV infection.
HFI supports a 5 percent increase for NIH in fiscal year 2007. HFI
also recommends a comparable increase of 5 percent in hepatitis
research funding at NIAID, NIDDK, NIAAA, and NIDA.
HFI is dedicated to the eradication of viral hepatitis, which
affects over 500 million people around the world. We seek to raise
awareness of this enormous worldwide problem and to motivate people to
support this important--and winnable--battle. Thank you for providing
this opportunity to present testimony.
______
Prepared Statement of In Defense of Animals
Six years ago, In Defense of Animals (IDA) testified before
Congress about the NIH's egregious oversight failures and illegal
funding of the New Mexico-based Coulston Foundation, at the time the
world's largest chimpanzee lab. IDA testified about Coulston's abysmal
animal care record and unprecedented violations, dating back to 1993,
of Federal animal welfare laws. IDA recommended, among other things, a
Congressional investigation.
Within weeks of IDA's March 2000 testimony, the NIH took ownership
of 288 chimpanzees from Coulston, citing concerns about the lab's
resources and ability to properly care for the animals, which IDA had
raised in our testimony. The NIH left the chimpanzees in Coulston's
``care'' and continued to illegally fund the lab despite its continued
animal welfare violations.
The NIH's Coulston oversight debacle resulted in international
media coverage, public outrage and intense Congressional scrutiny. As a
result, the NIH was finally forced to end its illegal funding of
Coulston in June 2001. The agency took over ownership of the lab where
the 288 chimpanzees were housed, renamed it the ``Alamogordo Primate
Facility'' (APF), and awarded a ten-year, $42 million taxpayer-funded
contract to Charles River Laboratories (CRL) to operate it. However,
the APF was now NIH-owned and part of the agency's Intramural Research
Program; the contract between the NIH and CRL explicitly states that
the NIH is responsible for ``day-to-day management'' of the lab,
including its ``associated animal activities.''
Subsequently, the House Committee on Energy and Commerce conducted
an investigation, and found that the NIH had indeed continued to fund
Coulston despite its violation of Federal administrative laws. This
prompted the Investigations subcommittee to question the NIH's
oversight and management of billions of dollars in taxpayer-funded
grants; this subcommittee consequently launched a broad investigation
of the NIH in March 2003.
Amazingly, six years after IDA's March 2000 testimony, the NIH
oversight debacle that launched a prior Congressional investigation is
actually worse, and cries out for Congressional action. That is because
in September 2004, New Mexico District Attorney Scot Key filed multiple
counts of criminal animal cruelty against CRL. After an independent
investigation that lasted almost one year, the D.A. found that it was
``standard practice'' for CRL to have trained animal care staff leave
at the end of the workday, and leave the ``care'' of critically ill or
injured chimpanzees to once-per-hour monitoring by untrained security
guards. This ``standard practice''--instituted in August 2002 as an
apparent cost-saving measure--resulted in the suffering and deaths of
two chimpanzees, Rex and Ashley, and the near-death of a third, Topsy.
The D.A. charged CRL and APF Director Rick Lee with three counts of
criminal cruelty alleging abandonment and failure to provide necessary
sustenance. This understaffed small-town D.A. with a caseload of
murders had stepped in to enforce the law and protect the chimpanzees
from a multi-billion dollar public company and a $28 billion Federal
agency. It should be noted that because the APF is now a Federal
research lab, the USDA has no jurisdiction under the Animal Welfare
Act. This was the first time in U.S. history that an entire lab had
been charged with criminal animal cruelty. This case, the culmination
of 10 years of NIH-funded abuse of these New Mexico chimpanzees,
contains shocking facts that cry out for further Congressional action.
Despite initial promises of cooperation, CRL instead hired a high-
powered criminal law firm perhaps best known for obtaining an acquittal
of a two-time husband killer after she had shot husband number two in
New Mexico. CRL refused to cooperate with the D.A.'s criminal
investigation. CRL refused to comply with the D.A.'s subpoena demanding
records relating to the three chimpanzees. The D.A. then obtained a
grand jury subpoena, but CRL still refused to supply the records to the
D.A. The NIH did nothing to force CRL to cooperate.
Tellingly, however, CRL did supply these records to an ad-hoc NIH
consultant with no law enforcement authority. During only a portion of
his one-day site visit, this veterinarian simply reviewed the records,
without interviewing a single witness, and, predictably, found no
problems. Neither the NIH nor CRL wanted an independent, legitimate law
enforcement officer, such as the D.A., to get within a mile of these
records, and did everything possible to prevent his obtaining them. The
NIH did not want any independent, legitimate investigation, since any
problems found would be an indictment of the agency's own management of
the lab. The NIH's responsibility for ``oversight'' at its own lab
constitutes an unmitigated conflict of interest. Had the NIH found a
chimpanzee shot in the head, the agency would no doubt have ruled it a
suicide.
Like CRL, the NIH has also refused to supply these records to the
public, even after IDA filed a Federal FOIA lawsuit in September 2004.
In its briefs, the NIH has actually claimed that it does not possess
these clinical records--for NIH-owned chimpanzees at an NIH-owned
facility that is part of the NIH's Intramural Research Program. This
laughable assertion is belied by the NIH's own contract with CRL, which
explicitly states that the NIH does indeed possess these records.
CRL submitted only one of two reports generated by the one-day NIH
site visit to the New Mexico court trying the criminal case--
predictably, the one praising CRL's veterinary care, which was based on
only a review of records, not any witness interviews nor an actual
investigation. However, the criminal charges had nothing to do with
CRL's veterinary care, but instead CRL's alleged ``standard practice''
of abandoning critically ill or injured chimpanzees to once-per-hour
monitoring by untrained security guards. The second report, written by
the NIH Project Officer for the CRL contract and obtained by IDA
through FOIA, clearly shows that the NIH was completely and totally
unaware of the abandonment alleged by the D.A.
During the time period covered by the multiple counts of criminal
animal cruelty, the NIH actually awarded CRL bonuses totalling $175,000
paid for with taxpayer funds. CRL received the maximum bonuses; the
major criterion for these bonuses was ``no animal care deficiencies.''
While the D.A.'s independent investigation--run by a 24-year police
veteran--took almost a year and interviewed six witnesses, including
eyewitnesses, the NIH interviewed no witnesses regarding Rex, Ashley
and Topsy and allowed the so-called ``investigation'' to be conducted
by CRL--another blatant conflict of interest. Because CRL refused to
cooperate--despite its initial promises--the D.A. could only interview
ex-CRL employees. But those ex-employees painted a devastating portrait
of the alleged acts of cruelty and CRL's operation of this NIH lab.
Dr. Kelly Avila started work at the APF only 58 days after she
graduated from veterinary school. She told the D.A.'s investigator that
she had been promised training, but instead found herself the main
clinician for over 250 chimpanzees. She confirmed that in August 2002,
APF Director Rick Lee instituted the policy where security guards would
take over for animal care at quitting time, 4:00 p.m. She repeatedly
stated that Ashley, the first chimpanzee mentioned in the criminal
charges, had shock. Avila had ``serious problems'' with APF practices,
and discussed problems associated with having security/maintenance
personnel perform animal care. She started a system of writing daily
reports of what she found on exams and also which chimpanzees were sick
and needed monitoring; apparently no such systemic surveillance existed
before her arrival. Being fresh out of vet school, she also said she
felt she had to defer to the more-experienced vets Lee and Langner. She
stated that financial considerations played a role in the standard of
care; if she wanted an animal care staffer to stay past quitting time
she would have to go through Andrea Lee, the APF's Program
Administrator and wife of Director Rick Lee. That would have ``meant
that Dr. Lee's wife would have gotten all over my case for overtime.''
Avila said that it was ``always a fight'' with Andrea Lee--who had no
veterinary training whatsoever--and that the ``veterinary staff . . .
either cowed down to this lady or you had to leave.'' Avila also stated
that Rick Lee, instead of training her as promised, ``spent his time in
the office doing director kind of activities,'' and that she hardly
ever saw him. Instead, she said her mentors included an online message
board, the Veterinary Information Network (VIN).
Dr. Avila posted dozens of messages to the VIN during her year
working at the APF. Perhaps the most devastating was posted on
September 16, 2002, only hours before Ashley died. Avila explains
Ashley's condition, that she was bleeding from a fight and suffered
from a condition that makes blood clotting more difficult. After
describing how she had treated Ashley to that point, she then asks the
chilling, all-revealing question: ``Does anyone have other ideas on how
to treat?'' Many of these messages demonstrate a facility in disarray,
and a veterinarian fresh out of vet school who was trying to do the
right thing but was clearly in over her head. Avila asked for advice on
almost every conceivable subject relating to chimpanzee care: reference
texts for chimpanzee nutrition (she noticed what she thought were signs
of malnutrition); how to conduct biopsies and take bone marrow samples;
how to treat hypertension; how to interpret ultrasounds and x-rays. She
repeatedly stated that she conducted her own medical literature
searches in attempts to find treatments. She tells of her APF
colleagues' ignorance of specific treatments and dangerous side effects
of drugs. In a May 23, 2003 post, she states ``I recently lost my fifth
chimp,'' then describes how a chimp died after a tooth extraction.
Importantly, she states that this chimp had a history of suffering from
grand mal seizures when given ketamine, which is one of the only two
sedatives allowed at the APF (the other is pharmacologically similar to
ketamine), and says that she had just been lucky prior to that because
she had given him only very small doses as supplements. She states this
is one of the reasons she is resigning. She tells VIN that respiratory
diseases, measles and chicken pox have been passed to the chimps from
human employees over the past year. She asks about vaccinations,
questioning why the APF only vaccinates against tetanus, and is told
that there is a standard series of vaccinations recommended for
chimpanzees, which includes tetanus, measles, mumps and rubella. She
describes her fight against a drug company trying to test a drug for
hepatitis C on chimpanzees, since the side effects in humans are so
severe and she is concerned that the chimpanzees would suffer, while
relating that she ``dislike[s] the pressure greatly'' that she is
getting from the drug company to perform the study. For one chimpanzee,
she is ``at her wits end'' in trying to find a treatment; one she had
previously used ``led to more edema so I won't be doing that again. Oh
well I guess I am learning here,'' and then asks for suggestions on how
to treat. She asks if anyone knows of a procedure for tapping the heart
(fluid) of a chimpanzee, and asks ``Do I proceed as I would with a
dog?'' In another revealing post, she asks if anyone has experience
with using steroids as an appetite stimulant in chimpanzees, for a 40-
year-old. Other vets chime in, saying that old age is not a disease,
and that this and some of her other posts indicate that she is treating
symptoms, not trying to get diagnosis so she can treat an underlying
disease. Avila responds with a devastating indictment of the APF
operation: ``I am working at getting actual diagnosis before I continue
treatments. There is great resistance to this as the old adage `if it
ain't broke don't fix it' applies here on a regular basis! However, it
is against my nature to give up and allow people to act foolishly while
I clean up the mess they leave behind so I will continue to try to find
specific diagnosis and treat those whenever I can.'' A similar post
concerns a self-mutilating chimpanzee; Avila is concerned about the
long-term effects of Prozac. Vets chime in again that she should try to
determine the underlying cause of the self-mutilation; one vet relates
that's what she did, and was able to stop the mutilation and wean a
baboon off of Prozac. Avila states that the APF behaviorist pretty much
wants to keep the chimpanzee on Prozac forever, and agrees that she
should try to find the underlying cause of the self-mutilation.
Maintenance man Ernest Farwell went into great detail about the
cases of Rex and Ashley to the D.A.'s investigator. He confirms Dr.
Avila's recollection that August 2002 is when CRL instituted the policy
of having maintenance/security, such as Farwell, take over from animal
care after quitting time. Like the other maintenance man interviewed,
Benjamin Thompson, Farwell confirmed that he received no special
training in chimpanzee care. He saw Rex unconscious, lying on his side
with his mouth open, vomiting, and an animal care staffer suctioning
out the vomit with an evacuation wand. He witnessed Dr. Avila say to
the animal care staffer ``We have to go, he won't let us stay.'' The
animal care staffer then actually removed Rex's life support, and he
and Avila left while Rex was still unconscious and vomiting. Farwell
later witnessed Rex on his side, but with the vomit coming out of his
mouth (since no one was there to suction it out). Rex was found dead
later that night; the pathology report showed vomit in his mouth and
trachea. Farwell also witnessed Ashley; when he first saw her, he was
shocked at the amount of blood in her cage, and she was still bleeding.
He then witnessed her shake violently; this was the symptom of shock
mentioned by Dr. Avila in her witness statement. Later he found her
dead. Farwell also states that APF employees were threatened with
polygraph tests when Rick Lee was trying to find out who gave
information to the D.A. about the alleged cruelty, and were ordered not
to speak with anyone, including the D.A., about the allegations. Such
threats violate the 1988 Federal Employee Polygraph Protection Act.
This climate of intimidation was also apparent when Farwell complained
about having to give medicine to chimpanzees, protesting that he wasn't
qualified, explaining ``If animal care found a problem with the boilers
you wouldn't expect them to fix it.'' He was then written up and felt
threatened, and signed an agreement that he would perform these duties
(i.e., care of chimpanzees) and anything else CRL told him to, for
apparent fear of losing his job.
The APF had problems from day one; for the first 6 months, the
facility did not have requirements for care as basic as euthanasia
drugs. This resulted in chimpanzee suffering; CRL actually had to
borrow euthanasia drugs from the Coulston Foundation, which was
offsite, miles away, and almost bankrupt. Although the chimpanzees
lacked for drugs, APF Program Administrator Andrea Lee--who made
decisions on animal care overtime--had plenty; in 2004, she was
criminally charged with 15 counts of fraudulently obtaining a
controlled substance (Vicodin). She had been illegally using the DEA
licenses of two APF veterinarians--at a taxpayer-funded facility--and
pled guilty to one count. APF veterinarian Cynthia Doane--not the NIH
or CRL management--became suspicious and began to investigate. Further
buttressing the existence of a climate of intimidation and fear at the
APF, Doane wrote a letter to the New Mexico Board of Pharmacy in April
2004, stating her willingness to help in the investigation, but that
``I emphasize, however, that I cannot trust anyone at my place of work
at this time.''
Instead of proclaiming its innocence by demanding its day in court,
CRL, presumably with the NIH's blessing, threw up one legal
technicality after another in a prolonged effort to hide from the
evidence accumulated by the D.A. and to prevent a jury, and the public,
from ever seeing it argued in open court. CRL claimed that the State of
New Mexico had no jurisdiction to prosecute its own animal cruelty
statute because the APF was located on a Federal Air Force Base,
despite the fact that the New Mexico legislature had specifically
amended its cruelty statute in 2001 because of the chimpanzee abuses at
this very same facility. This amendment gave the D.A. the legal
authority to prosecute CRL. The company claimed that because the New
Mexico cruelty statute did not require qualified personnel, there was
no abandonment because untrained security guards were in the vicinity
of the critically ill or injured chimpanzees (once per hour). And in
the most egregious of all the technicalities, CRL actually claimed that
it was engaged in the practice of veterinary medicine in the cases of
Rex, Ashley and Topsy, and because the cruelty statute exempts the
practice of veterinary medicine, the case should be dismissed. In other
words, according to CRL and the NIH, the deliberate policy of denying
veterinary care constitutes the practice of veterinary care.
Incredibly, the judge agreed with that technicality, and dismissed the
case--a dismissal having nothing to do with the merits of the D.A.'s
investigation or case. The D.A. appealed, and the case is currently
being adjudicated at the New Mexico Court of Appeals, the State's
second-highest court.
recommendations
IDA believes that given the NIH's egregious record, Congress should
both investigate and hold hearings, not only into the NIH/Coulston/
Charles River debacle, but the larger oversight issues raised by the
NIH's actions. One would have thought that, given the years of Coulston
Foundation administrative animal welfare violations, the NIH would have
been that much more careful in choosing and overseeing a successor.
Instead, the facility--now directly owned and managed by the NIH--
descended into alleged criminal animal cruelty. Given the NIH's ten-
year record of funding abuse against these chimpanzees, we respectfully
request that the NIH be barred from any responsibility whatsoever for
them. These chimpanzees have endured enough; the survivors should be
placed at a reputable private sanctuary for permanent retirement, with
the remainder of the $42 million contract going to the sanctuary. This
would be the morally and ethically correct course of action that is so
greatly overdue for these long-suffering chimpanzees.
______
Prepared Statement of Independence Technology
Mr. Chairman and members of the subcommittee, my name is Gregg
Howard and I am the Vice President for Sales and Reimbursement for
Independence Technology, LLC, a Johnson & Johnson company. I appreciate
the opportunity to provide comments in support of the many programs
within the jurisdiction of the subcommittee that are important to
citizens with disabilities.
The Institute of Medicine report, ``Disability in America: Toward a
National Agenda,'' began with the words ``Disability is an issue that
affects every individual, community, neighborhood, and family in the
United States.'' These words are as true today as when the IOM
published its report.
The demographic imperative resulting from the aging of the baby
boom generation will soon substantially increase the proportion and
numbers of Americans in the older age groups that are most at risk of
physical and mental impairments, limitations, and disabilities. At the
same time, certain trends in other age groups--for example, the
increased rates of survival of extremely premature infants, increases
in the prevalence of obesity in younger populations and a growing
number of disabled Iraq era veterans--are putting more children and
younger adults at risk of disabling conditions. Thus, the promotion of
good health, independence, and social integration for people with
disabilities and the prevention of disabling injuries, diseases, and
disorders are more important objectives than ever.
Mr. Chairman, the Labor, Health and Human Services, and Education
subcommittee funds the significant majority of Federal programs of
interest and benefit to citizens with disabilities. These programs are
in the Department of Labor, the Department of Health and Human
Services, and the Department of Education. At the end of this
statement, we list these many programs in tabular form and include a
fiscal year 2007 funding recommendation for each of these programs. We
join with the 100 plus organizations of Consortium for Citizens with
Disabilities in making these recommendations and would urge the
subcommittee's efforts to address these funding needs.
Mr. Chairman, also very importantly, the Social Security
Administration, Medicare and Medicaid programs are of significant
importance for citizens with disabilities. While these programs are
mostly viewed as entitlements and therefore fall in the jurisdiction of
the Senate Finance Committee and House Ways and Means Committee, your
subcommittee appropriates administrative funds that permit the
operations of these programs. On behalf of Independence Technology,
LLC, I would like to highlight a matter currently under consideration
by administrative personnel at Medicare that will have an important
impact on the lives of many disabled Americans.
Independence Technology, LLC, has invested over $100 million over
the last decade to develop a revolutionary new mobility system that
allows individuals with disabilities to achieve extensive function and
the physical mobility necessary in order to live independently. This
innovative technology is the first of its kind to largely eliminate
barriers by climbing stairs, improving reach, transversing various
surfaces, and balancing the seated user at standing eye level. For many
this technology can take the place of more costly and/or drastic
alternatives such as moving from one's home, extensive home
modifications, use of home health aides, and unnecessary
institutionalization or bed confinement.
While this new technology is clearly not appropriate for all
individuals with mobility impairments, for the subset disabled of
individuals for whom it is appropriate, it is a life changing device
which improves health, functional status, independent living, and
quality of life. In 2002 and 2003 the Veterans Health Administration
evaluated these devices and made a determination as to which subset of
disabled veterans could appropriately benefit from the device. Based on
this review and policy determination, the Veterans Health
Administration now prescribes and provides financial support for the
procurement of these devices.
Currently underway at CMS is a similar review process. On January
26, 2006 CMS posted for public comment the application by Independence
Technology, LLC, for the development of a National Coverage
Determination for an interactive balancing mobility system such as the
iBOT. A total of 151 comments were presented to CMS by patients,
disability groups, health care providers, and others affected by
disabilities. Letters were also sent in support of the application by
10 U.S. Senators and approximately 20 House Members. Overall, 97
percent of the comments provided to CMS on this matter were positive.
The comment period for establishing a National Coverage
Determination for ``interactive balancing mobility systems'' closed on
March 5, 2006. CMS now has up to 6 months to announce a decision on the
question of proceeding to the development of a National Coverage
Determination. It is our view that the establishment of coverage
criteria for this new state-of-the-art interactive balancing mobility
systems sends an important message that when research and development
results in technological advancements improving the health, functional
status, independent living, and quality of life, these advances will be
made accessible to those who will benefit.
Mr. Chairman, in summary we appreciate the leadership of you and
your subcommittee in championing so many important programs of benefit
to disabled Americans. While we recognize the limitations placed on the
subcommittee by spending ceilings, we would urge your careful review
and considerations of the funding recommendations found at the end of
this statement. We would also request the subcommittee's support and
direct guidance to CMS to support reimbursement policies that will help
bring new technological advances such as the iBOT to disabled Americans
who stand to benefit from their use.
Thank you for the opportunity to testify.
APPROPRIATIONS RECOMMENDATIONS FOR FISCAL YEAR 2007
[In millions of dollars]
------------------------------------------------------------------------
Fiscal year
Fiscal year 2007 Fiscal year
2006 final President 2007 CCD
------------------------------------------------------------------------
DEPARTMENT OF LABOR
Workforce Investment Act
(selected programs):
Adult Employment............. 857.0 712.0 987.9
Pilots, Demonstrations, 29.7 17.7 151.0
Research....................
Youth Activities............. 940.5 840.5 1,093.4
Office of Disability Employment 27.7 20.0 47.5
Policy..........................
Work Incentives Grants........... 19.5 ........... 20.7
DEPARTMENT OF HEALTH AND HUMAN
SERVICES
Health Services Resources
Administration:
Maternal & Child Health Block 693.0 693.0 724.0
Grant.......................
Developmental Disabilities
Act Programs:
Basic State Grants-- 71.8 72.0 84.5
Councils on DD..........
Protection & Advocacy 38.7 39.0 45.0
Systems--DD.............
University Centers for 33.2 33.0 37.0
Excellence in DD........
Projects of Nat'l Sig. & 11.4 11.0 22.6
Family Support..........
TBI State Grants............. 9.0 ........... 15.0
TBI Protection & Advocacy 3.1 ........... 6.0
Grants......................
Universal Newborn Hearing 10.0 ........... 10.0
Screening...................
Centers for Disease Control and
Prevention:
Birth Defects, Developmental 124.7 110.5 137.6
Disabilities, & Health......
Chronic Disease Prevention... 836.6 818.7 417.4
Environmental Health......... 149.9 141.0 153.0
Preventive Health Block Grant 99.0 ........... 133.6
Injury Prevention and Control 139.0 138.2 142.8
Epilepsy Program............. 7.7 ........... 8.0
TBI Registries and 5.3 5.3 9.0
Surveillance................
National Institutes of Health.... 28,578.0 28,578.0 29,750.0
Natl. Institute of Child 1,264.7 1,257.0 1,327.9
Health and Hum. Dev.........
Natl. Institute on Deafness & 393.0 392.0 412.7
Other Communication
Disorders...................
Natl. Inst. of Neurological 1,534.8 1,525.0 1,611.5
Disorders & Stroke..........
Natl. Institute on Mental 1,403.8 1,395.0 1,474.0
Health......................
Natl. Institute on Drug Abuse 1,000.0 995.0 1,050.0
Natl. Institute on Alcohol 435.9 433.0 457.7
Abuse.......................
Social Services Block Grant...... 1,683.0 1,200.4 2,380.0
Child Care & Development Block 2,062.1 2,062.0 2,588.0
Grant...........................
Head Start....................... 6,876.0 6,786.0 7,300.0
Child Abuse Prevention and 95.2 101.0 142.0
Treatment Act...................
Nat'l Family Caregiver Support 162.0 160.0 162.0
Program.........................
Grants to States to Remove 10.9 10.9 25.0
Barriers to Voting..............
Protection & Advocacy for Voting 4.9 4.8 10.0
Access..........................
SAMHSA:
Children's Mental Health 104.1 104.1 109.7
Services....................
PATH Homeless Program........ 54.3 54.3 57.1
Protection & Advocacy for 34.0 34.0 40.0
Indivs. with MI.............
Mental Health Block Grant.... 428.5 428.5 451.2
Projects of Regional and 263.2 228.1 285.9
Nat'l Significance..........
DEPARTMENT OF EDUCATION
Individuals with Disabilities
Education Act:
State and Local Grants Part B 10,582.8 10,682.9 16,938.9
Preschool Grants............. 380.8 380.8 841.0
Early Intervention Part C.... 436.4 436.4 680.0
Part D National Programs:
State Personnel 50.1 ........... 55.7
Development.............
Technical Assistance and 48.9 48.9 57.6
Dissemination...........
Personnel Preparation.... 89.7 89.7 108.7
Parent Information 25.7 25.7 28.6
Centers.................
Technology and Media..... 38.4 31.1 42.6
Transition Initiative.... ........... 2.0 5.5
Research and Innovation (Inst. 81.7 81.7 92.4
Ed. Sciences)...................
Rehabilitation Services
Administration:
Rehabilitation State Grant... 2,693.0 2,837.2 3,120.0
Client Assistance Programs... 11.8 11.8 13.0
Rehabilitation Training...... 38.4 38.4 42.7
Special Demonstrations....... 6.5 6.5 28.1
Recreation................... 3.0 ........... 3.0
Protection & Advocacy for 16.5 16.5 22.0
Individual Rights...........
Projects with Industry....... 20.0 ........... 50.0
Supported Employment State 29.7 ........... 50.0
Grant.......................
Migrant & Seasonal Farm 2.0 ........... 2.3
workers.....................
Independent Living State 22.6 22.6 25.0
Grant.......................
Centers for Independent 74.6 74.6 82.9
Living......................
Independent Living Serv. for 32.9 32.9 36.5
Older Blind Ind.............
State Assistive Technology 22.4 22.4 29.0
Programs and TA.............
Protection & Advocacy for 4.4 ........... 6.0
Assistive Tech..............
National Institute for Disability 106.7 106.7 120.0
& Rehabilitation Research.......
Demonstration Projects-Disability 6.9 ........... 10.0
(Higher Ed.)....................
National Council on Disability... 3.1 2.8 3.7
Helen Keller National Center..... 8.5 8.5 11.7
American Printing House for the 17.6 17.6 20.0
Blind...........................
------------------------------------------------------------------------
______
Prepared Statement of the International Foundation for Functional
Gastrointestinal Disorders
summary of fiscal year 2007 recommendations
--Provide a 5 percent increase for fiscal year 2007 to the National
Institutes of Health (NIH) budget. Within NIH, provide
proportional increases of 5 percent to the various institutes
and centers, specifically, the National Institute of Diabetes
and Digestive and Kidney Diseases (NIDDK).
--Accelerate funding for extramural clinical and basic functional
gastrointestinal disorders (FGID) and motility disorders
research at NIDDK.
--Continue to urge NIDDK to develop a strategic plan on irritable
bowel syndrome (IBS) with the purpose of setting research
goals, determining improved treatment options for IBS
sufferers, and assisting in recruitment of new investigators to
conduct IBS research.
--Urge the National Institute of Child Health and Human Development
(NICHD) and NIDDK to continue to support research into fecal
and urinary incontinence, including the development of a
standardization of scales to measure incontinence severity and
quality of life and to develop strategies for primary
prevention of fecal incontinence associated with childbirth.
--Provide funding to NIDDK and the National Cancer Institute (NCI)
for more research on the causes of esophageal cancer.
Chairman Specter and members of the subcommittee, thank you for the
opportunity to present this written statement regarding the importance
of functional gastrointestinal and motility disorders research. IFFGD
has been serving the digestive disease community for fifteen years. We
work to broaden the understanding about functional gastrointestinal and
motility disorders in adults and children. IFFGD speaks about and
raises awareness on disorders and diseases that many people are
uncomfortable and embarrassed to talk about. The prevalence of fecal
incontinence and irritable bowel syndrome or IBS, as well as a host of
other gastrointestinal disorders affecting both adults and children, is
underestimated in the United States. These conditions are truly hidden
in our society. Not only are they misunderstood, but also the burden of
illness and human toll has not been fully recognized.
Since its establishment, the IFFGD has been dedicated to increasing
awareness of functional gastrointestinal and motility disorders, among
the public, health professionals, and researchers. While maintaining a
high level of public education efforts, the IFFGD has also become
recognized for our professional symposia. We consistently bring
together a unique group of international multidisciplinary
investigators to communicate new knowledge in the field of
gastroenterology. In the spring of 2007, IFFGD will be hosting our
Seventh International Symposium on Functional Gastrointestinal
Disorders, bringing scientists, researchers, and clinicians from across
the world together to discuss the current science and opportunities on
IBS and other functional gastrointestinal and motility disorders. Also,
in November of 2002, we hosted a conference on fecal and urinary
incontinence, the proceedings of which were published in
Gastroenterology, the official journal of the American
Gastroenterological Association (AGA). The IFFGD has also been working
with the National Institute of Child Health and Human Development
(NICHD), the National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK), and the Office of Medical Applications of Research
(OMAR) in the NIH Office of the Director on the State of the Science
Conference on Fecal and Urinary Incontinence.
The majority of the diseases and disorders we address have no cure.
We have yet to completely understand the pathophysiology of the
underlying conditions. Patients face a life of learning to manage
chronic illness that is accompanied by pain and an unrelenting myriad
of gastrointestinal symptoms. The costs associated with these diseases
are enormous; estimates range from between $25-$30 billion annually.
The human toll is not only on the individual but also on the family.
Economic costs spill over into the workplace. In essence, these
diseases reflect lost potential for the individual and society. The
IFFGD is a resource and provides hope for hundreds of thousands of
people as they try to regain as normal a life as possible.
irritable bowel syndrome (ibs)
IBS strikes people from all walks of life affecting between 25 to
45 million Americans and results in significant human suffering and
disability. This chronic disease is characterized by a group of
symptoms, which include abdominal pain or discomfort associated with a
change in bowel pattern, such as loose or more frequent bowel
movements, diarrhea, and/or constipation. Although the cause of IBS is
unknown, we do know that this disease needs a multidisciplinary
approach in research and often treatment.
IBS can be emotionally and physically debilitating. Because of
persistent bowel irregularity, individuals who suffer from this
disorder may distance themselves from social events, work, and even may
fear leaving their home.
In the House and Senate fiscal years 2004, 2005, and 2006 Labor,
Health and Human Services, and Education Appropriations bills, Congress
recommended that NIDDK develop an IBS strategic plan. The development
of a strategic plan on IBS would greatly increase the institute's
progress toward the needed research on this functional gastrointestinal
disorder, as well as serve to advance our understanding of this
disease, determine improved treatment options for IBS sufferers, and
assist in recruiting new investigators to conduct IBS research. NIDDK
is formulating an action plan for digestive diseases through the
National Commission on Digestive Diseases and has indicated that IBS
will be included as a component of this overall plan. IBS must be given
sufficient attention, however, in order to increase the FGID and
motility disorders research portfolio at NIDDK.
fecal incontinence
At least 6.5 million Americans suffer from fecal incontinence.
Incontinence is neither part of the aging process nor is it something
that affects only the elderly. Incontinence crosses all age groups from
children to older adults, but is more common among women and in the
elderly of both sexes. Often it is a symptom associated with various
neurological diseases and many cancer treatments. Yet, as a society, we
rarely hear or talk about the bowel disorders associated with multiple
sclerosis, diabetes, colon cancer, uterine cancer, and a host of other
diseases.
Damage to the anal sphincter muscles; damage to the nerves of the
anal sphincter muscles or the rectum; loss of storage capacity in the
rectum; diarrhea; or pelvic floor dysfunction can cause fecal
incontinence. People who have fecal incontinence may feel ashamed,
embarrassed, or humiliated. Some don't want to leave the house out of
fear they might have an accident in public. Most try to hide the
problem as long as possible. They withdraw from friends and family, and
often limit work or education efforts. Incontinence in the elderly
burdens families and is a major reason for nursing home admissions, an
already huge social and economic burden in our increasingly aging
population.
In November 2002, the IFFGD sponsored a consensus conference--
``Advancing the Treatment of Fecal and Urinary Incontinence Through
Research: Trial Design, Outcome Measures, and Research Priorities.''
Among other outcomes, the conference resulted in six key research
recommendations:
1. More comprehensive identification of quality of life issues
associated with fecal incontinence and improved assessment and
communication of treatment outcomes related to quality of life.
2. Standardization of scales to measure incontinence severity and
quality of life.
3. Assessment of the utility of diagnostic tests for affecting
management strategies and treatment outcomes.
4. Development of new drug compounds offering new treatment
approaches to fecal incontinence.
5. Development and testing of strategies for primary prevention of
fecal incontinence associated with childbirth.
6. Further understanding of the process of stigmatization as it
applies to the experience of individuals with fecal incontinence.
The IFFGD has been working with the NICHD, NIDDK, and OMAR on a
State of the Science Conference on Fecal and Urinary Incontinence. The
goal of this conference will be to assess the state of the science and
outline future priorities for research on both fecal and urinary
incontinence; including, the prevalence and incidence of fecal and
urinary incontinence, risk factors and potential prevention,
pathophysiology, economic and quality of life impact, current tools
available to measure symptom severity and burden, and the effectiveness
of both short and long term treatment. Once the conference is
completed, the NIH must prioritize implementation of the
recommendations of this important conference.
gastroesophageal reflux disease (gerd)
Gastroesophageal reflux disease, or GERD, is a common disorder
affecting both adults and children, which results from the back-flow of
acidic stomach contents into the esophagus. GERD is often accompanied
by persistent symptoms, such as chronic heartburn and regurgitation of
acid. But sometimes there are no apparent symptoms, and the presence of
GERD is revealed when complications become evident. One uncommon
complication is Barrett's esophagus, a potentially pre-cancerous
condition associated with esophageal cancer. Symptoms of GERD vary from
person to person. The majority of people with GERD have mild symptoms,
with no visible evidence of tissue damage and little risk of developing
complications. There are several treatment options available for
individuals suffering from GERD.
Gastroesophageal reflux (GER) affects as many as one-third of all
full term infants born in America each year. GER results from an
immature upper gastrointestinal motor development. The prevalence of
GER is increased in premature infants. Many infants require medical
therapy in order for their symptoms to be controlled. Up to 25 percent
of older children and adolescents will have GER or GERD due to lower
esophageal sphincter dysfunction. In this population, the natural
history of GER is similar to that of adult patients, in whom GER tends
to be persistent and may require long-term treatment.
gastroparesis
Gastroparesis, or paralysis of the stomach, refers to a stomach
that empties slowly. Gastroparesis is characterized by symptoms from
the delayed emptying of food, namely: bloating, nausea, vomiting or
feeling full after eating only a small amount of food. Gastroparesis
can occur as a result of several conditions; it can occur in up to 30
percent to 50 percent of patients with diabetes mellitus. A person with
diabetic gastroparesis may have episodes of high and low blood sugar
levels due to the unpredictable emptying of food from the stomach,
leading to diabetic complications. Other causes of gastroparesis
include Parkinson's disease and some medications, especially narcotic
pain medications. In many patients a cause of the gastroparesis cannot
be found and the disorder is termed idiopathic gastroparesis. Over the
last several years, as more is being found out about gastroparesis, it
has become clear this condition affects many people and the condition
can cause a wide range of symptoms of differing severity.
esophageal cancer
Approximately 13,000 new cases of esophageal cancer are diagnosed
every year in this country. Although the causes of this cancer are
unknown, it is thought that this cancer may be more prevalent in
individuals who develop Barrett's esophagus. Diagnosis usually occurs
when the disease is in an advanced stage; early screening tools are
currently unavailable.
childhood defecation disorders and diseases
Chronic Intestinal Pseudo-Obstruction (CIP).--About 200 new cases
of CIP are diagnosed in American Children each year. Often life
threatening, the future for children severely affected with CIP is
brightened by the evolving promise of cure with intestinal or multi-
organ transplantation.
Hirschsprung's Disease.--A serious childhood and sometimes life-
threatening condition that can cause constipation, occurs once in every
5,000 American children born each year. Approximately 20 percent of
children with HD will continue to have complications following surgery.
These complications include infection and/or fecal incontinence.
Functional Constipation.--Millions of children (1 in every 10) each
year will be diagnosed with functional constipation. In fact, it is the
chief complaint of 3 percent of pediatric outpatient visits and 10-25
percent of pediatric gastroenterology visits.
functional gastrointestinal and motility disorders and the national
institutes of health
The International Foundation for Functional Gastrointestinal
Disorders recommends an increase of 5 percent for NIH overall, and a 5
percent increase for NIDDK and NICHD. However, we request that this
increase for NIH does not come at the expense of other Public Health
Service agencies.
We urge the subcommittee to provide the necessary funding for the
expansion of the NIDDK's research program on functional
gastrointestinal disorders (FGID) and motility disorders. This
increased funding will allow for the growth of new research on FGID and
motility disorders at NIDDK, a strategic plan on IBS, and increased
public and professional awareness of FGID and motility disorders. In
addition, we urge the subcommittee to continue to support and provide
adequate funding to the Office of Research on Women's Health (ORWH)
under the NIH Office of the Director, particularly for their
Specialized Centers of Research on Sex and Gender Factors Affecting
Women's Health (SCORs) program and the Building Interdisciplinary
Research Careers in Women's Health (BIRCWH) program. The ORWH supports
important research into IBS.
A primary tenant of IFFGD's mission is to ensure that clinical
advancements concerning GI disorders result in improvements in the
quality of life of those affected. By working together, this goal will
be realized and the suffering and pain millions of people face daily
will end.
Thank you.
______
Prepared Statement of the Industrial Minerals Association--North
America
It appears that the President's 2007 Budget for the Centers for
Disease Control (CDC) includes a proposed reduction from $255.2 million
to $250.2 million in funding for the National Institute for
Occupational Safety and Health (NIOSH). IMA-NA notes that the fiscal
year 2007 estimate carries forward fiscal year 2006 Conference language
to move management and administrative costs ($34.8 million) from
Occupational Safety and Health to Business Services Support. However,
please note that the portion of the NIOSH budget to cover CDC overhead
apparently has increased from 4.3 percent of NIOSH's budget in 2001 to
nearing 14 percent in fiscal year 2007. This fee appears to be taking
an increasingly larger share of NIOSH funds that otherwise would be
dedicated to occupational safety and health research. IMA-NA encourages
you to fund NIOSH as a stand-alone agency within the HHS organizational
structure.
IMA-NA also favors increasing the fiscal year 2007 budget to expand
the NIOSH in-house mining research program. Recent mining fatalities in
the underground coal-mining sector have highlighted the need for a
forward-looking initiative to improve mine emergency communications and
to develop reliable technologies for tracking the location of
underground miners. While IMA-NA supports these research initiatives,
there is concern that other critical mine safety and health-related
research important to the industrial minerals sector could be affected
adversely. IMA-NA encourages you to fund NIOSH mining-related
occupational safety and health research programs above current funding
levels to address such critical issues as cumulative musculoskeletal
trauma, dust control, and noise-induced hearing loss.
The Industrial Minerals Association--North America (IMA-NA) is a
trade association organized to advance the interests of North American
companies that mine or process industrial minerals. These minerals are
used as feedstocks for the manufacturing and agricultural industries
and are used to produce such essential products are glass, paints and
coatings, ceramics, detergents and fertilizers. The IMA-NA membership
includes producers of ball clay, bentonite, borates, feldspar,
industrial sand, mica, soda ash (trona), sodium silicate, talc and
wollastonite. IMA-NA's membership also includes many of the suppliers
to the industrial minerals industry, including equipment manufacturers,
railroads and trucking companies, and consultants.
IMA-NA respectfully requests your support in opposing reductions in
funding for occupational safety and health research, particularly as
they affect mine safety and health. In the latter regard, we
respectfully request additional funding above current levels.
______
Prepared Statement of the HHT Foundation International
Mr. Chairman and honorable members of the committee, thank you for
the opportunity to present my family's story in this testimony in
support of the HHT Foundation's legislative initiative. I would like
express my appreciation to Congresswoman DeLauro for all of her
assistance to make this testimony possible.
My name is Jane Ribicoff Silk, I was fortunate to be the daughter
of the former Senator Abraham & Mrs. Ruth Ribicoff, but I was
unfortunate to have inherited Hereditary Hemorrhagic Telangiectasia
(HHT). I am also the past president of the HHT Foundation,
International.
HHT is a hidden killer: 20 percent of people with HHT die early or
are disabled due to lung or brain involvement.
It is estimated that 70,000-100,000, or 1 in 3,000-5,000 Americans,
are affected with Hereditary Hemorrhagic Telangiectasia (HHT). HHT is a
genetic disorder, which affects blood vessels of the brain, spinal
cord, lung, liver, gastrointestinal tract and most commonly, the nose.
The affected blood vessels of the brain, spinal cord, and lung are
prone to rupture and may result in stroke, hemorrhage or death.
Bleeding from the nose and gastrointestinal tract can cause transfusion
dependency and anemia, which can lead to heart failure. HHT can be
treated successfully if correctly diagnosed. Children of an affected
parent have a 50 percent chance of inheriting HHT.
disability and death can be prevented with proper diagnosis, screening
and treatment.
Nine of 10 people with HHT are not yet diagnosed due to widespread
lack of knowledge by medical professionals.
HHT is a national health problem associated with high health care
costs that has long been neglected.
From the time I was a very young child, I experienced the trauma of
my grandmother's severe hemorrhages of the nose. The bleeding would not
stop. The ambulance came. My grandmother went to the hospital where she
received multiple transfusions of blood and came back home, her nose
packed with gauze--and still bleeding. This was not an infrequent
occurrence. In between her severe nosebleeds, there would be daily
nosebleeds lasting for more than an hour. My grandmother died at the
age of 67 from a transfusion tainted with hepatitis. The severity of my
grandmother's bleeding, and the number of transfusions she needed to
keep her alive, can now be prevented with modern therapy.
I realized at an early age that my mother, Ruth Ribicoff, also had
a bleeding problem. She bled from her nose multiple times a week and
every few months was hospitalized for transfusions due to blood loss.
In her mid forties, it was discovered that she was also bleeding from
her intestines. Additionally, she had HHT in her liver which caused her
heart to pump harder and to enlarge. This eventually led to heart
failure. She was often weak and never robustly energetic. Being the
wife of a busy congressman, governor, cabinet member and senator put an
additional social strain on my mother as she never knew at what
inopportune moment she might get a bad nosebleed. Every purse she owned
was stocked with a good supply of cotton.
In 1972, my mother died at the age of 64 of complications of the
liver, intestinal bleeding and nosebleeds that are treatable today.
Even today, it is still not recognized that 9 out of 10 people with HHT
are not diagnosed.
My older brother, Peter, has carried the family burden of HHT
almost his whole life and is the most impaired of all of us. His
quality of life has been greatly diminished and he suffers every day.
As a young boy he had occasional nosebleeds. When he was in his 20's he
started getting backaches. He went to several doctors who could not
help him, including Dr. Janet Travell, President Kennedy's personal
back specialist. When he was in his 30's he began to lose sensation in
the tops of his legs. An astute physician took some x-rays and noticed
some dark spots around his spine. The only doctor in the world at that
time, who used dye to see the blood vessels in the spinal cord, was in
Paris. So, my brother took his young family and went to Paris. During
his hospitalization, he was told to go home and have exploratory
surgery on his spine as there were malformations there that were most
likely life threatening. Indeed, they were life threatening. During a
9-hour surgery, it was discovered that his HHT had affected the
arteries of his spinal cord. He had had multiple hemorrhages over the
years, which had caused his mysterious backaches, and if he had waited
much longer, a massive hemorrhage of the malformed blood vessels of the
spinal cord would have occurred--which would have either paralyzed him
or killed him. So with meticulous care, each tangled and malformed
artery snaking through his whole spinal column was tied off. It was not
known if he would ever walk again. With extensive rehabilitation he did
walk. But the loss of sensation caused by nerve damage was never
regained. This has led to a continuously deteriorating condition for my
brother. With a loss of sensation in his legs, he has become stooped
over, uses a cane for balance and walks with a limp. Also due to his
nerve damage, he has multiple complications with his bladder. For years
he has had daily nosebleeds. He is in a weakened state all the time and
his life has been permanently affected. If recognized early, his spinal
cord malformation could have been treated and much suffering prevented.
Adding further insult to injury, my brother's daughter, Judith, a
successful young woman, has a liver abnormality associated with HHT.
When it was first discovered, doctors thought it was a tumor and almost
did a biopsy which could have led to her loss of life. The doctors had
no awareness of HHT. Fortunately, because of our experience with the
Yale University HHT Center of Excellence and Dr. Robert I. White, Jr.,
she was taken care of and is now leading a normal life.
Last, but not least is myself. My nosebleeds started in adolescence
and in my late teens and early 20's I had nosebleeds that could last 2
hours--and with HHT--you never have advance warning about when they are
coming! I have led a pretty normal life, but have never had a lot of
stamina.
When I was about 55, I went through a period of time of feeling
completely exhausted. A check up at the doctor showed that my liver
enzymes were unusually high. In the search for the cause, a CAT scan of
my liver was done. What was discovered was something that the doctors
in my community had never seen. They were ready to do a liver biopsy. I
insisted that the lead doctor speak to the Yale HHT Center of
Excellence. They explained that what they were looking at was not
uncommon for people with HHT and should not be touched at that time. I
am monitored regularly and as I get older, it is clear that of all of
those in my family I am the most fortunate.
I have a daughter with HHT and granddaughter with HHT who may one
day have children with HHT. I ask for funding so that not only my
family, but all future generations will not have to live with HHT
themselves or watch a family member slowly deteriorate or die a sudden
preventable death.
how the federal government can help
Stroke, lung and brain hemorrhages can be prevented through early
diagnosis, screening and treatment. Severe hemorrhages in the nose and
gastrointestinal tract can be controlled through intervention and heart
failure can be managed through proper diagnosis of HHT and treatments.
Access to effective evidence-based interventions and treatment should
be established through a joint legislative initiative between the 8
established National HHT Treatment Centers of Excellence and the
National Center on Birth Defects and Disabilities Hereditary Blood
Disorders Group with a legislative initiative of a $10 million set
aside at the CDC through the HHS Appropriations bill in support of the
8 U.S. HHT Centers. These funds will be used to provide surveillance;
create a multi-center clinical database to collect and analyze data;
support epidemiological studies; document effectiveness or patient
interventions, develop educational programs for health care programs
and ultimately improve the quality of life for people living with HHT
and future generations.
An additional $0.75 million is requested for the establishment of
an HHT National Resource Center through a partnership between the CDC
and the national voluntary agency representing HHT Families. These
funds would be used to provide family support, education targeted to
families and medical professionals, annual patient conferences,
national and international scientific meetings and an aggressive
research program. The CDC is ready and willing to work in partnership
with the HHT Foundation to accomplish this mission.
Mr. Chairman, again, thank you for the opportunity to testify. On
behalf of the HHT Foundation and all of its members I personally appeal
to the committee for funding for the 8 HHT Centers of Excellence. We
believe this will benefit those with HHT and also reduce health care
costs by the prevention of complications and the development of new
therapies for this condition.
______
Prepared Statement of the Lupus Foundation of America, Inc.
As President and CEO of the Lupus Foundation of America, Inc. (LFA)
I appreciate the opportunity to submit written comments for the record
regarding funding for lupus related programs for fiscal year 2007. The
LFA is the Nation's leading non-profit voluntary health organization
dedicated to improving the diagnosis and treatment of lupus, supporting
individuals and families affected by the disease, increasing awareness
of lupus among health professionals and the public, and finding the
causes and cure. As you may know, lupus is a debilitating, chronic
autoimmune disease that causes inflammation and tissue damage to
virtually any organ system; it can cause significant disability or even
death. Lupus is the prototypical autoimmune disease; therefore, finding
answers to questions about lupus may also provide understanding about
other autoimmune diseases that affect 22 million Americans. The leaders
and members of the LFA and the 1.5 to 2 million people suffering from
lupus respectfully request the following for fiscal year 2007 to reduce
and treat suffering from lupus:
--$29.7 billion for the National Institutes of Health (NIH) to
support lupus research. Specifically, we urge Congress to
direct NIH to support and bolster lupus research across all
relevant institutes, centers, and offices.
--$1 million in new funding for The Office of Women's' Health at the
Department of Health and Human Services (HHS) to support a
sustained national lupus education campaign. This campaign is
directed towards the general public and healthcare
professionals who diagnose and treat people with lupus, with
emphasis on reaching those individuals at highest risk--women
of color--a health disparity that remains unexplained.
--$1.5 million for the National Lupus Patient Registry (NLPR) at the
National Center for Chronic Disease Prevention and Health
Promotion within the Center for Disease Control and Prevention
(CDC) to sustain current epidemiological efforts, and expand
the CDC's work to include all forms of lupus and all affected
populations, particularly African Americans, Hispanics, and
Asian Americans who are disproportionately at-risk for--and
have worse outcomes associated with--lupus.
The purpose of the CDC lupus registry is to collect data and
conduct lupus epidemiological studies to better understand and measure
the burden of the illness, the social and economic impact of the
disease, and stimulate additional private investment by industry in the
development of new, safe and effective therapies for lupus. Existing
epidemiological data on lupus is decades old and no longer reliable.
Population-based epidemiological studies of lupus must be conducted at
strategically-located sites throughout the Nation that will provide
accurate data on all forms of lupus (i.e. systemic lupus, primary
discoid lupus, drug-induced lupus, neonatal lupus, antiphospholipid
antibodies) and the disparity among the various racial and ethnic
populations.
To ensure that we begin to comprehensively study and understand the
dramatic health disparities associated with lupus, the NLPR and
associated epidemiological studies must be expanded to include
additional sites that constitute a mix of urban and rural areas and
contain academic centers with a track record and some existing
infrastructure for performing epidemiological studies. Thank you.
I am Dr. Michael Madaio, Professor of Medicine at the University of
Pennsylvania School of Medicine, and a lupus researcher. I have been
funded for lupus research for over twenty years. I am proud to be
affiliated with the Lupus Foundation of America as a member of the
Medical Scientific Advisory Board and Chairman of the Medical Advisory
Board for the Southeastern Pennsylvania Chapter of the LFA. While I am
a nephrologist, since my research and clinical practice is focused on
lupus, I really work day-to-day within the realms of nephrology and
rheumatology as well as other medical specialties and subspecialty
areas. I understand the importance of biomedical research funding and
the impact that Federal research funding has had, does have, and can
have on the lives of the 1.5 million people living with lupus and the
22 million Americans with other autoimmune diseases.
After a tragic 40 year dearth of new treatments to manage this
often debilitating and devastating disease, the good news is that we
finally are on the brink of major breakthroughs, thanks to research
sponsored by the National Institutes of Health. Exciting research and
strides in treatments for people with lupus are on the horizon and a
sustained investment now in lupus research will speed the day to better
treatments and a cure. Specifically, I am conducting extensive research
on lupus nephritis, which is kidney involvement in lupus disease. My
field is advancing rapidly, due in large part to factors directly
dependent on NIH funding:
--the burgeoning growth in the number of new animal models, including
a wealth of informative transgenic and gene-targeted mutants;
--increased access to improved powerful technologies such as gene and
protein arrays, now available at many institutions and to many
investigators through NIH core facilities;
--new technologies that permit successful query of the very small
amounts of human tissue typically available from patients and,
collaboration across disciplines and across institutions to
bring crucial expertise together;
--new insights into underlying biology and pathophysiology in
immunity and lupus are constantly emerging;
--technologies to identify biomarkers are improved and accessible;
and
--new approaches to therapy are being explored.
These endeavors are bearing fruit but they are highly dependent on
NIH funding.
If funding for the NIH is cut or level funded, it could cripple or
paralyze current lupus research efforts.
As lupus is a systemic disease that can affect any organ or tissue
elucidating pathogenesis (or cause) and treatments of lupus will have
direct impact on many other autoimmune diseases (e.g. results and
treatments translating to other diseases). Providing adequate resources
to support lupus research will help the Nation turn the corner on
finding better treatments or a cure for lupus while also supporting
breakthroughs and progress for other disease states. It is important to
note that the corollary is true: cuts in lupus research funding also
will have an adverse effect on progress for lupus and for progress in
related diseases. Cuts in NIH funding could bring to a standstill
support of clinical trials and large observational studies, and could
curtail research on those at highest risk for lupus, women of color; it
also could negatively impact pediatric research at a time when
researchers have just begun to undertake studies in important new
areas. Furthermore, insufficient Federal funding also could slow much-
needed genetic research when we are just discovering the critical
components that may contribute to lupus and its effects. Therefore, it
is critical that biomedical researchers be provided the necessary
resources to continue seeking answers to the questions that will lead
to better lupus treatments. Increased research funding will help
deliver much-needed breakthroughs from the laboratory to patients in
need.
The National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS), the institute most involved in lupus research, is one
of the smallest institutes at NIH. In the past two years there has been
a decrease in research funding for NIAMS overall, with a ten percent
decrease in new research grants. Currently, only 12-15 percent of the
grant applications submitted to NIAMS receives funding. Further cuts
will cause this rate to drop precipitously to below 10 percent next
year. Just two or three years ago, funding levels were at 25-30
percent. Cuts in research funding, coupled with the rate of biomedical
research inflation (3-4 percent per year), further erode NIAMS' ability
to fund lupus research grant applications at the rate necessary to
begin making real progress. As such, an increase above the rate of
biomedical research inflation is necessary to allow NIH to sustain and
build on its research progress resulting from the recent budget
doubling while avoiding the severe disruption to that progress that
would result from a lesser increase or cut.
Furthermore, in the proposed budget for NIAMS for 2007 there will
be a loss of 10 training grants; each grant funds training for four
physicians, mostly rheumatologists. Young and senior investigators
alike are moving into other fields because of the lost of funding.
Exacerbating the situation, medical schools are struggling financially
due to public funding cuts thus eliminating any safety net for
researchers that may have previously existed. As a result, young
investigators are not attracted to lupus research which means there
will be not be a future generation of lupus scientists and clinicians
to do research. Moreover, after having attracted scientists to
translational immunology in the last five to ten years, when funding
was increasing, there is now a possibility we could lose both the
current and next generation of young investigators. Increased funding
is necessary to support an adequate number of training grants. Without
research and training funds lupus researchers might be forced to become
private practice physicians instead, leading to an imbalance in the
health care system: sufficient numbers of physicians to treat lupus
patients, but no new treatments with which to care for them, and no
researchers to develop the cures of tomorrow.
We recognize and appreciate that Congress and the Nation face
unprecedented fiscal challenges; however, we cannot afford to lose
ground in biomedical research at such a promising time. The LFA looks
forward to working with the subcommittee and others in Congress to
reduce and prevent the suffering caused by lupus. We stand ready to
serve as a resource for any information you may need in this regard and
thank you for this opportunity to submit written testimony for the
record concerning fiscal year 2007 lupus related funding.
______
Prepared Statement of the March of Dimes Birth Defects Foundation
The 3 million volunteers and 1,400 staff members of the March of
Dimes appreciate the opportunity to submit the Foundation's Federal
funding recommendations for fiscal year 2007. The March of Dimes is a
national voluntary health agency founded in 1938 by President Franklin
D. Roosevelt to prevent polio. Today, the Foundation works to improve
the health of mothers, infants and children by preventing birth
defects, premature birth and infant mortality through research,
community services, education, and advocacy. The March of Dimes is a
unique partnership of scientists, clinicians, parents, members of the
business community, and other volunteers affiliated with 52 chapters in
every State, the District of Columbia, and Puerto Rico.
The volunteers and staff of the March of Dimes are deeply concerned
that the funding recommendations in the President's Budget are not
sufficient to meet the challenge of improving the health of women and
children across the Nation. Continued under-funding of critical
research and public health programs imperils the health of mothers and
children today and in the future. In our judgment, the funding
increases recommended below would lead to an immediate positive impact
on reducing the incidence of preterm birth and birth defects, as well
as making newborn screening for treatable metabolic and functional
disorders more widely available.
national institutes of health
The March of Dimes joins the larger research community in
recommending a 5 percent increase in funding for the National
Institutes of Health (NIH), bringing total Federal support to just
under $30 billion. The administration's fiscal year 2007 budget
recommendation would necessitate absolute reductions in research
investments as the levels of funding proposed are insufficient even to
keep up with inflation and certainly will not sustain the necessary
investment in medical research.
National Institute of Child Health and Human Development
The March of Dimes recommends a 5 percent increase for NICHD in
fiscal year 2007 and an increase of at least $100 million over the next
five years to boost prematurity-related research. Additional resources
are needed to support research on the causes of preterm labor and
delivery and on strategies for improving the care and treatment of
infants born prematurely or at low birth weight. In addition, funding
should be provided to enable the Institute to work with the Office of
the Director of NIH to create a comprehensive strategic plan for this
research that includes coordination of strategies and studies across
multiple Institutes.
Since 1981, the preterm birth rate has increased 33 percent
resulting in more than 500,000 premature births in 2004--that is 1 in 8
births. Preterm birth is the leading cause of death in the first month
of life and, for those babies who do survive, one in 5 experiences
multiple health problems including cerebral palsy, mental retardation,
chronic lung disease, and vision and hearing loss. Preterm labor can
happen to any pregnant woman, and the causes of nearly half of all
premature births are unknown. This growing problem is a tragedy for
families and expensive for the Nation. In 2003, the national hospital
bill for the care of babies with a primary or secondary diagnosis of
prematurity exceeded $18 billion, half of which was borne by Medicaid
and other public programs and the remainder was charged to employers
and families. Until we know how to prevent preterm labor, the worsening
incidence of prematurity means that overall hospital charges will also
spiral upward.
In recent years, the NICHD has made a major commitment to
increasing our understanding of the factors that result in premature
birth and to developing strategies to prolong pregnancy. But additional
work is needed and adequate funding is key.
An area deserving more support is the collaborative Maternal-Fetal
Medicine Units (MFMU) and Neonatal Research (NR) collaboratives. One
clinical trial funded through the MFMU network reported a promising
preventive intervention that relies on a derivative of the hormone
progesterone. The incidence of preterm delivery was reduced by up to 30
percent in women who received weekly injections of the compound
compared to the women who were given a placebo. The results of this
intervention are impressive and additional funding is needed to support
further clinical trials of this promising intervention.
Finally, the March of Dimes urges the subcommittee to include in
its bill an increase of $57 million for the National Children's Study
(NCS). While the amount may seem substantial, it is dwarfed by the cost
of treating the diseases and conditions the study is designed to
address. If allowed to go forward, the NCS will generate groundbreaking
research that greatly increases our knowledge of the role family
genetics and the environment play in the health and development of
children. Planning for this study has been completed; the Vanguard
sites have been designated. The project is poised to start
implementation which will yield critical information for research on
preterm birth. The NCS will prove a rich and ongoing information
resource for use by scientists and clinicians to develop treatments and
preventive measures tailored for the pediatric population. Failure to
provide the resources needed for this study would be extremely
shortsighted.
centers for disease control and prevention (cdc)
Safe Motherhood/Infant Health
The National Center for Chronic Disease Prevention and Health
Promotion, Division of Reproductive Health works to promote optimal
reproductive and infant health. The March of Dimes recommends a $20
million increase in fiscal year 2007 to support expansion of research
to identify risk factors and to develop strategies for preventing
preterm birth. This can be accomplished with increased funding for the
two programs described below:
1. The Pregnancy Risk Assessment Monitoring System (PRAMS) is a
state-specific, population-based surveillance system designed to
identify and monitor selected maternal behaviors and experiences
before, during, and after pregnancy. Data collected through PRAMS is
used to increase understanding of maternal behaviors and experiences
and their relationship to adverse pregnancy outcomes, to improve
maternal and child health programs, and to facilitate the dissemination
of the latest research findings and clinical practice standards. The
March of Dimes recommends an increase of $5 million to improve PRAMS so
that CDC can develop national estimates on behavioral and demographic
risk factors for preterm birth.
