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DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2004
=======================================================================
HEARINGS
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS
UNITED STATES SENATE
ONE HUNDRED EIGHTH CONGRESS
FIRST SESSION
on
H.R. 2660/S. 1356
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, 2004, AND FOR OTHER PURPOSES
__________
Department of Education
Department of Health and Human Services
Department of Labor
Nondepartmental witnesses
__________
Printed for the use of the Committee on Appropriations
Available via the World Wide Web: http://www.access.gpo.gov/
congress/senate
______
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COMMITTEE ON APPROPRIATIONS
TED STEVENS, Alaska, Chairman
THAD COCHRAN, Mississippi ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri PATRICK J. LEAHY, Vermont
MITCH McCONNELL, Kentucky TOM HARKIN, Iowa
CONRAD BURNS, Montana BARBARA A. MIKULSKI, Maryland
RICHARD C. SHELBY, Alabama HARRY REID, Nevada
JUDD GREGG, New Hampshire HERB KOHL, Wisconsin
ROBERT F. BENNETT, Utah PATTY MURRAY, Washington
BEN NIGHTHORSE CAMPBELL, Colorado 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
James W. Morhard, Staff Director
Lisa Sutherland, Deputy Staff Director
Terrence E. Sauvain, Minority Staff Director
------
Subcommittee on Departments of Labor, Health and Human Services, and
Education, and Related Agencies
ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi TOM HARKIN, Iowa
JUDD GREGG, New Hampshire ERNEST F. HOLLINGS, South Carolina
LARRY CRAIG, Idaho DANIEL K. INOUYE, Hawaii
KAY BAILEY HUTCHISON, Texas HARRY REID, Nevada
TED STEVENS, Alaska HERB KOHL, Wisconsin
MIKE DeWINE, Ohio PATTY MURRAY, Washington
RICHARD C. SHELBY, Alabama MARY L. LANDRIEU, Louisiana
Professional Staff
Bettilou Taylor
Jim Sourwine
Mark Laisch
Sudip Shrikant Parikh
Candice Rogers
Ellen Murray (Minority)
Erik Fatemi (Minority)
Adrienne Hallett (Minority)
Administrative Support
Carole Geagley
C O N T E N T S
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Wednesday, March 19, 2003
Page
Department of Health and Human Services: Office of the Secretary. 1
Thursday, March 27, 2003
Department of Education: Office of the Secretary................. 79
Tuesday, April 8, 2003
Department of Health and Human Services: National Institutes of
Health......................................................... 125
Wednesday, April 9, 2003
Department of Labor: Office of the Secretary..................... 291
Nondepartmental Witnesses
Department of Health and Human Services.......................... 351
National Institutes of Health.................................... 401
Department of Education.......................................... 464
Related agencies................................................. 481
Miscellaneous.................................................... 492
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, EDUCATION, AND RELATED
AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2004
----------
WEDNESDAY, MARCH 19, 2003
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:01 a.m., in room SD-124, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senator Specter, Craig, Gregg, Harkin, Landrieu,
and Kohl.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
STATEMENT OF TOMMY G. THOMPSON, SECRETARY OF HEALTH AND
HUMAN SERVICES
opening statement of senator arlen specter
Senator Specter. Good morning, ladies and gentlemen. The
hearing of the Appropriations Subcommittee of Labor, Health,
Human Services, and Education will now proceed.
Our witness today will be the Secretary of HHS, Secretary
Tommy Thompson, the 19th Secretary of the Department which
oversees the health and welfare of the Nation.
The administration budget has proposed a discretionary
account for the Department of Health and Human Services of some
$60.7 billion which constitutes an increase of $514 million
over the fiscal year 2003 level, which, as obvious, does not
even account for an inflationary increase.
This Department has some of the most important funding in
our Nation, spanning medical research and Head Start and the
low-income health and energy costs, known as LIHEAP, and a
broad range of very, very important programs. It is, as usual,
a very difficult matter in allocating the resources which this
subcommittee has for three Departments, the Department of
Education, the Department of Labor, in addition to this
Department.
There is special concern about a number of lines. The
Centers for Disease Control, which is being asked to take on
additional responsibilities, as we speak, with this outbreak in
China. The National Institutes of Health, which have had
extraordinary results, have been limited in this year's
suggested funding by the administration to a $673 million
increase, which is a sharp decrease from the $3.5 billion
increase which the administration requested last year, which
really was a commentary on the phenomenal results which NIH
had. But we will be wrestling with these issues.
We appreciate the appearance of the Secretary today. To
give the maximum time for the Secretary's comments, we will
begin at this point.
Secretary Thompson began his public service back in 1966 as
a representative in the Wisconsin State Assembly. He served as
Governor of Wisconsin from 1987 to 2000, the longest-serving
Governor in Wisconsin history, well known for his innovative
activities in the welfare system and expanding health care
access to low-income children and families. He was chairman of
the National Governor's Association, the Education Commissioner
of the States and Midwestern Governors Conference. Both of his
degrees, bachelor and J.D., come from the University of
Wisconsin at Madison.
Thank you for joining us, Mr. Secretary, and we look
forward to your testimony.
summary statement of hon. tommy g. thompson
Secretary Thompson. Thank you so very much, Mr. Chairman. I
want to thank you at the outset for your passion, for your
leadership on so many issues that are very important to the
future of the health care and well-being of Americans, and I
thank you for that leadership.
I am sorry Mr. Harkin is not here, but I also want to
extend my appreciation to him as well.
Thank you so very much, Senator Specter, for inviting me to
testify today.
In my first 2 years at the Department, we have made, I
believe, tremendous progress in our efforts to improve the
health, the safety, and the well-being of the American people.
We continue to make extraordinary progress in providing health
care to lower-income Americans through waiver and State plan
amendments granted to States. We have been able to expand
access to health coverage for more than 2.2 million individuals
and have expanded the range of benefits offered to an
additional 6.7 million other Americans.
To build on this progress, the President proposed outlays
for HHS of $539 billion. $539 billion represents an increase of
$36.8 million, or 7 percent over last year's request, an
increase of more than $109 billion, or 25 percent, since 2001.
The discretionary part of the budget increases $1.64
billion, or 2.6 percent, to $65 billion of budget authority.
This would be $606 million, or 1.5 percent, higher than what
was enacted by the Congress in the fiscal year 2003
appropriation bill.
$539 billion is a large number, and I have a solemn
responsibility as Secretary to make sure that every one of
those dollars is put to good use. I owe it to the people who
pay the taxes, and I owe it to the people who consume the
services.
One way to ensure that these dollars are effective is to
work with you, Senator Specter, and Senator Harkin and other
committee members and other committees to improve and
strengthen our two largest health programs, Medicare and
Medicaid. I discuss these programs in my written testimony.
We are also making progress in keeping health care costs
down and preventing chronic diseases by encouraging Americans
to lead healthier lives. We have all heard the disturbing news
about the prevalence of diabetes, obesity, and asthma that
could be prevented through simple lifestyle changes. Diabetes
alone costs the Nation nearly $132 billion each year in direct
medical and indirect economic costs. Yet, modest lifestyle
changes, such as getting more exercise and losing weight, can
reduce the risk of this and other diseases dramatically.
The HHS budget, consistent with the President's HealthierUS
effort, proposes a coordinated Department-wide effort, Steps to
a HealthierUS, to promote healthier lifestyles, emphasizing
prevention of obesity, diabetes, asthma, heart disease, stroke,
and cancer. The fiscal year 2004 budget includes an investment
of $125 million for targeted disease prevention.
In order to improve patient safety, which I know, Senator
Specter, you have been an advocate and leader on, the Food and
Drug Administration is proposing two new rules to prevent
errors with medication.
The first of these proposals will require bar-coding on
almost all pharmaceuticals and blood products. This rule would
help reduce the number of medication errors by allowing health
care professionals to use bar-code scanning equipment to verify
that the right drug in the right dose is given to the right
patient at the right time.
We also support the creation of patient safety
organizations in order to collect data that can improve
procedures and prevent errors.
And thanks to your strong support, Mr. Chairman, we
recently completed a doubling of the budget of the National
Institutes of Health. This year we continue that commitment
with a budget of $27.7 billion, a net increase of $549 million
over last year.
But as a result of one-time projects that were funded in
fiscal year 2003 and not needing to be refinanced, actual NIH
research investment will rise by $1.9 billion, or 7.5 percent.
I would like to focus the remainder of my remarks this
morning on a topic that is probably on everyone's mind this
week, and that is bioterrorism. I would like to offer to you,
Mr. Chairman, and members of the committee, an opportunity to
come over to the Department at your choosing to see our new
bioterrorism communications center. It is state of the art, and
it is one that you would appreciate if you would come over and
have an opportunity to see.
The attacks on September 11 made it clear that the threat
of terror is more grave and more imminent than at any time in
modern history. Anthrax attacks make it clear that the threat
of terrorism includes weapons of unprecedented power and
ingenuity, and the proliferation of weapons of mass destruction
in the hands of outlaw regimes makes it even more urgent that
we prepare for a growing variety of threats.
We have already done a great deal, and the United States
today is better prepared than ever to meet and be able to
respond to the threat of a terrorist attack with a biological,
chemical, radiological, or nuclear agent.
The National Stockpile of Medical Countermeasures is large
and getting more extensive all the time. But that stockpile may
not be enough. Unfortunately, the medical treatment available
for many pathogens have improved very little in decades. The
smallpox vaccines available today hardly differ from those of
the 1960s. Some treatments for radiation and chemical exposure
have not changed much since the 1970s, and some diseases, such
as ebola, have never had an effective medical countermeasure.
These diseases lack effective or modern treatment in part
because they are so rare.
By contrast, the treatment of the vast majority of common,
naturally occurring illnesses have been able to be improved
dramatically as a result of ongoing innovations from biomedical
research and development. Heart attacks were often fatal in the
1970s, but they are much less so today. And better detection
and therapeutic options have significantly improved survival
rates for many kinds of cancer over the last 20 years.
We must bring that sort of progress to the rare, yet deadly
threats which are posed by bioterrorists, and that is why
President Bush, with the help of my Department, has been able
to announce Project Bioshield. He would spend roughly $6
billion over 10 years on new countermeasures to prepare America
for a bioterrorist attack. This proposal would speed up
research and approval of vaccines and treatments and ensure a
guaranteed funding source for their purchase, just the latest
in our forward-looking efforts to protect the homeland.
Our Department is doing well at getting bioterrorism money
out to State governments in many cases faster than they are
able to spend it.
So as we speak, Mr. Chairman, researchers are working to
identify the cause of the recent cases of what has been called
severe acute respiratory syndrome. While we have no reason to
think that this syndrome is related to influenza, the
appearance of similar symptoms in scattered locations reminds
us that this is the way an influenza pandemic might start.
The President's budget foresaw and prepared for an
influenza outbreak. It proposes to spend $100 million to ensure
the Nation has an adequate supply of influenza vaccine in the
event of a pandemic. And due to the constant changes in the
circulating influenza strains, we cannot stockpile influenza
vaccine, and the current manufacturing methods could not meet
the Nation's needs in the event of a pandemic. Funds will be
used for activities to ensure a year-around influenza vaccine
production capacity and development and implementation of
rapidly expandable production technologies. We will work
closely with industry to accomplish these goals.
The President has made improving our Nation's health and
health care one of his biggest priorities for this year. By
working together, we can make it one of our proudest
achievements.
I look forward to working with you, Mr. Chairman, Senator
Harkin, as well as Senator Craig, and all members of this
committee, and I know our discussion this morning will
certainly proceed and allow those things to be initiated.
prepared statement
I thank you, Mr. Chairman, and I would also, once again,
invite you and other members of the committee to come over to
the Department and see our very modern, state-of-the-art
communications system that will allow us to better respond to
any bioterrorist attack that may take place in this country.
Thank you again for giving me this opportunity to appear in
front of you, Senator.
[The statement follows:]
Prepared Statement of Tommy G. Thompson
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 2004 budget for the Department of Health and
Human Services (HHS). I am certain you will find that, viewed in its
entirety, our budget will help improve the health and safety of our
Nation. Before I discuss the fiscal year 2004 budget, I would like to
thank the committee for its hard work and dedication to the programs at
HHS.
Our fiscal year 2004 request totals $539 billion in outlays,
approximately 7.3 percent over the fiscal year 2003 budget. The
discretionary budget authority portion of the HHS budget, before this
committee, totals $60.7 billion, which is an increase of approximately
$1.5 billion, or 2.6 percent over the fiscal year 2003 President's
Budget and an increase of approximately $514 million, or 0.9 percent
over the fiscal year 2003 enacted appropriation. Mandatory outlays for
HHS total $475.9 billion in this budget proposal, an increase in excess
of 7 percent.
The budget proposed by the President for HHS will enable the
Department to continue its important work with our partners at the
State and local levels and the newly created Department of Homeland
Security. Working together, we will hold fast to our commitment to
protecting our Nation and ensuring the health and well-being of all
Americans. Many of our programs at HHS provide necessary services that
contribute to fighting the war on terrorism and provide us with a more
secure future. And, I am particularly focused on preparedness at the
State and local level, HHS's ability to respond rapidly to a
bioterrorist attack, research on and development of vaccines and other
therapies to counter potential bioterrorist attacks, and ensuring the
safety of our food supply.
The President's fiscal year 2004 budget request also continues to
support the needs of the American people by strengthening and improving
Medicare and Medicaid; enhancing Temporary Assistance for Needy
Families (TANF) and Foster Care; strengthening the Child Support
Enforcement Program; and furthering the reach of the President's New
Freedom Initiative.
The support of your committee is vital to achieving many of the
Administration's most important priorities. I am grateful for the close
partnership we have enjoyed in the past, and I look forward to working
with you again on an aggressive appropriations agenda to advance the
health and well being of millions of Americans. Today, I would like to
highlight for you the key issues in the President's budget.
supporting the president's disease prevention initiative
One of the most important issues on which we can work together is
chronic disease prevention. We all have heard the disturbing news about
the prevalence of diabetes, obesity, and asthma that could be prevented
through simple lifestyle changes. The statistics, I am sure, are as
alarming to you as they are to me. For example, the incidence of
diabetes and obesity among Americans is up sharply in the past decade,
putting millions more Americans at higher risk for heart disease,
stroke and other related medical conditions.
Diabetes alone costs the Nation nearly $132 billion each year in
direct medical costs and in indirect economic costs, including
disability, missed work, and premature death. Medical studies have
shown that modest lifestyle changes--such as getting more exercise and
losing weight--can reduce an individual's risks for developing this
serious health conditions.
The HHS budget, consistent with the President's HealthierUS effort,
proposes a coordinated, Department-wide endeavor--Steps to a
HealthierUS--to promote healthier lifestyles emphasizing prevention of
obesity, diabetes, asthma, heart disease, stroke, and cancer. The
fiscal year 2004 budget includes an investment of $125 million for
targeted disease prevention.
improving the nation's health
Of all the issues confronting this Department, none has a more
direct impact on the well being of our citizens than the health of our
Nation. Our budget makes a concerted effort to improve the health of
the American people by taking significant steps that include: reducing
prescription drug-related medical costs, financing vaccines, investing
in hospital information technology, and continuing the effort to
increase and expand the number of Health Centers.
The budget includes initiatives that will carry out the Best
Pharmaceuticals for Children Act (BPCA) and alleviate drug-related
medical costs. My budget request for NIH includes an additional $25
million, for a total of up to $50 million, to improve information
available for prescribing pharmaceuticals to children. NIH is focusing
its efforts on drugs that are no longer under patent. The request for
the Food and Drug Administration (FDA) includes $12.3 million to
increase Americans' access to safe, effective, and less expensive
generic drugs and a $1 million increase to expand the range of drugs
available over-the-counter.
The HHS budget includes a series of improvements in the financing
of childhood vaccines to meet three goals--(1) improve vaccine access
for currently eligible children, (2) restore tetanus and diphtheria
booster vaccines (Td, DT) to the Vaccines for Children (VFC) program,
and (3) build a national stockpile of childhood vaccines. Legislation
will be proposed to improve access to VFC vaccines for children already
entitles to them. The budget proposes to expand the number of access
points for underinsured children--those whose private insurance does
not cover the immunizations--by allowing them to receive their VFC
vaccines at State and local public health clinics. To help protect
against future shortages, HHS will, starting in fiscal year 2003,
develop a stockpiling strategic plan and begin building a vendor-
managed, 6-month supply of all childhood vaccines to be completed by
2006. The budget includes $707 million in fiscal year 2003 to 2006 for
the stockpile. Under current-law we can stockpile these vaccines. I
also propose to restore the tetanus and diphtheria booster shots to the
VFC program by removing outdated price caps that are so low for some
vaccines that vendors will not bid on VFC contracts.
The budget also contains $100 million to ensure the nation has an
adequate supply of influenza vaccine in the event of a pandemic. Due to
the constant changes in the circulating influenza strains, we cannot
stockpile influenza vaccine, and the current manufacturing methods
could not meet the Nation's needs in the event of a pandemic. Funds
will be used for activities to ensure a year-round influenza vaccine
production capacity and the development and implementation of rapidly
expandable production technologies. We will work closely with industry
to accomplish these goals.
Senator Specter, you were instrumental in ensuring that patient
safety is a primary focus of AHRQ's research portfolio. In fiscal year
2001, we made awards to 94 grantees in five areas to begin the first of
three years of research to improve patient safety across healthcare
settings. Nearly half of these demonstration projects are focusing on
the use of computers and information technology to prevent medical
errors and to improve reporting of medical errors data Through these
projects, grantees are piloting potential error-reducing technologies
like personal digital assistants (PDAs) for electronic prescription
writing, as well as Computerized Physician Order Entry (CPOE), a
technology that helps to ensure that patients receive the right
medication, at the right dose, at the right time. As a result of these
projects, AHRQ's first step in improving patient safety has been to
demonstrate the efficacy of certain interventions in reducing medical
errors.
Our next step must be to take what we have learned and disseminate
it to healthcare providers and networks. We are putting $50 million
into a new program at AHRQ that will improve patient safety by
increasing investments in hospital information technology. We are also
making a commitment to help implement these technologies in health
systems that otherwise may not be able to make the capital investment.
A focus on small community and rural hospitals will help to bridge the
so-called ``digital divide'' by helping these hospitals catch up with
those that are further along.
AHRQ's budget proposal also includes $24 million for ongoing
activities such as the work of the Patient Safety Task Force and the
Patient Safety Data Reporting System integration efforts, as well as
plans to initiate challenge grants and a patient safety improvement
corps; a $10 million increase for the expansion and enhancement of
information collected in the U.S. Census Bureau's Current Population
Survey; and a $2 million increase to improve the usability and
timeliness of Medical Expenditure Panel Surveys (MEPS) data and help
sustain prior year enhancements to the sample size and content of
surveys that collect information from medical providers, insurers, and
households.
We must do everything within our abilities to address the
disparities in health care in this Nation. The fiscal year 2004 budget
proposes numerous activities to address and alleviate health
inequities. Programs that cut across various HHS agencies strive toward
bettering the health of our Nation.
The fiscal year 2004 budget continues the third year of the
President's multi-year initiative to expand access to care for millions
of Americans especially those who are uninsured. The budget includes
$1.6 billion, a $122 million increase, to provide primary and
preventive health care services to nearly 14 million individuals.
Almost 40 percent of the patients treated at health centers have no
insurance coverage and many others have inadequate coverage. These
health centers are located in our most underserved communities. Over
half are in rural America. In support of the Health Center Initiative,
the President is also seeking to expand the National Health Service
Corps by adding $42 million to increase the number of health care
providers in rural and underserved areas, to a total field strength of
4,300 people; and provide for 2,400 loan repayments and scholarships.
In addition to childhood immunization, the fiscal year 2004
President's budget for the Centers for Disease Control and Prevention
(CDC) requests programmatic increases in several areas. I am seeking a
$12 million increase for the breast and cervical cancer program, which
supports screenings for low-income, underinsured, and uninsured women
between the ages of 50-64, and $5 million to expand School Health
Programs to reduce health risks such as tobacco use, poor eating habits
and obesity. The budget also includes an increase of $10 million for a
Public Health Information Network (PHIN) to integrate and expand CDC's
existing networks to establish a consistent exchange of information
between public health partners.
The Substance Abuse and Mental Health Services Administration's
proposed budget is $3.4 billion, a net program level increase of $198
million over fiscal year 2003. As part of the President's Drug
Treatment Initiative, the budget includes $200 million in fiscal year
2004, a total of $600 million over three years, to establish a new
competitive State substance abuse voucher program. This program will
assist 100,000 Americans in the first year in obtaining the critical
alcohol and drug treatment services they need but lack access to. This
effort complements existing alcohol and drug abuse treatment programs
by providing consumer choice and broadening the base of treatment
providers to include more faith-based providers. Through this new
program individuals seeking drug and alcohol treatment and support
services will be assessed and then receive a voucher to pay for
appropriate community treatment programs. This program will require
accountability by linking payment to providers to demonstrated
treatment effectiveness measured by abstinence from alcohol and drug
use after treatment.
The fiscal year 2004 request also includes an increase of $31
million for the Substance Abuse Block Grant. The Block Grant will
provide drug treatment services to 400,000 persons. In the area of
mental health, we propose $107 million, an increase of $9 million, for
Children's Mental Health Services to serve a total of 17,000 children
and adolescents with serious mental and emotional disorders along with
their families. We are also requesting $50 million, an additional $7
million, for Projects for Assistance in Transition from Homelessness to
serve a total of 147,000 homeless individuals. These funds link efforts
to move homeless individuals off the streets by providing them with
mental health services and substance abuse treatment.
fighting hiv/aids
HIV/AIDS is one of the most serious challenges facing humanity. No
country has been spared. Some have faced widespread devastation. All
have citizens whose lives have been destroyed by this horrible disease.
Our commitment to ending this pandemic is strong and unwavering. The
fiscal year 2004 budget for HHS includes $6.4 billion in discretionary
funds within HHS to combat HIV/AIDS. Within this level is $680 million
to support a variety of efforts to fight HIV/AIDS in developing
nations. For example, our budget includes $150 million to support the
Mother-to-Child transmission of HIV/AIDS prevention initiative. This
initiative seeks to treat approximately one million women annually in
developing countries in order to reduce transmission of HIV to their
children by 40 percent. This is an integral part of the President's
Emergency Plan for AIDS Relief, which seeks to stem the death toll from
AIDS. Currently, demographers project that, absent strong action, life
expectancy will fall from 66 to 33 years in Zambia and from 70 to 40
years in Zimbabwe.
The budget also, includes $2 billion for life sustaining care and
services for over 530,000 Americans under the Ryan White CARE Act. The
Ryan White programs target our resources toward the development of an
effective service delivery system by partnering with States, heavily
impacted metropolitan areas, faith-based and community-based providers
and academic institutions. Our budget includes $739 million to provide
drug therapies to approximately 159,000 individuals. These funds will
provide Americans living with HIV/AIDS a lifeline to care who might
otherwise have to choose between expensive medical treatments and other
necessities. These funds will help eliminate those difficult decisions.
maintaining our investment in biomedical research
I commend you, Mr. Chairman, Senator Harkin, and this Subcommittee,
for your unwavering commitment to doubling the budget for the National
Institutes of Health. After five years of outstanding growth that
doubled the NIH budget, the fiscal year 2004 Budget provides a
significant investment to ensure that the momentum gained over the last
five years is sustained. We have developed a plan that would increase
funding for on-going research by about $2 billion, approximately +7
percent. The fiscal year 2004 budget totals $27.9 billion, a net
increase of $718 million above the fiscal year 2003 enacted
appropriation. Within the NIH Budget, research grows much more rapidly,
as a result of redirecting one-time project cost savings into new
biomedical research funding. NIH will fund a record number of new and
competing research grants. Advances in scientific knowledge have
provided the foundation for improvement in public health and have led
to enhanced health and quality of life for all Americans. Much of this
can be attributed to the ground breaking work carried on by, and funded
by, the National Institutes of Health. Some additional highlights of
NIH funding include:
--Over $15 billion to fund an expected record number of research
project grants (at least 10,500 for competing grants and a
total of approximately 39,500 grants);
--An increase of $25 million for a total of $50 million for pediatric
drug use studies;
--An increase of $50 million for Type 1 diabetes research ($150
million total in mandatory appropriation); and
--An increase of $25 million for NIH's new strategic biomedical
research ``roadmap''.
fighting bioterrorism
Mr. Chairman, as Americans confront the realities of terrorism and
hostilities around us, it is imperative that the Federal Government be
prepared to keep our citizens safe and healthy.
HHS's $3.6 billion bioterrorism budget substantially expands
ongoing medical research, strengthens State and local preparedness and
targets investments to protect our food supply. State and local public
health preparedness activities funded by the Centers for Disease
Control and Prevention (CDC) and hospital preparedness efforts
supported by the Health Resources and Services Administration (HRSA)
would receive a total of $1.5 billion. The President's proposal
significantly increases ongoing biodefense research at the National
Institutes of Health (NIH). The budget includes a total of $1.6 billion
for basic research on the biology of microbial agents with bioterrorism
potential and applied research on the development of new or improved
diagnostics, vaccines, and therapies. We propose increasing support for
bioterrorism education for clinicians by $32 million, for a total of
$60 million, to provide incentives for 25 medical and health
professions curricula reform projects and provide continuing education
to 65,000 health care providers on the diagnosis, treatment, and
reporting of diseases that can be caused by the intentional release of
a biological agent. The bioterrorism budget also includes initiatives
to improve food safety: $15.5 million targeted on newly authorized
activities, including registration of domestic and foreign food
facilities and State grants to improve state food laboratories,
monitoring and inspections; and an additional $5 million for improving
information exchange with State food laboratories on food pathogens.
HHS, in cooperation with the Department of Homeland Security, will
spearhead the development of Project Bioshield. This project, which the
President recently announced, will bring together the scientific and
fiscal resources of the United States government in an innovative
effort to develop medical countermeasures against bioterror before they
are ever needed. Project Bioshield will have three (3) major goals:
--To ensure that sufficient resources are available to procure the
next-generation countermeasures. A guaranteed funding source
must be available to enable the government to purchase vaccines
and other therapies as soon as experts believe they can be made
and will be safe and effective, and spur industry investment in
the development of these vaccines/therapies.
--To Accelerate NIH research and development. This involves providing
more flexible contracting process and procurement authorities
for critical biodefense work.
--To make promising treatments available more quickly for use in
emergencies. This means establishing a new FDA Emergency Use
Authorization that would permit greater flexibility and
latitude than the current Investigational New Drug (IND)
authority in the use of promising medical countermeasures that
are under development in emergency situations.
While funding for the next generation countermeasures will be in
the new Department of Homeland Security (DHS), HHS will provide the
scientific direction, and will be responsible for the actual
procurements. Furthermore, HHS will continue to manage the Strategic
National Stockpile and provide the scientific and public health
direction needed to ensure that the pharmaceutical stockpiles include
appropriate amounts of vaccines, other therapeutics and emergency
equipment/supplies. New mandatory funding will also be included in DHS
which will ensure that adequate resources are available to procure new
medical countermeasures once sufficient research has been conducted to
demonstrate that the products will be proven safe and effective. A
guaranteed funding source must be made available to industry to
stimulate interest and investment in the development of these products.
This authority would be invoked only if there is no significant
commercial market for the products.
head start
Never has there been such a clear commitment on the part of Federal
and State governments to enhance the well being of children and
families. Never have we known so much about what children need for
healthy growth and development. Never have so many programs been
focused on meeting these needs of our most vulnerable citizens. There
are more resources currently available for low-income children and
families than at any other time in our nation's history. The
President's budget continues this commitment with a budget of $6.8
billion to provide 923,000 children Head Start services. However, not
all the news is good. Children in Head Start enter school further ahead
than other economically disadvantaged children. But unfortunately--even
after 30 years--Head Start children do not enter school at the same
level as more economically advantaged children.
To strengthen the Head Start program, improve services to low-
income children, and promote the coordination and integration of
comprehensive early care and education services, President Bush is
asking Congress to include in the reauthorization of the Head Start Act
a provision that will allow interested states to include Head Start in
their preschool plans. Under the President's proposal, states are
offered the opportunity to coordinate preschool programs with Head
Start programs in exchange for meeting certain accountability
requirements. States wishing to participate must submit a state plan
that addresses several fundamental issues concerning preschool
education.
faith based and community initiatives
In support of the President's Faith-Based and Community Initiative,
the HHS fiscal year 2004 budget supports programs that link faith- and
community-based organizations, State and local governments, and Federal
partners to provide effective substance abuse treatment and positive
youth development.
Another important program that helps some of our most vulnerable
children is the Mentoring Children of Prisoners program. We are asking
for funds to be increased to a total of $50 million, which would in
turn be made available to faith-based, community-based, state and local
governments, tribes, and public organizations for programs that provide
supportive one-on-one relationships with caring adults to children who
are more likely to succumb to substance abuse, gang activity, early
childbearing and delinquency. This down payment will help more than
30,000 adolescent children of prisoners receive guidance, have positive
role models, and give them a fighting chance to succeed.
The President's budget also proposes $20 million for promotion and
support of responsible fatherhood and healthy marriages. This funding
will promote and support involved, committed, and responsible
fatherhood and encourage the formation and stability of healthy
marriages.
In addition, the budget request for the Compassion Capital Fund is
$100 million, an increase of $65 million above the fiscal year 2003
appropriation. These funds would continue to be used to provide
technical assistance to faith- and community-based organizations to
expand and emulate model social programs.
strengthening and improving medicare
Even though Medicare is not under the jurisdiction of this
Committee, we are all aware that our Nation's Medicare program needs to
be modernized and improved to provide seniors with more choices and
better benefits. While we remain steadfastly committed to ensuring that
America's seniors and individuals with disabilities can keep their
current, traditional Medicare, the President is dedicating $400 billion
over ten years to provide access to subsidized prescription drug
coverage, better private options for those beneficiaries who want them,
full coverage for disease prevention, and better protection from high
out-of-pocket costs.
Under the President's framework, seniors happy with their coverage
under traditional Medicare will be able to keep it, with added
protection against high out-of-pocket drug expenses at no additional
premium. Seniors who want better coverage will be offered the same
types of plan choices available to members of Congress and federal
employees. Private plans will be available in each region of the
country, including rural areas. Plans will provide full coverage of
preventive care, protection against high out-of pocket medical costs,
and cost sharing that does not penalize the sick. Comprehensive,
subsidized prescription drug coverage will be available to those who
want it for an additional premium. Low-income seniors will face no
premium for drug coverage and will have only nominal cost-sharing
requirements. Seniors who enroll in these plans will maintain the
ability to choose any doctor and any hospital.
Seniors willing to accept a more selective provider panel will be
able to enroll in the same type of low-cost, high-coverage managed care
plans available today. These plans will offer a subsidized,
comprehensive drug benefit, as well as all the additional benefits I
just described. Plans can also offer extra benefits and broader
coverage.
strengthening and improving medicaid and schip
State Health Care Partnership Allotments
Another of our mandatory initiatives that I would like to briefly
highlight is our plan to strengthen and improve Medicaid and SCHIP.
Building on the successes of the State Children's Health Insurance
Program (SCHIP) and the Health Insurance Flexibility and Accountability
(HIFA) demonstrations have shown in increasing coverage while providing
flexibility and reducing the administrative burden on States, the
Administration proposes optional State Health Care Partnership
Allotments. Under this proposal, States would have the option of
electing to continue the current Medicaid program or to choose
partnership allotments. The allotment option provides States an
estimated $12.8 billion over seven years in extra funding over the
expected growth rate in the current Medicaid and SCHIP budgets. If a
State elects the allotments, the federal portion of the SCHIP and
Medicaid funding would be combined and states would receive two
individual allotments: one for long-term care and one for acute care.
States would be required to maintain their current levels of spending
on Medicaid and SCHIP, but at a lower rate of increase than the federal
allotment.
States electing a partnership allotment would have to continue
providing current mandatory services for mandatory populations. For
optional populations and optional services, the increased flexibility
of these allotments will allow each State to tailor its provision of
health benefit packages for its low-income residents. Let me stress
that this is an OPTION we are proposing for States.
New Freedom Initiative
Promoting home and community-based care as an alternative to
nursing homes for the elderly and disabled is a priority of this
Administration. The New Freedom initiative represents part of the
Administration's effort to allow Americans with disabilities to be more
fully integrated into their communities. Under this initiative, we are
committed to promoting the use of at-home and community-based care as
an alternative to nursing homes. The Administration will invest $350
million in fiscal year 2004, and $1.75 billion over 5 years on this
important initiative to help seniors and disabled Americans live in the
setting that best supports their needs.
Transitional Medicaid Assistance (TMA)
TMA provides health coverage for former welfare recipients after
they enter the workforce. TMA allows families to remain eligible for
Medicaid for up to 12 months after they lose welfare-related Medicaid
eligibility due to earnings from work. This budget proposal would
authorize the TMA program for five more years, at a cost of $400
million in fiscal year 2004, and $2.4 billion over five years. We are
also proposing modifications to TMA provisions to simplify it and make
it work better in coordination with private insurance. These
modifications cost $20 million in fiscal year 2004 and $290 million
over five years.
empowering america's families
Reauthorization of Temporary Assistance for Needy Families (TANF) and
the Child Care Development Fund
Building on the considerable success of welfare reform in this
great Nation, the President's fiscal year 2004 budget follows the
framework proposed in the fiscal year 2003 request, which includes the
reauthorization of TANF. We applaud passage of H.R. 4 and are committed
to working with both the House and the Senate to ensure the legislation
moves quickly and is consistent with the President's Budget. The
President's proposal includes five years of funding for the TANF Block
Grants to States, and Tribes; Matching Grants to Territories; and
Tribal Work Programs at current levels. In addition, the Budget
proposes to reauthorize state-based abstinence education grants for
five years at $50 million annually, to further assist with reducing the
number of out-of-wedlock births, reducing the spread of STDs among
teens, and helping teens make healthy life choices.
Increasing Support for Children in Foster Care
In a continuing effort to improve the lives of children who are at
risk of abuse and neglect, this Administration is proposing a child
welfare program option that States can use to improve their child
welfare service systems. This plan would allow States to choose a fixed
allocation of funds over a five-year period rather than the current
entitlement funding for the title IV-E Foster Care program.
Participating States would receive their funds in the form of flexible
grants which could be used for a wide array of child welfare-related
purposes, such as child abuse and neglect prevention, maintenance and
administrative payments for foster care, child welfare training, and
family support. The flexible funding will allow States to develop
innovative ways to ensure the safety, permanency and well-being of
children, tailed to meet the needs of their child welfare populations.
States which elect this option and experience emergencies affecting
their foster care systems may access additional funding from the TANF
contingency fund.
The Administration is proposing a nearly $5 billion budget for
Foster Care in fiscal year 2004, a $90 million increase over last
year's request. Not only will these funds support a child welfare
program option, but they also will be used to provide payments for
maintenance and administrative costs for more than 240,000 children in
foster care each month, as well as payments for training and child
welfare data systems. The President's budget also requests $200 million
for the Foster Care Independence Program.
Additionally, the Administration continues its commitment to the
Promoting Safe and Stable Families Program by requesting to $505
million to assist States in coordinating services related to child
abuse prevention and family preservation. This important program also
promotes adoption and provides post-adoption support to families.
Child Support Enforcement
The President's fiscal year 2004 budget will build on the
considerable success of the Child Support Enforcement program.
Legislation will be proposed to enhance and expand the existing
automated enforcement infrastructure at the Federal and State level and
increase support collected on behalf of children and families. When
combined with the opportunities to increase child support outlined in
the President's fiscal year 2003 budget (expanded passport denial,
offset of certain Social Security benefits, optional pass through of
child support to families on TANF, among others) these proposals offer
an impressive $7.5 billion in increased child support payments to
families over 10 years. The budget also recognizes that healthy
families need more than just financial support and increases resources
for the Access and Visitation Program to support and facilitate non-
custodial parents' access to and visitation of their children.
president's management agenda
I realize that as we work to improve the heath and well-being of
every American citizen, we also need to improve ourselves. I am
committed to improving the management of the Department of Health and
Human Services. The fiscal year 2004 budget supports the President's
Management Agenda and includes cost savings from consolidating
administrative functions; organizational delayering to speed decision
making processes; competitive sourcing; implementation of effective
workforce planning and human capital management strategies; and
adoption of other economies and efficiencies in administrative
operations. We have also included savings in information technology
(IT) which will be realized from ongoing IT consolidation efforts and
spending reductions made possible through the streamlining or
elimination of lower priority projects. The IT infrastructure
consolidation will further reduce infrastructure expenditures for
several HHS agencies and should be fully implemented by October 2003.
improving the health and safety of our nation
Mr. Chairman, the budget I bring before you today contains many
different elements of a single proposal. What binds these fundamental
elements together is the desire to improve the lives of the American
people. All of our proposals, from building upon the successes of
welfare reform to protecting the nation against bioterrorism; from
increasing access to healthcare, to strengthening Medicare; all these
proposals are put forward with the simple goal of ensuring a safe and
healthy America. I know this is a goal we all share, and with your
support, we are committed to achieving it.
Senator Specter. Thank you, Mr. Secretary.
Our practice is to have 5-minute rounds, and we will adhere
to that. Obviously, there will be a number of rounds for you
because of the very many issues which are involved here.
SEVERE ACUTE RESPIRATORY SYNDROME
The most immediate concern, among many immediate concerns--
it is hard to put anything ahead of bioterrorism today when the
48-hour period for President Bush's ultimatum will expire in
just a few hours. But there is grave concern about the
respiratory infection which has triggered a global health
alert, and in an era where everybody is worried about plots and
plans, some speculation has arisen as to whether this virus
might have been planted in China to see what the results would
be. And there is some grave concern that this could have
enormous implications as an infectious disease.
How serious is it, Mr. Secretary, as a potentially
infectious disease that could present an enormous health threat
around the world?
Secretary Thompson. Senator, we are very concerned about
it. It started in Guangdong Province, we think, but we are not
sure that there is actually a continuation of that. But
basically we think that there is a possibility that is where it
started. There were 300 cases there. I have met with the
Minister of Health here in Washington from China. At the
beginning he was not as cooperative as we would like, but
subsequently we have been working very closely with China, with
the World Health Organization. In fact, almost on a daily basis
I----
Senator Specter. Mr. Secretary, what are the details? The
reports were that they would not cooperate with us. Is that
true?
Secretary Thompson. That was true at the beginning,
Senator, but that has subsequently changed and we are now going
into Guangdong Province, as we speak, with CDC people and WHO
people.
Senator Specter. What was the cause for their initial
reluctance to be cooperative?
Secretary Thompson. They were in the process of changing
their government. They were also reluctant to have outsiders
from the United States come in and assist them at the
beginning. They thought they had it controlled and did not
think they needed any further help. And those were basically
the reasons given to me when I talked to the Deputy Minister of
Health when he appeared here in Washington about 12 days ago.
Senator Specter. Is there realistically potential for a
worldwide epidemic from this respiratory ailment?
Secretary Thompson. There is that possibility. We are not
certain it is a probability, but it is certainly a possibility.
It has showed up now in Hong Kong, Bangkok, Singapore, Sweden,
possibly in Germany, definitely in Canada. We are investigating
approximately 40 cases in the United States. Forty cases were
reported. We are looking at 11 cases, but nothing has been
confirmed. Two scientists in Germany have indicated from nasal
swabs that there is the possibly of the paramyxo virus, but
that has not been confirmed by either WHO laboratories or CDC.
Senator Specter. If so, what would that mean?
Secretary Thompson. It would mean that it would be a virus
that we could identify and would have some way then to control
and treat it. But so far, we have not been able, Senator
Specter, to make an accurate confirmation from CDC if it is
even a virus. We think it is, but we are not sure, and what
virus it is has not been confirmed. Therefore, until CDC's
laboratories confirm it, we do not make any kind of
speculations as to what this particular disease is.
Senator Specter. To the extent that you can answer this
question--and it may be impossible to answer--what causes
something like this?
Secretary Thompson. We are not sure, Senator. That is one
of the questions that we are still trying to find an answer
for.
[The information follows:]
Severe Acute Respiratory Syndrome
The cause of Severe Acute Respiratory Syndrome (SARS) is not known
at this time. Some researchers have reported finding paramyxovirus-like
particles in respiratory specimens from a few cases of SARS.
Paramyxovirus is a family of viruses that cause respiratory infections
and childhood illnesses including measles, mumps, and croup. The
Paramyxovirus family also includes a recently identified virus called
metapneumovirus. These are preliminary findings and at this time we
cannot say for certain that a paramyxovirus is the cause of SARS. Some
of the paramyxoviruses that cause respiratory infections are
widespread, especially during the winter season, so it is not
unexpected to see them in an upper respiratory specimen. Analysis of
laboratory specimens to identify a cause for SARS is ongoing both by
CDC researchers and by researchers from other countries.
Information currently available about SARS indicates that people
who appear to be most at risk are either health care workers taking
care of sick people or family members or household contacts of those
who are infected with SARS. That pattern of transmission is what would
typically be expected in a contagious respiratory or flu-like illness.
However, as the investigation continues, we will continue to consider
all possibilities.
Senator Specter. Well, it is obviously very difficult to
answer that kind of a question, but that is on everybody's
mind. Is there any possibly, however remote, that this could be
a virus planted as part of biological warfare?
Secretary Thompson. It is certainly possible, Senator. We
think it is very, very doubtful. We think this is some sort of
a virus, but we are not even certain of that.
All I can tell you is that the laboratory scientists and
technicians and analysts at CDC are working around the clock.
We have just received the specimens from Hong Kong late
yesterday afternoon. We needed those specimens. We have got the
specimens and the autopsy report in from Canada. We are
reviewing all of those things. The scientists are working
extremely hard. I meet either in person or by teleconferences
with Dr. Gerberding and the staff at CDC on a daily basis, and
we will have a conference at 9:30 a.m. tomorrow for an update
as to what the scientists were able to analyze over the
evening.
But at this point in time, there is nothing new to report
to you, Senator, but I will be more than happy, this afternoon,
when I get the update to call you and Senator Harkin so that
you can let the other members of the committee know what the
results are. We will give you up-to-date information on a daily
basis from my office as to what is transpiring, but right now
we do not know for sure where it really started. We think
probably Guangdong Province, but we are not certain. We are not
certain if it is a virus, and as soon as we do find answers to
those questions, I will give you a call and let you know
directly.
Senator Specter. Okay.
During your last answer, my red light went on, so I will
not ask another question until the next round.
I would note very briefly that in Pittsburgh recently we
see efforts made to get reports from doctors and hospitals to
try to see if there is any pattern of an illness which might
portend of a biological attack, and at a time when there is
such anxiety worldwide, to have this suddenly crop up, it is an
avenue which needs to be explored.
Then we are going to come back in the next round, as far as
I am concerned, to the CDC, a very important agency undergoing
enormous renovations with their laboratory facilities and the
budget cuts them at a time when they are an agency of
importance second to none. But I will await round two.
OPENING STATEMENT OF SENATOR TOM HARKIN
Now my distinguished colleague, Senator Harkin, Democrat of
Iowa.
Senator Harkin. Thank you very much, Mr. Chairman.
Mr. Secretary, thank you very much for your great
leadership at the Department on so many areas.
First, on the budget end, I just want to commend you for
your leadership in putting in the systems change grants. We
have talked about that in the past. You have taken great
leadership on that. This is one where it is going to make a
real difference in States in getting people out of institutions
and getting them in the community. So thank you very much for
that and for including these grants in your budget.
Again, I also want to compliment you on your great emphasis
on prevention in the budget and what you are doing on
preventative health care. I know you personally spearheaded
this new emphasis. I wish we had more dollars in there; I am
sure you do too.
But I would just make note that on another committee on
which I sit, the Agriculture Committee, this year we are
reauthorizing the school lunch, school breakfast WIC program,
summer feeding program. I hope there is a good cross-
fertilization between your Department and Agriculture on some
of these issues. There is a blending here, and we need, I
think, to start promoting, as you said in your own budget
proposal, healthier lifestyles, cutting down on childhood
obesity, getting kids more exercise programs, getting them
learning how to eat right in the beginning. So I guess I am
just making a plea for you to help us as much as you can in
another Department----
Secretary Thompson. I would love to.
Senator Harkin [continuing]. Because I think this is a
merge here and we need your help on these matters as we move
ahead.
After all those accolades, I will say I am disappointed in
the 2.5 percent increase for NIH. I do not know what we are
going to do about that, but that really is not acceptable. We
have got to have a bigger increase in NIH than that 2.5 percent
increase.
HEAD START
Lastly, again on Head Start, Mr. Secretary, you have been a
great leader in Head Start. I know your devotion to the
program. I know you have been very supportive of it. For years
now, I think for the 18, 19 years I have been on this committee
and on the authorizing committee, there have been at various
times proposals to take Head Start and move it into Education.
People think that this is an education program and we are going
to teach kids how to read. Well, that is a part of Head Start.
But as you have pointed out in your own document statement,
these kids come from low-income families. They do not have the
kind of family support. They do not even have the health
support. Their health matters are usually worse. Their living
conditions and socialization skills are worse. Head Start is
something that reaches into all these areas. So rather than
trying to move this to the Department of Education, I think we
need to put more emphasis on Early Head Start, the 0 to 3, and
getting more into that area.
So I say to you as a great friend and an admirer of yours,
Mr. Secretary, please go back and tell your boss and the other
people around that there are a number of us here who are not
going to let it be transferred to the Department of Education.
It ain't gonna happen.
Secretary Thompson. I have already said that, Senator.
Senator Harkin. Okay, well, then tell him you have got
backing up here. It is not going to happen. So we are on your
side on that, and we will do everything we can to support your
budget in that area.
CENTERS FOR DISEASE CONTROL AND PREVENTION INITIATIVE
Lastly, my time is about to run out. I made a statement,
but I guess my question would be getting back to CDC, the
Centers for Disease Control. You have that new $100 million
prevention initiative at CDC. Again, I just hope that we can
put a lot of emphasis on that and that we can focus some more
attention on building up CDC. We have done NIH. We got it
doubled. We need to keep it going. The 2.5 percent is too low.
But, Mr. Secretary, I just need your thoughts on CDC and
where we are headed this year in terms of getting them up to
speed and getting the kind of budget that they need both for
the prevention, which you are aimed at, which is good, but also
for the public health aspect that we need in America to build
up our public health infrastructure that I think--well, I do
not know if you agree or not--I think really went downhill over
the last 40 years, and we need to build it up again. So just
your thoughts on that.
Secretary Thompson. Thank you so very much. Can I just
quickly go through a lot of the points you raise?
Senator Harkin. Sure.
Secretary Thompson. First, on the Freedom Initiative and on
the grants initiative, thank you for your leadership. It is the
right thing to do to keep people in their own home, and I am
fully behind it, enthusiastic, glad we put the extra money in
because it is the right thing to do.
In regards to prevention, $152 billion a year spent on
tobacco-related illnesses. 400,000 people die. $132 billion a
year on diabetes. Seventeen million Americans are diabetic.
Sixteen million are pre-diabetic, and 200,000 people die a
year. We have done an exhaustive study in which 60 percent can
be prevented if, in fact, we walk 30 minutes a day and lose 10
to 15 pounds.
Senator Harkin. Can I interrupt you right there, Mr.
Secretary?
Secretary Thompson. Sure.
Senator Harkin. A recent study showed that 80 percent of
elementary school kids in America do not even get 1 hour of PE
a week at the schools--80 percent.
Secretary Thompson. It is not the right thing to do. And we
have got to get people out--$117 billion on obesity and 300,000
people die. Senator, we have to do it. Ninty-five percent of
the money in Medicare goes to waiting for people to get sick
and then getting them well, and only 5 percent on preventative
health. We need to put more money into it.
NIH, granted it is 2.5 percent. But the actual research
dollars will be $1.9 billion, or a 7.5 percent increase because
we put more money in fiscal year 2003 into buildings in one-
time costs, such as $250 million in anthrax expenditures, plus
the extramural capital expenditures. So actually we are going
to have a 7.5 percent increase in the research. There will be
more research grant dollars than ever before.
On CDC, in regards to preventative health and on State
health, you are absolutely correct. We let it go downhill.
But thanks to your leadership and that of Senator Specter
and this committee on a bipartisan basis in Congress, we put $1
billion last year in fiscal year 2002 in building up the State
health departments. And I want to tell you one of my concerns
is the States have only drawn down 19 percent of that money. We
got it out there and the States have only drawn down--we got an
additional $1,418,000,000 to send out this year, and we are in
the process of sending it out. So if you could help me get the
State of Iowa to draw more of their money down and use it, it
would be very helpful. We need to do it. Plus, we are asking an
additional $1.5 billion for fiscal year 2004 to do it. We have
the greatest opportunity, Senator, to be able to build up local
State health departments the way you envision it, the way I
envision it, than we have ever had before. The money is there.
The money is out the door and it has been allocated. It just
has not been drawn down by the States.
Senator Harkin. Fascinating. Thank you, Mr. Secretary. We
will look into that.
Senator Specter. Senator Craig.
OPENING STATEMENT OF SENATOR LARRY CRAIG
Senator Craig. Well, Mr. Chairman, thank you very much.
Mr. Secretary, great to have you with us this morning.
Secretary Thompson. Thank you, Senator.
COMMUNITY HEALTH CENTERS
Senator Craig. I have some comments and you may want to
react to them much like Senator Harkin, but let me commend you
first for your continued support of community health centers.
The budget proposal takes another positive step toward
improving the health care in rural America. Most of my State
still gets the definition of being rural. And the inclusion of
$122 million to provide primary and preventative health
services to nearly 14 million individuals is a great advance, I
think, for our Nation's health centers.
NATIONAL HEALTH SERVICE CORPS
In addition, your focus on the National Health Service
Corps I think would provide much needed scholarship and loan
assistance to additional health care providers in underserved
and rural areas.
AGING
I have a fun experience and a unique opportunity now,
serving as the chairman of the Special Committee on Aging. I
have got a great staff. We are doing a lot of exploratory
overview of the aging of America, Mr. Secretary. I must tell
you that it is, without question, time to modernize and improve
Medicare. All of us understand that. The prescription drug item
in it is going to be important if we can work out our
differences.
CHRONIC ILLNESS
But you have talked about the way health care is delivered.
We have got some excellent pilot programs going on at CMS as it
relates to managing chronic illnesses. We could literally take
all of those who have that situation, pay for their full health
care if they would simply adhere to the protocols, and we would
save billions and billions of dollars a year in health care
costs and certainly in their ability to conduct and live in
society.
OBESITY
But the thing that fascinates me most in this process--and,
Senator Harkin was talking about the growing epidemic of
obesity in this country. We have got 60,000-plus centenarians
in our country today. That is 100 years old or older. With
current trends, we are going to be over 1 million in 60 years.
And if we find the cure for cancer--and we know we are
certainly on the threshold of major breakthroughs--that number
skyrockets. Thank goodness, a positive sign in the lives of
Americans.
At the same time, those people are going to be able to live
a great deal better if they exercise and if they have good
nutritional advice and understand the value of nutrition. We
have held several hearings in that area today. It is dramatic
what happens in the senior community as it relates to the cost
of health care when they simply exercise and eat right. The
cost goes down dramatically and they live longer and they are
much healthier.
While we are not teaching our kids to exercise anymore, we
know that most people do exercise better, at least if they are
learning to, in groups. In certainly our seniors we are finding
that to be the case also. They will tend to exercise if they
can exercise together. That is some work we are going to spend
a good deal more time with. But it is something that, clearly,
as we look at our health care delivery systems, we ought to be
a lot more interested in preventative than maintenance. If we
can get at that, the costs involved will be dramatic.
I am pleased to see the President's Disease Preventative
Initiative and the support that is going on there. But it is
obvious to me that we have got to modernize our health care
delivery system or that part of it that we are participating
in--it is lagging by about 30 years, and it makes good sense to
get us active in promoting all of these things.
I think your budget certainly goes in that direction. It is
going to be a tight budget year. We all understand that. There
is a good deal more we would like to do, but this is probably a
year when we will not be able to do all we would want to do. I
am quite sure Americans will agree if we are in a time of war
and we have certain responsibilities there, there is going to
have to be an understanding of allocation.
But I thank you very much, and I am pleased to see the
direction we are headed in.
Secretary Thompson. Senator Craig, thank you so very much
for your comments. I appreciate them tremendously and I can
only say that I want to work with you on all of the subjects.
Community health centers, absolutely doing an awesome job. They
are serving the underinsured and the uninsured and a lot of
minorities. We are expanding them thanks to the cooperation on
a bipartisan basis. We are very appreciative of that support.
The National Health Service Corps. Very important to get
doctors graduated, get them out into underserved areas like
your State and my State and the States of the members on this
committee. I want to work with you on that. It is something
that we need to do more of.
Medicare-strengthening and prescription drug coverage.
Absolutely vital this year. You have certainly heard about the
trustees' report. Certainly I was very concerned when we met
this past Monday. Medicare is going to stop having a surplus in
the year 2013, 3 years sooner than it was before. This is going
to cause all kinds of problems. It will be absolutely broke by
the year 2026, 4 years earlier than it was estimated last year.
So it is accelerating, and that means that at the present time,
2 percent of the dollars that go into the budget come from
loans from Social Security and Medicare. It will no longer
happen after fiscal year 2009. A big concern of the Congress
and of mine.
Medicaid needs to be improved and strengthened, and that is
what we are trying to do with the new Medicaid proposal.
In regards to the individuals that are living longer, there
is no question about that. The demographics show that we must
start addressing that issue--and I do not think we have done a
very good job in the past.
Senator Craig. I agree.
Secretary Thompson. And I thank you so very much for taking
the leadership in this area.
We have got to find ways in which we can get some tax
credits for people to purchase long-term insurance. We have to
get more people involved. We have to figure out a way to get
tax credits, I think, for individuals who start leading
healthier lifestyles. It is going to be very difficult and
complex, but it is something that I think we should do.
I am setting up a summit with the National Institutes of
Health and the University of North Carolina Medical School in
which we are going to have a summit of health insurance
companies, of fast food industries and businesses, as well as
individual organizations around the America to talk about
preventative health and how we might be able to work together
in America to start changing lifestyles. That is why the $125
million is the request in there from my Department, from me
personally because I really believe that this is something we
have to do.
Unless we start exercising, unless we start eating properly
and losing some weight, we are going to continue to cause a
tremendous rupture in the health care delivery system because
$152 billion a year on tobacco-related illnesses, $132 billion
on diabetes, $117 billion on obesity, all of these can be
changed dramatically by watching what we eat and exercising.
That is why the $125 million is going to be put out there.
We are going to try and declare certain cities ``healthy
cities'' and have them vie for it. They have to show a
reduction in asthma and diabetes. They have to show that they
are improving their walking trails for families in their
communities. I think it is going to be a very well thought and
well received program. I have talked to the League of Cities
across America. They have been very supportive of it because
they can see what it would mean to their city if they are
designated as a healthy city.
I think that these are the kinds of things that we can work
together on a bipartisan basis and really improve the quality
of health, hold down on dollar amounts because we are spending
so much on waiting for people to get sick and then trying to
get them well when we could spend a lot less and keep people
healthier and lead a better quality of life for all Americans.
So I thank you and want to work with you on these
particular subjects, and we will, hopefully, be able to start
programs that are really going to accomplish these objectives.
Senator Craig. Well, Mr. Secretary, thank you for those
comments. I find it ironic, as we have worked over the last
several decades to take fat out of our diet, that we created an
obesity epidemic.
Secretary Thompson. We really have.
Senator Craig. I think we better revisit our nutritional
patterns.
Thank you.
Secretary Thompson. Thank you very much. I put the whole
Department of Health and Human Services on a diet and I want to
tell you that we are doing well.
Senator Craig. Good.
Senator Specter. Senator Landrieu.
OPENING STATEMENT OF SENATOR MARY L. LANDRIEU
Senator Landrieu. Thank you, Mr. Chairman.
Let me just begin by welcoming you, Mr. Secretary, and I
look forward to working with you on many of the issues that we
have worked well together on in the past and look forward to
some more progress in adoption and foster care and Head Start,
early childhood education, et cetera.
TAX CUTS
But just a couple of comments. I agree with the Senator
from Idaho about the sacrifices that we need to make at this
particular time with the war looming and with great challenges
on the home front. But I would hope that those sacrifices could
be equally shared and not borne disproportionately by the poor
children of this country and by the vulnerable elderly. So when
sacrifices have to be made, I hope perhaps some tax cuts for
certain segments could be postponed or put on hold while we
make sure that we are covering the essential services to poor
children and their families so that the sacrifices made do not
fall disproportionately on just those in uniform and their
families and the poor children and the vulnerable seniors. So
that is going to be a major debate as we frame the budget that
you are able to operate.
Second, with the modest increase that you are given, you
have got quite a challenge before you in terms of meeting the
challenges that you have just stated in answering many of the
questions: medical, Medicare, the obesity issue, substance
abuse, the number of children in foster care, the health care
system that you could claim in some ways is in a crisis
situation because we are not particularly geared right now to
handle just the regular medical challenges of this Nation, but
the bioterrorism challenges, which of course is homeland
defense, but nonetheless important.
FOSTER CARE
But let me, having just opened with that, ask you a couple
of questions about your budget. I noticed with great interest
your comments, although they were brief in the budget, about an
``alternative funding system for foster care.'' Would you just
take a moment to maybe elaborate on some of your ideas
regarding more flexibility in the foster care system in that we
are spending I think somewhere, including the State portion,
about $8 billion trying to--I do not know how you describe what
we are trying to do. I guess we are trying to keep families
together, but when they cannot be kept together, promote
adoption. In the meanwhile, we support the sort of temporary
foster care system that in my mind has gotten quite expensive.
I think that there would be ways to actually do a better
job servicing our families, saving children, promoting adoption
for maybe less money if we could rethink the way this funding
stream is put together. So could you just give a brief--and I
want to just give a minute to this if you could about what some
of your thoughts might be.
Secretary Thompson. I certainly will try, Senator Landrieu.
First off, let me thank you for your leadership in this
area because you have definitely been a leader on adoption and
foster care, and it is well recognized. And I want to work with
you. Senator Clinton and Congressman----
Senator Landrieu. DeLay.
Secretary Thompson [continuing]. Tom DeLay have contacted
me and want to work with me on this, and I would appreciate you
also working with me on it.
Right now, as you probably know, the foster care system is
somewhat arcane in that you can only use the Federal 4(e)
dollars in foster care for children who are defined under the
old AFDC formula, which was eliminated in 1996. So you have to
go back and compute the children under that formula, which is
no longer in existence, and you can only use the Federal
dollars for that and then you can only use the Federal dollars
after the family has broken up or has caused problems and the
child is removed and placed in a temporary foster home.
We think we should be able to spend the money, hopefully,
at the preventive stage. I am big on this prevention because I
think that is where we need to go as a Government, is to start
preventing things before they happen. If we could use some of
the Federal dollars in a preventative stage, on a voluntary
basis, I think we could cause a lot better outcome. I think the
families could stay together. The children could stay in the
families instead of being removed and going into the foster
care system. That is the thrust of our proposal and that is the
alternative funding, is to go into the preventative stage on a
voluntary basis. It would not be mandatory. It would be a
voluntary thing.
We are hopeful that we are going to be able to get
bipartisan support on this. It appears that the Governors are
very supportive so far, and it appears that we are getting
bipartisan support. I would certainly solicit your support in
this as well.
Senator Landrieu. I look forward to working with you. I
have got one more question, but I want to just encourage you
along that line because with the new legislation that has been
supported on a bipartisan basis to really promote unification
where possible, but then move quickly to adoption when it is
not, and focus also on the preventive aspects, which is
substance abuse treatment for some of these families that, if
treated, could potentially continue to raise their children and
do a good job. So I really encourage you and look forward to
working with you.
HEAD START
But my second point would be on Head Start. I would say to
the chairman and the ranking member while there are
disagreements right now or different views, I should say, about
this program, I hope that we would not establish victory for
either side as to whether it stays in the Department of
Education or just stays in the Department of Health and Human
Services. That should not be what we decide is victory. What
victory should be is having an early childhood education
program in this Nation that is up to the task of getting
children basically ready to learn when they hit that
kindergarten door.
That is going to take a combination of efforts, Mr.
Secretary, as you know, combining the resources of the cities,
the States, of the Department of Health and Human Services, and
the Department of Education. So I would like to really think
about using this not to create a fight between agencies, but
use it as an opportunity to really strengthen a signature
program that could have a dramatic impact, Mr. Secretary, if we
do it right, on all the things that you outlined and could be a
tremendous legacy for you and for your administration to get
that in place.
So I look forward to working with you and the members of
this committee to fund the reform efforts that you put down.
Thank you.
Secretary Thompson. Senator Landrieu, thank you so very
much for your comments, but thank you so very much for your
willingness to help on this Heat Start. I could not agree more
enthusiastically with what you want to have as the outcome. If
we can develop a better program--that is why you are in
Government. That is why I am in the administration. We should
work for that. I am confident that Secretary Paige and I will
work on a collaborative basis with you. Any suggestions you
might have on how to improve the program I will take very
seriously I know, and I know Secretary Paige will.
I think we can develop a much better program. What we are
trying to do is allowing for the States to be able to integrate
their early childhood dollars, because I think really there is
a disconnect there. And I would like to be able, on a voluntary
basis, to allow Governors to have more involvement in the early
childhood stages.
Second, I would like to put a lot more emphasis on the
earliest childhood, the 0 to 3. That is where we really need to
put some more emphasis. And I know you agree with that, and I
thank you so very much.
OPENING STATEMENT OF SENATOR HERB KOHL
Senator Specter. Senator Kohl, your timing is impeccable.
You arrived just in time for your round of questions.
ABUSE AND NEGLECT IN LONG-TERM CARE FACILITIES
Senator Kohl. Thank you, Senator Specter.
Welcome, Mr. Secretary. Mr. Secretary, at last year's
hearing we talked about how important it is to make sure that
State survey agencies and ombudsmen have enough funding so they
can inspect nursing homes and other long-term care facilities,
also to investigate complaints of abuse and neglect.
As you know, every year I have worked hard to increase
funding for these programs, and so I was disappointed to see
that the President's budget for this year actually cut survey
funding by $6 million from 2003 levels that we just enacted,
and it flat-lines the ombudsmen funding.
I cannot imagine how we can cut these programs when abuse
and neglect complaints jumped by nearly 14 percent least year.
So to me it is clear that we need an increase and certainly not
a decrease in our efforts to make sure that all patients in
long-term care are safe.
So I ask you, how can we expect States and ombudsmen to
carry out these critical duties if we cut their funding, and
can we do something about it?
Secretary Thompson. Senator Kohl, thank you so very much
and thank you for your leadership in this area. As you know,
when you and I worked together in the State of Wisconsin, we
got a mandatory proposal through, and I think it is probably
one of the best laws in the country in regards to that. I know
it was signed into law, and I know you were very supportive of
that.
Senator Kohl. Very much so.
Secretary Thompson. You know that I agree with you.
Second, it was not a cut, when we introduced it, Senator.
The problem was when we introduced the budget, the Congress had
not passed the fiscal year 2003 appropriation, and you were
very successful in getting additional money put in. So our
budget was in when the fiscal year 2003 budget was in, which
increased it by $6 million, which we had level funded it. We
had not cut it. We had level-funded it from the year before.
Third, it was a tough budget. This is one of the items I
had appealed, but I lost on the appeal to OMB. I understand
your concern. I just want to work with you to build the best
surveillance as we possibly can.
As you probably know, we have started nursing home quality
standards, and we started an experimental program with six
States. Now it is national. And it is working out very well.
The nursing home industry has bought into it, and we are now on
the CMS web page. We are able to allow people to look at the
comparisons of nursing homes within their State so that they
can find out which nursing homes are doing the best job in
various areas. This is also something I am sure you would
approve of. These are the things that we are trying to do to
improve the quality in our nursing homes for our senior
citizens.
Senator Kohl. I know how much you care about the issue and
I know that we will be able to continue working on it.
One other question in this area. As you know, Mr.
Secretary, over the years Congress has held many hearings on
abuse in nursing homes and we heard stories from people about
patients being beaten, raped, and even killed by employees who
are supposed to be caring for them. We know that the vast
majority of nursing home workers do a very good job, but as we
know, it only takes a few to corrupt a whole system.
I have introduced legislation to create a national registry
of abusive workers and require FBI criminal background checks
before hiring. The bill is supported by patient advocates, as
well as the nursing home industry. As we debate Medicare reform
this year, we will hear a lot of ideas about what exactly
reform means. But it seems to me at the very least one of the
most important reforms we should pass is to ensure the basic
safety of those who are already in nursing homes and already
covered by Medicare. Nursing homes receive more than $11
billion in Medicare funding in 2001, and I believe we have an
obligation to make sure that these dollars are well spent.
So will the administration support legislation to get a
national registry of potential nursing home employees and will
the administration, will you, work with me and others to get it
passed this year?
Secretary Thompson. As you know, I worked with you when we
got it passed in State of Wisconsin, and I will continue to
work with you, Senator. I think it is the right thing and I
hope that we can get it done.
Senator Kohl. I thank you so much. It is good to see you.
Secretary Thompson. It is always a pleasure.
Are the Bucks going to make it?
Senator Kohl. It is going to be tough.
Secretary Thompson. Well, let us do a little bit more in
that area too, Senator.
Senator Kohl. Well, I will but I want to assure you,
Governor, it is not because I am not paying them enough.
Secretary Thompson. I know that, Senator. Let us just hope
they make it to the playoffs.
Senator Kohl. All right.
Senator Specter. Senator Gregg, like Senator Kohl, your
timing is impeccable. You arrived just in time for your round
of questioning.
OPENING STATEMENT OF SENATOR JUDD GREGG
Senator Gregg. Well, I appreciate that. Unfortunately, I
have to head off to carry the Secretary's water at the markup
that I am starting on bioshield, respite care, and a variety of
other things he sent to us to do. So my only question would be
to the Secretary--well, I am going to reserve my questions
because it will take too long to answer, and I would have to
leave in the middle of the answer. But it is a pleasure to see
the Secretary here and I look forward to continuing to work
with him.
Secretary Thompson. Thank you, Senator Gregg, for your
tremendous support on the smallpox and bioshield initiatives.
And thank you for coming over and viewing the Department's new
communications center. I extended that invitation to all
members. I would like to have them come over because I think
you would attest that it is one of the most modern in the
Government.
Senator Gregg. An extremely impressive facility. I think it
could be of value to every Senator to have a chance to look at
it and see the resources there.
CENTERS FOR DISEASE CONTROL AND PREVENTION
Senator Specter. Secretary Thompson, on my first round I
was focused on what the CDC was doing on the China virus, and
the very broad responsibilities which CDC has on bioterrorism.
But I note that CDC has been cut by $160 million on their
overall budget and $152 million on CDC's buildings and
facilities.
Starting first with the $160 million cut, is that wise,
appropriate in the context where we consistently call on the
CDC to do more, illustrated by the current Chinese virus?
Secretary Thompson. The CDC budget, Senator, as you know,
is very important to you. It is very important to me. It is
very important to our country. During the process of give and
take with OMB, you are given so much money. You try and do the
best job possible.
In regards to the building program, I requested $250
million, which was sort of the glide path in order to get----
Senator Specter. You are talking on the building program
now?
Secretary Thompson. Yes.
Senator Specter. I am about to come to that. The building
program has been cut by $152 million.
Secretary Thompson. $152 million out of the $250 million.
Senator Specter. The facilities had been in a longstanding
state of disrepair which had not been focused on by your
predecessors until members of this committee went down and took
a look. You know that story.
Secretary Thompson. I know it very well.
Senator Specter. We had an emergency appropriation that
year, about 3 years ago, of $170 million, and we added $250
million and $250 million. We have had very vociferous
complaints from the community which is really up in arms. When
I was there, I saw distinguished scientists with desks in the
halls--you know about that--and very important chemical
substances unprotected, unsafeguarded. When was the last time
you saw the CDC, Mr. Secretary?
Secretary Thompson. I go to the CDC about every 6 months. I
am going down there again----
Senator Specter. Well, how was it when you saw it last? Are
the conditions still pretty bad?
Secretary Thompson. Conditions are improving. We are making
a lot of progress. We still have a long ways to go.
Senator Specter. They are improving, but are they still
pretty bad?
Secretary Thompson. The laboratories should be finished up
this year, and that was our highest concern. Our laboratories,
as well as for the security of them. That has come along very
nicely, but there are some other buildings.
The problem is we have three campuses, and we have 24 other
buildings that we are renting around the City of Atlanta. It
really causes a disconnect. There is not the synergism that we
could have if we could relocate those 24 buildings on campus
and have the building program go.
I understand your position, Senator. Oz Nelson and Bernie
Marcus have been leaders down there, and I think they met with
you yesterday. They have talked to me. I talk to them on a very
regular basis. We are trying to get $250 million which was the
glide path----
Senator Specter. Well, I hope you talk to them as regularly
as they call me.
Secretary Thompson. Well, I am sure they probably call you
more.
Senator Specter. I'm going to give WATS line with those
folks.
But we ask them to do so much.
My time is close to expiring, and I want to stick to the
time limits here.
NATIONAL INSTITUTES OF HEALTH FUNDING
CDC is tied very closely with the NIH funding, and the NIH
funding--you know what this subcommittee has done. When you
present a budget like this to us, Mr. Secretary, you really
leave us in a position of adding to the CDC and adding to the
NIH and taking away from other programs. And I know your
problems with OMB, but I suggest to you there has to be a
tougher level of advocacy on these lines.
The subcommittee would like to know how many grants have
been awarded by NIH, what will happen with the flow of grants
when the increase is only a figure of $673 million. I will ask
as the final question before my red light goes on, why does the
administration request only $673 million for NIH when last year
it was $3.7 billion?
Secretary Thompson. First off, Senator, I do not know how I
could be a stronger advocate than what I have been in the past.
Senator Specter. Well, you can take over OMB, Mr.
Secretary.
Secretary Thompson. Well, I suppose I could, but I was not
asked to do that, Senator, and I do not think they are going to
ask me to do it either.
I am a strong advocate. I am passionate about it. And I
thank you for you passion because it has been yours and Senator
Harkin's and members' of this committee that have been able to
do it.
In regards to NIH funding, it is a 2.5 percent increase
over what the fiscal year 2003 request was, but----
Senator Specter. How do you figure a 2.5 percent increase?
Do you have a different slide rule than I do?
Secretary Thompson. No, I do not. Subsequent to the
introduction of our budget, Congress passed the fiscal year
2003 appropriation bill which increased the amount of money
over and above what we had requested. Therefore, instead of a
2.6, it was about a 1.6 percent increase over what you
appropriated. But what we put in over what was in the fiscal
year 2002, it is a 2.6 percent increase. That is the
difference.
In regards to that, there was $250 million put in for the
purchase of anthrax which is no longer there. That has been
purchased. There was a one-time capital cost in the NIH budget
for building laboratories at Fort Detrick and also on the
campus, and also the remodeling of a laboratory in Montana.
Those things have been done. There was approximately $375
million put in for capital improvements on campuses, on
universities for bioterrorism laboratory advancements, as well
as other things. Those were one-time costs. When they are taken
out, you add that back into the research. Those one-time
dollars will no longer be going for the expenditure of anthrax
and for capital costs. They will be going back into research.
So the total amount of money going for research over last year
will be $1.9 billion, or a 7.5 percent increase, which will
allow us to send out more grants and more dollars than ever
before. And that is just how it works out, Senator.
Senator Specter. Senator Harkin.
Senator Harkin. Thank you, Mr. Chairman.
Mr. Secretary, I am shifting a little bit here. I just
again wanted to focus on this new Freedom Initiative, the
disability grants, which I compliment you for moving ahead on
that.
There are enough people who want to ask questions. Why do I
not write you a letter on this and discuss this with you? I am
concerned about what happens after the first year. You have got
these grants in there for the first year. What happens after
that? I mean, they cannot just drop off a cliff someplace. And
there is a match there for that first year. Then after that, we
do not know. So I am greatly concerned that States may go into
this, and then after the first year, they have nothing. And I
do not know what the plan is for that. But maybe I should write
you. Maybe you could respond to me on that basis.
[The information follows:]
New Freedom Initiative
There are several components to the New Freedom Initiative
proposal, the following are items with fiscal impact in the fiscal year
2004 and beyond (many of these demonstrations were also proposed in the
President's fiscal year 2003 Budget):
--Medicaid Spousal Exemption.--$95 million over five years, with $16
million proposed for fiscal year 2004. This proposal would give
States the option to continue Medicaid eligibility for spouses
of disabled individuals who return to work. Under current law,
individuals with disabilities might be discouraged from
returning to work because the income they earn could jeopardize
their spouse's Medicaid eligibility. This proposal would extend
to the spouse the same Medicaid coverage protection now offered
to the disabled worker.
--New Freedom Initiative Demonstrations.--$220 million over 5 years,
with $11 million proposed for fiscal year 2004. This initiative
would fund four demonstrations that promote home and community-
based care alternatives. Two of the demonstrations provide
respite care services for adults and substantially disabled
children. Another demonstration provides community-based care
alternatives for children who are currently residing in
psychiatric residential treatment facilities. The President
proposed these demonstrations for fiscal year 2003. Also
included is $3 million in discretionary spending for the CMS
Research and Demonstrations Budget that will fund the Direct
Service Worker National Demonstration.
--``Money Follows the Individual'' Rebalancing Demonstration.--$1.75
billion over 5 years, with $350 million proposed for fiscal
year 2004. This 5-year demonstration would finance Medicaid
services for individuals who transition from institutions to
the community. Federal grant funds would pay the full cost of
home and community-based waiver services for 1 year, after
which the participating States would agree to continue care at
the regular Medicaid matching rate. This demonstration would
also provide incentives to States for increased use of home and
community-based services and would help provide information on
costs of different approaches.
The fiscal year 2004 budget will also include $40 million for
``Systems Change Grants'' to support States in their planning to create
new systems to support people with disabilities in the community
instead of in institutions.
Secretary Thompson. Senator, I really think that the
evidence is going to show that this is the right thing to do. I
think that you have recognized that for many years and have
been pushing for this thing. It is something I did when I was
in Wisconsin. I moved people from nursing homes and left them
in their own homes.
Senator Harkin. I am aware of that.
Secretary Thompson. Also, for the disabled community, we
did the same thing. It is so much better--a quality of life
issue--that I just do not think, once you start down this path,
that you would ever be able to stop it. I think the advocates,
I think the Senators like you, Senator Harkin, and I think the
administration have made a commitment, and I think they have
made a commitment to the community and I think we are going to
stand by that. As long as I am here, I know I am going to be
pushing for it, and I know I am going to have your support in
order to accomplish that.
Senator Harkin. Thank you, Mr. Secretary.
Senator Specter. Senator Craig.
Senator Craig. Mr. Chairman, I have no further questions.
Senator Specter. Senator Landrieu.
SUBSTANCE ABUSE
Senator Landrieu. Yes. Mr. Secretary, let me just follow up
with our substance abuse focus, if we could, because as you
know, the record speaks clearly about the reason that I think
maybe 70 to 80 percent of children in foster care are there
because a parent or both parents have a serious substance abuse
problem. I do not have to share with you the statistics about
our prisons being full of people who have substance abuse
problems and for whatever reason--not that those reasons are
excused--turn to a life of crime, et cetera. My point being
that since we spend I think $30,000 or $40,000 per year to
incarcerate someone, it would seem to me that one of the
smartest investments we could make as a nation is trying to
find and continuing to pursue, even though it is difficult, a
very effective remedy or program for substance abuse.
Your budget here, the block grant that we provide to our
States, provides treatment services to 400,000 people. Do we
know how many people in the country are suffering from
substance abuse that could potentially be helped by a block
grant like this? Do we have a figure that we are shooting for?
Secretary Thompson. I am sure we do, but I do not have it
at the tip of my----
Senator Landrieu. Could anyone on your staff share with us?
Do we know what the universe is that we are dealing with?
Secretary Thompson. I know we have that information. I will
get it for you, Senator Landrieu.
Senator Landrieu. Because I think it is huge.
Secretary Thompson. It is.
Senator Landrieu. I think it is millions and millions and
millions of people that are suffering from substance abuse. And
I point out to the committee and to the chairman that the block
grant only provides for services for 400,000 people in the
country. So we are just woefully short in that line item. So if
you could provide for me the universe that we have at least
identified as the numbers of people who have serious substance
abuse--you know, chronic--I would just ask.
Secretary Thompson. We will get that information for you.
[The information follows:]
President's Drug Treatment Initiative
In fiscal year 2004, we are requesting a total of $2.6 billion for
the President's Drug Treatment Initiative to provide drug treatment
services to approximately to 725,000 individuals, an increase of
135,000 individuals over fiscal year 2003. We are requesting an
increase of $31 million for the Substance Abuse Prevention and
Treatment Block Grant and $200 million for a new voucher program,
Access to Recovery, to increase treatment options and expand access to
services to 100,000 individuals, including services provided by faith-
based organizations.
We believe that these increases in substance abuse treatment will
help us reach those people who need treatment. According to the 2001
National Household Survey on Drug Abuse, 5 million people needed but
did not receive treatment in 2001. Of this 5 million people, an
estimated 377,000 reported that they felt they needed treatment for
their drug problem. This includes an estimated 101,000 who reported
that they made an effort but were unable to get treatment and 276,000
who reported making no effort to get treatment.
Senator Landrieu. And then try to provide me, if you would,
in your opinion what are the one or two or three most effective
either statewide or regional programs. And by effective, I mean
a record, an objective record, of people entering the program
with problems, exiting the program cured, which is I know very
difficult. Because if we could identify some of those effective
programs, I would like to work with you on moving some of the
money out of corrections and out of foster care and into drug
abuse treatment and prevention so as to save this Government a
tremendous amount of money and, needless to say, a lot of
heartache in the process. So if you could provide that for me.
[The information follows:]
Substance Abuse Programs
Numerous studies have shown substance abuse treatment to be
effective in reducing substance use, crime, and infectious diseases,
while increasing employment and social functioning. For example, in
Louisiana, the Department of Health and Hospitals, Office for Addictive
Disorders administers substance abuse prevention and treatment services
in 10 regions throughout the State. The Office for Addictive Disorders
requires substance abuse treatment programs to screen, assess, and
place individuals in need of substance abuse treatment using
standardized assessment instruments such as The Diagnostic and
Statistical Manual (DSM-IV-R) of Mental Disorders, the Addiction
Severity Index, 5th Edition, and the Patient Placement Criteria for the
Treatment of Substance Related Disorders, 2nd Edition Revised. The
appropriate assessment and placement of individuals in need of
substance abuse treatment is critically important to the desired
treatment outcomes of achieving and maintaining abstinence and
recovery.
The Office for Addictive Disorders has identified two exemplary
programs:
1. Rainbow Social Detoxification, Alexandria, Louisiana (Region VI)
The program reported: 98.5 percent occupancy rate for the last
calendar year; 63 percent of clients admitted showed improvement in the
first two quarters of the current fiscal year according to exit data;
and 78 percent of the clients completed the treatment program in the
last fiscal year.
2. Infinity Women With Dependent Residential Program, New Orleans,
Louisiana (Region I)
This is a collaborative effort between the Office for Addictive
Disorders and the Office of Family Support utilizing TANF funding to
provide substance abuse treatment to women and their children.
Of the women who completed treatment: (1) 100 percent are enrolled
in school or employed at 1-month follow-up post discharge; (2) 100
percent reported a reduction in drug/alcohol usage at 1-month follow-up
post discharge; 92 percent of the children ages 0-5 demonstrated
improvement in their developmental assessments from admission to
discharge; and 53 percent of school aged children demonstrated improved
academic performance admission to discharge.
Additionally, the following programs have reported promising
treatment outcomes for their respective targeted population in need of
substance abuse treatment.
City of Boise Collaborative Methamphetamine Treatment Services Project,
Boise, Idaho
Target population: The target population for this SAMHSA-funded
project is adults ages 18 and up, methamphetamine users, male and
female, and their families in Boise and the surrounding community of
Ada County. The project will serve between 50-75 clients per year.
Outcomes: The project is estimating that a minimum of 75 percent of
all clients admitted will graduate from the treatment program with
client outcomes similar to those of other comparable Matrix model
programs in relation to being drug free, employed, or engaged in
productive activity; living in a permanent place within the community;
and having little or no involvement with the criminal justice system.
After fiscal year 2003, the project will determine the program's impact
on the following: (a) decreased crime, arrest, convictions, and
incarcerations; (b) decreased emergency room/medical/hospital visits;
(c) decreased foster care placements; and (d) reduced health and social
costs from associated drug use.
The Pinal Hispanic Council Adolescent Treatment Project, Eloy, Arizona
Target population: The target population for this Substance Abuse
Prevention and Treatment block grant-funded project are Chicano,
American Indian, and African American adolescent males and females
between the ages of 10-18.
Outcomes: Pinal Hispanic Council receives Federal and State funds
and is a multiethnic, adolescent treatment improvement project which
provides comprehensive substance abuse treatment services to a tri-
county rural community in southern Arizona. Their main office, located
in Eloy, is ``Centro de Ayuda'' (Help Center) and two satellite
offices, ``Centro de Unidad'' (Unity Center) are located in Coolidge
and Casa Grande. The program receives the majority of its patients from
the various public schools, families, and the juvenile justice
department. The drugs of choice are primarily alcohol, methamphetamine,
inhalants, marijuana, and crack cocaine. A home-based approach to
treatment is used and a bilingual multi-cultural staff ensures cultural
sensitivity. Approximately 85 percent of the 48 clients completed
treatment in the last fiscal year. This program is a model for both
delivering services in a rural community and in coalition building in a
rural community.
Secretary Thompson. Senator, thank you so very much. You
know we have also put in this new program for mentoring and
counseling children of prisoners because they are going to get
out and we want to be able to try to get them reintegrated back
in the family if it is possible and if there is not going to be
any kind of spousal abuse or anything like this. This is a
program that we think will be very effective. But there are
many demonstration programs out there that we would certainly
like to work with you on and see if we could make it a national
program.
Senator Landrieu. And the reason that I bring that up, is
because I think the public has a sense that there are no cures
or that they are so difficult, people just throw their hands up
and say what is the use of funding it, it does not work. So
what we have to do is give people hope that there are, in fact,
effective programs that do work, that can be put into place,
and that we can really make a serious advancement here on this
particular subject. So, thank you.
One other thing for the record. If you could supply me with
the grants that either universities or scientists, doctors,
physicians, the medical infrastructure in Louisiana has
received from NIH, I would appreciate that. I know that there
are records to that effect, and if your staff could get that
for me, that would be very helpful.
Secretary Thompson. For all the universities----
Senator Landrieu. For all universities in Louisiana in the
last 3 years.
Secretary Thompson. From NIH?
Senator Landrieu. From NIH. Thank you.
Secretary Thompson. I would be more than happy to. And if
you do not get it within 10 days, call me. Will you please?
[The information follows:]
NIH Grants and Contracts Awarded for the State of Louisiana
A list of all NIH grants and contracts awarded to recipients in the
State of Louisiana for the past 3 years is being provided under
separate cover. In summary, NIH made 334 grant and contract awards for
$78.6 million to recipients in Louisiana in fiscal year 2000; 324
awards for $85.8 million in fiscal year 2001; and 344 awards for $117.5
million in fiscal year 2002--a dollar increase of more than 49 percent
over fiscal year 2000.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
GRANT NUMBER NAME ORGANIZATION TITLE AWARDED
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FISCAL YEAR 2000
D43TW001086-02................. MATHER, FRANCES J................. TULANE UNIVERSITY OF LOUISIANA............... INTERNATIONAL TRAINING IN MEDICAL INFORMATICS.................. $146,438
D43TW001142-02................. BEIER, JOHN C..................... TULANE UNIVERSITY OF LOUISIANA............... ACTIONS FOR BUILDING CAPACITY.................................. 100,000
D43TW001142-02S1............... BEIER, JOHN C..................... TULANE UNIVERSITY OF LOUISIANA............... IMPACT OF MID-GUT BACTERIA ON ANOPHELES MOSQUITOES............. 40,000
F30DA005743-05................. MARTIN-SCHILD, SHERYL B........... TULANE UNIVERSITY OF LOUISIANA............... TYR-W-MIF-1 AND OPIATE TOLERANCE............................... 53,903
F31DA005907-02................. HORNER, KRISTEN A................. TULANE UNIVERSITY OF LOUISIANA............... CHANGES IN ENDOMORPHINS DURING OPIATE TOLERANCE................ 19,145
F31DA005926-02................. BRADLEY, AMY L.................... LOUISIANA STATE UNIV-UNIV OF NEW ORLEANS..... SYNTHESIS AND DEVELOPMENT OF NEW COCAINE MEDICATIONS........... 21,189
F31DA005948-02................. CZAPLA, MARC A.................... TULANE UNIVERSITY OF LOUISIANA............... ENDOMORPHIN AND CARDIORESPIRATORY CONTROL...................... 20,452
F31DA005968-02................. SMITH, REBECCA R.................. TULANE UNIVERSITY OF LOUISIANA............... ENDOMORPHIN PLASTICITY IN CHRONIC PAIN MODELS.................. 34,115
F31DA006010-01................. BEYER, CHAD E..................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... MEDIAL PREFRONTAL CORTEX'S ROLE IN COCAINE SENSITIZATION....... 18,654
F31DA006040-01................. GREENWELL, THOMAS N............... TULANE UNIVERSITY OF LOUISIANA............... ENDOMORPHIN-NEUROIMMUNE INTERACTIONS........................... 19,935
F31GM019387-03................. HAMILTON, KIMBERLY Y.............. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... CHIRAL SELECTOR IN CAPILLARY ELECTROPHORESIS................... 21,210
F31GM019876-02................. BURSE, JEANINE R.................. TULANE UNIVERSITY OF LOUISIANA............... PAST AND PRESENT BIOINDICATION OF RIVER POLLUTION.............. 23,805
F31GM020437-02................. CEDILLO, BERTHA M................. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... DEVELOPMENT OF A CHIRAL SELECTOR SYSTEM........................ 25,470
F31GM020603-01................. WILLIAMS, BRIDGET D............... TULANE UNIVERSITY OF LOUISIANA............... THE ROLE OF TRACT STABILITY IN TELOMERE MAINTENANCE............ 33,994
F31GM020686-01................. ROBINSON, TERI L.................. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... DENDRIMERS/POLYMERIC SURFACTANTS IN CHIRAL SEPARATIONS......... 25,573
F31GM020928-01................. AUSTIN, JOSEPH.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... MINORITY PRE-DOCTORAL FELLOWSHIP PROGRAM....................... 22,512
F31HG000207-02................. SIMMONS-WILLIS, TRACEY A.......... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... MINORITY PRE-DOCTORAL FELLOWSHIP PROGRAM....................... 13,896
F31NS011180-01................. CLAYTON BAUCOM, CATHERINE A....... TULANE UNIVERSITY OF LOUISIANA............... HUMAN HAND PREFERENCE--STRUCTURAL FUNCTIONAL MRI STUDIES....... 20,830
F32AA005543-02................. ZHANG, ZILI....................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... POSTTRANSLATIONAL INHIBITION OF TNF ALPHA BY ALCOHOL........... 40,936
F32DA005877-03................. STAFFORD, DAVID A................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... DRUG EFFECTS ON COCAINE PAIRED CONDITIONED REINFORCERS......... 40,936
F32DK009931-02................. ROSS, DONNA M..................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... RENAL CAPILLARY FAILURE IN DIABETIC NEPHROPATHY................ 32,416
F32EY006996-02................. LOUTSCH, JEANNETTE M.............. LOUISIANA STATE UNIV HSC NEW ORLEANS......... OCULAR HSV1 REACTIVATION--CONTROL BY THE LAT DOMAIN............ 39,232
F32HD008390-03................. GULLEDGE, CYNTHIA C............... TULANE UNIVERSITY OF LOUISIANA............... MECHANISMS OF OPIOID MODULATION OF MATERNAL BEHAVIOR........... 37,516
G11HD034961-03................. ISLAND, GLENDA J.................. GRAMBLING STATE UNIVERSITY................... GSU RESEARCH ADMINISTRATION INFRASTRUCTURE PROGRAM............. 91,749
G11HD038437-01................. OSAGIE, EMMANUEL I................ SOUTHERN UNIV A&M COL BATON ROUGE............ EXTRAMURAL RESEARCH DEVELOPMENT AWARD.......................... 1
G20RR015079-01................. BAKER, DAVID G.................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... TRANSGENIC FACILITIES FOR NUTRITIONAL RESEARCH................. 141,322
K01CA078318-02................. HEMENWAY, CHARLES S............... TULANE UNIVERSITY OF LOUISIANA............... BMI1 INTERACTING PROTEINS IN NEOPLASTIC TRANSFORMATION......... 109,982
K01GM000707-01................. CHETTY, KOTHAPA N................. GRAMBLING STATE UNIVERSITY................... HYPERCHOLESTEROLEMIA AND REPERFUSION INJURY.................... 22,803
K02DA000204-08................. LINDBERG, IRIS.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... OPIOID PEPTIDE PROCESSING ENZYMES.............................. 112,160
K02DA000211-07................. FRANCE, CHARLES P................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... BEHAVIORAL PHARMACOLOGY OF OPIOIDS............................. 37,261
K02DK002605-02................. KAPUSTA, DANIEL R................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... OPIOIDS AND CENTRAL NEURAL REGULATION OF RENAL FUNCTION........ 94,955
K02MH000967-07................. HAYCOCK, JOHN W................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... HUMAN TYROSINE HYDROXYLASE AND SCHIZOPHRENIA................... 106,040
K02MH001231-06A1............... O'DONNELL, JAMES M................ LOUISIANA STATE UNIV HSC SHREVEPORT.......... NOVEL MECHANISMS OF ANTIDEPRESSANT ACTIVITY.................... 69,863
K07HL003327-05................. ALI, JUZAR........................ LOUISIANA STATE UNIV HSC NEW ORLEANS......... TUBERCULOSIS ACADEMIC AWARD--COMPREHENSIVE EDUC PROGRAM........ 71,033
K08AI001438-05................. CHANG, WUN-LING................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... CD4+ T CELL REGULATION--EFFECTOR CELLS IN BLASTOMYCOSIS........ 118,800
K08AI001467-03................. MASON, ANDREW L................... OCHSNER CLINIC FOUNDATION.................... RETROVIRAL ETIOLOGY OF PRIMARY BILIARY CIRRHOSIS............... 118,800
K08AI049790-01................. PARADA, NEREIDA A................. TULANE UNIVERSITY OF LOUISIANA............... REGULATION OF IL-2 RECEPTOR BY THE CD4 LIGAND IL-16............ 110,700
K08EY000414-02................. COLITZ, CARMEN M.................. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... TELOMERASE FUNCTION AND REGULATION IN THE LENS................. 104,674
K08HL003569-05................. Ortiz, Luis A..................... TULANE UNIVERSITY OF LOUISIANA............... APOPTOSIS IN PULMONARY FIBROSIS--ROLE FOR TNF AND P53.......... 114,080
K08MH001706-03................. SCHEERINGA, MICHAEL S............. TULANE UNIVERSITY OF LOUISIANA............... TRAUMATIZED YOUNG CHILDREN--RISK FOR MALADAPTATION............. 150,627
K23DC000135-04................. FOUNDAS, ANNE L................... TULANE UNIVERSITY OF LOUISIANA............... NEUROBIOLOGIC SUBSTRATES OF STUTTERING......................... 80,271
K30HL004521-01................. FRIEDMAN, MITCHELL................ TULANE UNIVERSITY OF LOUISIANA............... CLINICAL RESEARCH CURRICULUM AWARD............................. 200,000
M01RR005096-11................. CORRIGAN, JAMES J................. TULANE UNIVERSITY OF LOUISIANA............... GENERAL CLINICAL RESEARCH CENTER............................... 2,223,025
N01AI075327-005................ Didier, Elizabeth Schmidt......... TULANE UNIVERSITY OF LOUISIANA............... PRECLINICAL EVAL. OF THERAPIES FOR MICROSPORIDIAL INFECT....... 397,907
N01HG065404-000................ ROTHSCHILD, HENRY................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... DETERM. OF GEN. SUSCEPTIBILITY LUNG CANCER FAM. S.O.LA......... 184,570
N01HG065404-006................ ROTHSCHILD, HENRY................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... DETERM OF GEN SUSCEPTIBILITY LUNG CANCER....................... 237,874
N01HG065404-007................ ROTHSCHILD, HENRY................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... DETERM OF GEN SUSCEPTIBILITY LUNG CANCER....................... 237,675
P01CA028842-17................. CORREA, PELAYO.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... ETIOLOGIC STUDIES OF GASTRIC CARCINOMA......................... 683,011
P01DK043785-10................. GRANGER, D NEIL................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... PATHOPHYSIOLOGY OF INTESTINAL ISCHEMIA/REPERFUSION............. 1,243,529
P30EY002377-22................. KAUFMAN, HERBERT E................ LOUISIANA STATE UNIV HSC NEW ORLEANS......... CORE GRANT FOR VISION RESEARCH................................. 432,575
P50AA009803-07................. SPITZER, JOHN J................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... ALCOHOL, HIV INFECTION AND HOST DEFENSE........................ 1,707,894
P50AA009803-07S1............... SPITZER, JOHN J................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... ALCOHOL, HIV INFECTION AND HOST DEFENSE........................ 105,817
P51RR000164-39................. LAROSA, JOHN C.................... TULANE UNIVERSITY OF LOUISIANA............... REGIONAL PRIMATE RESEARCH CENTER............................... 5,731,111
R01AA008846-08................. Bautista, Abraham P............... LOUISIANA STATE UNIV HSC NEW ORLEANS......... LIVER AND THE IMMUNODEFICIENCY OF ALCOHOLICS................... 169,292
R01AA009505-05................. PRUETT, STEPHEN B................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... MECHANISMS OF IMMUNOSUPPRESSION BY ONE DOSE OF ETHANOL......... 154,003
R01AA009876-06................. WOLCOTT, ROBERT M................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... FETAL ALCOHOL EFFECTS AND IMMUNE DEVELOPMENT................... 205,594
R01AA011224-04................. GILES, THOMAS D................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... MODERATE ALCOHOL USE--CARDIOVASCULAR RISKS AND BENEFITS........ 235,882
R01AA011760-04................. MASON, CAROL M.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... ALCOHOL, TB AND AIDS........................................... 181,995
R01AG016592-01A1............... BERENSON, GERALD S................ TULANE UNIVERSITY OF LOUISIANA............... EVOLUTION OF CARDIOVASCULAR RISK WITH NORMAL AGING............. 715,752
R01AG017887-01................. JAZWINSKI, S MICHAL............... LOUISIANA STATE UNIV HSC NEW ORLEANS......... NUTRITIONAL AND METABOLIC MECHANISMS OF AGING.................. 336,000
R01AG017981-01................. MCLAUGHLIN, MARK L................ LOUISIANA STATE UNIV A&M COL BATON ROUGE..... BETA-SHEET MIMICS FROM CONSTRAINED DIPEPTIDE UNITS............. 180,930
R01AG017983-01................. HAMMER, ROBERT P.................. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... INHIBITION OF FIBRILLOGENESIS WITH B-STRAND MIMICS............. 316,180
R01AG017983-01S1............... HAMMER, ROBERT P.................. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... INHIBITION OF FIBRILLOGENESIS WITH B-STRAND MIMICS............. 66,802
R01AG018239-01................. GEISELMAN, PAULA J................ LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... OBESITY PREVENTION AFTER SMOKING CESSATION IN MENOPAUSE........ 183,750
R01AG018648-01................. VANLANDINGHAM, MARK J............. TULANE UNIVERSITY OF LOUISIANA............... SOCIO-DEMOGRAPHIC IMPACT OF AIDS ON OLDER PERSONS.............. 109,678
R01AI019199-16................. KLEI, THOMAS R.................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... LYMPHATIC LESION PATHOGENESIS IN BRUGIA INFECTED JIRDS......... 222,143
R01AI022001-16................. O'CALLAGHAN, DENNIS J............. LOUISIANA STATE UNIV HSC SHREVEPORT.......... NUCLEIC ACIDS OF HERPES VIRUS INFECTED CELLS................... 330,781
R01AI031567-06................. CHERVENAK, ROBERT P............... LOUISIANA STATE UNIV HSC SHREVEPORT.......... DEVELOPMENTAL BIOLOGY OF T CELL PRECURSORS..................... 178,096
R01AI032556-06A1............... FIDEL, PAUL L..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... MUCOSAL CELL MEDIATED IMMUNITY IN VAGINAL CANDIDIASIS.......... 203,750
R01AI034754-07................. Garry, Robert F................... TULANE UNIVERSITY OF LOUISIANA............... ALTERATIONS OF ION TRANSPORT BY HIV............................ 236,098
R01AI040667-05................. VAN DER HEYDE, HENRI C............ LOUISIANA STATE UNIV HSC SHREVEPORT.......... MECHANISMS WHEREBY CD4 T CELLS ACTIVATE AMI AND CMI............ 194,558
R01AI041693-03................. FIDEL, PAUL L..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... HORMONAL REGULATION OF VIGINAL IMMUNITY TO C ALBICANS.......... 200,347
R01AI042146-02................. MUGGERIDGE, MARTIN I.............. LOUISIANA STATE UNIV HSC SHREVEPORT.......... ROLES OF HSV2 MEMBRANE PROTEINS IN MEMBRANE FUSION............. 173,012
R01AI042350-03................. LANDRY, SAMUEL J.................. TULANE UNIVERSITY OF LOUISIANA............... HELPER T CELL EPITOPE IMMUNODOMINANCE.......................... 199,020
R01AI042400-01A2............... DAVISON, BILLIE B................. TULANE UNIVERSITY OF LOUISIANA............... A RHESUS MONKEY MODEL OF MALARIA IN PREGNANCY.................. 566,402
R01AI042777-03................. CLEMENTS, JOHN D.................. TULANE UNIVERSITY OF LOUISIANA............... MECHANISM OF CHOLERA TOXIN AND E COLI LT ADJUVANTICITY......... 195,482
R01AI043000-02................. KOUSOULAS, KONSTANTIN GUS......... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... GENETICS & FUNCTIONS OF HSV1 GK IN VIRUS ENTRY & EGRESS........ 279,406
R01AI044424-03................. STACZEK, JOHN..................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... CHIMERIC VIRUS VACCINES FOR P AERUGINOSA INFECTION............. 183,600
R01AI045151-01A1............... FREYTAG, LUCIA C.................. TULANE UNIVERSITY OF LOUISIANA............... MUCOSAL IMMUNIZATION--PREVENTION OF SYSTEMIC CANDIDIASIS....... 222,750
R01AI045725-01A1............... GILLIS, THOMAS P.................. NATIONAL HANSEN'S DISEASE PROGRAM............ DEVELOP AND EVALUATE NEW LEPROSY AND TB VACCINES............... 110,275
R01AI046275-02................. Robinson, JAMES E................. TULANE UNIVERSITY OF LOUISIANA............... RHESUS MABS FROM SHIV INFECTED MACAQUES........................ 220,613
R01AI048499-01................. ROOP, ROY M....................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... BRUCELLA STATIONARY PHASE GENE EXPRESSION AND VIRULENCE........ 315,000
R01AR045982-03................. ALA-KOKKA, LEENA M................ TULANE UNIVERSITY OF LOUISIANA............... MUTATIONS CAUSING DISC DISEASE AND SCIATICA.................... 280,549
R01AR046976-02................. KIMPEL, DONALD L.................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... NOVEL IMAGING TECHNOLOGIES FOR RHEUMATOID ARTHRITIS............ 286,000
R01CA054152-09................. HILL, STEVEN M.................... TULANE UNIVERSITY OF LOUISIANA............... NEUROENDOCRINE INFLUENCES ON MAMMARY CANCER.................... 178,276
R01CA054576-07................. Dash, Srikanta A.................. TULANE UNIVERSITY OF LOUISIANA............... HEPATITIS C VIRUS AND HEPATOCELLULAR CARCINOMA A............... 244,525
R01CA065600-04................. SPARKS, RODNEY L.................. TULANE UNIVERSITY OF LOUISIANA............... CARCINOGENESIS AND LOSS OF DIFFERENTIATION CONTROL............. 173,347
R01CA075190-03................. BERKEL, HANS J.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... CHEMOPREVENTION OF ADENOMATOUS COLORECTAL POLYPS............... 651,800
R01CA075613-02................. HWANG, DANIEL H................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... CYCLOOXYGENASE AND TUMORIGENESIS............................... 189,257
R01CA078335-02................. GNARRA, JAMES R................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... HGF/SF SIGNALING BY THE VHL TUMOR SUPPRESSOR................... 216,802
R01CA078335-02S1............... GNARRA, JAMES R................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... HGF/SF SIGNALING BY THE VHL TUMOR SUPPRESSOR................... 70,117
R01CA080149-02................. MATHIS, J MICHAEL................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... ADENOVIRUS BASED P53 GENE THERAPY FOR OVARIAN CANCER........... 107,690
R01CA081125-02................. SCHWARZENBERGER, PAUL O........... LOUISIANA STATE UNIV HSC NEW ORLEANS......... IL-17 AND HEMATOPOIESIS........................................ 137,290
R01CA081506-01A1............... EHRLICH, MELANIE.................. TULANE UNIVERSITY OF LOUISIANA............... DNA HYPOMETHYLATION AND CANCER................................. 219,564
R01CA082689-02................. OCHOA, AUGUSTO C.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... INDUCTION OF ANERGY AND ALTERED SIGNAL TRANSDUCTION............ 201,812
R01CA083823-01................. Levy, Laura S..................... TULANE UNIVERSITY OF LOUISIANA............... SELECTIVE FORCES OPERATIVE IN FELV INFECTION................... 237,309
R01CA085693-01................. HARRISON, LYNN.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... DNA REPAIR OF MULTIPLY DAMAGED SITES IN CELLS.................. 218,250
R01DA005084-13................. LINDBERG, IRIS.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... OPIOID PEPTIDE SYNTHESIZING ENZYMES............................ 175,109
R01DA006013-08................. GOEDERS, NICHOLAS E............... LOUISIANA STATE UNIV HSC SHREVEPORT.......... ENVIRONMENTAL INFLUENCES ON COCAINE SELF ADMINISTRATION........ 207,513
R01DA008255-06................. VARNER, KURT J.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CHRONIC COCAINE/STIMULANTS--CARDIOVASCULAR CONSEQUENCES........ 170,943
R01DA009157-05................. FRANCE, CHARLES P................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... DISCRIMINATIVE EFFECTS OF BENZODIAZEPINE WITHDRAWAL............ 31,209
R01DA009820-05................. GLOWA, JOHN R..................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... DETERMINANTS OF DRUG EFFECTS ON DRUG MAINTAINED BEHAVIOR....... 318,520
R01DA009820-05S1............... GLOWA, JOHN R..................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... DETERMINANTS OF DRUG EFFECTS ON DRUG MAINTAINED BEHAVIOR....... 58,144
R01DA011417-02................. Moerschbaecher, Joseph M.......... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CANNABINOID ABUSE EFFECTS ON LEARNING AND MEMORY............... 189,130
R01DA011528-04................. TRUDELL, MARK L................... LOUISIANA STATE UNIV-UNIV OF NEW ORLEANS..... SYNTHESIS OF POTENTIAL COCAINE ABUSE THERAPEUTICS.............. 251,372
R01DA011655-03................. ZADINA, JAMES E................... TULANE UNIVERSITY OF LOUISIANA............... NEUROBIOLOGY OF ENDOMORPHINS................................... 134,463
R01DA011939-01A2............... Harlan, Richard E................. TULANE UNIVERSITY OF LOUISIANA............... THALAMOSTRIATAL MECHANISMS OF MORPHINE ACTION.................. 187,166
R01DA012267-02................. HARRISON, MURELLE G............... SOUTHERN UNIV A&M COL BATON ROUGE............ PREVENTING SUBSTANCE USE IN RURAL AFRICAN-AMERICAN YOUTH....... 571,834
R01DA012427-01A1............... WINSAUER, PETER J................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... COCAINE SELF-ADMINSTRATION: EFFECTS ON LEARNING................ 91,369
R01DA012427-01A1S1............. WINSAUER, PETER J................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... COCAINE SELF-ADMINSTRATION: EFFECTS ON LEARNING................ 10,010
R01DA012703-02................. TRUDELL, MARK L................... LOUISIANA STATE UNIV-UNIV OF NEW ORLEANS..... NOVEL NICOTINIC RECEPTOR MEDIATED THERAPEUTIC AGENTS........... 287,756
R01DC000303-13................. GUTH, PAUL S...................... TULANE UNIVERSITY OF LOUISIANA............... PHARMACOLOGY OF VESTIBULAR NEUROTRANSMISSION................... 212,969
R01DC003679-02................. Hood, Linda Jean.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... AUDITORY GENETIC STUDIES OF HEREDITARY HEARING LOSS............ 201,335
R01DC003792-02................. CAPRIO, JOHN T.................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... ENCODING OF BIOLOGICALLY RELEVANT ODOR SIGNALS................. 310,659
R01DC003896-02................. Ricci, Anthony J.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... ENDOGENOUS FACTORS REGULATING TRANSDUCER ADAPTATION............ 169,287
R01DC003896-02S1............... Ricci, Anthony J.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... ENDOGENOUS FACTORS REGULATING TRANSDUCER ADAPTATION............ 19,770
R01DC004196-02................. Keats, Bronya J................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... ID OF THE MOUSE DEAFNESS (DN) GENE ON CHROMOSOME 19............ 217,521
R01DE008851-10................. BLOCK, MICHAEL S.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... PROSPECTIVE EVALUATION OF IMPLANT SUPPORTED BRIDGES............ 109,415
R01DE008911-09................. WISE, GARY E...................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... MOLECULAR BASIS OF TOOTH ERUPTION.............................. 168,830
R01DE012178-03................. FIDEL, PAUL L..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... ORAL IMMUNE DYSFUNCTION AND CANDIDIASIS IN HIV INFECTION....... 222,477
R01DE012178-03S1............... FIDEL, PAUL L..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... ORAL IMMUNE DYSFUNCTION AND CANDIDIASIS IN HIV INFECTION....... 105,767
R01DE012178-03S2............... FIDEL, PAUL L..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... ORAL IMMUNE DYSFUNCTION AND CANDIDIASIS IN HIV INFECTION....... 25,622
R01DE012187-05................. SIXBEY, JOHN W.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... DETERMINANTS OF EPSTEIN BARR VIRUS MUCOSAL PATHOGENESIS........ 219,839
R01DE012329-02................. CHEN, YIPING...................... TULANE UNIVERSITY OF LOUISIANA............... MOLECULAR MECHANISMS OF VERTEBRATE TOOTH INITIATION............ 175,255
R01DE012916-02................. AMEDEE, ANGELA M.................. TULANE UNIVERSITY OF LOUISIANA............... SIV MACAQUE MODEL FOR BREAST MILK TRANSMISSION OF HIV.......... 284,210
R01DK034286-16................. RABON, EDWIN C.................... TULANE UNIVERSITY OF LOUISIANA............... GASTRIC ACID SECRETION: CATION BINDING IN H,K-ATPASE........... 188,931
R01DK039232-11................. CARDELLI, JAMES A................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... REGULATION OF PHAGOCYTOSIS..................................... 179,990
R01DK041868-10................. HWANG, DANIEL H................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... DIETARY N 3 FATTY ACIDS AND EXPRESSION OF CYCLOOXYGENASE....... 185,627
R01DK042714-08S1............... HORNBY, PAMELA J.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... CNS AUTONOMIC PATHWAYS AND GASTROINTESTINAL FUNCTION........... 10,000
R01DK042714-09................. HORNBY, PAMELA J.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... CNS AUTONOMIC PATHWAYS AND GASTROINTESTINAL FUNCTION........... 177,080
R01DK043337-08................. KAPUSTA, DANIEL R................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... OPIOIDS AND CENTRAL NEURAL REGULATION OF RENAL FUNCTION........ 142,501
R01DK044628-06................. Inscho, Edward W.................. TULANE UNIVERSITY OF LOUISIANA............... PURINERGIC REGULATION OF THE RENAL MICROVASCULATURE............ 231,761
R01DK045278-08................. York, David A..................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... ENTEROSTATIN REGULATION OF FAT INTAKE.......................... 213,473
R01DK045449-07................. BARICOS, WILLIAM H................ TULANE UNIVERSITY OF LOUISIANA............... PA/PLASMIN/GELATINASE CASCADE IN DIABETIC NEPHROPATHY.......... 208,020
R01DK046935-06................. Lancaster, Jack R................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... NITROGEN AND OXYGEN RADICAL INTERACTIONS IN SURGERY............ 193,177
R01DK047211-06................. VEDECKIS, WAYNE V................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... REGULATION OF GLUCOCORTICOID RECEPTOR GENE EXPRESSION.......... 175,335
R01DK047348-07................. BERTHOUD, HANS-RUDOLF............. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... AUTONOMIC REGULATION OF FOOD INTAKE AND METABOLISM............. 174,607
R01DK047663-06................. GRISHAM, MATTHEW B................ LOUISIANA STATE UNIV HSC SHREVEPORT.......... ADHESION MOLECULE EXPRESSION IN CHRONIC GUT INFLAMMATION....... 180,366
R01DK049703-05................. LINDBERG, IRIS.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CONTROL OF PEPTIDE HORMONE BIOSYNTHESIS BY PC2 AND 7B2......... 169,680
R01DK049703-05S1............... LINDBERG, IRIS.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CONTROL OF PEPTIDE HORMONE BIOSYNTHESIS BY PC2 AND 7B2......... 65,780
R01DK049703-05S2............... LINDBERG, IRIS.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CONTROL OF PEPTIDE HORMONE BIOSYNTHESIS BY PC2 AND 7B2......... 28,749
R01DK050736-04................. LOVEJOY, JENNIFER C............... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... MENOPAUSE EFFECT ON OBESITY, ENERGY BALANCE AND INSULIN........ 221,244
R01DK051392-04................. HAMMOND, TIMOTHY G................ TULANE UNIVERSITY OF LOUISIANA............... MECHANISMS OF URINARY BLADDER ENDOSOMAL FUSION................. 226,264
R01DK052968-02................. Stephens, Jacqueline M............ LOUISIANA STATE UNIV A&M COL BATON ROUGE..... REGULATION AND ACTIVATION OF STATS IN ADIPOCYTES............... 176,467
R01DK053113-02................. SMITH, BRENDA K................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... TASTE AND GENETIC MECHANISMS OF MACRONUTRIENT SELECTION........ 210,114
R01DK053697-04................. CORREA, PELAYO.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... HELICOBACTER INFECTION AND GROWTH OF CHILDREN.................. 116,698
R01DK053903-02................. Harris, Ruth B.................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... LEPTIN AND PERIPHERAL GLUCOSE METABOLISM....................... 178,683
R01DK054880-02................. KASTIN, ABBA J.................... TULANE UNIVERSITY OF LOUISIANA............... BLOOD/BRAIN BARRIER AND LEPTIN TRANSPORT IN OBESITY............ 318,730
R01DK054952-01A2............... HAMM, L. LEE...................... TULANE UNIVERSITY OF LOUISIANA............... REGULATION OF CITRATE TRANSPORT................................ 198,450
R01DK055626-01A2............... AWAYDA, MOUHAMED S................ TULANE UNIVERSITY OF LOUISIANA............... KINASE REGULATION OF THE EPITHELIAL NA CHANNEL................. 210,625
R01DK056264-01A1............... El-Dahr, Samir S.................. TULANE UNIVERSITY OF LOUISIANA............... INDUCIBLE DYSPLASTIC NEPHROPATHY IN B2-DEFICENT MICE........... 267,300
R01DK057242-01................. BERTHOUD, HANS-RUDOLF............. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... FUNCTIONAL ORGANIZATION OF THE VAGAL-ENTERIC INTERFACE......... 191,743
R01DK057446-02................. LOVEJOY, JENNIFER C............... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... INTERNET-AIDED PREVENTION OF PREGNANCY-INDUCED OBESITY......... 226,282
R01DK057476-02................. MARTIN, PAMELA D.................. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... PRIMARY CARE OFFICE MANAGEMENT OF OBESITY...................... 190,358
R01DK058152-01................. KOZAK, LESLIE P................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... GENETICS OF DEVELOPMENTAL PLASTICITY IN THE ADIPOCYTE.......... 419,610
R01ES004344-10................. BACKES, WAYNE L................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... TOXICOLOGICAL SIGNIFICANCE OF ALKYLBENZENE METABOLISM.......... 197,329
R01ES006766-07................. Brody, Arnold R................... TULANE UNIVERSITY OF LOUISIANA............... GROWTH FACTORS IN ASBESTOS INDUCED PULMONARY FIBROSIS.......... 246,479
R01ES007815-05................. Deutsch, Walter A................. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... OXIDATIVE DNA DAMAGE AND THE ANALYSIS OF 8-OXOG REPAIR......... 239,906
R01ES008663-04................. FRIEDMAN, MITCHELL................ TULANE UNIVERSITY OF LOUISIANA............... BIOCHEMICAL MECHANISM FOR OZONE PATHOLOGY...................... 190,024
R01ES009158-04................. PRUETT, STEPHEN B................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... MECHANISMS OF IMMUNOTOXICITY OF CHEMICAL STRESSORS............. 113,432
R01ES009870-01A1............... MEHENDALE, HARIHARA M............. UNIVERSITY OF LOUISIANA AT MONROE............ DIETARY RESTRICTION AND TOXICANT-INDUCED LIVER DISEASE......... 224,993
R01ES010046-01A1............... LASKY, JOSEPH A................... TULANE UNIVERSITY OF LOUISIANA............... DISRUPTION OF PDGF SIGNAL TRANSDUCTION IN LUNG FIBROSIS........ 222,750
R01EY002672-22................. KAUFMAN, HERBERT E................ LOUISIANA STATE UNIV HSC NEW ORLEANS......... OCULAR HERPES SIMPLEX.......................................... 446,207
R01EY003311-21................. KLYCE, STEPHEN D.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... INTEGRATED ASSESSMENT OF CORNEAL FORM AND FUNCTION............. 254,318
R01EY004928-18................. BAZAN, HAYDEE E................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CORNEAL LIPID METABOLISM AND RESPONSE TO INFLAMMATION.......... 191,428
R01EY006311-14................. HILL, JAMES M..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... OCULAR HSV--LATENCY, REACTIVATION, AND RECURRENCE.............. 225,251
R01EY006635-14................. BAZAN, HAYDEE E................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CELL SIGNAL TRANSDUCTION IN CORNEAL WOUND HEALING.............. 216,772
R01EY007380-11A2............... MENERAY, MICHELE A................ LOUISIANA STATE UNIV HSC NEW ORLEANS......... INTERACTIVE CELLULAR CONTROLS LACRIMAL GLAND FUNCTION.......... 277,869
R01EY008871-10................. HILL, JAMES M..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... OCULAR PATHOGENESIS AND THERAPY OF BACTERIAL KERATITIS......... 286,084
R01EY010974-05................. O'CALLAGHAN, RICHARD J............ LOUISIANA STATE UNIV HSC NEW ORLEANS......... STAPH KERATITIS--MECHANISMS/ARRESTING OF CORNEAL DAMAGE........ 249,898
R01EY011610-03................. BURGOYNE, CLAUDE F................ LOUISIANA STATE UNIV HSC NEW ORLEANS......... IOP RELATED FORCE AND FAILURE IN THE OPTIC NERVE HEAD.......... 274,018
R01EY012367-02................. JACOB, JEAN T..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... EPITHELIALIZATION OF TISSUE ENGINEERED CORNEAS................. 186,119
R01EY012416-02................. BEUERMAN, ROGER W................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... REGULATION OF PROTEIN SYNTHESIS IN THE LACRIMAL GLAND.......... 220,278
R01EY012540-02................. PALKAMA, ARTO K................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... AQUEOUS OUTFLOW AND STRUCTURAL CORRELATIONS.................... 332,155
R01EY012602-03................. ALLIEGRO, MARK C.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... CONTROL OF VEGF STIMULATED ENDOTHELIAL PROLIFERATION........... 170,373
R01EY012701-01A1............... CHANDRASEKHER, GUDISEVA........... LOUISIANA STATE UNIV HSC NEW ORLEANS......... GROWTH FACTOR RECEPTOR MEDITATED SIGNAL MECHANISMS LENS........ 174,794
R01EY012887-01................. KHOOBEHI, BAHRAM.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... RETINAL AND CHOROIDAL BLOOD FLOW IMAGING....................... 213,024
R01EY012961-01................. O'CALLAGHAN, RICHARD J............ LOUISIANA STATE UNIV HSC NEW ORLEANS......... MECHANISMS AND THERAPY OF BACTERIAL KERATITIS.................. 284,555
R01GM020818-27................. RHOADS, ROBERT E.................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... REGULATION OF EUKARYOTIC PROTEIN SYNTHESIS INITITATION......... 311,655
R01GM039844-09S1............... WARNER, ISIAH M................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... BIOANALYTICAL SEPARATIONS USING CHIRAL POLYMERS................ 18,277
R01GM039844-10................. WARNER, ISIAH M................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... BIOANALYTICAL SEPARATIONS USING CHIRAL POLYMERS................ 243,454
R01GM045668-08................. DEININGER, Prescott L............. TULANE UNIVERSITY OF LOUISIANA............... HUMAN DIMORPHISMS BY SINE MASTER GENES......................... 234,512
R01GM045842-08................. Gross, David S.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... STRUCTURE/REGULATION OF THE YEAST HSP90 GENES.................. 161,768
R01GM047789-16................. TATCHELL, Kelly G................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... GENETIC ANALYSIS OF PROTEIN PHOSPHATASE I IN YEAST............. 192,414
R01GM051261-04................. WALDROP, GROVER L................. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... CATALYTIC MECHANISM OF BIOTIN DEPENDENT ENZYMES................ 92,391
R01GM051521-07................. WITT, STEPHEN N................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... KINETICS AND MECHANISM OF THE HEAT SHOCK 70 PROTEIN DNAK....... 194,117
R01GM056526-04................. LUSTIG, ARTHUR J.................. TULANE UNIVERSITY OF LOUISIANA............... REGULATION OF TELOMERE DYNAMICS IN YEAST....................... 228,650
R01GM056835-03................. MCLAUGHLIN, MARK L................ LOUISIANA STATE UNIV A&M COL BATON ROUGE..... PEPTIDES ACTIVE AGAINST INTRACELLULAR PATHOGENIC DISEASE....... 166,651
R01GM058843-02................. LIMBACH, PATRICK A................ LOUISIANA STATE UNIV A&M COL BATON ROUGE..... IDENTIFICATION OF MODIFIED NUCLEOSIDES IN RIBOSOMAL RNA........ 126,851
R01HD008431-25................. KOZAK, LESLIE P................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... MOLECULAR GENETICS OF THERMOGENESIS............................ 302,854
R01HD035245-04................. Muneoka, Ken...................... TULANE UNIVERSITY OF LOUISIANA............... MSX GENES IN WOUND HEALING AND REGENERATION.................... 152,788
R01HD036822-02................. WANG, YU-PING..................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... PLACENTAL FUNCTION IN PREECLAMPSIA............................. 137,077
R01HD037811-01A1............... GASSER, RAYMOND F................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... HUMAN EMBRYO SECTIONS ON COMPUTER DISKS FOR EDUCATION.......... 367,391
R01HD039104-01................. WILLIAMSON, DONALD A.............. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... INTERNET-BASED OBESITY PREVENTION FOR BLACK ADOLESCENTS........ 157,972
R01HG001499-04................. SOPER, Steven A................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... HIGH THROUGHPUT DNA SEQUENCING USING NANO-REACTORS............. 430,128
R01HG001777-03................. LIMBACH, PATRICK A................ LOUISIANA STATE UNIV A&M COL BATON ROUGE..... DNA SEQUENCING BY MASS SPECTROMETRIC METHODS................... 136,475
R01HL018426-26S1............... Navar, L. Gabriel................. TULANE UNIVERSITY OF LOUISIANA............... REGULATION OF RENAL HEMODYNAMICS............................... 10,434
R01HL018426-27................. Navar, L. Gabriel................. TULANE UNIVERSITY OF LOUISIANA............... REGULATION OF RENAL HEMODYNAMICS............................... 281,221
R01HL026371-19................. Navar, L. Gabriel................. TULANE UNIVERSITY OF LOUISIANA............... RENAL FUNCTIONAL DERANGEMENTS IN HYPERTENSION.................. 231,372
R01HL026371-19S1............... Navar, L. Gabriel................. TULANE UNIVERSITY OF LOUISIANA............... RENAL FUNCTIONAL DERANGEMENTS IN HYPERTENSION.................. 73,309
R01HL026441-20................. GRANGER, D NEIL................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... TRANSCAPILLARY FLUID EXCHANGE.................................. 243,130
R01HL045670-08S1............... BOUCHARD, CLAUDE.................. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... HERITAGE-GENETICS, RESPONSE TO EXERCISE, RISK FACTORS.......... 284,054
R01HL045670-09................. BOUCHARD, CLAUDE.................. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... HERITAGE-GENETICS, RESPONSE TO EXERCISE, RISK FACTORS.......... 915,078
R01HL054797-07A1............... KORTHUIS, RONALD J................ LOUISIANA STATE UNIV HSC SHREVEPORT.......... PRECONDITIONING: PMN ADHESION AND MICROVASCULAR INJURY......... 290,000
R01HL056241-03................. LEFEVRE, MICHAEL.................. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... EFFICACY OF DIET THERAPY IN SUBJECTS AT RISK FOR CHD........... 323,842
R01HL058409-04................. AGRAWAL, KRISHNA C................ TULANE UNIVERSITY OF LOUISIANA............... MECHANISMS OF HEMATOLOGIC ABNORMALITIES IN AIDS................ 274,486
R01HL058610-04................. HOYLE, GARY W..................... TULANE UNIVERSITY OF LOUISIANA............... PULMONARY FIBROSIS IN PDGF TRANSGENIC MICE..................... 263,426
R01HL059699-03................. IMIG, JOHN D...................... TULANE UNIVERSITY OF LOUISIANA............... OXYGENASE METABOLITES AND RENAL VASCULAR ACTIVITY.............. 92,972
R01HL059724-04................. SHELLITO, JUDD E.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... T LYMPHOCYTE SUBSETS AND HOST DEFENSE AGAINST P CARINII........ 335,478
R01HL059879-02................. CLAYCOMB, WILLIAM C............... LOUISIANA STATE UNIV HSC NEW ORLEANS......... NOVEL GENE DISCOVERED IN THE HEART............................. 206,942
R01HL060300-04................. HE, JIANG......................... TULANE UNIVERSITY OF LOUISIANA............... EPIDEMIOLOGY STUDIES OF DIETARY FIBER AND BLOOD PRESSURE....... 129,736
R01HL060532-04................. Brody, Arnold R................... TULANE UNIVERSITY OF LOUISIANA............... EPITHELIAL GROWTH FACTORS IN ENVIRONMENTAL LUNG DISEASE........ 280,370
R01HL060849-02................. LEFER, DAVID J.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... MECHANISMS OF MYOCARDIAL REPERFUSION INJURY--DIABETES.......... 176,994
R01HL061271-02................. Kolls, Jay K...................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... NON CD4 HOST DEFENSE AGAINST P CARINII PNEUMONIA............... 73,902
R01HL061934-04................. MORRIS, CINDY A................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... MOLECULAR MECHANISM OF TAT INDUCED ANGIOGENESIS................ 214,500
R01HL062000-01A2............... HYMAN, ALBERT L................... TULANE UNIVERSITY OF LOUISIANA............... CARDIOPULMONARY SURGERY RESEARCH............................... 257,450
R01HL062052-03................. Kolls, Jay K...................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CD8 AND GAMMA/DELTA T CELLS IN P CARINII PNEUMONIA............. 250,250
R01HL062147-03................. PANDEY, KAILASH N................. TULANE UNIVERSITY OF LOUISIANA............... ANP RECEPTOR GENE--TARGETING AND EXPRESSION.................... 155,714
R01HL063128-01A2............... AGRAWAL, KRISHNA C................ TULANE UNIVERSITY OF LOUISIANA............... MECHANISMS OF CARDIOVASCULAR COMPLICATIONS IN AIDS............. 283,597
R01HL063195-02................. TRAYANOVA, NATALIA A.............. TULANE UNIVERSITY OF LOUISIANA............... CARDIAC TISSUE STRUCTURE IN THE DEFIBRILLATION PROCESS......... 147,940
R01HL064555-02................. CLARKSON, CRAIG W................. TULANE UNIVERSITY OF LOUISIANA............... MOLECULAR BASIS FOR DRUG INDUCED CARDIOTOXICITY IN AIDS........ 183,546
R01HL064577-02................. JOHNSON, ROBERT A................. TULANE UNIVERSITY OF LOUISIANA............... HEMODYNAMIC ROLES OF ENDOGENEOUS CARBON MONOXIDE............... 166,277
R01MH051175-06................. O'DONNELL, JAMES M................ LOUISIANA STATE UNIV HSC SHREVEPORT.......... NEUROPSYCHOPHARMACOLOGY OF CYCLIC AMP PDE INHIBITORS........... 197,207
R01NS009626-30................. LI, YU-TEH........................ TULANE UNIVERSITY OF LOUISIANA............... GLYCOSIDASES AS RELATED TO SPHINGOLIPIDOSES.................... 334,553
R01NS023002-15................. BAZAN, NICOLAS G.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... PHOSPHOLIPIDS AND ARACHIDONIC ACID AND EP...................... 265,361
R01NS025134-11................. HAYCOCK, JOHN W................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CELLULAR REGULATION OF TYROSINE HYDROXYLASE.................... 207,349
R01NS025987-12S1............... PHELPS, CAROL J................... TULANE UNIVERSITY OF LOUISIANA............... HYPOPHYSIOTROPIC NEURON DIFFERENTIATION--TARGET FEEDBACK....... 50,000
R01NS025987-13................. PHELPS, CAROL J................... TULANE UNIVERSITY OF LOUISIANA............... HYPOPHYSIOTROPIC NEURON DIFFERENTIATION--TARGET FEEDBACK....... 207,159
R01NS034926-04................. TASKER, JEFFREY G................. TULANE UNIVERSITY OF LOUISIANA............... GLUTAMATE MODULATION OF HYPOTHALAMIC NEURONS................... 177,854
R01NS036936-03................. ERICKSON, JEFFREY D............... LOUISIANA STATE UNIV HSC NEW ORLEANS......... VESICULAR TRANSPORTER SPECIFICITY.............................. 201,699
R01NS036936-03S1............... ERICKSON, JEFFREY D............... LOUISIANA STATE UNIV HSC NEW ORLEANS......... VESICULAR TRANSPORTER SPECIFICITY.............................. 50,000
R01NS037070-03................. ERZURUMLU, REHA S................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... CELLULAR MECHANISMS UNDERLYING PATTERN FORMATION............... 127,909
R01NS037963-03................. CANAVIER, CARMEN C................ LOUISIANA STATE UNIV-UNIV OF NEW ORLEANS..... FIRING PATTERN REGULATION IN MIDBRAIN DOPAMINE NEURONS......... 147,768
R01NS039050-01A1............... ERZURUMLU, REHA S................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... SOMATOSENSORY CORTICAL DEVELOPMENT AND PLASTICITY.............. 167,305
R01NS039099-01A1............... TASKER, JEFFREY G................. TULANE UNIVERSITY OF LOUISIANA............... HYPOTHALAMIC SYNCHRONIZATION BY LOCAL GLUTAMATE CIRCUITS....... 311,088
R01NS039458-01................. MAGEE, JEFFERY C.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... DENDRITIC INTEGRATION IN HIPPOCAMPAL PYRAMIDAL NEURONS......... 207,276
R03AG018034-01................. CHERRY, KATIE E................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... PERCEPTIONS OF FORGETFULNESS IN ADULTHOOD...................... 69,247
R03AG018187-01................. Inscho, Edward W.................. TULANE UNIVERSITY OF LOUISIANA............... RENAL MICROVASCULAR FUNCTION IN AGED RATS...................... 74,250
R03AG018600-01................. REDDIX, RHODA A................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... GLIAL CELL DERIVED NEUROTROPHIC FACTOR AND THE AGING GUT....... 71,500
R03AI042077-03................. Malone, John B.................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... GEOGRAPHIC INFORMATION SYSTEMS & SCHISTOSOMIASIS............... 72,787
R03CA081602-02................. HAGENSEE, MICHAEL E............... LOUISIANA STATE UNIV HSC NEW ORLEANS......... NONINVASIVE DETECTION OF ANTIBODIES AGAINST HPV................ 65,284
R03CA083050-02................. YU, HERBERT H..................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... ESTROGEN AND INSULIN LIKE GROWTH FACTORS IN BREAST CANCE....... 71,195
R03CA083095-02................. CORREA, PELAYO.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... HOST RESPONSE TO HELICOBACTER PYLORI INFECTION................. 66,985
R03CA083632-02................. ESPINOZA-DELGADO, IGOR............ LOUISIANA STATE UNIV HSC NEW ORLEANS......... TRIAL OF BRYOSTATIN/IL-2 TO ENHANCE ANTIGEN PRESENTATION....... 71,474
R03CA086378-01................. HAGENSEE, MICHAEL E............... LOUISIANA STATE UNIV HSC NEW ORLEANS......... DEVELOPMENT OF A URINE PCR ASSAY FOR HPV DNA DETECTION......... 69,350
R03CA088135-01................. SU, L. J.......................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... DIETARY SURVEY INSTRUMENT DEVELOPMENT FOR AN ETHNIC MINO....... 71,210
R03DA012547-01A1............... ROERIG, SANDRA C.................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... SPINAL NITRIC OXIDE IN CHRONIC INFLAMMATORY PAIN............... 69,978
R03DA013421-01................. LAHOSTE, GERALD J................. LOUISIANA STATE UNIV-UNIV OF NEW ORLEANS..... GAP JUNCTIONS AND DOPAMINE PLASTICITY.......................... 71,000
R03DA013546-01................. HUANG, TIEN L..................... XAVIER UNIVERSITY OF LOUISIANA............... NOVEL ANTI-PCP AGENTS WITH NEUROPROTECTIVE PROPERTIES.......... 69,975
R03DC003609-03................. OETTING, JANNA B.................. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... SLI WITHIN THE CONTEXT OF DIALECT DIVERSITY.................... 55,926
R03DE012944-02................. DEE, KAY C........................ TULANE UNIVERSITY OF LOUISIANA............... ADHESION/GROWTH-PROMOTING PROACTIVE DENTAL BIOMATERIALS........ 36,473
R03DK054971-03................. ABDEL-MAGEED, ASIM B.............. TULANE UNIVERSITY OF LOUISIANA............... METALLOTHIONEIN AND PROSTATE TUMORIGENESIS..................... 73,992
R03MH061944-01................. NORTHUP, JOHN A................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... STAR PROGRAM: EARLY & PREVENTIVE INTERVENTION OF ADHD.......... 73,500
R13GM061083-01................. MOUDGIL, GIRISH C................. TULANE UNIVERSITY OF LOUISIANA............... ALLERGY, IMMUNOLOGY, AND ANESTHETIC ACTION..................... 3,000
R15AI047297-01................. ENNIS, D G........................ UNIVERSITY OF LOUISIANA AT LAFAYETTE......... ANALYSIS OF DNA REPAIR AND SOS REGULATION IN BRUCELLA.......... 117,628
R18AI033449-06................. FREY, DANIEL J.................... LOUISIANA ORGAN PROCUREMENT AGENCY........... ENHANCING DONOR REGISTRY TO INCREASE DONATION.................. 282,669
R21AR047796-01................. PROCKOP, DARWIN J................. TULANE UNIVERSITY OF LOUISIANA............... EXPANSION OF STEM CELLS FOR SKELETAL TISSUES................... 74,250
R21CA078693-02................. EHRLICH, MELANIE.................. TULANE UNIVERSITY OF LOUISIANA............... PROGENITOR COLONY RT-PCR ANALYSIS IN CML TREATMENT............. 148,421
R21CA082618-02................. NATHAN, CHERIE-ANN O.............. LOUISIANA STATE UNIV HSC SHREVEPORT.......... MOLECULAR ANALYSIS OF SURGICAL MARGINS WITH EIF4E IN CAN....... 122,714
R21CA083198-01A1............... OCHOA, AUGUSTO C.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... T CELL SIGNAL TRANSDUCTION TO MONITOR HPV VACCINES............. 141,426
R21CA084095-01................. HYMAN, LINDA E.................... TULANE UNIVERSITY OF LOUISIANA............... ELONGIN C: FUNCTION AND ROLE IN VHL DISEASE.................... 148,500
R21CA091785-01................. MATHIS, J MICHAEL................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... ROLE OF CYSTATIN M IN BREAST TUMOR PROGRESSION................. 99,863
R24CA084625-01................. SOPER, Steven A................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... MICRO-INSTRUMENT PLATFORMS FOR GENETIC-BASED ANALYSES.......... 591,505
R24DA007970-08................. KOMISKEY, HAROLD L................ XAVIER UNIVERSITY OF LOUISIANA............... MIDARP AT XAVIER UNIVERSITY OF LOUISIANA....................... 393,470
R24HL060808-03................. STRONG, JACK P.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... PDAY CARDIOVASCULAR SPECIMEN AND DATA LIBRARY.................. 124,343
R24RR012545-02................. BASKIN, GARY B.................... TULANE UNIVERSITY OF LOUISIANA............... ANIMAL MODEL FOR GENE THERAPY OF INHERITED DISORDERS........... 503,804
R25CA047877-13................. LOPEZ-S, ALFREDO.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... SHORT RESEARCH EXPERIENCES IN CANCER........................... 63,123
R25GM051773-03A1............... HIMAYA, M A....................... GRAMBLING STATE UNIVERSITY................... PARTNERSHIP FOR MINORITY ACCESS TO BACCALAUREATE DEGREES....... 468,130
R25MH058560-03................. SAXENA, KRISHAN M................. GRAMBLING STATE UNIVERSITY................... NIMH HONORS MINORITY HIGH SCHOOL PROGRAM AT GSU................ 26,001
R29AI039023-05................. HOYLE, GARY W..................... TULANE UNIVERSITY OF LOUISIANA............... NEUROGENIC INFLAMMATION IN ASTHMA AND OZONE LUNG INJURY........ 110,151
R29CA069148-05................. DE BENEDETTI, ARRIGO.............. LOUISIANA STATE UNIV HSC SHREVEPORT.......... PROTO-ONCOGENE EIF-4E IN BREAST CANCER......................... 101,454
R29CA076186-03................. MEYERS, SHARI L................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... MOLECULAR MECHANISM OF TRANSFORMATION BY AML1/ETO.............. 100,955
R29DC003280-02S1............... Garcia, Meredith M................ TULANE UNIVERSITY OF LOUISIANA............... PROTEIN KINASE C IN CENTRAL AUDITORY PLASTICITY................ 20,000
R29DC003280-03................. Garcia, Meredith M................ TULANE UNIVERSITY OF LOUISIANA............... PROTEIN KINASE C IN CENTRAL AUDITORY PLASTICITY................ 98,502
R29DK052148-04................. KALOGERIS, THEODORE J............. LOUISIANA STATE UNIV HSC SHREVEPORT.......... NEUROHORMONAL CONTROL OF INTESTINAL APOLIPOPROTEIN A IV........ 100,588
R29ES007856-05................. MORRIS, GILBERT F................. TULANE UNIVERSITY OF LOUISIANA............... P53 IN ASBESTOS INDUCED LUNG DISEASE........................... 113,433
R29ES009055-03................. MILLER, CHARLES A................. TULANE UNIVERSITY OF LOUISIANA............... ARYL HYDROCARBON RECEPTOR STRUCTURE AND INTERACTIONS........... 87,585
R29EY012204-03................. GLEASON, EVANNA L................. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... METABOTROPIC GLUTAMATE RECEPTORS ON AMACRINE CELLS............. 96,588
R29HD036310-05................. VEAZEY, RONALD S.................. TULANE UNIVERSITY OF LOUISIANA............... ONTOGENY OF THE NEONATAL MACAQUE IMMUNE SYSTEM................. 115,261
R29HD036421-04................. KUBISCH, HANS M................... TULANE UNIVERSITY OF LOUISIANA............... MARKER ASSISTED SELECTION OF BOVINE BLASTOCYSTS................ 57,093
R29HL051306-05................. MAJID, DEWAN S.................... TULANE UNIVERSITY OF LOUISIANA............... NITRIC OXIDE AND MEDIATING PRESSURE NATRIURESIS................ 116,625
R29HL058806-04................. CRUMB, WILLIAM J.................. TULANE UNIVERSITY OF LOUISIANA............... CHARACTERIZATION ION CURRENT IN PEDIATRIC HUMAN ATRIA A........ 84,322
R29MH055654-04................. FRICK, PAUL J..................... LOUISIANA STATE UNIV-UNIV OF NEW ORLEANS..... CALLOUS/UNEMOTIONAL TRAITS AND CONDUCT PROBLEMS................ 95,780
R29NS033671-05................. ELMSLIE, KEITH S.................. TULANE UNIVERSITY OF LOUISIANA............... CALCIUM CHANNELS IN SYMPATHETIC NEURONS........................ 106,366
R29NS035865-04................. MAGEE, JEFFERY C.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... DENDRITIC K+ AND IH CHANNELS IN HIPPOCAMPAL NEURONS............ 104,280
R37AG006168-15................. JAZWINSKI, S MICHAL............... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CELLULAR AGING IN A YEAST MODEL SYSTEM......................... 411,022
R37AG006168-15S1............... JAZWINSKI, S MICHAL............... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CELLULAR AGING IN A YEAST MODEL SYSTEM......................... 5,000
R37AG006168-15S2............... JAZWINSKI, S MICHAL............... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CELLULAR AGING IN A YEAST MODEL SYSTEM......................... 120,640
R37DK032089-19................. BRAY, GEORGE A.................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... DIETARY OBESITY................................................ 293,153
R37DK036013-14................. ORLANDO, ROY C.................... TULANE UNIVERSITY OF LOUISIANA............... ESOPHAGEAL CYTOPROTECTION--AGENTS AND MECHANISMS............... 202,749
R37EY002580-20S2............... KAUFMAN, HERBERT E................ LOUISIANA STATE UNIV HSC NEW ORLEANS......... CORNEAL PRESERVATION AND KERATOPLASTY.......................... 165,943
R37MH051853-07................. MCCANN, SAMUEL M.................. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... MECHANISM OF ACTION OF CYTOKINES ON BRAIN AND PITUITARY........ 290,105
R42CA083756-03................. Pincus, Seth H.................... NORION DIAGNOSTIC INNOVATIONS, INC........... HIV INFECTIVITY TEST FOR ANTIVIRAL SUSCEPTIBILITY.............. 245,461
R43AI042464-01A2............... LO, WAI-CHUN J.................... ANOMERIC, INC................................ RAPID SCREENING OF MICROBES IN URINE........................... 100,000
R43DC004378-01................. JUNEAU, ROGER P................... SOFTEAR TECHNOLOGIES, LLC.................... BENEFITS OF A SOFT-SOLID HEARING INSTRUMENT.................... 99,237
R43GM061508-01................. SINHA, SUDHIR K................... RELIAGENE TECHNOLOGIES, INC.................. DIMORPHIC ALU REPEATS-APPLICATION IN IDENTITY TESTING.......... 100,000
R43NS038358-01A2............... NARDUCY, KENNETH W................ ST CHARLES PHARMACEUTICALS................... DEVELOPMENT OF ANALGESICS WITH FEWER SIDE EFFECTS.............. 99,999
R44CA083552-02................. MORGAN, LEE R..................... DEKK-TEC, INC................................ ISOPHOSPHORAMIDE MUSTARD--A PHASE 1 STUDY...................... 225,894
R44CA085021-01................. MORGAN, LEE R..................... DEKK-TEC, INC................................ DERIVATIVES OF DEMETHYLPENCLOMEDINE: ANTICANCER AGENTS......... 126,956
S06GM004531-11................. IFEANYI, FELIX I.................. GRAMBLING STATE UNIVERSITY................... MBRS SCORE PROGRAM AT GRAMBLING STATE UNIVERSITY............... 83,072
S06GM004531-11S1............... IFEANYI, FELIX I.................. GRAMBLING STATE UNIVERSITY................... MBRS SCORE PROGRAM AT GRAMBLING STATE UNIVERSITY............... 112,668
S06GM008008-29................. STEVENS, CHERYL L................. XAVIER UNIVERSITY OF LOUISIANA............... MBRS SCORE PROGRAM AT XAVIER UNIVERSITY........................ 587,409
S11ES009996-02................. BLAKE, ROBERT C................... XAVIER UNIVERSITY OF LOUISIANA............... ALTERATION OF GENE REGULATION BY ENVIRONMENTAL COMPOUNDS....... 1,103,872
S11ES010018-02................. MUGANDA, PERPETUA M............... SOUTHERN UNIV A&M COL BATON ROUGE............ CELLULAR & MOLECULAR TOXICOLOGY OF BUTADIENE................... 880,496
T32AA007577-02................. BAGBY, GREGORY J.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... BIOMEDICAL ALCOHOL RESEARCH TRAINING PROGRAM................... 186,499
T32CA065436-04................. JAFFE, BERNARD M.................. TULANE UNIVERSITY OF LOUISIANA............... RESEARCH TRAINING IN SURGICAL ONCOLOGY (T32)................... 35,288
T32DA007311-02................. GOEDERS, NICHOLAS E............... LOUISIANA STATE UNIV HSC SHREVEPORT.......... STRESS AND THE NEUROBIOLOGY OF DRUG AND ALCOHOL DEPENDE........ 260,724
T34GM007716-22................. BIRDWHISTELL, TERESA.............. XAVIER UNIVERSITY OF LOUISIANA............... MARC UNDERGRADUATE STUDENT TRAINING IN ACADEMIC RESEARCH....... 512,916
T34GM008714-03................. HIMAYA, M A....................... GRAMBLING STATE UNIVERSITY................... U STAR PROGRAM FOR MARC AT GRAMBLING STATE UNIVERSITY.......... 169,093
T34MH017102-18................. SAXENA, KRISHAN M................. GRAMBLING STATE UNIVERSITY................... NIMH COR HONORS UNDERGRADUATE PROGRAM AT GSU................... 78,921
U01AI032913-09................. VAN DYKE, RUSSELL B............... TULANE UNIVERSITY OF LOUISIANA............... TULANE/LSU PEDIATRIC AIDS CLINICAL TRIALS UNIT................. 869,072
U01AI038844-04S1............... Lertora, Juan J. L................ TULANE UNIVERSITY OF LOUISIANA............... AIDS CLINICAL TRIALS UNIT...................................... 656,013
U01AI042178-08S2............... BESCH, CERYL L.................... TULANE UNIVERSITY OF LOUISIANA............... LOUISIANA COMMUNITY AIDS RESEARCH PROGRAM...................... 201,108
U01AI042178-09................. MUSHATT, DAVID M.................. TULANE UNIVERSITY OF LOUISIANA............... LOUISIANA COMMUNITY AIDS RESEARCH PROGRAM (CPCRA).............. 734,999
U01CA083014-02................. ZAKRIS, ELLEN L................... TULANE UNIVERSITY OF LOUISIANA............... TULANE AIDS-ASSOCIATED MALIGNANCY CONSORTIUM................... 146,641
U01DK046636-06S1............... HENDRICKS, JAMES B................ CHILDREN'S HOSPITAL (NEW ORLEANS)............ DIABETES PREVENTION TRIAL-IDDM (DPT-1)......................... 32,167
U01DK048377-07................. BRAY, GEORGE A.................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... NIDDM PRIMARY PREVENTION TRIAL (DPT 2)......................... 647,180
U01DK056990-02................. BRAY, GEORGE A.................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... Clinical Center for Look AHEAD: Health in Diabetes............. 864,842
U01HD031315-07................. WILSON, JOHN T.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... PEDIATRIC PHARMACOLOGY RESEARCH UNIT........................... 299,009
U01HD032844-06................. ABDALIAN, SUE E................... TULANE UNIVERSITY OF LOUISIANA............... ADOLESCENT MEDICINE HIV/AIDS RESEARCH NETWORK.................. 178,365
U01HL038844-14................. BERENSON, GERALD S................ TULANE UNIVERSITY OF LOUISIANA............... EARLY NATURAL HISTORY OF ARTERIOSCLEROSIS...................... 1,153,179
U01HL057190-04................. BRAY, GEORGE A.................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... DIETARY PATTERNS, SODIUM INTAKE AND BLOOD PRESSURE............. 169,185
U01HL060571-03................. HARSHA, DAVID W................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... PREMIER--LIFESTYLE INTERVENE FOR BLOOD PRESSURE CONTRL......... 594,383
U01HL066855-01................. Webber, Larry S................... TULANE UNIVERSITY OF LOUISIANA............... TRIAL OF ACTIVITY FOR ADOLESCENT GIRLS (TAAG).................. 504,822
U10CA035272-17................. KARDINAL, CARL G.................. OCHSNER CLINIC FOUNDATION.................... OCHSNER COMMUNITY CLINICAL ONCOLOGY PROGRAM.................... 531,345
U10CA058658-08................. MILLS, GLENN M.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... SOUTHWEST ONCOLOGY GROUP....................................... 244,025
U10CA063845-06S3............... VEITH, ROBERT W................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... LSUMC MINORITY-BASED COMMUNITY CLINICAL ONCOLOGY PROGRAM....... 160,768
U10CA063845-06S4............... VEITH, ROBERT W................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... LSUMC MINORITY-BASED COMMUNITY CLINICAL ONCOLOGY PROGRAM....... 94,893
U10CA063845-06S5............... VEITH, ROBERT W................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... LSUMC MINORITY-BASED COMMUNITY CLINICAL ONCOLOGY PROGRAM....... 77,070
U19AI045511-02................. BEIER, JOHN C..................... TULANE UNIVERSITY OF LOUISIANA............... AFRICAN MALARIA VECTORS........................................ 592,666
U42RR003583-14S1............... ROWELL, THOMAS J.................. UNIVERSITY OF LOUISIANA AT LAFAYETTE......... ESTABLISHMENT OF A CHIMPANZEE BREEDING/RESEARCH PROGRAM........ 335,000
U42RR009895-05S2............... DRUILHET, ROBERT E................ UNIVERSITY OF LOUISIANA AT LAFAYETTE......... DEVELOPMENT OF A SPF PIGTAIL MACAQUE BREEDING COLONY........... 412,500
U42RR015087-01................. ROWELL, THOMAS J.................. UNIVERSITY OF LOUISIANA AT LAFAYETTE......... ESTABLISHMENT/MAINTENANCE OF BIOMEDICAL RESEARCH COLONY........ 820,281
U45ES010664-01................. WRIGHT, BEVERLY H................. XAVIER UNIVERSITY OF LOUISIANA............... WORKER HEALTH AND SAFETY TRAINING COOPERATIVE AGREEMENT........ 955,608
------------
TOTAL FY 2000............ .................................. ............................................. ............................................................... 78,633,407
============
FISCAL YEAR 2001
D43TW001086-03................. MATHER, FRANCES J................. TULANE UNIVERSITY OF LOUISIANA............... INTERNATIONAL TRAINING IN MEDICAL INFORMATICS.................. 149,371
D43TW001142-03................. BEIER, JOHN C..................... TULANE UNIVERSITY OF LOUISIANA............... ACTIONS FOR BUILDING CAPACITY.................................. 100,000
F06TW005588-01................. BEIER, JOHN C..................... TULANE UNIVERSITY OF LOUISIANA............... Vector ecology of urban malaria in Africa...................... 29,700
F31DA005907-03................. HORNER, KRISTEN A................. TULANE UNIVERSITY OF LOUISIANA............... CHANGES IN ENDOMORPHINS DURING OPIATE TOLERANCE................ 20,585
F31DA005926-03................. BRADLEY, AMY L.................... LOUISIANA STATE UNIV-UNIV OF NEW ORLEANS..... SYNTHESIS AND DEVELOPMENT OF NEW COCAINE MEDICATIONS........... 23,099
F31DA005948-03................. CZAPLA, MARC A.................... TULANE UNIVERSITY OF LOUISIANA............... ENDOMORPHIN AND CARDIORESPIRATORY CONTROL...................... 21,892
F31DA005968-03................. SMITH, REBECCA R.................. TULANE UNIVERSITY OF LOUISIANA............... ENDOMORPHIN PLASTICITY IN CHRONIC PAIN MODELS.................. 35,818
F31DA006040-02................. GREENWELL, THOMAS N............... TULANE UNIVERSITY OF LOUISIANA............... ENDOMORPHIN-NEUROIMMUNE INTERACTIONS........................... 21,431
F31DA014155-01................. BANNER, EDITH J................... LOUISIANA STATE UNIV-UNIV OF NEW ORLEANS..... Total Synthesis of Novel Decahydroquinolines................... 22,271
F31DC005116-01................. MCINVALE, ANDREW C................ TULANE UNIVERSITY OF LOUISIANA............... PSD Proteins: Functional Morphology at Auditory Synapses....... 21,500
F31GM019387-04................. HAMILTON, KIMBERLY Y.............. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... CHIRAL SELECTOR IN CAPILLARY ELECTROPHORESIS................... 22,650
F31GM019876-03................. BURSE, JEANINE R.................. TULANE UNIVERSITY OF LOUISIANA............... PAST AND PRESENT BIOINDICATION OF RIVER POLLUTION.............. 15,274
F31GM019876-03S1............... BURSE, JEANINE R.................. TULANE UNIVERSITY OF LOUISIANA............... PAST AND PRESENT BIOINDICATION OF RIVER POLLUTION.............. 5,575
F31GM020437-03................. CEDILLO, BERTHA M................. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... DEVELOPMENT OF A CHIRAL SELECTOR SYSTEM........................ 24,737
F31GM020686-02................. ROBINSON, TERI L.................. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... DENDRIMERS/POLYMERIC SURFACTANTS IN CHIRAL SEPARATIONS......... 27,013
F31GM020915-01A1............... GUTIERREZ, YANIRA I............... TULANE UNIVERSITY OF LOUISIANA............... PI3K-Mediated Hypoxia Survival Signaling Pathways.............. 24,470
F31HL068296-01................. ANDERSON, KIMBERLY M.............. TULANE UNIVERSITY OF LOUISIANA............... Studies of a novel A and B blood group cleaving enzyme......... 19,000
F31MH012816-01A1............... SANTUZZI, ALECIA M................ TULANE UNIVERSITY OF LOUISIANA............... PREDOCTORAL FELLOWSHIP PROGRAM (DISABILITY).................... 21,080
F32DA014162-01................. DANIEL, JILL M.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... Effects of Estrogen and Cannabinoids on Learning............... 33,260
F32DK009931-03................. ROSS, DONNA M..................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... RENAL CAPILLARY FAILURE IN DIABETIC NEPHROPATHY................ 40,196
F32DK010151-01................. WHITE, CHRISTY L.................. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... LEPTIN RESPONSIVENESS IN A DIETARY MODEL OF OBESITY............ 43,772
F32EY013651-01................. MARQUART, MARY E.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... Pseudomonas proteases as ocular virulence factors.............. 41,996
G08LM007108-01A1............... PERNOTTO, DENNIS A................ LOUISIANA STATE UNIV HSC SHREVEPORT.......... USING A LOUISIANA NETWORK TO TRAIN/SEARCH NLM DATABASES........ 49,489
G11HD034961-04................. ISLAND, GLENDA J.................. GRAMBLING STATE UNIVERSITY................... GSU RESEARCH INFRASTRUCTURE--PHASE II.......................... 81,148
G20RR016930-01................. BLANCHARD, JAMES L................ TULANE UNIVERSITY OF LOUISIANA............... BLDG D RENOV-ANIMAL RESOURCES IMPROVEMENTS..................... 699,950
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K01ES000358-01A1............... HUNT, JAY D....................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... Mutation and Environmental Exposures........................... 101,962
K01GM000707-02................. CHETTY, KOTHAPA N................. GRAMBLING STATE UNIVERSITY................... HYPERCHOLESTEROLEMIA AND REPERFUSION INJURY.................... 23,390
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P20RR016456-01................. WISCHUSEN, EVERETT W.............. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... Louisana Biomedical Research Network........................... 1,928,797
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R01AA009876-07................. WOLCOTT, ROBERT M................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... FETAL ALCOHOL EFFECTS AND IMMUNE DEVELOPMENT................... 211,762
R01AA010384-06A1............... Kolls, Jay K...................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... ALCOHOL, IMMUNOSUPPRESSION, AND TACE........................... 286,000
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R01AG017887-02................. JAZWINSKI, S MICHAL............... LOUISIANA STATE UNIV HSC NEW ORLEANS......... NUTRITIONAL AND METABOLIC MECHANISMS OF AGING.................. 336,000
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R01AG018239-02................. GEISELMAN, PAULA J................ LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... OBESITY PREVENTION AFTER SMOKING CESSATION IN MENOPAUSE........ 183,749
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R01AI032556-07................. FIDEL, PAUL L..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... MUCOSAL CELL MEDIATED IMMUNITY IN VAGINAL CANDIDIASIS.......... 214,500
R01AI033325-10................. KHAN, IMTIAZ A.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... LONG TERM IMMUNITY AGAINST TOXOPLASMOSIS....................... 258,541
R01AI040667-06................. VAN DER HEYDE, HENRI C............ LOUISIANA STATE UNIV HSC SHREVEPORT.......... Cell adhesion molecules in cerebral malaria.................... 253,750
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R01AI042146-03................. MUGGERIDGE, MARTIN I.............. LOUISIANA STATE UNIV HSC SHREVEPORT.......... ROLES OF HSV2 MEMBRANE PROTEINS IN MEMBRANE FUSION............. 180,021
R01AI042400-02................. DAVISON, BILLIE B................. TULANE UNIVERSITY OF LOUISIANA............... A RHESUS MONKEY MODEL OF MALARIA IN PREGNANCY.................. 454,121
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R01AI043000-03................. KOUSOULAS, KONSTANTIN GUS......... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... GENETICS & FUNCTIONS OF HSV1 GK IN VIRUS ENTRY & EGRESS........ 289,052
R01AI043693-05................. KHAN, IMTIAZ A.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... ENCEPHALITOZOAN CUNICULI--HOST IMMUNITY AND PATHOGENESIS....... 221,460
R01AI045041-03................. HURLBURT, BARRY K................. U.S. AGRICULTURE RESEARCH SERVICE-MIDSOU..... MECHANISMS OF VIRULENCE GENE REGULATION IN S. AUREUS........... 180,762
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R01AI046275-03................. Robinson, JAMES E................. TULANE UNIVERSITY OF LOUISIANA............... RHESUS MABS FROM SHIV INFECTED MACAQUES........................ 227,232
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R01AI049976-01................. PHILIPP, MARIO T.................. TULANE UNIVERSITY OF LOUISIANA............... 'Lyme disease: A possible test for cure........................ 152,000
R01AR045982-04................. ALA-KOKKA, LEENA M................ TULANE UNIVERSITY OF LOUISIANA............... MUTATIONS CAUSING DISC DISEASE AND SCIATICA.................... 281,321
R01AR046976-03................. KIMPEL, DONALD L.................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... NOVEL IMAGING TECHNOLOGIES FOR RHEUMATOID ARTHRITIS............ 290,000
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R01CA065600-05................. JETER, JAMES R.................... TULANE UNIVERSITY OF LOUISIANA............... CARCINOGENESIS AND LOSS OF DIFFERENTIATION CONTROL............. 178,547
R01CA067372-07................. SIXBEY, JOHN W.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... Epstein Barr Virus Induced Genomic Instability................. 326,250
R01CA075613-03................. HWANG, DANIEL H................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... CYCLOOXYGENASE AND TUMORIGENESIS............................... 191,184
R01CA078335-03................. GNARRA, JAMES R................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... HGF/SF SIGNALING BY THE VHL TUMOR SUPPRESSOR................... 214,314
R01CA078335-03S1............... GNARRA, JAMES R................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... HGF/SF SIGNALING BY THE VHL TUMOR SUPPRESSOR................... 72,221
R01CA080149-03................. MATHIS, J MICHAEL................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... ADENOVIRUS BASED P53 GENE THERAPY FOR OVARIAN CANCER........... 111,193
R01CA081125-03................. SCHWARZENBERGER, PAUL O........... LOUISIANA STATE UNIV HSC NEW ORLEANS......... IL-17 AND HEMATOPOIESIS........................................ 139,863
R01CA081506-02................. EHRLICH, MELANIE.................. TULANE UNIVERSITY OF LOUISIANA............... DNA HYPOMETHYLATION AND CANCER................................. 251,510
R01CA082689-03................. OCHOA, AUGUSTO C.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... INDUCTION OF ANERGY AND ALTERED SIGNAL TRANSDUCTION............ 207,865
R01CA083823-02................. Levy, Laura S..................... TULANE UNIVERSITY OF LOUISIANA............... SELECTIVE FORCES OPERATIVE IN FELV INFECTION................... 248,883
R01CA085693-02................. HARRISON, LYNN.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... DNA REPAIR OF MULTIPLY DAMAGED SITES IN CELLS.................. 195,750
R01CA088885-01................. OCHOA, AUGUSTO C.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... IMMUNE DYSFUNCTION AND IMMUNOTHERAPY OF RENAL CANCER........... 288,024
R01CA089057-01A1............... LI, LI............................ OCHSNER CLINIC FOUNDATION.................... Stromal Cell Molecules Required for Lymphoma Generation........ 166,250
R01CA089121-01A1............... Dash, Srikanta A.................. TULANE UNIVERSITY OF LOUISIANA............... Hepatitis C Virus and Hepatocellular Carcinoma................. 233,888
R01CA095783-01................. JONES, FRANK E.................... TULANE UNIVERSITY OF LOUISIANA............... ErbB4 signaling in the normal and neoplastic breast............ 234,226
R01DA005084-14................. LINDBERG, IRIS.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... OPIOID PEPTIDE SYNTHESIZING ENZYMES............................ 180,316
R01DA006013-09................. GOEDERS, NICHOLAS E............... LOUISIANA STATE UNIV HSC SHREVEPORT.......... ENVIRONMENTAL INFLUENCES ON COCAINE SELF ADMINISTRATION........ 213,738
R01DA009820-06................. GLOWA, JOHN R..................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... DETERMINANTS OF DRUG EFFECTS ON DRUG MAINTAINED BEHAVIOR....... 387,962
R01DA011417-03................. Moerschbaecher, Joseph M.......... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CANNABINOID ABUSE EFFECTS ON LEARNING AND MEMORY............... 194,804
R01DA011417-03S1............... Moerschbaecher, Joseph M.......... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CANNABINOID ABUSE EFFECTS ON LEARNING AND MEMORY............... 31,460
R01DA011528-05................. TRUDELL, MARK L................... LOUISIANA STATE UNIV-UNIV OF NEW ORLEANS..... SYNTHESIS OF POTENTIAL COCAINE ABUSE THERAPEUTICS.............. 257,932
R01DA011939-02................. Harlan, Richard E................. TULANE UNIVERSITY OF LOUISIANA............... THALAMOSTRIATAL MECHANISMS OF MORPHINE ACTION.................. 174,238
R01DA012267-03................. HARRISON, MURELLE G............... SOUTHERN UNIV A&M COL BATON ROUGE............ PREVENTING SUBSTANCE USE IN RURAL AFRICAN-AMERICAN YOUTH....... 598,668
R01DA012267-03S1............... HARRISON, MURELLE G............... SOUTHERN UNIV A&M COL BATON ROUGE............ PREVENTING SUBSTANCE USE IN RURAL AFRICAN-AMERICAN YOUTH....... 13,825
R01DA012427-02................. WINSAUER, PETER J................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... COCAINE SELF-ADMINSTRATION: EFFECTS ON LEARNING................ 97,643
R01DA012703-03................. TRUDELL, MARK L................... LOUISIANA STATE UNIV-UNIV OF NEW ORLEANS..... NOVEL NICOTINIC RECEPTOR MEDIATED THERAPEUTIC AGENTS........... 285,517
R01DA013463-01A1............... GOEDERS, NICHOLAS E............... LOUISIANA STATE UNIV HSC SHREVEPORT.......... Role for the HPA Axis in Methamphetamine Reinforcement......... 310,794
R01DA013470-01A1............... STEKETEE, JEFFERY D............... LOUISIANA STATE UNIV HSC SHREVEPORT.......... Medial Prefrontal Cortex and Cocaine Sensitization............. 53,717
R01DA013899-01A1............... MORSE, EDWARD V................... TULANE UNIVERSITY OF LOUISIANA............... Risk Reduction for Young African American IDUs................. 562,493
R01DC003679-03................. Hood, Linda Jean.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... AUDITORY GENETIC STUDIES OF HEREDITARY HEARING LOSS............ 207,374
R01DC003792-03................. CAPRIO, JOHN T.................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... ENCODING OF BIOLOGICALLY RELEVANT ODOR SIGNALS................. 319,975
R01DC003896-03................. Ricci, Anthony J.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... ENDOGENOUS FACTORS REGULATING TRANSDUCER ADAPTATION............ 166,126
R01DC004196-03................. Keats, Bronya J................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... ID OF THE MOUSE DEAFNESS (DN) GENE ON CHROMOSOME 19............ 224,047
R01DE008911-10................. WISE, GARY E...................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... MOLECULAR BASIS OF TOOTH ERUPTION.............................. 173,814
R01DE012178-04................. FIDEL, PAUL L..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... ORAL IMMUNE DYSFUNCTION AND CANDIDIASIS IN HIV INFECTION....... ...........