2. Epidemiological research conducted at CDC is vital to the
prevention of preterm labor and delivery. The March of Dimes recommends
an increase of $15 million for the expansion of basic etiologic
research, research on women at risk for preterm delivery and the social
and environmental factors contributing to higher rates of preterm
delivery in African-American women. Increasing CDC's research
activities related to preterm birth will lead to improvements in
screening and early detection and new interventions for women at risk
for preterm labor.
National Center on Birth Defects and Developmental Disabilities
The March of Dimes recommends a minimum of $135 million in fiscal
year 2007 funding for the National Center on Birth Defects and
Developmental Disabilities (NCBDDD). NCBDDD conducts programs to
protect and improve the health of children by: (1) preventing birth
defects and developmental disabilities; and (2) promoting optimal
development and wellness among children with disabilities. Of
particular interest to the March of Dimes is NCBDDD's birth defects
program that includes surveillance, research and prevention activities.
For fiscal year 2007, the March of Dimes requests an increase of $6
million to support surveillance and research and an additional $2
million for folic acid education. These modest increases are vital to
making progress in reducing the incidence of birth defects.
In the United States, about 3 percent of all babies are born with a
major birth defect. Birth defects are the leading cause of infant
mortality accounting for more than 20 percent of all infant deaths
every year. Children with birth defects who survive often experience
long term physical and mental disabilities, and are at increased risk
for developing other significant health problems. In fact, birth
defects contribute substantially to the Nation's health care costs.
According to CDC, the lifetime cost of caring for infants born with one
of the 18 most common birth defects exceeds $8 billion annually.
NCBDDD provides funding to assist States with community-based birth
defects tracking systems, programs to prevent birth defects and improve
access to health services for children with birth defects. In 2006, CDC
has been able to support only 15 States in their efforts to improve
surveillance programs, down from 28 States in fiscal year 2004.
Additional resources are sorely needed to help States seeking
assistance.
The causes of nearly 70 percent of birth defects are unknown and it
is therefore critical that the Committee increase funding for the
National Birth Defects Prevention Study. This groundbreaking CDC
initiative is being carried out by 9 regional Centers for Birth Defects
Research and Prevention located in Arkansas, California, Georgia, Iowa,
Massachusetts, New York, North Carolina, Texas, and Utah. Each of these
centers obtains data on infants with major birth defects through
interviews with their mothers and biological samples that provide
information about medical history, environmental exposures, and
lifestyle before and during pregnancy. The study focuses on both
genetic and environmental causes, including medication use during
pregnancy, maternal diet and vitamin use. This study is an ongoing
source of information for use in research on the causes of birth
defects. With adequate funding this study has the potential to
dramatically increase our understanding of the causes of birth defects
and will provide information for developing effective preventive
measures.
NCBDDD is conducting a national public and health professions
education campaign designed to increase the number of women taking
folic acid. CDC estimates that up to 70 percent of neural tube defects
(NTDs), serious birth defects of the brain and spinal cord including
anencephaly and spina bifida could be prevented if all women of
childbearing age consume 400 micrograms of folic acid daily, beginning
before pregnancy. Since fortification of grain products with folic acid
in 1996, the rate of NTDs in the United States has decreased by 26
percent, but more must be done to educate every woman of childbearing
age and the health professionals who treat them about the importance of
taking folic acid daily.
Finally, the March of Dimes recommends that additional funds be
provided to conduct surveillance and epidemiological research on
cerebral palsy through the network already in place for autism (Centers
of Excellence for Autism and Developmental Disabilities Research and
Epidemiology). Cerebral palsy is one of the most common developmental
disabilities and there is currently very limited surveillance and
research being conducted.
National Immunization Program
If the Nation is to meet the Healthy People 2010 goals of
vaccinating 90 percent of children and adults, CDC, States, and
localities will need the resources required to reach those in need of
immunizations. According to the CDC, nearly 25 percent of two-year-olds
have not received all of the recommended vaccine doses. CDC's National
Immunization Program provides grants to 64 State, local, and
territorial public health agencies to reduce the incidence of
disability and death resulting from 12 vaccine preventable diseases.
The March of Dimes urges the subcommittee to continue its longstanding
policy of ensuring that Federal vaccine programs are well funded. For
fiscal year 2007, the March of Dimes recommends $802.4 million to
ensure that the National Immunization Program has the resources it
needs to account for vaccine price increases, introduction of new
vaccines, and to implement recommendations by the Institute of
Medicine.
Polio Eradication
The March of Dimes supports a funding level of $101.254 million for
CDC's fiscal year 2007 global polio eradication activities. Level with
fiscal year 2006, this funding would allow CDC to continue its
supplementary immunization activities in the remaining endemic and
high-risk countries in Africa and Asia and to move quickly to interrupt
polio transmission in these regions. The U.S. Government must maintain
its commitment to the worldwide eradication initiative that promises to
save lives and reduce unnecessary health-related costs globally.
National Center for Health Statistics
The National Center for Health Statistics (NCHS) provides data
essential for both public and private research and programmatic
initiatives. The National Vital Statistics System and the National
Survey on Family Growth, for example, are major sources of information
on the utilization of prenatal care and on birth outcomes, including
preterm delivery, low birthweight and infant mortality. Increased
funding would enable CDC to introduce web-based technology to
facilitate more rapid and accurate compilation of data obtained from
health professionals and facilities. This information is used to track
trends in birth outcomes and to support State birth defects registries.
Data from NCHS surveys are also used to identify emerging trends and to
optimize use of existing program resources.
health resources and services administration (hrsa)
Newborn Screening
Newborn screening is a vital public health activity used to
identify genetic, metabolic, hormonal and/or functional conditions in
newborns that if left untreated can cause disability, mental
retardation, and even death. Although nearly all babies born in the
United States are screened for some genetic birth defects, the number
of these tests varies from State to State. The March of Dimes
recommends that every baby born in the United States receive, at a
minimum, screening for a core set of 28 metabolic disorders plus
hearing deficiencies.
In fiscal year 2005 and fiscal year 2006, Congress provided funding
for implementation of Title XXVI of the Children's Health Act of 2000;
specifically, to fund the Regional Genetic Service and Newborn
Screening Collaboratives that work to address the maldistribution of
genetic services and resources and bring services closer to local
communities. The March of Dimes supports an appropriation of $25
million to enable HRSA to improve the capacity of States to: (1)
provide screening, counseling, testing, and special services for
newborns and children at risk for heritable disorders; (2) educate
health professionals and parents on the availability and importance of
newborn screening; and (3) support States with technical assistance on
the acquisition and use of new technologies and newborn screening
services.
Healthy Start
The Healthy Start Initiative is a collection of community based
projects focused on reducing infant mortality, low birthweight and
racial disparities in perinatal outcomes. The March of Dimes strongly
supports Healthy Start and urges continued funding for this important
program to decrease this Nation's tragically high rate of infant
mortality.
Maternal and Child Health Block Grant
In recent years, Federal funding for Title V of the Social Security
Act, the Maternal and Child Health (MCH) Block Grant, has not kept pace
with increased demand for services. Although the MCH Block Grant
provides assistance for a growing number of community-based programs
(such as home visiting, respite care for children with special health
care needs and ``wrap around'' services for pregnant women and children
enrolled in Medicaid and SCHIP), the funding level was reduced by $24
million in fiscal year 2006. In order for maternal and child health
programs to shoulder responsibility for additional beneficiaries and
services, funding must be increased. The March of Dimes recommends full
funding of the MCH Block Grant at the authorized level of $850 million.
Consolidated Health Centers
Consolidated (Community) Health Centers are an important source of
obstetric and pediatric care for more than 15 million individuals,
approximately 40 percent of whom are uninsured. The Foundation
recommends new funding sufficient to increase the number of centers and
to improve the scope of perinatal services provided. Adding funds to
this program would be consistent with the President's five-year plan to
create and expand health center sites in 1,200 communities and to
increase the number of patients served annually to more than 16
million.
Thank you for the opportunity to testify on the federally supported
programs of highest priority to the March of Dimes. The Foundation's
volunteers and staff in every State, the District of Columbia, and
Puerto Rico look forward to working with members of the subcommittee to
improve the health of the Nation's mothers, infants and children.
______
Prepared Statement of the Medical Library Association and the
Association of Academic Health Sciences Libraries
Mr. Chairman, thank you for the opportunity to testify today on
behalf of the Medical Library Association (MLA) and the Association of
Academic Health Sciences Libraries (AAHSL) regarding the fiscal year
2007 budget for the National Library of Medicine (NLM). I am Marianne
Comegys, Director of the Louisiana State University Health Sciences
Center Library, Shreveport, Louisiana.
MLA, a nonprofit educational organization established in 1898,
comprises health sciences information professionals with more than
4,500 members worldwide. Through its programs and services, MLA
provides lifelong educational opportunities, supports a knowledgebase
of health information research, and works with a global network of
partners to promote the importance of quality information for improved
health to the health care community and the public.
AAHSL is comprised of the directors of the libraries of 142
accredited United States and Canadian medical schools belonging to the
Association of American Medical Colleges (AAMC). Together, MLA and
AAHSL address health information issues and legislative matters of
importance through a joint task force.
Mr. Chairman, the National Library of Medicine (NLM), on the campus
of the National Institutes of Health (NIH) in Bethesda, Maryland, is
the world's largest medical library. NLM collects material in all areas
of biomedicine and health care, as well as works on biomedical aspects
of technology, the humanities, and the physical, life, and social
sciences.
With respect to the Library's budget for the coming year, I would
like to touch briefly on six issues: (1) the growing demand for NLM's
basic services; (2) NLM's outreach and education services; (3)
Emergency preparedness and response; (4) NLM's health information
technology activities; (5) NLM's facility needs; and (6) NLM's
infrastructure that supports the NIH Public Access Policy.
the growing demand for nlm's basic services
Mr. Chairman, it is a tribute to NLM that the demand for its
collections continues to steadily increase each year. These collections
stand at 8.5 million items-books, journals, technical reports,
manuscripts, microfilms, photographs, and images. Housed within the
library is one of the world's finest collections of old and rare
medical works. NLM is a national resource for all U.S. health science
libraries through the National Network of Libraries of Medicine.
Increasingly, it is also becoming an international resource for world-
wide research collaboration.
Our Nation's healthcare providers, researchers, and consumers all
use the library's collections, through the reading rooms or through
interlibrary loan, and on the World Wide Web. Increasingly, NLM's
collection is also available in digital form. NLM is developing a
strategy for selecting, organizing, and ensuring permanent access to
digital information. By doing so they are ensuring their availability
for future generations. This availability of health information remains
the highest priority for the Library.
Mr. Chairman, simply stated, NLM is a national treasure. I can tell
you that without NLM our Nation's medical libraries would be unable to
provide the quality information services that our Nation's healthcare
providers, educators, researchers, and patients, have all come to
expect.
Recognizing the invaluable role that NLM plays in our healthcare
delivery system, the Medical Library Association and the Association of
Academic Health Sciences Libraries join with the Ad Hoc Group for
Medical Research Funding in recommending a 5 percent increase for NLM
and NIH overall in fiscal year 2007.
outreach and education
NLM's outreach programs are of particular interest to both MLA and
AAHSL. These activities, designed to educate medical librarians,
healthcare professionals and the general public about NLM's services,
are an essential part of the Library's mission.
The Library has taken a leadership role in promoting educational
outreach aimed at public libraries, secondary schools, senior centers,
and other consumer-based settings. NLM's emphasis on outreach to
underserved populations assists the effort to reduce health disparities
among large sections of the American public.
NLM's ``Partners in Information Access'' program is designed to
improve the access of local public health officials to health
information. The establishment of additional programs across the
country will go a long way towards ensuring that healthcare workers
across America are familiar with NLM and the National Network of
Libraries of Medicine. My own facility, the LSU Health Sciences Center
in Shreveport, Louisiana, participates in this program. Through it, we
are able to train public health workers on how to access health
information online.
We ask the Committee to encourage NLM to coordinate its outreach
activities with the medical library community.
PubMed Central
The medical library community also applauds NLM for its leadership
in establishing PubMed Central, an online repository for life science
articles. Introduced in 2000, PubMed Central was created by NLM's
National Center for Biotechnology Information and evolved from an
electronic archiving concept proposed by former NIH director Dr. Harold
Varmus. The site houses 615,000 articles from 232 journals including
the Proceedings of the National Academy of Sciences and Molecular
Biology of the Cell.
The medical library community believes that medical librarians
should continue to play a key role in the further development of PubMed
Central and we are pleased that medical librarians are members of the
PubMed Central Advisory Committee. Because of the high level of
expertise health information specialists have in the organization,
collection, and dissemination of medical literature, we believe that
our community can assist NLM with issues related to copyright, fair
use, and information classification. We look forward to continuing our
collaboration with the Library as this exciting project continues to
evolve.
MEDLINEplus
MEDLINEplus [http://www.nlm.nih.gov/medlineplus], a source of
authoritative, full-text, health information resources from the NIH
institutes and a variety of non-Federal sources, has grown tremendously
in its coverage and its usage by the public. In January of 2006,
MEDLINEplus had 8.6 million unique visitors research 67 million pages
of health information (including information from over 1,250
organizations). MEDLINEplus's features include illustrated interactive
patient tutorials, a daily news feed from the public media on health-
related topics, and the NIH SeniorHealth website [http://
www.nihseniorhealth.gov], a collaborative project between NLM and the
National Institute on Aging.
``Go Local'' is another new and exciting feature of MEDLINEplus. Go
Local enables local and State agencies and others to participate by
creating sites that connect the MEDLINEplus information seeker to local
hospitals, pharmacies, doctors, and other health services. These
agencies use the infrastructure created by NLM that makes this
possible. Using Go Local, a search by topic on MEDLINEplus will lead
the consumer to local services connected to that topic. Currently,
there are fourteen localities participating in the Go Local service,
and many more will be added in the near future. Through this service,
NLM and MEDLINE are becoming increasingly valuable tools, not just for
medical librarians and other health professionals but also for the
health consumer.
Clinical Trials
Mr. Chairman, I also want to address another frequently used
service offered by NLM--its clinical trials database [http://
www.clinicaltrials.gov]. This listing of more than 27,000 Federal and
privately funded trials for serious or life-threatening diseases was
launched in February 2000 and currently logs more than 8 million page
views per month and 25,000 visitors daily. The clinical trials database
is a free and invaluable resource to patients and families interested
in participating in cutting edge treatments for serious illnesses. The
medical library community congratulates NLM for its leadership in
creating ClinicalTrials.gov and looks forward to assisting the Library
in advancing this important initiative.
emergency preparedness and response
Since the late 1960s, NLM has been actively involved in disaster
response and management. As a Louisiana resident, I am pleased to
report about NLM's relief work in response to Hurricane Katrina. NLM's
Specialized Information Services (SIS) Division compiled a Hurricane
Katrina Web page on toxic chemical and environmental health information
resources. The Web page provided links to information on chemicals that
may have been released and on environmental concerns following the wind
and flood damage. The page also linked to the Wireless Information
System for Emergency Responders (WISER). WISER provides information on
400 of the most hazardous chemicals in NLM's Hazardous Substances
Databank. It can be downloaded to a Personal Digital Assistant (PDA) or
field laptop, providing first responders with ready access to basic
emergency haz-mat information. At the request of the Environmental
Protection Agency, NLM provided 15 PDAs loaded with WISER for the EPA
National Decontamination Team to take with them when they were deployed
to New Orleans. In addition, NLM's National Center for Biotechnology
Information (NCBI) has provided assistance to the State of Louisiana in
identifying Katrina victims with software tools that improve speed and
accuracy of DNA identification.
In addition to NLM's efforts on the national level, the South
Central Regional office of the NLM-supported National Network of
Libraries of Medicine provided specific help to the libraries in its
territory that were impacted by Katrina. When librarians were dispersed
to remote sites, the Regional office purchased laptops and printers for
them to use. Arrangements were also made for Katrina-area libraries to
have free interlibrary loans. The South Central Regional office also
created a blog, ``Hurricane Katrina in the SCR,'' for librarians to
post information regarding colleagues and building conditions. During
the first few weeks after Katrina, when we were unsure of where our
friends had relocated and how to contract them, the blog was an
invaluable resource for helping us to find them and for suggesting ways
to assist them.
Mr. Chairman, we applaud the success of NLM's outreach initiatives,
particularly those initiatives that reach out to medical libraries and
healthcare consumers. We look forward to continuing our work with the
Library in fiscal year 2007 on these important programs.
health information technology and bioinformatics
Mr. Chairman, NLM played a major role in creating and nurturing the
field of medical informatics. For nearly 35 years, the Library has
supported informatics research and training and the application of
advanced computing and communications to biomedical research and health
care delivery. Many of today's informatics leaders are graduates of
NLM-funded informatics research programs at universities across the
country. Many of the country's exemplary electronic health record
systems (e.g., in Indianapolis, Vanderbilt, and Pittsburgh) benefited
from NLM grant support. The Library began supporting informatics
research that addresses information management problems relevant to
disaster management several years ago. It has also funded innovative
telemedicine projects in various rural and urban medically underserved
communities, as models for evaluating the impact of telemedicine on
cost, quality, and care. A leader in supporting, licensing, developing,
and disseminating standard clinical terminologies for free nationwide
use, NLM works closely with the National Coordinator of Health
Information technology to promote adoption of interoperable electronic
records. Through its National Center for Biotechnology Information, NLM
creates and provides access to GenBank, the genetic sequence
repository, and a wide array of related scientific data and analysis
tools. These publicly accessible resources are speeding the pace of
scientific discovery around the world, including important insights
into the evolution of the flu. Building on this success, NLM will
develop databases to manage the vast amount of genetic, medical and
environmental information that will emanate from new HHS and NIH
efforts to analyze genetic variation in groups of patients with
specific illnesses and to devise new ways of monitoring personal
environmental exposures that interact with genetic variations and
result in human diseases.
We are pleased that NLM is supporting informatics research that
addresses information management problems relevant to disaster
management. Medical librarians and health information specialists have
an important role to play in supporting these cutting edge technologies
and in serving as important sources of health information for those
displaced by disasters. We encourage Congress and NLM to continue their
strong support of NLM's medical informatics and genomic science
initiatives, at a point when the linking of clinical and genetic data
holds increasing promise for enhancing the diagnosis and treatment of
disease. MLA and AAHSL also support Health Information Technology
initiatives in the Office of the National Coordinator for Health
Information Technology (ONCHIT) and the Agency for Healthcare Research
and Quality (AHRQ) that build upon initiatives housed at NLM.
nlm's facilities needs
Mr. Chairman, over the past two decades NLM has assumed several new
responsibilities, particularly in the areas of biotechnology, health
services research, high performance computing, and consumer health. As
a result, the Library has had tremendous growth in its basic functions
related to the acquisition, organization, and preservation of an ever-
expanding collection of biomedical literature. In order to complete
these functions, NLM has had to expand its staff. NLM now houses 1,100
staff in a facility built to accommodate only 650. This increase in the
volume of biomedical information and in the number of personnel has led
to a serious shortage of space at the Library.
In order for NLM to continue its mission as the world's premier
biomedical library, a new facility is urgently needed. The NLM Board of
Regents has assigned the highest priority to supporting the acquisition
of a new facility. The medical library community is pleased that
Congress appropriated the necessary architectural and engineering funds
for the design of the facility expansion at NLM in 2003. The community
is also pleased that the American Center for Cures Act, (S. 2104)
introduced in the Senate by Senator Lieberman, asks Congress to make a
special effort to fund the expansion of NLM's facilities.
We encourage the subcommittee to provide the resources necessary to
construct a new facility and to support the Library's health
information programs.
nih public access policy
MLA and AAHSL support the goals of the NIH public access policy to
create a central archive of NIH-funded research publications to advance
science and enable NIH to better manage its research portfolio, and to
provide electronic access to the public to NIH-funded research
publications. We are concerned, however, that the current rate of
participation in the voluntary policy is low--less than 4 percent.
Information provided by the NIH Public Access Working Group indicates
that the submission system is not difficult to use and that the
majority of NIH-funded researchers appear to know about the policy. For
these reasons, we concur with the conclusion of NLM's Board of Regents,
that the NIH Policy cannot achieve its stated goals unless deposit of
manuscripts becomes mandatory. We also support the Board of Regents'
recommendation that NIH and NLM develop a careful plan for
transitioning to a mandatory policy, and to provide clear guidance and
a reasonable timetable to minimize burden on NIH-funded researchers and
grantee institutions, and also to work with publishers to make it easy
for them to submit articles on behalf of their NIH-supported authors.
We encourage Congress to continue to ask for periodic evaluation of
the plan as it is implemented in the coming months and years.
Mr. Chairman, thank you again for the opportunity to present the
views of the medical library community.
______
Prepared Statement of The Mended Hearts, Inc.
The Mended Hearts, Inc. (MHI) is a national nonprofit organization
that offers the gift of hope to heart patients, their families and
caregivers for more than 50 years. Mended Hearts has 21,000 members
operating through 280 community-based chapters across the country, with
two in Canada. Chapters partner with more than 450 hospitals and
cardiac care facilities in providing patient-to-patient support
services. I have been appointed by the group as their legal
representative--a volunteer position. I am a heart disease survivor.
About 30 years ago, I was diagnosed with a rare heart disease.
After having chest discomfort and trouble breathing for more than two
years, I was diagnosed with hypertrophic cardiomyopathy (HCM), a
disease in which the heart enlarges. The heart muscle gradually
thickens so much that heart cannot pump blood out effectively. The new
heart muscle replacing the old heart tissue does not grow in the normal
parallel pattern. Instead, it grows in a helter-skelter pattern.
Studies show that 36 percent of young athletes who die suddenly have
probable or definite hypertrophic cardiomyopathy, but it also affects
men and women of all ages. HCM is one of the major causes of sudden
death due to cardiac arrhythmias. There is no cure for HCM. However,
medication may work, and there is surgery, which may alleviate the pain
and discomfort, prolonging the patient's life. If surgery does not
work, the alternative is a heart transplant, but donor organs are
scarce. The doctor who made my diagnosis was trained at the National
Institutes of Health's (NIH) National Heart, Lung, and Blood Institute
(NHLBI).
Initially, I received several medications, which enabled me to
engage in most activities. However, some activities, such as walking up
hills, caused shortness of breath and severe chest pains. But,
generally I could function normally. After about 10 years, the
discomfort was increasing, and it became apparent that I was in serious
trouble. I could not walk sixty feet without having to stop to catch my
breath. Sometimes the pain was so severe that I would almost double
over in the middle of the street. My wife told me later that my face
would become gray. And the perspiration would pour off my body. The
quality of my life had deteriorated so drastically that I knew I needed
some treatment.
In 1988, I went to Georgetown Hospital for an angiogram--the gold
standard for diagnosing heart problems. After the test, the
cardiologist told me that he had bad news and worse news. The bad news
was that I had a 95 percent blockage in my left anterior descending
heart artery at the location known as the ``widow-makers spot.'' The
worse news was that I had a major chance of suffering a severe heart
attack, with less than a 5 percent chance of survival because of the
HCM. At this point, my wife was quietly crying and I was perspiring
profusely.
Because Georgetown Hospital did not have the expertise to operate
on my condition, they called the NIH to see if they would accept me as
a patient. I was sent home pending notice from NIH. I knew that I had
run out of alternatives. No matter what the results, I needed treatment
and I needed it immediately.
Subsequently, the NIH accepted me. After entering the NHLBI on
February 9, my surgery occurred on February 11, 1998. No matter how
trite the expression, it is very true--the day after surgery was the
first day of the rest of my life. The surgery, a left ventricular
myotomy and myectomy, was considered drastic. I was later told that the
mortality rate was as high as 10 percent. That surgery is still done in
only a few hospitals. It is considered the gold standard for the
treatment of HCM. This Murrow Procedure, in honor of the innovator, was
developed and improved at the NIH.
Currently, there is a new experimental protocol in which the same
effect is now being attempted by using alcohol to deaden the excessive
heart tissue, instead of removing a piece of heart muscle from the
heart's main pumping chamber, as was done in my case.
Now, I am on medication for the rest of my life. My condition is
progressive. More than 10 years ago, I was fitted with a pacemaker to
ensure that my heart beats at the correct rate. I am 100 percent
dependent upon my pacemaker. Without the pacemaker, there are times
when my normal heart beat is so slow that I could die.
I am eternally grateful to the physicians funded by the NHLBI,
particularly to Dr. Charles MacIntosh and his staff, for the gift of
life. Because of this marvelous doctor and research, I have lived
eighteen years free of pain. I have seen two children graduate from
college, witnessed the birth of three grandchildren, and shared these
years with a wonderful wife. And, I have been able to work at my
profession--attorney at law.
I have had the gift of life restored to me. To express my gratitude
for that gift, under the aegis of the Mended Hearts, Inc., I visit
patients recovering from heart episodes at two hospitals: Washington
Hospital Center and Washington Adventist Hospital. Last year MHI
visited more than 228,000 patients and their families in our mission of
support. We have also made 6,700 visits over the telephone to give
succor to these patients.
If this tale of woe is not enough, about 3.5 years ago, I suddenly
began to have mini-strokes. I experienced five episodes within 13
months. The last episode was just a year ago. Medication, including
coumadin, now seems to have the incidents under control. Coumadin is a
blood thinning drug that requires constant monitoring. At least once a
month, I have to go to the hospital to get blood drawn from my arm to
check the level of the drug.
To advance the fight against heart disease and stroke, I
respectfully ask for the fiscal year 2007 appropriations in the
following amounts:
--National Institutes of Health--$29.8 billion
--National Heart, Lung, and Blood Institute--$3.1 billion
--National Institute of Neurological Disorders and Stroke--$1.6
billion.
My experience and my continued life is proof that the research
supported by the NIH benefits not just the patients at the Clinical
Center, but throughout the United States. The benefits go worldwide
too.
Cardiovascular diseases remain the major killer of men and women in
the United States. Nearly 40 percent of people who die in the United
States, die from cardiovascular diseases. From 1979 through 2003,
cardiovascular operations and procedures increased 470 percent.
______
Prepared Statement of the Montgomery County (Maryland) Stroke
Association
My name is Susan Emery. I am the President of the Montgomery County
Stroke Association and I am a stroke survivor.
Our Association conducts education and supports activities for
stroke survivors, their family members, and caregivers. We serve people
in the Maryland suburbs of Washington, D.C., and are fortunate to be in
the same county as the National Institutes of Health. We have benefited
on many occasions by the participation of NIH staff members in our
membership meetings. They have been generous in sharing information
with us about their research on stroke prevention and treatment.
On December 26, 1965, at the age of nine, I was playing a new game
with my brother and a few friends at the kitchen table. That is the
last thing that I remember. I was unconscious for the next two days. My
mother first learned, incorrectly, that I had spinal meningitis. I was
transferred to another hospital where my mother was told that I had
little chance of survival. Yet, I am here, more than 40 years later,
and I have survived a stroke.
People seldom associate strokes with children. These strokes are
rare, but they do happen. There are about three cases of stroke per
year in every 100,000 children aged 14 and under. One of the
difficulties in dealing with strokes in children is getting the right
diagnosis quickly. There are often delays in diagnosis of childhood
stroke.
I spent two weeks in the hospital and the subsequent 4 months in
intensive physical therapy. My 10th birthday was spent in the hospital,
and I have a picture in my photo album of myself with my mother and a
new friend. My right eye is turned down, my mouth is turned down, but I
am still smiling. During the 4 months in therapy at Holy Cross in
Detroit, I learned the basics: how to walk, how to talk, and how to
move the fingers on my right hand. My mother followed the doctor's
instructions and sent me back to school very quickly, where classmates
helped me button and unbutton my coat and carry my books, and teachers
taped papers to the desk so I could learn to write again. I survived
that 4 months, and would never wish to repeat it.
I have been in therapy six times in my life. I need to tell you
about the one time that was the most important to my family. I was 26
years old and had just had my first child. I kept her safe, for I knew
my limitations. I always used my left hand to support her. But when she
was 6 months old, she got to be a little heavy, and twice, as I was
putting her on the floor to change her diaper, my right hand slipped
from under her buttocks. She fell only inches in both cases and did not
even notice. But I noticed. I went in for 2 or 3 months of therapy
close to Denver, Colorado, where I was living at the time. Here, for
the first time, they helped my right hand and arm dexterity through
occupational therapy. I also learned that I had aphasia--the inability
to speak, write or understand spoken or written language because of
brain injury--because I called things like fruit baskets ``unicorns''
instead of cornucopias. Instead of the word being the same, I picked a
word that sounded the same. The therapists in Colorado worked with my
mind and my body and I will forever be in their debt.
Close to 15 years ago, I made a new life for myself in Maryland.
Here, I have been an outpatient at the National Rehabilitation Hospital
three times: once for my right foot, once for my Achilles tendon, and
once for my right knee. I have seen numerous physiatrists, all of whom
are excellent in their field. I have also seen my fair share of
therapists. Since I have had therapy on and off for most of my life, I
can honestly say that the first few times you go in to see a therapist,
you will come out hurting more than when you went in. But in the long
run, they help tremendously.
On a work related note, I received a Bachelor of Science in 1978
from Michigan State University in Computer Science and worked for 12
years in the field. I started working in the telecommunications
industry in 1990, and got a Master of Science from the University of
Maryland, University College in Telecommunications Management. I now
work for ITT Industries as a senior engineer on a contract supporting
the Federal Aviation Administration's leased telecommunications
activities, and have worked with the FAA for more than 10 years. I have
done more than survive. I have become a productive member of society.
Stroke research has changed my life. Without the research carried
out 40 to 50 years ago, I would not have benefited from electric shock
therapy that made me understand the muscles that move my fingers.
Without research done 30 years ago, I may not have been able to
understand how to exercise my hand for dexterity. Without research
performed 10 years ago, the people around me would not understand that
they need to get me to the hospital quickly if ever I have another
stroke. Without current support, researchers may never understand how
to stop strokes before they happen or how to make current stroke
survivors live healthier lives.
Stroke remains America's No. 3 killer and a major cause of
permanent disability. An estimated 5.5 million Americans live with the
consequences of stroke and about 1 in 4 is permanently disabled. Yet,
stroke research continues to receive a mere 1 percent of the National
Institutes of Health budget. I strongly urge you to significantly
increase funding for the National Institutes of Health-supported stroke
research, particularly for National Institute of Neurological Disorders
and Stroke-supported stroke research. NIH stroke research is essential
to prevent strokes from happening to children and adults in the first
place, and to advance recovery and rehabilitation of those who survive
this potentially devastating illness.
______
Prepared Statement of the National Association of Children's Hospitals
The National Association of Children's Hospitals (N.A.C.H.) is
pleased to submit a statement for the record in support of the
Children's Hospitals' Graduate Medical Education (CHGME) Program in the
Health Resources and Services Administration. On behalf of the Nation's
60 independent children's teaching hospitals, N.A.C.H. very much
appreciates Chairman Specter's and the subcommittee's early and
continuing commitment over many years to provide full, equitable GME
funding for these hospitals. CHGME seeks to give them a level of
Federal support for their teaching comparable to what all other
teaching hospitals receive from Medicare.
N.A.C.H. also appreciates the subcommittee's support for $300
million for fiscal year 2006. Ultimately this was reduced to $297
million, or less than level funding, due to a 1 percent across-the-
board cut in discretionary spending. This marked the third consecutive
year CHGME was reduced due to across-the-board cuts since Congress
first agreed to appropriate $305 million for fiscal year 2004.
CHGME has been a success. Thanks to the program, Federal GME
support to children's hospitals now approaches equity with Medicare GME
support to adult hospitals. CHGME has made it possible for children's
hospitals to strengthen their training of pediatric providers at a time
of national shortages, without having to sacrifice clinical or research
programs. It has enabled them to have strong financial positions, which
are essential for their capital intensive missions.
For fiscal year 2007, N.A.C.H. respectfully requests $330 million
for CHGME funding. This amount would make up for erosion in funding
over the last three years and address the cost of inflation, a critical
factor in a program associated with both wage-related and medical
teaching costs. Full funding would ensure the hospitals will have the
resources necessary to train and educate the Nation's pediatric
workforce. Given the challenges the subcommittee faces, we hope, at a
minimum, CHGME can be maintained at level funding and not lose further
ground in fiscal year 2007.
n.a.c.h. and children's hospitals
N.A.C.H. represents more than 130 children's hospitals. They
include independent acute care children's hospitals, children's
hospitals within larger medical centers, and independent children's
specialty and rehabilitation hospitals. N.A.C.H. helps its members
fulfill their missions of clinical care, education, research and
advocacy for the health and well-being of all children.
Children's hospitals are regional and national centers of
excellence for children with serious and complex conditions. They are
centers of biomedical and health services research for children and
serve as the major training centers for pediatric researchers, as well
as a significant number of children's doctors. They also are major
safety net providers, serving a disproportionate share of children from
low-income families, and they are advocates for the public health of
all children.
Although they represent less than 5 percent of all hospitals in the
United States, the three major types of children's hospitals provide 41
percent of the inpatient care for all children, 42 percent of the
inpatient care for children assisted by Medicaid, and the vast majority
of hospital care for children with serious conditions such as cancer or
heart defects.
background: the need for chgme
While they account for less than 1 percent of all hospitals,
independent children's teaching hospitals train nearly 30 percent of
all pediatricians, half of all pediatric specialists and the majority
of pediatric researchers. These hospitals provide required pediatric
rotations for many other residents and train more than 4,800 resident
full time equivalents annually. Shortages of pediatric specialists
across the Nation only heighten the importance of these hospitals.
Prior to initial funding of the CHGME program for fiscal year 2000,
the eligible hospitals faced enormous challenges in maintaining their
training programs. The increasingly price competitive medical
marketplace was resulting in more and more payers failing to cover the
costs of care, including the costs associated with teaching.
Because they see few--if any--Medicare patients, independent
children's hospitals were essentially left out of Medicare GME funding,
which had become the one major source of GME financing for other
teaching hospitals. Independent children's hospitals received only 1/
200th (or less than 0.5 percent) of the Federal GME support that all
other teaching hospitals received under Medicare. This lack of GME
financing, combined with financial challenges stemming from other
missions, threatened the hospitals' teaching programs, as well as other
services.
Safety Net Institutions.--Independent children's hospitals are a
significant part of the health care safety net for low-income children.
This critical mission puts the hospitals at financial risk. In fiscal
year 2005, children assisted by Medicaid were, on average, more than 50
percent of all discharges from independent acute care children's
hospitals. Yet, Medicaid, on average, paid only 79 percent of costs.
Without disproportionate share hospital payments, Medicaid would cover,
on average, only 73 percent of costs. Medicaid payment shortfalls for
outpatient and physician care are even greater.
Independent children's hospitals also are essential providers of
care for seriously and chronically ill children. The hospitals devote
more than 75 percent of their care to children with one or more chronic
or congenital conditions. They provide the majority of inpatient care
to children with many serious illnesses--from children with cancer or
cerebral palsy, for example, to children needing heart surgery or organ
transplants. In some regions, these children's hospitals are the only
source of pediatric specialty care. The services they must maintain to
assure access to high quality, complex care for all children are often
inadequately reimbursed.
Many of the independent children's hospitals also are a vital part
of the emergency and critical care services in their regions. They are
part of the emergency response system that must be in place for public
health emergencies. Expenses associated with preparedness add to their
continuing costs in meeting children's needs.
Mounting Financial Pressures.--The CHGME program, and its
relatively quick progress to full funding in fiscal year 2002, came at
a critical time. In 1997, when Congress first considered establishing
CHGME, a growing number of independent children's hospitals had
financial losses; many more faced mounting financial pressures. More
than 10 percent had negative total margins, more than 20 percent had
negative operating margins and nearly 60 percent had negative patient
care margins. Some of the Nation's most prominent children's hospitals
were at financial risk. Thanks to CHGME, these hospitals have been able
to maintain and strengthen their training programs.
Pediatric Workforce Development.--The important role CHGME plays in
the continual development of our Nation's pediatric workforce is not
lost on the larger pediatric community, including the American Academy
of Pediatrics and Association of Medical School Pediatric Department
Chairs. They support CHGME and recognize it is critical not only to the
future of the individual hospitals but also to provision of children's
health care and advancements in pediatric medicine overall.
congressional response
In the absence of movement to broader GME financing reform,
Congress authorized the CHGME discretionary grant program in 1999 to
address the existing inequity in GME financing for the independent
children's hospitals. The legislation was reauthorized in 2000, through
fiscal year 2005, and provided $285 million for fiscal year 2001 and
``such sums as necessary'' in the years beyond. Congress passed the
initial authorization as part of the ``Healthcare Research and Quality
Act of 1999'' and the reauthorization as part of the ``Children's
Health Act of 2000.''
With this subcommittee's support, Congress appropriated initial
funding for CHGME in fiscal year 2000, before the enactment of the
program's authorization. Following enactment, Congress moved
substantially toward full funding for the program in fiscal year 2001
and completed that goal, providing $285 million in fiscal year 2002.
Subsequently, Congress appropriated $290 million in fiscal year 2003,
$303 million in fiscal year 2004, $301 million in fiscal year 2005, and
$297 million in fiscal year 2006. (In the last three years, the funding
levels are net of across-the-board cuts in discretionary funding.)
Health Resources and Services Administration (HRSA).--CHGME funding
is distributed through HRSA to 60 children's hospitals according to a
formula based on the number and type of full-time equivalent residents
trained, in accordance with Medicare rules, as well as the complexity
of care and intensity of teaching the hospitals provide. Consistent
with the authorizing legislation, HRSA allocates the annual
appropriation in biweekly periodic payments to eligible independent
children's hospitals.
``Adequate'' Rating from Administration.--The Office of Management
and Budget gave CHGME an ``adequate'' rating in 2003, using its Program
Assessment Rating Tool (PART). The PART review found CHGME has a
``clear purpose,'' is ``effectively targeted,'' has specific ``long-
term performance measures'' that focus on outcomes, and holds grantees
``accountable for cost, schedule, and performance results.''
chgme success
The annual CHGME appropriation represents an extraordinary
achievement for the future of children's health and the Nation's
independent children's teaching hospitals:
--Thanks to CHGME, the Federal Government has made substantial
progress in providing more equitable Federal GME support to
independent children's hospitals. The hospitals now receive
about 80 percent of the level of Federal GME support that
Medicare provides to other teaching hospitals. This is still
not true equity, but it is dramatic improvement from the 0.5
percent of 1998.
--As a result of CHGME, children's hospitals have been able to make a
substantial improvement in their contribution to the Nation's
pediatric workforce, without having to sacrifice their clinical
or research missions. From 2000 to 2004, without the CHGME
hospitals being able to increase the numbers of general
pediatric residents they trained, the Nation would have
experienced a net decline in number of new pediatricians.
During the same time, CHGME hospitals accounted for more than
80 percent of new pediatric subspecialty programs and more than
60 percent of the new pediatric subspecialists trained.
--CHGME has allowed children's hospitals to achieve strong financial
positions. According to Moody's, before 2000, children's
hospitals tended to have negative to break-even financial
margins. Since then, their margins have improved. CHGME is a
major reason.
fiscal year 2007 request
N.A.C.H. respectfully requests that the subcommittee provide
equitable GME funding for independent children's hospitals by providing
$330 million in fiscal year 2007. Such funding is particularly
important for a program that has wage-related and medical teaching
costs and has experienced three years of successive reductions due to
across-the-board cuts. Given the challenges the subcommittee faces, we
hope CHGME at least can be maintained at level funding and not lose
further ground in fiscal year 2007.
Adequate, equitable funding for CHGME is an ongoing need.
Children's hospitals continue to train new pediatric residents and
researchers every year. Children's hospitals have appreciated very much
the support they have received, including the attainment of the
program's authorized full funding level in fiscal year 2002 and
continuation of full funding with an inflation adjustment in fiscal
year 2003 and fiscal year 2004. Congress can regain this progress by
providing $330 million in fiscal year 2007.
Continuing equitable CHGME funding is more important than ever in
light of budget shortfalls in many States and pressures for significant
reductions in State Medicaid spending. Because children's hospitals
devote such a substantial portion of their care to children from low-
income families, they are especially affected by cutbacks in State
Medicaid programs.
Support for a strong investment in GME at independent children's
teaching hospitals is also consistent with the repeated concern the
subcommittee has expressed for the health and well-being of our
Nation's children, through education, health and social welfare
programs. And it is consistent with the subcommittee's repeated
emphasis on the importance of enhanced investment in the National
Institutes of Health (NIH) and in NIH support for pediatric research in
particular, for which N.A.C.H. is grateful.
CHGME funding is essential to the ability of the independent
children's hospitals to sustain their GME programs. At the same time,
the program enables them to do so without sacrificing support for other
critically important services that also rely on hospital subsidy, such
as specialty and critical care services, child abuse prevention and
treatment services, poison control centers, services to low-income
children with inadequate or no coverage, mental health and dental
services, and community advocacy, such as immunization and motor
vehicle safety campaigns.
conclusion
In conclusion, CHGME is a success. The program is an invaluable
investment in children's health. The future of the pediatric workforce
and children's access to quality pediatric care, including specialty
and critical care services, depend upon CHGME. N.A.C.H. and the
independent children's teaching hospitals are deeply grateful to the
Chairman and subcommittee for your continuing leadership on behalf of
children's hospitals.
______
Prepared Statement of the National Association of County and City
Health Officials
summary
The proposed cuts in the fiscal year 2007 budget for the Centers
for Disease Control and Prevention (CDC) continue a pattern of reduced
funding for public health that gravely worries the Nation's local
health departments. The National Association of County and City Health
Officials (NACCHO) is particularly concerned about two funding streams
that directly benefit local health departments, although the range of
reductions in CDC's budget threaten overall work in prevention that we
fully support.
Last year, funding for State and local bioterrorism and public
health preparedness was cut by $95 million, more than 10 percent.
NACCHO understands that this will result in a cut of about 12 percent
in the cooperative agreement funding that goes directly to States and
four large cities. The Preventive Health and Health Services block
grant program, the other major source of CDC funding to local health
departments, was cut by $19 million, which was 16 percent below the
actual fiscal year 2005 funding made available to grantees, and almost
25 percent below the fiscal year 2005 appropriated amount. The fiscal
year 2007 budget freezes preparedness funds and eliminates the block
grant. Taken together, these reductions will seriously compromise the
ability of the Nation's governmental public health system to fulfill
its mission of protecting and promoting health.
Local public health departments work every day on the front lines
to combat threats to the health of their communities. They can ill
afford substantial reductions in Federal support for their roles as
first responders to bioterrorism and other public health emergencies.
Moreover, local public health departments receive about 40 percent of
the Preventive Health and Health Services block grant (PHHS) funds.
These enable them to carry out programs ranging from prevention of
heart attack and stroke to combating West Nile virus. In States where
local health departments rely exclusively on these funds to run
prevention programs activities to reduce the burdens of preventable
disease will cease.
At a time when the Nation is engaged in urgent work to protect the
homeland from terrorists and natural disasters, as well as to stop an
epidemic of obesity, it is profoundly counterproductive and irrational
to reduce support for local programs that are the first line of defense
against the greatest threats to the health of communities. NACCHO urges
Congress to continue funding these two CDC programs at levels no less
than those in fiscal year 2005. Those levels are $927 million for State
and local bioterrorism preparedness and $131 million for the Preventive
Health and Health Services block grant.
strengthening the governmental public health system to improve homeland
security requires sustained funding
Congress recognized in 1997 an unmet need to strengthen the
Nation's capacity to respond to an act of bioterrorism and initiated
funding for bioterrorism preparedness in fiscal year 1999. The initial
funding of about $121 million (which included $51 million solely for
stockpiling medications) assisted CDC and State and local health
departments to begin examining what plans and resources were necessary.
After 9/11 and the anthrax outbreaks in the fall of 2001, Congress
increased bioterrorism funding markedly and included $940 million for
building State and local capacities, of which about $870 million was
actually made available to States and localities. The Department of
Health and Human Services got these funds out to States and three large
cities via cooperative agreements very promptly, far ahead of other
homeland security funds for States and localities.
Substantial bioterrorism preparedness funds for improving all
aspects of preparedness have actually been in the hands of State health
departments since August 2002. Local public health departments, many of
which have been funded for less time, are justifiably proud of the
progress they have made.
Extensive response plans, developed in collaboration with local
emergency management systems, have been made. Numerous ``tabletop'' and
real field exercises have tested local capabilities. Mass vaccination
clinics have taken place, some as part of a real response to flu
vaccine shortages. Communications systems and equipment that enable
rapid electronic information exchange among and by health departments
to their communities are operational. Improved systems for disease
detection are in place.
Local health departments have engaged hospitals, physicians, and
others in the private sector to develop further their roles in
responding to a serious disease outbreak. Complex logistical
arrangements needed to distribute medications or equipment from the
Strategic National Stockpile to stricken populations have been
developed.
In some locations, genuine public health crises, such as flu
vaccine shortages or an influx of evacuees from the Gulf Coast in the
wake of Katrina, have demanded a response. In the act of responding,
local health departments and their community partners continually
identify new challenges and new ways to improve their ability to
respond. Improving a locality's ability to detect a disease outbreak
promptly and to contain it swiftly is a continuous process of training,
exercising, and improving plans based on these exercises. Interrupting
that process through funding cuts would take the Nation's public health
preparedness backwards, not forward. New capacities that are now in
place cannot be sustained without sustained funding.
Congress appropriated supplemental funding of $350 million to
assist States and localities in pandemic influenza preparedness. These
funds are greatly appreciated, but they cannot fill the gaps left by
other funding cuts. The narrow range of activities permitted by CDC's
grant guidance for the first $100 million now available to States adds
to the tasks required of health departments, but the sums available are
insufficient to enable hiring new personnel to carry them out.
Moreover, the production and exercise of plans for any biological
event, including pandemic influenza, is never a one-time activity.
Meaningful progress requires a continuous process of training,
exercising and improvement that involves not merely public health
responders, but all community partners that are part of any response,
including law enforcement, emergency management, hospitals, schools,
and a host of private sector partners.
The Nation has a long way to go before every citizen enjoys the
best possible protection by disease detection and response systems that
work as quickly as humanly possible. Providing this protection is the
job of the governmental public health system. No other entity can do
it. NACCHO urges Congress to reverse the cuts in funds available to
local public health departments, the Nation's first responders to
bioterrorism.
the phhs block grant is a linchpin for prevention
Local public health departments receive approximately 40 percent of
the Preventive Health and Health Services block grants nationally. The
proportion varies among States from less than 5 percent to almost 100
percent. The block grant funds fulfill three critical purposes. First,
they enable States to address critical unmet public health needs. The
coexistence of other Federal categorical public health funds does not
mean that sufficient funds are available to address all public health
needs. They are not. Improving chronic disease prevention through
screening programs and programs that promote healthy nutrition and
physical activity are prime examples of activities to which many
jurisdictions devote PHHS funds. Forty percent of fiscal year 2004
block grant funds were spent on chronic disease prevention, including
prevention of obesity, stroke, heart disease, cancer, diabetes, and
dental caries.
Second, PHHS funds provide some flexible funding to address
unexpected problems or problems unique to a particular geographic area.
West Nile virus, a fully preventable disease spread to humans by
mosquitoes, is one good example. Third, PHHS fund provide leverage for
more funds and in-kind resources from non-Federal sources. In one
southern State, local health departments collectively used $2.77
million in block grant funds to establish new prevention programs and
generate $5 million in additional resources for those programs.
States are fully accountable to the Department of Health and Human
Services for their expenditures of block grant funds and must report
how much money they spend by specific program area. In those States
where local health departments receive a significant amount of PHHS
funds from the State, local prevention efforts will diminish. Local and
State health departments are key leaders and providers of population-
based prevention programs. They work to keep prevention in the public
eye and build on programs that have been proven effective in reducing
disease and preventing premature death. As health care costs escalate,
reducing the Nation's commitment to prevention by eliminating the PHHS
block grant, weakening state and local public health departments, is
unwise and uneconomic.
The National Association of County and City Health Officials
(NACCHO) is the organization representing the almost 3,000 local public
health departments in the United States.
______
Prepared Statement of the National Coalition for Osteoporosis and
Related Bone Diseases
The National Coalition for Osteoporosis and Related Bone Diseases
(Bone Coalition) is pleased to comment on the fiscal year 2007 budget
for the National Institutes of Health (NIH) as it relates to bone
research. The Federal investment made to date goes a long way towards
improving the bone health of our citizens and we are appreciative of
the Committee's leadership over the years. We also congratulate the
Committee for recognizing the complexities of the issues in the bone
field and including language in the fiscal year 2006 committee report
directing the NIH to establish a ``Bone Health Research Blueprint.''
The recent Surgeon General's Report on bone health and osteoporosis
illustrates the large burden that bone disease places on our Nation and
its citizens. The Bone Coalition is committed to reducing the impact of
bone diseases through expanded basic, clinical, epidemiological and
behavioral research and through education leading to improvement in
patient care. The Coalition participants are leading national bone
disease organizations--the American Society for Bone and Mineral
Research, the National Osteoporosis Foundation, the Osteogenesis
Imperfecta Foundation, and the Paget Foundation for Paget's Disease of
Bone.
Bone diseases such as osteoporosis, osteogenesis imperfecta, and
Paget's disease of bone pose a significant public health and economic
challenge.
--Osteoporosis.--Is a disease characterized by low bone mass and
structural deterioration of bone tissue, leading to bone
fragility and an increased susceptibility to fractures of the
hip, spine, and wrist. It remains widespread across all
populations. This is due to several factors, such as the aging
of our population, the prevalence of secondary osteoporosis,
and low bone mass that is common in immobilized patients and
nursing home populations. Secondary osteoporosis, resulting
from numerous chronic medical conditions and the long-term use
of many medications, causes osteoporosis and related fractures
in children, adolescents, and young adults. Over 10 million
Americans have osteoporosis, the majority of whom (80 percent)
are women, and 34 million more have low bone mass, placing them
at increased risk for this disease. One out of every two women
and one in four men over 50 will have an osteoporosis-related
fracture in her/his lifetime. Osteoporosis is responsible for
more than 1.5 million fractures annually, and mortality and
morbidity following both spine and hip fractures is high when
compared to unaffected peers. The estimated national direct
expenditures for osteoporosis and related fractures total $18
billion (2002 dollars) each year.
--Paget's Disease of Bone.--The second most prevalent bone disease
after osteoporosis--is a chronic skeletal disorder that may
result in enlarged or deformed bones in one or more regions of
the skeleton. Excessive bone breakdown and formation can result
in bone that is dense, but fragile. Complications may include
arthritis, fractures, bowing of limbs, neurological
complications, and hearing loss if the disease affects the
skull. Prevalence in the population ranges from 1.5 percent to
8 percent depending on the person's age and geographical
location. Paget's disease primarily affects people over 50.
--Osteogenesis Imperfecta (OI).--Causes brittle bones that break
easily due to a problem with collagen production. For example,
a cough or sneeze can break a rib, rolling over can break a
leg. Besides fragile bones, people with OI may have hearing
loss, brittle teeth, short stature, skeletal deformities, and
respiratory difficulties. OI affects between 20,000 to 50,000
Americans. In severe cases fractures occur before and during
birth. In some cases, an affected child can suffer repeated
fractures before a diagnosis can be made. Undiagnosed OI may
result in accusations of child abuse.
--Cancer Metastasis to Bone.--A frequent complication of cancer is
its spread to bone (bone metastasis) that occurs in up to 80
percent of patients with myeloma, 70 percent of patients with
either breast or prostate cancer, and 15 to 30 percent of
patients with lung, colon, stomach, bladder, uterine, rectal,
and renal cancer causing severe bone pain and pathologic
fractures. Only 20 percent of breast cancer patients and 5
percent of lung cancer patients survive more than 5 years after
discovery of bone metastasis.
According to Dr. Zerhouni, ``. . . we are facing great challenges
in [the area of bone research]: an aging population at increasing risk
for bone problems; the attendant costs of bone disease, both in human
and financial terms; and the need for more physician-scientists to
continue the important work of discovery, treatment, and prevention.''
Bone diseases take many forms and cause complications such as
fractures, chronic pain, hearing loss, brittle teeth, respiratory
difficulties, bone metastasis from cancer, and neurological
complications that reduce people's quality of life and cost society
billions of dollars. These challenges in bone research cut across
numerous institutes/centers at the National Institutes of Health. They
traverse the focus of individual Institutes and require an
interdisciplinary scientific approach.
At the NIH, as part of the Roadmap Initiative, a series of awards
have been established that will make it easier for scientists to
conduct interdisciplinary research and an Office of Portfolio Analysis
and Strategic Initiatives has been established to coordinate trans-NIH
initiatives. The health problems in the bone field require new
approaches. We believe these new efforts will remove obstacles to
scientific progress and better coordinate the discoveries of tomorrow.
NIH-supported research in bone health has led to important
discoveries and has generated new treatments and pharmaceutical
products. It must be recognized that new discoveries and breakthroughs
could come from any areas of biomedical research and could result in
new treatments and eventually a cure for bone diseases.
--Research has taught us that those with low bone mass are at risk
for osteoporosis. These individuals can then address their risk
with exercise, diet, other behavioral and lifestyle changes,
and medication.
--Research has decreased fracture risk and extended the lifespan to
normal for people with OI.
--Research has identified drugs which improve the quality of life of
people whose cancer has metastasized to bone.
--Research has led us to develop simple, non-invasive and accurate
tests that can determine bone mass and help predict fracture
risk.
--Research has identified and demonstrated a variety of drugs that
can reduce bone loss and fractures, and even build new bone.
Thirty years ago, there was no treatment for osteoporosis.
--Research has helped us to understand the need for weight-bearing
exercise to build and maintain bone in order to reduce fracture
risk. Falling can be reduced by strength-building exercise that
increases balance and flexibility.
But much remains to be done. A concentrated effort is required to
address bone health. The Coalition is particularly interested in NIH
support for the following in fiscal year 2007:
--Research is needed into the pathophysiology of bone loss in varied
populations and in targeted therapies to improve bone density
and bone quality according to the etiology of osteoporosis. In
addition research is needed to identify patients at risk for
fracture who do not meet current criteria for osteoporosis, as
well as to study the effects of available and developing
osteoporosis treatments on the reduction of fracture risk in
these patients.
--NCI, NIAMS, NIA and NIDDK must support research to determine
mechanisms and to identify, block and treat cancer metastasis
to bone. Furthermore, NCI must expand research on osteosarcoma
to improve survival and quality of life and to prevent
metastatic osteosarcoma in children and teenagers who develop
this cancer.
--Although bone mineral density has been a useful predictor of
susceptibility to fracture, other properties of the skeleton
contribute to bone strength, including mechanical loading
(exercise) and mechanisms of biomineralization. However, at
this time little is understood as to how these properties
assist in the maintenance of bone strength. Support of this
research by NIA, NIAMS, NIBIB, NICHD, NIDDK, and NHLB will
achieve identification of these parameters and lead to better
prediction for prevention and treatment of bone diseases such
as osteoporosis, osteogenesis imperfecta, bone loss due to
kidney disease, and heart attacks due to hardening of the
arteries.
--Thousands of children and adolescents nationwide suffer from
musculoskeletal disorders and malformations, many of which have
devastating effects on mortality and disability. NIAMS and
NICHD must support research focusing on mechanisms of
preventing fractures and improving bone quality and correcting
malformations, on innovations in surgical and non-surgical
approaches to treatment, and on physical factors that affect
growth.
--Diseases such as osteogenesis imperfecta, fibrous dysplasia,
osteopetrosis, and Paget's disease are caused by poorly
understood genetic mutations. In Paget's disease, underlying
genetic defects can also be exacerbated by environmental
factors. NIAMS, NICHD, NIDCR, and NIDDK must support research
on genetic defects that cause bone disease.
--57.9 million Americans are injured annually, more than one-half
incur injuries to the musculoskeletal system. In the United
States, back pain is a major reason listed for lost time from
work and sports injuries are increasing in ``weekend warriors''
of both sexes. NIAMS, NIA, and NCCAM must study ways to better
understand the epidemiology of back pain, improve on existing
diagnostic techniques for back pain, as well as to develop new
ones. NIAMS, NIBIB, NIDDK and NIA must expand research to
improve diagnostic and therapeutic approaches to significantly
lower the impact of musculoskeletal traumas, and on research on
accelerated fracture healing, the use of biochemical or
physical bone stimulation, and bone substitutes such as
hydroxyapatite and allogeneic tissues.
To move this research forward, Congress must provide sufficient
funding to the National Institutes of Health to sustain the robust
research atmosphere in which to address the challenges in the bone
field. The revolution in genetics/genomics that has provided new tools
and databases and the powerful new imaging devices must not be
hindered. Research must continue to be accelerated in order to improve
the health of the Nation.
recommendations
The National Coalition for Osteoporosis and Related Bone Diseases
supports a 5 percent increase for the National Institutes of Health
(above the fiscal year 2006 funding level), as recommended by the Ad
Hoc Group for Medical Research, along with the National Health Council,
the Campaign for Medical Research and Research!America.
The recent Surgeon General's Report on bone health and osteoporosis
illustrates the large burden that bone disease places on our Nation and
its citizens. We support the establishment of a ``Bone Health Research
Blueprint'' to address the need for interdisciplinary approaches to
research and increased coordination of research efforts. We believe
that more deliberately integrated activities in the areas of bone
research at NIH and at extramural institutions will move our science
more rapidly to discoveries that will preserve health and cure disease.
Thank you for the opportunity to submit our statement regarding the
fiscal year 2007 budget for the National Institutes of Health.
______
Prepared Statement of the National Community Action Foundation
requesting level funding for the fiscal year 2007 community services
block grant, liheap, and head start programs
I first want to convey the deep gratitude of every one of the
Nation's 1,100 Community Action Agencies to Chairman Specter and
Senator Harkin for their leadership in amending the Budget Resolution
to preserve critical domestic programs.
We are requesting that the subcommittee go forward with the
Chairman's original intent of restoring all the programs that are
reduced or eliminated by the President's 2007 budget request. This
remains the correct priority in light of the extreme and, in our
opinion, destructive constraints placed on all domestic discretionary
spending. Of course, this one-year policy is no substitute for a
renaissance of investment in healthy children, in the workforce of
tomorrow, in the health of the public, and in the science that will
sharpen America's competitive edge in 21st century trade.
The following facts on the threat to Community Action's top
priority programs--CSBG, Head Start and LIHEAP--will indicate how
important to Community Action are the strategic decisions facing the
subcommittee.
The Community Service Block Grant (CSBG) is the funding that
underwrites the unique assignment of CAAs: their responsibility to
convene local leadership to make a plan with the low-income community
that implements a mix of strategies to bring in new investment and
social resources. CAAs sustain their communities' long-term commitment
to expand access to new opportunities for their residents who need to
become more productive and more self-sufficient. Fifty two Senators
have written the subcommittee opposing the President's request.
If CSBG is reduced or eliminated, important community institutions
will be lost.
In Pennsylvania:
--Mercer County's Weed & Seed Community Revitalization effort, Micro-
enterprise Development project that makes small business owners
out of former low-income workers and the Elm Street
revitalization project will cease.
--That CAA would also end its sponsorship of three HUD projects (22
units) which are home to special needs populations; those
precious subsidized apartments will be rented out at ``fair
market value''.
--In Venango and Crawford Counties services in the areas of youth
development, supportive housing services, and education would
be eliminated.
--The Pittsburgh and Philadelphia CAAs would close, their services
absorbed into a variety of city government departments;
--Outreach Centers across the State's rural areas would be shuttered.
In Iowa, eliminating CSBG means:
--91 outreach centers will close; these are the local offices where
programs operate, meet both those in need and offer the entire
community space for groups working on local betterment.
--The same will befall dozens of food pantries supported by CAA
warehouses, storage and trucking in which Churches and other
volunteers participate.
--633 homeless children in the Hawkeye area will have no preventive
screenings.
--117 elderly individuals around Davenport will lose the chore
assistance services that have allowed them to remain in their
own homes.
--In Des Moines the vast community gardens project will shut down and
three thrift stores the low-income community depends on will
close;
--In Dubuque, the financial literacy education initiative will end.
Even more ominous is the prospect that no future partnerships or
new initiatives will be imagined and developed; in the past two years,
CAAs across America have used their CSBG as the flexible ``venture
capital'' that supports the efforts to develop partnerships, plan
projects, and raise and package resources. Among the results that are
permanently changing their communities are: numerous dental clinics,
housing developments, job creation projects, energy services for all
the community, and clean water supply facilities. CAAs have developed
and improved communities with permanent investments such as these for
four decades. Ending CSBG dams up the stream of emerging community
infrastructure and services and cuts the ties that keep public-private
local partnerships that coordinate their resources to change local
conditions.
CAAs serve one-third of the Head Start and Early Head Start
participants.--The requirements for program quality have increased as
science's knowledge of early childhood; the expectations for the depth
and number of services and professional care are high. The staff cannot
receive cost of living increases, much less the salaries their skills
merit, without reductions in enrollment. The threat to children's hard
won gains grows with each reduction. CAAs will be forced to deny places
to 6,300 of the 19,000 qualified children that are anticipated to go
unserved under a freeze in fiscal year 2007 Head Start funding.
Finally, LIHEAP must be maintained at least at its current level.--
This year the Congress, led by the Senate with many Members of this
subcommittee in the vanguard, at last got LIHEAP right.
The $3.1 billion the Chairman and Ranking Member supported for the
fiscal year 2006 program is desperately needed. We have surveyed our
member agencies who, collectively, deliver more than a third of the
LIHEAP program nationwide. They are confident that, in spite of the
late start, all the new resources will be distributed either to
consumers who where shut out of the first round of assistance or to
participants whose initial benefits were too low to buy them more than
a few short weeks worth of fuel.
The ``Sunbelt'' programs that nearly doubled their initial grants
when the supplemental funds were appropriated are making especially
speedy and good use of the resources they have long needed. It is
surprising, but true, that low-income consumers in Florida, the Gulf
Coast States and the Southwest spend nearly as high a percentage of
their income on energy bills as do Midwesterners. That is just one
reason it is essential that most of 2007 LIHEAP funds be distributed
according to the statutory formula, as is the case with the fiscal year
2006 funding.
Further, the only good reason for a large contingency fund is to
correct for the extreme effects of the formula factors that deny the
cold States a fair share of appropriations above $2 billion. A
presidential contingency reserve for crises should only be an amount
sufficient to meet an unpredicted need--such as a major natural
disaster--during the period of awaiting major supplemental emergency
legislation. Winter and Summer do not qualify as unexpected events;
neither do high prices. The level and timing of program funding cannot
be abandoned to Presidential politics.
The Department of Energy predicted on April 11 that 2007 home fuel
prices will essentially remain at this year's record levels.(EIA Short-
term Energy Outlook) Last year, its April prediction for prices in
normal 2005-06 winter weather turned out to be about 10 percent under
the prices we faced in this unusually mild winter. Next winter, the
energy markets will afford no relief for struggling LIHEAP-eligible
customers. LIHEAP must, at least, be sustained.
Community Action will be beside and behind this subcommittee's
fight for a fair budget for America's priorities in every way possible
in every part of this Nation. Thank you for considering these views and
for your strategic and moral leadership.
______
Prepared Statement of the National AHEC Organization
summary of fiscal year 2007 recommendations:
1. Increase funding for the Health Professions and Nursing
Education programs under Title VII and Title VIII of the Public Health
Service Act to at least $550 million for fiscal year 2007.
2. Restore funding for area Health Education Centers (AHECs) to the
fiscal year 2003 level of $33.141 million.
3. Restore funding for the Health Education Training Centers to the
fiscal year 2003 level of $4.371 million.
Mr. Chairman, and members of the subcommittee, I am pleased to
present testimony on behalf of the National Area Health Education
Centers Organization (NAO). NAO is the professional organization
representing the Area Health Education Centers (AHECs) and the Health
Education Training Centers (HETCs).
I am Kathleen Vasquez, director of the Ohio Statewide AHEC program,
director of the Medical University of Ohio's AHEC program, and the co-
chair of the National AHEC Organization (NAO)'s Public Policy
Committee.
AHECs develop and support the community based training of health
professions students, particularly in underserved rural and urban
areas. They also provide continuing education and other services that
improve the quality of community-based health care. HETCs use the
infrastructure of the AHECs to address the needs of diverse populations
with persistent and severe unmet health needs. In 5 border and 6 non-
border States, HETCs train and support Community Health Workers to
provide health information and services in their communities. Last year
alone HETCs provided the initial training and continuing education for
over 5,000 Community Health Workers.
Since 1980, the Ohio AHEC program has played a vital part in
training the State's healthcare workforce. Through a community-based
education infrastructure, the delivery of direct patient care is
expanded and a pipeline of professionals is maintained to provide
future care. That pipeline of future professionals who will go on to
practice in rural and underserved areas is maintained through
collaborative partnerships with community health centers (CHCs) and the
National Health Service Corps (NHSC). These partnerships allow the
AHECs to help the Nation's health professions workforce to address
timely issues such as bioterrorism, flu prevention and the nursing
shortage.
community health centers and the national health service corps
Community Health Centers are dedicated to providing preventive and
ambulatory health care to the most uninsured and underinsured
populations by placing point-of-service facilities in these areas. A
March 2006 study published in the Journal of the American Medical
Association (JAMA) found that community health centers report high
percentages of provider vacancies, including an insufficient supply of
dentists, pharmacists, pediatricians, family physicians, and registered
nurses. These shortages are especially pronounced in rural community
health centers. Because Title VII programs (including AHECs and HETCs)
have a successful record of training providers who work in underserved
areas, the study recommends increased support for Title VII as the
primary means of alleviating the health professions shortage in rural
areas. The article serves as an important reminder that the success of
CHCs is highly dependent upon a well-trained clinical staff to provide
care.
The Ohio AHEC program has worked closely with Community Health
Centers to promote and support their complementary missions through the
co-sponsorship of educational programs, the development of clinical
training sites, and the recruitment of talented students. The Ohio AHEC
program places students in rotations at Community Health Centers all
over the State. For example, the Northeast Ohio AHEC places nursing,
nutrition, and health education students in rotations at the Health and
Dental Centers of Community Action Agency of Coloumbiana County. The
Summit Portage AHEC places third year medical students in an
``exploratory experience'' elective with the Akron Community Health
Resources. Other medical students are placed at the Ohio North East
System, which has three Community Health Centers in Youngstown, Warren,
and Alliance. The AHECs affiliated with the Medical University of Ohio
place students at the expansion community health center in Lima as well
as at the only designated migrant health center in Ohio, Community
Health Services in rural Fremont. A network of over 500 physicians
volunteer their time to teach the students at these Community Health
Centers along with students placed in other underserved and rural areas
of the State.
Through another partnership with the Ohio Primary Care Association
(OPCA), Ohio AHECs organized a statewide health literacy and diabetes
conference, with accompanying health literacy train-the-trainer
components. Through this type of train- the- trainer education, Ohio
AHECs have maximized limited resources to build capacity to continue
providing education beyond the initial offering. Many of the
participants in this health literacy and diabetes conference worked at
a Community Health Center.
The leadership of the Community Health Centers and the AHECs in
Ohio often work closely together. I, as the Director of the Ohio
Statewide AHEC program, serve on the board of a Community Health
Center. The Executive Director of that same Community Health Center
serves on the board of the Sandusky AHEC. And the Executive Director of
the Health and Dental Centers of Community Action Agency of Columbiana
County is a member of the Eastern Ohio AHEC Board. These partnerships
allow the AHEC program to help Community Health Centers in Ohio to
recruit, train, and retain well-qualified health professionals who are
passionate about serving in a rural or otherwise underserved area.
AHECs also undertake a variety of programs related to the placement
and support of National Health Service Corps (NHSC) scholars and loan
repayment recipients. The Ohio AHEC is a contractor of the NHSC
``SEARCH'' program. The AHECs, in collaboration with the Ohio Academy
of Family Practice and the Ohio Department of Health, annually recruit
70 students, develop training sites, monitor placements and advise on
individual community projects. These students will gain experience and
exposure to practice in rural, underserved and especially community
health center sites throughout the State.
bioterrorism and flu prevention
Ohio AHECs provide nearly 400 continuing education programs, which
are attended by 11,000 practicing professionals. These providers do not
have to leave their communities or arrange coverage in order to attend
these programs, because the programs are brought to them in their local
communities. The topics of continuing education programs are determined
by the needs of the practitioners in the community, so timely topics
such as avian flu and bioterrorism have been recently provided.
Ohio AHECs have stepped in to provide health professionals with the
latest updates on surveillance, reporting, risk communication,
treatment, and other responses to the threat of bioterrorism. In rural
areas of the State, AHECs bring in downlinks and sponsor bioterrorism
preparedness programs. Ohio AHECs have provided preparedness training
for clinicians at the Community Health Centers, and also provided
train- the- trainer education programs at 4 regional locations. In
addition, some of our sister AHEC programs are already heavily involved
in public education for flu prevention.
nursing shortage
Contrary to what may be commonly understood, persistent and severe
shortages exist in a number of health professions. Chronic shortages
exist for all health professions in many of our Nation's underserved
communities, and substantial shortages exist in all communities for
some high-need professions such as nursing.
Historically, the supply of and demand for health care
professionals has waxed and waned in a manner that produced cycles of
shortage and excess. However, it is reasonable to believe that the
current shortages are of a different and more persistent nature. First,
the breadth and depth of shortages are greater than at any time in the
past. More disciplines are in short supply, more sites of care
(hospitals, nursing homes, home care agencies, and clinics) are
experiencing shortages, and the duration of vacancies is longer.
Second, the demand for health care services is steadily and inexorably
increasing due to the aging population and the advances in medical
technology. Third, the health care provider population is aging itself.
Fourth, the resources with which the health care industry might respond
to shortages are inadequate. Due to the squeeze of managed care,
provider institutions are unable to increase salaries, and due to cuts
in government funding, educational institutions are unable to expand
class sizes. Finally, the career opportunities available to women, who
historically have dominated the nursing profession, have expanded
greatly.
Currently, AHECs and HETCs are working with schools of nursing,
State nursing associations, Community Health Centers, and the National
Health Service Corps, to increase the number of qualified applicants to
nursing schools, increase minority enrollment in nursing schools,
expand the number of community-based nursing training sites, and
retrain nurses who wish to re-enter the profession.
justification for funding recommendations
Mr. Chairman, I respectfully ask the subcommittee to support our
recommendations to increase funding for the health professions and
nursing education programs under Title VII and Title VIII of the Public
Health Act to at least $550 million for fiscal year 2007. Our
recommendations are consistent with those of the Health Professions and
Nursing Education Coalition (HPNEC). 56 of your colleagues (led by
Senators Reed and Roberts), signed a letter to the subcommittee,
stating that restoring funding to Title VII health professions programs
is vital to reversing health professions shortages in the Nation's
neediest communities.
Two of the Title VII programs, AHECs and HETCs, improve access to
primary and preventive care through community partnerships, linking the
resources of academic health centers with local communities. AHECs and
HETCs have proven to be responsive and efficient models for addressing
an ever-changing variety of community health issues, including
bioterrorism, flu prevention, and the nursing shortage. In order to
continue this potential, additional Federal investment is required. We
request that in fiscal year 2007 you restore funding to the fiscal year
2003 levels of $33.141 million for AHECs, and $4.371 million for HETCs.
______
Prepared Statement of the National Coalition for Heart and Stroke
Research
My name is Jack Owen Wood. I solicit your support for more
aggressive Federal funding for research into prevention and treatment
of the sister diseases, stroke and heart disease. Strokes and heart
attacks are occurring at an alarming rate.
I am representing the National Coalition for Heart and Stroke
Research. The coalition consists of 18 national organizations
representing more than 5 million volunteers and members united in
support for increased funding for heart and stroke research. Members of
the Coalition include: American Academy of Neurology; American Academy
of Physical Medicine and Rehabilitation; American Association of
Neurological Surgeons; American College of Cardiology; American College
of Chest Physicians; American Heart Association; American Neurological
Association; American Stroke Association; American Vascular Association
Foundation; Association of Black Cardiologists; Child Neurology
Society; Children's Cardiomyopathy Foundation, Inc.; Congress of
Neurological Surgeons; Heart Rhythm Society; Mended Hearts, Inc.;
National Stroke Association; Society of Interventional Radiology; and
Society for Vascular Surgery.
I will deal primarily with one man's personal experience with
stroke and its functional and financial costs--my own. I have only the
use of my right arm.
I was born in 1937, raised in Vicksburg, Mississippi, earned an
engineering degree at Mississippi State University and currently reside
in Port Orchard, Washington. I worked for the Boeing Company in
Seattle, am a former Director of the Washington State Energy Office,
served as Director of Cost and Revenue Analysis and as the Forecasting
Manager for a major Northwest Area Natural Gas Utility until May 1,
1995.
On May 1, 1995, at the age of 57, I was stricken and severely
disabled by my stroke. Two years later I experienced a triple bypass
heart operation. You might say I've ``been there and done that'' for
both major cardiovascular diseases. So you see, I am an expert.
Years ago I was offered an exciting and rewarding volunteer
opportunity. I was asked to lead the ``JACK WOOD STROKE VICTOR TOUR''
for the American Heart Association.
The JACK WOOD STROKE VICTOR TOUR was a 5-State lobbying tour.
Through it I tried to meet personally with every Northwest
Congressional representative on his or her home turf (in Alaska, Idaho,
Montana, Oregon and Washington). In each meeting I was joined by local
people, stroke survivors and their families and medical professionals.
I told my story and asked them to join the Congressional Heart and
Stroke Coalition and to support increased Federal funding for heart and
stroke research.
I am proud to say I traveled to 18 communities and met personally
with 28 members of our delegation or their staff.
One of the most powerful memories for me was the frequency in which
Members of Congress or staff members related their personal experience
with stroke. One member I spoke to lost both parents to stroke. I
suspect many of you have stories too.
I realize your interest is greater than the physical impact of my
stroke. Your concern must include the financial impact, not only to me,
but also on our country from increased health care costs and lost
productivity and its many implications.
I have confronted the difficult and painful task of calculating
that cost to me. Besides being a man whose stroke took his ability to
pick up and play with his grandchildren and his livelihood, I remain a
statistician at heart. I could not resist calculating and telling that
part of my story. But please remember my story is not dissimilar to
that of many of the 5.5 million stroke survivors in the United States.
Many of whom were stricken in their prime earning years. Who in a
matter of moments, seemingly without warning, are transformed from a
contributor and provider to a receiver and patient.
Allow me to highlight three figures that I feel sum up my data and
should be important to you. I estimate that my stroke at age 57:
--Reduced my earnings before retirement age 65 by more than $600,000.
--Subsequently, the cost to the Federal Government in lost income and
other taxes, early Medicare payments and Social Security
disability payments is more than $320,000.
--My HMO spent approximately $150,000 to respond to and treat my
stroke.
--One man, over $1 million.
About 700,000 Americans will suffer a stroke this year costing this
Nation an estimated $58 billion in medical expenses and lost
productivity.
Earlier I described a stroke as occurring seemingly without
warning. All too often as in my case, people either don't know or
ignore the signs of a stroke, even one in progress. When my stroke hit
I denied it. It took me two days after my stroke to acknowledge it and
seek help. Because of research into new treatments, we now have tPA, a
clot-busting drug, which if administered within 3 hours of the onset of
stroke symptoms, can dramatically reduce the damage of clot-based
strokes. Had I recognized and acknowledged my stroke, gone to a
hospital with a neurologist on staff and had there been tPA, the impact
of my stroke most certainly would have been lessened.
What is even more painful to me is that my impending stroke could
have been detected. Unfortunately, we need to create easier and less
expensive diagnostic techniques so that effective diagnostics can be
given routinely as part of regular health exams. And they must be
covered through insurance.
I am not asking for your sympathy. Instead, please think of me as
two of the ghosts in the famous Dickens' story. Please don't
misunderstand, I am not casting you as Scrooge. See me as both the
ghosts of things past and things yet to be. I too am here to tell you,
the future, which I represent, needs not be. It is largely up to you.
I hope my story and estimate of the cost of my stroke convinces you
that taking on stroke and heart disease through increased research,
leading to better prevention, diagnosis and treatment is fiscally
responsible. The human and financial costs are astronomical.
Thank you for your past support of research.
______
Prepared Statement of the National Multiple Sclerosis Society
Mr. Chairman and distinguished members of the subcommittee, we
appreciate the opportunity to submit written testimony on behalf of the
National Multiple Sclerosis Society. Multiple sclerosis (MS) is a
chronic, unpredictable and often disabling disease of the central
nervous system. Symptoms range from numbness in the limbs, to loss of
vision, memory deficits, and in some instances partial or total
paralysis. The progress, severity and specific symptoms of MS in any
one person can vary and cannot yet be predicted, but advances in
research and treatment are giving hope to those affected by the
disease.
Since its inception in 1946, the Society's highest priority has
been to end the devastating effects of MS by supporting research aimed
at finding the cause of MS, providing better treatments, and ultimately
discovering a cure. In 2006, the National MS Society will spend over
$40 million on MS research supporting over 350 MS investigations. By
the end of 2006, the Society cumulatively will have expended some $500
million since awarding its first three grants in 1947. This represents
the largest privately funded program of basic, clinical, and applied
research and training related to MS in the world.
Any effort to conquer MS will require the collective efforts of
many individuals as well as private and public organizations. The
Federal Government is a critical partner in the fight against MS and
must continue its vital role in furthering the scientific understanding
of MS. To this end, the Society supports the following proposals
related to Federal efforts:
--There is a great need to determine how many Americans have MS. We
therefore ask that the National Institutes of Health (NIH)
collaborate with the Centers for Disease Control/Agency for
Toxic Substances and Disease Registry (CDC/ASTDR), the Society
and other MS organizations to begin the task of establishing
the incidence and prevalence of MS.
--There is a great need to find treatments for the primary-
progressive form of MS (PPMS). We therefore ask that NIH bring
additional research focus to the primary-progressive form of
MS.
--There is a great need to develop laboratory tests to help
physicians easily diagnose and monitor MS. We therefore ask
that NIH expand its efforts to identify biomarkers for MS.
--There is a great need provide effective rehabilitation services to
Americans with MS. We therefore urge that the National
Institute on Disability and Rehabilitation Research (NIDRR) in
the Department of Education fund one additional Medical
Rehabilitation Research and Training Center for MS and take
steps to stimulate individual research projects in MS.
--There is a great need to sustain the country's research enterprise
and to accelerate the discovery of life-changing treatments for
MS. We therefore ask that Congress increase fiscal year 2007
NIH funding by 5 percent.
The National MS Society has had a long and productive relationship
with the NIH, particularly with National Institute of Neurological
Disorders and Stroke (NINDS). Our founder, Sylvia Lawry, helped
spearhead the legislation that established NINDS in 1950 and the
Society has been pleased to work with the NINDS on many areas of mutual
interest. Indeed, we extend our thanks to NINDS Director, Dr. Story
Landis, and key members of her staff, for meeting the Society's senior
leadership to explore collaborative opportunities. We look forward to
continued discussions with Dr. Landis and are eager to initiate similar
discussions with the leadership of other NIH institutes.
The Federal investment in the NIH and the NIDRR plays a major role
in MS research. At the NIH, there are two other institutes that conduct
or fund the majority of MS research: the NINDS, which funds 75 percent,
and the National Institute of Allergy and Infectious Diseases (NIAID),
which funds about 20 percent. The National Center for Medical
Rehabilitation Research (NCMRR--a unit of the National Institute of
Child Health and Human Development) also funds a small amount of MS
research specifically targeting rehabilitation issues. In addition to
the NIH, the NIDRR through the Department of Education invests in MS
research.
For fiscal year 2006 and fiscal year 2007, it is estimated that NIH
expenditures on MS research will be approximately $109 and 108 million,
respectively. For fiscal year 2006 and fiscal year 2007 NIDRR
expenditures on MS research will be approximately $1.6 million per year
out of a total budget of $107 million per year.
--While this demonstrates one measure of the Federal investment in MS
research, this amount pales in comparison with the annual
direct and indirect disease cost--approximately $23 billion for
all people with MS in the United States.\1\
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\1\ Based on a 1994 Duke University study, indexed for 2004 by the
National MS Society, the average annual cost of MS is estimated at
$57,500 per person due to lost wages, increased medical care and other
expenses. Nationwide, there are an estimated 400,000 people with MS.
---------------------------------------------------------------------------
investing in research priorities relevant to ms
The National MS Society recognizes that new discoveries and
breakthrough findings could come from almost any area of biomedical
research and could apply to the primary concern of our members: finding
a cure for MS. NIH plays THE major role in maintaining our country's
preeminence in the biotechnology industry and provides world-wide
leadership in health research and discovery. We thus encourage Congress
to focus on NIH as a whole, and on agencies of particular relevance to
our concern, knowing that a well-funded Federal research enterprise
will benefit all of us.
Determining how many Americans are affected by MS.--An area in
critical need of attention is determining the incidence, prevalence,
and distribution of MS. The last national study of incidence and
prevalence of MS in the United States took place more than 30 years
ago. Since that time the population of the United States has changed
dramatically in size, composition, and distribution. Moreover, numerous
questions have arisen concerning possible ethnic, geographic, and local
variations in the distribution of MS. Knowledge concerning these
distributions and possible causal factors may provide important
information concerning the nature of MS and its triggers. Rational
policy formulation for MS health care requires up-to-date information
concerning numbers and characteristics of persons with MS down to the
State level.
We are pleased to note that CDC/ASTDR has taken an important step
in addressing this issue by convening a workshop to discuss a proposal
for setting up national surveillance systems for MS and amyotrophic
lateral sclerosis (ALS). The Society was pleased to participate in this
meeting and looks forward to collaborating with CDC/ASTDR in planning
of regional pilot studies of methods to establish incidence and
prevalence of MS, and ultimately the design and deployment of a
national or multi-regional surveillance system for MS. Establishment of
such systems, however, is beyond the resources of the Society. We
therefore urge NINDS and other appropriate NIH institutes to
collaborate with the CDC/ATSDR and to allocate funds for the conduct of
the critical pilot studies and to support a national effort to
accurately measure incidence and prevalence of MS.
Finding new treatments for primary-progressive MS.--Advances in
immunology have provided clinicians with powerful tools to better
understand the underlying causes of MS, leading to new therapeutic
advances. Although there are FDA-approved treatments for relapsing MS,
there are still no approved treatments for progressive MS. The primary-
progressive form of MS (PPMS) is characterized from the onset by the
absence of acute attacks and instead involves a continuous and gradual
clinical decline.
Approximately 10 percent of individuals are diagnosed with PPMS
from the onset. Clinically, this form of the disease is associated with
a lack of response to any form of the approved MS therapies. This leads
to the concept that PPMS may in fact be a very different disease as
compared to relapsing-remitting MS. The Society identifies the study of
primary-progressive MS as an area that merits greater attention by the
research community in order to increase our understanding of PPMS and
to have effective therapies for this progressive form of the disease.
In the upcoming year, the Society encourages NIH to help the Society
address this underserved area of MS research.
Helping physicians with diagnosis and treatment.--The complexity of
MS poses many challenges for both diagnosis and treatment of the
disease. Biomarkers, substances that are detectible in blood or other
body fluids by laboratory testing, are a promising tool for physicians
since they could aid in diagnosis, treatment selection, and prediction
of disease course. In addition, valid biomarkers will be very useful in
evaluating the effectiveness of new drugs.
The fundamental importance of biomarkers for MS has been recognized
by the NIH Autoimmune Disease Coordinating Committee and NINDS, which
sponsored a workshop on this topic in 2004. Moreover we are pleased to
note that NINDS has provided $4 million for a major biomarker discovery
effort as part of a large-scale clinical trial, CombiRx. The CombiRx
trial is evaluating whether or not a combination of approved MS
therapies is more effective in treating MS than individual therapies.
We applaud NINDS for its efforts to-date and urge that NINDS and other
NIH institutes work with the Society to expand their efforts to support
research directed at the discovery and validation of biomarkers for MS.
expanding the scope of federal support for ms research
In addition to efforts at the NIH, the Society is pleased to note
that for more than 20 years, NIDRR has funded a Medical Rehabilitation
Research and Training Center (MRRTC) for MS. However, the institute's
overall investment in MS research remains limited, $1.6 million in
fiscal year 2006 and fiscal year 2007. It is dismaying that the current
NIDRR portfolio includes only 4 projects related to MS whereas spinal
cord injury, with a prevalence less than that of MS, has 39 active
projects in the NIDRR portfolio.
Since the advent of FDA-approved MS disease-modifying treatments in
1993, persons with MS have had access to therapeutics which can slow
the progression of disability. However, in order to maintain maximum
levels of independence, persons with MS need rehabilitation to address
residual deficits. Unfortunately, due to the limited support for MS
rehabilitation research, we know relatively little about the efficacy
of rehabilitative interventions in MS. We therefore urge the NIDRR to
increase its support for MS rehabilitation research through the funding
of at least one additional MRRTC along with initiatives to stimulate
individual research projects.
overall nih funding increase for fiscal year 2007
The Society is deeply concerned that NIH may face a fourth year of
overall low funding increases. This low funding level endangers the
potential breakthroughs and discoveries that motivated Congress to
complete a five-year campaign to double NIH's budget in 2003. In fact,
the trend toward flat or slightly decreased NIH funding could put NIH
on a trajectory to un-double its budget because the annual cost of
inflation cannot be covered.
Furthermore, we are gravely concerned that the current annual NIH
investment in MS research of $110 million is projected to drop by $1
million in 2007 and another $1 million in 2008. This trend jeopardizes
progress toward a cure and new treatments for MS. Indeed, we remind the
committee that in the 1990's, it was the NIH's basic and clinical
research that contributed greatly to the development of the first
disease modifying drugs for MS. Now there are 6 such drugs approved for
MS therapy, and the NIH is funding a major trial to test whether
combining drugs can enhance their benefit.
Moreover, NIH-funded research catalyzes industry efforts to develop
drugs in many ways. Industry tells us that developing biomarkers that
can measure the progression of MS could dramatically enhance their
efforts to develop drugs. Over the last several years, advances in
brain imaging for MS have taken a major step towards the goal of MS
biomarkers. The NIH has a major effort underway to identify additional
methods to measure the progression of MS, this is another step toward
increased understanding of MS. Moreover, because of these advances in
understanding of MS, biotech and pharmaceutical companies currently
have more than a dozen drugs for MS in various stages of clinical
testing. Despite these significant efforts, the number of new drug
applications to the Food and Drug Administration continues to decline.
The Society fears that this negative trend will be accelerated by
continued reductions in NIH-funded research.
A lack of Federal funds for biomedical research and MS research, in
particular, will also force junior and senior researchers to leave the
scientific workforce, further slowing the pace of research. Such an
outcome would mean that substantial investments biomedical research
would have been squandered, and replenishing this workforce would take
a generation. We therefore urge Congress to:
--Appropriate a 5 percent fiscal year 2007 funding increase for NIH.
--Balance the fiscal year 2007 NIH appropriation to allow growth
across all NIH institutes and all areas of disease research.
We ask the subcommittee to be mindful of the thousands of
Americans, and particularly those with MS, who will be affected if the
pace of research is slowed by reductions in NIH funding. While
treatments are available for MS, these are expensive and only partially
effective for some patients. Until a cure is found, people affected by
MS want more effective and more economical treatments.
The surest path to discovering treatments for MS, and for human
diseases in general, is by sustaining the country's investment in
innovative biomedical research at universities and small businesses.
Funding cuts threaten these efforts, and will invariably harm the
country's research infrastructure. Correcting such damage may take a
generation, and Americans with MS cannot afford to wait that long.
Moreover, the country cannot afford the economic consequences of
delaying the discovery of treatments that could change the lives of
those impacted by MS.
We thank the subcommittee for this opportunity to comment and
applaud your commitment to advancing the health and well-being of all
Americans through investment in biomedical research.
______
Prepared Statement of the NIH Task Force of the Bioengineering Division
of the Basic Engineering Group of the Council on Engineering of ASME
The NIH Task Force of the Bioengineering Division of the Basic
Engineering Group of the Council on Engineering of ASME, is pleased to
provide comments on the bioengineering-related programs in the National
Institutes of Health (NIH) fiscal year 2007 budget request. The ASME
Bioengineering Division is focused on the application of mechanical
engineering knowledge, skills and principles from conception to the
design, development, analysis and operation of biomechanical systems.
the importance of bioengineering
Bioengineering is an interdisciplinary field that applies physical,
chemical and mathematical sciences and engineering principles to the
study of biology, medicine, behavior, and health. It advances knowledge
from the molecular to the organ systems level, and develops new and
novel biologics, materials processes, implants, devices, and
informatics approaches for the prevention, diagnosis, and treatment of
disease, for patient rehabilitation, and for improving health.
Bioengineers have employed mechanical engineering principles in the
development of many life-saving technologies, such as the artificial
heart, prosthetic joints and numerous rehabilitation technologies.
background
NIH is the world's largest and most eminent organization dedicated
to improving health through medical science. During the last 50 years,
NIH has played a preeminent role in the major breakthroughs that have
increased average life expectancy by 15 to 20 years.
NIH is comprised of different Institutes and Centers that support a
wide spectrum of research activities including basic research, disease
and treatments related studies, and epidemiological analyses. The
missions of individual Institutes and Centers focus on a particular
organ (e.g. heart, kidney, eye), on a given disease (e.g. cancer,
infectious diseases, mental illness), on a stage of development (e.g.
childhood, old age), or, may encompass crosscutting needs (e.g.,
sequencing of the human genome and the National Institute of Biomedical
Imaging and Bioengineering (NIBIB).
The total fiscal year 2007 NIH budget request is $28.6 billion,
which represents approximately the same level as the fiscal year 2006
appropriation. Some $50 million of this increase is for radiological/
nuclear countermeasures development. NIH R&D, 97 percent of the total
NIH budget, would also remain flat at $27.8 billion next year. The
largest increases would go to the Office of Director and towards
biodefense R&D.
According to the President's fiscal year 2007 budget request,
``NIH's highest priority is the funding of medical research through
research project grants (RPGs). Support for RPGs allows NIH to sustain
the scientific momentum of investigator-initiated research while
pursuing new research opportunities.'' The administration estimates
that the fiscal year 2007 budget would support an estimated 9,337 new
research project grants (RPGs), an increase of about 275 new competing
RPGs from fiscal year 2006. Nevertheless, NIH projects a decline in the
total number of RPGs for the third year in a row, no inflation
adjustment for most new or continuing grants, and a decline in the RPG
success rate for the sixth year in a row down to 19 percent. RPGs
account for 52 percent of the 2007 NIH Budget Request.
The largest percentage increase would go to the Office of the
Director (OD; up 25.1 percent) to boost OD funding for clinical
research, high-risk basic research, and collaborative research in the
NIH Roadmap for Biomedical Research. The Roadmap would receive $443
million in fiscal year 2006 (up 34 percent), with $332 million coming
from institute budgets. Currently, the Roadmap Initiatives provides $80
million annually, or roughly 24 percent of the total roadmap budget,
for bioengineering-related project.
Other initiatives funded by the fiscal year 2007 budget request are
5 awards for the new K/R ``Pathway to Independence'' program and the
Genes, Environmental, and Health Initiative (GEHI) that will study
genetic factors associated with disease and accelerate technological
development that can measure human responses to environmental
influences on health.
The President's fiscal year 2007 budget requests $294.5 million for
the NIBIB, a reduction of $1.96 million (0.7 percent) below the fiscal
year 2006 enacted level. Most NIH institutes are also slated for
reductions in funding in the President's budget request.
Below are some highlights from the fiscal year 2007 budget request
for NIBIB. Further details can be found at http://www.nibib.nih.gov/
publicPage.cfm?pageID=263#FY2007.
NIBIB Extramural Research would decline 1.3 percent, to $268 million.
The number of research project applications to NIBIB continues to
grow, with the number doubling from fiscal year 2003 to fiscal year
2004 and then increasing by 20 percent from fiscal year 2004 to fiscal
year 2005. The research budget, however, has remained flat.
Consequently, the success rate for investigators applying for
extramural research grants from the NIBIB is the second lowest among
the NIH institutes and centers. It is estimated that the success rate
for these applications was 16.8 percent in fiscal year 2004, decreasing
to approximately 15 percent in fiscal year 2005. The projected success
rate for fiscal year 2006 is only between 10 and 15 percent
NIBIB Intramural Research would grow 6.3 percent, to $7.7 million.
In September 2004, the NIBIB Special Advisory Panel for Intramural
Programs met to develop recommendations for the National Advisory
Council on Biomedical Imaging and Bioengineering concerning an
intramural research program within the NIBIB. Intramural research
accounts for approximately 10 percent of the total NIH budget. The
NIBIB currently is at the low end in terms of funds it commits to
intramural research among all of the NIH institutes, both in terms of
dollars expended and percentage of its total budget. The Panel
recommended that NIBIB not pursue the near-term expansion of its
Intramural Research Program beyond the available funding in the current
budget and the fiscal year 2005 President's Budget proposal. The Panel
further recommended that NIBIB use its limited intramural funds
primarily to expand interdisciplinary training opportunities at the
postdoctoral level. In addition to the already established training
grants offered by the NIBIB, there is a new initiative co-sponsored by
the NSF Engineering Directorate to offer summer institute training for
undergraduate students. It is hoped that such programs can be offered
regularly now and/or expanded. More information can be found at http://
bbsi.eeicom.com/.
The estimate for NIH-wide bioengineering research was $1.291
billion in fiscal year 2006, and $1.32 billion in fiscal year 2005. The
proposed 2007 amount is $1.296 billion, a 0.4 percent increase over
2006. These numbers reflect bioengineering funding by any of the 27 NIH
institutes or Office of the Director.
recommendations
The Task Force is concerned that funding for bioengineering has
continued to lag compared to many areas of NIH, and will continue to do
so, especially now that the doubling of the NIH budget is complete and
the total funding for NIH remains flat. While a strong supporter of the
NIBIB, the Task Force is also concerned that bioengineering continues
to constitute less than half the budget for the NIBIB. There is a need
for advanced engineering concepts to be applied to basic and
translational biomedical problems for the potential of recent
biological advances to be realized. The request for more bioengineering
funding addresses a critical need for developing and applying more
complex engineering principles to biomedical problems. In many cases,
such engineered solutions to health care problems will result in a
reduction in health care costs. Therefore, the Task Force strongly
urges Congress to provide increased funding for bioengineering within
the NIBIB and across NIH. The NIBIB requires exceptional consideration
for funding increases in the coming years. It is notable that the
success rate for funding applications to the NIBIB is currently between
10-15 percent, even lower than the declining average NIH-wide success
rate of 19 percent. This is a direct manifestation of the continued
growth of the field outpacing funding increases to the NIBIB.
While the Task Force supports new Federal proposals that seek to
double Federal research and development in the physical sciences over
the next decade, the Task Force believes that strong Federal support
for bioengineering and the life sciences is essential to the health and
competitiveness of the Nation. Increased funding for the NIH has put
the United States is a leading position in pharmaceuticals,
bioengineering, and medical sciences. Long-term lack of funding for NIH
programs would harm the tremendous gains the United States has made
over the last decade.
ASME International is a non-profit technical and educational
organization with 125,000 members worldwide. The Society's members work
in all sectors of the economy, including industry, academic, and
government. This statement represents the views of the ASME NIH Task
Force of the Bioengineering Division and is not necessarily a position
of ASME as a whole.
______
Prepared Statement of the National Primate Research Centers
The Directors of the National Primate Research Centers (NPRCs)
respectfully submit this written testimony for the record of the U.S.
Senate Appropriations Subcommittee on Labor, Health and Human Services,
and Education. The NPRCs appreciate the commitment that the members of
this subcommittee have made to biomedical research through strong
support for the National Institutes of Health (NIH). Given your
leadership on this issue, the NPRCs urge Congress to direct resources
to NIH to ensure that the Federal investment in vital biomedical
research will not be compromised.
The NPRCs are a national network of eight primate research centers
supported by the NIH National Center for Research Resources (NCRR). The
centers comprise the National Primate Research Program (NPRP), which
was developed by Congress in 1960. The program seeks to address human
health problems through scientific research using the animal models
that most closely resemble humans in their genetics, physiology, and
disease processes--primates. NPRCs support research that is sponsored
by nearly every institute of NIH. For example, NPRCs conduct research
to help understand and treat diseases such as heart disease,
hypertension, cancer, diabetes, hepatitis, AIDS, kidney disease,
Alzheimer's disease, and Parkinson's disease. They also conduct
research on emerging infectious diseases and many aspects of
biodefense. Each NPRC makes its facilities available to investigators
from around the country. Our centers create collaborative research
environments that allow scientists to combine their individual
expertise beyond the scope of established disciplinary research
projects.
NPRCs endorse the fiscal year 2007 Ad Hoc Group for Medical
Research proposal to increase the NIH budget by five percent over the
fiscal year 2006 level. We recognize that the current budget
environment puts pressure on Congress to face difficult funding trade-
offs; however, as this subcommittee works to define priorities for the
year and set goals for the future, we ask that you maintain your long-
term commitment of support for NIH and its mission. The President's
fiscal year 2007 budget would flat-fund NIH. The five percent increase
for NIH supported by NPRCs would not only allow the agency to sustain
current programs but also invest in critical new initiatives. This
would prevent NIH from falling behind the ``Innovation Index''--the
rate of biomedical inflation as calculated in the Biomedical Research
and Development Price Index (BRDPI) plus a modest investment in new
initiatives. Using the fiscal year 2007 BRDPI projection as a base, NIH
would require an increase of at least 3.8 percent over fiscal year 2006
to maintain current programs. However, we strongly believe that an
increase for NIH above BRDPI is justified by the health needs as well
as current and burgeoning research capabilities of the Nation. An
increase above BRDPI would allow new innovative ideas to be funded and
would infuse existing programs to evolve as their research findings
push them to higher levels of basic understanding, translation and
clinical functionality.
As a result of years of expanded investment in biomedical research,
the demand for the NPRCs' resources has increased significantly. The
ability of NIH-funded researchers to conduct future projects with
primate models will depend on the enhancement of three key areas: (1)
the nationwide availability of primates; (2) the quality and capacity
of primate housing and breeding facilities, as well as the availability
of related state-of-the-art diagnostic and clinical support equipment
at NPRCs; and (3) the number of personnel trained in primate care and
management at NPRCs. These areas can be enhanced by an NIH/NCRR
commitment to increase the NPRCs P51 base grants (the mechanism that
funds each NPRC). Biomedical researchers across the Nation are
experiencing shortages in the availability of primates for essential
research. Increases to the P51 base grants would allow NPRCs to: expand
existing breeding colonies and develop bridging programs to use
effectively the under-utilized species of primates in research; invest
in repairs, renovation, and construction of research facilities, as
well as the purchase of modern laboratory equipment; and ensure that
adequate numbers of experts are trained in laboratory animal medicine
and research, because NPRCs must maintain primate management teams
comprised of behavioral specialists, veterinarians, and primate
research experts to ensure excellent primate care, health, and research
success.
Increases from NIH/NCRR to the NPRCs P51 base grant are necessary
to meet the needs discussed above and are critical to the ability of
NPRCs to supply adequate primate resources for scientists across the
Nation to carry out important research projects. As mentioned
previously, these research projects span the disease foci at NIH
institutes and centers, and also play important roles in the NIH
Roadmap, the NCRR Strategic Plan, and grand challenges facing the
scientific community. In the 1950's, primate research produced the
first vaccine for one of the world's worst childhood killers, the Polio
virus, reducing the number of cases in the United States from 58,000 to
one or two per year. Primates have also served as the best model for
various types of HIV research, and their availability for use has
resulted in at least 14 licensed anti-viral drugs for treatment of HIV
infection. Primate models will continue to be necessary to defend the
world against possible future epidemics such as SARS, West Nile Virus,
and avian flu. In addition to deadly viral epidemics, primate research
has enabled the discovery of better treatments and therapies for
diseases and occurrences such as stroke, cataracts, depression and
other psychiatric illnesses. Significant advances in prenatal and
postnatal care have also resulted from primate research.
Further, not only do primates have the potential to provide answers
for long-standing research questions, primate research provides an
unparalleled opportunity to address more recently defined research
priorities, such as those relating to genomics and bioterrorism. The
specific availability of information in the primate genome, which is
quite similar to the human genome, makes primates essential in studies
that require an integrated understanding of a whole biological system.
Recent reports suggest that extensive analysis of genome structure and
function in nonhuman primates could make immediate and significant
contributions to the overall mission of NIH by accelerating progress in
understanding many human diseases. Also, primates serve as critical
animal models in biodefense research projects for which, in some cases,
it would be inappropriate to conduct early clinical trials in humans.
Primates are recognized as vital research resources within Federal
strategic plans regarding biodefense research, including: the National
Institute of Allergy and Infectious Diseases (NIAID) Strategic Plan for
Biodefense Research; the NIAID Research Agenda for Category A Agents;
and the NIAID Research Agenda for Category B and C Priority Pathogens.
Also, NPRCs are partners in NIAID-funded Regional Centers of Excellence
for Biodefense and Emerging Infectious Diseases as well as with NIAID-
funded National and Regional Biocontainment Laboratories.
As NIH and the national biomedical research agenda evolve, NPRCs
adjust to meet the resource needs of the research community but also to
maintain research programs that are on the cutting-edge of science. The
reservoirs of knowledge residing within the NPRCs create new
opportunities for research partnerships with investigators at host
academic institutions and in the biomedical research community at
large. Never have the research questions been so profound, or the
implications for human health so critical. NPRCs are poised to bridge
the gap between knowledge already gleaned from simple cellular and
animal models and knowledge that is needed to promote human health and
cure human disease. Past accomplishments demonstrate, and current and
future research directions will rely on, the roles of robust primate
research programs in addressing critical research questions. The
breadth and success of primate research programs confirm the vital role
that the eight NPRCs play in biomedical research nationwide.
Thank you for the opportunity to submit this written testimony and
for your attention to the critical need for primate research and
enhancement of the NPRCs P51 base grant, as well as our recommendations
concerning funding for NIH in the fiscal year 2007 Appropriations Bill.
______
Prepared Statement of the National Prostate Cancer Coalition
On behalf of the National Prostate Cancer Coalition, I appreciate
the opportunity to submit written comments regarding funding to
Prostate Cancer programs. I would also like to offer our best estimates
on the resources necessary to continue to fight the war on prostate
cancer in fiscal year 2007, most specifically funding for prostate
cancer research, prevention, detection and treatment programs funded by
the Labor, Health and Human Services and Education Appropriations Bill.
history of prostate cancer funding
For the past ten years, the NPCC has worked to reduce the burden of
prostate cancer through awareness, outreach, and advocacy. As you may
know Prostate cancer is the most common cancer (next to skin cancer)
and the second leading cause of cancer-related death in men in the
United States. It is estimated this year over 234,000 men will be
diagnosed with prostate cancer, and more than 27,000 will die as a
result of the disease. Of the 10 million Americans living with cancer
today, two million of these have prostate cancer.
This past decade has been an exciting and important one for
prostate cancer research. Congress and the administration have taken
notice of the impact prostate cancer has on our Nation. In 1998,
Congress promised to double the budget of the NIH within 5 years, and
triple the amount of Federal funding for prostate cancer research. By
keeping that promise, prostate cancer research funding has increased
and expanded to record levels. As a result, more men are screened and
diagnosed with this disease and prostate cancer survivorship rates have
increased. Also for the first time since 1930, the number of cancer
deaths has decreased in 2003. These exciting results cannot continue
without a stable and reasonable level of funding to the NIH.
Unfortunately in fiscal year 2003, NIH funding did not keep up with the
increase of inflation. Last year in fiscal year 2006 the NIH and
prostate cancer research programs received a hard cut to programs at
the Center for Disease Control and the National Cancer Institute.
With less funding, researches cannot continue to discover ways to
combat prostate cancer. New drugs and treatment options are harder to
translate from the lab to the patients. We cannot fight the war on
prostate cancer without the proper tools. The National Prostate Cancer
Coalition understands the limited resources our Nation faces. However,
when research continues to show the eradication of cancer is within
research, we must continue to fund these programs which will save
millions of lives, reduce untold suffering and save the Nation billions
of dollars in healthcare costs.
It is important to note that Americans spend over $4.6 billion per
year for treatment of this disease (this does not include the burden of
lost productivity and wages). Statistics show that as baby boomers
continue to age, the number of Americans impacted by cancer will
increase. These statistics show the far reaching effects prostate
cancer can have, not only on individuals and their families, but the
Nation's economy as well.
funding requests
This year we have joined with the Cancer and Public Health
Communities to urge this committee and Congress to provide $29.7
billion for the NIH, a $1.4 billion increase of fiscal year 2006. We
request funding that will maintain current programs and progress at the
NIH. We would also request that Congress appropriate $5.034 billion for
the National Cancer Institute, a $240 million increase over fiscal year
2006. Again, this funding would only maintain the current discovery
pace. Additionally we ask for Congress to appropriate $20 million
(+6.07 million) for the Prostate Cancer Control Initiatives at the
Centers for Disease Control. With this program, the public receives
information about prostate screening and early detection. With
increased funding, this program can expand and improve outreach
efforts.
The NPCC urges these changes to the fiscal year 2007 Appropriations
bill to ensure funding to cancer research and related programs are a
top priority in fiscal year 2007 and in the future. We thank you for
the opportunity to discuss the need for these tools to fight the war on
prostate cancer. Again, we need to continue to fund these programs to
ensure that our Nation continues to make advances in cancer
eradication.
______
Prepared Statement of the National Sleep Foundation
summary of fiscal year 2007 recommendations
--Provide a 5 percent increase for fiscal year 2007 to the National
Institutes of Health (NIH) and a proportional increase of 5
percent to the individual institutes and centers, specifically,
the National Heart, Lung, and Blood Institute (NHLBI).
--Continue to urge the National Center on Sleep Disorders Research
(NCSDR) of the NHLBI and the Centers for Disease Control and
Prevention (CDC) to partner with voluntary health
organizations, such as the National Sleep Foundation (NSF), to
develop a collaborative sleep education and public awareness
initiative based on the roundtable model that other public
health-related agencies have used with success. In view of the
success of the CDC with similar initiatives, encourage and
support the CDC in taking a leadership role with the roundtable
initiative.
--Encourage the Director of the NIH and the Director of the National
Heart, Lung, and Blood Institute to name a permanent Director
to the National Center on Sleep Disorders Research.
--Encourage CDC to increase support for initiatives connecting sleep
to overall health and safety. Provide $6.321 billion for fiscal
year 2007 to the CDC, the same amount Congress provided to the
agency in fiscal year 2005.
--Continue to urge the United States Surgeon General to develop and
implement a report on sleep and sleep disorders in order to
call attention to the importance of sleep and develop
strategies to protect and advance the health and safety of the
Nation.
Mr. Chairman and members of the subcommittee, thank you for
allowing me to submit testimony on behalf of the National Sleep
Foundation (NSF). I am Dr. Barbara Phillips, Chairman of the NSF Board
of Directors and professor at the University Of Kentucky College Of
Health in the Department of Preventive Medicine. The NSF is an
independent, non-profit organization that is dedicated to improving
public health and safety by achieving understanding of sleep and sleep
disorders, and by supporting sleep-related education, research, and
advocacy. We work with sleep medicine and other health care
professionals, researchers, patients and drowsy driving victims
throughout the country as well as collaborate with many government and
public and private organizations with the goal of preventing health and
safety problems related to sleep deprivation and untreated sleep
disorders.
Sleep problems, whether in the form of medical disorders, or
related to work schedules and a 24/7 lifestyle, are ubiquitous in our
society. At least 50 million Americans suffer from sleep disorders and
millions of others experience sleep problems related to other medical
conditions; yet more than 60 percent of adults have never been asked
about the quality of their sleep by a physician, and fewer than 20
percent have ever initiated such a discussion. Millions of individuals
struggle to stay alert at school, on the job, and on the road.
According to the National Highway Traffic Safety Administration's 2002
National Survey of Distracted and Drowsy Driving Attitudes and
Behaviors, an estimated 1.35 million drivers have been involved in a
drowsy driving related crash in the past five years. A large number of
academic studies have linked work accidents, absenteeism, and school
performance to sleep deprivation and circadian effects.
Sleep apnea, a sleep-related breathing disorder which affects at
least 5 percent of adult Americans and is closely related to some of
America's most pressing health problems, such as obesity, hypertension,
heart failure, and diabetes. Chronic insomnia, experienced by at least
10 percent of our population is a strong risk factor for depression and
other widespread mental health conditions. The direct and indirect
costs associated with sleep disorders and sleep deprivation total an
estimated $100 billion annually.
Sleep science has clearly demonstrated the importance of sleep to
health and well-being, yet research studies continue to show that
millions of Americans are at risk for the serious health and safety
consequences of untreated sleep disorders and inadequate sleep.
Moreover their quality of life suffers and the personal and national
economic impact is staggering. The severity of the public health burden
represented by sleep issues are compellingly detailed in a
groundbreaking new report, Sleep Disorders and Sleep Deprivation: An
Unmet Public Health Problem by the Institute of Medicine.
NSF believes that every American needs to understand that good
health includes healthy sleep, just as it includes regular exercise and
balanced nutrition. We must elevate sleep to the top of the national
health agenda. We need your help to make this happen.
Our biggest challenge is bridging the gap between the outstanding
scientific advances we have seen in recent years and the level of
knowledge about sleep held by health care practitioners, educators,
employers, and the general public. Consequently, the NSF is
spearheading two important initiatives to raise public and physician
awareness of the importance of sleep to the health, safety and well-
being of the Nation.
First, because resources are limited and the challenges great, we
think creative and new partnerships need to be developed to address
sleep awareness. Therefore, the NSF has been working with the National
Center on Sleep Disorders Research (NCSDR) and the Centers for Disease
Control and Prevention (CDC), to develop an ongoing, inclusive
mechanism for public and professional awareness on sleep, sleep
disorders and the consequences of fatigue. Such collaboration between
Federal agencies and voluntary health organizations would create an
opportunity for dramatically improving public health and safety as well
as the quality of life for millions, if not all, Americans. Since
November of 2004, NIH, CDC, and NSF have been meeting with other
interested and diverse voluntary and professional groups and Federal
agencies to discuss the formation of a broad coalition dedicated to
raising public awareness of sleep. This effort should continue to
receive the support of Congress in order to encourage the participation
of relevant Federal agencies.
In relation to this effort, the National Center on Sleep Disorders
Research within the National Heart, Lung and Blood Institute (NHLBI)
currently has an acting director as the result of the recent promotion
of Dr. Carl Hunt. NCSDR was created in 1993 by the National Institutes
of Health Revitalization Act (Public Law 103-43) and has served an
important role in furthering the scientific and public health knowledge
related to sleep deprivation and sleep disorders. NSF requests that you
encourage both Drs. Elias Zerhouni, the Director of NIH, and Elizabeth
Nabel, the Director of the NHLBI to name a permanent director to this
vitally important Center as soon as possible, so that the mission of
the NCSDR is not significantly impacted. Additionally, given the
significant and unique mission of the Center, NIH should consider the
following characteristics for the NCSDR director position: history of
collaborative efforts among sleep investigators and educators;
recognition and stature in the field of sleep medicine; and familiarity
with the research needs and gaps in the field of sleep medicine.
Secondly, at the National Institutes of Health's Frontiers of
Knowledge in Sleep and Sleep Disorders conference, the U.S. Surgeon
General acknowledged widespread illiteracy in our country regarding
sleep loss and untreated sleep disorders. He emphasized that sleep
problems are easily related to the three top areas of the national
health agenda: prevention, preparedness, and health disparities.
Prevention of some of our Nation's most pressing health problems would
be fostered by attending to sleep disorders. Sleep deprivation is a
major barrier to maximizing preparedness and response in times of
crisis. Finally, like many health concerns, access to knowledge and
medical care for sleep problems is less accessible to some of our
citizens.
Conferences and workshops held by the Surgeon General involve
educating the public, advocating for effective disease prevention and
health promotion programs and activities, and providing a highly
recognized symbol of national commitment to protecting and improving
the public's health. The NSF believes it is time that the Federal
Government helps promote sleep as a public health concern through the
development of a Surgeon General's Report on Sleep and Sleep Disorders
in order to call attention to the importance of sleep and develop
strategies to protect and advance the health and safety of the Nation.
Therefore, the NSF is advocating for the development and dissemination
of a Surgeon General's Report on Sleep and Sleep Disorders.
The new report by the Institute of Medicine includes important
recommendations that support the sprit of these efforts and other
specific actions to be taken by the CDC, NIH and other Federal agencies
and private foundations to increase surveillance of and education on
sleep health and sleep disorders. CDC, NIH and the Surgeon General must
partner with voluntary health organizations and increase support for
initiatives that help ensure the health and safety of all Americans.
Thank you again for the opportunity to present you with this
testimony.
______
Prepared Statement of the NephCure Foundation
summary of recommendations for fiscal year 2007
(1) A 5 percent increase for the National Institutes of Health
(NIH) and the National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK).
(2) Continue to expand the NIH'S Nephrotic Syndrome (NS) and Focal
Segmental Glomerularsclerosis (FSGS) research portfolios by
aggressively supporting NIDDK grant proposals in this area and by
encouraging the National Center for Minority Health and Health
Disparities (NCMHD) to initiate studies into the incidence and cause of
NS and FSGS in minority populations.
Mr. Chairman and members of the subcommittee, I am pleased to
present testimony on behalf of the NephCure Foundation (NCF), a non-
profit organization driven by a panel of respected medical experts and
a dedicated band of patients and families working together towards a
common goal-to save kidneys and to save lives. NCF is the only non-
profit organization exclusively devoted to fighting idiopathic
nephrotic syndrome (NS) and focal segmental glomerulosclerosis (FSGS).
Now in its sixth year, the NephCure Foundation continues to work
tirelessly to support glomerular disease research.
FSGS: One Family's Story
My son, Bradly Grizzard, was diagnosed with focal segmental
glomerulosclerosis (FSGS) in 2002. In May of 2005, I donated one of my
kidneys to him.
FSGS is one of a cluster of glomerular diseases that attack the one
million tiny filtering units (nephrons) contained in each human kidney.
Glomerular disease attacks the portion of the nephron called the
glomerulus, scarring and often destroying these filters. Scientists do
not know why glomerular injury occurs, and there is no known cure for
these diseases.
FSGS patients, upon diagnosis, often take a downward plunge at a
rapid rate and it is extremely difficult to make a comeback. My son was
a star football player at his high school and was being recruited by
college football coaches before FSGS attacked his body. When his
kidneys failed, he was forced to give up football, and he had to try
and juggle college classes along with several hours of dialysis a day.
We were lucky that my kidney was a match for him, but even so the first
few hospitals that we approached refused to perform the transplant. We
were eventually able to find a doctor and a hospital that was willing
to perform the operation, and the transplanted kidney is now working
well. But Bradly must remain on costly immunosuppressant drugs for the
rest of his life. These drugs cause many unpleasant side effects and
medical complications.
My son's story is not unique. There are thousands of other people
in this country who have had their lives disrupted due to the sudden
onset of FSGS or NS. And although kidney transplants have been very
successful for thousands of patients, many patients end up rejecting
the transplanted kidney. Other times, the disease comes back and
attacks the transplanted kidney. In either case, the patient must then
again rely on daily dialysis as a means of survival. There are
thousands of young people who are in a race against time, hoping for a
treatment that will save their lives. The NephCure Foundation today
raises its voice to speak for them all, asking you to take specific
actions that will aid our quest to find the cause and cure of FSGS and
NS.
First and foremost, we join the Ad Hoc Group for Medical Research
Funding in asking for a 5 percent increase for the National Institutes
of Health (NIH) and the National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK).
More Research is Needed
We are no closer to finding the cause or the cure of FSGS.
Scientists tell us that much more research needs to be done on the
basic science behind the disease.
We are thankful that the NIDDK continues to work with the NephCure
Foundation on the FSGS clinical trial. Currently 150-175 patients
nationwide are enrolled in the trial. Recently, the steering committee
charged with providing programmatic direction to the trial decided on
several changes which would accelerate progress. NCF is also working
with the NIDDK to cosponsor ancillary basic biological material studies
of the enrolled patients.
The NephCure Foundation is also grateful to the NIDDK for issuing
two program announcements (PAs) that serve to initiate grant proposals
on glomerular disease. The first program announcement, issued in
December of 2005, includes glomerular disease as one of several kidney
or urologic diseases for which the PA will fund grant proposals. The
second PA, issued in March of 2006, is glomerular-disease specific.
Both of these announcements will utilize the R21 mechanism to award
researchers $275,000 over two years.
We ask the Committee to encourage the NIDDK to help find the cause
and the cure for glomerular disease by continuing its support for the
FSGS clinical trial and the ancillary basic biological material
studies. We also ask the NIDDK to continue to add glomerular disease to
program announcements.
Too Little Education About a Growing Problem
When glomerular disease strikes, it results in a loss of protein
from the urine and edema. The edema often manifests itself as puffy
eyelids, a symptom that many parents and physicians mistake as
allergies. With experts projecting a substantial increase in the number
of cases of glomerular disease in the coming years, there is a clear
need to educate pediatricians and family physicians about glomerular
disease and its symptoms.
The NephCure Foundation has numerous education programs underway. A
national FSGS conference will be held in Philadelphia from June 3rd-
4th, 2006. This conference will aim to provide attendees with the most
up to date information on this disease. Through speakers, information
sessions, and informal conversations with other patient families,
attendees will realize they are not alone and will be further energized
for the effort to find a cause and a cure for FSGS.
Also, this summer, the NIDDK will sponsor a working group
scientific conference. This working group will advise NIDDK on animal
models, reagents, and other resources for the study of glomerular
disease.