R01DE012178-04S1............... FIDEL, PAUL L..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... ORAL IMMUNE DYSFUNCTION AND CANDIDIASIS IN HIV INFECTION....... 108,940
R01DE012178-04S2............... FIDEL, PAUL L..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... ORAL IMMUNE DYSFUNCTION AND CANDIDIASIS IN HIV INFECTION....... 26,240
R01DE012329-03................. CHEN, YIPING...................... TULANE UNIVERSITY OF LOUISIANA............... MOLECULAR MECHANISMS OF VERTEBRATE TOOTH INITIATION............ 180,242
R01DE012916-03................. AMEDEE, ANGELA M.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... SIV MACAQUE MODEL FOR BREAST MILK TRANSMISSION OF HIV.......... 317,085
R01DK039232-12................. CARDELLI, JAMES A................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... REGULATION OF PHAGOCYTOSIS..................................... 185,261
R01DK041279-09A2............... GLASS, JONATHAN D................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... Molecular Mechanisms of Intestinal Iron Transport.............. 246,500
R01DK041868-11................. HWANG, DANIEL H................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... DIETARY N 3 FATTY ACIDS AND EXPRESSION OF CYCLOOXYGENASE....... 191,169
R01DK042714-10................. HORNBY, PAMELA J.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... CNS AUTONOMIC PATHWAYS AND GASTROINTESTINAL FUNCTION........... 182,394
R01DK043337-09................. KAPUSTA, DANIEL R................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... OPIOIDS AND CENTRAL NEURAL REGULATION OF RENAL FUNCTION........ 146,731
R01DK044510-08................. AW, TAK Y......................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... Glutathione redox control of intestinal cell responses......... 261,000
R01DK045278-09................. York, David A..................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... ENTEROSTATIN REGULATION OF FAT INTAKE.......................... 321,528
R01DK046935-07................. Lancaster, Jack R................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... NITROGEN AND OXYGEN RADICAL INTERACTIONS IN SURGERY............ 198,912
R01DK046935-07S1............... Lancaster, Jack R................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... NITROGEN AND OXYGEN RADICAL INTERACTIONS IN SURGERY............ 36,886
R01DK047211-07................. VEDECKIS, WAYNE V................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... REGULATION OF GLUCOCORTICOID RECEPTOR GENE EXPRESSION.......... 180,596
R01DK047348-08................. BERTHOUD, HANS-RUDOLF............. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... AUTONOMIC REGULATION OF FOOD INTAKE AND METABOLISM............. 179,844
R01DK047663-07................. GRISHAM, MATTHEW B................ LOUISIANA STATE UNIV HSC SHREVEPORT.......... ADHESION MOLECULE EXPRESSION IN CHRONIC GUT INFLAMMATION....... 177,703
R01DK048055-06A2............... MCCARTHY, KEVIN J................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... Proteoglycans in Diabetic Nephropathy.......................... 290,000
R01DK049703-05S3............... LINDBERG, IRIS.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CONTROL OF PEPTIDE HORMONE BIOSYNTHESIS BY PC2 AND 7B2......... 71,500
R01DK052968-03................. Stephens, Jacqueline M............ LOUISIANA STATE UNIV A&M COL BATON ROUGE..... REGULATION AND ACTIVATION OF STATS IN ADIPOCYTES............... 185,448
R01DK053113-03................. SMITH, BRENDA K................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... TASTE AND GENETIC MECHANISMS OF MACRONUTRIENT SELECTION........ 216,418
R01DK053697-04S1............... CORREA, PELAYO.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... HELICOBACTER INFECTION AND GROWTH OF CHILDREN.................. 25,000
R01DK053697-05................. CORREA, PELAYO.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... HELICOBACTER INFECTION AND GROWTH OF CHILDREN.................. 46,225
R01DK053981-04................. GETTYS, THOMAS W.................. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... MECHANISMS OF UCP REGULATION BY LEPTIN......................... 198,992
R01DK054880-03................. KASTIN, ABBA J.................... TULANE UNIVERSITY OF LOUISIANA............... BLOOD/BRAIN BARRIER AND LEPTIN TRANSPORT IN OBESITY............ 321,158
R01DK054952-02................. HAMM, L. LEE...................... TULANE UNIVERSITY OF LOUISIANA............... REGULATION OF CITRATE TRANSPORT................................ 198,450
R01DK055626-02................. AWAYDA, MOUHAMED S................ TULANE UNIVERSITY OF LOUISIANA............... KINASE REGULATION OF THE EPITHELIAL NA CHANNEL................. 222,750
R01DK056132-01A2............... SMITH, BRET N..................... TULANE UNIVERSITY OF LOUISIANA............... Neural Circuitry in the Caudal Solitary Complex................ 297,750
R01DK056264-02................. El-Dahr, Samir S.................. TULANE UNIVERSITY OF LOUISIANA............... INDUCIBLE DYSPLASTIC NEPHROPATHY IN B2-DEFICENT MICE........... 267,300
R01DK057242-02................. BERTHOUD, HANS-RUDOLF............. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... FUNCTIONAL ORGANIZATION OF THE VAGAL-ENTERIC INTERFACE......... 209,153
R01DK057446-03................. LOVEJOY, JENNIFER C............... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... INTERNET-AIDED PREVENTION OF PREGNANCY-INDUCED OBESITY......... 141,699
R01DK057476-03................. MARTIN, PAMELA D.................. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... PRIMARY CARE OFFICE MANAGEMENT OF OBESITY...................... 186,088
R01DK058152-02................. KOZAK, LESLIE P................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... GENETICS OF DEVELOPMENTAL PLASTICITY IN THE ADIPOCYTE.......... 432,199
R01DK058499-01A1............... AGRAWAL, KRISHNA C................ TULANE UNIVERSITY OF LOUISIANA............... Protease Inhibitor Related Adipogenesis in HIV Infection....... 282,150
R01DK060412-01................. RAVUSSIN, ERIC.................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... Fat Cell Size, Muscle Lipid and Insulin Resistance............. 613,281
R01ES006766-08................. Brody, Arnold R................... TULANE UNIVERSITY OF LOUISIANA............... GROWTH FACTORS IN ASBESTOS INDUCED PULMONARY FIBROSIS.......... 250,931
R01ES008663-05................. FRIEDMAN, MITCHELL................ TULANE UNIVERSITY OF LOUISIANA............... BIOCHEMICAL MECHANISM FOR OZONE PATHOLOGY...................... 193,757
R01ES009158-05................. PRUETT, STEPHEN B................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... Mechanisms of Immunotoxcity of Chemical Stressors.............. 205,350
R01ES009870-02................. MEHENDALE, HARIHARA M............. UNIVERSITY OF LOUISIANA AT MONROE............ DIETARY RESTRICTION AND TOXICANT-INDUCED LIVER DISEASE......... 248,832
R01ES010046-02................. LASKY, JOSEPH A................... TULANE UNIVERSITY OF LOUISIANA............... DISRUPTION OF PDGF SIGNAL TRANSDUCTION IN LUNG FIBROSIS........ 222,750
R01EY002672-23................. KAUFMAN, HERBERT E................ LOUISIANA STATE UNIV HSC NEW ORLEANS......... OCULAR HERPES SIMPLEX VIRUS.................................... 346,750
R01EY003311-22................. KLYCE, STEPHEN D.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... INTEGRATED ASSESSMENT OF CORNEAL FORM AND FUNCTION............. 259,731
R01EY004928-19................. BAZAN, HAYDEE E................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CORNEAL LIPID METABOLISM AND RESPONSE TO INFLAMMATION.......... 197,171
R01EY005121-17A1............... BAZAN, NICOLAS G.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... RPE Messengers, Transcription and Photoreceptor Renewal........ 250,250
R01EY006311-15................. HILL, JAMES M..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... OCULAR HSV--LATENCY, REACTIVATION, AND RECURRENCE.............. 121,399
R01EY006311-16................. HILL, JAMES M..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... Ocular HSV--Latency, Reactivation, and Recurrence.............. 160,875
R01EY006635-15................. BAZAN, HAYDEE E................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CELL SIGNAL TRANSDUCTION IN CORNEAL WOUND HEALING.............. 223,276
R01EY007380-12................. MENERAY, MICHELE A................ LOUISIANA STATE UNIV HSC NEW ORLEANS......... INTERACTIVE CELLULAR CONTROLS LACRIMAL GLAND FUNCTIONAL........ 286,000
R01EY008871-11................. HILL, JAMES M..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... OCULAR PATHOGENESIS AND THERAPY OF BACTERIAL KERATITIS......... 301,534
R01EY010974-06................. O'CALLAGHAN, RICHARD J............ LOUISIANA STATE UNIV HSC NEW ORLEANS......... STAPH KERATITIS--MECHANISMS/ARRESTING OF CORNEAL DAMAGE........ 257,394
R01EY011610-04................. BURGOYNE, CLAUDE F................ LOUISIANA STATE UNIV HSC NEW ORLEANS......... IOP RELATED FORCE AND FAILURE IN THE OPTIC NERVE HEAD.......... 328,054
R01EY012367-03................. JACOB, JEAN T..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... EPITHELIALIZATION OF TISSUE ENGINEERED CORNEAS................. 503,786
R01EY012416-03................. BEUERMAN, ROGER W................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... REGULATION OF PROTEIN SYNTHESIS IN THE LACRIMAL GLAND.......... 218,284
R01EY012540-03................. PALKAMA, ARTO K................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... AQUEOUS OUTFLOW AND STRUCTURAL CORRELATIONS.................... 337,419
R01EY012701-02................. CHANDRASEKHER, GUDISEVA........... LOUISIANA STATE UNIV HSC NEW ORLEANS......... GROWTH FACTOR RECEPTOR MEDITATED SIGNAL MECHANISMS LENS........ 175,955
R01EY012716-01A2............... GUIDO, WILLIAM.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... FUNCTIONAL STATE OF DEVELOPING RETINOGENICULATE SYNAPSE........ 204,137
R01EY012887-02................. KHOOBEHI, BAHRAM.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... RETINAL AND CHOROIDAL BLOOD FLOW IMAGING....................... 223,146
R01EY012961-02................. O'CALLAGHAN, RICHARD J............ LOUISIANA STATE UNIV HSC NEW ORLEANS......... MECHANISMS AND THERAPY OF BACTERIAL KERATITIS.................. 286,000
R01GM020818-27S1............... RHOADS, ROBERT E.................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... REGULATION OF EUKARYOTIC PROTEIN SYNTHESIS INITITATION......... 94,237
R01GM039844-11................. WARNER, ISIAH M................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... Bioanalytical Separation Using Chiral Polymers................. 351,000
R01GM039844-11S1............... WARNER, ISIAH M................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... Bioanalytical Separation Using Chiral Polymers................. 15,817
R01GM045668-09................. DEININGER, Prescott L............. TULANE UNIVERSITY OF LOUISIANA............... HUMAN DIMORPHISMS BY SINE MASTER GENES......................... 241,319
R01GM047789-17................. TATCHELL, Kelly G................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... GENETIC ANALYSIS OF PROTEIN PHOSPHATASE 1 IN YEAST............. 279,098
R01GM048045-10................. FLEMINGTON, ERIK K................ TULANE UNIVERSITY OF LOUISIANA............... EBV BZLF1 GENE PRODUCT......................................... 239,669
R01GM051261-05................. WALDROP, GROVER L................. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... CATALYTIC MECHANISM OF BIOTIN DEPENDENT ENZYMES................ 95,162
R01GM051521-08................. WITT, STEPHEN N................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... KINETICS AND MECHANISM OF THE HEAT SHOCK 70 PROTEIN DNAK....... 199,697
R01GM055420-11................. NEWCOMER, MARCIA E................ LOUISIANA STATE UNIV A&M COL BATON ROUGE..... ENZYMATIC ACTIVATION OF LIPOPHILIC SIGNALING MOLECULES......... 71,473
R01GM056835-04................. MCLAUGHLIN, MARK L................ LOUISIANA STATE UNIV A&M COL BATON ROUGE..... PEPTIDES ACTIVE AGAINST INTRACELLULAR PATHOGENIC DISEASE....... 171,443
R01GM058843-03................. LIMBACH, PATRICK A................ LOUISIANA STATE UNIV A&M COL BATON ROUGE..... IDENTIFICATION OF MODIFIED NUCLEOSIDES IN RIBOSOMAL RNA........ 130,415
R01GM059663-01A2............... WITTUNG-STAFSHEDE, PERNILLA E..... TULANE UNIVERSITY OF LOUISIANA............... COFACTOR ROLE IN BETA-SHEET PROTEIN FOLDING.................... 157,180
R01GM060000-01A2............... WIMLEY, WILLIAM C................. TULANE UNIVERSITY OF LOUISIANA............... Folding and design of beta sheets in membranes................. 173,500
R01GM061915-01A1............... STRONGIN, ROBERT M................ LOUISIANA STATE UNIV A&M COL BATON ROUGE..... Synthesis and Study of Novel Sensing Agents.................... 183,750
R01HD008431-26................. KOZAK, LESLIE P................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... MOLECULAR GENETICS OF THERMOGENESIS............................ 311,940
R01HD036822-03................. WANG, YU-PING..................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... PLACENTAL FUNCTION IN PREECLAMPSIA............................. 141,187
R01HD037811-02................. GASSER, RAYMOND F................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... HUMAN EMBRYO SECTIONS ON COMPUTER DISKS FOR EDUCATION.......... 244,821
R01HD039104-02................. WILLIAMSON, DONALD A.............. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... INTERNET-BASED OBESITY PREVENTION FOR BLACK ADOLESCENTS........ 158,490
R01HG001499-05................. SOPER, Steven A................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... HIGH THROUGHPUT DNA SEQUENCING USING NANO-REACTORS............. 393,493
R01HG001499-05S1............... SOPER, Steven A................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... HIGH THROUGHPUT DNA SEQUENCING USING NANO-REACTORS............. 31,605
R01HL026371-20................. Navar, L. Gabriel................. TULANE UNIVERSITY OF LOUISIANA............... RENAL FUNCTIONAL DERANGEMENTS IN HYPERTENSION.................. 327,703
R01HL026441-21................. GRANGER, D NEIL................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... TRANSCAPILLARY FLUID EXCHANGE.................................. 249,045
R01HL045670-10................. BOUCHARD, CLAUDE.................. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... HERITAGE-GENETICS, RESPONSE TO EXERCISE, RISK FACTORS-3........ 723,661
R01HL054797-08................. KORTHUIS, RONALD J................ LOUISIANA STATE UNIV HSC SHREVEPORT.......... PRECONDITIONING: PMN ADHESION AND MICROVASCULAR INJURY......... 290,000
R01HL059699-04................. IMIG, JOHN D...................... TULANE UNIVERSITY OF LOUISIANA............... OXYGENASE METABOLITES AND RENAL VASCULAR ACTIVITY.............. 27,519
R01HL059699-05................. IMIG, JOHN D...................... TULANE UNIVERSITY OF LOUISIANA............... OXYGENASE METABOLITES AND RENAL VASCULAR ACTIVITY.............. 69,000
R01HL059724-05................. SHELLITO, JUDD E.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... T LYMPHOCYTE SUBSETS AND HOST DEFENSE AGAINST P CARINII........ 357,165
R01HL059879-03................. CLAYCOMB, WILLIAM C............... LOUISIANA STATE UNIV HSC NEW ORLEANS......... NOVEL GENE DISCOVERED IN THE HEART............................. 213,150
R01HL060300-05................. HE, JIANG......................... TULANE UNIVERSITY OF LOUISIANA............... EPIDEMIOLOGY STUDIES OF DIETARY FIBER AND BLOOD PRESSURE....... 104,421
R01HL060532-05................. Brody, Arnold R................... TULANE UNIVERSITY OF LOUISIANA............... EPITHELIAL GROWTH FACTORS IN ENVIRONMENTAL LUNG DISEASE........ 285,524
R01HL060849-03................. LEFER, DAVID J.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... MECHANISMS OF MYOCARDIAL REPERFUSION INJURY--DIABETES.......... 180,586
R01HL061271-03................. Kolls, Jay K...................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... NON CD4 HOST DEFENSE AGAINST P CARINII PNEUMONIA............... 76,076
R01HL061934-05................. MORRIS, CINDY A................... TULANE UNIVERSITY OF LOUISIANA............... MOLECULAR MECHANISM OF TAT INDUCED ANGIOGENESIS................ 222,750
R01HL062000-01A2S1............. HYMAN, ALBERT L................... TULANE UNIVERSITY OF LOUISIANA............... CARDIOPULMONARY SURGERY RESEARCH............................... 43,065
R01HL062000-02................. HYMAN, ALBERT L................... TULANE UNIVERSITY OF LOUISIANA............... CARDIOPULMONARY SURGERY RESEARCH............................... 302,940
R01HL062052-03S1............... Kolls, Jay K...................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CD8 AND GAMMA/DELTA T CELLS IN P CARINII PNEUMONIA............. 4,976
R01HL062052-04................. Kolls, Jay K...................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CD8 AND GAMMA/DELTA T CELLS IN P CARINII PNEUMONIA............. 255,226
R01HL062052-04S1............... Kolls, Jay K...................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CD8 AND GAMMA/DELTA T CELLS IN P CARINII PNEUMONIA............. 4,976
R01HL062147-04................. PANDEY, KAILASH N................. TULANE UNIVERSITY OF LOUISIANA............... ANP RECEPTOR GENE--TARGETING AND EXPRESSION.................... 160,386
R01HL063128-02................. AGRAWAL, KRISHNA C................ TULANE UNIVERSITY OF LOUISIANA............... MECHANISMS OF CARDIOVASCULAR COMPLICATIONS IN AIDS............. 291,666
R01HL063195-03................. TRAYANOVA, NATALIA A.............. TULANE UNIVERSITY OF LOUISIANA............... CARDIAC TISSUE STRUCTURE IN THE DEFIBRILLATION PROCESS......... 165,539
R01HL063778-01A1............... LASKY, JOSEPH A................... TULANE UNIVERSITY OF LOUISIANA............... CTGF IN LUNG FIBROGENESIS...................................... 253,813
R01HL064555-03................. CLARKSON, CRAIG W................. TULANE UNIVERSITY OF LOUISIANA............... MOLECULAR BASIS FOR DRUG INDUCED CARDIOTOXICITY IN AIDS........ 189,054
R01HL064577-03................. JOHNSON, ROBERT A................. TULANE UNIVERSITY OF LOUISIANA............... HEMODYNAMIC ROLES OF ENDOGENEOUS CARBON MONOXIDE............... 167,296
R01HL065997-01................. WANG, YU-PING..................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... ENDOTHELIAL BARRIER FUNCTION IN PREECLAMPSIA................... 242,500
R01HL066158-01A1............... VEHASKARI, V M.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... Prenatal and Perinatal Programming of Adult Hypertension....... 239,500
R01HL066432-01A1............... MAJID, DEWAN S.................... TULANE UNIVERSITY OF LOUISIANA............... Superoxide and nitric Oxide Interactions in the Kidney......... 247,750
R01NS009626-31................. LI, YU-TEH........................ TULANE UNIVERSITY OF LOUISIANA............... GLYCOSIDASES AS RELATED TO SPHINGOLIPIDOSES.................... 344,502
R01NS009626-31S1............... LI, YU-TEH........................ TULANE UNIVERSITY OF LOUISIANA............... GLYCOSIDASES AS RELATED TO SPHINGOLIPIDOSES.................... 27,716
R01NS025134-12................. HAYCOCK, JOHN W................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CELLULAR REGULATION OF TYROSINE HYDROXYLASE.................... 214,604
R01NS025987-14................. PHELPS, CAROL J................... TULANE UNIVERSITY OF LOUISIANA............... HYPOPHYSIOTROPIC NEURON DIFFERENTIATION--TARGET FEEDBACK....... 213,375
R01NS035370-09A1............... DUNN, ADRIAN J.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... Cytokine Action on the CNS..................................... 283,070
R01NS036936-04................. ERICKSON, JEFFREY D............... LOUISIANA STATE UNIV HSC NEW ORLEANS......... VESICULAR TRANSPORTER SPECIFICITY.............................. 207,749
R01NS037070-04................. ERZURUMLU, REHA S................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... CELLULAR MECHANISMS UNDERLYING PATTERN FORMATION............... 131,747
R01NS039033-01A2............... PHINNEY, DONALD G................. TULANE UNIVERSITY OF LOUISIANA............... Marrow stromal cells for Lysosomal Disease CNS Defects......... 259,875
R01NS039050-02................. ERZURUMLU, REHA S................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... SOMATOSENSORY CORTICAL DEVELOPMENT AND PLASTICITY.............. 143,000
R01NS039099-02................. TASKER, JEFFREY G................. TULANE UNIVERSITY OF LOUISIANA............... HYPOTHALAMIC SYNCHRONIZATION BY LOCAL GLUTAMATE CIRCUITS....... 259,875
R01NS039458-02................. MAGEE, JEFFERY C.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... DENDRITIC INTEGRATION IN HIPPOCAMPAL PYRAMIDAL NEURONS......... 142,062
R01NS040373-01A1............... ARIMURA, AKIRA A.................. TULANE UNIVERSITY OF LOUISIANA............... Neuroprotection by PACAP in Stroke............................. 371,250
R01NS044000-01................. BASTIAN, FRANK O.................. TULANE UNIVERSITY OF LOUISIANA............... Spiroplasma 16S rDNA in TSE Brain Tissues...................... 181,745
R03AG019058-01................. MEHENDALE, HARIHARA M............. UNIVERSITY OF LOUISIANA AT MONROE............ AGING AND RESILIENCY TO LIVER TOXICITY......................... 66,844
R03AI043873-03................. Pincus, Seth H.................... CHILDREN'S HOSPITAL (NEW ORLEANS)............ ROLE OF MURINE LEUKEMIA VIRUS IN AUTOIMMUNITY.................. 70,000
R03CA083096-01A1............... JOHNSON, ERIC S................... TULANE UNIVERSITY OF LOUISIANA............... POSSIBLE OF ROLE OF AVIAN RETROVIRUSES IN HUMAN CANCER......... 71,513
R03CA086378-02................. HAGENSEE, MICHAEL E............... LOUISIANA STATE UNIV HSC NEW ORLEANS......... DEVELOPMENT OF A URINE PCR ASSAY FOR HPV DNA DETECTION......... 71,500
R03CA088135-02................. SU, L. J.......................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... DIETARY SURVEY INSTRUMENT DEVELOPMENT FOR AN ETHNIC MINO....... 69,695
R03DA012547-02................. ROERIG, SANDRA C.................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... SPINAL NITRIC OXIDE IN CHRONIC INFLAMMATORY PAIN............... 71,037
R03DA013421-02................. LAHOSTE, GERALD J................. LOUISIANA STATE UNIV-UNIV OF NEW ORLEANS..... GAP JUNCTIONS AND DOPAMINE PLASTICITY.......................... 71,000
R03DA013546-02................. HUANG, TIEN L..................... XAVIER UNIVERSITY OF LOUISIANA............... NOVEL ANTI-PCP AGENTS WITH NEUROPROTECTIVE PROPERTIES.......... 69,975
R03DA013647-01A1............... SMAGIN, GENNADY N................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... NEUROCHEMISTRY OF COCAINE REINFORCEMENT........................ 71,571
R03HD041052-01................. SCHMIDT-SOMMERFELD, EBERHARD...... LOUISIANA STATE UNIV HSC NEW ORLEANS......... PARENTERAL MEDIUM CHAIN TRIGLYCERIDES IN THE PREMATURE......... 71,500
R03MH061944-02................. NORTHUP, JOHN A................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... STAR PROGRAM: EARLY & PREVENTIVE INTERVENTION OF ADHD.......... 73,500
R03MH063814-01................. SCARAMELLA, LAURA V............... LOUISIANA STATE UNIV-UNIV OF NEW ORLEANS..... PARENTING AND TEMPERAMENT RECIPROCITIES IN TODDLERHOOD......... 71,000
R03MH064587-01................. ULLER, CLAUDIA.................... UNIVERSITY OF LOUISIANA AT LAFAYETTE......... MENTAL STATE ATTRIBUTION IN INFANCY............................ 66,720
R13ES011296-01................. MCLACHLAN, JOHN A................. TULANE UNIVERSITY OF LOUISIANA CONFERENCE.... E.HORMONE 2001................................................. 10,000
R15CA086833-01A1............... SYLVESTER, PAUL W................. UNIVERSITY OF LOUISIANA AT MONROE............ ANTIPROLIFERATIVE & APOPTOTIC MECHANISMS OF TOCOTRIENOLS....... 124,500
R18AI033449-07................. FREY, DANIEL J.................... LOUISIANA ORGAN PROCUREMENT AGENCY........... ENHANCING DONOR REGISTRY TO INCREASE DONATION.................. 263,035
R21AR047796-02................. PROCKOP, DARWIN J................. TULANE UNIVERSITY OF LOUISIANA............... EXPANSION OF STEM CELLS FOR SKELETAL TISSUES................... 74,250
R21CA083198-02................. OCHOA, AUGUSTO C.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... T CELL SIGNAL TRANSDUCTION TO MONITOR HPV VACCINES............. 143,000
R21CA084095-02................. HYMAN, LINDA E.................... TULANE UNIVERSITY OF LOUISIANA............... ELONGIN C: FUNCTION AND ROLE IN VHL DISEASE.................... 148,500
R21CA091785-02................. KEPPLER, DANIEL................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... ROLE OF CYSTATIN M IN BREAST TUMOR PROGRESSION................. 106,120
R21DC004994-01................. BOBBIN, RICHARD P................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... DRUG MANIPULATION OF NOISE-INDUCED HEARING LOSS................ 143,000
R21DK057390-01A1............... HORNBY, PAMELA J.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... VAGAL GASTRIC MOTOR CONTROL IN MICE............................ 143,000
R21NS043974-01................. EHRLICH, MELANIE.................. TULANE UNIVERSITY OF LOUISIANA............... FSHD SYNDROME--DNA REPEATS, METHYLATION, AND CHROMATIN......... 185,625
R21RR015016-02................. MURRAY, KERMIT K.................. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... MADLI MASS SPECTROMETRY FOR MICROFLUIDIC CHIP DETECTION........ 99,440
R24CA084625-02................. SOPER, STEVEN A................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... MICRO-INSTRUMENT PLATFORMS FOR GENETIC-BASED ANALYSES.......... 548,672
R24DA007970-09................. KOMISKEY, HAROLD L................ XAVIER UNIVERSITY OF LOUISIANA............... MIDARP AT XAVIER UNIVERSITY OF LOUISIANA....................... 406,111
R24HL060808-04................. STRONG, JACK P.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... PDAY CARDIOVASCULAR SPECIMEN AND DATA LIBRARY.................. 128,074
R24RR012545-03................. BASKIN, GARY B.................... TULANE UNIVERSITY OF LOUISIANA............... ANIMAL MODEL FOR GENE THERAPY OF INHERITED DISORDERS........... 517,001
R25CA047877-14................. LOPEZ S, ALFREDO.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... SHORT RESEARCH EXPERIENCES IN CANCER........................... 63,347
R25MH058560-04................. SAXENA, KRISHAN M................. GRAMBLING STATE UNIVERSITY................... NIMH HONORS MINORITY HIGH SCHOOL PROGRAM AT GSU................ 26,001
R29CA076186-04................. MEYERS, SHARI L................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... MOLECULAR MECHANISM OF TRANSFORMATION BY AML1/ETO.............. 101,500
R29DC003280-04................. GARCIA, MEREDITH M................ TULANE UNIVERSITY OF LOUISIANA............... PROTEIN KINASE C IN CENTRAL AUDITORY PLASTICITY................ 100,289
R29DK050151-06................. LI, MING.......................... TULANE UNIVERSITY OF LOUISIANA............... LVA CALCIUM CHANNEL AND PANCREATIC B CELL DEATH................ 112,174
R29DK052148-05................. KALOGERIS, THEODORE J............. LOUISIANA STATE UNIV HSC SHREVEPORT.......... NEUROHORMONAL CONTROL OF INTESTINAL APOLIPOPROTEIN A IV........ 99,757
R29ES009055-04................. MILLER, CHARLES A................. TULANE UNIVERSITY OF LOUISIANA............... ARYL HYDROCARBON RECEPTOR STRUCTURE AND INTERACTIONS........... 91,084
R29EY012204-04................. GLEASON, EVANNA L................. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... METABOTROPIC GLUTAMATE RECEPTORS ON AMACRINE CELLS............. 99,732
R29HD036310-06................. VEAZEY, RONALD S.................. TULANE UNIVERSITY OF LOUISIANA............... ONTOGENY OF THE NEONATAL MACAQUE IMMUNE SYSTEM................. 118,718
R29HD036421-05................. KUBISCH, HANS M................... TULANE UNIVERSITY OF LOUISIANA............... MARKER ASSISTED SELECTION OF BOVINE BLASTOCYSTS................ 133,523
R29MH055654-05................. FRICK, PAUL J..................... LOUISIANA STATE UNIV-UNIV OF NEW ORLEANS..... CALLOUS/UNEMOTIONAL TRAITS AND CONDUCT PROBLEMS................ 86,984
R29NS035865-05................. MAGEE, JEFFERY C.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... DENDRITIC K+ AND IH CHANNELS IN HIPPOCAMPAL NEURONS............ 106,678
R37AG006168-16................. JAZWINSKI, S MICHAL............... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CELLULAR AGING IN A YEAST MODEL SYSTEM......................... 410,300
R37DK032089-20................. BRAY, GEORGE A.................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... DIETARY OBESITY................................................ 300,943
R37DK036013-15................. ORLANDO, ROY C.................... TULANE UNIVERSITY OF LOUISIANA............... ESOPHAGEAL CYTOPROTECTION-AGENTS AND MECHANISMS................ 208,830
R37MH051853-08................. MCCANN, SAMUEL M.................. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... MECHANISM OF ACTION OF CYTOKINES ON BRAIN AND PITUITARY........ 290,105
R41AG018196-01A1............... NARDUCY, KENNETH W................ ST CHARLES PHARMACEUTICALS................... ANALGESICS FOR CHRONIC PAIN TREATMENT IN THE ELDERLY........... 100,000
R42CA083756-04................. PINCUS, SETH H.................... NORION DIAGNOSTIC INNOVATIONS, INC........... HIV INFECTIVITY TEST FOR ANTIVIRAL SUSCEPTIBILITY.............. 141,987
R43CA089772-01................. MORGAN, LEE R..................... DEKK-TEC, INC................................ A-007: IMMUNE MODULATION OF HPV--CERVICAL CANCER............... 191,517
R43CA090123-01................. GOTTLIEB, MARISE S................ ENDEAVOR CORPORATION......................... DNA BASED SENSITIVE ASSAY FOR LYMPOID MALIGNANCIES............. 122,123
R44CA083552-03................. MORGAN, LEE R..................... DEKK-TEC, INC................................ ISOPHOSPHORAMIDE MUSTARD--A PHASE 1 STUDY...................... 338,965
R44CA085021-02................. MORGAN, LEE R..................... DEKK-TEC, INC................................ DERIVATIVES OF DEMETHYLPENCLOMEDINE: ANTICANCER AGENTS......... 359,498
S06GM004531-12................. IFEANYI, FELIX I.................. GRAMBLING STATE UNIVERSITY................... MBRS SCORE PROGRAM AT GRAMBLING STATE UNIVERSITY............... 149,473
S06GM008008-30................. STEVENS, CHERYL L................. XAVIER UNIVERSITY OF LOUISIANA............... MBRS SCORE PROGRAM AT XAVIER UNIVERSITY........................ 570,861
S06GM008008-30S1............... STEVENS, CHERYL L................. XAVIER UNIVERSITY OF LOUISIANA............... MBRS SCORE RESEARCH AT XAVIER UNIVERSITY....................... 476,904
S06GM008025-28A1............... CHRISTIAN, FRED A................. SOUTHERN UNIV A&M COL BATON ROUGE............ MBRS SCORE PROGRAM AT SOUTHERN UNIVERSITY-BATON ROUGE.......... 55,505
S11ES009996-03................. BLAKE, ROBERT C................... XAVIER UNIVERSITY OF LOUISIANA............... ALTERATION OF GENE REGULATION BY ENVIRONMENTAL COMPOUNDS....... 970,632
S11ES010018-03................. MUGANDA, PERPETUA M............... SOUTHERN UNIV A&M COL BATON ROUGE............ CELLULAR & MOLECULAR TOXICOLOGY OF BUTADIENE................... 906,194
S21MD000100-01................. FRANCIS, NORMAN C................. XAVIER UNIVERSITY OF LOUISIANA............... XAVIER PHARMACY ENDOWMENT FOR MINORITY HEALTH.................. 2,300,000
T32AA007577-03................. BAGBY, GREGORY J.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... BIOMEDICAL ALCOHOL RESEARCH TRAINING PROGRAM................... 287,988
T32CA065436-05................. JAFFE, BERNARD M.................. TULANE UNIVERSITY OF LOUISIANA............... RESEARCH TRAINING IN SURGICAL ONCOLOGY (T32)................... 26,286
T32DA007311-03................. GOEDERS, NICHOLAS E............... LOUISIANA STATE UNIV HSC SHREVEPORT.......... STRESS AND THE NEUROBIOLOGY OF DRUG AND ALCOHOL DEPENDE........ 282,094
T34GM007716-23................. BIRDWHISTELL, TERESA.............. XAVIER UNIVERSITY OF LOUISIANA............... MARC UNDERGRADUATE STUDENT TRAINING IN ACADEMIC RESEARCH....... 514,676
T34GM008714-03S1............... HIMAYA, M A....................... GRAMBLING STATE UNIVERSITY................... U STAR PROGRAM FOR MARC AT GRAMBLING STATE UNIVERSITY.......... 148,110
T34MH017102-19................. SAXENA, KRISHAN M................. GRAMBLING STATE UNIVERSITY................... NIMH COR HONORS UNDERGRADUATE PROGRAM AT GSU................... 157,376
U01AI032913-09S1............... VAN DYKE, RUSSELL B............... TULANE UNIVERSITY OF LOUISIANA............... TULANE/LSU PEDIATRIC AIDS CLINICAL TRIALS UNIT................. 884,360
U01AI038844-04S2............... LERTORA, JUAN J. L................ TULANE UNIVERSITY OF LOUISIANA............... AIDS CLINICAL TRIALS UNIT...................................... 318,973
U01AI042178-10................. MUSHATT, DAVID M.................. TULANE UNIVERSITY OF LOUISIANA............... LOUISIANA COMMUNITY AIDS RESEARCH PROGRAM (CPCRA).............. 738,328
U01CA083014-03................. ZAKRIS, ELLEN L................... TULANE UNIVERSITY OF LOUISIANA............... TULANE AIDS-ASSOCIATED MALIGNANCY CONSORTIUM................... 151,039
U01DK048377-08................. BRAY, GEORGE A.................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... NIDDM PRIMARY PREVENTION TRIAL (DPT 2)......................... 700,258
U01DK056990-03................. BRAY, GEORGE A.................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... CLINICAL CENTER FOR LOOK AHEAD: HEALTH IN DIABETES............. 1,120,807
U01DK056990-03S1............... BRAY, GEORGE A.................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... CLINICAL CENTER FOR LOOK AHEAD: HEALTH IN DIABETES............. 7,350
U01DK060963-01................. HE, JIANG......................... TULANE UNIVERSITY OF LOUISIANA............... CLINICAL CENTER FOR PROSPECTIVE COHORT STUDY OF CRI............ 214,285
U01HD031315-08................. WILSON, JOHN T.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... PEDIATRIC PHARMACOLOGY RESEARCH UNIT........................... 371,253
U01HD040470-01................. ABDALIAN, SUE E................... TULANE UNIVERSITY OF LOUISIANA............... ADOLESCENT MEDICINE TRIAL NETWORK FOR HIV/AIDS................. 347,686
U01HL038844-15................. BERENSON, GERALD S................ TULANE UNIVERSITY OF LOUISIANA............... EARLY NATURAL HISTORY OF ARTERIOSCLEROSIS...................... 1,129,399
U01HL060571-04................. HARSHA, DAVID W................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... PREMIER--LIFESTYLE INTERVENE FOR BLOOD PRESSURE CONTRL......... 344,746
U01HL066855-02................. WEBBER, LARRY S................... TULANE UNIVERSITY OF LOUISIANA............... TRIAL OF ACTIVITY FOR ADOLESCENT GIRLS (TAAG).................. 555,628
U10CA035272-18................. KARDINAL, CARL G.................. OCHSNER CLINIC FOUNDATION.................... OCHSNER COMMUNITY CLINICAL ONCOLOGY PROGRAM.................... 410,631
U10CA058658-09................. MILLS, GLENN M.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... SOUTHWEST ONCOLOGY GROUP....................................... 283,805
N01HR0R01650-000............... DEBOISBLANC, BENNETT.............. LOUISANA STATE UNIVERSITY BATON ROUGE........ ADULT RESPIRATOR DISTRESS SYNDROME STUDY....................... 230,082
U10CA063845-07A1............... VEITH, ROBERT W................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... LSUHSC MINORITY BASED COMMUNITY CLINICAL ONCOLOGY.............. 240,283
U19AI045511-02S1............... BEIER, JOHN C..................... TULANE UNIVERSITY OF LOUISIANA............... AFRICAN MALARIA VECTORS........................................ 40,000
U19AI045511-03................. BEIER, JOHN C..................... TULANE UNIVERSITY OF LOUISIANA............... AFRICAN MALARIA VECTORS........................................ 606,005
U42RR015087-02................. ROWELL, THOMAS J.................. UNIVERSITY OF LOUISIANA AT LAFAYETTE......... ESTABLISHMENT/MAINTENANCE OF BIOMEDICAL RESEARCH COLONY........ 819,282
U42RR016026-01................. BLANCHARD, JAMES L................ TULANE UNIVERSITY OF LOUISIANA............... SPECIFIC PATHOGEN FREE INDIAN RHESUS MONKEY COLONY FOR A....... 725,069
U45ES010664-02................. WRIGHT, BEVERLY H................. XAVIER UNIVERSITY OF LOUISIANA............... WORKER HEALTH AND SAFETY TRAINING COOPERATIVE AGREEMENT........ 954,135
N01AO012747-000................ HASSELSCHWERT, DANA............... UNIVERSITY OF LOUISIANA AT LAFAYETTE......... DEVELOPMENT OF A SPF PIGTAIL MACAQUE BREEDING COLONY........... 1,175,750
N01NS092302-004................ ROWELL, THOMAS J.................. UNIVERSITY OF LOUISIANA AT LAFAYETTE......... SLOW, LATENT & TEMPERATE VIRUS INFECTIONS...................... 615,902
------------
TOTAL FY 2001............ .................................. ............................................. ............................................................... 85,845,703
============
FISCAL YEAR 2002
C06RR016483-01................. ROWELL, THOMAS J.................. UNIVERSITY OF LOUISIANA AT LAFAYETTE......... EXPANSION OF NIH CHIMPANZEE HOLDING FAC........................ 1,975,176
D43TW001086-04................. MATHER, FRANCES J................. TULANE UNIVERSITY OF LOUISIANA............... INTERNATIONAL TRAINING IN MEDICAL INFORMATICS.................. 152,358
D43TW001142-04................. BEIER, JOHN C..................... TULANE UNIVERSITY OF LOUISIANA............... ACTIONS FOR BUILDING CAPACITY.................................. 100,000
F30DA015262-01................. KAILAS, SUDHA R................... TULANE UNIVERSITY OF LOUISIANA............... MORPHINE, SEROTONIN, AND PROTEIN KINASE C...................... 43,075
F31DA005907-03S1............... HORNER, KRISTEN A................. TULANE UNIVERSITY OF LOUISIANA............... CHANGES IN ENDOMORPHINS DURING OPIATE TOLERANCE................ 3,026
F31DA006040-03................. GREENWELL, THOMAS N............... TULANE UNIVERSITY OF LOUISIANA............... ENDOMORPHIN-NEUROIMMUNE INTERACTIONS........................... 22,895
F31DA014155-02................. BANNER, EDITH J................... LOUISIANA STATE UNIV-UNIV OF NEW ORLEANS..... TOTAL SYNTHESIS OF NOVEL DECAHYDROQUINOLINES................... 24,177
F31GM019387-05................. HAMILTON, KIMBERLY Y.............. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... CHIRAL SELECTOR IN CAPILLARY ELECTROPHORESIS................... 24,556
F31GM019876-04................. BURSE, JEANINE R.................. TULANE UNIVERSITY OF LOUISIANA............... PAST AND PRESENT BIOINDICATION OF RIVER POLLUTION.............. 6,189
F31GM020437-04................. CEDILLO, BERTHA M................. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... DEVELOPMENT OF A CHIRAL SELECTOR SYSTEM........................ 26,643
F31GM020603-02................. WILLIAMS, BRIDGET D............... TULANE UNIVERSITY OF LOUISIANA............... THE ROLE OF TRACT STABILITY IN TELOMERE MAINTENANCE............ 20,300
F31GM020915-02................. GUTIERREZ, YANIRA I............... TULANE UNIVERSITY OF LOUISIANA............... PI3K-MEDIATED HYPOXIA SURVIVAL SIGNALING PATHWAYS.............. 22,356
F31GM020928-02................. AUSTIN, JOSEPH.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... MINORITY PRE-DOCTORAL FELLOWSHIP PROGRAM....................... 9,226
F31HD041928-01................. TRUJILLO, LEA A................... TULANE UNIVERSITY OF LOUISIANA............... MINORITY PREDOCTORAL FELLOWSHIP PROGRAM........................ 26,160
F31HL068296-02................. ANDERSON, KIMBERLY M.............. TULANE UNIVERSITY OF LOUISIANA............... STUDIES OF A NOVEL A AND B BLOOD GROUP CLEAVING ENZYME......... 22,206
F31MH012816-02................. SANTUZZI, ALECIA M................ TULANE UNIVERSITY OF LOUISIANA............... PREDOCTORAL FELLOWSHIP PROGRAM (DISABILITY).................... 22,986
F31NS011180-02................. CLAYTON BAUCOM, CATHERINE A....... TULANE UNIVERSITY OF LOUISIANA............... HUMAN HAND PREFERENCE-STRUCTURAL FUNCTIONAL MRI STUDIES........ 24,176
F32AR048481-01................. POCHAMPALLY, RADHIKA R............ TULANE UNIVERSITY OF LOUISIANA............... MARROW STROMAL CELLS IN OSTEOGENESIS IMPERFECTA MODEL.......... 37,820
F32DA014162-02................. DANIEL, JILL M.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... EFFECTS OF ESTROGEN AND CANNABINOIDS ON LEARNING............... 38,320
F32DC005284-01A1............... LEBLANC, CHRISTOPHER S............ LOUISIANA STATE UNIV HSC NEW ORLEANS......... HAIR BUNDLE MOVEMENTS AND OTOACOUSTIC EMISSIONS................ 38,320
F32DK010151-02................. WHITE, CHRISTY L.................. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... LEPTIN RESPONSIVENESS IN A DIETARY MODEL OF OBESITY............ 50,116
F32DK061137-01................. SAIFUDEEN, ZUBAIDA R.............. TULANE UNIVERSITY OF LOUISIANA............... TRANSCRIPTION FACTOR P53 IN TERMINAL NEPHRON DIFFERENT......... 50,116
F32EY013651-02................. MARQUART, MARY E.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... PSEUDOMONAS PROTEASES AS OCULAR VIRULENCE FACTORS.............. 48,148
F32MH064248-01A1............... DAVIS, SCOTT F.................... TULANE UNIVERSITY OF LOUISIANA............... BRAINSTEM CIRCUITS INVOLVED IN ADRENAL REGULATION.............. 38,320
F32MH065092-01A1............... BLUMER, JOE B..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... DEFINING THE ROLE OF AGS3 IN G PROTEIN SIGNAL PROCESSING....... 38,320
G11HD034961-05................. ISLAND, GLENDA J.................. GRAMBLING STATE UNIVERSITY................... GSU RESEARCH INFRASTRUCTURE--PHASE II.......................... 91,800
G11HD041839-01................. ORBAN, JOSEPH I................... SOUTHERN UNIVERSITY SHREVEPORT-BOSSIER....... BIOMEDICAL RESEARCH CENTER, SOUTHERN UNIVERSITY AT SHRE........ 27,000
G20RR017029-01................. BLANCHARD, JAMES L................ TULANE UNIVERSITY OF LOUISIANA............... BUILDING C RENOVATION WEST WING................................ 699,655
K01CA078318-04................. HEMENWAY, CHARLES S............... TULANE UNIVERSITY OF LOUISIANA............... BMI1 INTERACTING PROTEINS IN NEOPLASTIC TRANSFORMATION......... 140,282
K01ES000358-02................. HUNT, JAY D....................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... MUTATION AND ENVIRONMENTAL EXPOSURES........................... 104,372
K01GM000707-03................. CHETTY, KOTHAPA N................. GRAMBLING STATE UNIVERSITY................... HYPERCHOLESTEROLEMIA AND REPERFUSION INJURY.................... 23,994
K02DA000204-10................. LINDBERG, IRIS.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... OPIOID PEPTIDE PROCESSING ENZYMES.............................. 118,991
K02DK002605-04................. KAPUSTA, DANIEL R................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... OPIOIDS AND CENTRAL NEURAL REGULATION OF RENAL FUNCTION........ 100,440
K02MH000967-09................. HAYCOCK, JOHN W................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... HUMAN TYROSINE HYDROXYLASE AND SCHIZOPHRENIA................... 112,497
K08AI001467-05................. MASON, ANDREW L................... OCHSNER CLINIC FOUNDATION.................... RETROVIRAL ETIOLOGY OF PRIMARY BILIARY CIRRHOSIS............... 118,800
K08AI049790-03................. PARADA, NEREIDA A................. TULANE UNIVERSITY OF LOUISIANA............... REGULATION OF IL-2 RECEPTOR BY THE CD4 LIGAND IL-16............ 118,800
K08MH001706-05................. SCHEERINGA, MICHAEL S............. TULANE UNIVERSITY OF LOUISIANA............... TRAUMATIZED YOUNG CHILDREN-RISK FOR MALADAPTATION.............. 149,858
K12HD043451-01................. WHELTON, PAUL K................... TULANE UNIVERSITY OF LOUISIANA............... TULANE BIRCWH.................................................. 435,408
K22ES011025-02................. DUGAS, TAMMY R.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... COX-2 MEDIATED VASCULAR TOXICITY OF METHYLENEDIANILINE......... 108,000
K22HD001339-02................. DONZE, DAVID...................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... ANALYSIS OF CHROMOSOMAL INSULATOR/BOUNDARY ELEMENTS............ 134,200
K23RR016076-04................. BERGGREN, RUTH E.................. TULANE UNIVERSITY OF LOUISIANA............... MENTORED PATIENT ORIENTED RESEARCH CAREER DEVELOPMENT AW....... 123,390
K30HL004521-03................. FRIEDMAN, MITCHELL................ TULANE UNIVERSITY OF LOUISIANA............... CLINICAL RESEARCH CURRICULUM AWARD............................. 200,000
M01RR005096-13................. WHELTON, PAUL K................... TULANE UNIVERSITY OF LOUISIANA............... GENERAL CLINICAL RESEARCH CENTER............................... 2,588,372
P01DK043785-11A1............... GRANGER, D NEIL................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... PATHOPHYSIOLOGY OF ISCHEMIA-REPERFUSION INJURY................. 1,486,250
P20RR016456-02................. WISCHUSEN, EVERETT W.............. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... LOUISANA BIOMEDICAL RESEARCH NETWORK........................... 1,807,933
P20RR016816-01................. BAZAN, NICOLAS G.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... MENTORING NEUROSCIENCE IN LOUISIANA............................ 1,949,343
P20RR017659-01................. NAVAR, L. GABRIEL................. TULANE UNIVERSITY OF LOUISIANA............... TULANE COBRE IN HYPERTENSION AND RENAL BIOLOGY................. 2,346,364
P30EY002377-24................. KAUFMAN, HERBERT E................ LOUISIANA STATE UNIV HSC NEW ORLEANS......... CORE GRANT FOR VISION RESEARCH................................. 519,951
P50AA009803-09................. NELSON, STEVE..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... ALCOHOL, HIV INFECTION AND HOST DEFENSE........................ 1,645,309
P50AA009803-09S1............... NELSON, STEVE..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... ALCOHOL, HIV INFECTION AND HOST DEFENSE........................ 126,708
P51RR000164-41................. WHELTON, PAUL K................... TULANE UNIVERSITY OF LOUISIANA............... REGIONAL PRIMATE RESEARCH CENTER............................... 7,879,003
R01AA009505-07................. PRUETT, STEPHEN B................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... MECHANISMS OF IMMUNOSUPPRESSION BY ONE DOSE OF ETHANOL......... 181,208
R01AA009876-08................. WOLCOTT, ROBERT M................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... FETAL ALCOHOL EFFECTS AND IMMUNE DEVELOPMENT................... 218,115
R01AA010384-07................. KOLLS, JAY K...................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... ALCOHOL, IMMUNOSUPPRESSION, AND TACE........................... 286,000
R01AA012865-02................. KASTIN, ABBA J.................... TULANE UNIVERSITY OF LOUISIANA............... PEPTIDES AND ALCOHOL INTERACT AT THE BLOOD-BRAIN BARRIER....... 189,000
R01AA013543-01................. MOLINA, PATRICIA E................ LOUISIANA STATE UNIV HSC NEW ORLEANS......... CHRONIC ALCOHOL & AIDS IMPACT ON MUSCLE WASTING................ 191,969
R01AA013563-01................. VEAZEY, RONALD S.................. TULANE UNIVERSITY OF LOUISIANA............... THE EFFECT ALCOHOL ON SIV PATHOGENESIS......................... 283,392
R01AG016592-03................. BERENSON, GERALD S................ TULANE UNIVERSITY OF LOUISIANA............... EVOLUTION OF CARDIOVASCULAR RISK WITH NORMAL AGING............. 697,574
R01AG017887-03................. JAZWINSKI, S MICHAL............... LOUISIANA STATE UNIV HSC NEW ORLEANS......... NUTRITIONAL AND METABOLIC MECHANISMS OF AGING.................. 286,000
R01AG017983-03................. HAMMER, ROBERT P.................. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... INHIBITION OF FIBRILLOGENESIS WITH B-STRAND MIMICS............. 291,180
R01AG018031-02................. LUKIW, WALTER J................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... GENE EXPRESSION IN ALZHEIMER'S DISEASE......................... 237,738
R01AG018239-03................. GEISELMAN, PAULA J................ LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... OBESITY PREVENTION AFTER SMOKING CESSATION IN MENOPAUSE........ 183,416
R01AG018869-02................. SUITOR, JILL J.................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... PARENT-ADULT CHILD RELATIONS: WITHIN FAMILY DIFFERENCES........ 401,481
R01AI022001-18A1............... O'CALLAGHAN, DENNIS J............. LOUISIANA STATE UNIV HSC SHREVEPORT.......... NUCLEIC ACIDS OF HERPES VIRUS-INFECTED CELLS................... 468,495
R01AI022186-17................. KLIMSTRA, WILLIAM B............... LOUISIANA STATE UNIV HSC SHREVEPORT.......... MOLECULAR BASIS OF ALPHAVIRUS NEUROVIRULENCE................... 312,535
R01AI024030-15................. ROBINSON, JAMES E................. TULANE UNIVERSITY OF LOUISIANA............... HIV-1 NEUTRALIZING HUMAN MABS.................................. 297,000
R01AI024912-15................. CUTLER, JIM E..................... CHILDREN'S HOSPITAL (NEW ORLEANS)............ CANDIDA ALBICANS SURFACE ANTIGENS.............................. 315,000
R01AI031567-08................. CHERVENAK, ROBERT P............... LOUISIANA STATE UNIV HSC SHREVEPORT.......... DEVELOPMENTAL BIOLOGY OF T CELL PRECURSORS..................... 188,942
R01AI032556-08................. FIDEL, PAUL L..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... MUCOSAL CELL MEDIATED IMMUNITY IN VAGINAL CANDIDIASIS.......... 203,775
R01AI039968-04A1............... DIDIER, ELIZABETH SCHMIDT......... TULANE UNIVERSITY OF LOUISIANA............... MICROPORIDIOSIS IN AIDS........................................ 182,954
R01AI040667-07................. VAN DER HEYDE, HENRI C............ LOUISIANA STATE UNIV HSC SHREVEPORT.......... CELL ADHESION MOLECULES IN CEREBRAL MALARIA.................... 253,750
R01AI042146-04................. MUGGERIDGE, MARTIN I.............. LOUISIANA STATE UNIV HSC SHREVEPORT.......... ROLES OF HSV2 MEMBRANE PROTEINS IN MEMBRANE FUSION............. 185,394
R01AI042400-03................. DAVISON, BILLIE B................. TULANE UNIVERSITY OF LOUISIANA............... A RHESUS MONKEY MODEL OF MALARIA IN PREGNANCY.................. 501,878
R01AI043000-04................. KOUSOULAS, KONSTANTIN GUS......... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... GENETICS & FUNCTIONS OF HSV1 GK IN VIRUS ENTRY & EGRESS........ 295,109
R01AI044596-05................. MARX, PRESTON A................... TULANE UNIVERSITY OF LOUISIANA............... SIV-RCM AND RELATED PRIMATE LENTIVIRUSES IN WEST AFRICA........ 542,776
R01AI045041-04................. HURLBURT, BARRY K................. U.S. AGRICULTURE RESEARCH SERVICE-MIDSOU..... MECHANISMS OF VIRULENCE GENE REGULATION IN S. AUREUS........... 272,803
R01AI045151-03................. FREYTAG, LUCIA C.................. TULANE UNIVERSITY OF LOUISIANA............... MUCOSAL IMMUNIZATION--PREVENTION OF SYSTEMIC CANDIDIASIS....... 222,750
R01AI045725-03................. GILLIS, THOMAS P.................. NATIONAL HANSEN'S DISEASE PROGRAM............ DEVELOP AND EVALUATE NEW LEPROSY AND TB VACCINES............... 116,990
R01AI046275-04................. ROBINSON, JAMES E................. TULANE UNIVERSITY OF LOUISIANA............... RHESUS MABS FROM SHIV INFECTED MACAQUES........................ 234,049
R01AI047693-03................. BUNNELL, BRUCE A.................. TULANE UNIVERSITY OF LOUISIANA............... INTRAMARROW GENE TRANSFER IN NEONATES.......................... 327,456
R01AI049080-01A1S1............. VEAZEY, RONALD S.................. TULANE UNIVERSITY OF LOUISIANA............... MECHANISMS OF CD4 DEPLETION AND PROLIFERATION IN SIV........... 11,499
R01AI049080-02................. VEAZEY, RONALD S.................. TULANE UNIVERSITY OF LOUISIANA............... MECHANISMS OF CD4 DEPLETION AND PROLIFERATION IN SIV........... 442,426
R01AI049139-02................. OBERHELMAN, RICHARD A............. TULANE UNIVERSITY OF LOUISIANA............... PRACTICAL DIAGNOSTICS FOR AIDS-RELATED PEDIATRIC TB, PERU...... 206,190
R01AI049193-01A1............... PETERSON, KENNETH M............... LOUISIANA STATE UNIV HSC SHREVEPORT.......... SIGNAL TRANS. AND INTESTINAL COLONIZATION BY V. CHOLERAE....... 278,750
R01AI049293-01A2............... RAMAMOORTHY, RAMESH............... TULANE UNIVERSITY OF LOUISIANA............... RPOS AND GENE EXPRESSION IN BORRELIA BURGDORFERI............... 200,000
R01AI049744-01A2............... BEILKE, MARK A.................... TULANE UNIVERSITY OF LOUISIANA............... RETROVIRAL CO-INFECTIONS: HIV, HTLV AND DRUG ABUSE............. 359,125
R01AI049976-01S1............... PHILIPP, MARIO T.................. TULANE UNIVERSITY OF LOUISIANA............... 'LYME DISEASE: A POSSIBLE TEST FOR CURE........................ 24,000
R01AI049976-02................. PHILIPP, MARIO T.................. TULANE UNIVERSITY OF LOUISIANA............... 'LYME DISEASE: A POSSIBLE TEST FOR CURE........................ 160,000
R01AI050027-01A1............... ADAMS, LINDA B.................... NATIONAL HANSEN'S DISEASE PROGRAM............ GENE KNOCK-OUT MICE AS MODELS FOR THE LEPROSY SPECTRUM......... 150,000
R01AI051677-01................. SHELLITO, JUDD E.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... IL-17 AND KLEBSIELLA PNEUMONIA................................. 315,026
R01AR045982-05................. ALA-KOKKA, LEENA M................ TULANE UNIVERSITY OF LOUISIANA............... MUTATIONS CAUSING DISC DISEASE AND SCIATICA.................... 288,509
R01AR046976-04................. KIMPEL, DONALD L.................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... NOVEL IMAGING TECHNOLOGIES FOR RHEUMATOID ARTHRITIS............ 290,000
R01AR048323-02................. PROCKOP, DARWIN J................. TULANE UNIVERSITY OF LOUISIANA............... OSTEOPROGENITORS FOR POTENTIAL THERAPY OF OI................... 371,250
R01CA054152-10A2............... HILL, STEVEN M.................... TULANE UNIVERSITY OF LOUISIANA............... NEUROENDOCRINE INFLUENCES ON MAMMARY CANCER.................... 291,199
R01CA067372-08................. SIXBEY, JOHN W.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... EPSTEIN BARR VIRUS INDUCED GENOMIC INSTABILITY................. 326,250
R01CA074731-04A2............... LEVY, LAURA S..................... TULANE UNIVERSITY OF LOUISIANA............... PATHOBIOLOGY OF SAIDS-ASSOCIATED LYMPHOMAS..................... 257,753
R01CA078335-04................. GNARRA, JAMES R................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... HGF/SF SIGNALING BY THE VHL TUMOR SUPPRESSOR................... 295,132
R01CA080149-04................. MATHIS, J MICHAEL................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... ADENOVIRUS BASED P53 GENE THERAPY FOR OVARIAN CANCER........... 114,527
R01CA081125-04................. SCHWARZENBERGER, PAUL O........... LOUISIANA STATE UNIV HSC NEW ORLEANS......... IL-17 AND HEMATOPOIESIS........................................ 177,500
R01CA081506-03................. EHRLICH, MELANIE.................. TULANE UNIVERSITY OF LOUISIANA............... DNA HYPOMETHYLATION AND CANCER................................. 259,058
R01CA082689-04................. OCHOA, AUGUSTO C.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... ARGININE REGULATES T CELL SIGNAL TRANSDUCTION & FUNCTION....... 248,500
R01CA083823-03................. LEVY, LAURA S..................... TULANE UNIVERSITY OF LOUISIANA............... SELECTIVE FORCES OPERATIVE IN FELV INFECTION................... 246,155
R01CA085693-03................. HARRISON, LYNN.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... DNA REPAIR OF MULTIPLY DAMAGED SITES IN CELLS.................. 195,750
R01CA088885-02................. OCHOA, AUGUSTO C.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... IMMUNE DYSFUNCTION AND IMMUNOTHERAPY OF RENAL CANCER........... 225,602
R01CA089057-02................. LI, LI............................ OCHSNER CLINIC FOUNDATION.................... STROMAL CELL MOLECULES REQUIRED FOR LYMPHOMA GENERATION........ 166,250
R01CA089121-02................. DASH, SRIKANTA A.................. TULANE UNIVERSITY OF LOUISIANA............... HEPATITIS C VIRUS AND HEPATOCELLULAR CARCINOMA................. 233,888
R01CA092126-01A1............... CHOI, YONG S...................... OCHSNER CLINIC FOUNDATION.................... LYMPHOMAGENESIS................................................ 221,113
R01CA095783-02................. JONES, FRANK E.................... TULANE UNIVERSITY OF LOUISIANA............... ERBB4 SIGNALING IN THE NORMAL AND NEOPLASTIC BREAST............ 217,390
R01DA005084-15................. LINDBERG, IRIS.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... OPIOID PEPTIDE SYNTHESIZING ENZYMES............................ 181,401
R01DA011417-04................. MOERSCHBAECHER, JOSEPH M.......... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CANNABINOID ABUSE EFFECTS ON LEARNING AND MEMORY............... 200,650
R01DA011939-03................. HARLAN, RICHARD E................. TULANE UNIVERSITY OF LOUISIANA............... THALAMOSTRIATAL MECHANISMS OF MORPHINE ACTION.................. 179,465
R01DA012267-03S2............... HARRISON, MURELLE G............... SOUTHERN UNIV A&M COL BATON ROUGE............ PREVENTING SUBSTANCE USE IN RURAL AFRICAN-AMERICAN YOUTH....... 38,856
R01DA012267-04................. HARRISON, MURELLE G............... SOUTHERN UNIV A&M COL BATON ROUGE............ PREVENTING SUBSTANCE USE IN RURAL AFRICAN-AMERICAN YOUTH....... 382,294
R01DA012267-04S1............... HARRISON, MURELLE G............... SOUTHERN UNIV A&M COL BATON ROUGE............ PREVENTING SUBSTANCE USE IN RURAL AFRICAN-AMERICAN YOUTH....... 112,134
R01DA012427-03................. WINSAUER, PETER J................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... COCAINE SELF-ADMINSTRATION: EFFECTS ON LEARNING................ 100,570
R01DA012703-04................. TRUDELL, MARK L................... LOUISIANA STATE UNIV-UNIV OF NEW ORLEANS..... NOVEL NICOTINIC RECEPTOR MEDIATED THERAPEUTIC AGENTS........... 311,219
R01DA013463-02................. GOEDERS, NICHOLAS E............... LOUISIANA STATE UNIV HSC SHREVEPORT.......... ROLE FOR THE HPA AXIS IN METHAMPHETAMINE REINFORCEMENT......... 320,554
R01DA013899-02................. MORSE, EDWARD V................... TULANE UNIVERSITY OF LOUISIANA............... RISK REDUCTION FOR YOUNG AFRICAN AMERICAN IDUS................. 566,386
R01DC003679-04................. HOOD, LINDA JEAN.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... AUDITORY GENETIC STUDIES OF HEREDITARY HEARING LOSS............ 213,503
R01DC003792-04................. CAPRIO, JOHN T.................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... ENCODING OF BIOLOGICALLY RELEVANT ODOR SIGNALS................. 329,574
R01DC003896-04................. RICCI, ANTHONY J.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... ENDOGENOUS FACTORS REGULATING TRANSDUCER ADAPTATION............ 170,977
R01DC003896-04S1............... RICCI, ANTHONY J.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... ENDOGENOUS FACTORS REGULATING TRANSDUCER ADAPTATION............ 54,450
R01DC004196-04................. KEATS, BRONYA J................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... ID OF THE MOUSE DEAFNESS (DN) GENE ON CHROMOSOME 19............ 230,769
R01DE008911-11................. WISE, GARY E...................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... MOLECULAR BASIS OF TOOTH ERUPTION.............................. 178,924
R01DE012329-04................. CHEN, YIPING...................... TULANE UNIVERSITY OF LOUISIANA............... MOLECULAR MECHANISMS OF VERTEBRATE TOOTH INITIATION............ 185,282
R01DE012916-04................. AMEDEE, ANGELA M.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... SIV MACAQUE MODEL FOR BREAST MILK TRANSMISSION OF HIV.......... 257,756
R01DE014044-01A1............... CHEN, YIPING...................... TULANE UNIVERSITY OF LOUISIANA............... GROWTH FACTOR SIGNALING IN MOUSE PALATOGENESIS................. 297,000
R01DK041279-10................. GLASS, JONATHAN D................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... MOLECULAR MECHANISMS OF INTESTINAL IRON TRANSPORT.............. 246,500
R01DK041868-11S1............... HWANG, DANIEL H................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... DIETARY N 3 FATTY ACIDS AND EXPRESSION OF CYCLOOXYGENASE....... 85,260
R01DK044510-09................. AW, TAK Y......................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... GLUTATHIONE REDOX CONTROL OF INTESTINAL CELL RESPONSES......... 261,000
R01DK045278-10................. YORK, DAVID A..................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... ENTEROSTATIN REGULATION OF FAT INTAKE.......................... 330,750
R01DK046935-08................. LANCASTER, JACK R................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... NITROGEN AND OXYGEN RADICAL INTERACTIONS IN SURGERY............ 204,820
R01DK047211-08................. VEDECKIS, WAYNE V................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... REGULATION OF GLUCOCORTICOID RECEPTOR GENE EXPRESSION.......... 186,014
R01DK047348-09................. BERTHOUD, HANS-RUDOLF............. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... AUTONOMIC REGULATION OF FOOD INTAKE AND METABOLISM............. 185,241
R01DK047663-08................. GRISHAM, MATTHEW B................ LOUISIANA STATE UNIV HSC SHREVEPORT.......... ADHESION MOLECULE EXPRESSION IN CHRONIC GUT INFLAMMATION....... 182,736
R01DK048055-07................. MCCARTHY, KEVIN J................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... PROTEOGLYCANS IN DIABETIC NEPHROPATHY.......................... 290,000
R01DK049703-06A1............... LINDBERG, IRIS.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CONTROL OF PEPTIDE HORMONE BIOSYNTHESIS BY PC2 AND 7B2......... 310,483
R01DK050550-09................. LACKNER, ANDREW A................. TULANE UNIVERSITY OF LOUISIANA............... MECHANISMS OF INTESTINAL DYSFUNCTION IN SIMIAN AIDS............ 468,334
R01DK050736-04S1............... LOVEJOY, JENNIFER C............... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... MENOPAUSE EFFECT ON OBESITY, ENERGY BALANCE AND INSULIN........ 167,018
R01DK052142-05A1............... ROGERS, RICHARD C................. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... TNF, VAGAL TONE AND GASTRIC MOTILITY........................... 328,897
R01DK052968-04................. STEPHENS, JACQUELINE M............ LOUISIANA STATE UNIV A&M COL BATON ROUGE..... REGULATION AND ACTIVATION OF STATS IN ADIPOCYTES............... 189,070
R01DK053872-05................. CLARKE, STEVEN D.................. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... CONTROL OF GENE TRANSCRIPTION BY ESSENTIAL FATTY ACIDS......... 159,475
R01DK054880-04................. KASTIN, ABBA J.................... TULANE UNIVERSITY OF LOUISIANA............... BLOOD/BRAIN BARRIER AND LEPTIN TRANSPORT IN OBESITY............ 328,290
R01DK054952-03................. HAMM, L. LEE...................... TULANE UNIVERSITY OF LOUISIANA............... REGULATION OF CITRATE TRANSPORT................................ 198,450
R01DK055626-03................. AWAYDA, MOUHAMED S................ TULANE UNIVERSITY OF LOUISIANA............... KINASE REGULATION OF THE EPITHELIAL NA CHANNEL................. 222,750
R01DK056132-02................. SMITH, BRET N..................... TULANE UNIVERSITY OF LOUISIANA............... NEURAL CIRCUITRY IN THE CAUDAL SOLITARY COMPLEX................ 222,750
R01DK056264-03................. EL-DAHR, SAMIR S.................. TULANE UNIVERSITY OF LOUISIANA............... INDUCIBLE DYSPLASTIC NEPHROPATHY IN B2-DEFICENT MICE........... 267,300
R01DK056373-05................. ROGERS, RICHARD G................. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... BRAINSTEM ESOPHAGEAL--GASTRIC CONTROL REFLEXES................. 138,630
R01DK057242-03................. BERTHOUD, HANS-RUDOLF............. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... FUNCTIONAL ORGANIZATION OF THE VAGAL-ENTERIC INTERFACE......... 191,739
R01DK058152-03................. KOZAK, LESLIE P................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... GENETICS OF DEVELOPMENTAL PLASTICITY IN THE ADIPOCYTE.......... 445,163
R01DK058499-02................. AGRAWAL, KRISHNA C................ TULANE UNIVERSITY OF LOUISIANA............... PROTEASE INHIBITOR RELATED ADIPOGENESIS IN HIV INFECTION....... 282,150
R01DK059326-01A1............... BRISKI, KAREN P................... UNIVERSITY OF LOUISIANA AT MONROE............ CAUDAL BRAIN STEM LACTATE AVAILABILITY REGULATES FEEDING....... 81,699
R01DK060412-02................. RAVUSSIN, ERIC.................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... FAT CELL SIZE, MUSCLE LIPID INFILTRATION AND INSULIN RE*....... 560,060
R01DK062003-01................. HARRISON-BERNARD, LISA M.......... TULANE UNIVERSITY OF LOUISIANA............... AT1 RECEPTORS IN RENAL MICROVASCULAR PHYSIOLOGY................ 283,635
R01DK063453-01................. WILLIAMSON, DONALD A.............. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... WISE MIND: ENVIRONMENTAL APPROACH FOR OBESITY PREVENTION....... 220,500
R01DK063669-01................. ORLANDO, ROY C.................... TULANE UNIVERSITY OF LOUISIANA............... MECHANISMS OF ACID RESISTANCE IN BARRETT'S ESOPHAGUS........... 311,100
R01DK064156-01................. CLARKE, STEVEN D.................. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... DELTA-6 AND DELTA-5 DESATURASES................................ 280,770
R01EB000242-03................. KHOOBEHI, BAHRAM.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... RETINAL AND CHOROIDAL BLOOD FLOW IMAGING....................... 207,586
R01EB000739-01................. MCSHANE, MICHAEL J................ LOUISIANA TECHNOLOGICAL UNIVERSITY........... FLUORESCENT GLUCOSE SENSORS FROM POLYION MICROSHELLS........... 292,116
R01ES004344-11A1............... BACKES, WAYNE L................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... TOXICOLOGICAL SIGNIFICANCE OF ALKYLBENZENE METABOLISM.......... 315,300
R01ES006766-09................. BRODY, ARNOLD R................... TULANE UNIVERSITY OF LOUISIANA............... GROWTH FACTORS IN ASBESTOS INDUCED PULMONARY FIBROSIS.......... 255,518
R01ES009158-06................. PRUETT, STEPHEN B................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... MECHANISMS OF IMMUNOTOXCITY OF CHEMICAL STRESSORS.............. 207,375
R01ES009870-03................. MEHENDALE, HARIHARA M............. UNIVERSITY OF LOUISIANA AT MONROE............ DIETARY RESTRICTION AND TOXICANT-INDUCED LIVER DISEASE......... 188,055
R01ES010046-03................. LASKY, JOSEPH A................... TULANE UNIVERSITY OF LOUISIANA............... DISRUPTION OF PDGF SIGNAL TRANSDUCTION IN LUNG FIBROSIS........ 259,875
R01ES010497-03................. MURRAY, KERMIT K.................. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... REAL TIME MASS SPECTROMETRY OF BIOAEROSOLS..................... 147,000
R01ES010859-01A1............... ORTIZ, LUIS A..................... TULANE UNIVERSITY OF LOUISIANA............... TNF-ALPHA SIGNALING IN SILICA-INDUCED LUNG FIBROSIS............ 289,725
R01EY002672-24................. KAUFMAN, HERBERT E................ LOUISIANA STATE UNIV HSC NEW ORLEANS......... OCULAR HERPES SIMPLEX VIRUS.................................... 336,000
R01EY003311-23................. KLYCE, STEPHEN D.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... INTEGRATED ASSESSMENT OF CORNEAL FORM AND FUNCTION............. 315,720
R01EY004928-20................. BAZAN, HAYDEE E................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CORNEAL LIPID METABOLISM AND RESPONSE TO INFLAMMATION.......... 203,086
R01EY005121-18................. BAZAN, NICOLAS G.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... RPE MESSENGERS, TRANSCRIPTION AND PHOTORECEPTOR RENEWAL........ 250,250
R01EY006311-17................. HILL, JAMES M..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... OCULAR HSV-LATENCY, REACTIVATION, AND RECURRENCE............... 387,224
R01EY007380-13................. MENERAY, MICHELE A................ LOUISIANA STATE UNIV HSC NEW ORLEANS......... INTERACTIVE CELLULAR CONTROLS LACRIMAL GLAND FUNCTIONAL........ 286,000
R01EY011610-05................. BURGOYNE, CLAUDE F................ LOUISIANA STATE UNIV HSC NEW ORLEANS......... IOP-RELATED FORCE AND FAILURE IN THE OPTIC NERVE HEAD.......... 616,605
R01EY012416-04................. BEUERMAN, ROGER W................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... REGULATION OF PROTEIN SYNTHESIS IN THE LACRIMAL GLAND.......... 224,832
R01EY012540-04................. PALKAMA, ARTO K................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... AQUEOUS OUTFLOW AND STRUCTURAL CORRELATIONS.................... 300,113
R01EY012701-03................. CHANDRASEKHER, GUDISEVA........... LOUISIANA STATE UNIV HSC NEW ORLEANS......... GROWTH FACTOR RECEPTOR MEDITATED SIGNAL MECHANISMS LENS........ 176,170
R01EY012716-02................. GUIDO, WILLIAM.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... FUNCTIONAL STATE OF DEVELOPING RETINOGENICULATE SYNAPSE........ 178,750
R01EY012961-03................. O'CALLAGHAN, RICHARD J............ LOUISIANA STATE UNIV HSC NEW ORLEANS......... MECHANISMS AND THERAPY OF BACTERIAL KERATITIS.................. 286,000
R01EY013176-01A2............... ALLIEGRO, MARK C.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... NOVEL GENES EXPRESSED IN PROLIFERATING ENDOTHELIAL CELLS....... 204,690
R01EY013325-01A1............... KWON, BYOUNG S.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... OCULAR HSV-1, STROMAL KERATITIS, & T CELL COSTIMULATION........ 315,415
R01GM020818-28A1............... RHOADS, ROBERT E.................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... REGULATION OF EUKARYOTIC PROTEIN SYNTHESIS INITIATION.......... 320,850
R01GM039844-12................. WARNER, ISIAH M................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... BIOANALYTICAL SEPARATION USING CHIRAL POLYMERS................. 273,533
R01GM045668-10A1............... DEININGER, PRESCOTT L............. TULANE UNIVERSITY OF LOUISIANA............... SINE RETROTRANSPOSITION........................................ 259,875
R01GM047789-18................. TATCHELL, KELLY G................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... GENETIC ANALYSIS OF PROTEIN PHOSPHATASE 1 IN YEAST............. 228,375
R01GM051521-09................. WITT, STEPHEN N................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... KINETICS AND MECHANISM OF THE HEAT SHOCK 70 PROTEIN DNAK....... 205,446
R01GM055420-12................. NEWCOMER, MARCIA E................ LOUISIANA STATE UNIV A&M COL BATON ROUGE..... ENZYMATIC ACTIVATION OF LIPOPHILIC SIGNALING MOLECULES......... 235,200
R01GM059663-02................. WITTUNG-STAFSHEDE, PERNILLA E..... TULANE UNIVERSITY OF LOUISIANA............... COFACTOR ROLE IN BETA-SHEET PROTEIN FOLDING.................... 175,770
R01GM060000-02................. WIMLEY, WILLIAM C................. TULANE UNIVERSITY OF LOUISIANA............... FOLDING AND DESIGN OF BETA SHEETS IN MEMBRANES................. 185,625
R01GM061915-02................. STRONGIN, ROBERT M................ LOUISIANA STATE UNIV A&M COL BATON ROUGE..... SYNTHESIS AND STUDY OF NOVEL SENSING AGENTS.................... 183,750
R01HD008431-27................. KOZAK, LESLIE P................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... MOLECULAR GENETICS OF THERMOGENESIS............................ 321,299
R01HD036822-04................. WANG, YU-PING..................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... PLACENTAL FUNCTION IN PREECLAMPSIA............................. 145,425
R01HD037811-03................. GASSER, RAYMOND F................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... HUMAN EMBRYO SECTIONS ON DVDS FOR EDUCATION.................... 326,032
R01HD039104-03................. WILLIAMSON, DONALD A.............. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... INTERNET-BASED OBESITY PREVENTION FOR BLACK ADOLESCENTS........ 160,073
R01HG001499-06................. SOPER, STEVEN A................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... HIGH THROUGHPUT DNA SEQUENCING USING NANO-REACTORS............. 428,179
R01HL018426-28................. NAVAR, L. GABRIEL................. TULANE UNIVERSITY OF LOUISIANA............... REGULATION OF RENAL HEMODYNAMICS............................... 334,125
R01HL022252-26................. ROSELLI, CHARLES E................ LOUISIANA STATE UNIV A&M COL BATON ROUGE..... SYNTHESES OF HEMES FOR PROTEIN STUDIES......................... 367,500
R01HL026371-21................. NAVAR, L. GABRIEL................. TULANE UNIVERSITY OF LOUISIANA............... RENAL FUNCTIONAL DERANGEMENTS IN HYPERTENSION.................. 336,341
R01HL026441-22................. GRANGER, D NEIL................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... TRANSCAPILLARY FLUID EXCHANGE.................................. 255,138
R01HL032788-16................. CHILIAN, WILLIAM M................ LOUISIANA STATE UNIV HSC NEW ORLEANS......... MICROCIRCULATORY DYNAMICS IN THE CORONARY CIRCULATION.......... 320,215
R01HL045670-11................. BOUCHARD, CLAUDE.................. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... HERITAGE-GENETICS, RESPONSE TO EXERCISE, RISK FACTORS-3........ 749,187
R01HL054797-09................. KORTHUIS, RONALD J................ LOUISIANA STATE UNIV HSC SHREVEPORT.......... PRECONDITIONING: PMN ADHESION AND MICROVASCULAR INJURY......... 290,000
R01HL057531-05A1............... PANDEY, KAILASH N................. TULANE UNIVERSITY OF LOUISIANA............... ANP Receptor: Molecular approach of signaling mechanisms....... 222,750
R01HL060532-06................. Brody, Arnold R................... TULANE UNIVERSITY OF LOUISIANA............... TGF-B in Interstitial Lung Disease............................. 334,125
R01HL060849-04................. LEFER, DAVID J.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... MECHANISMS OF MYOCARDIAL REPERFUSION INJURY--DIABETES.......... 184,285
R01HL061271-04................. Kolls, Jay K...................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... NON CD4 HOST DEFENSE AGAINST P CARINII PNEUMONIA............... 78,314
R01HL061934-06................. MORRIS, CINDY A................... TULANE UNIVERSITY OF LOUISIANA............... MOLECULAR MECHANISM OF TAT INDUCED ANGIOGENESIS................ 222,750
R01HL062000-03................. HYMAN, ALBERT L................... TULANE UNIVERSITY OF LOUISIANA............... CARDIOPULMONARY SURGERY RESEARCH............................... 302,940
R01HL062052-05................. Kolls, Jay K...................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CD8 AND GAMMA/DELTA T CELLS IN P CARINII PNEUMONIA............. 255,226
R01HL063128-03................. AGRAWAL, KRISHNA C................ TULANE UNIVERSITY OF LOUISIANA............... MECHANISMS OF CARDIOVASCULAR COMPLICATIONS IN AIDS............. 299,899
R01HL063195-04................. TRAYANOVA, NATALIA A.............. TULANE UNIVERSITY OF LOUISIANA............... CARDIAC TISSUE STRUCTURE IN THE DEFIBRILLATION PROCESS......... 171,030
R01HL063778-02................. LASKY, JOSEPH A................... TULANE UNIVERSITY OF LOUISIANA............... CTGF IN LUNG FIBROGENESIS...................................... 259,875
R01HL064577-04................. JOHNSON, ROBERT A................. TULANE UNIVERSITY OF LOUISIANA............... HEMODYNAMIC ROLES OF ENDOGENEOUS CARBON MONOXIDE............... 166,634
R01HL065997-02................. WANG, YU-PING..................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... ENDOTHELIAL BARRIER FUNCTION IN PREECLAMPSIA................... 217,500
R01HL066158-02................. VEHASKARI, V M.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... Prenatal and Perinatal Programming of Adult Hypertension....... 214,500
R01HL066432-02................. MAJID, DEWAN S.................... TULANE UNIVERSITY OF LOUISIANA............... Superoxide and nitric Oxide Interactions in the Kidney......... 222,750
R01HL068057-01A1............... HE, JIANG......................... TULANE UNIVERSITY OF LOUISIANA............... Clinical Trial of Dietary Protein on Blood Pressure............ 655,198
R01HL069029-01................. FEELISCH, MARTIN.................. LOUISIANA STATE UNIV HSC SHREVEPORT.......... Redox-activation of vascular stores of NO by vitamin C......... 340,000
R01HL073774-01................. FARLEY, THOMAS A.................. TULANE UNIVERSITY OF LOUISIANA............... ATTENDED CITY SCHOOLYARDS TO INCREASE PHYSICAL ACTIVITY........ 222,750
R01LM007591-01................. CORK, ROBERT J.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... Enhancements to a human embryo, serial-section database........ 101,460
R01MH059931-03................. LANIER, STEPHEN M................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... A TRANSDUCTION COMPLEX FOR G PROTEIN COUPLED RECEPTORS......... 240,693
R01MH061192-05................. LACKNER, ANDREW A................. TULANE UNIVERSITY OF LOUISIANA............... CHEMOKINE RECEPTORS IN THE NEUROPATHOGENESIS OF AIDS........... 284,869
R01MH062640-01A2............... LEIDENHEIMER, NANCY J............. LOUISIANA STATE UNIV HSC SHREVEPORT.......... Regulation of GABAA Receptor Cell Surface Expression........... 264,961
R01NS009626-32................. LI, YU-TEH........................ TULANE UNIVERSITY OF LOUISIANA............... GLYCOSIDASES AS RELATED TO SPHINGOLIPIDOSES.................... 382,466
R01NS023002-16A1............... BAZAN, NICOLAS G.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... Phospholipid and Arachidonic Acid Signaling in Epilepsy........ 270,275
R01NS024821-13................. LANIER, STEPHEN M................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... STRUCTURAL ANALYSIS OF THE ALPHA 2 ADRENERGIC RECEPTOR......... 213,269
R01NS025987-15................. PHELPS, CAROL J................... TULANE UNIVERSITY OF LOUISIANA............... HYPOPHYSIOTROPIC NEURON DIFFERENTIATION--TARGET FEEDBACK....... 219,774
R01NS030769-11................. LACKNER, ANDREW A................. TULANE UNIVERSITY OF LOUISIANA............... NEUROPATHOGENESIS OF PEDIATRIC AIDS: A SIV MODEL............... 345,144
R01NS035370-10................. DUNN, ADRIAN J.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... Cytokine Action on the CNS..................................... 253,750
R01NS037963-04A1............... CANAVIER, CARMEN C................ LOUISIANA STATE UNIV-UNIV OF NEW ORLEANS..... Firing Pattern in Midbrain Dopamine Neurons.................... 168,625
R01NS039033-02................. PHINNEY, DONALD G................. TULANE UNIVERSITY OF LOUISIANA............... Marrow stromal cells for Lysosomal Disease CNS Defects......... 259,875
R01NS039033-02S1............... PHINNEY, DONALD G................. TULANE UNIVERSITY OF LOUISIANA............... Marrow stromal cells for Lysosomal Disease CNS Defects......... 72,765
R01NS039050-03................. ERZURUMLU, REHA S................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... SOMATOSENSORY CORTICAL DEVELOPMENT AND PLASTICITY.............. 143,000
R01NS039099-03................. TASKER, JEFFREY G................. TULANE UNIVERSITY OF LOUISIANA............... HYPOTHALAMIC SYNCHRONIZATION BY LOCAL GLUTAMATE CIRCUITS....... 259,875
R01NS039458-03................. MAGEE, JEFFERY C.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... DENDRITIC INTEGRATION IN HIPPOCAMPAL PYRAMIDAL NEURONS......... 230,823
R01NS039458-03S1............... MAGEE, JEFFERY C.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... DENDRITIC INTEGRATION IN HIPPOCAMPAL PYRAMIDAL NEURONS......... 50,000
R01NS040373-02................. ARIMURA, AKIRA A.................. TULANE UNIVERSITY OF LOUISIANA............... Neuroprotection by PACAP in Stroke............................. 371,250
R01NS044000-02................. BASTIAN, FRANK O.................. TULANE UNIVERSITY OF LOUISIANA............... Spiroplasma 16S rDNA in TSE Brain Tissues...................... 185,625
R01NS045694-01................. ZHANG, JOHN H..................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... Anti-apoptosis as a new therapy for cerebral vasospasm......... 253,750
R01NS045954-01................. TAYLOR, BRADLEY K................. TULANE UNIVERSITY OF LOUISIANA............... NEUROPEPTIDERGIC INHIBITION OF SPINAL PAIN TRANSMISSION........ 352,688
R03CA083096-02................. Johnson, Eric S................... TULANE UNIVERSITY OF LOUISIANA............... POSSIBLE OF ROLE OF AVIAN RETROVIRUSES IN HUMAN CANCER......... 74,250
R03CA091185-01A1............... RAJ, MADHWA H..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... A new tumor marker for Ovarian Cancer.......................... 71,208
R03CA097778-01................. MANDAL, DIPTASRI M................ LOUISIANA STATE UNIV HSC NEW ORLEANS......... Genetics of Prostate Cancer in an Af-Am Population............. 35,500
R03DA013647-02................. GOEDERS, NICHOLAS E............... LOUISIANA STATE UNIV HSC SHREVEPORT.......... Neurochemistry of Cocaine Reinforcement........................ 72,500
R03DA015618-01................. PHADTARE, SHASHIKANT K............ XAVIER UNIVERSITY OF LOUISIANA............... NEW PHENYL NUCLEOSIDES AS ANTI-HIV AGENTS...................... 72,554
R03DC004957-01A2............... FOUNDAS, ANNE L................... TULANE UNIVERSITY OF LOUISIANA............... Developmental Stuttering: MRI Studies in Children.............. 74,250
R03EY014021-01................. JACOB, JEAN T..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... Capillary Electrophoresis Profiling of Tears in Dry Eye........ 135,619
R03EY014135-01................. NAUMAN, ERIC A.................... TULANE UNIVERSITY OF LOUISIANA............... Intraocular Pressure-Mediated Damage to the Optic Nerve........ 141,225
R03HD041052-02................. SCHMIDT-SOMMERFELD, EBERHARD...... LOUISIANA STATE UNIV HSC NEW ORLEANS......... Parenteral Medium Chain Triglycerides in the Premature......... 71,500
R03HD042003-01................. VANLANDINGHAM, MARK J............. TULANE UNIVERSITY OF LOUISIANA............... Migration Effects on Health of Working Age Vietnamese.......... 74,250
R03MH065943-01................. STAFFORD, BRIAN S................. TULANE UNIVERSITY OF LOUISIANA............... Validity of Reactive Attachment Disorder....................... 74,250
R13AA013578-01................. MOLINA, PATRICIA E................ LOUISIANA STATE UNIV HSC NEW ORLEANS......... Alcoholism and Disease: Immune/Pathological Mechanisms......... 38,100
R13AG021441-01................. GRISHAM, MATTHEW B................ LOUISIANA STATE UNIV HSC SHREVEPORT.......... Ninth Annual Oxygen Society Meeting............................ 15,000
R13DA015297-01................. Harlan, Richard E................. TULANE UNIVERSITY OF LOUISIANA............... Workshop on Steroid Hormones and Brain Function................ 15,650
R13HL069204-01................. GRISHAM, MATTHEW B................ LOUISIANA STATE UNIV HSC SHREVEPORT.......... Eighth Annual Oxygen Society Meeting........................... 20,000
R15DA013512-01A2............... MANDAL, TARUN K................... XAVIER UNIVERSITY OF LOUISIANA............... SR Drug Delivery for the Treatment of Drug Abuse............... 68,113
R15ES011279-01A1............... ASRABADI, BADIOLLAH R............. NICHOLLS STATE UNIVERSITY.................... Air Pollution and Asthma in Southeast Louisiana................ 151,000
R18AI033449-08................. FREY, DANIEL J.................... LOUISIANA ORGAN PROCUREMENT AGENCY........... ENHANCING DONOR REGISTRY TO INCREASE DONATION.................. 387,407
R21AA013555-01A1............... McDonough, Kathleen H............. LOUISIANA STATE UNIV HSC NEW ORLEANS......... Alcohol Enhances HIV-1 Induced Cardiac Depression.............. 139,903
R21AA013828-01................. MACLEAN, ANDREW G................. TULANE UNIVERSITY OF LOUISIANA............... Alcohol and SIV neuroinvasion in vivo and in vitro............. 160,000
R21AI051414-01................. HALFORD, WILLIAM P................ TULANE UNIVERSITY OF LOUISIANA............... ROLE OF THE LAT-ICP0 LOCUS IN REGULATING HSV LATENCY........... 284,875
R21AI053290-01................. RAMSAY, ALISTAIR J................ LOUISIANA STATE UNIV HSC NEW ORLEANS......... Generation of protection against 'stealth' poxviruses.......... 210,900
R21AI053517-01................. LINDBERG, IRIS.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... Blockade of Anthrax Cytotoxicity Using Furin Inhibitors........ 204,600
R21CA089348-01A2............... SINGAL, RAKESH.................... U.S. DEPT/VETS AFFAIRS MED CTR(SHREVPRT)..... GSTP1 gene repression in prostate cancer....................... 75,000
R21DA016029-01................. MOHAMADZADEH, MANSOUR............. TULANE UNIVERSITY OF LOUISIANA............... Dendritic cell targeted hepatitis c virus immunotherapy........ 148,500
R21DC004994-02................. BOBBIN, RICHARD P................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... Drug manipulation of noise-induced hearing loss................ 143,000
R21DC005470-01................. Ricci, Anthony J.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... Mature mouse cochlea culture model for physiological inv....... 71,500
R21DC005514-01................. WATSON, GLEN M.................... UNIVERSITY OF LOUISIANA AT LAFAYETTE......... Target Proteins for Linkages in Membranes of Hair Cells........ 62,320
R21DE015051-01................. HAGENSEE, MICHAEL E............... LOUISIANA STATE UNIV HSC NEW ORLEANS......... Prevalence of HPV in the Oral Cavity of HIV+ Individuals....... 206,700
R21DK057390-02................. PARTOSEOEDARSO, ELITA R........... LOUISIANA STATE UNIV HSC NEW ORLEANS......... VAGAL GASTRIC MOTOR CONTROL IN MICE............................ 143,000
R21ES012026-01................. REISER, JAKOB..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... Protein trapping tools for mammalian cells..................... 213,000
R21GM065612-01................. POLLOCK, DAVID D.................. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... Protein sequence, structure, and computational analysis........ 138,348
R21NS042736-01................. BRISKI, KAREN P................... UNIVERSITY OF LOUISIANA AT MONROE............ Microscopic Quantitative Mapping Ion Flux in Rat Brain......... 99,500
R21NS043974-02................. EHRLICH, MELANIE.................. TULANE UNIVERSITY OF LOUISIANA............... FSHD Syndrome: DNA Repeats, Methylation, & Chromatin........... 185,625
R21RR015016-03................. MURRAY, KERMIT K.................. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... MADLI Mass Spectrometry for Microfluidic Chip Detection........ 89,570
R24CA084625-03................. SOPER, Steven A................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... MICRO-INSTRUMENT PLATFORMS FOR GENETIC-BASED ANALYSES.......... 537,986
R24CA084625-03S1............... SOPER, Steven A................... LOUISIANA STATE UNIV A&M COL BATON ROUGE..... MICRO-INSTRUMENT PLATFORMS FOR GENETIC-BASED ANALYSES.......... 33,075
R24HL060808-05................. STRONG, JACK P.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... PDAY CARDIOVASCULAR SPECIMEN AND DATA LIBRARY.................. 131,915
R24RR015395-01A2............... BAVISTER, BARRY D................. LOUISIANA STATE UNIV-UNIV OF NEW ORLEANS..... EMBRYO TECHNOLOGIES FOR PROPAGATION OF RHESUS MONKEYS.......... 250,176
R24RR016986-01A1............... Marx, Preston A................... TULANE UNIVERSITY OF LOUISIANA............... AN IMPROVED MACAQUE MODEL FOR SIV AND SHIV..................... 683,168
R25CA047877-15................. LOPEZ-S, ALFREDO.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... SHORT RESEARCH EXPERIENCES IN CANCER........................... 66,965
R25CA087994-03................. GREGORY, PAULA E.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... SCIENCE FOR THE NEW MILLENNIUM--HS CANCER RES PARTNER.......... 63,334
R25GM060926-01A2............... STEVENS, CHERYL L................. XAVIER UNIVERSITY OF LOUISIANA............... MBRS RISE Program at Xavier University......................... 137,138
R25MH058560-05................. Duhon, Stacey A................... GRAMBLING STATE UNIVERSITY................... NIMH HONORS MINORITY HIGH SCHOOL PROGRAM AT GSU................ 26,001
R29CA076186-05................. MEYERS, SHARI L................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... MOLECULAR MECHANISM OF TRANSFORMATION BY AML1/ETO.............. 101,500
R29DC003280-05................. Garcia, Meredith M................ TULANE UNIVERSITY OF LOUISIANA............... PROTEIN KINASE C IN CENTRAL AUDITORY PLASTICITY................ 102,566
R29ES009055-05................. MILLER, CHARLES A................. TULANE UNIVERSITY OF LOUISIANA............... ARYL HYDROCARBON RECEPTOR STRUCTURE AND INTERACTIONS........... 94,724
R29EY012204-05................. GLEASON, EVANNA L................. LOUISIANA STATE UNIV A&M COL BATON ROUGE..... METABOTROPIC GLUTAMATE RECEPTORS ON AMACRINE CELLS............. 99,231
R29HD036421-06................. KUBISCH, HANS M................... TULANE UNIVERSITY OF LOUISIANA............... MARKER ASSISTED SELECTION OF BOVINE BLASTOCYSTS................ 152,674
R37AG006168-17................. JAZWINSKI, S MICHAL............... LOUISIANA STATE UNIV HSC NEW ORLEANS......... CELLULAR AGING IN A YEAST MODEL SYSTEM......................... 327,656
R37DK032089-21................. BRAY, GEORGE A.................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... DIETARY OBESITY................................................ 308,966
R37DK036013-16................. ORLANDO, ROY C.................... TULANE UNIVERSITY OF LOUISIANA............... ESOPHAGEAL CYTOPROTECTION--AGENTS AND MECHANISMS............... 215,096
R37MH051853-09................. MCCANN, SAMUEL M.................. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... MECHANISM OF ACTION OF CYTOKINES ON BRAIN AND PITUITARY........ 290,105
R43CA094566-01A1............... MORGAN, LEE R..................... DEKK-TEC, INC................................ Clinical Development of 4-Hydroperoxyifosfamide................ 185,641
R44CA085021-03................. MORGAN, LEE R..................... DEKK-TEC, INC................................ DERIVATIVES OF DEMETHYLPENCLOMEDINE:ANTICANCER AGENTS.......... 122,592
R44GM061508-02................. SINHA, SUDHIR K................... RELIAGENE TECHNOLOGIES, INC.................. Dimorphic ALU repeats- Application in identity testing......... 469,306
R44NS038358-02................. NARDUCY, KENNETH W................ ST CHARLES PHARMACEUTICALS................... Development of Novel Therapeutics for Postsurgical Pain........ 435,340
S06GM008008-31................. STEVENS, CHERYL L................. XAVIER UNIVERSITY OF LOUISIANA............... MBRS SCORE PROGRAM AT XAVIER UNIVERSITY........................ 761,051
S06GM008025-29................. CHRISTIAN, FRED A................. SOUTHERN UNIV A&M COL BATON ROUGE............ MBRS SCORE PROGRAM AT SOUTHERN UNIVERSITY-BATON ROUGE.......... 44,708
S07RR018185-01................. WHELTON, PAUL K................... TULANE UNIVERSITY OF LOUISIANA............... Technology for Electronic Submission of IRB Protocols.......... 123,500
S10RR016963-01................. VEAZEY, RONALD S.................. TULANE UNIVERSITY OF LOUISIANA............... High-speed cell sorter......................................... 427,553
S11ES009996-04................. BLAKE, ROBERT C................... XAVIER UNIVERSITY OF LOUISIANA............... ALTERATION OF GENE REGULATION BY ENVIRONMENTAL COMPOUNDS....... 593,981
S11ES010018-04................. MUGANDA, PERPETUA M............... SOUTHERN UNIV A&M COL BATON ROUGE............ CELLULAR & MOLECULAR TOXICOLOGY OF BUTADIENE................... 985,060
S21MD000231-01................. FRANCIS, NORMAN C................. XAVIER UNIVERSITY OF LOUISIANA............... Xavier Pharmacy Endowment for Minority Health.................. 5,000,000
T32AA007577-03S1............... BAGBY, GREGORY J.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... BIOMEDICAL ALCOHOL RESEARCH TRAINING PROGRAM................... 49,758
T32AA007577-04................. BAGBY, GREGORY J.................. LOUISIANA STATE UNIV HSC NEW ORLEANS......... BIOMEDICAL ALCOHOL RESEARCH TRAINING PROGRAM................... 273,978
T34GM007716-24................. BIRDWHISTELL, TERESA T............ XAVIER UNIVERSITY OF LOUISIANA............... MARC U*STAR Training Program at Xavier University.............. 534,181
T34GM008714-04................. HIMAYA, M A....................... GRAMBLING STATE UNIVERSITY................... MARC U STAR at Grambling State University...................... 278,345
T34MH017102-20................. DUHON, STACEY A................... GRAMBLING STATE UNIVERSITY................... NIMH COR HONORS UNDERGRADUATE PROGRAM AT GSU................... 227,971
U01AG020478-01................. RAVUSSIN, ERIC.................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... Metabolic Adaptations to Two Year Caloric Restriction.......... 1,432,621
U01AG020478-01S1............... RAVUSSIN, ERIC.................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... Metabolic Adaptations to Two Year Caloric Restriction.......... 147,000
U01AG020478-01S2............... RAVUSSIN, ERIC.................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... Metabolic Adaptations to Two Year Caloric Restriction.......... 915,000
U01AI032913-10................. VAN DYKE, RUSSELL B............... TULANE UNIVERSITY OF LOUISIANA............... Tulane/LSU Pediatric AIDS Clinical Trials Unit................. 815,476
U01AI038844-04S3............... Lertora, Juan J. L................ TULANE UNIVERSITY OF LOUISIANA............... AIDS CLINICAL TRIALS UNIT...................................... 285,956
U01AI042178-11................. MUSHATT, DAVID M.................. TULANE UNIVERSITY OF LOUISIANA............... LOUISIANA COMMUNITY AIDS RESEARCH PROGRAM (CPCRA).............. 853,801
U01CA083014-04................. ZAKRIS, ELLEN L................... TULANE UNIVERSITY OF LOUISIANA............... TULANE AIDS-ASSOCIATED MALIGNANCY CONSORTIUM................... 154,826
U01DK048377-09................. BRAY, GEORGE A.................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... NIDDM PRIMARY PREVENTION TRIAL (DPT 2)......................... 304,921
U01DK056990-04................. BRAY, GEORGE A.................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... Clinical Center for Look AHEAD: Health in Diabetes............. 1,312,399
U01DK056990-04S1............... BRAY, GEORGE A.................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... Clinical Center for Look AHEAD: Health in Diabetes............. 7,350
U01DK060963-02................. HE, JIANG......................... TULANE UNIVERSITY OF LOUISIANA............... Clinical Center for Prospective Cohort Study of CRI............ 316,100
U01DK060963-02S1............... HE, JIANG......................... TULANE UNIVERSITY OF LOUISIANA............... Clinical Center for Prospective Cohort Study of CRI............ 250,000
U01HD031315-09................. WILSON, JOHN T.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... PEDIATRIC DRUG EVALUATION RESOURCE............................. 383,323
U01HD031315-09S1............... WILSON, JOHN T.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... PEDIATRIC DRUG EVALUATION RESOURCE............................. 178,033
U01HD040470-02................. ABDALIAN, SUE E................... TULANE UNIVERSITY OF LOUISIANA............... NEW ORLEANS ADOLESCENT MEDICINE TRIALS UNIT.................... 762,602
U01HL060571-05................. HARSHA, DAVID W................... LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... PREMIER--LIFESTYLE INTERVENE FOR BLOOD PRESSURE CONTRL......... 163,892
U01HL066855-03................. Webber, Larry S................... TULANE UNIVERSITY OF LOUISIANA............... TRIAL OF ACTIVITY FOR ADOLESCENT GIRLS (TAAG).................. 763,926
U01HL072274-01................. LEISSINGER, CINDY A............... TULANE UNIVERSITY OF LOUISIANA............... Hemostasis Clinical Research Network Protocols................. 300,000
U01HL072507-01................. HE, JIANG......................... TULANE UNIVERSITY OF LOUISIANA............... Genetic Epidemiology of Blood Pressure Intervention............ 1,432,730
U01HL072510-01................. LEFEVRE, MICHAEL.................. LSU PENNINGTON BIOMEDICAL RESEARCH CTR....... Diet, genetics, and CVD risk factor response in Blacks......... 2,098,725
U10CA035272-19................. KARDINAL, CARL G.................. OCHSNER CLINIC FOUNDATION.................... OCHSNER COMMUNITY CLINICAL ONCOLOGY PROGRAM.................... 467,005
U10CA058658-10................. MILLS, GLENN M.................... LOUISIANA STATE UNIV HSC SHREVEPORT.......... SOUTHWEST ONCOLOGY GROUP....................................... 324,550
U10CA063845-08................. Gilbert, Jill..................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... LSUHSC Minority Based Community Clinical Oncology.............. 211,735
U10NS044471-01................. RAO, JAYARAMAN.................... LOUISIANA STATE UNIV HSC NEW ORLEANS......... Nicotine and Neuroprotection in Parkinson's Disease............ 104,197
U19AI045511-03S1............... BEIER, JOHN C..................... TULANE UNIVERSITY OF LOUISIANA............... AFRICAN MALARIA VECTORS........................................ 76,005
U19AI045511-04................. BEIER, JOHN C..................... TULANE UNIVERSITY OF LOUISIANA............... AFRICAN MALARIA VECTORS........................................ 680,483
U19AI045511-04S1............... BEIER, JOHN C..................... TULANE UNIVERSITY OF LOUISIANA............... AFRICAN MALARIA VECTORS........................................ 40,189
U24RR018111-01................. BOHM, RUDOLF P.................... TULANE UNIVERSITY OF LOUISIANA............... ESTABLISHMENT AND EXPANSION OF A SPF RHESUS COLONY............. 769,149
U42RR015087-03................. ROWELL, THOMAS J.................. UNIVERSITY OF LOUISIANA AT LAFAYETTE......... ESTABLISHMENT/MAINTENANCE OF BIOMEDICAL RESEARCH COLONY........ 843,593
N01NS992302.................... ROWELL, THOMAS J.................. UNIVERSITY OF LOUISIANA AT LAFAYETTE......... SLOW, LATENT & TEMPERATE VIRUS INFECTIONS...................... 1,171,906
N01HR16150..................... DEBOISBLANC, BENNETT.............. UNIVERSITY OF LOUISIANA AT LAFAYETTE......... ADULT RESPIRATORY DISTRESS SYNDROME STUDY...................... 125,337
N01AO12747..................... HASSELSCHWERT, DANA............... UNIVERSITY OF LOUISIANA AT LAFAYETTE......... MAINTENANCE OF A SPF PIGTAIL BREEDING COLONY................... 1,922,466
N01AO22751..................... FONTENOT, BABETTE................. UNIVERSITY OF LOUISIANA AT LAFAYETTE......... BREEDING,HOUSING AND MAINTENANCE OF RHESUS MACAQUES IN SUPPORT 1,349,886
OF AIDS.
N01AO22754..................... HASSELSCHWERT, DANA............... UNIVERSITY OF LOUISIANA AT LAFAYETTE......... LEASING OF CHIMPANZEES FOR THE CONDUCT OF RESEARCH............. 1,360,000
U42RR016026-02................. BLANCHARD, JAMES L................ TULANE UNIVERSITY OF LOUISIANA............... SPECIFIC PATHOGEN FREE INDIAN RHESUS MONKEY COLONY FOR A....... 1,311,873
U45ES010664-03................. WRIGHT, BEVERLY H................. XAVIER UNIVERSITY OF LOUISIANA............... WORKER HEALTH AND SAFETY TRAINING COOPERATIVE AGREEMENT........ 993,562
------------
TOTAL FY 2002............ .................................. ............................................. ............................................................... 117,481,005
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
BIOTERRRORISM
Senator Specter. Mr. Secretary, coming back to the
bioterrorism, the budget has a figure of $3.6 billion. How is
help going to be given to the States on dealing with
bioterrorism? I have traveled my State. I know my colleagues
have traveled their States. But there are no funds which are
being devoted. The University of Pittsburgh Medical Center, for
example, has a very elaborate system where they have plans to
bring people in in the event of bioterrorism attack, showers,
quarantines, response to anthrax or smallpox or whatever else
may occur. But what is being done about distributing funds from
the Federal Government to the States?
Secretary Thompson. Last year, Senator, we had $918 million
that we could send out for the State departments and local
health departments and communities for biopreparedness. And we
had an additional $125 million that was sent out for hospitals
in order to find ways in which they might be able to expand
their surge capacity, and that was distributed on a formula
throughout all of the States in America.
But in addition to that, we asked them to make some
planning because we knew that we were going to ask for some
additional money in fiscal year 2003, which is $518 million,
which has been appropriated, less a reduction, I think, of
about 1 percent in the appropriation language. So there is $518
million, less that reduction for balancing the budget, that is
going to be sent out to the hospitals based upon their plans.
Senator Specter. How much money is that again?
Secretary Thompson. $518 million.
Senator Specter. Is that remotely enough?
Secretary Thompson. We are expecting that to be replicated
again this year in fiscal year 2004 and fiscal year----
Senator Specter. Do you have an estimate on how much money
it will take?
Secretary Thompson. We have lots of estimates, but I cannot
tell you off the top of my head right now exactly. I know it is
a lot more than----
Senator Specter. Could you provide for us what it will
cost? It seems to me that to adequately prepare the hospitals
in America for bioterrorism is a gigantic figure. I know you
are working on it. But would you provide for the subcommittee
what it is?
Secretary Thompson. Sure, absolutely.
[The information follows:]
Bioterrorism
We are providing $518 million, roughly the full authorization level
in Section 319C-1 of the Public Health Service Act, to improve and
expand the capacity of our Nation's hospitals to respond to biological,
chemical, and radiological terrorist attacks and situations involving
large scale casualties. These funds will supplement the $515 million
appropriated for these activities in fiscal year 2003, and $135 million
in fiscal year 2002, bringing the total to $1.2 billion over 3 years--a
significant investment. The fiscal year 2003 appropriation for the
District of Columbia also included $10 million for related hospital
preparedness activities. We believe that our investment is
significantly contributing to meeting the need of hospitals to
adequately prepare to deal with bioterrorism. We are working with the
States, the American Hospital Association, American Association of
Poison Control Centers, American College of Emergency Physicians,
American Academy of Pediatrics, National Association of EMS Physicians,
National Association of State EMS Directors, Association of State and
Territorial Health Officials, National Rural Health Association,
National Association of Community Health Centers, National Association
of Social Workers, and the American Nurses Association. Each State has
developed a plan for preparing their hospitals and other health care
facilities. These funds will be expended consistent with these State
plans and assessments.
Senator Specter. So we have some idea as to what it is and
how we are getting there.
Mr. Secretary, there is an enormous----
Secretary Thompson. If I could.
Senator Specter. Yes, go ahead.
Secretary Thompson. Pennsylvania has got an obligation of
$33 million, and they have only drawn down $9.5 million. There
are still $23 million undrawn for the State of Pennsylvania as
of right now.
Senator Specter. That is the 19 percent drawdown you have
talked about?
Secretary Thompson. Yes. Pennsylvania has drawn down a
little bit more, but it still has $23 million.
Senator Specter. And that is a simple matter for them to
draw it down?
Secretary Thompson. Yes. But this is before we sent out the
additional $1.5 billion, which we are in the process of sending
out right now.
Senator Specter. Well, that is important to move ahead on,
and we will assist on that.
Secretary Thompson. Thank you.
Senator Specter. I was about to say, Mr. Secretary, there
is enormous anxiety everywhere as to what is going to happen in
the course of the next several days. You are in the command
center. You have the responsibility for a big chunk of
preparedness on bioterrorism. Can you provide any insights as
to what people might expect as we have the countdown to war?
Secretary Thompson. We have, of course, gone from code
yellow to code orange, and there is a possibility we will be
going to code red. I am not sure about that, but there is a
possibility.
Senator Specter. Are you consulted? Is your Department a
party to that determination?
Secretary Thompson. The determination is by the Department
of Justice and the Department of Homeland Security, but we have
very close cooperation and communications with both of those
Departments. We work very closely with them.
What we are anticipating is, Senator, that there could
definitely be attacks, bioterrorism, chemical, radiological,
nuclear, whatever the case may be. We have placed some of our
DMAT teams on alert so that they can be moved very quickly.
Senator Specter. When you say radiological, what do you
mean by that?
Secretary Thompson. That is a dirty bomb, a nuclear bomb.
We have divided up the country into 10 regions. We have
approximately 8,000 medical doctors, nurses, morticians, and
veterinarians that can be called up. We have 600 tons of
medical supplies and equipment strategically located in 12
sites around America that we can move to any city in America
within 7 hours.
Senator Specter. And what kind of paraphernalia do you have
in these sites?
Secretary Thompson. All kinds of things from masks, to
antibiotics, to antidotes, to mark I kits for chemicals.
Vaccines are in a different place. There are also masks, other
kind of equipment to be used, stretchers and so on, if need be.
They are strategically located in 12 sites around America.
Senator Specter. Do you have adequate resources to handle
that particular issue?
Secretary Thompson. We think at this point in time we do,
Senator. I think we could allay your concerns tremendously if
you would come over and just take a look at what we have, how
we are set up to deploy people, equipment, and supplies, and
how we are able to monitor everything and stay in communication
with every State and local health department.
In our GIS, we are I believe the only one that has in our
database every hospital, every fire station, every police
station, all of the first responders. We have all the railroad
lines in our GIS system. We know daily how many beds are
available in each hospital. We can set up plume modeling for
any kind of chemical or any kind of gas that is exploded. On a
street level, we have every street in America in our GIS
database so that we can----
Senator Specter. Every street in America?
Secretary Thompson. Every street in every city.
Senator Specter. Okay. I am going to come take a look.
Secretary Thompson. I think you would be very impressed by
what we have done.
Senator Specter. I want to see the markings on Senator
Craig's street.
I want to see how closely you have him tabbed.
Senator Craig. Mr. Chairman, when you get ready to go, I
will go with you. I would like to see that too.
Secretary Thompson. It is absolutely amazing. I would love
to have you come over.
Senator Craig. The problem is my hometown does not have any
streets.
It has a road that goes to it.
Secretary Thompson. We have the capacity in our
communication room to hook up to any one of 4,000 local TV
stations across America so that if something would happen in
Idaho, we could bring up the TV stations and find out what is
happening on site in that particular area.
Senator Craig. That is very impressive.
Mr. Secretary, were you involved in a briefing with the
Governors in the last couple of days?
Secretary Thompson. No, I was not.
Senator Craig. Mr. Chairman, in relation to your express
concern here--and it is mine--as to the next 24 to 48 hours,
Homeland Security and I believe CIA were involved in a briefing
with all of our Governors in the last 24 hours that my Governor
tells me was the most comprehensive detail he has yet had and
he was very pleased about it. That kind of communication is
improving greatly, and the ability now for you all to tie, as
you are telling us you can, is a very real advancement.
Secretary Thompson. I think if you came over, you would be
very impressed.
Senator Craig. I will do that. I will make a point to do
it.
Secretary Thompson. We are in weekly, if not daily, contact
with all the State health departments through CDC and through
our communication room. So we are keeping everybody very well
up to speed as to what is going on, Senator.
Senator Craig. Thank you.
OBESITY AND LIFESTYLE
Senator Specter. On the issue of obesity and lifestyle,
this subcommittee held a hearing in San Francisco during the
last recess and developed a lot of fascinating information. A
big part of the problem may originate in fast foods where
people are encouraged to eat foods which are very harmful, so
it is said. There recently was a lawsuit against McDonald's
which was dismissed.
What can be done by way of so-called jawboning to try to
get fast food chains to do something about the kind of food
they serve?
Secretary Thompson. I held a meeting, Senator, with several
members of the fast food industry and the national restaurant
organization. We had a difficult but I think productive meeting
and got pledges from them that they would be helpful in trying
to put healthier items on their menu.
[The information follows:]
Fast Food Industry
Secretary Thompson has made it clear that obesity is a problem that
requires a multi disciplinary approach to address this unprecedented
epidemic. HHS has reached out to both public and private organizations,
including the fast food industry to find unique ways to establish
partnerships that will impact this epidemic.
HHS has strongly encouraged the fast food industry to provide
healthy choices on menus, aggressively market those choices to
consumers, and reduce portion sizes.
Senator Specter. Anything concrete? Anything specific?
Secretary Thompson. Nothing specific at this point in time.
That is why we are going to try and have this prevention
summit. I believe it is in April. I will let you know the date,
Senator, and hopefully you can come.
Senator Specter. What do you think of the litigation on the
analogy to smoking, to dangers in smoking? I see the Justice
Department just this week has taken a very strong position
about fraud on the tobacco companies in enticing juveniles to
smoke, put an enormous figure, into the hundreds of millions of
dollars. Is there any analogy to subjecting people to the risks
of adverse health from foods which are unhealthy?
Secretary Thompson. Well, as you know, there was a lawsuit
started and it was dismissed. I am not sure that that is the
most correct way to go, Senator. I think that a better way to
do it is to bring them in and try and convince them to do it. I
spent a half a day at Hamburger University, which is at the
McDonald's campus in northern Illinois, and they were willing
to be quite supportive to try and get healthier items on their
menus.
Senator Specter. Well, we would be very interested to see
what results you have.
Let me move to a couple of other subjects quickly and
terminate the hearing because we have kept you here a long
time.
TAX CREDITS FOR HEALTH INSURANCE
You talk about tax credits for health insurance. Is that an
administration position?
Secretary Thompson. No. It is mine.
Senator Specter. It would be a good idea. We see the number
of uninsured Americans. If you had a tax credit, that would be
a very effective way of dealing with the issue.
Senator Craig. Mr. Chairman?
Senator Specter. Senator Craig.
Senator Craig. Mr. Secretary, you did tie that comment,
though, to long term, did you not?
Secretary Thompson. Yes.
Senator Craig. Thank you. I agree with both, but clearly to
introduce long-term health care insurance into our economy
would be a tremendous advantage to get people investing in
insurance that carries them through to death of that kind.
Secretary Thompson. I would also like to see health
insurance charge lower premiums for people that lead healthier
lifestyles like they do on automobiles.
Senator Craig. I agree.
Secretary Thompson. It is something that we could work on.
TAX CREDITS ON MALPRACTICE INSURANCE
Senator Specter. On the issue of tax credits, one of our
colleagues in the Senate is talking about a tax credit on
malpractice insurance. We had a hearing last week on that
subject, and this is a new idea which is being considered. What
would you think of that, which could be tailored to the areas
which have the greatest problem at the present time?
Secretary Thompson. Senator, I have not looked at it. I am
not knowledgeable about that subject. I would like to read it.
It seems like it has got some possibilities.
Senator Specter. We had a lengthy hearing, Mr. Secretary,
and we had responses from Deputy Secretary Claude Allen. I
would appreciate it if you could find the time to review
Secretary Allen's testimony and give a response to the
subcommittee as to whether you think it was adequate in
answering the questions which we posed.
Secretary Thompson. Okay.
Senator Specter. I would appreciate that.
[The information follows:]
Tax Credit on Malpractice Insurance
I do not believe that the crisis can be fixed by giving doctors tax
credits to help pay the cost of malpractice insurance. This would
simply require the taxpayers to pay even more for the cost of the
excesses of the litigation system. They already are paying $70 billion
as patients and insured for the problems caused by the litigation
system. At the same time, a tax credit would do nothing to address the
underlying problems of the litigation system. It would feed, not fix,
the broken litigation system. We believe the Congress should enact
reasonable reforms such as those passed by the House in H.R. 5.
MEDICAL LIABILITY
Senator Specter. In looking at medical liability--and there
is a lot of concern. Pennsylvania has a very, very serious
problem. Quite a number of States do. When we talk about
frivolous lawsuits, we are talking about a subject matter which
I think really is containable. We have had testimony that 70
percent of the lawsuits are won, but even if the defendants
win, the cost of litigation is so high that it boosts rates.
There are ways to deal with that, sanctions on lawyers,
requirement of a certification by doctors from a panel that
there is something to be submitted to the court.
We have taken a look at the insurance industry. There was a
problem in Texas on homeowners insurance. Nobody could buy
homeowners insurance because there had been so many hurricanes
and the insurance companies had invested the money and the
stock market had gone down.
MEDICAL ERRORS
The medical errors issue. We are anxiously awaiting your
report on medical errors to see to what extent that impacts.
When you talk about caps, you are on a very sensitive subject,
but I think there is some latitude, if it is done carefully. I
think there has to be some exclusion for cases like the
transplant victim in North Carolina, something which is
catastrophic or something like we had a witness testify about a
double mastectomy which was erroneous. They got the wrong x-ray
slides. There is a lot of complaint and understandably about
the lottery, so to speak, with minor cases coming in with
gigantic verdicts.
Would you think that there could be some careful pruning?
There are some State laws on liability, for example, of
governmental units which exclude what they call catastrophic
cases, permanent impairment of bodily function or death or
major disfigurement. Would you think that would be an
appropriate line to make?
Secretary Thompson. Senator, the administration feels very
strongly that we need to have cap on noneconomic damages, but
what you are looking at are many new ideas that certainly
should be explored. I am willing to look at each and every one
of them.
We are looking at something in the Department that we are
going to try administratively and that is first offer. We do
not know if it is going to work, but we are going to try in
some of our cases to be able to offer money to a patient that
has been harmed and pay for their expenses. We are trying to
set it up administratively so that we could do it outside of
litigation. They still would have the right to appeal.
Senator Specter. First offer by the Government, by the
Department of Health and Human Services?
Secretary Thompson. That is correct. To see if we could
somehow show that this is a new procedure. We are working with
a professor I believe in North Carolina that has come up with
this new mechanism on how we might be able to reduce
litigation.
Senator Specter. Well, we would be interested to see the
details on that.
Senator Craig, anything more?
Senator Craig. I do not have anything more. Thank you, Mr.
Secretary, Mr. Chairman.
Senator Specter. Thank you very much, Mr. Secretary.
Secretary Thompson. Thank you, Senator.
Senator Specter. We will be working with you on this.
Secretary Thompson. Please do, and I appreciate it.
Senator Craig, thank you.
Senator Craig. Thank you.
Secretary Thompson. Thank you for your leadership on long-
term. That is great.
PREPARED STATEMENT RECEIVED
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, thank you for holding this hearing on the 2004 budget
for the Department of Health and Human Services. At this important
time, we must ensure that we are setting clear priorities and investing
wisely in the health and safety of all Americans. Thank you, Secretary
Thompson for appearing before us today and for the excellent job you
are doing as Secretary of HHS. I appreciated your visit to my state
last May.
As we consider the 2004 budget, I think our first priority should
be protecting the safety of our country's citizens. While the defense
of our country comes frist, we must make increased investments in the
health infrastructure of our nation. I am pleased to see the overall
commitment of over $3.5 billion in research and infrastructure funding
aimed at detecting and responding to a national emergency. This is a
wise investment because these public health capacities and research
findings improve our ability to respond to naturally occurring disease
outbreaks even if no bioterrorist incident ever occurs.
We must also remember that cooperation and coordination between HHS
and the Departments of Homeland Security, Agriculture, and Defense are
vital to our response to a biological or chemical attack. We must build
these relationships before an attack occurs.
We must not forget that our nation also faces other pressing health
problems. The biomedical research conducted by HHS has dramatically
improved the health of Americans. While the amazing growth of the NIH's
budget could not be sustained, the President's budget provides a 2
percent increase. I hope this figure can be increased so that we
continue the progress NIH and other agencies have made in understanding
disease.
The funding for the Centers for Disease Control also provides for
important public health research, especially with regard to chronic
diseases. The budget provides an additional $100 million for the
prevention of chronic diseases. This initiative has the potential to
provide tremendous returns. However, we must not shortchange the other
important areas such as infectious disease, birth defects, and
occupational injuries.
We must also continue to make investments in clinical and research
technology. NIH has been leading this effort. Biomedical technology
provides the great promise in the detection, treatment and prevention
of disease. It also provides our best opportunity to confront the
challenges of medical errors and patient safety.
The budget also provides for those in our country most in need of
health. The $1.6 billion provided for Community Health Centers will
create access to health care for over 1 million Americans, according to
the Department.
The budget also provides $47 million for the Office of Minority
Health and $193 million for the National Center for Minority Health and
Health Disparities. While it is important for us to continue to
increase these funding levels, it is also important for us to continue
to work to make sure that this research and outreach takes place in
those areas of the country where it is most needed.
Mr. Secretary, thank you for the leadership you continue to
provide. We look forward to helping you as you oversee the vital
programs that provide us a safe and healthy country.
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
medicaid drug rebate program
Question. You are proposing a Medicaid drug rebate program that is
estimated to save $13.2 billion over the next ten years, and save
states a similar amount. How much do you estimate will be saved in
Fiscal 2004?
Answer. CMS actuaries have estimated that the adjustment to the
Medicaid drug rebate formula will save the Federal Government $800
million in fiscal year 2004.
Question. Could this component of Medicaid reform be enacted as a
separate, free-standing initiative? Provide bill language that would
accomplish this rebate program.
Answer. Yes this legislation could be enacted as a separate free-
standing initiative. The savings I just gave you reflect what would be
the case without Medicaid and SCHIP modernization. As we have stated
previously there are some problems with the current formulation of the
drug rebate. There have been a number of suggestions on how the rebate
formula might be improved. One option suggested was to change the
rebate formula from the difference between Average Manufacturer's Price
(AMP) and best price, to the difference between Average Wholesale Price
(AWP) and best price. Another was to simply set the rebate equal to a
percentage of AMP. Both of these proposals, and others, would save us
money. We wish to work with Congress to come up with the plan that best
advances the interests of the Federal Government and the American
taxpayer.
medical liability reform legislation
Question. Last week, you issued a press release applauding the
House of Representatives for passage of Medical Liability Reform
Legislation. The statement said you looked forward to working with the
Senate to pass complementary legislation this year. I chaired a hearing
on this subject last week, and the matter of capping non-economic
awards at $250,000, without exceptions, for egregious cases, was very
controversial. Do you have a compromise plan to gain bi-partisan
support in the Senate?
Answer. The Department's report entitled: ``Addressing the New
Health Care Crisis: Reforming the Medical Litigation System to Improve
the Quality of Health Care,'' shows how problems associated with
medical litigation have worsened significantly in the past year.
Premiums charged to specialists in 18 states without reasonable limits
on non-economic damages increased by 39 percent between 2000 and 2001.
Premiums in these states have since gone up an additional 51 percent.
This report also documents the spiraling cost of insurance for health
care providers, which is impairing patients' access to care, as well as
the cost and quality of care.
Therefore, reasonable caps on non-economic damages increase
doctors; hospitals' and nursing homes' ability to stay in business,
which leads to greater access to care. In addition, caps on non-
economic damages reduce the growth of medical liability costs and
insurance premiums. Over the last two years, states with limits of
$250,000 or $350,000 on non-economic damages have seen increases in
premium quotes for specialists increase only 18 percent. States without
reasonable limits on non-economic damages, in states representing
almost half of the entire U.S. population, have seen average increases
of 45 percent. Since California implemented a reasonable cap on non-
economic damages and other critical procedural reforms 25 years ago,
liability premiums have increased by less than one-third as much as in
the rest of the country. It is important to implement caps at $250,000
for the sake of affordability and access to quality health care.
medicare payment policy
Question. MedPAC considers the implementation of a transition
method as an important aspect of any new payment system design when
establishing its framework for assessing Medicare payment policy
issues. Payment corridors, hold-harmless methods, blend approaches as
well as phase-in periods have been adopted in different circumstances
in order to cushion the impact of payment changes on individual
providers and prevent service disruptions. Did CMS consider
incorporating any of these methods when designing its new outlier
policy?
Answer. Extensive discussions were held on the best approach to
solving the problems caused by hospitals exploiting vulnerabilities in
the determination of outlier payments.
It must be kept in mind that the goal of Medicare is to make fair
and accurate payments for services rendered, these higher payments were
made because of a vulnerability in the determination of payments not as
a result of the true costs of services provided. The proposed outlier
rule will allow CMS to ensure that only hospitals that are truly
experiencing higher then expected costs can receive reimbursement.
hospital cost computation
Question. In its September, 1988 rulemaking process, HCFA (now CMS)
received a number of comments expressing concern about the timeliness
of the data used to compute hospital specific cost-to-charge ratios,
the issue that is at the core of the problem addressed by the newly
proposed regulatory change. In 1988 some suggested that data from the
latest filed cost report be used. CMS dismissed that suggestion stating
that Medicare costs are often overstated on the filed cost report and
are subsequently reduced by audit; CMS elected to use data from a
hospital's final settled cost report to establish the pertinent cost-
to-charge ratios. Now CMS is proposing to use information from a
hospital's tentatively settled cost reports to calculate hospital
specific ratios. To what extent do hospitals costs change between
tentative and final settlement?
Answer. Hospital costs can either increase or decrease between
tentative and final settlement. When a cost report is received by the
FI they ensure the cost report is complete before accepting it. Once
the cost report is accepted the FI has 60 days to make a tentative
settlement on this cost report. The tentative settlement process
usually entails looking at the providers past cost report history and
making any necessary adjustment to the current cost report based on
prior year data. In order to final settle the cost report, the FI will
perform a desk or field review of the cost report. Based on the review,
adjustments are made to costs, charges, and reimbursement in order to
final settle the cost report. This final settlement represents final
payment to the provider.
There is a variation in the change of hospital costs between
tentative and final settlement, depending on the areas reviewed and the
results of the review. However, it is highly unlikely that the cost
from the tentative to the final settled cost reports would change as
much as the latest changes in the cost per case (over 12 percent from
2001 to 2002). With this amount of year-to-year change in charges, it
is imperative to use the latest available cost-to-charge ratio.
Reconciliation at final settlement will take care of any large
differences used for payment and the actual ratio.
Question. Is the concern expressed by CMS in 1988 any less valid
today?
Answer. No, this issue is still pertinent, filed cost reports have
not been reviewed and if necessary audited, and are not an appropriate
basis of final payment. For this reason the proposed outlier rule uses
tentative cost reports which can include adjustments for ``known''
issues, to determine the initial payments. Final settlements are used
to adjust the initial payments and if necessary an adjustment for the
time value of money will be made if the initial payments were
inaccurate.
Our goal is always to make the most accurate payment possible. The
proposed outlier rule highlights that a change was necessary to prevent
hospitals from exploiting vulnerabilities in the determination of
outlier payments. Using tentative cost reports will help eliminate a
vulnerability in the system, and using the final settled cost reports
to determine final payments ensure their accuracy.
medicare drug benefit
Question. The President's budget dedicates $400 billion over ten
years for targeted improvements and modernization of Medicare,
including providing access to subsidized prescription drug coverage.
The Senate Budget Resolution also contains a $400 billion reserve fund
for Medicare. What would your proposal offer in prescription drug
coverage for those who stay in the traditional fee-for-service Medicare
program, compared to those who opt for a managed care plan?
Answer. The President's Framework to Modernize and Improve Medicare
gives beneficiaries immediate help with their prescription drug bills
starting in 2004, for beneficiaries in both traditional fee-for-service
and Medicare+Choice plans. A drug discount card will allow all
beneficiaries to save 10-25 percent off retail prices on their
medicines. Low-income beneficiaries will also get a $600 benefit added
to the drug card.
Beginning in 2006, beneficiaries will have three options for their
Medicare benefit: Traditional Medicare, Enhanced Medicare, and Medicare
Advantage. Under, the first option, Traditional Medicare, beneficiaries
could continue receiving their care through the existing program, while
getting a drug discount card that will allow them to save 10-25 percent
on their prescription drug bills. For no additional premium, fee-for-
service beneficiaries will also get protection from high out-of-pocket
drug costs.
Under the second option, Enhanced Medicare, beneficiaries could
choose to receive integrated benefits and drug coverage offered through
a FFS/PPO plan, like FEHBP or TRICARE. Plans would bid to serve one or
more of 10 different regions in the country, and the three best
qualified bids in each region would be awarded the opportunity to
compete for beneficiaries' business. All beneficiaries in a region
would be guaranteed access to all plans serving a region. Beneficiaries
who enroll in the plan submitting the middle-priced bid in their region
would pay a premium equal to the Part B premium in traditional
Medicare. Those choosing the plan with the low-priced bid would receive
most of the savings, while those choosing the high-priced bid would pay
a supplemental premium. All beneficiaries would pay an additional
premium for drug coverage, except for those with low incomes. New
benefits in the enhanced package include a combined deductible for Part
A & B services, free preventive benefits, and protection from high out-
of-pocket medical costs.
Under the third option, Medicare Advantage, beneficiaries could
choose to receive the integrated benefits and drug coverage through a
managed care plan. Plans in competitive markets would bid to provide
the enhanced benefit package. Beneficiaries who select the most
efficient plan could share in the premium savings (and possibly pay no
premium). Beneficiaries could select a plan without drug coverage if
they are satisfied with their current coverage. Like Enhanced Medicare,
beneficiaries would pay an additional premium for drug coverage, unless
they are low-income.
Question. What additional coverage are you suggesting for
preventive health services, such as nutrition education?
Answer. Beneficiaries enrolled in Enhanced Medicare and Medicare
Advantage will be able to receive preventive services absolutely free--
all current co-pays will be waived. As you may know, the Medicare
currently covers screening mammography, screening pap smears and pelvic
exams, colorectal cancer screening, prostate cancer screening, glaucoma
screening, diabetes self-management, medical nutrition therapy, bone
mass measurements, and certain vaccines. The President's Framework
promises that the cost of a co-pay will never stand in the way of this
potentially life-saving preventive care.
physicians' pay
Question. Congress replaced a 4.4 percent cut this year in Medicare
payments for physicians, with a 1.6 percent increase. Will this
correction be sufficient to avoid a payment cut in 2004?
Answer. The enactment of the Consolidated Appropriations Resolution
(CAR) corrected a statutory flaw in the physician payment formula
resulting in multi-year, permanent changes in Medicare expenditures for
physicians' services. The CAR provision increased Medicare spending by
an estimated $49.6 billion over 10 years by allowing the Centers for
Medicare and Medicaid Services (CMS) to revise the fiscal years 1998
and 1999 sustainable growth rates (SGRs) and establish a 1.6 percent
update to physician fee schedule rates for March 1 to December 31 in
place of the 4.4 percent reduction announced in our December 31, 2002
final rule. The revisions CMS made to the fiscal year 1998 and fiscal
year 1999 SGRs allow the physician fee schedule update and SGR system
to work as originally intended by the Balanced Budget Act of 1997.
While CMS had previously estimated positive updates for 2004 and
later years, we now estimate physician fee schedule updates will be
negative for 2004-2007 as a result of higher spending in 2002 for
physicians' services and lower real GDP per capita for both 2002 and
2003 than previously estimated. The revisions made to the fiscal year
1998 and fiscal year 1999 SGRs will result in higher physician fee
schedule updates for years beginning with 2004 than would have occurred
had the CAR of 2003 not been enacted.
Question. What would be the impact on the pay update of excluding
the cost of outpatient prescription drugs from the calculation of
spending targets for physician services?
Answer. We previously estimated a physician fee schedule update of
1.7 percent for 2004. However, more recent data on actual spending in
2002 and new figures for real per capita GDP changed this estimate to
4.2 percent. We estimate that 44 percent of the change is the result of
higher physician spending (other than for drugs). Another 41 percent of
change is the result of lower GDP figures for 2002 and 2003. Another 10
percent of the change is the result of higher spending for drugs and
the remaining 5 percent is the result of a small reduction in the
estimated Medicare Economic Index (MEI). More information on 2003
spending and real per capita GDP growth will likely change this figure
further. The 2004 update would be somewhat less negative if spending
for currently covered drugs were removed from the measurement of
spending under the 2003 sustainable growth rate.
smallpox vaccination program
Question. Public health groups are now estimating that the cost of
implementing the Smallpox Vaccination Program would range between $154
and $284 per vaccination with a median cost of $204. Does the
Administration plan to request an appropriation in the emergency
supplemental to provide states with resources so that they may carry
out the Smallpox Vaccination Plan without diverting funding from other
bioterrorism preparedness or core public health activities?
Answer. We understand that these estimates include a range of costs
over and above the direct costs of running an immunization campaign.
They include, for example, costs of infrastructure that States should
be building with the funds they have already received, costs of the
added epidemiologists that funds have been appropriated to cover, and a
range of potential indirect costs that State public health departments
would not have to pay. CDC is making every effort to assist States in
implementing the smallpox vaccination program including providing
training to the States, offering technical assistance on administering
the smallpox vaccine, and providing education to clinicians, public
health groups, and State health officers and organizations. To help
implement these plans, CDC and HHS is allowing States to request
immediate use of 20 percent of their fiscal year 2003 Bioterrorism
grant allocation to be used for immediate needs including implementing
the smallpox vaccination program. Although this may not cover all the
costs associated with the vaccination, CDC is committed to helping the
states in every way possible.
head start
Question. Mr. Secretary, the Administration's budget proposal has
identified the fiscal year 2004 as the transfer transition year for
Head Start, with the Department of Education taking over administration
in 2005. Please provide the specific evidence available that indicates
that the Head Start program would better achieve its goals under the
stewardship of the Department of Education and therefore support this
proposed transfer?
Answer. What I can assure you is that as long as Head Start is in
the Department of Health and Human Services, I am going to do
everything I possibly can to improve it an make it better.
Over the past two years we have increased our efforts to help Head
Start programs enhance school readiness and the development of early
literacy skills. In April 2002, the President announced his Good Start/
Grow Smart initiative which is designed to assure that every Head Start
teacher has the training skills they will need to provide Head Start
children the early literacy, language, and numeracy skills they will
need to be successful in school. The Strategic Teacher Education
Program, knows as STEP, launched last summer, was designed to ensure
that every Head Start program and every classroom teacher has a
fundamental knowledge of early development and literacy, and of state-
of-the-art early literacy teaching techniques. Good Start, Grow Smart
calls for not only the improvement and strengthening of Head Start
through intense, large-scale efforts in the areas of early language and
literacy, but also for a method to track the results of this effort.
This fall we will begin implementing the Congressionally mandated
assessments of the school readiness of all the four-year old children
in Head Start.
Question. What specific actions are being taken by either
Department related to this transition year?
Answer. Under the proposal to transfer Head Start to the Department
of Education, fiscal year 2004 would be a transition and planning year
with implementation in fiscal year 2005. An Interagency Task Force was
created in 2001 to consider issues related to the transfer. However,
our Department is currently focusing its main efforts on the existing
fiscal year 2003 priorities, such as improving early literacy skills in
Head Start and developing a national reporting system to better assess
child outcomes. This will create a stronger program and we anticipate
improvements will continue, should the administration of Head Start be
transferred. We are prepared to do the necessary transition planning in
fiscal year 2004.
head start faces and impact study
Question. Mr. Secretary, in your prepared statement for testimony
before this subcommittee on March 19, 2003, you indicated that:
``Children in Head Start enter school further ahead than other
economically disadvantaged children. But unfortunately--even after 30
years--Head Start children do not enter school at the same level as
more economically advantaged children.'' This subcommittee has
allocated substantial resources for HHS to carry out evaluations of the
Head Start program, including FACES and the National Head Start Impact
Study. Please provide the subcommittee with a summary of the latest
school readiness-related, program quality, and child development
findings from the FACES evaluation, as well as a status report on
progress made related to the Impact Study.
Answer. The Head Start Family and Child Experiences Survey (FACES)
is an ongoing, longitudinal study of Head Start program quality and
child outcomes, which currently has two nationally representative
cohorts (1997, 2000) and plans for a third. While it does not have a
control group of children who are not in Head Start, it does provide
important information on program quality over time, and child outcomes
from program entry through kindergarten follow-up. FACES uses a sample
of classrooms, children, and families that is scientifically
representative of all Head Start programs. Child outcomes can be
compared with national averages for children of all income levels on a
range of standardized assessments. From FACES we find:
The average Head Start classroom is of ``good'' quality as an early
childhood learning environment, consistently over several years of
measurement. On the Early Childhood Environment Rating Scale (ECERS), a
widely used and well-respected instrument for evaluating quality of
early childhood programs, scores can range from 1 (meaning
``inadequate'') to 7 (meaning ``excellent''). In both FACES 1997 and
FACES 2000, typical Head Start classrooms received ratings just below
5, or ``good.''
Few classrooms scored below minimal quality. In FACES 1997, no Head
Start classroom in the national sample received a mean ECERS score in
the ``inadequate'' range (1 or 2). In 2000, a few classrooms (two-
percent) scored in that range.
The use of integrated curriculum is linked to program quality. In
FACES 2000, Head Start programs using the two most widely used
integrated early childhood curricula--Creative Curriculum (39 percent)
and High Scope (20 percent)--were found to have higher average ECERS
language and overall quality factor scores than programs that used
``other'' curricula.
In addition, FACES 2000 has found that Head Start teachers have
higher levels of educational attainment than teachers studied in 1997-
1998.
The FACES study allows comparisons of Head Start scores with
national averages for children of all income levels. Children enter
Head Start with vocabulary scores that are at about the 16th percentile
nationally. They made significant progress over the Head Start year, in
both the 1997 and 2000 cohorts. For example, English proficient
children in FACES 2000 gained 3.8 points in standard scores from 85.3
to 89.1. Methodologists have called such gains ``educationally
meaningful'' and they are greater than the gains made by the typical
child of this age, regardless of income level. However, they do not
raise Head Start children to the national average in vocabulary scores.
Adding in children who were not proficient in English on entry into the
program, the average standard score in vocabulary changes from 81.4 to
85.7, representing a gain of 4.3 standard score points over the 2000-
2001 year.
In another important literacy area, pre-writing, Head Start
children make significant gains relative to national norms (in FACES
2000, 85.1 to 87.1), but are still below national averages. This gain
in early writing is slightly smaller than that seen in FACES 1997,
although still significant.
In FACES 2000, Head Start children are scoring higher on
assessments of letter recognition and book knowledge, areas in which
they lagged in 1997-1998. First, Head Start children in FACES 2000 are
making more progress in the area of letter recognition than they did in
1997-1998. Their scores meant that children learned the equivalent of 5
additional letters in Head Start and knew an average of 9 letters at
the end of the program year. In relation to national norms on the
Letter-Word sub-test, Head Start children advanced about as much as the
typical preschool-age child, and performed better than the 1997 cohort
but still remained below the national norm.
Second, Head Start children are performing better in the area of
book knowledge. Book and print concepts do not have national norms
available, but in FACES 1997, children did not show advances in this
type of knowledge from fall to spring. By contrast, in FACES 2000, mean
scores showed a significant gain, from 1.61 in the fall to 2.46 in the
spring.
In addition, Head Start children showed growth in social skills and
reduction in hyperactive behavior during the Head Start year, according
to teacher ratings of behavior. Behavior in Head Start is a predictor
of the child's adjustment and performance in early elementary school.
Children whose teachers rated them higher on social skills at the end
of Head Start were also rated higher by Kindergarten teachers. Children
whose teachers rated them higher on social skills and lower on behavior
problems also scored better on cognitive assessments at the end of
Kindergarten, even when their Head Start assessments were taken into
account.
The Head Start Impact Study is a longitudinal study involving
approximately 5,000 three- and four-year old children across 75
nationally representative grantee/delegate agencies (in communities
where there are more eligible children and families than can be served
by the program). The participating children have been randomly assigned
to either a Head Start group (that receives Head Start program
services) or a control group (that does not receive Head Start services
but may enroll in other available services selected by their parents or
be cared for at home). Every effort was made to minimize the burden on
individual programs and not to significantly change typical enrollment
and recruitment procedures.
Children enrolled in Early Head Start, Migrant Head Start, and
programs operated by Tribal organizations, as well as those considered
extremely new (i.e., in operation approximately less than 2 years), and
those considered severely out of compliance were not included in the
study.
Great care was taken to include only programs that were not able to
serve all of the eligible children in their community. It was important
to have a sufficient number of unserved, eligible children available
who could be randomly assigned to a control group, without causing any
fewer children to be served by the program than would otherwise be the
case. These ``saturation'' determinations were based on grantee/
delegate agencies' own reports of enrollment levels in the fall of
2001, along with other available information.
Data collection began in the fall of 2002 and is scheduled to
continue through 2006, following children through the spring of their
first grade year. It includes twice yearly in-person interviews with
parents, in-person child assessments, annual surveys with care
providers and teachers, direct observations of the quality of different
care settings, and teacher ratings of children. Data collection will
include:
--Individual child data in areas related to school readiness, such as
physical well-being and motor development, social and emotional
development, approaches to learning, language usage and
emerging literacy, cognition and general knowledge;
--Information pertaining to parenting practices, family resources and
risk factors, demographic and socio-economic data, and family
structure, including parents' descriptions of the types of
literacy activities they engage in with children at home;
--Information on structure, process, and quality of Head Start, child
care, and school settings through first grade, including
teachers' reports on their credentials and experience. Trained
observers will assess the quality of different care settings,
including assessments of classroom resources and instructional
practices; and
--Community level data relating to the availability and means of
formal and informal family support services.
An interim report is scheduled for September 2003 and the final
report in December 2006.
early learning fund
Question. The Performance Assessment Rating Tool for the Head Start
program, stated that Head Start is not well coordinated with other
early education and care programs. However, the Administration has once
again proposed to eliminate funding for the Early Learning Fund, a
program that seeks to remove barriers to the provision of an accessible
system of early childhood learning programs in communities throughout
the United States and facilitate the development of community-based
systems of collaborative service delivery models characterized by
resource sharing, linkages between appropriate supports, and local
planning for services. Why does the Administration oppose funding for
this program, when it could help states and local communities meet the
stated goals of coordination, program improvement, and early care and
education services?
Answer. No funds are being requested in fiscal year 2004 for the
Early Learning Opportunities Program because the fiscal year 2004
budget provides funding for similar activities in the Department of
Education through the Early Reading First program and the Early
Childhood Educator Professional Development Grants.
compassion capital fund
Question. On December 12, 2002, I was in Philadelphia with
President Bush for the White House Conference on Faith-based and
Community Initiatives. It was an appropriate setting, as members of the
Philadelphia community, in particular Public/Private Ventures, have
been leaders in the area of faith-based and community initiatives.
During his remarks, President Bush highlighted the Amachi program run
by Public/Private Ventures, which is serving as the model for the
Mentoring Children of Prisoners proposal. As you know, this
subcommittee has been very supportive of the faith-based agenda, and
just last year, funding for authorized programs received an increase of
almost 50 percent. Can you provide the subcommittee with an update on
the early lessons learned through grant funding provided by the
compassion capital fund, and explain how these lessons are informing
planning and implementation for the mentoring program and the
President's new substance abuse voucher program, as well as the broader
issue of providing an appropriate opportunity for faith and small
community based programs to compete for grants programs administered by
your Department?
Answer. Although we are in the early stages of implementation for
the Compassion Capital Fund, we have already contracted with two
research and development firms to begin the necessary work toward
performance measurement. Those firms will assess best practices in
faith-based organizations through several CCF demonstration project
grantees within a sample of eight to 10 intermediary organizations.
This effort is part of a comprehensive strategy to develop measures
that will not only assess the outcomes of the program's efforts, but
will also highlight what strategies work in utilizing this group of
organizations to provide services. Using information culled from the
assessment of grantees, the contractors will develop and maintain the
National Resource Center. The National Resource Center will document
programs operated under the Compassion Capital Fund so that practices
are measured, and successes emulated or expanded. We will share our
findings and experiences across government with interested agencies and
programs, including those involved in mentoring programs and the
President's substance abuse voucher program.
The Family and Youth Services Bureau (FYSB) within the
Administration on Children and Families has been assigned the
responsibility for implementing the Mentoring Children of Prisoners
program. FYSB has developed a program announcement soliciting
applications for grant funding for the program and expects to publish
the announcement in the Federal Register early this summer. While no
funding has been obligated to date, we anticipate making all grant
awards and obligating all funding by September 30, 2003. We expect to
make awards to a wide range of eligible applicants, including community
and faith-based organizations, State and local units of government, and
Tribes.
The President's new substance abuse voucher program, Access to
Recovery, is an innovative client-based program to increase access to
substance abuse treatment. We recognize there are several pathways to
recovery. Access to Recovery will increase substance abuse treatment
capacity by allowing an individual to use Federal substance abuse
dollars to choose effective treatment organizations, including faith-
based organizations. Individuals in need of treatment will first be
assessed and then will receive a voucher to pay for an appropriate
level treatment. This program emphasizes consumer choice and will
reward treatment effectiveness.
More broadly, the department has been busy eliminating the barriers
that in the past have prevented faith-based and community-based
organizations entry into the Federal funding stream. The Compassion
Capital Fund program, for example, supports intermediary organizations
to assist faith-based and community organizations in helping faith-
based and community organizations expand their capacity to provide
needed services to the community. Intermediaries assist these small
groups in their efforts to improve effectiveness and organizational
management, access funds from diverse sources and manage those funds,
develop and train staff, expand the types and reach of social services
programs in their communities and develop promising collaboration among
organizations dedicated to social service delivery. A National Resource
Center is also being established by the Compassion Capital Fund for
small faith-based and community organizations. Other accomplishments
include making applications more user-friendly, promoting diversity in
the grant review panels, and eliminating preference points for
organizations previously awarded grants. With these efforts, and the
assistance of intermediary organizations, the Department is building a
bridge between the federal government and small faith-based and
community organizations in the provision of needed services to
distressed individuals and communities.
unaccompanied children transfer to orr
Question. Mr. Secretary, as you know, section 462 of the Homeland
Security Act of 2002 transferred the INS Unaccompanied Alien Children
program to the HHS Office of Refugee Resettlement. Please provide the
subcommittee with your plan, including timeline and budget
requirements, for appropriately implementing this provision of the law.
Answer. The UAC program was transferred from INS to the Office of
Refugee Resettlement (ORR) on March 1, 2003. Along with this transfer,
the fiscal year 2003 funding base of $34.2 million was established for
this program. Unobligated fiscal year 2003 funds in the amount of
$20.142 million were transferred from INS to ORR on February 28, 2003,
in a Determination Order. Much of the transferred balance was committed
by INS for shelter care grants and contracts for secure detention prior
to the transfer of this program to HHS. These previously existing
grants and contracts were transferred to ORR. Twenty-one full-time
positions also transferred to ORR.
Consistent with Section 462 of the Homeland Security Act and the
Flores v. Reno settlement agreement, ORR will provide care and
placement for these children in the least restrictive setting possible.
To this end, we are (1) scheduling site visits to review all existing
facilities under contract to the former INS, (2) entering into
cooperative agreements with the two agencies experienced in the refugee
unaccompanied minor program to expand shelter and foster care capacity,
and (3) developing training for all staff on the assessment of the
children and the facilities.
ORR is currently working with the Department of Homeland Security
to finalize a Memorandum of Understanding to specify roles and
responsibilities for each agency under the transfer.
The fiscal year 2004 President's Budget includes $34 million in ACF
to support the UAC program. This funding level represents an estimate
developed before the transfer had been completed. The UAC budget
request does not include costs associated with activities not
previously performed by INS, newly authorized in the Homeland Security
Act, or to reach full compliance with the Flores v. Reno settlement
agreement. We look forward to working with Congress to ensure that
adequate support is provided for the care of these children.
medicare hearings transfer
Question. What planning and transition activities are being
undertaken with SSA to ensure that a timely and smooth transition
occurs, if legislation is enacted that transfers the Medicare appeals
function effective October 1, 2003, as proposed in the President's
budget?
Answer. The Department and SSA have agreed in principle to transfer
this function currently performed by SSA's Office of Hearings and
Appeals. Negotiations over the details and timing of the transfer are
on-going. CMS is preparing a Memorandum of Agreement that will reflect
these decisions.
We can transfer the responsibility by October 1, 2003, but to
transfer the work itself would be a monumental task to accomplish. For
one thing, the existing moratorium on hiring new administrative law
judges has not been lifted. For another, CMS's fiscal year 2003 budget
did not include funding for appeals reform so they have not been able
to begin building the framework of systems and operational support that
needs to be in place before this transfer can occur. These activities
would normally require 12 to 15 months. Given the delays and costs of
the existing process, we would ideally like to have sufficient time and
resources to design a process that provides fair and timely hearings
for our Medicare beneficiaries.
health wellness
Question. Under what circumstances would you support funding a
chiropractic demonstration project on health (Wellness) enhancement
rather than merely the treatment of pain or disease?
Answer. AHRQ has supported research in the area of chiropractic
care. One study found that chiropractic care is the most commonly used
alternative therapy for back problems, and is as effective as medical
care alone for reducing disability and pain in patients with low back
pain. To date, the Agency has not supported the wellness aspect of
chiropractic care. To continue to build the evidence-base in the area
of chiropractic care, AHRQ would give research proposal(s) in this area
every consideration under its peer review process.
Question. Given the growing support for lower healthcare costs with
evidence--board wellness care. Under what circumstances would you
support projects that develop wellness models for health delivery?
Answer. Evidence on effectiveness of care should drive the
implementation of wellness models that have been shown to improve
health outcomes and quality of life. AHRQ could evaluate the results of
biomedical and behavior change research in this area.
______
Questions Submitted by Senator Tom Harkin
head start
Question. Mr. Secretary, under the Administration's Head Start
reauthorization proposal, funding for training and technical assistance
in fiscal year 2004 would be reduced by approximately $65,000,000 at
the same time that Head Start programs are being asked to implement new
child and family literacy and other school readiness activities
proposed in the Good Start/Grow Smart initiative, as well as a new
outcomes-based accountability system. Please explain specifically how
much training/technical assistance funding will be allocated to support
these initiatives, as well as identify specifically what costs will be
borne by local programs and what source(s) of funds will be available
to them to pay for related activities. In addition, what types of
training are currently being conducted by local Head Start programs
that will have to be foregone in fiscal year 2004 in order to perform
these new initiatives?
Answer. The training and technical assistance budget has grown
dramatically in the last several years when compared to the number of
children served. Since fiscal year 1990, for example, funding for
training and technical assistance has grown 300 percent, while
enrollment has increased by only 58 percent. Moreover, grantees have
received considerable training and technical assistance resources as
part of the allocation of quality improvement funds. For example,
grantees currently receive $80 million annually for training and
related costs designed to increase the number of teachers with college
degrees. Allowing the Secretary discretion to best target these funds
means that in fiscal year 2004, we will be able to serve almost 10,500
additional disadvantaged children and families in areas of the country
which have the greatest unmet need for Head Start services.
The full costs to grantees of implementing the national reporting
system will be made available to grantees from the fiscal year 2003
increase, so grantees will not need to reduce any current activities to
pay for those costs. Further, much of the early literacy training has
been and will continue to be allocated directly to grantees to cover
travel and other costs associated with this training, so again there
will not be large costs being incurred by grantees.
Grantees, in fiscal year 2004, will continue to be able to address
important T&TA issues. We will work with all of our grantees to assure
that they have adequate resources to meet their priority needs and
will, as necessary, make adjustments in the amount of T&TA resources
expended on other areas to assure that this can happen.
child care development block grant
Question. A recent report by the Southern Regional Initiative on
Child Care after interviewing administrators in 15 states and the
District of Columbia found that states and localities were
collaborating successfully with Head Start in many areas. The Child
Care and Development Block Grant currently gives states a great deal of
flexibility and they can choose to take advantage of this flexibility
to encourage collaboration by aligning their policies with Head Start
in areas such as eligibility, eligibility redetermination,
reimbursement rates, hours of care, etc. However, the report found that
the major barriers to collaboration were not related to Head Start
policies but rather were caused by state policies for subsidized child
care. How does the administration plan to provide states with the
resources necessary to improve their child care policies in order to
strengthen collaboration?
Answer. The Administration is committed to promoting collaboration
across early childhood programs. Head Start, child care, and other
programs can best meet the needs of families and children by working
together.
However, we do not believe that barriers to collaboration are
solely caused by State policies for subsidized child care. The Southern
Institute on Children and Families report found that ``respondents
generally agreed that polices were not a barrier to collaboration, but
a few State child care policies were cited as burdensome to Head Start
providers because they required programs to operate differently
(emphasis added, p.6).'' From the perspective of a child care provider
wanting to collaborate, Head Start policies might seem burdensome
because they are different from child care policies.
There are fundamental differences between the Child Care and
Development Fund (CCDF)--which awards monies to States for child care
subsidies and quality improvements--and the Head Start program. CCDF
supports parental choice by primarily giving families vouchers that
they can use with an array of providers in the private child care
market while Head Start is a single-design, center-based program
operating within prescriptive Federal parameters [Note: Early Head
Start (EHS) has a home-based option, a center-based option and a
combined option]. CCDF dollars are awarded to States while Head Start
grants go directly to local entities. As a condition of eligibility,
CCDF requires families to work or attend training or education while
Head Start does not. Head Start requires parent involvement in services
to their children, CCDF does not. Head Start focuses on serving
families below the poverty level, while CCDF concentrates on families
transitioning from or at-risk of needing public assistance (some of
whom are above poverty). These and other differences make collaboration
between the two programs a challenge, but as the Southern Institute
report found, not an insurmountable one.
Under President Bush's plan to better prepare children for
kindergarten, the Administration has proposed a statutory change that
would allow States to better coordinate early childhood programs.
States would be given the option to manage Head Start funding, allowing
them to coordinate Head Start with other preschool programs in exchange
for meeting certain accountability requirements.
Additionally, the Child Care and Head Start Bureaus are taking
steps to encourage coordination. For example:
--The Child Care Bureau (CCB) has been charged with implementing
aspects of the President's Good Start, Grow Smart initiative to
help prepare children for school. This includes working with
States to develop early learning guidelines, professional
development plans, and collaboration plans. CCB's technical
assistance effort, including a recent series of regional
planning workshops, is designed to meet the needs of the entire
array of child care settings and providers and to encourage
collaboration across programs.
--The Child Care and Head Start Bureaus jointly fund the Quality in
Linking Together (QUILT) technical assistance initiative to
support full-day, full-year partnerships among childcare, Head
Start, prekindergarten, and other early education programs.
QUILT provides training, on-site consultation, written
materials, and a website of resources (www.quilt.org), and is
particularly adept at strategies to blend or braid funding.
--The Child Care and Head Start Bureaus encourage collaboration
between Early Head Start grantees and infant/toddler child care
providers, for example, by sponsoring joint training
institutes. The Child Care Bureau's new National Infant and
Toddler Child Care Initiative will provide technical assistance
and consultation to help teams of State stakeholders achieve
system-wide improvement in infant and toddler care.
Question. Mr. Secretary, in your prepared statement for your
Department's budget hearing on March 19, 2003, with respect to Welfare
Reform, you wrote: ``we are committed to working with both the House
and Senate to ensure legislation moves quickly and is consistent with
the President's budget.'' Before the Senate Committee on Finance, you
stated your support for additional child care funding in fiscal year
2004. Given that Senate Budget resolution assumes a discretionary
spending increase in the Child Care Development Block Grant of $214
million, while the President requested level funding, and the
resolution assumes a mandatory spending increase in the Child Care
Development Block Grant of $200 million, will the Administration put
forth a budget amendment consistent with these proposals? If not, does
the Administration support these increased resources and will it
propose appropriate offsets?
Answer. The Administration would support increased child care
funding, such as proposed in the House-passed TANF reauthorization bill
(H.R. 4), as it is accompanied by strengthened TANF work requirements
and improvements to the overall TANF program, and is accommodated
within the context of the overall budget.
independent living voucher program
Question. Mr. Secretary, I applaud the Administration's awareness
of the unique circumstances faced by individuals who will age out of
foster care, and its goal to help improve upon this situation with the
new Independent Living Voucher program. As you are aware, the Congress
provided approximately $42 million in the Department of Health and
Human Services Appropriations Act, 2003 to support this new program.
Please explain your plan for implementing this new program,
specifically how federal funds will be used efficiently and effectively
in conjunction with the base Independent Living program and other
programs and nonfederal funding streams to better serve the needs such
individuals.
Answer. As you mentioned, several purposes of the base Chafee
Foster Care Independent Living Program (CFCIP) focus on services and
supports to improve the educational outcomes for individuals aging out
of foster care. A recent survey indicates States are providing a wide
range of services to ensure that youth will stay in and complete high
school in order to be eligible for the newly available post secondary
education and training vouchers. These services include tutoring,
remedial instruction, the purchase of books, equipment, supplies and
school related travel and transportation.
Presently, we are developing guidance to the States to direct the
effective implementation of the Education and Training Voucher program
(ETV). The guidance requires States to submit an application amending
and expanding the base CFCIP plan, specifically the educational
assistance component. This application requires States to describe how
they will implement the new voucher program and its required
conditions, including strengthening the educational activities already
in place.
States are also being encouraged to coordinate their program with
other appropriate education, training and dropout prevention programs.
These programs include, but are not limited to, the Department of
Education's Upward Bound program, the Department of Labor's Workforce
Investment Programs for out-of-school youth, and private sector
initiatives such the Orphan Foundation of America's Scholarship program
and the Community College Foundation's Peer Counseling program in
California.
Another way we hope to ensure efficiency is by encouraging States
to work with the student financial offices of educational and training
institutions to certify an individual's eligibility for the voucher
program. In the guidance, we specifically reference the Free
Application for Student Financial Assistance (FASFA) as a resource to
assist jurisdictions in certifying eligibility for the ETV program.
States are encouraged to use the FASFA as it may be a helpful tool for
identifying youth eligible for the ETV program as a part of the case
planning activities specifically related to preparation for post
secondary education and training; and as a method for certifying the
youth's financial status.
______
Question Submitted by Senator Ernest F. Hollings
stroke
Question. Mr. Secretary, I would like to spend a minute discussing
your agency's stroke-related activities. As you know, stroke is the
third leading cause of death in United States and a major cause of
permanent disability. My home state of South Carolina falls within the
group of Southeastern states known as the ``Stroke Belt'' where stroke
death rates are significantly higher than the national average. More
than half of my state falls within the ``Stroke Buckle,'' a part of the
``Stroke Belt'' where stroke death rates are twice the national
average. South Carolina is at the epicenter of an epidemic. We have the
highest stroke death rate in the nation and have held that unfortunate
distinction for the past five decades.
I noted with great interest the recent release of the CDC's the
``Atlas of Stroke Mortality: Racial, Ethnic, and Geographic Disparities
in the United States.'' The document does a great job defining the
extent of the problem but does not prescribe a solution to the.
problem. For that we need a larger portfolio at the NIH. I am concerned
given the significant impact that stroke has on the lives of so many
citizens, the NIH invests only 1 percent of its budget on stroke
research. At the encouragement of this Subcommittee, the National
Institute of Neurological Disorders and Stroke's Stroke Progress Review
Group identified critical gaps in stroke knowledge and outlined 5
research priorities and 7 resource priorities. Mr. Secretary, what can
you tell us about your plans to implement these recommendations? I
would also appreciate hearing any additional plans you may have to
alleviate and prevent stroke in the ``Stroke Belt'' and the ``Stroke
Buckle?''
Answer. NIH continues to place a high priority on stroke-related
research. The stroke program of the National Institute of Neurological
Disorders and Stroke (NINDS) ranges from basic investigation of stroke
mechanisms through large studies of risk factors and clinical trials
aimed at prevention or treatment. Interventions under investigation
besides the ``clot-buster,'' t-PA, include drugs, surgery, vitamins,
physical therapy, and psychosocial modalities. Research is also
targeted to special issues of stroke in minority populations, women,
and children, and in geographic regions such as the ``stroke belt.''
The NINDS has formed a Stroke Working Group (SWG) of Institute
Program Directors who work on stroke to implement the recommendations
of the Stroke Progress Review Group (SPRG). This group matched current
NINDS stroke activities to SPRG goals, including basic genetic studies,
research to understand the process of stroke recovery, development of
better animal models of stroke, expansion of stroke imaging research,
and development of new designs and methods for stroke clinical trials.
The NINDS Stroke Working Group continues to meet regularly to review
progress in implementing the recommendations of the SPRG, and to
discuss plans for future activities.
The NINDS already supports, or is planing, a variety of stroke
center programs that address a number of SPRG recommendations. A new
initiative, Specialized Program of Translational Research in Acute
Stroke (``SPOTRIAS'') will facilitate translation of basic research
findings into clinical practice, in settings where patients are
evaluated and treated very rapidly after the onset of their symptoms.
The intent of the SPOTRIAS is to support a collaboration of clinical
researchers from different specialties whose collective efforts will
lead to new approaches to early diagnosis and treatment of acute stroke
patients. Training and career development will be part of the SPOTRIAS
program.
Other ongoing efforts are focusing on expanding education and
training of stroke medical and research personnel, a resource priority
identified by the SPRG. Initiatives in this area include the Mentored
Clinical Scientist Development Award, Mentored Patient-Oriented
Research Career Development Award, NINDS Career Transition Award, and
the Mid-Career Investigator Award in Patient-Oriented Research.
We know the ``Stroke Belt'' is an area in the Southeastern United
States with stroke mortality rates approximately 25 percent above the
rest of the nation, and contains a region of even higher stroke
mortality (the ``Stroke Buckle''). African American stroke mortality is
50 percent higher than in whites. The NINDS has initiated several
studies to address this phenomena. The NINDS, NHLBI and NCRR are
jointly supporting a Stroke Prevention/Intervention Research Program at
Morehouse School of Medicine in Atlanta. The goals are to further
understand the etiology of stroke among rural and urban African
Americans who reside in the Stroke Belt. Based on the data obtained,
community-specific stroke prevention and intervention projects will be
crafted and evaluated. Additionally, the Institute supports a study,
``Etiology of Geographic and Racial Differences in Stroke'' in Alabama.
The role of geographic and racial differences in incidence as
contributors to the differences in mortality rates will be examined and
risk factors estimated. Also, the role of candidate genes for stroke
will be investigated. This study addresses the wide range of
hypothesized causes of the excess stroke mortality in the Southeastern
US and among African Americans, and will provide information to design
interventions to reduce the excess stroke mortality in these
populations.
______
Questions Submitted by Senator Robert C. Byrd
medicare plus choice
Question. As I hear all this rhetoric about injecting competition
and choice into Medicare to save the program, I must ask myself,
where's the competition and choice in my State? There are only two
Medicare HMOs in the whole State of West Virginia, and they enroll less
than two percent of the entire State's Medicare population. The seniors
in my State depend on a strong and viable traditional, fee-for-service
Medicare program. ``Choice'' seems to be a favorite theme of this
Administration. In the Medicare program, right now, seniors have the
choice of their individual doctor. That's what most people in West
Virginia think about when they think about choice. The last thing
seniors in my State need is a forced choice between the family doctor
they know and trust and the prescriptions drugs they need to live. Mr.
Secretary, what happens under the Administration's current deregulation
scheme, to the poorest and sickest seniors in West Virginia who are
left in a Fee-For-Service Medicare plan, without drug coverage, facing
skyrocketing premiums, and with no HMOs or private health plans coming
to their rescue?
Answer. Senator, President Bush is not about to let that happen,
and the Framework to Modernize and Improve Medicare takes steps to
ensure that all Medicare beneficiaries have access to an Enhanced
Medicare plan with meaningful prescription drug coverage.
Enhanced Medicare will be a system of PPO-style plans that will be
awarded contracts to serve entire multi-state regions. Under those
contracts, the PPOs will be required to take all beneficiaries--those
in the cities, as well as those in the rural areas. This structure will
be fundamentally different than the county-by-county contracts you are
familiar with in Medicare+Choice. This system of regional contracting
has worked successfully for TRICARE in the military health system.
That's why we believe that the regional PPO approach is right for
Medicare.
PPOs have been a growing form of health insurance and are now the
most popular type of coverage in the private market. Among individuals
with employer group coverage, 52 percent are enrollees of PPOs as of
2002. Today's workers will age into Medicare with experience with PPO
coverage. Indeed, 78 percent of large employers offer a PPO option to
pre-65 retirees.
So all Medicare beneficiaries will have the option of Traditional
Medicare or Enhanced Medicare as described above. In addition, for
those who choose to stay in Traditional Medicare, the Framework
protects them from undue premium increases. Part B premiums would
continue to be calculated as though current law were in effect.
medicare prescription drug proposal
Question. Mr. Secretary, you have repeatedly stated that the
Administration's proposal to reform Medicare is modeled after the
Federal Employees Health Benefit Plan (FEHBP), which offers several
different health plans for Federal employees. However, in States like
West Virginia, comparing Federal employees participating in the FEHBP
to Medicare beneficiaries participating in the Medicare program is like
comparing ``apples and oranges.'' The Federal employees in West
Virginia are much younger, wealthier, and healthier than the Medicare
beneficiaries in West Virginia. Medicare beneficiaries in West Virginia
are either elderly or disabled, and tend to be heavy utilizers of
costly health care services. Further, the health plans offered to
Federal employees in West Virginia through the FEHBP are all
concentrated in only small pockets of my State, the Northern and
Eastern Panhandle regions, which are less rural. There are very few
Federal health plans offered in southern West Virginia. Mr. Secretary,
can you offer an explanation as to how a Medicare prescription drug
proposal, modeled after the Federal Employees Health Benefit Plan,
would work in West Virginia?
Answer. The difference, Senator, is in how Enhanced Medicare
defines its service areas. Under Enhanced Medicare, beneficiaries could
choose to receive integrated benefits and drug coverage offered through
a FFS/PPO plan, like FEHBP or TRICARE. The plans would bid to serve one
or more of 10 multi-state regions, and by doing so they would agree to
serve the entire region, cities and rural areas alike. In addition, all
beneficiaries in a region are guaranteed access to any of the three
plans that are entrusted to serve the region. Beneficiaries who enroll
in an average-priced plan in their region would pay a premium equal to
the Part B premium in traditional Medicare. Those choosing the plan
with the low-priced bid would receive most of the savings, while those
choosing the high-priced bid would pay a supplemental premium.
Beneficiaries would pay an additional premium for drug coverage, except
for those with low incomes. New benefits in the enhanced package
include a combined deductible for Part A & B services, free preventive
benefits, and protection from high out-of-pocket medical costs.
In designing the framework, the President is looking toward other
federal programs that have successfully brought coverage to federal
workers in big city offices, to forest rangers in remote areas, and all
federal workers and their dependents in between.
prescription drug cost
Question. Mr. Secretary, according to an article in The Wall Street
Journal on February 24, 2003, it appears that taxpayers as well as
Medicaid are being significantly overcharged for prescription
medications by certain pharmaceutical companies. The article states
that ``despite a 1990 law requiring drug makers to report to Medicaid
the lowest prices they charge anyone, some big pharmaceutical companies
simply aren't doing so.'' The result is taxpayers and Medicaid are
paying more than their fair share for prescription drugs. Mr.
Secretary, I find this matter deeply troubling and wonder why the
Administration has chosen to ignore this glaring loophole in the law in
its current Medicaid proposal?