We also applaud the work of the NIDDK in establishing the National
Kidney Disease Education Program (NKDEP), and we seek your support in
urging the NIDDK to make sure that glomerular disease remains a focus
of the NKDEP.
We ask the Committee to encourage the NIDDK to have glomerular
disease receive high visibility in its education and outreach efforts,
and to continue these efforts in conjunction with the NephCure
Foundation's work. These efforts should be targeted towards both
physicians and patients.
Glomerular Disease Strikes Minority Populations
Nephrologists tell us that glomerular disease strikes a
disproportionate number of African-Americans. No one knows why this is,
but some studies have suggested that a genetic sensitivity to sodium
may be partly responsible. DNA studies of African Americans who suffer
from FSGS may lead to insights that would benefit the thousands of
African Americans who suffer from kidney disease.
As an African-American female and the mother of a son with FSGS, I
ask that the NIH pay special attention to why this disease affects my
race to such a large degree. The NephCure Foundation wishes to work
with the NIDDK and the National Center for Minority Health and Health
Disparities (NCMHD) to encourage the creation of programs to study the
high incidence of glomerular disease within the African-American
population.
There is also evidence to suggest that the incidence of glomerular
disease is higher among Hispanic-Americans than in the general
population. An article in the February 2006 edition of the NIDDK
publication Recent Advances and Emerging Opportunities, discussed the
case of Frankie Cervantes, a six year old boy of Mexican and Panamanian
descent. Frankie has FSGS, and like Bradly, received a transplanted
kidney from his mother. We applaud the NIDDK for highlighting FSGS in
their publication, and for translating the article about Frankie into
both English and Spanish. Only through similar culturally appropriate
efforts can African American and Hispanic families learn more about
glomerular disease.
We ask the Committee to join with us in urging the NIDDK and the
National Center for Minority Health and Health Disparities (NCMHD) to
collaborate on research that studies the incidence and cause of this
disease among minority populations. We also ask that the NIDDK and the
NCMHD undertake culturally appropriate efforts aimed at educating
minority populations about glomerular disease.
______
Prepared Statement of One Voice Against Cancer
One Voice Against Cancer (OVAC) appreciates the opportunity to
submit written comments for the record regarding funding for cancer
programs for research, prevention, detection, and treatment as well as
programs that educate and train nurses in fiscal year 2007 at the
National Institutes of Health (NIH), the Centers for Disease Control
and Prevention (CDC), and the Health Resources and Services
Administration (HRSA). OVAC is a collaboration of more than 40 major
national organizations representing millions of Americans affected by
cancer, unified to urge Congress and the White House to increase
cancer-related appropriations. OVAC stands ready to work with
policymakers at the Federal, State, and local levels to ensure that
these important cancer and nursing initiatives at NIH, CDC, and HRSA
receive adequate funding in fiscal year 2007.
Our Nation's prior investments in cancer research-related programs
have saved thousands of lives and accelerated our progress toward the
Administration's goal of eliminating death and suffering due to cancer
by the year 2015. However, the challenge remains--cancer will strike
one of every two men and one of every three women in the United States.
This year alone, more than 1.4 million men and women in this country
will receive the devastating news that they have cancer; yet, more than
10 million cancer survivors can attest to the fact that we are making
real progress against this disease.
The Congress took a bold step forward in 1998 when it promised to
double the budget of the National Institutes of Health (NIH) within
five years. By keeping that promise, Congress opened the floodgates to
countless new opportunities and advances in cancer research and
programs. Thanks to the advances spawned by that infusion of support
for biomedical research, cancer survivorship rates have steadily
increased each year. For the first time since 1930, the number of
cancer deaths in the United States decreased in 2003. Congress must
maintain that promise with a stable and reasonable level of funding
increases to sustain the momentum of this exciting research. Since
fiscal year 2003, NIH funding levels have fallen far short of keeping
pace with inflation alone, and fiscal year 2006 resulted in a hard cut
to both NIH and National Cancer Institute funding levels.
Less funding translates immediately into fewer discoveries, fewer
new drugs in development, and fewer new treatments reaching patients.
We cannot reach the 2015 goal without the continued support of the
Congress. We appreciate that our Nation faces many challenges and
Congress has limited resources to allocate. However, the conquest of
cancer and elimination of health disparities is truly within our grasp.
Making cancer a national priority will save millions of lives, reduce
untold suffering, and save the Nation billions of dollars in healthcare
costs now and for the foreseeable future. The investment is surely
worth it.
sustain and seize cancer research opportunities
The tremendous investment our Nation has made in the National
Institutes of Health (NIH) has reaped remarkable returns and set the
table for a period of unparalleled innovation in the fight against
cancer and other diseases. For fiscal year 2007, OVAC joins with the
broader public health community and urges Congress to provide $29.7
billion for the NIH, a $1.4 billion increase over fiscal year 2006.
This is the minimal level of funding that will allow the NIH to
maintain the current pace of discovery and innovation.
OVAC recognizes the fiscal challenges facing policymakers, but does
not believe that those challenges require us to weaken our national
commitment to conquering cancer. While the long-term goal of providing
adequate funding to explore the most promising opportunities must
remain paramount, for fiscal year 2007, OVAC urges Congress to provide
the National Cancer Institute (NCI) with at least $5.034 billion, a
$240 million increase over fiscal year 2006. This level of funding is
the bare minimum required to protect our cancer research enterprise and
maintain the current pace of discovery.
While a minimal increase of $240 million will maintain current
programs, it is not sufficient to allow us to move forward with
advances that we know are possible. For fiscal year 2007, OVAC would
recommend an increase closer to that of the professional judgment
budget prepared by the NCI Director. This budget, which calls for $5.9
billion for fiscal year 2007, represents our national battle plan
against cancer, outlining the critical core research that is currently
underway and the most promising and extraordinary research
opportunities. These exceptional research opportunities include
expansion of the NCI-designated cancer centers program from 60 to 75
centers; implementation of the plan to reengineer cancer clinical
trials for greater standardization, speed, and efficiency; construction
of linkages between science and the new technologies of advanced
imaging, proteomics, and computational modeling; expansion of the use
of medical informatics and bioinformatics to cancer-specific
applications; and development of an integrative site-based approach to
cancer research through interdisciplinary team science and
collaboration. The professional judgment budget is developed through an
open and public process; it reflects the best thinking of cancer
researchers, patients, clinicians, and other constituency groups and is
focused on the Institute's goal of eliminating suffering and death from
cancer by the year 2015.
The National Center on Minority Health and Health Disparities
(NCMHD) was created by Congress to help address the undue burden of
chronic and acute disease, morbidity and mortality, and lower survival
rates borne by racial and ethnic minority groups, rural populations and
other medically underserved populations. OVAC urges the Congress to
provide the NCMHD with $200 million for fiscal year 2007 to advance its
critical work coordinating and advancing health disparities research
across the NIH. OVAC seeks to ensure that NCMHD has the resources to
develop and enhance initiatives aimed at reducing and ultimately
eliminating disparities in many chronic diseases, including cancer.
Having worked with Congress to establish the NCMHD, the members of OVAC
are committed to seeing it fulfill its mission and achieve its goals
and objectives.
boost our nation's investment in cancer prevention, early detection,
and awareness
The Centers for Disease Control and Prevention's (CDC) State-based
cancer programs provide vital resources for cancer monitoring and
surveillance, breast and cervical cancer screening, State cancer
control planning and implementation, and awareness initiatives
targeting skin, prostate, colon, ovarian and blood cancers. For fiscal
year 2007, OVAC requests the following funding levels for these proven
programs:
--National Comprehensive Cancer Control Program: $50 million (+$33
million).--The Comprehensive Cancer Control program provides
grants and technical assistance to help States develop and
implement plans addressing the cancers most significantly
affecting their communities through prevention, early detection
and treatment. OVAC's request will allow this program to help
more States implement previously developed plans.
--National Program of Cancer Registries: $65 million (+$16.89
million).--The National Program of Cancer Registries
facilitates State tracking of cancer trends and subsequent
allocation of resources to address specific needs, while also
identifying highly effective cancer control programs that can
be emulated across the country. The registry provides critical
data to ensure we remain on track in the fight against cancer.
OVAC's request will enable States to continue to collect and
analyze high-quality data as well as evaluate existing cancer
prevention efforts.
--National Breast and Cervical Cancer Early Detection Program: $250
million (+$47.57 million).--OVAC appreciates the
Administration's longstanding commitment to this important
program that provides free breast and cervical screening tests
to low income and uninsured women. Unfortunately, millions of
eligible women lack access to these critical tests due to lack
of funding. The CDC estimates that the program currently only
reaches 20 percent of eligible women aged 50 to 64. OVAC's
funding request for fiscal year 2007 would allow at least an
additional 130,000 women to be served by the program.
--Colorectal Cancer Screening, Education & Outreach Initiative: $25
million (+$10.51 million).--Strong scientific evidence has
shown that regular screening and treatment is a cost-effective
way to reduce colorectal cancer incidence and mortality.
However, screening rates for CRC are currently lower than for
other cancer screening services. The Colorectal Cancer
Screening, Education & Outreach Initiative helps increase
public awareness of colorectal cancer, educate health care
providers about colorectal screening guidelines and assist
State programs with colorectal cancer priorities. With
additional resources this program will be able to expand its
awareness initiatives and reduce the number of preventable
colorectal cancer deaths.
--National Skin Cancer Prevention Education Program: $5 million
(+$2.93 million).--Skin cancer is the most common form of
cancer in the United States and is largely preventable. OVAC's
request will allow the program to educate the public about ways
to protect themselves and reduce the risks of getting skin
cancer.
--Prostate Cancer Control Initiatives: $20 million (+6.07 million).--
This initiative provides the public, with special emphasis on
men and their physicians, with information about prostate
cancer screening and early detection. OVAC's request will allow
the program to expand and improve its outreach efforts.
--Ovarian Cancer Control Initiatives: $7.5 million (+$2.98
million).--The Ovarian Cancer Initiative partners with academic
and medical institutions to spur discovery of techniques that
will detect this cancer and develop more successful treatments.
OVAC's request will increase public and professional awareness
of the symptoms and best treatments for ovarian cancer,
restoring hope to the more than 20,000 women who will be
diagnosed with this devastating illness this year.
--Geraldine Ferraro Blood Cancer Program: $5 million (+$0.46
million).--Authorized under the Hematological Cancer Research
Investment and Education Act of 2002, this program was created
to provide public and patient education about blood cancers,
including leukemia, lymphoma and myeloma. OVAC's request will
allow the program to continue to provide patients with
educational, disease management and survivorship resources to
enhance treatment and prognosis.
securing and maintaining an adequate oncology nursing workforce
OVAC joins with the nursing community in asking Congress to provide
$175 million in fiscal year 2007 for the Nurse Reinvestment Act and the
other nursing workforce programs at the Health Resources and Services
Administration (HRSA). Over the next 15 years, the number of Medicare
beneficiaries with cancer is expected to double, while more than 1.1
million nursing positions go unfilled. The critical role of nurses in
our health care system cannot be overstated. Oncology nurses are on the
front-lines of the provision of quality care for cancer patients and
are vital to administering chemotherapy, managing patient treatments
and side-effects and providing counseling to patients and family
members.
Without an adequate supply of nurses, there will not be enough
qualified oncology nurses to provide quality, comprehensive cancer care
to a growing patient population in need. Nurses are also vital to
helping conduct cancer research through clinical trials, and a shortage
will slow down the pace of medical research progress. These programs
will help address the multiple factors contributing to the nationwide
nursing shortage, including the decline in student enrollments,
shortage of faculty and poor public perception of nursing as a viable
and worthwhile profession.
conclusion
OVAC stands ready to work with policymakers to ensure that funding
for cancer research and related programs is a top priority in fiscal
year 2007 and beyond. We thank you for this opportunity to discuss the
funding levels necessary to ensure that our Nation continues to make
gains in our fight against cancer and has a sufficient nursing
workforce to care for the patients with cancer of today and tomorrow.
______
Prepared Statement of the Ovarian Cancer National Alliance
On behalf of the Ovarian Cancer National Alliance (the Alliance), I
thank the subcommittee for this opportunity to submit written testimony
regarding the fiscal year 2007 funding allocations for programs in the
Labor-Health and Human Services and Education appropriations measure
that the Alliance and ovarian cancer community believe are necessary to
help reduce and prevent suffering from ovarian cancer. Since its
inception nine years ago, the Alliance has worked to increase awareness
of ovarian cancer and boost Federal resources to support scientific
research into diagnostics and treatments for the disease. Among the
most urgent challenges in the ovarian cancer field are late detection
and poor survival of women.
As a national umbrella organization with 50 regional, State, and
local groups, the Alliance unites and reaches more than 800,000
grassroots activists, women's health advocates, health care
professionals and the public to bring national attention to ovarian
cancer. As part of this effort, the Alliance advocates for a sustained
Federal investment in ovarian cancer research, awareness, education and
early detection. To that end, the Alliance respectfully requests that
the subcommittee provide the following in fiscal year 2007 funding:
--$7.5 million to the Centers for Disease Control and Prevention's
(CDC) Ovarian Cancer Control Initiative;
--$29.7 billion to the National Institutes of Health (NIH); and
--$5.034 billion to the National Cancer Institute (NCI).
These three agencies are working relentlessly to achieve much-
needed gains in ovarian cancer early detection, treatment and
survivorship. Consistent investment in ovarian cancer research and
public awareness campaigns at CDC, NIH and NCI is vital to our fight
against this deadly disease. The Alliance believes all women should
have the opportunity to survive ovarian cancer, but unfortunately,
unless our Nation makes significant investment in ovarian cancer
research and awareness efforts, thousands of women will continue to
lose their lives every year.
ovarian cancer's deadly statistics
Today, it is both striking and disheartening to see that despite
progress made in the scientific, medical and advocacy communities,
ovarian cancer mortality rates have not significantly improved during
the past decade. According to the American Cancer Society, in 2006 more
than 20,000 American women will be diagnosed with ovarian cancer and
approximately 15,300 will lose their lives to this disease, making it
the fifth leading cause of cancer death in women (behind lung, breast
and colorectal cancers). Every woman is at risk for ovarian cancer and
one in 58 will develop it in her lifetime.
Behind the sobering statistics are the lost lives of our loved
ones, colleagues and community members. The country recently lost a
national treasure to the disease when Mrs. Coretta Scott King died from
stage III ovarian cancer in January. Her disease was considered
terminal after a late-stage diagnosis. Unfortunately, Mrs. King's story
is common for women in our community. When detected early, the five-
year survival rate for women with ovarian cancer increases to more than
90 percent. However, a valid and reliable screening test--a critical
tool for improving early diagnosis and survival rates--still does not
exist for ovarian cancer. With no early detection test, more than 75
percent of women diagnosed with ovarian cancer are diagnosed in stage
III or IV. At these stages prognosis is worst as the five-year survival
rate drops below 30 percent. In simple terms, today, almost half (45
percent) of all women with ovarian cancer will die within five years of
their diagnosis.
Until a screening test is developed, public knowledge of the
symptoms of ovarian cancer and comprehensive, effective treatment
protocols are the keys to reduced mortality rates. The CDC Ovarian
Cancer Control Initiative, NIH and NCI work together to support
programs and research grants that seek to improve early detection and
treatment and educate women and health care providers about ovarian
cancer, thereby increasing awareness and ultimately saving lives.
the ovarian cancer control initiative at the centers for disease
control and prevention
The CDC Ovarian Cancer Control Initiative plays an essential role
in our Nation's fight to eliminate suffering and death from ovarian
cancer. Created by Congress in 2000, the program coordinates and funds
health activities aimed at identifying and filling any gaps in
knowledge of ovarian cancer diagnosis and treatment. According to the
program website, ``CDC enhances the limited knowledge about ovarian
cancer by initiating research projects with partners, colleagues and
national organizations to help identify factors related to early
disease detection and treatment and survivorship.'' The CDC Ovarian
Cancer Control Initiative actively partners with State cancer
registries and cancer centers across the country.
As the Nation's leading public health agency, the CDC plays an
important role in translating and delivering research discoveries at
the community level, especially ensuring that those populations
disproportionately affected by cancer receive the benefits of our
Nation's investment in medical research. With its extensive network of
health professionals and cancer registries, the CDC is the optimal
Federal agency for such work.
early detection and awareness
Most women and many health professionals remain unaware of the
signs and symptoms associated with ovarian cancer. Consequently, many
women suffer with the disease for months, even years, prior to
receiving an accurate--and often fatal--diagnosis. Since there is no
effective screening tool for ovarian cancer, it is imperative that
women and their health care providers be aware of the multiple ways
that ovarian cancer can present in a woman through symptoms. The CDC
Ovarian Cancer Control Initiative is unique among CDC cancer programs.
With no screening tool, the goal of the Ovarian Cancer Control
Initiative is to learn more about current practice and identify areas
of knowledge and practice patterns that need improvement to reduce the
overwhelming burden of ovarian cancer.
standards of care and treatment
The efforts of the CDC Ovarian Cancer Control Initiative also are
targeted at improving prognosis for women currently living with and
fighting the disease. Investigation into early symptoms, survival
trends based on care provided, and research into general epidemiology
will fill in information gaps to provide a stable body of knowledge
which will guide future research. Most significantly, examination of
survival trends based on care received contributes to the development
of best practice guidelines for women with ovarian cancer. Currently,
research funded by the Ovarian Cancer Control Initiative addresses four
public health questions:
--What factors influence risk perception and how does risk perception
affect screening behaviors?
--What are the primary diagnostic pathways in the diagnosis of
ovarian cancer?
--Are women receiving optimal surgical and chemotherapy treatments?
--Are women receiving optimal end-of-life care?
Investigation into these questions will allow the CDC to maximize
screening effectiveness by primary care physicians, improve early
detection and diagnosis and provide physicians with ``best practice''
guidelines for women diagnosed with ovarian cancer. According to the
CDC, $2.2 billion is spent on treatment for ovarian cancer each year.
This figure could greatly be reduced with earlier diagnoses and more
efficient practice guidelines.
cdc ovarian cancer control initiative-funded grants
Grants supported by the CDC Ovarian Cancer Control Initiative have
covered a diverse array of activities over the past six years, all
aimed at accomplishing the program's mission of increasing awareness
and improving treatment and survivorship of ovarian cancer. Current on-
going ovarian cancer studies include the following:
--The Division of Cancer Prevention and Control (DCPC) at the CDC is
investigating the influence of perceived risk of ovarian cancer
on screening behaviors. This information will be used to
maximize screening effectiveness in average and high risk
women.
--Analysis of records of ovarian cancer patients and healthy women
presenting symptoms similar to those associated with ovarian
cancer to create more specific guidelines for symptom-
recognition.
--Investigation into the relationship between patient
characteristics, provider characteristics, diagnostic
procedures and referral patterns leading to a positive
diagnosis to create best practice guidelines for primary care
physicians.
--Investigation into current surgical and chemotherapy practices for
women diagnosed with ovarian cancer to develop best practice
guidelines and to identify the demographics of women who
typically receive poor treatment plans.
--Research and development of end-of-life care guidelines to prevent
undue suffering in women with ovarian cancer.
boosting the cdc's ovarian cancer prevention and awareness efforts
In only six years of existence, the CDC Ovarian Cancer Control
Initiative has made important contributions to better understanding and
awareness of the disease. However, until the development of a valid and
reliable screening test, more must be done to increase awareness and
recognition of the symptoms of ovarian cancer. The full impact and
benefits of CDC Ovarian Cancer Control Initiative efforts will not be
fully realized unless the results are effectively translated into
public health interventions.
The CDC Ovarian Cancer Control Initiative must continue to build
its research efforts, but needs enhanced funding to move research
results out to health care providers and women. Most significantly,
increased resources are needed for a national effort to educate primary
care providers on the signs and symptoms of ovarian cancer. These
physicians and nurses are the most likely group to encounter women
presenting with ovarian cancer warning signs and symptoms that, if
recognized early, could lead to a faster diagnosis and therefore an
increased chance of survival.
Additional funding in fiscal year 2007 will enable the CDC to
expand the reach and scope of its current ovarian cancer initiatives to
help advance our Nation's efforts to reduce and prevent ovarian cancer
morbidity and mortality. The allocation of $7.5 million in fiscal year
2007 will continue the excellent progress being made and would help
expand the program's efforts to include:
--Development and implementation of two critical and complementary
national campaigns about the signs and symptoms of ovarian
cancer:
--(A) A public education campaign with a focus on the signs and
symptoms of ovarian cancer, the importance of regular
monitoring for high risk populations and strategies for
risk reduction.
--(B) A targeted education and awareness campaign involving primary
care physicians.
--Examination of the epidemiology of ovarian cancer and development
of appropriate strategies for addressing issues related to
incidence and survival in minority populations.
--Training of health care professionals in best practices for
treating ovarian cancer, emphasizing referral to gynecologic
oncologists for optimal survival outcomes.
a sustained commitment to fund cancer research
Our Nation has reaped many benefits from past Federal investments
in biomedical research at the NIH. The Alliance has joined with the
broader health community in urging Congress to provide NIH $29.7
billion and NCI $5.034 billion in fiscal year 2007 to allow these
agencies to sustain their efforts while also having the resources to
avoid the severe disruption to that progress that would result from a
minimal funding increase. The requested increase in NCI allocations
represents our national battle plan against cancer, focusing on
critical ongoing research and promising research opportunities.
When funding stagnates or does not keep pace with inflation,
progress in critical research programs can be halted or slowed
significantly. Inadequate funding for the NIH, NCI and the CDC can
result in inadequate funding for the lesser-known or less popular--yet
terribly devastating--diseases such as ovarian cancer. The requested
funding levels would provide the minimum resources required to preserve
our cancer research enterprise and maintain the current pace of
discovery.
summary and conclusion
The Alliance maintains a long-standing commitment to work with
Congress, the Administration, and other policymakers and stakeholders
to improve the survival rate from ovarian cancer through education,
public policy, research and communication. Please know that we
appreciate and understand that Congress has limited resources to
allocate, but we believe the health and safety of American women are
imperative to the strength of our Nation and should be a national
priority. We are concerned that without increased funding to bolster
and expand ovarian cancer education, awareness and research efforts,
the Nation will continue to see growing numbers of women losing their
battle with this terrible disease.
On behalf of the entire ovarian cancer community--patients, family
members, clinicians and researchers--we thank you for your leadership
and support of Federal programs that seek to reduce and prevent
suffering from ovarian cancer. Thank you in advance for your support of
the funding allocations we have requested for the CDC Ovarian Cancer
Control Initiative, NIH and NCI. Please know that we stand ready to
serve as a resource for any information you may need. Thank you for the
opportunity to submit testimony on fiscal year 2007 ovarian cancer
funding.
______
Prepared Statement of the Population Association of America/Association
of Population Centers
introduction
Thank you, Mr. Chairman Specter, Mr. Ranking Member Harkin, and
other distinguished members of the subcommittee, for this opportunity
to express support for the National Institutes of Health (NIH) and the
National Center for Health Statistics (NCHS)--two agencies important to
our organizations.
background on the paa/apc and demographic research
The PAA is a scientific organization comprised of over 3,000
population research professionals, including demographers,
sociologists, and economists. The APC is a similar organization
comprised of over 30 universities and research groups that foster
collaborative demographic research and data sharing, translate basic
population research for policy makers, and provide educational and
training opportunities in population studies. Over 30 population
research centers are located throughout the country, including two in
Ohio (Bowling Green State University and Ohio State University) and two
in Pennsylvania (Pennsylvania State University and the University of
Pennsylvania).
Demography is the study of populations and how or why they change.
Demographers, as well as other population researchers, collect and
analyze data on trends in births, deaths, and disabilities as well as
racial, ethnic, and socioeconomic changes in populations. Major policy
issues population researchers are studying include the demographic
causes and consequences of population aging, trends in fertility,
marriage, and divorce and their effects on the health and well being of
children, and immigration and migration and how changes in these
patterns affect the ethnic and cultural diversity of our population and
the Nation's health and environment.
The NIH mission is to support research that will improve the health
of our population. The health of our population is fundamentally
intertwined with the demography of our population. Recognizing the
connection between health and demography, the NIH supports population
research programs primarily through the National Institute on Aging
(NIA) and the National Institute of Child Health and Human Development
(NICHD).
national institute on aging
Over the next 25 years, the number of individuals age 65 and older
will likely double, reaching 70.3 million and comprising a larger
proportion of the entire population, rising from 13 percent today to 20
percent in 2030.\1\ This substantial growth in the older population is
driving policymakers to consider dramatic changes in Federal
entitlement programs, such as Medicare and Social Security, and other
budgetary changes that could affect programs serving the elderly.
Further, the macroeconomic and global impact of population aging on
competitiveness in the world economy is becoming a bigger issue. To
inform this debate, policymakers need objective, reliable data about
the antecedents and impact of changing social, demographic, economic,
and health characteristics of the older population. The NIA Behavioral
and Social Research (BSR) program is the primary source of Federal
support for research on these topics.
---------------------------------------------------------------------------
\1\ Federal Interagency Forum on Aging Related Statistics. Older
Americans 2000: Key Indicators of Well-Being. 2000.
---------------------------------------------------------------------------
In addition to supporting an impressive research portfolio, that
includes the prestigious Centers of Demography of Aging Program, the
NIA BSR program also supports several large, accessible data surveys.
Two such surveys, the National Long-Term Care Survey (NLTCS) and the
Health and Retirement Study (HRS) have become seminal sources of
information to assess the health and socioeconomic status of older
people in the United States. By using NLTCS data, investigators
identified the declining rate of disability in older Americans first
observed in the mid-1990s--a trend that continued and even accelerated.
This trend, if continued, could have momentous impact on reducing the
need for costly long-term care. The HRS, which was launched in 1992 and
has tracked 27,000 people, has provided data on a number of issues,
including the role families play in the provision of resources to needy
elderly and the economic and health consequences of a spouse's death.
The Social Security Administration recognizes and funds the HRS as one
of its ``Research Partners'' and posts the study on its home page to
improve its availability to the public and policymakers. In 2005, the
Center for Medicare and Medicaid Services (CMS) funded a supplemental
survey using the HRS to provide CMS with timely information on who is
likely to enroll in the new Medicare Part D prescription drug program
and how those decisions are related to knowledge of the program, drug
costs, and use.
With additional support in fiscal year 2007, the NIA BSR program
could fully fund its existing centers and support its ongoing surveys.
Additional support would allow NIA to expand the centers' role in
understanding the domestic macroeconomic as well as the global
competitiveness impact of population aging. NIA could also use
additional resources to support individual investigator awards by
precluding an 18 percent cut in its existing grants, improving its
funding payline, which is now in the 10th percentile, and sustaining
training and research opportunities for new investigators, which are
being heavily cut back.
national institute on child health and human development
Since its establishment in 1968, the NICHD Center for Population
Research has supported research on population processes and change.
Today, this research is housed in the Center's Demographic and
Behavioral Sciences Branch (DBSB). The Branch encompasses research in
four broad areas: family and fertility, mortality and health, migration
and population distribution, and population composition. In addition to
funding research projects in these areas, DBSB also supports a highly
regarded population research infrastructure program and a number of
large database studies, including the Fragile Families and Child Well
Being Study and National Longitudinal Study of Adolescent Health.
NICHD-funded demographic research has consistently provided
critical scientific knowledge on issues of greatest consequence for
American families: work-family conflicts, marriage and childbearing,
childcare, and family and household behavior. However, in the realm of
public health, demographic research is having an even larger impact,
particularly on issues regarding adolescent and minority health. For
example, in 2006, researchers with the National Longitudinal Study of
Adolescent Health, reported findings illustrating that by the time they
reach early adulthood (age 19-24), a large proportion of American youth
have begun the poor practices contributing to three leading causes of
preventable death in the United States: smoking, poor diet and physical
inactivity, and alcohol abuse. This study is striking in that it found
the health situation of young people--in terms of behavior, health
conditions, and access to and use of care--deteriorates markedly
between the teen and young adult years. The study reinforces the
importance of educating young people about adopting healthy lifestyles
after they leave high school and the parental home.
Understanding the role of marriage and stable families in the
health and development of children is another major focus of the NICHD
DBSB. Consistently, research has shown children raised in stable family
environments have positive health and development outcomes. Therefore,
NICHD supports research to elucidate factors that contribute to family
formation and strong partnerships. Recent findings have identified
factors that can destabilize relationships between new parents. These
factors include serious health or developmental problems of the
parents' child, lower earnings, less education, and a father who has
other children with different mothers. Policymakers and community
programs can use these findings to support unstable families and
improve the health and well being of children.
With additional support in fiscal year 2007, NICHD could restore
full funding to its large-scale surveys, which serve as a resource for
researchers nationwide. Furthermore, the Institute could apply
additional resources toward improving its funding payline, which has
gone from the 20th percentile range in 2003 to the 10th percentile in
January 2006. Additional support could be used to preclude cuts of 17
percent to 22 percent in applications approved for funding and to
support and stabilize essential training and career development
programs to prepare the next generation of researchers.
national center for health statistics
Located within the Centers for Disease Control (CDC), the National
Center for Health Statistics (NCHS) is the Nation's principal health
statistics agency, providing data on the health of the U.S. population
and backing essential data collection activities. Most notably, NCHS
funds and manages the National Vital Statistics System, which contracts
with the States to collect birth and death certificate information.
NCHS also funds a number of complex large surveys to help policy
makers, public health officials, and researchers understand the
population's health, influences on health, and health outcomes. These
surveys include the National Health and Nutrition Examination Survey,
National Health Interview Survey, and National Survey of Family Growth.
Together, NCHS programs provide credible data necessary to answer basic
questions about the state of our Nation's health.
In fiscal year 2006, Congress provided NCHS with the same level of
funding as in fiscal year 2005, and the Administration has recommended
NCHS receive the same level in fiscal year 2007. For fiscal year 2007,
the Friends of NCHS recommends the agency receive $139 million, a $30
million increase over the fiscal year 2006 level. This funding is
needed to, among other things, cover cost increases in basic survey
operations, improve data timeliness and access to data, and expand and
improve data collection to capture much needed information on issues
such as health disparities, assisted living, and community health
centers.
recommendations
At a time when our Nation is poised to reap the promise of the past
investment made in the NIH, the agency is facing the prospect receiving
flat funding in fiscal year 2007. When inflation is factored in, the
NIH could actually be facing being funded for the fourth year in a row
below the rate of biomedical research inflation. PAA and APC join other
organizations in expressing our concern about the precarious NIH
funding trajectory. Already, NIH has seen a 15 percent reduction in new
grants between fiscal year 2003 and fiscal year 2006. For population
research, increased support is needed to ensure the best research
projects, including new and innovative projects, are being awarded,
surveys and databases are supported, and training programs are
stabilized. With respect to NCHS, funding is needed to sustain and
update its major operations.
The PAA and APC join the Ad Hoc Group for Medical Research in
supporting an fiscal year 2007 appropriation of $29.75 billion, a 5
percent increase over the fiscal year 2006 appropriation, for the NIH.
In addition, the Friends of NCHS, support a fiscal year 2007
appropriation of $139 million, a 30 percent increase over the fiscal
year 2006 appropriation, for the NCHS. Finally, PAA and APC urge the
subcommittee to include language in the fiscal year 2007 bill, allowing
continuation of the National Children's Study at the NICHD.
Thank you for considering our requests and for supporting Federal
programs that benefit the field of demographic research.
______
Prepared Statement of the Pulmonary Hypertension Association
summary of fiscal year 2007 recommendations
--$250,000 within the Centers for Disease Control and Prevention for
a pulmonary hypertension awareness and education program.
--A 5 percent increase for the National Heart, Lung and Blood
Institute and the establishment of ``Specialized Centers of
Clinically Orientated Research'' on Pulmonary Hypertension at
the Institute.
--$25 million for the Health Resources and Services Administration's
``Gift of Life'' Donation Initiative.
Mr. Chairman, thank you for the opportunity to submit testimony on
behalf of the Pulmonary Hypertension Association.
I am honored today to represent the hundreds of thousands of
Americans who are fighting a courageous battle against this devastating
disease. Pulmonary hypertension is a serious and often fatal condition
where the blood pressure in the lungs rises to dangerously high levels.
In PH patients, the walls of the arteries that take blood from the
right side of the heart to the lungs thicken and constrict. As a
result, the right side of the heart has to pump harder to move blood
into the lungs, causing it to enlarge and ultimately fail.
PH can occur without a known cause or be secondary to other
conditions such as; collagen vascular diseases (i.e., scleroderma and
lupus), blood clots, HIV, sickle cell, and liver disease. PH does not
discriminate based on race, gender or age. Patients develop symptoms
that include shortness of breath, fatigue, chest pain, dizziness, and
fainting. Unfortunately, these symptoms are frequently misdiagnosed,
leaving patients with the false impression that they have a minor
pulmonary or cardiovascular condition. By the time many patients
receive an accurate diagnosis, the disease has progress to a late
stage, making it impossible to receive a necessary heart or lung
transplant.
While new treatments are available, unfortunately, PH is frequently
misdiagnosed and often progresses to late stages by the time it is
detected. Although PH is chronic and incurable with a poor survival
rate, the new treatments becoming available are providing a
significantly improved quality of life for patients. Recent data
indicates that the length of survival is continuing to improve, with
some patients able to manage the disorder for 20 years or longer.
Fifteen years ago, when three patients who were searching to end
their own isolation founded the Pulmonary Hypertension Association,
there were less than 200 diagnosed cases of this disease. It was
virtually unknown among the general population and not well known in
the medical community. They soon realized that this was unacceptable,
and formally established PHA, which is headquartered in Silver Spring,
Maryland.
Today, PHA includes:
--Over 6,000 patients, family members, and medical professionals.
--An international network of over 120 support groups.
--An active and growing patient telephone helpline.
--A new and fast-growing research fund. (A cooperative agreement has
been signed with the National Heart, Lung, and Blood Institute
to jointly create and fund five, five-year, mentored clinical
research grants and PHA has awarded eleven Young Researcher
Grants.)
--Numerous electronic and print publications, including the first
medical journal devoted to pulmonary hypertension--published
quarterly and distributed to all cardiologists, pulmonologists
and rheumatologists in the United States.
Mr. Chairman, at the age of 5, my wife and I noticed that our
daughter, Emily, could not keep up with the other kids in the
neighborhood. She seemed to lack the energy and strength to run and
play. This condition seemed to worsen to the point to where she would
have to stop and rest after coming down the steps in the morning. We
noticed that when she was sitting on the bottom step in the morning,
her lips appeared to have a bluish color.
After pressing for an answer to these problems for several months,
Emily was finally diagnosed with pulmonary hypertension and the doctors
gave a probable remaining lifespan of three years. That unforgettable
day was 8 years ago and, as you can see, Emily is still here today. She
is here because of continued advances in the treatment of pulmonary
hypertension and by the grace of God. There is however, NO cure for
pulmonary hypertension. Thanks to congressional action, Emily's chances
of a full life have greatly increased. We need, however, additional
support for research and related activities to continue to develop
treatments that will extend the published NIH life expectancy beyond
the 2.8 years after diagnosis.
fiscal year 2007 appropriations recommendations
(A) National Heart, Lung and Blood Institute
Mr. Chairman, PHA commends the National Heart, Lung and Blood
Institute (NHLBI) for its strong support of PH research. According to
leading researchers in the field, we are on the verge of significant
breakthroughs in our understanding of the disease and the development
of new and advanced treatments. Ten years ago, a diagnosis of PH was
essentially a death sentence, with only one approved treatment for the
disease. Thanks to advancements made through the public and private
sector, patients today are living longer and better lives with a choice
of five FDA approved therapies. Recognizing we have made tremendous
progress, we are also mindful that we are a long way from where we want
to be, and that is; (1) the management of pulmonary hypertension as a
treatable chronic disease, and (2) A CURE.
Mr. Chairman, it is our understanding that NHLBI is poised to
establish ``Specialized Centers of Clinically Orientated Research'' in
pulmonary hypertension later this year. We are very excited about the
promise these Centers hold for the future development of new treatments
and we encourage the subcommittee to support this worthy investment. In
addition, we applaud NHLBI and the NIH Office of Rare Diseases for
their plans to co-sponsor a two-day scientific conference on pulmonary
hypertension this Fall. This important event will bring together
leading PH researchers from the United States and abroad to discuss the
state of the science in pulmonary hypertension and future research
directions.
In order to facilitate the establishment of the Specialized Centers
of Clinically Orientated Research and maintain promising research
currently underway on PH, the Pulmonary Hypertension Association
encourages the subcommittee to provide NHLBI with a 5 percent increase
in funding in fiscal year 2007.
(B) Centers for Disease Control and Prevention
PHA applauds the subcommittee for its leadership over the years in
encouraging the Centers for Disease Control and Prevention to initiate
a Pulmonary Hypertension Education and Awareness Program. We know for a
fact that Americans are dying due to a lack of awareness of PH, and a
lack of understanding about the many new treatment options. This
unfortunate reality is particularly true among minority and underserved
populations. However Mr. Chairman, you don't have to rely solely on our
word regarding the need for additional education and awareness
activities. On November 11, 2005 the CDC released a long awaited
Morbidity and Mortality Report on pulmonary hypertension. In that
report, the CDC states:
(1) ``More research is needed concerning the cause, prevention, and
treatment of pulmonary hypertension. Public health initiatives should
include increasing physician awareness that early detection is needed
to initiate prompt, effective disease management. Additional
epidemiologic initiatives also are needed to ascertain prevalence and
incidence of various pulmonary hypertension disease entities.'' (Page
1, MMWR Surveillance Summary--Vol. 54 No. SS-5)
(2) ``Prevention efforts, including broad based public health
efforts to increase awareness of pulmonary hypertension and to foster
appropriate diagnostic evaluation and timely treatment from health care
providers, should be considered. The science base for the etiology,
pathogenesis, and complications of pulmonary hypertension disease
entities must be further investigated to improve prevention, treatment,
and case management. Additional epidemiologic activities also are
needed to ascertain the prevalence and incidence of various disease
entities.'' (Page 7, MMWR Surveillance Summary--Vol. 54 No. SS-5)
Mr. Chairman, we are grateful to CDC for their recent support of a
DVD highlighting the proper diagnosis of PH. However, despite repeated
encouragement from the subcommittee over the past 5 years, CDC has not
taken any steps to establish an education and awareness program on PH.
Therefore, we respectfully request that you provide $250,000 in fiscal
year 2007 for the establishment of a PH awareness initiative through
the Pulmonary Hypertension Association.
(C)``Gift of Life'' Donation Initiative at HRSA
Mr. Chairman, PHA applauds the success of the Health Resources and
Services Administration's ``Gift of Life'' Donation Initiative. This
important program is working to increase organ donation rates across
the country. Unfortunately, the only ``treatment'' option available to
many late-state PH patients is a lung or heart and lung
transplantation. This grim reality is why PHA established ``Bonnie's
Gift Project.'' ``Bonnie's Gift'' was started in memory of Bonnie
Dukart, one of PHA's most active and respected leaders. Bonnie was a PH
patient herself. She battled with PH for almost 20 years until her
death in 2001 following a double lung transplant. Prior to her death,
Bonnie expressed an interest in the development of a program within PHA
related to transplant information and awareness. PHA will use
``Bonnie's Gift'' as a way to disseminate information about PH,
transplantation and the importance of organ donation to our community
and organ donation cards.
PHA has had a very successful partnership with HRSA's ``Gift of
Life'' Donation Program in recent years. Collectively, we have worked
to increase organ donation rates and raise awareness about the need for
PH patients to ``early list'' on transplantation waiting lists. For
fiscal year 2007, PHA recommends an appropriation of $25 million (an
increase of $2 million) for this important program.
Mr. Chairman, once again thank you for the opportunity to present
the views of the Pulmonary Hypertension Association. We look forward to
continuing to work with you and the subcommittee to improve the lives
of pulmonary hypertension patients.
______
Prepared Statement of the Society for Investigative Dermatology
summary of the society for investigative dermatology's fiscal year 2007
recommendations
(1) A 5 percent increase for all of the National Institutes of
Health (NIH) and for the National Institute of Arthritis and
Musculoskeletal and Skin Diseases (NIAMS).
(2) Establishment of a skin disease clinical trials network that
will collect baseline data for specific orphan diseases and facilitate
the exchange of scientific data across disciplines and institutes.
(3) Encourage NIAMS to develop collaborative funding mechanisms
with other NIH institutes and private foundations that leverage skin
biology studies as a developmental model that will serve for the
advancement of research across a multitude of diseases and specialties.
(4) Encourage NIAMS to sponsor studies that capture general and
skin disease specific measures in order to generate incidence,
prevalence and quality of life data attributable to skin diseases.
(5) Increase the number of training awards through the NIH designed
to facilitate the entry of more individuals into careers in skin
disease research.
background
The Society for Investigative Dermatology (SID) was founded in
1938. Its 2,000 members represent over 40 countries worldwide,
including scientists and physician researchers working in universities,
hospitals and industry.
Our members are dedicated to the advancement and promotion of the
sciences relevant to skin health and disease through education,
advocacy, and the scholarly exchange of scientific information along
with our colleagues from the American Academy of Dermatology.
This collective commitment to research is evidenced in the
scientific journal published by the SID, the Journal of Investigative
Dermatology. The Journal is a catalyst for the exchange of scientific
information pertaining to the 3,000 skin diseases that afflict nearly
80 million Americans annually.
The purpose in presenting testimony is to increase awareness of the
need for more skin research, based on the burden attributable to skin
disease. It will also highlight some of the advancements that past
support has enabled.
We join with the Ad Hoc Group for Medical Research Funding in
asking for a 5 percent increase to the National Institutes of Health
(NIH) and the National Institute of Arthritis and Musculoskeletal and
Skin Diseases (NIAMS).
burden of skin disease
Prior bill report language directed NIAMS to ``consider supporting
the development of new tools to measure the burden of skin diseases,
and the training of researchers in this important area''. There only a
handful of researchers working on NIH-sponsored research that will
provide such measures.
Skin disease impacts our citizens more than previously estimated. A
recent report released by the Society for Investigative Dermatology and
the American Academy of Dermatology, ``The Burden of Skin Disease'',
compiled data from only 21 of the known 3,000 skin diseases and
disorders. The estimated economic costs to society each year from those
21 diseases totaled nearly $39 billion.
The true impact extends far beyond mere economics. These patients
encounter discomfort and pain, physical disfigurement, disability,
dependency and death. Skin conditions affect an individual's ability to
interact with others and compromise the self-confidence of those
inflicted.
One of the most striking findings in the study was the lack of
general and skin-disease specific measures that are needed to generate
data surrounding the incidence, prevalence, economic burden, quality of
life, disability and handicaps attributable to these diseases.
We ask the Committee to devote the resources needed to develop
components of national health surveys that capture dermatological data
above and beyond skin cancer incidence and prevalence.
research advances
Skin is the body's largest organ and serves as the primary barrier
to external pathogens and toxins. Researchers at the NIH campus and
institutions around the country are working diligently to define how
the skin functions to protect us, how this fails in disease, and how
compromised functions in disease can be restored.
Cell biology allows scientists to understand the life cycle of skin
and hair-producing cells and identify the causes of disease, leading to
better treatments and preventative measures. Advances in wound healing
and skin ulcers are helping the growing aging population, those with
diabetes, burn victims and our veteran population. Lasers continue to
provide less invasive options for patients requiring surgery.
Fundamental discoveries resulting from skin biology and
translational research have yielded advances that are broadly
applicable to human development and disease. Continued investment is
required to fully capitalize on these ground-breaking advances.
Important new research findings include the following:
--The genes responsible for skin cancer and inherited skin disorders
have been identified, making targeted therapy possible.
--The molecular mechanisms of auto-immune and inflammatory skin
diseases are better understood, allowing for the use of
focused, selective immunosuppressive therapy with greater
safety and efficacy.
--Oral medications to treat and prevent viral and fungal diseases
have become available.
--Lasers have made possible the removal of disfiguring skin
malformations.
--Modern phototherapy and photochemotherapy allow for more effective
treatment of inflammatory skin disease, lymphoma, depigmenting
disorders and auto-immune diseases.
--Retinoids and sunscreens have reduced the risk of skin cancer in
the elderly, in transplant patients, and in other populations.
--Painless transdermal drug delivery has become available.
Recent developments in the areas of clinical epidemiology,
biostatistics, economics, and the quantitative social sciences have
begun to provide objective evaluation measures, although additional and
improved measures are still desperately needed. These measures will
help to identify effective interventions and allow us to better
quantify contributions to the quality of life and health of Americans.
A significant portion of skin disease is chronic, resulting from
aging, genetics and environmental and occupational exposure.
We ask the NIH to work to identify additional biomarkers in order
to better understand skin disease pathways and interaction with other
diseases and environmental factors.
translating discovery to treatments for americans
The goal of skin disease research is to improve the quality of life
for the one in three Americans that suffer from skin disease. That goal
is embedded in the collective missions of the SID and the intramural
and extramural scientists funded through the skin portfolios of many of
the 27 Institutes and Centers of the NIH.
Medical research organizations such as the SID are the direct
recipients of the awards made possible through the rigorous peer-
reviewed grant system in place at the NIH. The ultimate beneficiaries
are the nearly 80 million Americans that stand to benefit from the
discoveries resulting from research grants.
Inadequate levels of Federal funding have forced Institute
administrators to reduce certain types of the available funding
mechanisms currently in place at the NIH, to decrease success rates, to
increase administrative cost reductions, to consider decreasing the
number of awards, and to cut award levels in existing programs.
Unfortunately, this reality impairs the ability of hypothesis-
driven research, the source of countless discoveries, to drive the
research system. Adequate funding levels will allow the peer-review
system to work at full potential, leading to findings that translate
into better care for those suffering from debilitating diseases.
Without sufficient funding provided specifically for skin research,
nearly one third of the Nation would be denied any hope for a better
quality of life.
We are grateful for the past support that has been given to the NIH
and ask you to look for innovative ways to avoid flat or decreased
funding levels to these Institutes that are charged with improving the
health of Americans.
______
Prepared Statement of the Society for Maternal-Fetal Medicine
The Society for Maternal-Fetal Medicine appreciates the opportunity
to comment on the fiscal year 2007 budget for the National Institutes
of Health. We are especially grateful for the Committee's support of
the National Institute of Child Health and Human Development over the
past years and urge your continued commitment to the critical medical
research conducted and supported by the National Institutes of Health.
Established in 1977, the Society for Maternal-Fetal Medicine (SMFM)
is a not-for-profit organization of over 2,000 members that are
dedicated to improving perinatal care through research and education.
Maternal-fetal medicine doctors have advanced knowledge of the
obstetrical, medical, genetic and surgical complications of pregnancy
and their effects on both the mother and fetus. The many advances in
research have allowed the maternal-fetal medicine physician to provide
the direct care needed to treat the special problems that high risk
mothers and fetuses face.
The SMFM applauds the National Institute of Child Health and Human
Development (NICHD) for its efforts to pursue research to understand,
prevent and treat the abnormal events that can occur during pregnancy.
For example:
Preterm birth.--Remains a leading cause of death, illness, and
disability among infants during their first year of life. It poses
great risks to both the infant and mother. Infants born too early are
at higher risk than full-term babies for medical and developmental
complications. The earlier the birth, the more risk of complications.
In addition even without any neonatal conditions, these infants face
serious adult complications including heart disease and diabetes
resulting from their intrauterine environment and low birthweight.
NICHD-supported research has improved the outlook for preterm
infants and families. The Maternal-Fetal Medicine Units (MFMU) Network
established in 1986, to address issues pertaining to preterm births and
low birth weight deliveries, has made steady and impressive strides in
these areas.
Researchers recently found that:
--A substance in the urine of pregnant women can be measured to
predict the later development of preeclampsia--a life-
threatening complication of pregnancy.
--Weekly injections of 17-hydroxyprogesterone can reduce preterm
birth by more than one third among women who are at increased
risk of preterm delivery.
However, despite these efforts, the rate of preterm births
continues to rise. SMFM therefore urges full support of the MFMU
Network so that it can continue to address these issues.
In addition, full funding of the new Genomic and Proteomic Network
will hasten a better understanding of the pathophysiology of premature
birth and discover novel diagnostic biomarkers. Studies to be
undertaken by this network will ultimately aid in formulating more
effective interventional strategies to prevent premature birth.
Stillbirth.--Is a major public health issue with morbidity equal to
that of all infant deaths. Despite this significant and persistent
burden of stillbirths, they have remained largely unstudied and, for at
least half of all stillbirths, the cause is undetermined. The NICHD
cooperative network has initiated a pilot study with the full study
planned to start this year. The information that will be obtained will
aid in future research to improve preventive and therapeutic
interventions and to understand the pathologic mechanisms leading to
fetal death. Increased knowledge regarding the causes of stillbirths
will benefit families who have experienced a loss, pregnant women, and
their physicians, and may lead to the development and evaluation of
improved clinical and preventive interventions. Full funding of this
study is urgently needed.
Near-Term Births.--The preterm birth rate is now over 12 percent of
all live births, and of these 75 percent are near term births. Near-
term birth occurs after 35-37 weeks of gestation. It is estimated that
this group encompasses 40 percent of Neonatal ICU admissions. These
infants are at risk for sepsis; pneumonia; feeding difficulties; white
matter damage; seizures; apnea; and remain at risk for higher
morbidities in early infancy. This group of infants has not been well
studied and may account for a portion of the increase in adverse long-
term outcomes such as autism, attention deficit disorders, and
neurodevelopmental disorders. Additional funding will allow NICHD to
facilitate the critical need for research in this area.
In addition to the need for funding for research, the state of
funding for physician scientists and researchers has become a major
problem and is in dire need of a fix.
Over the last decade, NICHD has responded to the scientific
community's need for enhanced training programs to provide a solid
framework for the development of physician scientists and researchers.
The expansion of research training programs has included a substantial
investment in the ``T'' (Training Programs) and ``F'' (Fellowship
Programs) line and the expansion of the ``K'' (Research Career Awards)
line. After completion of these programs it is anticipated that
investigators will be competitive for research awards. However, given
the substantial reduction in the payline, the new investigator's
ability to be successful is severely restricted. It is imperative that
NICHD identify and provide an opportunity for funding to investigators
that NIH has already invested in through completion of training
programs and who have demonstrated a commitment to a research career.
It is of major concern to the scientific community that a cadre of
scientists may be lost due to the stringent funding payline.
recommendations
--The Society for Maternal-Fetal Medicine supports a 5 percent
increase in fiscal year 2007 for the National Institutes of
Health (above the fiscal year 2006 funding level) as
recommended by the Ad Hoc Group for Medical Research, along
with the National Health Council, the Campaign for Medical
Research and Research!America.
--SMFM supports a 5 percent increase for the National Institute of
Child Health and Human Development and urge full funding
support for:
--the Maternal Fetal Medicine Unit Network
--the Genomic and Proteomic Network
--Research in the area of near-term births
--The stillbirth collaborative research network (SCRN)
--Physician scientists and researchers
Again, thank you for allowing SMFM the opportunity to express its
concerns regarding the need for sustained funding in fiscal year 2007
for the critical research programs supported by the National Institute
of Child Health and Human Development and the National Institutes of
Health overall.
______
Prepared Statement of the Society of Nuclear Medicine
The Society of Nuclear Medicine (SNM) appreciates the opportunity
to submit written testimony for the record regarding Federal funding
for biomedical research in fiscal year 2007. SNM is an international,
scientific, professional organization with more than 16,000 members
dedicated to promoting the science, technology, and practical
application of nuclear medicine. Over the last 50 years, since
biomedical imaging first began, the nuclear medicine community has had
a positive working relationship with the National Institutes of Health
(NIH). The research and development supported by NIH have made ground-
breaking discoveries in the field of nuclear medicine. Similarly, NIH
has benefited from the nuclear medicine research conducted through
Federal funding of the Medical Applications and Measurement Science
Program at the Department of Energy (DOE). Unfortunately, that $37
million in funding was eliminated in the fiscal year 2006 Energy and
Water Appropriations bill. Therefore, the Society requests and strongly
recommends that the Labor, Health and Human Services, and Education
(LHHS) Appropriations Subcommittee work with the Energy and Water
Development Appropriations Subcommittee to ensure that dedicated
funding for nuclear medicine research is fully restored in fiscal year
2007.
what is nuclear medicine?
Nuclear medicine is an established specialty that performs
noninvasive molecular imaging procedures to diagnose and treat diseases
and determine the effectiveness of therapeutic treatments, whether
surgical, chemical, or radiation. It contributes extensively to the
treatments and diagnoses of patients with cancers of the brain, breast,
blood, bone, bone marrow, liver, lungs, pancreas, thyroid, ovaries, and
prostate. Molecular imaging continues to provide critical information
to help doctors, technicians, and other health care personnel manage
abnormalities of the heart, brain, and kidneys. In fact, recent
advances in the detection and diagnosis of Alzheimer's disease can be
attributed to nuclear medicine imaging procedures, specifically
positron emission tomography (PET) scans. These advances--which were
made possible by research performed by nuclear medicine professionals--
helped lead the Centers for Medicare and Medicaid Services (CMS) to
extend Medicare coverage to include PET scans for some beneficiaries
who suffer from Alzheimer's and other dementia-related diseases.
The effect nuclear medicine has on the lives of men, women, and
children suffering from cancer, heart, and brain diseases is far-
reaching. Annually, more than 20 million men, women, and children
require noninvasive molecular/nuclear medical procedures. These safe,
cost-effective procedures include PET scans to diagnose and monitor
treatments in cancer, cardiac stress tests that analyze heart function,
bone scans for orthopedic injuries, and lung scans for blood clots. In
addition, patients undergo procedures to diagnose liver and gall
bladder functional abnormalities and to diagnose and treat
hyperthyroidism and thyroid cancer.
impact of the loss of federal funding for nuclear medicine research on
nih
In fiscal year 2006, the government abandoned its fifty-year
commitment to supporting nuclear medicine research by eliminating
funding for the Medical Applications and Measurement Science Program at
the DOE and making no accommodation to transition nuclear medicine
programs to another government agency. Over the years, the DOE Medical
Applications and Measurement Science Program has generated advances in
the field of molecular/nuclear medicine. For example, DOE funding
provided the resources necessary for molecular/nuclear medicine
professionals to develop PET scanners to diagnose and monitor the
treatment of cancer. PET scans offer significant advantages over CT and
MRI scans in diagnosing disease and are more effective in identifying
whether cancer is present, if it has spread, if it is responding to
treatment, and if a person is cancer free after treatment. In fact, the
DOE has stated that this program supports ``research in universities
and in the National Laboratories, and occupies a critical and unique
niche in the field of radiopharmaceutical research. The NIH relies on
our basic research to enable them to initiate clinical trials.''
The advances in molecular/nuclear medicine made possible by Federal
funding of nuclear medicine research at the DOE include:
--Modeling Radiation Damage to the Lung: Treatment of thyroid disease
and lymphomas using radioisotopes can cause disabling lung
disease. Investigators at Johns Hopkins University have
developed a Monte Carlo model that can be used to determine the
probability of lung toxicity and be incorporated into a
therapeutic regimen. This model will optimize the dose of
radioactivity delivered to cancer cells and avoid untoward
effects on the lung.
--New Radiopharmaceuticals with Important Clinical Applications: The
DOE radiopharmaceutical science program has developed a number
of innovative radiotracers at the University of California at
Irvine for the early diagnosis of neuro-psychiatric illnesses,
including Alzheimer's disease, schizophrenia, depression, and
anxiety disorders.
--Imaging Gene Expression in Cancer Cells: Images of tumors in whole
animals that detect the expression of three cancer genes were
accomplished for the first time by investigators at Thomas
Jefferson University and the University of Massachusetts
Medical Center. This advanced imaging technology will lead to
the detection of cancer in humans using cancer cell genetic
profiling.
--Rapid Preparation of Radiopharmaceuticals for Clinical Use: The
DOE-sponsored program at the University of Tennessee has
developed a new method for preparing radiopharmaceuticals by
placing a boron-based salt at the position that will be
occupied by the radiohalogen. The method has been used to
prepare a variety of cancer-imaging agents.
--Smaller, More Versatile PET Scanners: Brookhaven National
Laboratory (BNL) has completed a prototype mobile PET scanner,
which will record images in the awake animal. The mobile PET
will be able to acquire positron-generated images in the
absence of anesthesia-induced coma and correct for motion of
the animal. The long-term goal is to develop PET
instrumentation able to diagnose neuro-psychiatric disorders in
children.
--Highest Resolution PET Scanner Developed: Scientists at the
Lawrence Berkeley National Laboratory (LBNL) have developed the
world's most sensitive PET scanner. The instrument is 10-times
more sensitive than a conventional PET scanner and became
operational in 2005.
With restored Federal funding, essential molecular/nuclear medicine
research will continue at universities, research institutions, national
laboratories, and small businesses. Moreover, research with
radiochemistry, genomic sciences, and structural biology will be able
to usher in a new era of mapping the human brain and using specific
radiotracers and instruments to more precisely diagnose neuro-
psychiatric illnesses and cancer.
The future of life-saving therapies and cutting-edge research in
molecular/nuclear medicine and imaging depends on the restoration of
Federal funding for nuclear medicine research.
sustain and seize research opportunities
For decades, Americans and people from across the world have
benefited from the strong Federal investment in nuclear medicine and
biomedical research at NIH. SNM hopes that the LHHS subcommittee will
continue that trend and fund NIH and the National Institute of
Biomedical Imaging and Bioengineering (NIBIB) and the National Cancer
Institute (NCI) at sufficient levels in fiscal year 2007.
SNM is proud to join its colleagues in the public health community
in recommending that NIH receive $29.7 billion in fiscal year 2007
funding--the same level of funding that is included in the Senate-
passed budget resolution. This funding level would permit NIH to
sustain and build upon its current research activities, which are a
byproduct of the recent NIH budget-doubling effort. Even a minimal
decrease or slowed momentum in increased funding for NIH could cause
severe disruption in the Institutes' research activities and
capabilities.
Research in biomedical imaging and bioengineering is progressing
rapidly, and recent technological advances have revolutionized the
diagnosis and treatment of disease. In 2000, NIBIB was created to
specifically focus on biomedical imaging and bioengineering. It has
made great strides in helping the health care community and patients
recognize and understand different diseases and disorders. Pancreatic
transplantation, brain scans, and improvement in epilepsy surgeries are
just a few examples of how NIBIB research is helping to diagnose and
treat patients. In order for NIBIB to continue its important work, SNM
requests that Congress provide it with $388 million in Federal funding
for fiscal year 2007. This funding level would allow NIBIB to further
its research, development, and application of emerging and cutting-edge
biomedical technologies to facilitate improved disease detection,
management, and prevention.
In addition, SNM advocates that NCI receive $5.034 billion in
fiscal year 2007. The American Cancer Society predicts that more than
1.4 million Americans will be diagnosed with cancer in 2005.
Significant gains have been made in the war on cancer, and there have
been successful breakthroughs in diagnosing and treating this terrible
disease. Currently, PET scans are available to detect more than a dozen
types of cancer. Cancer research is leading to new therapies that
translate into longer survival and improved quality of life for cancer
patients. Extraordinary advances in cancer research have resulted
because of the strong commitment by the Federal, State, and local
governments in combating cancer.
conclusion
As outlined above, SNM has a strong interest in making sure that
biomedical research in the United States is sufficiently funded. Also,
since NIH relied on the pool of research conducted by the DOE's Medical
Applications and Measurement Science Program, SNM would like to stress
the impact that the loss of Federal funding for nuclear medicine
research will have on NIH. In order to ensure that the positive effects
and results of research and development are not seriously compromised,
SNM advocates the allocation of $29.7 billion for NIH, including $388
million for NIBIB and $5.034 billion for NCI, and requests that the
LHHS Appropriations subcommittee work with the Energy and Water
Development Appropriations Subcommittee to ensure that Federal funding
for nuclear medicine research is fully restored.
SNM stands ready to work with policymakers on both sides of the
aisle to advance biomedical research and innovation to help reduce and
prevent suffering from disease for all Americans. Again, on behalf of
the members of SNM, I thank you for the opportunity to submit testimony
regarding the need for increased Federal funding for biomedical
research.
______
Prepared Statement of the Society for Women's Health Research and
Women's Health Research Coalition
On the behalf of the Society for Women's Health Research and the
Women's Health Research Coalition, we are pleased to submit the
following testimony in support of biomedical research, and more
specifically women's health research.
The Society for Women's Health Research is the only national non-
profit women's health organization whose mission is to improve the
health of women through research, education, and advocacy. Founded in
1990, the Society brought to national attention the need for the
appropriate inclusion of women in major medical research studies and
the need for more information about conditions affecting women
disproportionately, predominately, or differently than men. In 1999,
the Women's Health Research Coalition was created by the Society as a
grassroots advocacy effort consisting of scientists, researchers, and
clinicians from across the country that are concerned and committed to
improving women's health research.
The Society and Coalition are committed to advancing the health of
women through the discovery of new and useful scientific knowledge. We
believe that sustained funding for biomedical and women's health
research programs conducted and supported across the Federal agencies
is necessary if we are to accommodate the health needs of the
population and advance the Nation's research capability.
national institutes of health
From decoding the human genome to elucidating the scientific
components of human physiology, behavior, and disease, scientists are
unearthing exciting new discoveries which have the potential to make
our lives and the lives of our families longer and healthier. The
National Institutes of Health (NIH) has made this all possible by
conducting and supporting our Nation's biomedical research. World-class
researchers, scientists, and programs at NIH are dedicated to
understanding how the human body works and to gain insight into
countless diseases and disorders. Congressional investment and support
for NIH has made the United States the world leader in medical research
and has had a direct and significant impact on women's health research
and the careers of women scientists in the last decade.
Great strides and advancements have been made since the doubling of
the NIH budget from $13.7 billion in 1998 to $27 billion in 2003.
However, we are concerned that the momentum driving new research will
erode under the current budgetary constraints. Medical research needs
to be considered an essential investment--an investment in thousands of
newly trained and aspiring scientists; an investment to remain
competitive in the global marketplace; and an investment in our
Nation's health. In fact, a recent national poll indicated that a 58
percent of Americans believe that a strong investment in research and
science is critical not only for our global scientific leadership but
for the health of our economy and citizens. Furthermore, 94 percent
consider accelerating medical research an important national priority--
comparable to homeland security.
The administration's fiscal year 2007 budget request of $28.6
billion for NIH is unraveling the successes from the doubling of NIH's
budget. The proposed budget would freeze NIH funding at the fiscal year
2006 appropriated level of $28.57 billion and cut most individual
Institute budgets from 0.5 to 0.8 percent. The proposed decrease does
not keep pace with the inflation rate. The annual change in the
Biomedical Research and Development Price Index (BRDPI) will increase
to 4.1 percent in fiscal year 2006 and 3.8 percent in fiscal year 2007
and fiscal year 2008. BRDPI indicates how much the NIH budget would
need to change to maintain purchasing power to compensate for the
average increase in prices and to maintain research activity at the
previous year's level.
A flat-funded budget will have a negative impact on the number of
grants NIH will be able to fund. NIH predicts total the total number of
grants funded will decrease by 656. The number of new grants funded by
NIH has already dropped by nearly fifteen percent from 10,393 in fiscal
year 2003 to an estimated 9,062 for fiscal year 2006. The shrinking
pool of available grants will have a significant impact on scientists
as they depend upon NIH support to help cover their salaries and
laboratory expenses. If one fails to obtain a grant they will be less
likely to achieve tenure and new, less established researchers will be
forced to consider other careers, resulting in a loss of the critical
workforce needed to sustain America's cutting edge in biomedical
research.
In order to continue the momentum of scientific advancement and
expedite the translation of research from the laboratory to the
patient, the Society calls for a five percent increase for the NIH
fiscal year 2007. In addition, we request that you strongly encourage
the NIH to assure that women's health research receives resources
sufficient to meet the health needs of all women.
Scientists have long known of the anatomical differences between
men and women, but only within the past decade have they begun to
uncover significant biological and physiological differences. Sex-based
biology, the study of biological and physiological differences between
men and women, has revolutionized the way that the scientific community
views the sexes.
Sex differences play an important role in disease susceptibility,
prevalence, time of onset and severity and are evident in cancer,
obesity, coronary heart disease, autoimmune, mental health disorders,
and other illnesses. This research needs to be supported and
encouraged. Congress recognizes this importance and should support NIH
at an appropriate level of funding and direct NIH to continue expanding
research into sex-based biology.
Sex differences research in heart disease has long been neglected.
Heart disease is the number one killer of women in United States,
killing 493,623 women. Information gaps related to the development,
diagnosis, and treatment of heart disease among women are enormous, in
part because women continue to be underrepresented in heart-related
research studies. As a result, women face misdiagnosis, delayed
diagnosis, under-treatment and mistreatment of their heart problems. In
fiscal year 2005 the Centers for Medicare and Medicaid Services highest
expenditure in women's health 2005 was cardiovascular/pulmonary
services. Despite large expenditures to treat heart disease, little
funding is targeted at research that could lead to more effective
prevention, diagnosis, and treatment. In order to address the
discrepancies, the Society in conjunction with WomenHeart: the National
Coalition for Women with Heart Disease compiled a list of ten questions
that must be answered if women are to receive optimal cardiovascular
care and treatment. The 10 unanswered research questions are:
1. Why do women receive significantly fewer referrals for advanced
diagnostic testing and treatments for heart disease than men, and how
can the referral rate for women be increased?
2. What are the best tools and methods for assessing women's risk
of heart disease?
3. What are the best strategies for preventing heart disease in
women?
4. What treatments for heart disease work best for women?
5. What are the most effective methods and treatments for diastolic
heart failure, which is the most common form of congestive heart
failure in women?
6. How can the heart disease diagnosis and care disparities between
white women and women of color be eliminated?
7. What are the biological differences between men and women in the
location, type, and heart disease risk level associated with fat
deposits, and what determines these differences?
8. How do sex differences in the regulation of heart rhythm affect
risk of heart disease and response to treatment?
9. What is the role of inflammation in heart disease in women?
10. Why are women ages 50 and younger more likely to die following
a heart attack than men of the same age?
We strongly believe and encourage that these questions serve as a
guide for NIH and other health related agencies while developing
research portfolios.
office of research on women's health
The NIH Office of Research on Women's Health (ORWH) has a
fundamental role in coordinating women's health research at NIH,
advising the NIH Director on matters relating to research on women's
health; strengthening and enhancing research related to diseases,
disorders, and conditions that affect women; working to ensure that
women are appropriately represented in research studies supported by
NIH; and developing opportunities for and support of recruitment,
retention, re-entry and advancement of women in biomedical careers.
ORWH strives to address sex and gender perspectives of women's health
and women's health research, as well as differences among special
populations of women across the entire life span, from birth through
adolescence, reproductive years, menopausal years and elderly years.
Two highly successful programs supported by ORWH that are critical
to furthering the advancement of women's health research are Building
Interdisciplinary Research Careers in Women's Health (BIRCWH) and
Specialized Centers of Research on Sex and Gender Factors Affecting
Women's Health (SCOR). These programs benefit both women's and men's
health through sex and gender research, interdisciplinary scientific
collaboration, and provide tremendously important support for young
investigators in a mentored environment.
The BIRCWH program is an innovative, trans-NIH career development
program that provides protected research time for junior faculty by
pairing them with senior investigators in an interdisciplinary mentored
environment. What makes BIRCWH so unique is that it bridges advanced
training with research independence across scientific disciplines. It
is expected that each scholar's BIRCWH experience will culminate in
becoming an established independent researcher in women's health. Since
2000, 197 scholars have been trained in the twenty-four centers
recording over 634 publications and 526 abstracts. The scholars have
secured forty NIH grants and seventy awards from industry and
institutional sources.
The SCOR program, administered by the National Institute of
Arthritis and Musculoskeletal and Skin Diseases, was developed by ORWH
in 2001. SCOR's are designed to increase the transfer of basic research
findings into clinical practice by housing laboratory and clinical
studies under one roof. The program was designed to complement other
federally supported programs addressing women's health issues such as
BIRCWH. The eleven SCOR programs are conducting interdisciplinary
research focused on major medical problems affecting women and
comparing gender difference to health and disease. Each SCOR works hard
to transfer their basic research findings into the clinical practice
setting.
Despite the advancement of women's health research and its
innovative programs, we were disappointed to see ORWH receive a
$250,000 cut in fiscal year 2006 from the Office of the Director.
Congress must direct NIH to continue its support of ORWH and its
programs.
department of health and human services
The Department of Health and Human Services (HHS) has several
offices that enhance the focus of the government on women's health
research. Agencies with offices, advisors or coordinators for women's
health or women's health research are the Department of HHS, the Food
and Drug Administration, the Centers for Disease Control and
Prevention, the Agency for Healthcare Quality and Research, the Indian
Health Service, the Substance Abuse and Mental Health Services
Administration, the Health Resources and Services Administration, and
the Centers for Medicare and Medicaid Services. These agencies need to
be funded at levels adequate for them to perform their assigned
missions. We ask that the Committee Report clarify that Congress
supports these offices and would like to see them continued and
strengthened in the coming fiscal year.
The focus on women's health within HHS has been critical to the
advances made in women's health in getting the appropriate message out
to patients and providers. Scientists have only just scratched the
surface of understanding female biology, with new information
forthcoming as a result of the recent sequencing of the human X
chromosome. Now is the time to press ahead with this vital research to
make discoveries and educate women about their health and clarify the
misinformation they have been given for years and these offices are
critical to the success of this effort. There are many important
programs that we could identify from these women's health offices but
we would like to specifically mention two in particular.
hhs office of women's health
The HHS Office of Women's Health (OWH) is the government's champion
and focal point for women's health issues. It works to redress
inequities in research, health care services, and education that have
historically placed the health of women at risk. The OWH coordinates
women's health efforts in HHS to eliminate disparities in health status
and supports culturally sensitive educational programs that encourage
women to take personal responsibility for their own health and
wellness. An extraordinary program initiated by the OWH is the National
Centers of Excellence in Women's Health (CoEs).
Developed in 1996, the CoEs offer a new model for university-based
women's health care. Selected on a competitive basis, the current
twenty CoEs throughout the country seek to improve the health of all
women across the lifespan through the integration of comprehensive
clinical health care, research, medical training, community outreach
and public education, and medical school faculty leadership
development. The CoEs are able to reach a more diverse population of
women, including more women of color and women beyond their
reproductive years. However, CoEs are vulnerable to pressures of
obtaining adequate funding and having to compete for scarce resources.
A CoE designation by the OWH is critical not only to patients and
surrounding communities but also to establishing foundation and other
non-government funding.
In fiscal year 2006 OWH received a decrease in its budget and the
proposed fiscal year 2007 would flat fund the office. We urge Congress
to provide an increase of $1.5 million for the HHS OWH to allow it to
continue to sustain and expand the National Centers of Excellence in
Women's Health.
agency for healthcare and research quality
The Agency for Healthcare Research and Quality (AHRQ) is the lead
Public Health Service agency focused on health care quality, including
coordination of all Federal quality improvement efforts and health
services research. AHRQ's work serves as a catalyst for change by
promoting the results of research findings and incorporating those
findings into improvements in the delivery and financing of health
care. This important information provided by AHRQ is brought to the
attention of policymakers, health care providers, and consumers who can
make a difference in the quality of health care women receive.
AHRQ has a valuable role in improving health care for women.
Through AHRQ's research projects and findings, lives have been saved
and underserved populations have been treated. For example, women
treated in emergency rooms are less likely to receive life-saving
medication for a heart attack. AHRQ funded the development of two
software tools, now standard features on hospital electrocardiograph
machines that have improved diagnostic accuracy and dramatically
increased the timely use of ``clot-dissolving'' medications in women
having heart attacks.
While AHRQ has made great strides in women's health research, the
Administration's budget for fiscal year 2007 could threaten life-saving
research. If a budget request of $319 million were enacted, AHRQ would
be flat funded for the third year in a row at fiscal year 2005 levels.
Flat funding prior to application of taps by Congress seriously
jeopardizes the research and quality improvement programs that Congress
demands or mandates from AHRQ.
We encourage Congress to fund AHRQ at $443 million for fiscal year
2007. This will ensure that adequate resources are available for high
priority research, including women's health care, gender-based
analyses, Medicare, and health disparities.
In conclusion, Mr. Chairman, we thank you and this Committee for
its strong record of support for medical and health services research
and its unwavering commitment to the health of the Nation through its
support of peer-reviewed research. We look forward to continuing to
work with you to build a healthier future for all Americans.
______
Prepared Statement of The Humane Society of the United States
On behalf of The Humane Society of the United States (HSUS) and our
more than 9.5 million supporters nationwide, we appreciate the
opportunity to provide testimony on our top funding priorities for the
Labor, Health and Human Services, Education and Related Agencies
Subcommittee in fiscal year 2007.
alternatives to animal testing
The ICCVAM Authorization Act (Public Law 106-545) requires Federal
regulatory agencies to ensure that new and revised animal and
alternative test methods be scientifically validated prior to
recommending or requiring use by industry. The internationally agreed
upon definition of validation, supported by the 15 Federal regulatory
and research agencies that compose the ICCVAM, is: ``the process by
which the reliability and relevance of a procedure are established for
a specific use.''
Function of the ICCVAM
The ICCVAM performs an invaluable function by assessing the
validation of new, revised and alternative toxicological test methods
that have interagency application. After appropriate independent peer
review, the ICCVAM recommends the test to the Federal regulatory
agencies that regulate the particular endpoint test measures. In turn,
the Federal agencies maintain their authority to incorporate the
validated test methods as appropriate for the agencies' regulatory
mandates. This streamlined approach of assessing the validation of test
methods has reduced the regulatory burden of individual agencies;
provided a ``one-stop shop'' for stakeholders for consideration of
methods; and set uniform criteria for what constitutes a validated test
method. The ICCVAM can also serve to appropriately assess test methods
that can refine, reduce and replace the use of animals in toxicological
testing.
The ICCVAM's representatives have rigorously assessed several test
methods that are now deemed scientifically valid and acceptable. In
addition, the ICCVAM is working to streamline assessment of methods
from the European Union (EU) that have already been validated for use
within the EU.
Request for Appropriations
Since passage of the ``ICCVAM Authorization Act'' in 2000, which
makes the entity a permanent standing committee, NIEHS has provided
between $1 and $2.6 million per fiscal year to NICEATM for ICCVAM's
activities. In order to ensure that Federal regulatory agencies and
their stakeholders benefit from the work of the ICCVAM, NIEHS funding
is important. We respectfully request $4 million for this purpose in
fiscal year 2007.
Request for Committee Report Language
The NIEHS should support the NICEATM/ICCVAM in creating a five-year
roadmap for assertively setting goals to prioritize ending the use of
antiquated animal tests for specific endpoints. It is also imperative
that the ICCVAM take a more proactive role in isolating areas where new
methods development is on the verge of replacing animal tests. These
areas should form a collective call by the Federal agencies that
compose the ICCVAM to fund any necessary additional effort that is
required to eliminate the animal methods. We also strongly urge the
NICEATM/ICCVAM to closely coordinate efforts with its European
counterpart, the European Centre for the Validation of Alternative
Methods (ECVAM), to ensure the best use of available funds and sound
science and to ensure industry has a uniform approach to worldwide
chemical safety evaluation.
We also respectfully request that the Committee consider including
the following report language: ``The Committee commends the National
Interagency Center for the Evaluation of Alternative Methods/
Interagency Coordinating Committee on the Validation of Alternative
Methods (NICEATM/ICCVAM) for its leadership role in the assessment of
new, revised and alternative scientifically validated methods for the
Federal Government. The Committee also commends the National Toxicology
Program (NTP) for finalizing its ``Roadmap to Achieve the NTP Vision, A
Toxicology Program for the 21st Century,'' which commits to ``develop
and validate improved testing methods and, where feasible, ensure that
they reduce, refine or replace the use of animals'' as one of its top
four goals.
The Committee directs the NICEATM/ICCVAM, in partnership with the
relevant Federal agency program offices and the NTP, to build on the
NTP Roadmap to create a five-year plan to research, develop, translate
and validate new and revised non-animal and other alternative assays
for integration of relevant and reliable methods into the Federal
agency testing programs. In this 5-year plan the Federal agency program
offices shall be directed to identify areas of high priority for new
and revised non-animal and alternative assays or batteries of those
assays to create a path forward for the replacement, reduction and
refinement of animal tests, when this is scientifically valid and
appropriate. The Committee directs a transparent, public process for
developing this plan and recommends the plan be presented to the
Committee by November 15, 2007. Funding for developing the plan shall
be from the NIEHS and the NTP, and shall not reduce the NICEATM/ICCVAM
funding base.''
breeding of chimpanzees for research
The HSUS requests that no Federal funding be appropriated for
breeding of chimpanzees for research, or for research that requires
breeding of chimpanzees, for the following reasons:
--The United States currently has a surplus of chimpanzees available
for use in research due to overzealous breeding for HIV
research and subsequent findings that they are a poor HIV
model.\1\
--The cost of maintaining chimpanzees in laboratories is exorbitant,
totaling between and $9.3 million each year for the current
population of 850 federally owned or supported chimpanzees
($15-30 per day per chimpanzee;\1\ $500,000 per chimpanzee's
50-year lifetime).
--The National Center for Research Resources has a publicly-declared
moratorium on breeding chimpanzees.
--Use of chimpanzees in research raises strong public concerns.
Background and history
Beginning in 1995, the National Research Council (NRC) confirmed a
chimpanzee surplus and recommended a moratorium on breeding of
federally owned or supported chimpanzees,\1\ who now number
approximately 850 of the 1,300 total chimpanzees available for research
in the United States. According to a National Research Resources
Advisory Council September 15, 2005 meeting, the National Center for
Research Resources (NCRR) of NIH extended the moratorium until December
2007 because of high costs of chimpanzee care, lack of existing colony
information, and failure of chimpanzees as an HIV model. There are,
however, cases in which the moratorium is not being obeyed, prompting
the need for Congressional action.
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\1\ NRC (National Research Council) (1997) Chimpanzees in research:
strategies for their ethical care, management and use. National
Academies Press: Washington, D.C.
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Deviations from the moratorium
Despite the NCRR breeding moratorium, which prohibits breeding of
federally owned or supported chimpanzee or NIH funding of projects that
require chimpanzee breeding (NCRR written communication, February 28,
2006), chimpanzee breeding is still being funded by NIH. For example,
the National Institute of Allergy and Infectious Diseases maintains a
contract with New Iberia Research Center in Louisiana to provide 10 to
12 infant chimpanzees annually for research projects. The 10-year
contract entitled ``Leasing of chimpanzees for the conduct of
research'' has been allotted over $22 million, with $3.9 million
awarded since its inception in September 2002.
Chimpanzees have often been a poor model for human health research
The scientific community recognizes that chimpanzees are poor
models for HIV because chimpanzees do not develop AIDS. Similarly,
though chimpanzees do not model the course of the human Hepatitis C
virus, they continue to be widely used for this research. According to
the chimpanzee genome, some of the greatest differences between
chimpanzees and humans relate to the immune system,\2\ calling into
question the validity of infectious disease research using chimpanzees.
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\2\ The Chimpanzee Sequencing and Analysis Consortium/Mikkelsen,
TS, et al.,(1 September 2005) Initial sequence of the chimpanzee genome
and comparison with the human genome, Nature 437, 69-87.
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Ethical and public concerns about chimpanzee research
Chimpanzee research raises serious ethical issues, particularly
because of their extremely close similarities to humans in terms of
intelligence and emotions. Americans are clearly concerned about these
issues: 90 percent believe it is unacceptable to confine chimpanzees
individually in government-approved cages, and 54 percent believe that
it is unacceptable for chimpanzees to ``undergo research which causes
them to suffer for human benefit'' (conducted by Zogby International
for Chimpanzee Collaboratory, 2001).
We respectfully request the following committee report language:
``The Committee directs that no funds provided in this Act be used
to support the breeding of chimpanzees for research or to support
research that requires breeding of chimpanzees.''
pain and distress research
It is estimated that at least $10.2 billion per year of the current
National Institutes of Health budget is devoted to some aspect of
animal research.\3\ At this time, no funding is set aside specifically
for determination of ways to reduce the amount of pain and distress in
animal research. Knowledge regarding recognition, assessment, and
alleviation of animal pain and distress is critical for both the
quality of scientific research and animal welfare.
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\3\ NIH extramural funding accounts for approximately 90 percent of
the NIH budget, or $25.5 billion. Of this, approximately 40 percent is
devoted to some aspect of animal research--totaling approximately $10.2
billion. Intramural research also accounts for some animal research,
but the exact figure is unknown.
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NIH may receive $28.6 billion in fiscal year 2007 if Congress
fulfills the President's budget request. Out of this funding, we seek
$2.5 million (0.009 percent) for research and development focused on
recognizing, assessing, and alleviating animal pain and distress in
research. This is not a request for basic research on pain pathways or
for application to the study of human pain, for example, but for the
benefit of animals used in painful and distressful research.
In addition to our request for $2.5 million for this purpose, we
also urge the Committee to specify in report language that this
research should be conducted in conjunction with, or ``piggy-backed''
onto, ongoing research that already causes pain and distress.
Infliction of pain and distress on additional animals is unnecessary,
given the volume of existing research that is believed to involve
moderate to significant pain and/or distress (we estimate a minimum of
20-25 percent of all animal research). Furthermore, it is expected that
the amount of research that involves animal pain and distress will
increase as animal use in biodefense research increases, as one
example.
NIH has a statutory mandate to conduct or support research into
alternative methods that produce less pain and distress in animals;
this was specified in the NIH Revitalization Act of 1993 regarding a
plan for the use of animals in research. Earmarked funding will assist
NIH in meeting this mandate. Additionally, researchers themselves often
comment publicly about the urgent need for funding in order to properly
understand and mitigate pain and distress in research animals and to
follow Animal Welfare Act and Public Health Service policy requirements
to minimize pain and distress.
It is well known that uncontrolled, undetected, and unalleviated
pain and distress has adverse effects on animal welfare, which leads to
adverse effects on the quality of science. Ultimately, the lack of
information on pain and distress leads to misinterpretation of research
results that could result in harmful effects in human beings when
animal research results are applied to human clinical trials.
Numerous surveys indicate that concern about animal pain and
distress strongly influences public opinion about animal research in
general. For example, 75 percent of the American public opposes
research that causes severe animal pain and/or distress, even when the
goal of the research is to benefit human health (survey conducted by an
independent polling firm for The HSUS, 2001).
Our Nation takes pride in leading the world in biomedical research,
yet we lag behind many other countries in our efforts to minimize pain
and distress in animal subjects. We urge the Committee to make this
small investment of $2.5 million to promote animal welfare and enhance
the integrity of scientific research. We also respectfully request this
accompanying committee report language:
``The Committee provides $2.5 million to support research and
development focused on improving methods for recognizing, assessing,
and alleviating pain and distress in research animals. No pain and
distress should be inflicted solely for the purpose of this initiative,
since the investigations can and should be conducted in conjunction
with ongoing research that is believed to involve pain and distress
under Government Principle IV of Public Health Service Policy, which
assumes that procedures that cause pain and distress in humans may
cause pain and distress in animals.''
Thank you for the opportunity to submit these requests on behalf of
The Humane Society of the United States.
______
DEPARTMENT OF EDUCATION
Prepared Statement of Americans for the Arts
request
Americans for the Arts is pleased to submit testimony supporting
fiscal year 2007 appropriations of $53 million for the Arts in
Education program of the U.S. Department of Education (USDE). We call
on the Senate Labor/HHS/ED Appropriations subcommittee to reject the
severe cuts to the Corporation for Public Broadcasting and instead
provide $430 million in fiscal year 2009. However, we support the
President's request of $41.39 million for the Office of Museum Services
within the Institute of Museum & Library Services (IMLS), also funded
through this subcommittee.
Americans for the Arts is one of the leading national nonprofit
organizations for advancing the arts and arts education in America.
With a 45-year record of objective arts industry research, we are
dedicated to representing and serving local communities and creating
opportunities for every American to participate in and appreciate all
forms of the arts.
arts education
Our belief in the importance of practical research causes us to
take special pleasure in supporting USDE's Arts in Education program,
which is generating impressive evidence on the best ways to improve
overall academic achievement by integrating the arts into the school
curriculum.
As members of the subcommittee know, the Elementary and Secondary
Education Act [20 USC 7271] provides that funding up to $15 million be
directed to the John F. Kennedy Center for the Performing Arts and
VSAarts. Prior to fiscal year 2001, funding never exceeded that level.
Since fiscal year 2001, however, Congress has appropriated funding
sufficient to support a broader array of arts education programs--for
fiscal year 2006, Congress appropriated $35.6 million.\1\ In addition
to the Kennedy Center and VSAarts, USDE now supports grant competitions
to further develop established arts education models and support
professional development for arts educators in four arts disciplines.
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\1\ This appropriation was reduced by a 1 percent across-the-board
rescission to $35.3 million.
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Three Reasons to Increase Arts Education Funding
Arts education works for children.--The most important reason to
support arts education is simply stated: arts education works for
children. Research increasingly confirms the beneficial effects of arts
education in several areas, including but not limited to academic
achievement. We refer the subcommittee to the research compendium
Critical Links: Learning in the Arts and Student Academic and Social
Development, released by the Arts Education Partnership in 2002, which
includes 62 separate studies pointing to ``critical links'' between
arts education and reading, writing, mathematics, cognitive skills,
motivation, social behavior, and the school environment. The studies
indicate that arts education is especially useful for students who are
economically disadvantaged and/or in need of remedial instruction.\2\
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\2\ http://www.aep-arts.org/CLhome.html.
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Arts education provides training for a competitive workforce.--
According to the 2002 National Governors Association publication The
Impact of Arts Education on Workforce Preparation, ``School districts
are finding that the arts develop many skills applicable to the `real
world' environment. In a study of 91 school districts across the
Nation, evaluators found that the arts contribute significantly to the
creation of the flexible and adaptable workers that businesses demand
to compete in today's economy.'' \3\
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\3\ http://www.nga.org/Files/pdf/050102ARTSED.pdf.
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In addition, with more than 548,000 arts-centric businesses
employing nearly three million people, arts education becomes a
critical tool in fueling the creative industries of the future with
arts-trained workers. Arts education is critical to the sustainability
of an industry that comprises more than 4 percent of all U.S.
businesses. We know from published research studies on the benefits of
arts education that early learning in the arts nurtures the types of
skills and brain development that are important for individuals working
in the new economy of ideas.
In his State of the Union address this January, President Bush said
``We must continue to lead the world in human talent and creativity.''
The arts are core to the development of creativity in our children. The
arts develop skills and talents that foster imagination, critical
thought, and teamwork: skills that are transferable to the workplace.
In the documentary ``The Arts and Children: A Success Story,'' Dr.
Sol Snyder--2003 recipient of the National Medal of Science and
Distinguished Service Professor of Neuroscience, Pharmacology and
Psychiatry at the Johns Hopkins University--said:
``In the arts, one trains one's senses to perceive and integrate
what's going on either in the visual environment, auditory involvement,
or even in the senses of smell, taste, and touch. The arts are very
good for building those talents, those abilities. Sensory perception
becomes quite important in mathematics, science, business.
``From my own background as a physician and research scientist, I
have noticed that the most talented, the most productive people in the
field are those who actually have a background in the arts because
simple narrow scientific training is not enough to make major
discoveries. The greatest scientists actually are artists in a sense.
They are creative; they put together disparate things.'' \4\
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\4\ http://www.nasaa-arts.org/publications/artsandchildren.shtml.
A similar theme on the essential integration of the arts and
innovation was mentioned in a recent New York Times column by Thomas
Friedman when he wrote, ``Innovation is often a synthesis of art and
science, and the best innovators often combine the two.'' He went on to
write that America's growing emphasis on math and reading must maintain
a balance with creative learning in the arts to optimize human
talent.\5\
---------------------------------------------------------------------------
\5\ ``Worried About India's and China's Booms? So Are They,''
Thomas Friedman, New York Times, March 24, 2006.
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There is solid research measuring how the arts are integrated into
the classroom and how they boost achievement in math and science.
Students who took four years of arts coursework outperformed those of
their peers who had one half-year or less of arts coursework by 38
points on the math portion of the SAT. Students who include art in
their studies are four times more likely to be recognized for academic
achievement and four times more likely to participate in a math and
science fair.
For example, the ``Math in a Basket'' program in the Long Beach,
CA, school district--funded through a U.S. Department of Education Arts
in Education Model Development & Dissemination grant--teaches students
how to plan, design, and make baskets from scratch. Students become
familiar with art concepts, measurement, algebraic formulas, and
geometric concepts as they work with their baskets to find the surface
area, perimeter, and volume of each basket. Participants in the ``Math
in a Basket'' program score an average of 20 points higher than the
control group on State math tests.\6\
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\6\ http://www.dramaticresults.org/results.php.
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Model programs are a wise investment.--Despite increases in overall
Federal spending for K-12 education, evidence is beginning to
accumulate that schools are neglecting those areas of the curriculum
that are not subject to the mandatory testing requirements of No Child
Left Behind (NCLB). The National Association of State Boards of
Education (NASBE) identified the threat in its 2003 report ``The Lost
Curriculum.'' \7\ In 2004, the Council for Basic Education released a
survey of school principals in four States; one quarter of them
reported that they have decreased instructional time in the arts.\8\
This finding was confirmed just last month in the Center for Education
Policy's (CEP) report ``From the Capital to the Classroom: Year 4 of
the No Child Left Behind Act,'' when it found that almost a quarter of
school districts surveyed reported that time in science, art, and music
had been reduced due to an increased emphasis on reading and math.\9\
The CEP report recommends that USDE should promote ``effective
practices being used by school districts to enhance instruction in
tested subjects without cutting time for other important subjects.''
The USDE arts education program is a wise investment in developing and
disseminating these effective practices.
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\7\ http://www.nasbe.org/Research_Projects/Lost_Curriculum.html.
\8\ http://www.ecs.org/html/Document.asp?chouseid=5058.
\9\ http://www.cep-dc.org/nclb/Year4/Press/.
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USDE Needs to Maintain Research Efforts in Arts Education
Meaningful research from USDE is needed to further determine the
status of dance, music, theater, and visual arts education. The Fast
Response Survey System (FRSS) report ``Arts Education in Public
Elementary and Secondary Schools'' is the only research produced by
USDE on the delivery of arts education and the last FRSS reported data
collected in the 1999-2000 school year. The next round of data
collection for an updated report is long overdue. We urge the
subcommittee to direct USDE to execute the FRSS study as intended.
Similarly, the National Assessment of Education Progress (NAEP)--the
national arts ``report card'' last performed in 1997--is scheduled to
be administered in 2008, and must stay on track. The next NAEP will
provide critical information about the arts skills and knowledge of our
Nation's students. Both of these quantitative studies are essential to
studying and improving access to the arts as a core academic subject.
The Model Development & Dissemination program and the Professional
Development program in the Arts in Education initiative at USDE receive
targeted funding and are tested and measured in a limited number of
implementation projects, and finally disseminated field-wide. This is a
highly appropriate use of Federal dollars. Through this program, USDE
promotes educational excellence, demonstrating how small projects can
be brought to scale across entire school districts. Increased funding
means more help for State and local departments of education to develop
models that will work in highly disparate school districts across the
Nation. We urge the Senate Subcommittee on Labor, Health and Human
Services, and Education to recommend $53 million in funding for USDE's
Arts in Education programs, with the bulk of the increase to be
allocated to the Arts in Education Model Development and Dissemination
Program and the Professional Development Program.
corporation for public broadcasting
We urge the subcommittee to reject the Administration's proposed
funding cuts to the Corporation for Public Broadcasting (CPB) in the
fiscal year 2007 Labor-HHS-Education appropriations bill. Any reduction
in CPB's budget will drastically reduce the access that many Americans
have to public broadcasting, and thus to high-quality arts and cultural
programming.
CPB supports public television through its partner, the Public
Broadcasting Service (PBS). A trusted community resource, PBS brings
quality programs and education services to nearly 100 million people
each week. With community-based arts programming and nationally
televised shows, PBS is often the only source of arts programming in
many rural parts of the country.
Public television airs arts programming that is not available on
commercial television. For example, the Legends of Jazz television
series on PBS marks the first time in 40 years that jazz has been the
focus of a national network weekly series. Hosted by noted jazz pianist
and radio personality Ramsey Lewis, the 13 weekly, 30-minute episodes
debuted in June 2005 on PBS stations nationwide.
Budget cuts will weaken National Public Radio (NPR) stations and
thus the availability of high-quality arts programming. Budget cuts
will impact public radio broadcasting, as CPB funding represents an
average of 13 percent of the budget for individual member stations of
NPR. If NPR loses CPB support, many stations will have to make severe
cuts to their programming and local services. This will especially
impact rural areas and stations serving minority populations, as these
stations heavily rely on Federal funding for their operating budgets.
While local and State arts agencies also support these stations, they
could not make up for a loss of Federal funding on this scale.
We join a broad coalition of public broadcasting supporters with
this request for funding:
CPB General Appropriations--$430 million for fiscal year 2009
CPB Digital Funding--$40 million for fiscal year 2007
CPB Interconnection--$36 million for fiscal year 2007
Ready to Learn--$32 million for fiscal year 2007
Ready to Teach--$15 million for fiscal year 2007
institute for museum & library services
We urge the subcommittee to support no less than the President's
proposed increase to $41.39 million for the Office of Museum Services
within IMLS in the fiscal year 2007 Labor-HHS-Education appropriations
bill.
IMLS encourages excellence and leverages State, local, and private
funds. National competition is a catalyst for excellence and improves
museum service nationwide. Federal leadership helps disseminate models
and puts a spotlight on the remarkable resources that museums bring to
education and to communities across the United States. In addition,
peer-reviewed IMLS grants assure State, local, and private funders that
a museum has met high national standards and is worthy of their
additional support.
IMLS reinforces the role of museums in lifelong learning. Funding
supports projects that address a full range of learning opportunities
in museums, including developing exhibitions, working with schools to
develop curriculum and programs, creating family and adult programs,
and developing internet content. American museums provide over 18
million instructional hours to K-12 schoolchildren. Seventy-one percent
work with school curriculum specialists to tailor programs to support
local and State curriculum standards, according to the 2003 edition of
the IMLS's report ``True Needs, True Partners.''
conclusion
As the research cited above demonstrates, Federal funds boost the
quality and quantity of support for arts education as well as the
knowledge that can be gained and disseminated across the education
establishment. Increased funding means more help for State departments
of education, educators in schools, and local education agencies. Most
importantly, it means a better education and more career opportunities
for our children.
Americans for the Arts is the leading nonprofit organization for
advancing the arts in America. With offices in Washington, DC, and New
York City, it has a record of more than 45 years of service. Americans
for the Arts is dedicated to representing and serving local communities
and creating opportunities for every American to participate in and
appreciate all forms of the arts. Additional information is available
at www.AmericansForTheArts.org.
______
Prepared Statement of the American Geological Institute
Thank you for this opportunity to provide the American Geological
Institute's perspective on fiscal year 2007 appropriations for the
Department of Education. The President's fiscal year 2007 request for
the Department of Education places an emphasis on increasing U.S.
competitiveness through math, science, and foreign language programs in
keeping with the Administration's American Competitiveness Initiative
announced in the President's State of the Union address. While $380
million is devoted to new funds for projects based on this initiative,
these new funds would be offset by significant cuts to other programs
within the Department of Education. The Department of Education budget
would be reduced by $3.2 billion for a total requested budget of $54.4
billion. AGI strongly supports the President's initiative and in
particular funding for improved science literacy for teachers and
students, however, we do encourage the subcommittee to retain and
provide support for other proven and effective programs.
The National Math and Science Partnership (MSP) program as part of
No Child Left Behind effectively strengthens K-12 science and math
education. The President's request includes $182 million for the MSP
program within the Department of Education, which is the same level of
funding appropriated in fiscal year 2006. AGI supports this stable
funding and encourages appropriate emphasis on science education.
Science often includes mathematical exercises applied to real-world
problems, giving students a comprehensive and interesting learning
experience.
The President's request for fiscal year 2007 focuses much new
spending on math education and less on science education. Funding
proposals based on the initiative include $125 million for Math Now for
elementary school students and $125 million for Math Now for middle
school students, plus an additional $10 million to create a National
Math Panel to review and develop math curricula. While a solid math
education is important, additional funding should also be devoted to
science education, which complements and expands upon a mathematical
foundation to understanding and exploring how physical, chemical and
biological processes work.
It is essential that highly qualified science teachers develop the
energetic, eager and curious next generation of scientists and
engineers. Skilled geoscientists and geoengineers, in particular, are
needed to find, develop and maintain our energy, agricultural, water
and air resources, to understand and mitigate natural hazards and to
ensure an educated public with a general understanding of the Earth
environment to enhance our public and private quality of life.
AGI is a nonprofit federation of 44 geoscientific and professional
societies representing more than 100,000 geologists, geophysicists, and
other Earth scientists. Founded in 1948, AGI provides information
services to geoscientists, serves as a voice for shared interests in
our profession, plays a major role in strengthening geoscience
education, and strives to increase public awareness of the vital role
the geosciences play in society's use of resources and interaction with
the environment.
In 1999, the Third International Math and Science Study found that
the longer U.S. students are in school, the farther they fall behind in
math and science proficiency in international comparisons. That
prompted President Bush to propose the National Math and Science
Partnership (MSP) program as part of No Child Left Behind. The goal of
the partnership program is to strengthen K-12 science and math
education by promoting a vision of education as a continuum that begins
with the youngest learners and progresses through adulthood with
teacher training. Among its activities, the program supports
partnerships that unite K-12 schools, institutions of higher education
and private industry.
Congress took the President's suggestion and authorized an MSP
program at the National Science Foundation (NSF) and another
partnership program at the Department of Education in 2002. These acts
of Congress fund two different types of partnerships to achieve the
overall goal of highly qualified math and science teachers ensuring
that all students have the basic knowledge to compete in the ever
changing and competitive job market. The funds allocated for the NSF's
MSPs go to the highest quality proposals chosen through a competitive
peer-reviewed grant program. The program focuses on modeling, testing
and identification of effective math-science activities. The funds
allocated for the Department of Education MSPs go directly to the
States as formula grants, providing funds to all States to replicate
and then implement the best of the NSF partnerships throughout the
country. Once States receive the money, they make competitive grants to
local partnerships.
The $120 million in funds for Secondary Education Mathematics
Initiative is part of the overall High School Initiative, which will
expand the application of No Child Left Behind principles to improve
high school education and raise achievement, particularly the
achievement of students most at risk of failure. This new initiative
combines a number of categorical programs in order to give States and
districts more flexibility and contains stronger accountability
mechanisms.
AGI believes the two MSPs are the most effective approach to
rapidly improving the abilities of all students to enhance their future
prospects regardless of their ultimate career goals. The two programs,
designed and authorized by Congress, are complementary. AGI supports
funding at NSF for competitive grants for teaching tools and teacher
training and funding at the Department of Education for formula grants
for implementation of these tools in K-12 education. The peer-review
process in the NSF program should be safeguarded as should the formula
grants for all States as administered by the Department of Education.
Moreover, the program within the Department of Education should not
suffer a net reduction in funding in order to support a new initiative
for mathematics. These funds should serve the Math and Science
Partnership with no earmarks or set-asides.
Thank you for the opportunity to present this testimony to the
subcommittee. If you would like any additional information, please
contact me at 703-379-2480, ext. 228 voice, 703-379-7563 fax,
rowan@agiweb.org, or 4220 King Street, Alexandria VA 22302-1502.
______
Prepared Statement of the Association of Minority Health Professions
Schools
summary of fiscal year 2007 recommendations
--(1) $550 Million for HRSA's Health Professions Training Programs,
Including:
--$34 million for Minority Centers of Excellence.
--$36 million for the Health Careers Opportunity Program.
--$47 million for Scholarships for Disadvantaged Students.
--(2) $83 million for HRSA'S Healthy Communities Access Program.
--(3) 5 percent increase overall for the National Institutes of
Health, including $250 million for the National Center on
Minority Health and Health Disparities.
--(4) $119 million for the National Center for Research Resources
Extramural Facilities Construction Program.
--(5) $65 million for the Department of Education's Strengthening
Historically Black Graduate Institutions Program.
--(6) $65 million for the HHS Office of Minority Health, including
support for a new health disparities initiative.
Mr. Chairman, thank you for the opportunity to present the views of
the Association of Minority Health Professions Schools (AMHPS). I am
Dr. Wayne Harris, Dean of the College of Pharmacy at the Xavier
University of Louisiana.
AMHPS is comprised of the Nation's twelve historically black
medical, dental, pharmacy, and veterinary schools. Combined, our
institutions have graduated 50 percent of African-American physicians
and dentists, 60 percent of all the Nation's African-American
pharmacists, and 75 percent of the African-American veterinarians.
Mr. Chairman, historically black health professions institutions
are addressing a pressing national need in carrying out their mission
of training minorities in the health professions. While African-
Americans represent approximately 15 percent of the U.S. population,
only 2-3 percent of the Nation's health professions workforce is
African-American. Studies have demonstrated that when African Americans
and other minorities are trained in minority institutions, they are
much more likely to: (1) serve in medically underserved areas, (2) care
for minorities, and (3) accept patients who are Medicaid dependent or
otherwise poor.
This is important Mr. Chairman because the gap in health status
between our Nation's minority and majority populations continues to
widen due in part to the lack of access to quality health care services
in minority communities. As a result, we believe it is imperative that
the Federal commitment to training African Americans and other
minorities in the health professions remains strong.
In spite of our proven success in training health professionals,
and the important contribution these professionals make, our
institutions continue to face a financial struggle inherent to our
mission. The financial challenges facing the majority of our students
affect our institutions in numerous ways. For example, we are unable to
depend on tuition as a means by which to respond to any discontinuation
of Federal support. Moreover, the patient populations served by the
AMHPS institutions are overwhelmingly poor. As a result, our
institutions cannot rely on patient care income at a time when the
average medical school gets 40-60 percent of its operating revenue from
health care services.
Mr. Chairman, before I go into a discussion of our Association's
fiscal year 2007 recommendations, I would like to share Xavier's
experience with Hurricane Katrina and update you on our recovery
efforts. Xavier is located in New Orleans and the entire campus was
flooded with 3-6 feet of water. Each building on campus had significant
damage on the first floor and the campus was shut down until January 9,
2006. The University developed an ambitious plan to repair damage and
resume operations on January 17, 2006 using a revised academic calendar
to complete the entire academic year in August 2006. I am happy to
report that the University resumed classes on January 17 as planned.
Overall University enrollment dropped, however, from approximately
4,000 students in August 2005 to approximately 3,000 students post-
Katrina. The College of Pharmacy enrollment was less severely affected
with enrollment dropping from 619 to 600.
Significant challenges still remain, including cash flow problems
as we deal with recovery costs in the range of $30 million for
construction and equipment and disruption of operations of key health
care institutions in New Orleans. These institutions are vital to the
clinical education program of the College of Pharmacy and to our
continued recovery. It is absolutely essential to the University that
health care delivery services are restored as quickly as possible.
The University recognized the need to resume our academic programs
as quickly as possible in order to continue to produce African American
health professionals and contribute to rebuilding the City of New
Orleans. By working with other Colleges of Pharmacy across the country,
we were able to allow senior pharmacy students to continue their
clinical education while under evacuation and we are pleased to report
that pharmacy students will graduate on May 20, 2006. Our rebuilding
effort is well underway but disruption of Federal support for important
programs such as HRSA'S Center of Excellence would severely hinder this
rebuilding effort.
fiscal year 2007 recommendations for federal programs of interest to
amhps
Health Resources and Services Administration
Health Professions Training
Mr. Chairman, we are disappointed that the President's budget all
but eliminates funding again this year for health professions training
programs focused on diversity in the workforce. The health professions
training programs administered by the Health Resources and Services
Administration are the only Federal initiatives designed to address the
longstanding under-representation of minority individuals in health
careers. HRSA's Minority Centers of Excellence, Health Careers
Opportunity Program, and Scholarships for Disadvantaged Students,
support health professions institutions with a historic mission and
commitment to increasing the number of minorities in the health
professions. For fiscal year 2007, AMHPS joins with the Health
Professions Nursing and Education Coalition in recommending an overall
funding level of $550 million for health professions training.
For the health professions programs specifically focused on
enhancing minority representation in the health care workforce, AMHPS
recommendations are as follows:
Minority Centers of Excellence
The purpose of the Minority Centers of Excellence program (COE) is
to assist schools that train minority health professionals by
supporting programs of excellence in health professions education at
those institutions. The COE program focuses on improving student
recruitment and performance; improving curricula and cultural
competence of graduates; facilitating faculty/student research on
minority health issues; and training students to provide health
services to minority individuals by providing clinical teaching at
community-based health facilities. For fiscal year 2007, AMHPS
recommends a funding level of $34 million for Minority Centers of
Excellence (an increase of $22 million over fiscal year 2006).
Health Careers Opportunity Program
Grants made to health professions schools and educational entities
under the Health Careers Opportunity Program (HCOP) enhance the ability
of individuals from disadvantaged backgrounds to improve their
competitiveness to enter and graduate from health professions schools.
HCOP funds activities that are designed to develop a more competitive
applicant pool through partnerships with institutions of higher
education, school districts, and other community based entities. HCOP
also provides for mentoring, counseling. primary care exposure
activities and information regarding careers in a primary care
discipline. Sources of financial aid are provided to students as well
as assistance in entering into the health professions school.
For fiscal year 2007, AMHPS recommends a funding level of $36
million for the Health Careers and Opportunities Program (an increase
of $32 million over fiscal year 2006).
Scholarships for Disadvantaged Students
The Scholarships for Disadvantaged Students program was established
to make scholarship funds available to eligible students from
disadvantaged backgrounds who are enrolled (or accepted for enrollment)
as full-time students. To be eligible for funding, a school must have
in place a program to recruit and retain students from disadvantaged
backgrounds (including racial and ethnic minorities) and demonstrate
that the program has achieved success based on the number or percentage
of disadvantaged students who graduate from the school. For fiscal year
2007, AMHPS recommends a funding level of $47 million for the
Scholarships for Disadvantaged Students program (an increase of $47
million over fiscal year 2007).
Healthy Communities Access Program
Mr. Chairman, Congress passed legislation in 2003 to reauthorize
the Community Health Centers program. Included in this important
measure was a provision which established a demonstration authority
within the Healthy Community Access Program to foster greater
collaboration between historically black health professions and
federally qualified CHC's. Specifically, this provision:
(1) Establishes a demonstration program for the development of
research infrastructure at historically black health professions
schools affiliated with federally qualified Community Health Centers.
(2) Establishes joint and collaborative programs of medical
research and data collection between historically black health
professions schools and federally qualified Community Health Centers
with the goal of improving the health status of medically underserved
populations.
(3) Supports the cost of patient care, data collection, and
academic training resulting from these partnerships.
Mr. Chairman, several of our member institutions received funding
in fiscal year 2005 under this promising new demonstration authority.
Unfortunately, the H-CAP program was eliminated in the fiscal year 2006
Labor-HHS bill, and the President's budget for fiscal year 2007 does
not provide any funding for the coming year. AMHPS encourages the
subcommittee to restore support for this important program in fiscal
year 2007 at the fiscal year 2005 level of $83 million.
National Institutes of Health
The National Center on Minority Health and Health
Disparities
Established in 2000 by the Minority Health and Health Disparities
Research and Education Act (Public Law 106-525), the National Center on
Minority Health and Health Disparities at NIH is charged with
addressing the longstanding health status gap between minority and
majority populations. The National Center has the authority to:
--Directly support biomedical research, training, and information
dissemination focused on eliminating health status disparities.
--Serve in a leadership capacity in developing a comprehensive plan
for minority health research at NIH.
--Participate as an equal when NIH institute and center directors
meet to determine research policy.
--Support the enhancement of biomedical research capacity at minority
health professions institutions through a ``Research
Endowment'' program.
--Support the development of health professions institutions with a
history and mission of serving minority and medically
underserved communities through a ``Centers of Excellence''
program.
For fiscal year 2006, AMHPS recommends a funding level of $250
million for the National Center. This is an increase of $54 million.
This new funding will enable the Center to support all of its new
programs and begin to meet the challenge of eliminating health status
disparities within minority and medically underserved communities
Extramural Facilities Construction
Mr. Chairman, if we are to take full advantage of the historic
funding increases for biomedical research that Congress has provided to
NIH over the past decade, it is critical that our Nation's research
infrastructure remain strong. The current authorization level for the
Extramural Facility Construction program at the National Center for
Research Resources is $250 million. The law also includes a 25 percent
set-aside for ``Institutions of Emerging Excellence'' (many of which
are minority institutions) for funding up to $50 million. Finally, the
law allows the NCRR Director to waive the matching requirement for
institutions participating in the program. We strongly support all of
these provisions of the authorizing legislation.
Unfortunately, funding for NCRR's Extramural Facility Construction
program was completely eliminated in the fiscal year 2006 Labor-HHS
bill. For fiscal year 2007, AMHPS encourages the subcommittee to
restore funding for this program to its fiscal year 2004 level of $119
million, or at a minimum, provide funding equal to the fiscal year 2005
appropriation of $40 million.
Research Centers in Minority Institutions
The Research Centers at Minority Institutions program (RCMI) at the
National Center for Research Resources has a long and distinguished
record of helping our institutions develop the research infrastructure
necessary to be leaders in the area of health disparities research.
Although NIH has received unprecedented budget increases in recent
years, funding for the RCMI program has not increased by the same rate.
Therefore, AMHPS recommends that funding for this important program
grow at the same rate as NIH overall in fiscal year 2007.
Strengthening Historically Black Graduate Institutions--Department of
Education
The Department of Education's Strengthening Historically Black
Graduate Institutions program (Title III, Part B, Section 326) is
extremely important to AMHPS institutions. The funding from this
program is used to enhance educational capabilities, establish and
strengthen program development offices, initiate endowment campaigns,
and support numerous other institutional development activities. For
fiscal year 2007, AMHPS recommends an appropriation of $65 million (an
increase of $7 million over fiscal year 2006) to continue the vital
support that this program provides to historically black graduate
institutions.
HHS Office of Minority Health
The HHS Office of Minority Health (OMH) has the potential to play a
critical role in addressing health status disparities throughout the
country. Unfortunately, the office does not currently have the
authority or resources necessary to support activities that will truly
make a difference in closing the health gap between minority and
majority populations. For fiscal year 2007, AMHPS recommends a funding
level of $65 million for the Office, with $10 million designated for
the following programs focused on medically underserved communities and
capacity building for the training of minorities in health professions:
(1) OMH sponsored programs to assist medically underserved
communities with the greatest need in solving health disparities and
attracting and retaining health professionals;
(2) Assistance to minority institutions in acquiring real property
to expand their campuses to increase the capacity to train minorities
for medical careers;
(3) Support of conferences for high school and undergraduate
students to pursue health professions careers; and
(4) Support for cooperative agreements with minority institutions
for the purpose of strengthening their capacity to train more
minorities in the health professions.
Once again, thank you for the opportunity to present the views of
the Association of Minority Health Professions Schools. We look forward
to working with you in support of these important programs.
______
Prepared Statement of the Center for Education
executive summary
The Department of Education's (ED) justification for eliminating
funding for the Education for Democracy Act is essentially the same as
it was for fiscal year 2006. It also includes the same omissions and
errors, as noted in the following response.
The Center for Civic Education (Center) and others supported under
the Act believe the three major findings of the ED report are not
adequately supported by the facts. Brief responses to the three
findings are presented here. More detailed responses follow.
1. ``Limited impact.'' The first paragraph of the ED justification
for eliminating the Civic Education program states that it is
``eliminating small categorical programs that have limited impact. . .
.'' The statement appears to be contradicted in the next paragraph
which recognizes the extent of the Center's programs: ``Districts in
nearly every State and major urban area participate in We the People
program activities.''
The Center's programs provide sound, sustained, and effective
instruction in the fundamental values and principles of constitutional
democracy annually to approximately 3 million domestic students and 2
million students in other nations at a cost of approximately $5-6 per
student. Research and evaluation have demonstrated the significant
impact of these programs that provide a cost-effective means of
reaching a significant number of students. Since its inception, the
Center's We the People program alone has reached more than 28 million
students in the United States.
2. ``Little or no reliable evidence of effectiveness.'' The ED
justification fails to cite or recognize the extensive research and
evaluation of Center programs as well as other significant evidence of
program effectiveness, none of which is matched by any other program in
the field.
3. ``Additional funding is not necessary for the successful
operation of this program.'' To anyone aware of the history of support
for civic education, and the policies, priorities, and practices of
private sector funding, it is clear that support for national and
international programs in civic education of the magnitude of those
implemented by the Center is simply not available from sources other
than the Federal Government. Federal funding is essential for the
continuation of this program.
The following information provides a more detailed response to the
ED report.
introduction
The Department of Education's (ED) justification for eliminating
funding for the Education for Democracy Act is essentially the same as
it was for fiscal year 2006. It also includes the same omissions and
errors as will be noted in the following response.
ED's justification is composed of three major parts: that the Civic
Education programs supported under the act (1) have ``limited impact,''
(2) have ``little or no reliable evidence of effectiveness,'' and that
(3) ``additional funding is not necessary for the successful operation
of this program.'' The Center for Civic Education (Center) and others
supported under the Act believe these findings are not adequately
supported by the facts. The Center's responses follow.
1. Response: The Civic Education program has ``limited impact''
The first paragraph of the ED justification for eliminating the
Civic Education program states that ED is ``eliminating small
categorical programs that have limited impact. . . .'' In the next
paragraph it states that ``The Center . . . is an established non-
profit organization with a broad network of program participants,
alumni, volunteers, and financial supporters at the local, state, and
national levels. Districts in nearly every State and major urban area
participate in We the People program activities.'' It is difficult to
square the first statement with the second, because for a relatively
small amount of Federal funds, the Center's domestic and international
programs have a significant impact on the education of students at the
pre-collegiate level as well as their teachers in the United States and
abroad. The following information supports this premise.
The fiscal year 2006 appropriation for the Education for Democracy
Act is $29.1 million. In round figures, the allocation of these funds
is as follows:
--Center for Civic Education (directed funding)
--Domestic programs = $17 million
--International programs = $4.5 million
--National Council for Economic Education (directed funding)
--International program = $4.5 million
--Competitive international exchange program = $3.1 million
--Note: The Center currently has a $1 million grant under this
program for Latin America and a $1 million grant for Africa
Impact of the Center's Domestic Programs
Approximately 70 percent of the Center's $17 million for domestic
programs is allocated to public- and private-sector institutions or
organizations at State and local levels in the form of sub-awards, free
curricular materials, and subsidized teacher training programs. These
funds are managed by approximately 120 coordinators located in public
or private sector agencies or organizations at State levels. They are
assisted by approximately 630 congressional district coordinators, many
of whom are affiliated with school districts. These coordinators,
essentially volunteers, receive a modest stipend to cover operating
costs. These coordinators in turn coordinate thousands of additional
volunteers who serve as judges, academic coaches, timers, facilitators,
and in other roles required by the size and scope of this endeavor. The
value of this volunteer network greatly amplifies the value of the
Federal investment and the reach of the program and exemplifies
American civic virtue in action. The remaining 30 percent of the funds
pays for technical assistance to this network and the administrative
operating costs of the Center.
The domestic network of coordinators oversees the implementation of
three major curricular programs that reach approximately 3 million
students annually at a cost of approximately $5.67 per student. For
this sum, each student receives the use of a free textbook and an
estimated 10 to 40 or more hours of instruction in the fundamental
values and principles of American constitutional democracy and how to
participate competently and responsibly in political life. As noted
below, ample research testifies to the positive outcomes of these
programs.
The Department of Education's rationale for cutting the Civic
Education program claims that its ``contribution to the Department's
mission is marginal.'' This statement does not seem to be in line with
the policy of President Bush, who stressed the importance of civic
education in the 2002 introduction to his initiative in History,
Civics, and Service, in which he stated that:
``American children are not born knowing what they should cherish--
are not born knowing why they should cherish American values. A love of
democratic principles must be taught. At this very moment, Americans
are fighting in foreign lands for principles defined at our founding,
and every American--particularly every American child--should fully
understand these principles.''
The question might be asked: What other programs in civic education
does ED support, if any, that accomplish the mission set forth in
President Bush's speech and which, if any, have the impact on students
per Federal dollar that result from programs supported under the
Education for Democracy Act? It should be noted that the Federal
funding for this program is matched by cost sharing at State and local
levels estimated at from $5-$8 in value for every Federal dollar spent.
The need for improvement in the civic education of our Nation's
students has been demonstrated repeatedly by research findings over the
past several decades. This need was clearly illustrated in a recent
survey in which only 28 percent of Americans could list two or more
First Amendment freedoms, while more than 50 percent could name at
least two cartoon characters from ``The Simpsons'' (McCormick Tribune
Freedom Museum Poll, March 1, 2006). The programs supported by Congress
under the Education for Democracy Act are a proven cost-effective means
of remedying this shortcoming in the education of our Nation's youth.
Impact of the Center's International Programs
As with its domestic programs, approximately 70 percent or more of
the Center's international funding is allocated to public- and private-
sector institutions or organizations at State and local levels in the
United States and similar organizations in approximately 70 emerging
and advanced democracies throughout the world. This support is provided
in the form of sub-awards, free curricular materials, and subsidized
teacher training programs. These funds are managed by public- and
private-sector organizations in 28 States and similar organizations in
the participating countries. The remaining 30 percent of the funds pay
for technical assistance to this network and the administrative
operating costs of the Center.
The international network of coordinators oversees the
implementation of curricular programs focused on education for
democracy. It is difficult in many cases to get accurate figures on
participation in these programs from the participating countries. We
believe that 2 million students per year is a modest estimate. The
students in these countries are being provided instruction in the
fundamental values and principles of constitutional democracy and how
to participate competently and responsibly in political life. As noted
below, ample research testifies to the positive outcomes of these
programs.