Answer. This administration has by no means ignored the
complications surrounding prescription drug pricing. In fact, the
President's budget proposes to work to work with congress to improve
the Medicaid drug rebate system. There are many means by which we can
generate program savings. We look forward to working with you to
determine the course of action that will best address the concerns of
the American taxpayer.
medicaid proposal
Question. Mr. Secretary, I am concerned that the Administration may
be trying to take advantage of the current fiscal crisis facing States
in order to sneak out of the Federal government's financial obligations
to the poor and disabled and to cap what is now a guarantee of specific
health benefits. The Administration's Medicaid proposal would
essentially eliminate the federal guarantee of certain health benefits
for a significant portion of the Medicaid population. Why is the
Administration dismantling this health care safety net at a time when
many Americans are vulnerable from the struggling economy and rising
health care costs?
Answer. The Administration has proposed State Health Care
Partnership Allotments to deal directly with the problems of coverage
being eliminated due to constrained State budgets. States can currently
eliminate coverage for non-mandatory populations and many states have
already made cuts. We are not eliminating any guarantees that currently
exist.
The Medicaid reform package gives States alternatives to merely
cutting the rolls. Instead of solving budgetary dilemmas by cutting
whole populations, the allotment model would allow States to
strategically construct services in ways that most ably address the
specific needs of their unique Medicaid and SCHIP populations.
Once again let me stress, mandatory services for mandatory
populations will not be affected by the reform package. We are not
allowing States to cut any populations they can't already cut through
State Plan Amendments. We hope that we have given States a more humane
alternative to eliminating benefits for needy Americans.
scientific advisory committee
Question. Mr. Secretary, I found it extremely disturbing to read on
the front page of The Washington Post last Fall that the Bush
Administration has been quietly overhauling the 250 scientific advisory
committees that guide the Department of Health and Human Services (HHS)
on a wide range of health issues. I am concerned that the Presidents
message to scientific advisory committees within his Administration
reads: either you're with us or you're against us. While the
Administration talks about supporting programs that are shown by
science to be effective, at the same time, the Administration is
reshuffling the independent panels and stacking them with handpicked,
partisan choices. Mr. Secretary, why should the general public have any
confidence in the recommendations of these advisory panels when their
independence and objectivity appear to have been compromised?
Answer. There are over 250 Secretarial Advisory Committees at the
Department of Health and Human Services. By Congressional charge the
Office of the Secretary is responsible for making appointments to these
committees. Vacancies on these committees occur regularly for a variety
of reasons including resignations and expiring terms. We are also
charged with maintaining the charters of these committees and from time
to time we must update charters as they also expire. As a result, we
will make hundred of appointments in the course of any year and update
several charters in the same time frame.
Let me assure you that this Department fully supports and
understands the need to select members for scientific advisory
committees who are the best suited to promote health in our nation.
Under the General Services Administration manual's chapter on Advisory
Committee Management, we are required to adhere to certain policies.
For example, we must ensure that the nomination, selection, and
appointment process results in selections that are balanced in terms of
views represented. I am confident that we have in place procedures to
ensure that we select members who are not only experts, but whom we
believe will provide objective assessments on important scientific
matters without prejudice or prejudgment.
SUBCOMMITTEE RECESS
Senator Specter. Thank you all very much. The subcommittee
will stand in recess to reconvene at 9:30 a.m., Thursday, March
27, in room SD-192. At that time we will hear testimony from
the Honorable Roderick Paige, Secretary, Department of
Education.
[Whereupon, at 10:27 a.m., Wednesday, March 19, the
subcommittee was recessed, to reconvene at 9:30 a.m., Thursday,
March 27.]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2004
----------
THURSDAY, MARCH 27, 2003
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:04 a.m., in room SD-138, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Stevens, Harkin, Murray, and
Landrieu.
DEPARTMENT OF EDUCATION
Office of the Secretary
STATEMENT OF HON. RODERICK PAIGE, SECRETARY OF
EDUCATION
ACCOMPANIED BY WILLIAM HANSEN, DEPUTY SECRETARY OF EDUCATION
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. Good morning, ladies and gentlemen. The
Appropriations Subcommittee on Labor, Health, Human Services,
and Education will now proceed.
This morning we will hear from the distinguished Secretary
of Education, the Honorable Rod Paige, who will present the
administration's budget, which is $53.1 billion, an increase of
$26 million over the fiscal year 2003 program level. That is an
increase, obviously, of a minor proportion, less than the
inflation rate.
PROGRAM REDUCTIONS AND ELIMINATIONS
As we take a look at some of the programs which are being
cut or eliminated, they pose some real issues for the
subcommittee--the reduction in GEAR UP, the Rural Education
program cut by $167 million, which would, I am told, eliminate
the program; a significant cut of $326 million for vocational
education programs; and a problem which confronts this
subcommittee is that the budget for education is joined in our
overall allocation with health and also labor worker safety,
which gives us a lot of very hard choices.
We have advanced the time of this hearing to 9 o'clock, so
that we could be available to meet with the full committee,
which is going to hear testimony from the Secretary of Defense
and the Secretary of Homeland Security at 10:00.
And I will yield now to the chairman of the full committee,
Senator Stevens, with your permission, Senator Harkin.
OPENING STATEMENT OF SENATOR TED STEVENS
Senator Stevens. Well, thank you, because I do have to
organize that other hearing with both the Homeland Security and
Defense. I do have a long statement. I would like to have it
put in the record.
Senator Specter. Without objection.
ALASKA'S REQUEST FOR FLEXIBILITY
Senator Stevens. I would like to personally ask the
Secretary about the problem of responding to Alaska's request
with regard to flexibility. We have had both the letter that
was written to you last June and then the meeting with our
Governor Frank Murkowski about the problem that we have of so
many small schools in areas where, in many cases, we are unable
to get teachers, let alone teachers' assistants; and we have
not received any indication that there is going to be any
flexibility in dealing with those issues.
RURAL EDUCATION IN ALASKA
I urge you to read my statement. I do not want to hold up
the committee. But Alaska's native population is 25 percent of
the enrollment of our schools. The bulk of it is in these small
areas, very small areas, small villages. And it is just
impossible for us to follow the bill we support, which is that
no child should be left behind, from the point of view of
getting the people that are necessary to carry it out. If we
cannot hire teachers, how can we hire teachers' assistants and
people, special people, to qualify those who are not keeping
up? And in many cases, it is a cultural language problem, where
the parents refuse to allow the children to study in English.
We do not have BIA schools. And yet we find that your
budget has reduced the funding for the two basic programs, the
Education Equity Act from $31 million to $14 million, and the
Alaskan-Native Hawaiian Institution Program from $8.2 million
to $4 million. And you also reduced the funding for the Carol
White Physical Education Program from its current level to $10
million. It was $60 million. That meant you put $10 million in
another program that is not really authorized by Congress.
Now, Mr. Secretary, some of us have taken on a lot of
responsibility around here trying to help run the Senate. And I
do not think that means we deserve any extra consideration, but
it means we should be treated as a State and as representing a
State in a way that we can get answers. I would again ask you
to come up and take a look at the villages and see the
problems. I do not think your people--your people came up, and
they did not leave the main cities. They did not go to the
villages. And our problems are in the villages. Even our small
Barrow College, the college that is there for native children,
your people ignored it entirely.
prepared statement
So I hope that by the time this markup comes, Mr. Chairman,
I am going to ask you to put some severe restrictions on the
Department of Education with regard to the use of funds unless
they pay attention to the rural areas that cannot comply with
this law.
Thank you very much.
[The statement follows:]
Prepared Statement of Senator Ted Stevens
Thank you Mr. Chairman, and I'm pleased to welcome Secretary Paige
to our subcommittee.
Mr. Secretary, I thank you for the leadership you are demonstrating
in working to ensure that no child in America is left behind in getting
an education that will prepare him or her to lead a productive life in
the 21st century.
Yours is not an easy task, especially in times like these when our
ability to provide funding for these programs is severely challenged by
the needs of homeland security and supporting our defense needs.
I do have some concerns about how your Department is responding to
our State of Alaska's need for flexibility in meeting the standards of
the ``No Child Left Behind Act.''
Last June, Alaska's education commissioner sent you a letter
requesting flexibility for our State in meeting timelines for
qualifications of teachers and teacher aides, and testing in english of
students at early ages.
To the best of my knowledge, the department has yet to receive a
written response from the Department to its request.
In January, Alaska's Governor, Frank Murkowski, met personally with
you and your senior staff to discuss the issues raised in the June 2002
letter.
I understand that the Department has taken the position that it
will not grant any waivers for the ``No Child Left Behind Act''
requirements.
I also understand that when the Department sent up a team to alaska
to ``peer review'' its proposed State plan, that the team did not
choose to accept the State's invitation to visit remote rural
communities to see just how different conditions in my State are from
those in the South 48.
Alaska has 54 school districts, with the largest 5 enrolling 70
percent of students. Thirty-nine school districts in my State each
enroll less than 1 percent of the student body.
My State has a large number of very small schools, each with only a
handful of teachers. Of 506 schools, 135 schools have fewer than 50
students and 82 enroll 25 or fewer students.
Many of these schools are located in villages not served by roads,
where the only means of transport among villages is via plane or dog
sled.
I am concerned about what my State perceives as a lack of
responsiveness by your Department to these issues.
Last year I invited you to come to Alaska and see these conditions
for yourself. Once again, I extend the same invitation.
I also ask that within the next 30 to 60 days you send appropriate
members of your staff to my State to visit representative schools in
rural Alaska and to work with Governor Murkowski's administration to
arrive at an equitable solution to these issues.
I'm also disturbed about several decreases and program eliminations
in your budget proposal.
Alaska's Native population is almost 25 percent of total enrollment
in our schools. Our State has assumed the responsibility for educating
all of its students, and we do not receive any Indian education
funding, nor do we have BIA schools.
Alaska's Native children need the resources provided under the
Alaska Native Education Equity Act to provide the extra help many of
them need to succeed in school.
Yet, for the second year in a row, your Department is proposing to
cut this funding to $14 million from its present fiscal year 2003 level
of $31 million.
In the higher education area, your budget proposes to cut funding
for the Alaska Native--Native Hawaiian Serving Institutions program
from its present level of $8.234 million to only $4 million.
You have eliminated entirely funding for the Echo Act, which
provides funding for cultural enrichment and job training activities
for our Alaska Native Heritage Center and our Inupiat Heritage Center.
All of these programs are authorized in law.
Mr. Secretary, I would like to have you share with this
subcommittee why your Department persists in slashing funding and even
eliminating programs which are desperately needed by my State's Native
people.
On another topic, the Department has also zeroed out funding for
the ``Carol M. White Physical Education for Progress'' program--also
authorized in law--from its current level of $60 million.
I am particularly disturbed by this, because you and the
administration have publicly voiced support for physical education
programs as a means of combating our epidemic of obesity among
America's children, and your budget proposes a similar initiative to be
funded at $10 million.
Mr. Secretary--what's wrong with my pep program--one that is
supported by most of the advocacy groups supporting increased emphasis
on physical fitness for kids?
Mr. Secretary, I'm also concerned over significant cuts to the
Impact Aid program, which is of great benefit to many schools in
Alaska, and I hope your staff will work with our subcommittee to
restore this important source of support to federally-impacted school
districts.
I look forward to your testimony Mr. Secretary and to your visiting
Alaska in the near future.
Senator Specter. Thank you, Senator Stevens.
Senator Harkin.
OPENING STATEMENT OF SENATOR TOM HARKIN
Senator Harkin. Thank you, Mr. Chairman. I will try to be
brief. I would also ask that my full statement be made part of
the record.
FISCAL YEAR 2004 BUDGET REDUCTIONS
I just want to associate myself with the statements of our
chairman, Senator Specter, in his opening remarks. The
President's budget would increase Education Department funding
by $26 million or .05 percent. It does not help schools meet
the requirements of No Child Left Behind.
In Iowa, it is estimated 56 percent of all the schools will
be designated next year as needing improvement under the No
Child Left Behind law. It will go up even higher in years after
that. But this budget cuts funding for the No Child Left Behind
programs by $1.2 billion from this year's level.
Now I noticed in your opening statement, you point out that
the President's budget represents more than a 25 percent
increase since 2001. Well, thanks to Congress. In spite of the
President's budget, we increased it that much. The President's
budget did not. We did here in the Congress on a bipartisan
basis. I just think that the cuts that are made in the budget
request from this year's level are really unconscionable.
The $400 million cut for 21st Century Community Learning
Centers would mean no more after-school services for 550,000
children. Surely the administration does not think kids will be
better off alone or home alone or out on the streets than in
after-school programs in school-based settings.
RURAL EDUCATION PROGRAM CUT
I also want to again repeat for emphasis' sake what the
chairman said. The $167 million cut in the Rural Education
program is really not acceptable. That zeroes out the whole
rural education fund program that we had specifically outlined.
It is important to my State of Iowa. It has never been a
partisan program, Republican or Democrat. It was authorized in
No Child Left Behind. It has broad support here. And yet the
administration wants to zero it out.
prepared statement
Mr. Secretary, again, I just repeat: This budget is totally
inadequate. And it is leaving us in a heck of a situation here
to try to correct it and get the education funding back up.
Again, as you know, I have personally a high regard for you and
respect for you. But this budget from the administration is
just unacceptable.
Thank you, Mr. Chairman.
[The statement follows:]
Prepared Statement of Senator Tom Harkin
Mr. Secretary, thank you for joining us today for this hearing. I
believe this is your third appearance before this subcommittee.
We've had some vigorous debates in the past, and maybe we'll have
another one today.
Unfortunately, once again I am disappointed in the President's
proposed budget for education. Overall, it would increase Education
Department funding by just $26 million. That's just 0.05 percent--it
doesn't even cover inflation.
The President's budget is far from adequate to help schools meet
the requirements of the No Child Left Behind Act.
In Iowa, many parents and educators are just now coming to grips
with the fact that next year, an estimated 56 percent of all the
schools in the state will be designated as ``needing improvement''
under this new law. The numbers will go up even higher in the years
after that.
But what does this budget do? It cuts funding for No Child Left
Behind programs by $1.2 billion from this year's level. That is
unconscionable.
I am particularly disturbed by the proposed $400 million cut for
21st Century Community Learning Centers. This cut would mean no more
afterschool services for 550,000 children. Does this administration
really think that children will be better off at home alone or out on
the streets than in a school-based, afterschool program?
But beyond the question of funding, I'm frustrated by the
Administration's disregard for Congressional priorities when it comes
to programs like rural education, dropout prevention, and dozens of
others that the President plans to eliminate.
Take the rural education program, which is particularly important
for my state of Iowa. This is not a Democratic program or a Republican
program. It is a bipartisan program authorized in the No Child Left
Behind Act. It has broad and strong support in Congress. It helps a
group of students that are particularly at risk of being left behind.
Members from both parties understand this. And yet the
Administration wants to zero it out.
Mr. Secretary, you know I have a great deal of respect for you
personally. I know you want all children to succeed. But this budget
will not do the job. I assure you that I and others on this
subcommittee will do everything we can to increase funding for
education in the months ahead.
I look forward to hearing your statement and discussing this more
in the question-and-answer period.
Senator Specter. Senator Murray, would you care to make an
opening comment?
OPENING STATEMENT OF SENATOR PATTY MURRAY
Senator Murray. Mr. Chairman, I know we have a short amount
of time, and we want to hear from the Secretary and have a
opportunity to ask our questions. So I will submit my statement
for the record.
BUDGET CUTS AND NO CHILD LEFT BEHIND ACCOUNTABILITY
But I want to associate myself with the remarks made by
both the chairman and the ranking member. I find the
President's budget to have serious shortfalls. And I think all
of us who have been home are hearing screaming and yelling from
our States. Everyone wants to meet the accountability
requirements of No Child Left Behind, but at this point they
really believe this is an unfunded mandate that has been passed
down to them because we have not followed through with the
resources.
prepared statement
I agree that zeroing out funding for impact aid and rural
education reductions in everything from after-school programs
to safe and drug-free schools, not meeting the commitments of
Title I, all of it just puts our schools at a serious
disadvantage in trying to meet the accountability requirements
they really want to meet. They want to work with us to do that.
So I am very disconcerted by the President's budget. And I have
some questions, and I will ask them during the round.
Thank you very much.
[The statement follows:]
Prepared Statement of Senator Patty Murray
Thank you Mr. Chairman for giving us this opportunity to discuss
the Administration's fiscal year 2004 budget with Secretary Paige. And
thank you Secretary Paige for being here today.
I'd like to remind everyone of the context in which we sit here
today. The Administration has sent us a budget that proposes a $1.2
billion cut in funding for the No Child Left Behind Act, while funding
a $1.4 trillion tax cut. This budget request--with its meager
investment in funding for the No Child Left Behind Act--fails our
children and fails their future. It fails the very promise that the
President made to students when he signed the No Child Left Behind Act
just two years ago.
Leaving no child behind is a noble goal, and with bipartisan
support, we passed an education reform bill to meet that goal. But this
budget does not come close to meeting the needs of our students or
keeping the promises of that legislation. When we passed the No Child
Left Behind Act, we passed it based on two commitments. First, we would
hold schools accountable for their progress, and second, we would
provide schools with the resources to meet those new requirements.
We're certainly keeping the first part of that bargain. But this
budget suggests that the Administration does not intend to keep the
second part of their promise. Why is this Administration willing to
keep the commitment to identify schools in need of improvement, but
unwilling to keep the commitment to provide the resources for those
schools to improve?
Let me highlight a few of the ways this budget shortchanges
America's students. This budget could cut funds for after school
programs for more than 500,000 latch key children. That's on top of the
more than 6 million latch key children we're already not serving. It
leaves 6 million of our most disadvantaged students behind by not
providing the Title I funding they need. Among other things, it also
falls short on funding for teacher quality and class size reduction,
for English language acquisition, for Impact Aid for Safe and Drug Free
Schools, and for rural education.
At a time when we are demanding more than ever from our students,
teachers and schools, this budget does not invest more in them. At the
Department of Education you are no doubt getting a bird's eye view of
how hard our states are struggling to implement this law. Everywhere I
go in my home state of Washington I hear from educators who believe in
the goals of the No Child Left Behind Act. They're willing to work as
hard as they have to do to make it work. But they can't do that without
resources. That's why the bill promised significant increases in
resources.
Leaving no child behind means making serious investments in things
like Title, IDEA, smaller classes, teacher quality and after school
programs. These are the type of real reforms that will make a
difference for our students, and these are the reforms that are
underfunded or cut in President Bush's proposal.
Senator Specter. Senator Landrieu, would you care to make
an opening statement?
OPENING STATEMENT OF SENATOR MARY LANDRIEU
Senator Landrieu. Yes, I do. Thank you.
And welcome, Mr. Secretary.
Secretary Paige. Thank you.
BUDGET REDUCTIONS AND NO CHILD LEFT BEHIND
Senator Landrieu. I look forward to continuing to work with
you as we fashion a stronger accountability program for our
Nation's schools. But just a note: I associate myself with the
remarks previously made. I want to go on record as saying that
the President's budget is wholly inadequate to support the
commitment that he made personally to the schools in Louisiana
and to the schools throughout our Nation. He reneged, in my
opinion, on his promise to fund the Leave No Child Behind Act.
I think it is the height of hypocrisy for him to open his
budget with the quote ``The time for excuse-making has come to
an end.'' The President himself continues to make excuses to
this Congress about why he cannot find the money to meet the
commitment that he made specifically to Title I and to Special
Education.
There was no, to my knowledge, misunderstanding in these
negotiations. I was in the room when the negotiations were
made. It was very, very clear in the negotiations made on Leave
No Child Behind that Congress would adopt the testing
requirements and the President would step forward with the
funding. Well, he reneged on this promise. He continues to make
excuses and I think it is a shame.
LOUISIANA ACCOUNTABILITY SYSTEM
Second, I want to say that there are five States in this
Union, Louisiana being one of them, that have an extraordinary
accountability system that was in place long before the one
that we designed went into effect. My superintendents and my
principals have been operating this system with extremely good
results. I am told the current Federal law is in some ways in
conflict with their efforts.
Louisiana is not asking, Mr. Chairman, for lower standards,
we are asking for using common sense. I know the Secretary is
aware of Louisiana's situation and I would like you to
personally examine our unique situation and try to respond as
soon as possible.
[TThe information follows:]
Louisiana State Accountability Plan Under No Child Left Behind
Louisiana's plan for an accountability system, which both builds
upon the State's existing accountability system and responds to the No
Child Left Behind (NCLB) Act requirements, has been approved by the
U.S. Department of Education. Louisiana is the 11th State to gain
approval of its State accountability plan.
Included below is the April 17, 2003 U.S. Department of Education
Press Release announcing the approval of Louisiana's plan. Information
on the No Child Left Behind Act may be found at the No Child Left
Behind website: /http://www.nclb.gov/. A copy of the Louisiana State
Accountability Plan, along with other approved State plans, may be
found at the Ed website: http://www.ed.gov/offices/OESE/CFP/csas/
index.html.
paige approves louisiana state accountability plan under no child left
behind
Baton Rouge, La.--Louisiana has completed work on a plan for a
strong state accountability system aligned with the No Child Left
Behind Act (NCLB) of 2001, U.S. Secretary of Education Rod Paige
announced today.
Paige made the announcement today during a visit to the state
capitol where he was joined by Governor Mike Foster and State
Superintendent Cecil Picard.
``Louisiana has built upon its existing state accountability
system to produce an even stronger and more cohesive plan to benefit
every child in the state,'' said Paige. ``I congratulate Superintendent
Picard and Governor Foster for this step forward. Louisiana has a
distinguished history of education reform and cutting-edge work in
assessment and accountability. With these improved accountability
provisions and an established record of reform, Louisiana is firmly on
the path to ensuring that no child is left behind.''
Under NCLB's strong accountability provisions, states must describe
how they will close the achievement gap and make sure all students,
including disadvantaged students, achieve academic proficiency. In
addition, they must produce annual state and school district report
cards that inform parents and communities about state and school
progress. Schools that do not make progress must provide supplemental
services such as free tutoring or after-school assistance, take
corrective actions and--if still not making adequate yearly progress
after five years--must make dramatic changes in the way they operate.
Louisiana is the 11th state to gain approval. Other states whose
plans have been approved include Colorado, Delaware, Indiana, Kansas,
Maryland, Massachusetts, Mississippi, New York, Ohio and West Virginia.
No Child Left Behind is the landmark education reform law designed
to change the culture of America's schools by closing the achievement
gap, offering more flexibility, giving parents more options and
teaching students, based on what works. Foremost among the four key
principles is an insistence on stronger accountability for results. To
achieve that, states must develop strong accountability systems or
improve those already in place, establish high standards and hold all
children to the same standards. They also must provide instruction by
highly qualified teachers that results in steady progress and,
ultimately, proficiency for all students by the 2013-14 school year.
Secretary Paige recently asserted that the new law aims to correct
the ``previous and pervasive separate and unequal education systems
that taught only some students well while the rest--mostly poor and
mostly minority--floundered or flunked out.''
All states submitted draft accountability plans to the U.S.
Department of Education by the Jan. 31 deadline. Following an initial
review and technical assistance, if needed, the next step is on-site
peer review of each state's proposed accountability plan. Teams of
three peer reviewers--independent, nonfederal education policy, reform
or statistical experts--conduct each peer review. Following a review of
the team's consensus report, the department provides feedback to the
state and works to resolve any outstanding issues. Ultimately, Paige
approves the state plan, as he did today.
To date, 47 states and the District of Columbia and Puerto Rico
have had peer reviews of their accountability plans. Additionally, the
senior staff of the Department of Education has finished meeting with
education officials from the states to discuss the specifics of their
plans and the unique challenges and issues in each state.
Despite all the priorities competing for our tax dollars, President
Bush's budget boosts federal education funding to $53.1 billion--an $11
billion increase since the president took office. Louisiana alone will
receive more than $914 million, including $385 million to implement
NCLB. If the president's budget is approved, federal education funding
for Louisiana will have gone up $166 million since he took office.
Louisiana's plan will be posted online in the coming days at:
http://www.ed.gov/offices/OESE/CFP/csas/index.html.
For more information about the No Child Left Behind Act, go to
www.nochildleftbehind.gov.
STATE ACCOUNTABILITY PLANS UNDER NCLB
Senator Specter. Senator Landrieu, could you conclude your
opening statement?
Senator Landrieu. Yes, I will.
The reason, Mr. Chairman, I raise this is because this
trend could be quite discouraging to the other States. If the
five States that are moving forward so aggressively are
discouraged from their efforts, then I fear that all the other
States will be discouraged and we will be defeating our
purpose.
prepared statement
I would end my remarks by saying: The time for excuses is
over. The President and his administration should be the ones
that stop making excuses and be a good example for everyone
else.
Thank you.
[The statement follows:]
Prepared Statement of Senator Mary Landrieu
Thank you, Mr. Chairman. Mr. Secretary, thank you for being here
this morning. As evidenced by my work in passing the No Child Left
Behind Act, I believe wholeheartedly in this law's founding principles:
accountability for results, flexibility and local control and the
targeting of resources to the school districts, who because of a lack
of local revenues, are most in need of federal assistance. The State of
Louisiana is proud to be a leader in the effort to hold schools and
districts accountable for performance. In fact, a nationally renowned
publication, Education Week, recently singled out our statewide
accountability system as being amongst the best in the Nation. I remain
hopeful that accommodations can be made by your department to allow
this success to continue.
I would like to begin my comments here this morning with a quote
from the speech that President Bush delivered on January 8, 2003, the
day he signed the NCLB Act into law. He said, ``the time for excuse
making has come to an end.'' The President is right, we can no longer
allow excuses to stand in the way of all of our children receiving a
high quality education. The future of our National economy is dependent
on our ability to replace excuses with results. But what I think may be
lost in the translation, is that the time for excuse making has come to
an end for us all. It is no longer appropriate for the federal
government to excuse themselves from their responsibility to America's
public school system.
Mr. Secretary, as you know there were a lot of things written into
to law by the No Child Left Behind Act. I would like to call your
attention to Section 1002 of Title I of this bill. It is here that we
made the commitment to increase Title I by $2.5 billion a year for the
next six years. In addition, in Section 4206, of this bill we carefully
laid out the funding for the 21st Century After School program. In both
cases, the amount of the increases were the result of a carefully
constructed compromise between the White House and members of Congress
who felt that reform and resources for reform must go hand in hand.
Despite this, the President's budget only calls for an $650 million
increase over last year for Title I and perhaps even more shocking,
calls for a reduction of $400 million in after school. By doing this,
the President, in essence, excuses himself from the requirements of
these sections of the NCLB act while at the same time insisting that
States, locals and schools be bound to all other requirements of this
bill.
In addition, the President insisted that all new programs,
particularly in reading, be research based programs and then excuses
himself from the federal commitment made to provide the funding to
promote this research and best practices through programs such as the
Comprehensive Regional Assistance Centers and the Eisenhower Regional
Math and Science Consortia. In my state of Louisiana, these programs
are crucial to our ability to translate research into effective
practice. The rationale behind these cuts, I am told, is that States
are allowed to use their limited Title I dollars to fund research and
best practices at the local level and it is the view of this
Administration that the states are better suited than Universities and
Regional Academic Consortia to engage in this practice. Not only does
this policy add to the burden on states to choose between the many
needs of limited Title I funds but it also wrongly assumes that states
are better equipped to perform this function.
The most disturbing excuse of all, however, is that these smaller
than promised increases and cuts are the consequence of a deficit
budget and the costs of the war. True, these efforts will require the
majority of our attention and resources. Yet, while the President is
saying that his recommended increase are all our current fiscal status
will allow he is at the same time able to find the resources to fund
$100 million mentoring program, $75 million school choice demonstration
program and a $2,500 tuition tax credit for children who transfer to a
higher performing schools. While each of these programs may be
worthwhile, I can't help but wonder if it is appropriate for us to be
spending our precious resources to give a few students the option to
attend a better school instead of funding the reform necessary to give
all students the opportunity to succeed.
Mr. Secretary, there are a lot of good things in this budget, but
there are also a lot of excuses. I hope that we can work together to
make the targeted investments necessary to provide the high quality
education our children need and deserve.
Senator Specter. It is not customary to have anybody but
the chairman and ranking make an opening statement. But in view
of the limited number of people here, I try to extend the
courtesy. But they have to be brief in the context where we are
having another hearing at 10 o'clock.
Mr. Secretary, the floor is yours.
SUMMARY STATEMENT OF HON. RODERICK PAIGE
Secretary Paige. I will be very brief, Mr. Chairman. And
thank you so much for this opportunity to come. Ladies and
gentlemen, thank you. I have just a brief statement here.
In total, the President's budget demonstrates his ongoing
substantial commitment to supporting educational excellence and
achievement. More importantly, it reaffirms that the Federal
support for education is about more than money. It is about
reform through high standards and through leadership and
through the use of proven education methods. Only through the
combination of these resources, with effective leadership
exemplified in the President's No Child Left Behind initiative,
can America's children and adults benefit.
prepared statement
I will end this by asking that you recognize that the
President's 2004 budget request is somewhat unusual in that it
was developed before the Congress completed its work on the
2003 appropriations. The request for the Department of
Education reflects the administration's relative priorities at
that time within the overall 2004 discretionary totals. We are
prepared to work with the Congress to adjust some of these
priorities in light of the 2003 appropriations, as long as the
overall discretionary appropriations do not exceed the total of
the President's budget.
Mr. Chairman, with that abbreviated statement in vieu of
the time, I end my statement.
[The statement follows:]
Prepared Statement of Hon. Roderick Paige
Mr. Chairman and Members of the Committee: Thank you for this
opportunity to testify on behalf of President Bush's 2004 Budget for
the Department of Education. I am proud to appear before you today,
discussing the many ways that President Bush's 2004 Budget and other
initiatives support educational opportunity for American children and
adults.
As you know, earlier this year we celebrated the first anniversary
of the No Child Left Behind Act of 2001, which President Bush signed
into law on January 8, 2002. State officials, administrators, and
teachers across the country now are working hard to strengthen their
accountability systems, identify research-based strategies for
improving student achievement, and offer new choices to parents whose
children attend low-performing schools.
The President's budget seeks $53.1 billion for Department of
Education programs in 2004. That represents more than a 25 percent
increase since 2001, and a 130 percent increase in Federal education
funding since fiscal year 1996. Key requests for the cornerstones of
the Federal role in education include:
--$12.4 billion for Title I, a 41 percent increase since the passage
of No Child Left Behind;
--$9.5 billion for IDEA grants to States, a 50 percent increase since
he was elected President; and
--$12.7 billion for Pell grants, for a record 4.9 million students.
In addition to discretionary spending, the President's budget
provides significant mandatory support for education. The President
seeks additional loan forgiveness for teachers in high-demand
disciplines. He also seeks changes in the tax code to improve
education. As you will recall, the President backs the CRAYOLA credit
for teachers, allowing them a $400 above-the-line deduction for out-of-
pocket expenses. He also continues to support the changes in last
year's tax law that help students and families save for higher
education.
In total, the President's budget demonstrates his ongoing,
substantial commitment to supporting educational excellence and
achievement. More importantly, it reaffirms that Federal support for
education is about more than money. It is about reform through high
standards, leadership, and the use of proven educational methods. Only
through the combination of these resources with the effective
leadership exemplified in the President's No Child Left Behind
initiative can American children and adults benefit.
Before I go into more detail about specific areas of our request, I
want to recognize that the President's 2004 Budget request is somewhat
unusual, in that it was developed before the Congress completed its
work on the 2003 appropriation. The request for the Department of
Education reflected the Administration's relative priorities--at the
time--within the overall 2004 discretionary total. We are prepared to
work with the Congress to adjust some of these priorities, in light of
the 2003 appropriation, as long as overall discretionary appropriations
do not exceed the total in the President's budget.
implementing no child left behind
As President Bush said on the first anniversary of No Child Left
Behind, ``We can say that the work of reform is well begun.'' The
Department of Education has approved the accountability plans of five
States, and all remaining States submitted their plans on schedule at
the end of January. We will be working with these States over the next
few months to refine and complete those plans, and I am confident that
all States will be on board when the new school year begins next fall.
Now that the fiscal year 2003 appropriations bill has been completed
and signed, the Department will be able to provide States with more
reliable estimates of the Federal funding that will be available for
the coming school year.
The 2004 Budget request will help ensure that this work does not
falter, but continues until, in the President's words, ``every public
school in America is a place of high expectations and a place of
achievement.''
The request would provide $12.4 billion for Title I Grants to Local
Educational Agencies to help States and school districts turn around
low-performing schools, improve teacher quality, and increase choices
for parents. This level represents a $3.6 billion increase, or 41
percent, in Title I Grants to LEAs funding since the passage of No
Child Left Behind. The budget also provides $390 million for State
Assessment Grants to help States develop and implement--by the 2005-
2006 school year--the annual reading and math assessments in grades 3
through 8 that are integral to the strong State accountability systems
required by the new law.
We are seeking $1.05 billion for Reading First State Grants and
$100 million for Early Reading First, two programs that require State
and local educational agencies that receive funds to capitalize on
recent research findings by supporting proven methods for improving the
reading skills of young children. A $185 million request for Research,
Development, and Dissemination would build on this research base and
fund new efforts to develop proven, research-based instruction in other
subjects like mathematics.
more choices for parents
No Child Left Behind provides unprecedented choice for parents of
children in low-performing schools. To support and enhance the law's
reforms, the budget provides $75 million for a new Choice Incentive
Fund to increase the capacity of State and local districts to provide
parents, particularly low-income parents, more options for obtaining a
quality education for students in low-performing schools; $25 million
for Voluntary Public School Choice grants that would encourage States
and school districts to establish or expand statewide and interdistrict
public school choice programs; and $100 million to expand the new
credit enhancement program that will help charter schools pay for
school facilities.
improving america's teaching corps
The President believes that well-prepared teachers are essential to
ensuring that all children reach high State standards. That is why in
his budget he calls for over $4.5 billion to support our Nation's
teachers. Included in this total is $2.85 billion for Title II Teacher
Quality State Grants; more than $500 million in loan forgiveness and
teacher tax reductions; an estimated $814 million in funds supporting
improvement through Title I, Educational Technology State Grants, and
Title III professional development grants; $25 million for Troops to
Teachers; and $190 million for the high-need areas of special education
and American history.
special education and vocational rehabilitation
President Bush has demonstrated a strong commitment to improving
educational opportunities for children with disabilities, both by
requesting significant annual increases for Special Education Grants to
States and in his determination to apply the same rigorous
accountability demanded by No Child Left Behind to the upcoming
reauthorization of the Individuals with Disabilities Education Act
(IDEA). Over the next year, we will be working with Congress to renew
IDEA to strengthen accountability for results, simplify paperwork and
increase flexibility to do what works based on sound research, and
increase choice and meaningful involvement for parents.
The President also recognizes, however, that educating students
with disabilities is a special challenge for States, school districts,
and schools. This is why his budget would provide $9.5 billion for
Special Education Grants to States, the highest level of Federal
educational support ever for children with disabilities, and a $3.2
billion or 50 percent increase in Grants to States since the President
took office.
The 2004 budget also supports the reform of the Federal
Government's overlapping training and employment programs, first
proposed in last year's budget, for individuals with physical or mental
disabilities. A $2.7 billion request for Vocational Rehabilitation (VR)
State Grants would help State VR agencies increase the participation of
those individuals in the labor force while at the same time reduce
duplication and complexity in the operation of Federal training
programs.
vocational and adult education
The Administration also will be proposing fundamental changes to
vocational and adult education programs during their upcoming
reauthorizations. For Vocational Education, this means greater emphasis
on student outcomes and stronger links with high school programs,
including activities supported by the ESEA Title I program. Our request
would provide $1 billion for a new Secondary and Technical Education
State Grants program that would create a coordinated high school and
technical education improvement program in place of the current
Vocational Education State Grants program. The new program would build
on No Child Left Behind by ensuring that States and LEAs focus more
intensively on improving student outcomes, such as academic
achievement, and that students are being taught the necessary skills to
make successful transitions from high school to college and college to
the workforce.
A $584 million request for Adult Basic and Literacy Education State
Grants would support reauthorization proposals that would strengthen
accountability, require State standards for adult literacy activities
leading to high school-level proficiency, and train teachers in the use
of research-validated instructional practices.
postsecondary education--grant, loan and work-study assistance
Finally, our 2004 request would support more than $62 billion in
grant, loan, and work-study assistance to an estimated 9.2 million
postsecondary students and their families. The cornerstone of this
assistance is a $12.7 billion request for the Pell Grant program. Since
taking office, President Bush has requested an unprecedented $4.7
billion in additional funding for this critical program. The 2004
request will enable almost 4.9 million students to receive a Pell
Grant, an increase of 1 million students or 25 percent since the
President took office 2 years ago.
Our postsecondary student loan programs also continue to make
available needed assistance to millions of students and their families.
For 2004, new student loans provided under the Federal Family Education
Loans and Federal Direct Student Loans programs will grow from $44.3
billion to $47.6 billion, an increase of $3.3 billion or 7.4 percent.
And these students are borrowing at the most favorable interest rates
in the history of the student loan programs--just 4 percent. At the
same time, student loan default rates remain low, reflecting both
improved management practices and flexible repayment plans that can
accommodate student needs both before and after graduation.
loan forgiveness for math, science and special education teachers in
low-income communities
Also, the President is again asking Congress to approve his plan to
provide additional loan forgiveness for highly qualified math, science,
and special education teachers who work in low-income communities. The
President's proposal will provide up to $17,500 in loan forgiveness for
teachers in these three fields who work for 5 consecutive years in
schools that serve high poverty student populations. This is more than
three times the $5,000 in loan forgiveness now allowed for other
qualified elementary and secondary teachers serving low-income
communities. This proposal will help our neediest schools recruit and
retain highly qualified teachers in fields that have critical teacher
shortages, as well as fields that face fierce competition from the
private sector.
tax-related assistance in paying college costs
In addition to grants and loans, postsecondary students and their
families benefit from a variety of tax-related assistance in paying
college costs passed as part of President Bush's tax proposal in 2001.
Under the new tax law, families are able to make tax-free withdrawals
from pre-paid qualified State tuition savings plans, and can contribute
up to $2,000 to Education IRAs. Plus, students are eligible for up to
$4,000 in above-the-line deductions for higher education expenses. The
tax bill also eliminated the 60-month limitation on student loan
interest deductions and increased the income levels of individuals able
to claim the deduction. This change makes this tax benefit simpler to
administer and increases the affordability of student loan repayment.
Additionally, the bill extended the income exclusion for employer-
provided educational assistance and the benefit of the exclusion to
graduate level courses. Combined with other tax benefits already on the
books, over $10 billion this year in tax breaks will be provided to
working families who are struggling to meet the skyrocketing cost of
college and to students who are repaying their student loans. The
President's 2004 Budget would make the important benefits provided in
the 2001 tax law permanent.
historically black colleges and universities and hispanic-serving
institutions
Our $224 million request for the Strengthening Historically Black
Colleges and Universities program demonstrates the President's
commitment to help close achievement and attainment gaps between
minority students and other students by assisting institutions that
enroll a large proportion of minority and disadvantaged students.
Similarly, a $94 million request for Hispanic-serving Institutions
would help increase academic achievement, high school graduation,
postsecondary participation, and life-long learning among Hispanic
Americans.
Overall, the President's 2004 higher education budget proposal
further demonstrates his commitment to invest in the future of
America's neediest students at all levels of education. The substantial
funding increase we are seeking will help millions of needy families
pay for higher education and give millions of students the opportunity
to pursue their educational goals and make the most of their potential.
departmental management--clean audit
While No Child Left Behind reforms are asking States and schools to
improve their accountability in the use of education funds, we have
tried to set an example by improving our own management. Just last
month, the Department of Education received its first clean audit since
1997 and only the second in the history of the Department.
president's management agenda--``green light''
I am also proud to report that the Office of Management and Budget
has given the Department its seal of approval by giving us a ``green
light'' for our progress in improving management on all items in the
President's Management Agenda. This is especially rewarding since we
had to work our way up from the bottom on each of the initiatives,
ranging from financial management to electronic government to linking
program performance and budgeting.
program assessment rating tool
Also, in the 2004 Budget, the Administration launched the Program
Assessment Rating Tool (PART) process to rate programs according to
performance. The President's goal was to rate 20 percent of all Federal
programs in the first year. In the 2004 Budget, the Department of
Education rated 18 programs, covering $28 billion, or more than half of
its appropriation. One finding was that many programs lacked
performance information. We will work on that in the future, because
the PART scores tend to fluctuate based on the strength of data about
program success. The PART is a new process and we look forward to
increasing our ability to base budget decisions on program
effectiveness.
I believe we have a strong budget for education in fiscal year
2004, one that puts significant resources where they can do the most to
help improve the quality of educational opportunities at all levels of
the American education system. I will be happy to take any questions
you may have.
RURAL EDUCATION
Senator Specter. Well, Mr. Secretary, thank you for those
comments. The critical aspect of what you said is that you will
work with us so long as it is within the total figure. And that
is the problem, as to how to stretch the dollars to reach so
many of these programs which will have to be cut.
Where there is such a major challenge with rural education,
how can we justify the elimination of the entire program with a
$167 million cut? Rural education is important not only to
Iowa, the ranking member's State, or Kansas, but also my home
State, Pennsylvania, which has more people living in rural
Pennsylvania, 2.5 million, than any State in the Union. How can
we go back to justify that to our constituents?
Secretary Paige. Yes. Mr. Chairman, let me respond to that
by using Alaska as an example, but the same thing will be true
for many of the other rural States. And we are learning a lot
about rural States, and we are moving now to have discussions
specifically about that topic, about rural education.
The various representatives from these States have had a
chance to sit down with us, and we with them, to learn about
their idiosyncratic issues. We have learned an awful lot about
these States. And we are continuing to learn how we can be
helpful to the States. They have enlisted the help of very
capable accountability experts and are making noble efforts to
include all students in their accountability efforts.
Alaska has proposed a comprehensive accountability plan
designed to hold all schools, even small schools, accountable.
And what they are finding is a Department of Education that is
willing to serve as a partner with them to help overcome some
of these difficulties. And the same thing is true with
Nebraska.
Senator Specter. Mr. Secretary, how does accountability
bear on eliminating the funding for a program? Mr. Secretary,
would you give us a written answer there? We have a very
limited amount of time.
Secretary Paige. Absolutely. I look forward to that,
because I think there are answers. And I would like very much
to have a chance to----
Senator Specter. If you would provide it in writing, I
would appreciate it.
Secretary Paige. Absolutely. We will do that.
[The information follows:]
Elimination of Rural Education Programs
We believe that providing funds through the large formula grant
programs, coupled with flexibility in using the funds, is the most
effective way to help rural districts to ensure that their students
meet challenging State academic content and student achievement
standards. No Child Left Behind (NCLB) is intended to encourage a more
comprehensive education reform strategy responsive to specific local
needs. We believe that school districts will identify problem areas,
adopt scientifically based improvement strategies, and use the
flexibility of the NCLB Act to combine Federal, State, and local
resources to support those strategies. In this context, the important
question is not whether a specific program receives a particular level
of funding, but whether local officials make effective use of the total
resources available.
In addition, recognizing the different needs of small, rural
districts, NCLB provided those districts with greater flexibility in
their use of Federal formula funds than is available to other
districts. For example, a district eligible for the Small, Rural School
Achievement program can consolidate its formula allocations from three
different programs (Improving Teacher Quality State Grants, Educational
Technology State Grants, State Grants for Innovative Programs, and Safe
and Drug-Free Schools and Communities State Grants) to carry out
activities authorized by any of the consolidated programs. In addition,
rural districts are able to use the consolidated funds for activities
authorized under Title I, Part A program, the Title III (Language
Instruction for Limited English Proficient and Immigrant Students)
program, and 21st Century Community Learning Centers.
Unlike districts that transfer funds under the State and Local
Transferability authority, the rural flexibility authority enables
eligible districts to carry out activities under the various
authorities without having to meet separate program requirements. We
know from discussions with States that eligible districts are taking
advantage of this increased flexibility.
Rural districts not eligible for the rural flexibility authority
may use the flexibility allowed by the new State and Local
Transferability Act, which allows a district not identified for
improvement under Title I to transfer up to 50 percent of its
allocation from four different formula programs to any of those
programs or to use those funds for Title I, Part A purposes.
GEAR UP
Senator Specter. The GEAR UP Program is also cut. That is
the other end of the spectrum, moving from rural education to
inner city. The GEAR UP Program has been advanced by
Congressman Chaka Fattah on the House side, and this
subcommittee has added enormous funds to it. GEAR UP seeks to
intervene with seventh graders who come from disadvantaged
backgrounds, to provide mentoring and close monitoring of
individuals to try to work with them through the next 6 years
of their education before college and then go on to college.
It seems to me that that is exactly the kind of a program
we ought to be emphasizing, where those inner city youth are
most at risk. Now should we not be adding funds to programs
like that instead of cutting?
MENTORING INITIATIVE
Secretary Paige. Yes. And that is why the President's
mentoring initiative is such an important part of our request.
What is included is, I think, $300 million over 3 years for a
mentoring program specifically for middle school students,
where the need is greatest, and to recruit mentors from all
across the spectrum of professional people who love children
and are willing to work with them. It is one of the most
exciting mentoring programs that we have seen anyplace.
So mentoring is a great concept. In fact, we believe that
the most important determinant of a child's success or failure
is the quality of the adult relationships in their lives. And
mentoring fills that gap. So, far from not thinking it is a
good idea, we think it is a superb idea.
FLEXIBILITY OF NO CHILD LEFT BEHIND
Senator Specter. Mr. Secretary, let me move to one more
question before my time expires, because I am going to observe
the time, I will expect other members to do so as well.
Yesterday there were some representatives here, in what
they call the Creative Coalition, emphasizing education. And
the group had a number of high-powered performers. One of them
was Ron Reagan, Jr., another of whom was Fran Drescher, who
made a very impassioned plea for funding for the arts in
schools. And she was almost poetic in her characterization of
the issue, trying to get young people to love themselves
instead of loathing themselves, trying to be productive instead
of destructive.
The question is: How can we structure funds from the
Department of Education to encourage or perhaps--well,
``mandate'' is a word we do not like to use in the Federal
Government, telling people what to do in schools--but to see to
it that there is more creative work on this very critical
aspect of the educational process, which is significantly
ignored?
Secretary Paige. Yes. Mr. Chairman, I think many people
miss the power of the creativity that is unleashed by the
flexibility in the bill, the No Child Left Behind Act. It
provides an opportunity for people at the scene, the local
level, who choose to focus on arts or focus on other
activities, or to be able to use funding flexibly to support
that. The amount of funding overall is up. The flexible funding
actually is a reallocation of funds, and putting it in
localities so that it can be used by those who are on the scene
who can make the judgments on where these funds would be best
used.
There are places across our Nation that have high interest
in the arts. There are places that have interests in other
priorities. Each of these things can be met by the flexibility
in the bill. So if we just judge, make a judgment, that there
is not a category with arts in it and a large number attached
to it, we fail to focus on the fact that that possibility
exists through election by the people who are at the local
level and who are best able to make those judgments.
IMPORTANCE OF READING AND READING INSTRUCTION
Senator Specter. Is art as important as reading?
Secretary Paige. I think reading is a fundamental activity.
I think it is the one upon which all other learning is based.
And if a child fails to read and fails to read early, all of
the other activities, I think, are made much more difficult.
And that is why the President has focused so heavily on
reading. About 50 percent of our special education students are
there because they cannot read or have never been taught to
read properly. If we can conquer the reading problem
substantially, we will reduce the other problems.
Senator Specter. Senator Harkin.
Senator Harkin. Thank you, Mr. Chairman.
FISCAL YEAR 2004 BUDGET REQUEST
Mr. Secretary, in your prepared statement and also in your
verbal statement here before us this morning--let me get back
to it and read it. You said that the President's 2004 budget
request is ``somewhat unusual in that it was developed before
the Congress completed its work on the 2003 appropriation. The
request for the Department of Education reflected the
administration's relative priorities, at the time, within the
overall 2004 discretionary total.''
Secretary Paige. Yes.
Senator Harkin. You said that. It is in your statement.
Secretary Paige. Absolutely.
Senator Harkin. You also said, and I made note of this,
``We are prepared to work with Congress to adjust some of these
priorities''----
Secretary Paige. Yes.
Senator Harkin [continuing]. ``In light of the 2003
appropriation''----
Secretary Paige. yes.
Senator Harkin [continuing]. ``As long as overall
discretionary appropriations do not exceed the total in the
President's budget.''
Secretary Paige. Yes.
Senator Harkin. Well, in plain English, what you are saying
is that the President would support cutting funding for some
other Cabinet agencies to increase funding for education. Is
that right?
TOTAL EDUCATION BUDGET REQUEST
Secretary Paige. I think it would be best to characterize
my thoughts about that in this fashion: That given all of the
other competing priorities for funds, the appropriate funds to
support education would be the $53.1 billion that the President
has recommended.
ADJUSTMENTS TO FISCAL YEAR 2004 EDUCATION REQUEST
Senator Harkin. Oh. Oh, so you are not saying that you want
any--wait a minute. Let me go back to this statement. You said
that ``we would work to adjust these priorities.'' You do not
mean any more money. You say--what you have requested in the
budget is the maximum. That is what you just said just now.
Secretary Paige. Yes. What we request in the budget is our
view of the appropriate funding level for education. Some of
the categories inside the request might be higher, viewed as
having a higher priority than others. Those kinds of
adjustments are entirely possible.
Senator Harkin. Oh, I see. Let me get this straight. What
you are saying, Mr. Secretary, is that when you are talking
about adjusting some of these priorities, you are talking about
within that amount that you submitted.
Secretary Paige. Yes.
Senator Harkin. You are not saying that you could get any
more than that.
Secretary Paige. Yes. I am saying that it is our view----
Senator Harkin. That is not what your written statement
said. Your written statement said the request for the DOE----
Secretary Paige. Yes.
Senator Harkin [continuing]. ``Reflected the
administration's relative priorities, at the time, within the
overall 2004 discretionary total.''
Secretary Paige. Yes.
Senator Harkin. And you said, ``We are prepared to work
with Congress to adjust some of these priorities, as long as
overall discretionary appropriations,'' that is, total----
Secretary Paige. Yes.
Senator Harkin [continuing]. ``Do not exceed the total in
the President's budget.'' So what that says to me is that the
President, and you, are saying that you are willing to increase
funding for the Department of Education as long as you cut it
someplace else. Is that right, or that is not right?
Secretary Paige. Yes, that is exactly right. That is what
we are saying.
Senator Harkin. You are--oh. So this is different than what
you just said about 2 minutes ago.
Secretary Paige. Okay.
Senator Harkin. Let us see if we can speak to each other
here.
Secretary Paige. Okay. Let us try that.
Senator Harkin. Let us try to speak to each other.
Secretary Paige. Okay.
Senator Harkin. Are you saying that the President would be
willing to cut some funding in other Cabinet agencies to
increase funding for education?
Secretary Paige. No.
We are speaking about the $53.1 billion for education and
adjusting the priorities within it.
Senator Harkin. Oh, I see.
Secretary Paige. Yes.
Senator Harkin. The President will not support more than
$53.1 billion.
Secretary Paige. I am not speaking for the President with
regard to that statement. The statement that I am making is
that within the $53.1 billion in our budget, it is our view of
the appropriate spending level for education. And inside that
$53.1 billion, adjustments----
Senator Harkin. Well, that is not what your statement says.
Secretary Paige. Give me just a minute. Give me just a
minute.
Senator Harkin. That is not what your statement says. But
we have to figure this thing out. I am just trying to get a
handle on whether or not we might have some hope here. Is hope
alive or not?
Secretary Paige. Okay. Let me try it again. And I have some
more counsel here.
ADJUSTMENTS TO THE FISCAL YEAR 2004 EDUCATION REQUEST
Within the overall President's budget, we can work with
some adjustments in education. It might go higher than $53.1
billion for education, as long as the overall spending in the
budget does not increase.
Senator Harkin. Then back to my point: If that is the case,
then there has to be some cuts in other Cabinet agencies.
Secretary Paige. That is true.
Senator Harkin. And the President would be willing to
support that.
Secretary Paige. That is right.
Senator Harkin. Do we have any suggestions where the
President might be willing to cut other departments, so that we
can have more money for education?
Secretary Paige. We do not have those suggestions
presently.
Senator Harkin. Could we expect to get something like that
from the administration?
Secretary Paige. I am sure we can.
Senator Harkin. Well, this committee, I am sure, Mr.
Chairman, would love to have some guidance and some suggestions
from the administration, since we appropriate money for all of
the Cabinet agencies--not our subcommittee here, but the full
Appropriations Committee--about where we might cut some of the
other departments to get money for education. To me, that is
encouraging. Thank you.
Secretary Paige. Mr. Harkin, if I could, the Office of
Management and Budget has been working with us. And I think the
same way in which we worked with you on the development of the
2003 bill, when the education budget went up and there were
other priorities, but it stayed within the President's overall
amount. During the appropriations process, the administration
will be happy to work with Congress as long as the overall
President's number remains the same.
Senator Harkin. Thank you.
Thank you, Mr. Chairman.
Senator Specter. Senator Murray.
Senator Murray. Well, thank you, Mr. Chairman.
I assume from that conversation then that we can expect to
see a revised budget request from the Department of Education.
Secretary Paige. No. We are saying that we are willing to
work with the Congress and talk to you about those issues.
Senator Murray. But you are not going to give us a formal
request of any kind so that we know how the President wants to
set these priorities?
Secretary Paige. That is correct.
FUNDING FOR TEACHER QUALITY IMPROVEMENT
Senator Murray. Well, okay. That makes it difficult for us,
as we try and manage this. But let me ask you about one of the
biggest challenges that I am hearing from the people in my
State. They are struggling to meet the requirements to have all
teachers and most paraprofessionals highly qualified by 2005,
which feels like it is fast approaching.
Do you not agree that fulfilling that kind of mandate will
require significant investments in training and recruiting and
retaining and testing teachers in order to meet that
requirement that we have put forward, that all teachers and
most professionals have to be highly qualified by 2005?
Secretary Paige. Yes, I do agree it will take significant
resources. And that is why the $4.5 billion in the President's
budget is there.
Senator Murray. But what I see in the President's budget is
your request of $2.85 billion for Title II teacher quality,
which is what the mandate was under the bill. Last year we
actually funded, in 2003, $2.95 million. So your request is
below what we funded in 2003. Now I know that you said that you
had to prepare this before we did the 2003 appropriations.
Secretary Paige. Yes.
Senator Murray. And despite the conversation you just had
with Senator Harkin, given that you are not going to send us a
revised budget, your budget actually calls for $2.85 billion--
which is less than we just appropriated for this year for
meeting this requirement. I do not see how our schools are
going to meet the requirements to have all our teachers and
professionals highly trained when we are providing them less
money to do it.
Secretary Paige. When we discussed Federal funding for
teacher quality, preparation, and recruiting and retention, we
have to look at the full gamut of support available in the
budget for that purpose. And when you do that, it will total
$4.5 billion, not just the $2.85 billion.
Mr. Hansen. And if I might add, Senator Murray, that is an
increase even over and beyond the $4.25 billion that is in the
current 2003 bill. If you look at our proposals on teacher loan
forgiveness, our troops-to-teachers, transition to teaching,
other proposals, and total what is provided for in our Title I
program with the 5 percent set-aside for teacher training----
Senator Murray. With all due respect, let me just tell you
that when we worked on the No Child Left Behind, the
authorization for this requirement and this money were under
the Teacher Quality State Grants. What you are now saying to us
is that we are not going to pay attention to the language of
the bill and the Teacher Quality State Grants. We are going to
pull money from all these other things that we do, and say that
that counts.
Well, that is--you know, the schools are already using
those funds for specific things. We have added a new
requirement, a new accountability requirement, on top of that.
And now you are just saying: Use the money you use for
something else. That is what it sounds like to me that you are
saying to our schools.
Secretary Paige. No. We are not saying that. What we are
saying is: All of the dollars in the budget for teacher quality
improvement are not captured under that line item that includes
the $2.85 billion. There are other places.
Senator Murray. When we wrote the No Child Left Behind, the
teacher quality money was under the Teacher Quality State
Grants. That is what we expected to work with the
administration in good faith to increase the funding for.
Mr. Chairman, I know we do not have much time. I have a
number of other questions I will submit for the record.
PUBLIC SCHOOL CHOICE REQUIREMENTS
But I do have one question in particular that I wanted to
ask about, because a lot of our schools, in trying to implement
the public school choice requirements, are following your
guidance. And your guidance says, and I am going to quote it,
``Lack of capacity and health and safety concerns, including
overcrowding problems, do not excuse an LEA from meeting the
Title I public school choice requirement.''
Well, I know you are an educator. And you cannot believe
that it makes sense to transfer students to schools that are
overcrowded even to the point of causing health and safety
concerns. So I am very concerned about that language in your
guidance, and I want you to clarify it for us.
Secretary Paige. Our language in the guidance was as
flexible as we could make it under the language in the law. And
so what we were doing there was trying to provide as much
flexibility as the law permits us to provide in the capacity
issue. We are fully aware of the problems that capacity
presents to teaching and learning.
TITLE IX ADVISORY COMMISSION RECOMMENDATIONS
Senator Murray. Well, I am deeply concerned about that. And
in my last 30 seconds, I want to just jump to one quick
question on Title IX. It is another issue that I have dealt
with your office on.
You said recently that you would consider only the advisory
commission recommendations on Title IX that are unanimous. And
two members, at least two members, of the commission have
repudiated their support for a number of those so-called
unanimous recommendations in their minority report. And I
wanted to find out from you this morning if you will consider
those recommendations as unanimous or if you will respect the
dissenting views on that question.
Secretary Paige. The two persons that you refer to voted
for the ones that we agree are unanimous. They were a party to
that and had more participation and discussion than anyone
there. They were part of----
Senator Murray. Well, Mr. Secretary, I have talked----
Secretary Paige. They were part of the unanimous vote. That
is why it is unanimous.
Senator Murray. Well, I have talked extensively to them.
And they believe that the way the report was written was not
the way that their discussions were going. They have submitted
a minority report saying that they have dissenting views on
that and do not consider them unanimous. I hope that you take a
look at that, because there is a lot of disagreement on that.
Secretary Paige. Senator, the other 13 members of the
commission thought that their conduct with respect to that was
very inappropriate. They voted for those issues that were
unanimous.
Senator Murray. Mr. Secretary, again, with all due respect,
I hope that you look at the language of the minority report.
They are very specific in their concerns about how those were
worded and what the final outcome of that was.
Secretary Paige. The commissioners were advised even before
they had their first meeting that we wanted them to reach
agreement, consensus, and that those were the issues that were
going to be included, and that we are going to consider. Even
before they had their first meeting, they were advised about
that. And so they were fully aware of what the ground rules
were and what the rules of engagement were before the meeting,
before the report was prepared.
Senator Murray. Will you look at the minority report?
Secretary Paige. I am going to look at the issues that were
voted on unanimously.
Mr. Hansen. Mrs. Murray, I think it is important to note,
too, that Cynthia Cooper, who is the co-chair of the
commission, takes great issue with the representation of the
other two commissioners--and I think actually the transcript
speaks very clearly as well that everybody knew exactly what
they were voting for. And I think Cynthia Cooper spelled it out
very clearly in the press conference during the----
Secretary Paige. And not only Cynthia Cooper, the other
members of the commission as well.
Senator Murray. I hope we will have further discussion.
Thank you, Mr. Chairman.
Senator Specter. Senator Landrieu.
FEDERAL ROLE IN EDUCATION
Senator Landrieu. Mr. Secretary, do you agree that one of
the roles of the Federal Government is to try to close the
opportunity gap between the affluent districts in this Nation
and the disadvantaged districts?
Surely, as your background suggests, you are aware that the
local school systems are funded, primarily through property
taxes; not in every case, but in most cases throughout the
Nation. In those school districts where there is a strong
middle class or affluent area, property taxes are paid and
therefore schools are fairly well funded. In other areas that
are poorer and more disadvantaged, where the property is not as
valuable, there is by contrast less money that goes into the
schools.
In my view one of the roles of the Federal Government is to
try to close that gap and help those children that come from
less affluent neighborhoods to actually have equal opportunity
to succeed. Do you agree?
Secretary Paige. Yes, especially if you mean by that the
equity. Our role is to--we have two roles--to ensure equity and
to promote excellence. And I would consider what you said
ensuring equity.
TAX CREDIT PROPOSALS
Senator Landrieu. Well, I am very encouraged by that,
because I think that is absolutely what we should be doing. But
I am perplexed and confused then about the President's
proposals. Two initiatives that I see outlined in this budget
from your Department and the President are to expand the
Coverdell tax credit and then to give an additional tax credit
for up to $5,000 in tuition costs. In order to get the tax
credit, you would have to be able to have paid $5,000 in
tuition, correct?
How do those two programs, one that you are seeking to
expand and one that is brand new, meet the objectives that you
just stated?
Secretary Paige. Well, we believe that one of our greatest
failings in education is tying a child to a school that is not
serving them well. And so the President is attempting here, and
I agree fully, to provide options for parents, so that if a
school is not serving a child well, that child has other
options. And this is a vehicle to promote that possibility.
Senator Landrieu. Well, let us discuss that a minute.
Explain to me how a child that comes from a family that cannot
afford even $1,000 for tuition would be helped by these two
programs. Go ahead and explain that to me, if you would.
Mr. Hansen. Well, the----
Senator Landrieu. In other words how does the tax credit
work for them?
Mr. Hansen. Senator Landrieu, the tax credit, it needs to
be kept in mind, that it is an above-the-line tax credit. So it
is specifically targeted to disadvantaged families. And I think
it is----
Senator Landrieu. Excuse me. Could you start again?
Mr. Hansen. Sure. It is an above-the-line tax credit for
families. It is also important to note that the average
tuition----
Senator Landrieu. Excuse me. Hold on. Explain what you mean
by ``above the line''?
Mr. Hansen. It basically means that they are eligible for
it no matter what the rest of their tax is. If they do not owe
any tax, they still are eligible for the tax credit.
Senator Landrieu. That is true, but in order to get it, do
they not have to first pay the tuition?
Mr. Hansen. That is correct. And that is also----
Senator Landrieu. So a parent has to have the $5,000, or up
to half of $5,000, to pay for tuition before they can either
claim the credit. Explain to me then how the people in this
country who have two children and who, let us say, make the
minimum wage can afford $10,000 in tuition they must pay to be
eligible for this credit.
Try to explain that to me how someone pays rent, buys food
and clothes, and then pays $10,000 tuition, what benefit are
you are offering them.
Secretary Paige. There are--go ahead.
Senator Landrieu. Go ahead, Mr. Secretary. That would be
good.
Secretary Paige. There clearly would be many people where
this would be a burden. And they would have to find other
sources. This category would meet some of the needs for some of
the parents. There are other parents who would have to look to
other sources. And there are other sources. This is just one of
many mechanisms that are designed to provide options for
parents.
Senator Landrieu. Well, I will finalize this point with my
37 seconds left. What you just stated, goes in direct
contradiction to your goal, which according to your testimony
is to help those parents that need the help the most, because
the gap is so great. The programs that you are proposing in
this budget go against that principle.
I am going to do everything I can to oppose these two
programs and instead try to support the public schools, as well
as choice for parents, real choice that means something to
them.
Thank you.
FISCAL YEAR EDUCATION BUDGET PRIORITIES
Mr. Hansen. Senator Landrieu, if I could, I think it is
important to note that the top three priorities in our budget
were a billion-dollar increase in the Title I program, with all
money in the targeted program; the billion-dollar increase in
the Special Education program, which serves the most
educationally disadvantaged children in our country. It also
included a $1.9 billion----
Senator Landrieu. I----
Mr. Hansen [continuing]. Let me finish, please--a $1.9
billion increase for our Pell Grant program. Ninty percent of
those dollars go to families making less than $40,000. So all
of our programs are geared to help those who need it the most.
This tax credit, if people do not take it, it does not go to
wealthy families. It is opportunities for those families that--
--
Senator Landrieu. I did not say it went to wealthy
families. Mr. Chairman, I want to get this on the record. I did
not say it went to wealthy families. I do not have a problem
helping wealthy families. My problem is when resources are
limited we should help the poor families first, the middle-
income families second, and the wealthy families third. Your
budget does not reflect that principle. I disagree with it.
Mr. Hansen. Our budget does do that.
IMPORTANCE OF ARTS EDUCATION
Senator Specter. Mr. Secretary, my concluding question to
you was about focusing on the arts. And reading, obviously, is
the critical issue on education of young people. And
mathematics is not far behind and so many of the substantive
issues, history and civics, health courses. But I would
appreciate it if you would direct some special attention to
what might be done to stimulate the arts.
I started to tell you about this group of The Creative
Coalition. A young woman, Fran Drescher, and young Ronald
Reagan, and others make such a compelling case. And the
emotionalism and self-worth that comes from theater and art are
so important that I would like you to take a special look at
it.
Now I am not quite sure how we get there, because we do not
direct the local boards as to what they do. But there are ways
that we can encourage it, perhaps.
Secretary Paige. Senator, we have a special interest in the
arts. So we would be happy and pleased to do that.
Senator Specter. Okay. We would appreciate that.
ATHLETIC OPPORTUNITIES FOR WOMEN AND GIRLS
The issue on Title IX with respect to athletic
opportunities has been of great concern. I appreciate your
focus on athletic opportunities for women and girls. It has
been really amazing to see the women compete in basketball. In
a bygone decade, that would have been thought to be
unobtainable. So much of the funds are directed to men's sports
because they are big moneymakers, big television, NCAA, et
cetera.
But with what we have now seen as to the competitive
capabilities of young women and what a vital part it plays in
the educational process and the development of women and girls,
I think that is a line which we have to take really very
positive steps to promote.
Let me turn to a question, Mr. Secretary.
Oh, do you want to make a comment?
Senator Harkin, sotto voce--in fact, not sotto voce.
Everybody in the room heard it.
He has a great article titled: ``Strike Up the Band, keep
music in schools.'' And in light of our limited time, we will
just make this a part of the record. We will get a copy for you
to read, Mr. Secretary.
Secretary Paige. Thank you.
Senator Harkin. I would like to have you read this. It was
written by the former CEO of Meredith Publishing Company. It is
a great article about the arts and school music. It is really a
great article, in light of what the chairman was just saying.
[The information follows:]
[From the Des Moines Register, March 25, 2003]
Strike up the Band (and Keep Music in Schools); Iowa View
(By James A. Autry)
I have just returned from a magical mystery tour in which I
witnessed a transformation from the ordinary to the sublime. The thing
is, this happens all the time but not many of us get to see it from
beginning to end. You have to be in the right place at the right time.
I was.
But I get ahead of myself.
First, let me begin with a confession: On Saturday night, March 15,
I let go of my adult inhibitions in the midst of 149 teenagers, and
screamed myself hoarse.
It happened when the chairman of the Heritage Music Festival at
Disneyland announced that the top festival award was being presented to
Des Moines Roosevelt High School. I jumped to my feet, pumped my hands
in the air and yelled my fool head off.
I was as caught up in the moment, as excited and exhilarated as
those band, orchestra and chamber choir students who had traveled to
Anaheim on March 12 for four days of fun and festival, and who were
taking home the top honors.
Later, I wondered if anyone would notice; if the media would bother
with a musical triumph when there's so much to be written and shown
about the triumphant world of sports.
I wondered how many people know there are more kids involved in
public school music than in all the sports put together.
And I thought about the proposed cuts in music programs, and the
havoc that may cause for bands, orchestras, choirs, and choruses as
they have cuts and changes in teaching staff, plus diminished resources
all around.
I am not attacking the administrators or the school board. I am
painfully aware of their difficult choices, and the so-called ``Leave
No Child Behind Act'' puts no emphasis on art and music programs.
My purpose is simply to assert that life is about more than the
basic ``3 Rs.'' What students learn from music and art programs can't
be taught anywhere else.
As a consultant and author, I work with companies that stress
teamwork and cross-functional projects. I tell managers to stop using
the metaphor of sports teams, with their superstars and bench-warmers,
and think of a band or orchestra in which every player has an important
role, in which the greatest accomplishment is the ensemble.
Isn't this what good organizations are about, what a democracy is
about, what communities are about?
There is no better education--repeat, no better education--for
becoming a productive member of society than participation in a musical
ensemble. In a band or orchestra or chorus, no child is ever left
behind.
And I know. Our son Ronald, now a senior at Roosevelt, has autism.
He's not the most accomplished musician in the band, but he always
gives it his best effort. And the band has been a defining activity for
him. I can't imagine how his high school experience would have been
without band.
While I think of the band as having put a little magic in Ronald's
life, that's not the magic or the mystery I started writing about. Just
as the awards ceremony was not the high point of the Anaheim trip.
That came earlier in the day when the symphonic band, chamber
orchestra and chamber choir performed. My description: an utterly
mystical experience.
How else would you explain the transformation of typical teenagers
into divinely performing musical ensembles? Picture busloads of young
people looking and acting as young people do, dressed in a strangely
conformist style (boys in baggy jeans, the waistline relocated
somewhere around the the mid-to-lower buttocks, girls with low-cut
jeans and bare bellies) and talking with one another in a language
hardly intelligible to aging adults.
Then picture those same kids in tuxedos and long, black evening
dresses, intensely attentive and concentrating fully on their
instruments (or voices) and the directions of the conductor, and
producing music of a quality unimaginable from high school musicians
back when I was one.
It is a mystical transformation brought about by two factors:
One is the transcendent quality of music that inspires kids to
reach beyond themselves to perform at their peak.
The key factor: teachers. I sit in awe of these educators--in this
case, Treg Marcellus, Joseph Rich, Sandra Tatge and John Wallag--who
devote their lives to bringing forth exquisite music from young people
who, when they begin, can't imagine the possibilities of what beauty
they can create together.
I wish everyone in Des Moines could have the experience I've just
had. They would be proud of the performances and the awards, but they'd
be equally proud of how the students behaved and represented our city
and state.
I can't imagine school activities that produce more positive,
lifelong outcomes than these music programs. They deserve everything we
can do to preserve them.
Senator Specter. Thank you, Senator Harkin, for insisting
on not interceding.
Senator Harkin and I always have a good time, in addition
to being very cooperative in how we handle these issues.
CAMPUS CRIME AND CLERY ACT ADMINISTRATION
Now, Mr. Secretary, on the subject of campus crime, we had
a particularly heinous rape/murder in Pennsylvania which
inspired the parents of the victim to come forward on a
crusade, which has been so well focused on trying to inform
parents and students who are going to college campuses what
kind of risks they might expect. And the Department prior to
your administration had not done a very good job in
administering these campus crime informational requirements.
We have provided you with $750,000 to provide institutions
of higher education with a handbook on how to comply with the
Clery Act, I would be interested to know how you intend to use
it. Do you have a plan now, or if not, you can submit it in
writing, if you have not focused on it? What activist programs
do you have to see to it that there is enforcement of the
provisions in law related to campus crime?
Secretary Paige. Well, we share your view about safety. The
Department is developing a handbook on compliance with the
Clery Act. We intend to use the funds that you have made
available in strict compliance with congressional intent. The
handbook will focus on explaining programs and regulations in
clear language to school officials. We are consulting with
interested organizations, including Security on Campus and
participating institutions. The handbook will be distributed to
all higher education institutions immediately after it is
completed.
We have some other activities going on as well, including a
data collection system to facilitate the submission of campus
crime data from postsecondary institutions--this is for the
third consecutive year--a help desk to provide institutions
with technical assistance, and a website to provide easy access
to campus security legislation and regulations and data and
resources.
We have an enormous array of activities that are underway
to promote campus safety. We are very grateful for the $750,000
that was provided, and we are going to make sure that it is
used in strict compliance with your intent.
Senator Specter. Well, thank you very much, Mr. Secretary.
PREPARED STATEMENT
Senator Thad Cochran's prepared statement will be made part
of the record at this point in the hearing.
[The statement follows:]
Prepared Statement of Senator Thad Cochran
Mr. Chairman, it is a pleasure to have Dr. Paige serving as
Secretary of Education. He is doing a fine job, and I look forward to
working with him on the Department's budget for fiscal year 2004.
One program I need to mention, because nearly every school in
Mississippi is dependent upon its funding, is the Title I program for
the education of disadvantaged students. I'm pleased to see an increase
of $1 Billion in this program. It is always a challenge, though, to get
a share of any increase directed to Mississippi. That is a result of
the formula distribution and also the child counts that are used by the
department to determine eligible students. I hope this year we can come
to a resolution that is fair to my state.
I am interested in, and some of the vocational and technical
education leaders in my state are concerned about, the Department's
proposal for eliminating the Perkins Vocational and Technical Education
Program. These are programs that have been very successful. The
Mississippi Department of Education and the vocational and technical
education centers have contacted me, and met with my staff. They do not
understand how a new formula based program will be beneficial to them.
So, as we work through the appropriations process, and the
reauthorization process, I hope you will consult with the people
currently running these programs.
There are also several small, but critically important education
programs in which I have a deep interest.
I'm happy that this year, some are included in the Department's
Budget request. I commend the Department, and you, Mr. Secretary, for
noticing in particular the benefits of and recommending continued
funding for the Ready to Learn Television Program, which provides
educational television shows to nearly every child in the United
States.
I congratulate you on placing a priority on civic education by
recommending funding for the Education for Democracy program. It
sponsors the We The People Program here in the United States and the
Cooperative Education Exchange Program in almost 30 emerging
democracies abroad.
There are however, a number of programs listed in the budget
proposal under the heading: ``Program Terminations.'' I know we have
difficult decisions to make, but I want you to know about a few of
those in which I continue to have an interest.
I understand that the Department plans to streamline as many
programs as possible, but school leaders in my state advise me that
even with the advantages of flexibility, there is still a need for
schools and districts to have direct access to grant making programs
and others that are best served through a single source.
The Arts in Education program funds a number of high quality
programs that use a small federal contribution to leverage other state
and private funding. Most successful has been the relatively new grants
to schools to provide arts education in their curriculum. The
Department of Education published a collection of studies in 1999 and
another one last year, both of which gave us clear evidence fo the
value of arts in schools. The variety of advantages are amazing. These
include decreased drop out rates, increased academic performance,
better interpersonal skills, and higher sensitivity to social issues.
Another Arts in Education program is VSA Arts. This is popular
program which supports a national network that assures accessible arts
programming for children and youth with disabilities. Each year
approximately 4.5 million individuals participate in VSA Arts programs.
The National Writing Project is another program that has not only
proven its worth, but I am advised that it consistently receives the
highest rating from its official federal review. The fact is, that the
modest federal funds that have been directed to this program ($14
Million in 2003) are leveraged as much as 7 times in some areas. The
National Writing Project does not dictate a certain method of teaching
writing, but it provides a highly trained network of teachers who share
proven methods with other teachers. Teachers are energized by this
training and become better teachers.
The grant program for foreign languages in schools is another one
that I truly hope we can continue to fund. Mr. Secretary, during the
celebration of International Education Week, you stated a commitment to
the elements of what you called a ``world-class'' education. Foreign
languages taught early and throughout a child's life is a corner stone
to that goal. Today we have national security issues that beg a
population better prepared to conduct themselves with an international
awareness. The experts told us at a hearing in 2000 that college is
simply too late. We need to start sooner.
There are other programs of importance, such as those which deal
with gifted education, physical education, and school counseling. All
of these need our attention.
I hope that during this appropriations process, we can again come
to some compromise and continue to fund the programs that have national
significance and have proven to be successful.
I know that you have the best interests of our children at heart,
and I look forward to working with you.
CHAIRMAN'S CLOSING REMARKS
Senator Specter. There are many more subjects. We had a
pretty good attendance with the five Senators here this morning
on an extraordinarily busy morning at 9 o'clock.
We are going to be proceeding to a full committee hearing,
as I said earlier, with Secretary Rumsfeld and Secretary Ridge.
And with the customary roller skates around here, I have to go
to a judiciary committee meeting for a few minutes to try to
confirm Justice Priscilla Owen.
But we thank you for what you are doing. We appreciate your
coming from Houston, from a very activist program in education
and taking on a very big responsibility. There are many other
questions of concern to my State, not only as to the rural
education but also as to big city education. We will be having
a dialogue with you further and I look forward to an
opportunity to invite you to Pennsylvania.
You have been very gracious with your time in the past. And
we look forward to working with you, Mr. Secretary.
SECRETARY'S CLOSING REMARKS
Secretary Paige. We thank you so much for your leadership.
And we invite you and the members of the committee,
subcommittee, to contact us if there is any discussion you want
to have around any of these issues.
Senator Specter. Thank you very much.
Secretary Paige. 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
title i school improvement
Question. Does the fiscal year 2004 budget request provide
sufficient funds to pay the costs of corrective actions--public school
choice, supplemental services, school restructuring, etc.--which must
be taken with respect to schools which fail to meet adequate yearly
progress standards for 2 or more consecutive years?
Answer. State and local educational agencies have been required to
take corrective actions to improve Title I schools in need of
improvement since the 1994 reauthorization. We believe that the
President's $12.4 billion 2004 request for Title I, an increase of $3.6
billion or 41 percent over the amount provided for the final year of
the previous law, is more than adequate to help States and school
districts provide the new educational options and carry out the
improvement measures required by the NCLB Act.
In particular, by statute, 2004 school improvement funding would
double from 2 percent to 4 percent of the overall Title I Grants to
LEAs funding. The President's request is large enough to ensure that
this increased school improvement funding comes from new funding and
not from existing Title I allocations.
Question. How many schools have been affected by this requirement
during the 2002-2003 school year?
Answer. We do not yet have precise figures from the States, but a
survey conducted last summer, combined with data from earlier years,
suggests that roughly 8,000 schools were identified for school
improvement in the 2002-2003 school year.
title i choice and supplemental services
Question. Have any localities received waivers from the requirement
to provide supplemental services?
Answer. Such waivers may be approved by State educational agencies
only if there are no available service providers and the school
district is itself unable to provide services. We do not yet have any
data on how many waivers have been granted by the States.
Question. What evidence is there that third-party supplemental
services providers will be any more successful than their regular
public schools in providing Title I services?
Answer. While we do not yet know how successful supplemental
educational services will be in raising student achievement, we do
know, first, that students are eligible for such services only when
their schools have failed, for at least three years, to meet adequate
yearly progress requirements. In other words, we know the schools are
not getting the job done. And, second, we know that there are service
providers that have a strong record of improving student achievement,
as demonstrated in part by the willingness of parents to pay for their
services.
I also should clarify that supplemental educational services, as
the name suggests, are not a replacement for regular Title I services,
but additional instruction available to those students with the
greatest need for improvement. Students receiving supplemental
educational services can continue to benefit from the regular Title I
program offered in their schools.
Finally, service providers are subject to monitoring by State
educational agencies and must meet performance objectives included in
the agreements negotiated with parents. If a particular provider
consistently fails to meet its objectives for improving student
achievement, few parents are likely to request its services and it will
likely lose the State-approved status required for participation in the
program.
parental notification of public school choice and supplemental services
options
Question. Are parents of affected pupils eligible for public school
choice and supplemental services options being informed of these
options in a timely and effective manner?
Answer. In general, I believe most school districts have made a
good-faith effort to notify parents of their children's eligibility for
both public school choice and supplemental educational services. Some
districts experienced difficulty in this area during the current school
year, in part because these are new requirements and districts are
still developing appropriate procedures and processes for complying
with those requirements. In addition, some States did not post their
lists of approved providers until well into the second semester of the
school year, making it difficult for local educational agencies to make
the services available on a timely basis.
I am encouraged by anecdotal reports in the media of districts
responding to complaints by parents by improving notification and
increasing the range of options available to parents. I expect this
improvement will continue as both districts and parents become more
familiar comfortable with the choice and supplemental service
requirements. In any case, this is an issue we will follow closely over
the coming months and years.
Question. Are the parents typically being offered a substantial
range of choices?
Answer. We do not yet have sufficient information to describe a
``typical'' public school choice program under the NCLB Act. Based on
reports in the media, the range of choices offered has varied
considerably, depending on such factors as the district's understanding
of the choice requirements and the number of eligible schools within
the district. I think this is pretty much what we expected,
particularly during the first year of implementation.
no child left behind ``report card'' requirements
Question. What are the costs to States and local educational
agencies of meeting the report card requirements of the No Child Left
Behind Act?
Answer. These costs will vary considerably based on such factors as
the size of the State and district involved and the number and type of
schools that must be included in State and local report cards. It is
important to remember, however, that report cards are not new to the
Elementary and Secondary Education Act, but were required under the
previous authorization. The NCLB Act did add some requirements for
additional information in the annual report cards, but this reflects
only incremental cost increases for an existing activity.
Question. How are most States and local educational agencies
disseminating their report cards?
Answer. Information about State and local plans and procedures for
disseminating their annual report cards was included in the
accountability plan workbooks that each State submitted in January 2003
as part of the consolidated application process. The Department is
currently subjecting the plans outlined in these workbooks to peer
review, and will have more data on report cards when the peer review
process is completed early this summer.
Question. If they are disseminated primarily through the Internet,
how will parents and other individuals without home computers and
Internet access obtain them?
Answer. We do not yet have any data suggesting that the Internet
will be the primary means of disseminating annual report cards.
However, the Title I regulations require that States and school
districts communicate all school improvement information, including
annual report cards, directly to parents through such means as regular
mail, and not just through broader means such as posting report cards
on the Internet.
Question. May Elementary and Secondary Education Act Title I-A
funds be used to develop or disseminate report cards?
Answer. Yes, States and school districts may use Title I, Part A
funds to meet the requirements of Title I, Part A of the ESEA, which
include annual report cards.
Question. How many States and local educational agencies are
currently meeting the No Child Left Behind Act requirements to publish
report cards on their performance?
Answer. The Department currently does not have complete data on the
number of States and school districts meeting the report card
requirements of the NCLB Act. Many States and school districts were
producing and disseminating report cards under the previous law, but
the NCLB Act required additional information that will likely require
modification to these pre-NCLB report cards. The Department will have
more data on State and local efforts to meet the new report card
requirements once it completes the process of peer reviewing State
accountability plans early this summer.
evaluation of 21st century community learning centers program
Question. The fiscal year 2004 budget proposes $600 million for
21st Century Community Learning Centers, a reduction of $393.5 million
from the amount provided in last year's bill. These centers help
communities provide extended learning opportunities for students--
including after school programs--and related services for their
families, such as family literacy. The stated reason for the proposed
reduction is that the Department's recent national evaluation of
centers revealed shortcomings in the program, in particular related to
the academic performance of students attending such programs.
Mr. Secretary, given that the findings from the national evaluation
that are your basis for reducing the program are not nationally
representative and are only first year findings, is it appropriate to
cut this program so significantly, especially given the fact that other
studies have found academic improvement and other benefits from such
programs?
Answer. The rapid growth in funding for the program over the past
few years occurred almost entirely in the context of an increased
emphasis on improving student achievement. For example, the 2001
request submitted by the previous Administration, which proposed to
more than double the appropriation to $1 billion, was justified by the
perceived need to give students in all low-performing schools the
opportunity to attend after-school programs to help improve their
academic achievement. There was a specific link between the size of the
request and the academic benefits expected from that request. In this
context, our proposal to scale back the program, on the basis of
evidence that it is not achieving those expected benefits, seems
entirely appropriate. Preliminary findings from the current evaluation
of 21st Century Community Learning Centers, conducted by Mathematica
Policy Research, Inc., indicate that the centers funded in the
program's first three years, on average, provided academic content of
limited intensity and had limited influence on academic performance, no
influence on feelings of safety, and no positive impact on student
delinquent behavior. Attendance in the programs was found to be low (on
average, less than two days per week, even though centers were open, on
average, four to five days a week).
Additional analyses compared the outcomes of frequent and
infrequent program participants. Frequent participants were more likely
to be from disadvantaged households and to want to improve in school;
however, analyses did not reveal that more frequent participation led
to better outcomes.
The evaluation study uses far more rigorous methodology than other
studies cited in the after-school program literature. The evaluation
includes an experimental research design (randomly selected
participants in programs) for the elementary school portion of the
study and a quasi-experimental research design (matched comparison
groups) for the middle school portion. Other studies in the literature
used less rigorous methodologies (and thus produced less reliable
results), often presented highly selective results from small samples,
and offered information about outcomes rather than impacts. (In
contrast to ``outcomes'' that provide description information on the
performance of those who chose to participate in the program,
``impacts'' provide evidence of outcomes that are caused by their
participation in the program.)
Question. Isn't it true that there were many positive findings from
the study, such as more parental involvement and better quality of
homework produced that argue against such a reduction?
Answer. The Department did not discount those findings. The report
states that the achievement gains of African-American, Hispanic, and
female students were very small (with improvements only in math and
then by less than 2 points on a 1-100 point scale). While parental
involvement is often thought to be important, the study reported no
clear evidence that a link to achievement exists.
impact of current vocational education programs
Question. Given that the National Assessment of Vocational
Education's final report has yet to be released by the Department, will
you provide specific information about any possible findings that have
led the Administration to conclude that the current vocational
education programs are not improving student outcomes?
Answer. Since 1917, the Federal Government has invested in helping
States and schools better prepare young people for the future, seeking
to ensure that every young person leaves high school with the skills he
or she needs to succeed. However, evidence shows that we are failing to
adequately prepare our youth for the future. For example:
--Recent NAEP and TIMSS data show little improvement in high school
students' relative academic performance. Nationally, the high
school graduation rate has declined, with many non-graduates
eventually obtaining GEDs or other alternative certificates
that have less value in the labor market than traditional high
school diplomas have.
--Large proportions of high school students enter college, but many
fail to complete. The best available data suggest that rates of
remediation in college are high, and that students who have
taken remedial course work are much less likely to persist and
eventually earn a college degree than are other students.
--With regard to employment and earnings, students with higher-level
math skills earn substantially more than do students with the
same level of educational attainment but weaker skills. A
similar pattern exists with regard to reading skills.
--Surveys of firms indicate that many test job applicants and that
the proportion of applicants who lack the necessary basic
literacy and/or math skills may be growing. Thus, even students
who enter the job market directly out of high school must have
a strong foundation of academic competencies.
--There is no evidence that vocational course taking, as it has been
structured, is likely to address deficiencies in academic
achievement or improve rates of college going. The previous
National Assessment of Vocational Education (NAVE) Final
Report, published in 1994, commissioned and reviewed several
studies and found: (1) no relationship between vocational
education and academic achievement gains, or a negative effect
if students substitute vocational for academic courses, and (2)
a similar relationship to postsecondary education. A more
recent rigorous evaluation of career academies, representing a
broad vision of vocational education, found that these programs
did not improve standardized math and reading achievement test
scores, had no effect on the graduation rate, and did not
increase the proportion of students who enroll in postsecondary
education by the end of the first year following high school
graduation.
The current structure of the Federal vocational and technical
education program is not adequately addressing these issues. The NAVE
final report is likely to provide additional supporting evidence of the
program's inadequacies.
Question. Are these findings applicable to all groups of students?
Answer. Yes. In fact, while there are significant achievement gaps
between low-income and minority students and their peers, the overall
academic attainment of all high school students is inadequate and
disappointing. Too few students, regardless of their family income,
race, or ethnicity, are leaving high school without the skills they
will need to succeed in postsecondary education and the job market.
reauthorization proposal for secondary and technical education
Question. Please explain how the Administration's proposed
secondary and technical education program would better prepare a
complete workforce, with a broad range of skills that will be needed in
the Nation's current and future economy.
Answer. The Administration's proposed Secondary and Technical
Education Excellence program would shift the Federal role from
supporting traditional vocational education to focusing on improving
high school academic achievement and on supporting high-quality
technical education programs that span the high school and college
levels, thus making sure that students are taught the academic
knowledge and technical and practical skills needed to make successful
transitions from high school to college and from college to the
workforce.
In particular, States would use their Federal formula allocations
to make grants to partnership of local educational agencies and
community and technical colleges to develop or implement academic/
technical education programs that show promise or are effective (or
show promise of) in improving students' academic and technical skills,
increasing degree attainment, reducing the need for remedial courses at
the postsecondary level, and improving employment outcomes. Further, to
improve the quality and labor market responsiveness of the curriculum
and to make it easier for high school graduates to transition to
postsecondary education, the proposed program will promote greater
collaboration between technical and community colleges and high schools
in planning and delivering technical education coursework for secondary
school students, as well as continue to support postsecondary programs
for adult, career-changing students.
Creating cutting-edge programs of this kind can be costly and time-
consuming for administrators, teachers, college faculty, and business
leaders, but the proposed program will provide communities with both
incentives and resources to take on the difficult but important task of
better preparing our young people for the future.
fiscal year 2004 budget request for the secondary and technical
education excellence program
Question. Given the proposed reduction of $326 million in
vocational education programs and the proposed authority to transfer
funds for use under Title I of ESEA, are you concerned that there would
be sufficient Federal financial assistance to support effective career
and technical education programs throughout the United States; and, if
not, why?
Answer. We believe that the 2004 budget request is sufficient for
the proposed Secondary and Technical Education Excellence program.
Under the current program, $1.19 billion is spread thinly, supporting
general expenses like equipment purchases and hiring of staff, but
having little direct impact on student learning. The new program would
target funds to a smaller number of high-need high schools that show
promise for raising student achievement and to community colleges that
are able to provide students with high-quality education and training
leading to successful employment outcomes.
In particular, at the high school level, the program would provide
funds to local educational agencies to develop or implement technical
education programs that include the high-level academics that all
students need in order to succeed in postsecondary education and the
job market. In addition to promoting high-quality community and
technical college programs for adult, career-changing students, the
program would encourage technical and community colleges to act as more
active partners in secondary technical education, both to improve the
quality and labor market responsiveness of the curriculum and to make
it easier for high school graduates to transition to postsecondary
education. Thus, Federal funds would be more tightly focused on
promoting the development and implementation of programs that are most
responsive to the academic and technical skill demands of the 21st
century workforce.
student aid administration
Question. The President's 2004 budget request proposes the
development of a new, discretionary Student Aid Administration (SAA)
account that would consolidate all student aid management costs
previously funded through the discretionary Program Administration and
Federal Family Education Loan Program (FFELP) accounts and the
mandatory Federal Direct Student Loan Programs (HEA Section 458)
account. Secretary Paige, could you please explain why the President
and the Department are seeking to move the mandatory funds obligated
under Section 458 of the Higher Education Act of 1965, as amended, from
a mandatory to discretionary account when the Higher Education Act is
up for reauthorization this year?
Answer. The current student aid administration budget structure--
split among multiple mandatory, discretionary, and subsidy accounts--
makes it difficult to hold Federal Student Aid, the performance-based
organization within the Department, accountable for reducing program
operations costs. The fiscal year 2003 appropriations act took a first
step toward rationalizing this structure by unifying discretionary
funding for student aid operations in the Student Aid Administration
account. We believe that it is appropriate to complete the process in
the 2004 appropriation, consistent with the President's management and
financial improvement agendas.
Question. Why should this provision be enacted through the
appropriations process, instead of taking the regular course through
the authorizing committee?
Answer. As noted above, the fiscal year 2003 appropriations act
took a first step toward rationalizing the funding structure for
student aid operations by unifying discretionary funding in the Student
Aid Administration account. Completing the process in the 2004
appropriation is a key component of the President's budget, management,
and financial improvement agendas.
Question. One of the purposes identified by the Congress for
establishing the Performance Based Organization (PBO) was to improve
service to students and other participants in the student financial
assistance programs authorized under title IV of the Higher Education
Act. Given that administrative expenses for the PBO are closely
associated with the number of loans issued in a given year--a level
which could be difficult to predict--how will the proposal to make
administrative expenses subject to annual appropriations better achieve
that purpose behind the creation of the PBO?
Answer. Mandatory administrative funding levels are typically set
for 5-year periods, and for the past few years have been straightlined
except for growth in guaranty agency administrative payments. We
believe that setting funding levels as part of the annual
appropriations process will actually allow greater flexibility to
ensure that sufficient funds are available to provide the best possible
service to student aid program participants.
The Administration is developing a true activity-based budget
formulation process for student aid administration to better
incorporate Department workload projections in its annual budget
request. (The number of loans in a given year is but one of a large
number of variables, including the number of student aid applications,
awards, loans in default, Direct Loans in repayment, etc., that
determine student aid administrative costs.) This process will also
allocate student aid management expenses to specific business
processes, allowing the Department to more accurately determine the
cost of individual activities or programs, and facilitating efforts to
budget administrative funds to each business process, set cost
reduction targets, and easily compare actual performance to budget
targets.
student aid appropriations and administrative costs
Question. What happens if funds appropriated fell short of the
amount required to meet the operations of the PBO?
Answer. We are confident that Department managers will be able to
operate their operations effectively within the requested funding
level. The Department has long experience managing program operations
with discretionary funds--as you know, it is already the case with the
Department's program administration funds and, indeed, virtually all
other administrative appropriations in the entire government.
Question. How would services to students and other participants be
affected?
Answer. We do not expect that this proposal would affect service to
students, schools, and other student aid program participants. This is
a management improvement designed to improve program efficiency while
being transparent to program beneficiaries.
student financial assistance: pell applicant growth and projected pell
funding shortfalls
Question. Given the unexpected 9 percent and 10 percent growth in
the Pell Grant program over the past two years, do you expect that your
estimates of 25 percent applicant growth in the coming academic year
and 1.5 percent for the following year create a shortfall greater than
the one estimated under the President's budget request?
Answer. The Administration believes that the applicant growth
estimates underlying the President's Budget request for Pell Grants are
prudent assumptions based on an analysis of historical trends. During
the previous period of Pell Grant funding shortfalls--from academic
years 1990-91 to 1993-94--the applicant growth rate increased
cumulatively by 22.5 percent, or at an annual average of 5.6 percent.
Immediately following this period of (then) unprecedented applicant
growth, the number of Pell applicants grew by only 1.4 percent in
academic year 1994-95. Furthermore, applicants grew only 13 percent
during the 7-year span between academic years 1994-95 and 2000-01. The
average growth rate per award year for this 7-year period was 1.6
percent.
During the current funding shortfall, Pell applicants increased
cumulatively by 18.6 percent during award years 2001-02 and 2002-03.
Based on historical data, the Department's applicant projection for AY
2004-05 assumes a similar pattern of decline immediately following
cumulative surges, as recorded during the last funding shortfall. In
addition, given the recent cumulative growth among older, independent
students and projected population figures for students in the
traditional college age cohort, it is possible that the pool of Pell
applicants not already receiving awards will begin to shrink.
pell grant funding history
Question. Over the life of the Pell Grant program, how often have
there been annual funding shortfalls, as reported in Pell Grant End-of-
Year (EOY) Reports?
Answer. A comparison between total expenditures and appropriation
level for a given award year in the Pell Grant EOY Report does not
accurately portray the cumulative funding shortfall or surplus since
prior-year unobligated funds may be used in current years and funds
from future appropriations are often used to cover current year
shortfalls. Moreover, appropriation levels are often determined based
on the estimates of prior-year shortfalls and surpluses, in addition to
the estimated current year program cost.
A table from the Award Year (AY) 2000-01 Pell Grant EOY Report is
provided, however, to illustrate the total expenditures, appropriation
level, current year shortfall/surplus, and the reduction method
employed to help alleviate Pell Grant shortfalls.
An additional table is provided to show a more accurate portrayal
of the Pell Grant shortfalls and surpluses dating back to 1989. These
data are taken from final budget documents and financial systems,
illustrating cumulative shortfall and surplus amounts over time.
HISTORY OF PELL GRANT FUNDING: AY 2000-01 EOY REPORT
--------------------------------------------------------------------------------------------------------------------------------------------------------
Current year
Fiscal year Award year Total Appropriation surplus/ Action
expenditures \1\ (shortfall)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1973...................................... 1973-74 $48,469,000 $122,100,000 $73,631,000 Stepped Reduction
1974...................................... 1974-75 361,188,000 475,000,000 113,812,000 Stepped Reduction
1975...................................... 1975-76 932,083,000 840,200,000 (91,883,000) Full Funding
1976...................................... 1976-77 1,485,164,000 1,325,800,000 (159,364,000) Full Funding
1977...................................... 1977-78 1,534,395,000 1,903,900,000 369,505,000 Full Funding
1978...................................... 1978-79 1,550,360,000 2,160,000,000 609,640,000 Stepped Reduction
1979...................................... 1979-80 2,369,911,375 2,431,000,000 61,088,625 Full Funding
1980...................................... 1980-81 2,400,656,660 2,157,000,000 (243,656,660) Flat $50 Reduction
1981...................................... 1981-82 2,313,263,380 2,604,000,000 290,736,620 Flat $80 Reduction
1982...................................... 1982-83 2,433,130,730 2,419,040,000 (14,090,730) Stepped
1983...................................... 1983-84 2,810,851,530 2,419,040,000 (391,811,530) Full Funding
1984...................................... 1984-85 3,066,734,552 2,800,000,000 (266,734,552) Full Funding
1985...................................... 1985-86 3,611,447,366 3,862,000,000 250,552,634 Full Funding
1986...................................... 1986-87 3,473,304,086 3,579,716,000 106,411,914 Linear Reduction
1987...................................... 1987-88 3,768,737,216 4,187,000,000 418,262,784 Full Funding
1988...................................... 1988-89 4,491,684,679 4,260,430,000 (231,254,679) Full Funding
1989...................................... 1989-90 4,794,454,987 4,483,915,000 (310,539,987) Full Funding
1990...................................... 1990-91 4,952,215,055 4,804,478,000 (147,737,055) Linear Reduction
1991...................................... 1991-92 5,811,633,979 5,375,500,000 (436,133,979) Full Funding
1992...................................... 1992-93 6,195,912,589 5,502,800,000 (693,112,589) Full Funding
1993...................................... 1993-94 5,673,231,640 6,461,900,000 788,668,360 Full Funding
1994...................................... 1994-95 5,537,849,327 6,636,700,000 1,098,850,673 Full Funding
1995...................................... 1995-96 5,489,766,815 6,146,800,000 657,033,185 Full Funding
1996...................................... 1996-97 5,798,361,158 4,914,000,000 (884,361,158) Full Funding
1997...................................... 1997-98 6,349,755,300 5,919,000,000 (430,755,300) Full Funding
1998...................................... 1998-99 7,252,057,389 7,344,900,000 92,842,611 Full Funding
1999...................................... 1999-00 7,039,119,041 7,704,000,000 664,880,959 Full Funding
2000...................................... 2000-01 7,975,801,349 7,640,000,000 (335,801,349) Full Funding
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Total Expenditures also include Administrative Cost Allowance (ACA) payments.
Note: Since prior-year unobligated funds may be used in current award years and funds from future appropriations may be used, fiscal year appropriation
levels are often based on estimates of prior-year funding shortfalls and surpluses--in addition to the estimated current year program cost. Therefore,
the comparison between total expenditures and appropriation level may not provide an accurate representation of funding shortfalls and surpluses
Moreover, obligation levels continue to fluctuate after the EOY Report has been printed.
HISTORY OF PELL GRANT FUNDING SURPLUSES/SHORTFALLSBASED ON BUDGET/FINANCIAL SYSTEMS: FISCAL YEAR 1989-2003
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual surplus/ Cumulative
Fiscal year Award year (Shortfall) Surplus/ Shortfall Action(s) taken for cumulative shortfall
--------------------------------------------------------------------------------------------------------------------------------------------------------
1989........................................ 1989-90 ($75,366,675) ..................
1990........................................ 1990-91 ($230,367,465) ($305,734,140) Fiscal year 1991 funds used.
1991........................................ 1991-92 ($396,568,870) ($702,303,010) Fiscal year 1992 funds used.
1992........................................ 1992-93 $18,219,444 ($684,083,566) Fiscal year 1993 Appropriation ($240M); fiscal
year 1993 Supplemental Appropriation ($341M);
Transfers ($9M); fiscal year 1994 funds used.
1993........................................ 1993-94 $459,709,140 ($224,374,426) Fiscal year 1994 Supplemental Appropriation
($250M); Transfers ($3.1M).
1994........................................ 1994-95 $807,731,000 $583,356,574
1995........................................ 1995-96 $715,845,000 $1,299,201,574
1996........................................ 1996-97 ($864,440,000) $434,761,574
1997........................................ 1997-98 ($396,000,000) $38,761,574
1998........................................ 1998-99 $123,934,000 $162,695,574
1999........................................ 1999-00 $474,000,000 $636,695,574
2000........................................ 2000-01 ($317,283,000) $319,412,574
2001........................................ 2001-02 ($1,242,000,000) ($922,587,426) Fiscal year 2002 funds used.
2002........................................ 2002-03 ($310,000,000) ($1,232,587,426) Fiscal year 2002 Supplemental Appropriation
($1B); fiscal year 2003 funds will be used.
2003........................................ 2003-04 ($305,353,000) ($1,537,940,426) Fiscal year 2004 funds will be used.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes: Funding surplus/shortfall amounts reflect supplemental appropriations, rescissions, and transfers
Data for award years 2002-03 and 2003-04 are estimates based on assumptions used in the President's fiscal year 2004 Budget and final fiscal year 2003
action.
Question. Please outline how each of those shortfalls has been
addressed?
Answer. As shown in the first table above, the Pell Grant maximum
award has been reduced in eight award years, by various methods, due to
insufficient funding. The additional table lists supplemental
appropriations, transfers, and other steps taken during the years of
cumulative shortfalls.
pell grant maximum award and cost of higher education
Question. Does your proposal to establish a maximum Pell Grant at
$4,000 for fiscal year 2004 mean that students served by the program
will lose ground relative to the price of postsecondary education?
Answer. Since 2000, the increase in the Pell Grant maximum award
has matched the increased average cost of attendance at 4-year public
institutions. We will work with our partners in States and institutions
to ensure students--especially the most needy students--retain access
to quality postsecondary education.
fiscal year 2004 education budget request and student access to
postsecondary education
Question. The fiscal year 2004 budget request reduces funding for
Supplemental Education Opportunity Grants, Federal Work-study, the
Perkins loan program, GEAR UP and TRIO programs. In addition, the
budget proposes reducing the maximum Pell Grant award to $4,000. The
Nation's neediest students are the ones supported by these programs.
How does the Administration justify reducing and in some cases
eliminating funding for these programs at a time when State budget
reductions are forcing higher tuitions and fees and there is a rapidly
growing population of needy students that want and should go to
college?
Answer. Because the fiscal year 2004 budget request was prepared
before the fiscal year 2003 appropriation was finalized, it was based
on the Administration's fiscal year 2003 budget request. As a result,
in a number of cases where the actual appropriation exceeded the 2003
request, the Administration's intent to provide level funding in fiscal
year 2004 now appears to be a decrease in support. (This is true for
the Pell Grant maximum and the Supplemental Education Opportunity Grant
(SEOG), TRIO and GEAR UP programs. Our request for Federal Work-Study
would be an increase over the final fiscal year 2003 level.) The
Administration is prepared to work with Congress to adjust priorities
in the fiscal year 2004 budget, but is committed to maintaining an
overall discretionary spending limit that is consistent with the
Administration's request.
That said, our priority for 2004, as it has been for the past few
years, is the Pell Grant program, the largest and most need-based of
Federal student grant programs. Accordingly, the President proposed a
record $1.35 billion, or 12 percent increase, for Pell Grants, for an
all-time high total of $12.7 billion. We believe that concentrating our
resources in this way--the Pell increase alone is actually
significantly larger than the entire SEOG or Work-Study program, or
TRIO and GEAR UP combined--is the most efficient way to help the most
needy students.
Question. What other sources of assistance are available under the
budget request to continue to provide access to quality postsecondary
education for all Americans?
Answer. Under the Administration's fiscal year 2004 budget request,
the Federal Family Education Loan and William D. Ford Direct Student
Loan programs will provide nearly $47.6 billion in loans to help
students and parents pay for postsecondary education. In addition, the
request maintains support for several other higher education programs
that help to provide access to postsecondary educational programs. The
Byrd Honors Scholarships program would receive $41 million under the
2004 request to provide more than 27,000 merit-based scholarships for
undergraduate students. The Javits Fellowships and Graduate Assistance
in Areas of National Need programs also would receive a combined $41
million to provide merit- and need-based awards for students pursuing
advanced degrees. Additionally, the Fund for the Improvement of
Postsecondary Education would receive $39.1 million to support a wide
range of innovative projects, including many focused on increasing the
access and retention of underrepresented students.
administration's proposed income tax provision and reduction of
erroneous student aid payments
Question. The Administration has proposed to allow the IRS to match
income tax return data against student aid applications, in order to
reduce the number of erroneous student aid payments. According to the
U.S. Department of Education, this proposal would save the Federal
Government $292 million in erroneous payments during the 2003-2004
academic year and $346 million in the 2004-2005 academic year. What
steps have you taken to gain the support of the authorizing committees
of jurisdiction?
Answer. We have been working closely with both tax writing
committees as well as the Joint Committee on Taxation (``JCT'') to
enact this proposal. While there is support for the goal of eliminating
erroneous payments in the student aid programs, the JCT has raised
questions about the privacy implications of allowing Department
contractors access to applicant tax data in order to implement the data
match. We are working closely with the JCT to demonstrate that the
Administration's proposal will actually strengthen protection of
applicant tax data versus the current verification process.
other steps taken to reduce and eliminate erroneous federal education
payments
Question. What other steps is the Department taking to reduce and
eliminate erroneous Federal education payments?
Answer. The Department is taking a number of steps to address the
problem of erroneous payments, including working closely with the
Office of Management and Budget in implementing Public Law 107-300, the
Improper Payment Information Act of 2002. The Act mandates tracking
erroneous payments down to the sub-recipient level for grants and all
procurements, in addition to loans, loan guarantees, etc. The threshold
will be 2.5 percent or $10 million in improper payments, whichever is
greater, proven by a statistical sample with a 90 percent confidence
level.
leveraging educational assistance partnerships
Question. Mr. Secretary, your budget eliminates the Leveraging
Educational Assistance Partnership (LEAP) program. Since nearly all
States are facing deficits, tuition rates are being forced up, and
research by the Advisory Committee on Student Financial Assistance and
others has documented the need for more State/Federal partnership
program funding to close the growing college access gap between low-
and high-income students, can you tell me why you think eliminating
this program is a good idea?
Answer. Since LEAP was first authorized as the SSIG program in
1972--when only 28 States had undergraduate need-based grant programs--
the State commitment to providing need-based student aid has grown
exponentially. Today nearly all States have need-based student grant
programs, with grant levels that have expanded greatly over the years,
and most States significantly exceed the statutory matching
requirements. For academic year 2001-2002, for example, estimated State
matching funds totaled nearly $1 billion, more than $950 million over
the level generated by a dollar-for-dollar match, and far more than
would be required even under the 2-for-1 match under Special LEAP. This
suggests a considerable level of State commitment, regardless of
Federal expenditures.
javits fellowships and graduate assistance in areas of national need
Question. Mr. Secretary, the Graduate Assistance in Areas of
National Need (GAANN) and Jacob Javits programs attract exceptionally
promising students into graduate study to pursue degrees in areas of
national need--such as chemistry, information sciences, and
engineering--as well as in the arts, humanities, and social sciences.
The fiscal year 2004 budget request proposes roughly level funding for
these programs at a time when supporting advanced study in these areas
is of great importance to the Nation. The National Science Foundation
(NSF) and the National Institutes of Health (NIH) have proposed
increasing their graduate education budgets for fellowships and
traineeships. Why have you not done the same, given the important niche
these programs serve in the Federal Government's graduate education
portfolio?
Answer. The general approach this year was to request increases for
selected high-priority programs. Our priority for 2004, as it has been
for the past few years, is the Pell Grant program, the largest and most
need-based of Federal student grant programs. We believe that
concentrating our resources in this way is the best way to help the
most needy students. The Administration supports the Javits Fellowships
and GAANN programs and recognizes that they play an important role in
preparing students for scholarly careers and careers in areas of
national need. The funding requested for these programs would support a
total of 1,116 fellowships, including approximately 400 new
fellowships. However, in light of the current budget conditions, the
Administration considered it necessary to demonstrate fiscal discipline
and limit program increases to only the highest-priority programs.
recreational programs for individuals with disabilities
Question. With a success/sustainability rate of nearly 75 percent,
recreational programs have proven to be an effective approach to
leveraging local and private funding to support the integration of
individuals with disabilities into the community. Budget documents
indicate that this program has limited national impact and that funding
is more appropriately derived from States, local agencies and the
private sector. Doesn't the Federal Government have a specific role in
stimulating and leveraging local and private funding for recreational
programs that support the community integration needs of individuals
with disabilities?
Answer. We do believe that the Federal Government has a role in
helping individuals with disabilities become full and active members of
society. We have targeted resources on those activities in which the
Federal role is critical. For example, the Department is supporting
over 20 National Institute on Disability and Rehabilitation Research
(NIDRR) projects that include some attention to issues relating to the
participation of individuals with disabilities in recreational,
physical exercise, or leisure activities. For example, NIDRR just began
support for a 5-year $5.4 million Rehabilitation Engineering Research
Center on Recreational Technologies and Exercise Physiology Benefiting
Persons with Disabilities. This center will study recreational
opportunities for individuals with disabilities, interventions to
increase physical activity and recreation participation of individuals
with disabilities, and strategies to reduce physical activity relapse
and dropout rates. The center will be conducting randomized clinical
trials to evaluate improvements in health and function.
Another example is the Traumatic Brain Injury (TBI) Model System
located at the University of Washington's Department of Rehabilitation
Medicine. The project conducts research on the effect of exercise on
depression after TBI. This low-cost community intervention seeks to
combat depression and emotional distress in persons with stable TBI, by
employing exercise as a positive approach to improved emotional and
physical functioning and socialization. This 5-year project began in
fiscal year 2002 and is budgeted to receive a total of $1.825 million.
continued availability of recreational programs for people with
disabilities
Question. What evidence does the Department have that recreational
programs for individuals with disabilities would continue to be
available to those in need of them without the seed money provided by
this program?
Answer. The best evidence the Department has is the track record of
the programs we have funded. Grantees are required to provide an
increased level of support from non-Federal sources over their 3-year
project period. Of the 33 grantees whose projects received their last
year of Federal support during fiscal years 1998 through 2000, 24
projects are still in operation and providing recreational services to
individuals with disabilities. Even more importantly, most recreation
programs have been initiated and sustained without Federal funds.
assistive technology act state grant program
Question. State Grant funding provided under title I of the
Assistive Technology Act has been critical to building an
infrastructure specifically designed to ensure that people with
disabilities--regardless of age or disabling condition--have access to
the technology devices and services they need to be independent and
productive members of society. Without this national infrastructure,
there will be unbridgeable gaps in access to Assistive technology
devices throughout the country. Why does the Department's budget
request propose to eliminate Federal financial support for these
activities?
Answer. The Assistive Technology (AT) State grant program was
designed to be time-limited. The authority for this program originally
authorized 10 years of funding for States. However, in fiscal year 1998
Congress enacted the new Assistive Technology Act in order to provide
States with an additional 3 years of funding, among other things. The
Administration believes that the AT State grant program has fulfilled
its original mission by providing 10 or more years of Federal funding
to States to assist them with achieving the goals of AT Act. In fiscal
year 2003, all States will have received 10 years of funding and 31
States will have received at least 13 years of funding.
helping people with disabilities achieve independence
Question. Numerous technological and policy changes such as the
Olmstead decision, Section 508 final guidelines, and the
Telecommunications Act Section 255 were not anticipated when the sunset
provisions related to Federal support of Tech Act Projects were
originally conceived. Does the Department believe that Assistive
Technology State grant projects have a role to play in building an
infrastructure that ensures that people with disabilities can be
independent and productive members of society?
Answer. The AT State grants program has helped States to increase
access to AT services and devices through changes in State laws,
regulations, policies, practices, procedures, and organizational
structures. State AT Act programs have had over 10 years of experience
in developing and implementing AT policies, procedures, and programs
that support community integration and full participation of
individuals with disabilities in home, work, education, and community
settings. States now have a much greater capacity to deal with changes
in policy and technology that have occurred since the AT Act was first
enacted. The Administration is committed to helping people with
disabilities achieve independence through such efforts as the New
Freedom Initiative. It has targeted Federal investments on such
activities as research and development, through the National Institute
on Disability and Rehabilitation Research's Rehabilitation Engineering
Research Centers, the AT alternative financing program, which makes
loans for purchasing assistive technology available to individuals with
disabilities, and dissemination and technical assistance efforts like
the NIDRR's Disability and Business Technical Assistance Centers
(DBTACs http://www.adata.org/dbtac.htm), which provide information,
materials, technical assistance, and training on the ADA and accessible
information technology.
Question. If so, what is that role and how will it be carried out
without Federal financial assistance?
Answer. Federal support provided under the AT State grants program
has played a role in building an infrastructure specifically designed
to ensure that people with disabilities, through assistive
technologies, have full access to home, work, education, and community
activities. States are well positioned to continue to identify consumer
needs and address changing trends.
programs eliminated in fiscal year 2004 budget
Question. The fiscal year 2004 budget request proposes to eliminate
48 categorical grant programs funded at $1.6 billion last year, ranging
from the Smaller Learning Communities program and Arts in Education to
Rural Education. Many of these programs are programs that were just
reauthorized last year as part of the No Child Left Behind Act and have
strong congressional backing. Can you explain why you propose to
eliminate these programs?
Answer. Major program increases in the 2004 President's budget are
offset in part by these proposed program terminations, nearly all of
which are narrow categorical activities that have achieved their
purpose, have a limited impact, or may be funded through other more
flexible State grant programs. Without these reductions, it would be
impossible to provide significant increases to major Administration and
Congressional priorities such as Title I, Special Education Grants to
States, and Pell Grants. In addition, the Administration believes it is
more effective to deliver scarce Federal education resources to States
and school districts through large, flexible formula grant programs
rather than small, categorical grant programs mandating particular
approaches to educational improvement.
assessing education program effectiveness
Question. Please provide the subcommittee with the names of and
primary findings from the evaluation studies used for identifying
ineffective programs. If it is the Department's view that these
programs are duplicative of other broader authorities, please provide a
list of the eliminated programs, categorized by the broad authorities
under which the activities may be undertaken.
Answer. The primary vehicle for assessing program effectiveness
during the development of the 2004 President's budget was the new OMB
``Program Assessment Rating Tool'' (PART), which was developed to help
integrate budget and program performance. The PART instrument rated
programs based on responses to 26 questions in four areas, including
program purpose and design, strategic planning, program management, and
program results. PART also relied on evaluation results whenever they
were available for the programs under review.
The PART process identified 4 of the Department's programs as
ineffective: Even Start, Safe and Drug-Free Schools and Communities
State Grants, TRIO Upward Bound, and Vocational Education State Grants.
For the Even Start program, the evaluation findings provided the basis
for the ineffective rating. The PART assessment found, among other
things, that 3 national evaluations of the program (National Evaluation
of the Even Start Family Literacy Program (1995), Second National
Evaluation of the Even Start Family Literacy Program: Final Report
(1998), and Third National Even Start Evaluation: Program Impacts and
Implications for Improvement (2003)) show that the program has had no
significant impact on the children and parents served.
Below is a list of programs authorized in NCLB that the 2004 budget
proposed for elimination because they are duplicative or the activities
authorized can be carried out under other programs, such as the Title I
Grants to Local Educational Agencies, Improving Teacher Quality State
Grants, Educational Technology State Grants, and Safe and Drug-Free
Schools and Communities State Grants. Also, if States and districts
chose to do so, activities supported by most of these programs can be
carried out under State Grants for Innovative Programs (Title V-A).
Comprehensive school reform; Close Up fellowships; Dropout
prevention programs; School leadership; Advanced credentialing;
National writing project; Preparing tomorrow's teachers to use
technology; Elementary and secondary school counseling; Smaller
learning communities; Javits gifted and talented education; Star
schools; Ready to teach; Community technology centers; Parental
assistance information centers; State grants for community service for
expelled or suspended students; Alcohol abuse reduction; Rural
education.
fiscal year 2004 budget vs. flexibility and accountability
Question. Under the State and Local Transferability Act enacted as
part of the No Child Left Behind Act, States and local school districts
are provided with additional flexibility to target certain Federal
funds to Federal programs that most effectively address the unique
needs of States and localities, and to transfer Federal funds allocated
to certain State grant activities to allocations for certain activities
authorized under Title I. How did the Department consider this
authority in making its fiscal year 2004 budget request?
Answer. The 2004 budget request maintains high levels of funding
for the programs that are included in the transferability authority
(Improving Teacher Quality State Grants, Educational Technology State
Grants, State Grants for Innovative Programs, and Safe and Drug-Free
Schools and Communities State Grants). Supporting State and local
efforts to transfer funds is consistent with the Administration's
belief that the most effective use of Federal funds is to provide them
to States and districts through flexible formula grant programs that
target funds to the classroom and allow local districts to use the
funds in a manner that best meets their needs. Federal formulas cannot
deliver funds to all school districts in amounts that align with their
priorities.
state and local transferability act authority
Question. How will the authority be considered in assessing the
relationship between Federal funding provided and the performance
outcomes achieved with such funds?
Answer. The Department plans to collect information, through
program performance reports and a study of resource allocation, on the
amount of funds transferred among programs under the transferability
authority. Unlike the other flexibility demonstration options,
transferability does not require States or districts to submit
applications or to meet additional performance goals or separate
accountability requirements. Through the statewide accountability
system, districts are accountable for making adequate yearly progress
(AYP). Transferability is a tool best used as part of a larger strategy
for improvement.
As for the relationship between Federal funding and performance
outcomes, in general, we believe that it is often not possible to
isolate the separate impact of many Federal programs on student
outcomes, in due to the fact that Federal programs frequently seek to
leverage broader State and local improvements in education programs.
However, we will also continue to collect and report information on
trends in student outcomes in order to assess the overall impact of
Federal, State, and local reform efforts on student achievement.
Question. How will this authority shape decisions on future budget
requests for affected programs?
Answer. The transferability authority supports the Administration's
emphasis on rationalizing and consolidating the delivery of Federal
education resources in order to give States and school districts
maximum flexibility in using these resources to meet local needs and
improve student achievement while reducing administrative, paperwork,
and regulatory burdens. As with the 2004 budget request, I expect that
we will work to maintain or increase funding for the flexible State
grant programs included in the transferability authority, while
reducing budget support for smaller categorical programs with limited
impact and more complex administrative requirements.
______
Questions Submitted by Senator Tom Harkin
fiscal year 2004 budget request for education
Question. Mr. Secretary, during the March 27 hearing, you agreed
after much discussion that the President would be willing to support
funding cuts in other Cabinet agencies in order to increase funding for
the Department of Education, as long as overall discretionary
appropriations do not exceed the total in the President's budget. You
stated that you did not have any recommendations at that time about
where to make cuts in the other Cabinet agencies, but that we could
expect some guidance later.
Given that the Senate Appropriations Committee could begin marking
up appropriations bills very shortly, we need that guidance as quickly
as possible. Do you have any suggestions for how much money the
Committee should add for education, and where it should offset those
increases with cuts?
Answer. The President does not intend to change his 2004 Budget
that was prepared and submitted to Congress, prior to Congress
completing action on the 2003 Omnibus bill. The President's 2004 Budget
was developed within a framework that set a proposed total for
discretionary spending in 2004, and each agency and program request
reflected the Administration's relative priority for that operation
within that total. We recognize that Congress may believe there is a
need to reorder and adjust some of these priorities, and the
Administration intends to work with Congress to develop alternative
figures for education programs as you go through the 2004 appropriation
process, always within the requirement, however, that whatever is done
for Education must fit within the overall President's 2004 budget total
for discretionary programs. As Congress considers Education and related
programs, I would urge you to consider our recommendations for reducing
or eliminating individual categorical programs that have fulfilled
their original purpose, proven ineffective, or which are duplicated by
other larger, more flexible grant programs. That is a good way to
stretch the education dollar.
fiscal year 2004 budget and title i formulas
Question. According to the Congressional Research Service (CRS),
the Education Finance Incentive Grant funding (EFIG) stream authorized
under Title I of the ESEA provides a modest financial reward, or
incentive, to those States with education finance systems that minimize
disparities in the distribution of State funding. CRS also reports
that, in fiscal year 2002, the EFIG formula targeted a higher
percentage of its funds to the two highest-poverty quintiles of needy
students than any other funding formula (50.4 percent of EFIG funds,
compared to 49.8 percent of targeted grant funds).
education finance incentive grant funding (efig) vs. title i targeted
grant formula
Question. The Department of Education Appropriations Act, 2003,
included $1.5 billion for EFIG, while the fiscal year 2004 President's
budget reduces this funding to the fiscal year 2002 level of $793
million and instead provides additional funding under the Targeted
Grant formula. Given that the education finance funding stream is more
targeted to the neediest students than any other formula and provides
an incentive to States for reducing disparities in funding streams, why
does the Administration propose reducing this funding stream and
providing all of its proposed fiscal year 2004 Title I increase under
the Targeted Grants program?
Answer. The budget requests the entire increase under the Title I
Targeted Grants formula because the formula delivers a larger share of
Title I funds to high-poverty local educational agencies (LEAs) than
the Education Finance Incentive Grant (EFIG) formula. Increasing the
funding for Incentive Grants would simply divert more resources away
from the highest-poverty States and districts with the greatest need
for Title I funds.
For example, the 10 poorest States by poverty rate account for 41.4
percent of the total population of children in poverty aged 5-17. Based
on fiscal year 2003 Preliminary allocations, these 10 States would
receive 45 percent of the Targeted Grants funds and only 40 percent of
the EFIG funds. By contrast, the 10 States with lowest poverty rate,
which account for 6.7 percent of children in poverty aged 5-17, would
receive 6.5 percent of the Targeted Grants funds and 7.9 percent of the
EFIG funds.
The EFIG formula, added to Title I in the 1994 ESEA
reauthorization, includes ``effort'' and ``equity'' factors intended to
benefit high-poverty districts by encouraging States to spend more on
education and to improve the equity of the State funding systems.
However, the formula unfairly shifts money from high-poverty States to
low-poverty States, and has a very limited impact.
The ``effort'' factor reduces the targeting of Title I funds to the
highest-poverty States, primarily because the lower level of resources
available for education in these States (at least on a per-capita
basis) produces a lower level of ``effort'' in the formula. This
reduced targeting is diametrically opposed to the purpose and design of
the Title I program.
States with the largest and highest-poverty urban centers--
including New York, Texas, and California--receive a significantly
reduced share of funding under the Incentive Grants formula when
compared to the Targeted Grants formula. For example, New York would
receive 9.65 percent of Incentive Grants funding compared to 12.65
percent of Targeted Grants funds and California's share of Incentive
Grants funding is 13.72 percent compared to 15.7 percent of Targeted
Grants.
The ``effort'' factor also could adversely affect States
experiencing a local recession, which may have to reduce education
spending in response to declining local tax revenues. A further decline
in Title I support--as would occur under the Incentive Grants formula--
would only exacerbate the problem faced by local districts and schools.
The ``equity'' factor, which produces highly variable patterns of
gains and losses among States, suffers from flaws that seriously
undermine its validity. These include the absence of any adjustment for
cost-of-living variations among LEAs and reliance on a single measure
of equalization.
Finally, the Education Finance Incentive Grant program does not
provide a significant incentive for States to increase education
funding or improve the equity of their funding systems. Even the $11.7
billion currently spent on Title I LEA Grants contributes only about 3
percent of national spending on elementary and secondary education.
______
Questions Submitted by Senator Thad Cochran
poverty data for fiscal year 2003 title i allocations
Question. Since fiscal year 1997, Elementary and Secondary
Education Act Title I funds have been allocated on the basis of
estimates of school-aged children from poor families provided by the
Census Bureau's Small Area Income and Poverty Estimates program, with
updates every two years. Until the 2000 Census became available,
Mississippi's poor student number was underestimated and using that
method would have decreased the amount of Title I money for our State.
For 2003, the Department has a choice of using these updates, or
school district population estimates from the 2000 Census. Which source
of data do you plan to use for fiscal year 2003?
Answer. In determining Title I school district allocations for
fiscal year 2003 (SY 2003-04), the Department will use the model-based
poverty estimates provided by the Census Bureau. These estimates
reflect sample data from the 2000 Census, which looks at income year
1999, and 1999 estimates provided through the Bureau's Small Area
Income and Poverty Estimates (SAIPE) program.
We believe that the updated poverty estimates produced through the
SAIPE model provide a more valid measure of school district poverty
levels than the Census 2000 data and a more reliable basis for
determining Title I allocations. These estimates factor in other, more
up-to-date poverty measures such as Federal tax return and Food Stamp
data, and address problems in the Census 2000 school district estimates
resulting from sampling error.
Question. Are there significant differences in State shares using
these two population data sources?
Answer. Overall, the total poverty count from the SAIPE model-based
estimates is about 2.5 percent greater than the counts from the 2000
Census. Both sources produce State shares that are very similar for
most States. For example, South Carolina's State share of the total 5-
17 poverty with the 2000 Census is 1.54 percent, compared to 1.48
percent with the SAIPE model-based estimates. This translates to a 3.9
percent difference in South Carolina's State share when comparing the
two. Over half of the States have State share differences less than 4
percent and three-fourths of the States have differences less than 7
percent. Only 6 States (Kansas, Idaho, Delaware, Maine, Massachusetts,
and South Dakota) have State share differences over 10 percent.
Massachusetts has the most significant difference in State shares, with
1.45 percent of the total 5-17 poverty count with the 2000 Census and
1.84 percent of the total 5-17 poverty count with the SAIPE estimates
(a 26.6 percent difference in State share).
no child left behind provision for annual updates on children in poor
families
Question. Finally, the No Child Left Behind Act allows for the use
of annually updated data on children in poor families, rather than
every second year--when do you expect to begin implementing this
provision?
Answer. We plan to use annually updated model-based poverty
estimates of children ages 5 through 17 by school district beginning
with the fiscal year 2004 (SY 2004-05) allocations. Fiscal year 2003 is
the final year for which we are using data updated on a biennial basis.
SUBCOMMITTEE RECESS
Senator Specter. Thank you all very much. The subcommittee
will stand in recess to reconvene at 9 a.m., Tuesday, April 8,
in room SD-192. At that time we will hear testimony from the
Honorable Elias Zerhouni, Director, National Institutes of
Health.
[Whereupon, at 9:51 a.m., Thursday, March 27, the
subcommittee was recessed, to reconvene at 9 a.m., Tuesday,
April 8.]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2004
----------
TUESDAY, APRIL 8, 2003
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10 a.m., in room SD-192, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Cochran, Harkin, and Murray.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
STATEMENT OF ELIAS ZERHOUNI, M.D., DIRECTOR
ACCOMPANIED BY:
DR. DUANE ALEXANDER, DIRECTOR, NATIONAL INSTITUTE OF CHILD
HEALTH AND HUMAN DEVELOPMENT
JAMES F. BATTEY, JR., M.D., PH.D., DIRECTOR, NATIONAL INSTITUTE
ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
WILLIAM R. BELDON, ACTING DEPUTY ASSISTANT SECRETARY FOR
BUDGET, DEPARTMENT OF HEALTH AND HUMAN SERVICES
FRANCIS S. COLLINS, M.D., PH.D., DIRECTOR, NATIONAL HUMAN
GENOME RESEARCH INSTITUTE
ANDREW C. VON ESCHENBACH, M.D., DIRECTOR, NATIONAL CANCER
INSTITUTE
ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE OF ALLERGY
AND INFECTIOUS DISEASES
DR. PATRICIA A. GRADY, DIRECTOR, NATIONAL INSTITUTE OF NURSING
RESEARCH
DR. JUDITH H. GREENBERG, ACTING DIRECTOR, NATIONAL INSTITUTE OF
GENERAL MEDICAL SCIENCES
GLEN R. HANSON, PH.D., D.D.S., ACTING DIRECTOR, NATIONAL
INSTITUTE ON DRUG ABUSE
RICHARD J. HODES, M.D. DIRECTOR, NATIONAL INSTITUTE ON AGING
THOMAS R. INSEL, M.D., DIRECTOR, NATIONAL INSTITUTE OF MENTAL
HEALTH
STEPHEN I. KATZ, M.D., PH.D., DIRECTOR, NATIONAL INSTITUTE OF
ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
DR. GERALD T. KEUSCH, DIRECTOR, THE JOHN E. FOGARTY
INTERNATIONAL CENTER
RAYNARD KINGTON, DEPUTY DIRECTOR, OFFICE OF THE DIRECTOR,
NATIONAL INSTITUTES OF HEALTH
CLAUDE LENFANT, M.D., DIRECTOR, NATIONAL HEART, LUNG, AND BLOOD
INSTITUTE
TING-KAI LI, M.D., NATIONAL INSTITUTE ON ALCOHOL ABUSE AND
ALCOHOLISM
DONALD A.B. LINDBERG, M.D., DIRECTOR, NATIONAL LIBRARY OF
MEDICINE
KENNETH OLDEN, PH.D., DIRECTOR, NATIONAL INSTITUTE OF
ENVIRONMENTAL HEALTH SCIENCES
AUDREY S. PENN, M.D., ACTING DIRECTOR, NATIONAL INSTITUTE OF
NEUROLOGICAL DISORDERS AND STROKE
RODERIC I. PETTIGREW, PH.D., M.D., DIRECTOR, NATIONAL INSTITUTE
OF BIOMEDICAL IMAGING AND BIOENGINEERING
JOHN RUFFIN, PH.D., DIRECTOR, NATIONAL CENTER ON MINORITY
HEALTH AND HEALTH DISPARITIES
DR. PAUL A. SIEVING, DIRECTOR, NATIONAL EYE INSTITUTE
ALLEN M. SPIEGEL, M.D., DIRECTOR, NATIONAL INSTITUTE OF
DIABETES AND DIGESTIVE AND KIDNEY DISEASES
STEPHEN E. STRAUS, M.D., DIRECTOR, NATIONAL CENTER FOR
COMPLEMENTARY AND ALTERNATIVE MEDICINE
LAWRENCE A. TABAK, D.D.S., PH.D., NATIONAL INSTITUTE OF DENTAL
AND CRANIOFACIAL RESEARCH
JUDITH L. VAITUKAITIS, M.D., DIRECTOR, NATIONAL CENTER FOR
RESEARCH RESOURCES
KERRY N. WEEMS, ACTING ASSISTANT SECRETARY FOR BUDGET,
TECHNOLOGY AND FINANCE, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
JACK WHITESCARVER, PH.D., DIRECTOR, OFFICE OF AIDS RESEARCH
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. Good morning, ladies and gentlemen. The
Appropriations Subcommittee on Labor, Health and Human
Services, and Education will proceed.
Dr. Zerhouni, we now turn to this portion of the hearing on
the National Institutes of Health.
Dr. Gerberding, we thank you for your participation. If you
would like to be a director of the NIH or one of the
institutes, you may stay.
If you choose to retain your current position at CDC, you
are free to excuse yourself. Thank you very much for joining
us.
Dr. Gerberding. Thank you. I think I will keep to my
present job.
Dr. Zerhouni. We would not mind having her as a director at
NIH.
Dr. Gerberding. Thank you.
Senator Specter. Dr. Zerhouni, we have already introduced
you with your impressive background and credentials coming from
Algiers at a young age. We thank you for the work you are doing
at NIH. It is good to hear that you were in Mississippi with
Senator Cochran. Thank you for coming to Pennsylvania to a very
interesting forum we had a few months ago at the University of
Pennsylvania. And now we look forward to your testimony.
SUMMARY STATEMENT OF DR. ELIAS ZERHOUNI
Dr. Zerhouni. Thank you, Senator Specter. And thank you,
members of the committee.
INTRODUCTION OF NEW INSTITUTE DIRECTORS
What I would like to do first and foremost is introduce to
you four new directors of NIH who have joined us over the past
year. Dr. Thomas Insel is the new Director of the National
Institute of Mental Health. Thomas can say hi. Dr. Nora Volkow
is going to assume the directorship of the National Institute
of Drug Abuse. Dr. Rod Pettigrew is going to be, is the new
Director of the National Institute of Bioimaging and
Bioengineering. And T.K. Li is the new Director of the National
Institute of Alcoholism and Alcohol Abuse.
To my right, I would like to introduce our new Deputy
Director for NIH, Dr. Raynard Kington, who has replaced Dr.
Ruth Kirschstein, who is now serving as the senior advisor to
the directors, with us today as well and continues to help both
Dr. Kington and I with her advice.
Senator Specter. Let me just pause for just a moment to
thank Dr. Ruth Kirschstein for her outstanding service at NIH
over many years, including serving as acting director. We
salute you and are glad to see that you are still on board.
Dr. Zerhouni. Again, I would like to really extend our
thanks to the full committee and to you, Mr. Chairman, and to
you, Senator Harkin. We know that without your leadership, the
doubling of NIH would not have occurred this year in the
difficult economic and budgetary circumstances that we are
facing. And we appreciate it very much.
RESEARCH PRIORITIES
I would like to quickly go over what NIH is planning to do
with the doubling of the NIH budget and what our priorities are
going to be. First and foremost, we want to make sure that the
resources you have given us are invested with the best people
and are invested on the best ideas that can promote the health
of our people.
This is done in the context of, first of all, major
priorities that continue to be priorities, but also evolving
challenges. These evolving challenges are truly fundamental to
the way biomedical research will need to be done in the future.
CHRONIC DISEASES
First and foremost, we have experienced over the past 40
years a tremendous shift in the landscape of disease in our
country going from acute diseases that were very lethal to more
chronic diseases. Seventy-five percent of the disease burden of
the United States today is related to long-term chronic
diseases. We have made great progress in cardiac diseases when
we control acute myocardial infarction. But these patients are
now surviving longer and have different kinds of problems.
AGING POPULATION
The second challenge is that of the aging population. And
we need to tackle that proactively.
HEALTH DISPARITIES
The third is health disparities, as I mentioned before.
EMERGING DISEASES
The fourth, as you heard today, is emerging diseases. Not
just infectious diseases, but also diseases that relate to the
change in our environment, all conditions. For example, the
rise in obesity and its implications on the incidence of
diabetes in our country. Last, but not least, is the biodefense
priorities, which we will continue to support.
STRATEGIC ROADMAP FOR NIH
Now to do so and to go forward, we wanted over the past
year to work with all the directors of NIH and all the
constituencies to define what we would call a strategic road
map for NIH and how we will invest the resources you have
placed in trust with us, and what are the priorities that we
think will make the greatest difference in terms of advancing
research, in terms of developing the best people, promoting the
best ideas, and essentially translating them to real benefits.
And there are three.
We will explore new pathways to discovery. And that is
essentially to fully exploit the unprecedented opportunity of
the genomic era. To us, this is the beginning, not the end, of
an era. The genome is allowing us today to explore completely
different ways of looking at disease than we had in the past.
Second, because of the scaling complexity of 21st century
research, we understand now that the problems cannot be tackled
by individual scientists alone. We need large multi-
disciplinary teams that are going to work together to in fact
do so.
Third, we need to re-engineer the clinical research
enterprise of our country. We need to more quickly translate
our discoveries into practice. And this will be a priority of
the NIH in the future.
Last but not least, we are submitting to you a request for
the fiscal year 2004 budget, which is a 2.6 percent change over
the enacted 2003 level. When we worked--and Senator Specter and
Senator Harkin and Senator Murray, I can tell you that we
worked very, very hard, including myself and Dr. Gerberding and
others to try to make sure that the impact on our programs in
the new budget will be as limited as possible, in terms of
critical mission areas. We did advocate internally, as you
recommended in your statement.
Research will not be affected at the 2.6 percent level, but
we will be able to maintain our research to the 7 percent
level. Excluding biodefense, we will maintain a 4.3 percent
level. And the number of grants will go 10,509.
At the bottom of the slide, you see why that is in 2004.
And the reason is because many one-time expenditures that were
related to building the infrastructure for biodefense,
buildings and facilities that were needed in 2003 have been
reinvested in the research portfolio in 2004. Now those are the
main elements of the budget we are submitting. And as you said,
Senator Specter, we are looking forward to your input in this
process. And obviously, we will provide you with all the
information that you may want us to provide you and answer all
your questions in that regard.
prepared statements
But rest assured that we will and are committed and will be
committed to make sure that the return on investment of the NIH
continues to be the same it was in the past. Thank you very
much.
[The statements follow:]
Prepared Statement of Dr. Elias Zerhouni
fiscal year 2004 president's budget request
Good morning, Mr. Chairman and members of the Committee. Let me
begin by expressing my deepest appreciation for the generous and
bipartisan support of the Congress, Secretary Thompson, President Bush,
and the American people for the completion of the doubling of the NIH
budget this year. I recognize and appreciate the extraordinary effort
of this committee and, Mr. Chairman, your leadership as well as your
efforts, Senator Harkin--without which the doubling would not have
occurred. I thank you for it.
I also want to assure you that NIH fully understands and embraces
its role as the steward of our Nation's investment in medical
discovery. We must ensure that these precious resources are used wisely
and lead to tangible benefits that touch the lives of everyone.
The year 2003 is truly a pivotal year for medical research. It is
the year when we celebrate the 50th anniversary of the discovery of the
structure of DNA and its direct consequence--the completed sequence of
the Human Genome. We have witnessed nothing short of a revolution in
science over the past 5 years. Some may see this year as the grand
finale. I think of it more as the overture. As the 21st century begins
to unfold, we are poised to make quantum leaps in our knowledge about
how to improve people's health.
In my testimony, I will demonstrate what health benefits have
resulted from the Nation's longstanding investment in the NIH, along
with some of our most recent advances. Finally, I will outline emerging
priorities and NIH's plans for responding to the health challenges
before us.
the nih tradition
NIH-led progress in medical research is changing the landscape of
disease. For example, NIH research led to a major reduction in
mortality related to coronary heart disease and stroke. NIH contributed
to this decline in a number of ways. First, we identified
cardiovascular risk factors and the importance of behavior
modification, such as smoking cessation, dietary changes, and exercise,
to reduce risk and improve cardiovascular health. Second, we supported
the basic science that led to the development of pharmaceuticals to
control hypertension and high cholesterol levels. NIH-funded research
also led to strategies as simple and inexpensive as taking aspirin to
prevent heart disease and stroke, and life-saving procedures such as
angioplasty and coronary artery bypass grafting. We also continue to
evaluate best therapeutic strategies in medical practice, as in the
recent ALLHAT trial (Antihypertensive and Lipid-Lowering Treatment to
Prevent Heart Attack Trial) that showed that hypertension can be
effectively managed with an initial choice of an inexpensive drug. Were
it not for these advances and others, the expected death toll from
coronary heart disease would have been over 1,300,000 in 2000 as
compared to the actual death toll of 514,000.
Progress has been equally remarkable for Hepatitis B (HBV) and
Hepatitis C (HCV) infections. New cases of these infections are on the
decline, in part, because of improved vaccines and the reduced risk of
infection from blood transfusion--both outcomes of NIH-funded research.
Because of changes in the criteria for donor recruitment and new and
improved approaches to testing blood, the risk of infection through
transfusion has been virtually eliminated.
The ability to screen for HIV infection--made possible by NIH
research serves as an important target for both prevention and
treatment of AIDS. The mortality rate of this devastating disease is
now one fifth of what it would have been without research on the
fundamental biology of the HIV virus. Research on behavioral
interventions to prevent HIV infection and improve its treatment also
contributed to better control of the spread of this disease in our
country.
One more dramatic example can be found in the development of the
Haemophilus Influenza B vaccine. The results of this NIH research have
led to a virtual elimination of this disease in our country and, the
disease is in the process of being eliminated worldwide. In the not too
distant past, the complications of Hib made this disease the leading
cause of acquired mental retardation in infants and children.
new challenges and strategies
Due in part to research advances; the burden of disease is now
shifting from more acute and lethal forms of disease to chronic
illness. Our success in conditions like myocardial infarction and
infectious diseases is leading to better survival rates. As the result
of such prolonged survival and the aging of the population, the
incidence of chronic and long-term diseases, such as congestive heart
failure, cancer, Alzheimer's disease, Parkinson's Disease, diabetes,
and obesity, among others, is increasing.
For example, although we have witnessed reductions in acute
coronary heart disease, the burden of congestive heart failure has
increased during the last 30 years of the 20th century. As another case
in point, more people are living with cancer, as therapies transform
this once acutely fatal disease into a more chronic and manageable
condition.
Furthermore, rapid changes in our environment and lifestyle lead to
disequilibrium between our genetic make-up and our ability to adapt to
these changes. The most dramatic recent example is the rise in the
incidence of obesity, due in part to the greatly increased availability
of food and reduced daily physical energy requirements.
It is imperative that we develop more comprehensive strategies to
address such emerging challenges. In all likelihood, these strategies
will require a better understanding of: (1) the series of molecular
events that lead to disease in the hope of affecting its course before
the disease develops, so-called Molecular Prevention; (2) the
interactions between genes, the environment, and lifestyle as they
relate to the etiology and progression of disease; ways of delaying the
onset of the disease and/or ways to reduce the severity of its course
and its impact on quality of life.
All of these strategies will need to be explored simultaneously and
it is this systematic approach, from most basic to applied research,
that will produce much needed results. Several important examples of
these strategies have already proved their value.
For example, a major cause of blindness, age-related macular
degeneration (AMD), currently affects 1.75 million Americans. They have
advanced degeneration in at least one eye. Over 7 million individuals
are at substantial risk of developing AMD. Its prevalence increases
dramatically with age; for more than 15 percent of white females over
80 years of age have AMD. By the year 2020, the number of people with
AMD will increase by 50 percent to 2.95 million.
NIH is engaged in a major research program to understand the
predisposing factors, the clinical course, and the prognostic factors
of AMD. Researchers found that giving high levels of antioxidants and
zinc reduce the risk of developing advanced AMD by about 25 percent.
These nutrients also reduce the risk of advanced AMD-induced vision
loss by about 19 percent. These findings may help people who are at
high risk of developing advanced AMD keep their vision. Over the next
five years, 329,000 people in the United States (66,000 per year) could
be saved from advanced AMD. More remains to be done. We need to spread
the word to change practices, and we need to continue work to identify
the genes that control the risk of this devastating disease as well as
to develop more interventions to prevent or delay the onset of
blindness.
In another example, many doctors today who are treating patients
with rheumatoid arthritis remember all too well how challenging
treatment was not so long ago. In the early 1980s, treatment was
initiated in what was known as a therapeutic pyramid. Patients would
first be given a course of aspirin or another non-steroidal anti-
inflammatory drug (NSAID), and would be followed to see if erosions
occurred in the bone. If erosions did occur or if the patients did not
respond to the NSAIDs, the next course was anti-rheumatic drugs that
were added one-by-one as the disease progressed. Sadly, the disease-
modifying therapy was initiated only after the patient was already on
the road to disability. The root causes of the disease were not known,
but the discovery, originally made through cancer research, of the role
of Tumor Necrosis Factor (TNF), a naturally occurring protein in the
body that mediates inflammation, dramatically changed the treatment
landscape. By specifically targeting this protein with customised
antibodies, entirely new drugs were developed and approved for the
treatment of rheumatoid arthritis, including etanercept and infliximab.
These were the first biological-response modifying antibody drugs that
behave as antagonists--meaning that they work by specifically blocking
the action and decreasing the availability of TNF.
These new-targeted therapies showed substantial effectiveness in
people with rheumatoid arthritis who had not previously responded to
other treatments. The treatments are generally well tolerated, although
some concerns have been raised recently about the long-term effects of
these agents. Other studies reported that infliximab and methotrexate
used in combination not only reduced the symptoms of rheumatoid
arthritis, but also halted the progression of joint damage when
compared to the use of previous forms of therapy. Scientists involved
in this study observed that in the last 2 years, aheumatoid arthritis
research has moved further than in the previous 30 years, and that a
wealth of new treatments is now available that have the potential to
prevent and heal structural damage to the joints of people with this
debilitating disease.
the need for a strategic roadmap
The change in the landscape of disease requires us to adopt new
approaches and accelerate the pace of our discoveries. The need has
never been so pressing, the opportunities have never been greater, and
challenges have never been more daunting. The NIH must simetaneously
learn from the past, act in the present, and plan for the future. It
must institute the changes necessary to improve the health of the
American people. We need to proactively define enabling initiatives--
how best to advance science as well as what science to advance. We need
to map the terrain and over the past nine months we have been engaged
in just such an effort.
Soon after I arrived at NIH, I convened a series of meetings to
develop a ``Roadmap.'' My goal was to develop a short list of the most
compelling initiatives that the NIH should pursue that would make the
biggest impact on biomedical research.
This assessment was needed because powerful and unifying concepts
of biology are emerging that hold the potential to lead to rapid
progress. For example, in the past, cancer research was considered
vastly different than heart or brain research. Today, with recent
discoveries in molecular and cell biology, we know that biological
systems obey common laws and follow similar pathways in both health and
disease. Efforts to fully understand these complex molecular events are
beyond the reach of any one laboratory or group of investigators. As we
begin to decipher the tidal wave of knowledge we have amassed, the
scope, the scale, and the complexity of 21st century science will
require us to devise even newer ways to explore biology for the sake of
improving health.
Three major themes emerged from these Roadmap meetings. First, we
must uncover new pathways to scientific discovery. For example, we must
develop a comprehensive understanding of the building blocks of the
body's cells and tissues and how complex biological systems operate.
Also, structural biology will provide vital information about the
proteins that make up the human body. Molecular libraries will give us
new tools and targets for effective therapies. Overall, these examples,
plus nanotechnology, computational biology and bioinformatics and
molecular imaging will provide the foundation upon which new
treatments, diagnostics and prevention strategies will emerge.
The second theme that emerged from our consultations is the
changing dynamics of the research teams of the future. Because of the
complexity and scope of today's scientific problems, traditional
``mentor-apprentice'' models must be replaced by integrated teams of
specialists from numerous disciplines that were considered unrelated in
the past. Imaging research, for example, requires cell biologists,
computer programmers, radiologists, and physicists to work
collaboratively on new diagnostics and treatments.
The third theme that was voiced again and again by researchers is
the need to re-engineer the national clinical research enterprise for
optimal translation of our discoveries into clinical reality. The list
of what is needed is long--it includes supporting multidisciplinary
clinical research training career paths, introducing innovations in
trial design, stimulating translational research, building clinical
resources like tissue banks, developing large clinical research
networks, and reducing regulatory hurdles. We must explore a standard
clinical research informatics strategy, which will permit the formation
of nation-wide ``communities'' of clinical researchers made up of
academic researchers, qualified community physicians, and patient
groups.
Our vision is to make sure that our citizens benefit from a vibrant
clinical research system--a system that will allow us to more
efficiently translate our breakthroughs in basic research with the goal
of improving health.
The three thematic areas that I just described, that is, new
pathways to discovery, multidisciplinary teams, and reengineering the
clinical research enterprise, focus on technologies and systems that
will enable researchers today and in the future to not only solve
problems more quickly, but also to ask questions that we have not been
able to ask before--questions so complex that without the aid of these
efforts they would be impossible to address.
Efforts to understand the building blocks of the body's cells and
tissues and to understand how complex biological systems work can lead
directly to new approaches to improving health or preventing disease. A
recently discovered biological phenomenon called RNAi--or RNA
interference--has led to the development of a new and potent research
tool, which is being used to identify the function of specific genes in
normal biological and disease processes.
A recent study, co-funded by NIH, used RNAi to identify genes
involved in the regulation of fat metabolism in the roundworm
experimental model in an effort to better understand obesity. One at a
time, each of the 17,000 genes of the round worm was turned off using
this novel method. Researchers found that inhibition of 305 genes
decreased body fat, whereas inhibition of 112 genes increased fat
storage. With this information, researchers identified new genes
involved in fat metabolism, genes common in many organisms, including
humans. These genes now give researchers multiple new opportunities for
understanding obesity and new targets for the development of therapies.
This is just one example of how these new approaches are beginning to
transform medical research.
Finally and importantly, the NIH must communicate our research
results both to the lay public and health professionals. NIH works in
partnership with many different organizations to communicate scientific
results and health information to the medical research community,
health care providers, patients, the media and the general public
across the nation. We conduct our education and outreach efforts in
collaboration with other federal agencies, state agencies, private
sector organizations and national health care organizations. We have
made progress in this area. For example, the NIH Web site is now the
most accessed of all government health and science web sites. This
aspect of our mission will continue to be a priority for NIH.
biodefense
Civilian biodefense research has become a new core priority at NIH
and a prominent component of our budget. Over the last year and a half,
we responded to the most urgent needs of biodefense, namely the
development of countermeasures such as vaccines, therapeutics, and
diagnostic tests. These will allow us to respond to and control the
intentional or unintentional release of agents of terrorism that affect
human health, including infectious disease and microbial toxins. We are
also now systematically reviewing our portfolio of biodefense research
to include radiation and chemical exposures, and mental health
preparedness research. Biodefense research will be the topic of a
separate hearing.
Mr. Chairman, I am pleased to present the President's fiscal year
2004 request for the National Institutes of Health of $27,663 million
for the programs of NIH that fall under the purview of this Committee.
This level will allow us to support our highest research priorities and
continue the momentum we gained during the historic doubling of the NIH
budget. In large part this is possible because of the very significant
amount of one-time costs supported in fiscal year 2003 that will not be
required in fiscal year 2004. Once these have been taken into account,
NIH will be able to increase the amount available for research by 7.5
percent. Even after excluding increases for the Administration's
highest priority--homeland defense--the research components of the NIH
budget will still increase by 4.3 percent. The request will allow us to
support the highest number of new and competing grants in history--
10,509 new and competing grants. At this level, we will be able to
continue to support approximately one-in-three of the research grant
applications we receive. The final enacted fiscal year 2003
appropriation is very close to the President's request. In the coming
weeks, NIH will work with appropriate staff to clarify discrepancies
between the fiscal year 2003 request and the enacted level.
Special emphasis will be placed on areas of growing concern such as
obesity and diabetes, the IDeA program, and the Best Pharmaceuticals
for Children's Act. A total of $35 million is requested through the
Director's Discretionary Fund to support our important Roadmap
activities. As the fiscal year 2004 budget is developed, NIH will work
with appropriate staff to clarify discrepancies.
In sum, the plans I have outlined here today are ambitious and
rightly so. They rise to the many scientific opportunities and
significant health challenges that lie before us. Once again, my thanks
to you and the American public for your continued investment in
biomedical research to improve the health of everyone.
buildings and facilities program
The Buildings and Facilities (B&F) program supports the physical
infrastructure required to carry out the in-house component of the
biomedical research mission of the National Institutes of Health (NIH).
The fiscal year 2004 Buildings and Facilities budget request supports
efforts to sustain a robust, modern, safe and secure physical
infrastructure for the conduct of basic and clinical research and
research support across the spectrum of biologic systems and diseases.
The B&F budget request is the product of a deliberate, corporate
facilities planning process both within the NIH and the Office of the
Secretary, Assistant Secretary for Administration and Management, HHS.
At the NIH, the Facilities Planning Advisory Committee (FPAC) oversees
this process and provides advice to the NIH leadership and Director.
The FPAC is also instrumental in adjusting priorities as necessary to
deal with unanticipated public health challenges and changes in
national priorities. The goal of the planning process is to optimally
meet the changing facility needs of the NIH research programs in the
Washington, D.C., region and across the NIH field stations with a mix
of owned and leased facilities. The fiscal year 2004 Buildings and
Facilities (B&F) budget request supports the NIH's research
infrastructure priorities. The request includes projects and programs
to responsibly manage the repair and upkeep of the existing physical
infrastructure, and to maintain our facilities at an optimal operating
standard to meet mission as well as safety and regulatory requirements.
The NIH appreciates the support from Congress in fiscal year 2003
for NIH's Physical Security, Biodefense facilities, and the final phase
of the construction of the Mark O. Hatfield Clinical Research Center.
The fiscal year 2004 request maintains responsible funding support
for the ongoing safety, renovation and repair, and related projects
that are vital to proper stewardship of the entire portfolio of real
property assets and continues the functional integration of the
clinical research components of the existing Building 10 with the new
Mark O. Hatfield Clinical Research Center (CRC).
The fiscal year 2004 B&F budget request is organized among three
broad Program Activities: Essential Safety and Regulatory Compliance,
Repairs and Improvements, and Renovations. The fiscal year 2004 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 Strategic Facilities Planning process and are the
NIH's capital facility priorities for fiscal year 2004.
fiscal year 2004 budget summary
The fiscal year 2004 budget request for Buildings and Facilities is
$80 million. The B&F request includes a total of $14 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; $0.5 million to address indoor air quality concerns and
requirements at NIH facilities; and $5 million for the continued
support of the rehabilitation of animal research facilities. In
addition, the fiscal year 2004 request includes $60.5 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. Finally, the
request includes $5.5 million in Renovations for the Building 10
Transition Program.
My colleagues and I will be happy to respond to any questions you
may have.
______
Prepared Statement of Dr. Duane Alexander
Mr. Chairman and Members of the Committee: I am pleased to present
the fiscal year 2004 President's budget request for the National
Institute of Child Health and Human Development (NICHD). The fiscal
year 2004 budget includes $1,245 million, an increase of $41 million
over the fiscal year 2003 enacted level of $1,205 million comparable
for transfers proposed in the President's request. The NIH budget
request includes the performance information required by the Government
Performance and Results Act (GPRA) of 1993. Prominent in the
performance data is NIH's second annual performance report which
compares our fiscal year 2002 results to the goals in our fiscal year
2002 performance plan.
Forty years ago, the U.S. Congress charged the NICHD with a broad
mandate. The Institute was asked to develop a research program to
ensure that people are able to have children when they want them; that
every child is born healthy; that women suffer no adverse consequences
from the reproductive processes; and that children experience healthy
physical, cognitive, behavioral, and social development, reaching
adulthood free of disease and disability, and able to lead productive
lives.
We have made exceptional progress toward those goals during the
last 40 years. Infant mortality has been cut by more than 70 percent,
largely due to NICHD research that has lead to new ways to treat and
prevent respiratory distress syndrome, to manage premature infants, and
to reduce Sudden Infant Death Syndrome. Mental retardation in the
United States has been significantly reduced because we have conquered
and controlled some of its leading causes: Hemophilus influenza type b
(Hib) meningitis, phenylketonuria (PKU), measles encephalitis, and
jaundice. Infertility that deprived millions of couples from conceiving
children can now be diagnosed and in many cases treated. Transmission
of HIV infection from mother to baby has been reduced from 27 percent
to less than 2 percent in the U.S. as a result of research showing the
effectiveness of administering antiretroviral drugs to the mother
during pregnancy and to the infant just after birth.
We look forward to building on 40 years of scientific achievements
and we would like to share with you recent achievements that are
improving the health of the American people.
premature birth: new research may reverse a trend
The number of infants who are born prematurely is increasing. While
infant mortality rates have decreased significantly in recent years,
the number of premature low birth weight babies born has increased by
11 percent over the last two decades. The number of premature very low
birth weight infants, weighing less than 1,500 grams, has increased by
24 percent. Research supported by the NICHD has helped many premature
infants to survive. But these infants can develop neurological,
respiratory, or other conditions causing life-long disabilities.
Recently, NICHD scientists discovered that weekly injections of
progesterone, a readily available hormone, can lower premature birth by
more than one-third among women who are at risk of premature delivery.
In this study, like many clinical studies, some of the women received
the progesterone and some received a placebo injection. The results
were so dramatic that the scientists halted the study and administered
progesterone to all women enrolled in the study.
oral contraceptives and breast cancer: no association
The NICHD research has also provided reassuring evidence to women
and their physicians who may be concerned about a possible relationship
between oral contraceptive use and breast cancer. About 80 percent of
U.S. women born since 1945 have used oral contraceptives. Conflicting
studies had caused concern about the possible effect of oral
contraceptive use on breast cancer risk. The NICHD's Women's
Contraceptive and Reproductive Experiences Study found that women
between the ages of 35 and 64 who took oral contraceptives at some
point in their lives were no more likely to develop breast cancer than
other women the same age who never took oral contraceptives. Many women
who took oral contraceptives during their reproductive years are now
reaching the ages of greatest breast cancer risk. This study should
resolve the long-standing concern that oral contraceptive use might be
associated with an increased risk of breast cancer in later life.
vasectomy and prostate cancer: no association
Another study supported by the NICHD answered an important question
for men who have had vasectomies. About one out of six American men
over the age of 35 has had a vasectomy. Some studies conducted in the
United States in the early 1990s reported a moderately increased risk
of prostate cancer among men who underwent vasectomy. Other studies
found no such risk. Because of this conflicting evidence, many
urologists have increased prostate cancer screening of men who had
vasectomies and have discouraged vasectomies in men with a family
history of prostate cancer. The NICHD study found that men who had a
vasectomy were no more likely to develop prostate cancer than those who
had not had a vasectomy. The study also found that men who had
vasectomies as long as 25 years ago did not have an increased risk of
prostate cancer. These results should reassure men who have had or who
are considering a vasectomy.
stroke patients improve function of impaired limb
The results of other NICHD-supported research provide encouraging
news to some stroke victims. Until recently, therapy for stroke victims
often involved teaching patients to strengthen their less impaired limb
for several weeks after a stroke. The prevailing view among
rehabilitation professionals was that patients' motor ability reached a
plateau at about six months after a stroke. They believed that
additional therapy would provide little if any additional benefit. But
new research has shown that the use of the impaired limb can improve
significantly a year or more after a stroke. Using ``Constraint Induced
Therapy,'' researchers showed that constraining the good or less
affected limb for 10 days can help restore a great deal of mobility to
the impaired limb.
traumatic brain injury network for better treatments
Traumatic brain injury is one of the leading causes of death and
disability in children and adults. An estimated two million head
injuries occur in the United States each year. As a result of advances
in emergency medicine at the accident scene and the hospital, many TBI
victims are living longer. However, many will live with persistent
physical, cognitive, behavioral and social deficits that compromise
their quality of life. Research over the last two decades has
demonstrated that not all neurologic damage occurs at the moment of
injury, but evolves over the minutes, hours, and days after an
accident. Research also has dramatically improved the immediate care,
follow-on care, and rehabilitative process for TBI patients. Yet there
are many unanswered questions about the underlying damage and the
reasons for reduced functioning associated with TBI. In addition, to
determine the most appropriate therapies for children and young adults
with TBI, multiple sites are needed to evaluate various interventions
with many patients. To address this need, the NICHD recently
established the Traumatic Brain Injury Clinical Trials Network. The
Network will evaluate medical, rehabilitative, and educational
interventions to identify which ones most effectively improve the long-
term outcomes of TBI patients.
new fragile x centers will develop treatment options
Fragile X syndrome is the most common genetically-inherited form of
mental retardation currently known. The condition occurs in every 1 out
of 2,000 males and in 1 in 4,000 females. The syndrome is caused by a
mutation in a specific gene (FMR1) on the X chromosome. In its fully-
mutated form, the FMR1 gene interferes with normal development. In a
partially mutated (premutation) form, the FMR1 gene can cause fragile X
syndrome in the children of a carrier (a person who has the premutation
gene). Until recently, however, the premutation form was not thought to
cause symptoms in carriers. Scientists have now identified a subgroup
of premutation FMR1 carriers with symptoms that appear to be associated
with the gene. Symptoms included mild cognitive and emotional problems
and, in female carriers, premature menopause. In older male carriers,
the premutation gene is associated with a neurological syndrome.
Identifying a genetic basis could be a first step toward accurate
diagnosis and, possibly, development of new treatments for these often
overlooked symptoms. In addition, to develop improved diagnostic
techniques and treatment options, the NICHD will begin funding three
new Fragile X research centers in fiscal year 2003. Each center will
call upon the combined expertise of several researchers working in
diverse fields to investigate different aspects of the disorder. The
new Fragile X Research Centers will study issues such as how the
fragile X affects the developing brain and nervous system, how the
disorder progresses throughout an individual's life span, and effective
treatments that can improve the behavior and mental functioning of
people with fragile X syndrome.
strategic alliances with minority groups to reduce sids
Less than ten years ago, the NICHD initiated a campaign urging
parents and care takers to place infants on their backs to sleep to
reduce the risk of Sudden Infant Death Syndrome (SIDS). Since that
time, the SIDS rate in the U.S. has declined by more than 50 percent.
This dramatic decline represents a significant public health
achievement because the SIDS rates had remained tenaciously steady
prior to the NICHD campaign. Although the SIDS rates have declined in
all populations since the campaign began, the SIDS rate among African
American infants remains double that of white infants. Among Alaska
Natives and many American Indian tribes, the rates are higher still. To
begin closing this gap, the NICHD has formed strategic alliances with
the Alpha Kappa Alpha sorority, The National Coalition of 100 Black
Women, and The Women in the NAACP. In collaboration with these
organizations, the NICHD has planned and will support a series of
``summit'' meetings in three U.S. cities with high rates of African
American SIDS deaths. These summits will enlist the resources of faith-
based and community organizations, public health officials, and service
organizations to help establish an infrastructure that will provide
information, material, and support for reducing SIDS among African
American infants. Each organization will take the lead in organizing
one of the summit meetings and will continue to serve as the catalyst
for SIDS risk reduction activity in that city and its surrounding
region.
The NICHD has also initiated a project with American Indian and
Alaska Native groups to reduce SIDS and infant mortality in these
populations. At NICHD-sponsored meetings in Minneapolis, MN and Rapid
City, SD, representatives of Tribal Chairman's Health Boards and Alaska
Native health organizations provided the NICHD with a blueprint to
support the activities of community health workers involved in SIDS
risk reduction education. The NICHD will develop and disseminate the
materials for this effort during the current year.
testing drugs to improve health of children and pregnant women
In fiscal year 2004, the NICHD will continue to invest in research
and programs that benefit the American people. One such investment is
the fulfillment of the Best Pharmaceuticals for Children Act (BPCA).
The immature physiology of children means that drugs approved to
prevent or treat illness in adults may have different effects in
younger patients, requiring children's physicians to prescribe
different doses and make other adjustments in drug therapies. However,
for approximately seventy-five percent of the pharmaceuticals approved
by the Food and Drug Administration (FDA) for adults, there are
inadequate safety and efficacy data to allow approval for pediatric
uses, or to guide physicians in prescribing these drugs for children.
The BPCA, signed into law in January 2002, directs the NIH to issue
contracts to test in children off-patent prescription drugs already
approved for adults. Working with the FDA and other experts, the NICHD
identified a priority list of drugs to be tested through the
Institute's Pediatric Pharmacology Research Units (PPRUs) and at other
sites. The fiscal year 2004 budget request includes an increase of $25
million, across all of the NIH Institutes and Centers (ICs), for these
studies.
Drugs prescribed to pregnant women are also a concern. Although
nearly two-thirds of all pregnant women take at least four to five
drugs during pregnancy and labor, the effects of these prescribed drugs
on a pregnant woman and her fetus remain largely unstudied. In
addition, little is known about how pregnancy-related changes in
cardiac output, blood volume, intestinal absorption, and kidney
function may influence drug absorption, distribution, utilization, and
elimination. Therefore, the NICHD will establish a new network of
Obstetric-fetal Pharmacology Research Units that will allow
investigators to conduct key pharmacologic studies of drug disposition
and effect during normal and abnormal pregnancies.
expansion of newborn screening through microarray technology
At present, all states routinely screen all newborns for only two
disorders: phenylketonuria (PKU) and congenital hypothyroidism. These
are conditions for which effective treatments are available. In
addition, most states screen for a mix of 1 to 15 other disorders, but
some commercially available tests can screen for up to 50 conditions. A
Secretarial-level panel and the American Academy of Pediatrics have
recommended that an expanded and standardized approach to newborn
screening be developed. To address this need, the NICHD proposes to
apply the knowledge and techniques garnered from the Human Genome
Project. Using cord blood and microarray technology, there is the
potential to identify disease genes at birth for more than 200 single
gene defects associated with mental retardation, nearly 100 associated
with immunodeficiency disorders, approximately 10 causes of muscular
dystrophy, and cystic fibrosis. Although treatments are available for
many of these conditions, effective study of potential new treatments
for others requires a population who has not yet developed symptons of
the condition. Screening of newborn infants can provide this
population. This testing could be done in one procedure so that
economies of scale and simplicity may overcome one of the major
obstacles to widespread acceptance of expanded newborn screening: cost.
The NICHD will collaborate with several other ICs, research
institutions, and industry to develop the appropriate microarray chip
and associated technology for mass screening and pilot test the new
screening technology. This approach would maximize the use of newborn
screening for preventive purposes. Moreover, by developing this
translational research, NICHD will fulfill one of the objectives of the
NIH road map activities.
Mr. Chairman, I will be happy to provide answers to any questions
you have.
______
Prepared Statement of Dr. James F. Battey, Jr.