The $4.5 million in baseline funding for this program from ED is
augmented by approximately $8 million more in grants from ED, the
Department of State, USAID, and other domestic sources. The program has
also precipitated funding from other sources of approximately $15
million to augment its impact. These sources include the European
Union, the Russian Ministry of Education, the InterAmerican Development
Bank, the World Bank, the Mexican Institute for Federal Elections, and
other public- and private-sector sources in other countries. This
additional support could not have been generated without the funding
from ED that has served as ``seed'' money for the establishment of
successful education for democracy programs in other nations.
The impact and success of these programs is supported by research
findings and numerous reports from U.S. Embassies and AID missions,
which have assisted the Center in their establishment. In many cases,
the successful impact of pilot programs supported by ED funds has
prompted these entities to add their own funds to augment the programs.
A notable example of such an occurrence was the Center's ED-supported
Jordanian pilot program in democracy education, which has received
approval for nationwide implementation by the Ministry of Education.
The success of this program led the State Department to provide an
additional $3.2 million to implement democracy education programs in
ten Arab nations in North Africa and the Middle East. In turn, the
success of that program led the State Department to request that the
Center submit a proposal for three years of funding for the region at
$3-4 million per year. None of this would have been possible without
the sustained funding from ED that enables the Center to initiate and
maintain education for democracy programs in spite of the changing
priorities of other sources of funding. It is important to note that
the State Department funding does not eliminate the need for the
baseline ED funding for the international civic education program and
that with continued ED funding, similar advances might be made in other
parts of the world.
It is clear that these programs are a significant and cost-
effective contribution to the administration's effort to further the
worldwide growth of democracy, which is why President Bush has met with
the Center's Russian partner, and Secretary of State Condolleeza Rice
has met with the Center's partner in Pakistan. It is also clear that
the international civic education for democracy movement, central to
the administration's foreign policy, is at risk without significant
continuing funding. Although a fledgling nongovernmental membership
organization--Civitas International--was founded by the United States
Information Agency in 1995 to assist efforts in this field, the
organization was never able to raise sustaining funds from other
organizations or individuals that would permit it to function
independently. Instead, the organization asked the Center to assist it
by folding its meetings and functions into the Center's civic education
network.
Note: In addition to those students reached by the Center's
international programs, the economics program funded under this Act and
implemented by the National Council for Economic Education reaches an
estimated 2.4 million students annually. The goal of this effective
program is to help students understand the principles and institutions
of market economies and their relationship to democracy.
Summary
Contrary to the Department of Education's assertion in its
justification for eliminating funding for the Education for Democracy
Act, the Center's programs have a significant impact on the civic
education of pre-collegiate students and their teachers in the United
States and abroad.
The Center's programs are proven, cost effective, and reach
millions of students throughout the world. Approximately 3 million
students in the United States benefit from the Center's curricular
programs at a cost of approximately $5.67 per student. The Center's
programs directly contribute to the mission of the Department of
Education by accomplishing the mission set forth in President Bush's
initiative in History, Civics, and Service.
Approximately 2 million students per year outside of the United
States are provided by the Center and its network of coordinators with
instruction in the fundamental values and principles of constitutional
democracy and learn how to participate competently and responsibly in
political life. Funding provided by the Department of Education is
essential for the establishment of successful education for democracy
programs in other nations. The spectacular success of Center
initiatives in Jordan and other Arab nations demonstrates the Center's
cost-effective contribution to the Bush administration's effort to
advance the worldwide growth of democracy.
2. Response: There is ``little or no reliable evidence of [the]
effectiveness'' of the Center's programs
The Department's document claims that studies of the programs of
the Center are not sufficiently rigorous to yield reliable results
about their overall effectiveness. To that end, a single study
conducted by the Center on students participating in the national
finals of the Center's annual We the People competition was cited. The
study employs nationally normed items from the National Assessment of
Educational Progress (NAEP), the National Election Studies, and the
College Freshman surveys. The positive results of this study were
challenged by ED because the students were a select sample--even though
that fact had always been clearly identified and understood as such,
and the Department accepted it as a valid performance indicator.
Indeed, the study in question is performed annually in partial
fulfillment of requirements placed on the Center by the Department of
Education.
Since its inception in 1965 at the University of California at Los
Angeles, the Center has conducted numerous studies on the effectiveness
of its curricular programs and contracted with third parties that have
also conducted such studies. (Most of these studies are not referred to
in the ED report.) Indeed, the We the People programs have been more
thoroughly researched than any other programs in the field.
Each of the recent studies cited below falls within the
recommendations of the What Works Clearinghouse at the Institute of
Educational Sciences (IES) of the Department of Education. IES
encourages the methodological rigor of studies that include
experimental or high-quality quasi-experimental design and cites them
as the best determinants for measuring curricular effectiveness.
Study: MPR Associates, Inc.-- A high-quality quasi-experimental
study of the We the People: The Citizen and the Constitution program
conducted in 2003 by MPR Associates, Inc., in collaboration with noted
research scholars Dr. Richard Niemi, University of Rochester, and Dr.
Elizabeth Theiss-Morse, University of Nebraska-Lincoln, found
statistically significant differences between We the People and non-We
the People students. Specifically, We the People students enrolled in
AP classes performed, on average, 30 percent better on the knowledge
survey than students enrolled in non-We the People AP classes. We the
People students in regular classrooms also significantly outperformed
their non-We the People counterparts.
The study also found that We the People students were more likely
than their peers to show greater growth in their sense of political
efficacy, sense of citizen responsibility, appreciation of obligations
of citizenship, and a greater sense of political and community
responsibility than the control group. The results of these studies
show the degree to which the Center's programs meet President Bush's
request for civic education initiatives that ``improve students'
knowledge of American history, increase civic involvement, and deepen
their love for our great country.'' (Bush 2002, 1) \1\ It should be
noted that the Center was unable to obtain funding for a proposal
submitted to the Department of Education in 2005 for a study employing
random assignment of students to the curriculum. The Center is still
seeking funds to use the instruments it has developed to conduct a
longitudinal study over seven years.
---------------------------------------------------------------------------
\1\ Bush, George W. (2002). ``President Introduces History and
Civic Education Initiatives.'' Remarks of the president on the Teaching
History and Civic Education Initiative, September 17.
www.whitehouse.gov.
---------------------------------------------------------------------------
Study: University of Texas.--Dr. Kenneth Tolo, University of Texas
at Austin, found that the Center's We the People: Project Citizen
program had positive effects on student attitudes and skills, including
students' attitudes about their own effectiveness and their engagement
in their communities. The program also enhanced student communication
and research skills.
The study also details seven key areas of Project Citizen
implementation--State administration, the recruitment of and outreach
to teachers and school administrators, teacher training, teacher and
class use, Project Citizen competitions, benefits to students, and
financial and political support--and offers recommendations for
maximizing implementation efforts in each of these areas. These
recommendations have been invaluable to improving the implementation
strategies of Project Citizen in the United States and abroad.
Study: RMC Research.--In 2004-2005, RMC Research used qualitative
and quantitative measures in a quasi-experimental study of students
taking part in the Project Citizen program in Oklahoma, Michigan,
Colorado, the Czech Republic, and Slovakia. The study found that
students in grades 6-12 increased their global knowledge of democracy.
The study found significant gains in students' knowledge of public
policy, support for freedom of belief, the right of citizens to
question government messages, and the right to join organizations.
Students' civic skills improved as well. Based upon these results, RMC
is improving item reliability and will conduct a second study in 2006.
Study: Indiana University at Bloomington.--A high-quality quasi-
experimental study of students in Indiana, Latvia, and Lithuania by
Thomas S. Vontz, Kim K. Metcalf, and John J. Patrick, Indiana
University at Bloomington, found that We the People: Project Citizen
develops students' civic knowledge, skills, and dispositions positively
and significantly, irrespective of nationality. The full report has
been published in a volume titled Project Citizen and the Civic
Development of Adolescent Students in Indiana, Latvia, and Lithuania.
Study: Center for Civic Education, Bosnia and Herzegovina.--A high-
quality quasi-experimental study of students in Bosnia and Herzegovina
in 2000 by Dr. Suzanne Soule, Center for Civic Education, found that
Project Citizen students showed greater confidence in their knowledge
of local government, were more skilled at explaining problems; showed
greater analytical abilities in using facts and reason to analyze other
people's positions on problems, had more positive attitudes with regard
to their own power in the community and internal efficacy, and showed a
greater propensity to hold public officials accountable. In 2002, First
Lady Laura Bush praised the program in remarks to the Organization for
Economic Cooperation and Development:
``The United States is also a partner in the Balkans, working with
the International Community and Civitas in Bosnia and Herzegovina to
develop a course in democracy and human rights. This course is taught
in (primary) schools throughout the region, including Brcko, and it has
been translated for all three ethnic groups. The course is part of a
larger effort called `Project Citizen.' Through `Project Citizen'
programs, children learn to identify and solve problems in their own
communities, from supplying clean water to improving dangerous traffic
crossings. Citizenship--a sense of belonging and responsibility--
strengthens societies.''
Study: Center for Civic Education, Indonesia.--A high-quality
quasi-experimental study of students in Indonesia in 2002 by Dr.
Suzanne Soule found Project Citizen participants' political
participation increased as a result of their involvement with the
program. In contrast to the control group, they participated more in
the political process, conducted more research by contacting experts to
obtain information on issues they cared about, and participated in
protests at higher rates. They also paid more attention to public
affairs in the media. The dispositions of students who participated
more fully in the program--by selecting their problems, presenting
their proposals, and engaging in other programmatic activities--changed
more. They became more interested in politics and public affairs. Their
confidence in their ability to participate, along with their sense of
political efficacy, increased. Further, high-involvement participants
increased their expectations of the proper responsiveness of
government, an important component of accountability.
Study: WestEd.--The Center is currently working with WestEd, a
leading survey-design firm, to devise knowledge and attitude tests for
We the People: Project Citizen domestic and international use. The
standardized test will be refined and used within and outside the
United States with various quasi-experimental and experimental studies
to ensure a maximum scale of comparability. The knowledge tests have
been piloted in Nigeria and South Africa and are to be utilized in an
experimental study in Colombia and Mexico in 2006.
State Department Report.--In a report released by the State
Department's Bureau of Western Hemisphere Affairs, the Center's ED-
supported Civitas Latin America program is presented as a model for
developing Cuban democracy (see Chapters 2 and 3). The report cites
success in training teachers and effectiveness of programs as important
for encouraging democratic thought and practice.
USAID Report.--The State Department report is in accord with an
independent assessment of civic education programs funded by USAID from
1990 to 2000, which found that ``We the People: Project Citizen has
many of the characteristics of the most effective civic education
programs. It is highly participatory, it relates to issues that affect
the participants in their daily lives, it produces tangible as well as
intangible results, and it is firmly rooted in the community in which
it takes place.'' (Brilliant, 2000, 38).\2\
---------------------------------------------------------------------------
\2\ Brilliant, F. (2000). Civic Education Assessment--Stage II.
Civic Education Programming Since 1990--A Case Study Based Analysis.
Report for the U.S. Agency for International Development.
---------------------------------------------------------------------------
Other Evidence of the Effectiveness of the Center's
Programs
In addition to previous references to visits with program
participants by President Bush, Mrs. Bush, and Secretary Rice, the
obvious effectiveness of the Center's programs has been recognized at
other times at the highest levels of government in the United States
and other nations. For example:
--In 1996, the Supreme Court hosted the newly elected U.S. Senate in
the Great Hall of the Court. The event was attended by seven
Justices and more than ninety senators. The major attraction of
the evening was a well-received demonstration of the We the
People competitive hearing by students from the State of
Oregon.
--In 1998, students from the We the People program were honored by
the Department of Education when Secretary Riley announced the
release of the findings of the NAEP study of student knowledge
of civics and government.
--In 2000, We the People students were invited to testify in Congress
on the subject of school violence. Members of the committee
before which the students testified said that they were better
prepared than many of the expert witnesses who had testified
earlier.
--In 2004, the Bush administration hosted a White House Conference on
History, Civics, and Service. The only civics program featured
was the We the People program. Students from Arizona
demonstrated their outstanding knowledge of the U.S.
Constitution and Bill of Rights before a panel composed of a
noted scholar and two Federal judges. One of the Federal judges
commented that the students had a firmer grasp of
constitutional principles than most attorneys who appear in her
court.
--In 2005, the Department of Education invited teachers of the We the
People program to speak to a Constitution Day assembly at the
Department, at which they were extremely well received.
--Other nations: The following are a few of the many incidences where
other nations have recognized the quality and effectiveness of
the Center's programs:
--The Russian Ministry of Education has approved the use of the
Center's We the People and Project Citizen texts in all Russian
schools.
--The Mexican Institute for Federal Elections has translated and
adapted the Project Citizen text and is implementing it in
classrooms in all States of Mexico.
--The Center has helped the U.S. Embassy in Bosnia and Herzegovina
develop a K-12 civic education program that is being
implemented in all schools in that country.
--The Jordanian Ministry of Education has approved the implementation
of Project Citizen in all schools in Jordan.
--The Kurdish Regional Authority in Iraq has translated and adapted
the Center's Foundations of Democracy program and implemented
it with more that 400,000 students in their region.
--The U.S. Embassy in Baghdad recently supported the training of
teacher trainers in the Center's curricular materials and
intends to support their implementation throughout the country.
--The textbook division of the Chinese Ministry of Education has
translated and adapted material from the Center's texts to be
used in schools throughout China. The division has also signed
a memorandum of understanding with the Center to work together
to develop more curricular materials.
Summary.--The following generalizations can be made from internal
and external research and evaluation studies conducted during the past
seventeen years. Students who participate in the Center's curricular
programs show the following results. In comparison with their peers and
some adults, students in Center programs:
--demonstrate a greater understanding of and commitment to
fundamental values and principles of constitutional democracy,
such as individual rights, the common good, the rule of law,
and civic responsibility. They are also less cynical, more
politically engaged, more politically tolerant, and think that
they can and do make a difference in the political life of
their communities and nations;
--demonstrate a greater understanding of politics and government at
local, intermediate, and national levels and a deeper knowledge
of how to participate effectively in the political process;
--possess better research, analytic, and communication skills. This
includes an increased capacity to evaluate, take, and defend
positions on public issues;
--demonstrate a greater capacity to work with others to effectively
monitor and influence the decisions of their government;
--pay more attention to politics and the media, discuss politics more
often, volunteer to work for candidates, register to vote, and
vote at significantly higher rates than their peers. Students
also take active roles in the enactment of policies to improve
the life of their communities and nations.
Please see the attached bibliography for a list of studies
conducted on Center programs.
3. Response: ``Additional funding is not necessary for the successful
operation of this program''
The Department's justification claims that ``additional funding is
not necessary for the continuation of this program.'' Further, the
Department asserts that:
``[the] Center also has a long history of success raising
additional funding support through such vehicles as selling program-
related curricular materials, trainings, and workshops, partnering with
non-profit groups on core activities, lobbying, and seeking support
from foundations. For example, the Center has received financial
support from such organizations as the Pew Charitable Trusts, the
National Endowment for the Humanities, the Joyce Mertz-Gilmore
Foundation, the Lincoln and Therese Filene Foundation, Inc., and an
increasing number of State and local entities. Also with a national
board that includes . . . noted scholars (etc.), the Center will have
many opportunities to generate additional support for core program
activities.''
The statements in this section of the report do not reflect a sound
knowledge of the history, policies, and practices of public- and
private-sector support for civic education programs in the United
States over the past fifty years, nor a firm grounding in the facts
regarding past and present funding of the Center or the probability of
obtaining the level of support necessary from sources other than the
Federal Government. To anyone aware of the history of support for civic
education, it is clear that support for national and international
programs in civic education of the magnitude of those implemented by
the Center and described above is simply not available from sources
other than the Federal Government. Federal funding is essential for the
continuation of this program.
The Center has always sought and sometimes received support from
other sources. In reference to the sources the ED report notes above,
the Center did receive $1 million from the Pew Charitable Trusts in
1988 to develop and promote the implementation of CIVITAS: A Framework
for Civic Education. In 1991, the Pew Charitable Trusts provided a
grant of $400,000 to match funds the Center received from the
Department of Education to develop the National Standards for Civics
and Government. For several years the Joyce Mertz Gilmore Foundation
awarded the Center $20,000 to partially offset the costs of an annual
bilateral conference on civic education the Center conducted with the
Federal Center for Political Education of Germany. For the past three
years the Lincoln and Therese Filene Foundation has provided about
$100,000 annually to support a summer institute for teachers. A similar
level of support has, in some years, been provided for the same purpose
by the National Endowment for the Humanities. The Center receives
$250,000 each year from the California State Department of Education to
augment its Federal funding for the implementation of Project Citizen
in California. Despite its efforts, the Center has never been able to
secure sustained funding in more substantial amounts from such sources
for its major programs.
The ED report claims that the Center receives income from ``such
vehicles as selling program-related curricular materials, trainings,
and workshops.'' Support from ED enables the Center to provide
approximately 450,000 free textbooks to schools each year. The Center
grosses approximately $1 million each year from the sale of these
texts, with the majority of these funds paying for printing, handling,
and other overhead costs connected to the materials. The remainder of
these funds is used to support and augment the programs supported with
Federal funds. The Center does not receive funds for ``trainings and
workshops'' which are, in fact, provided free to thousands of teachers
each year under its federally supported programs.
Summary.--Although the expansion of the Center's efforts has at
times been assisted through supplemental funding provided by States and
foundations, the core of its efforts depends on the Federal dollars
that the administration seeks to eliminate. Without these crucial
funds, much of the Center's national and international networks and
their many volunteers and programs in education for democracy will
simply cease to exist. The Center seeks to continue to develop
relationships with other agencies, nonprofit organizations, and funding
sources to expand its operations and ultimately to institutionalize its
efforts. However, if successful, the administration's attempt to
discontinue funding would undermine the very possibility of
institutionalizing the foremost civic education for democracy programs
in the world by prematurely cutting the lifeline of the Center's
networks and programs.
4. Chronological List of Research and Evaluation Studies Conducted by
Internal and External Evaluators on Center Domestic and
International Programs
1. A Programmatic Evaluation of Civitas: An International Civic
Education Exchange Program 2004-2005 (2006). Gary Marx, Center for
Public Outreach. A report to the Center for Civic Education.
2. We the People: The Citizen and the Constitution: 2005 National
Finalists' Knowledge of and Support for American Democratic
Institutions and Processes (2006). Sharareh Frouzesh Bennett and Dr.
Suzanne Soule, Center for Civic Education.
3. Evaluation of We the People: Project Citizen Summer Institutes:
How the Teachers Translated the Experience into Classroom Instruction
(2006). Jennifer Nairne, Center for Civic Education.
4. Political Education Beyond National Borders: Teaching Democracy
Abroad to Promote More Peaceful International Relations (2005). Dr.
Alden Craddock, Bowling Green State University. Paper presented at the
2005 German-American Conference--Responsible Citizenship, Education,
and the Constitution.
5. Project Citizen: Evaluation Report (2005). RMC Research
Corporation.
6. An Analysis of the Depiction of Democratic Participation in
American Civics Textbooks (2005). Sharareh Frouzesh Bennett, Center for
Civic Education. Paper presented at the 2005 German-American
Conference--Responsible Citizenship, Education, and the Constitution.
7. Changes in the Political Landscape and Their Implications for
Civic Education (2005). Dr. Margaret Branson, Center for Civic
Education. Paper presented at the 2005 German-American Conference--
Responsible Citizenship, Education, and the Constitution.
8. Differences in Gender and Civic Education in Ukraine (2005). Dr.
Alden Craddock, Bowling Green State University. Paper presented at the
European Consortium of Political Research General Conference.
9. Advancing Peace and Stability through Active Citizenship: The
Role of Civic Education (2005). Dr. Margaret Branson, Center for Civic
Education. Speech delivered at the Ninth Annual World Congress on Civic
Education.
10. Voting and Political Participation of We the People: The
Citizen and the Constitution Alumni in the 2004 Presidential Election
(2005). Dr. Suzanne Soule, Center for Civic Education.
11. Monitoring the Effectiveness of Youth Participation in Project
Citizen: A Civitas-Russia Evaluation Project: Summary of Preliminary
Findings (2005). Dr. Charles White, Boston University.
12. Civitas Latin America: A Civic Education Exchange Program
Annual Evaluation Report, Year 2 (2005). West Ed. A report to the
Center for Civic Education.
13. A Programmatic Evaluation of Civitas: An International Civic
Education Program 2003-2004 (2005). Gary Marx, Center for Public
Outreach. A report to the Center for Civic Education.
14. We the People: The Citizen and the Constitution Summer
Institutes: How the Teachers Translated the Experience into Classroom
Instruction (2005). Jennifer Nairne, Center for Civic Education.
15. American Identity, Citizenship, and Multiculturalism (2005).
Dr. Diana Owen, Georgetown University. Paper presented at the 2005
German-American Conference--Responsible Citizenship, Education, and the
Constitution.
16. Knowledge of and Support for American Democratic Institutions
and Processes by Participating Students in the National Finals 2005
(2005). (Reports available from previous years 1999-2004). Dr. Suzanne
Soule and Sharareh Frouzesh Bennett, Center for Civic Education.
17. An Independent Evaluation of Civic Education Programs in
Jordan, Egypt, and West Bank 2002-2003 (2004). Glaser Consulting Group.
18. A Rising Tide in Indonesia: Attempting to Create a Cohort
Committed to Democracy through Education (2004). Dr. Suzanne Soule,
Center for Civic Education.
19. We the People Curriculum: Results of a Pilot Test (2004). Dr.
Ardice Hartry and Kristie Porter, MPR Associates, Inc.
20. Civitas Latin America: A Civic Education Exchange Program
Annual Evaluation Report, Year 1 (2004). WestEd.
21. Evaluation Report on 2003 We the People: Project Citizen Summer
Institutes (2004). Sharareh Frouzesh Bennett, Center for Civic
Education.
22. Foundations of Democracy Program and Prevention of Aggressive
Behavior of Children in Preschool Educational Institutions (2003). Ivan
Glasovac, Croatian evaluator.
23. Learning to Live Together: An Evaluation of Civic-Link (2003).
Work Research Co-operative, independent evaluator.
24. Creating a Cohort Committed to Democracy? Civic Education in
Bosnia and Herzegovina (2002). Dr. Suzanne Soule, Center for Civic
Education.
25. Voting and Political Participation of the We the People: The
Citizen and the Constitution Alumni in the 2000 Presidential Election
(2001). Dr. Suzanne Soule, Center for Civic Education.
26. Programmatic Evaluation of Civitas: An International Civic
Education Exchange Program 2000-2001 (2001). Gary Marx, Independent
Evaluator.
27. Civic Education Assessment--Stage II. Civic Education
Programming Since 1990--A Case Study Based Analysis (2000). Dr. Franca
Brilliant. Report for the U.S. Agency for International Development.
28. Project Citizen and the Civic Development of Adolescent
Students in Indiana, Latvia, and Lithuania (2000). Drs. Thomas Vontz,
Kay Metcalf, and John Patrick, Indiana University.
29. Prevention of School Violence through Civic Educational
Curricula: Year One of a National Demonstration Program (2000). Dr.
Kenneth Tolo, LBJ School of Public Affairs, University of Texas at
Austin.
30. Beyond Communism and War: The Effect of Civic Education on the
Democratic Attitudes and Behavior of Bosnian Youth (2000). Dr. Suzanne
Soule, Center for Civic Education.
31. Programmatic Evaluation of Civitas: An International Civic
Education Exchange Program 1999-2000 (2000). Eva Stahl, independent
evaluator.
32. An Assessment of We the People . . . Project Citizen: Promoting
Citizenship in Classrooms and Communities (1998). Dr. Kenneth Tolo, LBJ
School of Public Affairs, University of Texas at Austin.
33. Bell Gardens Study on Fifth and Sixth Grade Participants in
Center and Constitutional Rights Foundation Curricula (1997).
University of California, Los Angeles.
34. Program Effectiveness Panel Validation of We the People (1995).
United States Department of Education National Diffusion Network.
35. Civic Education and Political Attitudes: Examining the Effects
on Political Tolerance of the We the People Curriculum (1994). Dr.
Richard Brody, Stanford University.
36. Testing for Learning: How New Approaches to Evaluation Can
Improve American Schools (1992). Dr. Ruth Mitchell.
37. An Evaluation of the Instructional Impact of the Elementary and
Middle School Curricular Materials Developed for the National
Bicentennial Competition on the Constitution and Bill of Rights (1991).
Educational Testing Service.
38. A Comparison of the Impact of the We the People. . . Curricular
Materials on High School Students Compared to University Students
(1991). Educational Testing Service.
39. An Evaluation of the Instructional Effects of the Nationals
Bicentennial Competition on the Constitution and Bill of Rights (1988).
Educational Testing Service.
______
Prepared Statement of the College Board
anchoring mathematics and science education reform in an expanded
advanced placement program
Introduction
The College Board is a national not-for-profit association of more
than 5,000 member schools, colleges and universities, with a
challenging mission: To connect students to college success and
opportunity. One of the College Board's most ambitious and important
teaching and learning programs is the Advanced Placement Program (AP).
As a set of 38 college-level courses taught in high school, AP has
become the most influential general education program in the country,
and it represents the highest standard of academic excellence in our
Nation's schools. The AP Program is a collaborative effort between
motivated students, dedicated teachers, expert college professors, and
committed high schools, colleges, and universities. Ninety percent of
the colleges and universities in the United States, as well as colleges
and universities in 30 other countries, have an AP policy granting
incoming students credit, placement or both on the basis of their AP
Exam grades. Many of these institutions grant up to a full year of
college credit (sophomore standing) to students who earn a sufficient
number of qualifying AP grades. Since its inception in 1955, the AP
Program has allowed millions of students to take college-level courses
and exams, and to earn college credit or placement while still in high
school.
President Bush's request for $90 million in new funding to train
70,000 new AP math, science, and world language teachers over the next
five years will dramatically improve the quality of instruction in
these areas. The ultimate outcome will include a substantial increase
in the number of high school graduates who enter college with the
desire and ability to succeed in science, technology, engineering, and
mathematics (STEM) fields and compete in a global marketplace.
Moreover, increased support for an expanded AP Program in these content
areas will contribute to raising standards and achievement in all of
our Nation's high schools. The AP Program benefits both the students
who take AP courses and those who do not take AP by promoting higher
standards and better teaching in all classes. As such, a significant
investment in the expansion of AP math, science, and world language
programs will have a profound effect on the overall quality of
education in our Nation's schools.
AP is a 50-year-old, time-tested program with an existing
infrastructure of tens of thousands of teachers and a network of
hundreds of training sites across the country. Funds invested in this
program will not need to be dedicated to creating a new system for
teacher professional development, course development, or the
administration and scoring of assessments. That system already exists
as a result of our efforts over the past 50 years, and as a result of
the involvement of thousands of schools, colleges and universities in
the operation of the AP Program. Thus, new Federal dollars invested in
AP can go directly into teacher training and student preparation and
support.
The table on page four of this statement provides a summary of the
total dollars that each State would receive through this initiative,
and provides one model for the use of those funds that illustrates how
many students and teachers could be served if the full $90 million
request were supported.
the ap program
The principles and values of the AP Program can be stated quite
simply:
--AP supports academic excellence. AP represents a commitment to high
standards, hard work, and enriched academic experiences for
students, teachers, and schools.
--AP is about equity. The AP Program should be open to all students,
and we believe that every student should have access to AP
courses and should be given the support he or she needs to
succeed in these challenging courses.
--AP can drive school-wide academic reform. Schools that use AP as an
anchor for setting high standards and raising expectations for
all students see significant returns not just in terms of AP
participation but in terms of increasing the overall quality
and intensity of their academic programs.
Across the Nation, every State, and most school districts are
exploring ways to raise standards and ensure that all students take
challenging courses that prepare them for success in college and work.
AP is recognized as a powerful tool for increasing academic rigor,
improving teacher quality, and creating a culture of excellence in high
schools. Students who take AP courses assume the intellectual
responsibility of thinking for themselves, and they learn how to engage
the world critically and analytically--both inside and outside of the
classroom. This is an invaluable experience for students as they
prepare for college or work upon graduation from high school. Moreover,
schools in which AP is widely offered--and accessible to all students--
experience the diffusion of higher standards throughout the entire
school curriculum.
ap mathematics and science courses
Increasing rigorous math and science education in the United States
will significantly boost our high school graduates' math and science
proficiency--and also increase the number of students who enter college
ready to succeed in science, technology, engineering, and mathematics
(STEM) careers. And we urgently need to create those opportunities for
our students. Today, only 32 percent of American undergraduates are
earning degrees in science and engineering, compared to 66 percent of
undergraduates in Japan, 59 percent in China, and 36 percent in
Germany. In 2004, China graduated 600,000 engineers, India graduated
350,000, and the United States graduated 70,000.\1\
---------------------------------------------------------------------------
\1\ Committee on Science, Engineering and Public Policy. Rising
Above the Gathering Storm: Energizing and Employing America for a
Brighter Economic Future. National Academies Press, 2006. This report
notes that America appears to be on a ``losing path'' today with regard
to our future competitiveness and standard of living.
---------------------------------------------------------------------------
The AP Program is an important tool in this Nation's efforts to
increase its economic competitiveness. AP math and science students are
much more likely than other students to major in STEM disciplines than
students whose first exposure to college-level math and science courses
is in college. For example:
--Sixteen percent of students who take AP Chemistry go on to major in
chemistry in college. By way of contrast, only 3-4 percent of
students who take general chemistry instead of AP chemistry
major in that field in college.
--More than 25 percent of students who take AP Calculus go on to
major in a STEM field in college, and 40 percent of students
who take AP Physics major in physics in college.
Furthermore, research indicates that AP math and science courses
prepare American students to achieve a level of proficiency that
exceeds that of students from all other nations. For example, in the
most recent TIMSS assessments, U.S. Calculus students ranked number 15
(out of 16 countries) in the international advanced mathematics
assessment. But AP Calculus students who scored a 3 or better on the AP
Calculus Exam ranked first in the world. Even AP Calculus students who
scored a 1 or 2 on the AP Calculus Exam--below ``passing''--were ranked
second in the world. AP Physics students, as compared to other U.S.
physics students and physics students internationally, were also at the
top of the ranking.
Most significantly, there are many, many more U.S. students who can
succeed in AP math and science courses--if they are simply given the
chance. This year in the United States, we anticipate that more than
100,000 students will earn a grade of 3 or above on the AP Calculus
Exam--the grade typically required for college credit. But in a
national analysis of the math proficiency of students enrolled in U.S.
high schools during the 2005-2006 academic year, we can identify, by
name and school, an additional 500,000 students who have the same
academic background and likelihood of success in AP Calculus as the
100,000 students who currently are fortunate enough to have an AP
Calculus course available. If we look at Biology, we see an even larger
gap; we expect that about 74,000 students will earn exam grades of 3 or
higher on the AP Biology Exam this year, whereas we know that at least
640,000 additional U.S. students have the academic skills that would
enable them to succeed in AP Biology if they only had a course
available to them and the encouragement to take on this challenge.
There are literally hundreds of thousands of high school students in
the United States who are prepared and ready to succeed in rigorous
high school courses such as AP Calculus, AP Biology, AP Physics, and AP
Chemistry. In many cases, the only thing preventing them from learning
at this higher level is the lack of an AP teacher in their school or
the lack of adequate encouragement and support to take the AP course.
The College Board believes AP has tremendous potential to drive
reform in a powerful way in all of our Nation's schools. No single
program can have as strong an impact on overall student and teacher
quality as AP. AP is not for the elite, it is for the prepared. The
Committee's support for expanded AP math, science, and world language
courses and exams will prepare many more students for the opportunity
to compete in a global environment and succeed in STEM fields in
college and work. We respectfully urge that you fully fund the
Administration's request for AP expansion.
----------------------------------------------------------------------------------------------------------------
Number of
students Number of
Total benefiting students
number of from benefiting
Potential New middle and teachers from
2007 AP high school receiving teachers
State funding Under teachers Pre-AP receiving
President's provided training AP training
Proposal with Pre-AP (20 (25
or AP students students
training per 5 per AP
sections) teacher)
----------------------------------------------------------------------------------------------------------------
Alabama.................................................. $1,600,989 750 60,037 3,752
Alaska................................................... 453,123 212 16,992 1,062
Arizona.................................................. 2,074,097 972 77,779 4,861
Arkansas................................................. 1,016,284 476 3,8111 2,382
California............................................... 12,527,993 5,872 469,800 29,362
Colorado................................................. 933,670 438 35,013 2,188
Connecticut.............................................. 542,351 254 20,338 1,271
Delaware................................................. 453,123 212 ,16992 1,062
District of Columbia..................................... 453,123 212 16,992 1,062
Florida.................................................. 4,948,272 2,320 185,560 11,598
Georgia.................................................. 2,823,013 1,323 105,863 6,616
Hawaii................................................... 453,123 212 16,992 1,062
Idaho.................................................... 453,123 212 16,992 1,062
Illinois................................................. 3,228,779 1,513 121,079 7,567
Indiana.................................................. 1,254,941 588 47,060 2941
Iowa..................................................... 482,954 226 18,111 1,132
Kansas................................................... 537,051 252 20,139 1,259
Kentucky................................................. 1,335,985 626 50,099 3,131
Louisiana................................................ 2,012,675 943 75,475 4,717
Maine.................................................... 453,123 212 16,992 1,062
Maryland................................................. 978,436 459 36,691 2,293
Massachusetts............................................ 1,093,966 513 41,024 2,564
Michigan................................................. 2,431,666 1,140 91,187 5,699
Minnesota................................................ 746,455 350 27,992 1,750
Mississippi.............................................. 1,349,629 633 50,611 3,163
Missouri................................................. 1,418,338 665 53,188 3,324
Montana.................................................. 453,123 212 16,992 1,062
Nebraska................................................. 453,123 212 16,992 1,062
Nevada................................................... 575,422 270 21,578 1,349
New Hampshire............................................ 453,123 212 16,992 1,062
New Jersey............................................... 1,500,749 703 56,278 3,517
New Mexico............................................... 827,151 388 31,018 1,939
New York................................................. 6,191,847 2,902 232,194 14,512
North Carolina........................................... 2,401,977 1,126 90,074 5,630
North Dakota............................................. 453,123 212 16,992 1,062
Ohio..................................................... 2,504,484 1,174 93,918 5,870
Oklahoma................................................. 1,132,521 531 42,470 2,654
Oregon................................................... 902,459 423 33,842 2,115
Pennsylvania............................................. 2,659,829 1,247 99,744 6,234
Rhode Island............................................. 453,123 212 16,992 1,062
South Carolina........................................... 1,338,960 628 50,211 3,138
South Dakota............................................. 453,123 212 16,992 1062
Tennessee................................................ 1,661,104 779 62,291 3,893
Texas.................................................... 8,742,609 4,098 327,848 20,490
Utah..................................................... 479,572 225 17,984 1,124
Vermont.................................................. 453,123 212 16,992 1,062
Virginia................................................. 1,443,618 677 54,136 3,383
Washington............................................... 1,340,908 629 50,284 3,143
West Virginia............................................ 615,683 289 23,088 1,443
Wisconsin................................................ 934,028 438 35,026 2,189
Wyoming.................................................. 453,123 212 16,992 1,062
American Samoa........................................... 453,123 212 16,992 1,062
Guam..................................................... 453,123 212 16,992 1,062
Northern Mariana Islands................................. 453,123 212 16,992 1,062
Puerto Rico.............................................. 3,877,930 1,818 145,422 9,089
Virgin Islands........................................... 453,123 212 16,992 1,062
Freely Associated States................................. .............. ........... ........... ...........
Indian set-aside......................................... .............. ........... ........... ...........
Other (non-State allocations)............................ 455,400 213 1,7078 1,067
------------------------------------------------------
Total.............................................. 91,080,000 42,694 3,415,500 213,469
----------------------------------------------------------------------------------------------------------------
______
Prepared Statement of the Council of State Administrators of Vocational
Rehabilitation (CSAVR)
This testimony is submitted on behalf of the Council of State
Administrators of Vocational Rehabilitation (CSAVR). The CSAVR is
composed of the chief administrators of the State Vocational
Rehabilitation (VR) Agencies serving individuals with physical and/or
mental disabilities in the United States, the District of Columbia and
the Territories. These agencies constitute the State partners in the
State-Federal Program of Rehabilitation Services provided under Title 1
the Rehabilitation Act of 1973, as amended. State VR agencies provide
individualized services and supports to eligible individuals with
significant disabilities that are required for them to go to work.
These services may include, but are not limited to, counseling and
guidance, job training, higher education, physical and mental
restoration services, and assistive technology. Nearly 1 million
individuals with disabilities are served annually. In fiscal year 2005,
these agencies placed 206,695 individuals with disabilities into
competitive employment.
The CSAVR, founded in 1940 to furnish input into the State-Federal
Rehabilitation Program, provides a forum for State administrators to
study, deliberate, and act upon matters affecting the rehabilitation
and employment of individuals with disabilities. The Council serves as
a resource for the formulation and expression of the collective points
of view of State rehabilitation agencies on all issues affecting the
provision of quality employment and rehabilitation services to persons
with significant disabilities.
csavr's recommendation for the fiscal year 2007 appropriation for the
public vocational rehabilitation program
For fiscal year 2007, CSAVR recommends an increase in the
Vocational Rehabilitation (VR) appropriation of $258 million above the
President's budget request for fiscal year 2007. The President's budget
proposes a 4.3 percent increase in funding for the Public VR program,
which is the mandated CPI increase, called for in law. However, the
President's budget request also eliminates funding for several smaller
programs, Supported Employment (SE), Projects with Industry (PWI), and
Migrant and Seasonal Farm Workers (MSFW), with a total loss of funding
of 51.7 million. With the majority of State VR Agencies operating under
an Order of Selection, a system of prioritization whereby individuals
with the most significant disabilities are served first, it is unlikely
that the State VR Agencies would be able to continue to provide
services, under Title 1 of the Rehabilitation Act, to all of the
individuals previously served under the programs that lost their
funding.
In addition to the proposed elimination of the SE, PWI, MSFW, and
Recreation programs, which CSAVR does not support, HR 27, the House
bill to reauthorize the Workforce Investment Act (WIA), and S 1021, the
Senate bill to reauthorize the WIA, expands the requirements for VR to
provide transition services to students with disabilities. Based on the
significant internal and external challenges facing the Public VR
Program, (i.e., staffing shortages, State budget shortfalls, increased
numbers of consumers seeking services, and increased service costs and
expectations, the CSAVR believes that an increased appropriation of 258
million above the President's budget request for VR, for fiscal year
2007, is an appropriate recommendation.
The CSAVR is requesting a $206 million increase specifically for
the purposes of implementing the new transition requirements in the
Rehabilitation Act. The most recent data on transition students,
published in 2003 in the Individuals with Disabilities Education Act
(IDEA) 25 Annual Report to Congress, indicates that there were
2,791,886 students between the ages of 12-17 and 283,265 between the
ages of 18-21. A small sample survey of State VR Agencies revealed that
the average annual cost to serve a transition student is $2062.00. The
CSAVR will have the capacity to serve 100,000 new transition students
in fiscal year 2007, with a funding increase of $206 million.
In addition, CSAVR is requesting that you restore the $51.7 million
to the MSFW, the SE and the PWI programs, whose budgets were eliminated
in the President's budget request for fiscal year 2007.
These three programs are vital to VR consumers and desperately
needed to assure that vital support services, necessary for successful
employment of certain populations, are maintained.
the public vocational rehabilitation program
The Public VR Program is one of the most cost-effective programs
ever created by Congress. It enables hundreds of thousands of
individuals with disabilities to go to work each year and become tax-
paying citizens. In fiscal year 2005, the VR Program assisted 984,315
individuals with disabilities who wanted to work, by providing them
with the job skills, training and support services they needed to
become employed. Of those served, 206,695 entered into competitive
employment. Funding for the VR Program requires a State match of 21.3
percent, and creates a State-Federal partnership that has worked
effectively for more than 86 years, and has assisted approximately 16
million individuals with disabilities to engage in employment and
become tax-paying citizens.
The Rehabilitation Act mandates that the annual Federal
appropriation for the VR Program grow at a rate at least equal to the
change in the Consumer Price Index (CPI) over the previous fiscal year.
While the mandate was intended to create a floor for the VR
appropriation, Congress has not appropriated funds above the mandated
CPI increase since 1999. This is particularly problematic because the
formula used to distribute these funds, which is based on a State's per
capita income and population, results in significant variations in the
increases in individual State's allotments. When the increase is
limited to the CPI increase and the formula is applied, not all States
receive increases that are equal to the annual rate of inflation. In
fiscal year 2006, 30 States did not receive the required CPI increase
in their State allotment.
challenges facing the public vr program
Over the last several years, the Public VR Program has faced a
number of external challenges that have been compounded by the minimal
increases in Federal funding.
special education
Between 1990 and 2004, the Federal appropriation for special
education increased by approximately 333 percent. During the same time
period, the Federal appropriation for the Public VR Program increased
by only 22 percent. As a result of these very significant increases in
special education funding, an ever-increasing number of special
education students are exiting the education system and seeking adult
services, including Vocational Rehabilitation, in order to participate
in post secondary education, job training, and/or to go to work.
impact of the workforce investment act of 1998 (wia)
The Public VR Program is a mandatory partner in the WIA and, as
such, is required to contribute significant resources to support the
infrastructure and other costs associated with the operation of the
One-Stop Centers. While VR's involvement in State Workforce Investment
Systems is critically important, WIA has placed yet another financial
burden on an already strained program, further reducing the percentage
of VR funds that are available to provide services and supports to
eligible individuals with disabilities. In addition, the House bill to
reauthorize the WIA, H.R. 27, proposes to take significant resources
from the Public VR Program far beyond the resources contributed to the
One-Stop Centers under current law. The Senate bill, S. 1021, also
requires resources from VR to fund the infrastructure costs and other
common costs associated with the operation of One-Stop Centers;
however, the CSAVR is very grateful for the graduated CAP on
infrastructure funding for VR in S. 1021.
--A 2002 Longitudinal Study of the Public VR Program provided
evidenced based research that the VR Program is effective in
putting people with disabilities to work in good jobs with
opportunities for advancement.
--A fiscal year 2006 Program Assessment Rating Tool (PART) Review,
conducted by the Office of Management and Budget (OMB) to rate
program performance, rated the VR Program favorably, and in
general, successful in meeting its program goal.
--A report by the Social Security Administration, released annually,
provides detailed information on the funds disbursed to State
VR Agencies, based on their successfully serving beneficiaries
on Social Security Disability Insurance (SSDI) and Supplemental
Security Income (SSI). In fiscal year 2004 SSA projected a
470.3 million savings to the Trust Fund by the VR Program, and
established that every $1.00 that SSA spends on VR results in a
$6.00 savings.
In this era of significant Federal and State budget deficits, and
an increase in the unemployment rate for individuals with disabilities,
we urge you to consider an increase in funding for the Public VR
Program, through which you can be assured to have positive outcomes,
based on the three factors mentioned above.
Our Nation's ability to be competitive in a global economy depends
on the quality of our workforce. According to information provided by
the Department of Labor, Employment & Training Administration, during
the fiscal year 2006 Budget Briefing, the American workforce will be
vastly different than it is today, as the 21st century unfolds. The
fastest growing jobs of the future will need to be filled by
``knowledge workers,'' who have specialized skills and training. Ninety
percent of the fastest growing jobs in the United States (U.S.) require
some level of post-secondary education and training. Yet, the U.S.
Census Bureau reports that in the United States, just 28 percent of
those 25 and older in 2004 had a bachelor's degree. Integrating all
available workers into the workforce, including workers with
significant disabilities, will be required for employers to meet the
demands of the 21st century economy. Significant numbers of large and
small employers have acknowledged that hiring individuals with
disabilities makes good business sense. It provides them with
dependable workers and access to a market of individuals with spending
power, which has historically been untapped. These same employers also
have long-standing, positive relationships with VR, to whom they look
to provide them with qualified workers with disabilities. Integrating
all available workers into the workforce, including workers with
disabilities, will require significant resources.
Recently, the CSAVR developed a National VR/Business Network for
the purposes of increasing significantly, the number and quality of
employment opportunities for VR's consumer. This National Network,
spearheaded by CSAVR's Director of Business Relations, has already
expanded the number of employment opportunities available to VR's
consumers in a significant number of States, and is continuing to grow.
VR's positive relationships with employers, who rely heavily on the
Public VR Program to meet their hiring needs, further emphasizes and
documents the need for additional resources for VR.
The Public VR Program, 86 years of history, 16 million individuals
served, and a demonstrated return on investment. With additional
resources, the Public VR Program can do more of what it does best--
provide the resources for individuals with disabilities to go to work
and live the American Dream.
The CSAVR thanks the Chairman and Members of the Senate
Appropriations subcommittee for the opportunity to submit written
testimony on behalf of the Public VR Program.
______
Prepared Statement of Gallaudet University
Mr. Chairman and members of the committee: I would like to express
my appreciation to you and to Congress for the generous support that we
received in fiscal year 2006 to continue maintaining and enhancing
academic programs and salaries at Gallaudet University. I am especially
grateful that Congress continues to support us during these challenging
times, and I am testifying in support of our appropriation request for
fiscal year 2007. As I prepare to retire as President at the end of
this calendar year, I would particularly like to express my
appreciation for the support that Congress has provided to Gallaudet
during the 18 years of my administration and of majority control of the
Board of Trustees by deaf individuals. One of my proudest
accomplishments is the increase in the percentages of our employees who
are deaf or members of minority groups. These percentages now stand at
41 percent and 38 percent respectively.
Consistent with our legal purpose, as stated in the Education of
the Deaf Act (EDA), we have greatly expanded programs at the doctoral
level. When I became President, we had only one doctoral level program
in administration and supervision--we now have additional doctoral
programs in audiology, clinical psychology, education, and linguistics.
At the undergraduate level we have focused on programs, such as
tutoring and first year seminars, designed for long term enhancement of
our persistence and graduation rates, and we have initiated a much
needed bachelor's level interpreter training program. At the Clerc
Center, following guidance from Congress during the 1992
reauthorization of the EDA, we have refocused our demonstration and
outreach activities at the pre-college level on high priority student
populations throughout the United States.
During my presidency, Gallaudet responded to the Government
Performance and Results Act (GPRA). In 2005, we had 31 ambitious goals
published under GPRA, with 17 of those fully accomplished in that year.
These goals reflect the wide array of programs and services that
Gallaudet provides as required by legislative mandate and performance
expectations as agreed to with the U.S. Department of Education. During
2005, Office of Management and Budget (OMB) conducted a Program
Assessment Rating Tool (PART) of Gallaudet, and, based on a limited and
narrow set of GPRA indicators, it gave Gallaudet an ``ineffective''
rating. I protested the rating in part because of the assessment's
limited scope and also because we were not involved in the assessment.
I am pleased to inform you that OMB has agreed to conduct a
reassessment of Gallaudet this year, and I will insist on a broader set
of indicators that truly represent Gallaudet's complex mission.
When I became President in 1988, every building on the Kendall
Green campus had been constructed with virtually 100 percent Federal
funding. Since I became President, every major construction or
renovation project we have undertaken has been supported either by
cost-sharing with the Federal Government or by private fundraising
alone. For example, the buildings constructed here most recently, the
Kellogg Conference Hotel at Gallaudet University and the Student
Academic Center, were constructed without any additional Federal
appropriations. We are currently well on the way to raising the funds
needed for a facility to house our language and communication programs,
including a $5 million leadership gift from the Sorenson family of
Utah.
When I became President, the Gallaudet endowment was valued at $10
million. Partly with the assistance of the Federal Endowment Program
created by the 1986 passage of the Education of the Deaf Act, our
endowment now stands at $165 million and generates more than $4 million
in annual income to support programs and scholarships.
When I became President in 1988, total staffing at Gallaudet stood
at about 1,450 employees. Following a comprehensive staffing reduction
program, it now stands at just over 1,100, a reduction of more than 20
percent. This reduction provided much needed budget flexibility during
a time when Congress was seeking to reduce the Federal budget deficit.
During my tenure, we have also decreased the proportion of our
operating budget that is supported by Federal appropriations by about
10 percentage points. This reduction was made possible in part by a
long term plan to increase tuition charges to Gallaudet students,
following an agreement between the University and the Department of
Education. For many years, we increased tuition at 7 percent annually,
more than twice the rate of inflation. Following expressions of concern
by members of Congress and by a consulting group we retained to study
our tuition policy, we reduced these increases to 3 percent annually
starting in fiscal year 2006. I believe that we have been very
responsible in our requests for Federal support and that we have done
everything we could to seek additional sources of funding during a time
when Congress has faced funding limitations.
Because of Congress's ongoing support of Gallaudet in fiscal year
2006, we have been able to maintain a competitive pay structure for our
employees while retaining the flexibility to meet the needs of a
changing student body. Given the unique student population we serve and
the communication skills our employees are expected to possess,
retaining skilled employees is critical to our mission. Gallaudet
employees received general pay increases of 2 percent in fiscal year
2003, 3 percent in fiscal year 2004, 2 percent in fiscal year 2005, and
2 percent again in fiscal year 2006, increases that are below what
Federal employees in the region received during the same timeframe, but
in line with increases in the Consumer Price Index (CPI). During the
most recent 12 month period, the CPI-U increased by 4 percent. It will
be important for Gallaudet to ensure that our employees receive at
least a 3 percent general pay increase in fiscal year 2007,
commensurate with current increases in inflation. We are also
requesting support for inflationary increases in non-salary areas,
especially in the cost of utilities and benefits. In this regard, I
need to point out that our benefits charges during the past several
years have increased by more than 2 percent of base salaries, and we
have had to fund those increases as part of our total payroll package.
The administration budget for fiscal year 2007 includes $106.998
million for Gallaudet, the same as our current fiscal year 2006
appropriation. I have carefully analyzed our fiscal year 2006 funding
needs and have determined that in order to award a 3 percent salary
increase to our faculty and staff, and to meet other inflation-driven
increases, we need an increase of about $5 million, 4.7 percent above
our current appropriation. All of our planning is now guided by a
comprehensive strategic plan driven by eight goals, arrived at in
consultations involving our Board, and our faculty and staff, relating
to student academic achievement within the liberal arts tradition,
excellence in research and other programs, diversity among students and
employees, leadership in the deaf community, and maintenance of a
strong resource base.
funding request for fiscal year 2007
In our budget request to the Department of Education for fiscal
year 2007, we addressed the need for inflationary increases as well as
support for program development. Given the funding issues currently
facing Congress, I am requesting support at this time for only our most
pressing inflationary needs. Funding our need to cover inflationary
costs will provide us some budget stability, but we will continue to
face the need for development and enhancement of our programs. Our
strategy will be to seek alternative sources of funding for some of
these program priorities and to defer others. We will continue to seek
support for program growth from both Federal and private sources in the
future.
Salaries.--I am requesting support for a 3 percent increase in
salaries, approximately $2.6 million.
Benefits.--I am requesting support for increases in benefits costs
that have created the need for increasing charges to our operating
units by 2 percent of base salaries, approximately $1.4 million.
Utilities.--The total cost for utilities at Gallaudet rose by $1.8
million, or 50 percent, between fiscal year 2002 and 2005, and I expect
these costs to continue rising steeply in fiscal year 2006. I am
seeking $1 million to partially offset these increases.
My total request for fiscal year 2007 is, thus, $112 million.
In summary, I appreciate the challenges that Congress faces in
making appropriations decisions for fiscal year 2007, but I believe
experience has shown that Gallaudet provides an outstanding return on
Federal dollars that are invested here, in terms of the educated and
productive deaf community that the Nation enjoys as a result.
______
Prepared Statement of the Health Professions and Nursing Education
Coalition
The members of the Health Professions and Nursing Education
Coalition (HPNEC) are pleased to submit this statement for the record
in support of the health professions education programs authorized
under Titles VII and VIII of the Public Health Service Act.
HPNEC is an informal alliance of over 50 organizations representing
a variety of schools, programs, health professionals, and others
dedicated to ensuring that Title VII and VIII programs continue to help
educate the Nation's health care and public health personnel. HPNEC
members are thankful for the support the subcommittee has provided to
the programs, which are essential to building a well-educated, diverse
health care workforce.
The Title VII and VIII health professions and nursing programs are
essential components of Americans' health care safety net, bringing
health care services to our underserved communities. These programs
support the training and education of health care providers with the
aim of enhancing the supply, diversity, and distribution of the
workforce, filling the gaps in the health professions' supply not met
by traditional market forces. The Title VII and VIII health professions
programs are the only Federal programs designed to train providers in
interdisciplinary settings to meet the needs of special and underserved
populations, as well as increase minority representation in the health
care workforce.
The final fiscal year 2006 Labor-HHS-Education Appropriations bill
cut Title VII & VIII programs by 34.5 percent, including a 51.5 percent
cut to Title VII programs. Moreover, the President's fiscal year 2007
budget proposes an additional 93.1 percent cut to Title VII and a 45.8
percent cut overall to both Title VII and VIII.
HPNEC members recommend that the Title VII and VIII programs
receive an appropriation of at least $550 million for fiscal year 2007.
This recommendation would ensure the programs have sufficient funds to
continue fulfilling their mission of educating and training a health
care workforce that meets the public's health care needs, restoring
some of the unprecedented cuts imposed on the programs in fiscal year
2006.
As described in an April 5 letter to the subcommittee, led by
Senators Pat Roberts and Jack Reed, and signed by 56 of your colleagues
(letter attached), restoring funding to Title VII health professions
programs is vital to reversing health professions shortages in the
Nation's neediest communities. An April 3 letter led by Senators Susan
Collins and Barbara Mikulski was signed by 54 Senators in support of
adequate funding for Title VIII nursing programs as well (letter
attached).
The enacted and proposed cuts to the programs will:
Exacerbate existing provider shortages in rural, medically underserved,
and federally designated health professions shortage areas
--With Title VII funding, the Department of Family Medicine at
Pennsylvania State University increased the number of students
entering primary care to 50 percent of all graduates. Through
rural rotations and required primary care clerkships, Penn
State placed 30 percent of graduates into medically underserved
areas over the last three years. With cutbacks in Title VII
funding, they will lose their ability to continue producing
physicians for underserved and rural areas.
--According to the University of Nebraska Medical Center, eliminating
Title VII funding will cut off access to psychologists for many
families in rural areas. Over the last four years, the Munroe
Meyer Institute Department of Psychology has served children
and families from over 140 Nebraska cities and towns (3,500
patients each year), and has placed Pediatric Psychologists in
five rural primary care practices. The rural programs will be
in severe financial crisis as a result of cuts, which would
further reduce Nebraska's already severely limited mental
health services to its rural citizens.
Impede recruitment of underrepresented minorities and students of
disadvantaged backgrounds into the health professions and
intensify health disparities among minority and underserved
citizens
--The Saint Louis University School of Medicine operates a Health
Careers Opportunity Program (HCOP). The negative impact of the
elimination of Federal funding on the development of pipeline
programming will be significant, as over 2,300 K-12 students
annually participate in one or more pipeline programs. A
correlative impact will be in the area of minority/
disadvantaged recruitment, as pipeline programs heighten
awareness of opportunities for medical and pre-medical training
(i.e., research opportunities) at Saint Louis University.
Elimination of Federal dollars will severely limit the ability
of Saint Louis University to continue to impact young people at
an early age to begin thinking about medicine. A reduction in
minority enrollment is certain to occur at a time when
enrollment diversity is having critical implications on
institutional and faculty development, as well as on cultural
competency initiatives.
--The University of Illinois' College of Medicine has received
Federal funding for its HCOP program for over 25 years and has
graduated over 1400 health professionals. With a loss of funds,
the school expects that the breadth of its recruitment
activities will be curtailed, resulting in fewer contacts with
underrepresented students, truncating the opportunities for
exposing students to medicine as a career choice, to financial
aid information, to curriculum preparedness, etc. These
programmatic impacts will shape the medical profession as a
whole, as there will be fewer underrepresented minorities who
are recruited, retained, and who graduate to become physicians;
fewer underrepresented minorities who are able to assist in
bridging the dearth of medical care in underserved areas; fewer
underrepresented minorities who are able to continue
eliminating health disparities and contributing to health
policy; and fewer underrepresented minorities who are
culturally competent to appropriately provide health care
services to the Nation's historically underserved populations.
Negatively impact vulnerable populations such as the elderly
--Over four years, the South Carolina Geriatric Education Center
(GEC) has trained over 6,000 physicians. The enacted cuts to
Title VII programs eliminate funding for geriatrics programs,
including those at the University of South Carolina School of
Medicine and the Medical University of South Carolina. As one
of the top five States in rate of growth for older individuals,
the direct impact on educating physicians and other health
professionals on the special needs of aging adults will
reverberate throughout South Carolina. On a national scale, the
cuts will affect 50 GECs throughout the country which train
over 50,000 health care professionals representing 35
disciplines annually. These centers log 8.6 million patient
encounters each year, and over two-thirds of GECs serve rural
areas and underserved populations. The effect of this lost
funding is devastating to both academic institutions and older
individuals who will not receive care from health professionals
equipped to address their unique needs.
Undermine efforts to encourage health professions students to enter
primary care
--The University of California, San Diego School of Medicine reports
that 71 percent of UCSD Hispanic Center of Excellence (HCOE)
alumni completed or are completing primary care residencies,
compared to only 57 percent of the UCSD alumni, graduating in
2002-2004, who have completed or are completing primary care
residencies.
A November 2002 report by the Advisory Committee on Training in
Primary Care Medicine and Dentistry emphasizes the essential role of
the Title VII programs in enhancing public health training for the
primary care health workforce. In its recommendations, the committee
notes that in 1998, 42 to 56 percent of graduates from the Title VII-
supported primary care programs entered practice in underserved areas,
compared to a mean of 10 percent of health professions graduates
overall. Data from 1998 also indicate that 35 to 50 percent of
graduates of these programs represented minority or disadvantaged
groups, compared to 10 percent minority representation overall.
Community health centers (CHCs) also benefit from Title VII and
VIII programs. A March 2006 study published in the Journal of the
American Medical Association found that community health centers report
high percentages of provider vacancies, including an insufficient
supply of dentists, pharmacists, pediatricians, family physicians, and
registered nurses; these shortages are especially pronounced among CHCs
in rural areas. Because Title VII programs have a successful record of
training providers who serve underserved areas, the study recommends
increased support for the programs as its primary means of alleviating
the shortages. Further, the publication serves as an important reminder
that the success of CHCs is highly dependent upon a well-trained
clinical staff to provide care.
During their 40-year existence, the Title VII and VIII programs
have created a network of initiatives across the country that supports
the training of many disciplines of health providers. These are the
only Federal programs designed to create infrastructures at our schools
and in our communities that facilitate customized training designed to
bring the latest emerging national priorities to the populations at
large and meet the health care needs of special, underserved
populations.
HPNEC members urge the subcommittee to consider the vital need for
these health professions education programs as demonstrated by the
passage of the Health Professions Education Partnerships Act of 1998
(Public Law 105-392), which reauthorized these programs. The
reauthorization provided additional flexibility in the administration
of these programs and consolidated them into seven general categories:
Minority and Disadvantaged Health Professions Training; Primary Care
Training; Interdisciplinary, Community-Based Linkages; Health
Professions Workforce and Analysis; Public Health Workforce
Development; Nursing Workforce Development; and Student Financial
Assistance.
--The purpose of the Minority and Disadvantaged Health Professionals
Training programs is to improve health care access in
underserved areas and the representation of minority and
disadvantaged health care providers in the health professions.
Minority Centers of Excellence support programs that seek to
increase the number of minority health professionals through
increased research on minority health issues, establishment of
an educational pipeline, and the provision of clinical
opportunities in community-based health facilities. The Health
Career Opportunity Program seeks to improve the development of
a competitive applicant pool through partnerships with local
educational and community organizations. The Faculty Loan
Repayment and Faculty Fellowship programs provide incentives
for schools to recruit underrepresented minority faculty. The
Scholarships for Disadvantaged Students (SDS) make funds
available to eligible students from disadvantaged backgrounds
who are enrolled as full-time health professions students.
Nursing students receive 16 percent of the funds appropriated
for SDS.
--The Primary Care Training category, including General Pediatrics,
General Internal Medicine, Family Medicine, General Dentistry,
Pediatric Dentistry, and Physician Assistants, provides for the
education and training of primary care physicians, dentists,
and physician assistants to improve access and quality of
health care in underserved areas. As noted in the November 2002
Advisory Committee report, two-thirds of all Americans interact
with a primary care provider every year, and approximately one-
half of primary care providers trained through these programs
go on to work in underserved areas, compared to 10 percent of
those not trained through these programs. The General
Pediatrics and General Internal Medicine programs provide
critical funding for primary care training in community-based
settings and have been successful in directing more primary
care physicians to work in underserved areas. They support a
range of initiatives, including medical student training,
residency training, faculty development and the development of
academic administrative units. Title VII is the only Federal
program that provides funding for family medicine residency
training, academic departments, predoctoral programs, and
faculty development. The General Dentistry and Pediatric
Dentistry programs provide grants to dental schools and
hospitals to create or expand primary care dental residency
training programs. Recognizing that all primary care is not
only provided by physicians, the primary care cluster also
provides grants for physician assistant programs to encourage
and prepare students for primary care practice in rural and
urban Health Professional Shortage Areas. Additionally, these
programs enhance the efforts of osteopathic medical schools to
continue to emphasize primary care medicine, health promotion,
and disease prevention, and the practice of ambulatory medicine
in community-based settings.
--Because much of the Nation's health care is delivered in areas far
removed from health professions schools, the Interdisciplinary,
Community-Based Linkages cluster provides support for
community-based training of various health professionals. These
programs are designed to provide greater flexibility in
training and to encourage collaboration between two or more
disciplines. These training programs also serve to encourage
health professionals to return to such settings after
completing their training. The Area Health Education Centers
(AHECs) provide clinical training opportunities to health
professions and nursing students in rural and other underserved
communities by extending the resources of academic health
centers to these areas. AHECs, which have substantial State and
local matching funds, form networks of health-related
institutions to provide education services to students, faculty
and practitioners. Health Education and Training Centers
(HETCs) were created to improve the supply of health
professionals along the U.S.-Mexico border. They incorporate a
strong emphasis on wellness through public health education
activities for disadvantaged populations. Given America's
burgeoning aging population, there is a need for specialized
training in the diagnosis, treatment, and prevention of disease
and other health concerns of the elderly. Geriatric Health
Professions programs support geriatric faculty fellowships, the
Geriatric Academic Career Award, and Geriatric Education
Centers, which are all designed to bolster the number and
quality of health care providers caring for our older
generations. The Quentin N. Burdick Program for Rural Health
Interdisciplinary Training places an emphasis on long-term
collaboration between academic institutions, rural health care
agencies and providers to improve the recruitment and retention
of health professionals in rural areas. The Allied Health
Project Grants program represents the only Federal effort aimed
at supporting new and innovative education programs designed to
reduce shortages of allied health professionals and create
opportunities in medically underserved and minority areas.
Health professions schools use the funding to help establish or
expand allied health training programs. The need to address the
critical shortage of certain allied health professionals has
been repeatedly acknowledged. For example, this shortage has
received special attention given past bioterrorism events and
efforts to prepare for possible future attacks. The allied
health project grants funding enables the training of much
needed allied health professionals, including those
experiencing significant shortages. The Graduate Psychology
Education Program provides grants to American Psychological
Association accredited doctoral, internship and postdoctoral
programs in support of interdisciplinary training of psychology
students with other health professionals for the provision of
mental and behavioral health services to underserved
populations (i.e., older adults, children, chronically ill, and
victims of abuse and trauma, including returning military
personnel and their families), especially in rural and urban
communities. Since its inception in 2002, the GPE Program has
supported 52 grants in 27 States.
--The Health Professions Workforce and Analysis program provides
grants to institutions to collect and analyze data on the
health professions workforce to advise future decision-making
on the direction of health professions and nursing programs.
The Health Professions Research and Health Professions Data
programs have developed a number of valuable, policy-relevant
studies on the distribution and training of health
professionals, including the soon-to-be-released Eighth
National Sample Survey of Registered Nurses (NSSRN), the
Nation's most extensive and comprehensive source of statistics
on registered nurses.
--The Public Health Workforce Development programs are designed to
increase the number of individuals trained in public health, to
identify the causes of health problems, and respond to such
issues as managed care, new disease strains, food supply, and
bioterrorism. The Public Health Traineeships and Public Health
Training Centers seek to alleviate the critical shortage of
public health professionals by providing up-to-date training
for current and future public health workers, particularly in
underserved areas. Preventive Medicine Residencies, which
receive minimal funding through Medicare GME, provide training
in the only medical specialty that teaches both clinical and
population medicine to improve community health. Dental Public
Health Residency programs are vital to the Nation's dental
public health infrastructure. The Health Administration
Traineeships and Special Projects grants are the only Federal
funding provided to train the managers of our health care
system, with a special emphasis on those who serve in
underserved areas.
--The Nursing Workforce Development programs provide training for
entry-level and advanced degree nurses to improve the access
to, and quality of, health care in underserved areas. Health
care entities across the Nation are experiencing a crisis in
nurse staffing, caused in part by an aging workforce, an
insufficient number of young people entering the profession,
and a shortage of nurse faculty. At the same time, the need for
nursing services is expected to increase significantly over the
next 20 years, with the demand for licensed, registered nurses
growing by over 29 percent within the next nine years alone.
Congress responded to this dire national need by passing the
Nurse Reinvestment Act (Public Law 107-205) which aims to
attract more people into the nursing profession, increase the
capacity for nurse education, and encourage practicing nurses
to remain in the profession. The Advanced Education Nursing
program awards grants to train a variety of advanced practice
nurses, including nurse practitioners, certified nurse-
midwives, nurse anesthetists, public health nurses, and nurse
administrators. Workforce Diversity grants support
opportunities for nursing education for disadvantaged students
through scholarships, stipends, and retention activities. Nurse
Education, Practice, and Retention grants are awarded to help
schools of nursing, academic health centers, nurse managed
health centers, State, and local governments, and other health
care facilities to develop programs that provide nursing
education, promote best practices, and enhance nurse retention.
The Loan Repayment and Scholarship Program repays up to 85
percent of nursing student loans and offers individuals who are
enrolled or accepted for enrollment as a full-time or part-time
nursing student the opportunity to apply for scholarship funds.
In return these students are required to work for at least two
years of practice in a designated nursing shortage area. The
Comprehensive Geriatric Education grants assist in training
individuals to provide geriatric care for the elderly. The
Nurse Faculty Loan program provides a student loan fund
administered by schools of nursing to increase the number of
qualified nurse faculty. The Title VIII nursing programs also
support the National Advisory Council on Nurse Education and
Practice, which is charged with advising the Secretary of
Health and Human Services and Congress on nursing workforce,
education, and practice improvement issues.
--The loan programs in the Student Financial Assistance support needy
and disadvantaged medical and nursing school students in
covering the costs of their education. The Nursing Student Loan
(NSL) program provides loans to undergraduate and graduate
nursing students with a preference for those with the greatest
financial need. The Primary Care Loan (PCL) program provides
loans covering the cost of attendance in return for dedicated
service in primary care. The Health Professional Student Loan
(HPSL) program provides loans covering the cost of attendance
for financially needy health professions students based on
institutional determination. The NSL, PCL, and HPSL programs
are funded out of each institution's revolving fund and do not
receive Federal appropriations. The Loans for Disadvantaged
Students (LDS) program provides grants to health professions
institutions to make loans to health professions students from
disadvantaged backgrounds.
HPNEC members respectfully urge support for funding of at least
$550 million for the Title VII and VIII programs, an investment
essential not only to the development and training of tomorrow's health
care professions but also to our Nation's efforts to provide needed
health care services to underserved and minority communities. We
greatly appreciate the support of the subcommittee and look forward to
working with members of Congress to achieve these goals in fiscal year
2007 and into the future.
______
Prepared Statement of the Institute for Student Achievement
Mr. Chairman and Members of the subcommittee, thank you for the
opportunity to submit testimony to the hearing record regarding the
Institute for Student Achievement (ISA), a national not for profit
educational organization.
introduction to the institute for student achievement
The Institute for Student Achievement's mission is ``to improve the
quality of education for youth at risk so that they can succeed in our
society.'' ISA has had a solid 15 year history of promoting high
achievement for underserved students, first through its legacy direct
service programs, COMET (for middle school) and STAR (for high school),
and now through its school reform model. ISA launched its high school
reform model in September 2001, with four pilot sites, three in New
York City and one in Fairfax County, Virginia. As you know, funds to
expand the work of ISA have been included in recent appropriations
cycles, and we appreciate the support of the subcommittee. As a result
we have created 31 small schools and learning communities serving over
8,000 students in New York State, Virginia (in partnership with Fairfax
County Schools), Atlanta, Georgia and Union City, New Jersey.
ISA partners with school districts to create new small schools or
to transform large existing high schools into clusters of autonomous
small schools or semi-autonomous small learning communities. The ISA
high school reform model targets underserved, underperforming young
people, including students from low-income families, students of color,
recent immigrants and English Language Learners. ISA helps schools to
develop small learning communities with the seven school design
principles that have succeeded in preparing all high school students,
including those who are disadvantaged and underperforming, to achieve,
graduate, and go on to college.
Briefly described, the 7 ISA Principles are:
A College Preparatory Instructional Program promoting rigorous
intellectual development, strong literacy and numeracy skills, critical
thinking, habits of mind and work, and practical knowledge of the
college application process.
A Dedicated Team of Teachers and a Counselor who collaborate to
ensure that students develop and achieve academically and socially.
Continuous Professional Development that strengthens the capacities
of teachers, counselors and school leaders to effectively provide a
college preparatory program through rich professional growth
experiences; regularly scheduled team meetings; classroom interventions
for teachers; and customized professional development on topics ranging
from inquiry in science to conflict resolution.
Distributed Counseling <SUP>TM</SUP> an approach in which faculty
get to know all students well, as both learners and people, and
integrate counseling into the education program so that students
graduate ready for college. The counselor provides ongoing guidance to
the teacher/advisors and direct services to students and their
families.
An Extended School Day and School Year provide extra time for
students to develop skills, complete assignments, engage in test
preparation, participate in community service projects and internships,
and have opportunities for talent development and enrichment.
Parent Involvement is integrated into school operations. The school
program is designed to allow--and encourage--parents to be full
partners in realizing educational excellence for their children.
Continuous Organizational Improvement focuses on optimizing student
learning. ISA and its higher education partner, the National Center for
Restructuring Education, Schools and Teaching (NCREST) of Teacher's
College, Columbia University, work with the small schools and small
learning communities to assess and evaluate in order to inform
instruction and enhance program development.
In each ISA small learning community or small school, a team of at
least four core subject teachers and a guidance counselor is dedicated
to a group of 100-125 students, staying with the students over multiple
years. Each ISA small school or small learning community selects an ISA
coach, who is experienced in the development of small or restructuring
schools, brings substantive knowledge of one or more core content
areas, and has considerable background in working closely with teachers
in reflecting on and improving their practice. The ISA coach works with
the school over a four-year period at the school site, supporting
school administrators and dedicated teacher/counselor teams as they
implement the seven ISA principles to meet the needs of their school
community.
The ISA coach works with individual teachers to strengthen their
pedagogical skills and facilitates curriculum development and
implementation. He or she helps the teacher/counselor teams to create a
personalized, supportive environment that optimizes student learning.
The team is further assisted with the implementation of ISA's
Distributed Counseling <SUP>TM</SUP> model and their efforts to
increase the level of parent involvement are informed by ISA best
practices. ISA also helps schools to develop extended day programming
that reinforces school day learning and offers young people
opportunities to prepare for college and career.
the conceptual age
Our mission today is even more important than it was when ISA was
founded because of the dramatic transformation of our economy and the
nature of work. The fact is, we are charged with preparing our children
to succeed in a world that in many ways bears little relation to the
world we entered when we left school--or even the world we woke up in
yesterday. In a microscopic measure of human time, we have moved
through the Agricultural Age, to the Industrial Age, to the Information
Age, and now to another era altogether. Author Daniel Pink calls this
new era the Conceptual Age. It requires us to be not only knowledgeable
and competent, but creative and inquisitive as well.
Studies have shown that many of our high schools, even those that
boast of high graduation and college-attendance rates, rarely demand
that students use information, skills, and technologies to construct
new knowledge and to solve complex problems, integrate concepts and
ideas across disciplines, communicate effectively orally and in
writing, and work in diverse groups. Yet this is precisely the kind of
learning students need for a Conceptual Age. Students themselves tell
us that they want to be held to high standards but that they find their
high schools boring, unchallenging, and disconnected from their lives.
the global challenge
Microsoft Chairman Bill Gates recently told the Nation's governors
that American high school education is ``obsolete.'' He said, ``When I
compare our high schools to what I see when I'm traveling abroad, I am
terrified for our workforce of tomorrow. . . . In 2001, India graduated
almost a million more students from college than the United States did.
China graduates twice as many students with bachelor's degrees as the
United States and [has] six times as many graduates majoring in
engineering. . . . America is falling behind.''
Gates was describing a global economy in which the chance to move
up into a better economic life is slipping overseas, along with jobs
that can be performed anywhere--manufacturing in China, technology
support in India, online order fulfillment across borders. The Internet
brings Bhutan and Bangalore just as close to our offices and living
rooms as Boise. Our children's competitors are not the other schools in
the district or the State or even the Nation. They are the
technologically literate young people in Taiwan, India, Korea, and
other developing nations. For today's American students, learning and
retraining will be a lifelong experience.
To be ``competitive'' now, U.S. students must develop sophisticated
critical thinking and analytical skills to manage the conceptual nature
of the work they will do. They will need to be able to recognize
patterns, create narrative, and imagine solutions to problems we have
yet to discover. They will have to see the big picture and ask the big
questions. How many high schools do you know that are nurturing minds
like that?
The 12th-grade data from the Third International Mathematics and
Science Study showed that of the 20 countries participating, only two--
Cyprus and South Africa--scored lower than the United States. American
students enrolled in the most advanced courses in math and science
performed at low levels compared to students in other countries.
leaving some students behind
Two serious gaps hold back most of our students and risk the
prosperous future of the entire country. The gap we hear least about is
the one between a rigorous, intellectually challenging curriculum and
the rote instructional program that is commonplace in far too many
classrooms. The gap we hear much more about is the one in student
achievement that is exposed when data is disaggregated by race,
ethnicity, and family income. Our challenge is to ensure that both gaps
are closed and that all children--not just some of them--receive a
high-quality education that will prepare them well for the world in
which they will live and work.
There are tremendous gaps in achievement among racial and ethnic
groups within our own country. We are systematically leaving behind
large numbers of our poor and minority students. On the 2005 National
Assessment of Educational Progress, 39 percent of white eighth-graders
scored at or above proficient on the math exam, while only 9 percent of
African-American and 13 percent of Hispanics achieved at that level.
A U.S. Department of Education study shows that the average 12th-
grade African-American student is reading and doing math at around the
level of the average eighth-grade white or Asian student. Hispanic
students are about as far behind. On the 2004 SAT, black students, on
the average, scored 104 points lower on the math test and 98 points
lower on the verbal test than white students. Between 25 to 30 percent
of America's teenagers fail to graduate from high school with a regular
diploma. That figure climbs to more than 50 percent for black male and
Hispanic students.
Clearly, this is not the path to global competitiveness. The
quality and the inequality of education in this country should be at
the top of the agenda for every meeting of the school board and
superintendent. An uneven playing field is everybody's turf--and it
needs tending.
the institute for student achievement is succeeding
At a time when the vast majority of jobs require a college degree
or some type of postsecondary degree, most low-achieving students are
relegated to classrooms where remediation and instruction in low-level
skills are the norm. But poor performance and a shortage of vision are
not inevitable characteristics of our educational system. ISA is
addressing this challenge.
Typically ISA schools have attendance rates of over 90 percent
average daily attendance. Over 95 percent of graduates from ISA schools
and learning communities have gone on to college. The small size, 400
students grades 9-12, results in a high level of personalization,
individual student attention, extensive, professional development, a
challenging curriculum, and family and community involvement. Our
research has shown that ISA small schools and learning communities have
higher graduation rates, very low dropout rates, outstanding student
attendance, increased teacher satisfaction and are more cost effective
than large high schools.
In fiscal year 2007, ISA has requested Federal funding to help us
continue our work in developing rigorous college preparatory high
schools in the States of Georgia, Virginia, New Jersey and New York.
Beyond that, our goal, with your help, is to expand the number of ISA
schools to over 100 throughout the Nation, over the next three years.
When we have met that challenge we will have demonstrated that there
are model public high schools that are successfully educating all
students in high need communities to be conceptual thinkers and ready
for the challenges we are confronting in today's global economy. We
hope that the subcommittee can be supportive of our efforts and our
request for funding.
______
Prepared Statement of the National Writing Project
I am Richard Sterling, Executive Director of the National Writing
Project (NWP). NWP is authorized under Title II, Subchapter C, Subpart
2 of the Elementary and Secondary Education Act of 1965. It has been
authorized as part of ESEA since 1991.
I appreciate the opportunity to present this testimony requesting
continued support for the National Writing Project. As you know, the
Department of Education's (ED) fiscal year 2007 budget request to
Congress did not include funding for this program.
NWP is a national organization, a network of local writing project
sites, working with teachers of all subject areas and at all grade
levels to improve the teaching of writing in the Nation's schools.
Today there are 195 university-based writing project sites in all 50
States, the District of Columbia, Puerto Rico, and the U.S. Virgin
Islands. NWP sites promote core principles of effective instruction
while they respond to the needs of local schools and communities. The
fiscal year 2006 appropriation for the NWP is $21.5 million. Another
$22 million in local support is leveraged by writing project sites
across the country.
By statute, the purposes of the NWP are to (1) ``support and
promote the expansion of the NWP network so that teachers in every
region of the United States have access to an NWP program,'' (2)
``ensure the consistent high quality of sites through ongoing review,
evaluation, and technical assistance,'' and (3) ``support and promote
the establishment of programs to disseminate effective practices and
research findings about the teaching of writing.''
The Department of Education's justification for elimination of the
NWP states that the ED is ``eliminating small categorical programs that
have limited impact and for which there is little or no evidence of
effectiveness.'' In addition, the ED States that, ``These small
categorical programs siphon off Federal resources that could be used by
State and local agencies to improve the performance of all students.''
In relation to the NWP network these findings are not adequately
supported by the facts. The NWP's response follows:
response to the statement: the nwp has ``limited impact''
It is difficult to understand the basis for the finding that the
NWP has ``limited impact.'' The impact of a funded project is
determined by the scale of services provided and the value of those
services to districts, schools, teachers, and students. In terms of the
scale of its services, the NWP is by far the largest provider of
professional development in writing in the country.
Data gathered by an independent evaluator, Inverness Research
Associates (IRA), show the scale of NWP as it affects students.
Approximately 1.95 million students are taught every year by teachers
who received professional development services from writing project
sites. In addition, NWP programs also directly serve 45,000 students
through school-year and summer youth writing programs each year. (Data
available from IRA, www.inverness-research.org.)
Data also demonstrate the scale of NWP's reach to teachers across
the country. The NWP network provides 19 hours of professional
development to 1 out of every 8 secondary language arts teachers and 1
out of every 35 elementary school teachers every year.
In 2004-2005 alone, more than 3,000 teachers attended intensive NWP
summer institutes. These summer institute participants directly teach
more than 60,000 students during the school year. (Their students are
representative of the student population: 42 percent students of color,
13 percent English language learners, 46 percent in Title I programs.)
These 2004-2005 teacher-participants join the more than 12,000 writing
project teacher-leaders from past summer institutes who are serving
their home communities. Together, these teachers conducted 7,288
professional development programs for more than 141,000 educators in
2004-2005.
The network of 195 local sites is a unique national asset now
providing geographical access to teachers in two-thirds of the counties
in the Nation. In 2004-2005, 1,657 districts (1 out of ten in the
Nation) and 2,907 schools (1 out of every 30 schools) chose to invest
their professional development dollars with NWP local sites. Local
writing project sites have formed ongoing partnerships with 371
districts and schools.
Thus, not only is the scale of work of the NWP network of national
significance, there is strong evidence that the services offered are
highly valued by States, local districts, schools, and teachers.
Expanding the NWP
Since 2000, the NWP network has added 60 new writing project sites
in 30 states. Each year between 6 and 10 new sites are established in
areas of the country that previously had not been served. This
addresses the statutory requirement to expand the NWP network ``so that
teachers in every region of the United States have access to an NWP
program.'' In addition to adding new sites, NWP has developed local
satellite programs so that existing sites can provide services to
teachers and schools at a distance from the host university. NWP
receives an average of 12 requests for new sites and satellites each
year from universities eager to bring the writing project to their
local communities.
Assuring program quality
In order to ensure the quality of local sites, NWP has conducted an
annual site performance review since 1994. As part of the process, each
local writing project site completes an extensive performance survey of
its programs as well as of its teacher and administrator participants.
The statistical data from these surveys are independently analyzed and
reported by IRA on an annual basis. Every site must reapply for funding
each year, and the analysis of these data, along with the site
application, are used in the site performance review. During this
annual review process, some sites are identified as in need of
technical assistance from the NWP. If the sites are unable to resolve
their issues after this technical support, they are no longer eligible
for Federal funding. Over the last 10 years, 51 site grants were not
renewed; however, 8 of these sites were re-funded after a transition
period that resolved their issues.
While each local NWP site receives a small amount of core funding
from the Federal grant, the vast majority of the work done by each
local NWP site is supported by States, counties, local school
districts, and individual teachers. States, districts, and schools must
make careful decisions about how they spend their resources for
professional development--the fact that they continue to invest in the
work of the NWP over many years is strong evidence of both the value
and the effectiveness of NWP services.
response to the statement: there is ``little or no evidence of
effectiveness'' of the nwp
The Program Assessment Rating Tool (PART) review concluded that
``there is insufficient evidence on the overall effectiveness of NWP
interventions.'' This assertion is based on incomplete information
about a range of studies conducted on the effectiveness of NWP
programs. In particular, the NWP PART section 2.1 provides incomplete
information concerning long-term performance measures that NWP has
employed to ``focus on outcomes and meaningfully reflect the purpose of
the program.''
In fact, since its inception in 1974 as a single writing project
site located at the University of California, Berkeley, NWP has
supported its sites in conducting numerous studies on the effectiveness
of their professional development programs and contracted with third
parties that have also conducted such studies. (Only two of these
studies are referred to in the ED report.) Multiple research studies
have shown that NWP programs significantly increase the instructional
knowledge of teachers to teach writing. High quality quasi-experimental
studies confirm significant gains for students of teachers who have
participated in writing project programs. The NWP's website
(www.writingproject.org) contains information on these and other recent
studies.
The PART assessment is based on incomplete information about the
establishment of long-term measures to ensure that NWP sites
disseminate effective practices in NWP teacher training programs.
Beginning in 1999, following the establishment of GPRA performance
indicators by ED, NWP contracted with IRA to collect and analyze
additional data on teacher satisfaction with the summer training they
received and to assess their implementation of effective instructional
strategies in the teaching of writing in the year following the
training. Targets were established by ED for this indicator in 1999.
NWP has exceeded the target established for every year of the
evaluation to date, with an average of 96 percent of elementary and
secondary teachers reporting that they gained effective teaching
strategies and up-to-date research that they can apply to their
teaching. The independent evaluation also showed that instructional
strategies that NWP participants learn in the institutes and use in
their classrooms correlate positively with greater student achievement
in writing on the NAEP Writing Assessment. This study is performed
annually in partial fulfillment of requirements placed on the NWP by
ED. To date, more than 15,000 teachers have been surveyed, with
consistent results across all six years of the evaluation. (These
annual reports are available at www.inverness-research.org, including
The National Writing Project Client Satisfaction and Program Impact:
Results from a Satisfaction Survey and Follow-up Survey of Participants
at 2004 Invitational Institutes, December 2005.)
The NWP PART assessment was also conducted before the conclusion of
five rigorous quasi-experimental design studies that measured the
extent to which students of teachers who received training by an NWP
site improved their writing skills. Student learning in writing project
teachers' classrooms was studied relative to student learning in
comparable non-writing project teachers' classrooms. A team of external
evaluators reviewed all of the research proposals and also designed and
oversaw the independent national scoring of student writing. These five
quasi-experimental studies have been completed and the results have
been submitted to ED as well as posted on the NWP website.
Central to each of the five studies conducted in 2004-2005 was the
writing project site's commitment to understand what difference writing
project professional development makes for participating teachers'
practices and, in turn, what difference those changes in instructional
practices make for student learning. Each study employed direct
assessments of student writing, and each included carefully matched
comparison classes and/or students. In an independent national scoring
of student writing, NWP students' improvement outpaced that of students
in carefully constructed comparison groups.
Every comparison across all five studies shows positive effects of
NWP programming. Student results were strong and favorable in those
aspects of writing that the NWP is best known for, such as organization
and the development of ideas. Students in writing project classrooms
made greater gains than their peers in the area of conventions as well,
suggesting that even these basic skills benefit from the NWP approach
to teaching writing. These quasi-experimental studies uniformly
indicate positive effects for the students of teachers who participated
in writing project programs.
These studies conform to the advice regarding rigor in quasi-
experimental designs as offered by the Institute of Educational
Sciences (IES) of ED.
response to the statement: ``small categorical programs siphon off
federal resources that could be used by state and local agencies to
improve the performance of all students''
Rather than ``siphon off'' resources, the Federal investment in the
NWP helps to augment and amplify local expenditures in the improvement
of writing. All NWP sites match their Federal base grant with State,
local, and private funding at a ratio of at least 1:1. The Federal
investment provides core funding for the NWP and enables local sites to
leverage additional funds from a variety of sources, including host
universities, surrounding school districts, private corporations, and
other entities. The quantity and quality of local professional
development depends on the modest Federal investment that has so
clearly demonstrated its power to attract and focus local resources.
Without these crucial Federal funds, the core writing project work that
develops teacher expertise and leadership and supports the
dissemination of research and effective practices will simply cease to
exist.
An independent analysis by IRA of cost-efficiency over the past
five years highlights the cost effectiveness of the Federal investment
in the NWP. Local sites have leveraged an average of $3.65 for every
Federal dollar they received from the NWP.
The need for strong literacy skills for our Nation's students is a
central tenet of all current school reform efforts. The NWP is a very
good example of a Federal-local partnership that addresses this core
need. The Federal funds: (1) enable local sites to maintain a minimal
but critically important effective group of teacher-leaders, (2)
develop ongoing working relationships between universities and school
districts, (3) respond to local needs, and (4) provide support to all
local sites so that they can continue to improve and expand their
programs. In summary, the NWP provides high quality, large scale, and
cost-effective support to teachers and students to improve writing and
learning in the Nation's schools.
______
Prepared Statement of the State Educational Technology Directors
Association
nclb title ii, part d--enhancing education through technology (eett)
Members of the State Educational Technology Directors Association
(SETDA) include the State directors of technology from the SEAs in all
50 States, D.C., and American Samoa. I am pleased to submit this
information and data which demonstrates how EETT is being utilized in
over 80 percent of school districts across this country. EETT supports
all areas of NCLB, including:
--Closing the Achievement Gap
--Recruiting and Retaining Highly Qualified Teachers
--Improving Data Systems to Meet AYP
EETT is also a key foundation to address the critical STEM and
Competitiveness issues and initiatives. EETT has already begun to
address these needs and will continue to do so through programs with
data to support their effectiveness, including:
--Improving math and science achievement
--Ensuring highly qualified teachers in math and science
--Ensuring students and teachers have skills to ensure that they are
prepared for the global workforce
This testimony includes the following:
1. Key Examples that illustrate the key role EETT plays in helping
schools, districts, and States to meet NCLB goals, but also demonstrate
the focus on math, science, and improving students' abilities to
compete in a global workforce.
2. Overview of National Trends Report on Round 3 of EETT Funding
data and results; the entire report on how EETT funds were used in all
50 States and D.C. can be accessed at http://www.setda.org/
content.cfm?sectionID=185.
1. key examples
Improvements in Math and Science Achievement
Iowa's Success With Algebra.--In Columbus Community School
District, with 70 percent high poverty and 65 percent Hispanic
populations, the 8th grade in the 2001-02 school year scored only 51
percent of the students as proficient on the ITBS Math Assessment.
Cognitive Tutor Algebra I implementation began in 2002 with the
instructor rating a very high level of implementation by the CEO of the
program. Columbus Students improved proficiency by 11 percent from
Grade 8 to Grade 9. They continued to improve and were 74 percent
proficient as 11th graders.
Louisiana's Online Algebra I Course.--Algebra I is often a
predictor for success in high school and beyond. Louisiana implemented
an online Algebra I course to provide additional opportunities for
student achievement. Preliminary evaluations indicate that students in
the online course, with similar pre-test scores are showing more
significant achievement gains compared to the control group as
indicated below:
------------------------------------------------------------------------
Pre-test Post-test
Group (fall) (spring)
mean mean
------------------------------------------------------------------------
Algebra I Online Students..................... 13.3 17.2
Control Students.............................. 13.4 15.6
------------------------------------------------------------------------
Michigan's Freedom to Learn Project.--This one-to-one initiative,
which includes each student having a computer and professional
development for teachers, showed significant impact with 7th-grade
reading scores jumping from 29 percent to 41 percent and 8th-grade math
scores increasing from 31 percent to 63 percent.
Closing the Achievement Gap
Missouri's eMINTS,--The eMINTS National Center provides tools to
teachers in grades 3-5 to integrate multimedia into lessons. Three
years of data analysis have demonstrated the highly positive effect of
the program on student achievement. Performance in the fourth grade in
the fiscal year 2002 cohort was essentially equalized between African-
American and white students. Indeed, African-American students in
eMINTS classrooms had a slightly higher average score in social studies
for fiscal year 2002 than white students not enrolled in those
classrooms; and in mathematics, the average performance between these
two groups was almost identical.
West Virginia's Basic Skills Computer Education Program.--
Researcher Dale Mann (ASBO, 2003) cited a direct correlation between
pupil performance and technology in instruction through West Virginia's
Basic Skills/Computer Education program. The study found that while per
capita income had not changed between 1991 and 1998, the infusion of
technology was the single factor that accounted for the State moving
from 33rd among the States for student achievement to 11th. In a
similar study, Mann found that the cost of advancing students one unit
in reading by decreasing the class size cost $636 and using technology
to achieve the same result cost $86 (Mann, 2003). Technology provides a
key opportunity to increase student achievement.
Providing Opportunities to Rural and Small School Districts Through
Distance Education.--The U.S. Department of Education and NCES' recent
Distance Education Courses for Public Elementary and Secondary School
Students: 2002-2003 (2005) documents the fact that smaller and rural
schools use distance education opportunities more often, with a strong
emphasis on foreign language courses. Additionally, 50 percent of
districts that provide distance learning opportunities had students
enrolled in Advanced Placement (AP) Courses. The recent NGA Summit on
High School reform indicated the importance of students' access and
participation in AP Courses. At least 80 percent of districts noted
that distance education allowed them to increase the course offerings
for their students. EETT provides a significant funding for these
opportunities.
Recruiting and Retaining Highly Qualified Teachers
North Carolina's IMPACT Model Schools Grant.--This EETT grant
program provides personnel, connectivity, hardware, software, and
professional development to improve student achievement. A
collaborative model, it focuses on using technology as a tool to
encourage authentic, project-based learning incorporating 21st Century
Learning Skills into all curriculum areas. In a time where more than
one-half of all teachers leave the teaching field within the first
three years, teachers who are scheduled to retire often choose to stay
in these IMPACT schools, others request transfers into them, and new
teachers clamor to be hired. ``These teachers like the way technology
is changing the way they teach, and the enthusiasm with which their
students approach learning,'' says Frances Bryant Bradburn, Director of
Instructional Technology for the North Carolina Department of Public
Instruction. Additionally, the initial results from this quasi-
experimental design evaluation demonstrate that:
--In first year, students in IMPACT schools had stronger growth than
comparison school students, and for particular subgroups there
was substantially stronger growth varying from small
differences to about half a grade level of extra growth,
depending on the outcome and grade level.
--IMPACT students often started lower than their comparison school
counterparts, but caught up within one school year.
--In general, the most challenged IMPACT students showed the most
growth in achievement.
Maryland Increasing Teacher Retention.--Nationally, 50 percent of
teachers leave the field within the first three years of their careers.
To provide additional support for new teachers, Prince George's County
has utilized Intel's Teach to the Future to provide extensive
technology integration training for teachers and opportunity for
graduate credit. Associated with Towson University, the first cohort of
125 beginning teachers are demonstrating a very high rate of retention:
94 percent.
Improving Data Systems to Meet AYP
Vermont Education Data Warehouse.--EETT funds in Vermont are being
utilized directly for the implementation of data systems to support
NCLB Accountability requirements through the Vermont Data Consortium
that is creating a statewide ``Education Data Warehouse.'' The State
grants provided through EETT funds support LEAs or schools in the
development of local data systems to improve student achievement,
support for teachers in analyzing data, improvement in evidence-based
policy, and data standards to address local interoperability.
Philadelphia's Instructional Management System (IMS).--A
comprehensive reform effort that includes new resources, a standardized
curriculum, after school programs, and professional development, IMS
provides teachers and administrators with immediate data on student
learning aligned to State and District standards. A benchmark
assessment, given every five weeks, allows teachers to differentiate
instruction, provide immediate remediation, and identify those students
who need additional assistance. In 2003, before these technology tools
were provided to teachers, only 9 of the 40 initial participating
schools had met AYP; and 15 were identified for Corrective Action. At
the end of the 2004 school year, 25 schools met their AYP targets, and
only 10 remained in Corrective Action II.
2. overview of national trends report on eett
Key Findings
1. Promising Interim Results at 3-Year Mark Warrant Continued
Investment
2. States Have Set the Bar High for Professional Development
3. States Are Making Progress with Evaluation and Impact Research
4. States Are Leveraging Resources through Collaborations and
Partnerships
Over 40 percent of States required LEAs that received NCLB II D
competitive grant funds to focus on reading or mathematics. States are
not only building the conditions essential to effective technology use,
but they are also seeing results as measured in increased student
learning.
Nearly 25 percent of States are funding or commissioning research
studies on the impact of educational technology on learning in schools.
Over 88 percent of States are collecting data annually from either
districts, schools, or both. States are increasingly triangulating data
sources (e.g., district surveys, school surveys, teacher surveys,
student surveys, and site visitations).
43 percent of the States went beyond the Title II D's 25 percent
minimum funding requirement to focus additional resources toward
professional development. Thus, over $159 million of grant funds was
dedicated to professional development during Round 3 of the NCLB II D
program.
Key Facts
1. Within the 50 States and the District of Columbia, 14,291
districts were eligible for Title II D funds, representing 89.3 percent
of LEAs. Collectively, the survey respondents administered $635,027,468
in NCLB Title II D funding for Round 3, fiscal year 2004.
2. Most States are encouraging school districts and schools to
integrate technology systematically and 23.5 percent actually require
that technology planning and school improvement be conducted within the
same process.
3. Funds are administered through both formula grants and
competitive grants. Approximately 48 percent of the formula grants are
under $5,000. That means that less than 4 percent of the funds require
almost 50 percent of the administrative support for formula grants.
4. The following States report that NCLB II D is the only source of
funding in their State for educational technology: Arizona, California,
Delaware, Illinois, Louisiana, Maryland, Michigan, Minnesota, Missouri,
New Hampshire, Oklahoma, Vermont, Washington, and Wisconsin.
5. On the other hand, many States, including Virginia,
Pennsylvania, Florida and Alabama, are leveraging EETT to secure
significant State investments in education technology through on-line
assessment, high school reform, one to one initiatives and on-line
learning initiatives.
Full copies of the National Trends Report are available for
download from the State Educational Technology Directors Association
(SETDA) Website, www.setda.org. SETDA is the principal association
representing the State directors for educational technology. SETDA?s
membership includes all 50 States, the District of Columbia, and
American Samoa.
Thank you for your consideration of this data. Please contact me at
mwolf@setda.org or 410-647-6965 with any questions.
______
RELATED AGENCIES
Prepared Statement of the National Federation of Community Broadcasters
Thank you for the opportunity to submit testimony to this
subcommittee regarding the appropriation for the Corporation for Public
Broadcasting (CPB). As the President and CEO of the National Federation
of Community Broadcasters, I speak on behalf of 250 community radio
stations and related organizations across the country. Nearly half our
members are rural stations and half are minority controlled stations.
In addition, our members include many of the new Low Power FM stations
that are putting new local voices on the airwaves. NFCB is the sole
national organization representing this group of stations which provide
service in the smallest communities of this country as well as the
largest metropolitan areas.
In summary, the points we wish to make to this subcommittee are
that NFCB:
--Requests $430 million in funding for CPB for fiscal year 2009, a
$30 million increase over the fiscal year 2008 advance
appropriation;
--Requests $40 million in fiscal year 2007 for conversion of public
radio and television to digital broadcasting. Also supports
funding for the Public TV interconnection system;
--Requests that advance funding for CPB is maintained to preserve
journalistic integrity and facilitate planning and local
fundraising by public broadcasters;
--Reject the Administration's proposal to rescind $103 million of
already-appropriated fiscal year 2007 and 2008 CPB funds;
--Supports CPB activities in facilitating programming and services to
Native American, African American and Latino radio stations;
--Supports CPB's efforts to help public radio stations utilize new
distribution technologies and requests that the subcommittee
ensure that these technologies are available to all public
radio services and not just the ones with the greatest
resources.
Community Radio fully supports $430 million in Federal funding for
the Corporation for Public Broadcasting in fiscal year 2009. Federal
support distributed through CPB is an essential resource for rural
stations and for those stations serving minority communities. These
stations provide critical, life-saving information to their listeners
and are often in communities with very small populations and limited
economic bases, thus the community is unable to financially support the
station without Federal funds.
In larger towns and cities, sustaining grants from CPB enable
Community Radio stations to provide a reliable source of noncommercial
programming about the communities themselves. Local programming is an
increasingly rare commodity in a Nation that is dominated by national
program services and concentrated ownership of the media.
For the past 30 years, CPB appropriations have been enacted two
years in advance. This insulation has allowed pubic broadcasting to
grow into a respected, independent, national resource that leverages
its Federal support with significant local funds. Knowing what funding
will be available in advance has allowed local stations to plan for
programming and community service and to explore additional non-
governmental support to augment the Federal funds. Most importantly,
the insulation that advance funding provides ``go[es] a long way toward
eliminating both the risk of and the appearance of undue interference
with and control of public broadcasting.'' (House Report 94-245.)
For the last few years, CPB has increased support to rural stations
and committed resources to help public radio take advantage of new
technologies such as the Internet, satellite radio and digital
broadcasting. We commend these activities which we feel provide better
service to the American people but want to be sure that the smaller
stations with more limited resources are not left out of this
technological transition. A step in this direction is the $3 million
Internet Service Grant Fund that will help rural and minority stations
serve their listeners and communities better through a website. We ask
that the subcommittee include language in the appropriation that will
ensure that funds are available to help the entire public radio system
utilize the new technologies, particularly rural and minority stations.
NFCB commends CPB for the leadership it has shown in supporting and
fostering the programming services to Latino stations and to Native
American stations. For example, Satelite Radio Bilingue provides 24
hours of programming to stations across the United States and Puerto
Rico addressing issues in Spanish of particular interest to the Latino
population. At the same time, American Indian Radio on Satellite
(AIROS) is distributing programming for the Native American stations,
arguably the fastest growing group of stations. There are now over 33
stations controlled by and serving Native Americans.
Last year CPB funded the establishment of the Center for Native
American Public Radio (CNAPR). Based on a comprehensive assessment of
the Native American Radio System, CNAPR will develop new funding
sources for Native stations and programming; provide direct services to
the Native Radio System; encourage collaborations; and represent the
Native Radio System. These stations are critical in serving local
isolated communities (all but one are on Indian Reservations) and in
preserving cultures that are in danger of being lost. CPB's assessment
recognized that ``. . . Native Radio faces enormous challenges and
operates in very difficult environments.'' CPB funding is critical to
these rural, minority stations. CPB's funding of the Intertribal Native
Radio Summit in 2001 helped to pull these isolated stations together
into a system of stations that can support each other. The CPB
assessment goes on to say: ``Nevertheless, the Native Radio system is
relatively new, fragile and still needs help building its capacity at
this time in its development.'' The Center for Native American Public
Radio promises to leverage additional, new funding to ensure that these
stations can continue to provide essential services to their
communities.
CPB also funded a Summit for Latino Public Radio which took place
in September 2002 in Rohnert Park, California, home of the first Latino
Public Radio station. These Summits have expanded the circle of support
for Native and Latino Public Radio and identified projects that will
improve efficiency among the stations through collaborations and
explore new ways of reaching the target audiences.
CPB plays a very important role for the public and Community Radio
system. They are the convener of discussions on critical issues facing
us as a system. They support research so that we have a better
understanding of how we are serving listeners. And they provide funding
to programming, new ventures, expansion to new listeners, and projects
that improve the efficiency of the system. This is particularly
important at a time when there are so many changes in the radio and
media environment with new distribution technologies and media
consolidation. An example of this support is the grant that NFCB
received to update and publish our Public Radio Legal Handbook online.
This provides easy-to-read information to stations about complying with
governmental regulations so that stations can function legally and use
their precious resources for programming instead of legal fees.
Finally, Community Radio supports $40 million in fiscal year 2007
for conversion to digital broadcasting by public radio and television.
It is critical that this digital funding be in addition to the on-going
operational support that CPB provides. The President's proposal that
digital money should be taken from the fiscal year 2007 CPB
appropriation would effectively cut stations' grants by over 20
percent. This would have a devastating impact as stations trying to
recover from hard economic times. And it would come at a time when the
local voices of community and public radio are especially important to
notify and support people during emergency situations and to help
communities deal with the loss of loved ones--things that commercial
radio is no longer able to do because of media consolidation.
While public television's digital conversion needs are mandated by
the FCC, public radio is converting to digital to provide more public
service and to keep up with what commercial radio is doing. The Federal
Communications Commission has approved a standard for digital radio
transmission. CPB has provided funding for 461 transmitters to convert
to digital, is supporting additional research on AM radio conversion,
and is working with radio transmitter and receiver manufacturers to
build in the capacity to provide a second channel of programming. Most
exciting to public and community radio is the encouraging results of
tests that National Public Radio has conducted, with funding from CPB,
that indicate that stations can broadcast at least two high-quality
signals, even while they continue to provide the analog signal. The
development of second audio channels will potentially double the public
service that public radio can provide, particularly in service to
unserved and underserved communities. This initial funding still leaves
nearly 400 radio transmitters that will ultimately need to convert to
digital or be left behind.
Federal funds distributed by the CPB should be available to all
public radio stations eligible for Federal equipment support through
the Public Telecommunications Facilities Program (PTFP) of the National
Telecommunications and Information Agency of the Department of
Commerce. In previous years, Federal support for public radio has been
distributed through the PTFP grant program. The PTFP criteria for
funding are exacting, but allow for wider participation among public
stations. Stations eligible for PTFP funding and not for CPB funding
include small-budget, rural and minority controlled stations and the
new Low Power FM service.
We appreciate Congress' direction to CPB that it utilize its
digital conversion fund for both radio and television and ask that you
ensure that the funds are used for both media. Congress stated, with
regard to fiscal year 2000 digital conversion funds:
``The required (digital) conversion will impose enormous costs on
both individual stations and the public broadcasting system as a whole.
Because television and radio infrastructures are closely linked, the
conversion of television to digital will create immediate costs not
only for television, but also for public radio stations (emphasis
added). Therefore, the Committee has included $15,000,000 to assist
radio stations and television stations in the conversion to
digitalization . . .'' (S. Rpt. 105-300)''
Community Radio also supports funding for the public television
interconnection system. Interconnection is vital to the delivery of the
high quality programming that public broadcasting provides to the
American people.
This is a period of tremendous change. Digital is transforming the
way we do things; new distribution avenues like digital satellite
broadcasting and the Internet are changing how we define the business
we are in; the concentration of ownership in commercial radio makes
public radio in general, and Community Radio in particular, more
important as a local voice than we have ever been. New Low Power FM
stations are providing new local voices in their communities. Community
radio is providing essential local emergency information, programming
about the local impact of the major global events taking place,
culturally appropriate information and entertainment in the language of
the native culture, as well as helping to preserve cultures that are
dying out. During the natural disasters of this last year, radio proved
once again to be the most dependable, available medium to get emergency
information to the public.
During these challenging times, the role of CPB as a convener of
the system becomes even more important. The funding that it provides
will allow the smaller stations to participate along with the larger
stations which have more resources, as we move into a new era of
communications.
Thank you for your consideration of our testimony.
______
Prepared Statement of the National Minority Consortia
The National Minority Consortia (NMC) submits this statement on the
fiscal year 2009 appropriation for the Corporation for Public
Broadcasting (CPB). The NMC is a coalition of five national
organizations dedicated to bringing a significant amount of programming
from our communities into the mainstream of public broadcasting and to
other media. The role we fulfill in this regard is crucial to public
broadcasting's mission. We are unique as organizations and as a
coalition of organizations in the services we provide to our
communities and to public broadcasting. In summary, we ask the
Committee to:
--Direct CPB to increase its efforts for diverse programming with
commensurate increases for minority programming and the
National Minority Consortia
--Direct CPB to continue its support for the Native radio system
--Recommend at least $430 million for CPB core funding for fiscal
year 2009, a $30 million increase over fiscal year 2008 and the
amount being requested by CPB
--Reject the Administration's proposal to end advance funding for CPB
--Reject the Administration's proposal to rescind $103 million of
already-appropriated fiscal years 2007 and 2008 CPB funds
report language
We ask for Committee report language, as a follow-up to report
language from last year, which recognizes the contribution of the NMC
and directs that the CPB partnership with us be expanded. The report
from last year stated:
``The Committee recognizes the importance of the partnership CPB
has with the National Minority Public Broadcasting Consortia, which
helps develop, acquire, and distribute public television programming to
serve the needs of African American, Asian American, Latino, Native
American, Pacific Islander, and many other viewers. As many communities
in the Nation welcome increased numbers of citizens of diverse ethnic
backgrounds, the local public television stations should strive to meet
these viewers' needs. With an increased focus on programming to meet
local community needs, the Committee encourages CPB to support and
expand this critical partnership.'' (S. Rpt. 109-103, p. 298)
We request that the above language be modified to direct CPB to
increase its support of the NMC and that it also include a reference to
radio.
fiscal year 2009 appropriation
We support a fiscal year 2009 Federal appropriation for CPB of at
least $430 million. This would be a reasonable, albeit modest,
contribution toward our national treasure of public broadcasting. The
quality gap between network television and public television has never
been wider, and it continues to grow with each new ``reality'' show.
Public broadcasting, including PBS, NPR, and Native Radio is
particularly important for our Nation's growing minority and ethnic
communities. While there is a niche in the commercial broadcast and
cable world for quality programming about our communities and our
concerns, it is in the public broadcasting industry where minority
communities and producers are more able to bring quality programming
for national audiences. Additionally, public television and radio is
universally available.
advance funding
We strongly oppose the Administration's proposal that the advance
funding for CPB be eliminated, a proposal that would stop CPB funding
for two years. We appreciate that Congress has rejected this proposal
each of the last five years. Reasons to continue advance funding for
CPB include:
--The development of production of programming for public
broadcasting usually takes several years and substantial lead
time is necessary for planning productions.
--Public broadcasting programs are supported by multiple funding
sources, and two years advance knowledge of the amount of
Federal funding allows CPB to more effectively leverage its
Federal funds to bring in other sources of revenue.
--The NMC administers a significant amount of CPB programming monies,
and elimination of advance funding would negatively affect our
organizations' planning, fundraising and producing work for
public television and radio.
rescission of fiscal year 2007 and 2008 funds
We are extremely concerned about the Administration's proposal to
rescind $103 million of already appropriated fiscal year 2007 and 2008
CPB funds ($53.5 million of fiscal year 2007 and $50 million of fiscal
year 2008 funds). Such a rescission/diversion of funds would wreck
havoc on our organizations and the independent producers that we help
support as well as many radio and television stations.
native radio
Native American Public Telecommunications--one of the five National
Minority Consortia organizations--works with both the radio and
television sides of public broadcasting. NAPT operates American Indian
Radio on Satellite (AIROS) which distributes programming to Native-
owned and other radio stations. Koahnic Broadcasting Corporation,
headquartered in Alaska, also produces and distributes Native American
programming.
Native-owned radio is the fastest growing area of community radio.
There are currently 33 Native-owned stations, all but one of which is
located in Indian country. We greatly appreciate CPB's central role in
the establishment late last year of the Center for Native American
Public Radio (CNAPR), an organization that will provide technical and
other services to Native radio stations. CNAPR's mission also includes
developing new sources of revenue for the Indian radio system and being
an advocate for Native radio. CPB is providing $1.5 million over a
three-year period for CNAPR.
We ask that this Committee urge CPB to continue its support for
Native radio.
about the national minority consortia
With primary funding from the Corporation for Public Broadcasting,
the NMC serves as an important component of American public television.
By training and mentoring the next generation of minority producers and
program managers we are able to ensure the future strength of public
television and radio television programming from our communities.
Individually, each Consortia organization is engaged in cultivating
ongoing relationships with the independent producer community by
providing technical assistance, program funding, programming support
and distribution. Often the funding we provide is the initial seed
money for a project, thus allowing it to develop. We also provide
numerous hours of programming to individual public television and radio
stations, programming that is beyond the production reach of most local
stations.
While the Consortia organizations work on projects specific to
their communities, the five organizations also work collaboratively.
One example is our joint effort on the public television four-part
series, Matters of Race that aired in the Fall of 2003. That series
explored the complexity of our rapidly changing multiracial,
multicultural society in America. The project resulted in more than
television programming. The project was designed so that modules could
be pulled out for classroom use. It was also formatted for radio
broadcast and for the internet, and included extended interviews. This
project provided a great opportunity for extensive and diverse
community outreach and collaboration throughout its development,
distribution, and use.
We also worked with American Public Television on 6 one-hour
programs (named Colorvision) featuring the work of Native American,
Asian American, Pacific Islander, Latino and African American
filmmakers and television producers. It is now in national distribution
for all public television stations.
Below is information about our individual organizations.
Center for Asian American Media
The Center's mission is to present stories that convey the richness
and diversity of the Asian American experience to the broadest possible
audience. Over our 25-year history we have provided funding for more
than 200 projects, many of which have gone on to win Academy, Emmy and
Sundance awards, examples of which are Daughter from Danang, Of Civil
Wrongs and Rights; The Fred Korematsu Story; and Maya Lin: A Strong
Clear Vision. The Center reaches large audiences through the annual
International Asian American Film Festival and distributes Asian
Pacific American media to schools, colleges, and universities.
Latino Public Broadcasting
LPB supports the development, production, acquisition and
distribution of non-commercial educational and cultural television,
representative of Latino people. The resulting programs, disseminated
to public television and other public telecommunications entities,
provide a voice to the diverse Latino community throughout the United
States. Productions that have received LPB support include Mirror
Dance; Visiones: Latino Art and Culture; Life and Time of Frida Kahlo;
The Blue Diner; Farmingville; and The New Americans.
National Black Programming Consortium
The mission of NBPC, founded in 1979, is to preserve and promote
complex and dynamic stories of the African Diaspora through program
development, outreach and audience development, and professional
development. NPBC has provided hundreds of hours of programming to the
national PBS schedule; provided seed money to hundreds of projects by
African American and other producers, and served as a window for
emerging producers to break into the national; public broadcasting
system. Currently under production is a film on issues surrounding
Hurricane Katrina. During Black History Month in 2005, over 30 hours of
programming were fed to stations. Examples of NBPC-supported programs
are Two Towns of Jasper; The Murder of Emmett Till; A Doula Story; and
Daughters of the Dust.
Native American Public Telecommunications
NAPT, founded in 1977, utilizes various media--public television,
public radio, and the internet--to bring awareness of Indian and Alaska
Native issues to the Nation. We market and distribute up to 10 hours
per year on public television stations nationwide and fund 5 to 10 new
Native productions annually. NAPT operates American Indian Radio on
Satellite (AIROS) which distributes programming to the 33 Native-owned
radio stations and other radio stations. Among the programming we offer
is a national daily radio talk show, Native America Calling, on Native
subjects, and we also cover live major Indian events. Between 2002 and
2005, NAPT delivered or supported the delivery of 24 hours of
programming to public television. We also funded 30 projects,
represented by 54 producers. NAPT projects garnered 3 national awards
and 15 film festival awards during this time period.
Pacific Islanders in Communications
PIC delivers programs and training that bring new voice and
visibility to Pacific Islands. A recent program which we helped bring
into being is the award-wining Whale Rider, a story about a young Maori
girl who confronts years of tribal tradition to fulfill her destiny as
the leader of her people. When this program was aired on PBS, 107
million households watched the film. In partnership with the Girl
Scouts, we held free screenings of the film and developed a website
about the Maori people. PIC offers a wide range of development
opportunities for Pacific Island producers through travel grants,
seminars and media training.
CPB Funds for the National Minority Consortia
The National Minority Consortia currently receives funds from two
portions of the CPB budget, organization support funds from the Systems
Support and programming funds from the Television Programming sections.
CPB financial support is critical to the work of our organizations. We
believe that we make a major contribution to public broadcasting with a
very modest amount of funding, but there is so much more that should be
done.
The organizational support funds we receive from CPB are used not
only for operations requirements but for also for a broad array of
programming support activities and for outreach to our communities. We
received $1.8 million in fiscal year 2006 CPB funds for organizational
support ($370,000 for each organization). This represents 0.45 percent
of the fiscal year 2006 CPB appropriation. We have received only very
small increases in operations support funds in the past several years.
The programming funds we receive from CPB are re-granted to
producers, used for purchase of broadcast rights and other related
programming activities. Each organization solicits applications from
our communities for these programming funds. We received $3.1 million
in fiscal year 2006 CPB funds for programming ($636,363 for each
organization). This represents 0.78 percent of the fiscal year 2006 CPB
appropriation. Our CPB programming funds have remained virtually flat
over the past nine years, despite increases in CPB appropriations.
Thank you for your consideration of our recommendations. We see new
opportunities to increase diversity in programming, production,
audience, and employment in the new media environment, and we thank
Congress for support of our work on behalf of our communities.
______
Prepared Statement of the Railroad Retirement Board
Mr. Chairman and Members of the Committee: We are pleased to
present the following information to support the Railroad Retirement
Board's (RRB) fiscal year 2007 budget request.
The RRB administers comprehensive retirement/survivor and
unemployment/sickness insurance benefit programs for railroad workers
and their families under the Railroad Retirement and Railroad
Unemployment Insurance Acts. The RRB also has administrative
responsibilities under the Social Security Act for certain benefit
payments and Medicare coverage for railroad workers. During fiscal year
2005, the RRB paid nearly $9.2 billion in retirement/survivor benefits
to about 634,000 beneficiaries, and $72.9 million in unemployment/
sickness insurance benefits to about 29,000 claimants.
We are requesting $103,517,570 for agency operations in fiscal year
2007, which is the same as the amount included in the President's
proposed budget. We are also requesting a legislative change to permit
the RRB to continue using the services of the Department of the
Treasury for disbursement of retirement and survivor benefits. In
addition, we are requesting that the appropriations language for the
Dual Benefits Payments Account be revised to make it clear that a
rescission does not preclude the availability of the 2 percent
supplemental funding in that appropriation.
agency administration
The President's proposed budget would provide $2 million more than
the RRB's appropriation for fiscal year 2006. The increase is intended
to provide for information technology improvements, which are needed to
maintain the agency's service delivery systems. We estimate that under
current legislation, the President's proposed budget would provide
sufficient funding for a staffing level of 895 FTE's, which is 53 FTE's
less than we expect to use in fiscal year 2006. In order to reach this
level, we would need to conduct a reduction-in-force (RIF) of about 31
employees at an estimated cost of $394,000. However, the RIF could be
avoided if the RRB is not required to contract for the services of a
nongovernmental disbursement agent in fiscal year 2007, as discussed in
the following section.
Administrative funding requested for fiscal year 2007 includes a
total of $2.7 million for information technology investments, of which
$1,557,000 would be used for a project begun in fiscal year 2005, to
transition our mainframe non-relational database management system to a
current technology relational database management system, DB2. The
project, which directly correlates with our Enterprise Architecture
Strategic Plan, will reduce the RRB's dependency on declining
technologies, with their attendant risk of failure, and enable the
agency to move ahead with further improvements to the benefit payment
systems. In fiscal year 2007, we plan to use contractual support to
optimize the performance of our databases and further reduce data
redundancy in order to ensure acceptable response times and system
availability.
We are also moving forward to streamline the RRB's field service
operations. In fiscal year 2005, we approved a high-level plan to
restructure the field service into a hub and satellite configuration
that will enhance the agency's ability to distribute work more
efficiently among offices. In fiscal year 2006, we hired a consultant
to assist in developing a 5-year plan that will include consolidation,
co-location, and/or the establishment of virtual offices in the field
service. The plan is to identify out-year savings while maintaining
good customer service.
nongovernmental disbursement agent
Section 107(e) of the Railroad Retirement and Survivors'
Improvement Act of 2001 (Public Law 107-90) provides for contracting
with a nongovernmental agent for the disbursement of railroad
retirement benefits. However, initial market research has indicated
that the cost of doing so would be about three times the cost of having
similar services provided by the Department of the Treasury. In
addition, our Inspector General has questioned whether certain services
provided by the Department of the Treasury, such as reclamations, would
be provided as effectively by a nongovernmental disbursement agent.
We have concluded that outsourcing this function would be
inconsistent with the President's policy of outsourcing only where the
government would reduce costs. For fiscal years 2005 and 2006, the
Congress added language to our appropriations bill prohibiting this
transfer: Section 516 of Public Law 109-149, the Departments of Labor,
Health and Human Services, and Education, and Related Agencies
Appropriations Act, 2006 provides that none of the funds appropriated
under the Act are to be used to contract with a nongovernmental
disbursement agent. The RRB also submitted separate legislation to the
Congress on May 5, 2005, to address this issue.