Mr. Chairman and Members of the Committee, I am pleased to present
the President's budget request for the National Institute on Deafness
and Other Communication Disorders (NIDCD). The fiscal year 2004 budget
includes $380,377,000, which reflects an increase of $10,190,000 over
the fiscal year 2003 enacted level of $370,187,000 comparable for
transfers proposed in the President's request. Disorders of human
communication exact a significant economic, social, and personal cost
for many individuals. The NIDCD supports research and research training
in the normal and disordered processes of hearing, balance, smell,
taste, voice, speech, and language. Results of NIDCD's research
investment will foster the development of more precise diagnostic
techniques, novel intervention and prevention strategies, and more
effective treatment methods for the millions of Americans with
communication disorders. My testimony will highlight some examples of
research progress in human communication sciences.
Cochlear Implants.--If Ludwig van Beethoven were able to reverse
his deafness and regain his hearing again as he reached the climax of
his career as a composer, would the world have been blessed with even
more of his music? Scientific technology has advanced significantly
since the 18th century, and assistive hearing devices are now able to
restore sound perception to deaf individuals. One such device, the
cochlear implant, has provided hope to thousands of deaf individuals
worldwide. A cochlear implant converts sound into electrical impulses,
bypassing the damaged sensory hair cells that detect sound, stimulating
the auditory nerve directly and restoring sound perception. According
to the Food and Drug Administration 2002 data, approximately 59,000
people worldwide have received cochlear implants. In the U.S., about
13,000 adults and nearly 10,000 children have received them. With over
30 years of NIH research investment, the cochlear implant has evolved
from an experimental device to a commercially available treatment to
assist those who are profoundly deaf or severely hearing impaired.
Hereditary Deafness Gene Discovery.--Within the last seven years,
over 70 different genes for hearing loss that is not associated with
other inherited characteristics (nonsyndromic hereditary hearing
impairment) have been mapped and over 25 identified. In addition,
several genes essential for normal auditory development and/or function
have been identified using mouse models. Recently, scientists have
discovered a new gene of unknown function, TMC1, in which mutations
cause deafness. NIDCD intramural scientists have identified a mutation
in the mouse Tmc1 gene which causes similar types of dominant and
recessive hearing loss found in large human family studies. In mice,
mutations in the Tmc1 gene causes defects in the function of the
specialized sensory hair cells of the inner ear. Hair cells detect and
convert the physical stimulus of sound into electrical impulses sent to
the brain via the auditory nerve. This research contributes to new
models for studying specific forms of human deafness.
Sensory Stereocilia Renewal Aid Recovery to Hearing Loss.--
Stereocilia, or hair cell bundles, are fine projections in the inner
ear that vibrate when stimulated by sound. The movement of the
stereocilia activates a molecular pathway that generates an electrical
signal from the auditory nerve to the brain, which is interpreted to be
sound. Stereocilia are located in the surface of the inner ear and are
supported by a rigid and dense core of filaments. Until recently, this
core was thought of as a stable structure whose sole function was to
serve as rigid supports for changes in the mechanical property of the
hair cells. NIDCD intramural scientists have discovered that there is a
continuous renewal of the stereocilia core every 48 hours. This process
occurs in the mature bundles during recovery from temporary noise-
induced hearing loss and suggests that the stereocilia core structure
plays an unforeseen role in this recovery process. Such a renewal
mechanism could also provide more information on the molecular basis of
genetic, environmental, and age-related inner ear disorders that
involve malformation or disruption of stereocilia.
Motor Protein Facilitates the Speed of Sound.--One important
component in the mechanical transmission of sound from the ear to the
brain is Myosin-1C, a major motor protein involved in the movement of
the stereocilia in the inner ear. It is hypothesized that motor
proteins serve as the link between the stereocilia's membrane and cell
core thereby changing the polarity of hair cells following sound
vibration. NIDCD-supported scientists are in the process of deciphering
how Myosin-1C works. Specifically, they used a chemical-genetic
approach to inhibit Myocin-1C motor protein activity in mice by
introducing a custom designed amino acid that alters the protein's
function. The designer amino acid rendered the protein susceptible to a
controllable inhibitor, thus allowing regulation of the protein's motor
function. These results demonstrate the importance of Myosin-1C in
transmitting sound to the brain, allows observation of protein function
in a controllable native environment and permits assessment of protein
function in a biological process.
Antibiotic Controls the Vertigo of Meniere's Disease.--Meniere's
disease is a distressing and often disabling disorder of inner ear
function, characterized by spontaneous attacks of vertigo, fluctuating
hearing loss, tinnitus and fullness in the ear. When vertigo cannot be
controlled by diet or medication, severing of a vestibular nerve from
the affected ear usually controls vertigo while preserving hearing.
NIDCD-supported scientists have demonstrated that a single injection of
the antibiotic, gentamycin, through the eardrum into the middle ear
space, is an alternative to surgery and is effective in diminishing
vestibular response and in controlling vertigo in individuals with
Meniere's disease. Experimental studies suggest that gentamycin reduces
vestibular responsiveness, and hence, vertigo, by causing a toxic
effect on the vestibular hair cells, the sensory receptors that detect
head motion stimuli and orientation.
Odorant Receptors Help Mosquitoes Smell Their Prey.--The sense of
smell (olfaction) plays an important role for blood-feeding female
mosquitoes in finding a host. Mosquito-borne disease is a serious world
health concern, and the mosquito is known to transmit a variety of
deadly diseases, including malaria, West Nile virus, dengue and yellow
fever. Host preference, especially to humans, in the female mosquito is
a critical component of disease transmission. NIDCD-supported
scientists are characterizing the genes that play a role in the
function of the olfactory system of Anopheles gambiae and have
identified odorant receptor-encoding genes selectively expressed in the
olfactory organs of this malaria-transmitting mosquito. Blood-feeding
and host preference selection involve only the female mosquito, so the
scientists studied the expression of odorant receptor genes, AgOr, in
the female mosquito's primary olfactory organ--its antennae. It was
observed that AgOr1 is turned off in the olfactory tissue of the female
mosquito 12 hours after a blood meal, which is consistent with
decreased host-seeking behavior. These findings suggest that AgOr1 may
detect an olfactory signal that is active in female mosquitoes before
but not after a blood meal. Developing selective antagonists to AgOr1
may help to control the transmission of malaria and other mosquito-
borne diseases, and may also represent a novel disease prevention
approach that is based on an understanding of olfactory receptor genes.
In addition, these findings may ultimately be useful in developing new
repellants and attractants that are more effective, economical and
ecologically friendly.
Discovery of an Amino Acid Taste Receptor.--Taste is responsible
not only for attraction and repulsion to various foods but is also
responsible for providing important information about the chemical
environment. The basic taste qualities are sweet, sour, salty, bitter
and umami (the taste of monosodium glutamate or the taste associated
with protein-rich foods). A major challenge in taste research is
identifying the various types of taste receptors on the tongue that
respond to different structurally diverse compounds. Recently,
scientists have identified a taste receptor dedicated to tasting amino
acids, the building blocks of proteins that are involved in the
biological processes in the body. It has been known that sweet-,
bitter- and umami-tasting substances activate G-protein-coupled
receptors in the tongue. NIDCD-supported scientists discovered that two
subunits in the T1R receptor family, T1R1 and T1R3, can combine to form
an amino acid receptor, T1R1+3, that responds to most of the 20
standard amino acids. Identification of an amino acid taste receptor
provides a new tool to help scientists decode the molecular basis for
detecting different taste qualities in mammals.
Do Stutterers Have Different Brains?--To study the brain activity
patterns in the cortical speech-language areas of the brain of
individuals who stutter, NIDCD-supported scientists performed brain
imaging studies on two groups of adults; those with or without
persistent developmental stuttering (PDS). Results of the analysis
showed that differences in the speech-language areas of the brain are
more common in adults with PDS, although no one anatomic feature
accounted for the group differences. The major anatomic finding was
that the size of the right and left planum temporale (PT) of the brain
were significantly larger in the adults with PDS. The PT is important
for higher order processing of language information. The results about
the PT size and other findings, such as variations of infolding
patterns of the brain, demonstrate that atypical size or shape of the
speech-language area may put individuals at risk for stuttering.
Speech-Sound Disorders are Risk for Later Academic Impairments.--
Children with speech-sound disorders often have difficulties in other
areas of language as well. These disorders are characterized by the
inability to use speech sounds that are normal for the individual's age
and dialect. Speech-sound disorders involve language difficulty
affecting an individual's ability to learn and organize speech sounds
into a system of sound patterns. Poor awareness of speech skills and a
weakness in vocal sound classification in verbal memory may put
children of preschool age with speech-sound disorders at risk for later
spelling difficulties. In a recent NIDCD-supported study, the spelling
errors of children with history of speech-sound disorders were analyzed
to predict the association between weaknesses in spoken language skill
in early childhood and school-age spelling abilities. The findings of
this study support previous research indicating that children with
early speech-sound disorders are at risk for later spelling
difficulties. Evidence from studying these families raises the
possibility of a common genetic cause for speech/language and written
language disorders. Although the genetic cause for these disorders is
not known, specific signs of the disorder suggest a male gender bias
since brothers were also more likely to have the disorder than sisters.
The findings of this study reveal that preschool children with speech-
sound disorders are at risk for later spelling impairments even after
productive speech disorders have resolved.
A Possible Gene for Childhood Language Disorders.--Children who
fail to develop language normally (in the absence of factors such as
neurological disorders, hearing impairments, or lack of adequate
opportunity) have specific language impairment (SLI). SLI has a
prevalence of approximately 7 percent in children entering school and
is associated with later difficulties in learning to read. Research
studies have consistently demonstrated that SLI clusters in families,
suggesting that genetic factors may be an important cause of SLI.
NIDCD-supported scientists are scanning the genome for the location of
the gene suspected of causing SLI, by studying families where multiple
members have with language/reading disorders. The study showed
significant evidence of a link between a region of chromosome 13 and
susceptibility to SLI. Further analysis also suggests two additional
gene locations on chromosomes 2 and 17 that may play a role in SLI. In
addition, mutations in the same region in chromosome 13 is implicated
in autism, and some children with autism show language deficits that
are very similar to SLI.
Mr. Chairman and Members of the Committee, these are just a few
examples of NIDCD's research advances. I would be pleased to answer any
questions you may have.
______
Prepared Statement of Dr. Francis S. Collins
Mr. Chairman and Members of the Committee: Due in great part to the
visionary leadership and commitment of Congress, this month the
International Human Genome Project (HGP), led by the National Human
Genome Research Institute (NHGRI) of the National Institutes of Health
(NIH), will have accomplished all of its original goals, ahead of
schedule and under budget. This historic achievement, in the month of
the 50th anniversary of Watson and Crick's seminal publication of the
structure of DNA, opens the genomic era of medicine. April will also
witness the publication of a bold vision for the future of genomics
research, developed by the NHGRI. This vision, the outcome of almost
two years of intense discussions with hundreds of scientists and
members of the public, has three major areas of focus: Genomics to
Biology, Genomics to Health, and Genomics to Society.
Genomics to Biology.--The human genome sequence provides
foundational information that allows development of a comprehensive
catalog of all of the genome's components, determination of the
function of all human genes, and deciphering of how genes and proteins
work together in pathways and networks.
Genomics to Health.--Completion of the human genome sequence offers
a unique opportunity to understand the role of genetic factors in
health and disease, and to apply that understanding rapidly to
prevention, diagnosis, and treatment. This opportunity will be realized
through such genomics-based approaches as identification of genes and
pathways and determining how they interact with environmental factors
in health and disease, more precise prediction of disease
susceptibility and drug response, early detection of illness, and
development of entirely new therapeutic approaches.
Genomics to Society.--Just as the HGP has spawned new areas of
research in basic biology and in health, it has created new
opportunities in exploring societal issues. These include analysis of
the impact of genomics on concepts of race, ethnicity, kinship,
individual and group identity, health, disease, and ``normality'' for
traits and behaviors, and defining policy options regarding the use of
genomic information in both medical and non-medical settings.
new nhgri initiatives
The NHGRI has already begun several new initiatives, and is
planning others, to meet the challenge of this new vision for the
future of genomics. Below are examples of these cutting edge programs.
The Creation of a Human Haplotype Map
Multiple genetic and environmental factors influence many common
diseases, such as diabetes, cancer, stroke, psychiatric disorders,
heart disease, and arthritis; however, relatively little is known about
the genetic basis of common diseases. The NHGRI has begun to create a
``haplotype map'' of the human genome to enable scientists to find the
genes that affect common diseases more quickly and efficiently. The
power of this map stems from the fact that each DNA variation is not
inherited independently; rather, sets of variations are inherited in
blocks. The specific pattern of particular genetic variations in a
block is called a haplotype. This new initiative, an international
public/private partnership led and managed by NHGRI, will develop a
catalog of haplotype blocks, the ``HapMap.'' The HapMap will provide a
new tool to identify genetic variations associated with disease risk or
response to environmental factors, drugs, or vaccines. Ultimately, this
powerful tool will lead to more complete understanding of, and improved
treatments for, many common diseases.
The ENCODE Project: ENCyclopedia Of DNA Elements
To utilize fully the information that the human genome sequence
contains, a comprehensive encyclopedia of all of its functional genetic
elements is needed. The identity and precise location of all
transcribed sequences, including both protein-coding and non-protein
coding genes, with their structure, transcription start sites,
polyadenylation sites, and alternative splicing variants must be
determined. The identity of other functional elements encoded in the
DNA sequence, including promoters, enhancers, and other transcriptional
regulatory sequences, and determinants of chromosome structure and
function, such as origins of replication and hot spots for
recombination, also is needed. The NHGRI has developed a public
research consortium to carry out a pilot project, focusing on a
carefully chosen set of regions of the human genome, to compare
existing and new methods for identifying functional genetic elements.
This ENCyclopedia Of DNA Elements (ENCODE) consortium, which welcomes
all academic, government, and private sector scientists interested in
facilitating the comprehensive interpretation of the human genome, will
greatly enhance use of the human genome sequence to understand the
genetic basis of human health and to stimulate the development of new
therapies to prevent and treat disease.
Chemical Genomics
One novel way that the NHGRI plans to pursue translating genomics
to human health is the development and deployment to the biomedical
research community of libraries of small organic compounds. This is a
fundamentally new approach for research in the public sector, and will
accelerate understanding of the function of the human genome and the
development of new treatments. The NHGRI proposes to use the types of
organic molecules in most marketed pharmaceuticals, ``drug-like,'' or
``small'' molecules, as a core of this resource. In collaboration with
other NIH institutes, the NHGRI is planning for a resource that
includes: (a) large libraries of chemical compounds of appropriate
structural diversity and properties; (b) assay development capacity;
(c) robotic assay capacity, also termed high throughput screening
(HTS); (d) medicinal chemistry capacity to transform ``hits''
identified by HTS into workable chemical probes; and (e) distribution
capacity to disseminate the reagents to the biomedical research
community efficiently.
Genome Technology Development
The NHGRI continues to invest in technology development that
furthers the uses of genomics. Technical advances have caused the cost
of sequencing to decline dramatically, from $10 to less than $0.09 per
base pair, but this cost must decline even further for all to benefit
from genomic advances. The NHGRI, along with many partners, will
actively pursue the development of new technologies to sequence any
individual's genome for $1,000 or less. Other areas of technology
development are also ripe for expansion and the NHGRI plans to pursue
them vigorously.
Studying the Genetic Basis of Health
Analytic methods to find genetic variants that contribute to
disease can also help find genes and genetic variants that contribute
to health. The NHGRI plans to support development of new tools and
analytical methods to discover the genetic components of resistance to
diseases, disorders, toxins, and drug reactions. By finding genetic
variants that convey reduced susceptibility, researchers will better
understand disease processes and how to slow, or even prevent, them.
Promising approaches for identifying disease-resistant gene variants
include studying people at high risk for a disease who do not develop
it, relatives of people with disease who do not themselves have the
disease, or individuals who reach extreme old age without serious
illness.
recent scientific advances in genomics
Progress in Sequencing Model Organisms
From the Human Genome Project's outset, the NHGRI and its partners
have included, among their research goals, mapping and sequencing the
genomes of several non-human organisms, since they would be of great
value in understanding the biological data encoded in the human DNA
sequence and, thus, in combating human disease. Genomic sequences for a
number of important organisms, beyond those initially identified by the
HGP, have been determined. Primary among these is the laboratory mouse.
In December 2002, an analysis of an advanced draft of the mouse genome
was published and provided a key tool for interpreting the human
sequence. The first assembly of the rat genome sequence was announced
in the same month by the Rat Genome Sequencing Project. A peer review
process now selects new genomes to sequence. To champion an organism,
scientists write a ``white paper'' that presents arguments for
prioritizing their proposed target for sequencing. After two rounds of
white papers, this process determined the highest priority as: chicken,
chimpanzee, cow, dog, a set of fifteen fungi, honeybee, sea urchin, and
two protozoans. Sequencing of the chicken, chimpanzee, and honeybee has
already begun.
ethical, legal and social implications of genetic research
The NHGRI devotes five percent of its annual budget to research
involving the ethical, legal and social implications (ELSI) of genetics
and genomics. Below are examples of this program's important work.
Genetic Discrimination
Most Americans are optimistic about the use of genetic information
to improve health, but many are also concerned that insurers and
employers will misuse genetic information. These concerns deter
participation in important biomedical research and the clinical use of
genetic information. The NHGRI has supported research efforts to
elucidate this issue. Such research has helped inform legislative
activity; over 40 states have passed genetic nondiscrimination bills.
Reducing Health Disparities
The NHGRI recognizes the critical importance of ensuring that the
potential of genomic research benefits all racial and ethnic groups.
The NHGRI has taken steps to engage and empower minority communities in
genomic research. The rewards of genomic research will be realized only
with active participation of all racial and ethnic groups. An important
area of genomic research is investigating how DNA sequence variation
affects differing susceptibility to disease among various populations.
The significant societal ramifications of this research also need
attention. Genomic research affects all populations; thus, all groups
need to set the research agenda and examine the broader issues it
raises. The NHGRI has intensified its efforts to address health
disparities by developing a strategic plan that identifies goals in
areas such as research projects, information sharing, development of
partnerships, and increasing diversity of the research workforce.
Effects of Gene Patents and Licenses on Genetic Testing and Research
The NHGRI continues to be concerned about the issues of gene
patenting and licensing. To gain a better understanding of these
issues, it has funded case studies and surveys to describe and analyze
the effects of patents that award proprietary claims to the use of DNA
sequences. The NHGRI held a roundtable discussion in December 2002 with
outside experts in gene patenting to explore the ramifications on
healthcare delivery and research of patenting and licensing genetic
sequence data and single nucleotide polymorphisms. The NHGRI will
utilize the insights provided at this roundtable to define further
research to inform the policy process.
conclusion
This year marks a very exciting transition in the field of
genomics, with the full sequencing of the human genome marking the
successful achievement of all of the HGP's original goals, and thus the
advent of the genomics era. When Congress decided to fund the HGP it
did so with the justifiable belief that this work would lead to
improved health for all. The ability to accelerate the realization of
this vision now lies before us. At the same time, we must be sure that
all our citizens have access to these technological advances and that
this information is not misused. It is our sincere belief that the
newly created discipline of genomics will make a profound difference on
the health and well being of the people of this world. We are
profoundly grateful for the support the Congress has given to this
program.
Mr. Chairman, I am pleased to present the President's budget
request for the National Human Genome Research Institute. The fiscal
year 2004 budget includes $478,072,000, an increase of $13,467,000 over
the fiscal year 2003 enacted level of $464,605,000 comparable for
transfers proposed in the President's request.
______
Prepared Statement of Dr. Andrew C. von Eschenbach
The early part of the 21st century promises to be a period of
unprecedented progress in conquering our most debilitating diseases
especially cancer. The nation's unwavering support of the biomedical
research enterprise, in particular, the unified effort by this
committee, all of Congress, and the President to double the NIH budget
over the past five years, has positioned us to attack this devastating
disease more effectively. Cancer affects nearly every family in
America. In 2003, 1.4 million of our citizens will face a diagnosis of
cancer--and over 560,000 of our citizens will die from their disease
this year. Every day, 1,500 Americans lose their own battle with
cancer. These are daunting statistics, and the aging of the baby boomer
population and shifting demographics of America during the next 15-20
years represent enormous healthcare and economic challenges that we
must begin to prepare for now.
But, there is reason for optimism! Our nation's investment in basic
research has fueled the engine of discovery, thereby enabling
unparalleled advances in illuminating the genetic changes and molecular
mechanisms that ultimately produce cancer. The sequencing of the human
genome and associated progress in new areas such as functional
genomics, animal models of cancer, and proteomics, provide us with a
clearer picture of the disturbances that cause cancer to develop and
ravage the human body. For the first time, we have within our grasp the
ability to design target-specific interventions to preempt this
process. We must enrich these extraordinary advances in basic science
with equally extraordinary efforts to develop new agents and
technologies to actualize these interventions at key steps in cancer
progression. We now understand that cancer is a process--a process with
multiple opportunities to develop new, more effective interventions to
prevent, detect and treat cancer.
To capitalize on this knowledge, we must significantly accelerate
the pace of progress across the entire research continuum. The pathway
begins with discovery of knowledge that underpins the development of
new molecules and tools and ends with the delivery of diagnostics and
therapeutics to patients. Discovery, development and delivery are
interlinked, and it is crucial that we take the steps needed to ensure
that all phases of the research enterprise are functioning optimally.
I believe that we stand at an ``inflection point'' in our nation's
effort to conquer cancer. The research enterprise has delivered
remarkable scientific achievements in biomedical research over the past
decades, and we now are positioned to experience a rapid increase in
the trajectory of this research. This affords us an unprecedented
opportunity to harness strategically these achievements to confront the
challenges of cancer today and tomorrow.
We now envision a time when the suffering and the death that are
caused by cancer will be eliminated; and we believe that it is
realistic to set ourselves a challenge goal to achieve this vision by
the year 2015. I have presented the cancer research community with this
challenge and am confident that they will achieve the goal. I want to
be clear what we mean by ``reduce suffering and death from cancer,''
and to explain why I believe that this vision is achievable.
We are not saying that all cancer will be cured or eliminated. What
we are saying is that in this 12-year time-frame, many cancers will be
cured, but many more will be transformed into chronic, manageable
diseases that patients can live with--not die from. There is precedent
for this paradigm shift. In a single generation, we made enormous
strides in reducing deaths from coronary artery disease and converting
this disorder into a condition that people live with and manage.
Likewise, using our knowledge of the AIDS virus, molecular biology, and
skills in developing target-based therapy, we have developed treatments
for AIDS patients that both save lives and preserve quality of life. I
think we can do the same for cancer.
This vision presents new challenges for the NCI and for everyone
working to conquer this devastating disease. We will meet those
challenges by further strengthening basic research, especially in
advancing our understandings about the mechanisms of cancer
progression. In parallel, we will intensify our focus on developing the
clinical research and delivery systems needed to provide the promise of
everything that science can provide to everyone in need.
I discovery, we will establish a national effort to ``map'' the
critical events of the complex of integrated cancer disease pathways at
the cellular level. This ``systems biology approach'' will allow us to
dissect strategically the complex and redundant reactions and
interactions within cells, and will enhance our technical capabilities
to identify molecular targets and create new therapies. We will also
focus on the exploration of new technologies, in reas such as molecular
imaging, proteomics and genomics, and nanotechnology. These new
technologies offer the promise of developing new platforms to monitor
cells, identifying intricate molecular changes, and delivering
therapeutics to specific targets within the cell. The application of
these advanced technologies is no longer a dream. Advances in positron
emission tomography, coupled with new molecular imaging agents, now
make functional monitoring possible, permitting clinicians to
``visualize'' the biologic progress of cancer. Scientists and engineers
are working to achieve this goal through NCI's unique programs that
foster the development of innovative technologies for cancer diagnosis
and treatment.
The NCI will also place new emphasis on the development process--
the translation of basic research advances into new products that are
ultimately delivered to cancer patients. This is especially true in the
area of cancer therapeutics. It currently takes 15-20 years for a
promising new molecule to reach patients. That is just unacceptable in
the 21st century. Genomics and proteomics are providing us with
hundreds, potentially thousands, of new therapeutic targets for cancer;
but the enterprise is not optimized to develop and deliver these ``new
paradigm'' drugs. This is a systems problem and it can be solved. In
collaboration with he NIH, the Food and Drug Administration (FDA) and
other partners, we will work to ``re-engineer'' the clinical trials
infrastructure for the evaluation of new cancer interventions.
Underpinning all of these initiatives will be the deployment of a
bioinformatics infrastructure that will allow us to use artificial
intelligence to convert massive amounts of data into new knowledge that
will inform discovery, development, and delivery to benefit patients.
The NCI will undertake programs to optimize the process of
developing new drugs trough an emphasis on validating new cancer
targets. We will also work more closely with the FDA to facilitate the
science necessary to create a seamless system of drug discovery,
development, and delivery. To achieve these goals, the NCI will create
novel partnerships with all of the sectors involved in developing and
delivering these new drugs. In all that we do, we will encourage the
removal of barriers that separate us by creating a new environment that
encourages and rewards multi-disciplinary research.
The emerging field of proteomics provides us with unimagined
opportunities to apply these new targeted therapies and preventive
strategies by detecting cancer early enough to stop, slow, or possibly
reverse disease progression. Novel disease biomarkers are finally
providing us with new screening tools to detect early-stage cancer in
populations and individuals; and the NCI will utilize its enormous
strength in molecular epidemiology to provide rational strategies for
cancer prevention and disruption of progression within populations.
All of these tactics will be directed to reducing suffering and
death from cancer. That does not mean that we will lessen our emphasis
on curing cancer--quite the opposite--but that will no longer be our
only defining goal. We will also embrace the vision of changing the
course of cancer by reducing its morbidity and mortality through the
application of technologies and knowledge that were only a dream just a
few short years ago. Those dreams can become reality.
Finally, I believe we stand at a pivotal crossroads--a defining
moment in the history of this nation's effort to prevent and cure
cancer. We now embark on a new course that will enable patients to live
with cancer as a chronic, non-debilitating disease that doesn't
threaten their vitality, careers, and families. An ever increasing body
of scientific knowledge and an array of advanced technologies provide
us with the opportunity to detect cancer early and preempt the
progression of the disease. We will be able to remove the fear of
cancer for many more people, but more importantly for those who must
live with their disease, life will take on new meaning. We have within
our grasp the power to eliminate the suffering and death from cancer--
and we will succeed.
budget statement
The fiscal year 2004 budget includes $4,770 million, an increase of
$183 million over the fiscal year 2003 enacted level of $4,587 million
comparable for transfers proposed in the President's request.
______
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 2004 budget includes $4,335,255,000, an increase
of $631,126,000 over the fiscal year 2003 enacted level of
$3,704,129,000 comparable for transfers proposed in the President's
request. The NIAID budget request includes the performance information
required by the Government Performance and Results Act (GPRA) of 1993.
Prominent in the performance data is NIAID's third annual performance
report, which compares our fiscal year 2002 results to the goals in our
fiscal year 2002 performance plan.
niaid: an overview
Since 1948, NIAID has conducted and supported basic research into
the etiology and pathogenesis of allergic, immunologic, and infectious
diseases, as well as targeted research to develop new and improved
interventions to prevent, diagnose, and treat these illnesses. Over the
past half century, and in the past decade in particular, progress in
the core disciplines of the Institute--immunology, microbiology, and
infectious diseases--has been extraordinary. The rapid growth in
scientific knowledge and the availability of new research tools has
facilitated the development of numerous vaccines, therapies and other
interventions that have saved or improved the lives of millions of
individuals. For example, NIAID-supported scientists helped develop
many of our most useful vaccines, including new or improved vaccines
that protect against invasive Haemophilus influenzae type b (Hib)
disease, pneumonia and meningitis caused by pneumococcal bacteria,
pertussis, influenza, measles, mumps, rubella, chickenpox, and
hepatitis A and B. These and other vaccines helped reduce infectious
disease mortality in the Unites States more than 14-fold in the 20th
century.
The scientific advances realized during 55 years of NAID research
have been applied to long-standing global health problems such as
asthma, autoimmune diseases, diarrheal diseases, malaria, and
tuberculosis, as well as to diseases and pathogens that have recently
emerged or re-emerged. Examples of the latter include the acquired
immunodeficiency syndrome (AIDS), highly virulent influenza viruses,
West Nile virus, drug-resistant microbes, severe acute respiratory
syndrome (SARS), and a new kind of emerging disease--one spread
deliberately by bioterrorists. As has been the case with AIDS and other
emerging health crises, the NIAID response to the threat of
bioterrorism has been swift and comprehensive, resulting already in
important progress both in basic science and in the development of
biodefense countermeasures.
niaid biodefense research
The anthrax attacks in the fall of 2001, which occurred soon after
the horror of the September 11 terrorist assaults on the World Trade
Center and the Pentagon, starkly exposed the vulnerability of the
United States and the rest of the world to bioterrorism. Since the fall
of 2001, NIAID has rapidly accelerated basic and clinical research
devoted to the prevention, diagnosis, and treatment of diseases caused
by potential agents of bioterrorism. Indeed, biodefense research
spending now accounts for approximately one-third of the NIAID research
portfolio. Our efforts have focused both on ``Category A'' agents
considered to be the worst bioterror threats (smallpox, anthrax,
botulinum toxin, plague, tularemia, and hemorrhagic fever viruses such
as Ebola), as well as on a longer list of Category B and C priority
pathogens agents that also pose significant threats to human health.
The NIAID biodefense program is guided by the NIAID Strategic Plan for
Biodefense Research, as well as by detailed research agendas for
Category A agents and Category B and C priority pathogens. Each of
these documents was prepared in consultation with blue-ribbon panels of
experts, and delineates immediate, intermediate, and long-range NIAID
plans for biodefense research and countermeasures development. Using
the roadmap outlined in these agendas, NIAID has developed a total of
46 biodefense initiatives to stimulate research in fiscal years 2002
and 2003: 30 are new initiatives and 16 are significant expansions.
During this same time period, NIAID has seen a 30 percent increase in
the number of grant applications; the vast majority of these are in
response to our biodefense initiatives.
The NIAID biodefense research program is anchored in the
traditional NIH processes of basic biomedical research; concurrently,
we are aggressively pursuing the goal of translating the findings of
basic research into definable and quantifiable endpoints such as
diagnostics, therapeutics, and vaccines. NIAID historically has sought
to translate basic research findings into ``real-world'' interventions,
as with the vaccines noted above. Until now, however, the path to
product development has not been central to our research strategy. The
attacks of September 11, 2001, and the subsequent anthrax incidents
have compelled us to modify somewhat the way we do business, with an
increased focus on translational research and product development. This
applied research is based on the strongest possible foundation of
fundamental knowledge of pathogenic microbes and the host immune
response.
As we pursue innovative biodefense countermeasures, we have
strengthened our interactions with the private sector, including
biotechnology companies and pharmaceutical manufacturers. Many
biodefense products do not provide sufficient incentives for industry
to develop them on their own, because a profitable market for these
products cannot be guaranteed. Therefore, NIAID has developed public-
private partnerships with industry to overcome such obstacles so that
new and improved interventions against bioterror threats can quickly be
developed.
A number of significant advances in understanding, treating, and
preventing potential agents of bioterror already have been realized.
For example, NIAID-supported scientists have identified antivirals that
may play a role in treating smallpox or the complications of smallpox
vaccination, as well as new antibiotics and antitoxins against other
major bioterror threats. Investigators have demonstrated that existing
stores of smallpox vaccine can be diluted five-fold and still retain
their potency, greatly increasing the Nation's available stock of
smallpox vaccine. These studies of diluted smallpox vaccine helped
fulfill an immediate goal delineated in our strategic plan for
biodefense. In the intermediate-term, new and improved vaccines against
smallpox, anthrax, and other potential bioterror agents are being
developed and evaluated at NIAID intramural facilities, as well as by
our grantees and contractors in academia and industry. One of these is
a smallpox vaccine based on a strain of the vaccinia virus that
replicates less robustly than the traditional smallpox vaccine virus,
and is known to be less reactogenic than the current smallpox vaccine.
In the long-term, we will develop even safer vaccines against smallpox
virus and other pathogens.
Advances in biodefense, as well in other areas of infectious
diseases research, are being facilitated by the detailed information
about pathogens that now can be rapidly gleaned by determining their
genomic sequence. The field of pathogen genomics has made remarkable
progress: sequencing of the genomes of more than 100 pathogens is
complete or nearing completion. Among them are approximately 30
different Category A, B and C agents, including multiple strains of the
anthrax bacterium. This genomic information is being used to inform the
development of new antimicrobials, vaccines, and diagnostics.
Progress in biodefense research depends on the availability of
research resources, such as animal models, standardized reagents, and
appropriate laboratory facilities, as well as on human capital, that
is, well-trained investigators. Among many initiatives to improve the
biodefense research infrastructure, NIAID will establish in fiscal year
2003 a nationwide network of Regional Centers of Excellence for
Biodefense and Emerging Infectious Disease Research, and design, build,
and renovate a system of Regional and National Biocontainment
Laboratories. These facilities will include a small number of Biosafety
Level-4 (BSL-4) laboratories, which have the containment safeguards
necessary to study highly pathogenic organisms. The new Centers and
laboratories will serve as national resources for biodefense research
and product development, as well as for the study of other emerging
diseases such as influenza and West Nile virus.
The many new NIAID initiatives in biodefense research will provide
benefits far beyond protection from deliberate acts of bioterrorism.
After all, the general philosophy and strategy of biodefense is
essentially the same as that for defense against naturally emerging and
re-emerging infectious diseases that threaten global public health.
With the careful NIAID planning process, new biodefense resources will
unquestionably have enormous benefits in our struggle against other
diseases, endemic and emerging, that far transcend the specter of
bioterrorism.
acquired immunodeficiency syndrome (aids)
Another major focus of the Institute, accounting for approximately
one-third of NIAID spending, is research devoted to finding
interventions to slow the pandemic of the human immunodeficiency virus
(HIV), the cause of AIDS. HIV/AIDS is the defining health crisis of our
generation, having claimed well over 20 million lives since the
beginning of the pandemic. Another 42 million people worldwide are
living with the virus. Most of the world's HIV-infected people live in
resource-poor countries, where HIV frequently is superimposed on other
significant health challenges, including endemic diseases such as
malaria and tuberculosis, and malnutrition. By 2010, more than 45
million new infections will occur, for a cumulative total of 105
million infections, according to estimates of the Joint United Nations
Programme on HIV/AIDS.
Despite these grim numbers, significant progress has been made
against the HIV/AIDS, much of it due to the research and prevention
efforts of NIAID and other NIH Institutes, the Centers for Diseases
Control and Prevention, and other agencies of the Department of Health
and Human Services. In this country, prevention efforts have reduced
the annual number of new HIV infections in the United States from
approximately 150,000 per year to about 40,000 annually. In recent
years, we have seen the positive impact of advances in HIV therapeutics
for many living with HIV/AIDS in the United States and other western
countries, and more recently the promise these medicines offer for
those in the developing world. All but one of the 19 antiretroviral
drugs licensed in the United States target one of two viral targets:
the HIV protease enzyme or the HIV reverse transcriptase enzyme. Over
the past few years, NIAID-supported scientists and their collaborators
have identified new targets for HIV therapy and novel drugs that block
other stages of the virus replication cycle. Among them are agents that
block viral genes from entering the host cell nucleus, and drugs that
keep the virus from attaching to or entering the cell in the first
place. In the latter category, a drug known as Fuzeon or T-20 that
blocks the fusion of HIV to the host cell membrane was recently
approved and holds great promise for the many HIV-infected patients who
harbor HIV that is resistant to current therapies.
To help turn the tide of the global HIV/AIDS pandemic, NIAID has
established research collaborations with international colleagues to
develop comprehensive approaches to the HIV pandemic in poor countries,
encompassing prevention activities, antiretroviral therapy when
feasible, and care of the HIV-infected person. These collaborations
have yielded extraordinary results, notably in developing methods to
reduce mother-to-child transmission of HIV. However, a rate-limiting
factor in HIV/AIDS research efforts in developing countries has been a
lack of funds for the purchase of antiretroviral drugs and for
improving existing healthcare infrastructure. In January 2003, the
Institute's international AIDS program received a substantial boost
with the announcement of the President's Emergency Plan for AIDS
Relief. This plan commits $15 billion over 5 years ($10 billion of
which is new money), starting with $2 billion in fiscal year 2004, for
HIV/AIDS prevention, treatment, and care in 14 of the hardest-hit
countries in sub-Saharan Africa and the Caribbean. This lifesaving
effort will not only reduce the suffering caused by HIV/AIDS in
countries that account for 50 percent of the world's HIV infections,
but will provide a framework that will facilitate NIAID research
efforts to develop new and improved tools of treatment and prevention.
Many approaches to HIV prevention are being developed or refined,
but the ``holy grail'' of HIV prevention remains the development of a
safe and effective HIV vaccine. Numerous vaccine candidates have shown
promise in monkey models of HIV infection, and the most promising ones
are rapidly being moved into human trials on the NIH campus and in the
domestic and international sites of the NIAID HIV Vaccine Trials
Network.
other vaccines
In addition to developing HIV and biodefense vaccines, NIAID
continues to make significant progress in the quest for new and
improved vaccines for other diseases of global health importance. The
NIH has three broad goals in vaccine research: identifying new vaccine
candidates to prevent diseases for which no vaccines currently exist;
improving the safety and efficacy of existing vaccines; and designing
novel vaccine approaches, such as new vectors and adjuvants, substances
that improve vaccine performance.
More than 100 vaccines currently are being developed by NIAID-
funded researchers, including promising candidates against emerging
diseases such as Ebola virus, West Nile virus, dengue, and dangerous
strains of influenza virus. Of particular note are novel tuberculosis
vaccines, which soon will enter clinical trials. These trials will mark
the first time in more than 60 years that new approaches to TB
vaccination have been assessed in humans. These vaccines are a tangible
``payoff'' of research funded by NIAID and others that led to the
availability of the complete genomic sequence of the tuberculosis
bacterium. The quest for a malaria vaccine received a significant boost
in 2002 when researchers funded by NIAID and others published the
genomic sequences of the malaria parasite Plasmodium falciparum, and
one of its main mosquito vectors, Anopheles gambiae. Together, these
projects are probably the most significant pathogen genome sequencing
effort to date. With the availability of the human genome sequence,
scientists now have detailed genomic information for each of the
organisms involved in human malaria: the human host, the mosquito
vector and the malaria parasite itself. This groundbreaking malaria
research promises to provide new targets for vaccine development and
other interventions against a disease that claims the lives of more
than a million people each year, most of them children in sub-Saharan
Africa.
immune-mediated diseases
Immune-mediated diseases such as autoimmune diseases, allergic
diseases, and asthma are important health challenges here and abroad.
Autoimmune diseases, for instance, afflict 5 to 8 percent of the U.S.
population; asthma and allergic diseases combined represent the sixth
leading cause of chronic illness and disability in the United States.
The past two decades of fundamental research in immunology have
resulted in a wealth of new information and extraordinary growth in our
conceptual understanding of the immune system and the pathogenesis of
immune-mediated diseases. Researchers now know a great deal about the
effector molecules that contribute to many immunological conditions,
knowledge that has led to the design and discovery of drugs to block
those molecules. For instance, we now have powerful treatments that
selectively target several of the immune system molecules that cause
inflammation, a hallmark of many autoimmune diseases. Blockers of an
immune system molecule called tumor necrosis factor-alpha are now
routinely used in patients with rheumatoid arthritis and other
immunologic conditions.
A relatively new avenue of research suggests that it may be
possible to interrupt deleterious immune responses, without dampening
protective ones, and provide patients with long-term clinical benefit.
The ability to induce ``immune tolerance'' by selectively blocking
deleterious immune response holds great promise for treatment of many
immune- mediated conditions, including type 1 diabetes, rheumatoid
arthritis and multiple sclerosis, as well as asthma and allergic
diseases. For example, researchers have shown in a small trial
conducted by the NIAID-sponsored Immune Tolerance Network (ITN) that
antibodies to the CD3 molecule on T-cells, given for two weeks soon
after patients were diagnosed with type 1 diabetes, appeared to halt
the destruction of the patients' insulin- producing cells for at least
a year, preserving their ability to produce some of their own insulin.
Further follow-up is underway to determine the long-term benefits of
this experimental therapy; a larger trial is currently recruiting
patients.
Induction of immune tolerance is also one our highest priorities in
organ transplantation research. The ability to selectively block the
immune response to a transplanted organ would diminish or eradicate the
risk of rejection, as well as the risks and morbidities associated with
current methods of immunosuppression. A trial currently underway in the
ITN is using a unique approach involving simultaneous bone marrow and
kidney transplantation in patients with multiple myeloma. Although only
a very small number of patients have undergone the procedure, early
results are encouraging, as they have tolerated their transplanted
kidneys without immunosuppressive medications for up to 3 years.
Another important NIAID research focus is the development of new
interventions to reduce the burden of asthma. NIAID has long been at
the forefront of discoveries leading to the characterization of asthma
and allergic diseases and is now vigorously pursing the translation of
basic knowledge into more effective treatment and prevention
strategies. The NIAID-sponsored Inner-City Asthma Study, completed in
2002, evaluated the effects of a home-based environmental intervention
on asthma symptoms and health care utilization in inner-city children
with moderate to severe asthma. The intervention led to an additional
three weeks of symptom-free days and a 14 percent reduction in
unscheduled emergency room or clinic visits in the first year of the
intervention; these effects largely persisted for a year following the
intervention phase. The improvement in symptoms was correlated with a
reduction in levels of key allergens in the home. Building on these
results, the NIAID in 2002 launched the Inner-City Asthma Consortium,
to conduct clinical trials of novel immune-based agents to treat or
prevent asthma.
conclusion
The role of NIAID in fighting infectious and immunologic diseases
has never been more important, particularly in the post 9-11 world.
Working with our many collaborators in the public and private sectors,
we hope to further reduce the burden of diseases endemic in the United
States and abroad, to enhance our preparedness against bioterrorism,
and to continue to prepare for new threats to public health that will
inevitably emerge in the future.
______
Prepared Statement of Dr. Patricia A. Grady
Mr. Chairman and Members of the Committee: The fiscal year 2004
budget includes $134,579 million, an increase of $4,060 million over
the fiscal year 2003 enacted level of $130,584 million comparable for
transfers proposed in the President's request.
Nursing research and nursing practice are converging to address the
challenges of maintaining and improving health and healthcare in our
country. During this time of heightened uncertainty in many aspects of
our lives, nursing research, which informs the practice of the nation's
largest number of healthcare professionals--2.7 million nurses--is
critical to developing and testing interventions that improve health.
Increasingly there is a need for health promotion research, which is a
special strength of nursing research. This need is reflected in a
recent Department of Health and Human Services (DHHS) Fact Sheet that
attributes 40 percent of premature deaths to unhealthy behaviors, such
as smoking and poor eating habits. Conversely, of the 30-year average
gain in life expectancy in the last century, the DHHS report states
that 25 of those years came from advances in public health, principally
from health promotion. Consistent with the NIH Research Roadmap for the
future, nursing research also focuses on multidisciplinary and clinical
research. The goal is to help healthcare professionals work smarter by
capitalizing on new technologies and research-tested methodologies that
extend the reach and quality of their practice in promoting health,
managing illness, and improving care. Now let me discuss some findings.
reducing postmenopausal women's risks for cardiovascular disease
Heart disease is the leading cause of death in women in the United
States. Even though the death rate has decreased in recent years, the
benefit is less for women than men. More needs to be known about the
effects of preventive strategies, such as exercise and diet, in
reducing risks of the disease. We know lowering total and low density
lipoprotein cholesterol (LDL-C) and raising high-density lipoprotein
cholesterol (HDL-C) reduces risk of cardiovascular disease in women.
Nurse researchers did a study that asked the question of why HDL-C, the
``good cholesterol,'' drops when post-menopausal, obese women adhere to
a low-fat diet. On a low-fat diet, weight loss occurs and the
deleterious LDL-C decreases, but the weight loss is accompanied by a
reduction of the good HDL-C. Findings of the study indicate that the
causal factor for the HDL-C reduction was not the type or amount of fat
the women consumed, but rather that they substituted simple sugars,
such as syrups and refined sugar, for fat in their diets. What the
women should have done was substitute complex sugars, such as high
fiber vegetables and starches. The current American Heart Association
guidelines recommend consuming 55 percent of energy from carbohydrates,
without specifying complex or simple. This study points out the need to
write more specific dietary guidelines that differentiate between types
of carbohydrates, in addition to types of fat. This study is especially
timely in an age where low-fat and fat-free foods often depend on
simple sugars to improve taste.
reducing risk factors for obesity and hypertension in adolescents
Obesity continues to be a major health problem in the United
States. The Centers for Disease Control and Prevention states that
about 15 percent of children and adolescents are overweight, a 4
percent increase since the last survey in 1994. The U.S. prevalence of
obesity increased by 61 percent in the 9 years prior to 2001. Habits
formed in childhood become the lifestyles that drive this upswing.
Researchers testing an intervention in children and adolescents have
been able to decrease risk factors for hypertension and obesity. As
part of the Cardiovascular Health in Children and Youth study,
researchers tested rural, mostly African-American middle school
students in an eight-week physical activities program combining
exercise and health education. Subjects were divided into four groups--
exercise, education, or both, and controls. Those in the two exercise
groups had a lower increase in body fat, and the blood pressure of the
three intervention groups decreased compared to controls. These results
demonstrate the effectiveness of regular aerobic exercise and health
education programs for school-aged children to help reduce their risks
for cardiovascular disease later in life.
coping with chronic obstructive pulmonary disease
People with Chronic Obstructive Pulmonary Disease (COPD), which
causes discomfort at best and severe, life-altering changes at worst,
report that there is little available to help improve their breathing.
Shortness of breath often results in inability to work, limited social
activities, and even difficulty in dressing themselves. As the nation's
fourth leading cause of death, COPD affects over 22 million people. In
confronting this issue, nurse investigators tested a ``self
management'' inspiratory muscle training technique to assist patients
in improving their own breathing and respiratory muscle strength. For
30 minutes, 5 days a week, over a 16-week period, patients used a
mouthpiece attached to a tube with openings that gradually decreased in
size to make inhalation more challenging. Following training, these
subjects' breathing, respiratory muscle strength, and endurance were
considerably improved compared to a control group, and they could once
again perform daily activities. The study also showed that subjects
were able to self-manage by performing inspiratory muscle training at
home without direct professional assistance.
improving care at the end-of-life care
Another important healthcare issue involves end-of-life and
palliative care. As the lead Institute at NIH for coordinating this
research, NINR supports research to improve the way the healthcare
system addresses end-of-life issues. A recent study commissioned by
Last Acts contributed more evidence of the need for change, concluding
that the United States does only a mediocre job of caring for seriously
ill and dying patients. The study also indicated that although many
would prefer to die at home or in a hospice, most die in the hospital,
where high tech efforts to prolong life and where patients' diminished
control over decisions are common.
Nurse researchers studied the outcomes for patients enrolled in the
Program for All-inclusive Care for the Elderly (PACE), a managed care
program for people 55 and older. Results showed that unlike the general
population, where 44 percent die in the hospital and 20 percent die at
home, the numbers are almost reversed in PACE, with 45 percent dying at
home and 21 percent in the hospital. Another outcome was improved
consistency and predictability of care. End-of-life care is often
fragmented, and in the case of advance directives, written instructions
may not be honored in the hospital, since staff may not have immediate
access to patient records from other care facilities. The PACE program,
however, offers consistent care, thus increasing the likelihood that
advance directives will be followed. PACE also helps older people
develop advance directives.
new and expanded initiatives
For fiscal year 2004, NINR plans include launching a new pediatric
end-of-life initiative, stimulated by the Institute of Medicine's
report: When Children Die: Improving Palliative and End-of-Life Care
for Children and Their Families. This report concluded that pediatric
end-of-life issues have received insufficient research attention. We
will also support the development of ethnically and culturally
sensitive interventions for those near the end of life and approaches
to improve communications between care providers, patients and
families.
Research on strategies for self-management of chronic illness will
be expanded to include reducing symptoms related to high blood
pressure, diabetes, dementia and developmental disabilities. These
strategies will incorporate age, gender, and ethnic and cultural
factors.
Minority men will be targeted for interventions that promote
healthy lifestyles, since they have a shorter life span and a higher
mortality rate than Caucasian men and all subgroups of women. NINR will
stimulate research on factors that influence decision-making for
healthy choices, such as nonsmoking, exercise, and proper nutrition.
Other issues to be addressed include: How can these men improve
management of stress? How do their families and their communities
influence their health-related behaviors? Because young minority men
are often underserved, studies in this area could create an important
strategy for effective public health interventions to follow.
We continue to have a strong interest in the significant health
disparities for minority women. NINR will expand research that targets
prevention of low birthweight babies, since according to Healthy People
2010, of the Department of Health and Human Services, the incidence
rate for low birthweight African-American women is twice that of
Caucasian women. Puerto Rican women are also especially likely to have
low birthweight infants. Issues include improving early identification
and management of complications during pregnancy, such as infection,
hypertension, and diabetes.
training nurse researchers for the future
NINR is addressing the future of nursing science--how to ensure
that sufficient, high-quality research continues to grow and play a
fundamental role in health care. In the early 90's, and again in 2000,
the National Academy of Science's National Research Council stated that
the number of nurse researchers must increase. Over the next four to
six years, our Nation is facing a critical nursing faculty shortage.
Nurse researchers form the backbone of university faculty in schools of
nursing. In rising to this workforce challenge, NINR emphasizes early
entry into research careers, including fast-track baccalaureate-to-
doctoral programs, to increase the number of nurse investigators. Other
opportunities are made available through the NINR Centers programs and
NINR/NIH research training mechanisms and career development awards.
Our centers provide an environment and infrastructure to promote
early entry into and sustained participation in research programs. NINR
funds nine Core Centers, each of which offers research and research
training opportunities to those in their geographic areas. We also fund
nine Developmental Centers that enhance emerging research programs. Our
recently-launched Nursing Partnership Centers to Reduce Health
Disparities funded 17 Centers which pair research-intensive nursing
schools with minority-serving schools of nursing. These Partnerships
are expected to expand research on health disparities and increase the
number of minority nurse investigators.
NINR is focusing on ways to integrate genetic science into nursing
research, education, and practice. Strategies include facilitating
lifestyle changes for those at risk, genetic counseling, and selecting
optimal therapeutic interventions based on genotype. The fourth NINR
Summer Genetics Institute will be offered this year. This is an
intensive, eight-week genetics training program held on the NIH campus.
Its goal is to produce graduates who develop successful research
careers and help integrate genetic information into research and
educational programs across the country.
Mr. Chairman, this concludes my remarks. I would be pleased to
answer any questions you and other members of the Committee may have.
______
Prepared Statement of Dr. Judith H. Greenberg
Mr. Chairman and Members of the Committee, good morning. I am
pleased to present the President's budget request for the National
Institute of General Medical Sciences (NIGMS). The fiscal year 2004
budget includes $1,923 million, an increase of $76 million over the
fiscal year 2003 enacted level of $1,847 million comparable for
transfers proposed in the President's request.
The NIH budget request includes the performance information
required by the Government Performance and Results Act of 1993.
Prominent in this data is NIH's fourth annual performance report, which
compared our fiscal year 2002 results to our fiscal year 2002
performance plan goals.
an impressive track record
Since its creation more than 40 years ago, the National Institute
of General Medical Sciences has built an impressive track record as a
strategic investor in the future of basic biomedical research. Though
not a household name, NIGMS is highly respected in the scientific
community as an Institute that nurtures the nation's brightest minds in
biomedicine. Through its forward-thinking funding programs, NIGMS
supports thousands of scientists nationwide whose fundamental research
is laying the foundation for promising new advances in disease
diagnosis, treatment, and prevention.
Perhaps the most notable indicator of that track record is the
number of NIGMS-supported scientists who have won Nobel Prizes-a
remarkable 53 to date. In 2002, both the Nobel Prize in Physiology or
Medicine and the Nobel Prize in Chemistry went to long-time NIGMS
grantees, Dr. H. Robert Horvitz of the Massachusetts Institute of
Technology and Dr. John B. Fenn of Virginia Commonwealth University,
respectively. Dr. Horvitz's discovery of key genes controlling cell
death shed new light on illnesses such as AIDS, Parkinson's disease,
stroke, and cancer. And Dr. Fenn's refinement of a technique called
mass spectrometry has made it possible to analyze large molecules in
biological samples, an advance now widely used for blood testing.
Our Institute's leadership in supporting biomedical science was
also recognized in 2002 with the prestigious Albert Lasker Award for
Basic Medical Research. NIGMS grantees Dr. James E. Rothman of the
Memorial Sloan-Kettering Cancer Center and Dr. Randy W. Schekman of the
University of California, Berkeley, were honored for discovering the
universal molecular machinery that drives ``cellular trafficking.''
Their work helped explain vital processes such as how insulin is
released in pancreatic cells, how organs develop inside embryos, and
how viruses infect their hosts.
Yet another acknowledgment of NIGMS' contributions to biomedical
research came late last year when the journal Science declared the
discovery of how small RNA molecules control the behavior of genes to
be the top scientific achievement of 2002. Funded in large part by
grants from NIGMS, this ``Breakthrough of the Year'' research shows
promise as the basis for new therapies to treat cancer, AIDS, and other
diseases.
As we look ahead to fiscal year 2004 and beyond, NIGMS is poised to
help make possible even more ground-breaking advances in biomedical
science. I would like to share with you some of our strategies for
accomplishing this important mission.
unraveling the 3-d structures of proteins
Fifty years ago, Drs. James Watson and Francis Crick made their
famous discovery of the double-helix structure of DNA. This year,
scientists will reach another milestone: the completion of a highly
accurate sequence representing the entire set of genetic instructions
encoded in human DNA. As the Human Genome Project achieves this
landmark goal, its promise to usher in a new era of molecular-based
medicine will depend on another, equally important undertaking:
discovering all the proteins our genes make and the functions these
cellular ``workhorses'' play in health and disease.
Key to this ambitious effort is the unraveling of the complex,
three-dimensional structures of proteins. Determining these structures
can in turn reveal how proteins function and help scientists tailor the
design of new drugs to treat diseases. NIGMS is the world's single
largest supporter of research in structural genomics, a field dedicated
to discovering the structures of proteins using sophisticated computer-
based methods.
In fiscal year 2000, NIGMS launched the Protein Structure
Initiative (PSI), with the goal of determining 10,000 protein
structures in 10 years. The nine pilot research centers we currently
support have made significant progress in developing tools for the
high-throughput determination of protein structures and have begun to
yield some promising results, with potential applications in
biomedicine and beyond.
In November 2002, for example, NIGMS-funded researchers at Argonne
National Laboratory determined the structure of a protein knot-one of
only a few such structures seen in nature, and the first found in a
protein from the most ancient type of single-celled organism, an
archaebacterium. The microbe that the newly discovered protein comes
from is of interest to industry for its ability to break down waste
products and produce methane gas.
NIGMS is considering additional activities to help the centers
reach their full capability, including a materials storage bank and a
database for protein production and crystallization experiments. The
production phase of the PSI, during which researchers will be rapidly
deriving protein structures, will begin in fiscal year 2005.
harnessing math & computers to solve biological problems
In addition to leading the way in structural genomics, NIGMS is
also at another forefront: a shift in biomedical science often called
the ``mathematization'' of biology. This shift represents a broadening
of biologists' research focus from studying how individual biological
molecules behave to investigating how a large number of molecules
interact with one another. In order to model and predict these complex
interactions, biomedical scientists are increasingly partnering with
quantitative scientists, including mathematicians, physicists, computer
scientists, and engineers. Together, they are applying their combined
expertise to solve particularly challenging problems in biomedicine,
such as understanding embryonic development, metabolism, cell growth,
and cell death.
To encourage more quantitative approaches in biological studies,
NIGMS established Centers of Excellence in Complex Biomedical Systems
Research. The first awards were for two center grants and seven
planning grants to lay the groundwork for future centers, designed to
foster a multidisciplinary research environment for develop ing
innovative methods to solve biomedical problems. These centers will
also lead the way in training the next generation of computational
biologists.
A good example of this teamwork is the recent work by NIGMS-funded
researchers who have produced the first comprehensive ``script of
life,'' describing the regulation of all the genes in yeast. Reporting
in the journal Science in October 2002, Dr. Richard Young, a biologist
at the Whitehead Institute for Biomedical Research, and Dr. David
Gifford, a computer scientist at the Massachusetts Institute of
Technology, detailed how they used advanced, high-throughput biological
and computing technologies to do in weeks what would have taken years
to achieve using traditional techniques.
The mathematization of biology and its importance in modeling
complex biological systems were also major themes at our Institute's
``Visions of the Future'' meeting, held in September 2002. NIGMS
invited visionary scientific leaders to identify the most important and
emerging areas of biomedical research. A recurring topic of discussion
was the need to develop mechanisms that encourage cooperative
interactions among mathematicians, physicists, computer scientists,
engineers, and biologists. Moreover, meeting participants stressed the
need for more rigorous quantitative training of undergraduate and
graduate students who are pursuing research careers in the life
sciences.
Such interaction and training were cited as keys to realizing some
of science's grandest visions. These include the development of
``virtual'' models--of cells, tissues, disease states, and ultimately
entire organisms--as well as new imaging tools and methods for making
``molecular movies'' of cellular machinery. Such technologies will help
fill enormous gaps in our understanding of how molecules move in three
dimensions and how they interact inside living cells in real time.
Through its support of research and training in computational biology
and other areas that cross traditional academic boundaries, NIGMS is
uniquely positioned to help turn these visions into reality.
guarding against infectious diseases & bioterrorism
As concern grows over bioterrorism and the emergence of new
infectious diseases, NIGMS is designing an initiative to address this
threat using computational approaches and mathematical modeling. Such
models will help predict the spread of microbes, the rate of disease
progression in individuals, the effectiveness of different treatment or
prevention strategies, and the community response to new infectious
diseases. These predictions will, in turn, provide policymakers with
critical information that will help them respond quickly to the threat
of a new disease or bioterrorism attack.
This new initiative follows on the footsteps of another successful
NIGMS program--one dealing with the evolution of infectious diseases.
Deadly viruses and bacteria can adapt to seemingly limitless
environmental conditions by making rapid genetic changes, far outpacing
our own ability to adapt. This microbial evolution renders previously
effective drugs useless and creates a moving target for drug designers.
However, by analyzing the evolution of infectious organisms,
researchers now have a leg up on how to outwit potentially dangerous
microbes.
One application of this area of study is antibiotic resistance, an
increasing problem throughout the world. Recently, NIGMS-funded
researcher Dr. Barry G. Hall of the University of Rochester developed a
computer simulation of microbial evolution. Dr. Hall determined through
experiment which bacterial genes are most susceptible to changes that
cause resistance to commonly used antibiotics. Using this approach,
pharmaceutical companies could create drugs for which bacteria have no
evolutionary escape route.
NIGMS is also leading the way in supporting structural studies of
infectious diseases. For example, the final piece of the anthrax
puzzle--the structure of the third toxic protein responsible for the
deadly effects of the anthrax bacterium--was discovered last year by
Dr. Wei-Jen Tang of the University of Chicago. The toxin, edema factor,
causes potentially lethal swelling and fluid buildup in the body. By
completing the detailed, three-dimensional the structure of edema
factor, Dr. Tang also found that the protein appears to be an ideal
drug target, opening the door to a possible new compound to combat
anthrax infection, as well as other bacterial diseases.
basic research: a vital return on investment
In closing, it is worth noting that our leading efforts in
structural genomics, computational biology, complex biological systems,
and multidisciplinary collaboration give NIGMS a pivotal role to play
in the trans-NIH ``Roadmap'' initiatives. Through its partnerships with
other NIH institutes and centers, NIGMS will help forge new pathways to
discovery and research teams of the future.
It is also important to emphasize that all of the scientific
advances I have shared with you today resulted from investing in basic
research on fundamental biological processes--the central mission of
NIGMS. As administrators of federal research dollars, we are asked to
show what we have done to ensure the best possible return on that
investment, and to show how we plan to continue doing so in the future.
I hope that the examples I have mentioned--from our Nobel Prize--
winning achievements to our cutting-edge initiatives-illustrate the
tremendous value of basic biomedical research to the strength of our
scientific workforce, the security of our nation, and the health of our
people.
Thank you, Mr. Chairman. I would be pleased to answer any questions
that you may have.
______
Prepared Statement of Dr. Glen R. Hanson
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Institute on Drug
Abuse. The fiscal year 2004 budget includes $995,614 million, an
increase of $34,496 million over fiscal year 2003 enacted level of
$961,118 million comparable for transfers proposed in the President's
request.
nida leadership
I have been very fortunate and privileged to serve as the Acting
Director of the National Institute on Drug Abuse for the past year and
a half during a time of burgeoning scientific advances that have
dramatically increased our understanding of brain, behavior and
addiction. I am extremely confident that the incoming Director for
NIDA, Dr. Nora Volkow, will be a strong leader and advocate for drug
abuse research. I am pleased to have this final opportunity to showcase
some of NIDA's most exciting advances and discuss how these and other
research findings are resulting in tangible benefits that will improve
the Nation's health.
public/private venture yields new medication for addiction
An important example of how NIDA-supported research is decreasing
the tremendous economic and human costs associated with drug abuse and
addiction, while meeting the national need for quality treatment, is by
bringing a new medication to the clinical toolbox of health care
professionals. Buprenorphine, approved by the Food and Drug
Administration in October 2002, is the first medication ever available
for the treatment of opiate dependence that can be prescribed and
dispensed by qualified physicians in an office setting, rather than at
a specialized addiction treatment clinic. The nearly 1 million people
who suffer from heroin addiction will benefit from the historic
collaborations that took place between legislators who passed the Drug
Addiction Treatment Act of 2000, Federal agencies, and the private
sector (Reckitt Benckiser Pharmaceuticals) to bring this new medication
to market. Buprenorphine marks the second medication to come directly
out of NIDA's relatively short investment in its Medications
Development Program. Developing medications for other drugs of abuse,
particularly stimulants like cocaine and methamphetamine, is a top
priority for the Institute, as is our commitment to develop practical
and more effective science-based behavioral therapies.
new targets for medications development
Building on a series of discoveries regarding the effects of
marijuana on the brain, researchers discovered a new neuromodulatory
called the cannabinoid system, which is involved in pain regulation,
memory, appetite, and addiction. This system was named after the active
ingredient in marijuana, tetrahydrocannabinol. Researchers from NIDA's
own intramural program have used a compound that blocks cannabinoid
receptors to demonstrate that the mood altering and cardiac effects of
marijuana in humans can be suppressed. Additionally, they discovered
that the cannabinoid system may also be involved in relapse to other
drug addictions. In animal models, this same blocking compound
prevented drug-seeking for cocaine following exposure to two of the
three conditions that typically trigger relapse in human addicts. The
discovery of this new brain system has opened the door for the
development of new treatments for addiction to a variety of drugs,
including cocaine and alcohol, and may also prove useful for treating
obesity and pain. As we continue to unravel the complexity of the brain
and identify new systems, molecules, proteins, and genes that can be
exploited for therapeutic development, the need for a repository or
molecular library where this information can be stored and shared with
other scientists increases. This is the goal of the proposed Molecular
Libraries project in the trans-institute NIH Road Map Initiative. We
hope to work with the pharmaceutical companies to more rapidly develop
novel and even more effective therapeutic strategies for addiction and
other brain diseases that have historically been extremely difficult to
treat and control, and are often overlooked by pharmaceutical
companies.
stress and the brain
We also are becoming increasing knowledgeable about the impact of
stress on brain function. Stress can be a major factor in both the
initiation of drug abuse and is known to be one of the most powerful
triggers to relapse to drug abuse in former addicts. Nowhere was this
more apparent than in a study published last year following the
September 11th attacks in Manhattan. Twenty-nine percent of the 1,000
respondents interviewed 1-2 months following the event reported an
increase in substance use, with the highest rates in those reporting
symptoms of Post-Traumatic Stress Disorder and/or depression. A study
released just last month in the journal, Neuron, elucidated one of the
ways in which stress and drugs of abuse produce a similar adaptation in
the brain through an effect on dopamine neurons. As we progress in our
understanding of the ways in which stress and drugs of abuse affect
common mechanisms, we can develop prevention and treatment strategies
that more effectively satisfy the needs of patients, particularly those
who suffer from comorbid substance abuse and mental disorders.
the role of genetics and the environment in addiction
Powerful new technologies, such as microarrays, 3-dimensional brain
mapping, and animal knockouts are accelerating the pace of science and
helping us to identify the roles that genes play in addiction. One gene
in particular (FAAH) produces an enzyme involved in the breakdown of
the brain's natural cannabinoid compound. A recent study showed that a
genetic variation in this gene was found more frequently in people who
abused drugs compared to those who did not. As other genes that
increase the risk of addiction are identified through NIDA's
Vulnerability to Addiction Research Initiative, it becomes even more
imperative that we understand how the environment can modify this risk.
Basic research is giving us important insight into this complex domain
of gene-environment interactions. A recent study conducted in monkeys
using brain imaging techniques found that the animal's social
environment can modify its neurobiology and ultimately its likelihood
to self administer drugs of abuse like cocaine. When monkeys were
housed together, the ones displaying dominant behavior were shown to
have altered expression of D2 receptors, which are important components
in the brain's reward pathway. They also were less prone to self
administer cocaine (a model of cocaine abuse). This illustrates that
the natural state of the dopamine system is altered by the environment,
which in turn influences the likelihood of using drugs of abuse. Future
studies which determine the interplay between genetic and environmental
factors will be important in gaining further insight into the
prevention and treatment of drug abuse and addiction.
reducing tobacco use by fighting the addiction
Tobacco use is responsible for more that 430,000 deaths per year
among adults in the United States, making it one of the Nation's top
preventable causes of death. It is addiction to nicotine that continues
to drive the use of tobacco, and why NIDA's expertise concerning the
neurobiology of nicotine and the mechanisms of the addiction process,
is so integral to the national effort to reduce this public health
burden. NIDA supported research has already paved the way for a number
of treatments, including behavioral therapies, nicotine-replacement
approaches such as the patch and gum, and Zyban, that help people
conquer their addiction. But we must accelerate our efforts to help the
estimated 48 million people according to a 2000 Surgeon General Report
who remain addicted to this drug. Capitalizing on new knowledge about
the biological substrates and behavioral mechanisms of nicotine and
tobacco addiction, NIDA has joined with other NIH institutes to launch
a number of new activities to more rapidly translate tobacco addiction
research into new treatments. NIDA is also supporting research that
focuses on preventing adolescents from starting to smoke.
good news in prevention research
There is good news in the epidemiology and prevention arena. NIDA's
long-standing annual Monitoring the Future Survey, which measures drug
use among 8th, 10th, and 12th graders, showed substantial decreases in
the overall use of all illicit drugs, as well as a reduction in the use
of cigarettes, marijuana, club drugs, and alcohol in the past year. One
of the most encouraging findings is the significant drop in the use of
MDMA (Ecstasy), the abuse of which had been rising at alarming rates in
recent years. We attribute these downward trends, in part, to our
prevention and education efforts. As a by product of our dissemination
of science-based information about all drugs of abuse, America's youth
are able to weigh the facts about drugs and are making better health
decisions. Understanding adolescent decision-making is an important
research area being addressed in NIDA's prevention portfolio. By
elucidating the cognitive expectancies of how an adolescent makes the
initial and subsequent decisions to try or not to try drugs, we will
gain new insight into how to develop interventions aimed at changing
the actual decision to use drugs. Preventing the initial use of drugs
and stopping the progression of drug use before it escalates to
addiction are two targeted objectives of NIDA's National Prevention
Research Initiative. The multi-disciplinary teams of basic researchers,
community leaders, prevention specialists, clinicians, and health
service providers who have been brought together as part of this
Initiative will use the power of science to reduce drug use in the
country.
combating hiv/aids, hepatitis domestically and internationally
Our efforts to reduce the burden of drug abuse goes beyond our
borders. Given the growing number of countries that report HIV and
hepatitis C infection associated with drug injection behaviors, NIDA
supports a strong research program that is yielding findings that are
beneficial both domestically and internationally. In the absence of a
vaccine or cure for AIDS, comprehensive HIV prevention strategies are
the most cost effective and reliable approaches for preventing new HIV
infections, and other bloodborne infections, such as hepatitis C. NIDA-
supported researchers are making progress in curtailing the spread of
these diseases. NIDA researchers, using molecular biology techniques,
have recently shown that new outbreaks of HIV infection among injection
drug users are spreading along drug trafficking routes and spreading
from drug users to non-drug using individuals through sexual
transmission. Some of the victims of such transmission are homeless
U.S. adolescents and AIDS orphans. Understanding how drug use related
HIV transmission occurs is critical to the development of culturally
specific behavior change strategies. NIDA remains committed to work
with other Institutes and federal agencies to discover more effective
ways to stop drug abuse-related spread of these infectious diseases and
work towards transferring these evidence-based strategies to slow the
spread of HIV and other related infections.
clinical trials network does more than just treat patients
HIV prevention interventions are some of the new protocols being
developed for testing in NIDA's National Drug Abuse Treatment Clinical
Trials Network (CTN). The CTN, which was established in 1999, provides
a national infrastructure to bring science-based behavioral and
pharmacological treatments for addiction into diverse patient and
treatment settings across the country. NIDA added three new sites in
the past year, which now allows our 17 centers or nodes to better serve
patients across a wider geographic area, in fact through the 115
community treatment programs involved in this endeavor we are serving
patients in 27 states. Over 8,000 patients are expected to be enrolled
in treatment protocols that are addressing the unmet needs of diverse
populations, including adolescents, pregnant women, and women who
suffer from Post-Traumatic Stress Disorder. Clinical trial networks for
cancer and diabetes have been active for decades, but NIDA's efforts
are the first ever to establish this model for addiction. Another first
for the field, is the unprecedented efforts being taken to reduce the
lag time between translating research discovery into practice. NIDA is
working with the Substance Abuse and Mental Health Services
Administration to disseminate science-based treatments into SAMHSA-
supported Centers and activities. Blending the expertise of
researchers, practitioners, and service-oriented professionals is the
hallmark of the CTN, and why the CTN has become more than just a way to
get quality treatment. It is the conduit through which research meets
practice.
conclusion
Reducing the adverse health, economic, and social consequences of
drug abuse to individuals, families, and communities is the ultimate
goal of our Nation's investment in drug abuse research. That goal is
being met by NIDA.
______
Prepared Statement of Dr. Richard J. Hodes
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Institute on Aging
(NIA) for fiscal year 2004. The fiscal year 2004 budget includes
$994,411,000, an increase of $1,342,000 over the fiscal year 2003
enacted level of $993,069,000 comparable for transfers proposed in the
President's Request. The NIH budget request includes performance
information required by the Government Performance and Results Act
(GPRA) of 1993. Prominent in the performance data is NIH's third annual
performance report, which compared our fiscal year 2001 results to the
goals in our fiscal year 2001 performance plan.
There are today approximately 35 million Americans ages 65 and
over, according to the U.S. Bureau of the Census. Thanks to
improvements in health care, nutrition, and the overall standard of
living, these men and women are more likely than ever before to be
healthy, vigorous, and productive: A recent meta-analysis of
demographic studies confirms that disability among America's elders has
declined steadily over the past decade. More older Americans are able
to participate in ``instrumental activities of daily living,'' such as
performing household chores and managing their own medications, while
fewer are experiencing limitations in basic physical tasks such as
walking or climbing stairs. The prevalence of severe cognitive
impairment also appears to be declining, although this finding needs
verification.
At the same time, diseases of aging continue to affect many older
men and women, seriously compromising the quality of their lives. For
example, more than half of all Americans over age 65 show evidence of
osteoarthritis in at least one joint.\1\ Over half of Americans over
age 50 have osteoporosis or low bone mass.\2\ Cardiovascular disease,
cancer, and diabetes remain common among older Americans. And,
according to the Alzheimer's Association, as many as 4 million
Americans suffer from Alzheimer's disease (AD), the most common cause
of dementia among older persons.
---------------------------------------------------------------------------
\1\ See ``Handout on Health: Osteoarthritis,'' National Institute
of Arthritis and Musculoskeletal and Skin Diseases, July 2002.
\2\ See America's Bone Health: The State of Osteoporosis and Low
Bone Mass in Our Nation. National Osteoporosis Foundation, February
2002.
---------------------------------------------------------------------------
conquering alzheimer's disease
We have made progress in several important areas of AD research.
For example:
We are improving our ability to diagnose AD early.--Scientists are
developing and refining powerful imaging techniques that target
anatomical, molecular, and functional processes in the brain. These new
techniques hold promise of earlier and more accurate diagnosis of AD,
as well as improved identification of people who are at risk of
developing the disease. For example, researchers have developed a new
method of functional magnetic resonance imaging (fMRI) based on oxygen
use by the brain during rest. This technique permits visualization of
signals from minute subregions of the hippocampus, a brain region
important for learning and memory that shows degenerative changes in
AD, and the researchers are using it to distinguish between hippocampal
changes that are related to normal aging and those that may indicate
the presence of neurodegenerative disease. Other researchers are
working to improve our ability to image AD's characteristic amyloid
plaques and neurofibrillary tangles in vivo, which will allow us to
diagnose the disease with greater accuracy and more closely follow its
progression. These and other NIA-funded neuroimaging studies support
the broader goals of the molecular imaging component of the NIH Roadmap
Initiative.
We are developing new, more effective treatments and preventive
interventions for AD.--Research into the underlying biology of AD is
suggesting new ways to treat the disease or even prevent it altogether.
For example, human stem cells, with their unique capacity to regenerate
and give rise to many tissue types, are of particular interest in AD
research because of their potential ability to generate new cells that
could renew damaged brain tissue, replace dying neurons, or enhance the
ability of the brain to respond to age-related impairments. Recent
findings suggest that both human embryonic stem cells (hES), which can
give rise to many cell types, and ``adult'' stem cells, which develop
into a specific cell type, show promise for the eventual treatment of
AD and other neurodegenerative conditions. Researchers have recently
developed a method for inducing hES cells to differentiate into
neurons. These newly-derived cells exhibit the properties of cells
ordinarily found in the brain and central nervous system, suggesting
that hES cells could provide a source for neural progenitor cells and
mature neurons for therapeutic use. Investigators have also found that
in the adult hippocampus, neural stem cells can give rise to functional
neurons that can integrate effectively into existing neural circuits.
NIA is currently supporting 18 AD clinical trials, seven of which
are large-scale prevention trials. These trials are testing agents such
as estrogen, anti-inflammatory drugs, and anti-oxidants for their
effects on slowing progress of the disease, delaying AD's onset, or
preventing the disease altogether. Other intervention trials are
assessing the effects of various compounds on the behavioral symptoms
(agitation, aggression, and sleep disorders) of people with AD. The
design and implementation of all of these clinical trials will be
carried out in the context of the NIH Roadmap initiative to enhance
clinical research infrastructure and methodology.
We are working to reduce the burden on caregivers of persons with
AD.--Most Americans with AD are cared for at home by an adult child or
in-law, a spouse, another relative, or a friend. For this reason, the
AD ``patient'' is, in a sense, not only the person with the disease,
but the entire family unit. The NIA's REACH Project (Resources for
Enhancing Alzheimer's Caregiver Health), a large, multi-site
intervention study aimed at family caregivers of AD patients, was
designed to characterize and test promising interventions for enhancing
family caregiving. Nine different social and behavioral interventions
were tested, and investigators found that the combined effect of
interventions alleviated caregiver burden, and that interventions that
enhanced caregiver behavioral skills reduced depression. The second
phase of the study, REACH II, combines elements of the diverse
interventions tested in REACH into a single multi-component
psychosocial behavioral intervention and is ongoing.
understanding the biology of aging
We are continuing to advance our understanding of the molecular and
cellular changes that underlie aging processes, with the goals of
identifying the factors that affect the life span of an organism and
using this information to develop interventions to extend life and
delay the onset of disease and/or disability.
Experiments in a number of animal models are providing valuable
insights into mechanisms of longevity. Investigators recently created a
transgenic mouse carrying a mutation in the Xpd gene, which codes for
an enzyme involved in both repair of DNA damage and transcription of
DNA into RNA (an important first step in gene activation). These mice
appear normal at birth but age rapidly and live only about half as long
as normal mice. This new mouse model will be useful for studying a
number of aspects of aging, including the roles of DNA damage and cell
death, as well as mechanisms by which the genome maintains itself and
how such maintenance contributes to longevity.
Researchers are also using animal models to identify interventions
that might be useful in delaying aging. For example, in one recent
study, fruit flies fed the chemical 4-phenylbutyrate throughout
adulthood lived significantly longer than expected, with no negative
effects on physical activity, stress resistance, or fertility. In
addition, last year the NIA issued a Request for Applications (RFA) for
the Aging Intervention Testing Program, a large-scale initiative to
test intervention strategies that may slow the rate of aging in animal
models. A number of unproven strategies are already in substantial and
growing use by older Americans; positive results using such strategies
in animals could lead to clinical trials to establish safety and
efficacy in humans. An important secondary goal is to identify
interventions that are not safe or are ineffective.
Work in animal models is also leading to the identification of
genes involved in regulation of the life span. In the tiny worm C.
elegans, researchers used a sophisticated genetic screen to identify
about 200 genes that cause an increase in longevity; many of these
genes were related to the worm's mitochondria (cellular energy
centers), while the exact function of many others remains unknown.
Such findings in model systems, as well as our increasing
understanding of genetic disorders such as Hutchinson-Gilford progeria
syndrome that exhibit features of premature aging, suggest important
roles for genes in human aging. Evidence for a genetic basis of human
longevity was strengthened by the recent finding that siblings of
centenarians have about half the risk of dying at every age compared
with people who do not have a centenarian sibling. In the same study,
the investigators found that brothers of centenarians were at least 17
times more likely to reach the age of 100 themselves; sisters were at
least 8 times more likely to reach 100 years of age.
reducing disease and disability
Evidence of the beneficial effects of exercise on older people
continues to increase. In a study last year, researchers assessed the
results of a resistive strength training program on men and women in
two age groups, 20-30 and 65-75. They found that the effects of the
program did not differ between the two groups: Participants in both age
groups increased strength and showed similar increases in muscle mass
and in resting metabolic rates, which generally decrease with age.
NIA is working to translate research findings in action through its
highly successful campaign to encourage older people to exercise. Since
the campaign was launched in 1998, NIA has distributed nearly one half-
million copies of its exercise guide and almost 60,000 copies of its
companion video to the public. A Spanish-language version of the guide
was published in January 2002, and over 50,000 copies were distributed
last year.
We are also working to reduce the troubling health disparities that
still exist among different racial and ethnic groups. In one study of
elderly heart attack patients, researchers found that black patients
did not live as long after discharge from the hospital as white
patients. Much of this disparity could be explained by the lower rate
of use of certain cardiac procedures among black patients, suggesting
that expanded use of effective procedures could substantially reduce
racial differences in long-term survival.
To address disability and disease in special populations, NIA
implemented a major new study of health disparities among different
racial, ethnic, and socioeconomic groups. The study, Healthy Aging in
Nationally Diverse Longitudinal Samples (HANDLS), focuses primarily on
cerebrovascular health, cardiovascular health, age-associated changes
in cognition, and strength and physical functioning. Through this
study, we hope to address hypotheses about aging and health disparities
in minority and poor populations to understand the significance of
environmental and genetic risk factors for disease. The pilot phase of
HANDLS, in which investigators assessed the logistics and feasibility
of this community-based study, was completed at the end of 2001, and
the larger population-based phase of this study is scheduled to begin
in late fall of 2003.
Other areas of research interest include:
Diabetes.--Last year, investigators in the multi-institutional
Diabetes Prevention Program (DPP) reported that people who are at high
risk for diabetes can sharply reduce their risk through a low-fat diet,
and a moderate exercise regimen. This effect was most pronounced among
study participants age 60 and over. Treatment with the drug metformin
(Glucophage) also reduced diabetes risk among study participants, but
for unknown reasons was less effective among older participants. With
other participating NIH Institutes, we are continuing to follow up the
DPP participants to determine long-term effectiveness of these
interventions.
Menopause.--Women approaching menopause may experience a variety of
uncomfortable symptoms, but uncertainty remains over the safety of
hormonal therapy due to reports of serious health risks related to some
combinations of hormones. NIA-supported researchers are working to find
effective treatments for the symptoms of menopause that do not increase
risk of adverse effects.
conclusion
It is becoming increasingly obvious that old age need not be
associated with illness, frailty, or disability. In fact, we have made
tremendous progress against all of the major diseases and conditions of
aging. However, much work remains to be done. NIA is committed to
supporting high-quality research to address all aspects of aging, from
conditions and diseases that primarily affect older people to physical,
behavioral, and cellular characteristics of the aging process. As more
Americans live longer, NIA will meet the challenges of our rapidly
aging society by continuing and intensifying research that improves the
health and well-being of older people.
______
Prepared Statement of Dr. Thomas R. Insel
Mr. Chairman, and members of the Committee, I am pleased to present
the President's budget request for the National Institute of Mental
Health (NIMH) for fiscal year 2004, a sum of $1,382 million, which
reflects an increase of $42 million over the fiscal year 2003 enacted
level of $1,340 million comparable for transfers proposed in the
President's budget.
In my statement, I will call to your attention the immense burden
on our Nation of mental and behavioral disorders. In addition, in the
context of a brief review of our research activities and
accomplishments, I will suggest how NIMH's expertise in behavioral
science and behavioral neuroscience are contributing to the Nation's
capacity to prepare for and respond effectively to the psychological
impact of bioterrorist attack.
the burden of mental illness
Mental disorders are real illnesses that are mediated by the brain
and can be diagnosed reliably and accurately. Thanks to the Nation's
willingness to invest generously in research, highly effective
treatments exist for most mental disorders; and recovery is a realistic
and attainable goal for many people who have a mental disorder. Despite
our research progress, our society faces a pressing need to strengthen
the quality and accessibility of clinical services for mental disorders
for all those who require such services. In keeping with our public
health mission, NIMH assigns high priority to the task of moving
information gained through research into the hands of providers,
systems, patients, and families.
The Surgeon General's Report on Mental Health noted that an
estimated 5.4 percent of Americans adults have a serious mental
disorder such as schizophrenia, major depression, and bipolar in a
given year, and about 5- to 9 percent of children and adolescents
suffer from mental and behavioral disorders that are sufficiently
severe to cause academic, social, or family impairment. Research
supported and conducted by NIMH has significantly strengthened the
ability of the Nation's health care providers to treat and manage these
disorders; still, the public health challenge posed by mental illness
remains formidable, in large part because many serious mental disorders
tend to strike in childhood, adolescence and young adulthood, and to
persist across much of a person's lifetime.
the president's new freedom commission on mental health
With the release of the final report of The President's New Freedom
Commission on Mental Health scheduled for this Spring, efforts to
translate our science into clinical service programs will assume added
importance and urgency. The Commission was charged to identify specific
examples of community-based care models that are demonstrably
successful in achieving desired outcomes. In its interim report, the
Commission noted that much can and is being done to improve the
delivery of high quality mental health care. The Commission found,
however, that the national mental health care system is hampered by
fragmentation of services and limited access to effective treatments.
We have worked closely with the Commission over the course of its
study, and look forward to helping to implement the its
recommendations.
An ongoing collaboration between NIH and the Substance Abuse and
Mental Health Services Administration (SAMHSA) anticipates the
Commission's interest in ensuring that individuals in every region of
the country have access to the best available treatments. NIMH, the
National Institute on Drug Abuse, and the National Institute on Alcohol
Abuse and Alcoholism have identified specific treatment and
preventative interventions that have a strong scientific evidence base
and we are working with SAMHSA officials as they develop plans to
assist State agencies implement these interventions. Built into this
initiative are processes designed to establish a systematic feedback
loop that will enable researchers to draw on real world experiences
with evidence-based practices in order to inform and guide future
intervention research.
Need clearly exists for NIMH to advise SAMHSA of completed research
that will improve the quality of care available immediately. Still,
opportunities have never been greater for fundamentally revamping our
approaches to developing new clinical treatments and preventive
interventions. New scientific knowledge about the brain and behavior,
as well as the emerging science of genomics, promise to yield new
treatments for mental disorders that ultimately will alter the delivery
of mental health care in far-reaching ways.
searching for schizophrenia vulnerability genes
After many years of searching, the recent discoveries of several
putative vulnerability genes for schizophrenia have been among the most
noteworthy achievements of the past year. Schizophrenia is a
genetically complex disorder, in which multiple genes are involved, but
no single one of them is sufficient or necessary to cause the disease.
Rather, multiple genes, interacting with environmental influences, lead
to illness. One newly discovered gene, called G72, plays a role in
regulating the activity of glutamate, an important excitatory
neurotransmitter in the brain. This is intriguing because decreased
glutamate activity appears to play a key role in negative, or deficit,
symptoms of schizophrenia such as social withdrawal, a lack of
motivation and expressiveness, and an inability to experience pleasure.
It is interesting that several of the recently discovered genes
believed to be associated with susceptibility for schizophrenia may
function by interfering with neurotransmitters in the prefrontal cortex
(PFC) and related brain regions. For example, another newly identified
gene encodes an enzyme that terminates the activity of dopamine in the
PFC. In work led by an NIMH scientist, this research has identified two
alleles, or variants, of this gene; one of these has been shown in
clinical studies to be associated with deficits in information
processing and memory, again symptoms central to schizophrenia. These
discoveries highlight the biological basis for schizophrenia and may
ultimately yield both diagnostic and therapeutic breakthroughs.
screening for drug discovery targets
One initial application of genetic discoveries will be to identify
the various molecules they encode and then design medications that act
on those molecules when they are implicated in various disorders.
Molecular processes gone awry can serve as targets for medications
designed to prevent, treat, or halt progression of a given condition.
As part of an initiative included in the NIH Roadmap, NIMH is
supporting research to generate a library of small molecules with novel
actions that will interact with particular biological targets.
Subsequent research will test these substances as candidates for the
treatment of mental disorders as well as for their utility as
diagnostic agents or research tools.
autism
Autism represents an urgent and significant scientific and public
health challenge that, given scientific opportunity and public concern,
is the appropriate focus of multiple NIH Institutes. The reported
incidence and prevalence of autism appears to be rising. Over the past
two decades, estimates of prevalence have escalated from \1/10000\ to
as many as \1/250\ (for autism spectrum) to \1/400\ (classic autism). A
recent investigation by CDC in Brick Township, New Jersey, found a
prevalence rate for autism of 4.0 per 1,000 children and a rate of 6.7
per 1,000 children for the more broadly defined category of autistic
spectrum disorders.
A biologically based developmental disorder, autism is
characterized by qualitative impairments in social interaction and both
verbal and nonverbal communication and behaviors, resulting in a
markedly restricted repertoire of activities. High quality clinical
care and management of children with autism can exert a draining
financial toll on families.
Last year, NIMH accepted leadership of the internal NIH Autism
Coordinating Committee (ACC), which operates in close communication
with the larger Interagency Autism Coordinating Committee (IACC). Other
NIH Institutes retain control over their own activities, such as the
long-standing Collaborative Programs for Excellence in Autism (CPEAs),
a network of sites funded by NICHD and NIDCD. In 2002, NIMH committed
to be the primary funding source for the Studies to Advance Autism
Research and Treatment (STAART) Centers program mandated by the
Children's Health Act of 2000. The Institute awarded grants to develop
STAART Centers, with co-funding provided by NINDS, NICHD, NIDCD, and
NIEHS. Two Centers were awarded in fiscal year 2002, and six additional
Centers are slated for funding in fiscal year 2003. This will complete
establishment of the network, exceeding the mandate of at least five
centers required by the Act.
Our research is yielding significant dividends. A recent study
found risperidone, one of a newer class of anti-psychotic medications,
to be successful and well tolerated for the treatment of serious
behavioral disturbance associated with autistic disorder in children
aged 5 to 17. Also near completion is a study evaluating the safety and
efficacy of methylphenidate (Ritalin) in treating overactivity,
impulsivity, and distractibility in children with autism spectrum
disorders.
psychological impact of bioterrorism
In light of the maxim that ``the purpose of terror is to
terrorize,'' prudence dictates that we use research not only to treat
the consequences of terrorism, but also to help refine our ability to
triage those individuals likely to be most susceptible to serious
adverse neurobiological responses to a bioterroist attack and, to the
extent possible, to ``innoculate'' the population against destabilizing
or unwarranted anxiety or panic. Over many decades, NIMH has supported
a robust behavioral science research portfolio that has informed us
about many basic behavioral mechanisms, including those influencing
group processes. More recently, we have supported studies that have
examined the psychological impact of natural disasters such as floods
and tornados, and the terrorist attacks in Oklahoma City in 1995 and on
September 11, 2001. Behavioral science and clinical research not only
provide a ``top-down'' systems-level context to help us understand what
is happening at molecular and cellular levels in the brain in the face
of overwhelming fear and anxiety, but also can help us to prepare for
and treat the psychological and social consequences of such events.
A key finding of this research to date is that people are very
resilient--the vast majority of victims of mass disaster and terrorist
attack do not develop a psychiatric disorder. For those individuals who
do, the most frequent adverse outcome is post-traumatic stress
disorder, or PTSD. This is a form of anxiety disorder that occurs after
exposure to an extreme stressor in which an individual experiences,
witnesses, or is confronted with actual or threatened death or serious
injury to self or others. Given its prevalence, disabling impact,
chronicity, and treatment resistance, PTSD represents a major public
health concern. Through the research we have conducted, however, we are
gaining an increasingly clear understanding of what variety of
psychological and behavioral problems to expect in the event of an
attack and the types of services that will be needed. We know that we
should expect to see increases in requests for therapy and medications
for common and troubling symptoms of fear, anxiety, hyperarousal, and
sleep problems. We know that survivors--particularly those with PTSD
and others who may have a comorbid, or co-occurring mental disorder--
actively use mental health services. In the event of a future attack,
as we move beyond needs for first aid, housing, and food, the majority
of those people who were directly affected will have need for
supportive counseling and assistance with resuming normal activities
such as household routines, school, and work. Research that has
examined the use of mental health interventions speaks to the clinical
significance of subjective distress even in subjects without recognized
psychiatric disorders. We also have information about who is most
likely to be at risk for developing longer-term problems and, thus, as
people present to health, educational and social service programs for a
variety of physical and mental health problems, it will be important to
apply what we know with the aim of preventing such problems. I would
also note that we also are drawing on behavioral science research
involving coping in response to threat to advise individuals and
communities how to anticipate and lessen the emotional burden caused by
trauma. It is clear that the availability of accurate information,
including information about health risk, for example, blunts the
anxiety- and panic-provoking nature of unjustified speculation about
risk and permits people to decide on action that they can take.
Research on basic behavioral processes involved in decision-making,
judgment, and health risk assessment--all involved in shaping
attitudes, affect, and behavior--is very useful in shaping the messages
we convey to our citizens.
I will be pleased to answer any questions.
______
Prepared Statement of Dr. Stephen I. Katz
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Institute of Arthritis
and Musculoskeletal and Skin Diseases (NIAMS). The fiscal year 2004
budget includes $502.778 million, an increase of $17.005 million over
the fiscal year 2003 enacted level of $485.773 million comparable for
transfers proposed in the President's request.
The budget increases over the last few years have made a tremendous
difference in the studies we have been able to launch, particularly in
clinical research including clinical trials in a wide variety of
diseases as well as the expansion of vital scientific infrastructure in
a creative way. As stewards of these funds, we have worked with a wide
range of advisers, both from the scientific community and from the lay
public, to ensure that we target areas of greatest scientific
opportunity. In addition, we worked to undertake studies that could
either be done solely or better by the Federal government. I am pleased
to be able to share highlights of some of the stories of progress and
promise that have resulted from our investments in medical research.
public/private partnerships
One of the priority areas in the new NIH Roadmap Initiative is the
development of public/private partnerships. The NIAMS has had a number
of positive experiences in this area, and I will mention two ongoing
examples. The first is the Osteoarthritis Initiative. Our Institute
partnered with the National Institute on Aging and several other NIH
components as well as with three pharmaceutical companies in launching
this public/private partnership aimed at developing clinical research
resources that support the discovery and evaluation of biomarkers and
surrogate endpoints for osteoarthritis clinical trials. This seven-year
project is being undertaken by four clinical sites and one data
coordinating center, and this consortium will likely serve as a model
for future endeavors that link the public and private sectors.
The second partnership involves the NIH and the Muscular Dystrophy
Association (MDA). The NIH has been actively engaged in implementing
the mandates of the MD-CARE Act, and has worked closely with
representatives of the muscular dystrophy (MD) research and patient
communities in this effort. Specifically, the NIAMS, NINDS, and NICHD
have partnered to issue new research solicitations for MD cooperative
research centers, and for developmental planning grants for future
centers. In addition, we are developing an initiative to support the
training of basic and clinical researchers to study muscular dystrophy.
To underscore the importance of stimulating and supporting further work
in this area, the NIH has established an MD Research Task Force, which
includes NIH scientific staff, as well as researchers, clinicians, and
patient representatives. This group will help ensure that we pursue all
promising opportunities to boost MD research and training, and it will
also complement the work of the newly established inter-agency Muscular
Dystrophy Coordinating Committee, which was called for in the MD-CARE
Act.
muscle diseases
One of the most active and productive areas within the Institute's
research portfolio is in the muscular dystrophies--a group of genetic
diseases characterized by progressive weakness and degeneration of the
skeletal or voluntary muscles which control movement. Research advances
from NIAMS investments in this area include: (1) the finding that
people with facioscapulohumeral muscular dystrophy (FSHD) have an
exclusive association with one of the two different forms of the
chromosomal region linked to the disease. This work may lead to a
better understanding of the instability of the genetic locus associated
with FSHD. (2) the discovery of how to reverse muscle degeneration in a
mouse model of Duchenne muscular dystrophy, a genetic disorder in which
muscle cells become progressively more damaged and die. Scientists have
devised a way to revitalize wasting muscle by using a special viral
carrier to introduce the missing dystrophin gene into the diseased
muscle tissue--a finding that could eventually lead to gene therapies
for patients with Duchenne muscular dystrophy. (3) the report that a
faulty gene is key to understanding myotonic dystrophy. The genetic
defect affects the conductance of electrical signals, resulting in
delayed muscle control. (4) the isolation of muscle-generating stem
cells that can improve muscle regeneration and deliver the missing
protein dystrophin to damaged muscles in a mouse muscular dystrophy
model. These results signal that some of the major obstacles to stem
cell transplantation may be overcome, resulting in more effective
treatments for muscular dystrophy and other muscle-related diseases.
and (5) the creation of a new animal model that has been labeled a
``marathon mouse,'' which expresses an energy-metabolizing protein that
increases the proportion of particular muscle fibers that give distance
runners their muscular stamina. Further work in this area could benefit
research efforts against muscle-wasting diseases like the muscular
dystrophies.
systemic lupus erythematosus
Some of the most promising research results in fur mission areas
have come from the ability of researchers to apply the explosion of
information in genetics and genomics. One example of this is the very
recent research report that a particular genetic ``signature'' has been
linked to the blood of patients with severe systemic lupus
erythematosus (SLE or lupus). A team of scientists supported by the
NIAMS, other parts of the NIH, and the private sector (the Minnesota
Lupus Foundation and the Alliance for Lupus Research) has discovered a
genetic ``signature'' present in some patients with lupus who develop
such life-threatening complications as blood disorders, central nervous
system damage, and kidney failure. These researchers analyzed thousands
of genes in the blood of patients with lupus, and, surprisingly, 14 of
the thousands of genes studied were linked to a subset of lupus
patients with severe disease. These 14 genes are associated with a
complex family of proteins involved in the regulation of immune
responses, and these findings provide strong support for developing new
therapies to block the affected pathways in patients with severe lupus,
as well as for identifying patients most likely to benefit from these
new therapies.
I want to also mention an important new clinical trial that we
launched in children with lupus. The trial is designed to test the
efficacy of statins (cholesterol-lowering agents) in preventing or
delaying progression of cardiovascular disease in children with lupus.
This research study involves 20 centers from the Pediatric Rheumatology
Research Network in establishing the largest cohort of pediatric lupus
patients ever prospectively studied.
bone and other musculoskeletal diseases
One dimension of the NIH Roadmap Initiative is translational
research, and we know that translating the results of basic bone
biology research into therapies that prevent or treat musculoskeletal
diseases can have a very significant impact on public health.
Development and maintenance of a healthy skeleton depends on
interactions between bone and bone marrow, blood vessels, and even the
central nervous system. Understanding these complex interactions will
depend on studies employing genetic and genomic tools, including NIAMS-
supported efforts in animal models that are expected to translate into
insights guiding the development of new preventive and therapeutic
approaches to conditions such as osteoporosis. In recent advances, a
variety of pharmacological agents and biochemical factors, some already
familiar in other contexts, has been found to have unexpected effects
on bone mass. For example, the actions of the cholesterol-lowering
drugs called statins, the hormone leptin (originally identified as
important for controlling obesity), and nitric oxide (best known for
its effects on the heart and blood vessels) all provide clues to ways
that new therapies might improve bone health. In addition, studies of
the genetics of bone mass are increasingly productive, including
reports of a gene that was previously unsuspected of playing any role
in bone emerging as a possible key to restoring bone in cases of
osteoporosis.
Research that has direct applicability to daily life of affected
individuals has determined that limb reconstruction and amputation
after trauma to the lower leg result in similar outcomes in terms of
function. We anticipate that the findings of this study will help
surgeons and patients make better informed decisions when choosing
between reconstruction (limb salvage) or amputation of a limb that has
been severely damaged. With a look to the future, a large United
States/Canada cooperative project is now underway to resolve
differences of opinion on the best way to repair the fracture of the
tibia--the most common long bone fracture in the human body. Factors
that will be considered in determining which of the groups being
studied has a more successful outcome include how soon patients return
to work and their general health status and quality of life. Finally,
plans are underway for an NIH Consensus Development Conference on
Primary Knee Replacement in December 2003 to address the issues that
exist in this area, to review the current state of the science, and to
identify directions for future research.
skin diseases
NIAMS-supported researchers recently reported exciting and
promising results from their gene therapy studies in the recessive form
of the devastating blistering skin disease dystrophic epidermolysis
bullosa. This disease is caused by the absence of a specific gene, and
researchers used a particular enzyme as the base for gene transfer. The
researchers were successful in stably integrating the DNA from the
missing gene into genomes of cultured skin cells from four patients
with this inherited skin disease. The skin that was developed using
these cells displayed stable correction of the hallmark features of
this disease. These results establish a potential practical approach to
nonviral genetic correction of severe human genetic disorders that
require stable genomic integration of large DNA sequences.
The Institute has recently called on scientific experts and lay
representatives to help us in three particular areas of skin diseases
research: (1) In response to fiscal year 2002 Congressional language,
the NIAMS sponsored the ``Workshop on the Burden of Skin Disease'' in
September 2002, to discuss the elements that comprise the burden of
skin diseases and their impact on public health and daily living;
current knowledge and data-collection instruments, and how to access
the data more effectively; and future data needs and instruments for
facilitating the collection of the data. The recommendations from this
workshop are being reviewed by the Institute to determine the need and
path for future initiatives in this area. The lessons learned from this
workshop can serve as a paradigm for other areas--all of which share
the challenge of defining the burden of a disease on an individual, the
family, the workplace, and society as a whole. (2) The NIAMS teamed
with the National Alopecia Areata Foundation in sponsoring the Fourth
International Research Workshop on Alopecia Areata in November 2002,
bringing together investigators from around the country for an exchange
of recent findings in alopecia areata and related fields of hair
biology. Results of this workshop will guide future research in this
field. (3) The Institute is planning a workshop on immune modulation in
the treatment of skin diseases, which will include new treatments for
psoriasis, atopic dermatitis, autoimmune bullous diseases, and other
skin diseases. The workshop will focus on trying to understand how some
new treatments are actually working so that we may better understand
the mechanisms underlying these diseases.
health disparities
In research related to health disparities, there are four efforts
that I want to highlight: (1) The NIAMS continues to support the
diversity initiative it has created and developed over the last few
years--the Health Partnership Program, a collaborative community-based
effort in Washington, D.C., that is directed at developing research
programs to understand and address health disparities in rheumatic
diseases in African American and Hispanic/Latino communities. (2)
Differences have been documented in the damage caused by lupus in
studies of Hispanic, African American, and Caucasian individuals with
this disease. The proportion of patients who had any organ damage was
higher among Hispanics than among the other two groups, confirming the
greater negative impact of lupus among members of this ethnic group.
The association of organ damage with poor coping skills was reported
for the first time, and it suggests that approaches designed to modify
patients' behaviors and attitudes to their illness could reduce the
damage to the body caused by lupus. (3) Research suggests that women
with lupus are at increased risk for both clinical osteoporosis and
cardiovascular complications at a much younger age, and more aggressive
control of the risk factors for these complications is needed to
prevent these conditions in women with lupus. (4) Social experience has
been shown to influence joint replacement decisions; that is, when
people think about having a hip or knee replaced, knowing someone who
has had the surgery may influence their decision. A recent study funded
by the NIAMS and the Robert Wood Johnson Foundation suggested that one
reason African Americans may be less likely than Caucasians to seek
joint replacement surgery, a procedure that makes a significant
difference in alleviating pain and improving function of severely
affected individuals, is because they know fewer people who have had
this procedure.
conclusion
We are proud of the advances that scientists supported by the NIAMS
have achieved and we are excited about initiatives that we have
launched. Patients and their families are looking to us with hope and
anticipation for answers to what causes their diseases, as well as how
their diseases can be better treated and even prevented. We are
confident that public health in general as well as daily life for
affected individuals in particular will benefit from NIAMS research in
the extensive and diverse array of chronic diseases within our mission
areas of bones, joints, muscles, and skin.
I would be happy to answer any questions.
______
Prepared Statement of Dr. Gerald T. Keusch
The fiscal year 2004 budget includes $64,266,000, an increase of
$2,073,000 over the fiscal year 2003 enacted level of $62,193,000
comparable for transfers proposed in the President's request.
science for global health
Thirty five years ago, the Fogarty International Center was
established to honor the memory of Congressman John E. Fogarty of Rhode
Island. The authorizing legislation, introduced by Representative
Melvin Laird of Wisconsin, stated ``. . . the committee has provided
funds to plan a lasting memorial to a man who for more than a quarter
of a century worked tirelessly for a healthier America in a healthier
world.'' (Congressional Record, House, May 25, 19867, p. 14062). It is
my privilege to report to you, that for the past 35 years, the Fogarty
International Center (FIC) has fulfilled this promise--Mr. Fogarty and
Mr. Laird would be proud of their legacy. Today the FIC is an essential
component of the DHHS and NIH response to global challenges in health,
representing the nexus between science and diplomacy and promoting both
at the same time. FIC is known and respected around the world for its
critical role in promoting research and capacity building for global
health.
The research and training supported by FIC is a window to a
brighter future for the low- and middle-income countries with heavy
burdens of disease. While people in these countries typically suffer
from high infant, child and maternal mortality rates, amplified
manyfold by the threats represented by AIDS, TB, malaria and other
seemingly intractable infectious diseases, increasingly these
populations are now subject to the ravages of chronic disease and
premature mortality represented by cardiovascular disease, diabetes,
and cancer. All of these conditions limit societal productivity,
economic growth, and stability. To this end FIC supports research to
better understand the impact of improving health on economic
development, political and social stability, and active participation
in the global marketplace of the 21st century. Because economic growth
invariably impacts on the environment, usually in an adverse manner,
FIC has also developed a research agenda to improve our understanding
of the impacts on population's health and individual's well-being
related to sustainable economic development. These programs are crucial
as we identify health care interventions that an improve both health
and development.
The programs of the FIC directly address five of the eight goals
outlined in the United Nations Millennium Declaration, including
eradication of extreme poverty (Goal 1), reducing child mortality and
improving maternal health (Goals 4 and 5), combating HIV/AIDS, TB and
malaria (Goal 6), and ensuring environmental sustainability (Goal 7).
These goals are daunting, but not incapacitating. As U.N. Secretary
General Kofi Annan has said, ``They are achievable, not by holding more
world conferences, but by people in every country, coming together and
taking action.'' This is precisely what FIC does every day. To maximize
and leverage the impacts of FIC programs, the Center has collaborated
extensively within the NIH, across the Department of Health and Human
Services, and beyond, including other components of the Federal
government, bilateral and multilateral agencies here and abroad,
foundations, and international organizations such as the World Health
Organization, The World Bank and the Regional Development Banks.
strengthening the global culture of research
For scientists to come together and take action requires them to
share a common culture of scientific ethos and values. This can only be
accomplished in an environment in which rapid communication is
possible, wherein scientific knowledge is readily available to all, and
where research is conducted based on partnership and equity. When
American scientists work across geographic boundaries in this manner,
the beneficiaries are the collaborating scientists, science in general,
the United States and foreign partner countries.
FIC strengthens this ``global culture of research'' through a range
of programs. The FIC International Bioethics Education and Career
Development Award provides trainees with a strong background in ethics
and an understanding of research. The cadre of thoughtful and
knowledgeable people trained through this program will insure that
internationally and United States-accepted ethical principles are
upheld in studies around the world, including in poor nations. An
additional component to strengthening a global culture of science is to
ensure that technological advances made in one country are accessible
to the greatest extent in all countries.
FIC addresses the growing divide in the development and use of
genetic technologies through the International Collaborative Genetics
Research Training Program. FIC-upported training in the technology of
modern genetics research is accompanied by a strong component of
ethical, social, and legal considerations and focuses on the
mplications of performing genetics research in low- and middle-income
countries.
The third pillar in support of the global culture of science is
access to information, which is addressed by the International Training
Program in Medical Informatics. This program enables U.S. institutions
to support training in order to build the capacity of scientists in
developing countries to access, utilize and construct computer-based
tools to access and exchange information to advance biomedical research
and public health. This program will recompete in fiscal year 2004. As
a companion to this initiative, FIC in collaboration with the National
Library of Medicine is embarking on additional programs to support and
improve the editorial content of key biomedical research and health
journals in developing countries, and to improve the quality and
accuracy of reporting on medical research and health by developing
country journalists, whether they are working in print, radio or
television.
As FIC works to strengthen the global culture of science through
all its programs, to maximize the benefits of individual initiatives in
fiscal year 2004 FIC proposes to pilot innovative International Glue
Grants. These grants will provide resources to link together regional
and national institutions in developing countries with their several
U.S. partner institutions, taking advantage of the perspective of
biomedical, clinical and behavioral and social scientists in creating
new ways to explore old and emerging health problems. We expect the
``glue'' will bring investigators together in a common framework for
addressing critical issues, enabling these collaborators to work more
cost-effectively and with greater productivity on critical challenges
such as AIDS, maternal health, and impacts on health from environmental
pollution.
Support for the movement of junior researchers across borders is
the fourth pillar of the broader effort to strengthen the global
culture of research and science. FIC will continue to invest in the
Global Health Research Initiative Program (GRIP), which provides
resources for developing country scientists who trained in the United
States to obtain, on a peer-reviewed merit-based system, funding to
conduct research upon their return home and remain linked in
collaborative research with their U.S. mentors. As a corollary to this
program, FIC is also investing in career pathways in international
research for young American investigators through the FIC International
Research Scientist Development Award (IRSDA). The IRSDA supports junior
U.S. scientists as they conduct research in the developing world on
issues of global import, then provides additional opportunities and a
``safety net'' on their return home. In addition, in fiscal year 2004,
will bring the first crop of students of medicine, public health and
allied medical sciences into a new program to provide a year of
mentored clinical research training in a developing country
collaborative research program. The rationale for this new program is
to expose students as early as possible in their professional careers
to research needs and prospects in the developing world as a means to
encourage them to select global health challenges as long-term career
pursuits. A partnership with the Ellison Medical Foundation, the
Association of American Medical Colleges, the Association of Schools of
Public Health and the FIC, the program will pair a U.S. student with
one from the host country to train and participate in clinical research
under the guidance of expert mentors from the United States and the
foreign country who already work together on clinical research studies.
A previously neglected area is that of gender and global health
research. Not only may risk factors, disease progression, and response
to treatment vary by gender, but societal responses based on gender may
exclude women from accessing health care or may imbue them with stigma
that adds significantly to the burden of disease. FIC is initiating two
new programs to address these issues. First, the Stigma and Global
Health research program, expected to be funded in fiscal year 2003,
will support studies to better understand the exclusion of stigmatized
populations from the benefits of medical care and participation in
medical research. Importantly, it will identify interventions to
address the major needs. Second, FIC, the NIH Office of Research on
Women's Health, the Canadian Institutes of Health Research, and Harvard
and Yale Universities are working with experts around the world to
develop a framework for the inclusion of gender issues across the range
of global research and training programs the Center and other science
funding agencies support. Included in this initiative is an effort to
enhance career development for women scientists from the developing
world.
continuing to invest in communicable disease research
FIC currently supports a broad program of research and training in
AIDS, tuberculosis, malaria and other emerging infectious diseases. In
fiscal year 2004 the Center will pursue these major global health
problems in three ways, first through its continuing focus on AIDS, the
greatest epidemic threat of our time, and second, through support of a
comprehensive program, the Global Infectious Disease Training and
Research Program (GLIDTR), to focus on infectious diseases that are
predominately endemic in or impact primarily upon people living in
tropical countries. Under the AIDS programs, a major new initiative
will be fully launched with the awarding of the first set of
comprehensive grants under the International Clinical, Operational and
Health Services Research and Training Award for AIDS and TB (ICOHRTA-
AIDS/TB). This program has as its major goal the promotion of excellent
clinical research in support of care of AIDS patients, along with the
necessary operational and health services research to move new
knowledge into practice as soon as possible. The GLIDTR is augmented by
FIC/NIH enlarging investments in the Ecology and Infectious Diseases
research program, a major collaboration between FIC and the National
Science Foundation. This innovative program is oriented towards
identifying predictive models for emergence of infectious diseases so
that preventive strategies can be implemented before a new global
calamity is unleashed on the world. Finally, FIC's Division of
International Epidemiology and Populations Studies is conducting and
coordinating research involving mathematical modeling of epidemic
disease, whether due to events in nature or caused by humans, in an
effort to better identify key questions and intervention points.
Working closely with NIAID, NIGMS, and the Office of Public Health
Emergency Preparedness at DHHS, FIC is coordinating work with leading
academic mathematical modeling groups in the United States and abroad.
expanding investments in non-communicable diseases
With the aging of populations worldwide, including in poor nations,
along with changing ifestyle patterns and migration into cities, there
is a growing recognition that the global burden of disease will
increasingly include non-communicable diseases. FIC's current programs
in this broad field address the burden of mental illness, the broad
range of brain disorders across the life cycle, and the major epidemic
of tobacco use and the inevitable epidemic of chronic pulmonary,
cardiovascular disease and cancer that will follow. To complement this
set of critical issues, FIC intends to explore ways to address the huge
and growing burden of morbidity and mortality due to trauma and injury,
whether intentional or un-intentional, such as road-traffic accidents.
Areas of interest include training and research activities designed to
better understand the body's systemic responses to major injury,
fostering more rapid application of this knowledge to wound healing
following trauma and burns, development of innovative low-cost and low-
maintenance prosthetic devices, integration of mental and physical
rehabilitation into primary care for victims of trauma, and to develop
and test effective cost-effective interventions.
A complete description of the FIC Strategic Plan is available on
the World Wide Web at http://www.nih.fic.gov/about/plan.html.
conclusion
Today, FIC, together with the Institutes and Centers at the NIH, is
exerting leadership in global health research in important new ways,
addressing critical global health problems while investing in the
training of United States and foreign researchers who can, together,
identify the solutions for tomorrow. As expressed by John E. Fogarty
before his death in 1967, ``The alternative is that the United States
will reduce its leadership role in furthering humanitarian programs,
and may become more of a responder than a leader.''
______
Prepared Statement of Dr. Raynard Kington
Mr. Chairman, Members of the Committee: I am pleased to present the
President's budget request for the Office of the Director (OD) for
fiscal year 2004, a sum of $317,983,000, which reflects an increase of
$44,031,000 over the comparable fiscal year 2003 appropriation. 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
environmental and public safety regulations of facilities. 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 each of these trans-
NIH offices in greater detail.
the office of aids research
The Office of AIDS Research (OAR) coordinates the scientific,
budgetary, legislative, and policy elements of the NIH AIDS research
program. Our response to the 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.
Each year, OAR oversees the development of the comprehensive 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
AIDS research budget for each Institute and Center; for determining the
use of AIDS-designated dollars; and for tracking and monitoring those
expenditures. OAR identifies scientific areas that require focused
attention and facilitates multi-institute activities to address those
needs. OAR coordinates, monitors and fosters plans for NIH involvement
in international AIDS research and training activities. OAR supports a
number of initiatives to enhance dissemination of research findings to
researchers, physicians, patients and communities. The fiscal year 2004
budget request for OAR is $60,942,000.
the office of research on women's health
The Office of Research on Women's Health (ORWH) serves as the focal
point for women's health research for the Office of the Director, to
ensure that women are appropriately represented in biomedical and
biobehavioral research studies supported by the NIH, and to develop and
support biomedical careers. The report: An Agenda for Research on
Women's Health for the 21st Century, provides the basis for the ORWH to
collaborate with the scientific and advocacy communities to address
scientific initiatives about women's health and sex and gender factors
in health and disease. In fiscal year 2004, the OD budget request of
$41,231,000 includes an increase of $808,000 over the fiscal year 2003
enacted budget of $40,423,000 for the ORWH to continue stimulating new
research and to implement innovative career development programs.
Research priorities for women's health emphasize the importance of
interdisciplinary collaboration, especially for chronic, multi-systemic
conditions; prevention and elimination of high risk behaviors, such as
overeating and physical inactivity, which contribute to morbidity and
premature mortality of women; and reproductive health, including such
gynecologic conditions as uterine fibroid tumors, and further exploring
issues related to the menopausal transition, such as hormone therapy.
The ORWH continues to partner with Institutes and Centers to monitor
compliance with NIH policies for the inclusion of women and minorities
in clinical research, and to ensure that analyses by sex/gender are
addressed. The ORWH is witnessing exciting expansion of new research in
its specialized centers of interdisciplinary research in women's health
and sex and gender factors. The ORWH has also expanded its unique
interdisciplinary career development program in women's health research
that fosters the mentored development of junior faculty and assists
them in bridging advanced training for junior investigators with
research independence. In addition, the ORWH has now implemented a new
Intramural Program on Research on Women=s Health to focus on NIH
intramural women=s health and sex and gender comparison research.
the office of behavioral and social sciences research
The NIH has a long history of funding health-related behavioral and
social sciences research, and the results of this work have contributed
significantly to our understanding, treatment, and prevention of
disease. The Office of Behavioral and Social Sciences Research (OBSSR)
furthers NIH's ability to capitalize on the scientific opportunities
that exist in behavioral and social sciences research by providing
leadership in identifying and implementing research programs in
behavioral and social sciences that are likely to improve our
understanding of the processes underlying health and disease and
provide directions for intervention. OBSSR works to integrate a
behavioral and social science approach across the programs of the NIH.
The fiscal year 2004 OD budget includes $26,179,000 for OBSSR, an
increase of $513,000 over the fiscal year 2003 appropriation.
Many exciting scientific developments are occurring at the
intersection of behavioral and social science research and biomedical
research. OBSSR and several ICs are in the process of developing new
approaches to train individuals to undertake a program of research that
extends well beyond traditional disciplinary boundaries. One such
initiative is a new postdoctoral program that would provide individuals
trained in one discipline with formal course work and hands-on training
in a second field. Collaboration between social and behavioral
scientists and biomedical investigators is still relatively uncommon,
in part, because traditionally trained social and behavioral
researchers lack sufficient expertise in the biomedical fields and vice
versa. The initiative will provide a mechanism for training
investigators to work in interdisciplinary teams to tackle some of our
most pressing health problems.
OBSSR is also developing an initiative that will encourage
investigators to expand on the current theoretical base of change
processes and intervention models, to expand our understanding of how
change, once achieved, is maintained over the long term. Maintaining
behavior change over the long term appears as challenging, if not more
so, than the initiation of behavior change. Past research efforts have
typically focused on short-term behavioral change. However, other
research indicates that relapse rates for addictive behaviors such as
substance abuse and tobacco use are very high. Additionally, while the
positive association between education and health has been well
documented, there is a paucity of scientific information on the
biological mechanisms and the causal pathways that underpin this
association. OBSSR in collaboration with other ICs issued a Request for
Applications to increase extramural research activity on this important
scientific question.
the 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 services to the public. The
Office of Disease Prevention (ODP) has several specific programs/
offices that strive to place new emphasis on the prevention and
treatment of disease.
In fiscal year 2004, the Office of Dietary Supplements (ODS) within
ODP requests a budget of $18,778,000. It will continue to promote the
scientific study of the use of dietary supplements by supporting
investigator-initiated research in conjunction with other ICs at NIH
and stimulating research through conduct of conferences and through
presentations at national and international meetings. In its continuing
efforts to inform the public about the benefits and risks of dietary
supplements, the ODS expanded the International Bibliographic
Information on Dietary Supplements (IBIDS) database to include a
consumer-oriented search strategy. It has also disseminated a database
devoted to federal funding of dietary supplement research, called
CARDS, which is currently populated with data about the NIH investment
from fiscal year 1999-2001. ODS publishes Fact Sheets about vitamin and
mineral dietary supplements in collaboration with the NIH Clinical
Center, as well as Fact Sheets about botanical supplements in
conjunction with the National Center for Complementary and Alternative
Medicine. ODS, in collaboration with the National Heart Lung and Blood
Institute and other NIH ICs, has sponsored a systematic review of the
relationship between omega-3 fatty acids and a series of clinical
indications, particularly coronary heart disease. Several reports will
be published in fiscal year 2003 and fiscal year 2004 based upon this
review, which will serve as the basis for planning further NIH research
on omega-3 fatty acids. To determine the future research studies of
efficacy and safety of dietary supplements containing ephedra, ODS
sponsored a systematic review of ephedra efficacy and safety, which has
recently been completed. ODS has initiated work on a pre-clinical study
of ephedra by the National Toxicology Program. Congressional language
in the fiscal year 2002 and fiscal year 2003 appropriation reports
directed ODS to enhance an ongoing collaboration for the development,
validation, and dissemination of analytical methods and reference
materials for botanical dietary supplements. ODS works with other
partners in the public and private sectors to meet this objective. ODS
supports the National Health and Nutrition Examination Survey (NHANES),
conducted by the National Center for Health Statistics at the Centers
for Disease Control and Prevention, in order to provide more
information about dietary supplement use in the US population. This
will inform future research about potentially important target
populations, such as children, women, and the elderly. Funding is used
to create and populate a database of dietary supplements, as well as to
support the measurement of blood levels of key metabolites associated
with dietary supplement use. In fiscal year 2003, ODS and USDA
published the proceedings of a workshop that examined the emerging
needs for dietary assessment, including supplement use, in national
surveys such as NHANES. A key outcome has been to develop an
analytically-based database of dietary supplement ingredients.
Another component of ODP, the Office of Rare Diseases (ORD),
develops and disseminates information to patients and their families,
health care providers, patient support groups, and others and forges
links among investigators with ongoing research activities in this
area. The ORD supports workshops and symposia to stimulate research on
rare diseases.
To provide better and faster information, ORD, together with the
National Human Genome Research Institute (NHGRI), established the
Genetic and Rare Diseases Information Center to respond to requests for
information about genetic and rare disorders. The fiscal year 2004
budget request for ORD is $11,423,000.
The ORD, supports together with NIH Institutes and Centers research
on rare diseases. Approximately 25 million people in the United States
are affected by an estimated 6,000 rare diseases. A ``rare disease'' is
defined as a condition affecting fewer than 200,000 Americans. On
November 6, 2002, the President signed the Rare Diseases Act of 2002
(Public Law107-280). The purposes of this Act are to establish the
Office of Rare Diseases in statute at the National Institutes of Health
and to increase the national investment in the development of
diagnostics and treatments for patients with rare diseases and
disorders.
the office of science education
The Office of Science Education (OSE) plans, develops, and
coordinates science education programs to strengthen and enhance
efforts of the NIH to attract young people to biomedical and behavioral
science careers and to improve science literacy in both adults and
children. The office's mission is to help people understand and use new
knowledge uncovered by the NIH in pursuit of better health for
everyone. The OSE works toward this mission by: creating programs to
improve science education in schools (the NIH Curriculum Supplement
Series); creating programs that stimulate interest in health and
medical science careers (the new LifeWorks Web site); creating programs
to advance public understanding of medical science, research, and
careers; promoting NIH educational resources and programs; and advising
NIH leadership about science education issues. All office 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 works closely with NIH
institutes, centers, and offices on science education issues, and
maintains the OSE Web site as a source of information about available
resources and programs. http://science.education.nih.gov.
The NIH Curriculum Supplements series are National Science
Education Standards-based lesson plans that are distributed free to K-
12 teachers across the country. They incorporate the best of both
science and education communities, and are intended to update science
content and allow the teacher to incorporate the latest NIH research
into classroom instructions. Life Works is a new OSE Web site created
as a source of career information for students, teachers, counselors,
and parents. The site will allow exploration of the educational
requirements, knowledge, skills, and abilities required for over 100
health and medical science careers. The fiscal year 2004 Budget request
for OSE is $3,866,000.
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, 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 the training of undergraduate students from
disadvantaged backgrounds in biomedical research careers and employment
at the NIH. The fiscal year 2004 Budget request for OLRS is $6,843,000.
nih roadmap
The NIH Director is taking an innovative approach to accelerate
fundamental discovery and translation of that knowledge into effective
prevention strategies and new treatments-an effort referred to as the
NIH Roadmap. The fiscal year 2004 budget request for the Office of the
Director includes an increase of $35,000,000 for strategic ``roadmap''
initiatives. These funds will be allocated by the NIH Director to the
Institutes and Centers to address critical roadblocks and knowledge
gaps that currently constrain rapid progress in biomedical research.
Three broad initiatives will be stimulated with these funds: (1) new
pathways to discovery, which includes a comprehensive understanding of
building blocks of the body's cells and tissues and how complex
biological systems operate, regenerative medicine, structural biology,
molecular libraries, nanotechnology, bioinformatics and computational
biology, and molecular imaging; (2) research teams of the future,
including multidisciplinary research and public-private sector
partnerships; and (3) re-engineering the clinical research enterprise.
These efforts will allow the NIH to rethink the infrastructure that is
required to translate findings from the genomic era into front-line
treatments and prevention strategies that benefit people in this
country and abroad..
Thank you for giving me the opportunity to present this statement;
I will be pleased to answer questions.
______
Prepared Statement of Dr. Claude Lenfant
I am pleased to appear before this Committee once again on behalf
of the National Heart, Lung, and Blood Institute (NHLBI). We are
extremely grateful for the generous budget increases of recent years
that have enabled us to capitalize on extraordinary research
opportunities.
progress and challenges
A recent report in The New York Times (``Gains on Heart Disease
Leave More Survivors, and Questions'') highlighted how far we have come
in the battle against heart disease--and how far we have yet to go. The
well-known good news is that heart disease death rates have been
plummeting for decades, and serious disease manifests itself much later
in life. The bad news is that an acute problem has become a chronic
problem that affects millions of Americans--this is ``the endgame of
the cardiovascular disease epidemic'' that we now confront.
clinical research and the nih roadmap
Our vigorous research effort is rapidly uncovering new knowledge
and technologies that will undoubtedly lead to treatments undreamed of
even 10 or 20 years ago. While they are being developed and tested,
however, we must do our best to ensure that rigorous science guides
appropriate use of more conventional treatments. Indeed, clinical
research that has direct application to public health issues is a major
focus of the NIH Roadmap that is currently being drawn and refined. The
NIH investment in clinical research and, particularly, in clinical
trials is absolutely critical if we are to provide health-care givers
and their patients with science-based information to guide their
decision-making. This is a role that the NIH is uniquely able to fill;
indeed, it is a job that would never be undertaken without support from
public funds. In this light, I am very pleased to mention some findings
from recent clinical trials that have enormous practical significance
for disease prevention and treatment.
blood pressure medications
The benefits of treating hypertension are widely appreciated.
However, the choice of a means to achieve blood-pressure lowering has
been complicated in recent years by the arrival on the market of new
drugs (e.g., calcium-channel blockers, angiotensin-converting-enzyme
inhibitors, alpha blockers) that, while expensive, were thought to have
advantages over older drugs. The ALLHAT (Antihypertensive and Lipid-
Lowering to Prevent Heart Attack Trial) compared these new drugs with a
diuretic--one of a class of blood pressure-lowering drugs that has been
used for many years and can be had for mere pennies a day. It found
that the diuretic did at least as good a job as newer agents in
preventing complications of hypertension--and a better job, according
to some measures. The study was conducted in a variety of practice
settings and its participants, all aged 55 and over, included high
proportions of women, minorities, and persons with type 2 diabetes.
Thus, the results are widely applicable to Americans with hypertension,
who number about 50 million, according to the National Health and
Nutrition Examination Survey.
postmenopausal hormone therapy
The merit of conducting rigorous research to challenge widely held,
but unproven, assumptions about treatment and prevention is illustrated
even more starkly by recent studies of hormone therapy in
postmenopausal women. When the NIH Women's Health Initiative was
started more than a decade ago, belief in the manifold benefits of
estrogen--and particularly its benefits with respect to heart disease
prevention--was so widespread that some thought such a trial was
neither feasible nor ethical. Thus, it was major news when the trial
reported last summer that a widely used form of postmenopausal hormone
therapy (estrogen plus progestin) is ineffective in reducing
cardiovascular disease risk and appears, in fact, to be harmful.
Estimates from U.S. Census data indicate that more than 40 million
American women are postmenopausal, so the implications of this trial,
in terms of both health and costs, are potentially very great.
treating atrial fibrillation
Yet another example of a study that contradicted popular wisdom is
the AFFIRM (Atrial Fibrillation Follow-up Investigation of Rhythm
Management) trial. It compared a well-regarded rhythm-management
approach to treating atrial fibrillation (an abnormal heart rhythm)
with a rate-control strategy. The trial found that the purported
benefits of the rhythm-management approach were nonexistent and,
moreover, that the approach carried an increased risk of adverse drug
effects. These findings are expected to alter fundamentally our method
for preventing complications, most notably stroke, of this arrhythmia,
which affects an estimated 2.3 million people in this country,
according to data from the American Heart Association.
preventing recurrent blood clots
Finally, the PREVENT (Prevention of Recurrent Venous
Thromboembolism) trial was recently halted ahead of schedule because of
persuasive intermediate results. It found that long-term use of low-
dose warfarin (a blood thinner) to prevent the recurrence of two blood-
clotting disorders, deep vein thrombosis and pulmonary embolism,
provided major benefits without significant side effects. As was the
case with the ALLHAT study, this trial addressed a research question
that would never have been pursued by industry, and identified an
important use for an old, very inexpensive therapeutic agent.
new research to address critical public health issues
Two of the most pressing public health priorities of today are
obesity and diabetes, conditions that have become epidemic in modern
America. Both are the object of NIH-wide multifaceted efforts; they
are, moreover, the special focus of concerted NHLBI attention because
their victims are inordinately susceptible to cardiovascular disease
complications. The NHLBI is undertaking new programs in both areas,
with the ultimate goal of reducing the toll of such complications.
obesity
Innovative worksite interventions for preventing and controlling
obesity in adults will be designed and tested. Although traditional
obesity-control strategies have focused on the individual, the
workplace constitutes a promising location for making positive, long-
lasting behavioral and environmental changes that may affect a broad
range of adults. It is envisioned that researchers will consider a
variety of approaches to make healthful foods available, affordable,
and desirable; promote physical activity; and establish support systems
that enable achievement and long-term maintenance of appropriate
weight.
A comprehensive research initiative on asthma and obesity will also
be undertaken. Studies have found that body mass index is strongly and
independently associated with risk of adult-onset asthma, and that
excessive weight gain in elementary school greatly increases risk of
developing asthma among young girls. Overweight also appears to
contribute to asthma exacerbations and diminished pulmonary function.
Experts from a variety of relevant disciplines believe that research
conducted collaboratively by scientists with expertise in asthma and in
body weight issues may yield important clues about hormonal, genetic,
and mechanical factors that influence the relationship between these
conditions. Stimulation of such collaboration is the goal of this new
program.
diabetes
A major new clinical trial will test approaches to lowering risk of
cardiovascular disease in adults with type 2 diabetes. The ACCORD
(Action to Control Cardiovascular Risk in Diabetes) study will evaluate
the effects of intense blood sugar control along with very aggressive
control of blood pressure and lipids. Type 2 diabetes presents an
enormous public health challenge; its many victims are highly
susceptible to developing such serious consequences as heart attack,
stroke, and limb amputation due to impaired circulation and an
estimated 70 percent of them ultimately die of cardiovascular disease.
More than 15 million Americans have diagnosed type 2 diabetes, and the
number is expected to climb to 27 million by 2050; thus, if this new
program uncovers a better treatment approach, its impact will be
significant.
The Institute is also working to develop a program to study the
causes, prevention, and treatment of cardiovascular disease in the
generally younger population of patients with type 1 diabetes. Such
patients who have advanced microvascular complications suffer
cardiovascular disease rates 10-20 times those of the general
population, and there is an urgent need to identify effective
approaches to prevent or postpone this complication. Undoubtedly, some
common factors contribute to the risk of cardiovascular disease in both
type 1 and type 2 diabetic patients, but the differences in
pathophysiology between the two diseases suggest there may also be
different factors. It is hoped that a closer look at existing data
regarding such factors will form the basis for development of
innovative preventive interventions.
spark ii conference
Although this testimony has focused attention on programs and
activities of immediate and obvious clinical relevance, I want to
assure the Committee that the Institute is moving forward briskly on
all fronts. This past October, we began revisiting a process (called
SPARK, a reference to the expectation that it would ignite a new world
of ideas) which had been first undertaken in 1998 to assist us in
determining the best use of the funds that came our way as part of the
doubling of the NIH budget. First, a working group of select scientists
was assembled to assist in identifying important opportunities that the
Institute should address over the next 3 to 5 years. Subsequently, a
conference was held to obtain the views of representatives of three
major professional societies associated with the mission of the NHLBI
(i.e., the American Heart Association, the American Thoracic Society,
and the American Society of Hematology). A research schema was
developed that focused on five areas of opportunity: regenerative
biology and replacement therapy, development and embryogenesis,
immunology and inflammation, health promotion and disease prevention,
and public health applications of genomics and proteomics. I expect
that we will have much good news to report to the Committee in the
upcoming years as the recommendations of SPARK II are implemented.
budget statement
The fiscal year fiscal year 2004 budget includes $2,868 million, an
increase of $76 million over the fiscal year 2003 enacted level of
$2,792 million comparable for transfers proposed in the President's
request.
I would be pleased to answer any questions that the Committee may
have.
______
Prepared Statement of Dr. Ting-Kai Li
I am pleased to present the President's budget request for the
National Institute on Alcohol Abuse and Alcoholism (NIAAA) for fiscal
year 2004. The fiscal year 2004 budget includes $430 million, an
increase of $14 million over the fiscal year 2003 enacted level of $416
million comparable for transfers proposed in the President's request.
Alcohol is the third leading preventable risk factor for premature
death in developed countries, according to the 2002 World Health
Organization report. In the United States, alcohol misuse costs society
about $185 billion each year.\1\
---------------------------------------------------------------------------
\1\ National Institute on Drug Abuse and the National Institute on
Alcohol Abuse and Alcoholism. The Economic Costs of Alcohol and Drug
Abuse in the United States, 1992. Analysis by the Lewin Group, Harwood,
H.; Fountain, D.; and Livermore, G. Bethesda, MD: DHHS, NIH, NIH
Publication No. 98-4327 (September 1998).
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The reason alcohol takes such a heavy toll is that its potential to
cause harm extends beyond alcoholism and behaviors that lead to fatal
injuries, major problems in themselves. Alcohol is not only a
psychoactive substance, but also a toxin that can damage any tissue or
organ in the body, unlike illegal drugs. Alcohol's toxic actions cause
or contribute to certain cancers, liver and pancreatic disease, brain
damage, and disturbances of the immune and endocrine systems, among
other conditions. But alcohol also presents a paradox. While heavy
drinking substantially raises the risk of heart disease and stroke,
studies suggest that moderate drinking appears to reduce them. Thus a
major contributor to disease appears to have the potential to improve
certain aspects of health.
variation holds the answer
The explanation for the paradox lies not only in degree of drinking
in terms of the quantity and the frequency of drinking, but also in
differences in our biological make-up. When we can answer the question
of why alcohol is harmful in some circumstances, but appears to be
beneficial in others, we'll also be likely to find answers to other
questions fundamental to our research: Why do only some of the people
who drink, but not others, develop alcoholism or tissue damage? Why
does the same medication result in sustained recovery from alcoholism
in some people, but fail completely in others?
The answers lie largely in variations in our genes and the hundreds
of biochemical activities they influence in our cells and, ultimately,
our organs and behaviors. Different individuals and different ethnic
populations can have different gene variants to yield a four-fold
difference in their metabolic and behavioral responses to alcohol.
Much of our research is aimed at identifying and understanding: (1)
the genes that influence how our organs and behaviors respond to
alcohol, (2) the association of specific variants of these genes with
specific alcohol-related outcomes, such as tissue damage or alcoholism;
(3) patterns of variation in gene activity, protein activity, and
metabolic activity with specific alcohol-related outcomes, and (4) how
environmental factors interact with these biological factors to
increase or decrease risk of alcoholism and alcohol-related problems.
Findings from this research form the basis on which we develop and
test pharmacological and behavioral strategies for prevention and
treatment. Through studies in humans as well as animals, a high-risk,
high-technology project currently underway is developing a biosensor
that will help us understand vulnerability to alcoholism and organ
pathology. This unobtrusive sensor will enable us to continuously
measure and integrate over time levels of alcohol and, simultaneously,
measure products resulting from alcohol metabolism in a number of
bodily processes.
One approach is an external skin sensor that periodically and
imperceptibly inserts a probe smaller than a human hair into an
individual subject's tissue or the fluid around it.
Another is to implant a microchip sensor subcutaneously. The
continuous data it generates will provide valuable information about
metabolic patterns of vulnerability. Clinically, alcohol levels also
will reveal whether patients are complying with treatment regimens,
providing clues about which treatment strategies are most effective.
clinical implications
Data from our basic research will enable us to do several crucial
things. We will be able to provide clinicians with reliable
biomarkers--laboratory tests--that will tell them which of their
patients are biologically and/or genetically at risk of becoming
alcoholic or of developing alcohol-induced tissue injury. Clinicians
also will have the potential to predict which patients are biologically
and/or genetically predisposed to respond to a specific medication for
treatment of alcoholism, and which patients will respond to another.
At the same time, this research is helping us to identify molecular
targets for new medications to treat both alcoholism and alcohol-
induced organ damage, a pressing need in the clinical setting. As we
follow the pathways from genes to physical and behavioral outcomes,
we're asking where, within the many biochemical reactions that occur
along the way, we can find the best molecular points at which to aim
pharmaceuticals that block alcohol's actions. We also are asking if
these points for intervention vary depending on variations in a
person's constellation of genes, necessitating different medications or
molecular targets for subtypes of the disorders.
One such point for intervention is about to be tested in human
clinical trials. Our scientists used several approaches to test a
hypothesis that blocking a specific receptor on brain cells--the CB1
receptor, a docking site for the brain's own version of marijuana-like
substances called endocannabinoids--reduces desire for alcohol. In each
approach, the CB1-receptor blocker (Rimonabant) reduced drinking.
Pending results of the clinical trials, Rimonabant could become an
important addition to our currently limited arsenal of effective
treatments for alcoholism. We have identified another 16 compounds that
are potential candidates for further development.
Our research also can help us isolate the biological mechanisms
that underlie alcohol's apparent beneficial effects. Since we don't yet
have clinically useful biomarkers that tell us who can benefit from
moderate alcohol use and who is at risk of alcohol-related problems,
and because alcohol carries with it so many well-documented risks, a
recommendation to drink moderately for those who do not drink would be
irresponsible at this point. If we can isolate the mechanisms that
underlie whatever benefits alcohol might have, we have a chance of
designing pharmaceuticals that mimic the actions of these mechanisms,
but don't have alcohol's many deleterious effects.
brain research
Alcohol exerts its principal actions in the brain. It is here that
heavy alcohol use results in brain-cell adaptations that lead to
alcohol addiction. We're approaching this crucial area of brain
research with our Integrative Neuroscience Initiative on Alcoholism
(INIA). This initiative is extending beyond traditional models of
collaboration to capture the potential of input from the many fields
that necessarily contribute to alcohol research, including genetics,
imaging, molecular biology, and behavior--each of which may use
different methods and attach different significance to findings.
At the scientific level, INIA has provided its investigators with
technologies and standardized animal models which ensure that the
significance of findings from each field are placed in the context of
alcohol research. INIA collaborations are occurring not only across
fields of research, but also across universities and organizations,
nationally and internationally.
More than that, INIA has created an operational structure that
enables us to pursue the most productive research, relatively
unencumbered by inflexible funding mechanisms. INIA's funding strategy
allows us to pursue productive investigations as they emerge, to
continue them, and to discontinue those that prove to be less promising
or have reached their potential. In short, INIA has removed roadblocks
to progress. This is enabling us to identify the structure and function
of neural circuits, networks of brain cells that work in concert as
intermediaries of alcohol's behavioral outcomes.
Molecular imaging techniques are permitting INIA investigators to
link alcohol-induced molecular responses with behaviors, in real time.
Through computational biology, INIA researchers are creating models
that predict how different brain structures and functions will respond
to alcohol under different scenarios. This kind of research can help us
determine optimal points for therapeutic intervention. A recent
expansion of INIA will enable us to conduct translational research, to
test whether neurobiological changes that occur in our animal models of
alcohol-related behavior also occur in humans.
under-age drinking
Drinking by children and adolescents is a concern reflected not
only in our research, but also in parents and the media. Young brains
are still forming nerve-cell connections, and they appear to be more
sensitive to the deleterious effects of alcohol. Researchers are
investigating how alcohol affects this and other processes in the
developing brain, and for how long. Early indications are that
adolescents who have gone through alcohol addiction and withdrawal risk
long-term deficits in learning ability and memory. Research also shows
that people who begin drinking at young ages are much more likely than
those who begin later to become alcoholic at a later point in life.
Children and adolescents also are still developing decision-making
capabilities, so important in formulating responses to environmental
influences, such as peer pressure, that are powerful contributors to
their choices about drinking. Almost 30 percent of 9th-12th graders
surveyed report that they have had five drinks in a row at least once
in the previous month.\2\
---------------------------------------------------------------------------
\2\ Centers for Disease Control and Prevention, Youth Risk Behavior
Survey. http://www.cdc.gov/nccdphp/dash/yrbs/2001/youth01online.htm
---------------------------------------------------------------------------
An important question in alcohol research is how different drinking
patterns affect risk of developing alcohol-related problems. Heavy,
episodic drinking (sometimes referred to as ``binge drinking'') appears
to be popular among some youth--notably college students, as newspaper
headlines frequently attest. A study widely publicized in the media
last year estimated that 1,400 college students die each year from
alcohol-related causes and that 500,000 are injured.\3\
---------------------------------------------------------------------------
\3\ Hingson, R.W.; Heeren, T.; Zakocs, R.C.; Kopstein, A.;
Wechsler, H. Magnitude of alcohol-related mortality and morbidity among
U.S. college students ages 18-24. Journal of Studies on Alcohol,
63(2):136-144, 2002. (164269)
---------------------------------------------------------------------------
In addition to our investigator-initiated research in this area, we
have formed the Task Force on College Drinking, a collaboration between
college presidents and scientists. The Task Force has released
recommendations on prevention strategies, literature for various
audiences, and a website, and has organized regional workshops. The
Institute recently issued a research announcement calling for
scientists with expertise in underage drinking to form rapid-response
partnerships with colleges that request help. Episodic heavy drinking
of alcohol has been ritualized and is an accepted part of life at
certain celebratory events in our society, not only among youth, but
also among adults. Among the questions we're asking are: How does this
kind of drinking practice become ritualized in our society in spite of
its deleterious consequences? How can we change the culture that leads
to it?
Meanwhile, our initiative on the biological mechanisms of
adolescent alcohol abuse is using imaging techniques that correlate
brain structure with function and behaviors, in addition to other
techniques, to reveal how alcohol affects specific brain areas, in
human and nonhuman primate and rodent animal model studies. We're also
asking how developmental and environmental factors and the interplay
between genes and environment affect youths' choices to drink and their
physical and behavioral responses to alcohol.
prevention and risk reduction
Alcohol prevention research is aimed at reducing the causes and
consequences of alcohol abuse and alcoholism. For example, whether the
relationship between early onset of drinking and subsequent alcoholism
is one of cause and effect or the result of factors that predispose
people to both those behaviors, and others, is unclear. Our
investigators are studying this issue, and their findings will help us
understand why people become alcoholic. Meanwhile, preventing youth
from drinking and reducing the harm it causes are essential, not only
because early onset drinking predicts subsequent alcoholism, but also
because of the immediate harm that alcohol misuse can cause injury,
violence, early introduction into the criminal justice system, legal
repercussions, derailed scholastic careers, and death, to name a few.
We are conducting studies that develop and test strategies to
prevent drinking by youth of different ages and backgrounds.
Particularly important among these are longitudinal studies that can
tell us whether strategies that show promise among a given subgroup of
youth, such as rural adolescents, are successful or can be adapted for
others, such as urban youth. These studies examine the impact of a
number of factors, such as school programs, parental and family
influence, peer influence, alcohol advertisements, and community
policies and practices.
Prevention research at NIAAA also focuses on the general population
and segments with unique needs. Among them are pregnant women (and
their unborn children, who are at risk of fetal alcohol syndrome) and
the elderly, who may be prone to depression and dangerous interactions
between alcohol and prescription drugs. One of our initiatives is
determining if community-based approaches successful in preventing
alcohol-use disorders in the short-term can result in long-term
prevention at different life stages.
outreach
Public and private partnerships are helping us send our prevention
messages to the community. The Leadership to Keep Children Alcohol-
Free, a prevention campaign in which the Robert Wood Johnson Foundation
has joined us, has recruited 33 governors' spouses to act as
spokespersons.
Other partners in our efforts to prevent under-age drinking include
the National Highway Traffic Safety Administration, the Department of
Justice, the Department of Education, and the Substance Abuse and
Mental Health Services Administration. Our outreach efforts also target
clinicians, including physician groups such as the National Hispanic
Medical Association, and the National Medical Association, that serve
special populations. A science-to-service program provides clinicians
with information about current research, and links them with scientists
who advise them on specific areas of practice, at the clinician's
request. We work with States to engage their treatment providers and
administrators. After exchanging information about our current research
findings and the practitioners' obstacles to providing treatment, we
place experts in temporary residencies in treatment programs that have
identified specific areas of need. Medical schools generally aren't
thorough in their coverage of alcohol-related problems, and we have
produced a physician's guide to help fill the gap. Through these
efforts, we promote the practical application of our research where
it's most needed.
______
Prepared Statement of Dr. Donald A. B. Lindberg
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 2004, a sum of $316,040,000, which reflects an
increase of $9,334,000 over the fiscal year 2003 enacted level of
$306,706,000 comparable for transfers proposed in the President's
request.
For more than 150 years one institution has been the nation's
primary source of published medical information--your National Library
of Medicine (NLM). Originally part of the Army, the Library became a
civilian organization in the 1950s and a part of the NIH in the 1960s.
Innovation in disseminating medical information has been a hallmark of
the Library since the 19th century, including the first successful
application of computers (40 years ago) to a large-scale bibliographic
system. Today NLM not only maintains the world's largest collection of
biomedical books and journals, but it has become, via the Web, a
ubiquitous source of authoritative information for scientists, health
professionals, and consumers around the world. Some half a billion
searches of the various NLM databases are done each year.
The NLM in the 21st century is distinguished especially by two
features unknown to it just two decades ago: the institution has become
the leading source of human genome information and at the same time an
important source of nontechnical health information for the public. The
proximate source of the information that makes both these features
possible is the National Institutes of Health. The NLM, through the Web
operations of its National Center for Biotechnology Information,
receives more than a quarter million visitors a day seeking molecular
biology information ranging from DNA sequences and protein structures
to the related research literature. On the other hand, the extensive
health information issued by the various NIH institutes and centers
forms the backbone of the MEDLINEplus information service offered to
the general public.
An unusual aspect of the NLM's contemporary role that there is a
direct connection between the Library's research and information
programs and the defense against bioterrorism and medical and public
health preparedness for disaster management and terrorist attack. To
cite a few examples: genomics research databases for targeted
development of drugs, vaccines, and other forms of treatment for such
diseases as smallpox, anthrax, plague, Ebola, and cholera; informatics
R & D related to terrorism and disaster management; training for health
professionals in the use of pertinent information resources; developing
experimental information resources targeted at first responders; and
improving the information infrastructure so that vital data can be
shared during a crisis. As to post-9/11 information services, NLM
quickly placed pages on its Web site about post-traumatic stress
disorder, biological and chemical warfare agents, anthrax, and other
information related to bioterrorism.
tools for scientists and health professionals
In its role as the world's largest medical library, the National
Library of Medicine continues to provide access to the enormous
literature of the health sciences, including even priceless historical
treasures dating to the 11th century. Most medical researchers and
health professionals have, directly or indirectly, availed themselves
of the Library's services some time in their career; there are those
who access MEDLINE/PubMed (to take one popular example) almost daily.
Another heavily used information resource is GenBank (with DNA sequence
data).
MEDLINE is a database of 12 million references and abstracts to the
world's medical literature published since the 1960s; PubMed is the
Web-based retrieval system that makes this wealth of information freely
and easily searchable to health professionals and others. MEDLINE/
PubMed is an evolving system. The database expands at the rate of about
half a million records a year. Several years ago NLM introduced links
between MEDLINE references and publisher websites so users could
retrieve the full text of articles. Today, more than 3,000 of the 4,600
publications indexed for MEDLINE have such links. Another element in
the evolution of MEDLINE is converting information from the 1950s,
MEDLINE form, so that valuable research data, on smallpox and
tuberculosis to take just two pertinent examples, will be available to
today's scientists. A recent improvement is a text version of PubMed
for users who require special adaptive equipment to access the web.
This has had the additional benefit of making the system much more
friendly for those using hand-held devices.
GenBank, on the other hand, is accessed primarily by scientists--
some 50,000 of them each day. It is a collection of all publicly
available DNA sequences and is thus a key element in ensuring that the
flood of data resulting from research around the world, including the
Human Genome Project here at home, is available for further research
and for further analysis and for gene discovery. GenBank is maintained
by NLM's National Center for Biotechnology Information (NCBI) and now
contains more than 15 million sequences and 29 billion base pairs from
over 130,000 species. These are limited to chromosome maps, gene
protein products, and other relevant genetic information for human and
many smaller species.
An increasingly popular NCBI service for the scientist and health
professional is PubMedCentral. This is a digital archive of life
sciences journal literature under which publishers electronically
submit peer-reviewed research articles, essays, and editorials to be
included. NLM undertakes to guarantee free access to the material;
copyright remains with the publisher or the author. Creating ``digital
archives'' is an important NLM responsibility in this electronic age.
Electronic health data standards are also part of the information
infrastructure of the 21st century. Such standards are needed for safe
and effective health care, efficient clinical and health services
research, and timely public health and bioterrorism surveillance. NLM
plays an important role in HHS initiatives to promote standardization
of electronic patient data by supporting the maintenance, distribution,
and linking of key clinical terminologies within the Unified Medical
Language System (UMLS) Metathesaurus. As a result, these clinical
terminologies are available for use throughout the United States in
clinical research databases, patient care, and public health
surveillance. NLM is providing funding for the development,
enhancement, and distribution of several clinically specific
vocabularies. The UMLS Metathesaurus provides a common distribution
vehicle for such vocabularies and a mechanism for linking them to
HIPAA-mandated administrative code sets, basic research vocabularies,
and thesauri designed to index the scientific literature. In addition,
pilot projects for testing the use of the vocabulary in different
settings will be critical for maximizing the benefit of electronic
health data standards for improving patient safety, reducing costs, and
enhancing effective information exchange to combat bioterrorism.
information services for the public
Since 1998, NLM has expanded its mission beyond serving health
professionals and researchers to encompass providing high quality
electronic health information services for the public. To serve this
audience, the Library developed a new information resource,
MEDLINEplus, a Web-based service that provides integrated access to the
high quality consumer health information produced by NIH and HHS
components and other reputable organizations. About 1.8 million unique
visitors obtained health information from MEDLINEplus in January 2003.
The main features of MEDLINEplus: 600 ``health topics,'' from Abdominal
Pain to Yeast Infections, consumer-friendly information about thousands
of prescription and over-the counter drugs, an illustrated medical
encyclopedia and medical dictionaries, directories of hospitals and
health professionals, a daily health news feed from the major print
media, 150 interactive and simply presented tutorials (with audio and
video) about diseases and medical procedures, and connections from the
health topics to current clinical trials.
Like MEDLINE, MEDLINEplus is a constantly evolving system. Links
are checked daily and new health topics added weekly. A completely
Spanish-language version of MEDLINEplus was introduced in 2002 and is
receiving heavy use. Early in 2003 a prototype ``MEDLINEplus Go Local''
system was introduced in North Carolina, a joint effort of the
University of North Carolina and the NLM. This system allows
MEDLINEplus users access to ``NC Health Info,'' which contains links to
local, county, and state health services in North Carolina and,
conversely, users of NC Health Info can link into the detailed,
authoritative health information about particular diseases and
conditions in MEDLINEplus.
The NLM casts a wide net in creating and promoting MEDLINEplus,
working closely with the Public Library Association and other
organizations not associated with NLM's mission, as well as with the
4,700 member institutions of the National Network of Libraries of
Medicine. Network librarians not only assist in identifying and
evaluating information to be included in MEDLINEplus, but are of
tremendous help in demonstrating MEDLINEplus locally and publicizing
it.
Another major consumer information resource, ClinicalTrials.gov,
was developed by the NLM on behalf of the entire NIH in response to a
mandate from Congress. The database provides patients and families
access to information about clinical trials and opportunities to
participate in the evaluation of new treatments. The site was launched
in February 2000 and currently contains approximately 7,200 clinical
studies sponsored by NIH, other Federal agencies, and the
pharmaceutical industry.
nlm research and development programs
The Library is at the cutting edge of research and development in
medical informatics--the intersection of computer technology and the
health sciences. NLM has a program of grants and contracts to
university-based researchers and also a cadre of in-house scientists in
the Lister Hill National Center for Biomedical Communications and the
National Center for Biotechnology Information. The Lister Hill Center
sponsors many exciting communications research projects, such as those
in telemedicine and the Visible Human Project. The NLM-supported ``A
Clinic in Every Home'' is an especially promising telemedicine project
for medically underserved rural Iowa residents to provide them with
access to high quality health care. The expectation is that this system
will both raise the quality of health care and lower costs. Another
Lister Hill Center program is the initiative to fund projects that
demonstrate the medical community's technical needs in using high-speed
communications networks for critical healthcare applications, including
computing in support of disaster management.
The Visible Human Project comprises two enormous data sets, male
and female, of anatomical MRI, CT, and photographic cryosection images.
These data sets, licensed to more than 1,700 individuals and
institutions in 43 countries, are being used in a wide range of
educational, diagnostic, treatment planning, virtual reality, artistic,
mathematical, and industrial applications. Projects run the gamut from
teaching anatomy to practicing endoscopic procedures to rehearsing
surgery. NLM's AnatLine is a web-based image delivery system that
provides retrieval access (even from a home computer) to large
anatomical image files of various parts of the Visible Human male
thoracic region, such as the heart and stomach, including 3D images.
The other major NLM component involved in R & D is the National
Center for Biotechnology Information, noted above as the source of the
GenBank database of DNA sequence information. NCBI is more than just
assembler of genomic data, however. NCBI investigators have developed
sophisticated computational tools such as the BLAST suite of programs
that makes it dramatically easier for researchers to scan huge sequence
databases for similarities, and to evaluate the resulting matches.
Another NCBI product, Entrez, is an integrated database that allows
users to easily and quickly search enormous amounts of sequence and
literature information. The newest tool is the ``Reference Sequence
Collection'' that is serving as a foundation for genomic research by
providing a centralized, integrated, non-redundant set of sequences,
including genomic DNA, transcript (RNA), and proteome (protein product)
sequences, integrated with other vital information for all major
research organisms. As genomic sequence data continues to accumulate
and be made available in ingenious ways through the web, we can expect
discoveries that promise future medical breakthroughs.
NLM extramural programs have an important role in supporting R & D
in biocommunications. One timely example is the early warning public
health surveillance system developed at the University of Pittsburgh
and recently demonstrated to the President. NLM's grant program also is
a key supporter of NIH's ``Biomedical Information Science and
Technology Initiative.'' The Library has expanded its support from 12
to 18 training programs at universities across the nation to train
experts to carry out research in general informatics and in
bioinformatics. The NLM has recently augmented each of the training
programs with a ``BISTI supplement'' and has also funded two planning
grants that will eventually lead to the development of what are called
National Programs of Excellence in Biomedical Computing.
serving special communities
The NLM has been working with the National Institute on Aging to
create NIHSeniorHealth.gov. Accessible from MEDLINEplus, the new site
contains information in a format that is especially usable by senior
citizens. At present NIHSeniorHealth.gov contains information on topics
like Alzheimer's and exercise for older adults, but it will soon be
expanded to include more topics of special interest to seniors as other
NIH institutes contribute to it. NLM is working on adapting special
software that would allow the visually impaired to exercise control and
hear Web pages read to them. This would also be a boon to some senior
citizens.
The National Network of Libraries of Medicine, noted above in
connection with MEDLINEplus, places a special emphasis on outreach to
underserved populations in an effort to reduce health disparities. For
example, there are programs to assist in remedying the disparity in
health opportunities experienced by such segments of the American
population as African Americans, Latinos, Native Americans, senior
citizens, and rural populations. One of the NN/LM outreach efforts
involves a telemedicine ``connections'' program for Native Americans in
the Pacific Northwest conducted through the Regional Medical Library at
the University of Washington.
Another highly successful NLM outreach program has been
strengthening Historically Black Colleges and Universities so that they
can train people to use information resources in dealing with
environmental and chemical hazards. Under this program, faculty and
students in more than 80 minority institutions have received such
training. Through these schools, NLM is working to promote high-quality
Internet connectivity and using technology for research and education.
There are other NLM programs targeting groups of citizens with
special health information needs. In the past several years, the
Library has made more than 50 awards to continue its HIV/AIDS-related
outreach efforts to community-based organizations, patient advocacy
groups, faith-based organizations, departments of health, and
libraries. This program supports local programs to improve information
access for AIDS patients, the affected community, and caregivers.
Emphasis is on providing information in a way meaningful to the target
community, and may include training in information retrieval, sending
interlibrary loans, and providing Internet access.
NLM's efforts to reach special populations in need are not limited
to the United States. An international partnership in which the NLM is
a key player is the Multilateral Initiative on Malaria. NLM's mandate
as leader of the Communications Working Group has been to leverage
partnerships (at 13 installations) to create a malaria research network
in Africa, enabling scientists there to have full access to the
Internet and the Web as well as access to medical literature. The aim
is to allow researchers, any time of the day or night, to have
instantaneous Internet access that will enable them to send and receive
e-mails, search for literature, interrogate databases, share files and
images with colleagues, and generally move to a new and more efficient
way of doing collaborative research.
future prospects
NLM is responsible for acquiring, indexing, cataloging, and
preserving the world's biomedical literature--in all languages and
media--and for providing reference and research assistance and document
delivery from this comprehensive collection. NLM also collects,
processes and distributes genome sequence data through NCBI. Both of
these core areas are experiencing unprecedented growth. The cost of
purchasing the biomedical literature typically increases about 10
percent per year, irrespective of general inflation, and the move to
electronic publishing has not diminished this rate of increase. NLM
uses advanced technology to improve the efficiency of its basic
operations, and contractors currently perform the majority of
activities required to provide NLM's basic services.
______
Prepared Statement of Dr. Kenneth Olden
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). The fiscal year 2004 budget includes
$630,774,00, an increase of $17,358,000 over the fiscal year 2003
enacted level of $613,416,000 comparable for transfers proposed in the
President's request.
introduction
Voluminous literature derived from epidemiological studies as well
as human and animal experiments has shown that environmental factors
play an important role in human health and disease. That is, most
complex diseases arise from the interplay between genetics, environment
and behavior. However, understanding of these interactions has remained
grossly descriptive and the molecular mechanisms elusive. But, thanks
to the rare confluence of technology breakthroughs in genomics and
proteomics and the rethinking and redirection of the environmental
health sciences over the past decade, the link between the environment
and human health and disease can now be investigated with more rigor
and specificity. For example, the sequencing of the human genome and
the development of high throughput technologies to monitor the
expression of genes and proteins in response to specific environmental
exposures has created an unparalleled opportunity to study gene-
environment interactions.
new initiatives
Breast Cancer and Environment Research Centers.--There is
surprisingly little information on the development of the normal
breast. The lack of knowledge about the biological and molecular
mechanisms involved in normal breast development hinders our ability to
identify environmental triggers of breast cancer. How can we identify
early adverse changes in breast tissue if it is not known how the
tissue normally develops? To fill this research gap, NIEHS is funding a
consortium centers program that will provide new information on the
normal growth and development of the breast and reproductive systems,
evaluate the impact of environmental exposures on the breast, and
explore potential times of increased sensitivity and vulnerability of
breast tissue to environmental effects. These centers represent a
collaborative effort with the National Cancer Institute.
NIEHS is also continuing the effort to establish a cohort of
unaffected sisters of breast cancer cases to clarify the gene-
environment interactions in this disease. This cohort can be used to
examine breast cancer risk in relation to factors such as endogenous
hormones, growth factors and environmental contaminants, and to study
these factors jointly with genes to elucidate genetic modifiers of
response.
Toxicogenomics.--NIEHS developed the National Center for
Toxicogenomics (NCT) to coordinate a nationwide research effort for the
development of a toxicogenomics knowledge base. Toxicogenomics is a new
discipline that studies how genes respond to environmental stressors or
toxicants. It combines genetics (genomic-scale mRNA expression),
proteomics (cell and tissue-wide protein expression), metabonomics
(metabolite production) and bioinformatics with conventional toxicology
to investigate the role of gene-environment interactions in health and
disease. New molecular technologies, such as DNA microarray analysis
and protein chips, can be used to measure the expression of thousands
of genes and proteins, providing the potential to accelerate discovery
of toxicant pathways and specific chemical and drug targets.
When a person is exposed to a chemical, cells in the body may
respond by switching on some genes and switching off others. The on/off
pattern of various genes is different for different chemicals, creating
a characteristic pattern or ``signature,'' which scientists hope will
be useful in classifying chemicals and other stressors by their
biological activity. This signature pattern would provide a means of
predicting effects on human health from chemicals we currently know
little about. Toxicogenomics seeks to use these signature gene
expression patterns to go beyond the traditional toxicological tools of
testing animals for adverse outcomes that might indicate toxicity.
One aim of the NCT is to create a Chemical Effects in Biological
Systems (CEBS) Database. The CEBS database will contain data on global
gene expression, protein expression, metabolite profiles, and
associated chemical/stressor-induced effects in multiple species. With
such information, it will be possible to derive functional pathways and
network information based on cross-species homology. Once sufficient
high quality data have been accumulated and assimilated, it will become
possible to predict the toxicity of an unknown chemical by comparing
its gene and/or protein expression profile to compendia of expression
profiles in the database. As the field of toxicogenomics evolves,
toxicogenomics databases will begin to support predictive toxicology
and hazard assessment. This will help scientists predict the
toxicologic impact of suspected toxicants and calculate how much of a
hazard these toxicants actually represent to human and environmental
health.
The pharmaceutical industry is making huge investments in this
technology because of their interest in finding ways to speed up the
process of toxicological assessment of new research and development
products. Identifying molecular events that serve as precursors of
adverse health outcomes early in the development process would
eliminate much of the expense (estimated in the billions of dollars
annually) associated with the development of new pharmaceutical
products.
Susceptibility to Environmental Exposures.--Although reference is
made to the human genome, the concept of a single genome is misleading.
Each individual's genetic makeup, with the exception of identical
twins, is unique. While the genomes of individuals are 99.9 percent
identical, the 0.1 percent variation leaves considerable room for
individual differences among the approximately three billion nucleotide
base pairs that make up the human genome. However, it should be
emphasized that genes are not the only factors that contribute to
differences in susceptibility to environmental exposures; age or stage
of development, behavior, and general health or nutritional status can
have a spectacular influence. Both the genetic and age/stage of
development-related aspects of susceptibility are being addressed by
NIEHS.
Differences in susceptibility to environmental exposures had
received little attention until NIEHS launched the Environmental Genome
Project (EGP) and the Children's Environmental Health Research and
Prevention Centers in 1998. There is now considerable evidence that
hundreds of genes exist in the human genome that make some individuals
more or less susceptible to the effects of pollutants or other
environmental chemicals, contributing to everything from cancer to
birth defects and Parkinson's Disease. The key objective of the EGP is
to discover the alleles or genetic variants (called polymorphisms) that
confer susceptibility or resistance.
The Children's Environmental Health Research and Prevention Centers
were developed, in collaboration with the EPA, to explore the
relationship between the timing of exposure, the stage of development
and susceptibility. Because of the rapid rate of growth and development
of major organ systems (e.g., the lung, brain, and heart), children are
thought to be particularly vulnerable to environmental toxicants. They
can be more vulnerable than adults to adverse health outcomes, and the
consequences of these adverse effects are sustained throughout life,
making the reduction of childhood exposures a critical component of
environmental public policy.
We are also exploring the possibility of susceptibility studies in
seniors. For a variety of reasons, older Americans are also more
susceptible to environmental stress (e.g., the combination of poor air
quality and extreme heat during the summer months). This important
public health issue has received almost no attention, but dialogue is
ongoing with the EPA and the National Institute on Aging about ways to
include older Americans in more environmental health studies.
Parkinson's Disease Research Consortium.--NIEHS created a
Parkinson's Disease Consortium Centers Research Program in 2002 because
we believe that a collaborative, multidisciplinary, multi-institutional
approach is required to elucidate the complex interactions between
genes and environmental factors likely to be involved in the
development of this devastating disease. Collectively, the three
centers that make up the consortium have expertise in basic
neurosciences, human genetics, clinical research, and epidemiology, and
long-standing collaborative interactions with the various non-profit
organizations that represent patient advocates. These scientific
disciplines were included in the consortium because a major impediment
in Parkinson's Disease research has been that significant findings in
one field were not readily disseminated among investigators in the
other related fields. It is our intent to expand the Consortium Centers
concept in 2004 to capture some of the outstanding activities not
funded earlier.
The knowledge and technologies developed in the Institute's EGP,
the Mouse Genome Centers, and the National Center for Toxicogenomics
will also be made available to this cohort of investigators as they
become available. For example, new Parkinson's Disease susceptibility
genes and new environmental risk factors are likely to be discovered,
and new mouse models of the disease are likely to be created using gene
``knockout'' and ``knockin'' technologies. These new resources will be
invaluable to the Parkinson's Disease research community.
The Development of Multidisciplinary Research Teams and Novel
Technologies.--The solution to complex problems often requires the
collective knowledge and experience of multiple investigators and novel
approaches developed at the boundary of several disciplines. While the
individual investigator approach remains the cornerstone of innovation
of science and technology development, translation often requires a
team approach. In fact, lack of infrastructure to support the
development of multidisciplinary research teams is hampering our
ability to realize the benefits of the nation's expenditures for
biomedical research. While the NIH has invested in infrastructure to
build maps of the human genome and develop technologies for genotyping
and monitoring gene and protein expression, it is the deployment of
these data bases and technologies to prevent human illness that has
proven to be the most challenging.
Also, the inadequacy of current analytical methods to investigate
complex interactions involving genes, proteins and environmental
factors has been a bottleneck in understanding the development of
complex diseases resulting from such interactions. While high
resolution structural analysis of proteins is critical for
understanding molecular interactions between genes, or proteins and
toxic chemicals, new technologies will be needed to determine how the
latter disrupts structure and function of highly coordinated biological
pathways or networks at the level of the cell and tissue. NIEHS has
developed the Center Programs described here to catalyze the formation
of multidisciplinary research teams to investigate gene-environment
interactions using emerging expertise and technologies.
summary
The data generated by the studies I have described will allow for a
more rational approach of gauging environmental threats, and will
reduce the need to rely on default assumptions in extrapolating results
from animal models to humans and in setting exposure limits. These
studies will also lead to the development of high throughput
technologies that could both accelerate and reduce the costs of
toxicity testing of pharmaceuticals and environmental xenobiotics. This
approach to understand how genes and the environment interact shifts
the focus of disease management from symptom-based classification to
biological causation and prevention. The objective is to provide a
database that will allow for the use of precursors or molecular markers
in assessment of disease states.
______
Prepared Statement of Dr. Audrey S. Penn
Mr. Chairman and Members of the Committee, I am Audrey Penn, Acting
Director of the National Institute of Neurological Disorders and Stroke
(NINDS). I am pleased to present the President's budget request for
NINDS for fiscal year 2004. The fiscal year 2004 budget includes $1,469
million, an increase of $13 million over the fiscal year 2003 enacted
level of $1,456 million comparable for transfers proposed in the
President's request.
The mission of NINDS is to reduce the burden of neurological
disorders, that is, the many diseases that affect the brain, spinal
cord, muscles, and nerves of the body. Neurological disorders cause
enormous suffering and loss of life, often defying the best efforts of
modern medicine. However, we are making progress in prevention and in
treatment, derived from continuing advances in fundamental scientific
understanding of the nervous system, which enhance the prospects for
the future. Today I will touch on these points and concentrate on what
NINDS is doing to expedite progress.
the burden of neurological disorders
Neurological disorders can compromise the complex thinking and
emotions that make us human, the routine perception and movement that
we take for granted, and even the control of bodily systems that are
normally beneath our awareness. Diseases of the nervous system strike
at every age. Some, such as stroke, chronic pain, epilepsy, and
traumatic brain injury, are among the most common of all causes of
death and disability. Hundreds of less common neurological disorders
take an incalculable toll on patients and families too. Also demanding
attention are substantial disparities in impact by ethnic group,
gender, socioeconomic status, and geography.
progress and prospects for the future
Progress in preventing and treating neurological disorders has been
notable. As Dr. Zerhouni has testified previously, this year alone
almost a quarter of a million fewer deaths from stroke will occur in
the United States than would have been expected without advances in
prevention--progress that represents the cooperative efforts of many
groups, public and private. Prevention of nervous system birth defects,
such as spina bifida, and genetic counseling for inherited disorders,
such as Tay-Sachs disease, are also having a major impact on public
health. The first acute treatments for ischemic stroke and spinal cord
injury--though still far from adequate--have proven effective for
reducing neurological damage. Immune therapies now reduce relapses and
slow the progression of disability in multiple sclerosis. Surgical
options employ implantable devices to compensate for brain circuits
unbalanced by disease in Parkinson's disease and epilepsy. Enzyme
therapies have brought the first successes in treating lipid storage
disorders. Advances in molecular genetics and brain imaging are further
augmenting clinicians' insights to diagnose and to guide therapy.
Progress is gaining momentum, with an unprecedented variety of new
treatment and prevention strategies under development: drugs to home in
on the molecules that cause disease, stem cell therapies to replace
lost nerve cells, neural prostheses to read control signals directly
from the brain, immune tolerance approaches to prevent stroke,
therapies to repair or replace defective genes, and behavioral
interventions to encourage the latent ``plasticity'' of the brain and
spinal cord toward self-repair. Each of these strategies relies upon
remarkable advances in understanding how the normal nervous system
works and what goes wrong in disease.
A few findings from the past year illustrate this progress:
Scientists studying genes discovered a mutation that causes a form of
Charcot-Marie-Tooth disorder, a common disabling disease of peripheral
nerves; pinpointed the site of a gene contributing to autism; and found
clues about how a chromosome defect causes facioscapulohumeral
dystrophy, a common form of muscular dystrophy. In animal models of
human disease, themselves often the product of gene research, gene
therapies have yielded encouraging results for neurofibromatosis, Fabry
disease and Parkinson's. Scientists on the trail of cell therapies
discovered that primitive precursor cells in the adult rat brain can
respond to experimental damage by multiplying, migrating to the site of
damage, and making new nerve cells, and that transplanted embryonic
stem cells show promise in animal models of Parkinson's disease,
stroke, and other disorders. Scientists focusing on the immune system
found that a strategy, which suppresses immune reactions, prevents
strokes in hypertensive rats; that an anti-cholesterol drug, the statin
Lipitor, reduces symptoms in an animal model of multiple sclerosis; and
that the gene defect in Batten disease may result in unexpected immune
reactions, which could contribute to the devastating consequences in
the brain. In research on drug treatments, the antibiotic minocycline
slowed progression of amyotrophic lateral sclerosis in mice; the
natural brain chemical inosine stimulated rewiring of the brain
following stroke in rats; and coenzyme Q10 may slow progression of
Parkinson's disease. Scientists studying new technologies developed a
device that enabled rats to control a robot arm just by thinking about
it; devised better ways to delivery therapeutic agents to the brain;
used microarrays to monitor the activity of thousands of genes,
yielding insights about brain tumors and multiple sclerosis; and for
the first time, recorded activity of the human fetal brain in response
to light, which may lead to better prenatal diagnostics.
expediting progress
NINDS continues to rely on the insight and ingenuity of scientists
and physicians throughout the nation to seek out scientific
opportunities, propose research studies, and advise on promising ideas.
Since Congress began the NIH budget doubling effort, the Institute has
taken a more active role in directing research. Efforts are motivated
by scientific opportunity, enabled by resources, guided by extensive
and inclusive planning efforts, and quality-assured through peer
review. Programs target specific diseases and cross-cutting
opportunities to enhance the effectiveness of research. A few examples
illustrate the wide range of activities:
The NIH Parkinson's Disease Research Agenda is the pacesetter for
disease-focused NINDS activities. The Agenda began in January 2000 with
a working group that included Parkinson's disease researchers, patient
advocates, industry representatives, and NIH scientific staff. Follow-
up meetings, most recently a July 2002 ``summit'' called by the NIH
Director, have updated priorities to reflect the changing scientific
landscape and to address roadblocks to progress. Since March 2000, the
Parkinson's effort has included more than 20 solicitations, more than a
dozen workshops, establishment of a network of Morris K. Udall Centers,
major clinical trials, and funding of the Deep Brain Stimulation
Consortium. The NINDS Office of Minority and Health Research is also
leading a major effort to implement the NINDS Five Year Strategic Plan
on Minority Health Disparities, and developing goals specific to
neuroAIDS, stroke and epilepsy. Implementation of planning efforts in
brain tumor, stroke, and epilepsy are also under way. Other initiatives
are focusing on diseases such as autism, muscular dystrophy, and spinal
muscular atrophy, and NINDS continues to support a variety of disease-
focused scientific workshops to assess current understanding, stimulate
research interest, and foster collaborations.
Re-engineering the research enterprise.--NINDS has designed and
conducted pioneering clinical trials to test the safety and
effectiveness of interventions to prevent and treat neurological
disorders. In recent years, the Institute augmented clinical trials
activities with new grant mechanisms for planning trials and for pilot
trials; developed procedures and increased professional staff to
optimize trial design and monitoring; and created a subcommittee of the
NANDS Council to provide broad advice on priorities for clinical
research, including trials. This year, NINDS is beginning to supplement
ongoing clinical trials to capture genetic samples for a newly
established DNA and cell line repository. For the future, the Institute
is exploring options to create a network of physician-investigators to
carry out clinical trials. Such a program might speed trials, minimize
costs, enhance accessibility for patients, facilitate the recruitment
of a diverse spectrum of participants, improve feasibility of trials
for rare diseases, and accelerate the transfer of results to practice
in community settings.
A highlight of the clinical trials program is an innovative trial
of neuroprotective drugs for Parkinson's disease, that is, drugs which
slow disease progression rather than just temporarily improving
symptoms. The Institute reached out widely to academia and industry,
here and abroad, for suggestions of possible drugs, and developed a
rigorous evaluation process, which has selected the most promising drug
candidates. A network of more than 40 clinical sites, with central
statistical and data coordination, has been established to carry out
the trial. NINDS is working closely with voluntary groups to recruit
patients. The first pilot studies may begin this spring.
Translational research is another major focus of cross-cutting
efforts. NINDS has a long history of translational research, which
moves fundamental discoveries about the brain and disease toward
therapies and clinical trials. Advances in neuroscience are yielding
increasing opportunities for translation, and NINDS responded in July
2002 by launching a comprehensive program to foster translational
research. Essential to this program are peer review criteria tailored
to the needs of translational research, milestone driven funding, and
training a cadre of investigators to carry out translational research.
The goal is to provide an environment where coalitions of basic
scientists and clinicians can design and carry out preclinical studies
required to bring therapeutic candidates to the point where clinical
studies can begin.
New pathways to discovery.--Several NINDS programs are exploring
new avenues for discovery. NINDS has established a goal of identifying
small molecules that are active in the nervous system and show promise
as therapeutic candidates, diagnostic agents, or research tools. In
2002, the Institute established a consortium to test more than 1000
drugs, most previously approved by the U.S. Food and Drug
Administration (FDA) for other conditions, against 29 rapid laboratory
assays (tests) related to neurodegenerative diseases. The best
candidate chemicals are moving to further testing in animal models
through an NINDS supplement program. NINDS has also awarded a contract
for a high throughput screening (HTS) center, and is soliciting
proposals for the development of assays for HTS. HTS rapidly tests
thousands of chemicals to find lead compounds for drug development. In
another effort, a contract-based approach to therapeutics development
for spinal muscular atrophy will test a new model that might apply to
other diseases. The NIH Molecular Library Roadmap Project will speed
the discovery process for drugs and chemical research tools by
providing access to information databases and to potentially useful
compounds. The Institute has also established a facility to provide
researchers access to microarray technology, which allows simultaneous
monitoring of the activity of thousands of genes in health and disease.
Stem cell research remains a high priority for the Institute. NINDS has
provided supplements for grantees to pursue stem cell research, and
joined with other components of NIH in stimulating this research and
targeting aspects critical for the nervous system. An NINDS intramural
investigator will lead a new NIH facility to characterize the available
approved lines of human embryonic stem cells.
Research teams of the future.--Increasingly, progress against
neurological disorders requires cooperation among multi-disciplinary
teams of investigators. NINDS is enhancing the opportunities for team
approaches with general programs to support common resources and
specific initiatives tailored to areas such as Parkinson's disease,
stroke, autism, muscular dystrophy, spinal cord injury and health
disparities. The Institute is also addressing critical training needs
in areas such as translational and clinical research. In the NIH
Intramural program, the John Edward Porter Neuroscience Center will
bring together scientists from ten NIH components that focus on the
brain.
conclusion
Neurological disorders have always challenged the best efforts of
medicine. The intricacy of the brain is awesome, its workings are
elusive, and an extraordinary variety of disorders affect the nervous
system. Furthermore, the brain and spinal cord are difficult to access,
sensitive to intervention, and reluctant to regenerate following
damage. However, building on advances in basic science, progress is
improving peoples' lives, and prospects for the future are even more
encouraging. We are working to engage the best minds in the nation and
provide them with the resources they need to devise ways to prevent,
treat, or, ultimately, cure neurological disorders. Thank you.
______
Prepared Statement of Dr. Roderic I. Pettigrew
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Institute of Biomedical
Imaging and Bioengineering (NIBIB). The fiscal year 2004 budget
includes $282,109,000, an increase of $3,838,000 over the fiscal year
2003 enacted level of $278,271,000 comparable for transfers proposed in
the President's request.
The NIBIB's mission is to lead the development and application of
breakthrough technologies in the physical and engineering sciences to
facilitate an improved fundamental understanding of complex biological
processes. This research agenda will dramatically advance the Nation's
health care by improving the detection, management, understanding and,
ultimately, the prevention of disease. Health care and technology have
long been linked in the United States. Today, cardiac pacemakers,
mammograms, sustained release medications, and artificial hips are but
a few examples of how biomedical imaging and bioengineering are
transforming health care.
In September 2002, I began my tenure as the first Director of the
NIBIB. I assumed my role during a time when the landscape of conducting
biomedical research is changing. It is this altered landscape, wherein
the most efficacious medical advances depend on multidisciplinary
findings obtained from researchers working together at the interface
between the biological and quantitative sciences, that led to the
creation of the NIBIB. This new environment, combined with recent
budgetary increases, visionary predecessors, the rapid pace in
technology development, and high-quality investigator-initiated
research, has allowed the NIBIB-just in its second year of operation-to
establish a strong research foundation on which to capitalize. To
illustrate these points, my testimony will highlight recently achieved
milestones, outline research plans and directions, and describe areas
of progress and opportunity.
milestones to success
The NIBIB, the newest Institute at the National Institutes of
Health (NIH), was established by law December 29, 2000, and received
its first appropriation and grant funding authority in fiscal year
2002, just 15 months ago. Since its establishment, NIBIB staff have
achieved significant milestones. In fiscal year 2002 the NIBIB funded
approximately 300 research applications, participated in approximately
170 extramural symposia, planned 16 NIH-based symposia and workshops,
served as lead on 5 trans-NIH initiatives, and collaborated on 4 trans-
NIH programs.
Additional milestones have been achieved in fiscal year 2003. In
January, the NIBIB held the first meeting of its National Advisory
Council. The Institute has also built a solid research infrastructure
through the release of numerous basic and applied research
solicitations in promising areas of scientific investigation, including
tissue engineering, advanced biomaterials, image-guided interventions,
low-cost medical imaging modalities, biosensor technology, and cellular
and molecular imaging.
The NIBIB has successfully fostered extensive linkages and
collaborations with other NIH Institutes and Centers, Federal agencies,
academic institutions, private industry, and scientific societies. As
examples, the NIBIB administers and participates in the Bioengineering
Consortium (BECON), an NIH-wide consortium dedicated to promoting and
coordinating bioengineering research across the NIH. The NIBIB and the
National Science Foundation are collaborating with the National Academy
of Engineering-a private, independent, nonprofit institution-on a
project entitled ``Engineering and the Health Care System.'' This study
focuses on ways to harness advances in engineering applications to
improve health care delivery. The NIBIB will collaborate with the
National Institute of Diabetes and Digestive and Kidney Diseases to
develop a program for monitoring pancreatic insulin cell failure in
diabetes. This would constitute a significant advance in diabetes
research.
the nibib research portfolio
In December 2002, the NIBIB officially launched its strategic
planning process with an interactive workshop entitled ``Future
Research Directions.'' This workshop helped identify high-priority
research focus areas and associated high-impact projects and
technologies that could contribute significantly to biomedical research
and global healthcare needs. Areas identified as highly relevant to
NIBIB's mission include image-guided interventions, cellular and
molecular imaging, computational biology, biosensor technologies,
optical imaging technologies, and regenerative medicine. The Institute
is now poised to realize the promise within these areas of opportunity.
advanced technologies
Biomedical imaging and bioengineering are interdisciplinary fields
that require collaborations not only among imagers and engineers, but
also with biologists, chemists, mathematicians, computer scientists,
and clinicians of all specialties. Today, the imaging and engineering
sciences are essential for improved understanding of biological
systems, detecting and controlling disease, and enhancing human health.
Recent advances in these fields have enabled the diagnosis and
treatment of various diseases using increasingly less invasive
procedures. Benefits associated with minimally invasive imaging
applications include quicker and more accurate diagnoses leading to
improved patient outcomes at reduced costs. Minimally invasive image-
guided interventions now serve as powerful tools in the operating room
and can be applied to surgical procedures in urology, oncology,
neurosurgery, ophthalmology, cardiology, and orthopedics. However,
these techniques are in relatively early stages of development. A goal
of the NIBIB is to further establish and validate minimally invasive
image-guided therapies as standards for patient care and to support
additional research in therapeutic areas where minimally invasive
technologies do not yet exist. The NIBIB also has initiatives underway
to encourage investigator-initiated research for tracking anatomical
targets and instruments and for developing steerable devices, including
catheters, endoscopes, and needles. A goal is to develop theses
techniques so that they may be used to routinely identify disease at
its earliest stages, even before symptoms arise. At that point,
treatments can be instituted to cure the disease or preempt any serious
consequences.
The combination of image-guided therapies with genomics and
proteomics, has given researchers the capacity to develop new molecular
probes and targets for disease detection, and to immediately direct
treatment to the diseased site. By studying how a person's genetic
blueprint is expressed through proteins, and how these proteins differ
in healthy and diseased cells, researchers will be able to develop
therapies tailor-made for an individual. As a first step towards
``personalized medicine,'' NIBIB researchers are investigating tiny
``barcoded'' metal particles as a method for analyzing proteomes-the
complete set of an organism's proteins. Advances in miniaturized
devices not only have the potential to identify and characterize new
proteins, but to advance the rapid screening of multiple compounds in
the drug development process.
Molecular imaging provides a way to monitor cellular activities in
normal and diseased states. The development of novel imaging
technologies, combined with new or enhanced probes that bind to defined
cellular targets, will allow this technique to be more broadly applied
to biomolecules that are known indicators of a diseased state, such as
an enzyme that may be overexpressed in a specific tumor. For example,
NIBIB researchers have developed artificial fluorescent agents, called
quantum dots, that glow and act as cell markers when bound to certain
cancer cells. Further testing of these agents in animal models of
cancer will determine their utility as effective imaging agents for the
early detection of cancer in humans.
bioinformatics and computational biology
Advances in bioinformatics and computational biology have been
identified as one of the areas of greatest need, and one of the areas
having the greatest potential for positive impact on the universe of
medical science and health care. In recognition of the critical role
these disciplines play in biomedical imaging and bioengineering, NIBIB
supports fundamental research in computing technology, the targeted
development and application of new biocomputing tools, and technologies
that provide structural and functional data at the cellular level.
Areas of NIBIB interest include the development of high performance
computing and visualization methods applicable to the modeling of
biological systems, the utilization of medical imaging data in
computational modeling of biological systems and human physiology, the
development of algorithms and software for the manipulation and
analysis of imaging data, and computer modeling of tissue mechanics.
Our goal is to advance an understanding of the integrated function of
biological systems through the development and application of
computational models, and to apply these models to the design of novel
treatments and therapeutics. In support of this goal, a NIBIB
researcher is developing a brain-computer interface (BCI) system that
acquires and analyzes brain signals to create a communications channel
directly between a person's brain and a computer. BCI technologies can
allow people who are completely paralyzed to express wishes to
caregivers and to use computer programs.
nanotechnology: sensors for medicine
The term nanotechnology is used to describe many types of research
at the atomic, molecular, or macromolecular level-research where the
characteristic dimensions are less than one-thousandth of the diameter
of a human hair. Biosensors are nanoscale devices that detect, monitor,
and transmit information about a physiological change, or about the
presence of various chemicals, gases, or biological materials (bacteria
and viruses). Laboratory diagnostics used in hematology, clinical
chemistry, pathology, and microbiology already employ sensor
technologies to perform simultaneous measurements for hundreds, maybe
thousands, of substances in urine, blood, saliva, sweat, and
interstitial fluids. The NIBIB has an active research program in sensor
technologies and is expanding this area of research.
Knowledge gained through NIBIB-supported advances in
nanotechnology, particularly in the areas of biosensors and molecular
imaging, will be further leveraged for the development of sensors that
can be applied to other critical research areas. For example, NIBIB
researchers are adapting highly sensitive and selective biosensor
arrays to provide a fingerprint for the identification of harmful
bacteria and environmental health hazards. Future NIBIB efforts being
planned in nanotechnology and sensors focus on the development of low-
cost, miniaturized, integrated sampling detector systems for field use,
including the development of systems that provide ``detect-to-warn''
capabilities, and that enable the rapid and accurate verification of
exposure to harmful environmental agents.
multidisciplinary research teams of the future
The era of the solo independent investigator is passing. Our
research culture must be redirected to the formation of teams that span
academic departments and scientific disciplines. Their formation is
critical to the development and validation of new technologies to aid
in disease detection, treatment, and prevention. Therefore, a major
goal of the NIBIB is to catalyze team science through initiatives that
encourage multi-organizational and multidisciplinary teams. Programs
differ from traditional NIH opportunities as they require collaborative
efforts between quantitative and biomedical researchers. These will
support institutional needs, infrastructure development, and the costs
associated with making team science viable and attractive to academic
institutions. Within a given area, specific clinical problems-such as
our current effort to image pancreatic beta cell function in diabetes-
will be identified to serve as a catalyst to drive the formation of the
research team. The value in catalyzing team science lies not only in
strengthening research capacity, but in fostering the formation of
research teams among disciplines where they previously have not
naturally formed.
In conclusion, the NIBIB is dedicated to promoting the development
of emerging technologies and establishing opportunities that will
encourage the necessary interdisciplinary collaborations to advance
biomedical and global health care priorities. I would be pleased to
respond to any questions that the Committee may have.
______
Prepared Statement of Dr. John Ruffin
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 2004, a sum of
$192,724,000, which represents an increase of $7,010,000 over the
comparable fiscal year 2003 appropriation.
Despite improvements in the overall health of the general
population, over the past decade, African Americans, Hispanics,
American Indians, Alaska Natives, and Asians and Pacific Islanders the
fastest growing communities in this country and the urban and rural
poor, continue to suffer an unequal burden of death, disability, and
disease.
With the goal of addressing health disparities through science, the
Congress enacted Public Law 106-525, the Minority Health and Health
Disparities Research and Education Act of 2000, to establish the NCMHD.
The mission of the Center is to promote minority health and to lead,
coordinate, support, and assess the National Institutes of Health's
(NIH) effort to ultimately eliminate health disparities. I am grateful
to the Congress for its wisdom in creating the NCMHD so that America
can be more responsive to its increasingly diverse and complex health
and human services needs. And, I thank you for your ongoing support of
the Center. I also want to thank Dr. Elias Zerhouni, Director of the
NIH, and the Directors of the NIH Institutes and Centers (ICs) and
Offices for all of their cooperation and continued commitment to making
the elimination of health disparities a top priority for the NIH.
In January 2003, the NCMHD celebrated its second anniversary. The
staff at the NCMHD has been diligent, working hard to make the
priorities envisioned for the Center by the Congress a reality. Today,
I am happy to report to you the highlights of our accomplishments.
trans-nih strategic plan and budget
The NCMHD has worked together with the Director of the NIH and the
Directors of the other ICs at the NIH, to develop the first
comprehensive NIH Strategic Research Plan and Budget to Reduce and
Ultimately Eliminate Health Disparities. This Plan, which was developed
with substantial stakeholder input from the health disparities
populations, has three main goals--research, research infrastructure,
and community outreach through information dissemination and public
health education. This is an evolving document, that will be updated
each year, and it includes current NIH activities and future plans to:
address the health disparities; build a culturally competent cadre of
biomedical and behavioral investigators; and increase the number of
minority clinical and basic medical scientists who are essential to the
success of our efforts. The Plan will be posted for public comment on
the NCMHD website at www.ncmhd.nih.gov.
nih fiscal year 2001 annual report on health disparities research
The NCMHD also collaborated with the other ICs to develop the NIH
fiscal year 2001 Annual Report on Health Disparities Research, which
highlights the NIH's activities, and describes the progress emanating
from the NIH's research strategies, structures, processes, and programs
to ultimately reduce and ultimately eliminate health disparities.
ncmhd programs
As authorized by the Congress, the NCMHD has established its three
core programs, which have been successfully launched with substantial
assistance from the other NIH ICs. The Centers of Excellence in
Partnership for Community Outreach, Research on Health Disparities, and
Training (Project EXPORT) Program supports the conduct of research,
research training, and community outreach activities in the field of
health disparities at Centers of Excellence. The Research Endowment
Program is designed to build minority health and other health
disparities research capacity at Health Resources and Services
Administration (HRSA) Section 736 Centers of Excellence. The NCMHD has
established two distinct extramural Loan Repayment Programs to increase
the participation of health professionals in health disparities
research and to increase the participation of individuals from
disadvantaged backgrounds in clinical research. The Center also
administers the Research Infrastructure in Minority Institutions (RIMI)
Program to provide support for institutions that enroll a number of
students from minority health disparity populations to develop and
enhance their capacity and competitiveness to conduct biomedical or
behavioral research. By expanding the infrastructure of institutions
committed to health disparities research and supporting the education
and training of racial and ethnic minorities, as well as the medically
underserved, these programs will provide sustained effort aimed at
eradicating health disparities.
ncmhd co-funded research
The NCMHD also supports research through collaborative agreements
with other NIH ICs and HHS agencies, for example the: Racial and Ethnic
Approaches to Community Health Program (REACH 2010) at the Centers for
Disease Prevention and Control (CDC); Excellence Centers to Eliminate
Ethnic/Racial Disparities Program (EXCEED) at the Agency for Healthcare
Research and Quality; Jackson Heart Study at the National Heart, Lung
and Blood Institute (NHLBI); Appalachia Cancer Network and Native
Hawaiian Cancer Awareness Research & Training Network at the National
Cancer Institute (NCI); National Latino and Asian American Study at the
National Institute of Mental Health, and Tribal Epidemiology Centers
Program at the Indian Health Service.
Through these and many other co-funded projects the NCMHD works to:
pilot new health disparities programs; improve recruitment and
retention of racial and ethnic minorities in clinical trials; and
provide competitive supplements to expand the focus of existing
research programs.
nih health disparities research
Along with the NCMHD, all of the ICs at the NIH actively support
health disparities research within their categorical missions. Let me
provide a few illustrative examples:
The NHLBI supports the Jackson Heart Study, co-sponsored with the
NCMHD, to address the cardiovascular health of African Americans; the
Strong Heart Study, directed at cardiovascular disease risk factors and
development in American Indians; the Multi-Ethnic Study of
Atherosclerosis, which is examining the development and progression of
subclinical disease in a multi-ethnic and predominately minority
population; the Family Blood Pressure Program, which is identifying
major genes associated with high blood pressure in a predominately
African American population; studies aimed at identifying genetic and
other biological factors that increase susceptibility to hypertension-
related injury and damage; and programs examining genetic factors
associated with asthma in minority populations.
To lead the NCI's efforts to examine the causes of cancer health
disparities, develop effective and sustainable interventions to
eliminate them, and actively facilitate their implementation across the
cancer continuum, the NCI established the Center to Reduce Cancer
Health Disparities. Among the NCI's other major initiatives are the
expansion of public, private, academic, and community-based partners to
increase enrollment of minorities in clinical treatment and prevention
trials and to investigate the socioeconomic, cultural, health system
related, and other causes of disparities in cervical cancer mortality.
The NCI also has established interdisciplinary research Centers for
Population Health and Health Disparities to better understand the
interaction of determinants of cancer and the behavioral and biologic
factors that contribute to them, and the Institute has expanded and
improved the efficiency and utility of the Surveillance Epidemiology
End Results Program on several fronts.
The National Institute of Allergy and Infectious Diseases (NIAID)
continues to focus on those research areas that have a major impact on
health disparities by supporting: the Innovation Grant Program, which
fosters exploratory investigator-initiated HIV vaccine research at the
early stages of concept development; the Legacy Donor Registry Project,
which supports efforts to increase organ donation in minority
populations; Genetic studies in African-American kidney transplant
recipients regarding tissue (organ) rejection; Autoimmunity Centers of
Excellence, which evaluate immunotherapies for Systemic Lupus
Erythematosus (SLE) and Scleroderma; the Inner City Asthma Consortium,
which evaluates the safety and efficacy of promising immune-based
therapies to reduce asthma severity and prevent disease onset in
minority children in inner city dwellings; and Hepatitis C Cooperative
Research Centers, which study factors that contribute to resistance to
treatment in African Americans and disease outcome in Alaska Natives
and Hispanics.
The National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) has established its Office of Minority Health Research
Coordination to help implement its strategic plan for health
disparities. The Institute places high priority on supporting studies
of many diseases, including type 2 diabetes, hepatitis C, and kidney
disease, which disproportionately impact the health of minority
populations. Recently the Diabetes Prevention Program showed that
modest improvements in diet and exercise could dramatically decrease
the incidence of type 2 diabetes in those at risk, the benefits of
which extend to all racial and ethnic groups. American Indian and
Alaska Native communities have the highest rates of diabetes in the
world. Using the network of Tribal Colleges and Universities, the NIDDK
Diabetes-Based Science Education in Tribal Schools Program is
developing supplemental curricula for Tribal elementary, middle and
high schools to instruct students about lifestyle changes that can
dramatically reduce the risk of diabetes. The NIDDK also has initiated
the National Kidney Disease Education Program, initially targeting
cities with African-American populations showing high incidence of
chronic kidney disease.
Since the National Institute of Child Health and Human Development
(NICHD) launched its national ``Back to Sleep'' campaign in 1994, the
Sudden Infant Death Syndrome (SIDS) rate has fallen by more than 50
percent. Even though the death rates from SIDS have declined at about
the same rate for White and African-American infants, a
disproportionate number of African-American infants are still lost to
SIDS. To begin closing this gap, the NICHD enlisted the help of the
Alpha Kappa Alpha sorority, the National Coalition of 100 Black Women,
and the Women in the NAACP to conduct a series of ``summit'' meetings
in three U.S. cities with high rates of African-American SIDS deaths.
These summits will help develop strategies and create an infrastructure
for establishing community-based programs to further reduce SIDS among
African-American infants. The NICHD also is developing outreach
activities and products that encourage American Indian/Native American
communities to place babies on their back to sleep.
conclusion
The NCMHD is working together with the other ICs at the NIH to
ensure that all Americans have an opportunity to lead long, healthy,
and productive lives. I am grateful to the Congress for giving the
Center a unique opportunity to bring together the expertise of health
professionals, researchers, businesses, communities, academia, public
health agencies, and government to eliminate health disparities. It's
going to take all of us working together to build a healthy America.
______
Prepared Statement of Dr. Paul A. Sieving
Mr. Chairman an members of the Committee: I am pleased to present
the President's budget request for the National Eye Institute (NEI) for
fiscal year 2004. This budget includes $648 million, an increase of $16
million over the fiscal year 2003 enacted level of $632 million
comparable for transfers proposed in the President's request.
It is my privilege to be here as the Director of the NEI and tell
you about 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.
glaucoma research
Glaucoma leads to blindness from damage to the optic nerve of the
eye. Glaucoma is often, but not always, associated with increased
pressure within the eye caused by inadequate drainage of aqueous humor,
the fluid within the eye that nourishes the cornea and lens. Results
from two important clinical trials were reported during this past year.
Investigators conducting the Ocular Hypertension Treatment Study found
that eye drops used to treat elevated pressure inside the eye can be
effective in delaying the onset of glaucoma. The study identified
several significant risk factors that were associated with the
development of glaucoma in study participants. These included personal
risk factors, such as older age and African descent, as well as ocular
risk factors, such as higher eye pressure and certain characteristics
of the optic nerve and cornea. These results mean that treating people
at higher risk for developing glaucoma may delay or possibly prevent
the disease.
In a separate study researchers conducting the Early Manifest
Glaucoma Trial, which was designed to compare the effect of immediate
therapy to reduce pressure inside the eye with late or no treatment on
the progression of newly detected open-angle glaucoma, found that
progression was less frequent in the treated group (45 percent) than in
the control group (62 percent), and occurred significantly later in
treated patients. This finding demonstrates definitively that treatment
to lower pressure inside the eye can slow glaucoma damage and
subsequent vision loss.
Continuing the progress in the genetics of glaucoma reported last
year by the finding of a new gene mutation that caused a form of adult-
onset glaucoma, scientists recently reported identification of a human
gene that is linked to a disease known as ``low-tension'' glaucoma.
This form of glaucoma has the characteristic pattern of optic nerve
degeneration but the elevation in pressure within the eye normally
associated with this pattern of damage is not evident on clinical
examination. The gene that was identified produces a protein that is
expressed in a number of tissues including the brain and retina and is
believed to have a significant neurological function. The
identification of genes associated with glaucoma provides a tool to
study the biochemical pathways leading to optic nerve degeneration, as
well as giving insight into designing neuroprotective strategies.
Additionally, NEI sponsored a meeting on ganglion cell and optic nerve
degeneration that brought together laboratory and clinical scientists
studying glaucoma and those studying other neurodegenerative diseases
to explore common mechanisms of nerve cell damage and potential methods
of protection.
retinal disease research
The retina is the transparent, light-sensitive tissue that lines
the back of the eye. Diseases and disorders of the retina and its blood
vessels account for much of the blindness and visual disability in this
country. An important barrier to therapeutic intervention in human
retinal disease is the identification of the gene or genes that cause
vision loss. Visual loss and the degenerative and other changes in the
retina are largely linked to rod and cone photoreceptors, the light-
sensing nerve cells in the retina.
Scientists have recently undertaken a comprehensive genetic
analysis of rod photoreceptors, the most abundant sensory neuron in the
retina, in order to identify all the possible genes expressed in these
cells. Rod cells play an essential role in the visual pathway and may
be especially vulnerable to any genetic defect involving the retina or
other visual centers. For many identified retinal disease genes, a
photoreceptor gene is mutated and its product is altered due to the
mutation. Work is progressing on completing a database that will
simplify the identification of candidate retinal disease genes, and
many new genes in rod photoreceptors have already been identified.
Scientists have identified a mutation in a gene on the X chromosome
that normally is associated with a form of retinitis pigmentosa (RP)
that causes a progressive loss of rod photoreceptors in the peripheral
retina and results in blindness in adulthood. This mutation was also
reported to cause a unique type of degeneration in the macula, in a
particular family. Further study may help us understand how this
mutation specifically targets the macula and causes this unique loss of
cones. This may lead to an understanding of the mechanisms of damage in
other forms of macular degeneration and perhaps to the development of
the means to prevent this type of damage to the macula.
The NEI is also funding studies on ocular albinism, a set of
hypomelanotic diseases and conditions that are characterized by
deficient cellular production of the pigment melanin. Deficiency in
this pigment causes a cosmetic loss of ocular and skin pigmentation,
but more importantly, it limits the development of vision in infants
and children by fundamentally altering the connections between the eye
and the brain. Recently the OA1 gene, which is associated with most
cases of the disease, was identified. The form of the disease
associated with OA1 is an X-linked or hereditary blinding eye disease
that primarily affects boys at an early age. Although the cause or
causes are unknown, misrouting of the neurons that go from the retina
to the brain is involved. Understanding the causes of the abnormal
neural cell axon guidance in ocular albinism may help us understand the
fundamental neurobiology that underlies this disease and represents an
important research initiative for the NEI.
corneal disease research
NEI-supported scientists have also made progress against blinding
diseases of the cornea. The cornea is the transparent tissue at the
front of the eye that plays an important role in refracting or bending
light to focus visual images sharply on the retina. Because the cornea
is the most exposed surface of the eye, it is especially vulnerable to
damage from injury or infection. One such infection is ocular
onchocerciasis, commonly known as river blindness. Although river
blindness is rare in developed countries, it is the second leading
infectious cause of blindness in the world. This infection occurs when
a nematode worm infects the cornea. Researchers have found that
development and growth of the worm depends on a bacterium that lives
within it. They found that the blindness associated with the infection
was due to the reaction of the patient's immune system to the bacterium
and not to the worm. The scientists discovered that an antibiotic that
killed the bacterium also caused the death of the worm but without
causing blindness. Further development of this treatment could
revolutionize treatment of river blindness throughout the developing
world.
cataract research
Although cataract treatment in this country is one of the most
successful of all surgical procedures, development of non-surgical
approaches to preventing or treating cataracts remains an important
area of research, because of the potential that it holds for reducing
costs to the Medicare system and improving the quality of life of our
senior citizens. A cataract is an opacity of the eye's normally clear
lens that interferes with vision. Age-related cataract formation is
believed to result from the complex effects of aging on normal
physiological processes. Because the end-result, cataract formation, is
in most cases far removed in time from the initial insult, exacting a
cause and effect relationship has been difficult. Lens transparency
results from the very high concentration of soluble proteins, the
crystallins, within a specialized lens fiber cell. During aging and
cataract formation, soluble lens crystallins tend to combine or
aggregate into large complexes that cause light to scatter. NEI-
sponsored researchers have found that alpha-crystallin, which normally
protects the lens by binding to other proteins, may itself become the
vehicle for the aggregate formation that accelerates cataract
formation. Additional research in this area may provide the means for
clinicians to intervene prior to the formation of a clinically evident
cataract.
Other scientists are attempting to determine the genes that control
one of the earliest events in the development of the eye, the
development of the lens. Scientists studying lens development have
identified a master gene that controls the expression of a number of
other critical genes. Two of these critical genes that have recently
been discovered. Without these two genes, the development of the lens
is stopped and crystallin-synthesizing cells fail to form. These
findings add to our understanding of the overall control of lens and
eye development and may ultimately enhance our knowledge of the
molecular basis of congenital diseases of the eye, thereby opening the
possibility of future interventions.
strabismus, amblyopia, and visual processing research
The most frequent causes of vision loss in our children are
strabismus, a misalignment of the eyes, and the development of
amblyopia, or lazy eye. Strabismus results in diseases in which visual
processing is abnormal. Amblyopia can result from this misalignment or
from unequal refraction between the eyes. NEI-supported scientists have
found that eye drops used to treat amblyopia work as well as the
standard treatment of patching the eye. This research finding may lead
to better compliance with treatment and improved quality of life in
children with this eye disorder. Patients continue to be followed in
this study to better assess the long term effects these treatments have
on visual acuity.
Recent work by NEI-sponsored researchers has helped our
understanding of nerve cell regeneration. Following injury or disease,
neurons in the central nervous system (CNS) have a limited regenerative
capacity, unlike nerve cells in the peripheral nervous system.
Nerve cells typically have two types of extensions that arise from
their cell bodies. Axons are normally quite long and extend over
considerable distances. Dendrites are much shorter and extend short
distances from the cell body. The inability of CNS neurons to
regenerate is due to the failure of their axons to re-grow. These
scientists found that axon growth may be due to a factor within the
nerve cell itself rather than in the surrounding environment and may be
regulated by signals from other nerve cells. Further research may allow
discovery of the signals that switch neurons back to the axonal growth
mode to repair damage to nerve tissue from injury or disease.
health disparities
Scientists recently reported the prevalence of glaucoma in a
population-based study conducted among 4,774 Mexican American adults
residing in two communities in Arizona. Glaucoma prevalence rates have
been reported previously for white and African American adults, but no
similar studies have been conducted among the U.S. Hispanic population.
The prevalence of open-angle glaucoma in this Mexican American
population was intermediate between the high rates reported for African
Americans and the lower rates reported for whites. Of those diagnosed
with glaucoma, only 38 percent were aware they had the disease. The
prevalence of glaucoma increased rapidly with age and was the leading
cause of bilateral blindness in this population. This information will
allow health educators to create additional glaucoma awareness
campaigns to increase awareness of the importance of glaucoma treatment
in the Mexican American population, thereby allowing eye care providers
to identify and treat those at greatest risk so that blindness can be
prevented.
program initiatives
Diabetic retinopathy is a potentially blinding complication of
diabetes characterized by the uncontrolled growth of fragile new blood
vessels in the retina that may leak fluid and blood threatening vision.
It is the leading cause of new cases of blindness in working age adults
in the United States. Macular edema secondary to diabetic retinopathy
is also a major cause of visual loss in patients with diabetes. The NEI
is developing a clinical research network of core centers and
participating clinics that will help satisfy the need to evaluate
promising new approaches to treat diabetes induced retinal disorders
and to investigate other approaches as they become available. This
network approach will provide a framework for rapid initiation of
important studies, efficient use of pooled clinical expertise in idea
generation and protocol development, and efficient use of central
resources for data management, quality control, and endpoint
evaluation.
The NEI is also planing to increase the pace of research in age-
related macular degeneration (AMD) prevention and treatment by
supporting a wide array of laboratory and clinical studies. AMD is the
leading cause of severe vision loss in older persons in the United
States, and it will have an increasingly important social and economic
impact as the population ages. These studies may range from pilot work
to the establishment and implementation of clinical research networks.
It is anticipated that a network approach to AMD clinical research will
hasten development of the more successful therapies for the treatment
or prevention of AMD.
The NEI is also undertaking a major effort to reinvigorate the
intramural research program and enhance resources to neurodegenerative
and genetic forms of vision loss. Ocular genetics research has
demonstrated that many common eye diseases have complex genetic and
environmental etiologies that must be understood before innovative
biological treatments can be designed. NEI is working on a new
laboratory program devoted to complex human eye disease to hasten
progress in this area.
Mr. Chairman that 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. Allen M. Spiegel
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Institute of Diabetes
and Digestive and Kidney Diseases (NIDDK) for fiscal year 2004, a sum
of $1,670,007,000, which reflects an increase of $66,846,000 over the
comparable fiscal year 2003 appropriation. The fiscal year 2004 budget
comprises $1,820 million which includes $150 million ($100 million in
fiscal year 2003) for the Special Appropriation for Research on Type 1
Diabetes through Public Law 107-360. The NIDDK transfers some of these
to other institutes of the NIH and to the CDC. Adjusted for these
mandatory funds, this is an increase of $48 million over the fiscal
year 2003 enacted level of $1,622 million comparable for transfers
proposed in the President's request. The NIH budget request includes
the performance information required by the Government Performance and
Results Act (GPRA) of 1993. Prominent in the performance data is NIH's
second annual performance report, which compared our fiscal year 2002
results to the goals in our fiscal year 2002 performance plan.
obesity research
I appreciate the opportunity to testify on behalf of the NIDDK,
which supports research on a wide range of chronic, debilitating
diseases. Many of these diseases, including type 2 diabetes,
nonalcoholic fatty liver disease, gallstones, end-stage kidney disease,
and urinary incontinence, are caused, directly or indirectly, by
obesity. Data from the Centers for Disease Control and Prevention
documents that obesity is growing at an alarming rate in both adults
and children, and that it disproportionately affects minorities. Recent
results from the Framingham Heart Study indicate that obesity cuts six
to seven years off of life, comparable to the effects of smoking. The
2001 Surgeon General's Call to Action to Prevent and Decrease
Overweight and Obesity reports that each year, it costs this country an
estimated $117 billion in health care related expenditures.
We must approach obesity, not as a cosmetic or moral problem, but
rather as a health problem. To address this problem, research is vital,
and the NIDDK and the National Institutes of Health are formulating a
bold and coordinated research plan. Obesity and its associated diseases
result from complex interactions of biologic and environmental factors.
The environmental factors include social, demographic, and economic
changes that encourage people to eat more food than necessary to meet
their energy requirements, and discourage physical activity that would
increase their energy expenditure. These environmental factors
disproportionately affect individuals who are biologically more
susceptible to becoming obese and to develop obesity-associated
diseases.
Tremendous progress has been made recently in understanding the
biologic basis of obesity, and I will cite just a few examples. We now
understand better how appetite is controlled through newly discovered
hormones such as ghrelin and PYY. They are produced by the stomach and
small intestine, and signal the brain, respectively, to increase and
decrease appetite. Blood levels of ghrelin peak just before meals, and
peaks are significantly higher in obese individuals who have lost
weight by dieting, perhaps explaining why sustaining weight loss is so
difficult. Bariatric, or gastric bypass, surgery is being increasingly
performed in the United States, and part of its effectiveness in
achieving sustained weight loss may be explained by the recent finding
that ghrelin levels are suppressed by some forms of the surgery.
Blocking the action of ghrelin is thus a potentially attractive target
for drug development
Similar advances are being made in understanding how the body
decides whether and where to metabolize or store fat. Discovery of
hormones such as leptin and adiponectin secreted by fat have shown that
fat signals to brain, liver, and muscle to regulate fuel metabolism and
response to insulin. Such discoveries help explain how obesity leads to
insulin resistance and type 2 diabetes, and offer new ways of treating
or preventing obesity-associated disorders. Epidemiologic results and
clinical studies show that differences in distribution of body fat may
also be important in determining which individuals develop obesity-
associated disorders.
Progress in behavioral research provided the basis for the
lifestyle intervention of our Diabetes Prevention Program (DPP), which
revealed that participants who lost 5 to 7 percent or more of their
body weight and who performed at least 150 minutes of physical activity
per week reduced their risk of developing type 2 diabetes by 58
percent. We are conducting a follow-up DPP Outcomes Study to assess the
durability of the DPP interventions in preventing diabetes, and to
determine whether the interventions reduce cardiovascular disease. Our
Look AHEAD: Action for Health in Diabetes clinical trial is testing the
effect of sustained weight loss on prevention of cardiovascular disease
in obese individuals who already have type 2 diabetes.
To further sharpen the NIDDK's obesity research efforts, I recently
announced creation of a new Office of Obesity Research within the NIDDK
that is bringing together expertise in our Division of Diabetes,
Endocrinology, and Metabolic Diseases, and our Division of Digestive
Diseases and Nutrition, both of which have important input to obesity
research. This new group is framing initiatives across a wide range of
obesity research areas to address the epidemic of obesity, from the
fundamental biologic aspects to the behavioral and environmental.
Examples include a study of the life cycle of the fat cell directed at
discovery of novel targets for treatment of obesity and associated
metabolic disorders. In order to address obesity-associated diseases
such as type 2 diabetes, we will expand our Diabetes Genome Anatomy
Project to include genetic analysis of all the major organ systems
affected by diabetes and its complications . We are helping re-engineer
the clinical research enterprise by creating a new Bariatric Surgery
Clinical Research Consortium (BSCRSC). The BSCRC will develop a common
data collection protocol to accelerate clinical research and progress
in understanding the development of severe obesity and its
complications, as well as understanding the risks and benefits of
bariatric surgery as a treatment method.
In behavioral research, we have begun a clinical trial to develop
effective strategies to prevent type 2 diabetes in children. This
initiative focuses on school-based primary prevention programs to
decrease risk factors for type 2 diabetes and lower the incidence of
the disorder. We are supporting research to translate the results of
the highly successful Diabetes Prevention Program, into clinical
practice for prevention of type 2 diabetes in individuals and
communities at risk. Of particular interest will be interventions that
focus on underserved and minority populations disproportionately
affected by the disease. Given the environmental influences fueling the
obesity epidemic, we are encouraging research to study promising
interventions that would target environmental factors contributing to
inappropriate weight gain in children, adolescents and adults. We are
asking investigators to partner with community organizations or
businesses, such as schools, supermarkets, restaurants, churches,
community groups, and worksites to develop interventions that could
potentially be translated into larger-scale interventions.
These are just some of the ways we are encouraging research to
combat obesity and its co-morbid conditions. We believe NIDDK and NIH
research is our best hope for stemming the tide of this epidemic. Why?
Because we stand poised, given new information about the human genome
and the advent of new research tools to determine the biologic and
genetic factors that make one person more (or less) susceptible to
obesity than another. Why is this important? Because it should allow
targeted obesity prevention and allow the development of new kinds of
drugs and therapies that should be more successful in preventing weight
gain and in helping people lose weight and to sustain weight loss. Tied
to this is improved research-based behavioral approaches to weight loss
and maintenance. In addition, NIH research ultimately will provide the
scientific basis for policy decisions on needed changes in
environmental factors that affect diet, nutrition, and physical
activity. Obesity is a complex problem requiring a multi-disciplinary
research approach if we are to reverse this ominous threat to our
nation's health.
diabetes
Approximately one million Americans suffer from a type of diabetes
that is not obesity-related. Rather, type 1 diabetes involves immune
destruction of the insulin-producing beta cells of the pancreas. We are
vigorously pursuing cutting-edge research opportunities for prevention
of type 1 diabetes through our TrialNet, and for treatment and cure of
type 1 diabetes through support of the field of regenerative medicine.
One example of the latter is our Beta Cell Biology Consortium, which
brings together multi-disciplinary teams of investigators with
expertise in pancreatic development, beta cell biology, stem cell
biology, and bioinformatics. Through such collaborative research
programs, we are laying a solid foundation for the future development
of innovative, cell and regenerative growth factor therapies for
diabetes and other debilitating diseases. Increased understanding of
beta cell biology should also improve our ability to develop
noninvasive, functional imaging technology that would, for example,
help monitor type 1 diabetes prevention trials.
hepatitis c
The hepatitis C virus is the cause of the most common form of end-
stage liver disease in the United States. We recently held a Consensus
Development Conference on the management of hepatitis C that
recommended directions for future research, and led to development of
initiatives that are encouraging further basic and clinical research on
hepatitis C, research on management of hepatitis C in people with
chronic kidney disease, and research on new therapies for children with
hepatitis C. From such research should emerge more effective forms of
treatment and prevention.
gastrointestinal diseases
We are bolstering our research activities across the full spectrum
of gastrointestinal (GI) diseases, ranging from celiac disease, in
which a known dietary factor triggers intestinal damage in genetically
susceptible individuals, to functional GI disorders such as irritable
bowel syndrome. Our strong research portfolio in inflammatory bowel
disease (IBD) is paying dividends. A recent clinical trial reported
that a recombinant monoclonal antibody that blocked the action of
certain cell adhesion molecules could be used to reduce the symptoms
and improve quality of life of patients with Crohn's disease, an
inflammatory bowel disease. The NIDDK supported the basic research
underpinning this exciting work, providing another example of the
critical role of NIH research in the development of therapies for human
disease. Our IBD Genetics Research Consortium aims to identify genes
associated with increased risk of developing Crohn's disease and
ulcerative colitis. The long-term goal is to increase molecular
understanding of IBD so as to facilitate development of novel therapies
and new diagnostic methods.
kidney disease
We are addressing the sharp rise in end-stage renal disease (ESRD)
by supporting research on the causes, treatment, and prevention of the
major forms of kidney disease leading to ESRD. The discovery that the
proteins encoded by the polycystic kidney disease (PKD) genes are
localized to cilia (hair-like projections) in kidney tubular cells
demonstrates the rapid progress in understanding the pathogenesis of
the major cause of inherited ESRD. Results from some of our major
kidney disease trials have significant implications for clinical
practice. Our African American Study of Kidney Disease and Hypertension
(AASK) showed that angiotenson-converting enzyme inhibitors, compared
with calcium channel blockers, slowed kidney disease progression by 36
percent, and drastically reduced the risk of ESRD by 48 percent in
patients who had at least one gram of protein in the urine, a sign of
kidney failure.
The Institute's HEMO clinical trial recently showed that the
standard recommended hemodialysis dosage and filters are adequate for
reducing morbidity and mortality in ESRD patients, and that increasing
dialysis dose using a conventional three times per week regimen does
not provide greater benefit to patients. However, the important
question now is the duration and frequency of dialysis. We therefore
have planned clinical trials to compare conventional dialysis with more
frequent dialysis in patients with ESRD. We also have launched a
prospective epidemiological study of children with chronic kidney
disease to determine the risk factors for decline in kidney function,
and associated morbidities such as impaired neurocognitive development,
cardiovascular disease, and growth failure.
urologic diseases
Our major clinical trial on Medical Therapy of Prostate Symptoms
(MTOPS) recently demonstrated that two drugs commonly used to treat
benign prostatic hyperplasia (BPH), finasteride and doxasozin, are
significantly more effective at preventing symptomatic BPH incidence
and progression when given in combination. Samples collected during the
MTOPS trial will be used by our new MTOPS Prostate Samples Analysis
Consortium to discover and validate biologic markers for detection and
risk assessment of BPH.
Our Bladder Progress Review Group report provides a strategic plan
for future bladder research. We are already implementing the report's
recommendations on interstitial cystitis (IC), a debilitating, chronic
syndrome of urinary urgency, frequency, and pelvic pain, by encouraging
basic research pertinent to IC, the ultimate goal being the development
of reliable diagnostic tools, and new and effective disease treatments
and prevention.
Mr. Chairman and Members of the Committee, these are just a few
examples of our many research advances and initiatives. I would be
pleased to answer any questions.
______
Prepared Statement of Dr. Stephen E. Straus
I am pleased to present the President's fiscal year 2004 budget
request for the National Center for Complementary and Alternative
Medicine (NCCAM). The fiscal year 2004 budget includes $116,202
million, an increase of $2.9 million over the fiscal year 2003 enacted
level of $113,302 million comparable for transfers proposed in the
President's request.
introduction
Arthritis, depression, menopause, cancer . . . for millions of
Americans, these and other health concerns are not being adequately
addressed through conventional medicine. Many are turning outside the
medical mainstream to approaches that embrace the whole person--mind,
body, and spirit. From acupuncture to dietary supplements,
complementary and alternative medicine (CAM) approaches are affordable
and accessible, but largely untested. Under NCCAM's leadership,
researchers are applying the tools of modern science to discover which
CAM practices work, why and how they work, and whether they are truly
safe. Exploring CAM through rigorous science will lead to the
integration of proven CAM practices with conventional medicine, thus
improving the lives of all Americans.
standardization & characterization of dietary supplements
Dietary supplements, one of the most popular categories of CAM
practices, are used by 10 percent of American adults.\1\ Many consumers
use dietary supplements with the expectation that they are effective in
the self-treatment and prevention of disease and the promotion of
wellness and, further, with the assumption that they are safe. Under
the law, supplements are classified as foods and not held to the same
rigorous standards as drugs.
---------------------------------------------------------------------------
\1\ Hanyu NI, Catherine Simile and Ann M. Hardy, ``Utilization of
Complementary and Alternative Medicine by United States Adults: Results
From the 1999 National Health Interview Survey,'' Medical Care, Vol.
40, No. 4, pp. 353-358.
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Research supported by NCCAM indicates that Americans who take
ginseng on a regular basis cannot rely on the label to accurately
reflect the product's contents. After examining 25 commercial ginseng
products, one NCCAM grantee recently reported that, the concentrations
of ginseng differed by as much as ten-fold from the label. The lack of
standardized dietary supplements is not only an issue of consumer
safety; it is also an issue for researchers who need to protect their
patients and work withwell-characterized and standardized products to
scientifically and accurately examine study their purported benefits.
NCCAM's recent experience with PC SPES, a patented mixture of eight
herbs, is an example of the other vexinganother problem with some
dietary supplements contamination. In 2001, thousands of men with
advanced prostate cancer in America tookwere taking PC SPES. Based on
encouraging early clinical results, NCCAM was supporting four research
studies, including a clinical trial, to determine the safety, efficacy,
and mechanism of action (i.e., how it works) of PC SPES. In February
2002, the California Department of Health Services and the Food and
Drug Administration reported that PC SPES was contaminated with
undeclared prescription drug ingredients. This finding led the
manufacturer to recall the product and subsequently cease its
operations. NCCAM immediately put its studies on hold and convened
meetings with scientists, prostate cancer specialists, patients, and
industry representatives to determine howif a ``cleaner'' an
uncontaminated product could be made available to the publicreenter the
marketplace and the research pipeline, allowing the research to resume.
As part of this strategya result of these meetings, NCCAM resumed its
laboratory studies of the cellular and molecular biology of PC- SPES
and pronounced declared its interest in resuming clinical trials once
an unadulterated, fully characterized, and standardized product is
available.
NCCAM is taking several steps is taking several stepsto address the
critical issue of product standardization and quality. Among the top-
selling products in the dietary supplement industry are products like
echinacea (Echinacea purpurea), taken to prevent and treat colds, milk
thistle (Silybum marianum), taken to treat chronic hepatitis and
cirrhosis, and feverfew (Tanacetum parthenium), taken to lower fevers.
All of these products have shown promise in small uncontrolled studies;
however, each has problems with standardization, precluding their full
and objective study. NCCAM is making awards under using the Small
Business Innovative Research (SBIR) program to obtain well-
characterized and standardized clinical-trial-grade materials of these
supplements. This investment in high-quality productsessential first
step will be followed by studies to define the optimal dose of each
product. To implement this second step, in 2004, NCCAM plans toplans to
establish a Dietary Supplement Standardization and Characterization
Center (DSSCC), which willto serve as a resource for the analysis of
dietary supplements, especially botanical products, before they are
used in clinical trials.
determining the mechanisms of action of cam interventions
While pursuing innovative approaches to ensuring the safety of its
clinical trial products, NCCAM continues to support basic and clinical
studies NCCAM continues to support basic and clinical studies. The
central objective of many of these studies is to examine the mechanisms
of action underlying various CAM therapies. In 2002, for example,
NCCAM-supported researchers conducted an important body of research on
alternatives to conventional hormone therapy--an area of obvious
interest for millions of menopausalwomen who are seeking safe and
effective alternatives to conventional hormone therapy for relief of
menopausal symptoms and related conditions. Specifically, scientists
are using in vitro systems to examine how some popular dietary
supplements act on biochemical pathways responsive to estrogen. Others
are examining the estrogenic activity and specific mechanisms of
estrogen receptor regulation of a Chinese herbal extract; identifying
the active compounds of black cohosh (Cimifuga racemosa) and red clover
(Trifolium pratense); and investigating the range and mechanisms of
action of two plant-based estrogens, genistein and diadzein, and
extracts of soy on immune function. These studies will clarify what
biochemical effects supplements might have on women and indicate which,
if any, are worthy of testing in a clinical trial.
Building on the results of a detailed scientific review that NCCAM
conducted with the Agency for Healthcare Research and Quality on the
popular dietary supplement, S-Adenosyl-L-Methionine (SAMe), the Center
is also supporting mechanistic projects on the mechanisms of action of
SAMe that are consistent with the findings of the report associated
with key areas identified by the report. One grantee is using cultured
cells to better characterize the biochemistry of liver injury and what
role SAMe may play in preventing liver damage. Another investigator is
using a mouse model of hepatitis and liver cancer to study the role of
SAMe in regulating liver cell growth and death.
A trio of studies indicate that Ginkgo biloba may provide multiple
levels of protection to neural tissues and contribute to the body of
evidence explaining how Ginkgo may be beneficial in preventing the
onset of dementia. NCCAM-supported investigators reported that a
standardized Ginkgo extract protects cells from oxidative stress and
apoptosis (programmed cell death). Using model systems to study the
factors that regulate cell death, the investigators showed that the
Ginkgo extracts increase the lifespan of the worm, Caenorhabditis
aenorhabditis elegans, protect cultured neural cells from undergoing
programmed death, and hinder an early step in the biochemical processes
leading to neurodegeneration.
In fiscal year 2003, NCCAM made several awards as part of the
initiatives it launched with NIH partners to elucidate the underlying
biological pathways of the placebo effect and to reveal factors
important for eliciting the placebo effect in clinical practice
setting. The Center designated mind-body medicine as a priority
research area in fiscal year 2003, recognizing the potential
contributions to prevention and treatment of chronic diseases that
could be made by interventions based on evidence from innovative
psychophysiological research. NCCAM will enhance the support for
research into the mechanisms of mind-body medicine. Most recently,
NCCAM joined other NIH partners to solicit applications from
institutions poised to advance research on mind-body interactions and
health. The Center also designated mind-body medicine as a priority
research area in fiscal year 2003, recognizing the potential
contributions to prevention and treatment of chronic diseases that
could be made by interventions based on evidence from innovative
psychophysiological research.
evaluating cam therapies in rigorous clinical trials
A chief goal of the basic and preclinical research NCCAM supports
isbasic and preclinical research to test therapies for eventual use in
clinical trials with the ultimate objective being to translate safe and
effective therapies into widespread practice. Another purpose ofIn
addition, NCCAM-supported clinical trials is to test CAM products
already being widely used by the public. Ultimately, NCCAM wants to
answer the central question: ``does it work?''
In 2002, NCCAM announced the results of its first large-scale
clinical trial. The trial evaluated a one product containing St. John's
wort (Hypericum perforatum) product, a popular herbal remedy for
depression, as a treatment for major depression of moderate severity
and found it to be ineffective as compared to placebo. Although the
results of this trial were negative showed that St. John's wort is not
effective for this type of depression, the outcome provided
practitioners and patients alike with valuable data. In addition, the
outcome informed researchers who are testing St. John's wort as a
treatment for less severe forms of depression. NCCAM is following-up on
this finding by co-funding a new trial to test St. John's wort as a
treatment for minor depression, a less severe but very common type of
depressive illness. The trial begins this year and will enroll 300
patients at three sites nationwide.
Because CAM products and practices are already used by millions of
Americans, NCCAM supports relatively morea higher percentage of
clinical research than all of the other NIH Institutes and Centers. As
part of its clinical research portfolio, the NCCAM extramural research
program is already supporting 12 ongoing large-scale clinical trials
with other NIH Institutes and Centers. These trials include the largest
ever herbalstudy of Ginkgo biloba for the prevention of dementia a
critical study given the aforementioned body of evidence that exists
regarding Ginkgo's potential protective effects. The list also includes
the largest ever studieslargest ever study of dietary supplements
(selenium and vitamin E), involving 30,000 men, for the prevention of
prostate cancer. In fiscal year 2002, NCCAM cosponsored the first large
clinical trial to test chelation therapy as a treatment for coronary
artery disease. Also in fiscal year 2002, the NCCAM Intramural Research
Program initiated its first clinical trial, which is evaluating
electroacupuncture in reducing the severe nausea experienced by many
children following intensive cancer chemotherapy. NCCAM is taking
actionactive to ensure the quality and safety of NCCAM-supportedits
clinical trials.
In 2002, the Center established the Office of Clinical and
Regulatory Affairs to help plan, coordinate, and monitor NCCAM-
supported clinical trials. All of these activities reflect NCCAM's rich
investment in and commitment to clinical research.
building research infrastructure and intellectual capital
The success of NCCAM's future research endeavors is contingent upon
depends on the availability of skilled investigators in both the
conventional and CAM research communities. Toward this end, NCCAM is
supporting dozens of mentored and independent trainees, from the pre-
doctoral level through mid-career and senior faculty members. In 2002,
NCCAM made institutional training and clinical research career awards
to CAM institutions and joined the new NIH-wide loan repayment program
with awards to two junior practitioner-investigators, marking a series
of ``firsts'' for NCCAM.
In addition to its support ofinvestment in training programs, NCCAM
continues to support a robust research centers program, providing a
critical CAM research infrastructure. In 2002, NCCAM sought to
strengthen its centers program by convening sought to strengthen its
centers program by cing an expert panel to evaluate the program's
current structure and objectives. The panel recommended a more flexible
approach to supporting future centers research. This new approach,
which employs a mix of funding and research mechanisms, will ideally
expand ideally the participation among investigators with varying
degrees of research expertise at both CAM and conventional institutions
in a multi-disciplinary fashion. Implementation of this strategy began
in fiscal year 2003 and will continue through fiscal year 2005.
conclusion
NCCAM has made remarkablesignificant progress in its first 4 years.
Between fiscal year 2000 and fiscal year 2001, the number of people
enrolled in NCCAM-supported clinical research projects doubled. The
Center, in a partnership with other NIH Institutes, launched some of
some of the largest clinical studies of CAM therapies ever conducted.
NCCAM took pro-activesteps to improve the safety and efficacy of its
clinical research studies and the quality of the information
disseminated to the public about CAM therapies. Finally, the Center
increased its level of support to researchers who are applying cutting-
edge scientific tools to study the most promising CAM approaches to the
most important public health challenges facing our nation. I look
forward to keeping you and the American public apprised of NCCAM's
future activities and accomplishments.
______
Prepared Statement of Dr. Lawrence A. Tabak
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 2004. The fiscal year
2004 budget includes $382,396,000, an increase of $11,254,000 over the
fiscal year 2003 enacted level of $371,142,000 comparable for transfers
proposed in the President's Request.
molecular medicine enters the mouth
When molecular biologists discuss the future of medicine and
dentistry, many foresee a day when health care professionals will
possess the technological tools to dust a patient's cells, like a
detective dusts for fingerprints, and pull up a ``molecular
fingerprint'' of the activity inside. This fingerprint will allow them
for the first time to examine the patterns within the cells for
disease-causing abnormalities in the genes, proteins, and protein
networks. Based on these specific biological clues, doctors will have
far more detailed information at hand to make a correct diagnosis and
perhaps one day tailor a person's care to treat the specific molecular
defects that underlie the disorder.
salivary diagnostics
Scientists have long recognized that our saliva serves as a
``mirror'' of the body's health, in that it contains the full
repertoire of proteins, hormones, antibodies, and other molecular
analytes that are frequently measured in standard blood tests. The
Institute recently launched a major research effort that, in keeping
with the National Institutes of Health (NIH) Roadmap initiative, seeks
to identify and address major cross-cutting biomedical challenges, and
will further develop needed technologies and create the first
comprehensive baseline catalogue of all proteins found in oral fluids
of healthy individuals. The NIDCR envisions that this basic research
could one day translate into miniature, hi-tech tests, or so called
``labs'' on a silicon chip, that rapidly scan oral fluid for the
presence or absence of multiple proteins linked to various systemic
diseases and conditions. Ultimately, this approach could be used for
real-time health surveillance--rapidly identifying persons most at risk
at the earliest moments of detectable change in key diagnostic markers.
the genomics and proteomics of periodontal diseases
Although ``molecular medicine'' is still in its infancy, the NIDCR
continues to help lay its basic intellectual foundations. The tools of
molecular medicine offer promising new strategies for addressing oral
infectious diseases such as periodontitis. These conditions begin when
bacteria colonize a ``biofilm'' that forms on the surface of teeth.
Many of these microorganisms remain uncultivated and only recently have
some of these bacteria been identified by their molecular fingerprints.
Some of these bacteria are highly virulent; they elaborate noxious
substances that damage hard and soft tissues of the mouth. Furthermore,
oral bacteria can trigger an immune response that often proves
destructive both within the mouth and elsewhere in the body. Indeed,
recent studies with animal models and epidemiologic surveys have linked
periodontal diseases with pre-term delivery and low birth weight.
With the advent of more powerful research tools, NIDCR supported
scientists will now be able to assemble a molecular ``parts list'' of
all the genes and proteins involved in periodontal diseases. For the
first time, a detailed understanding of the microbial and host
signaling pathways that are activated or deactivated during periodontal
disease progression will be mapped. This represents an important step
in defining new therapeutic targets to overcome one of the most
prevalent infectious diseases of humankind.
tissue engineering
The NIDCR continues to invest heavily in regenerative medicine,
with a strong interest in engineering new bone to repair dental and
craniofacial wounds and birth defects. Of particular interest are adult
bone marrow stromal stem cells, the natural progenitors that create the
body's bone-forming cells. In recent years, scientists have envisioned
healing bone fractures by inserting these cells directly into the
wound. The adult stem cells would replicate in the wound, create
millions of new bone cells, and heal the fracture rapidly and
efficiently. As appealing as this approach is, however, technical
challenges have emerged to slow the research. One of the most
formidable obstacles is the discovery that adult bone marrow stromal
stem cells stop growing soon after they are introduced into cell
culture and quickly lose their ability to form new bone. Because
hundreds of thousands of stem cells are required to heal even a minor
bone fracture, scientists have been hard pressed to generate an
adequate supply of these precursors.
For the first time, NIDCR scientists and grantees reported that
they have more than doubled the life span of adult bone marrow stromal
stem cells, under laboratory conditions, by incorporating the
catalytic, or active, component of a much-studied enzyme called
telomerase, termed the hTERT gene, into the stem cells. This was
particularly interesting because hTERT is the catalytic, or active,
component of a much studied enzyme called telomerase. Telomerase has
been shown to counter the shortening of telomeres, the tips of
chromosomes, by triggering a chemical reaction that adds new base pairs
to them and extends the life of the cell. In follow-up animal studies,
the scientists found that the newly formed bone, generated from the
stem cells, had all of the hallmarks of normal bone--including
organized collagen fibers and various mineral components.
sjogren's syndrome
The NIDCR is also applying tissue engineering strategies to
Sjogren's syndrome, a relatively rare condition that affects over one
million Americans. The syndrome is caused when the immune system
mistakenly attacks various parts of the body, often including cells
that produce saliva. When this occurs, people develop chronically dry
mouths, which can impair their ability to taste and swallow as well as
lead to oral disease. While studies are ongoing to pinpoint the root
cause of this condition, NIDCR continues to explore the possibility of
developing an artificial salivary gland, an approach that one day could
help to restore adequate levels of saliva for Sjogren's patients.
In studying Sjogren's syndrome, one of the major barriers always
has been logistical. People with the syndrome are scattered throughout
the country, and scientists are sometimes uncertain about how to find
them. To ensure that researchers have access to sufficient numbers of
Sjogren's patients with well defined clinical histories and relevant
biological samples, NIDCR will support the first international registry
of Sjogren's patients. The registry will be crucial in tracking the
incidence and natural history of the condition. It also will allow
NIDCR to launch more rapidly the necessary clinical trials to evaluate
promising diagnostic and therapeutic leads as they emerge. NIDCR also
plans to identify biomarkers--genes, proteins, or even protein
networks--which will allow early diagnosis, determination of disease
progression, and stratification of high risk individuals. By developing
a battery of sensitive and highly specific diagnostic and prognostic
biomarkers, critical molecular information will be available to more
accurately diagnose and treat Sjogren's syndrome, a long-held hope of
many Americans affected by this condition.
pain research
For the past four decades, the NIDCR has been one of the key
players at NIH in the study of the basic biology and treatment of pain.
While current analgesic drugs help many ease discomfort, millions of
others have pain management needs that remain completely or partially
unmet. Nearly all available analgesics were developed based on overly
simplified, linear models of pain transmission. Recent advances show
that pain transmission is a far more dynamic process that often
involves multiple routes, or pathways. Each pathway integrates a
convergence of molecular signals, then relays them along their own
specific, hard-wired routes to the brain. The research challenge is to
define the molecular details of these multiple routes of pain
transmission with the aim of increasing the repertoire of pain
management strategies.
In keeping with the NIH Roadmap initiative, progress is now being
made in defining the biological pathways and networks of pain. For
example, a group of NIDCR grantees have discovered several biological
factors that influence pain perception. This multidisciplinary team
focuses its research on developing novel, real-time imaging techniques
that track the mu-opioid system, a specific type of protein receptor in
the brain that researchers have long suspected triggers a dampening of
the pain. In a seminal study published last year, the team confirmed
the role of the mu-opioid system in enhancing a person's tolerance of
pain. According to the research team, this marked the first study ever
that combined prolonged pain with simultaneous brain scan monitoring of
the mu-opioid system and self-reported pain ratings of human
volunteers.
The group found that the onset and slow release of jaw muscle pain
(that mimics, in part, the symptoms of individuals suffering from
Temporomandibular muscle and joint diseases and conditions) over 20
minutes caused a surge in the release of endorphins, naturally produced
chemicals that bind to the mu-opioid protein receptors that are
displayed on the surface of brain cells. Once the endorphins activated
the receptors, the volunteers said they felt a reduction in pain and
emotions related to the sensation. Specific brain regions--especially
those that play a role in emotional responses or that help to process
signals from the body's sensory systems--had the greatest increase in
endorphin levels. The research also revealed major variations among
volunteers in baseline and pain-induced levels of opioids. The
scientists noted that their results establish that people vary both in
their capacity to produce mu-opioid receptors and in their ability to
release the anti-pain chemicals themselves. This variability appears to
determine the emotional and sensory aspects of a painful experience and
might explain why some people react to pain differently. It may also
help to explain why some people are more prone to chronic pain
conditions or do not benefit from certain anti-pain medications.
The group and its collaborators have published two important
followup studies. In the first study, the scientists observed that, at
matched levels of pain intensity, men and women differ in the degree
and direction of the mu-opioid response in distinct areas of the brain.
In particular, men had greater activation of mu receptors in specific
regions of the brain--the anterior thalamus, ventral basal ganglia, and
amygdala. Women, conversely, had reductions in the resting levels of
these receptors when they experienced pain in the nucleus accubens, an
area of the brain previously associated with hyperalgesic responses to
the blockage of these receptors.
In the second study, the scientists focused on a gene that produces
a key enzyme involved in the mu-opiod system. The group found that
people who inherit an extremely common variation in the gene have a
lower natural threshold of pain than those who were born without the
variation. The scientists speculated that the variant gene encodes a
slightly altered enzyme that functions somewhat differently than the
normal enzyme, leading to lower brain levels of pain-killing
endorphins. This finding highlights the growing recognition that pain
treatment should be customized to meet the specific needs of individual
patients.
Because of the mouth's unique role in the human body, NIDCR is well
positioned to make key contributions to the future of molecular-based
medicine--not only in alleviating oral conditions but also toward
improving systemic health. This Institute's continued contributions
represent hope for millions of Americans today, as well as improved
health and quality of life for generations to come.
______
Prepared Statement of Dr. Judith L. Vaitukaitis
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Center for Research
Resources (NCRR) for fiscal year 2004, a sum of $1,053,926, a decrease
of $84,738,000 from the fiscal year 2003 enacted level of $1,138,664
comparable for transfers proposed in the President's request.
Infrastructure is at the heart of NCRR. For more than 40 years, it
has been NCRR's mission to develop and support essential research
resources that strengthen and enhance research environments for health-
related studies. NCRR provides the nation's scientific community with
access to broad-ranging resources, including animal models, advanced
technologies, research facilities, and clinical research centers that
explore new approaches for diagnosing, treating, and preventing human
disease.
To be responsive to emerging needs, NCRR works in trusted
partnership with the biomedical research community, with other NIH
institutes and centers, and, in some cases, with other Federal agencies
and private sector organizations. In anticipation of emerging needs,
NCRR in recent years has funded construction of biocontainment
laboratories for the study of dangerous infectious agents; islet cell
resources to explore novel therapies for diabetes; and creation of
transgenic animals that enhance understanding of human disease.
Scientists today are exploring biomedical problems of enormous
complexity. Some of the nation's most pressing health concerns can best
be addressed through multidisciplinary research teams, which integrate
technologies and expertise from a variety of fields. NCRR, with its
cross-cutting mission, is ideally positioned to facilitate this
evolving approach. Today I will outline NCRR's plans for meeting the
ever-changing infrastructure needs and describe just a few of the
research advances enabled through NCRR-supported research
infrastructure.
advanced technologies
NCRR has a long history of developing and enhancing access to new
technologies. Magnetic resonance imaging, mass spectrometry,
synchrotrons for crystallography and optical imaging are just a few of
the now-indispensable tools that NCRR supported in their infancy,
primarily through the nationwide network of Biomedical Technology
Resource Centers. NCRR must remain positioned to ensure that innovative
technologies are developed and accessible before research progress is
compromised.
Novel insights into the prevention or treatment of disease will
arise from synthesis of massive amounts of molecular, genetic, and
biologic data. To take advantage of these rich sources of information,
researchers need new bioinformatics tools and approaches to selectively
retrieve, analyze, and interpret data stored in many different formats
and at different levels of aggregation in locations spread across many
sites. Tool development, including new database architecture, is needed
to manipulate large data sets with data object entries that vary
markedly in size and complexity. Seamless integration of information
across these data sources is a major research challenge.
NCRR has begun to address such issues through its Biomedical
Informatics Research Network (BIRN). The test bed encompasses diverse
locations nationwide. The initial development of BIRN focuses on
generating several robust technologies, computational tools, and
communications networks. These networks simplify and facilitate the
sharing of scientific expertise, technologies, and data. BIRN currently
provides links, via Internet2, among several General Clinical Research
Centers and Biomedical Technology Resource Centers. NCRR now plans to
extend the scope of these networked resources by connecting all NCRR-
supported research resource centers to Internet2, which will enhance
nationwide access to databases, bioinformatics tools, and enabling
resources for clinical and basic research in a second test bed that
will concentrate on infrastructure for clinical research.
In another facet of the BIRN development, NCRR will work in concert
with other NIH components to expand the advanced technologies used or
developed for BIRN and apply them to build a National Electronic
Clinical Trials and Research network, called NECTAR. This effort will
include designing a web-based approach for entering clinical data,
developing advanced tools for integrating datasets, and enabling
manipulation of complex datasets from remote sites. Initial development
of the NECTAR network will focus on therapeutic development networks,
particularly for the treatment of rare diseases. Ultimately, the tools
developed for NECTAR may be readily scaled up for larger
investigations, including collaboratories.
With today's multifaceted studies, biomedical scientists
increasingly depend on a systems approach that integrates, for example,
advanced technologies for macromolecular structures, structure-based
drug design, novel technologies to discern the gene-gene interactions
and molecular imaging. To enable such studies, NCRR proposes to develop
and support comprehensive research resource centers equipped with
state-of-the-art technologies and a team of investigators with wide-
ranging but complementary expertise. These comprehensive centers, which
may provide remote access to resources, will allow investigators to
characterize the thousands of proteins expressed by the human genome.
Scientists will be positioned to address fundamental questions that
cannot be answered by examining one protein at a time. Such
``postgenomic'' studies may provide clues to complex disease-related
processes that may be prevented or arrested with novel interventions.
model development and genetic medicine
NCRR is also at the forefront in developing nonhuman models and
tools for genetic medicine. In recent years, numerous gene-targeting
and transgenic studies have produced a wealth of information on gene
function and their role in development, aging, and disease processes.
But the enormous volume of collected data is often unwieldy and
difficult to analyze. NCRR will enhance this promising area of research
by supporting a national network of resources to systematically
classify and characterize genetically altered animal models and to
support the development of new technologies to rapidly phenotype new
mutants. With the decoding of the human genome and development of new
technologies, biologic models may help unravel the causes and identify
cures for such complex diseases as diabetes, hypertension and cancer.
The mouse has gained new prominence in biomedical laboratories now
that scientists can readily modify the animal's genome to create
transgenic and ``knockout'' 1models of human disease. In 1999, NCRR
established the Mutant Mouse Regional Resource Centers to expand the
nation's capacity for preserving specialized mice and distributing them
to biomedical researchers. Because of the program's success and value
to the scientific community, NCRR now plans to extend the scope of the
mouse resource centers to an international level. Collaborations will
be established with Mutant Mouse Resources at sites in Europe and
Japan, thereby minimizing unplanned duplicative efforts on a global
scale.
NCRR also proposes to initiate a network of Mutant Rat Regional
Resource Centers--similar to the successful mouse network--to import,
validate, cryopreserve, and distribute mutant rats to investigators
globally. Up to three rat resource centers will be established along
with a complementary informatics center to design and maintain a
database of relevant data for each mutant rat included in the network,
and mantain a dedicated Internet linkage among the Centers to provide
investigators access the information on validated mutant rat models
within the network's collection and relevant information a centralized
web site and database.
Research using swine models has expanded significantly over the
past five years, resulting in the need for animal production,
appropriate husbandry and care, and genetic technologies related to
pigs. In 2002, an NCRR-supported research team at the University of
Missouri succeeded in creating the world's first ``knockout'' pigs--the
gene function is altered so that the gene can no longer add specific
sugars to the outer surface of liver cells, which, in turn, decreases
the immune-mediated tissue rejection response. The knockout pigs
represented a first step toward developing genetically engineered swine
suitable for cross-species transplantation, or xenotransplantation,
into humans. NCRR proposes to establish a National Swine Regional
Resource Center with the capacity to import, cryopreserve,
characterize, maintain, and distribute well-characterized specific-
pathogen-free swine strains. The Resource Center will also have an R&D
component to enhance the research scope and expertise of investigators
there.
prevention, diagnosis, and treatment
NCRR is also an ardent supporter of clinical research. The
nationwide network of General Clinical Research Centers (GCRCs)
provides a collection of research resources and professional research
staffing for conducting state-of-the-art clinical research and career
development programs to develop independent investigators. GCRCs are
encouraged to reach out to investigators at nearby institutions without
GCRCs and provide access to the resources of the GCRCs. NCRR also funds
clinical research centers at minority institutions.
To address the public's concern about the safety of clinical
research, NCRR implemented the Research Subject Advocate (RSA) program
to assure that research conducted on NCRR-supported GCRCs and minority
clinical research sites are in compliance with Federal laws,
regulations and policies. Research Subject Advocates work closely with
research subjects to help them understand the research project for
which they agreed to participate and also work closely with clinical
investigators to apprise them of their ethical responsibilities to
research subjects. The RSA organizes workshops to inform investigators
about the several local and Federal regulations and policies that
relate to clinical research. Because of the enthusiastic institutional
responses to the Research Subject Advocate program, NCRR proposes to
begin phasing in support for RSAs for all NIH-supported patient-
oriented research at GCRC host institutions.
In addition, NCRR intends to support research to identify factors--
for example, biologic, economic or cultural--which lead to health
disparities and how to modulate for eliminate those factors in racial
and ethnic minority Americans. Through establishing dedicated
Comprehensive Centers for Health Disparities Research, NCRR support
will develop the clinical research skills and translational research
capacity of students, postdoctoral research fellows and faculty at
minority medical schools. NCRR also will continue to encourage
multidisciplinary collaborations among minority institutions and
institutions with established research programs to not only accelerate
the development of independent clinical research investigators but also
to enhance our understanding of the factors that contribute to health
disparities and how to negate them.
enhancement of research capacity
NCRR's purview is research infrastructure, in the broadest
interpretation of the term. Insight leading to novel research
approaches to prevent, treat or ameliorate disease will result from
synthesis of massive amounts of molecular, genetic, and biologic data.
Seamless integration of information across these data sources is a
major research challenge.
NCRR will expand the advanced technology used or developed for the
neuroscience testbed for BIRN to build a National Electronic Clinical
Trials and Research (NECTAR) network. This effort will include
designing a web based data entry approach for clinical trials and other
types of clinical research, development of a host of other tools,
including advanced grid technology to integrate datasets and develop
tools to manipulate these datasets at distributed sites. The NECTAR
network will generate heterogeneous data types which have distinct or
unique requirements for data collection, storage, integration, and
analysis. Initially this phase of the NECTAR network development will
focus on therapeutic development networks, particularly in rare
diseases. The tools developed at this stage may be readily scaled up to
include, for example, collaborative clinical research across wide
geographic sites, primary care physician clinical trial networks, other
provider networks, and private sector partners. This infrastructure
will constitute the foundation for a nation wide NECTAR-BIRN to
accelerate the rate for which health research advances at the bench
reach patients who are the intended benefactors of biomedical research.
The BIRN allows access to databases, bioinformatics tools, scalable
computing up to the teraflop level, research resources for clinical,
animal and basic research; it also includes federated databases, web-
based data collection for clinical trials and access to virtual
laboratories for crystallography, magnetic resonance imaging, electron
microscopy. This cyberspace-based network will be intertwined with a
``ground-based'' network of technology-based resources. The
complementary networks will continue to evolve with technologic needs
and research complexities. Similarly, technologies and resources
networked for human, animal and basic research will also evolve across
this national infrastructure for land-based and cyber-spaced networks.
In essence, as research problems become more complex, infrastructure to
facilitate that research must undergo a paradigm shift.
The Institutional Development Award (IDeA) program includes two
subprograms to strengthen the research infrastructure among 23 states
and Puerto Rico to improve their research competitiveness for NIH grant
awards. The two infrastructure-building programs--Centers of Biomedical
Research Excellence (COBRE) and the Biomedical Research Infrastructure
Network (BRIN)--have been in place for three and two years,
respectively. In that short time span, preliminary observations are
extremely encouraging. Between 1997 and 2002, the application rate for
NIH grants increased 16 percent--but the number of competitive NIH
grant awards increased 37 percent. The IDeA programs' impact has
resulted from providing support for modern laboratories and research
equipment, recruitment established investigators to lead the research
effort as well as to mentor graduate students and junior faculty to
become independent investigators. There has been a spinoff to small
industry as well. For example, a faculty member of the COBRE in West
Virginia has invented a microfludics chip (``lab on a chip'') that will
enable researchers to analyze and identify proteins more rapidly, an
innovation that may lead to new diagnostic strategies and treatments.
Both the COBRE and BRIN programs are enthusiastically embraced by
students, mentor-faculty, and institutional leadership. In fiscal year
2004 the NCRR will develop new COBRE research centers and will develop
a follow-on program to the BRIN, initially funded as a planning grant,
to capitalize on statewide networks to facilitate biomedical research
efforts at undergraduate institutions and to further enhance the
pipeline for promising baccalaureate and graduate students in fields
relevant to biomedical research.
Finally, NCRR will further strengthen institutional biomedical
research infrastructure and also design specific programs to develop
the research skills of graduate students and junior faculty in both
basic and clinical sciences at RCMI and IDeA institutions. Programs
will be designed to enhance early career scientists to transition from
a mentored research environment to an independent research career to
bolster the collective research capacities of this subset of
institutions. To continue to address the shrinking pool of clinical
investigators, NCRR plans to expand and extend the successful
Institutional Mentored Clinical Research Scholars (CRS) Program to
include a consortium of minority medical schools associated with the
Research Centers in Minority Institutions (RCMI) program. This cohort
of investigators will be included in a dedicated network to foster
their research through the Clinical Research Infrastructure initiative.
conclusion
In conclusion, the health-related advances of tomorrow will depend
on the availability of essential, shared research resources, including
nonhuman models, advanced technologies, and tools for exploring new
diagnostics, therapies, and preventive strategies. NCRR is poised to
provide these essential resources to the biomedical community. As we
have for more than 40 years, NCRR remains committed to providing the
enabling tools and technologies that advance biomedical science and
improve the health of our nation's citizens. In collaboration with the
National Science Foundation, Internet2, and investigators from several
universities, NCRR has become a major supporter for upgrading the
infrastructure for health-related research focusing on development of a
bioinformatics tool box, a more efficient clinical trials system and
use Internet2 interface for the several tools and algorithms for data
visualization, efficient clinical trials networks and development of
grids for security, computation, and data storage.
My colleagues and I will be happy to respond to any questions you
may have.
______
Prepared Statement of Dr. Jack Whitescarver
Mr. Chairman and Members of the Committee, I am pleased to present
the President's budget request for the AIDS research programs of the
NIH for fiscal year 2004, a sum of $2,869,858,000 an increase of
$122,395,000 above the comparable fiscal year 2003 appropriation.
The NIH represents the largest and most significant public
investment in AIDS research in the world. It supports a comprehensive
program of basic, clinical, and behavioral research on HIV infection
and its associated opportunistic infections and malignancies that will
lead to a better understanding of the basic biology of HIV, the
development of effective therapies to treat it, and the design of
better interventions to prevent new infections. Perhaps no other
disease so thoroughly transcends every area of clinical medicine and
scientific investigation, crossing the boundaries of the NIH
institutes. The Office of AIDS Research (OAR) plays a unique role at
the NIH. OAR coordinates the scientific, budgetary, and policy elements
of the NIH AIDS program, supported by nearly every Institute and
Center; prepares an annual comprehensive trans-NIH plan and budget for
all NIH-sponsored AIDS research; facilitates NIH involvement in
international AIDS research activities; and identifies and facilitates
scientific programs for multi-institute participation in priority areas
of research.
the worldwide pandemic
HIV has already infected more than 60 million people around the
world. According to a new CIA report, ``The HIV/AIDS pandemic continues
to spread around the world at an alarming rate, and the number of
people with the disease will grow significantly by the end of the
decade, as it becomes more geographically diffuse. By 2010, we estimate
that five countries of strategic importance to the United States--
Nigeria, Ethiopia, Russia, India, and China--collectively will have the
largest number of HIV/AIDS cases on earth.'' A recent article in
Foreign Affairs magazine stated, ``The spread of HIV/AIDS through
Eurasia, in short, will assuredly qualify as a humanitarian tragedy--
but it will be much more than that. The pandemic there stands to
affect, and alter, the economic potential--and by extension, the
military power--of the region's major states . . . Over the decades
ahead, in other words, HIV/AIDS is set to be a factor in the very
balance of power within Eurasia--and thus in the relationship between
Eurasian states and the rest of the world.'' Dramatic increases in HIV
infection also are occurring in Eastern Europe, Central Asia, Latin
America, and the Caribbean. An article in the New York Times recently
reported another dimension to the epidemic: ``As a result of HIV, the
worst-hit African countries have undergone a social breakdown that is
now reaching a new level: African societies' capacity to resist famine
is fast eroding. Hunger and disease have begun reinforcing each
other.''
the u.s. epidemic
The Centers for Disease Control and Prevention (CDC) recently
reported that more people were diagnosed with AIDS in 2001, the latest
year for which reliable statistics are available, than the previous
year, or any year since 1998. After years of sharp declines, thanks
largely to successful treatment with new antiretroviral therapies
(ART), this report indicates a reversal in cases of AIDS in the U.S.
Further, CDC reported that the rate of new HIV diagnoses, which had
remained stable since 1990, also appears to be increasing. New HIV
infections rose a striking 8 percent between 1999 and 2001, based on
data from 25 states with mandatory HIV reporting, which does not
include the two highest prevalence states of New York and California.
HIV infection rates continue to climb among women, racial and ethnic
minorities, young homosexual men, individuals with addictive disorders,
and people over 50 years of age. In addition, use of ART has now been
associated with a series of side effects and long-term complications
that may have a negative impact on mortality rates. The appearance of
multi-drug resistant strains of HIV presents an additional serious
public health concern. According to CDC reports, approximately one
quarter of the HIV-infected population in the United States also is
infected with Hepatitis C virus (HCV). AIDS affects African Americans
and Hispanics disproportionately. According to CDC figures through
December 2001, approximately 64 percent of newly infected women are
African American and 17 percent are Hispanic. Among newly infected men,
approximately 43 percent are African American and 20 percent are
Hispanic. This expanding and evolving U.S. epidemic presents new and
complex scientific challenges.
comprehensive aids research plan and budget
To address these compelling scientific questions, the OAR develops
an annual comprehensive trans-NIH AIDS research plan and budget, based
on the scientific priorities and opportunities that will lead to better
therapies and prevention strategies for HIV infection and AIDS. The
planning process is inclusive and collaborative, involving the NIH
Institutes, as well as eminent non-government experts from academia,
industry, foundations, and AIDS community representatives. The Plan
serves as the framework for developing the annual AIDS research budget
for each Institute and Center, for determining the use of AIDS-
designated dollars, and for tracking and monitoring those expenditures.
The Plan establishes the NIH AIDS scientific agenda in the areas
of: Natural History and Epidemiology; Etiology and Pathogenesis;
Therapeutics; Vaccines; and Behavioral and Social Science. In addition,
the plan addresses the cross-cutting areas of: Microbicides; Racial and
Ethnic Minorities; Women and Girls; Prevention Science; International
Research; Training, Infrastructure, and Capacity Building; and
Information Dissemination. In consultation with the Director of NIH,
the OAR determines the total annual AIDS research budget. Within that
total, the OAR establishes the AIDS research budgets for each NIH
Institute and Center, in accordance with the priorities and objectives
of the Plan, at each step of the budget development process up to the
Conference Committee. To accomplish this, OAR consults regularly with
the Institute and Center Directors. This process allows the OAR to
ensure that NIH AIDS research funds will be provided to the most
compelling scientific opportunities, rather than a distribution based
solely on a formula.
OAR plays a crucial role in identifying scientific areas that
require focused attention and facilitating multi-Institute activities
to address those needs. OAR fosters this research through a number of
mechanisms, such as designating funds and supplements to jump-start or
pilot program areas, sponsoring workshops or conferences to highlight a
particular research topic, and sponsoring reviews or evaluations of
research program areas to identify research needs.
The overarching priorities that continue to frame the NIH AIDS
research agenda are: prevention research to reduce HIV transmission,
including development of vaccines, microbicides, and behavioral
interventions; therapeutics research to develop simpler, less toxic,
and cheaper drugs and drug regimens to treat HIV infection and its
associated illnesses, malignancies, and other complications;
international research, particularly to address the critical needs in
developing countries; and research targeting the disproportionate
impact of AIDS on minority populations in the United States. All of
these efforts require a strong foundation of basic science, the bedrock
of our research endeavor.
new challenges in therapeutics research
While multiple ART drug combinations continue to successfully
reduce viral load and restore immune responses in many HIV-infected
individuals, these regimens also can result in serious toxicities and
side effects, single- and multiple drug-resistance, and other
complications which make them unacceptable for some individuals. These
side effects and complications appear to be increasing as HIV-infected
individuals continue on drug regimens. More deaths occurring from liver
failure, kidney disease, and cardiovascular complications are being
observed in this patient population. NIH-sponsored research efforts
continue to develop better antiretroviral drugs and treatment regimens
that demonstrate less toxicity, activity in viral and cellular
reservoirs, reduced development of drug resistant virus, improved
pharmacodynamics and pharmacokinetics, easier compliance, and lower
cost.
While the incidence of certain opportunistic infections (OIs) and
malignancies has decreased with the advent of ART, the number of cases
of TB, multiple drug resistant TB, and other coinfections such as
Hepatitis B virus and Hepatitis C virus has increased. The development
of practical and affordable treatment regimens against HIV coinfections
and endemic diseases in developed and developing nations is an NIH
priority.
prevention research
NIH supports a comprehensive approach to HIV prevention research
that includes contributions from the biomedical, behavioral, and social
sciences. Our biomedical prevention research priorities include the
development of vaccines, topical microbicides, strategies to prevent
mother-to-child transmission-including a better understanding of risk
associated with breast-feeding-and management of sexually transmitted
diseases (STDs). NIH also supports behavioral research strategies,
including interventions related to drug and alcohol use. Efforts
continue to identify the most appropriate intervention strategies for
different populations and sub-epidemics in the United States and around
the world. As a result of increased NIH funding, many new approaches to
HIV vaccines are being pursued. Although production of candidate
vaccines for clinical study has proceeded slowly, at least 10 new
candidate vaccines will enter Phase I trials in the next 2 years.
Several new combinations of products, which are expected to provide
better immune responses, also will be tested in Phase I or II trials.
The Dale and Betty Bumpers Vaccine Research Center, located on the NIH
campus, recently launched the first Phase I clinical trial of a multi-
clade, multi-gene vaccine candidate.
international research
To address the increasing urgency of the AIDS pandemic, the OAR
established an initiative and strategic plan for global research on
HIV/AIDS and has significantly increased research efforts in the past
several years to benefit resource- and infrastructure-poor nations. NIH
supports a growing portfolio of research conducted in collaboration
with investigators in developing countries. Results of this research
benefit the people in the country where the research is conducted, as
well as people affected by HIV/AIDS worldwide. Critical to the success
of these international studies are foreign scientists who are full and
equal partners in the design and conduct of collaborative studies. To
that end, NIH also supports international training programs and
initiatives that help build infrastructure and laboratory capacity in
developing countries where the research is conducted.
women and minorities
Women experience HIV/AIDS differently from men. NIH research has
demonstrated that women progress to AIDS at lower viral load levels and
higher CD4 counts than men. Women also experience different clinical
manifestations and complications of HIV disease. These findings may
have implications for care and treatment of HIV-infected women,
particularly with ART. There are many research questions that remain
unanswered about specific characteristics of women and girls that might
play a role in transmission, acquisition, or resistance to HIV
infection during different stages of the life course.
In many U.S. urban centers, HIV seroprevalence rates mimic those
found in some developing nations. These findings, along with the
resurgence of STDs and associated high-risk behaviors, demonstrate the
need for comprehensive strategies to decrease HIV transmission in
affected vulnerable populations, and improve treatment options and
treatment outcomes. OAR is directing increased resources toward
research to develop new interventions that will have significant impact
on these groups. These include interventions that address the co-
occurrence of other STDs, hepatitis, drug abuse, and mental illness;
and interventions that consider the role of culture, family, and other
social factors in the transmission and prevention of these disorders in
minority communities. NIH is making significant investments to improve
research infrastructure and training opportunities for minorities and
will continue to ensure the participation of minorities in AIDS
clinical trials, as well as in natural history, epidemiologic, and
prevention studies. OAR has provided additional funds to projects aimed
at increasing the number of minority investigators conducting
behavioral and clinical research; targeting the links between substance
abuse, sexual behaviors, and HIV infection; increasing outreach
education programs targeting minority physicians and at-risk
populations; and expanding the portfolio of population-based research.
One of these projects is a series of Training and Career Development
Workshops that provide minority investigators with an opportunity to
learn more about available NIH funding mechanisms and to meet and
network with senior minority investigators who receive significant
levels of NIH funding.
summary
The human and economic toll of the AIDS pandemic is profound. It
requires a unique response that is complex, comprehensive, multi-
disciplinary, and global. The NIH role in this response is fundamental
and unprecedented. The diverse AIDS research portfolio demands
scientific coordination and management of research funds to enhance
collaboration, minimize duplication, and ensure that precious research
dollars are invested in the highest priority areas of scientific
opportunity. The nation's investment in AIDS research is reaping even
greater dividends, as AIDS research is unraveling the mysteries
surrounding many other infectious, malignant, neurologic, autoimmune,
and metabolic diseases.
The authorities of the Office of AIDS Research allow NIH to pursue
a united research front against the global AIDS epidemic. We are deeply
grateful for the continued support this Committee has provided to our
efforts.
ACTING DIRECTORS
Senator Specter. Thank you very much, Dr. Zerhouni.
Are there any other institutes which have acting directors
at the present time?
Dr. Zerhouni. Yes. We have three institutes this minute.
NIGMS, the General Medical Science Institute is--the Acting
Director is Dr. Judy Greenberg. And she is with us today.
Senator Specter. And when do you expect to have a permanent
director there?
Dr. Zerhouni. Senator, I have worked--the top priority for
my first year was to complete all six--I mean, to fill all six
vacancies for the six institutes that were vacant within the
year. So I expect that, I hope on my first anniversary that all
institutes will have new directors that have acting directors
today.
Senator Specter. Dr. Zerhouni, the subcommittee would
appreciate knowing a little more about your efforts there.
There is an inevitable sense that a full-time director with
that authority is necessary to move an institute along at top
speed. So would you submit to us in some detail, in writing,
your expectations and the progress and keep us informed as to
how you are doing on full-time directors for those institutes?
Dr. Zerhouni. I will certainly do. And I agree with your
views on that.
[The information follows:]
Progress on Full-Time Directors
Mr. Chairman, I consider the selection of outstanding, highly
qualified scientist-administrators as directors of the various
institutes to be among my highest priorities. Over the past eleven
months, I have filled three of the vacancies for Directors of
Institutes at NIH and have appointed:
Dr. Thomas Insel, Director, National Institute of Mental Health
Dr. T. K. Li, Director, National Institute on Alcohol Abuse and
Alcoholism
Dr. Nora Volkow, Director, National Institute and Drug Abuse
Two other vacancies remain and I and my staff are working very hard
to complete the searches so that I can make appointments:
--The search for the Director, National Institute of Neurological
Disorders and Stroke has been prolonged, unfortunately. It
started in March, 2001 and, after careful consideration, the
leading candidate withdrew and took a position at a
pharmaceutical company in November, 2001. The vacancy
announcement was re-issued and a slate of three highly
qualified candidates was sent forward, all of whom were
interviewed by the Acting Director, NIH between late February
and March, 2002. A candidate was offered the position at the
end of March, accepted verbally and subsequently, withdrew in
early April 2002.
Upon my assuming the Directorship of NIH, I discussed the
situation with my senior staff and decided to reconstitute the
search committee, and solicit applicants myself. This resulted
in several new applicants and consideration of several previous
candidates. Five candidates were interviewed and as of the time
of submission of this response, I am in active discussion with
my selectee. I anticipate that I will be able to name a
Director for NINDS within a very short time.
--The search for the Director, National Institutes of General Medical
Sciences was initiated in mid-March, 2002. The search committee
interviewed a total of ten candidates between late September,
2002 and February, 2003. Of the group, I and my senior staff
have interviewed three during March and early April and
anticipate conducting one more interview. I anticipate that a
selection will be made in the next month.
SALIVARY DIAGNOSTICS
Senator Specter. Dr. Zerhouni, one of the questions which
we characteristically ask is the question about what progress
is being made on major ailments and what could be done with
greater funding. And it is obviously a very difficult question.
It may be an impossible question when we ask when will a cure
be found for Parkinson's. I choose Parkinson's because 5 years
ago there were estimates that Parkinson's would be cured within
5 years.
Nobody can hold you to a cure time. But we would be
interested in your projection on where you see NIH heading on
the ailments to give us some projection as to what your
expectations are. We understand that it is not possible to be
scientifically precise. And then to tell us what more you can
do with increased funding, what level of funding on the
specific ailments would enable you to project an earlier time
and by how much.
Our colleagues in the Congress are very goal-oriented. And
even questions which are really not answerable with precision
are pursued. So to the extent that you could give us some ideas
on those questions, the subcommittee would be very
appreciative.
Let me turn to Dr. Lawrence Tabak of the Dental Institute
on a question which has recently come to the attention of the
subcommittee on the presence of a cancer-related protein in
saliva that could result in more acute, less costly ways to
diagnose breast cancer in women. The question, Dr. Tabak, is,
how much is being requested in the budget to pursue this line
of research? And do you have any plans to conduct clinical
trials in this area?
Dr. Tabak. Thank you for the question, Senator Specter. In
this current fiscal year, NIDCR is expending approximately $7
million in the general area of salivary diagnostics. And for
the next fiscal year, we hope to spend approximately $1.5
million more to continue in this effort.
Senator Specter. $1.5 million?
Dr. Tabak. Yes, sir, that is correct.
Senator Specter. What is the total budget of your
institute?
Dr. Tabak. Currently, it is $371 million, sir.
Senator Specter. Does this new test pose real promise to
give an easier, better diagnosis of breast cancer?
Dr. Tabak. This and other salivary diagnostic tests do
offer a great deal of promise, sir. The test to which you are
referring, as you know, was worked out at the University of
Mississippi. It is a test which recognizes a protein which can
be found both in blood and saliva. But because of the ease of
detection and the ease of sample collection in saliva, we feel
that there are certain advantages for the saliva-based test.
Senator Specter. Dr. Tabak, if you allocated more than $1.5
million, do you think you could get a faster result on this
important test?
Dr. Tabak. Certainly, sir, resources are always welcome.
But there is a point at which basic information needs to be
gathered. And until that basic information is obtained, it
would be premature to expend additional funds in a particular
area.
Senator Specter. Are you saying that is the maximum amount
that can be efficiently spent on that research?
Dr. Tabak. In terms of bringing this work to a full-blown
clinical trial, sir, I think it would be premature. What we are
now doing is termed phase-one trials to begin to understand
whether or not this test is both accurate and efficacious. Once
that base information is obtained, sir, then it would be
appropriate to go on to larger scale trials.
Senator Specter. Thank you.
Senator Murray.
Senator Murray. Thank you very much, Mr. Chairman.
PEDIATRIC RESEARCH
Dr. Zerhouni, when you were confirmed, you and I talked
about pediatric research. And I wanted to ask you today about
any progress you have made. I think we have made a lot of
progress on reducing gender bias, but I am still deeply
concerned that we have not made much progress on making sure
that we are looking at everything in terms of what happens to
children.
Can you give us an update on your pediatric research
initiative?
Dr. Zerhouni. Well, as you know, the pediatric research
initiative is guided by a major document that we have been
following in terms of implementation. There is no doubt in my
mind that pediatric research is a priority, continues to be a
priority. We have to also invest and continue to invest in the
multiple areas of pediatric research.
We are, for example, invested in terms of talent and
developing talent and training capabilities for pediatric
research. We are continuing to make investments in many of the
pediatric diseases separately. For example, we have increased
our investment in muscular dystrophy or increased our
investment in spinal muscular atrophy. And in every category we
have a disease-specific plan.
But in terms of the overall investments in pediatric
research, we need to integrate the pediatric research agenda
within not just the NICHD Institute, which is primarily
responsible for pediatric research, but all institutes.
So I think it is work in progress. I think we are making
good progress. But we will continue to consider that a
priority, realizing as well, Senator, that many of the changes
we need to make relate to these priority areas that I
described--multidisciplinary teams that should invest in
pediatric research, clinical research networks. For example,
the Office of Rare Diseases is looking at establishing networks
across the country to look at these rare diseases that tend to
affect children.
So we are looking at a multi-pronged approach and a
strategic approach in pediatric research.
FUNDING OF RESEARCH PRIORITIES
Senator Murray. Dr. Zerhouni, as you well know, there is a
lot of misunderstanding about NIH research dollars. There is
kind of this assumption out there that NIH only funds
politically correct diseases or that you have to have a high-
profile celebrity in order to secure any NIH funding. And I
know this subcommittee under Senators Specter and Harkin have
really resisted any efforts to earmark NIH dollars by disease.
We can express our thoughts through report language.
But could you explain for us how you establish the
priorities for NIH funding and what criteria is used in
evaluating research applications?
Dr. Zerhouni. Certainly, Senator. This is a question that
is a recurring theme, especially when any particular area feels
underserved. So that when we look at the decisionmaking
process, we realize that there are fundamentally several
factors that come into play. One, the first and foremost is the
burden of the disease as we know it through epidemiological
studies. And second, the predicted future burden of disease.
For example, just as a matter of example, you look at
diabetes and the rise in expenditures in diabetes, it parallels
what we predict the burden of disease in diabetes is going to
be. When you look at obesity research, we are now investing at
an accelerated pace in obesity research because of the
prediction. Even though when you look at the disease burden,
per se, you cannot really decide that this is the only factor
that you should look at, because the second factor is, have we
made enough scientific advances to invest in the particular
area with results that are likely to occur?
So we look fundamentally at the investments in terms of, A,
the burden of disease; B, the priority setting in terms of
science. And we get advice in that context for many more
sources than any. I am very impressed with the fact that NIH
receives advice from 21,000 advisors every year on every single
condition that we face.
So the process is not an easy one to consider. But clearly,
the patient advocacy groups are also interested in looking at
how we invest. And my gratitude goes to you, because I think
earmarking would not be a good direction for setting scientific
priorities at NIH. And we try to avoid that and try to not be
politically correct, as you state.
Senator Murray. Well, I think it is really important to
keep talking about how you set your criteria to the general
public, because we do have a misperception constantly that if
you get a high-profile person, that you get more funding. And
so it makes it harder on us. And, as I said, Senator Specter
has done a really good job managing that. But it is very
difficult.
I think it is important that we base it on science. So I
appreciate your comments.
Thank you, Mr. Chairman.
Senator Specter. Thank you, Senator Murray.
Dr. Zerhouni, I broach the subject of some delicacy now,
which has already been communicated to you. Last year the
Senate figure was cut by $25 million because the conference
committee concluded that to reach the doubling, which was an
astronomical figure, was more than sufficient. We have an
enormous number of complaints from other research agencies
about, candidly, the favoritism that NIH gets. And we have
fought those battles out.
We have heard from a number of people about directors of
the institutes who have said that certain grants could not be
applied or certain research could not be undertaken because the
budget was cut and have attributed the $25 million reduction,
which was not a cut at all, because there was an increase of
more than $3.7 billion to the NIH budget.
It would be amazing, I think, to many of you ladies and
gentlemen, how fast the information travels from what you may
tell someone who is applying for a grant or you may tell
someone who is concerned about more research right back to my
ears. You would be surprised.
The advent of this very, very heavy increase in funding for
NIH, which has come from this subcommittee, has had the
reverberating effect of having this subcommittee contacted by
many, many, many people, which had not been the case before we
took up the cause of increasing the NIH grant. So if you do not
want to make some allocation or you do not want to make a grant
or you do not want to undertake some research, if you say it is
because you got a cut in your budget, that is going to come
back to the Congress.
We hope you do not ever have a cut in your budget. But bear
in mind that these people--and I know you have a good sense of
this yourself--feel so very intently about these subjects,
very, very emotional, when you have a child with one of these
maladies, it is just the edge of the ledge. And I know that you
dedicated men and women are well aware of that. But I thought
it important to make a quasi-public statement. I have not said
very much on the subject in the brief remarks I have just made.
Let me turn now to the question of stem cell research. And
I would like to direct this question to Dr. James Battey of the
Deafness Institute and also to Dr. Allen Spiegel of the
Diabetes and Digestive and Kidney Institute. Last September,
this subcommittee held a hearing regarding the implementation
of the Federal stem cell policy. And as you all know, back on
August 9, 2001, President Bush articulated a modification of
Federal policy to allow Federal funding on existing stem cell
lines.
At the September 25, 2002 hearing, Dr. Curt Civin stated,
``Embryonic stem cell research is crawling like a caterpillar,
while NIH has listed eligible lines in its registry at 78. Only
a tiny fraction of these lines are accessible and only to those
persistent and patient enough to jump through a series of hoops
and endure lengthy waits. I am still waiting to receive my
first stem cell line.''
Dr. Battey and then Dr. Spiegel, what steps has NIH taken
to help people like Dr. Civin and other scientists gain access
to embryonic stem cell lines? And how many are now accessible?
ACCESS TO EMBRYONIC STEM CELL LINES
Dr. Battey. The process of scaling up an embryonic stem
cell derivation to the point where it can be distributed as a
high-quality, well-characterized cell line takes about a year
from start to finish. It is an expensive, time-consuming,
technically demanding process that requires enormous care to
maintain the cells in their state of pluripotency, which means
their ability to differentiate into many different cell types,
as well as to remain continuously self-renewing.
To facilitate this very expensive and time-consuming
process, the NIH has awarded infrastructure grants awards to
eight suppliers that have derivations on the NIH stem cell
registry. And I am pleased to tell you, Mr. Senator, that
between the September hearing and the hearing today, if you had
a research laboratory and wanted to order cell lines, in
September you could have ordered five such cell lines. And
right now, you could order 11 lines today.
That effort is continuing to expand. And we expect that
increasing numbers of cell lines will be widely available and
actively shipped to the research community over the next 6
months to a year.
Senator Specter. How many stem cells are currently
available?
Dr. Battey. You could order 11 lines today.
Senator Specter. Is that sufficient for the research which
people want to undertake?
Dr. Battey. At this point in time, the fundamental
challenge in the human embryonic stem cell research arena is a
basic research challenge. It is a challenge to understand what
growth factors, transcription factors, and other molecules
regulate the ability of embryonic stem cells to differentiate
into one cell type versus another. It is an understanding of
the interaction between the host and the transplanted cell that
allows that cell to persist for a long time within the host and
to function correctly.
It is a challenge to understand how you control the cell
cycle division of the cell, because once it is transplanted
into a host, you do not want it to continue to be self-renewing
in the same way that it was in the laboratory before it was
transplanted.
These basic research questions are readily addressable with
the cell lines that are currently available and will become
available within the next few months to a year.
Senator Specter. Do we have sufficient stem cell lines for
the research that people want to undertake?
Dr. Battey. We have sufficient cell lines to embrace the
basic research challenge that is in front of us today.
Senator Specter. Well, is there some facet besides the
``basic research challenge,'' which is in front of us today?
Dr. Battey. The major questions that confront the stem cell
research community today can be addressed with the cell lines
that are available.
STEM CELL INFRASTRUCTURE AWARDS
Senator Specter. Dr. Spiegel, would you care to amplify on
Dr. Battey's answer?
Dr. Spiegel. I would be happy to. Thank you, Senator
Specter.
Some general comments to amplify on what Dr. Battey said
would include the provision of support through so-called
infrastructure awards to the providers of these human embryonic
stem cell lines. NCRR is funding the majority of these
infrastructure awards. NIDDK is funding two of them. And this
provides support to allow the distribution of these cells
because they are very, very difficult to grow.
Several NIH institutes have combined to provide training
courses. As Dr. Battey has emphasized, one of the rate-limiting
steps here is bringing new investigators into the field. It is
not trivial to learn how to grow human embryonic stem cells.
And these training courses are directed at that.
A further example, which again comes out of the NIH Stem
Cell Task Force, for which Dr. Zerhouni appointed Dr. Battey
the Chair and on which I am pleased to serve, is an intramural
NIH facility, which will be under Dr. Ron McKay and the
Neurology Institute with extramural investigators as advisors.
This effort will be comparing and looking critically at the
different available human embryonic stem cell lines to provide
information that is critical before investigators order them to
work on in their own lab.
Let me then just briefly speak on NIDDK specifically.
NIDDK, like many of the other NIH institutes, has invested
heavily in all aspects of stem cell research. So-called adult
stem cell research, animal stem cell research, because animal
models are very important, as well as human embryonic stem cell
research. The aggregate figure for fiscal year 2002 for NIDDK
was $58.3 million.
One particular new initiative that we undertook, based on a
trans-NIDDK planning group was so-called stem cell genome
anatomy projects. These span the entire spectrum of the NIDDK
mission so that we have projects directed at understanding the
development of cells in the bone lineage, which we do with the
Arthritis Institute, in the gastrointestinal and liver lineage,
in the urology and the kidney lineage, and then so-called
hematopoietic stem cells.
One of our most important initiatives relating specifically
to Type 1 and Type 2 diabetes is the so-called beta cell
biology consortium. Of course, it is the beta cell that makes
insulin, which is lacking in Type 1 diabetes and deficient in
Type 2 diabetes. This consortium is looking at every avenue of
approach to the development of these critical cells.
Thank you.
STEM CELLS AND MOUSE FEEDER CELLS
Senator Specter. Dr. Spiegel, what about the research to
isolate stem cells without the use of mouse feeder cells?
Dr. Spiegel. Currently, to my knowledge, although there
have been reports from industry about the ability to grow human
embryonic stem cells absent mouse feeder cells, the lines that
are in use or available that Dr. Battey referred to do use
mouse feeder cells. As Dr. Battey emphasized, this is not
hampering the ability to do the basic research that we need to
do to really be able to understand how we can trigger in a very
organized and efficient way the development of these cells into
various therapeutic possibilities.
Senator Specter. Is it not true that research without the
use of mouse feeder cells is indispensable, necessary to use
those stem cells in humans?
Dr. Spiegel. I totally agree. The comment that I was going
to make is that a critical intermediate step before anyone
should contemplate--in terms of safety and every other
consideration--going into human trials, would be animal models,
from small animal models and eventually to non-human primate
models. Here, too, the mouse feeder layer issue is not rate-
limiting.
But, you are certainly correct that to go into human
trials, there would be issues that would have to be addressed
in terms of possible mouse viruses and other contaminating
proteins.
Senator Specter. Should not those issues be addressed now
by NIH?
Dr. Spiegel. I think that that is an important issue. I
think that, in terms of the available lines, there are
important technical developments that can be undertaken that
are critical to understand what the factors are that these
mouse feeder-layers are eliciting that are necessary to keep
the human embryonic stem cells from differentiating
spontaneously. That is really the critical issue for which they
are used.
I believe that the kind of research that is being done,
research that we can support, will very much address those
kinds of issues. That is, after all, the goal, to really
understand how to trigger development along a pathway that we
want, and yet to prevent spontaneously differentiation. And
such growth factor and other signaling research is being
undertaken.
Dr. Battey. If I could, Mr. Senator. Dr. Spiegel----
Senator Specter. Wait just a minute. I find that very
interesting, if not totally understandable. But what about the
basic question of having some research without the use of mouse
feeder cells? Do you not think that would be a pretty good idea
with all you are doing? How many millions did you say you were
spending?
Dr. Spiegel. The total figure for NIDDK for fiscal year
2002 was $58.3 million.
Senator Specter. Well, why not some research without the
mouse feeder cells? If they are to be used in humans, you are
going to have to move in that direction.
Ladies and gentlemen, what I want to be sure about, and I
cannot quite accomplish it in this hearing today, is that we
are not making any political decision, that you are making
scientific decisions. That is what we expect from you
scientists. That is why we are putting up $27 billion, which is
a very, very big public trust.
Do you want to say something more, Dr. Battey?
MOUSE FEEDER CELLS
Dr. Battey. I just wanted to add to what Dr. Spiegel said.
The first challenge to getting rid of the mouse feeder layer is
figuring out what the mouse feeder layer is providing to the
embryonic stem cells to render them able to differentiate into
many different cell types and be self-renewing. And there is
active research efforts to identify the factors that allow
these cells to remain in that state. And when those factors are
known and understood, we will be in a position to attempt to
grow these cells absent a mouse feeder layer.
Senator Specter. Dr. Penn, let me direct a question to you
with respect to spinal muscular atrophy, a genetic motor neuron
disease characterized by the wasting away of skeletal muscles.
It is the leading killer of infants and toddlers. Twenty-five
thousand Americans have the disease with up to 1,000 new babies
born with the disorder each year.
While there is a transitional research program, we are
concerned about how effectively it is being put into operation.
When spinal muscular atrophy was selected for this transitional
research program--when was SMA selected for this transitional
research program? And when will the first grants be awarded?
Dr. Penn.
SPINAL MUSCULAR ATROPHY RESEARCH
Dr. Penn. Yes, Senator. Spinal muscular atrophy actually is
the leading genetic cause of infant mortality. It is not always
lethal--there are three or four forms of it. In one form, it is
really deadly to babies. But in several others, adults can grow
and function and live with this disease.
Spinal muscular atrophy, we feel, is a great scientific
opportunity, because we not only know the genetic defect, but
we know something about how to try to render this disease
perhaps not cured, but to help it by dealing with the genetic
defects. And therefore, we did decide to move this disease
toward treatments, and I must say with a lot of help from the
voluntary agencies, as well as the Muscular Dystrophy
Association. And this is actually part of an institute-wide
effort to move in what we call translational research, dealing
with the basic mechanisms of a disease and then going to
treatments.
So we do have a brand-new way of pursuing working toward
trying these treatments and doing clinical trials. We will go
to the point of an investigational new drug application with
FDA. And it has taken time to do this properly. This is so new
that we have worked very hard to make it--to have a really
excellent product.
Actually what we are going to do is have a contractor issue
subcontracts. And the subcontracts will be directed at the
group of investigators out there that have done wonders to
figure out what is going on with this disease since the gene
was identified in 1995.
So we will not be issuing grants. The contractor will
actually call for subcontracts. We expect the whole group of
investigators to come in for these. There will then be let a
contract. And they will have to achieve milestones. It is not
so much reporting on what you--yes, reporting on what you have
done. You have to achieve something.
There are drugs, actually drugs, that could be used in this
disorder. And one of our intramural investigators, who is
internationally recognized in these areas, is trying one of
these drugs right now. But he is only working on cell lines
from the patients. Again, we have to be very careful about
using some of these things and moving to human beings.
It has taken time. But we are issuing--we have issued the
requests for proposals for this contract. And we expect to have
this move by the end of the summer.
Senator Specter. Dr. Penn, the question is, when was SMA
selected for this transitional research program?
Dr. Penn. Over a year ago. It took a year and a half to get
it to this point.
Senator Specter. Well, when will the first grants be
awarded?
Dr. Penn. The first subcontracts, sir, will be awarded, I
would say, this winter.
Senator Specter. When?
Dr. Penn. This winter, sir.
Senator Specter. Why is it taking so long?
Dr. Penn. To do it properly and to get our intramural
program up and running with it and to make sure that we develop
and design this whole program so that we would have a really
excellent result.
Senator Specter. Well, why does it take almost 2 years, Dr.
Penn?
Dr. Penn. As I said, sir, this is something brand-new for
us. It is a contract-based program. And it has taken 2 years.
Senator Specter. It is something brand-new, but it is a
contract-based program.
Dr. Penn. It is brand-new for us. And we have--we are going
to have a steering committee made up of the experts, both
academic and----
Senator Specter. You are going to have a search committee?
Dr. Penn. A steering committee, sir, to run----
Senator Specter. You are going to have a steering
committee?
Dr. Penn. For it to run----
Senator Specter. Has the steering committee been appointed?
Dr. Penn. It is being appointed right now.
Senator Specter. Why does that take so long?
Dr. Penn. Well, we had not gotten to that phase of the
exercise.
Senator Specter. Well, why have you not gotten to that
phase?
Dr. Penn. It just took this long to do this properly. It
took this long----
Senator Specter. Dr. Zerhouni, would you take a look at
that and submit in writing----
Dr. Zerhouni. Yes, Senator.
Senator Specter [continuing]. What has happened?
Dr. Zerhouni. I have looked----
Senator Specter. I would like to have--but I am not going
to take it up now.
Dr. Zerhouni. Fine.
Senator Specter. I would like to have precise answers as to
when the program was adopted, as you call it a translational
research program.
Dr. Zerhouni. Understood.
Senator Specter. And when a steering committee is adopted.
And this subcommittee wants to examine whether there is an
appropriate sense of urgency. It certainly has not satisfied a
lot of parents whose children have this ailment.
Dr. Zerhouni. I will respond directly to you on the record,
sir.
Senator Specter. Okay. We would appreciate it, if you
would.
[The information follows:]
Spinal Muscular Atrophy
The NIH is committed to accelerating research toward finding a
treatment for SMA, and fully appreciates the sense of urgency expressed
by the parents of children with this disease, as it does the concerns
of the parents of children affected by the scores of other neurological
disorders--many of which are genetic and are often disabling or lethal.
The NINDS recently launched a comprehensive program designed to
encourage and support translational research for all neurological
disorders. By translational research, I mean the process of applying
insights and discoveries from basic scientific inquiry to the treatment
or prevention of disease; the emphasis is on those activities focused
on bringing therapeutic strategies to readiness for clinical testing.
The specific, contract-based, SMA translational project to which
you refer is in addition to all the other funding opportunities that
are currently available for SMA research. It will use a performance-
based contract mechanism to allow rapid funding of translational
research, in a milestone-driven process, to identify treatments for
SMA. The NINDS presented the idea for this program to its National
Advisory Neurological Disorders and Stroke Council in February 2002.
The primary contract for the SMA project, which we expect to award
on or about September 30 of this year, will provide overall scientific
direction and organizational support for the program. A Steering
Committee, drawn from academia, industry, the public, and NIH, will
guide the program and play an integral oversight role for the
Contractor throughout the project. A working group of the Council,
including members of the proposed Steering Committee, will develop
detailed recommendations for a plan for research on promising
therapeutic strategies for SMA, such as drug development, gene therapy
and stem cell therapy. The plan will address all the steps required,
ultimately, to develop an IND--Investigational New Drug--application.
The implementation of the research plan will be finalized by the
Contractor, with guidance from the Steering Committee. The Steering
Committee will assist the Contractor in evaluating success in
accomplishing milestones, and in developing additional calls for
research proposals as needed. Because the role of the Steering
Committee is so integral to, and defined by, the contract, it would
have been premature to establish its membership in advance of the
publication of the statement of work in the request for proposals (RFP)
for the SMA program; this RFP was issued on April 22, 2003.
Importantly, efforts to recruit the Steering Committee are well
underway, and there will be detailed recommendations for the research
plan ready for presentation to the Council in September; calls for
research projects can be issued in October 2003, shortly after the
contract is awarded, and research projects should be underway by
February 2004.
The SMA translational program is not just a novel program for SMA,
but also for the NINDS. The aim is to develop treatments that will be
tested in people, and we hope this effort will serve as a model for
expediting therapy development for other disorders. This program will
require a significant investment of resources; the contract will be
awarded for four years, and NINDS intends to fund the research
subcontracts at a level of $4.5 million per year, which we anticipate
will fund up to approximately ten research subcontracts per year. The
NINDS intramural program will be involved throughout the process,
providing expertise in neurogenetics and SMA, and will be equipped to
rapidly initiate Phase I/II clinical trials when appropriate. For all
of these reasons, careful planning has been essential.
Senator Specter. Senator Harkin.
Senator Harkin. Thank you, Mr. Chairman. I have an interest
in SMA, also. I have met with families in Iowa about this. And
I am concerned, as Senator Specter, that the leading cause of
infant mortality is something that----
Senator Specter. You ladies and gentlemen would be amazed
with how many families we have met with with SMA and the other
ailments.
Senator Harkin. Yes. I started meeting with them maybe a
couple years ago in Iowa or something. And this is something I
had not even known about before. And now I just--now we find
out that it is the leading cause of infant mortality. And we
just have not done that much research on it. So I agree with
you, we have to push hard on that. We have to get this thing
moving. And I do not know why it has not by now. So I agree
with the chairman on this, that we have to find out about that.
Senator Specter. Well, there is one fellow who suffers from
Parkinson's, who has an hourglass. Whenever he sees me, he
turns the hourglass. And the ticking sands are going through
the hourglass on every hour of his life. And these parents come
to us with SMA and other ailments.
I am about to go through a fairly long list of questions.
We are going to take a little more time today, because we want
to know what the sense of urgency is as to how these issues are
being addressed.
These people come to us and say, you are giving NIH all the
money. What is happening? I do not like to hear talk of long
periods of time on appointing steering committees.
Senator Harkin.
Senator Harkin. Thank you again, Mr. Chairman.
I understand that you, in my absence--I was unavoidably
absent from here a little bit--that you did cover the issue of
stem cell research. And I just again want to buttress what you
have said and hope that we can move ahead aggressively in this
area, too. I understand that has been covered. So I will not go
into that.
The only thing that I just wanted to cover with you, Dr.
Zerhouni, was just basically broader picture of the funding of
NIH. We, as you know, basically just finished the doubling over
5 years. Senator Specter and I are both, with his leadership
and with my support, starting to get on another pathway of
trying to get it up to a tripling, that is, from what we
started in 1998.
To maintain that level, it seems to me we are going to have
to have somewhere in the neighborhood of about 7 or 8 percent a
year, if I am not mistaken, increases. And it is my
understanding, also, that just to maintain and kind of keep
doing what we are doing, we are going to need somewhere in that
level of funding. And yet the budget request this year is a 2.5
percent request.
So how can we keep from falling back from what we have
done? And how can we continue to move ahead with a fairly
aggressive level of expansion of NIH basic research at 2.5
percent, or 2.6 percent, I guess it is?
Dr. Zerhouni. Thank you.
Senator Harkin. I mean, my point is, you asked for 2.6
percent.
SUSTAINING RESEARCH PROGRAMS ON MODEST BUDGET INCREASES
Dr. Zerhouni. Thank you for your question. This is a very
important consideration. Because one of the issues that we have
to match with the concept of doubling is why are we doubling?
And what are we trying to accomplish? And I think one of the
issues that I raised was that we have evolving challenges. We
have in fact stimulated in our country an incredible change in
the way we do biomedical research. And we are in the transition
phase in terms of understanding the new methods of research and
the new teams that need to do this research.
When you look at the 2004 budget, I worked very hard with
the administration, with the Department, and with the Office of
Management and Budget, when you look at the 2.6 percent
overall, and we worked so that the effect on our research would
be about 7.5 percent overall. And the reason for that is
because we have essentially used one-time expenditures that
related to building the infrastructures that we needed for
biodefense research and other one-time items and reinvested it
in research.
So for 2004, the impact on the research portfolio in terms
of growth is greater than the 2.6 percent, Senator.
Senator Harkin. Well, I want to delve into that. In fiscal
year 2003, Congress funded more than $300 million for
extramural construction with allergies and infectious diseases,
bioterrorism.
Dr. Zerhouni. $375 million.
Senator Harkin. $375 million?
Dr. Zerhouni. Yes.
Senator Harkin. I think you can argue that was probably a
one-time expense.
Dr. Zerhouni. Correct.
Senator Harkin. But if I look at the extramural facilities
renovation and construction program, going back just the last
few years, this is an ongoing funding stream that this
committee has funded, under different chairmanships here. We
have all been supporting extramural construction and
renovation. We know that some of the labs around the United
States are deficient. They need to be upgraded. I am sure
Senator Specter has visited, as I have. And so we embarked on
this, also, a few years of making a funding stream every year
available.
So how can you say that this is a one-time expense? I could
see saying that the $300-and-some million that we put in last
year was a one-time expense for bioterrorism. But we have an
ongoing extramural renovation and construction program that
last year was $119 million, aside from that $300-and-some
million. It was $110 million the year before. Now it was $75
million a year for a few years before that. But then we bumped
it up, because we saw the need out there. And now in fiscal
year 2004, we are requesting zero dollars.
To me, that is not a one-time expense. It is an ongoing
commitment that we have to rebuild and modernize our laboratory
infrastructure in the United States.
FUNDING COMMITMENT TO EXTRAMURAL CONSTRUCTION
Dr. Zerhouni. For the 2004 year, what we tried to do was to
preserve and maintain the momentum in what is the most critical
resource, and that is people applying for grants and getting
support so that the teams of the scientists that we have
stimulated continue to be stimulated. So we had to make hard
choices, Senator. And that is one of them.
Senator Harkin. But if we make the choice here to continue
to fund extramural construction, then you will not have that
money for research, will you? It will be down to 2.6 percent.
Dr. Zerhouni. That is----
Senator Harkin. If we keep the level of funding----
Dr. Zerhouni. In each category the same per year, you are
correct. You are correct, Senator.
Senator Harkin. Dr. Zerhouni, are you advising us that we
should zero out all funding for renovation and building of
laboratory facilities?
Dr. Zerhouni. For the year 2004, because of the portfolio
of construction that we had to do and that we had to continue
to fund, we thought that the best strategy to maintain the
research momentum so that we can invest it in programs that
relate to diseases was to make that choice and----
Senator Harkin. For next year.
Dr. Zerhouni. For next year. Correct.
Senator Harkin. Well, then, Dr. Zerhouni, let me carry this
one step further. The President's budget documents call for a
1.9 percent increase in 2005, a 2 percent increase in 2006, and
2.2 percent in 2007. So carrying this logic forward, then for
the next 3 years, we will be asked to zero out any funding for
extramural construction and renovation, if that is the case. So
it may be so next year. We may be looking at 4 or 5 years
here----
Dr. Zerhouni. Right.
Senator Harkin [continuing]. Of zeroing out any--I do not--
I can only speak for myself, but to me that is unacceptable. We
cannot do that. And so I just--you know, this idea that somehow
we are going to squeeze out of this and get a 7 percent for
basic research and to make sure we keep the grant funding going
out at that level, it does not square with what we have to do
with extramural construction.
So I--maybe you might do it 1 year. I do not think you can.
I think we just cannot go to zero funding for 1 year. We can
cut out the $300-and-some million, because that was a one-time
expenditure for bioterrorism. But then there is the underlying
program that I do not think that we can cut out. So I just
wanted to make that point. I know what you are trying to do,
but I do not think it fits. And we are simply going to have to
come up with that extra money. And I am going to keep proposing
that the President has to put that in his budget next year.
Thank you, Dr. Zerhouni.
Thank you, Mr. Chairman.
Senator Specter. Thank you, Senator Harkin.
Dr. Zerhouni, I am going to go over a series of questions.
We have been asked to have separate hearings on many of the
institutes. And that is not possible, given all of the
difficult schedules. We have been asked to have a separate
hearing on tuberous sclerosis, where scientists have reportedly
isolated the genes responsible for this disease that affects
all of the body's organs.
I would like you to submit in writing and in some detail
how much NIH is currently investing in research on tuberous
sclerosis, and how that research is being coordinated among the
various institutes involved.
[The information follows:]
Tuberous Sclerosis Complex
The NIH reported actual funding for tuberous sclerosis research in
fiscal year 2002 was $6.1 million; the fiscal year 2003 estimated
funding is $6.4 million. While the National Institute of Neurological
Disorders and Stroke--NINDS--is the lead institute for research on
tuberous sclerosis complex, TSC, several other institutes conduct and
support TSC research, which is reflective of the multiple organs
affected. The National Cancer Institute--NCI; the National Heart, Lung,
and Blood Institute--NHLBI; and the National Institute of Diabetes and
Digestive and Kidney Diseases--NIDDK, support TSC research. Funding by
Institute is summarized in the table that follows:
----------------------------------------------------------------------------------------------------------------
Fiscal years
-----------------------------------------------------
2002 actual 2003 estimate 2004 estimate
----------------------------------------------------------------------------------------------------------------
NCI....................................................... $638,000 $657,000 $677,000
NHLBI..................................................... 2,140,000 2,279,000 2,336,000
NIDDK..................................................... 717,000 700,000 700,000
NINDS..................................................... 2,596,000 2,803,000 2,859,000
OD........................................................ 30,000 ................ ................
-----------------------------------------------------
Total............................................... 6,121,000 6,439,000 6,572,000
----------------------------------------------------------------------------------------------------------------
The systems affected in TSC are quite distinct, and therefore, much
of the research supported may be unique to a particular institute's
mission, for example, NINDS to investigate the development of epilepy
and autism in children with tuberous sclerosis; NCI for studies to
examine what causes skin tumors to develop in patients with TSC; and
NHLBI to study the molecular and cellular basis for the development of
lymphangioleiomyomatosisL--AM--a severe destructive lung disease, in
patients with tuberous sclerosis complex. However, we recognize the
value in tracking and coordinating the TSC research that NIH supports,
as well as identifying potential partnering opportunities, and on this
NINDS has the lead. Coordination is achieved in many ways, not the
least of which is regular communication among the program directors who
manage the TSC portfolio in each institute. In addition, NINDS is
coordinating input from several institutes, extramural researchers, and
the advocacy community in developing the NIH research plan for tuberous
sclerosis. For example, program staff from NIDDK and the National
Institute of Arthritis and Musculoskeletal and Skin Diseases--NIAMS--
participated in the September 2002 NINDS-sponsored workshop on TSC
research, the proceedings of which are providing the framework for the
research plan, and these institutes, along with the National Institute
of Child Health and Human Development--NICHD, NHLBI, and NCI, are being
consulted in the development of the NIH TSC research plan.
Senator Specter. There is another subject matter of
scleroderma, where there has been a tremendous amount of
interest. And there is significant vascular and autoimmune
components to scleroderma. And the question is whether there
are other institutes, aside from the National Institute of
Arthritis, Musculoskeletal, and Skin Disorders or the National
Heart, Lung, and Blood Institute, that you would recommend
scleroderma researchers pursue to find experiments aimed at
finding a cure.
Since the leading cause of death in scleroderma patients is
through pulmonary hypertension and its effects on heart
function, should grants on pulmonary hypertension that
encompass issues unique to scleroderma patients be directed
at--and this question goes to Dr. Katz and Dr. Lenfant. Should
those research grants be directed at NHLBI, instead of NIAMS?
These questions are so complicated that I have to read
them, which is not my style.
What do you think, Dr. Lenfant? Are you willing to defer
that to another agency, or should they be directed to your
agency? I would appreciate as much brevity as you can bring
here, because there are quite a few more questions. And we need
to finish this hearing by 11. Actually, we need to finish this
hearing by 10:45.
SCLERODERMA RESEARCH
Dr. Lenfant. Senator, in view of the complexity of this
condition, I think the research must be conducted by the two
institutes. And it is so happens that Dr. Katz and I work very
well on many conditions besides this one. And I am quite
confident that this cooperation, should it continue, it will be
the best way to handle that condition.
Senator Specter. How are you doing, Dr. Lenfant, on finding
a cure for scleroderma?
Dr. Lenfant. Scleroderma, or systemic sclerosis, is of
considerable interest to the NHLBI because of the lung problems
that so often accompany it. Indeed, 8 out of 10 patients with
scleroderma eventually develop some degree of lung disease, and
interstitial pulmonary fibrosis (scarring) is now the leading
cause of death among such patients. Since 1999, the NHLBI has
supported the Scleroderma Lung Study, a clinical trial to
evaluate treatment with cyclosphosphamide, a drug that has
effects on inflammation and the immune system. The goal is to
determine whether cyclophosphamide helps stabilize or improve
measures of lung function; the trial will also assess changes
in quality of life, activity, and shortness of breath. A
positive outcome of this trial would be of great importance by
offering a scientific basis for treatment. Similarly, a
negative result, demonstrating no benefit from cyclophosphamide
therapy, would provide an important basis for avoiding a
hazardous and expensive therapy that is now being used in many
patients.
SCLERODERMA
Senator Specter. Dr. Katz, how close do you think you are
coming to finding a cure for scleroderma?
Dr. Katz. We are pursuing every scientific opportunity
possible in scleroderma research and working with the community
as well as with our colleagues at NHLBI in this area, which
includes pulmonary fibrosis. We are pursuing research on blood
vessel abnormalities genetic controlled fibrosis, as well as
other genetic dimensions of scleroderma. So we are pursuing----
Senator Specter. Is it a realistic question to ask you how
close you are to a cure?
Dr. Katz. Yes, sir. It is a realistic question.
Senator Specter. Can you give me a realistic answer?
Dr. Katz. I cannot give you a date, if that is what you are
looking for. But I----
Senator Specter. Can you give me a time frame, a ballpark?
Dr. Katz. I would hope that in the next 5 years we will
have some better information on the complexity of this disease.
Senator Specter. Sometime within the next 5 years we would
have better information on the complexity of the disease.
Dr. Katz. Right.
Senator Specter. I would like you to supplement that in
writing, focusing on my question, please.
Dr. Katz. I would be happy to.
[The information follows:]
Scleroderma
I am very pleased to tell you that research on scleroderma is at a
very important and promising juncture. We have a solid foundation of
grants in our portfolio, we have very powerful research tools to apply
to scleroderma, and we are building on significant research advances in
our understanding of scleroderma. Examples of recent advances include
identifying a genetic marker for scleroderma in two populations; basic
research that identified defective microfibrils in cultured fibroblasts
from people with scleroderma; and the determination that the risk of
having scleroderma increases significantly (on the order of 10 to 27
times) if a family member has scleroderma. These are just highlights of
progress. With a look to the future, I am very optimistic that within
the next 5 years we will have much better information on the complexity
of scleroderma. My optimism is based on the multi-pronged approach that
we have taken in research on scleroderma, including the ongoing, 5-
year, multicenter clinical trial that is seeking to determine the
efficacy of oral collagen in the treatment of scleroderma; the funding
that the NIAMS provides for two Specialized Centers of Research focused
on scleroderma that will enhance translational research; support for
the National Family Registry for Scleroderma that will provide vitally
important information on the genetic/family dimensions of this
disorder; and the outcomes of the 10 new research grants that the NIAMS
funded in fiscal year 2001 as the result of a special solicitation. We
can expect that research findings will begin to emerge from these
grants over the next few years and will contribute significantly to our
understanding of the complexity of scleroderma. In addition, I would
note that scleroderma is an autoimmune disease, and the knowledge base
in this area is progressing at a rapid pace. Findings that we learn
from one autoimmune disease can be very useful in informing us about
other autoimmune diseases. So if we look broadly, advances in genetics
and autoimmunity will accelerate the pace of progress in scleroderma
and many other diseases. We know that medical research is an
investment, and I believe that the investments we have made over the
last few years will provide critical, key pieces of the multi-
dimensional, challenging puzzle that scleroderma represents.
Senator Specter. Dr. Zerhouni, we are having a lot of
comments on the Muscular Dystrophy Care Act, which called for
the creation of multiple centers of excellence, signed into law
in 2001. That was before your watch. The subcommittee on three
occasions has said that a minimum of three such centers should
be funded. A request for proposals has finally gone out to
organize the centers. But the only assurance of the scientific
community is that two centers will be funded.
I would like you to submit in writing an answer to the
question, why only two? And what funding level is projected for
these centers?
[The information follows:]
Muscular Dystrophy
The NIH has been actively engaged in implementing the mandates of
the MD-CARE Act, including efforts to establish research centers for
muscular dystrophy. Specificially, in the Fall of 2002, the NIH issued
two Requests for Applications (RFAs) in this area. The first solicited
applications for up to three awards for Muscular Dystrophy Cooperative
Research Centers, and the second solicited applications for up to five
awards for Developmental Planning Grants for future centers. During
fiscal year 2003, following peer review, we will make grant awards in
response to these two RFAs; the number of grants actually awarded, up
to the specified numbers, will depend on scientific merit. In fiscal
year 2004, we plan to re-issue the RFA for Cooperative Research
Centers, and expect to fund up to two additional meritorious centers in
fiscal year 2005. Subject to the number of applications we receive and
the results of scientific peer review, the combined solicitations could
result in funding up to a total of five MD cooperative centers.
We anticipate that the total costs for each center will be
approximately $1.5 million for 5 years. If the combined solicitations
result in funding a total of five MD cooperative centers, the total
costs of all centers for 5 years is estimated at $37.5 million.
Senator Specter. A question to the Cancer Institute to be
responded to by Dr. von Eschenbach. On June 21, 2001, we held a
hearing on blood cancers. And Dr. Klausner, then the Director
of the Cancer Institute, testified that Gleevec has shown
remarkable results in treating chronic leukemia. The question
is: Why is Gleevec only effective on this particular form of
cancer? And in what specific ways would Federal funding of stem
cell research expedite the treatment and cures of blood cancer?
GLEEVEC
Dr. von Eschenbach, would stem cells be helpful there, stem
cell research?
Dr. von Eschenbach. Thank you, Senator. As you are well
aware, there has been a great deal of research with regard to
adult stem cells, and particularly in their application
therapeutically in support of the treatment of blood cancers.
The issue of Gleevec, that is a very important story. Because
one of the wonderful things that we have seen as a result of
the progress made in using a drug like Gleevec, targeted to a
specific genetic defect in leukemias, the understanding of how
that drug works in that pathway is now being extended to a
whole variety of other cancers. Gleevec is being used in
prostate cancer and it is being used in other childhood
cancers. So the return on investment of Gleevec is going far
beyond the blood cancers.
Senator Specter. Dr. Insel, the prevalence of autism is
increasing, with the disease affecting, as we understand it,
some 500,000 people in this country at a cost of $13 billion
annually. Autism advocates are requesting the NIH expand its
research portfolio as well to finance a tissue bank program
that would enhance resources and provide centralized tracking
of research projects among all autism research participants.
What are your plans to develop a tissue bank? And how much
has autism research increased since the NIH doubling began?
AUTISM RESEARCH
Dr. Insel. Thank you, Senator. The interest in the autism
tissue bank has increased greatly in the last few months. We
held a workshop just in the last 6 weeks, bringing----
Senator Specter. Greatly? Greatly?
Dr. Insel. Yes.
Senator Specter. How much?
Dr. Insel. In terms of the interest? There is a wide----
Senator Specter. Increase in funding is the question.
Dr. Insel. I was saying interest in the tissue bank. The
workshop that we held 6 weeks ago brought in people from around
the country who are experts in autism. There is a plan to roll
out the specifics at the next Interagency Autism Coordinating
Committee meeting.
Senator Specter. Is a tissue bank now being developed?
Dr. Insel. We anticipate it will be public by July, the
first week in July.
Senator Specter. And how much has autism research
increased?
Dr. Insel. In 1998, the NIH budget for autism was
$26,889,000. In 2002, it was $73,850,000.
Senator Specter. Dr. Fauci, let us come back to smallpox
one more time. The Federal Government is not recommending
vaccination for the public. But HHS has stated that it will try
to accommodate members of the public who want to be vaccinated.
As the program is projected this year, the public has two
options. First, enrolling in ongoing clinical trials; or
second, for those who want to be vaccinated but who do not meet
the trial criteria, HHS has proposed that it will allow
vaccinations under an investigational new drug approach, which
will require informed consent.
Now this is because the new vaccine has not yet been
licensed. Once the new vaccine is licensed in 2004, concluding
that it will be at that time, the only way the public will be
able to get it is from HHS.
My question to you is, vaccination for the general public
is at the impetus of the individual. Do you think this is
sufficient, or should there be a national vaccination strategy
for the general public as opposed to waiting for the individual
to come forward?
NATIONAL VACCINATION PROGRAM
Dr. Fauci. Mr. Chairman, given the current threat
assessment, I think a national vaccine program for the general
public, beyond just someone coming and asking for it, is not
necessary at this time. The first priority, as you know, is to
vaccinate the core smallpox response team and ultimately the
first responders.
But given the current threat assessment, if we get that
core group vaccinated, which we hopefully will, then in the
event of an attack, the logistic capability of vaccinating
anyone who is within the range of a contact would be much
easier than it is right now. So the combination of the
Department of Homeland Security and HHS have come to the
judgment that we do not need to implement a pre-event program
for the general public at this time.
Senator Specter. Dr. Fauci, I hope you are right.
Dr. Fauci. I hope so.
Senator Specter. We have gone back and forth. We have had
quite a number of hearings on the subject. We have talked about
our grandchildren. There is no precise, cannot be a precise,
evaluation of what the risk is of a smallpox attack, try to use
that as a biological warfare weapon. People who have taken the
vaccine with some bad results. People do not like the risk.
Pretty tough to undertake a risk from the vaccination when
there is no identifiable risk of bioterrorism in the field.
Dr. Fauci. Right.
Senator Specter. But at the moment, the policy is sort of--
perhaps it is not drifting along, but it is pretty hard to
formulate it with precision. But I respect your conclusion that
the policy has been thought through. And you have decided to do
no more. But we all hope you are right that we do not find a
bioterrorism attack and insufficient cautions having been
taken.
Dr. Fauci. Excuse me, sir. In the event of an attack, there
is a response capability that we are building on right now that
would very likely, almost certainly, be able to protect the
country. The reason that the program has not been recommended
for the public is because the threat assessment of an attack is
balanced against the known toxicities of the currently
available Dry Vax, and it is felt that a preemptive total
vaccination of the Nation is not necessary.
This will change if one of two things happen. If the threat
assessment changes and we feel the threat is greater. And what
we are striving for in the next couple of years is a smallpox
vaccine that has many fewer toxicities or adverse events. If we
had the attenuated vaccine at the current time, I believe there
would be a good deal more flexibility in the broad general
recommendations for the general public.
Senator Specter. Well, thank you very much, ladies and
gentlemen. This is the longest hearing we have had in awhile.
We are into the third hour. And it is hard to attract the
attention of Senators for very long around here, given the
problem of the war in Iraq and what we are going to do with
North Korea and how we are going to handle the Middle East and
what we are going to do with terrorism and what we are going to
do with double taxation of dividends, probably the foremost
question on the minds of everybody in this room today. I mean,
not the foremost question on the minds of everybody in this
room today.
We appreciate what you are doing. There are going to be
questions submitted for the record. And when Senator Taylor
calls you up and brings issues to your attention, she is
speaking for the whole Congress. She does not speak for just
herself.
She does not speak just for me. She does not speak for
Senator Harkin and me or this subcommittee or the full
Appropriations Committee or the Senate. She speaks for the
whole Congress.
We have become a lightning rod for inquiries and demands.
You have no idea how many irate parents we see, or irate
children we see for interest in their parents. So if we convey
a sense that we are looking for a greater sense of urgency, if
you get that message today, you are right. But we do know that
you are in the trenches doing very, very important work. And we
have a tougher issue now than we have ever had before on
finding the money for NIH and the CDC. But we are going to plug
away. And we look for your continued success.
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 to the National Institutes of Health
Questions Submitted by Senator Arlen Specter
pancreatic cancer
Question. Director von Eschenbach, this Subcommittee has taken a
keen interest in the status of pancreatic cancer research at your
Institute. Pancreatic cancer is the now the 4th leading cause of cancer
death for men and women in this country. It also has the highest
mortality rate making it the cancer you are most likely to die from, if
you are diagnosed with this disease, because of the lack of reliable
diagnostics.
I would like for you to update the Subcommittee on the status of a
number of pancreatic cancer initiatives:
Last year's report expressed the strong intent of this Committee
that the NCI fund at least five Pancreatic Cancer Specialized Program
of Research Excellence (SPORE) grants by fiscal year 2004. Will you be
following the Committee's intent--as expressed in last years report
language--to fund five Pancreatic Cancer SPORE Grants by fiscal year
2004?
Answer. In fiscal year 2004 NCI expects to fund three pancreatic
cancer SPORE grants. The NCI announced a special initiative to enhance
and promote translational research in pancreatic cancer and received
fourteen pancreatic SPOREs applications. Thirteen of these applications
were reviewed by a Special Emphasis Panel following general peer-review
principles established by the NIH. Only three of these SPORE
applications were found to have sufficient scientific merit to be
considered for funding by the NCI. No definitive decisions can be
presented at this time since our funding recommendations will undergo a
second level of review by the National Cancer Advisory Board at the
next meeting in June 2003. We anticipate these three meritorious
applications will be funded as P20 Development awards. We are hopeful
these preliminary programs will jump start the field and serve as a
foundation to develop additional strong researchers and programs in
this field.
Question. How many of the meritorious individual projects from non-
funded SPORE Grants and program project applications does the NCI
intend to fund in fiscal year 2004?
Answer. Four projects from the remaining applications were
considered by the peer review as highly scientifically meritorious.
These applications will be recommended for submission to our R01 grant
mechanism for individual funding.
Question. I compliment the NCI's past efforts to increase the
paucity of researchers through extending the payline for grants that
were 100 percent relevant to pancreatic cancer. I understand that this
initiative may have been the single most important action taken by the
NCI to finally give pancreatic cancer the support that it needs, yet it
was discontinued after just one year. Why was this important payline
initiative discontinued?
Answer. Extending the payline for applications that were 100
percent relevant to pancreatic cancer enabled the NCI to fund only
three additional pancreatic cancer research projects in fiscal year
2002. The NCI discontinued the extended payline for pancreatic cancer
applications in fiscal year 2003 and agreed to use a mechanism for
exception funding to include grants that meet only 50 percent
relevancy. The NCI remains firmly committed to increasing the amount of
research focused on pancreatic cancer. Therefore, the NCI is granting
pancreatic cancer applications higher priority for exception funding,
even those with only 50 percent relevance to the disease. We are
hopeful that this mechanism will significantly increase the number of
meritorious grants that will impact on pancreatic cancer.
Question. Do you have plans to reinstate this extended payline, and
what are the estimated costs to continue it for a period of five years?
Answer. Since extending the payline for pancreatic cancer
applications reduced the number of better scoring applications that the
NCI could fund, the NCI does not intend to reinstate the extended
payline. This decision is not made on basis of cost but rather a
strategic effort to encourage meritorious research relevant to
pancreatic cancer.
Question. If not, how do you intend to develop the critical mass of
researchers needed for pancreatic cancer?
Answer. In its recently released strategic plan for addressing the
recommendations of the Pancreatic Cancer Progress Review Group (http://
prg.cancer.gov/pancreatic/pancreatic.pdf), the NCI lays out a multi-
faceted approach for developing a critical mass of pancreatic cancer
researchers. The Institute has implemented some of the strategies in
the plan already. These include:
--Granting special consideration to pancreatic cancer applications
beyond the payline, even those with only 50 percent relevance
to the disease.
--Soliciting and promoting applications for SPOREs in pancreatic
cancer. The top-scoring applications will undergo a required
second level of review by the National Cancer Advisory Board in
June.
--Informing investigators of new funding opportunities in areas of
particular relevance to pancreatic cancer, such as host-tumor
interactions, the tumor microenvironment, and nanotechnology
development for early detection.
NCI plans to put additional strategies in place in fiscal year 2003
and fiscal year 2004, but actual implementation will depend upon a
final determination that these strategies are feasible and sound, and
the receipt of high-quality applications from the research community.
These strategies include:
--Expanding the Transition Career Development Award (K22) to extend
the funding period and include all scientists.
--Increasing the number of pancreatic cancer research mentors through
the National Research Service Award program.
Question. It is my understanding that the NCI is continuing to make
good on its commitment to implement the report of the Pancreatic Cancer
Progress Review Group (PRG)--which is a national agenda for the
research needed on pancreatic cancer. I have been told that since the
PRG Report came out in February 2001, the NCI has been moving forward
to implement the suggestions raised in the report, and that most
recently the NCI has developed a ``Strategic Plan for Addressing the
Recommendations of the Pancreatic Cancer Progress Review Group'' to
further detail and prioritize the research needed on this disease. With
the President's proposed NIH increase of roughly 2.6 percent for fiscal
year 2004, how many of the strategies identified in the ``NCI Strategic
Plan'' can actually be put into place next year, and which ones do you
plan to implement?
Answer. The NCI has already implemented some of the strategies in
its pancreatic cancer plan. These strategies include:
--Granting special consideration to pancreatic cancer applications
beyond the payline, even those with only 50 percent relevance
to the disease.
--Soliciting and promoting applications for Specialized Programs of
Research Excellence (SPOREs) in pancreatic cancer.
--Funding the development of new pancreatic cancer mouse models.
--Funding phase 1 and phase 2 studies for chemoprevention of
pancreatic cancer.
--Holding a state-of-the-science meeting on management of pancreatic
cancer symptoms.
NCI plans to put additional strategies in place this year and next,
but actual implementation will depend upon a final determination that
these strategies are feasible and sound, and the receipt of high-
quality applications from the research community. These strategies
include:
--Funding the development of nanotechnologies that use small samples
for early detection of pancreatic cancer.
--Identifying markers for early detection of pancreatic cancer
through NCI's Center for Proteomics.
--Funding research on normal pancreas biology and pathogenesis of
pancreatic cancer (with NIDDK).
--Expanding NCI's cohort consortium to include pancreatic cancer.
--Supporting large case-control studies in HMOs to improve
understanding of pancreatic cancer risk factors.
Question. I know the request was made before you came to the NCI,
but in the fiscal year 2002 report, this Committee specifically
requested that the NCI develop a professional judgment budget due April
1, 2002 for research on pancreatic cancer for the next five years. The
goal here was to ascertain how much the NCI is actually spending on
pancreatic cancer and compare the current funding level to what is
actually needed to make some inroads on this disease, which has a 99
percent mortality rate, making it the cancer you are most likely to die
from, if you are diagnosed with this disease. While I am delighted to
hear that movement is being made on the findings of the Pancreatic
Cancer Progress Review Group, we have not received the Five-Year
Professional Judgment Budget to implement these recommendations. When
might we receive it?
Answer. Over the past several years, NCI has convened Progress
Review Groups (PRGs) on several types of cancer, and the reports
generated by these groups have formed the basis of expanded and
intensified research in these areas. Completed PRG reports have
identified gaps in research in breast, prostate, colo-rectal, brain,
pancreatic, hematologic, lung, and gynecologic cancers. As with all
other PRGs, NCI developed an implementation plan to move forward with
the recommendations for pancreatic cancer research in a prioritized
fashion. This was done with participation by outside scientists and
advocates who also participated in the PRG itself.
NCI announced a 10-point plan of action that allows NCI to take
immediate steps to address the gaps in pancreatic cancer research. Some
strategies have already been implemented such as granting special
consideration to pancreatic cancer applications beyond the payline and
funding Specialized Programs of Research Excellence (SPOREs) in
pancreatic research. The plan's approach involves expanding existing
programs, as well as developing new initiatives. Additional strategies
are being considered, including funding the development of mechanisms
for early detection and expanding proteomics research.
We estimate that we will spend $38 million on pancreatic cancer
research in fiscal year 2004. The preparation of a Professional
Judgement Budget will take into account the implementation of these
programs and their expected expenditures and increases over the next
five years. Subsequent initiatives will be included in a rolling
forward budget plan as reflected in our Bypass Budget.
protemomic patterns
Question. In last years report, this Committee encouraged the NCI
to ``rapidly identify predictive proteomic patterns relevant to
pancreatic cancer'' and ``to develop and implement methods for rapid
case ascertainment.'' Can you please provide us with the status of
progress in both of these areas including what has been developed and
implemented?
Answer. The body's 30,000 or so genes carry the blueprint for
making proteins, of which all living matter is made. Each protein has a
particular shape and function that determine its role in the body. NCI
has an extensive research program in proteomics, the study of protein
shape, function, and patterns of expression, in hopes of developing
better prevention, screening, and treatment options.
There has been a joint effort including the Food and Drug
Administration (FDA), the NCI Clinical Proteomics Program, and
Correlogic Systems Inc. which has brought together two scientific
disciplines: proteomics and artificial intelligence computer programs.
Last year, there was an exciting announcement that with a
preliminary diagnostic test, which could be completed in 30 minutes
using blood that can be obtained from a finger stick, researchers were
able to differentiate between serum samples taken from patients with
ovarian cancer and those from unaffected individuals. Further study is
continuing to confirm the sensitivity and accuracy of this technique as
a diagnostic tool. The hope is that by combining the proteomic approach
with other methods of ovarian cancer diagnosis, such as ultrasound, its
accuracy can be further improved. This new diagnostic concept is
potentially applicable to any type of disease and is now being tested
on pancreatic, prostate, lung and breast cancer.
NCI has made significant progress in the early detection of
pancreas cancer using serum proteomic patterns. We are pleased to have
already made progress in the application of this technology to
pancreatic cancer. Scientists tested 350 plasma samples from the
University of Minnesota. The sample groups were (a) unaffected, (b)
diabetes only, (c) pancreatitis only and (d) pancreatic cancer. NCI
researchers discovered a serum proteomic pattern that was greater than
95 percent sensitive and specific in the classification of pancreas
cancer compared to the other non cancer groups. Currently there is no
other reliable test for pancreas cancer. We are now moving forward to
validation of these preliminary results in a larger population of
patients with and without pancreatic cancer. At the same time we are
applying this technology to other cancers. If validated in larger
series serum, proteomics could constitute a new approach to the early
diagnosis of pancreatic cancer.
comprehensive cancer center program
Cancer is a disease that affects families of all backgrounds in all
parts of the country. However, cancer affects more families in my state
than most others. We hold the unfortunate distinction of ranking among
the top five in the nation in rates of multiple myeloma and oral,
prostate, pancreatic, and esophageal cancer. We are also not far behind
in regard to cervical and larynx cancer.
Through the significant investment this Subcommittee has made in
cancer research, we have enabled scientists from across the country to
expand our basic understanding of cell growth and death and to develop
effective forms of treatment and prevention. Much of this work was
accomplished in NCI-designated comprehensive cancer centers. I am
troubled that these centers tend to cluster in the Northeast and along
the Pacific Coast, and bear little correlation to cancer incidence or
mortality rates. In fact, only three of the fifteen states with the
highest cancer mortality rates have a comprehensive cancer center.
While we should continue to fund the best and brightest in their
efforts to find cures for cancer, I believe the current concentration
of comprehensive cancer centers deprives us of gaining valuable
knowledge in the parts of the country where cancer is most prevalent.
Question. Director Zerhouni and Director von Eschenbach, I would
like to hear your plans for how you intend to grow the comprehensive
cancer center program and how you intend to ensure that areas with high
cancer rates receive the full attention of these centers.
Answer. At the present time, NCI has 60 clinical and comprehensive
cancer centers. They have a wide geographic distribution and leverage
the extraordinary talents and resources of major medical centers. These
spheres of influence go far beyond their geographic location as a
Center of Excellence of cancer treatment.
Over the years, the NCI has worked closely with a number of smaller
institutions in underrepresented areas through the P20 planning grant
program. At the present time, six centers are recipients of planning
grants. Four of these are in states that currently have no cancer
center and a fifth serves a primarily minority population. We are
developing mechanisms to promote consortium centers in areas where one
institution does not have the capability to apply independently, with
concordant revision of NCI requirements to accommodate their unique
structure. In at least one state, such a consortium has received
legislative support and funding.
The NCI's Special Populations Network program is establishing a
robust and sustainable infrastructure to promote cancer awareness
within minority and medically underserved communities, and launching
more research and cancer control activities aimed at specific
population subgroups. The current Special Populations Networks consists
of 18 projects in 15 states across the United States. Initial projects
were begun after funding was awarded in April 2000 to groups that
addressed ways of building relationships between large institutions and
community groups. During the first year, cancer awareness projects were
implemented in the community and project plans were developed. In the
second and third years, partnerships between the project and NCI
sponsored groups should enhance minority training and minority
participation in cancer trials. In the last two years of these awards,
full-fledged investigator-initiated research grant applications will be
developed based on the initiative projects.
The NCI is also considering other options to improve access of
patients in underserved areas to the benefits of cancer research. One
such concept is that of a Regional Enhancement and Cancer Community
Health (REACH) initiative, which would pair smaller institutions in
these areas as formal partners with existing NCI designated centers for
collaborative research activities and delivery of cutting edge care. As
currently envisioned, this would involve providing small grants to the
smaller centers for encouragement of research, as well as some form of
NCI designation. An additional alternative might be to provide moderate
support for the existing affiliate networks already established by the
centers. These networks are primarily focused on clinical care but
additional support could be provided to specifically foster the more
extensive delivery of clinical trials into the community setting.
Finally, through the emphasis of the NCI on the ``Discovery,
Development, Delivery'' continuum, we anticipate that links between
existing Cancer Centers, their affiliates and partners in research, and
the state, municipal and private organizations within their communities
will continue to expand. These links, once firmly established, should
result in a more unified approach to the conquest of cancer, and a more
uniform delivery of the benefits of cancer research into the community.
NCI is actively seeking mechanisms to foster both the vertical
integration (i.e. from the cancer centers through the community layers
they serve) and the horizontal integration (i.e. across cancer centers
and a nationwide network of public and private partners) of the
benefits of cancer research.
sjogren's syndrome
Question. Some progress has been made regarding Sjogren's syndrome
at the NIAID. However, the NIAMS conducts research on closely related
diseases such as lupus, scleroderma and rheumatoid arthritis. Are you
conducting research on Sjogren's syndrome and are you coordinating this
research with other Institutes at the NIH?
Answer. In collaboration with the NIAID and the NIDCR, the NIAMS
supports research on Sjogren's syndrome and other autoimmune diseases
that ranges from basic science investigations to genetic studies to
prevention research. The NIH Autoimmune Diseases Coordinating
Committee, of which the NIAMS is an active member, helps ensure the
coordination of effort among various Federal and private entities that
conduct autoimmunity research, education, and outreach. The NIAMS funds
work to better understand the molecular basis of autoimmune diseases
such as Sjogren's syndrome; to identify genes that predispose
individuals to autommunity; and to develop animal models which will
provide insights into the human form of diseases such as Sjogren's.
stem cell research
Concerns have been raised by some in the scientific community that
not all NIH institutes are aggressively pursuing a stem cell research
agenda.
Question. Would you please submit for the record how each of your
institutes and centers has been implementing the embryonic stem cell
research policy?
Answer. In November 2001, NIH issued NOT-OD-02-005 Notice of
Criteria for Federal Funding of Research on Existing Human Embryonic
Stem Cells (hESCs) and Establishment of NIH Human Embryonic Stem Cell
Registry. This notice describes how federal funds can be used to
support research in human embryonic stem cells that meet the criteria
established by the President. This Notice also references the NIH Stem
Cell Registry--a registry that only lists those human embryonic stem
cell lines that meet the eligibility criteria. All NIH institutes
comply with points described in the Notice and for those that support
human embryonic stem cell research, only support human embryonic stem
cell research that uses cell lines listed on the NIH Stem Cell
Registry. In addition, NIH has a Stem Cell Implementation Committee
with representatives from the NIH Institutes that assists with
implementation. This Committee works in tandem with the NIH Stem Cell
Task Force to ensure that policy and major research initiatives are
communicated to all Institutes and provide a means for inter-Institute
cooperation and exchange.
Complimenting these NIH-wide implementation efforts are many
Institute-specific Program Announcements (PAs), Requests for
Applications (RFAs), scientific workshops, and outreach efforts to
encourage and support research on human embryonic stem cells. The NIH-
wide and Institute-specific initiatives are described for each
Institute with portfolios relevant to human embryonic stem cells:
The National Institute on Aging (NIA) is encouraging and supporting
research on human embryonic stem cells through a number of Program
Announcements, Requests for Applications, Requests for Proposals, and
workshops. NIA is co-sponsoring with other NIH Institutes PA 02-054
Short-Term Courses in Human Embryonic Stem Cell Culture Techniques, PAR
02-023 Human Embryonic Stem Cell Research Resource Infrastructure
Enhancement Award, and PA-02-025 Plasticity of Human Stem Cells in the
Nervous System. In addition, PAR 03-056 NIA Pilot Research Grant
Program specifically encourages stem cell research pilot projects and
NIA has issued a Request For Proposal (RFP) 260-03-16 on
Characterization of Human Embryonic Stem Cell Lines to establish a
contract to develop, maintain, and distribute data on the properties of
undifferentiated human embryonic stem cell lines. The NIA intramural
program is supporting one of the six intramural labs conducting
research on human embryonic stem cells. Within NIA, a Stem Cell Working
Group meets regularly to disseminate policy information on receipt,
tracking, review and administration of grants involving human embryonic
stem cell lines, as well as to plan and implement activities involving
support of human embryonic stem cell research. In May 2003, NIA is
hosting a meeting on Stem Cells and Aging to promote exchange and
enhance research among NIA stem cell research grantees.
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is
encouraging research on human embryonic stem cells and has issued an
RFA 02-010 on Alcohol and Stem Cells that encompasses research
objectives that include human embryonic stem cell research.
The National Institute of Allergy and Infectious Diseases (NIAID)
is working to ensure that the scientific community has every
opportunity to advance research into the potential of human embryonic
stem cells in accordance with federal policy. NIAID is co-supporting
with other NIH institutes PA 02-054 Short-Term Courses in Human
Embryonic Stem Cell Culture Techniques and PAR 02-069 Career
Enhancement Award for Stem Cell Research. In addition, new research
grant mechanisms are available to support human embryonic stem cell
research: PA 02-038 NIAID-Investigator-Initiated Small Research Grants
(R03) and PAS-02-160 Application of Exploratory/Developmental
Technologies to NIAID-Funded Research (R21). NIAID also accepts and
supports requests for administrative supplements to add human embryonic
stem cell research to an existing NIAID grant.