Our estimates indicate that the cost of contracting with a
nongovernmental disbursement agent would be about $3 million for the
first year and $2.3 million in subsequent years. By comparison, the
annual cost of having these services provided by the Department of the
Treasury is about $800,000. Enactment of legislation to remove this
requirement would provide sufficient savings in fiscal year 2007 to
enable the RRB to cover essential operating costs at the proposed
budget level.
vested dual benefits payments appropriation
The President's proposed budget includes $88 million to fund the
continuing phase-out of vested dual benefits, plus a 2 percent
contingency reserve, $1,760,000, which ``shall be available
proportional to the amount by which the product of recipients and the
average benefit received exceeds $88,000,000.''
The requested funding level of $88 million reflects the RRB Chief
Actuary's current estimate of the amount needed to pay full benefits in
fiscal year 2007. However, the estimate does not provide for the effect
of a possible rescission, which could significantly reduce the total
amount provided in the budget year. Because the Dual Benefits Payments
Account is classified as discretionary rather than mandatory,
appropriations to the account have been reduced in recent years by
across-the-board rescissions enacted as part of the annual
appropriations process. The reductions have created a risk that vested
dual benefits payments would need to be reduced due to insufficient
funding in the account.
The Railroad Retirement Act provides that vested dual benefits
payments in a fiscal year may not exceed the amount appropriated for
that year. If the amount appropriated is not sufficient to fund full
payments, individual vested dual benefits must be reduced on a pro rata
basis. However, the current appropriations language is unclear as to
whether the 2 percent contingency reserve would be available to cover a
shortfall due to a rescission. We request that the appropriations
language be revised to clarify that the contingency reserve may be used
if needed to prevent a reduction of current-year benefits for any
reason.
In addition to the requests noted above, the President's proposed
budget includes $150,000 for interest related to uncashed railroad
retirement checks.
financial status of the trust funds
Railroad Retirement Accounts.--The RRB continues to coordinate its
activities with the National Railroad Retirement Investment Trust
(NRRIT), which was established by the Railroad Retirement and
Survivors' Improvement Act of 2001 to manage and invest railroad
retirement assets. Through fiscal year 2005, the RRB transferred a
total of $21.276 billion to the NRRIT for this purpose. During the same
period, the NRRIT transferred $2.673 billion to the Railroad Retirement
Account for payment of retirement and survivor benefits. As of
September 30, 2005, the market value of NRRIT-managed railroad
retirement assets was approximately $27.7 billion.
In June 2005, we released the annual report on the railroad
retirement system required by Section 22 of the Railroad Retirement Act
of 1974, and Section 502 of the Railroad Retirement Solvency Act of
1983. The report, which reflects changes in benefit and financing
provisions under the Railroad Retirement and Survivors' Improvement Act
of 2001, addresses the 25-year period 2005-2029 and contains generally
favorable information concerning railroad retirement financing. The
report includes projections of the status of the retirement trust funds
under three employment assumptions. These indicate no cash flow
problems throughout the projection period. The findings represent an
improvement over last year's report and reflect continued favorable
employment experience in the railroad industry.
Railroad Unemployment Insurance Account--The equity balance of the
Railroad Unemployment Insurance Account at the end of fiscal year 2005
was $94.2 million, an increase of $14.3 million from the previous year.
The RRB's latest annual report on the financial status of the railroad
unemployment insurance system was issued in June 2005. The report
indicated that even as maximum daily benefit rates rise 39 percent
(from $56 to $78) from 2004 to 2015, experience-based contribution
rates maintain solvency, with the exception of small, short-term cash
flow problems in 2007 and 2008. Projections show quick repayment of the
loans, even under our most pessimistic assumption. The average employer
contribution rate remains well below the maximum throughout the
projection period, but a 1.5 percent surcharge is now in effect and is
expected for calendar year 2007. We did not recommend any financing
changes based on this report.
In conclusion, we want to stress the RRB's continuing commitment to
improving our operations and providing quality service to our
beneficiaries. Thank you for your consideration of our budget request.
We will be happy to provide further information in response to any
questions you may have.
______
Prepared Statement of the Railroad Retirement Board
Mr. Chairman and members of the subcommittee: My name is Martin J.
Dickman, Inspector General of the Railroad Retirement Board (RRB). I
would like to thank you, Mr. Chairman, and the members of the committee
for your continued support for the Office of Inspector General. I wish
to describe our fiscal year 2007 appropriations request and our planned
activities.
The Office of Inspector General requests funding of $7,606,000 to
ensure the continuation of its independent oversight of the RRB. The
agency is responsible for managing benefit programs which paid $9.2
billion in retirement and survivor benefits to approximately 634,000
beneficiaries in fiscal year 2005 and an additional $73 million in net
railroad unemployment and sickness insurance benefits to 29,000
claimants. The RRB also administers Medicare Part B, the physician
services aspect of the Medicare program, for qualified railroad
retirement beneficiaries. Through this program, approximately $870
million in annual Medicare benefits are paid to approximately 535,000
beneficiaries.
In fiscal year 2007, the Office of Inspector General will continue
to concentrate its efforts on the performance of reviews of significant
policy issues and program operational areas. We will coordinate our
efforts with agency management to identify and eliminate operational
weaknesses. We will also continue our investigation of allegations of
fraud, waste and abuse, and refer cases for prosecution and monetary
recovery action.
We also request the removal of the prohibition on the use of
appropriated funds for any audit, investigation or review of the
Railroad Medicare program. The RRB manages a nationwide contract for
processing Medicare Part B claims for railroad beneficiaries. The
agency is responsible for the enrollment of beneficiaries, premium
collection, answering beneficiary inquiries and conducting the annual
Carrier Performance Evaluation for the Medicare carrier.
The prohibition does not permit this office to fulfill its
statutory oversight responsibilities for a major agency program.
Removal of the prohibition would benefit both the Railroad Retirement
Board and its constituents, and would be consistent with the priorities
established by the Administration and the Congress to reduce fraud in
one of the largest Federal programs.
We also request oversight authority to conduct audits and
investigations of the National Railroad Retirement Investment Trust
(NRRIT), the body responsible for the investment of approximately $29
billion in trust funds used to support Railroad Retirement Act benefit
programs. This office would ensure sufficient reporting mechanisms are
in place and that the NRRIT members are fulfilling their fiduciary
responsibilities. We have repeatedly expressed concerns about RRB
management's passive relationship with the NRRIT, and identified the
issue as a serious challenge for the RRB.
We are currently required to reimburse the agency for office space,
equipment, communications, office supplies, maintenance and other
administrative services. We are the only Federal OIG that cannot
negotiate a service level agreement with its parent agency, and,
therefore, request that the current appropriation language be amended
accordingly.
office of audit
Auditors will perform the audit of the RRB's 2006 financial
statements and preliminary work for the 2007 financial statements to
ensure the issuance of reliable financial information. The OIG will
obtain contractor actuarial services to audit the statement of social
insurance.
Audit staff will work with agency management to ensure detailed and
verifiable financial information is available from the National
Railroad Retirement Investment Trust (NRRIT). As discussed above, we
believe RRB management should take a more active interest in NRRIT
activities.
Auditors will conduct the annual evaluation of the RRB's
information systems security to meet the requirements of the Federal
Information Security Management Act of 2002. They will also monitor the
agency's information systems operations to determine if the agency is
meeting the goals established in its Strategic Information Resources
Management Plan and to ensure the agency is in compliance with the
provisions of the Information Technology Management Reform Act.
Auditors will continue to monitor agency actions to address
security deficiencies and complete corrective actions. They will ensure
that network and system security safeguards are in place to protect the
confidentiality of sensitive financial and personal information.
Auditors will also perform assessments of the agency's e-government
initiatives to identify and eliminate system vulnerabilities, and to
ensure compliance with the E-Government Act of 2002. We will continue
our monitoring efforts of the RRB's document imaging activities and the
expansion of paperless processing to ensure the integrity of records.
Auditors will continue to review RRB benefit processes and
procedures to identify ways to reduce administrative and adjudicative
errors. They will offer recommendations to strengthen the agency's debt
collection program to reduce the outstanding receivables.
office of investigations
The Office of Investigations (OI) identifies, investigates and
presents cases for prosecution, throughout the United States,
concerning fraud in RRB benefit programs. In fiscal year 2007, OI will
continue to focus its resources on the investigation of cases with the
highest fraud losses. OI currently has approximately 500 active
investigations involving fraudulent benefit payments and fraudulent
reporting with fraud losses of approximately $11.8 million. These cases
involve all RRB programs that provide sickness and unemployment
insurance benefits to injured or unemployed workers, retirement
benefits, and disability benefits for workers who are disabled.
We will coordinate our efforts with agency program managers to
address weaknesses in agency programs that allow fraudulent activity to
occur, and will recommend changes to ensure program integrity.
We will concentrate resources on cases with the highest fraud
losses, those related to the RRB's retirement and disability programs.
OI will dedicate considerable time to the investigation of nationwide
schemes to defraud the RRB disability program. Disability cases
currently constitute about 44 percent of our investigative caseload.
These cases involve more complicated schemes and result in the recovery
of substantial funds for the agency's trust funds.
In fiscal year 2007, we will continue to use the Department of
Justice Affirmative Civil Enforcement (ACE) program for those cases
which do not meet the criminal guidelines of U.S. Attorneys. Through
this program, we are able to obtain civil judgements and recover trust
fund monies for the RRB.
summary
In fiscal year 2007, the Office of Inspector General will continue
to focus resources on the reviewing RRB program operations and ensuring
the integrity of agency trust funds. We will also continue to
aggressively pursue individuals who engage in activities to
fraudulently obtain RRB funds.
______
Prepared Statement of The Nature Conservancy
Mr. Chairman and members of the subcommittee, I appreciate this
opportunity to present The Nature Conservancy's recommendations for
fiscal year 2007 appropriations. The Nature Conservancy is an
international, nonprofit organization dedicated to the conservation of
biological diversity. Our mission is to preserve the plants, animals
and natural communities that represent the diversity of life on Earth
by protecting the lands and waters they need to survive. Our on-the-
ground conservation work is carried out in all 50 States and in 27
foreign countries and is supported by approximately one million
individual members. We have helped conserve nearly 15 million acres of
land in the United States and Canada and more than 102 million acres
with local partner organizations globally.
The Conservancy owns and manages approximately 1,400 preserves
throughout the United States--the largest private system of nature
sanctuaries in the world. We recognize, however, that our mission
cannot be achieved by core protected areas alone. Therefore, our
projects increasingly seek to accommodate compatible human uses, and
especially in the developing world, to address sustained human well-
being.
The focus of my testimony is on the Americorps National Civilian
Conservation Corps (NCCC) program, which has made a tremendous
contribution, as well as provided cost savings, to conservation and
public recreation in the United States. The President's fiscal year
2007 Budget proposes to cut funding for the program from $26.7 million
to $4.9 million, with the intention of eliminating the program
completely. The Nature Conservancy urges the Committee to retain
funding for the NCCC program at its current levels.
NCCC has been known in recent months for the critical support its
participants provided to disaster relief efforts after Hurricane
Katrina. We applaud those efforts. We also want to highlight the
important conservation work that NCCC participants have engaged in over
the past years. Many Federal, State, and local government agencies, as
well as non-profit conservation organizations, use the NCCC program to
implement Federal programs and to achieve significant public benefits
at low cost. At the Conservancy, we have employed NCCC participants to
do the following:
--Provide outdoor recreational opportunities and health benefits for
Americans across the country;
--Use prescribed fire to reduce hazards to communities and restore
ecosystems;
--Control invasive species; and
--Train the next generation of natural resource managers.
The program has saved our organization millions of dollars in
recent years, and has provided work that would otherwise take years to
accomplish, or simply would not get done at all. Below are some
examples of specific results that NCCC has achieved.
providing americans with recreational opportunities and health benefits
As the country's appetite for outdoor recreation grows--and issues
like childhood obesity demonstrate the importance of increased outdoor
activity--there is a growing need to provide safe, beautiful places for
Americans to use and experience. The Nature Conservancy and our
partners help provide these opportunities through a system of preserves
and parks. Our efforts are significantly augmented by NCCC
participants. The NCCC has built and maintained trails and boardwalks,
restored campsites, repaired interpretive signs, provided wildlife
protection, planted trees and developed archaeological dig sites. These
activities provide the public with greater access to the outdoors, at
low cost, and enhance the outdoors experience.
using prescribed fire to reduce hazards and restore ecosystems
As reflected in recent legislative actions, including passage of
the Healthy Forests Restoration Act of 2004, reduction of hazardous
fuels on the Nation's forested lands is one of the country's greatest
land management challenges. President Bush has emphasized the need to
reduce fire hazards to communities, and restore ecosystems, through
prescribed burning and other management techniques. Each year, the U.S.
Forest Service and the Department of the Interior set acreage goals for
burning and related treatments. The Nature Conservancy provides
training and personnel to assist in meeting these goals.
In recent years, NCCC participants have comprised a new cadre of
fire managers, bringing skills and knowledge to individual projects,
and assisting government agencies and non-profit land managers alike.
The Nature Conservancy has used NCCC participants in at least eleven
States to assist in burning tens of thousands of acres at a cost
savings of several hundred thousand dollars. We also work with NCCC to
burn on military bases, U.S. Forest Service lands, State parks and
natural areas, and other public lands.
On some projects, fire management results in restoration efforts
that ease the burden on private landowners and Federal land managers in
complying with the Endangered Species Act. For example, in Virginia,
NCCC-assisted burns have restored habitat and supported the recovery of
an endangered species, the red-cockaded woodpecker. Finally, NCCC
participants assist land managers and public agencies in measuring
performance and evaluating the success of fuels treatment efforts.
reducing the threat of invasive species
Invasive species--primarily weeds and insects--are one of the
principal threats to our natural resources across the United States;
they have damaged many natural landscapes as well as reduced the value
of working lands. NCCC participants have assisted in abating impacts of
invasive species at many locations. Their activities have included
controlling invasive plants that are destroying valuable salt marshes
and fens in New York; restoring natural tallgrass prairie by removing
invasive trees in Minnesota; and preserving riparian and old growth
forest habitat in Oregon.
Along with actual removal of invasive species, NCCC participants
have worked to educate the public on threats of invasive species and
measures to control them.
building a new generation of natural resource managers
As the country's population grows and threats to the environment
increase, we face constant challenges to the conservation of our
natural heritage. We will not be able to meet those challenges unless
we encourage young people to pursue conservation careers and we provide
them with the necessary training. The NCCC program has succeeded in
doing this. Our experience is that NCCC participants are organized,
well-trained and enthusiastic, and that they care deeply about
conservation--in part because they understand the benefits to
communities and to people that conservation provides.
In particular, because of the job training focus of NCCC, its
participants make up a substantial portion of the country's future fire
managers--a group of professionals we cannot afford to lose, given the
hazards that wildfire poses to our communities. A significant portion
of the Federal fire workforce will retire in the next five years, and
the NCCC program plays a critical role in replenishing that workforce.
NCCC makes an important contribution to Americans' access to and
enjoyment of the outdoors, as well as to conservation of our natural
heritage. We urge the Committee to provide funding at current services
levels for this important program.
Thank you again for the opportunity to testify. If you have
questions, please contact Louise Milkman at 703-247-3675.
______
Prepared Statement of the Voices for National Service
Mr. Chairman and members of the subcommittee: We are writing as
members of Voices for National Service to urge you to reject funding
cuts to AmeriCorps, Learn and Serve America, and the National Civilian
Community Corps (NCCC) included in the Administration's fiscal year
2007 budget.
Voices for National Service is a coalition of more than 160
community-based organizations, faith-based groups, governor-appointed
State commissions, private sector partners, institutions of higher
education, and others dedicated to expanding opportunities for
Americans to serve community and country.
Our message to the Labor-HHS Subcommittee is quite simple:
AmeriCorps, Learn and Serve America, and the NCCC are cost-effective
programs that meet critical community needs, and funding for these
programs should be sustained and increased. While we recognize the
fiscal constraints that lawmakers must operate under, now is not the
time to cut funding for national service. We urge you to fund these
programs at their fiscal year 2004 enacted levels:
--$441 million for AmeriCorps;
--$43 million for Learn and Serve America; and
--$26 million for the NCCC.
We would like to note the following areas of concern and
consideration as they relate to the appropriation for these programs:
--We are concerned that the Administration's budget proposes to cut
funding for the NCCC to $5 million in fiscal year 2007, and to
eliminate the program by 2008. As numerous first-hand accounts
by Gulf Coast residents, newspaper stories and op-eds have
attested in the past weeks, the NCCC responded to the crisis in
the Gulf Coast heroically, deploying 1,600 members to the
region who have provided critically needed services and
support. This is not the time to eliminate a program with a
proven track record in strengthening America's disaster
preparedness and relief capacity.
--While we are eager for NCCC's funding to be reinstated, we hope
that you will not preserve this program at the expense of other
critical programs like AmeriCorps State and National and Learn
and Serve America. Like the NCCC, these programs have had a
profound impact in the Gulf Coast and in the communities they
serve. Americans want to serve. We should be expanding their
opportunities, not eliminating them.
--We are concerned that despite strong bipartisan support, the
proposed budget would result in a 17 percent reduction in
AmeriCorps State and National funding since fiscal year 2004.
AmeriCorps is a critically needed program that provides
opportunities for 70,000 Americans to serve each year, and its
funding should be sustained or increased, not cut.
--We are concerned that the proposed funding cut to Learn and Serve
America would have serious negative consequences for both the
1.5 million students who participate in this program and the
communities they serve. Compared to its fiscal year 2004
funding level of $43 million, the proposed cut to $34.2 million
would mean:
--300,000 fewer students serving their communities through Learn
and Serve America;
--A loss of $34 million in leveraged private and community
resources; and
--A decline of 7.3 million service hours to communities.
We are concerned that the Corporation for National and Community
Service's plan to continue to recruit 75,000 AmeriCorps members in
spite of the program's proposed cuts will be detrimental to programs
running full-time, stipended corps. The proposed cuts include a $300
reduction in the average Federal contribution per full-time corps
member. AmeriCorps programs have been required to absorb an increasing
percentage of their program operating costs. As fixed and mandated
costs grow, annual reductions in operating support are destabilizing
the AmeriCorps field. Efforts to do more with less threaten AmeriCorps'
historic mix of full-time and part-time, stipended and non-stipended
corps.
about americorps, learn and serve america, and the nccc
AmeriCorps State and National is a network of local, State, and
national service programs that connect at least 70,000 Americans each
year in intensive service to meet our country's needs in education,
public safety, health, and the environment.
Learn and Serve America provides State formula and competitive
grants to support service-learning in K-12 schools, colleges and
universities, and non-profit organizations. Service-learning integrates
community service with academic study to enrich learning, teach civic
responsibility, and strengthen communities. At an average cost of only
$28 per participant, Learn and Serve America leverages private and
community resources to yield $4 in services to the community for each
$1 invested by the government. The program also fosters collaboration
between educational institutions and civic, faith-based, and community
groups to engage youth in meaningful service to address local needs,
help young people answer President Bush's Call to Service, and assist
in meeting the Corporation's strategic goal of having quality service-
learning in half of all K-12 schools by 2010.
The AmeriCorps NCCC is a full-time residential program for men and
women ages 18-24 that strengthens communities while developing leaders
through direct, team-based national and community service. The NCCC is
a trained force that can be immediately deployed. Four trained NCCC
teams were pulled from other assignments and sent to support shelters
in Mississippi and Alabama one day after Hurricane Katrina hit.
the role of national service in meeting critical needs in the gulf
coast
The Administration's budget provides the NCCC with a modest $5
million appropriation to graduate its final class of corps members and
permanently close the program's five regional campuses. The budget also
proposes to cut funding for AmeriCorps State and National, reducing
funding levels by 17 percent since fiscal year 2004. And yet as we
write, thousands of AmeriCorps and NCCC members are on the front lines
in the Nation's response to the greatest natural disaster in U.S.
history, serving our Nation in the Gulf Coast.
To date, more than 13,000 national service members have contributed
to hurricane relief efforts in the Gulf and around the country. NCCC
members were among the first on the scene, and to date, 1,600 NCCC
members have served on more than 100 separate disaster service projects
in the Gulf Coast region, providing humanitarian aid and physical
service, as well as managing the thousands of outside volunteers who
want to help. This program embodies the important role that citizens
must play in partnering with government to respond to community crises
and national disasters.
According to Malcolm Jones, City Attorney of Pass Christian,
Mississippi who worked closely with a team of NCCC members to provide
services to town residents, ``Our town, on the Gulf Coast of
Mississippi, 7,000 people, we got the hardest part of [the storm]. When
I came back after evacuating for Katrina. . . . I found out that
AmeriCorps [is] a very powerful, powerful thing. [W]hen we lost hope,
[AmeriCorps] came.''
Because of AmeriCorps, young people from around the country are
putting their talents to work in the Gulf Coast region by doing
everything from clearing debris and repairing roofs in Mississippi, to
preventing further damage to historic buildings in New Orleans, to
managing a supply warehouse in Louisiana, and serving displaced
residents aboard ships in Alabama. We would like to share a few of
their stories with you as examples of the critical services that
AmeriCorps and NCCC members are providing:
Kenye Quiroga was sent to Louisiana one week after joining
AmeriCorps. He writes that, ``While in D'Iberville we stayed on pallets
in an old community center with only half a roof. The living definitely
wasn't easy, but I had the opportunity to get to know some great
people. By the end of our mission in D'Iberville, my team had assessed
every household in the town and brought food, water, and medication to
families who needed emergency supplies.''
According to Kimberly Walker of Jackson, Mississippi, ``In the
aftermath of the Hurricane, Mississippi Primary Health Care Association
served as one of the many distribution points to assist Hurricane
victims with basic supplies. Our team . . . carried supplies to a
larger designated distribution site and was able to meet and talk first
hand to some of the victims. . . . We assisted in directing them to
other services available to them.''
Carrie Ann Smith from the West Seneca, New York AmeriCorps program
was deployed to Slidell, Louisiana. She writes, ``I felt like I was
entering a war zone. I felt the pain and frustration that still loomed
in the air, but most of all I felt the need to help, to serve, and to
make a difference. That's what AmeriCorps does and I am proud to be a
member of such a noble and upstanding organization. But even more so, I
am proud to be an American who was given the opportunity to help my
fellow Americans in a time of tragedy and such utter devastation. I
would not have had that opportunity if not for AmeriCorps.''
These young people, and thousands like them, served and continue to
serve with great distinction, bringing hope and relief to fellow
citizens, and learning the value of civic engagement and giving to
communities in need. The national service response, however, has not
been limited to the on-the-ground effort in the Gulf. In communities
across the country, national service programs are joining with local,
State and Federal agencies and nonprofit organizations to provide long-
term relief to those uprooted and displaced by the storms. For example,
tens of thousands of students supported by Learn and Serve America are
collecting school supplies, raising funds and preparing disaster relief
kits.
national service accomplishments across america
In addition to responding to needs in the Gulf Coast region,
AmeriCorps members are also serving in thousands of communities across
the United States. Every day, 70,000 AmeriCorps members add value to
school curricula by tutoring and mentoring, operating after-school
programs, expanding the reach of community health centers, teaching in
underserved public and parochial schools, and improving our
environment.
Below are just a few examples of the many community needs that
AmeriCorps members met in 2004-2005:
--In Florida, members recruited 2,000 community volunteers to provide
education services, maintained and expanded 200 acres of
habitat for threatened and endangered species, and built 40
homes for low-income families.
--In Kentucky, members educated more than 1,000 at-risk elderly about
home safety and conducted 265 Home Safety Assessments for
seniors.
--In Maryland, members removed 453 tons of trash, improving the
quality of storm water run-off into the Chesapeake Bay and
1,900 homeless families received food, clothing, or furniture.
--In Mississippi, members conducted life skills trainings with 715
people with disabilities, helped train mentally and
developmentally disabled adults for employment, and mentored
1,100 low income and underachieving middle school students.
--In New York, members transported 1,000 children to medical
appointments, delivered meals and snacks to about 58,000
children and seniors, and provided literacy activities to
almost 17,000 children.
--In Ohio, members trained more than 9,000 youth in conflict
resolution, built repaired, or rehabilitated 364 housing units,
and provided educational support services to 1,500 students
during the summer months.
--In Pennsylvania, members tutored almost 14,600 elementary and high
school students and more than 6,800 citizens received either
needs assessment or support in the areas of domestic violence,
foster care, mental health, and housing for homeless veterans.
impact of national service programs
In the last decade, more than 500,000 young Americans dedicated
themselves to either full or part-time service through AmeriCorps to
improve their communities and their country. Through dedicated service
to our Nation, AmeriCorps members have earned Education Awards worth
more than $1.5 billion that have helped them afford higher education or
career training.
Evaluations prove that AmeriCorps works. Recent studies by the
Center for Leadership and Public Service at Harvard University and
Bridgestar indicate that the United States is facing a significant
leadership gap in the next decade. Given the need for an emerging group
of young leaders to fill leadership positions in the social, private,
and public sectors, the results of AmeriCorps programs in terms of
building civic skills and a commitment to public service are striking.
To cite but a few examples of some of the positive results of recent
program evaluations:
--A rigorous multi-site control group evaluation by Abt Associates
and Brandeis University reported significant employment and
earnings gains by young people who join service or conservation
corps.
--A study of Teach for America (TFA) by Mathematica Research Group
found that ``it supplies low-income schools with academically
talented teachers who contribute to the academic achievement of
their students. TFA teachers . . . produce higher student test
scores than the other teachers in their schools.''
--An evaluation of City Year alumni by Policy Studies Associates
showed that more than three-quarters of alumni reported an
increased commitment to public responsibility and greater
knowledge and skills that improved their ability to address and
solve community problems.
Learn and Serve America has tremendous impact and support.
According to a 2004 study by RMC Research, ``Service-learning, when
implemented with high quality, yields statistically significant impacts
on students' academic achievement, civic engagement, acquisition of
leadership skills, and personal/social development.'' Evaluations also
indicate that the program correlates with a reduction in the number of
behavioral problems, and reduced sexual activity and pregnancy among
students.
the fiscal year 2007 request
We understand the funding constraints of the current appropriations
process, and appreciate your leadership in seeking to provide support
to the many programs that are meeting community needs across the Nation
in a challenging fiscal environment.
Given the track record of AmeriCorps, Learn and Serve America, and
the NCCC in serving children, families, and communities and in
responding effectively and efficiently to the recent disasters in the
Gulf Coast region, we urge you to reject the funding cuts to these
programs in the administration's fiscal year 2007 budget request and to
fund these programs at their fiscal year 2004 levels. These programs
have proven to be worthy of your investment.
LIST OF WITNESSES, COMMUNICATIONS, AND PREPARED STATEMENTS
----------
Page
Alexander, Dr. Duane, Director, National Institute of Child
Health and Human Development, National Institutes of Health,
Department of Health and Human Services, prepared statement.... 135
Alving, Dr. Barbara M., Acting Director, National Center for
Research Resources, National Institutes of Health, Department
of Health and Human Services, prepared statement............... 138
American:
Academy of:
Family Physicians, prepared statement.................... 319
Pediatrics, prepared statement........................... 322
Association:
For:
Cancer Research (AACR), prepared statement........... 384
Geriatric Psychiatry, prepared statement............. 387
Of:
Colleges of:
Nursing, prepared statement...................... 327
Osteopathic Medicine, prepared statement......... 331
Immunologists, prepared statement.................... 391
Nurse Anesthetists, prepared statement............... 394
College of Obstetricians and Gynecologists, prepared
statement.................................................. 398
Diabetes Association, prepared statement..................... 401
Foundation for the Blind, prepared statement................. 403
Geological Institute, prepared statement..................... 541
Lung Association, prepared statement......................... 407
Nephrology Nurses' Association, prepared statement........... 410
Nurses Association, prepared statement....................... 332
Physiological Society, prepared statement.................... 404
Public:
Health Association, prepared statement................... 412
Power Association, prepared statement.................... 338
Society:
For:
Clinical Pathology, prepared statement............... 415
Microbiology, prepared statements..................417, 429
Of Nephrology, prepared statement........................ 423
Americans:
For:
Nursing Shortage Relief, prepared statement.............. 336
The Arts, prepared statement............................. 538
Association of:
Academic Health Centers, prepared statement.................. 426
American Cancer Institutes, prepared statement............... 428
Farmworker Opportunity Programs, prepared statement.......... 311
Independent Research Institutes, prepared statement.......... 430
Maternal and Child Health Programs, prepared statement....... 338
Minority Health Professions Schools, prepared statement...... 543
Women's Health, Obstetric and Neonatal Nurses (AWHONN),
prepared statement......................................... 431
Auerbach, Judith, Ph.D., vice president, Public Policy and
Program Development, Amfar, the Foundation for Aids Research... 208
Berg, Dr. Jeremy, Director, National Institute of General Medical
Sciences, National Institutes of Health, Department of Health
and Human Services, prepared statement......................... 140
Centers for Disease Control and Prevention Coalition, prepared
statement...................................................... 340
Central Valley Opportunity Center, prepared statement............ 313
Chao, Moses, M.D., Christopher Reeve Foundation.................. 209
Charles R. Drew University of Medicine and Science, prepared
statement...................................................... 435
Coalition of Northeastern Governors, prepared statement.......... 406
Cochran, Senator Thad, U.S. Senator from Mississippi:
Prepared statement........................................... 33
Statement.................................................... 32
College Board, prepared statement................................ 555
College of New Rochelle, NY, prepared statement.................. 344
Collins, Francis S., M.D., Director, National Human Genome
Research Institute, National Institutes of Health, Department
of Health and Human Services................................... 105
Prepared statement........................................... 125
Comstock, Amy L., chief executive officer, Parkinson's Action
Network........................................................ 209
Prepared statement........................................... 210
Cooley's Anemia Foundation, prepared statement................... 437
Council of State Administrators of Vocational Rehabilitation
(CSAVR), prepared statement.................................... 558
Craig, Senator Larry, U.S. Senator from Idaho.................... 64
Crohn's and Colitis Foundation of America, prepared statement.... 439
Diabetes Care Coalition, prepared statement...................... 346
Digestive Disease National Coalition, prepared statement......... 441
Doris Day Animal League, prepared statement...................... 444
Durbin, Senator Richard, U.S. Senator from Illinois.............. 65
Dystonia Medical Research Foundation, prepared statement......... 446
Emerson, Stephen, M.D., associate director for clinical research,
Abramson Cancer Center, University of Pennsylvania Hospital.... 211
Prepared statement........................................... 212
Eng, Lauren A., president, Spinal Muscular Atrophy Foundation.... 213
Prepared statement........................................... 214
Fauci, Anthony S., M.D., Director, National Institute of Allergy
and Infectious Diseases, National Institutes of Health,
Department of Health and Human Services........................ 105
Prepared statement........................................... 128
Foster Grandparent Program, prepared statement................... 453
Fox, Dr. Philip C., director of clinical research, Department of
Oral Medicine, Carolinas Medical Center on behalf of the
American Association for Dental Research....................... 215
Friends of:
NIDA Coalition, prepared statement........................... 458
The National Institute on Aging, prepared statement.......... 456
FSH Society, prepared statement.................................. 449
Furlong, Patricia, co-founder and chief executive officer, Parent
Project Muscular Dystrophy..................................... 216
Prepared statement........................................... 217
Gallaudet University, prepared statement......................... 560
Gandy, Sam, M.D., Ph.D., Chair, Medical and Scientific Advisory
Council, Alzheimer's Association............................... 217
Prepared statement........................................... 218
Gibbons, Ann, member, board of directors, Autism Speaks.......... 219
Prepared statement........................................... 220
Goldstein, Robert, M.D., Ph.D., chief scientific officer,
Juvenile Diabetes Research Foundation.......................... 221
Prepared statement........................................... 221
Grady, Dr. Patricia A., Director, National Institute of Nursing
Research, National Institutes of Health, Department of Health
and Human Services, prepared statement......................... 143
Harkin, Senator Tom, U.S. Senator from Iowa:
Prepared statements.........................................10, 108
Questions submitted by......................................97, 256
Statements..................................................64, 107
Health Professions and Nursing Education Coalition, prepared
statement...................................................... 562
Heart Rhythm Society, prepared statement......................... 461
Hemophilia Federation of America, prepared statement............. 464
Hepatitis Foundation International, prepared statement........... 465
HHT Foundation International, prepared statement................. 478
Hodes, Dr. Richard J., Director, National Institute on Aging,
National Institutes of Health, Department of Health and Human
Services, prepared statement................................... 145
Holzman, Lawrence B., M.D., chairman, scientific advisory board,
Nephcure Foundation............................................ 225
Prepared statement........................................... 226
Houser, Steven R., Ph.D., director, cardiovascular research
center, Temple University School of Medicine on behalf of the
American Heart Associa-
tion........................................................... 227
Prepared statement of........................................ 228
Hrynkow, Dr. Sharon, Acting Director, Fogarty International
Center, National Institutes of Health, Department of Health and
Human Services, prepared statement............................. 148
In Defense of Animals, prepared statement........................ 468
Independence Technology, prepared statement...................... 471
Industrial Minerals Association--North America, prepared
statement...................................................... 477
Inouye, Senator Daniel K., U.S. Senator from Hawaii, questions
submitted by.............................................53, 100, 258
Insel, Dr. Thomas R., Director, National Institute of Mental
Health, National Institutes of Health, Department of Health and
Human Services, prepared statement............................. 151
Institute for Student Achievement, prepared statement............ 566
International Foundation for Functional Gastrointestinal
Disorders, prepared statement.................................. 474
InterTribal Bison Cooperative, prepared statement................ 349
John B. Amos Cancer Center, prepared statement................... 351
Katz, Dr. Stephen I., Director, National Institute of Arthritis
and Musculoskeletal and Skin Diseases, National Institutes of
Health, Department of Health and Human Services, prepared
statement...................................................... 153
Kington, Raynard, Deputy Director, Office of the Director,
National Institutes of Health, Department of Health and Human
Services, prepared state-
ment........................................................... 156
Knapp, Richard M., M.D., Chair, Ad Hoc Group for Medical Research 205
Prepared statement........................................... 206
Kohl, Senator Herb, U.S. Senator from Wisconsin:
Prepared statement........................................... 18
Questions submitted by.................................55, 101, 269
Koo, Daniel, M.D., on behalf of the Deaf and Hard of Hearing
Alliance....................................................... 233
Prepared statement........................................... 234
Landis, Dr. Story C., Director, National Institute of
Neurological Disorders and Stroke, National Institutes of
Health, Department of Health and Human Services, prepared
statement...................................................... 159
Landrieu, Senator Mary L., U.S. Senator from Louisiana........... 2
Prepared statement........................................... 235
Landrigan, Philip J., M.D., MSC, FAAP, president, Campaign for
American Children's Health..................................... 235
Leavitt, Hon. Michael O., Secretary, Office of the Secretary,
Department of Health and Human Services........................ 61
Prepared statement........................................... 68
Summary statement............................................ 66
Li, Dr. Ting-Kai, Director, National Institute on Alcohol Abuse
and Alcoholism, National Institutes of Health, Department of
Health and Human Services, prepared statement.................. 162
Lindberg, Dr. Donald A.B., Director, National Library of
Medicine, National Institutes of Health, Department of Health
and Human Services, prepared statement......................... 164
Lupus Foundation of America, Inc., prepared statements.........242, 480
March of Dimes Birth Defects Foundation, prepared statement...... 482
Matria Healthcare, prepared statement............................ 352
Mayer, Emeran, A.M.D., on behalf of the Digestive Disease
National Coalition............................................. 239
Prepared statement........................................... 239
McDonnell, Peter, M.D., on behalf of the National Alliance for
Eye and Vision Research........................................ 240
Medical Library Association and the Association of Academic
Health Sciences Libraries, prepared statement.................. 485
Mildenberg, Juanita M., Acting Director, Office of Research
Facilities Development and Operations, National Institutes of
Health, Department of Health and Human Services, prepared
statement...................................................... 167
Montgomery County (Maryland) Stroke Association, prepared
statement...................................................... 490
Murray, Senator Patty, U.S. Senator from Washington:
Prepared statement........................................... 23
Questions submitted by....................................... 56
Statement.................................................... 63
Nabel, Elizabeth G., M.D., Director, National Heart, Lung, and
Blood Institute, National Institutes of Health, Department of
Health and Human Services...................................... 105
Prepared statement........................................... 133
National:
AHEC Organization, prepared statement........................ 500
Alliance to End Homelessness, prepared statement............. 353
Association:
For State Community Services Programs, prepared statement 359
Of:
Children's Hospitals, prepared statement............. 491
Community Health Centers, prepared statement......... 357
County and City Health Officials, prepared statement. 494
Workforce Boards, prepared statement................. 301
Coalition for:
Heart and Stroke Research, prepared statement............ 503
Osteoporosis and Related Bone Diseases, prepared
statement.............................................. 496
Community Action Foundation, prepared statement.............. 499
Consumer Law Center, prepared statement...................... 362
Federation of Community Broadcasters, prepared statement..... 575
Job Corps Association, prepared statement.................... 305
Kidney Foundation, prepared statement........................ 366
League for Nursing, prepared statement....................... 367
Minority Consortia, prepared statement....................... 577
Multiple Sclerosis Society, prepared statement............... 504
Primate Research Centers, prepared statement................. 509
Prostate Cancer Coalition, prepared statement................ 511
Sleep Foundation, prepared statement......................... 512
Writing Project, prepared statement.......................... 569
Youth Employment Coalition, prepared statement............... 306
NephCure Foundation, prepared statement.......................... 514
Niederhuber, John E., M.D., Acting Director, National Cancer
Institute, National Institutes of Health, Department of Health
and Human Services............................................. 105
Prepared statement........................................... 123
NIH Task Force of the Bioengineering Division of the Basic
Engineering Group of the Council on Engineering of ASME,
prepared statement............................................. 507
Oncology Nursing Society, prepared statement..................... 368
One Voice Against Cancer, prepared statement..................... 515
Oregon Human Development Corporation, prepared statement......... 309
Ovarian Cancer National Alliance, prepared statement............. 518
Pancreatic Cancer Action Network, prepared statement............. 371
People for the Ethical Treatment of Animals, prepared statement.. 373
Pettigrew, Dr. Roderic I., Director, National Institute of
Biomedical Imaging and Bioengineering, National Institutes of
Health, Department of Health and Human Services, prepared
statement...................................................... 168
Population Association of America/Association of Population
Centers, prepared statement.................................... 521
Project R&R, prepared statement.................................. 376
Pulmonary Hypertension Association, prepared statement........... 524
Railroad Retirement Board, prepared statements.................580, 582
Raymond, Sandra, on behalf of the Lupus Foundation of America.... 241
Reid, Senator Harry, U.S. Senator from Nevada, questions
submitted by................................................... 261
Roberts, Senator Pat, et al., letter from........................ 378
Rodgers, Dr. Griffin P., Acting Director, National Institute of
Diabetes and Digestive and Kidney Diseases, National Institutes
of Health, Department of Health and Human Services, prepared
statement...................................................... 170
Ruffin, Dr. John, Director, National Center on Minority Health
and Health Disparities, National Institutes of Health,
Department of Health and Human Services, prepared statement.... 173
Schwartz, Dr. David A., Director, National Institute of
Environmental Health Sciences, National Institutes of Health,
Department of Health and Human Services, prepared statement.... 176
Shelby, Senator Richard C., U.S. Senator from Alabama:
Prepared statement........................................... 109
Statement.................................................... 108
Sieving, Dr. Paul A., Director, National Eye Institute, National
Institutes of Health, Department of Health and Human Services,
prepared state-
ment........................................................... 179
Skelly, Thomas, Director, Budget Service, Office of the
Secretary, Department of Education............................. 1
Society:
For:
Investigative Dermatology, prepared statement............ 526
Maternal-Fetal Medicine, prepared statement.............. 528
Women's Health Research and Women's Health Research
Coalition, prepared statement.......................... 531
Of Nuclear Medicine, prepared statement...................... 529
Specter, Senator Arlen, U.S. Senator from Pennsylvania:
Opening statements.......................................1, 61, 105
Prepared statement........................................... 2
Questions submitted by.............................33, 88, 250, 274
Spellings, Hon. Margaret, Secretary, Office of the Secretary,
Department of Education........................................ 1
Prepared statement........................................... 6
Summary statement............................................ 4
Spina Bifida Association, prepared statement..................... 379
State Educational Technology Directors Association, prepared
statement...................................................... 572
Straus, Dr. Stephen E., Director, National Center for
Complementary and Alternative Medicine, National Institutes of
Health, Department of Health and Human Services, prepared
statement...................................................... 181
Tabak, Dr. Lawrence A., Director, National Institute of Dental
and Craniofacial Research, National Institutes of Health,
Department of Health and Human Services, prepared statement.... 184
Taylor, Herman A., Jr., M.D., on behalf of the Jackson Heart
Study.......................................................... 243
Prepared statement........................................... 244
The:
Humane Society of the United States, prepared statement...... 535
Mended Hearts, Inc., prepared statement...................... 489
Nature Conservancy, prepared statement....................... 584
Tuomey Healthcare System, prepared statement..................... 382
Vogel-Scibilia, Suzanne, M.D., president, National Alliance on
Mental Ill-
ness........................................................... 246
Voices for National Service, prepared statement.................. 585
Volkow, Dr. Nora, Director, National Institute on Drug Abuse,
National Institutes of Health, Department of Health and Human
Services, prepared statement................................... 186
Zerhouni, Elias A., M.D., Director, National Institutes of
Health, Department of Health and Human Services................ 105
Prepared statement........................................... 111
Summary statement............................................ 109
SUBJECT INDEX
----------
DEPARTMENT OF EDUCATION
Office of the Secretary
Page
A Broad Emphasis on Competitiveness.............................. 6
Academic Competitiveness:
And National Smart Grants.................................... 21
Smart Grants................................................. 56
Additional Committee Questions................................... 33
Addressing the High School Dropout Problem....................... 31
Adjunct Teachers................................................. 20
Program...................................................... 19
Advanced Placement Incentive Program............................. 49
Advancing America Through Foreign Language Partnerships.......... 50
And DOD National Flagship Language Initiative................ 50
Allocation of Budget Resources................................... 17
America's Opportunity Scholarships for Kids......................38, 57
American Competitiveness Initiative...........................4, 18, 33
Arts Education................................................... 44
Building State Capacity for School Improvement................... 7
Civic Education.................................................. 59
Commission on the Future of Higher Education..................... 49
Comprehensive School Reform as School Improvement Strategy....... 34
Data Management Initiative....................................... 43
Department:
Expenditures for Public Relations and Outreach............... 53
Lauded for Hurricane Response................................ 3
Department's Comments on the Silent Epidemic..................... 32
Distribution of Highly Qualified Personnel....................... 14
Early Childhood Education Funding................................ 55
Education:
Funding in High-Poverty and Low-Poverty Districts............ 15
Funds Disbursed for Hurricane Recovery....................... 4
Response for Hurricane Recovery.............................. 13
Effectiveness of Supplemental Services........................... 9
Elementary and Secondary School Counseling Program............... 56
Enforcement of Highly Qualified Teachers Requirement............. 41
Ensuring Highly Qualified Teachers for Students of all
Socioeconomic Sta-
tus............................................................ 42
Equitable Distribution of Education Resources.................... 14
ESEA Title I:
Funding...................................................... 30
Proposed Funding Decrease.................................... 29
Expansion of the SES Pilot Program............................... 38
Federal:
Efforts to Address Inequitable Distribution of Highly
Qualified and Unqualified Teachers......................... 42
Perkins Loans................................................ 34
Student aid.................................................. 49
Fiscal Year:
2006 Funding Level of Proposed Terminations.................. 26
2007:
Budget:
Request.............................................. 4, 13
Priorities....................................... 8
Education Department Budget Request...................... 11
Foreign Language Assistance Program.............................. 43
Funding for Higher Education..................................... 50
HEA Title IX..................................................... 22
High School:
Dropouts--the Silent Epidemic................................ 31
Reform Initiative............................................25, 27
Highly Qualified Teachers........................................ 39
Impact of Medicaid Change on Children With Disabilities.......... 58
Improving Teacher Quality Programs............................... 39
Information Dissemination on Highly Qualified Teacher
Requirements................................................... 41
Innovative High School Restructuring in Idaho.................... 19
Investment in:
Advanced Placement........................................... 48
Secondary Education.......................................... 16
Limitation on Reduction of Title I Grants for School Improvement
Purposes....................................................... 35
Math and Science................................................. 7
Education.................................................... 48
Math now Program and Math and Science Partnerships....... 47
Partnerships and Math now Program Activities................. 47
Measuring Performance of the Impact Aid Program.................. 39
National:
Assessment of Educational Progress........................... 52
Mathematics Panel............................................ 47
Native Hawaiian Education........................................ 53
No Child Left Behind Flexibility Provisions...................... 11
Office of Communications and Outreach............................ 52
OMB PART Ratings for Programs Proposed for Termination in the
Fiscal Year 2007 Budget Request................................ 27
Other Programs................................................... 7
Pell Grants......................................................12, 17
Per Pupil Expenditures Across the Nation......................... 15
Perkins Loans and Other Student Aid Programs..................... 55
Proposed:
Education Budget Cuts........................................ 11
GEAR UP Program Elimination.................................. 24
Public School Choice and Supplemental Services................... 8
Ready to:
Learn:
Continuation Projects.................................... 46
Program.................................................. 45
Teach Program and Math and Science Education................. 45
Requirements of Advancing America Through Foreign Language
Partnerships Grantees.......................................... 51
Rigorous High School Curriculum.................................. 21
School:
Dropouts..................................................... 32
Improvement:
And High School Reform................................... 5
Grants Program and Effective School Improvement
Activities............................................. 36
Categorized as Needing Improvement........................... 30
Within-Schools............................................... 20
Selection of Districts for SES Pilot Program..................... 37
Special Education................................................ 12
Funding...................................................... 55
Start of GEAR UP Program......................................... 25
States' Reporting of Highly Qualified Teacher Data............... 41
Statewide:
Data Systems Program......................................... 51
Longitudinal Data Systems.................................... 52
Student Participation and Achievement Under the SES Pilot Program 38
Supplemental Educational Services................................ 37
Pilot Program................................................ 37
Teacher Quality Enhancement Program and Teacher Recruitment and
Retention...................................................... 42
Title I:
Funding...................................................... 3
Grants to LEAS............................................... 12
Improvement Funding Generated by 4 Percent Set-Aside......... 35
School Improvement:
Monitoring............................................... 36
Set-Aside................................................ 35
Title IX:
Report....................................................... 57
Technical Assistance......................................... 57
12th Grade NAEP Initiative--Reading and Math Assessments......... 52
21st Century Community Learning Centers.......................... 58
Use of Title I School Improvement Funds for Comprehensive School
Reform......................................................... 34
Vocational Education Funds....................................... 16
Women in Technology.............................................. 54
Workshop Approach to Outreach and Impact on Student Learning Out-
comes.......................................................... 46
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
A:
Record of Real Success....................................... 124
Winning Strategy Against Cancer.............................. 194
Additional Committee Questions................................... 250
Addressing the Threat of Emerging and Re-Emerging Infectious
Diseases: Prediction and Preemption............................ 149
Advanced Technologies Accelerate Progress........................ 125
Advances:
Against the Threat of Pandemic Influenza..................... 113
In:
Cancer................................................... 112
Cardiovascular Disease and Stroke........................ 112
Diabetes and Related Illnesses........................... 113
Health Information for Scientists and the Public......... 114
HIV/AIDS................................................. 113
Image-Guided Microsurgery................................ 114
Age-related Macular Degeneration................................. 270
Alzheimer's Disease.............................................. 269
And the Neuroscience of Aging................................ 146
Asthma........................................................... 135
Autoimmune Diseases.............................................. 198
Baccalaureate to Doctoral Programs............................... 259
Battle Against HIV/AIDS.......................................... 149
Better Pain Treatments for Jaw Condition......................... 185
Biodefense Research.............................................. 131
Bridging the Physical and Life Sciences.......................... 168
Budget Request................................................... 111
Buffergel Shown to be Safe Contraceptive......................... 137
Burden and Cost of Mental Illness................................ 151
Cancer:
Centers...................................................... 259
Genome Atlas................................................. 193
Cataract......................................................... 180
Changing Landscape of Disease.................................... 115
Chronic Fatigue Syndrome (CFS)................................... 261
Clinical:
And Translational Science Awards............................. 253
Research..................................................... 160
Collaborating:
Across NIH................................................... 184
Among Institutes............................................. 256
Collaborative Research........................................... 162
Community-based Rehabilitation Intervention...................... 138
Complex Genetics................................................. 154
Conflicts of Interest............................................ 257
Consultation Protocol............................................ 260
Corneal Diseases................................................. 180
Creating Partnerships: Rare Diseases Network..................... 139
Current Challenges............................................... 177
Dawn of Personalized Medicine.................................... 141
Developing Nurse Researchers..................................... 259
Development of Biodefense Research............................... 113
Disseminating Information........................................ 183
Drug Addiction Treatment Works................................... 189
Dry Mouth and Radiation Therapy.................................. 186
Emerging and Re-Emerging Infectious Diseases..................... 129
Enhanced Support for New Investigators........................... 170
Envisioning Personalized Care.................................... 151
Epilepsy......................................................... 269
Expand Community-Linked Research................................. 178
Expanding Training and Career Development........................ 183
Facilitating Integration......................................... 183
Fetal Development: Jump Start on Life............................ 136
Fiscal Year 2007 Budget Summary.................................. 167
From Bench to Bedside to Community............................... 190
Funding for Pandemic Influenza................................... 192
Furthering the Research Mission.................................. 182
Future Research: Newborn Screening............................... 137
Gene:
Environment and Health Initiative--a Novel Partnership....... 178
Programs Early Development and Neural Migration.............. 137
Genes:
And Neurological Disorders................................... 160
May Hold the Key to Treating Uterine Fibroids................ 137
Environment, and:
Behavior................................................. 187
Health Initiative........................................ 204
Glaucoma and Optic Neuropathies.................................. 180
Global Burden of Trauma and Injury............................... 150
Greater Emphasis on Large Clinical Studies....................... 185
Health:
Communications and Promotion................................. 148
Disparities Research Agenda.................................. 174
Healthy Mothers and Healthy Children............................. 143
HIV/AIDS:
And Minority Disparities..................................... 190
Research..................................................... 130
Heart Truth Road Show............................................ 252
Impact of Budget Cuts............................................ 191
Importance of Early Intervention................................. 171
Improving the Nation's Oral Health............................... 186
Increase Funding:
At the Centers for Disease Control (CDC)..................... 230
For:
NIH Heart and Stroke Research............................ 229
The:
Agency for Healthcare Research and Quality (AHRQ).... 231
Carol M. White Physical Education Program (PEP)...... 231
National Institutes of Health (NIH).................. 228
Information Services for the:
Public....................................................... 165
Scientific Community......................................... 165
Integrating Clinical and Translational Science................... 138
Integrative Research on Human Disease............................ 177
Interagency Collaborations....................................... 125
Irritable Bowel Syndrome......................................... 270
Liver Disease Research Branch.................................... 250
Loan Repayment and Scholarship Program........................... 159
Looking Toward the Future........................................ 184
Lupus............................................................ 199
Management Innovations........................................... 116
Mathematics and Science Cognition and Learning................... 137
Molecular Medicine and Oral Cancer............................... 185
Multi-bug Approach on Vaccines................................... 203
Nanotechnology for Disease Detection and Drug Delivery........... 169
National:
Children's Study............................................. 196
Primate Research Center...................................... 256
NCMHD Health Disparities Efforts................................. 174
New:
Diagnostic and Therapeutic Technologies...................... 114
NHGRI Initiatives............................................ 127
Research Tools............................................... 114
Next Generation Minimally-Invasive Technologies.................. 169
NIEHS Strategic Plan--A New Outlook.............................. 178
NIH:
And Diabetes Research--A Strong Return on Federal Investment. 223
Blueprint.................................................... 170
Neuroscience Blueprint....................................... 181
Roadmap...................................................... 181
For:
Biomedical Research.................................. 170
Medical Research..................................... 156
NIMH Initatives for Fiscal Year 2007............................. 153
NINR and the NIH Roadmap......................................... 145
Nursing Shortages and Training Nurse Researchers................. 144
Obstetric Pharmacology--Treatment for Pregnant Women............. 136
Office of:
AIDS Research................................................ 156
Behavioral and Social Sciences Research...................... 157
Disease Prevention........................................... 158
Portfolio Analysis and Strategic Initiatives................. 159
Research on Women's Health................................... 157
Science Education............................................ 158
Ongoing NHGRI Initiatives........................................ 126
Opasi Trans-NIH Funding Program.................................. 252
Other:
Aging-related Research....................................... 147
Areas of Interest..........................................128, 166
Our Goal Remains the Same........................................ 123
Pandemic Flu..................................................... 257
Patients and Families at the End of Life......................... 144
Pediatric Heart and Lung Disorders............................... 134
Periodontal Disease and Preterm Birth............................ 185
Polycystic Kidney Disease........................................ 255
Power of the Mind................................................ 142
Practical Clinical Trials........................................ 152
Practice-based Research Networks................................. 184
Predicting Preeclampsia.......................................... 136
Prednisone....................................................... 199
Preempting Chronic Diseases and Their Complications.............. 171
Premature Birth Research......................................... 136
Preparedness for Pandemic Influenza............................191, 201
Prescription Drug Abuse--the Problem With Painkillers............ 187
Preventive Medicine.............................................. 153
Program Funding.................................................. 200
Promoting Science and Health Literacy............................ 140
Providing Critical Links: Nonhuman Primate Research.............. 140
Rapid Advances in the Genomic Era................................ 116
Re-evaluate Programmatic Investments............................. 178
Recruit and Train the Next Generation............................ 177
Reducing Disparities in the Nation's Oral Health................. 186
Regenerative Medicine............................................ 155
Research Collaborations.......................................... 175
Research on Immune-Mediated Diseases............................. 132
Restore Funding for the Rural and Community Access to Emergency
Devices Program................................................ 231
Retinal Diseases................................................. 179
Return on Investment on NIH Funding.............................. 110
Role in the Research Mission..................................... 167
Selected Accomplishments of NIH and Their Impact on Health....... 112
Setting the Course............................................... 182
Sickle Cell Disease.............................................. 135
SMedical Robotic................................................. 169
Social Neuroscience.............................................. 188
Spurring Advances Through Data Sharing........................... 139
Staying Healthy Throughout Adulthood............................. 143
Strabismus, Amblyopia and Visual Processing...................... 179
Strategic Vision for NIH: From Curative to Preemptive Care....... 115
Strengthening the:
Evidence Base in Dental Care................................. 184
Pipeline..................................................... 141
Stroke........................................................... 253
Teaming Science for Public Health Gains.......................... 141
Technologies to Improve Health Care Delivery..................... 168
Traditional Healing Practices.................................... 258
Training:
A New Generation of Scientists............................... 117
For the Future............................................... 170
Translating:
Discoveries Into Better Medical Treatment.................... 117
Technology Into Clinical Practice............................ 168
Translational Research.........................................155, 161
Understanding Aging and Caring for the Elderly................... 144
Urology Research Strategic Planning.............................. 251
Value of a Systems Approach...................................... 142
Widening the Net: Under-represented Populations and Areas........ 139
Women's:
Health Initiative............................................ 197
Heart Disease................................................ 196
Office of the Secretary
Additional Committee Questions................................... 88
Administration on Aging (AoA) Budget Cuts........................ 79
Aging Services Programs..........................................86, 87
Alzheimer's Demonstration Grants................................. 80
Baccalaureate to Doctoral Programs............................... 100
CDC:
Budget Cuts.................................................. 80
Physical Plant............................................... 81
CMS:
Adequate Provider Reimbursement.............................. 96
Power Wheelchairs............................................ 97
Prompt Pay Discount.......................................... 97
Regulatory Authority for Reimbursement....................... 97
Status of Quality Demonstration Project...................... 95
Community Health Centers......................................... 75
Compassion Capital Fund.......................................... 85
Disease Prevention............................................... 83
Emergency Medical Services for Children.......................... 100
FDA Generic Drug Applications.................................... 78
Fiscal Year 2007 HHS Budget...................................... 67
Generic Drugs/FDA................................................ 101
Health:
Centers Program.............................................. 100
Professionals Training....................................... 88
Historical Pandemics............................................. 71
Institute of Medicine Policy Recommendations..................... 84
Medicaid/Special Education Benefits.............................. 98
Medical Professional Availability................................ 66
Medicare:
Drug Benefit Enrollment Deadline............................. 102
Electronic Payments.......................................... 88
Fraud........................................................ 97
Improper Payments............................................ 94
Integrity Program............................................89, 94
Part D:
Deadline Extension....................................... 63
Enrollment............................................... 76
Deadline............................................. 76
Formulary Prices......................................... 65
Plan Choice.............................................. 78
National Institutes of Health:
Budget Cuts.................................................. 65
Funding...................................................... 103
Levels................................................... 82
Research..................................................... 84
Grants................................................... 81
Sleep Disorders Conference Report............................ 90
Office of Minority Health........................................ 90
Pandemic Influenza:
Infrastructure............................................... 75
Preparedness.................................................72, 91
Plan Implemention........................................ 93
Respirator Masks............................................. 93
Surge Capacity............................................... 92
Vaccine......................................................83, 92
Distribution............................................. 73
Stockpile................................................ 72
Programs Serving Older Americans................................. 101
Rural Health..................................................... 102
Rural Healthcare................................................. 80
Special Exposure Cohorts......................................... 99
Underage Drinking Prevention..................................... 90
Uninsured Access to Pandemic Influenza Treatment................. 93
Wellness and Disease Prevention.................................. 75
DEPARTMENT OF LABOR
Office of the Secretary
Administration and Management.................................... 280
Adult Training Funds............................................. 294
Appalachian Council/Working for America Institute................ 290
Asbestos Exposure................................................ 276
Built-in and Program Changes..................................... 284
Career Advancement Accounts...................................... 295
Comments on Cecil Roberts Testimony.............................. 278
Competitiveness Agenda........................................... 291
Economic Growth Efforts.......................................... 295
Elimination of:
Job Bank Program............................................. 296
Migrant:
Job Training............................................. 275
Programs................................................. 292
Youth Training Grants........................................ 295
Employment Service Cuts.......................................... 292
Foreign Labor Certification...................................... 298
Immigration Bill................................................. 276
Impact of Job Training Cuts...................................... 275
Job:
Corps Funding................................................ 274
Training Staff............................................... 290
Medical Leave Program............................................ 277
Mine Safety...................................................... 274
National Reserve Fund............................................ 293
Older Worker Employment Program.................................. 279
OSHA Penalties for Asbestos Violations........................... 276
Program Direction................................................ 282
Proposed Workforce Legislation................................... 296
Rapid Response:
Funds......................................................277, 298
Services..................................................... 293
Rational for Workforce Training.................................. 291
Re-allocation of Unspent Funds................................... 277
Reintegration of Youthful Offenders.............................. 275
Safe Places in Mines............................................. 290
Voucher Proposal................................................. 291
Women in Apprenticeship.......................................... 290
Workforce Training Cuts.......................................... 276
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