The National Institute on Arthritis and Musculoskeletal and Skin
Diseases (NIAMS) is encouraging research on human embryonic stem cells
through several Program Announcements and Requests for Applications
with research objectives that could encompass the use of human
embryonic stem cells. These initiatives include: PA 03-009 High Risk
Rheumatic And Musculoskeletal And Skin Diseases Research; RFA 02-003
Basic And Applied Stem Cell Research For Arthritis And Musculoskeletal
Diseases; PA 02-136 Precursor Cells in Skeletal Muscle Repair and
Hypertrophy; and PAR 02-030 NIAMS Small Grant Program for New
Investigators. In addition, administrative supplements to an existing
NIAMS grant may be requested for the addition of studies of human
embryonic stem cells.
The National Institute of Biomedical Imaging and Bioengineering
(NIBIB) is fully aware of the policies and procedures governing the
funding and use of human embryonic stem cell research and takes the
necessary steps to keep grantees informed. Scientific workshops are
held and talks are presented to a wide variety of audiences in academia
and private industry, concerning tissue engineering, biomaterials,
sensors and other areas of research that may include human embryonic
stem cells. Recent outreach efforts included presentations at a PGH
Engineering Tissue Growth meeting and at a meeting for BEACON, a
bioengineering consortium in New England. At every appropriate outreach
opportunity, human embryonic stem cells research policy is delineated
to current and potential researchers. Training workshops for current
and potential grantees address this issue as well. The NIBIB currently
has two Requests for Applications, RFA 03-09 Development of Advanced
Biomaterials and RFA 03-010 Research Opportunities in Tissue
Engineering that request grant applications related to tissue
engineering, which may include human embryonic stem cell research.
The National Cancer Institute (NCI) actively encourages research on
human embryonic stem cells and widely disseminates NIH policies and
procedures to grantees. In addition, NCI is co-sponsoring with other
NIH institutes supporting the Program Announcement, PAR 02-054 Short-
Term Courses in Human Embryonic Stem Cell Culture Techniques, which
provides funding to develop, conduct, evaluate, and disseminate short-
term courses on laboratory research techniques for human embryonic stem
cell lines.
The National Institute of Child Health and Human Development
(NICHD) actively encourages and supports research on human embryonic
stem cells. The Institute has implemented the embryonic stem cell
research policy through the issuance of special NICHD initiatives in
the form of Requests For Applications, Program Announcements and
Notices that include embryonic stem cells as potential targets for
research. These include: RFA 02-018 Female Health and Egg Quality; RFA
02-029 Specialized Cooperative Centers Program in Reproductive
Research; PA 01-005 Reproductive Genetics; NOT 03-005 NICHD
Administrative Supplements for Human Embryonic Stem Cell Research.
NICHD is also co-sponsoring with other NIH Institutes two program
announcements: PAR 02-054 Short-Term Courses in Human Embryonic Stem
Cell Culture Techniques, and PAR 02-023 Human Embryonic Stem Cell
Research Resource Infrastructure Enhancement Awards to help build the
infrastructure and capacity to disseminate human embryonic stem cells
eligible for federal research support. In addition, NICHD funded the
first formal training course on human embryonic stem cells that was
held at the Jackson Laboratory, Bar Harbor, Maine in August 2002. NICHD
has also conducted numerous outreach presentations at scientific
meeting on opportunities for NICHD research support for human embryonic
stem cell research.
The National Institute on Drug Abuse (NIDA) sponsored a two-day
meeting ``Stem Cells--Opportunities for Drug Abuse Research'' where
developmental and general neuroscientists were brought together to
pursue the link between drug abuse research to stem cell research and
to provide input to NIDA about research directions in this area of
endeavor.
The National Institute on Deafness and Other Communication
Disorders (NIDCD) is encouraging investigator-initiated projects on
high risk/high impact research and administrative supplements to
facilitate scientists that would like to pursue preliminary work in
stem cell research. NIDCD is sponsoring RFA 02-003 on Cellular Repair
Studies of the Auditory and Vestibular Systems. In addition to these
research initiatives, the NIDCD Director currently serves as the Chair
of the NIH Stem Cell Task Force, a group of high-ranking scientists
from a number of NIH Institutes with expertise in the research area of
human embryonic stem cells. NIDCD also provides staff support to the
activities of the Task Force. The purpose of the Task Force is to
identify obstacles to moving the stem cell research agenda forward and
to develop strategies to overcoming these challenges.
The National Institute of Dental and Craniofacial Research (NIDCR)
encourages and supports research on human embryonic stem cells in
studies on oral, dental, and craniofacial development and the
development stem cell-based treatments for the repair and regeneration
of orofacial structures that have been compromised by congenital
disorders, diseases, and injuries. In addition, the Institute co-
supports PAR 02-054 Short-Term Courses in Human Embryonic Stem Cell
Culture Techniques.
The National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) has disseminated NIH policies and procedures to
grantees through development of a web-based Investigator's Guide to
Human Embryonic Stem Cell Research. In addition to encouraging and
supporting investigator-initiated research, NIDDK has a number of RFAs
and PAs with research objectives that could encompass the use of human
embryonic stem cells. This list includes: PA 01-129 Innovative and
Exploratory Research in Digestive Diseases and Nutrition; PA 02-127
Pilot and Feasibility Program Related to the Kidney; PA 01-128 Pilot
and Feasibility Program in Hematological Diseases; PA 01-093 NIDDK
Expanded Awards for SBIR at NIDDK; and, PA 02-008 Pilot and Feasibility
Programs in Diabetes Endocrinology and Metabolism. Also, NIDDK is co-
supporting with other NIH institutes research training and
infrastructure initiatives targeting the needs of human embryonic stem
cell research. These initiatives include: PAR 02-023 Human Embryonic
Stem Cell Research Resource Infrastructure Enhancement Awards; PA 02-
054 Short-Term Courses in Human Embryonic Stem Cell Culture Techniques;
and, PAR 02-069 Career Enhancement Award for Stem Cell Research.
The National Institute of Environmental Health Sciences (NIEHS)
actively encourages research on human embryonic stem cells and has
established a stem cell research emphasis area to encourage research on
organ toxicology with potential for regenerative intervention/
prevention technologies. Also, the Institute has initiated working
discussions with biotechnology companies to promote their development
of programs in human liver stem cell research to address the major
public health organ transplantation issues leading to liver failure. In
addition, the Institute held a scientific meeting in November 2002
entitled ``Stem Cells: Scientific Progress and Future Research
Directions'' that discussed the potential of human stem cell research
both globally and with respect to the environmental health sciences
mission of NIEHS. This spring, NIEHS is co-sponsoring the ``Frontiers
in Human Embryonic Stem Cells Research Training Course and a sequel
symposium entitled ``Embryonic Cell Biomedicine: The Journey from Mice
to Patients'' both of which will be held at the University of
Pittsburgh.
The National Institute of General Medical Sciences (NIGMS)
encourages and supports research on human embryonic stem cells. In
fiscal year 2002, NIGMS supported a ``Workshop on the Basic Biology of
Mammilian Stem Cells'' that included key scientists in the field of
human embryonic stem cells. Based on this workshop, NIGMS developed the
RFA 03-003 Exploratory Center Grants for Human Embryonic Stem Cell
Research. In addition, NIGMS issued a Notice 03-002 for Administrative
Supplements for Human Embryonic Stem Cell Research and is co-supporting
with other NIH institutes the Program Announcement PAR 02-054 Short-
Term Courses in Human Embryonic Stem Cell Culture Techniques.
The National Heart, Lung, and Blood Institute (NHLBI) actively
encourages and supports research on human embryonic stem cells through
a number of Program Announcements, Requests for Proposals, and
workshops. NHLBI has invited research applications encompassing human
embryonic stem cell research through the following: PA 02-017
Innovative Concepts and Approaches to Developing Functional Tissues and
Organs for Heart, Vascular, Lung, and Blood Applications; PA 02-018
Basic Research on Mesenchymal Cell Biology; PA 02-019 Research on Stem
Cell Biology and Cell-based Therapies for Heart, Lung, Blood, and Sleep
Disorders; and PAR 03-063 NHLBI Competitive Supplements for Human
Embryonic Stem Cell Research. Also, the Institute announced NOT 02-009
NHLBI Administrative Supplements for Human Embryonic Stem Cell Research
that resulted in the support of several administrative supplements to
current grantees to include research on human embryonic stem cells. In
addition, NHLBI is co-sponsoring several initiatives with other NIH
institutes including: PA 02-025 Plasticity of Human Stem Cells in the
Environment of the Nervous System; PAR 02-069 Career Enhancement Award
for Stem Cell Research; PAR 02-023 Human Embryonic Stem Cell Research
Resource Infrastructure Enhancement Award; and, PA 02-054 Short Term
Courses in Human Embryonic Stem Cell Culture Techniques for which NHLBI
serves as the coordinator and designated administrative contact for all
resulting grants. NHLBI also is sponsoring BAA 03-06 and RFP 03-07 for
Somatic Cell Therapy Processing Facilities and Administrative Center
that could involve human embryonic stem cells and assist in preparing
the cells for clinical research. In addition, the Institute also
sponsored an ``NHLBI Working Group: Cell-Based Therapies for
Regenerative and Reparative Medicine--Vision, Scope, and Directions''
in May 2002 that addressed the area of embryonic stem cells, including
their future therapeutic potential.
The National Institute of Mental Health (NIMH) disseminates NIH
policies and procedures to grantees through development of a web page
on NIMH Support for Stem Cell Research. In addition to encouraging
investigator-initiated research on human embryonic stem cells, NIMH is
co-sponsoring two Program Announcements with other NIH Institutes: PAR
02-023 Human Embryonic Stem Cell Research Resource Infrastructure
Enhancement Award and PA-02-025 Plasticity of Human Stem Cells in the
Nervous System. In addition, NIMH sponsored a satellite symposium at
the Society for Neuroscience Meeting (November 2002) on ``Neuroscience
Opportunities in Human Embryonic Stem Cell Research: An International
Perspective'' and is co-sponsoring an up-coming scientific workshop on
``American-Swedish Network for Stem Cell Biology and Neural Repair''
currently scheduled for September 2003.
The National Institute of Neurological Disorders and Stroke (NINDS)
actively encourages and supports research on human embryonic stem
cells. The Institute has developed an NINDS Stem Cell website to update
investigators about NIH policy, funding opportunities, upcoming
meetings, and other relevant information. In addition, NINDS is
sponsoring PAR 02-139 NINDS Cooperative Program in Translational
Research and co-supporting with other NIH Institutes PA 02-025
Plasticity of Human Stem Cells in the Environment of the Nervous System
and PA 02-054 Short-Term Courses in Human Embryonic Stem Cell
Techniques. The Institute has issued several Notices requesting
applications for administrative supplements: NOT 02-007, NOT 02-010,
NOT 03-002 NINDS Administrative Supplements for Research on Human Stem
Cells. These Notices have resulted in support of several administrative
supplements that allow current grantees to include and pursue research
on human embryonic stems. Also, NINDS co-funded four conferences
focused on stem cell research: 8th International Conference on Neural
Transplantation and Repair; International Society for Stem Cell
Research Meeting; Conference on Stem Cells: Origins, Fate and
Functions; and, Gordon Research Conference on Neural Development.
The National Center for Research Resources (NCRR) actively
encourages and supports research on human embryonic stem cells. NCRR
co-supports PAR 02-023 Human Embryonic Stem Cell Research Resource
Infrastructure Enhancement Award and serves as coordinator and
designated contact for all the human embryonic stem cell infrastructure
grants. In addition, the Institute is supporting a Infrastructure
Awardees Meeting in June 2003 that will involve all current
infrastructure awardees in an exchange about obstacles and progress to
date in developing the respective eligible cells lines for distribution
to the scientific community.
The Fogarty International Center (FIC) has been active in
conducting outreach with foreign sources of eligible human embryonic
stem cell lines. FIC has coordinated the interests of the NIH with the
U.S. Department of State and respective U.S. Embassies to establish
dialogues with eligible stem cell providers in India, Israel, Sweden,
Australia, and South Korea. These efforts have significantly
contributed to the five NIH infrastructure awards made to-date to
eligible foreign sources.
Question. Please share with us the steps NIH has taken to create a
positive environment for human embryonic stem cells and the researchers
seeking cures using this promising research tool?
Answer. Over the past 20 months, the NIH has undertaken a number of
new initiatives to enable the field of human embryonic stem cell
research to move forward:
Train new investigators to culture and work with human embryonic
stem cell lines. Currently, there is a limited pool of scientists with
the hands-on experience needed to reliably perform experiments using
approved human embryonic stem cells. To address this need, the NIH
issued a Program Announcement soliciting applications for ``Short Term
Courses in Human Embryonic Stem Cell Culture Techniques.'' Five
applications were received in October 2002, subsequently reviewed and
plans are underway to make awards to all five applications. In
addition, to assist mid-career investigators in their efforts to
initiate research studies, the NIH issued the Program Announcement.
``Career Enhancement Award in Stem Cell Research.'' These grants will
provide salary support as well as some support for other research
costs, to allow scientists to join an established research group
working with approved human embryonic stem cells for six to twenty-four
months.
Provide support to scale up and characterize human embryonic stem
cells eligible for Federal funding and increasing accessibility to
these lines. In early Winter 2001, many of the 71 independent human
embryonic stem cell derivations listed on the NIH Human Embryonic Stem
Cell Registry were in the early phases of development and had not been
expanded or characterized to the point where they could be readily
distributed to the research community. Expanding and characterizing
cells derived from human embryos are time- and resource-consuming
processes. To help make these cells available to the research
community, the NIH issued a Program Announcement, ``Human Embryonic
Stem Cell Research Resource Infrastructure Enhancement Awards'' to
provide support to allowable sources of human embryonic stem cells to
scale up and distribute cell lines to investigators seeking such lines.
The first Infrastructure grant was awarded in April 2002. To date,
eight such awards have been issued. As a consequence of this support
the number of cell lines available for widespread distribution has
grown from a single cell line in Spring 2002 to eleven cell lines at
present, with more anticipated in the near future.
Provide assistance to the research community wishing to use human
embryonic stem cell lines in navigating the intellectual property
rights (IPR) and licensing agreements or material transfer agreements
that needed to be obtained with the owners of the cell lines. The human
embryonic stem cells available for Federal funding are owned by private
sources, not by the Federal Government. A U.S. patent exists for human
embryonic stem cell lines and the techniques used to develop such
lines. NIH negotiated a memorandum of understanding with the patent
holder (WiCell Research Institute) in September 2001, as well as with
several other sources for the use of their cells. While the NIH can
only develop such agreements for the NIH intramural research program,
the terms of these agreements require the provider to offer the cells
under no more stringent terms to other investigators using federal
funds to conduct non-commercial research.
Encourage established investigators to initiate research projects
involving human embryonic stem cells. In an effort to help established
investigators begin experiments using human embryonic stem cells, the
NIH announced the availability of Administrative Supplements to
existing NIH grants. These supplements are supporting collection of
preliminary data that will lead to investigator-initiated research
grant applications whose major focus is research using human embryonic
stem cells. To date, 42 supplements have been awarded. In addition to
these supplements, the NIH is currently supporting 13 investigator-
initiated grant awards and additional applications will be considered
for funding during the remainder of 2003, and in years ahead. Six NIH
Intramural laboratories are currently engaged in research using human
embryonic stem cell lines.
Establish an NIH Human Embryonic Stem Cell Characterization Unit.
The research community has expressed a need for information on the
characteristics of the available cell lines, to allow scientists to
select which lines are most suitable for their intended experiments. To
address this important need, the NIH intramural program is creating a
Stem Cell Characterization Unit. The mission of this unit is to provide
reliable and standardized data derived from assays performed on human
embryonic stem cell lines available to be shipped to the research
community. Performing these assays in a single laboratory will allow a
direct side-by-side comparison to be made among the cell lines that are
available for shipment, and will facilitate comparison with adult stem
cells. These data will arm the scientific community with peer reviewed
information about the properties of available lines, so scientists can
make an informed choice when ordering one or more of the available cell
lines. Data will be posted on a stem cell web site as soon as they have
been validated. The assays performed by this Unit will be overseen by a
Steering Committee comprised of leading stem cell biologists in both
the extramural and NIH Intramural Research community. In a
complementary effort, the Mammalian Gene Collection at NIH has
established contracts to construct cDNA libraries from several human
embryonic stem cell lines, and to perform expressed sequence tag (EST)
sample sequencing from these libraries. These libraries will be made
available to the research community, and all sequences will be
deposited into readily accessible public databases.
Provide support for multidisciplinary teams of investigators to
define the properties and potential of human embryonic stem cells. The
research community also articulated the need for multidisciplinary,
multi-investigator teams of researchers to explore the growth and
maintenance, biochemical and molecular properties, and other unique
properties of human embryonic stem cells. In response to a June 2002
workshop sponsored by the National Institute of General Medical
Sciences, a Request for Applications to support exploratory center
grants has been issued. These awards are intended to lead to Research
Centers within three years of funding the exploratory center award.
Establish NIH Stem Cell Task Force. In August 2002, the NIH Stem
Cell Task Force was established to oversee and coordinate the trans-NIH
activities involving human embryonic stem cells, as well as other types
of stem cells. Comprised of leading NIH scientists with expertise in
stem cell research, the Task Force will continue to monitor the state
of this rapidly evolving science, identifying barriers to research
progress and addressing the needs of the research community.
Update NIH Stem Cell Web Site. The NIH continues to serve as a
resource for stem cell information by hosting a web site. Scientists
have access to information on stem cell funding opportunities sponsored
by NIH. The web site also includes the NIH Human Embryonic Stem Cell
Registry, which lists the eligible cell lines that are available for
shipping to researchers.
Host NIH Stem Cell Symposium. The NIH plans to showcase its
scientific progress in human embryonic stem cell research by sponsoring
a scientific conference at NIH on June 12, 2003. The symposium will
feature a morning plenary session with presentations from NIH-supported
researchers and an afternoon session will feature workshops and poster
sessions.
Question. How many RFAs related to human embryonic stem cell
research has your institute sponsored and cosponsored?
Answer. Currently NIH has issued nine Requests for Applications
(RFAs) related to human embryonic stem cell research. One RFA invites
applications for multiple P20 Exploratory Grants that will support
multi investigator teams to conduct research using human embryonic stem
cells. Sponsored by the National Institute of General Medical Sciences
(NIGMS), this RFA encourages and enables basic biologists with little
or no prior hESC experience to work with hESC and establish the utility
of hESC as a model system by supporting the development of an
institutional infrastructure for research using hESC; encouraging
research on the growth and maintenance requirements of hESC;
identifying biochemical and molecular markers of hESC; stimulating
research that will lead to a better understanding of the unique
properties of hESC; and supporting pilot projects that exploit the
advantages of hESC as a model system to further the study of
fundamental research problems.
Additional RFAs related to hESC research include:
--Innovative Concepts and Approaches to Developing Functional Tissues
and Organs for Heart, Vascular, Lung and Blood Applications.
These exploratory and developmental grants are sponsored by the
National Heart, Lung and Blood Institute (NHLBI).
--Basic and Applied Stem Cell Research for Arthritis and
Musculoskeletal Diseases, sponsored by the National Institute
of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
--Stem Cells in Development/Repair of Orofacial Structures, sponsored
by the National Institute of Dental and Craniofacial Research
(NIDCR).
--Basic Research on Mesenchymal Cell Biology, sponsored by the
National Institute on Aging (NIA) and National Heart, Lung, and
Blood Institute (NHLBI).
--Comprehensive Programs in Beta Cell Biology sponsored by the
National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK).
--Cellular Repair Studies of the Auditory and Vestibular System,
National Institute on Deafness and Other Communication
Disorders (NIDCD).
--Research on Stem Cell Biology and Cell-Based Therapies for Heart,
Lung, Blood, and Sleep Disorders (NHLBI)
--Stem Cell Research for Alcohol related Disorders, National
Institute on Alcohol Abuse and Alcoholism (NIAAA)
Question. How many Program Announcements related to human embryonic
stem cell research has your institute sponsored or cosponsored?
Answer. The Following Program Announcements related to hESC have
been issued by NIH:
--Short Term Courses in Human Embryonic Stem Cell Culture Techniques
are supported by 11 NIH Institutes. Five awards will be made in
Spring 2003.
The 11 Institutes supporting the short-term courses are:
--National Heart, Lung, and Blood Institute (NHLBI)
--National Cancer Institute (NCI)
--National Center for Research Resources (NCRR)
--National Institute of Allergy and Infectious Diseases (NIAID)
--National Institute of Child Health and Human Development (NICHD)
--National Institute of Dental and Craniofacial Research (NIDCR)
--National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK)
--National Institute of General Medical Sciences (NIGMS)
--National Institute of Mental Health (NIMH)
--National Institute of Neurological Disorders and Stroke (NINDS)
--National Institute on Aging (NIA)
--Career Development Awards which are sponsored by NIDDK, NIAAA,
NINR, NIAID and NHLBI. The announcement was made in March 1,
2002 and expires in June 1, 2005. The purpose of these awards
is to provide mid-career investigators with training to use
hESC in their research.
--Plasticity of Human Stem Cells in the Nervous System sponsored by
NINDS, NIA, NIMH and NHLBI. The purpose of this Program
Announcement is to study the fundamental properties of all
classes of human stem cells, and to confirm, extend, and
compare the behavior of human stem cells that are derived from
different sources and ages or exposed to different regimes in
vitro and in vivo.
Question. How much funding has been provided for human embryonic
stem cell research in each of fiscal years 2001 and 2002?
Answer. In fiscal year 2001, no funding was provided for human
embryonic stem cell research and $10.7 million was provided for fiscal
year 2002.
Question. Approximately how much funding is your institute planning
to provide for human embryonic stem cell research in fiscal year 2003?
Answer. NIH estimates $17.1 million will be provided for human
embryonic stem cell research in fiscal year 2003.
Question. Please explain your plans to expand funding within your
institutes for human embryonic stem cell research over the next three
years?
Answer. Investigator-initiated research is the foundation of grants
supported by NIH. To date, NIH is supporting only 13 investigator-
initiated research grants using human embryonic stem cells but NIH
anticipates a substantial number of applications over the next three
years as this field of research matures and more scientists receive
stem cell biology training through various training courses, such as
the NIH-supported short-term training courses mentioned above or
through training offered directly by eligible providers of human
embryonic stem cells. Upon completion of the training, it is expected
that scientists will address the basic research questions that need to
be answered for the field to move forward before being used for human
therapies: What are the molecular pathways that govern stem cell
differentiation to a specific cell type? How can stem cell growth be
regulated? How can stem cells be safely transplanted and how is cell
rejection prevented? How long will the stem cell transplant continue to
function? Can animal models be developed to test the efficacy of stem
cells?
Question. Please identify any administrative or program hurdles
that are impeding your institute from maximizing the potential of human
embryonic stem cell research in helping your institute achieve its
mission?
Answer. Currently, the rate limiting step of hESC research is the
lack of well-trained investigators. NIH has taken steps to remedy the
situation by funding five short term training courses for up to three
years starting in fiscal year 2003. In addition, career enhancement
awards to train scientists in the lab culturing techniques and growth
methods for hESC are currently being offered for mid-career scientists
who are interested in learning to work with hESCs. In addition, NIH is
supporting short-term training courses to teach scientists cell
culturing techniques. Currently, WiCell, UCSF and ES Cell International
are providing additional stem cell training, independent of the NIH-
supported short term training courses. NIH has awarded infrastructure
grants to providers of hESCs which allows them to grow and culture the
federally approved cell lines, making more cells available to the
research community. This will enable scientists to gain easier access
to the eligible stem cell lines. In June, the NIH is sponsoring a
symposium to showcase NIH supported hESC research. The symposium is
attracting worldwide interest. NIH believes that these activities will
assist in attracting new investigators to the field and alleviate the
current shortage of trained investigators.
Question. Several scientists have suggested to the Subcommittee
that NIH should create new funding mechanism to support human embryonic
stem cell research, given that this is such a new area of science. Are
you considering creating a mechanism that requires less preliminary
data?
Answer. In an effort to help established investigators begin
experiments using human embryonic stem cells, the NIH is issuing
Administrative Supplements to existing NIH grants. These supplements
are supporting collection of preliminary data that will lead to
investigator-initiated research grant applications whose major focus is
research using human embryonic stem cells. In addition, NIH is
providing other funding mechanisms that are used to support high risk/
high impact research as a means for generating preliminary data. Also,
the NIH Center for Scientific Review has implemented processes to
facilitate the peer review of human embryonic stem cell grant
applications. One example is informing scientific review administrators
about this new field of research and the preliminary data, which is
often part of an application or may be lacking in some grant
applications and should not be considered a penalty.
Question. If so, when can we expect this to be announced? If not,
how do you plan to spur this field?
Answer. NIH is currently implementing these initiatives. In
addition, NIH is undertaking other initiatives to spur this new
research field by enabling eligible stem cell providers to scale up
cells for shipping, providing easier access of stem cells to
researchers, becoming a source of information to the scientific
community on stem cell characteristics, and providing a forum for
scientists to share their data through a stem cell research symposium.
clinical research
Question. Most of this type of research takes place at academic
health centers, many of which are struggling financially. I also note
that you want to re-establish the Biomedical Research Support Grant
program to help support academic health centers. Are you requesting
funds for that purpose in this budget?
Answer. No funds are requested in fiscal year 2004 to re-establish
the Biomedical Research Support Grant (BRSG) program.
Question. For the record, would you provide the Subcommittee with a
description of how that program would work, and how much money it would
take to adequately support the program.
Answer. No funds are requested in fiscal year 2004 to re-establish
the Biomedical Research Support Grant (BRSG) program.
Question. How much does NIH devote to translating basic research
into improved health care for the patient?
Answer. An integral component of NIH's mission is to communicate
research results both to the lay public and health professionals. NIH
works in partnership with many different organizations to communicate
scientific results and health information to the medical research
community, health care providers, patients, and the general public
across the nation. NIH communicates basic research findings through
publication in professional journals and by distributing news releases
to the science and general media. NIH scientists speak to reporters to
explain the significance of the research and put it into the broader
context of making progress against disease. Some examples of the
translation of research findings from bench-to-bedside that are
provided below:
--In 2001, the National Institute of Neurological Disorders and
Stroke (NINDS) launched a multi-faceted public education
campaign to educate people about how to recognize stroke
symptoms and to call 911 to get to a hospital quickly for
treatment. Know Stroke: Know the Signs, Act in Time includes:
public service advertising for radio, television and print; as
well as consumer education materials that include an award-
winning 8-minute film, brochures, and posters. Because stroke
attacks the brain, a stroke patient often cannot act alone to
call 911 and seek medical treatment. Bystanders are integral to
acting quickly and getting stroke patients to the hospital.
To date, the campaign materials have derived excellent results.
The television PSA garnered more than 87 million viewer
impressions and hundreds of thousands of dollars worth of free
broadcast time; the radio PSAs received more than 46,000
broadcasts on 272 stations; the airport dioramas were placed in
117 airports, in cities such as Atlanta, Dallas, Denver and
Baltimore and received more than 800 million annual
impressions; billboard advertising focused in the Southeastern
United States, known as the Stroke Belt, averaged more than
800,000 daily impressions for the months they were placed; bus
side advertising placed in 10 markets resulted in more than
115,000,000 over the course of three months; a matte service
article has generated more than 2 million impressions and about
15,000 requests for Know Stroke brochures, and the consumer
education materials developed for the campaign have been
requested by thousands of nursing homes, hospitals, senior
centers and other organizations. Many of these activities have
been done in partnership with the American Stroke Association,
a division of the American Heart Association, and the National
Stroke Association, the two largest voluntary organizations
serving stroke patients and their families.
--The National Diabetes Education Program (NDEP), established in
1995, is a federally-sponsored initiative that involves public
and private partners to improve the treatment and outcomes for
people with diabetes, to promote early diagnosis, and to
prevent the onset of type 2 diabetes. The National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK) of the
National Institutes of Health (NIH) and the Division of
Diabetes Translation of the Centers for Disease Control and
Prevention (CDC) jointly sponsor the program with the
participation of over 200 partner organizations. The Program's
target audiences include people with diabetes and their
families, with special attention to Hispanics/Latinos, African
Americans, Asian Americans, Pacific Islanders, and American
Indians, people at risk for type 2 diabetes, especially those
with pre-diabetes, health care providers, health care payers,
purchasers, and policy makers. The program's main initiatives
include the ``Control the ABCs of Diabetes'' campaign to
promote the link between cardiovascular disease and diabetes
and the importance of controlling blood glucose, blood pressure
and cholesterol, and the ``Small Steps, Big Rewards. Prevent
type 2 Diabetes'' campaign, designed to promote the message
that diabetes can be prevented to the 16 million Americans with
pre-diabetes, a condition that puts them at high risk for
developing type 2 diabetes.
--Co-sponsored by NIH and organizations such as the Maternal and
Child Health Bureau, the American Academy of Pediatrics, the
SIDS Alliance, and the Association of SIDS and Infant Mortality
Programs, the ``Back to Sleep'' National Public Health
Education Campaign has resulted in a 50 percent relative
decrease in the rate of Sudden Infant Death Syndrome since its
launch in 1994. This campaign is directed at mothers and family
members of young infants, the professionals responsible for
their care, and the public in general.
--The National Eye Health Education Program (NEHEP) has established
public and professional education programs to help promote
public awareness on how to prevent vision loss. The NEHEP
comprises more than 50 public and private organizations, which
plan and implement eye health education programs. The NEHEP has
created educational kits on glaucoma and diabetic eye disease
for health professionals and community leaders. The kits
provide information and materials to educate people at high
risk about eye health and the need for regular dilated eye
exams. The NEHEP also has launched four national public service
campaigns. Materials and messages of the campaigns have been
tailored to high-risk populations.
--The National Heart, Lung, and Blood Institute supports several
long-standing national programs that rely the cooperative
efforts of its partners to educate the lay public and health
professionals about preventing and treating some of the major
chronic diseases of our time. The National High Blood Pressure
Education Program (NHBPEP) is a cooperative effort among
professional and voluntary health agencies, state health
departments, and many community groups interested in
hypertension prevention and control. At the core of the program
is the NHBPEP Coordinating Committee, composed of
representatives from 38 national professional, public, and
voluntary health organizations and 7 federal agencies. The
program aims to reduce death and disability related to high
blood pressure through programs of professional, patient, and
public education. The National Cholesterol Education Program
(NCEP) was established to raise awareness and understanding
about high blood cholesterol as a risk factor for coronary
heart disease (CHD) and the benefits of lowering cholesterol
levels as a means of preventing CHD. The NCEP Coordinating
Committee, with its membership of more than 40 partner
organizations representing major medical and health
professional associations, voluntary health organizations,
community programs, and governmental agencies, helps bring
cholesterol information to a wide audience. The National Asthma
Education and Prevention Program (NAEPP) was initiated to
address the growing problem of asthma in the United States,
particularly among children, African Americans, and the
elderly. Through its Coordinating Committee, composed of
representative from 43 partner organizations from professional
medical and health associations, public and voluntary health
organizations, and federal agencies, the NAEPP works to raise
awareness that asthma is a serious chronic disease, ensure
recognition of symptoms, and ensure appropriate diagnosis and
effective control of asthma.
clinical research
Question. I have a copy of your ``road map'' for streamlining the
process of taking research from the laboratory to the bedside. Is this
still in the planning stages or have you implemented it?
Answer. A national effort, led by NIH, to re-engineer the clinical
research enterprise is being planned at this time. In the course of
developing this key agency priority, the Director, NIH convened a two-
day meeting to develop a plan to identify the critical roadblocks and
knowledge gaps that constrain rapid advances, and to conceptualize and
develop far reaching solutions to build the sophisticated clinical
research enterprise of the future.
In January 2003, meeting participants developed a plan to re-
engineer the clinical research system over next 10 years. They
recommended creation of: (1) National Clinical Research Networks, which
would accrue data on clinical outcomes and quality of care at the point
of service; provide an infrastructure for rapid initiation of large
clinical trials; and inform patients and consumers; (2) a Translational
Research Infrastructure which would facilitate the transfer of clinical
research findings to the front lines of clinical care-and back; and (3)
a Clinical Research Workforce which is diverse, well trained, and
capable of collaborating optimally in cross-disciplinary teams.
Since that time, NIH workgroups on translational research, clinical
networks and clinical training have been reviewing, consolidating,
harmonizing, prioritizing, and determining the fiscal implications of
the myriad recommendations to NIH to emerge from the Clinical Research
Roadmap Meeting. Workgroups are actively taking into account key
national priorities, scientific opportunities, feasability, timing, and
resources. Draft suggestions for implementing the key recommendations
for streamlining and updating the clinical research enterprise are
being considered by agency leadership. The NIH Director, in
collaboration with Institute and Center Directors, will make the final
determination of which of the many key directions will be most likely
to yield the most substantial benefits to the health of the American
people over the course of the next century. Once agreement is reached
amongst the NIH Institutes and Centers, operational plans and a
timeline will be devised for implementing the new clinical research
infrastructure. We look forward to keeping you up to date as these
priorities develop.
Question. One of the items in this road map calls for establishing
``a natural home within NIH for clinical trials of medical
importance.'' Last year, the Subcommittee encouraged you to establish
an Office of Clinical Research to provide a central focus. So we seem
to be on the same wave length. Where does that stand?
Answer. NIH views clinical research, which focuses on the causes
and consequences of disease in human populations, as the key link in
the pathway from basic research to improvements in health. This area of
research includes the development of new technologies, mechanisms of
human disease, therapeutic interventions, clinical trials,
epidemiologic and behavioral studies, and outcomes and health services
research. We concur with your strong interest in ensuring the
advancement of clinical research. In recent years, the NIH appreciably
expanded its clinical research program; for example, by establishing
both intramural and extramural clinical research fellowship programs
targeted to medical and dental students at the NIH; expanding the
resources available for the diverse needs of the clinical research
community, including attention to inpatient, outpatient, and critical
care clinical research; and investing heavily in Patient-Oriented
Research Career Development Awards, Mid-Career Investigator Awards in
Patient-Oriented Research, Graduate Training in Clinical Investigation
Awards, and Clinical Research Curriculum Awards. In addition, the NIH
Loan Repayment Program has been expanded to include health
professionals engaged in clinical research funded by non-profit
support.
In an unprecedented effort to be responsive to the many and varied
research priorities advanced by different stakeholders--practicing
physicians, the pharmaceutic and biotechnology industries, researchers,
health plans, and patient groups, the NIH Director has convened a
series of Roadmap meetings with extramural and intramural scientists
and the Institute and Center Directors to explore the scientific
challenges in clinical research and the roadblocks to progress. As a
result of the recommendations to emerge from these meetings, the NIH is
moving forward to re-engineer the clinical research enterprise, and to
develop innovative solutions to ensure the promise of a viable 21st
century clinical research enterprise.
The development of any new organizational entity at this juncture
in the agency's deliberations would stimulate premature closure
pertaining to this complex issue affecting all NIH Institutes and
Centers. As we continue to develop the NIH clinical research roadmap
plan, we look forward to keeping the committee apprised of our progress
in implementing these goals as this groundbreaking process continues to
unfold.
increased stipend levels
In March 2001, NIH announced a commitment to increase stipend
levels for Kirschstein research training awards:
The NIH supports higher stipends for NRSA recipients and therefore
announces tentative targets of $25,000 for graduate and $45,000 for
entry-level postdoctoral stipends. Future budget requests will
incorporate 10 to 12 percent stipend increases until these targets are
reached. After attainment of these targets, the real value of stipends
will be maintained with annual cost-of-living adjustments.
Question. The Administration's fiscal year 2004 budget departs from
this commitment. Can you comment on the rationale for this change in
policy?
Answer. The change came about through recommendations included in a
2000 National Academy of Sciences report. In fiscal year 2003 the
Senate Appropriations Committee and the Conference Committee reports
asked NIH to comment on that report. The NIH remains committed to the
stipend targets described in our responses on that report. The request
for funds to cover a 4 percent increase in fiscal year 2004 will permit
the NIH to continue to increase stipends.
appointment of study section members
Question. What role should the Administration have in the
appointment of NIH study section members?
Answer. NIH operates study section and appoints study section
members primarily based on the scientific expertise needed for review
of applications assigned to the specific scientific review committees.
Technical evaluation and advice regarding the scientific merit of the
proposed research requires that the advising panel has the appropriate
collective scientific expertise. The Federal Advisory Committee Act,
which regulates establishment and operation of NIH study sections, also
requires that committees be ``balanced'' and not ``inappropriately
influenced by the appointing authority.'' Trained NIH scientists who
develop these committees have the skills and experience to ensure this
balance and the presence of the appropriate scientific expertise so as
to achieve fair and rigorous reviews. In addition, NIH attempts to
ensure diversity (of race and ethnicity, gender, geographic
distribution, small and large institutional affiliation, public and
private institutional affiliation, academic and small business, etc.)
on study sections.
fully funded grants
Question. In the Administration's fiscal year 2004 budget request
for NIH, 322 new grants are ``fully-funded,'' that is, rather than
receiving funding over the 3 or 4-year lifespan of the grants, all
funding for these grants would be disbursed in fiscal year 2004. Is my
understanding is that this is a pilot or test that is being pushed by
the Office of Management and Budget correct?
Answer. Certain grant programs, such as the Academic Research
Enhancement Awards (AREA), and the James A. Shannon awards, have always
been fully funded. In fiscal year 2004, NIH will increase the number of
fully funded grants. NIH will undertake a study to determine the type
of grants that can reasonably be fully funded from both the point of
financial stewardship and scientific accountability. Other categories
of grants may also be proposed for full funding.
Question. If this is to be a test, by what criteria will the
success of full funding be judged?
Answer. Factors include ensuring grantee accountability for the use
of Federal funds and the availability of funds for new researchers with
new ideas.
Question. Currently, as grants are funded over a four-year cycle,
there is annual oversight of the research being performed as non-
competing continuations are awarded. Will there be less oversight if
the grants are fully-funded at one time?
Answer. The overall institutional compliance responsibilities are
the same for grants that are fully funded. As noted above, NIH
currently has two long-standing award programs that are ``fully
funded.'' For example, the Academic Research Enhancement Awards (AREA)
program provides for a three -year-award to AREA-eligible institutions.
AREA recipients are required to submit an annual progress report to
NIH.
Question. As a researcher and research administrator, what is your
view of fully-funded grants?
Answer. As a researcher, there are advantages with fully-funded
grants in that one can plan a research project with full knowledge and
control of the entire amount of the grant award. Thus, one can better
plan and manage the budget for personnel, equipment and resources as
these are needed to meet the milestones of the project. As a research
administrator, full funding could provide additional flexibility in
managing future year commitments made to NIH researchers.
Question. Are there upsides or downsides that OMB, the Department
or the Congress might not be aware of?
Answer. When determining the type of grants that can reasonably be
fully-funded, NIH will consider financial stewardship and scientific
accountability, NIH's goal of supporting stable numbers of new grants,
impact on research priorities supported through other mechanisms of
support, and the impact on new researchers entering the research arena.
training stipends
Question. In March of 2001, NIH adopted a policy of increasing
training stipends by 10 percent a year until appropriate stipend levels
are reached. In fiscal year 2002 and fiscal year 2003, the
Administration has chosen to ignore NIH's policy and request
significantly lower increases for training stipends than are necessary,
and the Appropriations Committee has had to take action to ensure that
stipends were increased. Here we are in fiscal year 2004, and the
Administration has once again underfunded training stipends. What is
NIH's view of the need for a 10 percent increase in fiscal year 2004?
Answer. The NIH remains committed to the stipend targets of $25,000
for predoctoral and $45,000 for entry level postdoctoral Kirschstein--
NRSA recipients as identified on April 30, 2001. The 10 percent annual
increases specified in the 2001 NIH statement would have permitted us
to reach the indicated targets by fiscal year 2006. The indicated
targets could still be achieved at 4 percent annual increases, albeit
not until 2011, by which point they would need to be adjusted to
account for changes in the cost-of-living.
Question. What are the numbers of students supported and at what
levels?
Answer. Based on distribution of research training positions to
various career levels in fiscal year 2001, we estimate that the
positions funded in fiscal year 2004 will be filled according to the
following table.
REQUESTED FISCAL YEAR 2004 KIRSCHSTEIN--NRSA TRAINEES AND FELLOWS BY
LEVEL OF TRAINING
[Full-time training positions]
------------------------------------------------------------------------
Fiscal year
Number of 2004 est.
Career level positions stipend
levels
------------------------------------------------------------------------
Predoctoral................................... 10,046 $19,631
Postdoctoral:
Years of experience:
0..................................... 1,339 33,629
1..................................... 1,163 35,498
2..................................... 818 40,494
3..................................... 704 42,273
4..................................... 842 44,032
5..................................... 783 45,803
6..................................... 449 47,574
7..................................... 1,053 49,588
-------------
Total Postdocs...................... 7,151
=============
Total Full-Time Training Positions.. 17,197
------------------------------------------------------------------------
Question. Is it your view that stipends are adequate and that we
have enough high-quality students in the pipeline?
Answer. As indicated in my previous response, the NIH believes that
Kirschstein-NRSA stipends should be adjusted upward to $25,000 and
$45,000 for predoctoral students and entry-level postdoctorates,
respectively. Stipends are not being adjusted to influence the supply
or the quality of students in the pipeline. Based on recent studies,
the health-related sciences continue to attract highly motivated
students that score very well on national, standardized tests. Stipends
are being adjusted upward as recommended by the National Academy of
Sciences in recognition of increases in the cost-of-living and because
of the high level of education and professional skills involved in
biomedical research.
Looking at this budget proposal, I am reminded of those slow motion
films of crash tests for cars. My suspicion is that, under the
Administration's proposal, we are taking a $27 billion dollar research
enterprise and driving it into a brick wall at 60 miles an hour. Fiscal
year 2004 is the instant that the car's bumper hits the wall, the crash
dummies in the car are just starting to be thrown forward, and perhaps
the hood is starting to buckle. I fear that in fiscal year 2005 and
beyond we may well ``total'' the NIH. I didn't double the NIH over the
past five years so that we could drive it into a brick wall.
embryonic stem cell research
Question. Please discuss how human embryonic stem cell research
fits into the mission of the NCI. Has NCI been actively encouraging
research on human embryonic stem cell research in order to advance your
mission?
Answer. Currently, NCI has not received any research grant
applications relating to human embryonic stem cell research. We do
believe that we will see basic research applications in the future.
NCI has an extensive commitment to the field of stem cell biology,
including both adult and animal embryonic stem cells. This research is
important in expanding our fund of knowledge that can be applied to
future human embryonic stem cell research. The Institute has publicized
to all of our grantees by listserv announcements the current applicable
NIH policies and procedures. In fiscal year 2002, NCI spent a total of
$95 million in both animal and human adult stem cell research. NCI has
also provided vital resources to the research infrastructure through
its Mammalian Gene Collection program. This program works with the
source of stem cells, such as the program at the University of
Wisconsin-Madison, to create public resources for full-length cDNA and
genomic libraries of human ES cell lines. In addition, NCI also
participates in the NIH task force and implementation team that are
facilitating interactions with the scientific communities.
Question. What is NCI doing to provide investigators with the
training necessary to maximize the potential of these cells?
Answer. In fiscal year 2002 NCI supported training and education
programs for investigators to acquire the skills and techniques
necessary to grow and maintain the human embryonic stem cell (hSEC)
lines. NCI provided co-funding support to NHLBI for the T15 short
courses in hESC culture techniques. The total funding provided was
$50,000 per year, divided among the five (5) successful applications.
These five awards were made to training programs to help establish the
workforce necessary to pursue this research field. These awards will
develop, conduct, evaluate, and disseminate short-term courses on
laboratory research techniques for human embryonic stem cell lines. The
courses will include hands-on experience to improve the knowledge and
skills of biomedical researchers to maintain, characterize, and utilize
human embryonic stem cells in basic research studies. The courses will
improve the skills of biomedical researchers in the maintenance of
human embryonic stem cells in culture and their application of this
research tool in basic research studies. The long-term objective of the
courses is to increase the number of researchers who have both
knowledge and skills in the use of human embryonic stem cells in basic
research.
regenerative medicine
Question. Regenerative medicine is an area of research that could
be shared by government, academia and industry--a true public-private
partnership. Can you outline for the Subcommittee how regenerative
medicine fits into your plan for the NIH research agenda?
Answer. Regenerative medicine involves collaboration between
several research fields--stem cell biology, biomolecules/biomaterials,
and tissue engineering; and involves several scientific disciplines--
medicine, biology and bioengineering. NIH places a high priority on
supporting regenerative medicine research and is bringing together
several working groups to identify research obstacles and address
research opportunities for regenerative medicine especially in
application to stem cell biology and biomolecules/biomaterials. This
process will serve todevelop an NIH roadmap for regenerative medicine
with the goal of attracting more scientists to this emerging
multidisciplinary field that has the potential of revolutionizing
health and quality of life of millions of people.
Recent advances in stem cell research have spurred new interest in
the field of regenerative medicine. Before new therapies using human
embryonic stem cells (hESC) can proceed to the clinical phase, much
basic research must be conducted. There is a need for validating the
long-term stability of hESCs in culture and after transplantation,
understanding cell cycle control and cell specialization, and
evaluating cell-host interactions. In response to these needs, the NIH
Stem Cell Task Force is convening a working group with representatives
from government, academia and industry to develop recommendations about
what steps NIH could take to help improve or develop supporting
technologies and research tools in basic research of hESC biology.
Topics for discussion would include assessing the needs for supporting
supplies, materials, reagents, databases with broad public access;
assessing needs, progress, and opportunities for characterization
studies, genomic, and proteomic approaches to better define stem cell
lines; determining protocols for directed differentiation of stem
cells; and recommending needs for enhancing research tools to the Task
Force.
salivary diagnostics
Early detection offers the best hope for cure for many serious
diseases. However, many of the existing ways of diagnosing disease can
be difficult, invasive, time-consuming, and expensive, so that by the
time people have a test done, it may be already too late. I understand
that saliva as a diagnostic tool is a promising area of research for
addressing this issue.
Question. Is there, in the 2004 budget, an investment in this area
of research and if there is, how much are you budgeting for saliva
research?
Answer. We need to improve methods for detecting and diagnosing
disease in the early stages. Unfortunately, there are also many
barriers to effective diagnosis. Current methods, like blood tests and
imaging technologies, are often uncomfortable, invasive, and expensive.
Some diagnostic methods also carry risks themselves. Currently many
diagnostic tests do not allow for real time monitoring of the state of
health or disease because testing can take days or even weeks to
complete.
One of the most promising lines of research for diagnostic testing
involves the use of saliva. Like blood and urine, saliva can be used to
detect and measure many compounds in the body. Unlike blood and urine,
saliva is easy to collect in a physically non-invasive manner, and the
mouth is accessible for continuous monitoring. The science of microchip
technology is evolving so rapidly that it is possible to envision the
day when a microchip could be attached to a patient's tooth and be
capable of continuously monitoring not only specific disease conditions
but also an individual's overall health status.
NIH is using its resources to make this vision a reality. In fiscal
year 2002, NIDCR funded a series of grants to develop strategies to
measure and analyze multiple substances in saliva quickly and
simultaneously. Working in partnership with colleagues in industry and
academia, these grantees are using microchip technology to develop
diagnostic tests for a variety of conditions. As these studies are
completed, follow-up research will be conducted to determine the
efficacy of these new tools.
NIDCR will spend an estimated $9.0 million in fiscal year 2004 on
salivary diagnostics research.
Question. Is saliva being used for HIV diagnosis?
Answer. A number of companies have been working on saliva tests to
measure antibodies to HIV. However, the sensitivity and specificity is
lower than desired, mostly due to the fact that saliva contains low
levels of immunoglobulin G. Thus, two companies are using mucosal
transudate, the fluid that naturally seeps from the soft tissues of the
mouth, as a diagnostic medium. The existing systems are really
collection devices. The sample is sent to a laboratory, and the results
are obtained after a week or two. Both companies, however, have
developed rapid tests that are pending FDA approval for use in the
United States. One company received FDA approval on Jan. 31, 2003 for a
rapid test that utilizes a finger stick (i.e., blood sample) and
provides results in 20 minutes. The same company also has an
application before the FDA that uses the same technology with a sample
of oral mucosal fluid. FDA approval of the oral mucosal rapid test is
expected by the end of 2003.
Question. I hear people talk about the need to develop an ``HIV
rapid test''. Can you explain what that is and are you close to
accomplishing that?
Answer. An ``HIV rapid test'' implies that it can be conducted on
site within a very short time frame without the need for specialized
equipment or trained laboratory personnel. The NIDCR is working to make
this vision a reality. In fiscal year 2002, the Institute funded
several grants to develop technologies to measure and analyze multiple
substances, including HIV, in saliva. Working in partnership with
colleagues in industry, national laboratories and academia, these
grantees are focusing their efforts on developing ``labs on a chip'',
miniaturized systems about the size of a credit card for the detection
of HIV and other substances. These technologies will allow real-time
analysis of a large number of proteins (including antibodies to HIV),
nucleic acids (DNA, RNA) and small molecules (e.g., drugs, metabolites)
in oral fluids. The development of these technologies would permit
fast, highly sensitive and accurate diagnosis of HIV in small amounts
of saliva. To date, grantees at the University of Washington and the
University of Pennsylvania working in partnership with industry have
developed miniaturized prototypes for immunoassays of substances in
blood. This technology is currently being adapted for the rapid
diagnosis of HIV antibodies in saliva. Once these technologies are
developed, they will need to be validated prior to widespread use.
clinical trials research in dental and oral health
This Committee appreciates the need to support definitive, high-
quality clinical trials. We understand that such trials are especially
critical in dental and oral health, where large numbers of Americans
continue to suffer from oral diseases and disorders.
Question. Are there clinical trials in the area of oral health that
need to be conducted?
Answer. Continuing scientific progress in oral health has created
opportunities for state-of-the-art clinical trials to determine the
effectiveness of new treatment approaches and to broaden our
understanding of the link between oral health maintenance and overall
health. For example, new clinical trials are underway to assess the
effectiveness of periodontal treatment on control of systemic health
conditions such as preterm birth. The NIDCR has taken several steps to
increase the number of applications and awards for high-quality
clinical trials and to enhance the oral health research community's
capacity to conduct such trials.
Question. And what plans does NIH have to respond to this need?
Answer. As support for clinical trials in oral health has expanded
from about $10.8 million in fiscal year 2000 to nearly $18 million in
fiscal year 2002, NIDCR instituted a new process designed to better
assist investigators to develop and conduct clinical trials. The
Institute has given priority to Phase III clinical trials that are
likely to have a major impact on public health policy and/or clinical
practices, and that will provide important new information to
practitioners and consumers.
NIDCR recently reorganized its extramural programs to delineate
more clearly and to focus more prominently on the development and
management of clinical trials and recruited additional program staff
with expertise in clinical trials. Furthermore, a new, defined path for
clinical trial applications has been established, which will assist
investigators in developing and conducting trials. NIDCR has given the
highest priority to Phase III clinical trials with the potential for
high public impact. In addition, the Institute is using a variety of
funding mechanisms to strengthen the scientific workforce through
expanded training in clinical trial methods. The extramural community
has been very positive about these program enhancements, as reflected
in the increased number of applications and funding for clinical
trials.
sma research budget
Question. What is the budget for SMA basic research for fiscal year
2003 and fiscal year 2004?
Answer. The NIH total estimated funding for Spinal Muscular Atrophy
(SMA) is $7,351,000 in fiscal year 2003 and $11,489,000 in fiscal year
2004.
sma translational research budget
Question. As a result of promising breakthroughs in basic research
along with the severity and incidence of this disease in newborns and
infants, NIH has selected SMA as a model for translational research.
What is the budget for translational research for SMA in fiscal year
2003 and fiscal year 2004?
Answer. To enhance our current research efforts on SMA, we
anticipate awarding a contract for the SMA translational project on or
about September 30, 2003. The contract will be awarded for four years,
and the research will be conducted as subcontracts. The NINDS intends
to fund these research subcontracts at a level of $4.5 million per
year, which will support up to ten research subcontracts.
implementation of sma translational research program
Question. Please provide specific details on your plan of action
for implementing SMA translational research?
Answer. The NINDS has developed a performance-based contract
approach to allow rapid funding of translational research in a
milestone-driven process to identify treatments for SMA. The members of
the steering committee, selected by the NINDS Director and drawn from
academia, industry, the public, and NIH, are in the process of being
identified and recruited; they will guide the program and play an
integral role throughout the project. During the Summer of 2003, a
working group will develop recommendations for a detailed plan for
research on promising therapeutic strategies, such as drug development,
gene therapy and stem cell therapy, which will address all steps
ultimately required to develop an IND-Investigational New Drug-
application, the formal procedure usually required before a treatment
can be tested in people. The primary contract for the SMA project will
provide overall scientific and organizational support. Subcontracts
will support individual research projects, which will be highly-
targeted and milestone-driven, as is often the case in industry. The
steering committee will evaluate progress toward the specified
milestones and prepare calls for additional subcontracts to do the next
steps along each therapy development pathway, as appropriate. The NINDS
intramural program, which has substantial expertise in SMA and other
neurogenetic disorders, will play an integral role throughout this
effort, and is capable of performing early phase clinical trials when
these become appropriate.
oversight of sma translational research
Question. Who has been appointed within the NINDS to oversee and
execute the SMA translational research project? What mechanisms are in
place to review the process of the project on an ongoing basis with NIH
leadership and Congress?
Answer. Dr. Jill Heemskerk, an NINDS Program Director, will be the
Project Officer for the SMA contract. She will receive advice from the
steering committee and other NINDS staff. To allow optimal management
and monitoring of research progress by the steering committee, projects
will be short-term, goal-directed, and milestone-driven. The steering
committee will review research progress at biannual oversight meetings;
advise the Contractor in assessment of research milestones; and advise
on strategies for overcoming difficulties in research progress.
Institute staff have briefed Dr. Zerhouni extensively about the
project and will continue to do so. We have responded to many questions
about the project, by letter and phone, from members of Congress, and
will continue to keep Congress informed.
timeline and plan for sma translational research
Question. Please provide a timeline and strategic plan for the
implementation of the translational research project and identify any
potential roadblocks?
Answer. In December 2002, NINDS published a notice on the
``Collaborative Program to Accelerate SMA Therapeutics Development'' in
the NIH Guide to Grants and Contracts to help develop the statement of
work and a request for proposals. A March 23, 2003 notice in Federal
Business Opportunities announced that the formal request for proposals
will be issued in April, and a similar notice appeared in the NIH Guide
on April 8th. We expect to award the primary contract on or about
September 30, 2003. Subsequently, calls for proposals for highly-
targeted research sub-projects will be issued quickly, and initial
research projects should be underway in January or February 2004.
Importantly, efforts to establish the steering committee are underway,
and a working group should have detailed recommendations for research
plans ready by the end of the summer, in time to begin issuing calls
for specific research and development projects once the contract is
awarded.
With regard to roadblocks, the project depends, of course, on
receiving proposals that are sufficiently scientifically meritorious so
that we can responsibly fund them. The most serious obstacles to
success, however, are scientific. It is important to keep in mind that
developing effective treatments for neurogenetic diseases such as SMA
is very much on the frontier of medicine. There are very substantial
scientific difficulties that must be overcome to develop a treatment
for SMA.
promoting awareness of and research on sma
Question. What is NINDS doing to solicit grant applications? What
workshops and conferences have been organized this year and next year
to increase awareness of SMA and promote research funding
opportunities?
Answer. We are using both grant and contract mechanisms to enhance
research on SMA. SMA research funding at NINDS increased by 21 percent
from fiscal year 2001 to fiscal year 2002; SMA funding grew by more
than 500 percent from fiscal year 1998--$945,000--to fiscal year 2002--
$5.6 million. This reflects in part the stimulus provided by an NIH
workshop and a request for applications--RFA--on SMA and amyotrophic
lateral sclerosis--ALS--in Spring 2000. Much of the growth, however,
arises from the increased scientific opportunities, and reflects the
strength of the traditional investigator-initiated grant process in
responding to new avenues for progress. Given the state of the science,
we expect grant applications in SMA will continue to increase.
The translational project in SMA that I described is contract-
based. In December 2002, NINDS published a notice on the
``Collaborative Program to Accelerate SMA Therapeutics Development'' in
the NIH Guide for Grants and Contracts to help develop the statement of
work and Request for Proposals--RFP--for this program. On March 23,
2003 and April 8, 2003 NINDS published notices in Federal Business
Opportunities and the NIH Guide, respectively, that the RFP will be
released in April.
Other efforts include an NINDS consortium, developed through a
solicitation, to screen all FDA approved compounds for activity against
neurodegenerative diseases, which included a test specific to SMA. The
Institute has a program to rapidly provide supplemental funding for
testing candidate treatments that emerge from this, or other efforts,
in rodent models. Through a solicitation, the NINDS has also
established a high throughput drug screening facility and called for
proposals for disease assays, specifically listing SMA among those
disease assays being sought. In recent years, we have offered
solicitations in several cross-cutting areas that may provide results
that are relevant to SMA, focused on areas such as gene therapy for the
nervous system, neural stem cells, and pediatric neurological diseases.
The NINDS is also assisting voluntary groups in organizing a scientific
conference for Spring 2004 that will, among other goals, help inform
biotechnology companies and the pharmaceutical industry about
opportunities to develop therapies for SMA.
promoting professional and public awareness of sma
Question. Please identify other NIH institutes and federal agencies
that NINDS is working with to promote professional and public awareness
of the disease. Please describe the programs that are being developed
with a timeline and list of objectives?
Answer. The NINDS has an SMA public information page with links to
advocacy organizations, relevant clinical studies, and research
literature. The National Library of Medicine also has an information
page for SMA with many useful links. In addition, scientific workshops
and the variety of research solicitations addressing or referencing
SMA, as well as program staff contacts, provide outreach to the
professional community. There are a number of voluntary health advocacy
groups focused on SMA that undertake extensive activities to inform the
public and the research community, as is appropriate to their role, and
we have cooperated with these groups in various ways.
status and costs of clinical trials for sma
Question. What is the status of clinical trials for promising SMA
treatments?
Answer. The NINDS is funding a grant to lay the groundwork for
clinical trials in SMA by developing a consortium of investigators and
by validating appropriate outcome measures. However, at this time we
need to emphasize translational research to bring potential treatments
to the point where clinical trials are warranted. The NINDS is
addressing this need in several ways. The contract-based translational
research project for SMA is, of course, an important part of that
effort.
Question. What is the estimate cost per trial?
Answer. Estimating the cost of trials and the possibilities of
partnering with industry depend on the specific drugs or other
therapies that might be tested, so we are not yet at the point
scientifically where I can give a specific answer.
Question. For FDA approved drugs, what efforts have been made to
partner with the manufacturer of these drugs?
Answer. We also support a consortium of investigators to screen FDA
approved drugs for potential use against neurodegenerative diseases,
including SMA. We have recently developed a high-throughput drug
screening facility as well, and called for proposals to develop
disease-specific tests, including those focused on SMA. In addition,
the NINDS intramural program will be capable of conducting clinical
trials on candidate therapies that emerge from these or other efforts.
additional resources required for sma research
Question. What additional resources are necessary to execute the
SMA translational research project? What additional resources do you
require to increase the focus of SMA research at the NIH?
Answer. We believe we have the resources to execute the SMA
translational project at this time. This and all other efforts against
SMA depend on the response of the research community to these efforts.
The substantial increases in funded research on SMA over the last few
years reflect exciting scientific advances, which have brought
increases in the scientifically meritorious proposals we receive from
investigators, which is very encouraging. The growth also reflects our
commitment to addressing this terrible disease.
duchenne muscular dystrophy--nichd involvement
Question. Duchenne Muscular Dystrophy is the world's most
prevalent, lethal childhood genetic disorder. Only in the past year has
the Child Health Institute at NIH had any involvement in this disease.
Has the Child Health Institute devoted any specific, significant
resources to this disease?
Answer. Since the passage of the MD-CARE Act, the NICHD has
partnered with the National Institute of Neurological Disorders and
Stroke (NINDS) and the National Institute of Arthritis and
Musculoskeletal and Skin Diseases (NIAMS) to support the Muscular
Dystrophy Cooperative Research Centers and the Developmental Planning
Grants for Muscular Dystrophy Research Centers. In addition, over the
past five years, NICHD, although it does not have primary
responsibility for muscular dystrophy research, has sponsored an active
portfolio of grants concerned with the muscular dystrophies, muscle
pathophysiology and other neuromuscular disorders. NICHD, along with
other NIH Institutes, also has an active role on both the NIH MD
Research Task Force and the MD Coordinating Committee.
In addition, through the NICHD-sponsored network of Mental
Retardation and Developmental Disabilities Research Centers, resources
created under this network have been used to conduct research in some
topics related to muscular dystrophy. The National Center for Medical
Rehabilitation Research within NICHD has also sponsored research on
muscle and neuromuscular disorders including such topics as the effect
of stress on dystrophic muscle and the role of strength on child
mobility. Finally, the Intramural research program at NICHD has for
several years had a research focus on understanding muscle
pathophysiology.
duchenne muscular dystrophy--congressional priority
Question. Funding for DMD is approximately \1/2500\ of the NIH
budget. This committee has held a hearing on the subject; strong report
language has been attached to the Labor/HHS appropriation for three
years in a row; a comprehensive muscular dystrophy authorization bill
has been signed into law. Is the spending of NIAMS, NINDS, and other
institutes consistent with the congressional priority that has been
identified for this disease?
Answer. Yes, NIH's funding of muscular dystrophy research is
consistent with Congressional priorities. Indeed, from fiscal year 2000
to fiscal year 2002, NIH funding for muscular dystrophy--MD--research
has more than doubled. In fiscal year 2000, NIH funding for MD was
$12.6 million; NIH funding increased to $21.0 million in fiscal year
2001 and to $27.6 million in fiscal year 2002. Funding for DMD during
the same period also increased from $7.0 million in fiscal year 2000 to
$12.4 million in fiscal year 2002.
md-care act--centers of excellence
Question. The Muscular Dystrophy CARE Act called for the creation
of multiple Centers of Excellence, and was signed into law in 2001.
This committee on three occasions has said that a minimum of three such
Centers should be fully funded. I understand an RFP has finally gone
out to organize the Centers, but the only assurance to the scientific
community is that two Centers will be funded. Why so few? What funding
level is assumed for these Centers?
Answer. The NIH has been actively engaged in implementing the
mandates of the MD-CARE Act, including efforts to establish research
centers for muscular dystrophy; the Act did not provide for a specific
number of Centers. Specifically, in the Fall of 2002, the NIH issued
two Requests for Applications--RFAs--in this area. The first solicited
applications for up to three awards for Muscular Dystrophy Cooperative
Research Centers, and the second solicited applications for up to five
awards for Developmental Planning Grants for future centers. During
fiscal year 2003, following peer review, we will make grant awards in
response to these two RFAs; the number of centers actually funded, up
to the specified numbers, will depend on scientific merit. In fiscal
year 2004, we plan to re-issue the RFA for Cooperative Research
Centers, and expect to fund up to two additional meritorious centers in
fiscal year 2005. Subject to the number of applications we receive and
the results of scientific peer review, the combined solicitations could
result in funding up to a total of five MD cooperative centers. Direct
costs for the research centers can be a maximum of $1 million per
center per year, for five years.
md-care act--cbo estimates
Question. The MD-CARE Act was scored by CBO two years ago to cost
$54 million over four years. Apparently there was a minor increase in
funding during the past year, but it is exceptionally difficult to see
that this Act is going to be fully funded at the current pace of NIAMS/
NINDS activity. What are the prospects for full funding of this Act?
Answer. The Congressional Budget Office--CBO--estimated that
implementing the MD-CARE Act--including aspects that are the
responsibility of other HHS components--would cost $4 million in fiscal
year 2002 and $56 million over the five year period of fiscal years
2002 through 2006. Of this amount, the costs of the NIH activities and
of the MD Coordinating Committee, which was established by the Act,
were estimated at $2 million in fiscal year 2002, and at $28 million
total over the fiscal year 2002 to fiscal year 2006 period. From fiscal
year 2001 to fiscal year 2002, NIH actual funding for muscular
dystrophy research increased from $21.0 million to $27.6 million, an
increase of $6.6 million or 31.4 percent--considerably more than the
CBO estimate for fiscal year 2002. Budget estimates for fiscal year
2003 suggest that NIH muscular dystrophy funding would increase another
13.8 percent this fiscal year to an estimated $31.4 million. While this
trend of increasing support for MD research is dependent upon future
scientific opportunities and meritorious applications, it should be
evident that the NIH is fully committed to implementing the MD-CARE
Act, and to defining and advancing the MD research agenda.
muscular dystrophy--cinrg
Question. Has NIH ever funded translational research into muscular
dystrophy--in particular, has NIH ever subsidized the only human
clinical trials network (the Cooperative International Neuromuscular
Research Group, or CINRG) that is testing pharmacological approaches to
delay the progression of this disease?
Answer. The CINRG, with the Children's National Medical Center as
its coordinating center, conducts a multicenter clinical trials program
to investigate the most promising treatments for DMD and related
disorders. NIH currently funds a number of researchers who serve as
principal investigators at participating centers for these clinical
trials. In addition, NINDS has supported clinical trials on muscular
dystrophy through both its intramural and extramural programs, and
welcomes proposals for translational and clinical research aimed at
delaying the progression of MD and related neuromuscular diseases.
Translational research, by which we mean the process of applying
ideas, insights, and discoveries generated through basic scientific
inquiry to the treatment or prevention of human disease, is a high
priority for the NIH. The emphasis in translational research is
squarely on projects focused on the identification and pre-clinical
testing of new therapeutics. The Muscular Dystrophy Cooperative
Research Centers will promote side-by-side basic, translational, and
clinical research, and will be designed to accelerate the translation
of fundamental advances to the clinic. In addition, in July 2002, NINDS
initiated a comprehensive program designed to encourage and support
translational research for all neurological disorders, complemented by
specific initiatives in areas such as drug discovery, gene therapy, and
stem cells. Translational research is also an area of focus in the
ongoing NIH Roadmap initiative.
muscular dystrophy--nih coordination
Question. DMD is untreatable and incurable, and has, throughout
history, taken the lives of children in their teenage years. Because of
the extraordinary burdens placed on families of children with this
disease, most of the benevolence on this affliction goes to subsidize
care, not research. While DMD is the#1 genetic child killer, it
afflicts one out of 3,500 boys, which is not a threshold high enough to
attract private drug money. Hence NIH research is the leading hope for
this generation of sufferers. Yet only in the past year has NIH created
a muscle biology study group--the only one devoted to the study of the
largest organ of the body, out of 110 study groups in all of NIH.
Scientific interest in this disease for years had been dampened and
frustrated because of this structural flaw. Congress on repeated
occasions has suggested that NIH coordinate its activities, and begin
to fund this disease commensurate with others--on the basis of
prevalence, severity, need, and scientific opportunity. Yet the process
of securing adequate funding in this area has been painfully,
tortuously slow--testing the limits of congressional patience and
willingness to entrust the Institutes alone to designate funding
priorities. What assurance can you give that this will change?
Answer. NIH has already taken numerous steps to coordinate its
activities with regard to muscular dystrophy. In early 2002, NIH formed
the Muscular Dystrophy Research Task Force to help guide efforts to
intensify research on muscular dystrophy. The Task Force is made up of
physicians, scientists, NIH professional staff, and representatives of
voluntary health organizations with a focus on muscular dystrophy. The
purpose of the group is to help NIH add new capabilities to the
national effort to understand and treat muscular dystrophies, without
duplicating existing programs. The Task Force has met twice already--in
May 2002 and January 2003.
In September 2002, NINDS, NIAMS, and NICHD jointly issued the
request for applications--RFA--``Muscular Dystrophy Cooperative
Research Centers--MDCRC,'' and in November 2002, issued another RFA,
``Developmental Planning Grants for Muscular Dystrophy Research
Centers.'' These centers will constitute a cohesive program, the MDCRC
Program, operating under guidelines for NIH cooperative agreements. The
centers will promote cooperation and coordination of activities and
resources across the entire MD research community.
Coordination of MD research and education activities across the
entire MD community will also be greatly enhanced by the formation of
the Muscular Dystrophy Coordinating Committee--MDCC, as called for in
the MD-CARE Act. The MDCC has broad representation from a number of HHS
agencies, including the CDC, FDA, and HRSA as well as other government
agencies, MD advocacy organizations, and the public, with an interest
in MD research and education. The MDCC is tasked with developing a plan
for conducting and supporting research and education on muscular
dystrophy through the national research institutes. This plan is to be
developed within a year of the establishment of the MDCC and will
further enhance the coordination of activities and funding
opportunities relevant to MD across NIH.
muscular dystrophy--niams efforts
Question. What is the NIH doing to ensure an integrated research
approach regarding Muscular Dystrophy? What specific corporate
processes exist to ensure research synergies and research success?
Please provide for the record NIAMS efforts in these regard.
Answer. The NIH has a strong and growing interest in research on
muscular dystrophy, and a number of collaborative efforts illustrate
this commitment. Over the past few years, several NIH Institutes,
including the NIAMS and NINDS, have partnered to support scientific
meetings and research initiatives designed to advance the field of
muscular dystrophy research. Projects funded as a result of these
efforts include work on several forms of the disease, including the
Duchenne, facioscapulohumeral, myotonic, and limb-girdle dystrophies.
To underscore the importance of expanding and intensifying programs in
this field, the NIH has established a Muscular Dystrophy Research Task
Force, which includes NIH scientific staff, as well as researchers,
clinicians, and patient representatives. This group will help ensure
that we pursue all promising opportunities to enhance muscular
dystrophy research and training. It will also complement the work of
the newly established inter-agency MD Coordinating Committee, which was
mandated by the MD-CARE Act. Among other NIH Institutes, the NIAMS has
a very active role on both the Research Task Force and the Coordinating
Committee.
duchenne muscular dystrophy--``roadmaps''
Question. Are the specific Science and Technology ``roadmaps''
established for diseases such at Duchenne Muscular Dystrophy? What are
the disciplines involved? If so, for the record, please provide these,
demonstrating how they integrate multidisciplinary sciences and
technology efforts.
Answer. The ``Roadmap'' Action Plans being developed by Dr.
Zerhouni, with input from a broad range of NIH staff and extramural
scientific experts, are not disease or discipline specific, but rather
take a cross-cutting approach to identify scientific challenges and
roadblocks to progress. The ``Roadmap'' Action Plans will focus on
facilitating and accelerating multi-disciplinary aspects of basic,
translational, and clinical research. It is likely that several of
these areas will be applicable to research on DMD. With regard to
muscular dystrophy research overall, the MD Coordinating Committee--
MDCC--is tasked with developing a plan for conducting and supporting
research and education on muscular dystrophy through the national
research institutes. This plan will be developed within a year of the
establishment of the MDCC.
muscular dystrophy--translational research
Question. Has the NIH ever considered a technology maturity
assessment methodology akin to the NASA technology readiness levels or
TRLs? Outline for the record the means and process for determination of
transition from laboratory science to clinical trial?
Answer. As was mentioned before, translational research--the
transition from laboratory science to clinical trial--is the process of
applying ideas, insights, and discoveries generated through basic
scientific inquiry to the treatment or prevention of human disease.
There are rigorous criteria and procedures, which are unique to medical
science, for determining when it is appropriate to begin a clinical
trial. At the present time, the NIH is in the midst of developing
Roadmap Action Plans that will identify opportunities and roadblocks,
as well as establish goals, in cross-cutting, multidisciplinary areas
such as translational research. We expect that, as these needs are
addressed over the next several years, the rate of successful
translation of scientific advances into clinical trials will increase.
md-care act--implementation
Question. Outline the specific steps and associated timetime that
the Department of Health and Human Services and NIH have been on to
fully implement the provisions of the MD-Care Act of 2001. The
Congressional Budget office scored the MD Care Act act approximately
$54 million for implementation. What are the total resources that NIH
has dedicated to implementation of this Act currently reflected in the
fiscal year 2004 President's Budget Submission? Please provide for the
record fiscal year 2002 and fiscal year 2003 obligations and
expenditures for muscular dystrophy. Please indicate by institute by
form of MD, to include, Duchenne, Becker, Limble-Girdle etc.
Answer. In September 2002, NINDS, NIAMS, and NICHD jointly issued
two RFAs related to establishing the MD Research Centers provided for
in the Act. The RFA for ``Muscular Dystrophy Cooperative Research
Centers,'' will establish research centers, each of which will bring
together expertise, infrastructure and resources focused on major
questions about muscular dystrophy. In November 2002, another
solicitation was issued for ``Developmental Planning Grants for
Muscular Dystrophy Research Centers.'' These capacity-building grants
are targeted to investigators who are not yet ready to compete to
establish a muscular dystrophy research center, but would like to do so
eventually.
With respect to the MD Coordinating Committee called for in the
Act, the public members of the MDCC have been appointed as of April 20,
2003. Nine of the 10 Federal agency members have been designated by the
Secretary, HHS, and it has been recommended that the DOD be invited as
a member of the MDCC, based on the establishment in fiscal year 2003 of
muscular dystrophy research as a project within the DOD's Defense
Health Program. Committee members have been contacted about scheduling
the first meeting, which is expected to be held in July.
The NIH has also been expanding and intensifying its efforts in MD
research. In fiscal year 2002, NIH funding for MD was $27.6 million.
Estimated NIH funding for MD research in fiscal year 2003 is $31.4
million and $32.4 million in the President's fiscal year 2004 Budget.
The funding by institute follows:
----------------------------------------------------------------------------------------------------------------
Fiscal year
-----------------------------------------------
2002 actual 2003 estimate 2004 estimate
----------------------------------------------------------------------------------------------------------------
NHLBI........................................................... $1,099,000 $1,170,000 $1,200,000
NINDS........................................................... 9,843,000 12,327,000 12,589,000
NICHD........................................................... 599,000 600,000 600,000
NIA............................................................. 1,265,000 1,300,000 1,330,000
NIAMS........................................................... 11,081,000 12,000,000 12,450,000
NHGRI........................................................... 2,253,000 2,413,000 2,502,000
NCRR............................................................ 1,438,000 1,631,000 1,679,000
-----------------------------------------------
NIH....................................................... 27,578,000 31,441,000 32,350,000
----------------------------------------------------------------------------------------------------------------
The NIH funding for Duchenne MD was $12.4 million in fiscal year
2002, and the estimated funding for fiscal year 2003 is $13.7 million.
The reported funding for Duchenne MD in fiscal year 2002, fiscal year
2003, and fiscal year 2004, by institute follows:
----------------------------------------------------------------------------------------------------------------
Fiscal year
-----------------------------------------------
2002 actual 2003 estimate 2004 estimate
----------------------------------------------------------------------------------------------------------------
NINDS........................................................... $4,050,000 $4,373,000 $4,459,000
NIA............................................................. 1,265,000 1,360,000 1,400,000
NIAMS........................................................... 4,571,000 5,000,000 5,200,000
NHGRI........................................................... 2,160,000 2,312,000 2,398,000
NCRR............................................................ 384,000 430,000 454,000
OD............................................................. .............. 200,000 ..............
-----------------------------------------------
NIH....................................................... 12,430,000 13,675,000 13,911,000
----------------------------------------------------------------------------------------------------------------
muscular dystrophy research--infrastructure
Question. What are the specific NIH ``infrastructure'' shortfalls
associated with MD research? (ie. RDT&E equipment, laboratory
equipment, facilities, facility improvements) Please list any unfunded
requirements by institute.
Answer. The NIH's Muscular Dystrophy Research Task Force has
identified a number of infrastructure priorities, including the need
for multidisciplinary training programs to ensure a steady pipeline of
MD researchers; the importance of developing better animal models for
MD; the need to enhance bioinformatics and imaging resources; and the
need for tissue repositories, DNA samples, and cell lines that can be
used by the MD research community. Some of these needs will be
addressed through the Muscular Dystrophy Cooperative Research Centers
that NIH is planning to fund over the next few years, while others may
require novel partnerships with industry and MD voluntary
organizations.
muscular dystrophy research--cooperation with dod
Question. Is there any relationship or cooperative research
activities with the Department of Defense regarding muscle or
myopathies? Between NIAMS and DOD? Or any other institute and DOD?
Answer. NIAMS is aware of the Department of Defense's (DOD)
involvement in muscular dystrophy research, as reflected in the fiscal
year 2003 DOD Appropriation for the Defense Health Program--Public Law
107-248--in that area. As a result, NIH is recommending that the
Secretary of HHS solicit a nomination for a DOD representative to the
Muscular Dystrophy Coordinating Committee. This will help to foster the
communication and cooperation between DOD and NIH with regard to MD
activities.
myopathies research--niams and nasa
Question. In similar fashion, is there any cooperative RDT&E
between NIAMS and NASA on muscle, muscle wasting, or myopathies? Is
there any significant relationship to human physiology of flight,
especially for long-duration manned space flight? Have NIH institutes
made use of any data from NASA regarding muscle preservation with long-
duration space flight? Please provide for the record.
Answer. Research cooperation between NIAMS and NASA can be traced
at least to the early 1990's, highlighted by a 1990 meeting entitled,
``The Effects of Space Travel on the Musculoskeletal System'' and a
program announcement, which resulted in several grants. In 2000, NASA
and a number of NIH institutes--including NIAMS--collaborated on the
program announcement, ``Earth-Based Research Relevant to the Space
Environment,'' to encourage research applications related to biomedical
effects of space flight on humans, including the effects of gravity on
the musculoskeletal system. Thus far, the announcement has resulted in
the award of at least one NIAMS grant, a project which may provide
insights into the use of resistance exercise as a countermeasure to the
loss of muscle and bone that occurs during space flight.
duchenne and becker dystrophies--clinical trials
Question. What is the status of potential clinical trials on
Duchenne and Becker dystrophies? Are these efforts fully funded in the
fiscal year 2004 President's Budget Submission? Where is this in NIAMS
research priorities for fiscal year 2004 and the outyears? Please
provide for the record the current status of research on systematic
delivery of the dystrophin gene? What are the specific impediments to
gene therapy in DMD/Becker? What resources are reflected in the fiscal
year 2004 PB for these efforts? Provide a comprehensive list of the
``critical technical issues'' associated with efficiency of systemic
delivery.
Answer. Although much promising research is being done in animal
models of muscular dystrophy, significant work remains before the
science progresses to the level where major clinical trials in humans
are safe and appropriate. Recent progress in developing simple and
effective tests that detect more accurately the precise genetic defects
in forms of muscular dystrophy may help advance clinical research in
this area. By establishing a correct genetic diagnosis, we can identify
potential gene replacement strategies, and more accurately estimate
risks in families with a history of the disease. In addition, the NINDS
has recently funded a pilot clinical trial that will test whether the
common antibiotic gentamicin has therapeutic potential for patients
with both the Duchenne and limb-girdle forms of muscular dystrophy.
This trial may provide new insights that will help shape the course of
future clinical studies in this area. Other clinical trials are
currently under development.
One potential avenue to pursue, gene therapy, which uses vectors
such as viruses to deliver a replacement for the defective gene, is
seeing some success in the mouse. Current issues in muscular dystrophy
gene therapy include obtaining vectors in significant numbers,
effective gene delivery to affected muscles, and prevention of immune
reactions to the vector itself. NIH also supports promising work in
animal models on the therapeutic properties of muscle stem cells to
devise potential new approaches for treatment of MD. Discussions by the
NIH Muscular Dystrophy Research Task Force are expected to address
these issues.
duchenne and becker dystrophies--research initiatives
Question. What specific research initiatives exist regarding the
neuropsychological aspects of DMD/Becker? What resources and institutes
are associated with this effort?
Answer. NIH realizes the importance of studying and integrating
research on all aspects of a disease--from the physiological to the
psychological. NIH has supported research and invites proposals on the
neurocognitive and neuropsychological aspects of DMD. More broadly,
four NIH Institutes--NINR with NIAMS, NICHD, and NINDS--in May 2002,
issued a solicitation on ``Increasing Quality of Life in Mobility
Disorders.'' This initiative seeks applications for grants to study the
psychosocial aspects of conditions with limited mobility, which could
include DMD. These psychological consequences may include anxiety,
depression, social isolation, and lowered self-esteem. In February
2003, NINDS also issued a Request for Information for a contract that
NINDS is considering to develop a coordinated approach to defining and
measuring quality of life in neurological disorders. Patients' social
and psychological condition, as well as mental well-being, are among
the parameters that may be measured. In addition, NINDS funds very
basic studies on the effects of MD-related proteins in brain function.
These studies may provide the basis for developing studies on
neuropsychological aspects of MD.
The Muscular Dystrophy Coordinating Committee, which is tasked with
developing a research and education plan for muscular dystrophy, has
broad representation from a number of HHS agencies, such as the CDC,
FDA and HRSA, as well as other government agencies such as the
Department of Education. This will ensure that all aspects of MD,
including the neuropsychological aspects of the disease, are considered
in developing the research and education plan.
duchenne and becker dystrophies--pharmacologic approaches
Question. What specific pharmacologic approaches to DMD/Becker are
currently being pursued by NIH and NIAMS? What are the resource
implications and institutes involved?
Answer. Several years ago, NIAMS-funded scientists successfully
used the common antibiotic gentamicin to restore the function of the
missing protein dystrophin in mouse models of DMD. More recently, the
NINDS has funded a pilot clinical trial that will test whether
gentamicin has therapeutic potential for patients with both the
Duchenne and limb-girdle forms of muscular dystrophy. This trial may
provide new insights that will help shape the course of future clinical
studies in this area. The NINDS is also supporting work in mouse models
to test the efficacy of the protein biglycan as a potential therapy for
Duchenne muscular dystrophy. In addition, early advances involving
enzyme inhibitors and growth factors could eventually lead to new
pharmacologic treatments.
The NICHD has established a Pediatric Pharmacology Research Unit
Network which could prove to be a resource for developing
pharmacological approaches in this area.
duchenne and becker dystrophies--steroids
Question. Has the NIH developed a consensus statement regarding
steroids in DMD/Becker? What is the progress here and target dates for
such a statement? How is NIAMS participating in this?
Answer. In the spring of 2000, several NIH Institutes, including
NIAMS and NINDS, sponsored a scientific workshop on ``Therapeutic
Approaches for Duchenne Muscular Dystrophy.'' The goals of this
workshop were to address key questions in improving treatments for DMD,
and identify areas of needed scientific knowledge, impediments, and
critical next steps to promote effective therapies. One of the areas
covered in the workshop was the use of steroids in treating DMD
patients, specifically the lack of guidelines for use and concerns
about side effects in children. Subsequent to this workshop, the
American Academy of Neurology--AAN--charged a Practice Parameters
Committee with looking at this treatment approach and developing
clinical guidelines. The AAN is expected to publish these guidelines in
the next few months.
md care act--cooperative research centers
Question. The MD Care Act mandated the creation of coordinated
research centers in muscular dystrophy research, and suggested a budget
of $54 million. Would you verify for the record that the NIH has indeed
responded to this by requesting applications for ``Muscular Dystrophy
Cooperative Research Centers?'' Additionally, please detail your goal
of funding 2 to 3 centers at the cost of $1 million direct costs each
for 5 years a total of about $15-21 million over 5 years. Is this
currently reflected in the fiscal year 2004 President's Budget Submit?
Answer. The CBO estimate of $56 million for implementation of the
MD-CARE Act encompasses more than just the creation of research
centers; it is an estimate for implementing all aspects of the Act,
including those outside of NIH.
As one of the first steps in implementing the Act, NIH issued two
requests for applications related to Muscular Dystrophy Research
Centers. In September 2002, NIH issued an RFA entitled ``Muscular
Dystrophy Cooperative Research Centers,'' to establish research
centers, each of which will bring together expertise, infrastructure
and resources focused on major questions about muscular dystrophy. In
fiscal year 2003, following peer review and selection of applications
of the highest merit, NIH will fund up to three centers. In November
2002, NIH issued a second RFA for ``Developmental Planning Grants for
Muscular Dystrophy Research Centers.'' These grants, which will be
awarded in fiscal year 2003, are targeted to investigators who are not
ready to establish a muscular dystrophy research center but would like
to do so eventually. Since the President's fiscal year 2004 budget
reflects commitments from awards made in fiscal year 2003, the Centers
are reflected in the fiscal year 2004 budget.
In fiscal year 2004, we plan to reissue the RFA for Cooperative
Research Centers, and expect to fund up to two additional meritorious
centers in fiscal year 2005. Direct costs for the research centers can
be a maximum of $1 million per center per year, for five years.
md cooperative research centers--resource cores
Question. The committee understands that a second round of
competitive awards is anticipated in late 2004, with funding shared
between NINDS, NICHD, and NIAMS. Please outline for the record the
concept of ``Scientific Research Resource Cores.'' Does this include
the Muscular Dystrophy Cooperative Research Centers grant mechanism?
Does this initiative ensure that the very best support infrastructures
are present and enable the nation-wide muscular dystrophy research
community some advantage?
Answer. In fiscal year 2004, we plan to re-issue the RFA for
Muscular Dystrophy Cooperative Research Centers, and expect to fund up
to two additional centers in fiscal year 2005. At present, NIAMS and
NINDS are committed to funding centers of the highest scientific merit
through this follow-up initiative. The Scientific Research Resource
Cores that will be funded as part of these new centers are expected to
serve the national muscular dystrophy research community, in addition
to supporting research within the centers. These resource cores will
foster multidisciplinary collaborations across departments at a single
institution, as well as among investigators at several institutions,
through the sharing of novel research tools. Examples of scientific
cores include, but are not limited to, tissue and DNA repositories,
medical imaging, special animal facilities, and bioinformatics.
Investigators at the cooperative research centers are expected to
promote the use of the core facilities among researchers within the
parent institution and among scientists at other institutions.
md research resource cores--access and funding
Question. A successful competitive clinical trial network could
accept clinical trials for promising therapeutic approaches from
muscular dystrophy investigators that are not formally part of one of
the two or three funded MDCRCs. Likewise, a successful gene vector or
stem cell core facility could produce these critical reagents for
laboratories throughout the country. Is the potential increased work
load of a successful Scientific Research Resource Cores planned to be
funded by the NIH via administrative supplements? Please outline your
plans and the funding profiles for record for fiscal year 2004 and the
outyears.
Answer. It is expected that an MDCRC will be able not only to
accommodate the research ideas and needs of participating scientists,
but also to be responsive to other muscular dystrophy research
enterprises that may not have direct connections to the center.
Cooperation is a key part of the MDCRC's name; the centers are designed
to both foster research, and to share knowledge and resources with the
muscular dystrophy community at large.
In fiscal year 2004, we plan to reissue the RFA for Cooperative
Research Centers, and expect to fund up to two additional meritorious
centers in fiscal year 2005. Direct costs for the research centers can
be a maximum of $1 million per center per year, for five years. The
Scientific Research Resource Cores will be funded as part of these
centers. In general, administrative supplements are awarded to already
funded researchers in response to identified needs and opportunities
within the scope of the original grant award. Since the center grants
have not yet been awarded, any discussion of supplements would be
premature.
md cooperative research centers--funding
Question. It appears that innovative and novel mechanisms that they
have put into place for executing the congressionally directed muscular
dystrophy cooperative research centers. Please outline for the record
the anticipated funding levels and implementation dates for three
competitive centers, and evidence of implementation of the innovative
Scientific Research Resource Cores via administrative supplements.
Answer. As stated in the recent solicitations for muscular
dystrophy cooperative research centers and for developmental planning
grants for future centers, the NIH expects to fund up to three research
centers and up to five planning grants in fiscal year 2003. In fiscal
year 2004, we plan to re-issue the RFA for Muscular Dystrophy
Cooperative Research Centers. Direct costs for the research centers can
be a maximum of $1 million per center per year, for five years. The
Scientific Research Resource Cores, which will be funded as part of
these new centers, are expected to serve the national muscular
dystrophy research community, in addition to supporting research within
the centers.
nih tuberous sclerosis funding
Question. How much is NIH currently investing in research on
tuberous sclerosis complex (TSC)?
Answer. The NIH reported actual funding for TSC research in fiscal
year 2002 was $6,121,000. The fiscal year 2003 estimated funding is
$6,439,000.
investment in tuberous sclerosis by institutes
Question. Since tuberous sclerosis can affect all of the body's
organ systems, which institutes are currently supporting this research,
and how much is each institute investing?
Answer. The National Cancer Institute--NCI; National Heart, Lung,
and Blood Institute--NHLBI; National Institute of Diabetes and
Digestive and Kidney Diseases--NIDDK; and National Institute of
Neurological Disorders and Stroke--NINDS support TSC research. Funding
by Institute is summarized in the table that follows.
----------------------------------------------------------------------------------------------------------------
Fiscal year
-----------------------------------------------
2002 actual 2003 estimate 2004 estimate
----------------------------------------------------------------------------------------------------------------
NCI............................................................. $638,000 $657,000 $677,000
NHLBI........................................................... 2,140,000 2,279,000 2,336,000
NIDDK........................................................... 717,000 700,000 700,000
NINDS........................................................... 2,596,000 2,803,000 2,859,000
OD.............................................................. 30,000 .............. ..............
-----------------------------------------------
Total..................................................... 6,121,000 6,439,000 6,572,000
----------------------------------------------------------------------------------------------------------------
coordination of tuberous sclerosis research
Question. Has there been any attempt to coordinate research on
tuberous sclerosis among the institutes involved?
Answer. Yes. The Program Director at NINDS who manages the TSC
research portfolio is in regular contact with his counterparts at other
Institutes. In addition, program staff from the National Institute of
Arthritis and Musculoskeletal and Skin Diseases--NIAMS and NIDDK
participated in the September 2002 NINDS-sponsored workshop on TSC
research, and these institutes, along with the National Institute of
Child Health and Human Development--NICHD, NHLBI, and NCI, are being
consulted in the development of the NIH TSC research plan.
tuberous sclerosis research plan and report
Question. On September 19-22, 2002, NIH, the Office of Rare
Disorders and the Tuberous Sclerosis Alliance sponsored a research
conference entitled New Perspectives in Tuberous Sclerosis Complex. In
the fiscal year 2003 Senate report the Committee asked to receive a
progress report on efforts to develop a research plan. When can we
expect to receive this report, and how will it affect future research
on tuberous sclerosis?
Answer. In response to a joint resolution of Congress, passed in
2001, NIH is preparing a five-year TSC research plan. Efforts are
currently underway, led by NINDS, to craft the recommendations that
emerged from the September 2002 conference into a formal research plan.
NIH expects to finalize the plan and then submit a report to Congress
in June 2003. This plan will help guide the development of NIH
initiatives related to TSC and provide a framework that will allow the
NIH Institutes and research and advocacy communities to coordinate
their efforts to advance TSC research.
pain research
Question. Chronic pain affects anywhere from 35-110 million
individuals per year, and is the most common reason consumers seek
health care, accounting for 20-30 percent of doctor visits and 10
percent of prescriptions sold.
The NIH Pain Research Consortium has been in existence since 1996.
Can you please provide this Committee with evidence of its activities
over the past three years, and its planned activities for fiscal year
2004?
Answer. The NIH Pain Research Consortium was established in 1996 to
enhance pain research and promote collaboration among researchers
across the many NIH Institutes and Centers that have programs and
activities addressing pain. Since its inception, the Consortium has
been co-chaired by the Director of the National Institute of Dental and
Craniofacial Research (NIDCR) and Director of the National Institute of
Neurological Disorders and Stroke (NINDS), and most recently the
Director of the National Institute of Nursing Research (NINR) has
joined as the third co-chair. The working membership of the Consortium
has been comprised of the key representatives of the Institutes,
Centers (ICs) and Offices conducting and sponsoring pain research and
programs at the NIH. It is designed to promote pain research and to
increase awareness in the various NIH ICs in order to stimulate
collaborative research initiatives, to coordinate both intramural and
extramural research programs, to foster and maintain contact with
research and patient communities, and to ensure that the results of
NIH-supported pain research are widely communicated.
In its first few years the Consortium:
--Sponsored the symposium ``New Directions in Pain Research,'' which
brought together scientists within the mainstream of pain
research and exposed them to the work of investigators who do
not normally focus on pain. In this way, the symposium brought
new ideas, methodologies and techniques to pain researchers,
where novel approaches to understanding and treating pain are
greatly needed. Summary reports from the meeting appeared in
the journals Neuron and Science.
--Sponsored the Symposium ``Gender and Pain,'' which covered subjects
such as the differing impact of the sex hormones testosterone
and estrogen on pain, brain imaging of nerve pathways involved
in the pain response, and efforts to identify genes that affect
pain sensitivity. This meeting received a great deal of media
attention, and thus information dissemination on the differing
responses to pain and current research.
--Established a Pain Research Consortium website on the NIH web that
included information on the consortium's mission, its
membership, activities being coordinated both intramurally and
extramurally, conference proceeding and collaborative funding
announcements, among other things.
--Developed a number of multi-institute supported Program
Announcements and Requests For Applications in the area of pain
research, that were also listed on the website.
--Gave rise on the NIH campus to the formation of the Pain Interest
Group, which sponsors seminars, informal discussions and
communication via subscription to a list accessible to members
of the NIH community.
In addition to these efforts, a number of institute-initiated
efforts have been ongoing. Examples include:
--In an effort to enhance the pain consult services within the NIH
Clinical Center, the highly successful Pain and Palliative Care
Service was established under the direction of a nationally
recognized pain clinician, Ann Berger, RN, MD.
--Similarly, the NIDCR-directed Pain Research Clinic accounts for the
vast majority of translational pain research done intramurally
at NIH and has influenced the field of pain research through
training and the scientific productivity of its senior
investigators.
--The NIH-FDA Analgesic Drug Development workshop attracted 250
registrants, resulted in a FDA Advisory Committee hearing in
July to develop new criteria for multi-dose studies and claims
structure for drugs indicated for Rheumatoid Arthritis and
Osteoarthritis, and has catalyzed the first revision of the
analgesic drug development process in nearly two decades.
--The NIAMS-led Osteoarthritis Initiative resulted in greater than
$50 million in funding, with significant contributions from the
pharmaceutical industry, to develop improved clinical trials
methods, identification of biomarkers, and an innovative format
for future clinical trials for this disease.
More recently, efforts are underway to capitalize and build upon
these above activities and to reinvigorate the Consortium. Over the
last six years, several changes of leadership in the NIDCR and the
NINDS have resulted in a number of changes in individual co-chairs,
and, as noted, NINR has joined as the third co-chair. Drs. Lawrence
Tabak, Audrey Penn, and Patricia Grady, the current co-chairs of the
Consortium, with the support of NIH Director, Dr. Elias Zerhouni, are
facilitating the necessary efforts to see the Consortium reach its full
potential to catalyze activities both intra- and extramurally in pain
research.
To this end, each Institute and Center Director, as well as the
central NIH Office Directors, have been contacted and asked to reaffirm
their commitment to the pain Consortium as members, and to update their
liaisons to the Consortium. In addition, invitations to participate in
the Consortium have been extended to NIH's sister agencies, including
the Food and Drug Administration, and to pain researchers in the
Department of Defense and the Veteran's Administration. An
organizational meeting of the revitalized Consortium has been scheduled
by the co-chairs to convene on June 10, 2003 to collectively frame the
scope and activities of this group for the future, and update the
scientific agenda for NIH pain research. Plans for the Consortium,
which will address current IC activities as well as those for fiscal
year 2004 and beyond, include catalyzing additional multi-institute
supported research efforts within both the extramural and intramural
programs, including more highly integrated, multi-institute sponsored
PAs and RFAs in the area of pain research. The website for the
Consortium will also be enhanced to make it an interactive source of
more comprehensive information on pain and pain research for its
various stakeholders, e.g., pain researchers; patients and patient
advocate groups, professional associations, the public, and the media,
among others.
Question. According to pain advocacy groups, the NIH has difficulty
in accurately accounting for its expenditures in pain and symptom
management. Past estimates indicate that the NIH spends less than 2
percent of its total budget on primary pain care research. The American
Pain Foundation maintains that in a conversation with the NIH Office of
Budget last summer, that office indicated that the NIH spent $124
million on pain-related projects in fiscal year 2000, with an increase
to $134.9 million in fiscal year 2001. However, other sources believe
that those figures may exaggerate the actual expenditures because they
included grant figures where pain was an underlying or secondary focus
in the study.
Can you prepare for this Committee an accurate accounting of the
NIH's intramural and extramural activity in pain and symptom management
research, to include detailed information and accounting on the
projects that are primarily addressing pain issues from across the
institutes and centers?
Answer. Thirteen of the NIH organizations have reported support for
pain-related research, as detailed in the following table and narrative
descriptions:
NATIONAL INSTITUTES OF HEALTH; FISCAL YEAR 2002 ACTUAL OBLIGATIONS; PAIN CONDITIONS, CHRONIC
[In millions of dollars]
----------------------------------------------------------------------------------------------------------------
Extramural Intramural Fiscal year
Participating ICs research research total
----------------------------------------------------------------------------------------------------------------
NCI............................................................. 10.6 0.4 11.0
NHLBI........................................................... 10.3 .............. 10.3
NIDCR........................................................... 21.4 5.1 26,5
NINDS........................................................... 47.7 1.4 49.1
NICHD........................................................... 4.8 1.1 5.9
NIA............................................................. 1.8 0.7 2.5
NIAMS........................................................... 6.6 .............. 6.6
NIMH............................................................ 5.9 .............. 5.9
NIDA............................................................ 22.6 0.4 23.0
NINR............................................................ 10.9 .............. 10.9
NCRR............................................................ 11.4 .............. 11.4
NCCAM........................................................... 9.0 .............. 9.0
OD.............................................................. 1.9 .............. 1.9
-----------------------------------------------
NIH....................................................... 164.9 9.1 174.0
----------------------------------------------------------------------------------------------------------------
The National Cancer Institute (NCI)
NCI supports clinical trials on secondary or indirect pain-related
research where pain alleviation is a factor in determining patient
quality of life during the patient's experimental treatment and care.
Pain assessment/pain management research grants investigate how to
overcome cultural barriers between providers and patients to better
manage cancer related pain. These studies consider gender differences
in the effectiveness of similar pain medications. NCI researchers are
also developing new methods of pain measurement that are computerized
for ease of patient use at the provider site or in the patient's home.
Other complementary and alternative medicine pain relief research
includes: hypnosis for postoperative breast surgery pain, massage for
short-term relief from pain in advanced stage cancer patients, and
acupuncture or acupressure for pain relief in advanced pancreatic
cancer patients.
Other NCI research examines the biological or molecular basis of
pain. Researchers are studying cellular proteins that may be elevated
in cancer cells to activate the pain response in humans or animal
models. NCI has several ongoing studies on the reduction of therapy-
induced pain. These include studies on reversing opioid related
constipation as well as determination of initial dosing rates to
minimize the pain associated with use of photodynamic therapy for
treatment of certain skin cancers. There are several phase II clinical
trials underway on therapy induced pain in advanced stage cancers,
including a study of radionuclides for metastatic prostate cancer
tumors ablation, arsenic trioxide for pain relief of advanced prostate
cancer, and radiation as a palliative care measure in advanced lung
cancers. NCI is also funding pharmaceutical research on new delivery
systems for natural delta-9-tertahydrocannabinol (THC) to alleviate the
marked loss of appetite and weight in cancer and AIDS patients.
Emerging evidence from several groups reveals that the capsaicin
receptor (a biologic molecule involved in pain sensation) is modulated
not only by compounds like capsaicin but also by signaling pathways
such as protein kinase C. NCI is actively investigating the regulation
of other (vanilloid) receptors by protein kinase C as well as the
design of molecules that can manipulate the protein kinase C pathway to
obtain useful therapeutic outcomes, such as modulation of pain.
The National Heart, Lung and Blood Institute (NHLBI)
NHLBI supports research on the management of painful episodes
associated with sickle cell disease (SCD). Its current portfolio
includes a study to ascertain the impact of acute and chronic pain
events on health care utilization among adults with SCD, as well as an
examination of the relationship between sickle cell pain, mood, and
stress in adolescent and adult patients. The NHLBI is also funding a 5-
year follow-up of adult patients who participated in a landmark
clinical trial that established the usefulness of the drug hydroxyurea
in preventing complications of SCD. The goal of the follow-up study is
to assess the continuing effectiveness of hydroxyurea in decreasing
rates of painful sickle cell episodes and improving quality of life.
The National Institute of Dental and Craniofacial Research (NIDCR)
The history of pain research at NIH began over five decades ago
when the NIDCR recognized many Americans' association of dentistry with
pain. Since that time, NIDCR, in conjunction with other NIH Institutes,
has built a comprehensive portfolio of pain research. Its scientists
and grantees have made important contributions to define the basic
neurocircuitry of pain, as well as translating this understanding into
improved treatments that benefit millions of Americans.
The NIDCR has established relevant research programs initiatives in
both its intra- and extra-mural components. NIDCR scientists have long
studied oral-facial pain, not only because of its importance in oral
disease, but also because it provides an accessible model of pain
elsewhere in the body. These investigations have greatly enriched our
understanding of the basic mechanisms of pain perception and modulation
and have helped delineate the complex pathways and multiple
transmitters that convey pain signals. The NIDCR recognizes that a
unique opportunity now exists, with the emergence of genomic,
proteomic, and other powerful, information-generating technologies, to
define in greater detail the genetic and molecular basis of pain. This
basic research will serve as the pipeline for new strategies in pain
management, allowing future clinicians to more selectively and
efficiently control the pain process.
NIDCR grantees are defining biological factors that might account
for differences in pain perception. Novel imaging techniques that track
the ``mu-opioid'' system, have revealed that people vary both in their
capacity to produce mu-opioid receptors and in their ability to release
the anti-pain chemicals themselves. Researchers found that at matched
levels of pain intensity, men and women differ in the degree and
direction of the mu-opioid response in distinct areas of the brain.
Variability in the mu-opioid system appears to determine the emotional
and sensory aspects of a painful experience may also help to explain
why some people are more prone to chronic pain conditions or do not
benefit from certain anti-pain medications. While the neurocircuitry
involved in each of these processes is extraordinarily complex and
inadequately understood, these initial imaging studies of pain
perception offer an important starting point to further explore human
perception and diversity.
In preliminary animal studies, NIDCR scientists have demonstrated a
treatment approach that selectively controls the chronic pain
associated with tissue damage and recurrent inflammation. This
discovery builds upon laboratory studies of the cell-surface protein
vanilloid receptor I, known by the unrelated acronym TRPV1. Researchers
have isolated a TRPV1-binding compound, which in animal studies
selectively eliminates an entire class of pain-sensing neurons from the
peripheral nervous system. This compound, known as resiniferatoxin
(RTX), killed certain neurons, and blocked inflammatory pain,
hyperalgesia, and thermal pain sensation. Importantly, the animals
maintained their ability to sense pain and remained well coordinated,
an indication that RTX did not affect proprioceptive nerves in the
muscles and joints. These NIDCR researchers have yielded in just over a
year of work a novel approach to pain management. This finding has
important implications for the field of pain research, as well as the
potential to impact American public heath. Additional studies are under
way that will move RTX and related compounds into human clinical
trials.
The National Institute of Neurological Disorders and Stroke (NINDS)
NINDS supports a broad range of research focused on both
understanding the causes and mechanisms of pain and on developing
effective treatments for pain. Our portfolio includes research on the
unique roles in processing and regulating pain that are played by
different areas of the nervous system including: the peripheral nervous
system, spinal cord, brainstem, and cerebral cortex. The portfolio also
includes research aimed at gaining a better understanding of the
different neurotransmitter systems involved in mediating pain. The
NINDS supports research on a wide variety of pain conditions,
including: neuropathic pain, visceral pain, pelvic pain, causalgia,
painful peripheral neuropathies, cancer pain, back pain, muscle pain,
migraine and other types of headache pain, post-surgical pain, and
inflammatory pain. Research on the mechanisms of anesthesia and
analgesia is another area funded by NINDS. The NINDS supports a number
of clinical studies aimed at testing the effectiveness of different
types of treatments (both drug and non-drug) for several pain
conditions. For example, one clinical trial is comparing the
effectiveness of either a drug or cognitive behavioral therapy for
treatment of chronic tension-type headaches. Another clinical study is
examining whether behavioral changes (e.g., changes in diet and
exercise) can prevent the pain associated with peripheral neuropathy in
individuals who have Impaired Glucose Tolerance, a condition of
impaired glucose metabolism. Finally, the NINDS supports training
programs at both the pre- and post-doctoral level with the goal of
giving young scientists and physician-scientists a broad experience in
the pharmacological, pathological, and molecular biological methods of
pain research.
National Institute of Child Health and Human Development (NICHD)
Chronic pain is a secondary condition in persons with disabilities.
Currently funded research on the management of chronic pain explores
the efficacy of innovative non-pharmacologic therapies, such as virtual
reality analgesia in children with cerebral palsy and burns. Cognitive
restructuring, relaxation training and hypnotic analgesia are pain-
management approaches being investigated in persons with cerebral
palsy, multiple sclerosis, acquired amputation, and spinal cord injury.
Research focused on the biomechanics of wheelchair propulsion may
reduce shoulder pain and increase the mobility of wheelchair users.
In the area of reproductive health, several investigators are
studying pharmacologic treatments for the pelvic pain associated with
vulvodynia, endometriosis, dysmenorrhea and hysterectomy. Other pain
research examines the effects of epidural analgesia, used commonly to
reduce pain in labor. There is evidence that suggests epidural
analgesia may also prolong labor, influence the position of the fetus
during labor and increase the likelihood of a high-risk cesarean
delivery. Pre-term infants are subjected to many painful procedures in
the NICU environment. The long-term neurodevelopmental effects of early
exposure to pain and the effects of the sedatives and opioid analgesics
used to reduce neonatal pain are the focus of other NICHD-supported
research.
National Institute on Aging (NIA)
It has been estimated that chronic pain affects approximately half
of older adults living at home, and may cause significant disruption of
physical, psychosocial, and cognitive function. Management of pain is
also of particular concern in older surgical patients, Alzheimer's
patients and other patients with diminished cognitive capacity, as well
as in end-of-life care. NIA extramural studies include a study of pain
management in hip fracture patients and the potential problem of
overlooking pain symptoms in patients who experience delirium as well
as an investigation of chronic low back pain and its effect on
physical, psychosocial, and cognitive function in a group of adults
over age 65. Another extramural study is examining the possible effects
of a multidisciplinary palliative care consultation on pain management,
dypsnea, and anxiety in a group of seriously ill, hospitalized older
patients. A new study will research the effect that identifying pre-
visit concerns of older adult patients has on improved health status
for the primary outcomes of pain and physical function. There is also a
study to understand the major determinants of postoperative outcomes
and improve functional recovery of elderly surgical patients, including
the relationship between improved pain management and improved daily
functioning.
NIA has two intramural studies of pain. The first is a study of
chronic musculoskeletal pain in hereditary disorders of connective
tissue, such as Ehlers-Danlos syndrome and Stickler syndrome, that
examines the efficacy of the use of the ``Mindfulness-Based Stress
Reduction Program'' in the relief of chronic pain. The second is an
epidemiologic study of the impact of pain and other symptoms of chronic
diseases on the daily lives and functioning of older disabled women,
which is specifically investigating whether musculoskeletal pain
increases the risk for falls and other adverse health outcomes and if
the risk can be reduced through the use of analgesic medications.
National Institute of Arthritis and Musculoskeletal and Skin Diseases
(NIAMS)
The mandate of the NIAMS is broad and diverse, focusing on the
whole array of diseases that affect the muscles, joints, bones, and
skin. Many of these diseases are chronic, and are also accompanied by
significant pain. The origin of pain and effective strategies for pain
management are areas of research supported by the NIAMS. The NIAMS pain
research portfolio includes a significant number of studies on
fibromyalgia, a complex and chronic disorder that is characterized by
widespread musculoskeletal pain, fatigue, and multiple tender points.
``Tender points'' refers to tenderness that occurs in localized areas,
particularly in the neck, spine, shoulders, and hips. The NIAMS
supported studies related to fibromyalgia and pain include efforts to
identify the central factors causing fibromyalgia; research on the
changes that occur in the nervous and the hormonal systems in people
with fibromyalgia; and a study that is using chronic low back pain as a
model for fibromyalgia. Additional research topics include: exploring
the roles of sex hormones, stress, and pain in fibromyalgia; work on
the employment and health status of women with fibromyalgia; and
adaptation to pain and stress in fibromyalgia. Other studies are
focusing on rheumatoid arthritis and exploring the value of coping
skills training for early rheumatoid arthritis as well as the roles of
stress and adaptation to rheumatoid arthritis. Also, the NIAMS has
teamed with the NIH Office of Research on Women's Health in funding a
new Specialized Center of Research on gender differences in sensitivity
to pain.
National Institute of Mental Health (NIMH)
In keeping with the NIMH's mission, over one-half of the pain
research NIMH supports is devoted to examining the relationship between
pain and mood states. Examples of this work include studying the
effects of anxiety on pain perception, and research evaluating
depression as a consequence of pain. The NIMH portfolio also includes
research on the basic neurophysiology of pain, including both central
and peripheral nervous system mechanisms. NIMH also supports studies of
the relevant receptors, neurons, neurotransmitters, and neuropeptides
implicated in pain. NIMH-funded work also investigates the efficacy of
psychosocial interventions in alleviating and preventing chronic pain.
Thirty percent of the pain research funded by NIMH focuses specifically
on children and elderly populations.
National Institute on Drug Abuse (NIDA)
The National Institute on Drug Abuse (NIDA) has a comprehensive
research portfolio that looks at all aspects of drug abuse and
addiction and includes a significant pain and analgesia research
program. NIDA's interest in this area stems from the fact that many
analgesics also have abuse potential and research on drug abuse and
addiction is relevant to pain issues. Thus, NIDA supports the
development of treatments for chronic pain, including the use of
opioids (e.g. morphine, oxymorphone, fentanyl, codeine) as well as
finding alternatives to opioids. Innovative research funded by NIDA
includes a device using transcutaneous electrical nerve stimulation
(TENS) that was developed through NIDA's Small Business Innovation
Research (SBIR) program. TENS stimulates certain nerves in the skin,
and this activation inhibits pain. This device is now FDA approved and
commercially available. NIDA also supports research on treating some
severe forms of pain, such as cancer pain, using transplanted cells
from the pituitary gland that produce opioids. Initial work in this
area showed that implanting these cells into the spinal cord reduces
pain in rats. Researchers are now looking at the use of this technique
in monkeys. Another technology using ``targeted neurotoxins'' is being
developed in animal models by several NIDA researchers. This technology
is expected to reduce chronic pain by eliminating specific chronic pain
fibers in the spinal cord. NIDCR has been examining specific targeted
agents acting on ion channels in pain-sensing neurons that have shown
potential as a clinical pain treatment. NIDA is partnering with NIDCR
in completing toxicology studies on this agent and getting FDA approval
for clinical trials in the treatment in cancer patients.
National Institute of Nursing Research (NINR)
Nursing research focuses on ethnically and culturally sensitive
interventions for pain prevention, assessment, management, and
treatment. Emphases include end-of-life pain management and
interventions that help people manage their own pain caused by chronic
diseases, such as arthritis. NINR also focuses on the interaction of
pain, the immune system, and illness at biological and cognitive
levels. NINR supports research on non-pharmacologic interventions to
reduce pain, including exercise, music and art therapy, and
biofeedback, as well as the improving clinicians' ability to assess
pain in those unable to express the level of pain they experience,
including infants and cognitively impaired elderly.
Research findings have set a new direction for pain research. For
the first time, the influence of gender on pain relief was
demonstrated. Study results showed that Kappa opioids, when used for
acute pain, are more effective in women than men and have fewer side
effects than stronger drugs, such as morphine. The role of hormones on
the effectiveness of treatment is currently under study. NINR also
conducts research on the importance of pain relief in improving the
immune systems response to metastasis following surgery. In an animal
model, researchers found that if morphine is provided before and after
surgery, the immune system is less depressed, which suggests that pain
relief improves resistance to the spread of cancer. Other research
findings suggest that exercise helps fibromyalgia patients, who
typically have both localized and widespread pain. Patients
participating in muscle strengthening achieved the greatest benefit
without significant exercise-induced flare-ups in pain.
National Center for Research Resources (NCRR)
NCRR develops and supports critical research technologies and
resources that underpin and advance health related research supported
by the NIH and other research organizations. Research is carried out
through support from the four NCRR divisions: Biomedical Technology,
Clinical Research, Comparative Medicine, and Research Infrastructure.
The Division of Biomedical Technology supports research resources that
enable investigators to do basic research on the biochemistry and
physiology of pain. NCRR's Division of Clinical Research supports
General Clinical Research Centers where researchers are studying the
clinical aspects of pain, including: drug testing and development,
gender differences in pain, and pain associated with specific diseases.
The Division of Comparative Medicine supports research on pain
treatments in animal models, including a mouse model of analgesic
regimens for surgery. Finally, the Division of Research Infrastructure
supports studies on musculoskeletal pain and pain in children.
National Center for Complementary and Alternative Medicine (NCCAM)
NCCAM supports an extramural pain research portfolio that involves
extensive testing of complementary and alternative (CAM) therapies,
such as acupuncture, chiropractic medicine, and yoga, to determine
their efficacy in preventing and treating pain associated with a
variety of conditions and diseases. For example, in a partnership with
the National Institute of Arthritis and Musculoskeletal and Skin
Diseases, NCCAM is supporting a large clinical trial to determine the
efficacy of acupuncture in treating pain and functional limitations
imposed by degenerative arthritis of the knee. At the Northwestern
Health Sciences University, investigators are comparing chiropractic
spinal manipulation, prescription medication, and self-care advice for
neck pain, while at Harvard University investigators are evaluating the
placebo effect and its role in treating repetitive strain injury. One
of NCCAM's major research interests is to study how alternative
therapies, primarily botanicals, interact with other medications. At
the Fred Hutchinson Cancer Research Center researchers are studying how
St. John's wort, a popular herb taken as an antidepressant, interacts
with pain relieving opioids in the context of cancer pain therapy. In
addition, NCCAM-supported researchers at the Johns Hopkins University
Center for Complementary and Alternative Medicine are developing an
animal model to study the reduction of cancer pain using herbal
medicines that appear to contain anti-inflammatory properties. To help
ensure a cadre of clinical investigators in the field of CAM research,
including pain research, NCCAM has also awarded a grant to the Palmer
Chiropractic University to develop a curriculum on research
methodologies for chiropractors.
Office of the Director (OD)
The Office of Research on Women's Health co-funded a total of $1.9
million in pain research projects in the areas of: lower back pain, sex
differences that influence pain, cellular mechanisms of neuropathic
pain, pain management in temporomandibular disorders, and chronic pain
conditions that predominantly affect women.
scleroderma
Question. There is significant vascular and autoimmune component to
scleroderma, are there other institutes aside from the NIAMS at the NIH
that you would recommend scleroderma researchers pursue to fund
experiments aimed at finding a cure? For example, since the leading
cause of death in scleroderma patients is through pulmonary
hypertension and its effects on heart function, should grants on
pulmonary hypertension that encompass issues unique to scleroderma
patients be directed to the NHLBI instead of the NIAMS?
Answer. Research on scleroderma is of interest to a number of NIH
components. This is one of the strengths of the NIH--that we study
diseases from a variety of perspectives. These efforts are
complementary, not duplicative. To give an illustration, not an
comprehensive list, in the case of scleroderma, the NIAMS is the lead
Institute with interests in connective tissue and skin involvement.
Other researchers interested in particular aspects of scleroderma
include those supported by the National Heart, Lung, and Blood
Institute (for example, work on pulmonary fibrosis, pulmonary
hypertension, and vascular involvement), the National Institute of
Diabetes and Digestive and Kidney Diseases (for example, work on the
gastrointestinal tract and kidney function), the National Institute of
Allergy and Infectious Diseases (for example, work on autoimmunity),
and the NIH Office of Research on Women's Health (because scleroderma
affects more women than men). As well, the National Center on Minority
Health and Health Disparities also has an interest because of the
increased incidence of scleroderma in Native Americans. This means that
researchers interested in studying scleroderma should first consider
what particular dimension they wish to pursue and contact the relevant
Program Director within that Institute. The NIH web site includes links
to the individual web sites of each Institute, so this is an effective
way to identify the appropriate Program Director for the particular
area of interest. I do want to underscore the close collaboration and
collegial spirit that we have at the NIH--we team together to sponsor
solicitations and to support research in targeted areas as well as
jointly sponsor scientific meetings. All of this means that the NIH is
able to bring a wealth of experience and complementary interests to a
disease like scleroderma.
Question. In your opinion is there sufficient infrastructure (i.e.,
enough scientists in the field) to support a significant increase in
scleroderma funding? Aside from funding more grants specific to
scleroderma research, how would the NIH propose increasing interest in
the field?
Answer. The issue of infrastructure is of significance to all
scientific disciplines and diseases, and the NIH is actively working to
address all of the dimensions of infrastructure. When we look
specifically at scleroderma, I am pleased to tell you that this is an
area that is the focus of a broad array of research efforts, and I want
to cite highlights of several investments. First, the NIAMS made a
significant commitment to boosting research on scleroderma when the
Institute issued a special solicitation for research applications in
fiscal year 2000. This successful solicitation resulted in the funding
of ten new research grants totaling more than $2 million. These
included both basic and clinical studies, and we were joined by the NIH
Office of Research on Women's Health in co-funding two of the grants.
The NIAMS also currently funds two Specialized Centers of Research in
Scleroderma--one at the University of Texas Health Science Center and
one at the University of Tennessee. Specialized Centers of Research
(SCORs) increase the transfer of basic research findings into clinical
practice by conducting basic and clinical studies under one roof. These
SCORs focus only on scleroderma, and they serve as a national resource
for researchers studying scleroderma. In addition,, the NIAMS
established a national Scleroderma Family Registry and DNA Repository
for scleroderma in June 2001 with the goal of identifying
susceptibility genes. We believe these investments will provide
critically important information on the causes of scleroderma and help
us to develop improved treatments. In addition, through Dr. Zerhouni's
Roadmap Initiative, infrastructure will be strengthened to facilitate
clinical research across the spectrum of clinical diseases.
With regard to increasing interest in the field, scleroderma is an
autoimmune disease-a broad category of diseases in which the body's
immune system attacks the body's own tissues as if they were foreign
invaders, causing significant damage to target organs. The whole field
of autoimmunity is currently exploding with activity and newly launched
initiatives. Information that we learn from studying one autoimmune
disease will provide valuable information for all autoimmune diseases.
It is my opinion--and the goal of the NIAMS--that the significant,
ongoing work on scleroderma as well as the broad interest in
autoimmunity will be of great benefit for affected patients and their
families and care givers.
Question. There is strong scientific support for the NIH's
``roadmap'' meetings with scientists from various disciplines to
identify major cross-cutting biomedical challenges that the NIH could
help address. How can representatives from the scleroderma community
fit into one or several of these meetings to accelerate promising
clinical opportunities and better enable new pathways to discovery for
scleroderma and other illnesses?
Answer. There is great excitement at the NIH as well as in the
voluntary and professional communities about the newly launched NIH
Roadmap Initiative and what it will mean to medical research. The NIH
is committed to the participation of all of the voluntary and
professional groups in this process. Opportunities range from serving
as a member on one of the Working Groups that are just being formed, to
providing comments through other venues such as public representatives
serving on Institute National Advisory Councils or meetings of the NIH
Director's Council of Public Representatives. As well, as the Roadmap
Initiative moves forward, there will be opportunities to review draft
recommendations from the many components of the Initiative as
information is posted on the NIH Website and comments sought. I can
assure you that NIH is seeking very broad input on this new Initiative,
and will welcome the participation and thoughts of members of the
scleroderma community as well as all of the other constituent
communities.
Question. Approximately what percentage of scleroderma-related
grants or requests for funding did the NIH fund last year compared to
the last five years?
Answer. NIAMS is the lead Institute at NIH for funding research on
scleroderma, and the Institute has undertaken several initiatives over
the past 5 years to increase funding in this area. The total NIAMS
spending for scleroderma research has grown from $4 million in fiscal
year 1998 to over $10 million in fiscal year 2002-an increase of 155
percent. NIH-wide, funding for scleroderma research has grown to a
total of $15.1 million in fiscal year 2002.
As mentioned previously, the NIAMS has recently increased efforts
to expand the scleroderma portfolio including co-sponsoring a
conference on ``Emerging Opportunities in Scleroderma Research,'' which
led to the funding of a very successful special solicitation; support
for two Specialized Centers of Research on scleroderma to enhance
translational research; and support for the development of a national
scleroderma family registry and DNA repository, with the overall
objective of identifying genes that influence susceptibility to the
disease.
vascular disease
Question. There seems to be evidence that vascular diseases--
including stroke, high blood pressure, and diabetes--are associated
with an increased risk of Alzheimer's disease. Some promising initial
studies suggest that cholesterol-lowering drugs and changes in diet
could reduce that risk. Are you conducting any research along these
lines?
Answer. A growing body of evidence suggests that some vascular
conditions may be associated with an increased risk of cognitive
impairment and/or Alzheimer's disease (AD), and such findings suggest
that interventions to treat or prevent these conditions, particularly
cholesterol-lowering drugs or dietary changes, could also be used to
treat or prevent AD. For example, recent results from a biracial
(African American and white) population-based community study in
Chicago have suggested that dietary intake of vitamin E can decrease
the risk of cognitive impairment and AD and that intake of dietary fats
may increase or decrease risk of AD depending on the type of fat, while
several epidemiological studies have suggested that individuals who
take cholesterol-lowering drugs known as statins may have a reduced
risk of cognitive impairment or AD.
The NIA is currently conducting several clinical studies of
cholesterol-lowering drugs and dietary modifications for AD treatment
or prevention. For example, recent results from the Framingham Heart
Study indicate that high blood levels of the amino acid homocysteine, a
known risk factor for cardiovascular and cerebrovascular disease, may
also be a risk factor for AD. The Alzheimer's Disease Cooperative Study
(ADCS) will soon begin a clinical trial to determine whether lowering
homocysteine using a combination of vitamins B6 and B12 and folic acid
can modify progression of AD over a one-year period. Several other
studies using various antioxidants to prevent or treat AD are ongoing.
The NIA has also initiated a clinical trial through the ADCS to
determine whether the cholesterol-lowering drug simvastatin can slow
the progression of AD in people who have mild to moderate disease.
Studies using another statin drug, lovastatin, are ongoing or planned.
In addition, the NIA supports a number of basic studies elucidating
the mechanisms of interventions that ameliorate both vascular and
cognitive dysfunction. These include animal studies on the effects of
cholesterol and cholesterol-lowering drugs on cognition. The Institute
has provided support to several long-term cardiovascular health
studies, including the Framingham Study, the Honolulu Heart Study, and
the Cardiovascular Health Study, to explore links between vascular
disease and cognitive impairment. We are also working with the National
Heart, Lung, and Blood Institute to identify potential areas of
collaboration in both epidemiologic studies and clinical trials.
diabetes and hypertension
Question. Within the next 30 years, minorities will make up one-
fourth of the elderly population. (16 percent today) Some studies
suggest that the two diseases that are most common in minority
populations--namely diabetes and hypertension--are associated with an
increased risk of Alzheimer's disease. Are you pursuing any research in
this area?
Answer. The NIA supports a number of epidemiological studies that
are looking for risk and protective factors for AD, including diabetes
and cardiovascular disease, in minority populations. For example, the
Sacramento Area Latino Study on Aging (SALSA), a study of nearly 1,800
community dwelling Latinos, primarily Mexican Americans aged 60 and
above, has recently reported that risk of dementia was nearly 8 times
higher in those individuals with both type 2 diabetes mellitus and
stroke. In a community-based sample of African Americans in
Indianapolis, the investigators found that use of antihypertensive
medications was associated with preservation of cognitive function in
older adults.
The need to understand the driving factors behind persistent black-
white health disparities in cardiovascular disease, cerebrovascular
disease, and overall longevity has led to the development of the HANDLS
(Healthy Aging in Neighborhoods of Diversity across the Lifespan)
study, a community-based research effort focusing on evaluating health
disparities in socioeconomically diverse African-Americans and Whites
in Baltimore. This multidisciplinary project will assess physical,
genetic, demographic, psychosocial, and psychophysiological parameters
over a 20-year period. It will also employ novel research tools to
improve participation rates and retention. HANDLS researchers will
investigate the longitudinal effects of socioeconomic status and race
on the development of cerebrovascular disease and cardiovascular
disease, as well as changes in psychophysiology, cognitive performance,
strength and physical functioning, health services utilization, and
nutrition, and their influences on one another and on the development
of cardiovascular, cerebrovascular, and cognitive decline.
alzheimer's disease
Question. In your testimony you talk about the remarkable strides
that have been made in understanding Alzheimer's disease. How quickly
can we expect some of that new information to be put into the hands of
physicians who are treating Alzheimer's patients? Along the same lines,
do you feel that there are sufficient clinical researchers trained to
translate all of this new knowledge into treatments and better patient
care?
Answer. NIA is currently conducting 18 clinical trials, seven of
which are large-scale prevention trials. These trials are testing
agents such as estrogen, anti-inflammatory drugs, and anti-oxidants for
their effects on slowing progress of the disease, delaying AD's onset,
or preventing the disease altogether. Other intervention trials are
assessing the effects of various compounds on the behavioral symptoms
(agitation, aggression, and sleep disorders) of people with AD. In
addition, the NIA has a contract in place to facilitate testing of
potential new therapeutic compounds in animals. This contract mechanism
has now been in place for 8 years and has yielded several potentially
promising compounds. So far, two of the drugs that have been tested,
AIT-082 and phenserine, have entered human clinical trials.
Although I cannot predict when potential treatments will be
available to physicians treating AD patients, I am hopeful that the
ability to support clinical trials directed at the multiple molecular
targets identified by recent research advances will lead to positive
results in the not-too-distant future.
Expanding the numbers of AD-focused clinical researchers has long
been a priority of the NIA. Opportunities for clinical research
training exist throughout NIA's 29 AD Centers, as well as through the
Alzheimer's Disease Cooperative Study. Many of our program project
grants have also provided an avenue for training young physician-
scientists. An important aspect of each of these mechanisms is the
exposure of basic scientists to clinical research; a number of these
``clinically-trained'' basic scientists are now making important
advances in the clinical arena. NIA has also initiated the Markey
Training Program, which provides support for supervised research and
study for clinically trained professionals who wish to redirect their
careers toward research on Alzheimer's disease. In fiscal year 2002,
six investigators received Markey Awards.
Efforts are ongoing to find better ways to encourage and facilitate
entry of clinicians into research careers (e.g., public/private
collaborations, Beeson scholarships for training in geriatric
research). Dr. Judy Salerno, NIA Deputy Director, has been leading a
major effort, in collaboration with members of the National Advisory
Council on Aging, to identify issues that affect the numbers of
clinicians entering or remaining in research careers. Related to this
effort, a symposium was held in November 2002 in Bethesda entitled
``Finding Synergy: Advancing the Development of Physician-Investigators
in Aging and Geriatrics'' at which experts in the field shared their
views of what would be needed to increase the numbers of clinical
researchers.
women's heart education
Question. I am concerned that heart disease remains the leading
cause of death of women in the United States, yet many women do not
realize this fact. I hear that you have been working with the fashion
industry in your Women's Heart Health Campaign to increase women's
knowledge about their No. 1 killer. Please tell the Committee about
this initiative.
Answer. The NHLBI launched a new campaign, The Heart Truth, last
September to convey the message ``Heart disease is not just a man's
disease--it's the No. 1 killer of women.'' The Institute unveiled the
Red Dress Project as part of the campaign during Mercedes-Benz Fashion
Week, February 7-14, 2003, in New York. Fashion Week is a twice-yearly
event in which top fashion designers in the United States unveil their
new garment lines for the following season. It garners attention from
media in the United States and around the world, including editors from
most daily newspapers, women's magazine editors/writers, and
broadcasters such as Entertainment Tonight and local network
affiliates. The Red Dress Project provides a platform to promote the
messages of the campaign via the slogan ``heart disease doesn't care
what you wear.'' Nineteen red dresses were contributed by leading
fashion designers from either vintage or current collections and
showcased throughout Fashion Week. A Red Dress Pin, specially designed
for The Heart Truth campaign by a leading accessory designer, was
introduced as the national symbol for women and heart disease.
First Lady Laura Bush wore the Red Dress Pin during her visit to
the Red Dress Project display in New York on Valentine's Day. She
appeared on Good Morning America, Today, and The Early Show to promote
awareness of women and heart disease. On February 21, in the Great Hall
of the Hubert H. Humphrey Building, U.S. Department of Health and Human
Services Secretary Tommy G. Thompson presented The Red Dress Project
and designated the third Friday of February as Women's Heart Day. The
Red Dress Project is the cover story of the May 2003 issue of
Prevention magazine and has been featured in People magazine and
Newsweek. A national tour of the Red Dress Project is also being
developed, as well as plans to disseminate The Heart Truth messages and
Red Dress Pin through channels that will reach a diverse population of
women.
parity
Question. Dr. Insel, as you know there has been a lot of discussion
during the last several years concerning the issue of mental health
parity--that is, the requirement that health insurance coverage for
mental disorders be provided on the same basis as that provided for
coverage of so-called physical disorders. What is your view of that?
Answer. As you know, the President has come out in support of
parity coverage for mental disorders. Mental disorders are real and
devastating illnesses. They account for a large proportion of the
disability caused by all medical illnesses. Research supported by NIMH
shows that the increase in cost to provide parity coverage for mental
disorders can be limited, but not treating them would be very costly.
men and depression program
Question. I note that NIMH has recently launched--with the help of
the Surgeon General of the United States--a major public campaign
focused on men and depression. Can you tell me why you've done that?
Answer. Depression is a treatable medical disorder that causes
terrible suffering for its victims and is the cause of many of the
Nation's 30,000 suicides each year. A major obstacle to getting people
into treatment, however, is the stigma that accompanies admitting that
you're depressed and that you need help--and this is especially true of
men, including men who have suffered trauma. To help men recognize the
signs of depression and to guide them toward more information and
sources of assistance, the NIMH recently launched the ``Real Men/Real
Depression'' public education campaign.
Question. Isn't it true that far more women than men develop
depression?
Answer. Yes, more women than men are diagnosed with depression, but
men do have depression and are less likely to seek treatment. One
indication of the importance of this campaign is that four times as
many men as women die by suicide. Figures from the Centers for Disease
Control and Prevention and the 2000 census show that more than 70
percent of all suicide victims are white males.
Question. What do you hope to accomplish with this?
Answer. The NIMH estimates that more than 6 million American men
suffer from depression every year. We are trying to overcome the
barriers that prevent these men from seeking help, and we are hoping to
reduce the number of suicides in this country as a result of this
effort. We already appear to be having success, based on the many
thousands of e-mails and letters asking for help or more information
that we have received to date--not only from depressed men, but from
their friends, their family members, their co-workers, and others who
care about them.
budget request
Question. For fiscal year 2004, the President is proposing $1.382
billion for scientific and clinical research at NIMH. This is $41
million over the fiscal year 2003 appropriation of $1.341 billion--a 3
percent increase. This is barely enough to cover inflation and below
expected increases in the cost of conducting clinical research. The
Subcommittee is concerned that this funding request could prevent NIMH
from sustaining the ongoing multi-year research grants that have been
initiated over the past 2-3 years. What would be the impact of holding
increases at NIMH to 3 percent this year? Would NIMH be able to
continue ongoing, multi-year research programs such as the plan on mood
disorders and bipolar disorder? Can you provide us with an estimate of
the number of qualified grant proposals that you would expect to be
unable to fund if NIMH's budget is held to a 3 percent increase in
fiscal year 2004?
Answer. Under the proposed 3 percent increase for NIMH's fiscal
year 2004 budget, the Institute will honor its commitments to ongoing
grants that have been funded over the past several years. The proposed
budget provides funds to proceed on schedule in addressing the
scientific priorities identified in The Strategic Plan for Mood
Disorders Research. In fiscal year 2004, the NIMH estimates receiving a
total of 2,535 applications for research project grants (RPGs). At the
fiscal year 2004 President's Budget level, NIMH would fund an estimated
636 of these applications while the remaining 1,899 RPGs would be
unfunded. This is a success rate of 25 percent and is consistent with
NIMH success rates over the last few years
research
Question. While steady funding increases have been achieved in the
area of severe mental illness research, research on these illnesses
remains underfunded, given the severe burden that these diseases
present to the nation's public health. A 1996 independent study by the
World Bank and World Health Organization (DALY: Disability Adjusted
Life Years) found that four of the top ten causes of disability
worldwide are severe mental illnesses: major depression, bipolar
disorder, schizophrenia, and obsessive-compulsive disorder. But using
the most recent estimates from NIH, research on mental illness lags far
behind other diseases relative to public health costs, lost
productivity, disability, etc.
What efforts are underway at NIMH to focus greater attention and
resources on promising research at the basic, clinical, and services
levels on severe mental illness such as schizophrenia, bipolar disorder
and major depression?
Answer. NIMH maintains energetic communications, public liaison/
outreach, and public education programs, all of which are designed to
draw attention to the opportunities and payoff of research on mental
and behavioral disorders. The Institute's award-winning home page
presents a wealth of information, (www.nimh.nih.gov) about mental
disorders and recent progress in NIMH sponsored research. The page
receives approximately 10 million hits per month from the public as
well as members of the scientific and clinical communities. In April,
NIMH launched a new mass media campaign, Real Men. Real Depression.,
which is focused on the leading cause of disability adjusted life years
in the United States. The campaign features real men--that is, not
actors--describing in everyday language what it felt like for them to
be depressed. They talk about their confusion and concern for their
ability to care for their families, about their jobs, about plans and
hopes that are so easily shattered by depression. They talk about the
difficulty of acknowledging that they were depressed and the struggle
to force themselves to get help--help that is available largely because
of NIMH-sponsored research.
treatments
Question. In the last decade, many new treatments and services have
been developed and proven for severe mental illnesses such as
schizophrenia. Yet most individuals with these illnesses receive
extremely poor treatment. What efforts are underway (or ongoing) to
ensure that the improved treatment interventions being developed now
will be effectively disseminated to providers and made available to the
people who so desperately need these treatments?
Answer. NIMH supports research on testing the best methods for
dissemination of knowledge, whether in the form of evidence-based
reports, algorithms, or guidelines. In addition to building a stronger
base for understanding what are the best methods for sharing
information, we also are engaged in research that seeks to determine
how information is translated into sustained practice, or more simply
put, how to get individuals, practitioners, and health care systems to
adopt effective research-based practices. Examples of some of the
grants we currently fund include studies that examine the use of
depression guidelines in primary care settings, and the use of practice
guidelines by physicians to improve care for hospitalized youth with
aggression and impulsivity. Another project examines the use of the
internet in educating families on care issues related to schizophrenia,
while another applies technology for physicians' use with decision
making in prescribing medications in community mental health clinics.
Examples of program activities that occurred during 2002 include:
--Two workshops on diffusion of evidence based practices in state
mental health systems
--Workshop on special issues in disseminating research findings for
child and adolescent mental health
--Initiation of new grants mechanisms that increase the capability of
providing centers to evaluate the delivery of their
interventions and improve their practices; and expedited
submission, review and funding of applications where evaluation
of changes being made in a delivery system requires time
sensitive research.
Question. How is NIMH collaborating with SAMHSA and the Center for
Mental Health Services (CMHS) on these efforts?
Answer. The Science to Service Initiative that involves SAMHSA
Centers and NIH institutes (NIMH, NIDA, and NIAAA) has as one of its
goals the exchange of evidence-based practices that can be implemented
by SAMHSA in natural settings, and then further researched by NIH as
treatment and services questions arise from the practice field. NIMH is
the principal source of support for mental health services research in
the DHHS. In the past 22 months, we have been able to increase the
number of services research applications by 45 percent. We are
providing technical assistance to former SAMHSA grantees through
workshops and individual consultations and working closely with CMHS
staff members. Through co-sponsored activities we are working together
to build the capacity of state mental health agencies and other
``natural treatment settings'' to conduct research on the treatment
they are providing, to evaluate its effectiveness and to examine
factors that will increase readiness for adoption of research-based
care.
services research
Question. Administration is returning agencies to their core
mission, meaning that NIMH, rather than the Substance Abuse and Mental
Health Services Administration, will be conducting services research on
mental health issues.
To what degree is NIMH prepared to assume greater responsibility
with respect to services research?
Answer. NIMH is the principal source of support for mental health
services research in the DHHS. In the past 22 months, we have been able
to increase the number of services research applications by 45 percent.
We are providing technical assistance to former SAMHSA grantees through
workshops and individual consultations and working closely with CMHS
staff members. The Science to Service Initiative that involves SAMHSA
Centers and NIH institutes (NIMH, NIDA, and NIAAA) has as one of its
goals the exchange of evidence-based practices that can be implemented
by SAMHSA in natural settings, and then further researched by NIH as
treatment and services questions arise from the practice field.
Question. People with mental illnesses often have conditions
besides a mental health diagnosis. To reflect the real world in which
mental health services are delivered, how will NIMH services research
address people with multiple diagnosis?
Answer. To insure rigor and maximize the possibly of detecting a
treatment effect, randomized, controlled clinical trials--the
traditional ``gold standard'' for medical research--have excluded
anyone with a comorbid mental disorder, substance use disorder, general
medical illness or other conditions ranging from pregnancy to active
suicidality. Thus, the typical clinical trial for an antidepressant
would be conducted with a relatively small, highly homogenous number of
outpatients or, less frequently, inpatients, usually in an academic
health center. The major outcome criterion would be a decrement on a
behavioral rating scale such as the Hamilton Depression Scale.
In real life, of course, the patient who typically appears in a
psychiatrist's office is quite unlike the patient enrolled in the
traditional clinical trial. Accordingly, while the NIMH will continue
to fund the traditional form of clinical trial, the Institute's
researchers also are adapting to the changing nature of treatments,
patients, and the health care environment. In order to help clinicians
provide optimal care to patients, research today also involves trials
with larger sample sizes and with fewer exclusion criteria; trials are
being conducted not only in academic clinics but also in more real
world settings including managed care settings; and outcomes are
assessed not only on the basis of symptom reduction but also on
measures of functional rehabilitation, the end result that is of
greatest interest to families and patients as well as employers and
others who pay for treatment. This new type of trial--often called an
``effectiveness'' trial--need not give up any of the traditional and
indispensable emphasis on rigor. In trials of both pharmacotherapies
and psychotherapies, the information sought should be geared toward
helping clinical decision-making in real world settings and should
demonstrate compelling types of functional outcomes. From a
methodological perspective, new analytic techniques are being developed
that allow clinical investigators and services researchers to move away
from linear patterns and account for the complex interactions that
occur in the real world.
Question. Research at NIH focuses on randomized, clinical trials,
despite the fact that many other proven research methods are more
conducive to services research (such as multi-site research or analysis
of nationally representative data sets such as the Census Bureau's
Current Population Survey or the National Health Interview Survey). To
what degree will NIMH utilize these other methods?
Answer. NIMH supports a wide array of research designs and methods,
not just randomized clinical trials. Researchers have the freedom to
use the best techniques available to address the questions they are
asking. This might involve using statistics to analyze large national
data sets as in studies of risk factors for depression in children, or
the use of interviews and qualitative techniques for research questions
that require more context to understand. Other studies require control
of variables to get at causation; thus randomized clinical trials are
appropriate. Epidemiologic studies are also conducted in which surveys
are the basic tools used. In summary, no one approach is used-the
research question asked dictates the method to be used.
schizophrenia
Question. Schizophrenia is the most devastating mental illness,
affecting approximately 2.2 million American adults, or 1.1 percent of
the population age 18 and older. Scientists still do not know the
specific causes of schizophrenia; like many other medical illnesses
such as cancer or diabetes, schizophrenia seems to be caused by a
combination of problems including genetic vulnerability and
environmental factors that occur during a person's development. While
newer treatments for schizophrenia such as atypical anti-psychotic
medications are proving effective, these treatments are largely
palliative and help patients live with, rather than recover, from the
illness.
Given the enormous public health burden associated with
schizophrenia and the demand for new treatments, what is NIMH doing to
assure that the research base studying schizophrenia is strengthened
and expanded?
Answer. Recognizing that schizophrenia is among the most serious
public health problems facing Americans, the NIMH has increased the
proportion of it's budget devoted to this and other related
neurodevelopmental disorders from 16 percent to 23 percent in the last
five years. Reflecting the higher priority afforded this severe illness
within NIMH, new initiatives have been launched that balance the need
to focus on discovering the fundamental cause of the disease so a cure
might be possible, with the need to improve treatments for patients who
are suffering today.
Efforts to understand the etiology of schizophrenia and other
devastating mental illnesses are grounded in the neurosciences. For
example, the NIMH Human Genetics Initiative is in the process of
collecting biological materials on over 17,000 individuals to create a
national scientific resource of DNA for broad use by investigators in
the scientific community. Such samples help to identify risk genes
associated with schizophrenia and shed light on the mechanisms
malfunctioning in the brain. The Research Centers of Excellence (Silvio
Conte Centers for the Neuroscience of Mental Disorders) have been
established to develop and follow new leads generated by genetic and
other basic studies in order to clarify abnormalities in brain
functioning associated with major psychiatric illnesses. Over half of
these Centers focus on schizophrenia, including two new centers (Mt
Sinai, in New York City, and the University of North Carolina, Chapel
Hill) that have been funded in the last fiscal year.
bioploar disorder
Question. Bipolar disorder, or manic depression, is a serious brain
disorder that causes extreme shifts in mood, energy and functioning. It
affects 2.3 million adult Americans, or 1.2 percent of the population.
Currently, there is no cure for bipolar disorder. While it can be a
highly treatable and manageable illness, most of the approved
treatments are indications associated with medications that were
developed for other illnesses (anti-convulsants for epilepsy and anti-
depressants). In 1997, Congress requested NIMH to undertake a national
research plan on bipolar disorder. This request resulted in the current
research plan on mood disorders at NIMH. Can you please update the
Subcommittee on the mood disorders research plan and what NIMH is
learning about the causes and new treatments for bipolar disorder?
Answer. NIMH completed the Strategic Plan for Mood Disorders last
year and is now in the process of implementing the highest priority
recommendations for new research on the nature, course, treatment, and
prevention of these disorders. In addition, we are systematically
monitoring and evaluating the ongoing research activities in each of
the Divisions from neuroscience to services, to ensure movement toward
our goals.
In 1998 NIMH initiated funding of the STEP-BD program (Systematic
Treatment Enhancement Program for Bipolar Disorder), a multisite study
of bipolar disorder that is now following nearly 3,000 individuals
receiving care for bipolar disorder in 18 centers across the United
States. The budget for STEP-BD is approximately $25,000,000. This study
is providing unique information on the course of bipolar disorder and
on targets for treatment. We have learned, for example, that even under
optimized treatment conditions about 5 percent of people with bipolar
disorder will experience a relapse during the course of a year.
Significantly, and counter to expectations, 80 percent of these
relapses are depression, not mania, thus highlighting the need for safe
and effective treatments for bipolar depression. Studies have been
initiated to explore the value of rational strategies of combination
treatment targeting bipolar depression. One of the benefits of large
studies, such as STEP-BD is they provide training grounds and engender
interest for new studies in bipolar illness. In fiscal year 2003 NIMH
will be funding the first center specifically targeting interventions
in bipolar illness in adolescents and adults-this new center is
established at one of the primary sites of the STEP-BD study.
With an increased awareness that bipolar disorder also affects
children and adolescents, NIMH has recently funded two multisite trials
to study the benefits of medications for youths with this disorder.
______
Questions Submitted by Senator Tom Harkin
parkinson's
Question. Dr. Zerhouni, I appreciate that you have focused some of
your attention on Parkinson's disease during your first year as
director and that you and your staff have developed a ``matrix'' that
outlines future NIH-funded research on Parkinson's. This matrix follows
the release in 2000 of the NIH Parkinson's Disease Research Agenda. As
you know, I have been concerned that funding for PD research during the
past few years has increased at a rate below the overall percentage
increase for NIH, despite the professional judgment estimates included
in the Research Agenda. Please explain what the NIH is doing to fully
implement the Research Agenda as well as the matrix.
In addition, the President's proposed budget for fiscal year 2004
includes $35 million for ``Roadmap Funding.'' The Budget describes its
purpose ``as an additional effort to accelerate fundamental discovery
and translation of that new knowledge into preventive and therapeutic
strategies.'' Will you be focusing on any particular diseases when you
implement the Roadmap, and will Parkinson's disease be one of the
diseases you will choose?
Answer. With regard to funding, NIH funding for Parkinson's disease
research has been growing much more rapidly than the growth of the
overall NIH budget, which of course has been very significant. During
the first four years of the doubling effort--fiscal years 1999 through
2002--actual NIH funding for Parkinson's disease research rose
approximately 92 percent, while the overall NIH budget rose by a very
generous 72 percent. To fully appreciate this increase, it is critical
to recognize that in fiscal year 1998--the ``base'' year of the
doubling--NIH had just increased its funding of Parkinson's disease
research by 23 percent over fiscal year 1997, while the overall NIH
budget increased only 7.2 percent in that time frame.
More importantly, the NIH Parkinson's Disease Research Agenda and
its updates encompass every research area critical to Parkinson's
disease--genetics, environmental factors, cell death and survival,
pharmacological treatments, deep brain stimulation, gene therapy, stem
cell research, and the non-motor effects of Parkinson's--and the NIH is
addressing every scientific aspect of that Agenda. This includes
hundreds of research grants and contracts, at all levels of research,
from basic through translational to clinical, including major clinical
trials. We are following all plausible strategies to develop therapies,
including drugs, surgery and cell transplantation. We have also held
several scientific meetings since the original Agenda was developed to
adjust to the changing scientific landscape, and to make sure that all
scientific opportunities are pursued. This includes a ``summit'' of
Parkinson's disease researchers that I convened in July 2002 to
identify roadblocks that might be impeding progress. The Summit was
very successful in identifying roadblocks, and NIH staff has drafted a
matrix of short-to-long term, and low-to-high risk action items
designed to target these issues. NIH is actively addressing these
action items, both through enhanced support of individual Institute and
Center efforts, and through improved coordination and collaboration
with the research and voluntary Parkinson's communities.
The Roadmap initiatives, being developed with input from a broad
range of NIH staff and extramural scientific experts, are not disease
or discipline specific, but rather take a cross-cutting approach to
identify scientific challenges and roadblocks to progress. Driven by
the enormous convergence in fundamental research approaches and
technologies across diseases, organs and biological systems, the
Roadmap will focus on facilitating and accelerating multi-disciplinary
aspects of basic, translational, and clinical research. Roadmap
initiatives will exploit new unprecedented opportunities and
technologies that will accelerate progress in disease areas across the
27 Institutes and Centers of the NIH. The exact nature of the progress
will differ with each disease depending on our current knowledge of the
disorder. Some diseases, which are in need of further basic research,
will be aided by initiatives supporting portions of the Roadmap such as
New Pathways to Discovery. Other diseases will benefit from Roadmap
efforts aimed at optimal translation of discoveries into clinical
reality, such as Clinical Trial Networks.
national library of medicine
Question. The NLM and its Center for Biotechnology Information have
made a major contribution to the fight against disease. To maximize
this contribution, this committee has supported the design of a new
facility. How is that going, and are you ready to initiate construction
if funds are made available?
Answer. The design of the National Center for Biotechnology
Information is expected to be complete by August-September 2003 at
which time the NIH, in consultation with the HHS Office of Facility
Management and Policy, will develop a plan for scheduling and financing
this project while considering other demands and priorities.
______
Questions Submitted by Senator Pete V. Domenici
mental illness research
Question. Dr. Zerhouni, can you please update the Subcommittee on
efforts underway at NIH and NIMH to focus greater attention and
resources on promising research at the basic, clinical, and services
levels on severe mental illness such as schizophrenia, bipolar disorder
and major depression to ensure that advances rapidly translate into
better treatment for individuals living with these illnesses?
Answer. At NIMH extensive efforts are underway to translate basic
science findings (from genetics, structural and functional brain
imaging, analysis of human post-mortem brain specimens, etc.) to an
enhanced understanding of the causes (etiology and pathophysiology) of
the major mental disorders. In the past few years significant progress
has been made in identifying risk genes, refining disease phenotypes
(characterizing more homogeneous subpopulations of patients), and
implicating particular brain molecules, cells, circuits and structures
as key players in these processes. The goal of these investigations is
to develop more specific treatments and, ultimately, curative and
preventive interventions. NIMH established a Clinical Neuroscience
Research Branch in 1999 specifically to address these issues of
translational science and, in the past several years, has significantly
expanded its ``flagship'' translational program--The Silvio Conte
Centers for the Neuroscience of Mental Disorders (currently 13 Centers
are funded at an annual cost of $24 million).
Carefully controlled, randomized, double-blind trials remain a
cornerstone of clinical research sponsored by the NIMH. As
practitioners are well aware, however, such studies cannot be the end
of treatment research but a beginning. Clinical treatment research must
adapt to the changing nature of treatments, patients, and the health
care environment. Accordingly, NIMH has launched a series of clinical
effectiveness trials that are characterized by large sample sizes and
few exclusion criteria; to ensure the generalizability of findings,
these trials occur not only in academic clinics but also in more real
world settings including primary care settings. The approach also calls
for aggressive dissemination of results. Four large-scale, multi-site
clinical effectiveness trials include: (1) Systematic Treatment
Enhancement Program for Bipolar Disorder (STEP-BD) to investigate
strategies for managing bipolar disorder, (2) Clinical Antipsychotic
Trials of Intervention Effectiveness (CATIE) to study the effectiveness
of the new atypical antipsychotics in schizophrenia and Alzheimer's
disease, (3) Sequenced Treatment Alternatives to Relieve Depression
(STAR*D) to develop algorithms for managing especially difficult to
treat depression, and (4) Treatment of Adolescents with Depression
Study (TADS). In mid-fiscal year 2003, all of these trials are well on
their way to attaining the targeted number of research participants.
Through the network of research centers participating in these
effectiveness trials, NIMH is creating an infrastructure for future
clinical research involving direct comparisons of treatments and their
benefits to different populations that can be conducted independently
of pharmaceutical companies.
Recognizing that much of the screening for mental illness and
treatment is provided in other than specialty settings, NIMH continues
to gain a better understanding of cost and financing associated with
care in three different settings: juvenile justice system, school
systems, and primary care. Use of non-traditional settings offer an
opportunity to learn new ways of treating and managing co-existing
addiction and mental illness problems through the use of non-specialty
care providers working with the less numerous specialty providers.
Research is also exploring preferences of individuals with mental
disorders or combined disorders to seek treatment in general health
care, or social services settings and determining if access to
treatment in a preferred setting improves seeking treatment, staying in
treatment, and adherence to treatment plans.
schizophrenia research
Question. Schizophrenia is the most devastating mental illness,
affecting approximately 2.2 million American adults, or 1.1 percent of
the population age 18 and older. Schizophrenia interferes with a
person's ability to think clearly, make decisions, and relate to
others. Scientists still do not know the specific causes of
schizophrenia, but research has shown that the brains of people with
schizophrenia are different, as a group, from the brains of people
without the illness. While newer treatments for schizophrenia
(including atypical anti-psychotic medications) are proving much more
effective in treating both the positive and negative symptoms of
schizophrenia, these treatments are largely palliative and help
patients better live with, rather than recover from the illness.
Given the enormous public health burden associated with
schizophrenia and the need for new treatments, what is NIMH doing to
ensure that schizophrenia research becomes a higher priority within the
agency?
Answer. Recognizing that schizophrenia is among the most serious
public health problems facing Americans, the NIMH has increased the
proportion of it's budget devoted to this and other related
neurodevelopmental disorders from 16 percent to 23 percent in the last
five years. Reflecting the higher priority afforded this severe illness
within NIMH, new initiatives have been launched that balance the need
to focus on discovering the fundamental cause of the disease so a cure
might be possible, with the need to improve treatments for patients who
are suffering today.
Efforts to understand the etiology of schizophrenia and other
devastating mental illnesses are grounded in the neurosciences. For
example, the NIMH Human Genetics Initiative is in the process of
collecting biological materials on over 17,000 individuals to create a
national scientific resource of DNA for broad use by investigators in
the scientific community. Such samples help to identify risk genes
associated with schizophrenia and shed light on the mechanisms
malfunctioning in the brain. The Research Centers of Excellence (Silvio
Conte Centers for the Neuroscience of Mental Disorders) have been
established to develop and follow new leads generated by genetic and
other basic studies in order to clarify abnormalities in brain
functioning associated with major psychiatric illnesses. Over half of
these Centers focus on schizophrenia, including two new centers (Mt
Sinai and University of North Carolina, Chapel Hill) that have been
funded in the last fiscal year.
Although the delusions and hallucinations of schizophrenia are
often treated effectively by available medications, research indicates
that impairments in cognition (memory, planning, abstract thinking) are
most associated with disability in this illness. Unfortunately,
available medicines do little to reverse this aspect of schizophrenia.
To address this problem, NIMH has launched a Schizophrenia Treatment
Development Initiative focused on both developing new drug treatments
to remedy cognitive impairments. With the cooperation of the FDA, this
initiative will develop standard measures and methods to test new drugs
that target cognition in schizophrenia in order to provide the
pharmaceutical industry with guidelines for drug registration and
hence, enhanced incentives to invest in developing treatments for this
aspect of schizophrenia. To jumpstart this effort, in fiscal year 2004
NIMH will establish a new clinical trials network focused on
collaborating with industry to identify and test new agents for
cognition in schizophrenia.
In addition to the large Clinical Antipsychotic Trials of
Intervention Effectiveness (CATIE) project, which is designed to
determine the long-term effects and usefulness of antipsychotic
medications in a broad cross-section of persons with schizophrenia,
NIMH is conducting a range of studies concerned with how to best use
available treatments for schizophrenia. These include clinical trials
of combination medication strategies. Recognizing that medication
adherence is a crucial issue for many patients, active efforts to
stimulate research on this problem have yielded a series of new studies
designed to develop and test adherence-oriented intervention. Finally,
rehabilitation-oriented studies are encouraged and supported to develop
new approaches to enhancing patient skills and functioning.
focus & accountability on severe mental illness at nimh
Question. Dr. Insel, as you know, NIMH has been criticized in the
past for failing to maintain an appropriate focus on severe mental
illness in its portfolio. Over the years, concern has been expressed
that basic scientific and clinical research on schizophrenia, bipolar
disorder and other severe mental illnesses remain low priorities at
NIMH. In order to challenge and rebut these criticisms, would you
support a requirement for NIMH to provide an accounting of new and
existing research grants broken down by specific illnesses?
Answer. First, let me make clear that direct support for research
of so-called ``serious mental disorders,'' such as schizophrenia, is a
priority at NIMH. It is the lead Federal agency responsible for
supporting research on mental and behavioral disorders. The goal of
NIMH's portfolio of research on mental illness is to better understand,
treat, prevent, and ultimately cure mental illness. This requires both
direct and indirect approaches, which may not be apparent in accounting
for spending by disease.
Basic research, the relevance of which might not be immediately
apparent, can produce knowledge critical for understanding mental
illness. For example, studies of the brains of songbirds, brought the
unexpected and startling news that adult brains can regenerate new
nerve cells, a finding that completely changed scientists' thinking
about the possibility for brain repair. Similarly, in October 2000, Dr.
Eric Kandel, an NIMH grantee, won the Nobel Prize for Medicine based on
his work with sea slugs, in recognition that this research had
profoundly increased understanding of brain function and medication
effects in humans. Both scientists have accelerated our understanding
of brain processes important for mental illness.
Over the years, Congress has expressed interest that NIMH take
responsibility for many areas beyond mental illness including HIV/AIDs
risk behaviors, violence, gambling, and many others. Nevertheless, NIMH
has a strong and abiding commitment to a core focus on severe mental
illnesses. Indeed, NIMH has launched four large-scale, public health
oriented clinical trials in major disease conditions, including bipolar
(manic depressive) illness; schizophrenia/Alzheimer disease; treatment-
resistant depression; and major depression in adolescents. These trials
investigate ``real world'' effectiveness of mental health treatments,
and because they are carried out in community settings they do not
exclude people because they have a co-occurring substance abuse
disorder or other problems B unlike typical short-term pharmaceutical
trials. People with these disorders live in the community, and NIMH is
committed to assuring that treatment interventions will work where the
patient lives.
NIMH is supporting many new activities with a focus on severe
mental illnesses, and has increased the percentage of its overall
research portfolio in this area. One major new initiative, for example,
will look at the cognitive deficits associated with schizophrenia B the
deficits that make it very difficult for people affected by the disease
to be employed or otherwise function fully in society. This is an
effort to develop new insights into the neurobiology of attention,
working memory, and other fundamental cognitive processes in order to
identify and test potential therapeutic agents targeting cognitive
deficits in schizophrenia. As a part of this effort focused on
schizophrenia, NIMH is establishing an expert Schizophrenia Cognition
Measurement Development Group. Without measurement consensus, the Food
and Drug Administration cannot recognize cognition as a valid treatment
endpoint for industry-sponsored research and drug registration. Since
cognitive impairment, rather than delusions and hallucinations, may be
the major determinant of functional outcome in people with
schizophrenia, this is an extremely important effort. NIMH also will
support a Cognition Treatment Network to identify, evaluate, and
acquire pharmacological agents to treat cognitive deficits in
schizophrenia and related psychoses.
In summary, the goal of NIMH's portfolio of research on mental
illness is to better understand, treat, prevent, and ultimately cure
mental illness. While the NIMH has significantly increased the
percentage of its portfolio devoted specifically to studies related to
severe and persistent mental illnesses, it continues to honor its
mission and responsibility to support basic biomedical and behavioral
research that will elucidate the underlying causes of these disorders.
A strict focus on specific diseases would make this very difficult, if
not impossible, and would certainly hamper scientific progress.
______
Questions Submitted to the Social Security Administration
Questions Submitted by Senator Arlen Specter
Question. Commissioner, since 1997 the General Accounting Office
(GAO) has included the Supplemental Security Income program in its list
of programs that are at high risk for waste, fraud and mismanagement.
Thanks to the Agency's dedicated effort, GAO's 2003 High Risk Update
did not include the Supplemental Security Income program. However, as
indicated by your Corrective Action Plan, additional steps can be taken
to continue to strengthen program oversight and reduce the incidence of
erroneous payments.
What specific actions are supported in the fiscal year 2004 budget
request to prevent the occurrence of erroneous payments in the SSI
program and strengthen program oversight?
Answer. The President's fiscal year 2004 budget includes
appropriation language requiring the Social Security Administration
(SSA) to spend no less than $1.446 billion of the Limitation on
Administrative Expenses (LAE) for program integrity activities,
including continuing disability reviews (CDR), non-disability
redeterminations of eligibility in the Supplemental Security Income
(SSI) program, and overpayment workloads. This language will ensure
adequate resources for these three important and cost-effective
workloads that reduce erroneous payments, within the overall SSA
request of $8.53 billion. The fiscal year 2004 program integrity
investment will return lifetime program savings of more than $10
billion. The three key activities are:
--Continuing Disability Reviews.--SSA conducts periodic reviews to
ensure that only those beneficiaries who are truly disabled
continue to receive benefits.
--SSI Redeterminations.--Experience has shown that the most powerful
tool SSA has to detect and prevent improper payments in the SSI
program is to perform periodic reviews of the non-disability
factors of eligibility for SSI.
--Overpayment Collections.--Prompt processing of the Agency's debt
collection workload is an important element of sound financial
management and program stewardship. Having sufficient
administrative resources will allow SSA to process substantial
overpayment workloads and move forward as quickly as possible
to implement new tools of prevention, detection and collection.
SSA's substantial program integrity initiatives result in
significant benefits to the Government in terms of detecting and
collecting overpayments. Without these program integrity efforts, the
Agency would pay out billions of trust fund and general fund dollars in
erroneous payments. Experience has shown a $9-to-$1 return on for
investments in CDRs and a $7-to-$1 return for investments in SSI
redeterminations. Because these activities pay for themselves, many
times over, resources to support them shouldn't compete with resources
needed for service delivery; and the President's budget proposes
funding them through adjustments to discretionary spending caps.
The fiscal year 2004 budget also supports a number of initiatives
to prevent and collect erroneous payments in the SSI program and
strengthen program oversight, including piloting an automated monthly
wage reporting system using voice recognition and touch-tone phone
technology, testing electronic access to records of financial
institutions, and implementing cross program recovery, credit bureau
referrals, and Treasury Department administrative offset.
SSA's fiscal year 2004 budget also contains a legislative proposal
to apply the same requirements now in effect for reviewing title II
initial disability allowances to title XVI adult disability allowances.
Preeffectuation reviews have a high rate of return on investment, would
strengthen the integrity of the SSI program and help assure the
American people that their tax dollars are going only to individuals
who are truly disabled under the law.
Question. How will this budget request fully utilize all of the
tools provided by Congress for preventing and collecting erroneous
payments, in particular those authorized by the Foster Care
Independence Act of 1999? Also, if erroneous payment prevention and
collection authorities currently available are not being fully
utilized, is it because of a lack of resources available to the SSA? If
not, what is preventing SSA from fully utilizing these authorities and
what steps are being taken to overcome those barriers to full
implementation?
Answer. SSA has a vigorous program for developing all debt
prevention and collection tools authorized by Congress. The Agency's
program encompasses the authorities granted by the Foster Care
Independence Act (FCIA) of 1999, authorities given by other laws, and
self-initiated projects. SSA's strategy for implementing all of the
tools is to use its available resources first to develop those that
yield the most savings or that can be easily integrated into the
existing debt management framework.
The authorities granted by FCIA are: access to financial
institutions, credit bureau reporting, administrative offset,
establishing overpayments on the records of representative payees of
deceased beneficiaries, Federal salary offset, private collection
agencies, and interest charging. Authorities granted by other laws
include mandatory cross program recovery and administrative wage
garnishment.
debt prevention
The top two reasons for SSI overpayment errors are unreported wages
and unreported bank accounts with substantial assets. In the past, SSA
has focused on the detection of errors in payments already made.
Initiatives either planned or underway offer substantial promise as a
means to preventing error.
--Automated Monthly Wage Reporting Using Voice Recognition and Touch-
Tone Phone Technology.--The Monthly Wage Reporting Pilot using
voice recognition and touch-tone phone technology is one of the
steps SSA is exploring to facilitate wage reporting and reduce
the incidence of erroneous overpayments in the SSI program.
Each year we detect approximately $500 million in overpayments
due to wages. Over half this amount is due to the failure to
report changes to SSA. SSI recipients are required to report
whenever there is a change in their income or the income of a
deemor (a spouse or parents of a child under the age of 18
living in the same household but not receiving SSI). Some
individuals report changes as required, but many do not.
Currently, few SSI recipients have access to the Internet.
Therefore, we are testing a new automated telephone reporting
system that could quickly process large numbers of wage
reports. We will ask approximately 4,000 people to use this new
system to report wages once a month for a 6-month period, May
through October 2003. We will then verify the wage amounts to
determine if they reported accurately. If this test is a
success, automated monthly wage reporting will be rolled out
nationwide.
--Access to Financial Institutions.--SSA will test a process using
authority granted by FCIA to access the records of financial
institutions. Use of this tool during the initial claims
process will provide access to information on unreported income
or assets. Similarly, use of the tool during the SSI
redetermination process and periodically throughout the life of
a SSI recipient's entitlement will provide information
regarding a recipient's assets in relationship to limits
affecting eligibility. SSA is currently working to finalize the
rules for publication, which will enable SSA to proceed with a
proof of concept to test the capability of electronic access of
financial records later this year. If the proof of concept is
successful, SSA will develop plans for a phased rollout of the
new business process.
debt collection
SSA is constantly striving to improve its debt management program.
Since 1992, when the Agency implemented Tax Refund Offset (TRO) to
collect delinquent title II overpayments, SSA has put in place eleven
different improvements. These improvements include two major expansions
to the TRO program, credit bureau reporting and administrative offset
for delinquent title II overpayments and a streamlined remittance
process that uses state-of-the-art equipment. In addition, SSA worked
with Treasury's Financial Management Service to implement Benefit
Payment Offset and the Federal Payment Levy Program, whereby Social
Security benefits are offset or levied as collection toward delinquent
tax and non-tax debts owed by beneficiaries to other Federal agencies.
--Recent Initiatives.--In keeping with its developmental strategy,
SSA implemented mandatory cross program recovery in 2002
because of its promise of large debt collections. In fact cross
program recovery has enabled SSA to collect over $50 million in
SSI debt in less than one year. SSA also implemented credit
bureau reporting and administrative offset in 2002 because
those tools could be integrated easily into the existing debt
management system.
--Current Initiative.--SSA also is developing administrative wage
garnishment (AWG), which was authorized by the Debt Collection
Improvement Act. We believe AWG has the potential to yield the
largest amount of collections of all the remaining tools. We
estimate this tool will yield $105 million in the first five
years of its use ($80 million in title II collections and $25
million in title XVI collections).
--Future Initiatives.--When SSA completes its work on AWG, it will
move on to a pair of debt collection tools authorized by FCIA:
establishing overpayments on the records of representative
payees of deceased beneficiaries and Federal salary offset.
Although these two tools will yield direct collections from
payment sources such as tax refunds, other Federal payments and
Federal salaries, they will not approach the collection
potential of AWG, and that is why they will be developed after
garnishment.
Implementation of interest charging and use of private collection
agencies will follow the completion of Federal salary offset and the
establishment of overpayments on the records of representative payees.
full utilization of fcia tools
Debt management represents one of the many different areas
requiring resources. In fact, SSA has a multitude of initiatives
spanning all aspects of its business process. The Agency must
prioritize projects and choose the order in which they are developed.
SSA has a process for determining the priority of initiatives. This
process is manifested in SSA's Information Technology plan, where
projects are assessed based on their return on investment and other
critical factors. Based on this rigorous examination of projects, SSA
is focusing first on monthly wage reporting, access to financial
information and administrative wage garnishment.
Question. The ``Justification of Estimates for Appropriations
Committees'' for the fiscal year 2004 budget request for Social
Security Administration (SSA) states that: ``The Ticket to Work Program
is up and running in 33 States and the District of Columbia and will be
expanded to all States and U.S. territories in 2003.''
Specifically, how much funding is available within the fiscal year
2004 request for the Limitation for Administrative Expenses account to
support implementation of the Ticket to Work program and what
activities are supported?
Answer. SSA's fiscal year 2004 LAE account includes $39 million to
fund the following activities in support of the Ticket to Work program:
--Benefits Planning and Assistance Cooperative Agreements ($23
million).--Benefits planning, assistance and outreach (BPAO)
cooperative agreements are intended to ensure that these
community based services are available in every state, the
District of Columbia and every U.S. territory. The law
authorizes $23 million to be appropriated each year through
2004 for this purpose, and SSA's fiscal year 2004 budget
includes funding in this amount (including costs of related
training and technical assistance).
--Protection and Advocacy Grants ($7 million).--The 1999 Ticket to
Work Legislation authorizes $7 million to be appropriated each
year through 2004 for Protection and Advocacy (P&A) grants.
These grants will be used to provide advice to beneficiaries
and to provide an avenue for resolving disputes. Consistent
with the $7 million authorization, we plan to spend $7 million
(including costs of support services such as training and
technical assistance) for P&A in fiscal year 2004.
--Program Manager Contract ($9 million).--The Program Manager
contract was awarded to Maximus Inc. in fiscal year 2000 at a
total cost of $56 million covering the period September 29,
2000 through September 30, 2005. Maximus is a private Virginia
based organization that will help SSA manage the over-all
Ticket to Work program. Phase IV of the contract is funded in
fiscal year 2004 at $9.4 million.
In addition SSA's administrative budget supports other Return to
Work activities such as:
--The Ticket to Work and Work Incentives Advisory Panel advises the
Commissioner of SSA, the President, and Congress on issues
related to work incentives for people with disabilities.
--Other administrative costs include quality assurance contracts,
notices, miscellaneous printing costs such as public education
materials and reference guides, postage, training, travel, and
systems enhancements.
--Nationwide training and outreach efforts to build employment
support expertise in SSA's field offices. SSA also is looking
at its current incentives as they pertain to young people with
disabilities who are making the transition from school to work
and to disabled individuals with more challenging
rehabilitation issues.
Question. How much funding from other sources support the program
within the fiscal year 2004 budget request?
Answer. SSA's fiscal year 2004 budget includes program funding to
cover outcome and milestone payments made to Employment Networks (EN)
under the Ticket to Work program. Milestone payments are provided to
ENs based on a beneficiary's successful achievement of prescribed work
activity. Outcome payments are made once an individual's benefit
payments cease due to work activity and earnings. For fiscal year 2004,
we have budgeted $25 million in each program--Social Security (OASDI)
and Supplemental Security Income--to cover Ticket payments. In
addition, SSA provides reimbursement payments to State Vocational
Rehabilitation (VR) agencies, which elect to be paid under this system
and not as ENs, when they are successful in rehabilitating disability
beneficiaries. The budget includes an estimated $73 million to cover
OASDI VR reimbursement payments and $75 million to cover SSI
reimbursement payments in fiscal year 2004.
In addition, SSA's fiscal year 2004 section 1110 research budget
request, funded through the SSI appropriation, includes $5.2 million
for evaluation of the Ticket to Work and Self-Sufficiency Program. This
project will identify the most promising components of the Ticket to
Work initiative, the most efficient incentive structure for the
program, the refinements necessary to improve Ticket outcomes, and the
individuals most likely to benefit from the program. It also will
examine the adequacy of incentives in delivering services under the
program for hard-to-serve beneficiaries.
SSA's fiscal year 2004 budget for research and demonstration
projects also funds several other projects that support the return-to-
work initiative and the Ticket to Work program's goal of transitioning
disabled individuals into the workforce, including the Youth Transition
Process Demonstration, the Early Intervention Demonstration, and
evaluation of the Disability Program Navigator project with the
Department of Labor.
Question. Now that the SSA has roughly one year of experience with
Social Security and SSI disability recipients receiving Tickets for VR
services, what trends are evident in terms of the choices consumers are
making whether to utilize their ticket, the characteristics of
participating individuals, the organizational characteristics of
selected Employment Networks (including VR agencies), the way in which
such Employment Networks are paid and the employment outcomes for
participating individuals?
Answer. Our early information reveals that a fairly diverse group
of beneficiaries have made the decision to assign Tickets to providers
and to begin employment. So far, the profile of beneficiaries who have
assigned Tickets closely tracks the profile of Ticket-eligible
beneficiaries with regard to type of benefit, sex, type of disability
and time on the rolls. One interesting trend we will be watching is
that younger beneficiaries, those under age 40, are assigning Tickets
at a much higher rate than older beneficiaries are.
With respect to providers, approximately 85 percent of individuals
participating in the Ticket program have assigned their Tickets to the
State VR agencies; of these, about 60 percent are new clients to VR. VR
agencies have elected to receive payment under the traditional cost
reimbursement program for 95 percent of these beneficiaries. ENs with
Tickets assigned to them include traditional employment service
providers in the public and private sectors, and such non-traditional
providers as employers, colleges, employment agencies and job placement
services, hospitals, faith-based organizations and Department of Labor
One-Stop centers.
As of May 8, 2003, about 4 million Tickets have been mailed, and
more than 16,000 have been assigned to ENs or VR agencies. Although we
have information regarding payments to providers, it is still too early
to draw broad conclusions regarding the employment outcomes of
beneficiaries participating in the Ticket program. We will be
evaluating the Ticket program to identify its most promising
components, refinements needed to improve Ticket outcomes, and the
individuals most likely to benefit from the program, as well as to
assess the program's cost effectiveness. Nevertheless, many Ticket
participants are now working, and we are pleased to learn the success
stories from individuals whose receipt of the Ticket has provided them
the opportunity to return to productive employment.
By the end of this year, the Ticket-to-Work program will be
available in all 50 States. I truly believe that we're entering a new
era for people with disabilities--an era of new attitudes, new
possibilities, and new hopes. Many people want to work, and this
program helps them do that:
--Arizonian, Bob Q., used his Ticket, set up an appointment with an
employment network, and is now working as a marketing designer
for the real estate industry.
--Didi A. credits the Ticket-to-Work program for helping to provide
the motivation that brought her to Arizona Bridge to
Independent Living (ABIL). Using her Ticket, she met with a job
counselor who prepared her for work. Last September, Didi
accepted a position with the Arizona State Government.
--Vera L. has the longest recorded employment of the Ticket Program,
more than a year. Vera works 40 hours a week as a personal
assistant and has already received a raise.
Question. Through what means has SSA informed eligible
beneficiaries and recipients, employers, service providers and other
stakeholders about the Ticket program?
Answer. We've informed beneficiaries and recipients, employers,
service providers and other stakeholders about the Ticket program
through:
--The initial Ticket mailings, which we will complete in 2004;
--Media events to kick-off the Ticket program in several States in
the first two rounds of Ticket roll-out. I joined former
Senator Roth in Wilmington, Delaware to highlight presenting
``The First Tickets in the First State'' to individuals in
Delaware. I also hosted Ticket media events with Senator Ted
Kennedy in Boston, MA and Representative J.D. Hayworth in
Phoenix, AZ., and with Virginia State officials in Arlington,
VA;
--Partnering with the Office of Personnel Management (OPM) to promote
the Ticket program throughout the Federal government;
--Partnering with the Department of Labor's Office of Disability
Employment Policy to utilize its Employer Assistance Referral
Network and create a subunit named Ticket to Hire (TTH), which
specializes in matching employers with job-ready candidates
from the Ticket program;
--Partnering with private organizations to promote the program to a
diverse mix of employer groups;
--Recruitment fairs to educate service providers about the Ticket
program and encourage them to become ENs;
--Significant outreach to service providers and others by MAXIMUS,
our contracted program manager;
--Our Internet website, which educates and provides resources to
Ticket to Work stakeholders;
--National and regional representation, by specialized Ticket to Work
staff, at hundreds of conferences and forums that promote the
hiring of people with disabilities; and
--SSA's extensive informational materials provided in print and other
formats. SSA's Red Book on Work Incentives and a number of
other materials are used extensively in the field to inform and
train beneficiaries, advocates, service providers and others.
We are working on further enhancements to our outreach and public
information efforts. Plans include written and video presentation of
Ticket success stories, a new training effort to assist present and
potential ENs with information on potential funding sources and
analysis of emerging data on the Ticket program to target our
informational efforts.
Question. How much funding within the fiscal year 2004 Budget
supports training, technical assistance and outreach to these different
groups?
Answer. SSA's fiscal year 2004 administrative budget includes $39
million for BPAO cooperative agreements, P&A grants, and continuation
of the Program Manager contract. A large portion of that amount is used
to provide training, outreach and public information.
Question. How has SSA provided support to individuals in making
well-informed, work-related decisions, as well as in ensuring that
their legal rights are protected under new program authorities?
Answer. SSA has a multi-faceted approach to help beneficiaries with
disabilities obtain accurate and timely information and support
regarding return to work. The approach centers around continued
education and training for all direct service employees, the
establishment of partnerships with other agencies and organizations,
improved workload management and control systems, and the establishment
of a corps of full-time Area Work Incentives Coordinators (AWIC). The
AWIC will specialize in employment support workloads and services, and
serve as the Agency's ombudsman and focal point of contact for
advocates.
Two grant programs authorized by the Ticket to Work and Work
Incentives Improvement Act of 1999 provide support to individuals
regarding their participation in the Ticket program.
benefits, planning, assistance and outreach (bpao)
SSA awarded 116 cooperative agreements to a variety of community-
based organizations for BPAO projects. The goal of the BPAO program is
to enable SSA's beneficiaries with disabilities to make well-informed,
work-related decisions.
BPAO projects cover every State, Territory, and the District of
Columbia. Collectively they employ over 400 Benefits Specialists who
explain the complex interrelationship of SSA's benefits, those of other
Federal agencies and an individual's local programs. They assess the
potential impact of employment on a beneficiary's Federal and State
benefits eligibility and overall financial well being. Benefits
Specialists then develop a comprehensive framework of possible options
and projected results for each as part of the career development
process. Benefits assistance involves effective management of benefits
as well as problem-solving support as needed. It includes analysis,
reassessment, education, advisement and monitoring. Almost 50,000
beneficiaries have received direct services under the program to date.
Outreach activities by the BPAO projects are ongoing efforts to
inform beneficiaries, their families, service providers and other
stakeholders about the work incentives available. By enhancing
awareness and understanding of the supports to be had, the Benefits
Specialists alleviate the fear and uncertainty of beneficiaries
considering work. The BPAO program has become an important step on the
road to economic self-sufficiency for persons with disabilities.
SSA contracted with 3 universities to provide ongoing technical
assistance and training to BPAO projects so they may effectively and
responsibly serve clientele. Benefits Specialists must pass an
intensive 7-day orientation class and successfully complete a field
assignment before providing services under the program. In addition,
they attend refresher and follow-up courses throughout the award
period. This training is necessary to ensure dissemination of accurate
and timely information to our beneficiaries. SSA has provided an arena
in which persons with disabilities can confidently ask questions of a
trained professional who is not a federal employee.
protection and advocacy (p&a) grants
The Ticket to Work and Work Incentives Improvement Act of 1999 also
granted the Commissioner authority to make payments to P&A systems for
the purpose of providing services to beneficiaries with disabilities.
Those services include providing information and advice about obtaining
vocational rehabilitation and employment services as well as providing
advocacy or other services that a beneficiary with a disability may
need to secure or regain gainful employment. Under this new program,
P&A grantees ensure that beneficiaries' legal rights are protected.
SSA awarded a total of 57 grants to each of the States as well as
the District of Columbia, Puerto Rico, the United States Virgin
Islands, Guam, American Samoa, the Commonwealth of the Northern Mariana
Islands, and one for the Native American community.
In 2002 alone, more than 10,000 beneficiaries with disabilities
received P&A services free of charge which ranged from information and
referral to legal representation. The P&As gave over two thousand
outreach presentations during this period. Through conferences,
seminars, publications, websites, and public service announcements on
television and radio, the projects made people aware of viable
approaches to overcoming employment barriers. Examples of the
assistance provided under this program include:
--Fighting discrimination by employers against persons with
disabilities;
--Obtaining reasonable accommodations in the workplace;
--Mediating disputes involving job coaches and individual plans for
employment;
--Resolving transportation issues related to work;
--Acquiring tuition assistance and accommodations at educational
institutions;
--Locating the best Employment Network for a beneficiary's specific
circumstances;
--Working to improve Employment Networks' grievance procedures;
--Educating beneficiaries regarding the employment supports and
incentives available; and
--Educating the local community regarding the legal rights of
individuals with disabilities.
other initiatives
In addition to these programs, SSA plans to create a new position,
the Area Work Incentives Coordinator, to provide technical information
and assistance to beneficiaries and outside groups and coordinate work
incentive-related activities within the field offices of the Area they
represent.
At the same time, we plan to provide a customized training
curriculum to accommodate training needs specific to each employee's
role in administering employment support programs. For example,
continuing education on Ticket to Work and related issues of concern to
our beneficiaries will allow our public affairs personnel, using their
communications skills and community outreach opportunities, to become
effective ambassadors for these programs. In addition, our enhanced
training will ensure that field and 800-Number personnel will maintain
expertise on work incentives and employment support programs to be
responsive to inquiries and process actions as appropriate.
SSA is enhancing systems and establishing procedural changes that
will assist field personnel in processing actions efficiently and
accurately and will provide information to beneficiaries with
disabilities who are working or want to work. SSA is also building
these systems to improve workload management control and to provide
more management information about beneficiaries with disabilities who
are able to return to the workforce. It is important that there be a
pool of experts with technical expertise in the complicated issues that
can arise with a disability recipient who is pursuing and taking
advantage of employment opportunities. But it is equally important that
we continue to change the organizational culture to make return-to-work
an integral part of the entire Agency's mission.
In addition to providing designated experts, we plan to leverage
our resources by heightening the awareness of employment support
programs internally and externally and broadening the knowledge of our
entire Operations workforce.
Question. How has SSA collaborated with other federal agencies and
partners to increase the work opportunities of individuals receiving
Social Security and SSI disability payments and what resources are
included within the fiscal year 2004 budget request to carry out such
activities?
Answer. SSA is collaborating with others in the following research
and demonstration projects to increase the work opportunities of
individuals receiving Social Security and SSI disability payments.
Amounts budgeted for these activities and evaluations in fiscal year
2004 total about $20 million.
--Youth Transition Process Demonstration.--SSA will support State
projects to test and deliver needed services to young Social
Security and SSI beneficiaries with disabilities to assist them
in achieving independence.
--Disability Research Institute.--One of the goals of this
cooperative agreement with the University of Illinois at
Urbana-Champaign is to provide research findings in critical
disability policy areas, such as return to work strategies.
--State Partnership Initiative (SPI).--States have been testing
innovative approaches to coordinating vocational planning and
support, employer and employee coaching, financial planning,
health and long-term care, and other necessary supports for
disability beneficiaries. SSA will be evaluating the
effectiveness of these approaches.
--Disability Program Navigator.--SSA has partnered with the
Department of Labor (DOL) to support Benefit Navigators at DOL
One-Stop Career Centers to provide beneficiaries with
information on the Ticket to Work program and other SSA work
incentives and well as assistance with related programs that
may affect their ability to enter and retain employment
(Medicare and Medicaid, housing, etc.).
SSA also is collaborating with the U.S. Department of Labor (DOL)
to sponsor the Ticket to Hire program. This free nationwide referral
service is designed to assist employers in locating and hiring
qualified job candidates with disabilities from the Ticket to Work
program. Ticket to Hire connects employers to ENs or State VR agencies
from SSA's Ticket to Work program with job ready candidates. Ticket to
Hire provides the employer with a referral list of ENs in their
community. The employer can then contact these organizations to find
qualified candidate(s) who are participants in the Ticket to Work
program.
Ticket to Hire is a specialized unit of Project EARN (Employer
Assistance Referral Network), which is also sponsored by DOL and SSA.
If the Ticket to Hire staff is unable to locate organizations with
qualified candidates in their database, the vacancy information is
shared with EARN. EARN staff then searches a database that includes
additional organizations that are employment service providers and may
not be participating in the Ticket to Work program.
Question. The fiscal year 2004 budget request proposes obligations
of $2 million for Medicare Savings Program Outreach to continue
outreach efforts to all new eligible individuals, as well as to a
portion of those previously notified. Specifically, what outreach
efforts will be undertaken to newly- and previously-eligible
individuals? What portion of those previously eligible will be notified
in fiscal year 2004 and subsequent years?
Answer. SSA intends to send Medicare Savings Programs outreach
letters annually to all new beneficiaries who meet the statutory income
test and are not already receiving help with their share of Medicare
expenses. SSA will mail outreach letters to two groups of Medicare
beneficiaries who were on the roles before the previous letter
selection:
--Beneficiaries who had too much income for this help before but now
meet the statutory income test (e.g., as a couple there was too
much income, but the new widow's income now meets the statutory
test); and
--One-fifth of people who received outreach letters before who
continue to meet the statutory income test and are not already
receiving help with their share of Medicare expenses.
SSA will continue to share electronic files of selected potentially
eligible beneficiaries of the Medicare Savings Programs with their
servicing Medicaid State agencies.
SSA plans to continue the letter and file-sharing activities
described above for new and previous eligibles annually. These
activities will ensure that every potentially eligible beneficiary
receives an outreach reminder letter at least once every five years and
States will receive appropriate information each year.
Question. How has the GAO evaluation of outreach efforts guided
development of your proposed fiscal year 2004 activities?
Answer. GAO has not yet shared evaluation data or results with SSA.
SSA looks forward to receiving the GAO evaluation as a potential source
of information that could be used to improve this process.
Question. Earlier this year, the General Accounting Office (GAO)
added Social Security's disability programs to its list of High-Risk
programs. Your fiscal year 2004 budget request supports making
substantial progress towards national implementation of an electronic
disability process--AeDib--by the end of fiscal year 2004 as a means to
improving the timeliness of and efficiency associated with disability
decisions.
How much funding is included in the request to support the AeDib?
GAO has stated (GAO-03-225, page 132) that the agency has had ``mixed
success in past technology investments.'' How has the agency's previous
experience with major technology investments helped guide the design
and implementation strategy for this new initiative?
Answer. The Agency will begin national implementation of the
Accelerated Electronic Disability System (AeDib) on January 1, 2004.
Over an 18-month period the system will be installed in every State
Disability Determination Services (DDS) center in the country. We
estimate an initial IT investment of about $150 million during the
budget period for AeDib planning, development and implementation. In
addition, significant SSA staff effort will be devoted to project as
well as related non-IT support costs.
A previous effort to automate the disability process at SSA was
called the Reengineered Disability System (RDS). In 1999 Booz Allen
Hamilton assessed RDS and made recommendations to the Agency concerning
the use of technology to improve future disability processing. AeDib is
based on those recommendations.
Many technological lessons were learned from RDS. For example,
while RDS was designed to create one processing system for all of the
State DDSs, AeDib will not replace the current DDS case processing
systems. Instead, each State is upgrading and enhancing its systems in
order to accommodate the Electronic Folder.
SSA is building applications that allow the public to file for
disability over the Internet. SSA also is creating a fully automated
Office of Hearings and Appeals Case Processing and Management System.
This system will automate the hearing process from initial receipt
through final disposition.
In order to evaluate our progress every step of the way and to
continue to meet the goals of the project, each project associated with
AeDib has been or will be rolled out in phases. This process allows SSA
to gain the experience it needs in order to continue to meet the
customer's needs.
To effectively enhance the capabilities of the Electronic Folder
and to provide the infrastructure needed for other initiatives, SSA has
completed an initial upgrade to its telecommunications infrastructure.
SSA also is maximizing the use of Commercial Off-the-Shelf products.
To document and ensure that we target our development work by
determining specific areas with the highest paybacks, Booz Allen
Hamilton has completed a Cost Benefit Analysis for AeDib.
Question. What actions are planned to ensure that all components,
including state disability determination services, have sufficiently
trained staff, available technical and program support and adequate
resources to implement this initiative and how much is provided within
this budget request for these activities?
Answer. AeDib will provide the infrastructure to support paperless
and electronic processing of disability claims from initial contact
through the hearing decision. To ensure success and ease implementation
activities, AeDib has been broken into several interrelated projects.
First, the American public will have the ability to complete
disability claims over the Internet. We have already successfully
implemented the adult version of the Social Security disability
application and medical form. Prior to national implementation, members
from the public came to SSA headquarters to test the disability form.
Between now and January 2004, we will be adding additional forms to the
Internet.
What the Internet provides for the public, the Electronic
Disability Collect System (EDCS) provides to field offices. EDCS is
used to electronically collect medical information previously obtained
on paper forms for initial adult and children cases. Regional trainers
from across the nation came to SSA headquarters to receive ``Train the
Trainer'' instruction on EDCS. As of February 2003, every field office
received EDCS training. Between now and January 2004, additional
functionality including hearings and continuing disability reviews will
be added to the program.
The next (and most complicated) project is the Electronic Folder. A
prototype of the Electronic Folder was completed in October 2002, and
pilots are scheduled to run from July 2003 through December 2003. One
of the major activities that SSA needed to accomplish to allow the
State Disability Determination Services (DDS) to interface with the new
Electronic Folder was to provide them with new computer hardware. We
accomplished this in September 2002. We provided the hardware training
to the DDSs. We are now in the process of upgrading the software.
Implementation of the Electronic Folder, combined with EDCS, will
significantly change the business process and reduce case processing
times.
The last project is to create an automated system known as the
Office of Hearings and Appeals Case Processing and Management System
(CPMS). Currently OHA has very limited automation. This project will
automate the process from initial receipt through the final decision,
which will improve case processing and contribute to productivity
improvements. We are working closely with our user groups to build a
successful CPMS prototype.
Our training strategy also is multifaceted. SSA has conducted AeDib
training for regional trainers at SSA headquarters. At SSA
headquarters, technical staff has been undergoing extensive training to
learn how to use and integrate new technologies.
In order to ensure a successful implementation of the Electronic
Folder, SSA will provide onsite technical training and support to the
various components. The goal is to ensure that the architecture is
operating smoothly and that SSA/DDS staffs supporting the system are
provided with expert training. SSA, working with the DDSs, will also
provide hands-on business training to all Federal and State components
working with the new Electronic Folder.
Our fiscal year 2004 budget includes approximately 300 workyears in
order to support these implementation initiatives and meet our goals.
Question. What steps have been taken to secure the privacy of
electronic information collected?
Answer. Several steps are being taken to secure the privacy of
electronic information for the AeDIB process as well as for other
projects SSA is undertaking. Specifically for AeDIB:
--Developers are following the SSA Systems Development Life Cycle,
which includes ongoing security review (access controls,
separation of duties, integrity, audit trail etc.), on an
iterative basis.
--We are currently piloting a secure transport mechanism for
disability data.
--A systems manager responsible for the overall project has been
named and is drafting a security plan for the project.
--We are in process of awarding a contract for a security risk
assessment monitored by the project officer, system manager and
security staff.
--We have implemented ongoing monitoring of Electronic Medical
Evidence and Security status meetings by Chief Security Officer
staff.
Question. What additional steps are being considered to improve the
accuracy, timeliness and cost-efficiency of the disability
determination process and what is the timeline for their
implementation?
Answer. AeDib is one of the key steps SSA is taking to improve the
disability process. AeDib rollout will begin in January 2004 and
continue for 18 months. While processing time is expected to improve
slightly in 2004, this initiative is expected to substantially reduce
processing time over the long term.
--AeDib will provide us with tools to move work seamlessly from place
to place, increasing access to agency medical and technical
expertise, maximizing agency resources, and supporting quality
adjudication. The first piece of AeDib is the electronic intake
system Electronic Disability Collect System (EDCS) which began
in October 2002. By automating data collection, the accuracy of
the information will be enhanced and more complete information
will be passed to the Disability Determination Services (DDS)
and later to the Office of Hearings and Appeals.
--We will be conducting assessments throughout start-up and rollout
of the new system and process. Additionally, we will be
conducting a post implementation review that will help
determine impacts, efficiencies and quality results based on
AeDib.
--SSA also is working with the medical community to leverage their
electronic processes in coordination with our AeDib medical
evidence activities. Our goal is to increase the electronic
exchange of medical evidence to maximize efficiencies in
alignment with Health Insurance Portability and Accountability
Act (HIPAA) regulations. On May 8, I met with representatives
from some of the nation's largest medical professional
associations to discuss SSA's medical evidence needs, the
process for obtaining evidence, the new HIPAA compliant
authorization form, and our vision of a future electronic
business process.
SSA has been engaged in a number of efforts to redesign and improve
the disability determination process by testing several initiatives
over the past several years. Based on our review of their results, we
have decided to:
--Encourage early and frequent contacts with claimants during the
development process;
--Eliminate the claimant conference at the end of the process; and
--Temporarily extend the ``elimination of reconsideration step''
feature in the Prototype States that are currently doing this,
while SSA develops an alternative approach.
The amount of time the SSA appeals process takes also has been a
major concern. SSA has made the following near-term changes to the
hearing process, based on analysis of the Hearings Process Improvements
(HPI) initiative:
--Include ALJs in early case screening to more quickly identify cases
for dismissal and possible on-the-record decisions;
--End the requirement that cases be certified as ``ready to hear'',
removing a step in the process;
--Allow ALJs to issue fully favorable decisions from the bench
immediately after a hearing; and
--Expand the use of technology in the Office of Hearings and Appeals,
including video teleconferencing, speech recognition and
digital recording of hearings.
SSA also is assessing its policies and procedures to enable
simplification of data collections and case documentation. We have
revised and consolidated data collection forms to ensure consistency
and accurate data propagation. For example, we are combining 3 forms
into a single public-use document as part of the appeals process.
SSA currently reviews at least 50 percent of all title II initial
disability allowances made by State agencies on behalf of SSA. The
fiscal year 2004 President's budget includes a proposal to apply the
same requirement for adult disability allowances in the SSI program.
That is, when fully phased in, 50 percent of initial SSI disability
allowances would be reviewed, applying consistency across both
disability programs.
We expect to make recommendations soon regarding additional steps
we can take to improve the disability process.
Question. Commissioner, you have stated that the Hearings Process
Improvements (HPI) initiative, which was implemented in 2000, has not
worked and that SSA has implemented additional changes to the process,
based on your assessment of HPI.
What lessons has SSA learned from the failure of HPI and how were
they used to develop and implement the latest changes?
Answer. What we learned during the course of HPI has yielded
insights valuable to the further refinement of our hearings processes.
We have not yet implemented our contemplated mid-term and long-term
process changes. Therefore, these responses chiefly address changes we
have made in the short-term.
We learned that the HPI processes included unnecessary case
handoffs. In our latest changes, we sought to eliminate these handoffs.
For instance, we observed that attorney and paralegal certification of
cases as ``ready to hear'' before sending those cases to Administrative
Law Judges (ALJs) for prehearing review was a step of limited value. We
have eliminated that step. Though we had initially thought that
rotating functional assignments among support staff would improve
overall hearing office performance, we discovered that rotation
actually undermined the strengths of our staff. Consequently, we
discontinued rotations and created a new position, the Case Intake
Assistant, with duties that incorporated the previously rotated
functions.
HPI taught us the importance of a strong management team in the
hearing offices. We are striving to strengthen the management structure
in the field. HPI also taught us the importance of prompt
implementation of systems support needed to support new initiatives. We
are proceeding as expeditiously as possible with the development and
implementation of new technology and applications to support the Office
of Hearings and Appeals' (OHA) business processes.
Question. Given that implementation of reforms is very costly in
terms of additional delay for individuals involved in the process, lost
production time, and staff anxiety, what steps were taken to involve
all stakeholders in the latest reform and what resources are included
in the fiscal year 2004 request for staff training and support of
implementation?
Answer. We haven't undertaken a major reform of the hearing process
since HPI. However, we recognize there are significant hearing backlogs
and we need to make every effort to move toward reducing those
backlogs. For this reason, with the proposed transfer of Medicare
hearings to the Department of Health and Human Services in fiscal year
2004, this budget redirects 478 workyears previously used to process
Medicare hearings to processing SSA disability hearings and appeals
instead. This will enable SSA to process 46,000 more SSA hearings in
fiscal year 2004 than in fiscal year 2003 and improve service by
reducing the hearings processing time.
We have focused on processing the work with incremental initiatives
that could be effectuated in the short term with little delay for
individuals involved in the process and minimal, if any, loss of
production time. We believe the nature of these changes, our candid
discussions with all of the unions representing our employees, and the
initiatives' incremental implementation over the past year have helped
to minimize any potentially adverse impact on employee morale and
productivity. And, despite additional investments in training, savings
from initiatives will increase the overall production rate for SSA
hearings from fiscal year 2003 to fiscal year 2004.
The budget continues to support base levels of ongoing and new
staff training for OHA staff, plus significant training for
technological enhancements to the business process in fiscal year 2003
and fiscal year 2004, including training related to implementation of
AeDIB. Most of the cost of staff training is the workyear cost, along
with related non-payroll expenses for instructors and travel. For
fiscal year 2004, we estimate about 250 workyears for OHA training,
including about 100 workyears related to AeDIB.
Question. How will the latest reforms improve timeliness, accuracy
and efficiency of decision making? What other changes have been
implemented to help improve productivity and increase the likelihood of
getting the right decision at the earliest possible time?
Answer. We are preparing cases for hearing more quickly and in
greater numbers with the aid of contract file assemblers, who furnish
clerical support for file preparation. As previously noted, we also
have eliminated rotational assignments for case technicians. These
actions free case technicians to concentrate their attention on more
complex case preparation tasks.
We have asked our most highly trained employees, ALJs, to join
other professional hearing office employees in early screening and
reviewing cases most likely to warrant on-the-record decisions. ALJ
participation in this process facilitates review of a higher percentage
of such cases, thus increasing the number of cases that can be decided
early, without the necessity of a hearing.
We have implemented a new decision writing program for fully
favorable decisions that is easy for ALJs and decision writers to use
and fully documents the legal basis for fully favorable decisions.
Providing the new program as a tool for their use, we have asked ALJs
to use their personal computers to draft any fully favorable decisions
they reach as a result of early screening, as well as any decisions
that they announce orally at a hearing. This eliminates case handoffs
to the decision writers and frees the decision writers to concentrate
on more complex cases.
We are providing speech recognition software to ALJs and decision
writers to facilitate decision drafting. The introduction of this
software will eliminate the need for transcription of dictated
decisions by case technicians, shortening case processing time and
freeing the case technicians for case preparation duties.
Question. The GAO Report ``Social Security Disability: Efforts to
Improve Claims Process Have Fallen Short and Further Action is Needed''
(GAO-02-826T) found that in fiscal year 2000, about 40 percent of the
applicants whose cases were denied at the initial level appealed this
decision and about two-thirds of those who appealed were awarded
benefits. What resources and activities are supported in the fiscal
year 2004 budget request to specifically address this issue and reduce
the likelihood that initial decisions are changed upon appeal?
Answer. Our goal is to make the right decision on disability claims
as early in the process as possible. We should note, however, that a
different decision during the appeals process does not necessarily mean
that the initial decision was wrong when it was issued. Unfortunately,
currently many months may elapse between the initial determination and
the various steps of the appeals process and, during that time, the
claimant's medical condition may have worsened. And, we allow a
claimant to provide additional information at any time during the
process. So a person who may not have met the criteria for disability
assistance at the first step may meet those criteria by the time a
hearing can be held. This kind of situation shows the importance of
reducing the delays and backlogs that currently make the appeals
process take so long. (We also are working on finding ways to ensure
that complete information is provided at the initial determination step
so that the decision-maker can consider all factors that may affect the
decision.) For this reason, I have made eliminating backlogs a primary
focus.
As I indicated in my testimony at the March 4, 2003 House
appropriations hearing before the Subcommittee, the President's budget
request for fiscal year 2004 demonstrates our commitment to continuing
efforts to improve service, efficiency and program integrity in the
disability program. Issues regarding the appeals process and reducing
the likelihood that initial decisions are changed upon appeal are
longstanding concerns in the disability program. We expect to make
recommendations that address those issues in the coming months, and
expect to propose changes that are cost-neutral in terms of the overall
impact on SSA's budget.
In order to effectively address the systemic issues in the
disability process, we need to get the existing disability workloads
under control. Based on the work that has been done on our Service
Delivery Assessment, it is clear that eliminating backlogs and
processing special workloads are prerequisites for providing good
service to the public. Although approximately 40 percent of disability
claims are approved within three and a half months of initial
application, for applicants who exercise all administrative appeal
rights provided under current law and current processes, an average of
1,153 days is required for a final Agency decision. Based on our
analysis, almost 50 percent of this time in the process results from
the backlog of cases.
We are taking a number of actions in the near term to reduce
processing times and increase efficiency. The fiscal year 2004 budget
request supports those actions. As indicated above, we are engaged in
review of strategies to further improve the disability program and
expect to make recommendations soon.
Question. The fiscal year 2004 President's Budget proposes to
transfer responsibility for Medicare hearings from SSA to the
Department of Health and Human Services (HHS).
What are the actual expenditures and associated workload processed
in fiscal years 2000, 2001 and 2002, as well as those estimated in
fiscal year 2003?
Answer. The chart below provides actual expenditures and associated
workloads for Medicare hearings for fiscal years 2000, 2001 and 2002 as
well as those estimated for fiscal year 2003 in the fiscal year 2004
President's budget. The estimates for fiscal year 2003 assume an
increase in receipts related to the Medicare, Medicaid and SCHIP
Benefits Improvement and Protection Act of 2000 (BIPA) and
implementation of a streamlined process for handling Medicare appeals.
Neither of these has occurred.
----------------------------------------------------------------------------------------------------------------
Actual fiscal year Estimate
Medicare hearings --------------------------------------- fiscal year
2000 2001 2002 2003
----------------------------------------------------------------------------------------------------------------
Receipts.................................................... 77,872 77,726 71,576 122,147
Processed................................................... 88,084 69,663 77,388 105,000
Pending..................................................... 35,904 43,517 37,705 54,852
Expenditure (dollars in millions)........................... $79 $74 $78 $79
----------------------------------------------------------------------------------------------------------------
Question. What planning and transition activities are being
undertaken with HHS/CMS to ensure that a timely and smooth transition
occurs, if legislation is enacted that transfers the Medicare appeals
function effective October 1, 2003 as proposed in the President's
budget?
Answer. While we have agreed with HHS/Centers for Medicare and
Medicaid Services (CMS) in principle to transfer responsibility for the
Medicare hearings function effective October 1, 2003, we are still
working out the details of the workload transfer. In January 2002, I
established an executive level position on my staff to work directly
with the CMS Administrator and his staff to provide technical
assistance in the design of a hearing process and service delivery plan
tailored to the unique needs and opportunities of Medicare appeals. SSA
and HHS/CMS have had an ongoing dialogue since that time. These
discussions focus on issues such as transfer of cases, sharing of
resources (e.g., video teleconferencing), and systems support. A
Memorandum of Agreement that will reflect these decisions is being
prepared.
Beginning with fiscal year 2004, consistent with the
Administration's plan to transfer the Medicare hearings function to the
Department of Health and Human Services, SSA's annual budget request
does not include the resources that would be needed to process Medicare
hearings. The President's budget now includes the Medicare hearings
function and related funding under the Department of Health and Human
Services, which is accountable by law for management and administration
of the Medicare program.
Question. What amount of budget authority is required in fiscal
year 2004 to process fully this workload, if legislation is not enacted
consistent with the President's budget?
Answer. Funds to process Medicare hearings are budgeted in HHS/CMS
for fiscal year 2004. Consistent with our assumption that HHS/CMS will
assume responsibility for the Medicare hearings function beginning
October 1, 2003, SSA has not included any resources in its fiscal year
2004 budget request to process this workload.
Question. In January 2001, the General Accounting Office identified
strategic human capital management as a governmentwide high-risk area.
What steps are you taking to acquire, develop, and retain an
appropriate mix of agency staffing/talent, particularly in light of the
Agency's impending retirement wave? What is the agency's plan for
creating an organizational culture that promotes high performance and
accountability and empowering and including employees in setting and
accomplishing programmatic goals? How does the fiscal year 2004 budget
support these activities?
Answer. SSA is taking a number of steps to acquire, develop, and
retain an appropriate mix of agency staff.
SSA started retirement wave analysis and planning over five years
ago. This analysis was the impetus for our Future Workforce Transition
Plan (FWTP), which positions us well to transition to the workforce of
the future. The FWTP contains milestones regarding recruitment,
retention, employee development and a satisfying work environment. It
is aligned with our mission, goals and objectives and is integrated in
budget, strategic and performance plans. Selected highlights of our
activities include:
To acquire staff, SSA:
--Created a national recruitment coordinator position with
responsibility for developing and implementing recruitment
initiatives SSA-wide;
--Uses recruitment and retention incentives, including above minimum
starting salaries, recruitment bonuses, relocation bonuses and
retention allowances;
--Uses delegated expedited methods to reduce the time it takes to
fill jobs, and continues to work with the Office of Personnel
Management to find ways to accelerate the staffing process;
--Is piloting a competency-based hiring process;
--Fills vacancies as early as possible in the fiscal year, subject to
budget and hiring authority; and
--Rehires experienced annuitants in times of critical need.
To develop and retain staff, SSA:
--Incorporates organizational values into entry level training and
new hire orientation;
--Offers extensive technical and leadership training via Interactive
Video and the Intranet. Personal development courses are also
available online and can be taken at home.
--Is restructuring curricula around identified competencies to ensure
that employees have the knowledge and skills to respond to
emerging needs;
--Has a variety of career paths for employee advancement;
--Offers career counseling services;
--Offers national Leadership Development Programs designed to build
identified leadership competencies for GS-9 through GS-14
employees, as well as a Senior Executive Service (SES) Career
Development Program designed to develop executive leadership in
the Agency's succession planning efforts. SSA's organizational
components also have a variety of development programs at
various grade levels nationwide; and
--Offers SES development opportunities outside of the formal
programs.
SSA is creating an organizational culture that promotes high
performance and accountability and empowering and including employees
in setting and accomplishing programmatic goals. SSA's revised SES
performance management system is linked to strategic goals and
distinguishes between high and low performance. A revised system for
non-bargaining unit GS-15s will be implemented October 1, 2003. An
executive level workgroup is currently developing alternative
performance systems models for all other employees, taking into account
the connection with the awards and promotion systems. Plans for all
other employees will take effect with the signing of a new labor
contract with AFGE in fiscal year 2004.
Also, SSA sets programmatic goals through our strategic planning
process. This process considers our responsibilities to the public we
serve and environmental factors such as demographics, health and
disability trends, technological advances and workforce trends. Our
employees are key to success in accomplishing these programmatic goals.
They are actively encouraged to offer suggestions through our newly
automated suggestion program. They are invited to participate on
workgroups or provide input as we develop and test new processes.
Additionally, in early fiscal year 2003 I held a series of 11
candid, interactive meetings with all supervisors, managers and
executives in the Baltimore/Washington headquarters area, discussing
leadership principles, management philosophy and the Agency's four
major performance areas. During the summer of fiscal year 2003, I plan
to discuss this same set of critical topics with the full management
cadre in each of the 10 regional office cities and from field offices
in commuting distance of those cities.
The fiscal year 2004 budget supports these activities with a
consistent level of baseline funding to accomplish many of the
activities cited. Consistent with actual spending in fiscal year 2002,
the fiscal year 2004 budget also includes approximately $4 million in
project-specific funding for the following initiatives:
--Interactive Video Teletraining
--Leadership Development Programs: Senior Executive Service, Advanced
Leadership Program, Leadership Development Program, and
Presidential Management Intern Program;
--Leadership Seminars
--Performance Management Training
SSA's budget also provides funding for participation in LEGIS
Fellows Programs, OPM Management Development Programs and Federal
Executive Institute programs. Funding to maintain the recruitment
marketing program developed in fiscal year 2002 and to advance the
competency-based recruitment initiative also is included in the budget.
Question. The Congress appropriated additional funds from fiscal
year 1996 through fiscal year 2002 to ensure that the Agency would
carry out a 7-year plan to become current in processing CDRs. The
fiscal year 2004 request includes dedicated funding of $1.4 billion,
for among other things to process continuing disability reviews.
Is the Agency on schedule to remain current with processing CDRs in
fiscal year 2003?
Answer. In fiscal year 2003, SSA is focusing on keeping up with
claims workloads so that the number of disability claims pending does
not grow. Consequently, we will not be able to process all CDRs
necessary to remain current. We began this year under a continuing
resolution and operated for four months at last year's level. In
addition, we are absorbing an across-the-board rescission of .65
percent and a higher-than-budgeted pay raise. Nevertheless, we will
continue to assess our ability to process more CDRs in fiscal year 2003
than reflected in the fiscal year 2004 President's budget, while
keeping up with claims receipts, and will increase the number of CDRs
processed to the extent that we are able.
Question. What lessons did SSA learn during this 7-year period
about efficiently using these funds to stay current with its CDR
obligations?
Answer. If SSA is adequately funded for CDRs we can stay current
with this workload. However, we also have learned that we need to work
closely with the States and balance the resources applied to CDRs with
those for processing initial claims. We have been unable to keep up
with incoming disability claims receipts since fiscal year 1997. This
situation was compounded by a recent surge in initial receipts. As a
result, DDSs entered fiscal year 2003 with the highest initial pending
level in DDS history. Currently, it is difficult to ensure adequate
funding for stewardship activities when they compete for the same
discretionary dollars. Specifically, we face two significant competing
demands: (1) the need to pay disabled claims as quickly and
proficiently as possible; and (2) the need to serve as stewards of the
public trust and perform CDRs to protect program integrity in our trust
fund and general fund programs.
The discretionary funding cap adjustments for CDRs authorized by
Congress for fiscal years 1996 through 2002 were crucial to realizing
currency for both the title II and title XVI disability review programs
at the close of fiscal year 2002. The discretionary spending cap
adjustment for CDRs and other integrity workloads that the President is
recommending in the fiscal year 2004 budget would ensure adequate
funding for the future to maintain currency with CDRs and process other
cost-effective program integrity work thereby, enabling SSA to meet
both its stewardship responsibilities and overall service demands.
The Agency would not have achieved currency at the close of fiscal
year 2002, nor will it be able to remain current in the future, without
the CDR profiling/mailer process. SSA uses highly skilled statistical
support from contractors in performing the statistical analyses that
determine who can be sent a CDR mailer, what action to take (automated
decision logic) when a CDR mailer is returned, and many of the
automated functions of both CDR mailer and full medical processing. SSA
has a wealth of data at its disposal resulting from hundreds of
thousands of CDR decisions. Over the past several years the
contractors' products have enabled SSA to perform mailer, rather than
full medical reviews, for several hundred thousand additional CDRs than
was possible in the first few years of the 7-year plan.
The CDR mailer process involves little public burden (it is
estimated to take approximately 15 minutes to read the instructions and
complete the form), and it is also cost-effective. Agency budget
documentation indicates that the unit cost of a CDR mailer in fiscal
year 2001 was $27, while the unit cost of a full medical review was
$689. In fiscal year 2001, the CDR mailer accounted for over 50 percent
(about 895,000 of 1,731,000) of reviews reported to Congress. In fiscal
year 2001 alone, even if the Agency had the workforce capacity, an
additional 895,000 full medical reviews would have cost an additional
$592 million when compared to processing the same number of CDR mailer
deferral actions. (The Agency did not have the workforce capacity that
would have allowed us to accomplish these medical reviews had there
been funding available.)
Since its inception, integrity sampling has been a key element in
assuring that the process is a legitimate alternative to a full medical
review. The CDR mailer process undergoes continuous, rigorous studies
and audits, including yearly audits by PricewaterhouseCoopers as agent
for SSA's Office of the Inspector General.
Question. What is SSA's plan for remaining current this year and in
the future for processing CDRs?
Answer. As previously indicated, in fiscal year 2003 SSA is
focusing on keeping up with claims workloads and therefore will not be
able to remain current with CDRs this year. SSA plans to include
sufficient resources in its budget requests to maintain currency with
CDR workloads. In support of that goal, the fiscal year 2004
President's budget includes earmarked funding of $1.446 billion for SSA
program integrity workloads, including CDRs, and a proposal to treat
this funding outside the discretionary spending caps.
Question. Please provide the subcommittee with a breakdown of the
administrative costs associated with legislative proposals included in
the fiscal year 2004 budget. Are these costs fully covered within the
fiscal year 2004 budget request for LAE?
Answer. The President's fiscal year 2004 budget for SSA includes
eight legislative proposals, only one of which would have significant
administrative costs for SSA. That is the proposal for implementation
of pre-effectuation reviews (PER) of SSI adult disability allowances,
similar to the reviews now in place for Social Security disability
program allowances. SSA's fiscal year 2004 LAE request includes $10
million to implement SSI PER. Generally, SSA's administrative budget
requests to Congress are based on current law. We have made an
exception to the general practice in this case, due to the likelihood
of enactment of SSI PER, based on the progress of this proposal in the
107th Congress and now in the 108th. Implementation of SSI PER will
yield substantial program savings.
The other SSA legislative proposals are as follows:
--Improved reporting of pension income from non-covered employment--
The Administration is working to determine the best way to
obtain noncovered pension information systematically from State
and local government employers, for enforcement of the Windfall
Elimination Provision (WEP) and Government Pension Offset (GPO)
provision of the law. The details of the proposal are still
being developed.
--Close the loophole that allows exemption of spouses from the GPO
based on one day in covered employment.
--Trust fund compensation for Military Service Wage Credits--This
proposal makes the trust funds whole for FICA tax equivalents
that remain unpaid by the Department of Defense for 2000 and
2001, including appropriate interest, together with adjustments
for prior years. There is no administrative impact.
--SSI Program proposals:
--Exclude from determination of individual income all interest and
dividend income earned on countable liquid resources and
revise the infrequent and irregular income exclusion.
--Remove the restriction on payment of benefits to children who are
born or who become blind or disabled after military parents
are stationed overseas.
--Treat all cash military compensation as earned income.
--Count nonrecurring income only for the month it is received
during the transition to retrospective monthly accounting
during the first three months of eligibility.
SUBCOMMITTEE RECESS
Senator Specter. Thank you all very much. The subcommittee
will stand in recess to reconvene at 9:30 a.m., Wednesday,
April 9, in room SD-138. At that time we will hear testimony
from the Honorable Elaine L. Chao, Secretary, Department of
Labor.
[Whereupon, at 11:10 a.m., Tuesday, April 8, the
subcommittee was recessed, to reconvene at 9:30 a.m.,
Wednesday, April 9.]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2004
----------
WEDNESDAY, APRIL 9, 2003
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:35 a.m., in room SD-138, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Byrd, Harkin, and Murray.
DEPARTMENT OF LABOR
Office of the Secretary
STATEMENT OF HON. ELAINE L. CHAO, SECRETARY OF LABOR
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. Ladies and gentlemen, the Appropriations
Subcommittee on Labor, Health and Human Services, and Education
will now proceed. This morning, we have the distinguished
Secretary of Labor.
Secretary Elaine Chao was sworn in on January 31, 2001, the
24th Secretary of Labor. She had been president and CEO of the
United Way Foundation, served as director of the Peace Corps
and Deputy Secretary for the Department of Transportation under
President George H. W. Bush, distinguished fellow at the
Heritage Foundation, MBA from Harvard Business School and an
undergraduate degree from Mount Holyoke. She has also studied
at MIT, Dartmouth, and Columbia University. She is a veritable
Ivy League participant.
Madam Secretary, we welcome you this morning. We are
examining your budget and the activities of your Department,
and it is always a difficult matter to allocate funding, but
the subcommittee is concerned that the discretionary budget
request for fiscal year 2004 is more than $368 million under
the current budget, and we realize that budgets are established
by the Office of Management and Budget of the administration,
but we express concern about decreases and elimination of
programs. The dislocated worker assistance program is down by
more than $78 million, and that's a very difficult area. Just
yesterday at a hearing of the Steel Caucus we heard the
concerns of dislocated workers who were being impacted by the
acquisition of Bethlehem Steel by the International Steel
Group.
We note the elimination of a program on reintegration of
youthful offenders, which in my view is a very important
program, trying to take youthful offenders out of the crime
cycle, something I worked with for many years as District
Attorney of Philadelphia, and have on the Judiciary Committee,
and the elimination of the program of youth opportunity grants,
cuts in mine safety and health, a tough issue. We had an
enormous problem in my State, Somerset County, with a mine
disaster last summer. This subcommittee held hearings there,
and cuts in that program are troubling. Cuts in the OSHA
training grants and the job training pilot program and
international labor affairs are all matters of concern to the
subcommittee.
With those opening comments, Madam Secretary, we are
pleased to have a chance to discuss these issues with you in an
ongoing relationship, and we now look forward to your
testimony. The floor is yours.
SUMMARY STATEMENT OF HON. ELAINE L. CHAO
Secretary Chao. Thank you, Mr. Chairman. I hope you will
not let the Ivy League background be held against me.
Senator Specter. I would consider it very much in your
favor, having some association myself.
Although the days I spent at the University of Oklahoma,
which has been very non-Ivy League compared to the fancy Yale
Law School or the fancy University of Pennsylvania, I think
non-Ivys have a lot to recommend them, too, but so do we Ivys,
Madam Secretary.
Secretary Chao. Mr. Chairman, thank you for the opportunity
to present the Department of Labor's fiscal 2004 budget. The
focus of this budget can be summarized in two words, employment
and enforcement. The fiscal year 2004 budget and the
President's Economic Growth Package reflects this
administration's commitment to helping Americans find good jobs
and to ensuring that our workers remain skilled, safe, and
fairly compensated.
The total request for the Department in fiscal year 2004 is
$56.2 billion in budget authority and 17,503 FTE, of which
$11.5 billion is the discretionary portion.
The Department is proposing several changes to the
Workforce Investment Act which we believe will improve
accountability, eliminate duplication, enhance the role of
employers in training and placement, and increase State
flexibility. We request $2.6 billion for youth employment and
training programs to help young people make a successful
transition to the world of work, family, and responsibility.
The proposal includes $1 billion for a reformed youth
grants program. Twenty percent of these funds will be set aside
for challenge grants to cities and rural areas experiencing
unique youth development needs. $3.1 billion is requested for
adult employment and training programs. As part of WIA
reauthorization, we propose to consolidate adult dislocated
worker State grants together with employment services. This
will give States the flexibility to target resources where
they're needed most, eliminate duplication, and serve more
participants than ever before.
In addition, we request $47 million to increase marketplace
demand for people with disabilities as part of the President's
New Freedom Initiative. Some of these funds will be used to
test a new pilot disability employment survey by BLS and the
Office of Disability Employment Policies. This administration
is also strongly committed to meeting the employment needs of
our veterans. We requested $220 million and 250 FTE to maximize
employment opportunity for veterans and to protect their
employment rights when they return.
These are just a few highlights of the Department's
proposed employment and job training initiatives, which are
described in much greater detail in my written statement.
WORKER PROTECTION
Enforcement of the worker protection laws is both an
obligation and a priority of this Department. During our
tenure, wage and hour enforcement has achieved new records.
Last year, we recovered $126 million of pension assets for
beneficiaries, and occupational injury and illnesses rates have
reached historic lows, but as we all have said, more can be
done.
Among our requests is included an increase in certain civil
money penalties for MSHA and Wage and Hour, $5.3 million for
OSHA's expanded outreach and assistance program, including
specific funding for outreach to non-English-speaking employers
and employees, strengthening MSHA's enforcement, education, and
compliance assistance programs for small mines, an additional
$12.3 million and 69 FTE to enhance enforcement in the Employee
Benefits Security Administration, and $2.5 million and 20 FTE
to strengthen the Inspector General's request for labor and
racketeering initiatives.
The cornerstone of worker safety is OSHA and the Mine
Safety and Health Administration. Consistent with their goals,
OSHA and MSHA will continue to focus on the most serious
hazards and dangerous workplaces. Requests for the Department's
other enforcement agencies are detailed in my written
statement.
The Department's 2004 budget, of course, also includes
initiatives for implementing the President's Management Reform
Agenda and, as I mentioned at the beginning of my statement, I
believe that the President's fiscal year 2004 budget request
for the Department reflects the administration's strong
commitment to helping Americans find jobs and to strengthening
enforcement of our employment laws.
And with that, thank you very much for inviting me to be
here today, Mr. Chairman, and I will be glad to answer any
questions.
[The statement follows:]
Prepared Statement of Hon. Elaine L. Chao
Mr. Chairman, and distinguished Members of the Subcommittee, thank
you for the opportunity to appear before you today to present the
Department of Labor's fiscal year 2004 Budget.
The Department of Labor (DOL) continues to heed the call of
President George W. Bush that ``Government should be results-oriented--
guided not by process but guided by performance.'' The Department's
fiscal year 2004 budget was developed with just such a focus--and the
outcome is the Department's first-ever integrated performance budget.
With the ongoing war against terrorism and the related conflict in
Iraq, every department of the government must continue to take a hard
look at all of its programs. We must provide more funding for those
programs that work; reform and revitalize those that can be improved;
and cut or eliminate those that have not proven effective, are
duplicative of other programs, or are not currently a great national
priority. The Department's budget was developed with this outlook in
mind.
The total request for the Department in fiscal year 2004 is $56.2
billion in budget authority and 17,503 full-time equivalents (FTE). The
request for the Department's discretionary programs is $11.5 billion.
The Department's fiscal year 2004 budget was developed around four
critical themes designed to make a difference in the lives of America's
working families: Helping Americans Find Jobs; Protecting Americans'
Employee Benefits; Protecting America's Workers; and Bringing DOL into
the 21st Century.
Helping Americans Find Jobs
In 2003, the Administration will use the opportunity presented by
the expiration of the Workforce Investment Act (WIA) to make
significant improvements in Federal job training and employment
programs. These reforms will improve accountability; eliminate
duplication through program consolidation; enhance the role of
employers in the national workforce system; and increase state
flexibility.
This theme will be further accomplished through Personal
Reemployment Accounts (PRAs) for job seekers who are at risk of
exhausting their Unemployment Insurance benefits. The President's
economic growth plan, released January 7, 2003, includes $3.6 billion
for this new tool, which states will have considerable flexibility to
design. The accounts will provide up to $3,000 to job seekers to allow
them to purchase the training, re-employment, or supportive services
needed to get back to work.
The fiscal year 2004 budget and the President's Economic Growth
package reflect the Administration's commitment to assisting American
workers find and keep work--and will accomplish the Department's first
focus of helping Americans Find Jobs. Through funding for job training,
a new initiative to help unemployed workers, and reform of existing
programs, the Administration is improving opportunities for American
workers. The 2004 budget proposes a major overhaul of the
administrative structure of the Unemployment Insurance (UI) system,
which is an unwieldy relic that badly needs an overhaul. This proposal
would make the UI system more responsive to the needs of workers and
employers by giving states flexibility and control.
protecting americans' employee benefits
Effective last month, the Department changed the name of its
Pension and Welfare Benefits Administration to Employee Benefits
Security Administration, or EBSA. This was done to better reflect the
agency's mission and direction. Though newly named, EBSA continues to
lead the way in protecting workers' health and retirement security.
As I will touch on later, this budget includes resources to enhance
employee benefits and retirement security. With these additional
resources, EBSA expects to dispose of 19 percent more civil and
criminal cases compared with fiscal year 2003 and restore, protect, or
recover $69 million more in pension plan assets. This proposal to
increase the EBSA budget--at a time when other national priorities such
as the war on terrorism and homeland security are so compelling--is a
reflection of the Administration's commitment to protecting workers'
and retirees' benefits.
In fiscal year 2004, the Department's Office of Inspector General
will continue its role in bolstering DOL's efforts related to this
theme through initiatives aimed at achieving the OIG strategic goal of
safeguarding and improving worker and retiree benefit programs.
protecting america's workers
While occupational injury and illness rates have reached historic
lows, more can and must be done. In fiscal year 2004, DOL will continue
to balance enforcement and compliance assistance activities through the
ongoing efforts of its Occupational Safety and Health Administration
(OSHA); Mine Safety and Health Administration (MSHA); the Employment
Standards Administration's Wage-Hour Division, Office of Federal
Contract Compliance Programs (OFCCP), and Office of Labor Management
Standards (OLMS); and the Office of Inspector General (OIG).
Initiatives include:
--Strengthening existing enforcement by proposing increases for
certain Civil Monetary Penalties under MSHA and Wage and Hour;
--$5.2 million and 3 FTE to expand and improve OSHA's outreach and
assistance, including efforts to reach non-English-speaking and
contingent workers, provide small business assistance, and
increase the number of Voluntary Partnership Programs;
--Strengthening MSHA's enforcement and creating a new Small Mine
Office to provide information and assistance to small mining
operations; and
--Related efforts include the OIG's Labor Racketeering Initiative, to
which $2.5 million and 20 FTE will be applied in fiscal year
2004 to address union corruption.
bringing dol into the 21st century
The final theme of the Department's fiscal year 2004 budget will be
accomplished by several initiatives related to the DOL's ongoing
implementation of the President's Management Agenda. These include a
$20 million, first-year investment in a new department-wide accounting
system for the Office of Chief Financial Officer, which will update and
improve Departmental financial management. $48.6 million is also
requested in fiscal year 2004 for the Department's successful
Information Technology Initiative, which will, in part, consolidate all
DOL agency requests in support of the President's Management Agenda
component Expanded E-Government. For fiscal year 2004, $23.5 million is
also requested for the Department's Management Initiative to centrally
manage DOL's efforts on implementing the other four government-wide
initiatives on the President's Management Agenda.
Further, in fiscal year 2004, DOL intends to resubmit two
legislative proposals to restore the solvency of the Black Lung Trust
Fund and improve and update the Federal Employees' Compensation Act
(FECA). Because it integrates administrative and worker benefit costs
and provides an incentive to improve workplace safety, the fiscal year
2004 Budget also re-proposes the FECA Surcharge.
The Department will also continue to advocate viable options to
reform its Unemployment Insurance program and will support legislation
allowing employers to offer employees the option of taking paid time
off in lieu of receiving overtime pay.
employment and training programs
Overall, the fiscal year 2004 discretionary request for the
Department's Employment and Training Administration is $9.2 billion in
discretionary funds and 1,360 FTE. The fiscal year 2004 budget request
for Employment and Training Programs is $6.389 billion in new budget
authority.
These resources will be combined with the estimated 2004 spending
of $2.0 billion on Personal Reemployment Accounts included in the
President's Economic Growth Package.
Youth
A total of $2.6 billion is requested in fiscal year 2004 for
employment and training programs for Youth. This investment will help
young people make a successful transition to the world of work and
family responsibility. This proposal reforms the youth program through
reauthorization of WIA. The reformed Youth Grants program will be
funded at $1.0 billion, the same level at which Youth Activities is
funded in fiscal year 2003. Twenty-five percent of the Youth funds will
be used to provide Challenge Grants to promote collaborative and
innovative approaches to preparing youth for success in the labor
market.
Adults
A total of $3.1 billion is requested in fiscal year 2004 for
employment and training programs for Adults. The proposal reflects a
new program to be authorized by an amended WIA that will consolidate
the former Adult and Dislocated Worker Employment and Training
Activities, together with the Employment Service.
The new consolidated adult program will include formula grants and
a National Reserve, and will give States the ability to target
resources where needed, facilitate coordination, and eliminate
duplication in the provision of services to adults. With this request,
we expect to be able to serve more participants than ever before.
Other Employment and Training Programs
The fiscal year 2004 budget includes $742 million for Other
Employment and Training Programs. This includes $101.0 million,
approximately the same as fiscal year 2003 levels, for new methods of
providing workforce and related information through One Stop Career
Centers using America's Labor Market Information System (ALMIS). In
fiscal year 2004, a $500,000 initiative is included for the Wage Record
Interchange System (WRIS), in order to help States better track
performance. Efforts to improve access to One Stop information and
services include enhanced technology for serving individuals including
those with disabilities.
In fiscal year 2004, an increase of $49.4 million will be provided
as the first of a two-year investment to eliminate the 300,000 case
backlog in the permanent Foreign Labor Certification program. In
addition, funding will be provided in the Program Administration
account to provide the Federal support necessary to address the
backlog. To effectively address the situation, the backlog elimination
will begin in fiscal year 2003 as DOL makes changes to the program that
will prevent future backlogs by expediting certification and
eliminating the state role in the processing of applications.
In fiscal year 2004, the budget includes $20 million for Work
Incentive Grants, the same level provided in fiscal year 2003, to
enhance the prospects of employment for individuals with disabilities.
This effort is undertaken in conjunction with the Department's Office
of Disability Employment Policy to increase the participation of
individuals with disabilities in DOL programs and services. These
grants augment the capacity of the One Stop Career Center system to
deliver a full array of effective employment and training services to
people with disabilities. Likewise, this effort will ensure that people
with disabilities are better prepared to enter, re-enter, and remain in
the workforce. In fiscal year 2004, the program will increase by about
five percent the number of individuals placed in unsubsidized
employment after program exit.
Office of Disability Employment Policy
The U.S. Department of Labor's Office of Disability Employment
Policy's (ODEP's) mission is to provide leadership to increase
employment opportunities for adults and youth with disabilities. ODEP
is additionally tasked with serving as the lead agency in the
Department's implementation of the employment-related goals of
President George W. Bush's New Freedom Initiative. ODEP's fiscal year
2004 budget request of $47.3 and 65 FTE million will be used to
increase marketplace demand for people with disabilities and support
DOL's strategic goals through implementation of demonstration programs.
A primary area of emphasis will be on developing a reliable
statistical measurement to determine the employment rate of people with
disabilities because of the critical need for such data to inform
policies and programs. In fiscal year 2004, ODEP and Bureau of Labor
Statistics will pilot test disability employment rate questions through
the Current Population Survey.
Veterans' Employment and Training Service
The Department's Veterans' Employment and Training Service (VETS)
is requesting $219.9 million and 250 FTE to maximize employment
opportunities for veterans, protect their employment rights and meet
labor market demands with qualified veterans. VETS meets its primary
responsibilities through the funding of state veterans employment and
outreach specialists, referred to as Disabled Veterans' Outreach
Program (DVOP) and Local Veterans' Employment Representative (LVER)
positions.
As our Nation continues its war on terrorism, the activation of
thousands of Reservists and National Guard members has made providing
technical assistance to them and their employers one of the highest
priorities for the Department. The Department, through VETS,
administers USERRA--the Uniformed Services Employment and Reemployment
Rights Act--a law that protects the jobs of these servicemembers at
this critical time in our Nation's history.
The 2004 request funds the Homeless Veterans Reintegration Project
at $19 million, an increase over the 2003 level. This program will
provide employment and training assistance to homeless veterans, with
expected job placements and retention of approximately 9,000 veterans.
worker protection
As we have recently discussed, Mr. Chairman, I remain deeply
committed to enforcing the many laws that protect workers' safety and
economic security. As demonstrated in the following initiatives, the
Department's fiscal year 2004 budget was crafted to only strengthen
that commitment.
employment standards administration
The Department's Employment Standards Administration (ESA)
administers and enforces a variety of laws designed to enhance the
welfare and protect the rights of American workers. The budget request
to conduct these programs in fiscal year 2004 is $529.8 million and
4,360 FTE, down $38.4 million from fiscal year 2003. This decrease is
due largely to reduced funding for the Health and Human Services
component of the Energy Employees Occupational Illness Compensation
Program.
Office of Workers' Compensation Programs
As mentioned earlier, ESA's budget request includes a legislative
proposal to finance the operations of the FECA program via a surcharge.
Under this proposal, the direct budget authority for FECA program
administration ($87.6 million) would be replaced with offsetting
collections to be paid by Federal agencies based on their employees'
pro rata share of workers' compensation benefits. Integration of the
full cost of FECA benefits and administration in the appropriate
agencies will boost Federal agencies' incentives for improving safety
in their workplaces.
The Budget includes additional legislative proposals to promote
benefit equity and to discourage unnecessary claims in the FECA
program. Specifically, the budget proposes to amend FECA to move the
waiting period before the continuation-of-pay period, conform the FECA
benefits of future beneficiaries over the age of 65 to a benefit level
typical to what they would receive under Federal retirement programs,
and make a number of other changes to improve and update FECA.
Wage and Hour Division
The discretionary funding request for the Wage and Hour Division
(WHD) is $5.4 million and 3 FTE higher than in fiscal year 2003. Wage
and Hour will continue to use its multi-pronged approach of compliance
assistance, partnerships, and enforcement to further its goals to
promote high quality workplaces, a secure workforce, and customer
satisfaction. The budget also includes $0.3 million and 3 FTE for
enhancing compliance assistance to small and minority businesses. Wage
and Hour's mandatory funding would decrease by an estimated $7.1
million from fiscal year 2003 due to the expiration of the American
Competitiveness in the Twenty-first Century Act on September 30, 2003,
and the corresponding reduction in fee revenues from the H-1B visa
worker program.
WHD's budget includes a legislative proposal to increase civil
penalties for child labor violations that cause the death or serious
injury of a young worker. Our proposal would increase the maximum
penalty from $11,000 to $50,000, for any type of child labor violation
that leads to death or serious injury. We also propose to raise to
$100,000 the maximum penalty for willful or repeat violations that lead
to death or serious injury of a young worker. This proposal would
provide the Department with the tools needed to address the most
serious of child labor violations.
Office of Labor-Management Standards
The fiscal year 2004 budget request for the ESA's Office of Labor-
Management Standards is $40.6 million and 372 FTE. OLMS enforces
provisions of Federal law that require reports from unions and others
and establishes certain standards for union democracy and financial
integrity. OLMS conducts criminal investigations (primarily union funds
embezzlement) and investigative audits of unions; conducts civil
investigations (primarily concerning union officer elections);
supervises remedial union officer elections, as required; administers
statutory reporting requirements; and provides for public disclosure of
filed reports.
The fiscal year 2004 budget request includes $5.3 million and an
additional 75 FTE for enhanced outreach assistance activities and
enforcement to ensure compliance with the Labor-Management Reporting
and Disclosure Act. The budget request maintains resources for
electronic filing and Internet public disclosure of the statutorily
required reports. The budget also includes a proposal to authorize OLMS
to impose Civil Money Penalties on unions, union officers, employers
and consultants, and bonding companies that fail to file their required
financial reports on a timely basis. The intent is to improve
compliance, not penalize inadvertent lapses in filing reports.
Office of Federal Contract Compliance Programs
Total funding for OFCCP in fiscal year 2004 will increase by $2.0
million. OFCCP continues to ensure that federal contractors' hiring,
promotion, and pay practices fully comply with federal equal employment
opportunity laws. OFFCP targets and effectively remedies systemic
discrimination in companies it monitors, extending the level playing
field to large numbers of Americans working or seeking employment in
thousands of establishments across the nation. OFCCP has recently put
in place a case management process that makes key improvements to
investigations and information management and continues to work closely
with the Office of the Solicitor to bring legal expertise to bear on
its investigations.
occupational safety and health administration
The cornerstone of worker safety is the Occupational Safety and
Health Administration (OSHA), which promulgates and enforces
occupational safety and health standards and provides compliance
assistance to employers and employees. OSHA also assists Federal
agencies in establishing and maintaining occupational safety and health
programs and provides funding for state-administered safety and health
consultation programs. To meet its goals of reducing workplace
injuries, illnesses, and fatalities, OSHA will focus on the most
serious hazards and dangerous workplaces and expand compliance
assistance opportunities. The fiscal year 2004 OSHA budget request is
$450.0 million and 2,236 FTE.
Standards and Guidance
OSHA's standards and guidance activities provide for the
development, promulgation, review and evaluation of occupational safety
and health standards and non-regulatory products. In fiscal year 2004,
OSHA will continue to base all standards on clear and sensible
priorities and review existing rules to revise or eliminate obsolete
and confusing standards or provisions. Consistent with the findings of
the Administration's Performance Assessment Rating Tool (PART), OSHA
will also conduct more rigorous cost-benefit analyses of its proposed
standards. The fiscal year 2004 budget provides $14.5 million and 85
FTE for this activity.
Federal Enforcement
OSHA's Federal Enforcement activity increases compliance with
workplace standards under the Occupational Safety and Health Act of
1970 through the on-site inspection of work places and by encouraging
employers and employees to see safety and health as adding value to
their businesses and their lives. OSHA will continue to target
inspections based on the worst hazards and the most dangerous
workplaces. In fiscal year 2004, the budget request for federal
enforcement activity is $165.3 million and 1,581 FTE.
Compliance Assistance
The Agency will assist employers by continuing important programs
like the Voluntary Protection Program and the State Consultation
Program, which provides free, on-site compliance assistance for small
employers. OSHA will also increase its efforts to reach vulnerable
populations like non-English-speaking and contingent workers. The total
request for compliance assistance activities is $124.0 million and 356
FTE.
mine safety and health administration
The Mine Safety and Health Administration (MSHA) protects the
safety and health of the Nation's miners through enforcement of the
Federal Mine Safety and Health Act of 1977. The fiscal year 2004 budget
request for MSHA is $266.8 million and 2,334 FTE. MSHA created an
additional budget activity for fiscal year 2004, Program Evaluation and
Information Resources (PEIR). In the past, PEIR activities (including
information technology and support of the Government Performance and
Results Act) have been funded by drawing resources from each of MSHA's
budget activities. The fiscal year 2004 Budget requests funds for these
activities in a separate line (funding for PEIR activities is level
with the fiscal year 2003 President's Budget).
Enforcement: Coal
The Coal Mine Safety and Health activity is responsible for
ensuring the safety and health of the Nation's coal miners through
special emphasis programs, compliance and training assistance, and
periodic regular inspections and special investigations. The fiscal
year 2004 request includes $113.4 million and 1,086 FTE for this
activity, including $350 thousand for the cyclical replacement of
health and safety sampling equipment.
Enforcement: Metal/Nonmetal
The fiscal year 2004 Budget includes $66.4 million and 622 FTE for
Metal and Nonmetal Mine Safety and Health activities. These activities
promote a healthful working environment in the Nation's metal and
nonmetal mines and mills--and MSHA will accomplish this goal through
compliance and training assistance, periodic regular inspections, and
special investigations.
The request includes a $2.0 million and 20 FTE increase over the
fiscal year 2003 request for health, safety, and compliance assistance
to respond to the growth of the metal and nonmetal mining industry. The
request also includes an increase of $200 thousand for the cyclical
replacement of health and safety sampling equipment.
Educational Policy and Development
The fiscal year 2004 request includes $2.4 million and 21 FTE for a
new Small Mine Office. The Office will help small mining operations by
providing compliance assistance, guidance, and training; and reviewing
regulations that impose undue burdens on small mines.
retirement security
President George W. Bush and I share the priority of ensuring
increased retirement security--and the Department of Labor continues to
lead the Nation's efforts in achieving such a goal.
employee benefits security administration
The name change that I mentioned earlier--from the Pension and
Welfare Benefits Administration to the Employee Benefits Security
Administration--does not alter and only strengthens the agency's
mission: to protect the pension, health, and other benefits of
participants in private sector employee benefit plans. In fiscal year
2004, the total request for EBSA is $128.6 million and 930 FTE. This is
an increase of $12.3 million and 69 FTE over fiscal year 2003. The
request includes $8.6 million and 69 FTE for the Department's Enhanced
Retirement Security initiative which was designed to bolster compliance
assistance and enforcement efforts related to pension and health fund
protections.
In accomplishing its mission, EBSA directly affects the livelihood
of over 150 million people who participate in Employee Retirement
Income Security Act (ERISA)-covered plans, and protects the U.S.
economy's single largest source of capital for investment: pension
funds. EBSA will employ an integrated approach that encompasses
programs for enforcement, compliance assistance, interpretive guidance,
legislation, and benefits research to protect employee benefits and
retirement security for our Nation's workers and retirees.
Enforcement and Participant Assistance
Mr. Chairman, since I appeared before this Subcommittee last year,
EBSA has received 185,000 calls for assistance from Americans with
questions about their retirement or other benefit plans. Many of those
calls led to investigations. It is this activity that conducts criminal
and civil investigations, performs reviews to ensure legal compliance,
and further ensures compliance with applicable reporting requirements,
as well as accounting, auditing, and actuarial standards. During 2002,
as a result of EBSA's enforcement action, there were 134 criminal
indictments issued, 4,925 civil investigations closed with monetary
results of over $832 million. The 2004 request includes an initiative
to enhance retirement security and nationwide enforcement coordination.
In fiscal year 2004, the budget request for enforcement and participant
assistance is $106.7 million and 800 FTE.
Policy and Compliance Assistance
This activity conducts policy, research, and legislative analyses
on pension, health, and other employee benefit issues. Agency staff
supporting this activity provide compliance assistance, especially to
employers and plan officials, draft regulations and interpretations,
and issue individual and class exemptions from regulations. In fiscal
year 2004, the budget request for this activity totals $17.4 million
and 108 FTE.
Executive Leadership Program
This activity provides leadership, policy direction, strategic
planning, and administrative guidance in the management of employee
benefits security programs. It provides analytical and administrative
support for financial and human capital management and other
administrative functions related to coordination and implementation of
government-wide management initiatives. This activity also manages the
technical program training for enforcement, policy, legislative and
regulatory functions. In fiscal year 2004, the budget request for this
activity totals $4.5 million and 22 FTE.
office of inspector general
The Department's request for the Office of Inspector General is
$67.1 million and 473 FTE for fiscal year 2004, an increase of $4.9
million and 20 FTE over fiscal year 2003.
Program Activities
The OIG budget includes resources for audit; program fraud; labor
racketeering; special evaluations and inspections of program
activities; and executive direction and management. The OIG performs
audits of the Department's financial statements, programs, activities,
and systems to determine whether information is reliable, controls are
in place, resources are safeguarded, funds are expended in a manner
consistent with laws and regulations and managed economically and
efficiently, and desired program results are achieved.
The OIG also administers an investigative program to detect and
deter fraud, waste, and abuse in Departmental programs and to identify
and reduce labor racketeering and corruption in employee benefit plans,
labor management relations, and internal union affairs.
The fiscal year 2004 request includes $2.5 million and 20 FTE to
conduct a nationwide comprehensive initiative to combat labor
racketeering relative to: pension and health care plan corruption and
organized crime or corruption affecting industries and union
leadership.
international labor affairs
As I referenced before, Mr. Chairman, the Department's budget
request was developed with careful consideration of all the realities
now facing our country. Development of the Bureau of International
Labor Affairs (ILAB) budget was no exception. During the budget
process, we had to set priorities to fund from our limited pool--and
our Nation's current economic and employment conditions must be
included more prominently in this equation. As a result, our fiscal
year 2004 request for ILAB is $12.3 million and 60 FTE. This is a
reduction of $135.0 million and 65 FTE from fiscal year 2003.
The fiscal year 2004 budget request refocuses ILAB on U.S.
international policies and programs of greatest concern to American
workers. ILAB will continue to coordinate the Department's global
responsibilities in 2004 and to provide expert support for many of the
Administration's international initiatives, including the promotion of
core labor standards. The Bureau will continue to represent the U.S.
Government at the International Labor Organization (ILO) and on the
Employment, Labor and Social Affairs Committee of the Organization of
Economic Development. The Bureau will also continue to fulfill the
Department's responsibilities related to our participation in the
development of U.S. trade policy and the negotiation of trade
agreements.
The Department will continue to play a supportive role for other
federal agencies in their efforts to further prevent and eliminate
child labor and combating the spread of HIV/AIDS and will help to
ensure that those priorities are addressed.
implementing the president's management agenda
Before I close today, Mr. Chairman, I also want to highlight the
Department's ongoing efforts to implement the President's Management
Agenda--as well as to discuss our recent experiences with the Office of
Management and Budget's Program Assessment Rating Tool (PART).
At my fiscal year 2003 appropriations hearing last year, I briefed
the Subcommittee on the Department's progress in implementing the
President's Management Agenda. As you know, Mr. Chairman, the
President's Management Agenda is an aggressive strategy for improving
the management of the Federal government with a focus on five
government-wide areas: Strategic Management of Human Capital;
Competitive Sourcing; Improved Financial Performance; Expanded E-
Government; and Budget and Performance Integration. Further, DOL is
also one of just five Cabinet agencies with Agenda responsibilities
related to Faith-based and Community-based initiatives.
On a quarterly basis, the Office of Management and Budget has
continued to rate the government's progress in implementing the
President's Management Agenda on a ``stoplight'' color grading scale--
and DOL continues to lead the way. As of the most recent OMB scorecard
of December 31, 2002, DOL received a Yellow baseline rating for Human
Capital with a Green progress score. For Competitive Sourcing, DOL
received a Red baseline score with a Yellow progress rating. For
Financial Management, DOL received a Yellow status score with a Green
rating for progress--the exact same scores for E-Government, Budget and
Performance Integration, and Faith-based and Community-based
Initiatives. With that assessment, DOL continues to lead all Cabinet
agencies in Status scores.
As OMB Director Mitchell E. Daniels, Jr., indicated at OMB's mid-
session review last summer, ``Labor has demonstrated a sustained
commitment to implementation of the management agenda and is making
good progress. A key component of the department's success is its
Management Review Board, which monitors progress by regularly reviewing
department-wide reform implementation.''
Program Assessment Rating Tool (PART)
Improving programs by focusing on results is an integral component
of the President's budget and performance integration initiative. As
such, the Administration rated effectiveness with its PART for
approximately 20 percent of Federal programs. As part of this process,
nine DOL programs were reviewed in calendar year 2002: Bureau of Labor
Statistics; OSHA; EBSA (formerly PWBA); Office of Federal Contract
Compliance Programs; FECA; Community Service Employment for Older
Americans; Dislocated Worker Assistance; Trade Adjustment Assistance;
and Youth Activities. Each program was rated on Purpose, Planning,
Management, and Results/Accountability and the experience provided an
invaluable management tool.
Highlights and results of the reviews, along with discussion of
reforms we will make to address certain weaknesses identified using the
PART, are included in the agency-specific sections of the Department's
Congressional Budget Justification. We are already working with OMB on
the programs to be reviewed in the next round of PART.
conclusion
Mr. Chairman, this is an overview of what we have planned at the
Department of Labor for fiscal year 2004.
I will be happy to answer any questions you may have on the
Department's fiscal year 2004 budget request.
Senator Specter. Thank you very much, Secretary Chao.
Picking up on the issue of dislocated worker assistance,
there are enormous problems in many industries, but using the
steel industry as illustrative, as you are well aware, the
American steel industry--before I proceed with the questioning,
let me turn to Senator Murray for an opening statement.
OPENING STATEMENT OF SENATOR PATTY MURRAY
Senator Murray. Thank you very much, Mr. Chairman. Thank
you for your statement, Madam Secretary, and I do have
questions. Let me just say quickly that last Friday's March
unemployment report brought more bad news for working men and
women in this country of another 108,000 jobs lost nationwide,
and that's on top of the nearly 2.4 million Americans who have
lost their jobs since this administration took office. I'm
really disappointed that the fiscal year 2004 budget request
for the Department of Labor's Employment and Training
Administration fails to recognize the workforce needs of this
country and continues a pattern of short-changing and denying
American workers access to the training and resources that they
are increasingly requiring.
prepared statement
We're seeing tremendous suffering across the country in
terms of economic hardship and record long-term joblessness,
and I think we all know that studies have shown that 75 percent
of the American workforce will need to be retrained to merely
retain their jobs. In Washington State we have lost 80,000
good-paying jobs since September 11 in our aerospace airline
and information technology industries, and there's not much
future hope in those industries in the short term, and
hopefully it will look better in the long term, but I think we
really need to train a skilled workforce, and I am concerned
that we are not meeting those needs.
Mr. Chairman, I do have a number of questions, and I
appreciate the opportunity for opening remarks.
[The statement follows:]
Prepared Statement of Senator Patty Murray
Madame Secretary, thank you for your testimony.
Last Friday's March unemployment report brought more bad news for
the working men and women of this country.
--Another 108,000 jobs were lost nationwide.
--That's on top of the nearly 2.4 million Americans who have lost
their jobs since this Administration took office.
Unfortunately, the fiscal year 2004 budget request for the
Department of Labor's Employment and Training Administration (ETA)
fails to recognize the workforce needs of this country.
It also continues a pattern of shortchanging and denying American
workers access to the training resources they need and that employers
increasingly are requiring.
At a time when American workers are suffering continuing economic
hardship and record long-term joblessness, the Bush budget proposes a
cut of $678 million for Workforce Investment Act-funded programs.
Recent studies have shown that 75 percent of the American workforce
will need to be retrained merely to retain their jobs.
In Washington we have lost 80,000 good-paying jobs since 9/11 in
the aerospace, airline and information technology industries, with
little prospect for near term rehires.
And while the U.S. economy's demand for a skilled workforce has
increased dramatically over the last 20 years, federal funding to meet
these needs has decreased by 25 percent.
I am concerned that we are not meeting the needs that exist.
DISLOCATED WORKER ASSISTANCE
Senator Specter. Thank you, Senator Murray. Senator
Murray's point is in line with the question that I was about to
propose, Madam Secretary.
The steel industry is only illustrative of one of the
industries which is victimized by foreign subsidies and
dumping, and the President personally intervened with the
tariffs which were put into effect a little more than a year
ago, and in Pennsylvania we are looking at very difficult times
with dislocated workers, and it is not just a Pennsylvania
problem, it is a national problem.
On our Steel Caucus meeting yesterday we had concerns
expressed by Senators from West Virginia and Maryland and
Minnesota. Are the funds which will be allocated for dislocated
worker assistance sufficient, in your opinion?
Secretary Chao. Let me make a statement at the outset that
the number of people served will not change, and the $78
million----
Senator Specter. How can that be, with the cut of some $78
million?
Secretary Chao. Because primarily, the workforce investment
system still has approximately $1.7 billion in overhang. That
is a figure that we have talked about in the past, but it seems
as if every year there continues to be about $1.7 billion in
overhang. Our commitment to helping dislocated workers cannot
be questioned and during these particular times we are, of
course, aware and want to help workers who are having a
difficult time.
There is a whole array of assistance programs available to
dislocated workers, and that includes a one-stop career center,
that includes transitional assistance, of which there have been
two temporary extensions of unemployment insurance benefits.
There is trade adjustment assistance as well, so we believe the
current figures, including the overlay, and also what we're
trying to do is consolidate the three funding streams,
dislocated workers, adult programs, and employment services
under the Workforce Reinvestment Act through the consolidation
of all the different programs, we believe that there will be
actually more resources that will be more flexibly applied to
where it is needed most, to workers who need it.
PENNSYLVANIA TAA FUNDING
Senator Specter. Madam Secretary, Pennsylvania has had
insufficient funding in that line with the current larger
allocation, and I am advised by State officials that
Pennsylvania was just allocated another $10 million in fiscal
year 2003 for training, and that those funds may be used both
to enroll new trainees and pay for costs stemming from trainees
already enrolled. Is that correct?
Secretary Chao. We can take another look at that, but if I
understood the question, apparently Pennsylvania has committed
more money for training under this program than was available
in both fiscal year 2002 and 2003. We have been working with
the State on exploring various options to address this need,
but the problem is that, absent specific statutory authority,
obviously the funding available in a particular fiscal year
could not be used for a prior year obligation, which is what we
found.
Senator Specter. Well, would you take a look at that and
see if there is some way that can be worked out to the
satisfaction of the State officials?
Secretary Chao. We will take another look.
Senator Specter. Pennsylvania has seen what has been termed
to me a major mismatch between eligible recipients and Federal
dollars. Aside from deferring new applications, what is the
Labor Department's position as to how to allocate those funds?
Secretary Chao. I am not totally informed on the specifics
of your question, so let me go back and ask about that.
Senator Specter. All right. We would appreciate it if you
would supplement your testimony here today when you have had a
chance to review that.
[The information follows:]
Pennsylvania Trade Adjustment Assistance
The Trade Adjustment Assistance (TAA) program provides assistance
to workers adversely impacted by trade. Workers certified by the
Department of Labor under the TAA program are eligible for an array of
services, including income support and job training. Once the
Department of Labor certifies workers as eligible for TAA services,
states are responsible for enrolling certified workers into
reemployment services, which may include job training. Only training,
income support, and out-of-area job search and relocation allowances
may be funded by TAA; other reemployment services are provided through
other WIA One-Stop delivery system partners.
Under the Trade Act of 2002, which amended the TAA program, the
total resources available for training nationwide is capped at $220
million, an increase of $110 million available annually prior to the
amendment. Because this is a ``capped entitlement,'' individuals are
entitled to training to the extent that funds are available. DOL
distributes these funds to states upon review of information provided
by states that includes estimates of the number of individuals who
would require training and anticipated costs.
In recent years, the $110 million cap was reached well before the
end of the fiscal year. In an effort both to better manage the limited
funds available to serve trade-impacted workers and to better integrate
the trade program services with the Workforce Investment Act (WIA)
Dislocated Worker program services, DOL's Employment and Training
Administration (ETA) issued guidance to states in September 2000
reminding them to coordinate with WIA Dislocated Worker programs to
fund training for trade-impacted workers.
In February 2003, officials from the Commonwealth of Pennsylvania
met with the Assistant Secretary of Labor for ETA, Emily Stover
DeRocco, regarding $16 million owed by the State to providers for
training invoices involving TAA participants that was in excess of the
TAA training funds provided to the State for fiscal year 2002. Fiscal
year 2003 TAA training funds could not be used since the costs were
incurred prior to the fiscal year 2003 funds being appropriated.
Currently, ETA is working with the Commonwealth to address an
additional shortfall in trade training funds for fiscal year 2003,
which has the potential of impacting services to workers and payment to
educational institutions and training providers. The deficit has raised
serious concerns regarding the Commonwealth's operation of the TAA
program and management of training funds.
ETA senior officials visited the Commonwealth and determined that
the shortfall of funds in both years was caused by state employees
approving and contracting for training for eligible workers without
regard to the TAA training funds made available by ETA. State officials
justified this because of what they believed to be the entitlement
nature of the program. They indicated that, up until this recent
problem, they did not concern themselves whether funding was available
at the time of state obligation, as long as it was available when the
bills had to be paid. The result was unpaid fiscal year 2002 bills and
fiscal year 2003 training commitments that are not backed by Federal
funds.
A letter was sent to the state requesting they review the $16
million in invoices from last year to identify how much was for
training that began after July 1, 2002 that could be financed from
currently available National Emergency Grant (NEG) monies and they
determine the amount committed to workers for training begun or
scheduled to begin after October 1, 2002 that is not presently covered
by Federal TAA funding.
Also, subsequent to these findings, while awaiting the results of
the Commonwealth's review, an additional $11.5 million in TAA funds for
fiscal year 2003 were provided to cover the cost of new and future
obligations incurred. State officials elected to use these monies to
reduce the fiscal year 2003 shortfall and allow participants already in
the program to continue their training.
The state did undertake a review of records as requested and
responded on April 28th. They indicated that:
--$14.6 million in fiscal year 2002 training invoices has been paid
for from non-Federal funds or are unpaid. The Commonwealth
submitted a request for National Emergency Grant funds to cover
these costs.
--There is an estimated shortfall this year of $16.2 million in
fiscal year 2003 obligations for training already approved by
the Commonwealth. Total obligations are $37.9 million compared
with the Federal awards of $21.7 million for TAA training.
--The Commonwealth estimates that an additional $14.1 million needed
to cover the costs of services for TAA applications currently
pending.
Pennsylvania has been encouraged to use other available resources,
including unexpended formula funds provided under WIA, to meet the
needs of trade-impacted workers. The WIA funds that may be used to
assist these workers are provided through dislocated worker and adult
funding streams, and include funds reserved by the state for statewide
activities and funds allocated to local workforce investment areas
pursuant to substate funding formulas.
In addition, we are currently reviewing Pennsylvania's application
for National Emergency Grant funds under WIA to satisfy fiscal year
2002 needs occurring after July 2002. We are also considering the $16.2
million and the $14.1 million current year's requirements along with
needs identified by other states. As you know, sufficient funds will
not be available this year to satisfy demand. A final decision on the
amount that will be made available to Pennsylvania is pending analysis
of the needs of all states.
Senator Specter. With 14 seconds left I am going to not
pose another question which I couldn't get out in that length
of time, and yield at this point to Senator Murray.
UI EXTENSION FOR AIRLINE WORKERS
Senator Murray. Thank you very much, Mr. Chairman.
Madam Secretary, let me start with the issue of the
unemployment insurance benefits for airline workers. I was
really disappointed yesterday to see the President's opposition
to a temporary extension of unemployment insurance benefits to
our unemployed airline industry workers who have lost their
jobs.
I was very heartened to see that 67 Republicans in the
House joined all of the House Democrats to instruct the
appropriations conference to help our workers, but if you can
just tell us today, as Secretary of Labor, do you agree with
the administration that we should provide billions of dollars
in Federal aid to our industries without doing anything to
support our workers who have played by the rules and have lost
their jobs?
Secretary Chao. The Department's total outlay last year,
mandatory plus discretionary, was about $71 billion. The
majority of that was for unemployment insurance. Included in
that was $12 billion for our workforce investment system, which
basically helps people train for new jobs. So, in essence, 97
percent of the Department of Labor's $71 billion budget is
divided among unemployment insurance, transitional assistance,
and training needs of workers, dislocated workers----
Senator Murray. Well, you understand that many of our
airline workers have skills that are not transferable. They're
Boeing machinists, they're airline workers who have very
specific skills and training. We all, I think, expect the
airline industry to get back on track hopefully in the near
future rather than in the later future, but just saying, well,
you get unemployment for a short amount of time and then we
expect you to retrain for another industry, both leaves our
airline industry in the future short of workers, but it also
sets a very high expectation that somehow we're going to
retrain thousands of people for jobs that don't exist.
The unemployment extension merely helps these people
through a difficult time in our Nation's economy through tragic
circumstances that have occurred in the airline industry beyond
anybody's control.
Secretary Chao. I agree with that. I didn't finish my
answer. We do have also national emergency grants, of which
I've given out, I believe, about $150 million to help
specifically airline workers in this industry. We've had two
extensions of unemployment insurance and right now potentially
a worker can get up to 65 weeks of benefits.
We do have serious concerns about singling out one group of
workers, and from an administrative point of view of how does
that work----
Senator Murray. Well, let me go right to that. In fact,
Mitch Daniels said in his letter, and I quote, to provide
benefits for a specific industry would be unusual, unfair, and
potentially harmful to our national unemployment system. Well,
Madam Secretary, is it the administration's position that trade
adjustment assistance, which does provide benefits to specific
industries, is also unusual and unfair?
Secretary Chao. Trade adjustment assistance was certainly
expanded in the last TPA discussions.
Senator Murray. But it is a program that provides to
specific industries, correct?
Secretary Chao. It is for people who have been harmed by
trade.
Senator Murray. To specific industries. So under the
standard that an unemployment extension for airline industries
is, and I quote: ``unfair and potentially harmful because it
provides benefits for a specific industry, and by the same
standard, trade adjustment assistance would be''----
Secretary Chao. Well, that's law by now, so I don't know
whether it makes any sense to rehash that.
MIGRANT AND SEASONAL FARM WORKERS
Senator Murray. Okay. Well, let me ask a different
question.
It appears that the Department no longer believes that a
national program for migrant and seasonal farm workers is
needed. How are we going to avoid burdening our Governors and
local one-stops with the responsibility of trying to serve
workers who may work and reside in their States for brief
periods during this time of huge and growing State deficits?
Secretary Chao. The original intent of this program for
migrant workers was to help them train for new skills so that
they can get out of this low-paying and very difficult work. As
it has turned out, based on experience, we have found that this
program was used much more for income support.
If indeed these resources are to be used to supplement
income and to be used as income support, there are other
programs which this can be melded into.
Senator Murray. Such as?
Secretary Chao. Well, I think they should be linked into
the workforce investment system overall, and other available
programs.
Senator Murray. There isn't enough money in the workforce
system now. If we say to all seasonal workers and migrant
workers, we're now expecting you to be taken care of under that
program, too, we are adding a huge burden to that.
Secretary Chao. Well, the workforce investment system right
now is underutilized, first of all, and second, the migrant
workers, segregating them into a specific area will not be
helpful to fully integrating them into local communities.
GAO REPORT REGARDING WIA SPENDING
Senator Murray. Well, let me go back to that, because I'm
confused. You keep arguing that employment and training
services can be accomplished without impacting service delivery
because of carryover funds in the WIA formula programs, but the
GAO conducted an investigation and found the administration's
argument inaccurate, and it said, and I quote: ``our analysis
of Labor's data shows that States are rapidly spending their
funds.''
In fact, nationwide, States have spent 90 percent within 2
years, even though the law allows 3 years to spend the money,
and, in fact, my State was to have spent 98 percent of their
formula funding in 2001, so I don't understand how we keep
hearing you say that. I mean, I have the GAO report here.
Secretary Chao. May I answer that?
Senator Murray. Yes.
Senator Specter. She's correct, you may answer, even though
the red light is on.
Secretary Chao. We obviously disagree with the GAO report.
I think we all need to take a look at the balances outstanding,
and clearly, in every single State there are positive balances.
This balance is not only for 1 year but, in fact, it's for
every year. So there is a disagreement about whether to use
obligations versus expenditures, and there is a disagreement as
to how much the overlay means, but when it continues year after
year, I think that needs to be looked at.
But let me also say the total level of funding remains the
same in our proposal. Primarily, we are consolidating these
various different programmatic streams, because it's very
confusing for the recipient, to have to go to all these
different programs. What we want to do through Workforce
Investment Act reauthorization, which we discussed before, is
to make the program simpler, give the States more flexibility
so that there is more leeway with which to allocate resources
to these various different groups of people who need
assistance.
Senator Murray. Mr. Chairman, my time is up, but I would
like permission to submit my other questions for the record.
Senator Specter. By all means, Senator Murray, they will be
submitted.
The ladies and gentlemen who are standing in the rear can
find seats here along the side, or if you're intending a career
in journalism you can sit at that table.
If you plan to be Senate staffers you can sit in the chairs
behind the podium. If you plan to be Senators, you may sit in
the chairs at the dias here.
Now I turn to my distinguished ranking member, Senator Tom
Harkin, Democrat of Iowa.
Senator Harkin. Thank you very much, Mr. Chairman. Sorry
I'm a little late.
Senator Specter. It looks like the journalists have it,
Tom. That table is filled.
Senator Harkin. A wise choice.
INTERNATIONAL CHILD LABOR
Madam Secretary, I hope your staff has given you all the
stuff. I'm sure they know what I'm going to talk about.
Secretary Chao. I hope so, too.
Senator Harkin. Child labor. Child labor, child labor----
Secretary Chao. Thank you.
Senator Harkin [continuing]. Child labor. Let me repeat for
you what you said to me last year, if I can get my proper page
out here, in a hearing, since you zeroed out all these things
in the budget. You said--this is your words. So please be
assured that we are not differing at all in terms of the goal.
This is on the international program for the elimination of
child labor, ILAB. We want to work with you on this. The issue
is how best to do so and how we can work, and how ILAB can
absorb all this money in such a short period of time, but the
commitment, I assure you, is absolutely there. We look forward
to working with you on that. Well, I will work with you on it.
Well, here we are. Your budget justification touts the fact
that ILAB child labor programs targeted more than 103,000 at-
risk children in fiscal year 2002, exceeded its goal of
targeting 90,000 children. Your own document, I quote, says:
``13 countries established a total of 15 new action plans,
demonstrating concrete commitments at the highest levels of
local and national Government to eliminate child labor.'' Well,
that's pretty good news. That's good news.
Well, now your budget eliminates all funding aimed at
preventing exploitive child labor. The U.S. contribution to
IPEC is zeroed out. The money to provide bilateral assistance
to other countries, to promote access to basic education for
child labor, a critically important part of this, is zeroed
out. Now, tell me about your absolute commitment.
Secretary Chao. Well, this request doesn't mean that the
Department will play no role in supporting international
efforts to prevent and also eliminate, child labor. Rather, we
hope to use the interagency process to make sure the Government
agencies active in international affairs address these
priorities on an ongoing basis.
Ongoing ILAB projects will also not come to an abrupt halt.
There is still funding remaining for 2-year moneys appropriated
in fiscal year 2003. I think the overall goal is that our
technical assistance projects will continue to operate as ILAB
transitions into a more policy-oriented role rather than a
grant-making one.
Senator Harkin. Well, I'm not certain I know what all that
means. I don't know what that means, Secretary Chao. To me,
that's gobbledygook written by somebody back there in your
Department, but it's some kind of a gobbledygook justification
for zeroing this out. I mean, I'm looking at the figures. This
says something to me. Total ILAB, $12.2 million. Do you know
what we enacted last year?
Secretary Chao. $147 million.
Senator Harkin. $148 million. Senator Specter and I and
others on a bipartisan basis enacted that, and you're telling
me with $12 million you're going to continue the program, and
that it's a total commitment.
Now, I don't know. I mean, I take you at your word, but I
don't know. I don't know if this is OMB, or where this is
coming from, but somebody's got their priorities terribly
wrong, whoever came up with this. I mean, your own Department
has shown that this is working. It's doing great stuff around
the world.
I mean, you know, I realize--I look around and I see all
what we are doing now, and our military is strong, and we're
very powerful, but I've got to tell you, this means more to
people in third world countries than anything else we're doing,
getting those kids out of those jobs, getting them a basic
education, and when it has the imprint of the United States on
it, that means something, and it's happening in countries that
we're going to have some problems with in the next few years,
and for $148 million it seems to me that that's a mere pittance
of what we're spending in other areas.
Well, Madam Secretary, I'm just really disappointed. I'm
just really disappointed in this, and I hope that we can come
up with the money. It's a tight year, and obviously we have to
take our cues--I know the burden the chairman labors under.
I've had that position myself. I know what it's like to labor
under a position where the budget comes out, and the
administration, especially if it's one of your own party, isn't
supporting something like this. It's very tough.
But I hope that you'll take back to OMB and to the White
House that they're making a terrible mistake here, a terrible
mistake. It just paints the United States once again as
uninterested in helping kids around the world break the bonds
of child labor.
Oh, yeah, we'll say nice things about it. Oh yeah, we're
opposed to child labor, we don't like that, but when it comes
to putting the money out and doing things that have proven
effective by your own Department's standards, and then we cut
it back, I think it paints a very bad picture of the United
States in many, many parts of the world, and it's dooming a lot
of kids to continue that cycle, that generational cycle of
poverty, no education, so they're condemned to living a life of
menial work, and then their kids, the same thing.
Well, I've said enough. I don't need to say any more, but
I'm really disappointed in this.
Thank you.
MINE SAFETY AND HEALTH
Senator Specter. Thank you, Senator Harkin.
Madam Secretary, turning to the issue of mine safety, last
October 21 this subcommittee held a hearing in Johnstown on the
mine disaster at Quecreek, and in this year's budget we have
$10 million allocated for digitizing mine maps. There was a
problem with mine maps. The 2004 budget proposes an overall
increase of 35 staff, but coal mine inspectors will not be
increased.
Would you take a look at that and respond to the
subcommittee in writing as to your best efforts to try to
increase coal mine inspectors within the allocated funds, and
would you also include a specification as to how you're going
to use the $10 million for mine mapping activities, and when
you propose to start on that? Since we were so late in getting
a budget to you, you understandably wouldn't be in a position
to tell us what you've done in the short interval, but if you
would respond in writing----
Secretary Chao. I will do so.
Senator Specter [continuing]. The subcommittee would
appreciate that.
Secretary Chao. Are you interested in getting some of the
answers now, or would you like me to submit it in writing?
Senator Specter. What was that?
Secretary Chao. Would you like some of the answers now, or
would you like me to submit it in writing?
Senator Specter. I would like it in writing----
Secretary Chao. Okay.
Senator Specter [continuing]. Because there are so many
other priority subjects to be covered.
[The information follows:]
Proposed Plan of the Mine Safety and Health Administration Distributing
Fiscal Year 2003 Appropriations of $10 Million for Digitizing Mine Maps
and Developing Technology to Detect Mine Voids
As defined in the House/Senate Conference agreement, $10,000,000
was appropriated to MSHA ``for digitizing mine maps and developing
technologies to detect mine voids, through contracts, grants, or other
arrangements, to remain available until expended.'' Due to the across-
the-board budget rescission of .0065, the $10 million is decreased by
$65,000 to $9.935 million. The purpose of this undertaking is to
mitigate potential hazards to miners resulting from water and gas
inundations when mining in close proximity to abandoned mines.
MSHA proposes a 3-year disbursement plan to allocate the funds in
accordance with congressional intent. The funds will be allocated in
two areas. The first area will be for use by state mining agencies for
``Digitizing Mine Maps.'' The second area will be funding ``Applied
Technology Demonstration Projects.'' These projects will demonstrate
the viability of new or existing mining technology to identify
abandoned mines (voids) and the extent of their workings.
MSHA proposes allocating 40 percent of the funds to mine mapping
and 60 percent to void detection. MSHA will disburse to the states
$2,000,000 the first year and $1,000,000 each of the following years
for mine mapping. MSHA will disburse funds for Applied Technology
Demonstration Projects on a periodic payment schedule over the life of
the project.
Digitization of Mine Maps.--It is estimated there are approximately
150,000 abandoned mines in Kentucky, 15,000 in Pennsylvania, 6,000 in
Virginia, and 100,000 in West Virginia. In February 2003, MSHA held a
meeting with representatives of various Federal agencies with
responsibility for mine maps. Representatives from the Department of
Interior's United States Geologic Survey (USGS), Bureau of Land
Management (BLM) and Office of Surface Mining (OSM) attended. MSHA
found that OSM provides funding to the states for hardware and software
purchases for digital mine mapping efforts. OSM is currently surveying
the states to determine the number of abandoned mines, the extent of
state map digitizing efforts, and details of the current status of that
state's work. When MSHA receives the OSM survey results, the Agency
will be able to identify states' needs and develop the specific
criteria to be used to distribute the funds. MSHA and OSM have
discussed the possible transfer of funds to OSM through an Interagency
Agreement. OSM could distribute the funds along with funds they are
already providing the states. As an alternative, MSHA may enter into
contracts directly with the states.
Once all known maps are digitized, detailed information on
abandoned mines will be available prior to mining. This will reduce the
likelihood of mining into abandoned mines.
Applied Technology Demonstration Projects.--MSHA is aware of
technologies that exist which show potential for detecting in-seam
voids (detection of abandoned mines). We expect companies that
specialize in some of these technologies to submit proposals for
demonstration projects. Also, experts at universities and contractors
for government agencies such as DOE and DOD may submit proposals. Some
promising technologies that MSHA hopes to have contractors explore:
Subterranean Robots Demonstration Project.--Field Robotics
represents proven technology. Robots can be used to physically enter,
provide a visual image, and ultimately map abandoned underground mines
that are not safe for human entry. In addition to the drive components
and navigational system, robots can be equipped with sonar and laser
scanners to measure and map fine details. The primary challenge is to
develop mine-worthy robots that can be adapted to the aggressive and
diverse mine environment, with sufficient mobility through debris, mud,
water, and dry conditions. For example, researchers from the Robotics
Institute at Carnegie Mellon University have already field-tested a
mine-mapping robot, that traversed more than one mile in a mine in 3.5
hours. They are interested in developing borehole robots for both wet
and dry coal mine conditions.
Ground Penetrating Radar (GPR) Sensors Demonstration Project.--
Technology located underground on the working section may be available
that can ``sense'' at least 22 feet into a coalbed to detect air or
water-filled voids. The system involves a radar device encased within
an MSHA-approved flameproof enclosure. The device could be periodically
moved to the mine face and readings taken to determine the presence of
and distance to either an air- or water-filled void, differentiate
between the two, and provide the operator with a graphical display of
the conditions.
Seismic Reflection Demonstration Project.--Seismic technology may
be a method to identify abandoned mines. It can be either a surface- or
underground-based device. Surface-based devices are used to identify
coal bed methane for the oil and gas industry. This technology may be
adapted to detect air- or water-filled voids. Since this type of
testing is widespread in the oil/natural gas industry, there would
likely be a number of companies capable of demonstrating this
technology under a variety of field conditions.
In-seam seismic techniques have proven successful in some
situations. Possible projects may be to use the continuous mining
machine cutting drum as a seismic source, and automating the system to
cause a fail-safe shut-down of equipment before cutting-through into an
abandoned mine. Borehole seismic tomography projects to demonstrate
mine-to-borehole and borehole-to-borehole seismic methods may also be
viable.
Long-Hole Directional Drilling Demonstration Project.--This
technology would demonstrate whether directional long-hole drilling
could be used to establish the minimum width of an outcrop barrier by
drilling a hole that is parallel to, but offset from, the outcrop line
of a coal seam. This could identify the intact width of outcrop
barriers in cases where an impoundment overlies the outcrop of a seam
that is being actively mined. It would require investigating the
capabilities, limitations, and safety considerations inherent to using
this system underground. Further development and use of borehole
geophysical instruments could enhance the capabilities of long-hole
drilling immensely by accurately assessing the trajectory of an
undulating coal seam. Adding geophysical logging tools would also allow
the driller to determine the distance that the drill string is from the
mine void, whether the void contains air or water, the thickness of the
coal seam, and any geologic anomalies that could impact inundation
risk.
______
Filling Coal Mine Inspectors Positions
Filling vacant coal mine inspector positions can be a lengthy
process, especially due to the requirements for background
investigations and medical examinations. MSHA has taken steps to
compress that process where possible. MSHA Assistant Secretary Dave
Lauriski has initiated an aggressive recruiting effort to fill vacant
coal mine inspector positions. He has established specific deadlines
for filling positions.
MSHA has traditionally filled inspector positions by selecting
applicants for consideration from standing registers of eligible
candidates. To increase the pool of applicants, MSHA is now
supplementing this process by posting individual vacancy announcements
for specific geographical locations. This will allow individuals whose
names are not on the standing registers to apply and be considered for
a particular vacancy. The Agency is placing vacancy announcement
notices on the web site of the Department of Labor and the USAJOBS web
site of the Office of Personnel Management. State employment offices
access the USAJOBS site and make the announcements available. MSHA
staff are recruiting applicants at job fairs and at universities. This
aggressive recruitment effort will enable the Agency to fill vacant
positions in a more timely manner.
ERGONOMICS
Senator Specter. Turning to the issue of ergonomics, last
year in April you proposed to reduce ergonomic injuries through
voluntary guidelines, but to have enforcement under OSHA's
general duty clause. OSHA, I am informed, has conducted more
than 400 nursing home inspections in the last year and 103
ergonomics inspections were conducted in industries other than
nursing homes. Would you give us the detail in writing as to
where those 103 ergonomic inspections were conducted, and give
us your evaluation as to whether you think the inspections are
adequate, and advise us as to how much funding is being
directed to those inspections to evaluate voluntary
compliances?
Secretary Chao. We will do so.
Senator Specter. And the general duty inspections have
disclosed, have resulted in citations, four citations, and we
are advised that others are reportedly in progress. The
subcommittee would like to know what has happened with those
citations, what others are in progress, and whether you
consider four citations to be adequate on some 491 inspections
which have been conducted.
Secretary Chao. Well, musculoskeletal injuries have
actually dropped 10 percent last year. We will provide the
answer, of course. In trying to work on these four general duty
clauses, we want to make sure that they are effective. We
talked a lot of target inspections and how we wanted to make
sure that we are able to use leverage and utilize most
effectively this general duty clause to get at the bad actors.
We will ensure that there is some kind of further followup with
relation to our four-prong strategy of our ergonomics plan.
Senator Specter. Well, we need to evaluate what your
voluntary guidelines are producing. Off-hand, on the surface,
it would appear to me that 103 ergonomic inspections in all
other industries beyond nursing homes is a small number. Do you
think that's adequate? Tell me now.
Secretary Chao. We're very committed, as I mentioned
before, to ensuring that ergonomic injuries decline, and last
year's results facts speak for themselves. There's been a 10-
percent decrease in ergonomic----
Senator Specter. Madam Secretary, I understand your
commitment.
Secretary Chao. Yes.
Senator Specter. My question is, is that a sufficient
number of inspections for all industries other than nursing
homes?
Secretary Chao. We conduct 37,000 inspections, so in
addition to other inspections, these are just totally focused
on other industries.
Senator Specter. You conduct how many inspections?
Secretary Chao. 37,000.
Senator Specter. My red light is on, and I'm going to
observe the time limit which I'm asking everyone else to do.
Secretary Chao. I will submit the answer.
Senator Specter. So if you would respond----
Secretary Chao. I will.
Senator Specter [continuing]. In writing, we would
appreciate it.
[The information follows:]
OSHA has targeted ergonomic inspections to industries with high
rates of musculoskeletal disorders. Inspections under OSHA's National
Emphasis Program (NEP) for Nursing and Personal Care Facilities, which
focuses on patient-handling hazards, began on September 17, 2002. Since
this time, OSHA has completed over 469 inspections in Nursing Homes
under the Nursing Home NEP. Over the past winter, Regional and Area
Offices implemented Local Emphasis Programs (LEPs) to address
ergonomics in several other industries with high rates of
musculoskeletal disorders.
In all, OSHA has assessed ergonomic conditions in 675 of the
inspections opened between January 1, 2002 and March 31, 2003. These
inspections include 469 in nursing and personal care facilities
pursuant to the NEP; 106 in other industries as a result of SST
inspections or complaints or referrals; and 50 inspections in
industries targeted by ergonomic-related Local and Regional Emphasis
Programs.
------------------------------------------------------------------------
Number of
Inspection type Time period inspections
------------------------------------------------------------------------
Nursing Homes under the Nursing September 17, 2002 469
Home NEP. through March 31,
2003.
Ergonomic Related--Non-Nursing January 1, 2002 106
Homes. through March 31,
2003.
LEPs--Ergonomic Related............ December 15, 2002 50
through March 31,
2003.
------------------------------------------------------------------------
The resources utilized to address ergonomics in both the fiscal
year 2003 and fiscal year 2004 budget request are contained within all
of OSHA's budget activities and are not separately identified or
earmarked to address ergonomics or any other specific issue. Rather,
the comprehensive approach to ergonomics involves focused activity by
the entire agency in addressing the four prongs of the ergonomics
policy: industry specific and task-specific guidelines, strong
enforcement, outreach and assistance, and research.
As part of our four-pronged approach to ergonomics, OSHA is
increasing its outreach and assistance efforts through its Ergonomics
Webpage, cooperative programs, and other means.
OSHA's cooperative programs are achieving tangible results and are
an integral part of our strategy to reduce workplace ergonomics
hazards. OSHA recently entered into a national partnership with the
U.S. Postal Service, the National Postal Mail Handlers Union and the
American Postal Workers Union to address ergonomic hazards in postal
facilities. In addition 15 of OSHA's National Alliances focus on
ergonomics.
The level of interest in OSHA's initiatives and activities is
demonstrated by participation in stakeholder meetings, visitors to our
ergonomics web page, inquiries regarding enforcement policy, alliances
and partnerships which affect ergonomics, requests for consultation and
compliance assistance, and interest in the work of the National
Advisory Committee for Ergonomics.
OSHA has committed to achieving significant overall reductions in
workplace injury and illness rates. Reducing the number of injuries due
to ergonomic hazards is an important part of meeting these goals.
Senator Specter. We have been joined by the distinguished
former chairman of the Appropriations Committee, former
president pro tempore, current ranking member of the full
committee.
Senator Byrd. Thank you, Mr. Chairman.
We've had great success in sending a man to the moon and
bringing him home to earth again, but we've never been able to
perfect a good public address system.
MINE SAFETY AND HEALTH INSPECTORS IN WEST VIRGINIA
Can you hear me, Madam Secretary?
Secretary Chao. I sure can, thank you.
Senator Byrd. Last January, an air shaft explosion killed
three workers at the McElroy mine in Cameron, West Virginia.
According to news reports, MSHA's District 3 office, where the
McElroy explosion occurred, was extremely short-staffed. One
news journal reported that, according to MSHA records, between
December 2001 and December 2003, when the McElroy mine should
have had six surface inspections, it had been inspected only
once. No underground inspections were performed. The MSHA
district manager reportedly requested additional inspectors and
resources, but was granted less than half of his request
because of personnel shortages.
Now I read that the President has proposed to cut MSHA's
budget for coal enforcement activities below the $119 million
appropriated for fiscal year 2003 to $113.4 million in fiscal
year 2004. Coal miners toil every day in an occupation where an
accident can mean loss of a life. They trust that MSHA will do
all that it can to reduce the risk of accidents. Why are there
not enough inspectors in MSHA's District 3 office to conduct
adequate safety inspections, and is insufficient staffing a
problem that is widespread through MSHA?
Secretary Chao. The simple answer is no, it is not. In
fact, if you look at the last year's results there has been a
30 percent increase in site visits, 83,000, there's been a 21
percent decrease in fatalities, 11 percent decrease in
injuries, 8 percent increase in citations and orders at coal
mines.
The number of mines and inspection completion rates for
coal mines actually stayed, from about--a 99 percent completion
rate, which is an impressive number. The issue is that the
number of coal mines has actually decreased since 1997, the
last 5 years alone. There were 2,600 coal mines in 1997. Today,
there are only 2,000, and yet the number of inspectors have
remained the same.
In the next year we expect to add 35 increased coal miner
inspectors, 20 metal/nonmetal inspectors, and another 21 to
make sure the small mine companies and operators are abiding by
the law as well, and we want to help them understand what their
responsibilities, and also help the employees, the workers
understand what their rights are. So we in fact have about a 76
increase, new inspectors coming on board.
Senator Byrd. The UMWA wrote to me just a few days ago to
apprise me of their concerns with regard to the number of MSHA
inspections at our Nation's mines. The UMWA wrote that the MSHA
District 3 office in Morgantown, West Virginia is bringing MSHA
inspectors in from Pennsylvania and housing them in hotels to
inspect District 3 mines in an attempt to keep up with MSHA's
mandatory inspection requirements.
The UMWA cited a series of accidents that have occurred
since last April in Kentucky, Illinois, Pennsylvania, and West
Virginia. Last year's Quecreek accident alone endangered 18
miners. Had it swung the other way, which it easily could have,
fatalities would have increased last year greatly, rather than
decreased, so are we really giving MSHA all of the resources it
needs to protect our miners from these kinds of accidents?
Secretary Chao. We actually have increased MSHA's budget,
so we believe yes. With the problem specifically with district
number 3, that is a district that we have heard complaints
about. The UMWA has been very concerned about that. Many of the
steps, actually, that we've taken are actually in response to
what they want.
Senator Byrd. Would you say that again? Would you say that
again, what you just said?
MSHA DISTRICT 3 REGIONAL OFFICE IN WEST VIRGINIA
Secretary Chao. District number 3 is a district that we
know has had some complaints, and a lot of the complaints
circled around personnel. We have made certain changes. Certain
other allegations of personnel changes were not true. That's
the district that again----
Senator Byrd. What allegations were not true?
Secretary Chao. That certain managers were moved out. That
is not true. The one manager that was moved out, the UMWA
wanted the person moved out, so we've done that.
Senator Byrd. If there are reports that mines are not being
inspected because of the shortage of personnel, how can you be
sure about whether more MSHA inspectors are needed?
Secretary Chao. With the inspection completion rate of 99
percent, there is only 1 percent that we can do better. We will
certainly try to do that, but I think there are very few other
endeavors in which you have a 99 percent completion rate. As I
mentioned, while there are injuries and fatalities, which are
intolerable, the overall record in terms of safety has actually
improved quite a bit in the last year.
As I mentioned, we have had a 30 percent increase in
inspection citations, and an 8 percent increase in orders.
There have been decreases in fatality rates. In fact, the
mining industry had one of its best years in the last year, in
terms of safety. The number of injuries dropped as well, and we
are adding 76 more inspectors in this coming year.
RETIREMENT OF MSHA INSPECTORS
Senator Byrd. Madam Secretary, you have been lucky. As I
indicated earlier, if last year's Quecreek accident had swung
the other way, which it easily could have, fatalities would
have greatly increased last year rather than decreased.
The United Mine Workers of America also raised concerns
about the upcoming retirement of a number of MSHA inspectors.
MSHA has said that it takes 1 to 2 years to train a new
inspector. When you tell this subcommittee that the President's
budget request for MSHA is adequate to hire inspectors, are you
considering these impending retirements?
Secretary Chao. Yes, we are. It does take a great deal of
skill to manage the personnel resources that are available
within the Department. Part of the issue also is that it is
difficult sometimes to find people at the locations in which
they are needed. Many times an inspector, or a potential
inspector, would not want to move to another part of the
country or region in which he or she is not familiar.
There have been attempts in the past to accelerate the
responsibilities, the time in which it would take for an
inspector to get into their inspection activities, and we don't
approve of that either. We want to make sure that the mine
inspectors are doing their job, that they're highly qualified
and highly skilled, because as you said, we want to make sure
the miners get home every night, but we view this
responsibility very seriously.
Senator Byrd. I helped to craft the 1969 and 1977 Federal
Mine Health and Safety Acts. I did so with the belief that we
need strong mine safety standards that are enforced through
frequent inspections, and further, that appropriate stiff
penalties be imposed on those mine operators who wilfully
violate the law and endanger the lives of the Nation's coal
miners, so I am concerned about this administration.
What I'm concerned about is how this administration is
reconciling MSHA's enforcement and compliance assistance roles.
I see resources and personnel being shifted away from
enforcement activities. I hear about the failure to cite safety
violations. I hear that violations at our site have sometimes
languished unchecked for months. I hear about personnel
transfers because of complaints from coal mine operators to
administration officials that MSHA enforcement actions are too
tough.
MSHA is not a consulting firm. It was created to enforce
our mine safety laws. Just as the FBI should not act as a
consultant to criminals, MSHA should not act as a consultant to
coal companies that wilfully violate the law. Why should MSHA
be distracted from its principal responsibility of enforcing
our mine safety laws and protecting our miners so that it can
act as an advisor to coal companies that break the law?
Secretary Chao. Well, first of all, those allegations that
you have cited earlier in your statement are just not true.
Senator Byrd. Which allegations are not true?
Secretary Chao. The coal operator who claimed that he moved
certain personnel out. There is a very comprehensive answer to
those spurious charges by Dave Lauriski, the Administrator of
MSHA, that is in the Courier-Journal, and I will send that over
if you have not seen it already.
Second of all, I think some people would take exception to
the----
Senator Byrd. You will send that over, you say?
Secretary Chao. Sorry?
Senator Byrd. You say you will send that over?
Secretary Chao. I will do so, yes.
Senator Byrd. How soon will I see that?
Secretary Chao. Just to make sure, I will send it over.
[The information follows:]
[From the Courier-Journal, Louisville, KY, March 16, 2003]
MSHA Says: ``Protecting Miners Comes First''
(By Dave Lauriski, Special to The Courier-Journal)
The writer is assistant secretary of Labor for mine safety and health.
Over the last two years, the Bush administration has instituted a
culture of accountability and performance in the enforcement programs
that protect miners' lives--and the clear result is that miners are
safer than ever before. But you wouldn't know it from the biased and
baseless screeds The Courier-Journal is negligently posting on its
opinion pages today.
Here are the facts:
--We conducted 87,957 mine inspection and en-forcement events in
2002--an increase of 30 percent since the previous
administration.
--Over the last two years, citations and enforcement orders issued
against coal mine operators passed the 125,000 mark--up 8
percent since the last administration.
--During that same period, we assessed mine operators with $27.3
million in civil penalties--an 11 percent jump.
Here are the results:
--Because of our no-compromise enforcement policy, fatal injuries at
mines have declined to their lowest point in history.
--Coal mine injury rates have fallen by nearly 10 percent since we
came into office, and are lower than at any time in the last 20
years.
--The only way to achieve results like these is to insist that
protecting miners comes first--not protecting the bureaucracy,
the industry or individual coal operators.
For these reasons, it is both stunning and sad to see Cecil
Roberts, president of the United Mine Workers of America, sign his name
to an irresponsible opinion piece that accuses the administration of
putting politics ahead of miners' safety. Cecil is a decent man, and we
have worked well with him on mine safety issues. But the arguments he
makes--mostly cribbed from a West Virginia radio story--are flatly
contradicted by the facts and even conflict with the views expressed by
senior leaders in his own organization.
Roberts says he has grounds to be ``suspicious'' of the
reassignment of MSHA's District 3 manager, insinuating that it was
payback for enforcement actions against Robert Murray, a politically
active coal operator. That's odd, because the organization that Roberts
runs has complained bitterly about the District 3 manager and demanded
that we take action.
Roberts' own safety director wrote to MSHA, ``A number of
complaints have been filed with the MSHA District 3 and Arlington
offices. . . . As you know, miners became so fed up with the actions of
the Agency and particularly the MSHA District 3 manager that they
staged a protest at an MSHA meeting two months ago.'' The UMWA has
accused the District 3 management of ``tolerating hazardous
conditions,'' turning ``a blind eye'' to violations and stopping MSHA
inspectors ``from issuing enforcement actions.'' Richard Eddy,
president of UMWA District 31, also wrote to complain about decisions
made by MSHA's District 3 manager. Eddy urged me to ``take whatever
actions you deem necessary.''
Seemingly unaware of all this, Roberts blames the reassignment of
the District 3 manager on ``threats'' allegedly made by coal operator
Robert Murray. As we say in the country, that dog won't hunt.
Roberts also alleges that I met with Murray in April 2002 and that
``the result of those meetings was the sudden reassignment of District
2 officials Kevin Stricklin . . . and Tom Light, whose reassignment
Murray [had] bragged about. . . .'' None of that is remotely true.
There was no such April meeting. And Kevin Stricklin is still with
District 2; the only ``reassignment'' he had was a leadership
development rotation as assistant to the coal administrator, one of the
most highly responsible positions at MSHA. The same goes for Tom Light,
who is also still with District 2 and, far from being punished, was
promoted to the second-ranking job in the regional office.
Finally, Roberts claims that Murray asserted his political
influence to threaten two other MSHA enforcement officials in the
District 3 office. Regardless of any threats made by anyone, I'm the
one who is responsible for all personnel decisions in MSHA--and both of
those officials are still at their posts.
The only MSHA official mentioned by Roberts who was permanently
transferred is the former manager of District 3. But Roberts' own
safety director and local union president are on record insisting that
action be taken against him. So why is Roberts cooking up conspiracy
theories against this administration? I refuse to believe that Roberts
would play politics with miners' safety--even though he has falsely
accused MSHA of doing the same. Roberts appears to be the victim of
overzealous staff who failed to do good research and left him out to
dry.
The truth is that the Bush administration and MSHA take miners'
safety very seriously. One of the first decisions the new
administration made was to fully defend and enforce the Black Lung
Program regulations that were issued in the waning days of the previous
administration. Mine operators like Robert Murray strongly urged the
administration to back down. Instead, we took the side of protecting
miners' health--a decision strongly endorsed by The Courier-Journal and
Cecil Roberts' UMWA.
Today, we are setting new records in enforcement and reduced injury
and fatality rates. But we are not resting on these achievements,
because our job is to bring miners home to their families, safe and
sound. In our budget for next year, we proposed tougher penalties for
mine safety violations and added funding to hire 55 more mine
inspectors. And we continue to pursue a major enforcement case against
the Ohio Valley Coal Company--owned by none other than Robert Murray.
The accusation that anyone in this administration assigns a higher
value to political contributions than to miners' health and safety is
insulting and clearly disproved by the facts. It is uncharacteristic of
Roberts to make such irresponsible attacks. However, placing these
baseless claims on the opinion page does not absolve The Courier-
Journal from the responsibility of doing some basic fact checking
before printing them.
Senator Byrd. It won't be like your response to my January
letter, will it, the response that just came yesterday?
Secretary Chao. What response?
Senator Byrd. The response to my January letter.
Secretary Chao. I'm not--you're saying it came in too late,
is that what----
Senator Byrd. Pardon me?
Secretary Chao. Are you saying that it came in too late?
Senator Byrd. Well, I wrote you in January. I got a
response yesterday, the day before this hearing.
Secretary Chao. We have lots of letters to answer, but I
apologize for that. We will certainly do better in terms of our
reply.
Senator Byrd. You've got lots of room to improve.
COAL MINING INSPECTORS
Secretary Chao. We'll try.
The second thing also is, I think there might be some
exception, some people who would take exception that coal
miners, operators would be compared to criminals. I think that
there are lots and lots of rules and regulations----
Senator Byrd. Nobody is comparing coal miner operators to
criminals.
Secretary Chao. There are lots of rules and laws----
Senator Byrd. Have you ever lived in a coal mining camp?
Secretary Chao. No. I lived in Queens, New York, in a
little tenement house when I came to America.
Senator Byrd. You haven't lived around a coal mine.
Secretary Chao. No, not really.
Senator Byrd. No. Well, you should try it sometime.
Secretary Chao. Yes. There are lots of experiences that we
should all share, I think, to help us understand the world.
Senator Byrd. You might share that one so we could really
talk about coal mine inspections.
Secretary Chao. Yes, sir.
Senator Byrd. Now, go ahead, will you, if I've interrupted
you.
Secretary Chao. There are lots of rules and regulations,
so--I'll make it very short. So we want to help employers and
workers understand what their obligations and rights are so
that workers can be better protected. That's the whole point
about the inspections and the compliance assistance. There has
not been any faltering of enforcement, as the numbers that I
just cited indicate.
Senator Byrd. I see the light is red. If I may just ask
this one final question, Mr. Chairman.
Senator Specter. Of course, Senator Byrd.
NATIONAL EMERGENCY GRANTS
Senator Byrd. Thank you.
I have been contacted by the Governor's Office of West
Virginia about the slow response from the Labor Department in
processing our State's national emergency grant applications.
To expedite the release of these emergency job training funds,
the Congress annually appropriates money to the Labor
Department for the future fiscal year so that the Labor
Secretary can quickly allocate these funds as grants, and yet
West Virginia has had to wait for 5 months for its application
to be processed.
In the meantime, the number of West Virginians waiting for
those job training funds has jumped from 500 workers to over
1,200 workers. Why are these emergency funds being delayed?
Secretary Chao. Well, I hope that's not the norm, and I
will look into it, because we have just--I signed off about
$107 million of these national emergency grants. We tried to be
very prompt in turning them around, and in fact we prefer, we
like them better.
Senator Byrd. Would you look into this?
Secretary Chao. I sure will.
Senator Byrd. And give me a specific response to that
question?
Secretary Chao. Yes, I will.
Senator Byrd. Let me repeat it, why are these emergency
funds being delayed?
Secretary Chao. I hope they're not being delayed, but I
will look at them.
Senator Byrd. I beg your pardon?
Secretary Chao. I hope they're not being delayed.
Senator Byrd. You hope they're not.
Secretary Chao. No. Sometimes it requires working with the
State to make sure that the application comes in the right
form, even though it's a very simple application form, and to
make sure that the workers are indeed eligible and all that.
Senator Byrd. All right.
Secretary Chao. But we will certainly take a look.
Senator Byrd. Could you please, not only take a look, but
let this subcommittee know your response to that question?
Secretary Chao. I will.
Senator Byrd. And give me a letter----
Secretary Chao. I will.
Senator Byrd [continuing]. Addressed to me, with an
explanation, and you might elaborate on some of the other
answers that you've given me.
Secretary Chao. I will.
Senator Byrd. I don't find them to be altogether
satisfactory, with all due respect to you. Thank you very much.
[The information follows:]
Status of National Emergency Grant Request for West Virginia
Helping American workers who have lost their jobs is a top priority
for this Administration.
The State of West Virginia submitted an application for National
Emergency Grant (NEG) funds in the amount of $4,985,714 to serve
approximately 450 of the 750 workers impacted by layoffs and closures
of coal mines. Companies identified in the NEG application include Pine
Ridge Big Mountain No. 16 in Boone County, Ruffner Mine (ARCH) in Logan
County, A.T. Massey, Inc. in Boone, McDowell and Raleigh Counties,
Colony Bay Surface Mine in Boone County, Bar K Incorporated in Kanawha
County, Kanawha Eagle in Boone County and BJM in Nicolas County.
Officials in Department of Labor's Employment and Training
Administration are reviewing the request for the NEG funds very
closely. Part of this review includes an assessment of existing funds
in the state.
--As of the December 2002 reporting period, West Virginia has over
$30 million in unexpended WIA Dislocated Worker Program formula
funds.
--The United Mine Workers of America was designated by the Congress
to receive a PY 2002 hard-mark, which was awarded on October 3,
2002 in the amount of $2 million to serve dislocated mine
workers in West Virginia, Pennsylvania, and Virginia.
ETA officials learned that A.T. Massey began to increase coal
production, and therefore rescinded the Worker Adjustment and
Retraining Notification (WARN) Act notice which announced the lay off
of 37 workers. ETA officials also learned that the Ruffner Mine will
not be laying off the 260 workers identified in the NEG application.
Many of the remaining workers who were impacted by the coal mine
closures are accessing services through WIA Dislocated Worker Program
formula funds.
You have my assurances that we will monitor the situation closely.
When a final decision is made, you will be notified promptly.
Senator Specter. Senator Harkin.
NATIONAL EMERGENCY GRANTS
Senator Harkin. Mr. Chairman, thank you.
I have a followup to Senator Byrd's just recent question
about dislocated workers and about the length of time that it's
taking to get applications approved. Senator Byrd, I want to
give you some examples of what's happened out in our State, and
Madam Secretary, I'm going to ask you about this. You say you
hope this is not a pattern, but after listening to Senator Byrd
and looking at what's happening in my State, I'm wondering if
it is a pattern. For example, let me give you some examples:
117 days to approve the application of R. R. Donnelley in Des
Moines for 375 workers; 125 days to approve the application for
Rockwell-Collins, 153 workers; 111 days to approve the
application for International Paper in Clinton for 126 workers;
248 days to approve Iowa dislocated farmer grants for 300
individuals.
That's the delay. Then when the grants were approved,
listen what happens.
In June of 2002, the Department of Labor approved a
national emergency grant of nearly $300,000 for dislocated
workers from Sioux Tools and Terex-Schaeff up in Northwest
Iowa. The approval took 83 days, but that was in June of 2002.
Only $79,507 has actually been received. A request for the
additional $217,865 was submitted last September, and to date
there has been no response from DOL.
Secretary Chao. May I answer that, or----
Senator Harkin. Sure. Well, I've got some more. You answer
that and I'll give you some more.
Secretary Chao. I will, of course, go back and take a look.
Sometimes the national emergency grants are, I don't want to
use the word confused, because I don't mean to be insulting,
but sometimes they're mixed up with the TAA grants. Now, the
TAA grants do take quite a while. On average they take about 4
months.
The national emergency grant is a fairly easy process, so
we do tout its flexibility and its ability to move quickly. The
TAA grants, on the other hand, are----
Senator Harkin. I'm told by my staff these are all national
emergency grants.
Secretary Chao. And sometimes the glitch is not with the
Department of Labor. Sometimes it goes back to the State
Departments of Labor. They have to provide the right
information, and the State workforce agencies also share in
these issues, because sometimes they don't provide sufficient
information that States need to have to use these dollars, so
it is a very decentralized system, but generally speaking we
are able to move it fairly quickly.
Senator Harkin. Well, Madam Secretary, would your staff,
who is with you, respond why it took so long for R. R.
Donnelley?
Secretary Chao. Sure.
Senator Harkin. Why it took so long for Rockwell-Collins?
Secretary Chao. I sure will.
Senator Harkin. Why it took so long for International Paper
in Clinton, and why farmers are always the last?
Secretary Chao. I hope that's not the case.
Senator Harkin. Why are farmers always--248 days to approve
it for dislocated farmers.
Secretary Chao. Well, we will see, again, what happened to
those, and I want to make sure also that it's not the
Department's----
Senator Harkin. That's why I want to know.
Secretary Chao. Yes.
Senator Harkin. I want to know where the glitch is. If you
say the glitch maybe some place else, I want to find out about
it.
Secretary Chao. These grants are reviewed and handled by
career professionals.
Senator Harkin. But what's your average time for national
emergency grants?
Secretary Chao. We like to say pretty--you know, I'm a
little reluctant now to say how much we like to see, but we
have told people that it can come out within a month or so.
Senator Harkin. Well, I just gave you some examples here
that are a lot longer.
How about, can you answer this for me? How about the one
that went to Sioux Tools and Terex-Schaeff? In June of 2002
they approved it. That's last June. $79,000 has been received.
They submitted the additional request for $217,000 in
September, and no response yet.
Secretary Chao. Again, I don't know the specifics of that.
Senator Harkin. I'm sure you don't.
Secretary Chao. I don't know whether it's at the Department
or whether it's at the State level, but we'll certainly take a
look, but it does require cooperation with the State
departments of labor, the State workforce agencies, the WIB
boards to make all this happen.
Senator Harkin. One last one. The last one I mentioned was
Sioux Tools.
Secretary Chao. Right. We'll take a look at all of them.
Senator Harkin. The last one I've got is $739,073 in
January of last year, in 2002, not this January, for workers
who lost their jobs when three plants closed, Exide
Technologies, that's a battery company, Wabash National and
Keokuk-Ferro-Sil. They submitted a request for the final
installment for $237,190 last November and they're still
waiting.
Secretary Chao. Sometimes the State work agencies will also
submit requests, but these requests may not be truly the----
Senator Harkin. Well, my time is up.
Secretary Chao. Okay.
Senator Harkin. I just want--as long as your staff is here,
there are three more Iowa grants pending at the Department.
Secretary Chao. There is a tendency to ask for the request,
but we do take a look at the request, see what the dislocated
worker situation is within the particular State or the region,
and see from that how best to put out the grant.
Senator Harkin. Let me just tell you, there is one grant
that came in on October 18 of 2002. That's been 164 days now,
164 days, one, two, three, four, five different companies,
APAC, Andrew Corporation, Celestica, Charleston Place, and
Bluebird Bus, the bus builders, and I'd like to have you take a
look at that.
Secretary Chao. I will do so. There's not very much
discretion at my level. I mean, basically this is all done with
the career ranks. They have a lot of experience in how these
programs are administered, what is required for x number of
individuals, and this is the analysis that they go through, but
we will take a look and, as I mentioned, a lot of workforce
investment boards will ask for lots of things sometimes.
Sometimes a grant may be smaller than a request because we
will go into a region and see what the actual number of
dislocated numbers are, and it could be smaller than the actual
requested amount.
Senator Harkin. Well, I just think the length of time is
just unacceptable, how long it's taking.
Secretary Chao. We'll take a look at it.
Senator Harkin. I don't know whether it's the bureaucracy
or whatever it is, but you're in charge of the bureaucracy.
They work for you.
Secretary Chao. We'll take a look at it.
Senator Byrd. Perhaps a quote from William Wordsworth might
be appropriate.
Senator Specter. This will come out of your fourth round of
questions, Senator.
Senator Byrd. Okay. I expect to be charged for it.
Wordsworth said, it matters not how high you may be in your
department. You're still responsible for what your lowliest
clerk is doing.
Senator Specter. Was he a Senator, Senator Byrd?
Senator Byrd is replete with pithy, relevant, instructive
quotations. We thank you for that.
Secretary Chao. I by no means shirk the responsibility, and
I just checked, these numbers, unfortunately are not that
different from previous years.
Senator Harkin. They're not----
Secretary Chao. They're not that different from previous
years, but we want to improve, so let's take a look.
Senator Harkin. But you told me that national emergency
grants go out in a matter of just days or weeks, and I've given
you some that take months.
Secretary Chao. Well, we've been trying to improve them,
but those numbers that you cite are not different than previous
years.
Senator Harkin. So you're not doing any better now than
you've ever done.
Secretary Chao. We're trying, but obviously by your
example----
Senator Harkin. I hate to be so provocative--I hate to be
provocative, but when you tell me that emergency grants go out
in a matter of days or weeks, and I've given you some that have
taken months, you come back and tell me, well, it's the same as
it's always been, so don't----
Secretary Chao. Well, I'm just trying to say----
Senator Harkin. Something's not adding up.
Secretary Chao. We're doing our best, but that's been the
record. We're going to continuously improve, and we'll check
into the ones that you want.
Senator Harkin. Thank you.
[The information follows:]
Status of National Emergency Grant Requests for Iowa
The President and I are committed to helping displaced workers
access the job and skills training they need to find new jobs that will
enable them to provide for themselves and their families.
In Program Year 2002, which began on July 1, 2002, the Department
awarded $2,550,470 in National Emergency Grant funds to provide
reemployment assistance to workers dislocated as a result of the
closure of an International Paper plant, workers laid off from Rockwell
Collins avionics plant, Ball Corps, Mau Trucking, MCI Worldcom, Inc.
and farmers.
Most recently, I approved a request for $217,000 to aid 55 Iowa
workers dislocated from Sioux Tools and Terex-Schaeff located in Sioux
City, Iowa. The project will be operated by the Western Iowa Tech
Community College, and will provide reemployment services, including
job search assistance, job development, job placement, basic skills
training and counseling.
Officials in the Employment and Training Administration are also
reviewing three other National Emergency Grant applications from Iowa,
including a request for incremental funding for a Northern Engraving
project, APAC Teleservices and American Growers Insurance Company. Part
of this review includes an assessment of existing funds in the state.
As of December 2002, which is the most recent WIA reporting period,
Iowa has an unexpended balance of $4,630,710. These funds can also be
used to provide assistance to workers impacted by plant closures and
layoffs.
You have my assurances that we will monitor the situation closely.
When a final decision is made, you will be notified promptly.
ERGONOMICS INSPECTIONS
Senator Specter. Secretary Chao, I don't want to spend any
more time on ergonomics because I've asked you to supply the
materials in writing, but when you come up with this figure of
37,000 inspections, I didn't want to pursue it, but staff has
advised me that that's the total number of inspections
conducted by OSHA, and I had quoted for you 388 inspections of
nursing homes and 103 on others. What's the relevance in
responding about 37,000 inspections when the question related
to ergonomics inspections?
Secretary Chao. Just to--well, maybe it didn't--I thought
it made sense at the time, but I'm trying to show the number of
inspections overall that OSHA does. In fact, that's been an
increase of more than 7 percent, so we have stepped up our
inspections.
Senator Specter. But the question is not about the total
number of inspections. The question is about ergonomics
inspections, in an attempt to----
Secretary Chao. Well----
Senator Specter. May I finish?
Secretary Chao. Yes, please.
LM-2 PROPOSED REGULATION
Senator Specter. In an attempt to evaluate whether your
voluntary system is working. It's very hard to--well, you get
the point, Secretary Chao.
Let me come to the question of the new report requirements,
and I had written to you raising some questions as to how these
reporting requirements contrasted with other reporting
requirements of the Small Business Administration or for
corporations under the Sarbanes act or by the General
Accounting Office, and I got your response, and I noted your
statement that I should meet directly with the Department's
Inspector General and Chief of the Division of Enforcement for
the Department's Office of Labor Management Standards, and
candidly that's quite an undertaking for me to do, but I do
want to pursue this question, starting at the staff level.
We may need a hearing on this generally, but in the few
minutes we have remaining on this hearing, Madam Secretary, let
me ask you to compare reporting requirements for small
businesses which go to annual receipts under $6 million,
contrasted with the requirement for labor unions with annual
receipts under $200,000. Why should there be such a significant
divergence on reporting requirements?
Secretary Chao. The $200,000 limit is what is currently in
the rules, stemming from the statute. We have not changed that,
number one. That's the current level.
Number two, when comparing the whole issue about
accountability and transparency with the labor unions, when you
compare them with any other organization, any other sector,
there are basically four layers of protection. There is usually
a requirement for quantitative information, for qualitative
information pertaining to materiality, for example, there is
also another layer of internal controls mandated by the law,
and also internal audits.
Senator Specter. When you raise the issue of materiality,
you move into what the Securities and Exchange Commission does,
and their standards require the disclosure of, as you put it,
material information.
Madam Secretary----
Secretary Chao. The disclosure just refers to the first----
Senator Specter. Madam Secretary--I'm asking you a question
right now----
Secretary Chao. Please.
Senator Specter. Madam Secretary.
Should labor unions be required to have more detailed
reporting requirements than their corporate, private corporate
counterparts?
Secretary Chao. Well, currently they do not, and under the
proposed new rule they still will not.
Senator Specter. Well, that's what I would like to work
out. I commend--there's no doubt about the need for reporting,
and for knowing what goes on with union records, and I've had
some experience on that going back to the days of the McClellan
Committee, which investigated labor racketeering back when John
F. Kennedy was a Senator, and when I was an assistant district
attorney I got the first conviction on labor racketeers arising
from the investigations of the McClellan Committee.
Six union leaders went to jail after their conviction for
conspiracy to cheat and defraud Local 107 of the Teamsters
Union, and I have some appreciation for this sort of an
inquiry, but what I would like to do initially at the staff
level, Madam Secretary, and we will be propounding some
questions for the record, is to take a look at what has been
done and what are the requirements for small businesses, what
are the requirements for corporate America.
I appreciate your interest in wanting to find out what is
going on, and this subcommittee shares your concern, and we
will work with you on that, but we want to see to it that
there's an appropriate balance, and the comparison is always
made on so many lines, financing of elections reporting, to
have an equitable burden as you take a look at corporate
America with unionized workers.
Secretary Chao. There's a great disparity, and the unions
do not have a fraction of the reporting requirements as
required by corporations.
Senator Specter. Senator Harkin, do you have another line
of questions?
LM-2 REPORTING REQUIREMENTS
Senator Harkin. I'd like to follow up on that, Madam
Secretary. Words--I'm listening to the words you're using. You
say that maybe the unions don't have the reporting requirements
of corporations. You mean publicly held corporations.
Let me ask you this question. A labor union with receipts
of $500,000 a year, its reporting requirements compared to a
privately held company--not a public corporation. Now, public
corporations, you're right, they do have to have more reporting
than labor unions. That's because they're publicly held. I'm
talking about a private corporation. A labor union is not a
publicly held corporation, so compare for me a union with
receipts of $500,000 with a privately held business that makes
$500,000, and compare for me the reporting requirements, would
you, please?
Secretary Chao. I'd be more than glad to. First of all----
Senator Harkin. And you say----
Secretary Chao. I would be glad to.
Senator Harkin. Okay.
Secretary Chao. The comparison is not analogous. First of
all, most people are partnerships, single proprietorships, or
small companies who have some degree of control over their
resources. If you are a union member, you do not have control
over your resources. Ten of the top 20 labor unions do not have
any audits by the Office of Labor Management Standards. There
are only two forms that they currently have to file.
Senator Harkin. 10 of the top 20----
Secretary Chao. That's true.
Senator Harkin. 20 top in what regard?
Secretary Chao. Largest.
Senator Harkin. 10 of the top 20 largest unions have no
what?
Secretary Chao. Have never had an audit by OLMS.
Senator Harkin. Have never had an audit by whom?
Secretary Chao. The Office of Labor Management Standards,
which is the office within the Department of Labor, the only
office in the Government, aside from the IRS----
Senator Harkin. Is that because the OLMS is prohibited by
law from auditing them?
Secretary Chao. No. They don't have the resources. That was
under the Landrum-Griffith act. They don't have the resources.
Also, there's no requirement for audited financial statements.
There are no requirements for auditing for compiling financial
statements according to the GAAP, that's generally accepted
accounting practices, or generally accepted accounting
standards. There are no whistleblower protections. There are no
internal controls mandated by the law. All of this is mandated
in most cases for corporations and for small companies. You
have to have audited statements. You have to have certified
public statements.
Senator Harkin. By corporations.
Secretary Chao. Even private companies, you have to have--
--
Senator Harkin. What do private companies have to have?
Secretary Chao. The larger issue is, in a small company----
Senator Harkin. I think you misspoke, but go ahead.
Secretary Chao. In a small company, most stakeholders have
some control over the resources of that entity.
Senator Harkin. Well, I would say that in a union they have
some because the union officers are elected. There's a vote, a
democratic vote.
Secretary Chao. There are other issues about disclosure,
quantitative disclosure, qualitative disclosure, internal
controls, and internal audits. None of those occur.
Senator Harkin. Has any of those top 10 of the top 20
unions that you say they've never been audited by OLMS, are you
aware if they've ever been audited with outside auditors?
Secretary Chao. They probably have, but it's not mandated
by law, as it is with other organizations.
Senator Harkin. But if they've been audited by outside
auditors, and those audits are available to its membership and
to others----
UNION AUDITS
Secretary Chao. Whether it is or not, we don't quite know.
There have been complaints that they've not been available.
Certainly the union leadership claim that they are available,
and then we also have heard from some certain members that it's
not available.
Senator Harkin. The recent thing about this union, ULICO
thing, you know, that's sort of been in the news lately, I'm
told that that came to light not because of you or because of
the Department of Labor or anything else, it came because of
audits that were done by the unions themselves. It was a
voluntary program and they brought it to light. Is that not
true?
Secretary Chao. That is not true. We had heard about it
before, and it was under investigation. The same thing with the
American Teachers Federation.
Senator Harkin. But who did the audits?
Secretary Chao. That I'm not sure of.
Senator Harkin. I was told that was internal audits, or
audits, not internal, but audits that were done by outside CPAs
and stuff that came in that the unions asked to have it
audited, and that's how they found it.
Secretary Chao. We have 11 criminal convictions a month,
and not all of that is self-revealed through the unions.
Senator Harkin. You've got 11 criminal convictions a month
on what, criminal convictions of whom, of what?
Secretary Chao. Of labor unions. We have about 200 audits a
year. It's a very enfeebled office at this point. Its budget
and FTEs were cut more than 40 percent in the last 10 years, so
this small office conducts about 200 audits a year, and there
are investigations ongoing on others. On average there are
about 11 criminal convictions a month.
Senator Harkin. A month.
Secretary Chao. Yes.
Senator Harkin. Convictions, by you or by whom? Convictions
by whom?
Secretary Chao. The courts, Justice Department.
Senator Harkin. Are these under State courts? Are these
Federal cases you bring? I mean, 11 criminal convictions a
month, are these because of your investigations? Is that what
you're saying?
Secretary Chao. A lot of them are instigated not by us but
by the Office of the Inspector General, because they are in
charge of a lot, and then also by the Office of Labor
Management Standards, yes.
Senator Harkin. All right. When you submit the comparisons,
don't just use publicly held corporations. I want you to use
privately held companies, closely held companies that would
have the same kind of receipts in a year as the labor union,
and compare them to see what the reporting requirements are.
Secretary Chao. Labor unions basically don't report very
much today, anyway. They only report two forms to the Office of
Labor Management Standards.
Senator Harkin. Well, what does a privately held company
with the same receipts have to report?
Secretary Chao. That's not an analogous comparison.
Senator Harkin. To try to compare it to publicly held
corporations, why is that analogous?
Secretary Chao. No, the labor unions actually wanted to be
compared to publicly accounted public companies. They claim
that they are held to a higher standard than public
corporations, which is not true.
Senator Harkin. Well, this could go on and on. Thank you
very much, Madam Secretary.
[The information follows:]
Comparison of the Financial Disclosure Regimes for Labor Unions and
Privately Held Companies
Legally mandated financial disclosure regimes for both unions and
publicly held corporations are designed primarily to address a
fundamental problem common to both institutions--the principal/agent
dilemma. This dilemma exists whenever managerial control of an entity
lies beyond the direct control of the people who fund the entity. This
occurs in both unions and publicly held companies. Corporate and union
financial disclosure regimes are supposed to reduce the informational
advantages agents have over principals and permit principals to monitor
and assess the performance of agents. Adequate transparency encourages
union officers and corporate directors (agents) who are elected by
union members and corporate shareholder (principals) to conduct the
business of their organizations in the best interests of the people who
provide the operating funds. Agents failing to do so can be removed
through the mechanisms of corporate and union democracy.
There is no principal/agent dilemma in a privately held enterprise
where the operator of the business is also the source of the venture's
financing. There is no principal to perform the monitoring and no agent
to be monitored. While privately held companies are required to make
certain financial disclosures related to franchise taxes, Small
Business Administration loans, FCC licenses and other regulatory
schemes, these disclosures are designed to assess taxes, fees or
eligibility for government provided benefits, not to ensure
transparency of managerial performance. The only scenario in which it
is rational to compare the financial disclosure regime of a privately
held company to a union is when a privately held firm creates a
principal/agent relationship by accepting funding through the venture
capital markets.
The Labor Management Reporting and Disclosure Act of 1959 (LMRDA)
established a unique financial disclosure regime for labor
organizations designed for two purposes. First it was supposed to
provide union members insight into how union officials managed members'
dues so that they could make informed decisions during union elections.
Second, it was supposed to deter the pervasive infiltration of
organized crime into unions that was highlighted during the McClellan
hearings.
The disclosure regime for labor organizations has not been
materially updated in more than four decades. The modernized union
disclosure regime on which the Department of Labor requested public
comment is far less rigorous than the disclosure regime currently
mandated for publicly held companies following the passage of Sarbanes-
Oxley and in many respects less rigorous than the legally enforceable
transparency regimes that privately held firms accept as a condition of
receiving venture capital funding. The efficacy of these disclosure
systems as a means to address the principal/agent dilemma and the
burden associated with them can be evaluated by the extent to which
they provide adequate quantitative information; qualitative
information; and audit requirements and internal management controls
designed to guarantee the integrity of qualitative and quantitative
disclosures.
Senator Specter. Thank you, Senator Harkin. Thank you very
much, Madam Secretary, for coming in today. It is a big job to
administer the Department of Labor, and we are very pleased to
work with you on the budget. It's an enormous responsibility to
have the $11.5 billion allocation of funding and all of the
responsibilities which you have, and budgets are always
difficult, and in allocating these budget resources, as you
know, this subcommittee has to balance off Labor requests with
Education requests and with Health and Human Service requests
because it is a unified budget the subcommittee has, and we
have to make the allocations. When you talk about worker safety
and worker training and contrast it with Head Start and Pell
Grants and the National Institutes of Health, it is difficult.
Thank you for coming in today.
Secretary Chao. Thank you. We're very committed, obviously,
to helping workers train, and we want to work with the
committee.
Senator Specter. Thank you.
Secretary Chao. Thank you.
PREPARED STATEMENT OF SENATOR THAD COCHRAN
Senator Specter. We have received the prepared statement of
Senator Thad Cochran that will be made part of the hearing
record.
[The statement follows:]
Prepared Statement of Senator Thad Cochran
Mr. Chairman, I am pleased to join you in welcoming Secretary Chao.
I look forward to working with her on issues that are of special
importance to Mississippi and to our nation.
The migrant and seasonal farm worker housing program is of
particular interest to me.
In the past, this subcommittee has included report language
directing the continuation of this small, but important program that
assists farm workers gain better housing. Since 1983, I have worked
with the Department to ensure a network of local organizations,
including one in my state, receives funding to plan, develop, and
manage housing for migrant and seasonal farm workers. There is now a
well established network of local housing organizations that receives
these funds.
I look forward to working with you, Madam Secretary, on this and
other important Department of Labor programs. 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
hispanic and immigrant workers
Question. Over the past years, there has been an alarming increase
in fatalities among Hispanic and Immigrant Workers. The Department of
Labor has acknowledged this fact and has included $2.2 million in the
fiscal year 2004 budget request for a Hispanic Worker Initiative. At
the same time that this program is being proposed, however, the
Administration is proposing to cut funds for worker training and
education grants by more than $7 million. Many of the programs
conducted under these training grants have been directed towards
Hispanic and Immigrant workers, the very workers that DOL has stated
are a priority. Why is the Administration proposing to cut funds
directed towards training and education, including programs targeted at
Hispanic and Immigrant workers? Have these programs been unsuccessful?
Answer. OSHA has included an increase of $5,250,000 in its fiscal
year 2004 budget to expand outreach and assistance activities, almost
half of which will be dedicated to efforts to reach non-English
speaking, hard-to-reach and contingent workers. This is in addition to
a large number of ongoing programs designed to reach, train and educate
these workers.
The President is also requesting $4,000,000 for OSHA training and
education grants in fiscal year 2004. We continue to believe that the
emphasis for OSHA's training and education grants should be the
development and distribution of training materials for the broadest
possible audience. To meet the changing needs of employers, and to take
advantage of new technologies, OSHA has outlined a revised grant
program that would fund short-term grants to nonprofit organizations to
develop, evaluate and validate safety and health training materials for
OSHA that would primarily be distributed to the public via the Web. The
training materials would be targeted principally to employees and small
business employers and could be tailored to the varying needs of
selected industries and workers. This change would make more materials
available for employers and other interested parties to utilize for
training their workers. These materials would also be a useful resource
for OSHA compliance assistance specialists by complementing the
services they provide. Rather than teaching a few workers at a time, we
will be able to develop a variety of new training materials on a
continuing basis to benefit more workers throughout the country.
Question. What specifically does the Department propose to do under
the new Hispanic Worker Initiative that is proposed? How will these
initiatives differ from the programs that have been conducted under the
training grant program?
Answer. The Department is expanding its efforts to address the
safety and health of employees in hard-to-reach sectors of the
workforce, including young workers, as well as Hispanic and other non-
English-speaking workers. For example, OSHA plans to improve the
operations of its toll-free number, which offers assistance in English
and Spanish. OSHA will also expand its current web page for Spanish
speakers and plans to create a Spanish version of many of the agency's
information publications. A Spanish version of ``All About OSHA,'' the
pamphlet that describes the agency's responsibilities and workers'
rights, already exists. OSHA is also forming partnerships with groups
like the Hispanic Contractors of America, INS., to raise awareness of
safety and health assistance offered by OSHA and its state partners.
The Department is also actively recruiting Spanish-speaking
employees to work in front line positions. For example, OSHA currently
has 180 Spanish-speaking employees in Federal and State OSHA programs.
consolidation of employment and training programs
Question. The administration proposes consolidating adult, and
dislocated worker funding under the WIA and Employment Service programs
into a single block grant. An historic function of federal job training
funding is to target dollars to areas and individuals of greatest need.
The adult WIA program allocates funding according to poverty levels
to help communities with large numbers of economically disadvantaged
workers. Dislocated worker funding is targeted to communities with high
unemployment, and it also provides for state Rapid Response programs to
intervene early with help for workers and companies in trouble.
The result of the administration's proposed block grant is to
eliminate discrete programs that provide vital services to groups with
special needs and could pit welfare recipients against unemployed
workers in competition for limited funds.
Why does the administration seek to block grant programs at a time
when there is a continued need for targeted, fully-funded programs
aimed at the special needs of disadvantaged and dislocated workers?
Answer. The Administration's proposal is to consolidate the three
separate funding streams that currently provide overlapping employment-
related services to adults into a single, more flexible, comprehensive
and effective program. The three separate streams, while providing
similar services, currently have separate funding formulas, eligibility
criteria, performance measures, reporting requirements, and other
elements that reduce efficiency, promote duplication of efforts, and do
not enhance the provision of services. Consistent with the principles
of program integration underlying the Workforce Investment Act of 1998
(WIA), this consolidation of funding streams would simplify and enhance
the delivery of services to adults.
The critical services authorized under the current separate
programs to meet the needs of special populations would continue to be
authorized under the consolidated comprehensive program, but without
the burdensome administrative requirements that currently result from
having to track three separate streams of funding.
Funds under the new program will be allocated to states by formula,
and a portion will be held in reserve at the national level in a
discretionary account for National Dislocated Worker Grants (currently
``National Emergency Grants''), demonstration grants and technical
assistance.
At the state level, funds will be allocated to local areas.
Governors would maintain a reserve for statewide activities, including
rapid response, support for core services in the One Stop program, and
demonstration projects.
At the local level, the core, intensive and training services
currently available under the separate programs would be available
through One-Stop career centers under the new comprehensive program,
with enhanced flexibility to determine the appropriate combination of
services. Priorities with respect to providing intensive and training
services would be given to the unemployed and, if local funding
available to serve low-income individuals is insufficient, to low-
income workers. The core services would be available on a universal
basis to job seekers and employers.
The Administration believes this proposal enhances, rather than
diminishes, the ability of States and local areas to tailor services to
meet the special needs of disadvantaged, dislocated and other workers.
Question. States have not used the flexibility they have right now
to receive waivers and to transfer funds between adult and dislocated
worker programs. So why does the administration feel the need to
consolidate adult and dislocated worker programs when states haven't
taken advantage of the flexibility they currently have?
Answer. States have taken advantage of the waiver authority in the
current law, with 36 states requesting waivers, and many of them
requesting multiple waivers of a variety of provisions in the law. In
addition, over half of the states have transferred funds between their
adult and dislocated worker programs. It should also be noted that
because the current waiver authority contains significant restrictions
on the requirements that may be waived, the Department has been unable
to approve a number of waiver requests that we have received. This
experience indicates a significant interest on the part of the states
for greater flexibility in the statute.
The Administration believes the consolidation of the three funding
streams (Adult, Dislocated Workers, and Wagner-Peyser) into a single,
comprehensive program for adults would provide significant flexibility
that will result in enhancing the provision of services to job seekers
and employers.
elimination of the united states employment service
Question. The administration proposes to eliminate the 60-year-old
United States Employment Service (ES), a federal-state partnership that
provides assistance in matching job seekers with employers. This
proposal will replace the ``honest broker'' function of the ES with
myriad organizations whose purpose will be driven by profit, not public
service.
The U.S. Employment Service provides a nationwide public labor
exchange for all workers and employers. How does the Department expect
fifty states to carry out this national purpose without compromising or
undermining the principle of universal access and a free, public
national labor exchange?
Answer. The universal labor exchange services currently provided
under the Wagner-Peyser Act are also required to be provided under the
current WIA adult formula program, and labor exchange services for
dislocated workers are required to be provided under the WIA dislocated
worker formula program. All three programs are to make these services
available through the One-Stop delivery system established in each
local area under WIA.
Rather than have these overlapping and duplicative requirements for
the provision of labor exchange services under three different
programs, the Administration believes the three funding streams should
be consolidated into a single, comprehensive program for adults which
includes as a key element the availability of universal public labor
exchange services for all job seekers and employers. Rather than
undermining or compromising the principle of universally accessible
labor exchange services, the Administration believes the consolidation
would strengthen and enhance the provision of those services.
Question. The U.S. Employment Service provides a range of services
in addition to labor exchange including special assistance to migrant
and seasonal farmworkers and veterans. It also conducts important labor
market research and labor certification functions. How will the
Department ensure that these functions are continued?
Answer. The functions described in the question will continue to be
carried out.
The assistance to migrant and seasonal farmworkers will be carried
out through the One-Stop delivery system under the consolidated WIA
adult program. Similarly, the special programs for veterans, the
Disabled Veterans Outreach Program (DVOP) and Local Veterans Employment
Representatives (LVER) program, that assist veterans in job placement
will be carried out in coordination with the consolidated adult program
through the One-Stop delivery system.
Other initiatives funded through the America's Labor Market
Information System (ALMIS)/One-Stop line item would also continue.
These initiatives create the foundation for a Workforce Information
System that provides for the data collection, aggregation, formatting,
and delivery needed for day-to-day decision-making by our One-Stop
partners and for the efficient delivery of information and labor
exchange services through a set of Internet-based electronic tools. The
funds are also used to insure that our information delivery is up to
the high-quality standards set for e-Government.
The ALMIS/One-Stop budget for fiscal year 2004 has been re-aligned
with ETA's priorities and strategic plan. The budget requested will
provide sufficient funding for a comprehensive Workforce Information
System and for the continued development and delivery of information
through the Career One-Stop set of national electronic tools.
The Department of Labor will continue to provide funds to State
Workforce Agencies to continue to perform certain alien labor
certification functions.
trade adjustment assistance (taa) program
Question. The new TAA program significantly increased the number of
workers who are eligible for training, income support, and health care.
Estimates are that the TAA program enrollments will double. Congress
authorized $10 million for TAA health care programs in fiscal year 2004
yet the administration proposes no new funding to provide states with
the resources necessary to administer the new health care tax credit
and provide interim coverage for TAA-eligible individuals.
Given the expected demand for services, how can the Department of
Labor expect the already strapped National Emergency Grant (NEG)
program under WIA to provide states with resources to administer a
complicated health care tax credit program and to provide interim
health coverage to the thousands of TAA-eligible participants?
Answer. As you know, the Trade Adjustment Assistance Reform Act of
2002 established new mechanisms by which certain TAA participants, as
well as eligible Pension Benefit Guaranty Corporation pension
recipients, can receive assistance in covering the cost of health
insurance.
These mechanisms include two different types of National Emergency
Grants (NEGs). The first NEG is authorized under the new section 173(f)
of WIA and is primarily to provide administrative support to the States
in carrying out the health tax credit (HCTC). The second NEG is
authorized under the new section 173(g) of WIA and is primarily to
provide interim assistance in paying for qualified coverage until the
HCTC is available on an advanceable basis. Since the law requires that
the advanceable credit be available not later than August 1, 2003, we
do not believe additional resources will be needed in fiscal year 2004
and thereafter for the interim assistance NEG. Fifty million was
appropriated to carry out that NEG in fiscal year 2002 and remains
available.
For administrative support NEGs the Congress appropriated $10
million in fiscal year 2002 and $30 million in fiscal year 2003. Since
the program is new, it is difficult to determine the appropriate level
of resources that will be needed in future fiscal years. Beginning in
fiscal year 2004 the Administration believes that in lieu of a separate
appropriation this NEG would be better administered if funded under the
same source of funding as the other NEGs for dislocated workers. This
would provide the Secretary with appropriate flexibility in managing
NEG funds so that the Secretary could shift more funds to these HCTC
activities if needed, or if additional resources are not needed, to use
the funds for other dislocated worker assistance.
h-1b training programs
Question. The Administration will not seek to renew the H-1B
training program, which created a $98 million training fund for U.S.
workers, paid for through employers' H-1B visa application fees. At the
same time, the budget requests an increase of $49.5 million to expedite
processing of permanent foreign labor certifications.
How can the administration abandon worker training in skill
shortage occupations when H-1B visas will still be provided to
thousands of foreign workers?
Answer. The Administration is not abandoning job training in skill
shortage occupations. That is one of the important functions of all of
the job training programs administered by the Department, including the
formula programs administered by States and local areas under title I
of WIA. The Department is continuing to work to ensure job training is
linked to occupations in demand, particularly skill shortage
occupations.
It may also be noted that Department has awarded over $218 million
through 90 H-1B technical skills training grants. In January 2003, the
Department issued a revised Solicitation for Grant Applications, and
approximately $200 million in additional funding is available for
grants.
We will continue to make funds available for H-1B Technical Skills
Training Grants, as authorized under the law, until the funds are
expended.
Grants for the H-1B technical skills grants program have been
awarded under the authority of Section 171 of the Workforce Investment
Act (WIA), which requires programs and activities carried out under
that section be thoroughly evaluated. An evaluation being conducted by
Lee Bruno and Associates and Westat Research is examining all aspects
of the program, including how grantees have innovated to develop
effective tools and approaches; the extent to which participants have
achieved increased skill levels resulting in degrees, licensures,
certifications, or occupational/wage upgrades; and the feasibility of
examining the programs' net impact on the employment-related outcomes
of trainees and the employment of foreign workers with H-1B visas.
It is the Department's intent, based on this and other studies, to
examine what strategies do and do not work in technical high skill
training. We plan to share the knowledge gained through these studies
with States and local Workforce Investment Boards who administer the
WIA program, so that knowledge can be applied in the administration of
the job training activities that are funded at the State and local
level under WIA, and to other programs administered by the Department,
such as Trade Adjustment Assistance.
wia youth programs
Question. At a time when increasing numbers of young people are at-
risk in the labor market, the administration proposes to cut youth
training programs and to phase out the Youth Opportunity Grants
program, which provides at-risk youth education and training
opportunities in high-poverty areas. It also proposes to limit WIA
Youth Activities formula program to out-of-school youth.
Why has the administration cut funding for programs designed to
help the most at-risk students, including those in- and out-of-school?
Answer. Reaching out to out-of-school youth is very important and
not the focus of other Federal youth programs. School dropouts and
other out-of-school youth deficient in basic skills need help in
reconnecting with the education system and getting the necessary skills
to find employment. Our proposal will target this hardest-to-reach
population, which is most in need of services, while the Administration
has proposed that the Department of Education focus on in-school youth.
This program will target DOL's formula resources to out-of-school
youth programs, providing services that have proven effective in
assisting such youth. Our youth investments will focus on providing
young people with a strong, core academic foundation in conjunction
with post secondary skills certifications or degrees, and transitions
to career path employment.
We will apply what we have learned regarding how to better
coordinate with local community and faith-based organizations in
serving these youth; and how to work with the local private sector to
set up internships and other employment experience opportunities for
these youth.
We will also apply what we have learned to enhance coordination
with the local juvenile justice system to serve youth returning home
from correctional facilities and youth being put on probation and how
to better coordinate with major employers such as UPS and Federal
Express to provide employment opportunities for out-of-school youth.
Question. Why is the administration abandoning help to at-risk, in-
school youth? Answer. The Administration's budget does not abandon help
to at-risk, in-school youth. The proposal targets resources to those
youth most in need of assistance to reconnect to the education and
workforce systems-specifically school dropouts and other out-of-school
youth who are basic skills deficient. The Administration has proposed
that the Department of Education focus on in-school youth. The new WIA
Youth program would be funded at $1.001 billion in fiscal year 2004.
Seventy-five percent of the funds will be allocated by formula to
states to serve out-of-school youth. It may be noted that the remaining
25 percent will be reserved for national challenge grants, which may be
used for a number of activities to assist youth in acquiring the
skills, credentials, and employment experience necessary to succeed in
the labor market. Those grants could include services to some at-risk
in-school youth. However, the primary purpose of the revised youth
program is to target resource to out-of-school youth who are currently
underserved and most in need of the assistance the WIA youth program
can provide.
pension operations
Question. The President's fiscal year 2004 budget includes a
provision to eliminate the limit on administrative expenses of the
Pension Benefit Guaranty Corporation (PBGC). Shouldn't we be tightening
up on the definition of the administrative expense limitation, instead
of ceding control to the Executive Branch to determine spending?
Answer. Although the President's budget proposes eliminating the
administrative expenses limitation for the Pension Benefit Guaranty
Corporation (PBGC), it actually would provide a greater degree of
Congressional oversight for PBGC's entire budget than under the current
process by:
--Simplifying PBGC's budget structure with a single funding source
and making it more transparent to its stakeholders in terms of
cost of administration for terminated pension plans and the on-
going pension insurance program.
--Providing a more meaningful presentation of all of PBGC's
operational expenses.
--Reviewing mid-year operating budget adjustments necessitated by
termination of large pension plans not identified in the annual
budget request process.
Currently, Congress reviews PBGC's entire operational budget each
year as part of its appropriations process following submission of the
President's Budget. Over 90 percent of PBGC's work is now devoted to
the termination, trusteeship and administration of failed pension plans
in the private sector. Funding for this work comes from PBGC's trust
funds, which are made up of the private assets transferred to PBGC from
terminated pension plans when PBGC assumes responsibility for their
administration. These are not appropriated funds.
For several years, PBGC has had two operational budgets: one coming
from the trust funds for plan termination-related work and the second
coming from PBGC's collected premium revenues paid by on-going, defined
benefit pension plans. The premium revenues constitute a permanent
appropriation. As PBGC's plan termination work has escalated in recent
years, the amount of its operational expenses paid by the trust funds
has also risen to over 90 percent.
Continuing to manage two operational budgets for a relatively small
agency has proved both burdensome and confusing to stakeholders not
dealing with internal budget matters. The President has proposed to
simplify PBGC's operational budget by providing a single source of
funding coming from the trust funds. In addition, he has proposed that
Congress be able to review PBGC reapportionment requests from OMB when
a major pension plan termination(s) cause PBGC's operations to expand.
These reapportionments have in recent years resulted in substantial
increases in PBGC's budget coming from the trust funds in order to
quickly support processing of very large terminated pension plans such
as TWA and LTV Steel. Over the years, PBGC has used its reapportionment
flexibility in only the most serious situations. Although this use has
resulted in substantial increases, PBGC expenses per participant have
substantially decreased over the last 10 years.
Under the new proposal, PBGC's full annual budget request would be
subject to Congressional review--not just during the normal
appropriations cycle but throughout the year. Congress would receive
advance notice of reapportionment requests, which would afford it an
opportunity it does not currently have to raise questions and request
additional information before any new funds could be used.
young offenders
Question. Your budget justification material states that the United
States has experienced rapid growth in the number of people who are
incarcerated or under supervision of the criminal justice system. It
further states that an estimated 500,000 inmates will return to
communities this year. Yet you are proposing termination of the
Responsible Reintegration of Young Offenders program, which currently
serves 10,400 participants with a budget of $55 million.
Shouldn't we be expanding this pilot program, and not terminating
it?
Answer. In 1998, the Department of Labor initiated a five-year
Youth Offender Demonstration Project to assist the reentry needs of ex-
offenders and at-risk youth. The program is currently in it fifth year.
We are applying what we have learned from the Youth Offender
Program to the reauthorization of the WIA youth formula program, which
will target resources to out-of-school youth, including youth coming
out of the juvenile justice system and will integrate Youth programs
with the One-Stop system. We believe this targeted approach to the WIA
youth program will enhance the effectiveness of our efforts to help
those served by the Youth Offender Program, as well as school dropouts
and other out-of-school youth.
Question. What other resources are available to assist these young
people?
Answer. During 2004, the Department will provide technical
assistance to transition the Youth Offender Demonstration Project
directly to state and local workforce agencies. We will share the
demonstration findings and disseminate information to local communities
about best practices for serving youth offenders in the existing One-
Stop delivery system, using formula WIA, Wagner-Peyser Act and other
funds that have been shown through research to strengthen and expand
local partnerships and enhance One-Stop services to such youth.
This year, the Department, in partnership with the Departments of
Justice and Health and Human Services and other cabinet agencies,
supported a companion effort called the Serious and Violent Offender
Reentry ``Coming Home'' Initiative, which provided grants to 68
communities totaling $100 million ($48 million of which is Department
of Labor funds) to address the reentry problems of the most serious ex-
offenders.
national labor relations board
Question. The National Labor Relations Board (NLRB) is an
independent federal agency (under Relateds, not under Labor) which was
created in Congress in 1935 to administer the National Labor Relations
Act. The two primary functions of the NLRB are to: (1) prevent and
remedy statutorily defined unfair labor practices; and (2) to conduct
secret-ballot elections to determine whether employees wish to be
represented by a union. Due to lack of FTEs and being unable to hire
new staff because of the fiscal year 2002 levels of last year, the
backload of unfair labor practice cases has increased dramatically.
------------------------------------------------------------------------
Fiscal year--
--------------------------------------
2003
2001 2002 (estimate)
------------------------------------------------------------------------
Case Backload by the end of...... 970 1,496 2,346
------------------------------------------------------------------------
The NLRB's main function is to help solve disputes regarding unfair
labor practices, thus often acting as a liaison between the Unions, and
company management. However, the backlog in unfinished cases is growing
annually. We recognize that this is a federal agency completely
independent from your own, however their role in labor matters is
vital. Can you give us an idea of the workload of cases that the NLRB
handles and their budgetary needs? What importance do you place on
increased funding for this independent agency? Of what importance would
you judge this agency in helping mediate and settle labor practices,
and to act as this sort of liaison?
Answer. While the Department is aware of the important role played
by the NLRB in resolving issues under the National Labor Relations Act,
that agency is, as your question recognized, completely independent.
The Department is not involved in the preparation of the budget for the
NLRB and has no supervisory role with respect to the operations of that
agency. Accordingly, the Department is not in a position to comment on
the NLRB's workload or budget needs.
ergonomics budget
Question. What level of funding has been targeted to support your
``comprehensive approach'' to ergonomics in the fiscal year 2003 budget
and the fiscal year 2004 budget request? For which activities has
funding been requested?
Answer. The resources utilized to address ergonomics in both the
fiscal year 2003 and fiscal year 2004 budget request are contained
within all of OSHA's budget activities and are not separately
identified or earmarked to address ergonomics or any other specific
issue. Rather, the comprehensive approach to ergonomics involves
focused activity by the entire agency in addressing the four prongs of
the ergonomics policy: industry specific and task-specific guidelines,
strong enforcement, outreach and assistance, and research.
Question. How many FTE's have been assigned to work on ergonomics?
Answer. The agency has not specifically identified or tracked the
number of staff working on ergonomics. The staff necessary to address
ergonomic concerns is available as needed within the ongoing
enforcement, outreach, and regulatory activities of the agency.
Question. How many ergonomists does OSHA currently employ? What are
their responsibilities?
Answer. Although there is no formal Federal job classification
titled ``ergonomist,'' OSHA currently employs three Certified
Professional Ergonomists. Two of these ergonomists are employed in two
different Regional Offices and the third works at our Salt Lake
Technical Center. Their responsibilities include providing training and
assistance to compliance staff, outreach and assistance to the
regulated community, and serving on the Ergonomics Response Team. The
agency also employs six compliance officers who have advanced degrees
in industrial engineering, with concentrations in ergonomics; nearly 30
regional personnel who have extensive training in ergonomic
interventions in specific industries, such as meat-packing and
textiles; and three Health Response Team members with extensive
ergonomics expertise and training.
ergonomics enforcement and guidelines
Question. How many enforcement actions has OSHA taken pertaining to
ergonomic hazards during fiscal year 2002 and fiscal year 2003 to date?
Answer. Inspections under OSHA's National Emphasis Program (NEP)
for Nursing and Personal Care Facilities, which focuses on patient-
handling hazards, began on September 17, 2002. Over the past winter,
Regional and Area Offices implemented Local Emphasis Programs (LEPs) to
address ergonomics in several other industries with high rates of
musculoskeletal disorders.
In all, OSHA has assessed ergonomic conditions in 675 of the
inspections opened between January 1, 2002 and March 31, 2003. Of these
inspections, 469 have been in nursing and personal care facilities
pursuant to the NEP for this industry and 156 have been in other
industries, including 50 inspections in industries targeted by
ergonomic-related Local and Regional Emphasis Programs.
------------------------------------------------------------------------
Number of
Inspection type Time period inspections
------------------------------------------------------------------------
Nursing Homes under the Nursing September 17, 2002 469
Home NEP. through March 31,
2003.
Ergonomic Related--Non-Nursing January 1, 2002 106
Homes. through March 31,
2003.
LEPs--Ergonomic Related............ December 15, 2002 50
through March 31,
2003.
------------------------------------------------------------------------
Question. Specifically, how many hazard warning letters have been
issued on ergonomic hazards, and how many general duty clause--
5(a)(1)--citations have been issued?
Answer. Although many of the ergonomic inspections are still
ongoing, those that have concluded have resulted in 88 ergonomic
related Hazard Alert Letters (EHALs) (55 to nursing homes and 33 to
establishments in other industries) and six 5(a)(1) citations for
ergonomic hazards. Each EHAL recommends ways to reduce ergonomic
hazards, and indicates that OSHA may conduct a follow-up inspection to
assess the extent to which the employer has taken such action.
Question. Please provide a list of the establishments for which
hazard warning letters or 5(a)(1) citations have been issued, and the
date of their issuance.
Answer. Alpha Health Services, Inc. received three of the citations
for hazards at three different facilities. Alpha Health Services was
inspected under the NEP for Nursing and Personal Care Facilities. Other
establishments receiving 5(a)(1) citations included Security Metal
Products, which manufactures door frames; SuperValu; and Brown
Printing.
OSHA is in the process of creating a list of the 88 establishments
to which EHALs have been sent, including the date of issuance. Once we
have created this list, we can provide it to the Committee.
Question. How many inspections on ergonomic hazards does OSHA plan
in fiscal year 2003 and fiscal year 2004?
Answer. In general, OSHA does not have a pre-determined number of
inspections under which we target ergonomics. OSHA's efforts are geared
towards targeting establishments with the highest injury and illness
rates. OSHA's Site-Specific Targeting Program focuses our inspection
efforts on those employers who report the highest rates of injuries and
illnesses. Because many of these injuries and illnesses are caused by
ergonomic hazards, ergonomics will continue to be a focus of our
inspections. Among the occupations with the highest numbers of days
away from work were nurses' aides and orderlies. Under the current NEP
for Nursing and Personal Care Facilities, we plan to inspect 1,000
nursing home establishments from September 17, 2002 through September
30, 2003. If this program is renewed, we will continue to focus on
injuries that result from resident handling in nursing homes.
Question. To date OSHA has issued one final ergonomics guideline
for the nursing home industry and announced that guidelines for 3 other
industries (retail grocery, poultry and shipyards) will be developed.
What is the schedule for the issuance of these guidelines in proposed
form and final form? What other ergonomic guidelines does OSHA plan to
issue in fiscal year 2003 or fiscal year 2004, and what are the
schedules for issuance of these guidelines?
Answer. OSHA published the nursing home guidelines less than a year
after the announcement of the agency's four-pronged approach to dealing
with ergonomics and after engaging in a public process that stressed
stakeholder participation. OSHA has also released for public comment
the draft retail grocery guidelines, and poultry processing guidelines.
The agency intends to publish both of these guidelines in final form
later this year. OSHA is working on the shipyard guidelines, and hopes
to publish draft guidelines this fall with final guidelines completed
early in 2004. The next topics to be addressed have not yet been
determined but plans for additional guidelines will be announced in the
next few weeks, as we complete work on draft guidelines for grocery
stores and poultry processing.
osha standards
Question. One of OSHA's primary responsibilities is to set new
safety and health standards to protect workers from injuries and
illnesses. It is my understanding that there are several rules that
have gone through the rulemaking process and are pending final action.
These include rules on tuberculosis and employer payment for personal
protective equipment. Both of these are important standards. The TB
rule would protect health care workers not only from TB, but also other
infectious agents like the new virus SARS. The payment for PPE rule
would not impose any new requirements, but simply clarify that it is
the employers' responsibility to pay for protective equipment provided
by OSHA standards. This is particularly important for low-wage
immigrant and Hispanic workers who are at increased risk of injury and
death, who cannot afford to pay for their own protective equipment.
It is very disturbing that the Administration has repeatedly put
off action on these two rules. Why has the Administration failed to act
on these rules and when do you plan to issue the final rules on TB and
Payment for Personal Protective Equipment?
Answer. In the current regulatory agenda, both the tuberculosis and
employer payment for personal protective equipment (PPE) rulemakings
were slated for a decision on the next step. We are continuing to
review the records of both rulemakings. As appropriate, the agency will
update the status of these and other rulemaking proceedings in the next
regulatory agenda.
Question. What other proposed or final rules does the
Administration plan to issue in fiscal year 2003 and fiscal year 2004,
and what is the projected schedule for issuing these rules?
Answer. In fiscal year 2003, OSHA has issued proposals for:
Commercial Diving Operations; Fire Protection in Shipyards; and
Standards Improvement Project. During the remaining months of fiscal
year 2003, proposals are expected to be published for: Assigned
Protection Factors for Respiratory Protection; Controlled Negative
Pressure Fit Testing Protocol; Vertical Tandem Lifts; General Working
Conditions in Shipyards; and Electrical Safety. A proposal for Electric
Power Generation, Transmission, and Distribution is currently in the
SBREFA panel process, and should be published later this year. A
proposal addressing Confined Spaces in Construction will also begin the
SBREFA panel process soon.
OSHA has issued final rules for Exit Routes and parts of the
Occupational Injury and Illness Recording and Reporting Requirements in
fiscal year 2003. The agency expects to issue another final rule in
fiscal year 2003 for Occupational Injury and Illness Recording and
Reporting, as well as a final rule for Commercial Diving Operations.
With regard to fiscal year 2004, the current regulatory agenda does
not provide commitments throughout that year. It is expected that final
rules for Fire Protection in Shipyards and the Standards Improvement
Project will be issued in the first quarter of fiscal year 2004.
Question. Last year as part of a reorganization of OSHA, the
Directorate of Safety Standards and the Directorate of Health Standards
were merged and the charge of the new combined directorate expanded to
include the development of voluntary guidance. The proposed standard
setting budget for fiscal year 2004 of $14.5 million is $1.6 million
less than what was appropriated for standard setting in fiscal year
2003 ($16.1 million). Why are you proposing to cut the standard setting
budget? What percent of the budget will be used to develop and issue
mandatory standards and rules and what percentage will be used to issue
voluntary guidelines?
Answer. OSHA's fiscal year 2004 budget for the Directorate of
Standards and Guidance is sufficient to support the proposed regulatory
agenda and develop other non-regulatory approaches to dealing with
safety and health hazards.
The work involved in developing standards is similar to that
involved in developing guidelines. As a consequence, the agency does
not distinguish in its budget between standards development and the
development of guidance materials.
osha enforcement
Question. The Administration has proposed $165.3 million for
federal OSHA enforcement for fiscal year 2004. While this represents a
small increase in dollars over the fiscal year 2003 appropriated
levels, it is not sufficient to maintain the number of FTEs budgeted in
fiscal year 2003. How many FTEs for Federal enforcement are currently
filled? How many are vacant? Please provide the number of FTEs and a
list of the positions that will be eliminated if the Administration's
fiscal year 2004 budget request for federal OSHA enforcement is
adopted.
Answer. There are currently 1,603 employees filling positions in
Federal Enforcement. OSHA has requested 1,581 FTE for Federal
Enforcement for fiscal year 2004, a total of 31 less than the fiscal
year 2003 authorized level. This reduction will not affect the number
of safety and health inspections or the number of front-line OSHA
enforcement staff. Consistent with the Department's workforce
restructuring plans, which seek to streamline decision making processes
and eliminate unnecessary overhead positions, OSHA proposes to
eliminate field and national office positions that provide
administrative and management support.
With the fiscal year 2004 Budget, OSHA has committed to achieving
significant safety and health improvements--specifically a 5 percent
reduction in the fatality rate, and an 8 percent reduction in the
injury and illness rate. OSHA's proposed staff allocation enables it to
meet those goals.
Question. In March, OSHA announced a new ``Enhanced Enforcement''
policy to focus attention on employers who were persistent serious
violators of OSHA safety and health standards. Based upon agency press
statements, it appears that this policy will consist largely of
enhanced oversight. During previous administrations, including the
Reagan and Bush I Administrations, OSHA instituted similar enhanced
enforcement policies including the egregious policy which significantly
increased penalties on egregious violators through the application of
instance by instance citations and penalties.
Does the new enhanced enforcement policy include any provisions for
enhanced citations or penalties? If so, what provisions are included?
And if not, why aren't these employers being treated more severely with
respect to citations and penalties than other employers?
Answer. Many of the specifics of the new Enhanced Enforcement
Program are still being developed and will be embodied in a directive
that OSHA will be issuing in the near future; they will, however,
conform to the approach announced by the Secretary in March. The main
intent of the program is to give OSHA a better targeting tool so we can
focus resources on the employers who have shown the least regard for
worker safety and health.
The new program will focus on employers whose inadequate attention
to worker safety and health results in high-gravity citations. In these
cases, OSHA will make sure that the employer's corporate headquarters
receives copies of the citations. Additional inspections of workplaces
affiliated with the same corporation will be more likely. When these
employers choose to settle citations, we will use the settlement
process to encourage the employers to implement systemic improvements
to their safety and health practices. Finally, strong consideration
will be given to Federal Court enforcement under Section 11(b) of the
OSH Act. Although, in keeping with the law, the actual citation
characterizations and penalty amounts will depend on the nature and
circumstances of each violation cited, we will consider using all
applicable OSHA sanctions, including instance-by-instance citations and
penalties.
extended benefits for airline industry
Question. I was very disappointed to learn yesterday of the
President's opposition to a temporary extension of unemployment
insurance benefits to help unemployed airline industry workers who have
lost their jobs. But I was heartened to see that 67 House Republicans
joined all of the House Democrats to instruct the Appropriations
conferees to help our workers.
As the Secretary of Labor, do you agree with the Administration
that the government should provide billions of dollars in federal aid
to ailing industries while doing nothing to support workers who have
played by the rules, but have still lost their jobs?
Answer. The Administration has supported two federal extensions of
unemployment benefits to workers who have not been able to find new
jobs before exhausting regular state unemployment benefits. While we
have concerns about providing a more generous level of benefits to
workers in a particular industry, the Administration will continue to
work with Congress to determine how these workers can be assisted in
finding reemployment.
extension of unemployment compensation
Question. If economic conditions do not rebound by the summer will
you support an extension of unemployment compensation benefits to allow
additional time for job growth to occur?
Answer. The President and I are focused on job creation. The
Administration proposed a Jobs and Economic Growth Plan, including tax
relief and Personal Reemployment Accounts, to provide meaningful
stimulus for the economy. Additionally, we will work with the Congress
to help unemployed workers who have exhausted their benefits before
finding new jobs.
trade adjustment assistance
Question. In the letter Mitch Daniels sent to Congressional
Appropriations leaders yesterday, he said the White House opposed the
Murray airline workers amendment because, ``To provide benefits for a
specific industry would be unusual, unfair and potentially harmful to
our national unemployment system.''
Is it the Administration's position that Trade Adjustment
Assistance which provides benefits to specific industries is also
unusual and unfair?
Answer. The Trade Adjustment Assistance Program does not provide
benefits to specific industries. The program is not industry-based and
is available to any worker group impacted by foreign trade.
Worker groups in virtually all industries have been certified for
TAA benefits at one time or another. Workers whose firms are adversely
affected by increased imports or a shift in production to a country
which has a free trade agreement with the United States or a country
under certain specified Acts are potentially eligible for TAA
certification. Further, workers who are found to be secondarily-
impacted, as defined in the Act, may also be eligible.
migrant and seasonal farmworkers elimination
Question. It appears that the Department no longer believes that a
national program for migrant and seasonal farm workers is needed.
How will we avoid burdening Governors and local One-Stops with the
responsibility of trying to serve workers who may work and reside in
their states for brief periods during this time of huge and growing
state deficits?
Answer. The Workforce Investment Act (WIA) created the federally-
funded One-Stop Career Center system, designed to provide an integrated
system of workforce investment services at the local level and to
provide universal access to these services for all customers. The
Administration's fiscal year 2004 budget proposal seeks to tap the
system's potential to serve more migrant and seasonal farmworkers by
providing job training services for them through the One-Stop delivery
system and turning to other appropriate agencies to provide social and
supportive services, housing, and other related assistance.
To facilitate the transition, we have been working with the current
National Farmworker Jobs Program (NFJP) grantees to identify
initiatives that can be undertaken to support the One-Stop delivery
system's efforts to be responsive to farmworkers. We are considering
pilot and demonstration projects to test new ways to increase
farmworkers' employment and earnings, and training and technical
assistance to states and localities to meet the challenge of providing
universal and effective workforce services.
We believe that workforce investment services organized through the
One-Stop delivery system play a vital role in building strong local
economies, and that providing services to farmworkers through the One-
Stop delivery system will increase the number served and have a
positive employment and earnings impact on those who receive services.
asbestos tainted vermiculite
Question. I remain concerned that workers across the country are
still being exposed to unacceptably high levels of asbestos. I am
particularly concerned that workers are being exposed to asbestos-
tainted vermiculite, which may still be in as many as 35 million homes.
Do you believe OSHA and EPA need to do more to warn workers and
homeowners not to disturb this product?
Answer. Since OSHA's inception in 1971, the agency has used its
authority for standard-setting, enforcement, and compliance assistance
to protect workers from the threat of asbestos.
In addition to the final asbestos rule issued in June 1972, the
agency issued two subsequent emergency standards, the last of which
published two final asbestos standards, one for general industry and
one for construction; added shipyards as a covered industry; and
lowered the PEL to 0.1 fibers per cubic centimeter. All employers are
required to communicate information about asbestos hazards to all
potentially affected employees at a worksite.
OSHA enforces the current asbestos standard through routine, random
or targeted inspections. Many of the several thousand inspections
conducted by Federal or State OSHA programs, in which violations of the
standard were cited, were initiated as a result of employee complaints
and referrals from Federal or State agencies.
OSHA provides compliance assistance to employers and employees to
help them understand the dangers of asbestos, and how to minimize or
eliminate the threat. OSHA's Web page connects computer users to
concise and easy-to-read publications on asbestos, which are available
to the public free of charge. Pamphlets explain the requirements of the
standards for both general industry and construction. Included in each
is a list of sources of assistance. OSHA's Web page also includes
reports, links to other Web sites, slides, and information about taking
samples and controlling exposure to asbestos. OSHA offers an intensive
course covering the recognition and control of asbestos at its Training
Institute in Illinois.
OSHA has also developed software that can be downloaded from its
Web site to provide interactive expert advice for building owners,
managers and lessees, as well as for contractors of building
renovation, maintenance and housekeeping services. Once installed on a
computer, the software asks questions about a building site. It then
asks follow-up questions based on answers, and produces a report on
responsibilities under the asbestos rules.
In all 50 states, OSHA's free on-site consultation program is
available and provides expert assistance on asbestos to small
businesses.
cuts in employment and training services and gao
Question. In the past, you have argued that cuts in employment and
training services can be accomplished without impacting service
delivery because of a carryover of funds in WIA formula programs.
The General Accounting Office (GAO) recently conducted an
investigation and found that the Administration's argument was not
accurate. It said, ``Our analysis of Labor's data shows that states are
rapidly spending their funds--in fact nationwide states have spent 90
percent within 2 years, even though the law allows 3 years to spend the
money.'' In fact, my state was found to have spent 98 percent of their
formula funding in fiscal year 2001.
Would you now agree that cuts in funding will mean cuts in
services?
Answer. Absolutely not. The President's 2004 Budget and the
Administration's WIA reauthorization proposal not only would maintain,
but allow for increases in, job training participation. As the
Assistant Secretary for Employment and Training said in the Department
of Labor's (DOL) February 7th response to GAO's report, DOL does not
dispute that states are exceeding the minimum requirements for spending
under the Act. However, DOL and the Administration believe that it is
important to look beyond the minimum expectations when making these
workforce investment decisions. The Department has never questioned
whether these funds will be spent over time. What concerns us is the
amount that is carried over from one program year to the next that
could have been used for program services during the year for which the
funds were appropriated. For the past few years, large and record-level
amounts of WIA state grants have remained unspent and in the Treasury
at the end of the year. For fiscal year 2004, these balances still will
be an estimated $1.7 billion. So, while the state under-spending
problem has improved somewhat, the fiscal year 2004 budget request
takes into account these continuing large amounts of unexpended carry-
over funds.
--The recent GAO report (GAO-03-239) found that states are spending
their WIA funds much faster than required under the law.
However, our own analysis of state spending data indicates that
spending rates of available funds continue to increase only
marginally as state programs become more established and
financial reporting procedures are improved.
--Despite improved spending rates, there remain large amounts of
state unexpended carryover funds from the previous two years
that compel us to prudently keep our fiscal year 2004 budget
request at roughly the fiscal year 2003 levels. This budget
would provide adequate funding to maintain and even increase
services in the coming year. Any need for additional funding in
local communities can be addressed within the flexibility of
other provisions in WIA.
--Further, the Administration's fiscal year 2004 job training policy
provides new authority to the Secretary and states to
reallocate funds to the few states and localities that have
exhausted the resources available to them. The Administration
proposes to recapture funds from states with more than 30
percent of all funds that were available for expenditure during
the prior program year (including carry-in funds from previous
years) that remain unexpended, compared to the current law
provision which only recaptures funds from states with more
than 20 percent of funds from the prior program year's
allotment that remain unobligated. The proposal more directly
targets areas where there are significant levels of under-
spending.
personal reemployment accounts
Question. The President's Economic Stimulus package proposes to
spend $3.6 billion on a new untested program called Personal
Reemployment Accounts. This proposal has received criticism from the
workforce community and Republicans and Democrats in the Congress.
Given the unlikely enactment of this new scheme by the Congress,
why not use this money to more adequately fund programs for adults,
youth and dislocated workers that are part of the already well
established Workforce Investment Act?
Answer. The President's 2004 Budget and the Administration's WIA
reauthorization proposal not only would maintain, but allow for
increases in, job training participation. The concept of the Personal
Reemployment Accounts (PRA) initiative, and particularly its elements
of greater flexibility and customer choice, are important to the
President and considered key to the success of today's unemployed
workers in reattaching to the labor market. Even if the Congress fund
the PRA initiative, the Administration proposes to offer PRAs as a
service option using funds available through a reauthorized Workforce
Investment Act (WIA).
wia formula amendments
Question. Last week DOL's Employment and Training Administration
(ETA) released the state formula allocations for fiscal year 2003 for
the WIA formula funded programs. Despite having the second highest
state unemployment rate in the nation Washington received a cut of over
$33 million in its WIA formula funds, with most of the reduction ($29
million) coming in the dislocated worker account.
Clearly the Workforce Investment Act (WIA) formula factors do not
accurately reflect current economic conditions in a state.
Madame Secretary, will you work with me during the reauthorization
of WIA to develop formula factors that more accurately reflect and are
responsive to current economic conditions in a state?
Answer. Yes. We are aware the current statutory formulas are
outdated and are hopeful that changes will be made as part of the WIA
reauthorization process. The Administration's reauthorization proposal
consolidates three funding streams (Adult, Dislocated Worker, and
Employment Services) into a single comprehensive funding stream
designed to provide services to adults. Under current law, funds under
each of the three separate streams are distributed according to
specific statutory formulas based on a range of factors (such as
unemployment, civilian labor force, etc.).
The Department recognizes a need to develop a new formula. The
development of a new formula is also consistent with a recent GAO study
that found that the current statutory language dates back to programs
run in the 1970s and are outdated and inconsistent with current
programmatic goals. Under the Administration's recommended formula,
states will no longer experience the dramatic funding swings that
currently exist from year to year under the Dislocated Worker program.
youth program cuts
Question. Why is the Administration proposing to cut youth formula
training programs, which currently serve less than 10 percent of the
eligible youth and to phase out the Youth Opportunity Grant (YOG)
program, which provides at-risk youth education and training
opportunities in high poverty areas, at a time when research has shown
that nearly 50 percent of those Americans who have lost their jobs over
the last two years are under 25 years of age?
Answer. Proposed funding for youth programs under WIA is $1 billion
for fiscal year 2004. The proposal targets resources to those youth
most in need of assistance to reconnect to the education and workforce
systems-specifically school dropouts and other out-of-school youth who
are basic skills deficient. Seventy-five percent of the funds will be
allocated by formula to the states to serve out-of-school youth. This
program will provide services that have proven effective in assisting
such youth. Our youth investments will focus on providing young people
with a strong, core academic foundation in conjunction with post
secondary skills, certifications or degrees, and transitions to career
path employment
It may be noted that the remaining 25 percent will be reserved for
national Challenge Grants, which may be used for a number of activities
to assist youth in acquiring the skills, credentials, and employment
experience necessary to succeed in the labor market. Those grants could
include services to some at-risk in-school youth. However, the primary
purpose of the revised youth program is to target resources to out-of-
school youth who are currently underserved and most in need of the
assistance the WIA youth program can provide.
The Youth Opportunity Grants were five-year demonstration grants
and every grantee received their five-year commitment. Although we
currently do not have outcome results, we intend to use lessons learned
from the Youth Opportunity Grant initiative and other demonstrations in
designing the new Challenge Grants. We will incorporate proven
strategies and build upon the positive features of the Youth
Opportunity Grants while addressing problems of the program. For
example, we will seek to increase the current 15 percent diploma rate
for out-of-school youth. Other improvements include greater private
sector involvement, and enhanced coordination with other local
agencies, including community and faith-based organizations.
youth opportunity cuts
Question. If you do not support the Youth Opportunity Grants
because it is a discretionary grant program targeted to 30-40
communities, why are you asking Congress to fund a new, untested Youth
Challenge Grant Program that will be targeted to a small number of
sites, while reducing the youth formula funding by 25 percent ?
Answer. The Administration will build on the lessons learned in
Youth Opportunity Grants as we implement the new Challenge Grants. We
believe that we will be improving on Youth Opportunity Grants and other
past investments in several ways. First, there will be much stronger
private sector involvement. Second, matching requirements will result
in stronger local ownership and commitment to the program because DOL
will require matching resources. Third, there will be more of an
emphasis on placement and training in demand occupations. Fourth, there
will be an emphasis on strategies of demonstrated effectiveness in the
areas of improving educational and labor market outcomes.
The Administration's WIA proposal reserves 25 percent of the youth
activities appropriation for Youth Challenge Grants, 80 percent would
be available for competitive grants and 20 percent would be available
for discretionary grants. Generally, competitive grants will be aimed
at geographic areas of substantial need, and discretionary grants will
be awarded to programs of demonstrated success.
The purpose of the competitive grants is to promote collaboration
and innovation in providing activities to assist youth in acquiring the
skills, credentials, and employment experience necessary to succeed in
the labor market.
The competitive grants may be awarded to States, local boards,
recipients of Native American program grants, and public or private
entities (including consortia of such entities) applying in conjunction
with local boards. Initial awards would be made for one year, with four
additional years available depending upon satisfactory progress and
availability of funds. The Secretary would be authorized to require
that grantees provide a nonfederal share of the cost of activities
carried out under a grant, and may require that such share be provided
in cash or noncash resources.
Youth ages 14 through 19, as of the time the eligibility
determination is made, may be eligible to participate in activities
provided under these grants. Funds would be used for the activities to
assist youth in acquiring skills, credentials, and employment
experience, including training and internships in high-growth sectors
for out-of-school youth; after-school dropout prevention programs for
in-school youth; activities to assist special youth populations, such
as court-involved youth and youth with disabilities; and activities
combining remediation of academic skills, work readiness training, and
work experience, and including linkages to postsecondary education,
apprenticeships, and career-ladder employment.
To be eligible, an entity must submit an application to the
Secretary that includes a description of the activities the eligible
entity will provide to eligible youth; a description of the programs of
demonstrated effectiveness on which the provision of the activities are
based, and a description of how such activities will expand the base of
knowledge relating to the provision of activities for youth; a
description of the private and public, and local and State resources
that will be leveraged to provide the activities described; and the
levels of performance the eligible entity expects to achieve with
respect to the indicators of performance for youth.
Factors to be considered in awarding these grants include the
quality of the proposed project, the goals to be achieved, the
likelihood of successful implementation, the extent to which the
project is based on proven strategies or the extent to which the
project will expand the knowledge base on activities for youth, other
Federal and non-Federal funds available for similar purposes, and the
additional State, local or private resources that will be provided.
In addition, discretionary grants for youth activities would be
authorized that will assist youth in preparing for, and entering and
retaining, employment. These grants are intended to provide the
flexibility to assist a variety of entities and organizations in
providing innovative and effective activities for eligible youth,
including special populations. The Secretary may award discretionary
grants to public or private entities that the Secretary determines
would effectively carry out activities relating to youth.
The Administration believes these grants would provide enhanced
opportunities to replicate proven strategies in assisting youth and to
apply such strategies in innovative ways.
elimination of h-1b
Question. The skills gap in this country keeps growing wider. The
training component of the H-1B program, which represents a key
investment in American workers, is set to expire this year. The GAO
issued a report this fall which said the program is meeting specific
workforce needs. Despite this positive report your Department is not
seeking reauthorization for the program, but is seeking additional
funding to process alien certification applications from foreign
workers.
Should the Labor Department be expediting the importation of more
foreign labor into this country, while refusing to support proven high
skills training for American workers?
Answer. The Administration is committed to job training in skill
shortage occupations as a key element of all of the job training
programs administered by the Department, including the formula programs
administered by States and local areas under title I of WIA.
In addition to providing training linked to occupations in demand
under WIA, TAA and other employment and training programs, the
Department of Labor will continue to make approximately $200 million in
collected employer fees available for H-1B Technical Skills Training
Grants until the funds collected as the employer fees for this program
are fully expended. The authorization for that program expires
September 30, 2003.
The Department also administers the labor certification
requirements of the work-based permanent immigration and temporary visa
programs and attempts to do so in a timely and effective manner. The
2004 Budget funds the first part of a two-year effort to eliminate
unacceptable backlogs that have grown under the permanent program in
recent years while, in 2003, the Department will implement reforms in
the program to help eliminate future backlogs. Effective, efficient
processing of labor certification applications for the H1-B and other
programs meets the legislative intent to protect jobs for American
workers while responding to employers' legitimate need for staff to
meet limited skill shortages.
one stop infrastructure
Question. When I visit local One-Stop Career Service Centers in my
state the first question that workforce managers ask is, ``Why can't
the federal government reinstitute a dedicated One-Stop infrastructure
funding stream to assist in real estate acquisition, management
information system updates, staff development and other non-service
delivery issues?''
Madame Secretary, how do you answer that question?
Answer. Through WIA reauthorization, the Department proposes that
part of the operational cost of the certified One-Stop centers be
financed through dedicated ``One-Stop infrastructure'' funding. Each
partner program would contribute a portion of their funds to the
Governor to be allocated for One-Stop infrastructure funding in the
State. This approach would create a greater sense of partner
``ownership'' of the system than currently exists and would move toward
comprehensive workforce system reform by using existing dollars to
support an integrated service delivery system at the state and local
level.
The portion of funds to be provided by each One-Stop partner would
be determined, subject to certain limitations, by the Governor after
consultation with the State board, which includes representatives from
the One-Stop partner programs. In making the determination regarding
the funds to be contributed, the Governor would be required to consider
the proportionate use of the One-Stop Career Centers by each partner,
the costs of administration unrelated to the use of the One-Stop Career
Centers by each partner, and other relevant factors that are also to be
considered in developing the allocation formula for these funds, such
as the number of certified One-Stop Career Centers in the local area,
the services provided by the centers, and other factors relating to the
performance of the centers.
In those States where the State constitution places policymaking
authority in an entity or official that is independent of the authority
of the Governor for the adult education and literacy program under
title II of WIA and postsecondary vocational education program under
the Carl D. Perkins Vocational and Technical Education Act of 1998, the
Governor would make the determination of the funds to be contributed by
those programs with the entity or official that has the independent
authority.
In addition, the funds provided by the One-Stop partner programs
for the infrastructure costs are to be provided from funds available
for administrative costs under each program, and those funds are
subject to whatever administrative cost limits are applicable to each
program. There would be a specified limit for the contributions that
may be required of the Vocational Rehabilitation program of 0.75
percent of the funds provided for such program to the State for a
fiscal year. There would also be a limitation that the contributions
required of Federal direct spending programs (such as TANF, the Child
Support Enforcement program, and the Food Stamps Employment and
Training program) may not exceed the amount equal to the proportionate
use of the One-Stop Career centers by those programs.
The formula for allocating these funds to the local areas for the
certified One-Stop centers would be developed by the State board,
including factors such as those described above. The infrastructure
funds would be used to pay for the non-personnel costs that are
necessary for the general operation of the certified One-Stop Career
centers, including the rental costs of the facilities, the costs of
utilities and maintenance, and equipment (including adaptive technology
for individuals with disabilities).
While the infrastructure funding would address the primary common
costs of operating the One-Stop Career Centers, there would remain some
common costs that would not be covered by these funds. These additional
common costs would be funded using the procedures that currently apply
to all operating costs and the provision of core services. The partners
would provide funding or noncash resources, to cover the costs of
providing the core services that are applicable to the participants
from each program and other common costs, such as infrastructure costs
in excess of the amount provided by the new infrastructure grants, and
other common costs not included in the infrastructure definition (such
as personnel). The local memorandum of understanding among One-Stop
partners would remain the vehicle for determining these common costs
and how to allocate these costs since these costs would be more locally
variable. The State board would provide guidance to facilitate the
determination of appropriate funding allocation in local areas
elimination of employment service
Question. The U.S. Employment Service provides a nationwide public
labor exchange for all workers and employers.
With the proposed elimination of the Employment Service, how does
the Department expect 50 states to carry out this national purpose
without compromising or undermining the principles of universal access
and a free, public, national labor exchange?
Answer. The job search assistance services provided under the
Wagner-Peyser Act are also required to be provided as a core service
for all adults under the WIA Adult program and for all dislocated
workers under the WIA Dislocated Worker program. All three programs are
to make these services available through the One-Stop delivery system
established in each local area under WIA. Rather than have these
overlapping and duplicative requirements for the provision of these
labor exchange services under three different programs, the
Administration believes the three funding streams should be
consolidated into a single, comprehensive program for adults which
includes as a key element the availability of universal public labor
exchange services for all job seekers and employers. Rather than
undermining or compromising the principle of universally accessible
labor exchange services, the Administration believes the proposed
consolidation would strengthen and enhance the provision of those
services.
fair labor standards act
Question. The Department's decision to abandon the two-tiered
salary test, which provides greater protections to salaried workers
with lower earnings than to those who earn more, makes it easy for an
employer to manipulate job duties in order to deny overtime protection
to many low-wage earners. How does the DOL justify a proposed salary
threshold that will allow employers to deny overtime pay to many who
need and rely on it?
Answer. The Department has not abandoned the two-tiered salary
level tests, and the Department's proposed salary threshold will not
deny overtime pay to employees who need and rely on it. To the
contrary, the Department's proposed regulatory changes will increase
overtime protections for 12 million employees--including an additional
1.3 million low-wage salaried workers who will be guaranteed overtime
protections for the first time.
The current regulations establish two different salary levels for
each of the exemption categories: Employees paid below the minimum
salary level of $155 a week are not exempt from overtime regardless of
their duties. Employees paid above the minimum salary level of $155 a
week are only exempt if they meet the ``long'' duties test. Employees
paid above a higher ``upset'' salary of $250 a week are exempt if they
meet a ``short'' duties test.
The Department has long recognized that salary level may be the
best indicator of whether an employee is a bona fide executive,
administrative or professional employee. Because the salary levels have
not been raised in 28 years, since 1975, the existing salary levels
have become meaningless. Under the current minimum salary level of $155
a week, only employees who make less than $8,060 a year are guaranteed
overtime pay. By contrast, a minimum wage employee who works 40 hour a
week earns over $10,700 a year. Thus under the current regulations, a
minimum wage employee can be classified as an exempt executive. This
perverse result demanded action by the Department of Labor.
The Department's proposed regulations would raise this minimum
amount to $425 a week, or $22,100 a year--a $270 a week increase and
the largest increase in the 65 year history of the FLSA. The largest
prior increase was by only $50 a week. As in the current regulations,
employees who earn less than this minimum salary level are guaranteed
overtime pay. This increase in the minimum salary level will guarantee
overtime pay to 1.3 million additional low-wage workers.
Under the Department's proposal, similar to the current
regulations, employees earning more than $425 per week can only be
classified as exempt if they also meet a ``standard'' duties test. The
proposed standard duties test would streamline the current regulations
by replacing the separate ``long'' and ``short'' duties tests with one
test representing a middle ground between the current long and short
tests. The Department believes this change will make the regulations
easier for both employees and employers to understand who is entitled
to overtime pay under the FLSA.
Although the proposal replaces the ``long'' test and ``short'' test
terminology, the proposal does not eliminate the two-tier salary
structure. As noted above, the current regulations contain a ``special
proviso for high salaried'' employees (see, e.g., Sec. 541.119)--the
so-called ``short test''--which currently requires a salary of only
$13,000 a year. The Department's proposed special provision for higher
compensated employees would require guaranteed compensation of $65,000
a year. The Department has proposed to minimize the duties requirements
that must be met before an employee earning more than $65,000 a year
may be classified as exempt. However, the $65,000 annual guarantee is
well above the current $13,000 requirement. The $65,000 annual
guarantee is also well above the $43,000 salary level requested by the
AFL-CIO in a letter to the Department as the increase necessary to
fully correct the current $13,000 level for inflation since 1975.
The Fair Labor Standards Act was intended to set minimum salary and
overtime standards to protect the most vulnerable, low-wage workers in
our society. Because so many years have passed since the Department
updated the Part 541 regulations defining exempt executive,
administrative and professional employees, the protections intended by
the FLSA have been severely eroded. The Department's proposal will
strengthen minimum wage and overtime guarantees for the low-wage
workers the FLSA was designed to protect. In addition, by simplifying
and clarifying the rules, the proposed regulations will allow the
Department to more strongly enforce the FLSA minimum wage and overtime
provisions. The Department expects and welcomes public comment on the
proposed salary levels and proposed duties tests.
lm-2 financial disclosure
Question. Under your LM-2 financial disclosure proposal, a labor
organization would have to itemize every disbursement made to an entity
or individual that reaches a threshold of between $2,000 and $5,000 in
one of eight categories. The organization also would have to itemize
aggregate disbursements to an entity or individual that reach this
threshold over the reporting period. Within these parameters, I am
advised that it would not be unusual for a medium-sized union to report
9,000 individual disbursements during a given year. Add to that
separate disbursements that aggregate to $2,000 and the potential
exists for a significant amount of numbers to report.
How would this then practically conform with 67 Fed. Reg. at 79281,
that the reported information provide ``union members with useful data
that will enable them to be responsible and effective participants in
the democratic governance of their unions?'' Will this information be
useful to union members?
Answer. The Department received many comments regarding the
itemization thresholds and we are still reviewing those comments. When
that review is completed, we hope to be better able to address these
questions. The proposal, however, was based upon certain facts that may
be helpful in understanding the likely impact of an itemization
requirement, if it is adopted. For example, it should be noted that the
median LM-2 filer has approximately $650,000 in annual receipts.
Assuming that the annual receipts of a union are roughly equal to its
annual disbursements, and if $2,000 itemization threshold were adopted,
a union with $650,000 in disbursements is likely to have no more than
325 itemized transactions. In practice, however, the number of itemized
transactions would actually be lower because a number of transactions
are likely to be more than $2,000. Moreover, not all disbursements will
be subject to itemization. If roughly half of all disbursements fall
into categories that would not require itemization these unions might
have to itemize fewer than 150 disbursements per year. If a $5,000
itemization threshold were adopted, an average union might have to
report less than 60 itemized transactions.
For the average LM-2 filer union, that has approximately $2.8
million in annual receipts, and a roughly equivalent amount in annual
disbursements, a $2,000 itemization threshold would be likely to
require the reporting of less than 650 itemized transactions. If a
$5,000 itemization threshold were adopted, a union with $2.8 million in
disbursements might only have to report less than 260 itemized
transactions. Less than 675 unions, or just 2.3 percent of all unions
and 12.4 percent of all LM-2 filers, have annual receipts of $3.0
million or more.
Even in those cases where there may be many itemized transactions,
not all commenters agree that union members will not find the
information useful in any event. The proposed LM-2 contains summary
data in aggregate categories that reflect the services performed by
unions for their members so that union members would continue to be
able to assess the overall status of the union by looking at just a
couple of pages. In addition, the Department's proposal indicated that
the requirement that these reports be filed electronically would make
it easier to provide union members with easy access to detailed
information regarding the major transactions of their union by using an
online, searchable database that will display only those transactions
of interest to the member. The intent of the Department's proposal is
to better enable union members to judge the financial health and
integrity of their unions and to hold their leaders accountable for the
financial condition of their union.
Question. Additionally, unions would have to itemize their
officers' and employees' salaries. How is this information useful to
union members?
Answer. Officers' and employees' salaries have always been itemized
or individually reported on the forms; the law requires it. Although
the proposed salary schedules would require the salaries of officers
and employees to be allocated to the appropriate disbursement
categories, to reduce reporting and recordkeeping burdens the
Department has proposed that officers and employees be allowed to
estimate their time to the nearest 10 percent, rather than requiring
them to make exact calculations and keep daily records of their time.
Because salaries are often the largest disbursement for many unions,
the Department proposed this requirement to improve the transparency
and accountability of labor organizations to their members and better
enable them to exercise their democratic rights of self-governance.
Question. Mandatory electronic filing is at the heart of your
proposal. As I understand it, the computer software is what will make
it financially possible for labor organizations to comply with the new
disclosure requirements. However, I am advised that this software does
not yet exist.
Will you complete development of this software before requiring
unions to comply with the proposed regulations? Can the proposed
regulations be promulgated prior to development of the software?
Answer. The purpose of the software is to reduce the reporting
burden on unions and to reduce the cost of disseminating the
information on the Internet to union members. It is important to note,
that the software to be provided by the Department is not a bookkeeping
system. The software has no impact on the burden of collecting data for
the LM-2. The implementation of the reporting software will come in two
phases. First, the Department will provide a Data Specifications
Document before the effective date of the reform that will give unions
the information they will need to interface with the software and
report their information to the Department electronically. The
Department is also going to establish a help line to answer any
questions and will make other compliance assistance available. Second,
the software will be provided to the unions well before they will have
to use it to file their report, which will give the Department plenty
of time to conduct compliance assistance and answer questions posed by
the filing community. Moreover, all of the information that unions will
need to update their internal recordkeeping and reporting requirements
for the proposed Form LM-2 will be contained in the final rule that is
published in the Federal Register.
Question. In your response to my April 2, 2003, letter, you cite
the finding of a 1998 hearing of the House Education and Workforce
Subcommittee on Oversight and Investigations that ``the current LM-2
Form is inadequate to prevent and uncover financial corruption, and the
form should therefore be substantially revised.''
How does requiring unions to itemize most of their expenses deter
fraudulent activity?
Answer. Increased transparency and disclosure is a natural
deterrent to criminal activity and financial mismanagement. The more
detailed information is reported regarding specific transactions, the
more difficult it is for an unscrupulous person to conceal their
activities and the easier it is for union members and the Department to
uncover fraudulent activity. Again, the intent of the Department's
proposal, including the proposed itemization requirement, is to help
meet the objectives of the statute by providing union members with
useful data that will enable them to be responsible and effective
participants in the democratic governance of their unions. As
Representative Robert Griffin, a cosponsor of the LMRDA, stated: ``. .
. [I]n a larger sense, the effectiveness of the Act will depend also
upon the rank-and-file union members themselves. For in the last
analysis, it is they who must make the law meaningful by taking hold of
the tools of democracy and using them to clean corruption out of their
unions and to keep them clean.''
Question. Has the Department considered requiring unions to undergo
independent audits, as are SEC regulations currently require of public
corporations?
Answer. Yes, the Department has considered requiring audits. Some
commenters suggested requiring audits; the Department is currently
reviewing those comments and has not yet reached any final conclusions.
It is important to note, however, that the laws enforced by the SEC are
very different from those enforced by DOL.
Question. In your response to my April 2, 2003, letter, you note
that ``most of the Department's proposed changes affect only the
largest 20 percent of unions subject to the Labor Management Reporting
and Disclosure Act.''
How would the proposed changes affect the smallest of those unions
subject to the reporting requirements? Has the Department assessed what
the cost would be for those unions to comply, particularly those which
marginally exceed the $200,000 threshold? Has the Department taken any
steps to minimize the cost to smaller unions?
Answer. The Department is always conscious of the regulatory burden
imposed on smaller entities. The smallest unions, over 81 percent of
all labor organizations would not be affected by most of the reforms
proposed. The Department's proposal would require all unions to file a
new Form T-1 to report financial information for large trusts or other
funds in which they have an interest, but only if the union contributed
$10,000 or more to the trust during the year. The Department has
received comments arguing that this requirement should be dropped, as
well as comments arguing that all of the proposed changes should be
applied to all unions. The Department has not yet made a final decision
on any of these issues.
The Department also requested comments on whether the filing
threshold should be raised from $200,000 to adjust for inflation and
those comments are being considered. The Department has estimated the
costs for various sizes of LM-2 filers and the burden estimates were
calculated as weighted averages of those groups of unions. Under the
proposed rule the average burden for the smallest group of LM-2 filers
for the first three years would be 81.7 percent less than the burden
for the largest group of LM-2 filers.
The Department's proposal also included many features to minimize
the burden. First, the proposed levels of itemization of disbursements
would ensure that small unions would have to identify very few
transactions. For instance, a $2,000 itemization threshold is likely to
require a union with $250,000 in disbursements to itemize less than 60
transactions and a $5,000 threshold is likely to require a union with
$250,000 in disbursements to itemize less than 25 transactions. Second,
the filing software is being designed to fit the needs of the unions,
so that small LM-2 filers will be able to simply type information in
the forms or copy-and-paste, whereas larger LM-2 filers will be able to
take advantage of greater automation and download information directly
into the software. Finally, a union can apply for and be granted a
hardship exemption to allow them to file a paper report if they can
demonstrate that electronic filing would impose an unreasonable burden.
Question. Has the Department consulted with the Small Business
Administration Office of Advocacy to determine whether the proposed
rules are in compliance with the Regulatory Flexibility Act of 1980 as
amended (5 U.S.C. 601-612)?
Answer. Yes. The Department took all required steps to ensure that
the proposal is in full compliance with the provisions of the
Regulatory Flexibility Act of 1980 as amended, and consulted informally
with the SBA.
Question. Has the Department considered drafting different
regulations that reflect the different sizes of unions subject to
compliance under the Labor Management Reporting and Disclosure Act?
Answer. Yes, the Department's regulations already permit smaller
unions to file simplified forms LM-3 and LM-4. Additionally, the
Department took the concrete steps described above in the proposed rule
to limit the burden on smaller LM-2 filers and is reviewing comments
that it sought on whether the current $200,000 threshold for Form LM-2
filers should be raised to $250,000 or some other amount, or, instead,
whether it should be left unchanged.
Question. Do you believe that the 90-day comment period for these
proposed regulations was sufficient? Did your Department consider
extending this period to fully accommodate suggestions and criticisms
by those organizations that would be affected by the proposed
regulations?
Answer. Yes, the 90-day comment period was sufficient. The
Department carefully considered all requests for an extension of the
60-day comment period, and a 30-day extension was granted. The
Department received nearly 36,000 comments, including many substantive
comments from unions, non-profits, and others, indicating that 90 days
was a sufficient period of time to comment on the rule. This timeframe
is also consistent with other major rulemakings of the Department and
other federal agencies.
Question. In your response to my April 2, 2003, letter, you
indicate that ``the regulatory regime governing financial reporting by
small and large public companies is much more extensive than the system
that exists for labor organizations.'' You then note that ``Government
Accounting Office regulations governing accountability for federal
funds mimic the extensive system of regular audits, extensive internal
controls and disclosure of material qualitative and quantitative data
that exist for publicly-traded companies.''
I have been advised that some of the proposed LM-2 requirements
mandate more extensive itemization of information than is required by
the SEC under the Sarbanes-Oxley Act of 2002 and by the GAO. For
example, under current LM-2 requirements, labor organizations subject
to compliance are required to list all employees whose total salaries,
allowances, and other direct and indirect disbursements from the union
exceed $10,000 per year; the union must also detail the employees'
position, affiliated organization, gross salary, allowances and
disbursements. The proposed changes would additionally require that
labor organizations report for each employee his or her net salary,
withholding and direct taxes, disbursements for other withheld amounts,
direct payroll taxes, and allocation of each employee disbursements
into new functional categories. The SEC does not require this level of
detailed information, only requiring salary information for top
executives. Given your above statement, how do you explain this
disparity between LM-2 and SEC reporting requirements?
Answer. The laws and regulations governing corporations and unions
serve very different purposes and are understandably quite different.
The LMRDA established a unique financial disclosure regime for labor
organizations designed to address concerns about unions that were
highlighted by Congressional hearings on financial and other misconduct
in labor unions. To the extent that a comparison is relevant, the
regulatory regime governing financial reporting by small and large
public companies is much more extensive than the system that exists for
labor organizations. In addition to mandating the disclosure of certain
types of quantitative data, the financial reporting scheme for public
companies, as amended by the Sarbanes-Oxley Act, also requires the
disclosure of qualitative information and imposes strict audits and
detailed internal controls on public companies, their officers,
directors, auditors, accountants and attorneys.
The SEC only requires reporting of the salaries of ``top
executives'' because that is what their statute mandates. OLMS requires
reporting of the salaries of all officers and employees earning $10,000
or more annually from the union because that is what our statute
mandates. As for the specific information collected in the salary
schedules, it would be inappropriate to discuss our specific views
because the Department is in the process of analyzing and responding to
the comments we received from the public on the NPRM. In general, the
Department believes that the details contained in the LM-2 will be
useful to union members and will fulfill the statutory requirements of
the LMRDA. The SEC would have to respond to whether this sort of
disclosure would be appropriate and useful under the statutes they
enforce.
Neither the current LM-2 reporting regime nor the Department's
proposed rule require labor organizations to provide their members with
any qualitative information, much less the detailed analysis public
companies are required to disclose. Federal law also does not mandate
that unions use governance structures that ensure independent oversight
of financial operations, such as independent audit committees and union
members have no comparable whistleblower rights to those provided
employees under the Sarbanes-Oxley Act. Unions are not currently
required, nor would they be required under the proposed transparency
reforms, to provide any qualitative information to their rank-and-file
membership about the financial health of their union, the strengths or
weaknesses of any substantial investments by their union, the financial
performance of any programs, contracts or cost centers managed by the
union, or any future risks associated with the union's business
relationships, including its main bargaining unit employers, membership
composition or other factors. Considered in this context, the
Department does not believe that the proposed LM-2 is overly burdensome
when compared to corporate disclosure.
______
Question Submitted by Senator Thad Cochran
farmworker housing
Question. The fiscal year 2003 Omnibus Appropriations bill includes
$4.64 million for Department of Labor Farmworker Housing activities. In
recent years, the Appropriations Committee has directed the Department
of Labor to use these funds to continue the long-established network of
local housing organizations working to plan, develop, and manage
housing for migrant and seasonal farmworkers.
What is the status of fiscal year 2003 funds, how will they be made
available, and what steps are the Department taking to ensure that the
current network of organizations remains in place?
Answer. The $4.64 million pre-rescission appropriation for
farmworker housing assistance grants is being awarded through an open
competitive grants selection process. The Employment and Training
Administration (ETA) recently published the Solicitation for Grant
Applications (SGA) for the housing assistance grants and an SGA for the
National Farmworker Jobs Program (NFJP) in the Federal Register, and
the application period will close on May 16, 2003, and the awards will
be announced before June 30, 2003.
Every proposal submitted in response to the SGA, including those
from current grantees, will be given full and fair consideration. They
will be reviewed and rated on their merit by an impartial review panel.
______
Questions Submitted by Senator Ernest F. Hollings
association health plans
Question. I would like to know how much Congress must appropriate
for the Labor Department to effectively regulate Association Health
Plans, if legislation to exempt them from state oversight is enacted.
In 1997, Olena Berg, Assistant Secretary of Labor in the Clinton
Administration, said that DOL did not have the resources to regulate
AHPs and that it would take 300 years to complete a review of each
existing pension and health plan. A recent GAO report found that it
would take DOL's current investigative staff 90 years to do a baseline
assessment of noncompliance for pension plans alone. An analysis of
federal regulatory costs by Georgia State University found that it
would cost $2.3 billion over a seven-year period for DOL to effectively
take over the responsibility for regulation of AHPs. It does not appear
that your budget includes any funding to regulate and oversee AHPs--
Does it?
Answer. DOL's current budget does not include funding for AHP
certification or enforcement because the legislation has not become
law. If the legislation is enacted, we will dedicate the resources
necessary to implement it effectively and administer AHPs successfully.
As the legislation proceeds through Congress, the Department will work
within the Administration to determine the appropriate resources
necessary, depending upon the legislative requirements. The costs would
depend on many factors, including the number of AHPs that are created,
and how many are uninsured. The creation of AHPs may lower our costs in
other areas, such as our activities related to Multiple Employer
Welfare Arrangements (MEWAs).
Question. How would you regulate AHPs and how much would it cost?
Answer. Under the current legislative proposal, DOL would be
responsible for certifying AHPs, and would have ongoing oversight and
enforcement authority. For AHP that purchase policies from insurance
companies, state insurance regulators would enforce solvency and
consumer protection provisions. For self-insured AHPs, DOL would be
responsible for overseeing solvency and the consumer protection
provisions included in the bill, as well as ERISA's general
requirements. Regarding cost, as the legislation authorizing AHPs has
not been enacted, DOL cannot speculate on associated costs.
______
Question Submitted by Senator Patty Murray
coal industry grant to china
Question. Why has $6.4 million been awarded to promote the coal
industry in China? What are the details on this grant?
Answer. In the fall of 2002, the department awarded two grants to
support activities in China--a $4.1 million grant supports programs
that promote the labor rule of law, and a $2.3 million grant provides
technical assistance in the enforcement of China's health and safety
laws at coal mines. Neither of the two grants was to promote the coal
industry in China.
Both grants were awarded through an open and competitive process.
The labor rule of law grant was awarded to a consortium formed by
Worldwide Strategies, Inc., the Asia Foundation, and the National
Committee on U.S.-China Relations. The mine safety and health grant was
awarded to the National Safety Council, headquartered in Illinois.
CONCLUSION OF HEARINGS
Senator Specter. Thank you all very much for being here.
That concludes our hearings.
[Whereupon, at 10:49 a.m., Wednesday, April 9, 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, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2004
----------
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 HEALTH AND HUMAN SERVICES
Prepared Statement of the Blue Cross and Blue Shield Association
The Blue Cross and Blue Shield Association (BCBSA), which
represents 42 independent, locally operated Blue Cross and Blue Shield
Plans throughout the nation, is pleased to submit written testimony to
the subcommittee on fiscal year 2004 funding for Medicare contractors.
Blue Cross and Blue Shield Plans play a leading role in
administering the Medicare program. Many Plans contract with the
federal government to run much of the daily work of paying Medicare
claims accurately and timely. Blue Cross and Blue Shield Plans serve as
Part A Fiscal Intermediaries (FIs) and/or Part B carriers and
collectively process most Medicare claims.
This testimony focuses on three areas:
Background, including a description of Medicare contractor
functions;
Current financial challenges facing Medicare contractors; and
BCBSA recommendations for Medicare contractor fiscal year 2004
funding.
background
Blue Cross and Blue Shield Medicare contractors are proud of their
role as Medicare administrators. While workloads have soared, operating
costs--on a unit cost basis--have declined about two-thirds from 1975
to 2003. In fact, contractors' administrative costs represent less than
1 percent of total Medicare benefits.
Medicare contractors have four major areas of responsibility:
Paying Claims.--Medicare contractors process all the bills for the
traditional Medicare fee-for-service program. In fiscal year 2004, it
is estimated that contractors will process over one billion claims,
more than 3.8 million every working day.
Providing Beneficiary and Provider Customer Services.--Contractors
are the main points of routine contact with Medicare for both
beneficiaries and providers. Contractors educate beneficiaries and
providers about Medicare and respond to over 40 million inquiries
annually.
Handling Hearings and Appeals.--Beneficiaries and providers are
entitled by law to appeal the initial payment determination made by
carriers and FIs. These contractors handle nearly 8 million annual
hearings and appeals.
Special Initiatives to Fight Medicare Fraud, Waste, and Abuse.--All
contractors have separate fraud and abuse departments dedicated to
assuring that Medicare payments are made properly. Few government
expenditures produce the documented, tangible savings of taxpayers'
dollars generated by Medicare anti-fraud and abuse activities. For
every $1 spent fighting fraud and abuse, Medicare contractors save the
government $14.
current financial challenges
Of utmost importance to attaining outstanding performance is an
adequate budget. However, Medicare contractors have been severely
underfunded since the early 1990's. Reductions in funding concurrent
with increases in workload have seriously eroded contractors' ability
to fight fraud and abuse and ensure the accuracy and appropriateness of
Medicare payments. Between 1989 and 2002, the number of Medicare claims
climbed over 70 percent to nearly 1 billion, while payment review
resources grew less than 11 percent. As a result, the amount allocated
to contractors to review claims shrank. Because of the significant cost
of reviewing claims, this decline in funding resulted in CMS directing
contractors to reduce the percentage of claims that were scrutinized
and investigated. Similarly, the percentage of cost reports audited
declined--between 1991 and 1996, the chances that any institutional
provider's cost report would be reviewed in detail fell from about 1 in
6 to about 1 in 13.
The Medicare Integrity Program (MIP) created by Congress in 1996 as
part of the Health Insurance Portability and Accountability Act (HIPAA)
provided a permanent, stable funding authority for the portion of the
Medicare contractor budget that is explicitly designated as fraud and
abuse detection activities. MIP funding was set at $500 million in 1998
and rose to $720 million in fiscal year 2003. However, the permanent
authorization is now capped at $720 million despite continuing
increases in claims volume (11 percent increase in claims is projected
in fiscal year 2004).
BCBSA supports the authorized funding mechanism for MIP and urges
Congress to extend funding increases beyond fiscal year 2003 so that
Medicare contractors can continue important activities to reduce the
amount of fraud, waste, and abuse in the Medicare program and ensure
accuracy of Medicare payments.
Contractors' enhanced anti-fraud and abuse efforts due to MIP
funding contributed to the significant decline in improper claims and
deficient documentation submitted by providers. The OIG audit of fiscal
year 2002 claims estimated that improper Medicare payments had dropped
to $13.3 billion, or about 6.3 percent of the $217.7 billion in
Medicare payments. The fiscal year 2002 improper payment rate is the
lowest to date and less than half of the 13.8 percent reported in
fiscal year 1996.
But, the creation of MIP did not solve the budget problems for the
remainder of the contractor budget. The largest portion of the
contractor budget--Medicare operations--continues to face severe
funding pressures. Medicare operations activities include claims
processing, beneficiary and provider education and communications,
hearings and appeals of claims initially denied, and systems
maintenance and security.
CMS and its Medicare contractors have been severely underfunded for
years. The problem has been more acute since passage of HIPAA and
subsequent legislation placing additional responsibilities with
insufficient resources to perform these new duties. For example,
between 1992-2002 Medicare benefits outlays increased 97 percent;
claims volume increased 50 percent; yet Medicare operations funding
increased a mere 26 percent. Contractors staffing only increased by 6
percent during this time even though many new responsibilities were
added and claims volume continued to rise. Clearly funding has not kept
pace with additional work.
Whenever possible, contractors respond to reduced funding by
achieving significant efficiencies in claims processing, but it has not
been enough to keep pace with rising Medicare claims volume and
diminishing funding levels. Earlier this year in the absence of
appropriated funding contractors were instructed to reduce provider and
beneficiary service and offer minimum outreach activities. Since paying
claims is a top priority, funds were shifted from other important
activities. For example discretionary outreach activities such as
mailings to beneficiaries and onsite workshops about benefits and
availability of services were curtailed. Provider call quality
monitoring activities and in-person training services were reduced.
Funding levels also are entirely inadequate to conduct the necessary
provider outreach to ensure providers are compliant with the HIPAA
electronic transactions and code sets by October 16, 2003.
Inadequate budgets for Medicare operations also impact Medicare's
fight against fraud and abuse. While many think of Medicare operations
activities as simply paying claims, these activities are Medicare's
first line of defense against fraud and abuse and are critically linked
to MIP activities. As an example, many of the front-end computer edits
(e.g., preventing duplicate payments and detecting inaccurately coded
claims or claims requiring additional screening) are funded through
Medicare operations. Inadequate funding impacts different functions at
different times, but always disrupts the integration of all the
functional components needed to ``get things right the first time.'' It
thus results in inefficiency and higher costs.
bcbsa fiscal year 2004 funding recommendations for medicare contractors
BCBSA is pleased that many Members of this subcommittee recognize
the need for adequate administrative resources at CMS. We are concerned
the Administration's fiscal year 2004 budget does not appropriately
reflect the expected costs to cover Medicare workloads and it relies on
a proposal for $201 million in new user fees from providers. BCBSA
urges Congress to take the following steps to allow Medicare
Contractors to meet increased workloads as well as beneficiary and
provider needs:
Increase Medicare Contractor Medicare Operations Funding to $1,835
Million for Fiscal Year 2004
Medicare contractors continue to face significant increases in
Medicare claims volume. Further reductions in administrative costs, as
proposed in the President's budget, would seriously jeopardize
contractors' ability to administer Medicare. BCBSA recommends:
Provider Education and Training (PET) Funding be Restored
The President's budget would eviscerate funding for PET from $41.5
million in 2003 to $6.5 million requested for 2004--an 85 percent cut.
CMS indicates $30 million will be provided for PET through the MIP
program. However this transfer would mean that even fewer claims are
reviewed, jeopardizing efforts to safeguard the trust fund. With CMS
issuing 172 Medicare program changes in the first quarter of fiscal
year 2003, it is critical that contractors have resources to educate
providers on constant changes. Further, based on current costs, BCBSA
estimates the total annual cost to educate and train providers for
fiscal year 2003 will approximate $74 million. If CMS is to meet its
goal of reducing the error rate--currently at 6.3 percent--to 4.8
percent in fiscal year 2004, $30 million additional funding is
necessary.
Claims Processing Funding Must be Maintained to Handle
HIPAA Implementation
The President's budget would decrease claims processing costs by
$0.02 per claim under the assumption that HIPAA electronic
transactions, effective October 2003, will lower costs. Contractor data
show HIPAA is likely to cost more, not less, particularly since many
providers are not likely to be compliant by the deadline. This will
likely result in an increase in more costly paper claims submission and
could require contractors to maintain parallel systems. Further, the
HIPAA transactions rule is unlikely to result in contractor savings as
current Medicare electronic claims submission rates are already
extremely high--98 percent of Medicare Part A and 84 percent of
Medicare Part B. CMS currently provides contractors with higher unit
costs for processing claims due to increased claims volume. There is
every indication that claims volume will continue to exceed estimates,
putting additional pressure on the cost of processing claims.
Therefore, the current unit costs for processing Medicare claims must
be maintained, requiring an additional $22 million.
Systems Security Funding Must be Enhanced
The President's budget would substantially reduce funding for
critical activities such as systems maintenance, security and CMS
operations. Adequate funding is imperative to ensure software is
updated, new applications are tested, systems are secure, provider
toll-free lines are staffed, and provider bills are appropriately paid.
BCBSA recommends an additional $6 million for these important
activities.
Increase Medicare Integrity Program (MIP) Funding to $740 Million
MIP anti-fraud and abuse funding must be increased by a minimum of
$20 million to keep pace with rising workloads, which are projected to
increase 11 percent in 2004. The President's budget does not provide
any increased funding for MIP and in fact diverts $30 million even
though HHS data shows $14:1 return on the investment. Inadequate
funding will curtail important activities such as medical review and
Medicare secondary payer activities--both of which significantly
contribute to program savings and recoveries.
As the fiscal year 2004 Labor/HHS/Education appropriations process
begins, we urge Congress to fund Medicare contractor as follows:
MEDICARE CONTRACTOR BUDGET
[In millions of dollars]
----------------------------------------------------------------------------------------------------------------
Administration BCBSA fiscal year
Fiscal year 2003 fiscal year 2004 2004
recommendation recommendation
----------------------------------------------------------------------------------------------------------------
Medicare Operations..................................... 1,748.0 1,777.0 1,835.0
=======================================================
Medicare Contractor Ongoing Activities.............. 1,128.0 1,184.0 1,235.0 (+52)
Systems Maintenance................................. 85.0 72.1 78.1 (+6)
CMS Operations...................................... 103.0 82.6 82.6
Enterprise Activities............................... 59.0 53.0 53.0
Legislative Mandates................................ 343.0 354.0 354.0
Program Improvements................................ 19.0 17.3 17.3
Information Technology Infrastructure Plan.......... 11.0 14.0 14.0
-------------------------------------------------------
Total, Medicare Operations........................ 1,748.0 1,777.0 1,835.0 (+58)
-------------------------------------------------------
Medicare Integrity Program.............................. 720.0 720.0 740.0
-------------------------------------------------------
Total Contractor Budget........................... 2,468.0 2,497.0 2,575.0
----------------------------------------------------------------------------------------------------------------
______
Prepared Statement of the American Academy of Family Physicians
The 94,300 member American Academy of Family Physician submits the
following statement for the record on three issues of critical
importance to family physicians in the United States: (1) funding for
family medicine training in Section 747 of the Public Health Service
Act; (2) funding for the Agency for Healthcare Research and Quality
(AHRQ); and (3) funding for rural health programs. We deeply appreciate
the level of funding provided for the Title VII Health Professions
Programs for fiscal year 2003 during a challenging appropriations
process.
family medicine training programs
Recommendation
The Academy continues to support appropriations of $169 million for
Section 747 of Title VII of the Public Health Service Act for fiscal
year 2004.--Section 747 authorizes the Primary Care and Dentistry
cluster, which includes support for family medicine, general internal
medicine and general pediatrics, physician assistants and general and
pediatric dentistry. This figure includes $96 million for family
medicine programs and is the result of consultation between the groups
receiving funding under this cluster.
President's Budget Request for Fiscal Year 2004 Zeros Out Primary Care
Funding
As you know, the President's budget once again zeroes out funding
for the Primary Care Medicine and Dentistry cluster. In addition, the
Administration proposal includes only $11 million for all Title VII
Health Professions programs, which is the same request made last year.
Fiscal year 2003 spending levels for Title VII were $295 million.
Funding is directed only to ``increasing diversity in the health
professions and nursing workforce.'' The proposal continues, ``The
fiscal year 2004 budget continues the policy of not funding more
general training efforts--primary care, interdisciplinary community
projects, training for diversity and public health.''
What Does Title VII Do?
Section 747 is the only program at the federal level that supports
family medicine training programs at both the undergraduate and
graduate level. It is designed to increase both the number of primary
care physicians and the number of individuals who will provide health
care to the underserved. The program has succeeded in achieving its
goals and Congress should support it at higher funding levels.
Title VII Meets Its Goals: Grants Increase the Number of Primary Care
Physicians
Due to Section 747 funding, thousands of physicians are making
career choices to go into primary care and family medicine and to serve
millions of patients.
A study by the Robert Graham Center for Policy Studies showed that
medical schools that received Section 747 family medicine funds
produced more medical students who practiced ultimately:
--in family medicine or primary care (family physicians, general
practitioners, general internists or general pediatricians);
--in a rural area; or
--in a whole county Primary Care Health Professions Shortage Area
(those counties with inadequate numbers of family physicians,
general pediatricians, general internists or obstetrician/
gynecologists).
Sustained funding during the years of medical school training had
more positive impact than intermittent funding.
Loss of Grant Funding Would Hurt the Underserved
Without family physicians, counties around the United States would
not receive essential primary care services.--Another study by the
Robert Graham Center showed that the United States relies on family
physicians more than any other physician specialty. Specifically, the
study looked at counties designated as Primary Care Health Professions
Shortage Areas (HPSAs).
Of the 3,142 counties in the United States, 1,189 (63 percent) are
designated full or partial county HPSAs, meaning that the desired ratio
of one primary care physician to 3,500 people is not met. If family
physicians are removed or choose to remove themselves from the system,
the large majority of U.S. counties would become full or partial county
HPSAs.
In addition, an article in The Journal of Rural Health found that
Title VII funding is key to ending HPSAs. According to the study,
without this funding, not only would HPSAs not be eliminated, but the
number of shortage areas would continue to grow. In addition, the
article states that Title VII funding has cut to 15 years the time
needed to eliminate all HPSAs. Doubling the funding for these programs
would decrease the time for HPSA elimination to as little as 6 years
(Robert M. Politzer, ScD, et al., Winter, 1999). It is clear that
underserved populations, particularly in rural areas, depend on the
care that family physicians provide.
Section 747 Advisory Committee Recommends Higher Funding
In 1998, Congress established an Advisory Committee to review and
make recommendations on Section 747. The Advisory Committee on Training
in Primary Care Medicine and Dentistry (ACTPCMD) recently released
their recommendations to Congress and the Secretary of the Department
of Health and Human Services. The first of six recommendations urges
greatly expanding federal support for Section 747 to $198 million. The
Committee notes the growing need for primary care providers, as well as
the success of Title VII funded programs
Proposed OMB Performance Measures Need to Be Redefined
The performance measures proposed recently by the Office of
Management and Budget to gauge effectiveness are neither measurable nor
appropriate. Consequently, assessments based on these conclusions are
highly flawed.
For example, the target set for the proportion of underrepresented
minorities (URMs) and disadvantaged students in health professions
funded programs is set at 40 percent for 2004. This is the target
although only 12.5 percent of current medical school graduates are
URMs, and data on disadvantaged backgrounds is not routinely, or even
accurately, collected. The concept of disadvantaged background varies
based on income related to family size, or is based on a vague, non-
quantifiable notion of persons growing up in environments that do not
prepare them to enter health professions schools.
For all of the health professions, minority representation has
risen from 8.3 percent in 1985 to 11.7 percent in 2000. Given this
data, it is simply unrealistic to expect a health professions program
to increase its minority representation in one year to 40 percent.
Future Funding Priorities
ACTPCMD's report to Congress lays out priorities for training
primary care providers. If additional funds are made available, Title
VII dollars could enhance current training, allowing the program to be
even more effective at providing:
--high-quality health care for underserved populations
--culturally competent care
--continued demonstration authority to address emerging health
initiatives
--additional interdisciplinary learning opportunities
--better quality of health care, eliminating health disparities, and
improving patient safety
Primary Care Training Programs React Quickly to Emerging Health
Challenges
Title VII dollars have created an infrastructure that allows
educational programs to respond to contemporary health care issues.
Specifically, the ACTPCMD report states that:
``Investment in education to provide primary care has effects that
touch the largest number of people in the country. No other group of
health care providers can exert such a broad influence on the kind and
quality of health care in the United States. Primary care training
programs are ideally positioned to react quickly to meet ever-changing
health care needs and issues, whether they are related to HIV/AIDS,
growing numbers of elderly with chronic illnesses, implications of the
modern genetics revolution, the threat of bioterrorism, or other issues
that will continue to emerge and demand rapid educational intervention.
Thus, this infrastructure is uniquely able to play a pivotal role in
bringing emerging issues in health care to the population at large.''
agency for healthcare research and quality
Recommendation
We recommend appropriations of $390 million for the Agency for
Healthcare, Research and Quality (AHRQ) in fiscal year 2004.--AHRQ
conducts primary care and health services research geared to physician
practices, health plans and policymakers that helps the American
population as a whole.
What Does AHRQ Do?
AHRQ has the following three goals:
--Improve physician practice and Americans' health outcomes;
--Improve the quality of health care (e.g., patient safety);
--Improve the health care system (e.g., increase access and reduce
costs).
In brief, AHRQ ``helps to improve the health and health care of the
American people . . .''----(AHRQ report, March, 2001).
President's Budget Request for Fiscal Year 2004 Cuts AHRQ Funding
The Agency for Healthcare Research and Quality receives only $279
million in the President's proposal; the current funding level is $299
million. Of this figure, $84 million is slated for patient safety
efforts, which includes $50 million for activities related to
information technology investments defined as computerized physician
order entry, computer monitoring for potential adverse drug events and
computerized patient records, among others. In addition, $10 million is
targeted to ``promoting and accelerating the development, adoption and
diffusion of information technology in health care.''
How Does AHRQ Meet Its Goals?
AHRQ translates basic science research findings like those of the
National Institutes of Health into information that doctors can use
every day in their practice. Another key function of the agency is to
support research on the conditions that affect most Americans.
AHRQ Translates Research into Everyday Practice
Congress has provided billions of dollars to the National
Institutes of Health, which has resulted in important insights in
preventing and curing major diseases. AHRQ takes this basic science and
produces information that physicians can use every day in their
practices. AHRQ also distributes this information throughout the health
care system. In short, AHRQ is the link between research and the
patient care that Americans receive.
For example, research shows that beta blockers reduce mortality.
AHRQ supported research to help physicians determine which patients
with heart attacks would benefit from this medication.
AHRQ Supports Research on Conditions Affecting Most Americans
Most typical 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--not the problems
that send them to the hospital.
For example, AHRQ supported research that found older, cheaper
antidepressant drugs are as effective as new antidepressant medications
in treating depression, a condition that affects millions of Americans.
Institute of Medicine Recommends $1 Billion for AHRQ
The Institute of Medicine's report, Crossing the Quality Chasm: A
New Health System for the 21st Century (2001) recommended $1 billion
for AHRQ to ``develop strategies, goals, and actions plans for
achieving substantial improvements in quality in the next 5 years . .
.'' The report looked at redesigning health care delivery in the United
States. AHRQ is a linchpin in retooling the American health care
system.
rural health programs
Finally, the Academy supports continued funding for several rural
health programs. In particular, we support the programs of the Federal
Office of Rural Health Policy; Area Health Education Centers, two
programs that are equally important to health care in rural areas and
in our inner cities; the Community and Migrant Health Center Program;
and the National Health Services Corps. 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 dwellers. Continued funding for these rural programs is vital if
we wish to provide adequate health care services to America's rural
citizens.
______
Prepared Statement of the Digestive Disease National Coalition
summary of fiscal year 2004 recommendations
--Provide increased funding for the National Institutes of Health
(NIH) at 10 percent for fiscal year 2004. 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 by 10
percent for fiscal year 2004.
--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.
--$25 million for the Centers for Disease Control and Prevention's
(CDC) National Colorectal Cancer Awareness 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 25 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 10 percent to $29.8 billion for the
National Institutes of Health (NIH) and all of its Institutes.
Specifically the DDNC recommends that the National Cancer Institute
(NCI), the National Institute of Diabetes and Digestive and Kidney
Disease (NIDDK), and the National Institute of Allergy and Infectious
Diseases (NIAID be given $5.08 billion, $1.79 billion, and $4.1 billion
respectively. 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 historic doubling of the budget for NIH completed 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 will
continue its work in IBD research. The DDNC would also commend NIDDK
for organizing and hosting the upcoming meeting entitled ``Research on
Inflammatory Bowel Disease,'' later this month.
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 2004.
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. An example
of this commitment has been the convening of the second National
Institutes of Health Management of Hepatitis C Consensus Development
Conference, which occurred in June 2002. The Conference made 17
specific and high priority research recommendations that need to be
pursued to develop better treatments and a cure for hepatitis. The DDNC
urges that these recommendations be funded in fiscal year 2004. The
DDNC also commends NIDDK for the establishment of the Biliary Atresia
Research Consortium and the Adult-to-Adult Living Donor Liver
Transplant Cohort Study. The convening of conferences on Hepatitis C
and Renal Disease and Hepatitis C in Prisons, plus the New Direction
for Therapy of Primary Biliary Cirrhosis are just some more positive
examples of the work NIDDK has undertaken to combat hepatitis and liver
disease. The DDNC urges NIDDK to continue support research in this
area.
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.
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 2002, an estimated 28,300 people in the United States were found
to have pancreatic cancer and approximately 28,200 died from the
disease. Pancreatic cancer is the fifth leading cause of cancer death
in men and women. Only 2 out of 10 patients will live 1 year after the
cancer is found and only a very few will survive after 5 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 commends NIDDK for the
establishment in 2002 on an initiative entitled: Liver, Pancreas, and
Gastrointestinal Cell Genome Anatomy Project. The DDNC hopes this new
initiative will call more attention and greater resources to the
diseases of the Pancreas. 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 and fickle 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 than 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't 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.
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 two 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.
The DDNC along with our Celiac Disease applauds the NIDDK for
organizing and hosting the upcoming meeting entitled ``Consensus
Development Conference on Celiac Disease.'' The DDNC urges the
Subcommittee to recommend more research, medical education, and public
awareness around Celiac Disease.
The DDNC understand the challenging budgetary constraints and times
we live in that is 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 Immune Deficiency Foundation
Mr. Chairman, thank you for the opportunity to testify today on
behalf of the Immune Deficiency Foundation (IDF).
IDF is the national non-profit, voluntary health organization
dedicated to improving the treatment of primary immune deficiency
diseases through research and education. Head-quartered in Towson,
Maryland, IDF was founded in 1980 by a group of parents of primary
immune deficient children who wanted to focus attention on the needs of
primary immune deficient patients, physicians, and researchers.
Primary immune deficiency diseases are inherited disorders in which
parts of the body's immune system are missing or do not function
properly. The World Health Organization has identified more than 70
different primary immune deficiency diseases. These disorders affect an
estimated 50,000 Americans, regardless of race, age, or gender.
Fortunately, most primary immune deficient patients are able to
maintain their health through regular infusions of intravenous
immunoglobulin (IGIV). IGIV is a pooled plasma derivative that bolsters
the patient's immune system. IGIV is administered intravenously every
three weeks for the lifetime of the patient. However, if primary immune
deficiency diseases are not properly diagnosed and treated, they can
lead to serious illness and early death.
I am here today to speak as a patient, but I am also a physician.
My case is quite representative of a typical immune deficient patient.
I was diagnosed with Common Variable Immuno-deficiency 10 years ago,
following years of repeated infections, which were unresponsive to
antibiotics, and undiagnosed by numerous physicians who were colleagues
of mine. This led to numerous unsuccessful surgeries resulting in
permanent lung and sinus damage. Prior to my diagnosis, a day was
considered successful if I had enough energy to get out of bed.
Following appropriate diagnosis and treatment with IGIV, I have been
able to return to my medical practice and have a new lease on life.
In my testimony today, I would like to highlight the following
issues of importance to the primary immune deficiency community:
--Primary immune deficiency research at the National Institutes of
Health, including the National Institute of Allergy and
Infectious Diseases' Primary Immunodeficiency Disease Research
Consortium.
--Protection for primary immune deficiency patients as part of the
Centers for Disease Control and Prevention's smallpox
vaccination campaign.
primary immune deficiency research at the national institutes of health
Mr. Chairman, I would like to take this opportunity to thank the
subcommittee for its longstanding support of biomedical research at the
National Institutes of Health. IDF applauds your leadership in
finalizing the five-year effort to double the NIH budget in fiscal year
2003. For fiscal year 2004, we encourage the subcommittee to provide a
10 percent increase to NIH in fiscal year 2004. Moreover, we urge the
subcommittee to continue its support of primary immune deficiency
research at the National Institute of Allergy and Infectious Diseases
(NIAID), the National Institute of Child Health and Human Development
(NICHD), and the National Cancer Institute (NCI).
NIAID Primary Immune Deficiency Disease Research Consortium
Mr. Chairman, NIAID is currently in the process of establishing a
Primary Immune Deficiency Disease Research Consortium. IDF welcomes
this exciting new initiative, which will establish a cooperative group
of investigators to address clinical and pre-clinical research
questions, including the development of new treatments such as gene
therapy. The Consortium will utilize the current registry of primary
immune deficiency patients, which IDF and NIAID currently administer
jointly. These registries provide a comprehensive clinical picture of
each primary immune deficiency disorder, including estimates of disease
prevalence, clinical course, and complications.
Another important element of the Consortium is a repository for
biomedical specimens. IDF encourages the subcommittee to support this
critical research component. The Foundation looks forward to working
closely with NIAID in the development and management of the Consortium.
We believe that IDF is uniquely positioned to serve as NIAID's primary
partner on this important new initiative. We encourage the subcommittee
to support the Primary Immune Deficiency Disease Research Consortium at
a level of $12.8 million in fiscal year 2004.
protection for primary immune deficient patients as part of cdc's
smallpox vaccination program
Mr. Chairman, as you know, our nation has been involved in a
difficult debate over the issue of vaccinating Americans against
smallpox. The Immune Deficiency Foundation supports the
Administration's goal of protecting Americans, specifically our first
responders, from the threat of this terrible disease. However, we
believe it is critical that the federal government take all prudent
steps to protect vulnerable populations from the potential ill effects
of exposure to the smallpox vaccine.
Because of their compromised immune systems, primary immune
deficient patients should not be vaccinated against smallpox.
Unfortunately, the potential exists for primary immune deficiency
patients to contract life-threatening complications from just being
exposed to an individual who has been vaccinated. Consequently, IDF has
been working closely with CDC to ensure that the agency's educational
materials related to the smallpox vaccination campaign include
appropriate references to the unique concerns of the primary immune
deficiency community. We are pleased that CDC has incorporated our
proposed references to primary immune deficiency patients in their
printed materials and on their smallpox prevention website.
Mr. Chairman, thank you for the opportunity to present the views of
the Immune Deficiency Foundation. We look forward to continuing to work
with you on these important issues.
______
Prepared Statement of the National Area Health Education Centers
Organization
summary of fiscal year 2004 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 2004.
2. Increase funding for Area Health Education Centers (AHECs) to
$40 million.
3. Increase funding for Health Education Training Centers (HETCs)
to $10 million.
Mr. Chairman, and members of the subcommittee, I am pleased to
present testimony on behalf of the National AHEC Organization.
I am director of the Ohio Statewide AHEC Program, director of the
Medical College of Ohio AHEC program, and a member of the National AHEC
Organization. NAO is the professional organization representing the
Area Health Education Centers (AHECs) and Health Education Training
Centers (HETCs). Together, we seek to enhance access to quality health
care, particularly primary care and preventative care, by improving the
supply and distribution of health care professionals through community-
academic partnerships
persistent workforce shortages
Mr. Chairman, 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 professions such as nursing,
pharmacy, and certain allied health fields. While the supply of
physicians in the non-primary care specialties may well be adequate,
supply and distribution problems for primary care physicians, nurses,
and many allied health professionals are undermining access and quality
in many of our nation's communities.
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 to the challenges. 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 dominate the health care professions, have
expanded greatly.
Health care workforce shortages are occurring in a context of an
increasingly aged population with greater needs for health care
services. In addition, health technology steadily produces advances
that require a higher level of training and sophistication on the part
of health care providers. These trends are occurring at time when the
number and the level of academic preparedness of students entering the
health professions are decreasing.
In addition, minority and disadvantaged populations are egregiously
under represented in the health professions. Given the demographic
trends in the United States, minority populations constitute a major
untapped source of future health care professionals.
what ahecs do
Mr. Chairman, the AHEC/HETC network is the federal government's
most flexible and efficient mechanism for addressing a wide and
evolving variety of health care issues on a local level. Through AHECs
and HETCs, national initiatives can be targeted to the areas of
greatest need and molded to the particular issues confronting
individual communities. Whether the issue is the nursing shortage,
bioterrorism preparedness, access for the uninsured, or recruiting
under-represented minority students into the health professions, AHECs
and HETCs, where they exist, can assemble the appropriate local
collaboration and apply federal, state, and local resources in a
precise and cost-effective manner.
Since our inception almost thirty years ago, AHECs have partnered
with local, state, and federal initiatives and educational institutions
in providing clinical training opportunities to health professions and
nursing students in rural and underserved communities. We bring the
resources of academic health centers to bear in addressing the health
care needs of these communities. Currently, there are 46 AHEC programs
and 180 centers located in 43 states and the District of Columbia. AHEC
programs are based at schools of medicine, which are the federal AHEC
grant recipients, and are implemented through the regional offices
(centers), each of which serves a defined geographic area.
AHEC programs perform four basic functions:
1. They develop and support the community based training of health
professions students, particularly in underserved rural and urban
areas. Exposing health professions students to underserved communities
increases the likelihood that they will return to these communities to
practice.
Last year (2001-2002 academic year), Ohio's AHECs supported the
clinical education of 578 nursing students and 1353 medical students
and residents at community-based rural and underserved sites. Ohio
AHECs have developed a network of over 800 physicians who volunteer
their time to teach the next generation of health professionals.
Through the AHEC in their region (the Canton Area Regional Health
Education Network), nutrition students from Kent State University-Stark
Campus are placed in senior centers to provide nutritional assessments
of older adults at risk of malnutrition and chronic disease. The
students benefit from clinical experience and the seniors obtain a
valuable but otherwise unavailable service.
2. They provide continuing education and other services that
improve the quality of community-based health care. Improving the
quality of care also enhances the retention of providers in underserved
communities, particularly community health centers.
For example, last year Ohio AHECs provided more than 516 continuing
education programs, which were attended by 10,972 practicing
professionals. These providers did not have to leave their communities
or arrange practice coverage to attend these programs, because the
education programs were brought to them in their local communities. In
this way Ohio AHECs support the viability and, often, the continued,
independent existence of small community hospitals. The Sandusky AHEC
sponsors monthly clinical cancer conferences at nine small hospitals,
which routinely attract the entire medical staff.
3. They recruit under-represented minority students into the health
professions through a wide variety of programs targeted at elementary
through high schools. Minority students are grossly under-represented
in the health professions and are more likely to practice in
underserved communities.
Ohio AHECs provide schoolchildren with classroom education on
health careers, school counselors with updates on the latest
opportunities in the health careers, summer science and medicine
camps', and health career directories for schools.
Additionally, the AHEC in Tuscarawas, Ohio is now training 16
promatoras to become community health workers to improve the health of
Hispanic populations. Currently, health fairs are being planned for
this population with local social service agencies. The promatoras will
staff each agency table to translate and we hope that the agencies will
hire them for future translation assistance. In addition, it is funding
three medical students this summer. Each will spend 8 weeks to develop
health-screening events, develop a Hispanic health risk assessment, and
assist physicians in Hispanic populations to provide medical care and
teach cultural competence.
4. They facilitate and support practitioners, facilities, and
community based organizations in addressing critical local health
issues in a timely and efficient manner.
Ohio has the fourth highest death rate due to diabetes in the
country. Incidence of the disease is much higher among the poor, older
adults, African Americans, and Hispanics. Nearly 50 percent of Ohioans
read at a 5th grade level or lower, greatly reducing the ability for
patients to manage their condition well and to understand the
information presented to them. That is why the Ohio Statewide AHEC
Program developed the ``Best Practices and Real Results Conference:
Diabetes and Literacy.'' This conference will assist health care
professionals to understand the growing burden of diabetes, and the
impact of low literacy.
the role of hetcs
The HETC programs were created to address the public health needs
of severely underserved populations in border and non-border areas.
Currently, HETC programs exist in 12 states and are supported by a
combination of federal, state, and local funding, the majority of which
comes from non-federal sources.
Because the majority of preventable health problems are due to
health behaviors and the environment, HETCs focus on community health
education and health provider training programs in areas with severely
underserved populations. HETCs target minority groups, disadvantaged
communities, and communities with diverse culture and languages.
collaborative efforts
Virtually all AHEC and HETC programs are collaborative in nature.
They routinely partner with a wide variety of federal, state, and
locally funded programs. Examples of these collaborations include
health professions schools, primary care residency programs, community
health centers, primary care associations, geriatric education centers,
the National Health Service Corps, public health departments, health
career opportunity programs, school districts, and foundations.
Additionally, AHECs and HETCs often go beyond their core functions
to undertake a wide variety of innovative programs that are tailored to
specific health issues affecting the communities they serve. Because
health issues vary from community to community, the programs of each
AHEC and HETC also vary considerably. AHECs and HETCs respond to
changing health and health workforce needs in a flexible and timely
manner. Examples of current issues for which we are directing our
resources are:
1. The nursing shortage.--Currently, AHECs and HETCs are working
with schools of nursing, state nursing associations, and others 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.
Ohio's AHECs are attacking the nursing shortage at multiple levels;
from leadership at both local and state level policy and education
planning forums to directly providing health career education programs
to high school students. The AHEC in Allen County began a RN-to-BSN
program several years ago. By providing pre-admission counseling,
arranging local and on-line coursework and instructors, and placing in
local hospitals computer workstations linked to the Medical College of
Ohio library, RNs can remain on the job in the community while
obtaining a BSN degree. In the past eight years over 400 nurses have
completed the program.
2. Bioterrorism education.--Currently, AHECs and HETCs are working
with public health departments to educate health and public health
professionals on surveillance, reporting, risk communication,
treatment, and other responses to the threat of bioterrorism.
Ohio's AHECs have stepped in to provide health professionals with
the latest updates on bioterrorism. In rural areas of the state, which
often do not have satellite capabilities, AHECs bring in downlinks and
sponsor bioterrorism preparedness programs. In 2002 Statewide Ohio AHEC
Program received one of 6 federal bioterrorism grants to fund a two
component approach to bioterrorism training and education for health
professionals in Ohio. The focus of the training us on skills necessary
for a wide range of health professionals to be prepared to offer
medical assistance in the first moments through 12 to 24 hours after an
act of terrorism. This year, the Statewide Ohio AHEC Program began its
Basic Anti-Terrorism Emergency Life-Saving Skills (BATELS) program to
prepare health care professionals with a basic fund of knowledge
concerning intentional incidents within the context of an all hazards
disaster management approach. After one session, the Statewide Ohio
AHEC has trained 70 health care professionals, most of whom work in
community health centers. At the Medical College of Ohio, BATELS is a
required course for medical students, and is provided by the school's
AHEC program.
3. The National Health Service Corps (NHSC).--AHECs and HETCs
undertake a variety of programs related to the placement and support of
NHSC scholars and loan repayment recipients.
The Ohio University AHEC has actively supported the NHSC ``SEARCH''
program by interviewing prospective students, recommending community
preceptors, and monitoring placements of 15 students each summer in
rural and Appalachian sites.
4. Expansion of community health centers.--AHECs and HETCs are
collaborating with health professions schools, primary care
associations, and community health centers to increase the supply of
providers willing and able to work in community health centers. In
addition, AHECs/HETCs are working directly with CHC providers to
improve the quality of care
The Ohio AHEC program and the Ohio Primary Care Association have
worked together to promote and support their complementary missions
through co-sponsorship of educational programs and development of
clinical sites such as, ``Diabetes and Literacy'' and ``BATELS'' for
community health centers.
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 Service Act to at least $550 million. Our recommendations are
consistent with those of the Health Professions and Nursing Education
Coalition (HPNEC).
The AHEC and HETC programs improve access to primary and
preventative 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.
However, AHECs and HETCs have not yet fully realized their
potential to be a nationwide infrastructure for local training and
information dissemination. In order to realize that potential
additional federal investment is required. That is why we are
requesting an increase in funding to $40 million in fiscal year 2004
from $33.4 million in fiscal year 2003 for AHECs and $10 million in
fiscal year 2004 from $4.4 million in fiscal year 2003 for HETCs.
______
Prepared Statement of the Association for Professionals in Infection
Control and Epidemiology
Infection control professionals nationwide wish to thank Congress
for its long-standing support of the Centers for Disease Control and
Prevention (CDC), particularly with regard to strengthening the overall
public health infrastructure in recent years. Although enhancements to
our system have only just begun, these widespread efforts have already
had a monumental impact on safeguarding the health of our nation.
Indeed, if stronger infrastructure were not currently in place, we
would find ourselves unable to adequately address the significant
threat posed by Sudden Acute Respiratory Syndrome (SARS).
Emerging pathogens will continue to confound and challenge even the
strongest of public health systems. Changes in human behavior,
alterations to the environment, widespread antibiotic usage, and
dramatic increases in international commerce and travel are factors
contributing to the proliferation of drug resistance and resurgent and
emerging microorganisms. It is imperative that we continue to enhance
surveillance sites, strengthen epidemiological and laboratory response
capabilities and support efforts to address emerging infectious disease
on a global level.
Since the CDC is the primary entity responsible for safeguarding
the public health, it is imperative that it be granted adequate
resources to perform this monumental task. APIC recommends a fiscal
year 2004 funding level of $7.9 billion and we hope that Members of
Congress will take this into consideration during the appropriations
process.
These enhancements will also help our nation to mobilize in the
event of a bioterrorist act. However, the public health aspect is only
part of the equation. We can no longer ignore the critical role of
health care providers and health care facilities in our nation's
response efforts. Hospitals and other care providers simply do not have
the resources necessary to treat and contain medical cases that may
occur as a result of a bioterrorist event or a new emerging pathogen.
Additional resources are needed to fund supplies, special isolation
rooms, specialists in infection control and disease prevention as well
as educational programs to train all health care providers.
Facilities will succeed in this effort only through proper
enhancements to their current systems and with adequate personnel and
resources. Without this support, they cannot possibly take on these
crucial public health-related activities on top of their current
responsibilities. If the Health Resources and Services Administration
(HRSA) is to be charged with distributing such funds, we would
respectfully request that a much more realistic amount be allocated for
this purpose.
We are seeking Congressional support in ensuring that federal
funding reaches the level of the individual health care facilities as
soon as possible. The health and safety of our citizens depend upon it.
funding request
APIC is recommending the following funding levels for enhancing
hospital infrastructure and bioterrorism preparedness.
--$3 billion for the Centers for Disease Control and Prevention (CDC)
to continue building adequate public health infrastructure for
responding to bioterrorism. This would increase the CDC
Bioterrorism budget by $748 million over fiscal year 2002 and
represents an increase of $1.4 billion over the President's
fiscal year 2003 budget request.
--$620 million for the Health Resources and Services Administration
(HRSA) to support the continued enhancement of bioterrorism
readiness infrastructure at hospitals and other health care
facilities. This would increase the HRSA Hospital Preparedness
and Infrastructure Program by $485 million over fiscal year
2002, and is $102 million above the President's fiscal year
2003 budget proposal.
what is needed?
Enhanced Infection Surveillance and Reporting.--for syndromes and
diseases potentially associated with bioterrorism. Extensive
surveillance is needed in emergency departments, admissions, and other
affiliated sites, not just the primary care facility, reported in real-
time, and then tabulated/communicated back to appropriate recipients of
data. This would include ambulatory care sites and ancillary sites.
Surveillance tools need to be developed that facilitate rapid analysis
and communication of suspected bioterrorism. These tools are best
utilized when they are consistent in nature, user friendly, and
wireless compatible.
Timely, Effective Communication with the Public Health Community.--
The current infrastructure is insufficient; we need to develop and
ensure rapid communication and electronic real-time reporting
capabilities among the Federal, State, and Local levels. This includes
the quick fine-tuning and deployment of NEDS or comparable systems.
Current computer and communication systems are not technologically
advanced to support the potential influx of data and provide feedback
instantaneously. This also includes the necessary mobile devices to
support collection of information and transmission to a centralized
location/database. Communication needs to include smallpox vaccination
data of health care providers and related smallpox Rapid Response Team
members, available electronically throughout all jurisdictions.
Adequate Laboratory Services.--To ensure the availability of rapid,
effective laboratory methodologies. In response to cost containment
pressures, many facilities have chosen to outsource certain testing.
This has a direct impact on the timeliness of results--a crucial factor
in addressing a bioterrorist event. Furthermore, managed care
constraints have forced practitioners to limit the ordering of tests
required to document infectious agents which may impede our ability to
detect a problem if there is one. The designated lab facilities that
have requested status for testing need support to train personnel and
or employ experienced personnel for handling and testing of specimens.
Adequate Airborne Infection Isolation Rooms (AIIRs) in All
Facilities.--To ensure that facilities can isolate patients in
environmentally appropriate conditions and still provide essential
health care services. Development of such architectural plans should be
done via appropriate multidisciplinary teams using the American
Institute of Architects' 2001 ``Guide for Design and Construction of
Hospitals and Health Care Facilities.'' There is a great deal of
disparity among facilities in regard to airborne isolation capability.
Older facilities are often ill-equipped to triage, evaluate and admit
patients--and may have very rudimentary, if any, airborne isolation
rooms. Many facilities also have discrepancies in what type of patient
even needs isolation and when to take them out, so they may report
adequate or inadequate rooms based on their current interpretation of
symptoms and/or syndromes. It is critical that every hospital has the
capability to safely care for patients with potentially communicable
conditions.
Education--To train clinicians on the signs, symptoms, and
appropriate control measures for infectious agents likely to be used by
terrorists. Education is paramount in training the personnel
responsible for caring for patients to ensure the optimal safety of
both patient and health care provider.
Adequate Health Care Personnel/Resources.--To ensure optimal
patient care. We are currently in the midst of a major nursing shortage
and there is a critical need to address this issue, as it will have
drastic implications. We also need adequate and trained hospital
epidemiologists and infection control professionals to implement and
sustain the recommendations of the CDC and professional organizations
at the grassroots level. These professionals are the community link to
the public health system and are a vital partner in controlling and
preventing the spread of contagion.
Strong Occupational Health and Safety Programs.--To ensure the
safety and health of this critical workforce. Vaccination programs and
other occupational health programs need to address liability, furlough
and workers' compensation issues for health care facilities.
We also need to ensure continued funding and support of patient
care activities that enhance patient safety and health care worker
safety. Implementation of recommendations to isolate and contain new
pathogens like SARS and other agents stress the budget of hospitals and
ambulatory care centers due to the increased utilization and costs for
personal protective equipment and supply management.
The Association for Professionals in Infection Control and
Epidemiology (APIC) is a nonprofit professional organization comprised
of some 12,000 members, most of whom work in health care facilities
preventing and controlling infections. In the event of a bioterrorist
attack, these health care professionals will be helping to lead the
response for their facilities--caring for victims as well as
controlling the spread of infection to others.
For more information, please contact Jennifer Thomas-Barrows,
Director of Public Policy at 860-675-6869 jthomas@apic.org or Dale
Dirks, Health & Medicine Counsel of Washington, 202-544-7499
dirks@hmcw.org
association for professionals in infection control and epidemiology
APIC is a multi-disciplinary, voluntary, international
organization, which promotes wellness and prevents illness and
infection world-wide by advancing health care epidemiology through
education, collaboration, research, practice, and credentialing.
______
Prepared Statement of the Pulmonary Hypertension Association
summary of fiscal year 2004 recommendations
--$1 million within the Centers for Disease Control and Prevention
(CDC) for a pulmonary hypertension awareness and education
program.
--A 10 percent increase for the National Heart, Lung and Blood
Institute (NHLBI).
--$30 million for the Health Resources and Services Administration's
(HRSA) ``Gift of Life Donation Initiative.''
Mr. Chairman, thank you for the opportunity to submit written
testimony regarding fiscal year 2004 appropriations for the Centers for
Disease Control and Prevention (CDC), National Institutes of Health
(NIH), and Health Resources and Services Administration (HRSA).
PH is a rare disorder involving both the heart and the lungs. The
walls of the blood vessels that supply the lungs thicken and often
constrict, making them unable to carry normal amounts of blood. The
heart works harder to compensate and eventually can't keep up. Life is
threatened. Currently, there is no cure. Symptoms of pulmonary
hypertension include shortness of breath with minimal exertion,
fatigue, chest pain, dizzy spells and fainting.
When PH occurs in the absence of a known cause, it is referred to
as primary pulmonary hypertension (PPH). This term should not be
construed to mean that because it has a single name it is a single
disease. There are likely many unknown causes of PPH.
Secondary pulmonary hypertension (SPH) means the cause of the
disease is known. Common causes of SPH are the breathing disorders
emphysema and bronchitis. Other less frequent causes are scleroderma,
CREST syndrome and systemic lupus. In addition, the use of diet drugs
can lead to the disease.
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.
Eleven years ago, when three patients who were searching to end
their own isolation founded this organization, 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 not enough and as membership began to
grow--driven by a newsletter written by patients and distributed by
doctors--and as a community began to form, an 800 number support line
was launched, support groups were established, a Scientific Advisory
Board (SAB) was formed, a Patient's Guide to Pulmonary Hypertension was
written, and a web site was launched.
Today, PHA includes:
--Over 4,500 patients, family members, and medical professionals.
--An international network of over 100 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 seven Young Researcher
Grants.)
--A host of 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.
centers for disease control and prevention
PHA applauds the subcommittee for its leadership in encouraging CDC
to initiate a professional and public PH awareness campaign. Currently,
we are working with officials at the CDC to establish this important
program that will better inform health care professionals and the
general public about PH, its symptoms, and treatment options.
PHA knows that Americans are dying because of a lack of awareness
of both pulmonary hypertension and recent advances in research and
treatments. Most particularly, this is true among underserved
populations. These are the least likely and the least able to see the
three and four doctors it often takes to get a correct diagnosis. We
believe that activities proposed below need to include special focus on
reaching underserved populations and their medical services.
The following is a description of the specific initiatives we hope
to launch in collaboration with CDC.
(1) Increasing awareness and understanding of PH among primary care
physicians is critically important, because these practitioners are
usually the first point of contact for PH patients. If the primary care
doctor misses the symptoms, then the chance for early diagnosis depends
upon the intuition and persistence of the patient. They have a chance,
if they aggressively pursue diagnosis by trained and aware specialists.
If they are not aggressive, or if they are in a health plan that
requires their general practitioner to prescribe the referral, they are
more likely to go undiagnosed until it is too late to control their
illness. To increases awareness we propose to launch the following:
--Written and video diagnostic tools for placement on the Internet.
--Working with state health departments and clinic administrators to
develop information for mailing to primary care physicians,
medical schools and medical centers in the United States
drawing their attention to the new web resources.
--A simplified and visually attractive print version of the proper
diagnostic procedures, which will be targeted to primary care
physicians, public health clinics, medical schools, and medical
centers in the United States.
--Advertising in publications general practitioners and public health
professionals are likely to read. The emphasis will be the
importance of early diagnosis and the ease of accessing
diagnostic tools via the Internet.
--Improvements to an already produced CD-ROM that explains pulmonary
hypertension from a variety of perspectives. We would like to
make these available to the medical community and patients
through our web site on an as requested basis and at
conferences and through targeted mailings.
(2) Due to the advancements in treatment for PH, it is important
that we also focus on educating cardiologists and pulmonologists. Our
strategies for reaching cardiovascular specialists include:
--Expansion of the first Pulmonary Hypertension Journal focused on
educating a cardiologists and pulmonologists on issues related
to the diagnosis and treatment of the illness.
--Placement of additional detailed information on the illness on the
web. The PH Journal and other publications will promote this
availability.
--Expansion of the medical section of PHA's international conference
on pulmonary hypertension (the largest PH conference in the
world).
--Expansion of PHA's Pulmonary Hypertension Resource Network. This
program is focused on increasing awareness and knowledge of PH
among nurses, respiratory therapists, technicians and
pharmacists through peer education.
(3) Finally, PHA is committed to increasing PH awareness among the
general public through the development of the following initiatives:
--A series of 10, 15, and 30 second public service announcements on
PH. These PSAs will be in both audio and video form.
--A PH media relations manual.
--An organ donation and transplant listing Awareness Campaign
(unfortunately, many PH patients die before finding a suitable
organ donor).
--Expansion of awareness and information activities on PHA's web
site.
We look forward to working with the CDC to implement these and
other initiatives aimed at increasing awareness of PH in the United
States and throughout the world. For fiscal year 2004, we encourage the
subcommittee to continue to support the mission of the CDC with an
overall appropriation of $7.9 billion. Moreover, we urge you to provide
$1 million within CDC's Cardiovascular Disease program for a PH
awareness campaign.
national heart, lung and blood institute
Mr. Chairman, PHA commends the leadership of the National Heart,
Lung and Blood Institute (NHLBI) for its support of PH research. Two
years ago, two separate groups of scientists funded by NHLBI
simultaneously identified a genetic mutation associated with primary
pulmonary hypertension.
The two groups independently reported that defects in the BMPR2
gene, which regulates growth and development of the lung, are
associated with PPH. The defects in the gene lead to the abnormal
proliferation of cells in the lung characteristic on PPH.
Although both studies suggest that only one gene is involved in
PPH, neither group identified the defects in BMPR2 as the sole cause of
PPH. In addition, since many people without a known family history of
PPH get the disease, both groups suggested that other factors may
interfere with control of the tissue growth. Now that we have
pinpointed a gene, we can focus on learning how it works. Hopefully,
that information will enable researchers to devise better treatments
and perhaps eventually a preventive therapy or cure.
We were pleased and excited that NHLBI recently convened a meeting
of leading PH researchers to chart the future of PH research. We
appreciate the agency's commitment to advancing research to better
understand and ultimately cure this disease.
Mr. Chairman, PHA would like to thank you and the subcommittee for
your leadership in support of funding for the National Institutes of
Health. Moreover, we would like to thank the subcommittee for the
inclusion of committee recommendations on PH research at NHLBI in the
fiscal year 2003 Senate L-HHS report. For fiscal year 2004, PHA joins
with the Ad Hoc Group for Medical Research Funding in supporting a 10
percent increase for NHLBI.
gift of life donation initiative at hrsa
Mr. Chairman, PHA commends the leadership of Secretary Thompson on
the success of his ``Gift of Life Donation Initiative.'' Currently,
there are three drugs that PH patients can be prescribed to help
improve the quality of life with PH. Eventually, many patients must
move toward lung or heart and lung transplantation. PH is a difficult
to diagnose illness and while patients often list soon after diagnosis,
for many PH patients it is too late. This why PHA is developing the
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, the importance of early
listing, the importance of organ donation to our community and organ
donation cards.
Consequently, PHA applauds the administration for its ``Gift of
Life Donation Initiative,'' which is designed to increase organ
donation rates throughout the country. We look forward to working with
the ``Gift of Life Donation Initiative'' to increase awareness of the
importance of organ donation among the PH community, the medical
community and the public. Mr. Chairman, PHA supports $30 million in
fiscal year 2004 for HRSA's ``Gift of Life Donation Initiative.''
conclusion
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. If you have any questions or would
like additional information, please do not hesitate to contact me or
the PHA National Office in Silver Spring, Maryland (301) 565-3004 x101.
______
Prepared Statement of the Society of Teachers of Family Medicine, the
Association of Departments of Family Medicine, the Association of
Family Practice Residency Directors, and the North American Primary
Care Research Group
Mr. Chairman, on behalf of the Society of Teachers of Family
Medicine, the Associations of Departments of Family Medicine, the
Association of Family Practice Residency Directors, and the North
American Primary Care Research Group, we of would like to thank you for
the opportunity to provide this statement for the record on behalf of
funding for family medicine training, and the Agency for Health Care
Research and Quality (AHRQ).
health professions: the primary care medicine and dentistry cluster
Mr. Chairman, the Organizations of Academic Family Medicine would
like to thank you for this committee's commitment to these programs. We
appreciate the funding included in the fiscal year 2003 appropriations
funding bill, especially in light of fiscal constraints. Family
medicine training programs are funded under Section 747, the Primary
Care Medicine and Dentistry cluster, of Title VII of the Public Health
Service Act. We ask that you continue your support for family medicine
training, and bring the appropriations level for section 747, the
Primary Care Medicine and Dentistry Cluster, up to $169 million for
fiscal year 2004, of which $96 million is needed for family medicine.
This statement is designed to show the committee how its investment is
paying off. This statement will discuss the success of these programs
and include recommendations about what still needs to be done. As you
look at all the opportunities you have to fund domestic health programs
you need to be able to make judgments about the value and utility of
these programs. We have been asked in various venues to show proof that
these funds actually do what they are designed to do. We must show that
this money makes a difference. In this statement we intend to do just
that. In addition, we believe Congress also needs to understand the
unmet needs that exist in our nation--needs Health Professions programs
can successfully help address.
President's Budget Request for Fiscal Year 2004 Once Again Zeros Out
Primary Care Funding
The President's budget zeroes out funding for the Primary Care
Medicine and Dentistry cluster. In addition, the proposal includes only
$109 million for all of the Health Professions programs (Title VII and
VIII), a sharp cut of almost 75 percent from the fiscal year 2003 level
of $423.8 million. The budget also claims these programs are
ineffective, although we believe the analysis used by OMB to determine
this is extremely flawed. While OMB has criticized the entire group of
21 health professions programs taken together as lacking clear purpose,
the goals of those specific programs under Section 747 are very clear.
According to several studies (see below), Title VII dollars in general,
and family medicine funding in specific have proven effective in
addressing several major health professions problems.
Family Medicine Training Programs Are A Success
First, let's take a look at health professions training--
specifically family medicine training. These programs are producing the
outcomes that Congress has requested. In a current study (Family
Medicine, June 2002), the Robert Graham Center For Policy Studies In
Family Practice and Primary Care has shown that federal funding through
Title VII of family medicine departments, predoctoral programs, and
faculty development has made a difference. The study shows that:
--All three types of grants made a difference in producing more
family physicians, and more primary care doctors
--Predoctoral and department development grants made a difference in
producing more primary care doctors serving in rural areas, and
more primary care doctors serving in primary care he alth
professional shortage areas.
--Sustained funding during the years of medical school training had
more positive impact than intermittent funding.
We must conclude from this data that this funding means that
thousands of physicians are making different career choices, choices
that positively affect millions of patients in underserved areas and in
primary care. Moreover, if this money were to ``go away'' fewer
students would be making these career choices.
Other Indicators Of Success
The federal government's independent General Accounting Office
(GAO) has also shown that this money works. The GAO, in two reports in
1994, addressed the question of how do we know Title VII money is well
spent? A July 1994 report, states that ``the programs were important
for funding innovative projects and providing `seed money' for starting
new programs. For example, Title VII was considered important in the
creation and maintenance [emphasis added] of family medicine
departments and divisions in medical schools.'' In another report, the
GAO states in October 1994 that ``students who attended schools with
family practice departments were 57 percent more likely to pursue
primary care.'' In addition, the report goes on to say that ``students
attending medical schools with more highly funded family practice
departments were 18 percent more likely to pursue primary care and
students attending schools requiring a third-year family practice
clerkship were [also] 18 percent more likely to pursue primary care.''
The money spent on Section 747 of Title VII is directly targeted in
these areas.
Loss of Funding for Family Medicine Training Would Cause Tremendous
Impact on Service to the Underserved
Data show that if production of family physicians was to fall, the
impact on the nation's underserved would be great. The fewer the number
of family physicians produced, the greater the number of new health
professional shortage areas, or HPSAs. This holds true even in
comparison with the combined loss of internists, pediatricians and
obstetrician/gynecologists. The United States relies on family
physicians unlike any other specialty. Without family physicians an
additional 1332 of the United States' 3082 urban and rural counties
would qualify for designation as primary care HPSAs. This contrasts
with an additional 176 counties that would meet the criteria if all
internists, pediatricians, and ob/gyns in aggregate were withdrawn. The
bottom line is that without family physicians 1332 counties would
qualify for primary care HPSA designation vs. 176 counties if other
primary care specialists were withdrawn.
What Is The Unmet Need? Why Must We Continue To Fund And Grow These
Programs?
According to a study by Politzer, et al (The Journal of Rural
Health, Winter, 1999) Title VII funding is key to ending HPSAs. This
funding has led to the time needed for HPSA elimination to decrease to
15 years. Doubling the funding for these programs would decrease the
time for HPSA elimination to as little as 6 years. According to the
study, without this funding, not only would HPSAs not be eliminated,
but the number of shortage areas would continue to grow. Moreover,
success has been attained by an allocation of funds more favorable to
family medicine than the other two primary care specialties. Title VII
funding has indeed accomplished many of the objectives for which it was
designed:
--Funding of in novative projects
--Providing ``seed money'' for the start-up of new projects
--The creation and maintenance of departments of family medicine in
the nation's medical schools
--The development of 3rd year clerkships in family medicine
--The increase in students selecting primary care residencies from
those schools with funded family medicine departments and 3rd
year clerkships
--The increased rate of graduates from Title VII funded projects
entering practice in medically underserved areas (MUAs), with a
resultant reduction in the time required for Health Professions
Shortage Area (HPSA) elimination
Section 747 Advisory Committee Recommends Higher Funding
In 1998, Congress established an Advisory Committee to review and
make recommendations on Section 747. The Advisory Committee on Training
in Primary Care Medicine and Dentistry (ACTPCMD) recently released its
recommendations to Congress and the Secretary of the Department of
Health and Human Services. The first of six recommendations urges
greatly expanding federal support for Section 747 to $198 million. The
Committee notes the growing need for primary care providers, as well as
the success of Title VII funded programs. The training enterprise that
does not value primary care either financially or otherwise is a key
part of the problem. Title VII funds that support the infrastructure
and stability of family medicine departments in medical schools have to
be sustained in order to keep producing the current levels of primary
care physicians and, more specifically, those who will practice in
rural and other underserved areas. Clearly, the programs of Title VII
are on the right track toward meeting the health care challenges of the
21st century. So, while we believe that current funding must be
maintained, more needs to be done.
Proposed Performance Measures Need to be Redefined
The current proposed performance measures are neither measurable
nor appropriate. Consequently, assessments of effectiveness of the
programs based on these measures are highly flawed. For example, the
target set for the proportion of underrepresented minorities (URMs) and
disadvantaged students in health professions funded programs is set at
40 percent for 2004, even though only 12.5 percent of current medical
school graduates are URMs, and data on disadvantaged backgrounds is not
routinely, or accurately collected. The concept of disadvantaged
background varies based on income related to family size, or is based
on a vague--non-quantifiable--notion of persons growing up in
environments that don't prepare them to enter health professions
schools. In 2000 approximately 12.5 percent of the medical degrees
awarded in the United States went to underrepresented minorities. For
all of health professions minority representation has risen from 8.3
percent in 1985 to 11.7 percent in 2000. Given this data, it's simply
unrealistic to expect any program to increase its minority
representation in one year from 12.5 percent to 25 or 40 percent.
Primary Care Training Programs React Quickly to Emerging Health
Challenges
Title VII dollars have created an infrastructure that allows
educational programs to respond to contemporary health care issues.
Specifically, the ACTPCMD report states that:
``Investment in education to provide primary care has effects that
touch the largest number of people in the country. No other group of
health care providers can exert such a broad influence on the kind and
quality of health care in the United States. Primary care training
programs are ideally positioned to react quickly to meet ever-changing
health care needs and issues, whether they are related to HIV/AIDS,
growing numbers of elderly with chronic illnesses, implications of the
modern genetics revolution, the threat of bioterrorism, or other issues
that will continue to emerge and demand rapid educational intervention.
Thus, this infrastructure is uniquely able to play a pivotal role in
bringing emerging issues in health care to the population at large.''
Mr. Chairman, we know that this committee has to weigh the value of
funding various programs against each other. We hope that the evidence
we have presented here will bring the committee to the conclusion that
funding spent on these programs would bring value for the money and
would be money exceptionally well spent.
funding for the agency for health care research and quality (ahrq)
Mr. Chairman, once again, we thank you and this committee for
increasing funding for this important agency. It is apparent that the
key federal agency available to fund primary care research is the
Agency for Healthcare Research and Quality (AHRQ). In it's recent rea
uthorization, Congress established within the Agency a Center for
Primary Care Research to ``serve as the principal source of funding for
primary care practice research in the Department of Health and Human
Services.'' The statute defined primary care research as research that
``focuses on the first contact when illness or health concerns arise,
the diagnosis, treatment or referral to specialty care, preventive
care, and the relationship between the clinician and the patient in the
context of the family and community.
Funding Request For AHRQ
We recommend appropriations of $390 million for the Agency for
Healthcare Research and Quality (AHRQ) in fiscal year 2004. AHRQ
conducts primary care and health services research geared to physician
practices, health plans and policymakers that helps the American
population as a whole.
President's Budget Request for Fiscal Year 2004 Cuts AHRQ Funding
The President's budget includes $279 million for AHRQ, a cut of
about $24 million, from the current funding level of $303.7 million. If
this budget request of $279 million were enacted, a reduction of
funding of over 8 percent would result. Under this scenario, AHRQ would
be unable to award any new non-patient safety grants in fiscal year
2004 and existing non-patient safety grants would have to be cut by 15
percent. We are particularly grateful for this committee's efforts last
year when the President's proposed budget would have reduced AHRQ by
$48 million. Your restoration of AHRQ's funding in the final funding
bill was critical in continuing research needed to improve health care
quality, access, and financing in the United States. Now as you develop
your fiscal year 2004 budget, we ask that you not only maintain, but
enhance funding for this critical agency.
What Does AHRQ Do?
AHRQ's three goals are to (1) improve physician practice and
Americans' health outcomes, (2) improve the quality of health care
(e.g., patient safety), and (3) improve the health care system (e.g.,
increase access and reduce costs). In brief, AHRQ ``helps to improve
the health and health care of the American people.'' (AHRQ report,
March, 2001).
How Does AHRQ Meet Its Goals?
AHRQ translates research findings from basic science entities like
the National Institutes of Health into information that doctors can use
every day in their practice with their patients. Another key function
of the agency is to support research on the conditions that affect most
Americans.
AHRQ Translates Research into Everyday Practice
Congress has provided billions of dollars to the National
Institutes of Health, which has resulted in important insights in
preventing and curing major diseases. AHRQ takes this basic science and
produces information that physicians can use every day in their
practices. AHRQ also distributes this information throughout the health
care system. In short, AHRQ is the link between research and the
patient care that Americans receive. An example of this link is basic
science research showing that beta blockers reduce mortality. AHRQ
supported research to help physicians determine which patients with
heart attacks would benefit from this medication.
AHRQ Supports Research on Conditions Affecting Most Americans
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. AHRQ looks at the
problems hat bring people to their doctors every day--not the problems
that send them to the hospital. For example, AHRQ supported research
that found older antidepressant drugs are as effective as new
antidepressant medications in treating depression, a condition that
affects millions of Americans.
Institute of Medicine Recommends $1 Billion for AHRQ
The Institute of Medicine's report, Crossing the Quality Chasm: A
New Health System for the 21st Century (2001), recommended $1 billion a
year for AHRQ to ``develop strategies, goals, and actions plans for
achieving substantial improvements in quality in the next 5years . .
.'' The report looked at redesigning health care delivery in the United
States. AHRQ is a linchpin in retooling the American health care
system.
recommendations for family medicine training and research
The Organizations of Academic Family Medicine have two main
recommendations for the fiscal year 2004 Labor/HHS Appropriations bill.
They are as follows:
--We ask that you continue your support for family medicine training,
and bring the appropriations level for section 747, the Primary
Care Medicine and Dentistry Cluster, up to $169 million for
fiscal year 2004, of which $96 million is needed for family
medicine.
--In order to support critical practice-oriented primary care
research, and to ensure that existing grants and contracts will
not be cut, we are asking that the Agency for Healthcare
Research and Quality be funded at $390 million.
______
Prepared Statement of the March of Dimes Birth Defects Foundation
The March of Dimes is pleased to have the opportunity to submit
testimony on behalf of its 1500 staff and over 3 million volunteers,
and share with you some of the Foundation's federal funding priorities
for fiscal year 2004. As you may know, 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 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 54 chapters in every state, the District of
Columbia and Puerto Rico.
centers for disease control and prevention (cdc)
National Center on Birth Defects and Developmental Disabilities
Of the four million babies born each year in the United States,
approximately 150,000 are born with one or more serious birth defects.
Birth defects are the leading cause of infant mortality accounting for
more than 20 percent of all infant deaths and are responsible for about
30 percent of all pediatric hospital admissions. In addition, birth
defects are the fifth-leading cause of years of potential life lost and
contribute substantially to childhood morbidity and long-term
disability. Because the causes of about 70 percent of all birth defects
are unknown, the public continues to be anxious about whether
environmental pollutants cause birth defects, developmental
disabilities, or other adverse reproductive outcomes. The public also
has many questions about whether various occupational hazards, dietary
factors, medications, and personal behaviors cause or contribute to
birth defects.
The National Center on Birth Defects and Developmental Disabilities
(NCBDDD) at the CDC works to improve the health of children and adults
by preventing the occurrence of birth defects and developmental
disabilities; and promoting health and wellness among children and
adults with disabilities. The March of Dimes urges this Subcommittee to
increase funding for the Center to $125 million in fiscal year 2004.
This modest increase will provide the resources necessary to expand
many of the important activities supported by the Center. Of particular
interest to the March of Dimes is the prevention of birth defects for
which causes have already been identified and the identification of
causes for those which have not. A comprehensive program that includes
surveillance, research and prevention activities is being administered
by the National Center on Birth Defects and Developmental Disabilities
(NCBDDD). A modest increase of $15.9 million in funding for three
programs is a vital step to making progress in the fight against birth
defects.
Surveillance: State Cooperative Agreements to Improve Birth
Defects Tracking
NCBDDD provides funding to states to develop, implement, and/or
expand community-based birth defects tracking systems, programs to
prevent birth defects, and activities to improve access to health
services for children with birth defects. Surveillance forms the
backbone of a vital, functional and responsive public health network.
CDC is now supporting cooperative agreements with 28 states, each
funded between $100,000 and $200,000 a year for each of three years.
The March of Dimes encourages the Subcommittee to add $3.4 million
($7.5 million total funding) to state-based birth defects surveillance
activities. As you may be aware, resources have not been adequate to
fund all the states seeking CDC assistance. These additional resources
are needed to help all the states seeking CDC assistance and to
increase the level of assistance to states already receiving support.
Research: Regional Centers for Birth Defects Research and
Prevention
NCBDDD funds 10 regional Centers for Birth Defects Research and
Prevention, each receiving approximately $900,000 per year, to conduct
epidemiological research on birth defects. The centers are located in
Arkansas, California, Georgia, Iowa, Massachusetts, New Jersey, New
York, North Carolina, Texas, and Utah. These centers identify cases and
obtain data for inclusion in the National Birth Defect Prevention
Study, the largest case-control study of birth defects ever conducted.
Now the centers are using this data for studies on the effectiveness of
various methods for the primary prevention of birth defects, the
teratogenicity of various drugs, the environmental causes of birth
defects and the genetic factors that make people susceptible to
environmental causes of birth defects, the behavioral causes of birth
defects, and the costs of birth defects. The March of Dimes encourages
the Subcommittee to add $10 million ($16.3 million total funding) to
fund all these areas of promising research and continue operating all
the centers.
Prevention: Folic Acid Education Campaign
NCBDDD is conducting a national public and health professions
education campaign designed to increase the number of women taking
folic acid daily. Each year, an estimated 2,500 babies are born with
neural tube defects (NTDs), birth defects of the brain and spinal cord,
including anencephaly and spina bifida. CDC estimates that up to 70
percent of NTDs could be prevented if all women of childbearing age
consume 400 micrograms of folic acid daily, beginning before pregnancy.
Significant progress has been made and the rates of spina bifida have
declined 31 percent. With increased funding and in collaboration with
the National Spina Bifida Program, which also has a prevention focus,
this campaign could be expanded to reach more women of childbearing age
and their health care providers. The March of Dimes recommends an
appropriation of at least $5 million for fiscal year 2004 to promote
this lifesaving intervention.
national institutes of health
The March of Dimes joins the research community in recommending a
10 percent increase in funding for the National Institutes of Health
(NIH), which would bring total funding to $30 billion. A sustained
investment in medical research is vital to solving many of the diseases
and conditions affecting mothers and children. Specifically, and of
particular interest to the March of Dimes, are the research activities
at the National Institute of Child Health and Human Development.
National Institute for Child Health and Human Development
The mission of National Institute for Child Health and Human
Development (NICHD) is closely aligned with that of the March of Dimes.
The Foundation recommends an overall increase of 10 percent for NICHD.
With this increase in funding, NICHD could expand research in several
areas that are crucial to the health of mothers and children.
Additional funds would permit expansion of research into the causes of
birth defects, and also the causes of prematurity. Increased funding
would also enable NICHD to accelerate the timetable for implementing a
much-needed analysis of environmental influences on child health and
development that will be conducted as part of the National Children's
Study authorized by the Children's Health Act of 2000.
Pre-term labor and delivery is the number one problem in obstetrics
today and a serious problem in pediatrics. It is the leading cause of
neonatal mortality, and many babies born prematurely have serious
physical and mental disabilities, such as cerebral palsy, mental
retardation, chronic lung disease, and vision and hearing loss, that
last a lifetime. Prematurity is also a growing problem. Between 1991
and 2001, the annual percentage of newborns delivered preterm in the
United States increased from 10.8 percent to 11.9 percent. More than
476,000 babies in the United States-nearly 12 percent of all US babies-
were born prematurely in 2001. Prematurity is also one of the clearest
indices of racial disparities. Rates of preterm birth vary
significantly by race and ethnicity. In 2001, rates for blacks were
highest among all racial and ethnic subgroups--17.5 percent as compared
to 11 percent for white Americans.
The March of Dimes recommends increased funding of at least $50
million over the next five years to boost prematurity-related research
at NICHD, with particular emphasis on expanding the collaborative
networks for Maternal-Fetal Medicine Units and Neonatal Research. More
funds are needed to reveal the underlying causes of preterm delivery,
to identify prevention strategies and improve the treatment and
outcomes for infants born preterm.
health resources and services administration (hrsa)
Newborn Screening
One of the great advances in preventive medicine has been the
introduction of newborn screening. Newborn screening is a public health
activity used to identify certain genetic, metabolic, hormonal and/or
functional conditions in newborns. As the Committee members know, such
disorders, if left untreated, can cause death, disability, mental
retardation and other serious problems. Although nearly all babies born
in the United States undergo newborn screening tests for genetic birth
defects, the number and quality of these tests vary from state to
state. The March of Dimes recommends that every baby born in the United
States receive, at a minimum, a core set of 10 screening tests.
The March of Dimes proposes an appropriation of $25 million to
support HRSA's work with states to implement the heritable disorders
(newborn screening) program authorized in Title XXVI of the Children's
Health Act of 2000. This program is designed to strengthen states'
newborn screening programs; to improve states' ability to develop,
evaluate, and acquire innovative testing technologies; and to establish
and improve programs to provide screening, counseling, testing and
special services for newborns and children at risk for heritable
disorders.
Thank you for the opportunity to testify on the programs of highest
priority to the March of Dimes. The staff and volunteers of the March
of Dimes look forward to working with members of the Subcommittee to
improve the health of mothers, infants and children.
______
Prepared Statement of the American Dental Education Association (ADEA)
ADEA is the premier national organization that speaks for dental
education. It is dedicated to serving the needs of all 56 U.S. dental
schools, 731 U.S. dental residency programs, 266 dental hygiene
programs, 6,150 dental assisting programs, and 24 dental laboratory
technology programs, as well as the 11,332 full- and part-time dental
school faculty, more than 5,060 dental residents and the nation's
37,300 dental and allied dental students. It is at dental education
institutions that future practitioners and researchers gain their
knowledge; the majority of dental research is conducted; and
significant dental care is provided to many underserved low-income
populations, including individuals covered by Medicaid and the State
Children's Health Insurance Program (SCHIP).
Dental schools across the country are doing their part to increase
access to oral health care for underserved populations and to build
upon research for the good of all. According to a study conducted by
the American Dental Association,\1\ nearly half of all patients treated
at dental school clinics are covered by public assistance with a
majority of patients having an income of $15,000 or less. Examples of
the commitment dental education is making to improve access and build
the research capacity can be found in the states such as Pennsylvania,
Iowa, Texas, Mississippi, and South Carolina include:
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\1\ ``Study of Dental School Facilities and Programs,'' American
Dental Association, August, 1999.
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--In Pennsylvania, the University of Pittsburgh School of Dental
Medicine provides state-mandated dental screenings for
kindergarten, grades 3 and 7 at the Wilkinsburg School
District; while the Temple University School of Dentistry
provides services at its school-based dental clinic at Roberto
Clemente Middle School and at its rural dental clinic in
Wellsboro, in addition to providing dental and nutritional
services to HIV/AIDS patients at its Rosenthal Clinical Center.
--Iowa's large elderly population makes it imperative that students
build skills for treating older adults. Students at the
University of Iowa College of Dentistry spend 25 percent of
their senior year providing oral health care in extramural
programs, largely in community-based clinics.
--In Texas, the state's three dental schools are successful in
increasing access to oral health care. The University of Texas
Health Science Center at San Antonio Dental School provides
emergency care to indigent patients and provides pre-surgical
treatment to patients undergoing organ transplants and their
Department of Pediatric Dentistry staffs Santa Rosa Hospital's
dental clinics, which provides care to both patients being
treated for cancer, birth defects and other life-threatening
problems.
The Baylor College of Dentistry is the largest single provider of
oral health care services in the Dallas/Fort Worth area and the
University of Texas Health Science Center at Houston Dental Branch is
one of the primary sources of dental care for the city's rapidly
growing underserved populations.
--Mississippians directly benefit from primary care dentistry
training programs with more than 70 percent of all of the
University of Mississippi School of Dentistry's graduates
staying in state to practice. They practice in 68 of the
state's 82 counties, and many are in small towns and rural
areas where the need is greatest.
--Through funding from the National Institute of Health (NIH)
National Center for Research Resources the Medical University
of South Carolina College of Dental Medicine established a
Center of Biomedical Research Excellence in Oral Health that
addresses two health issues in which significant disparities
exist nationally and in the state--the relationship between
oral health and overall health (focusing on patients with
diabetes) and oral cancer.
Congress' commitment to sustained federal funding is one of the
keys that make these kinds of successes happen. Federal funding unlocks
the doors of promise in America--the promise of access to health care
for underserved communities, the promise to students who seek to
achieve their dream of becoming a dentist, and the promise that federal
investments made in health research will be implemented to benefit all
people in the United States.
Several federal programs play a significant role in responding
positively to the challenges of oral health disparities, dental
education, and diversity in the workforce that are outlined in the
Surgeon General's Report.\2\ The Report alerts Congress and the nation
to recognize the importance of oral health and the deleterious effects
of inadequate oral health care. It calls attention to the fact that the
burden of oral diseases and conditions is disproportionate among the
U.S. population. Reports from the General Accounting Office and the
National Governors Association corroborate these findings.
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\2\ ``U.S. Surgeon General Report: Oral Health in America'', 2000.
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Other significant challenges exist with regard to the
infrastructure of dental education and the oral health delivery system.
For instance:
--The ratio of professionally active dentist-to-population is
projected to continue declining, from its peak of 60:100,000 in
1994 to 54:100,000 in 2020.\3\ As a sizable portion of the U.S.
population has difficulty availing itself of needed or wanted
oral health care, the decline is creating concern as to the
capability of the dental workforce to meet emerging demands of
society and provide services efficiently.
---------------------------------------------------------------------------
\3\ ``Future of Dentistry,'' American Dental Association, Health
Policy Resources Center, 2001.
---------------------------------------------------------------------------
--Dental education debt has increased, affecting both career choices
and practice locations. In 2002, about 59 percent of
individuals who had educational debt graduated with debt over
$100,000, and nearly 30 percent had debt greater than $150,000.
The average educational debt for students with such debt was
$122,491.
--A crisis in the number of faculty and researchers threatens the
quality of dental education, oral, dental, and craniofacial
research, and, ultimately, access to necessary oral health care
for Americans. Presently, there are approximately 350 vacant
faculty positions at U.S. dental schools. The issue of access
to care cannot be addressed successfully without increasing the
numbers of dentists entering academia and research, and
--Lack of diversity and the number of under-represented minorities in
the oral health professions is disproportionate to their
distribution in the population at large. Their low rate of
applications and enrollment in dental schools forebodes their
continued under-representation in academia, research, and the
dental workforce.
Several of the important health education, research and training
programs for which we are making recommendations will be decimated if
the Administration's proposal to eliminate their funding is enacted. It
is imperative that Congress appropriate adequate funding for their
continuation and enhancement. They are essential to the health and
vitality of the nation. Consequently, the American Dental Education
Association requests:
(1) $15 million to fund the General Dentistry and Pediatric Dentistry
Residency Training programs
The ADEA strongly objects to the Bush Administration's elimination
of funding for the Title VII general dentistry and pediatric dentistry
residency programs. Eliminating funding for these programs runs
contrary to the Advisory Committee on Training in Primary Care Medicine
and Dentistry that recommended to the Secretary of HHS \4\ that Title
VII be ``expanded substantially'' with an ``increased budget level.''
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\4\ ``Comprehensive Review and Recommendations: Title VII, Section
747 of the Public Health Service Act,'' November 2001.
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General and pediatric dentistry residency training programs are
effective in increasing access to care while providing dentists with
the skills and clinical experiences needed to deliver a broad array of
oral health services to patients, including Medicaid and SCHIP
populations, as well as medically compromised patients.
Pediatric dentistry is the dental counterpart to general pediatric
medicine. Currently, there are only 3,800 pediatric dentists in the
country; some states have fewer than 10. Pediatric dentistry training
positions have only recently begun to expand as a direct result of
federal investment.
Dentists who complete primary care dental residency training are
better able to address a wide variety of oral health maladies without
referring patients to specialists. Each year approximately 165 students
enter one of the nation's 59 accredited pediatric dentistry programs,
while 1,484 students enter one of the country's 313 accredited general
dentistry programs.
(2) $135 million to fund the Health Professions Education and Training
Programs for Minority and Disadvantaged Students, including $3
million for the Faculty Loan Repayment Program
The President's budget proposes to eliminate funding for programs
that have been successful in creating the basic infrastructure for
educating a primary care workforce to help care for vulnerable
populations. However, the infrastructure that has been established by
previous federal investment requires sustained and increased support to
meet the challenges of diversifying the health care workforce,
addressing student indebtedness, eliminating faculty shortages, and
eliminating oral health care disparities in underserved communities.
The Centers of Excellence (COE) and the Health Careers Opportunity
Program (HCOP) play critical roles in preparing, recruiting and
retaining disadvantaged students in predoctoral health professions
schools. As the U.S. population becomes increasingly multicultural, so
must the faculties and students in academic dental institutions. The
federally funded COE and HCOP programs are key in assisting health
professions schools to prepare disadvantaged and minority students for
entry into dental, medical, pharmacy, and other health professions. The
federal government has a responsibility to help to develop a culturally
competent workforce that will reduce health care disparities related to
cultural factors.
Among the four dental schools that have an HCOP grant is the
University of California at San Francisco School of Dentistry. Its
program collaborates with three high schools, four universities, and
one community based organization. The program provides recruitment
activities, preliminary education during the academic year and summer,
financial aid information dissemination, facilitating entry activities,
counseling, mentoring and other services to develop a more competitive
applicant pool of students to enter and complete training in the field
of dentistry.
If the President's budget request were enacted, the Faculty Loan
Repayment Program (FLRP) that assists dentists and other qualified
clinicians to enter academia would be eliminated. It is the only
federal program that endeavors to increase the number of economically
disadvantaged faculty members. The program takes on additional
significance in light of current and predicated faculty shortages. ADEA
urges Congress to increase funding for the program and also broaden
eligibility for the Faculty Loan Repayment Program to faculty members
with qualifying student loan debt, regardless of their background.
(3) $19 million, a modest increase of $5.5 million over the fiscal year
2003 level, to fund the Ryan White HIV/AIDS Dental
Reimbursement Program of the Ryan White CARE Act (Part F)
Federal support for this program increases access to oral health
services for HIV/AIDS patients, while, at the same time, providing
dental students and residents the education and training necessary to
deliver oral health care to this population. This important program
accomplishes two appropriate objectives of the federal government--
service to patients of limited means and education of future
practitioners.
As a result of immune system breakdown, HIV/AIDS patients are more
susceptible to oral diseases, such as oral lesions that cause
significant pain and oral infection leading to fevers, weight loss, and
difficulty in eating, speaking, or taking medication. In fact, many of
the first physical manifestations of HIV infection are found in the
oral cavity. A dentist is often the first health care professional to
diagnose these patients.
Private insurance and Medicaid coverage for dental services is very
limited or simply unavailable for adults. This lack of adequate
reimbursement particularly affects those dental education clinics that
serve as the safety net for a significant number of Medicaid and HIV/
AIDS individuals. The Ryan White HIV/AIDS Dental Reimbursement Program
encourages treatment of patients by alleviating some of the financial
burden incurred by the dental education institutions that serve them.
(4) $420 million to fund the National Institute for Dental and
Craniofacial Research (NIDCR) in support of the American
Association for Dental Research (AADR) funding level request
The National Institute for Dental and Craniofacial Research is
deserving of enhanced federal funding. Past support has yielded
significant results applicable not only to oral health, but to health
in general. Through collaborative efforts with NIDCR, oral health
researchers in U.S. dental schools have built a base of scientific and
clinical knowledge that has been widely communicated and used to
improve oral health. Research is advancing investigations in bone
formation and craniofacial development, treatment of facial pain,
salivary gland disorders, the link between periodontal diseases and
pre-term low birth weight and arteriosclerosis, to name just a few.
The majority of dental, oral and craniofacial research is performed
in the nation's dental schools. The dental schools are a national
resource for the advancement through research of knowledge relevant to
the NIDCR mission. As such, ADEA supports NIDCR's dental school
initiative to develop and implement comprehensive institutional plans
to improve research support infrastructure, to recruit research
personnel, and to establish linkages to other research entities to, in
turn, augment and expand their own research capacity.
A prime example of NIDCR-funded research at a U.S. dental school
can be found at the University of Maryland where the dental school's
research program is strong in neuroscience related to pain, mechanisms
of bone growth and remodeling, dental disease, head and neck cancers,
AIDS research, and dentistry's role in the event of a bioterror attack.
(5) $213 million to fund the National Health Service Corps (NHSC) in
support of the President's funding level request
ADEA strongly supports the National Health Service Corps (NHSC)
Scholarship and Loan Repayment Programs that assist students with the
rising costs of financing their health professions education, while
promoting primary care access to underserved areas. It is critical that
the NHSC receive increased funding to meet the health needs in the
national rural and underserved communities. With the passage of the
Health Care Safety Net Amendments Act last session of Congress, ADEA
and the NHSC have begun exploring ways in which we can increase
participation in the Corps.
(6) $105 million for the Indian Health Service Dental Programs
The Indian Health Service Loan Repayment Program provides oral
health care service to Native Americans and Alaska Natives focusing on
the prevention and amelioration of oral health diseases. In exchange
for full-time clinical practices at one of the 280 hospital sites
located in 35 states, dentists receive up to $20,000 per year on their
qualified student loans in addition to a salary (2000 salary range was
$46,000-$82,000).
(7) $18 million to fund the Centers for Disease Control and Prevention
(CDC) Oral Health Program in support of the American Dental
Association's funding level request
The CDC Oral Health Program supports state and community-based
programs and communicates with the public to prevent oral disease and
reduce disparities in oral health. It works with states to establish
surveillance systems that provide valuable health information to assess
the effectiveness of programs and target them to populations at
greatest risk.
CDC funding and expert assistance strengthens state oral disease
prevention programs, allowing each state, territory or tribe to develop
the vital public oral health infrastructure and capacity to be able to
successfully support community based oral disease prevention programs.
(8) $20 million to fund the Dental Health Improvement Act, passed as
part of the Health Care Safety Net Amendments of 2002 (Public
Law 107-251)
A newly authorized program which now needs funding is the Dental
Health Improvement Act, which will assist states in developing
innovative dental workforce programs specific to their needs. Monies
could be used for a variety of initiatives including: increasing access
to oral health care for underserved populations, recruiting additional
dental school faculty and practitioners in states, developing a
prevention program which would include services such as water
fluoridation, dental sealants, nutritional counseling, and establishing
a state dental officer position or augmenting a current state dental
office to coordinate oral health and access issues.
In conclusion, ADEA and its membership, thanks the Committee for
the opportunity to present our views and budget requests for dental
education and research programs in fiscal year 2004. Continuing the
federal investment in these programs is vital. So too is the
development of a partnership between the federal government and dental
education programs to implement a national oral health plan that
guarantees access to dental care for everyone, ensures continued dental
health research, eliminates disparities, and eliminates workforce
shortages.
______
Prepared Statement of the National Rural Health Association
The National Rural Health Association (NRHA) thanks Chairman
Specter, Ranking Member Harkin and members of the Subcommittee for the
opportunity to submit this testimony for the record regarding fiscal
year 2004 appropriations for programs important to our nation's rural
health care delivery system. We believe we can offer you an insightful
look at the unique health care needs of rural and frontier Americans.
The NRHA and its membership are grateful for the funding provided
to rural health programs in fiscal year 2003 and the support shown for
rural health by Congressional leaders. In fiscal year 2003 the
Community Health Centers program, the National Health Service Corps,
State Offices of Rural Health received increased funding. In addition,
$5 million was added to the Rural Hospital Flexibility Grant Program to
help small hospitals respond to the requirements of HIPAA, upgrade
billing systems and implement quality improvement.
More than 62 million Americans live in rural and frontier areas.
More than 8 million rural residents are uninsured and another 4.5
million are underinsured. The federal programs profiled below have a
proven track record of expanding access to health care services in
rural areas, thereby ensuring that the benefits of health care are
available to all Americans, regardless of where they live.
The NRHA is a national nonprofit membership organization that
provides leadership on rural health issues. The association's mission
is to improve the health of rural Americans and to provide leadership
on rural health issues through grassroots advocacy, communications,
education and research. The membership of the NRHA is a diverse
collection of individuals and organizations, all of whom share the
common bond of an interest in rural health. Individual members come
from all disciplines and include hospital and rural health clinic
administrators, physicians, nurses, dentists, non-physician providers,
health planners, researchers and educators, state offices of rural
health and policy-makers. Organization and supporting members include
hospitals, community and migrant health centers, state health
departments and university programs.
One of the NRHA's top priorities is the National Health Service
Corps program. The National Health Service Corps (NHSC) is a federal
program aimed at encouraging health care professionals to practice in
underserved rural and urban areas. Since 1972, more than 20,000 NHSC
clinicians have fulfilled a pledge to serve rural and urban underserved
communities in exchange for scholarships or loan repayment. Today more
than 4.6 million people who would otherwise lack access to health care
are served by over 2,400 NHSC professionals. 60 percent of these
provide health care services to rural and frontier Americans. The NRHA
believes that the National Health Service Corps deserves funding in
fiscal year 2004 of $250 million to allow the program to provide access
to health care to many more underserved rural and frontier communities.
State offices of rural health coordinate rural activities and
interests across the state, provide information and technical
assistance to rural communities and help to improve recruitment and
retention of health professionals. State offices of rural health also
serve as coordinators for national programs such as the Rural Hospital
Flexibility Program and the State Children's Health Insurance Program.
State offices of rural health are funded by a 3:1 state to federal
match, with states providing three times the contribution of the
federal government. The NRHA is appreciative of the increase in fiscal
year 2003 to $8.5 million for State Offices of Rural Health, and
supports $12 million in funding for fiscal year 2004.
The Consolidated Health Centers Program is comprised of four parts:
Community Health Centers, Migrant Health Centers, Health Care for the
Homeless Programs and Public Housing Primary Care Programs. Currently
over 1,000 health centers serve more than 11 million patients.
Community health centers are an important part of the rural safety net,
providing care to the uninsured and underinsured who would otherwise
lack access to health care, including 5.4 million rural residents (1
out of 10). Community health centers focus on wellness and prevention
in addition to primary care services and foster community bonds through
consumer boards governing each center. President Bush's five year
Health Centers Initiative will add 1,200 new and expanded health center
sites to raise the number of people served each year to 16 million by
2006. To adequately meet this goal and ensure new community health
centers are added in rural areas, increased funding is necessary. The
NRHA supports the expansion of the community health center program and
advocates fiscal year 2004 funding of $1.769 billion.
The Rural Health Outreach and Network Development Grant Program
serves to support innovative health care delivery systems as well as
vertically integrated health care networks in rural America. Rural
Health Outreach and Network Development Grants help establish new
partnerships between health organizations and other community
institutions to improve the delivery of clinical care and enable health
care providers to be more efficient by sharing resources. According to
data collected on the Rural Health Outreach program, about 80 percent
of grantees have continued to provide services five years beyond their
federal grant period. Since 1991, over 3.2 million people in almost
every state have been served by the Outreach and Network Development
Grant Program. The grants provide up to $200,000 a year for three years
to each grantee.
The Huntingdon County Wellness Improvement Network and System
Project is an Outreach grantee in Huntingdon, Pennsylvania. Huntingdon
County is a rural community designated as a Health Professional
Shortage Area (HPSA). The Project's goal is to develop and implement
strategies to increase the number of health care professionals in the
county; strengthen and integrate the health care and social service
delivery systems; promote health, wellness, and disease-prevention to
reduce risk and cost of chronic behaviorally-related diseases; improve
the availability of clinical data to monitor outcomes; provide better
quality and coordinated services; and support the expansion of services
to meet community health needs. The grant supports a network membership
which consists of the local hospital and several community-based
agencies.
One Outreach grantee in rural Iowa is the Horn Memorial Hospital,
in Ida Grove, Iowa, whose Timely Life Care (TLC) Project work to
improve the quality of life for the chronically ill and provide
caregiver support and education to the targeted population of persons
50 years and older. The TLC Project provides a palliative approach to
patients whose disease is not responsive to curative treatment. The
grant helps provide services that include home visits, respite,
telemonitoring, education, counseling, pain management, and medication
review. Community collaboration also plays a vital role in the program,
with collaborators including a hospital, primary health care centers
and rehabilitation centers.
The NRHA advocates $60 million in fiscal year 2004 for the Rural
Health Outreach and Network Development Grant Program. Each year
applications for this program greatly exceed funds available. Rural
Health Policy Development (Research) funds health policy research
focusing on the implications for rural Americans of decisions made by
policymakers in Washington. The rural health research centers provide
data on issues such as Medicare reimbursement, workforce and managed
care in rural areas. The NRHA advocates $20 million in fiscal year 2004
for Rural Health Policy Development (Research). In adding special
project earmarks to this line item, the NRHA strongly urges the
Administration not to let the base funding for Rural Health Policy
Development to fall below the fiscal year 2003 level of $9 million.
The Rural Hospital Flexibility Grant Program allows small, low-
volume hospitals to convert to Critical Access Hospitals (CAHs), which
provide needed emergency, outpatient and short-stay inpatient services.
CAHs are encouraged to develop a network with other full-service
hospitals in their region in order to provide a full range of needed
services. It also helps communities to ensure that needed services,
such as emergency medical services, will be available to their
citizens. The Flex Program has been a lifeline to many communities,
allowing them to keep their hospital open while networking different
types of providers to ensure a continuum of care is available to rural
residents. The NRHA advocates $50 million in fiscal year 2004 for the
Rural Hospital Flexibility Grant Program.
The Small Hospital Improvement Program provides funds to help small
hospitals respond to the requirements of HIPAA, upgrade billing systems
and implement quality improvement. The NRHA advocates $50 million in
funding for this program in fiscal year 2004.
The NRHA is very concerned about the shortage of health
professionals in rural areas and supports health professions programs
that train the future workforce for the rural health care
infrastructure. Many health professions grant programs funded by the
Department of Health and Human Services have a rural focus or
component. Graduates of training programs with a rural component are
more likely to practice in rural areas, therefore funding of these
programs is critical to ensuring access to health care for rural
residents.
Included in the Bureau of Health Professions (BHPr) are several
programs that help to support the delivery of health care services in
rural areas. The Primary Care Training cluster includes 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.
In the Interdisciplinary, Community-Based Linkages cluster of BHPr,
the Area Health Education Centers have been a critical part of
delivering the resources of academic health centers to students and
clinicians in more remote rural and frontier areas. The Quentin N.
Burdick Program for Rural Health Interdisciplinary Training facilitates
collaboration between academic institutions and rural health care
providers to improve the recruitment and retention of health
professionals to serve rural areas.
The Public Health Workforce Development programs in BHPr are
designed to increase the number of individuals trained in public health
as well as to update the training of current public health
professionals. Recent bioterrorism challenges and threats have
highlighted the extent to which the public health infrastructure in the
United States is uneven in its ability to respond to these challenges.
Data compiled by the U.S. Department of Health and Human Services shows
that less than half of the nation's public health agencies have the
capacity to provide essential public health services. At this time when
public health professionals are being asked to take on a critical role
in surveillance and responding to bioterrorist attacks and threats, the
public health workforce development deserves continued support by the
federal government.
The Nursing Workforce Development programs provide training for
basic 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 and lack of young people entering the profession.
This crisis is felt more acutely in rural and frontier areas, which
have a harder time recruiting staff and have trouble competing with the
higher salaries and benefits offered in suburban areas. The Nursing
Workforce Development programs are critical to making sure that health
care professionals are available to provide services in underserved
areas.
The NRHA is concerned that the President's proposed budget includes
a drastic cut in funding for Health Professions programs and advocates
funding of $940 million (including $250 million for National Health
Service Corps) in fiscal year 2004 for these programs.
Telehealth services address essential access to health care needs
for rural Americans. These innovative programs currently provide
medical care, technical assistance, distance learning and training
programs to rural Americans in more than 30 states. The NRHA advocates
$36 million for this program in fiscal year 2004. In adding special
project earmarks to this line item, the NRHA strongly urges Congress
not to let the base funding for Telehealth to fall below $6 million.
The Community Access Program (CAP) provides grants to health care
providers to build integrated health care networks to serve uninsured
and underinsured local residents. Because rural communities have a high
rate of uninsured, CAP has been an essential program in various rural
communities throughout the nation. The NRHA urges Congress to continue
funding for this program, and advocates funding of $125 million in
fiscal year 2004 for CAP.
The NRHA thanks Chairman Specter and the members of the
subcommittee for the opportunity to submit testimony for the record on
vital rural health programs supported by the federal government. We
look forward to working with you as the annual appropriations process
moves forward, and stand ready to help the Subcommittee and the
Congress to ensure access to quality health care services for rural and
frontier Americans.
______
Prepared Statement of the Coalition of Northeastern Governors
The Coalition of Northeastern Governors (CONEG) is pleased to
provide this testimony to the Senate Subcommittee on Labor, Health and
Human Services, and Education regarding fiscal year 2004 appropriations
for the Low Income Home Energy Assistance Program (LIHEAP). The
Governors appreciate the Subcommittee's consistent support for the
LIHEAP program, particularly the action to increase program funding
this year. We also recognize the difficult decisions facing the
Subcommittee this year. In light of sharply higher home energy prices
and a lagging economy, we request the Subcommittee to provide $3
billion for LIHEAP in regular fiscal year 2004 funding and to provide
advance appropriations for fiscal year 2005, with the authority to
permit the release of emergency funds for unforeseen circumstances,
such as price spikes in natural gas or heating oil, severe weather and
other potential emergencies.
LIHEAP is a valuable tool in making home energy affordable for over
4 million of the nation's very low-income households--the elderly and
disabled on fixed incomes and families with young children. Recent data
shows that the percentage of income spent on home energy by these
households can be four times higher than average households. For many
of these households, annual income is simply not sufficient to pay high
winter heating bills, even in periods of economic growth. Many low-
income residents are forced to make dangerous choices between heating
their homes or purchasing food or vital medications.
The recent rise in winter heating fuel prices has hit these
vulnerable citizens especially hard. The Northeast is heavily dependent
on deliverable home heating fuels such as home heating oil, kerosene,
and propane. Price volatility in these fuels adversely affects the low-
income households who, without the disposable income to purchase fuels
off-season, typically enter the market when both the demand for and
price of fuels are high.
This winter, sharp increases in the price of home heating fuels,
increased joblessness and a lagging economy have created a heightened
demand on the states' already-stretched LIHEAP programs. States across
the country have seen significant increases in their regular caseloads
as well as in requests for emergency assistance from those households
in imminent danger of a fuel service cut-off. The projected need far
outweighs the available funding, with only a fraction of eligible
households nationwide--about 15 percent--being served at recent LIHEAP
funding levels.
An increase in the regular LIHEAP appropriation to $3 billion for
fiscal years 2004 and 2005 will enable states across the nation to
reach more of those vulnerable citizens in need of assistance and more
fully implement cost-effective measures to meet their continuing energy
needs. Today, most winter heating programs have exhausted their program
resources at the end of the heating season. As a result, they have
limited ability to assist families who, in arrears on heating bills,
face the prospect of having their home heating source cut off. In
addition, without funds to carryforward to the new heating season,
State LIHEAP programs lack the capability to undertake the ``pre-buy''
programs that help stabilize heating fuel prices for low-income
households and expand the reach of limited program funds. An increased
federal appropriation, and advance funding, would allow states to
manage the program resources in a manner to better take advantage of
market opportunities.
Enactment of advance funding is vital to the states' program
planning activities for the coming heating season. In the Northeast,
where the heating season begins in early October, states generally
spend up to 70 percent of the LIHEAP funds during the first two
quarters of the fiscal year. Therefore, states must begin to plan and
do program outreach in the spring and summer if they are to begin their
LIHEAP program as soon as the new fiscal year starts. Advance funding
helps ensure that states have the necessary funds to open their
programs and provide timely assistance to low-income families who lack
the financial resources to bear the initial costs of deliverable home
heating fuels.
The current uncertainty of world energy markets underscores the
importance of states being able to prepare for the potential of
volatile energy prices. These preparedness activities, while critical,
cannot fully shield our lowest-income citizens from the impacts of
higher heating fuel prices. Your support for fiscal year 2004 LIHEAP
appropriations at the $3 billion level and the enactment of advance
fiscal year 2005 appropriations is urgently needed to enable our states
to help mitigate the potential life-threatening emergencies and
economic hardship that confront the region's most vulnerable citizens.
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 Society of Thoracic Surgeons and the American
Association for Thoracic Surgery
ahrq research is essential to cqi in health care
The Society of Thoracic Surgeons and the American Association for
Thoracic Surgery represent essentially all practicing cardiac and
thoracic surgeons in the United States. We strongly support the
extremely important work being done by the Agency for Healthcare
Research and Quality (AHRQ) in determining best medical practices and
in translating this knowledge to actual clinical implementation.
Important as is the research work of the NIH, we have learned from
recent reports of the Institute of Medicine (most particularly the
IOM's second study, Crossing the Quality Chasm) that major improvements
are not only possible, but urgently needed, in the quality of care in
the United States. This is not as simple as finding obvious ``errors''
in medical practice; progress in medical quality of care often depends
on educational and other translational work that promotes the wide
adoption of best practices.
Such translational work to extend the use of best medical practices
is not the function of NIH; the responsibility falls to AHRQ. In the
context of our country's commitment to medical research, AHRQ's funding
at present is minimal and should be significantly increased.
We speak from first-hand experience. In 2001, AHRQ funded research
and analysis of data in the existing risk-stratified data base on
outcomes in Coronary Artery Bypass and Graft Surgery maintained by the
Society of Thoracic Surgeons since 1989. The STS National Cardiac
Database (STS NCD) is the largest voluntary clinical database in
medicine with over 2.1 million patient records harvested since its
inception. This AHRQ-funded analysis demonstrated that wider adoption
of two practices--pre-operative use of beta blockers and, in older
patients, use of the Internal Mammary Artery for at least one bypass
(use of the IMA was already accepted as state of the art for younger
patients) would significantly improve outcomes--that is, that adoption
of these practices would save lives. These findings were published in
the Journal of Thoracic and Cardiovascular Surgery and in JAMA in May
2002.
In addition, in 1999 AHRQ awarded the Society a $1.4 M grant award
to scientifically validate the ability of a Medical Specialty Society
to undertake CQI on a national scale. The STS implemented a national
randomized clinical trial to determine if a low-intensity educational
campaign would lead to faster adoption of these improved methods of
patient treatment.
The AHRQ grant was the first national randomized trial in Quality
Improvement in the surgical arena, with the potential to impact on
overall CABG morbidity and mortality nationwide.\1\ Two regional STS
organizations, in Iowa and Colorado, have been created as a result of
this grant effort; importantly, both have created unique partnerships
with CMS Quality Improvement Organizations in their respective states.
---------------------------------------------------------------------------
\1\ T. Bruce Ferguson Jr., Eric D. Peterson, Laura P. Coombs, Mary
E. Eiken, Meghan Carey, Elizabeth R. DeLong, The Society of Thoracic
Surgeons, Chicago, IL and the Duke Clinical Research Institute, Durham,
NC. CQI in CABG: A National Randomized Trial in Quality Improvement
Presented at the Late Breaking Clinical Trials session of the American
Heart Association Scientific Sessions, November 19, 2002.
---------------------------------------------------------------------------
Results of the trial are positive, demonstrating that a multi-
faceted, physician-led low-intensity effort can have an impact on the
adoption of care processes into national practice. Adoption of these
two practices has been significantly more rapid in the two states in
which the educational QI effort was carried out than in the randomized
control state. This successful CQI in CABG trial is a model for large-
scale QI efforts across all disciplines of medicine.
Results from the trial were presented at the Late Breaking Clinical
Trials session of the American Heart Association Scientific Sessions in
November 2002. A manuscript based on the results of this trial has been
submitted for possible publication in JAMA. Full funding of AHRQ is
essential to the continuing improvement of medical practice through CQI
projects similar to this groundbreaking work. Only AHRQ is carrying out
research with this kind of immediate impact on patients' lives.
We ask that the Congress recognize the importance of the work being
done by AHRQ through significant increases in its funding for fiscal
year 2004. AHRQ programs in Continuous Quality Improvement (CQI) should
be specifically
______
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 2003 appropriation. We are requesting flat funding this
year in order to continue the efforts of the Community Services Network
in assisting those families remaining on welfare with the intensive
services they need to transition to work and to assist low-income
workers in remaining at work through supportive services such as
transportation and child care. These funds will also continue to assist
states in developing services in the four percent of counties that are
not currently served by the CSBG.
The fiscal year 2003 appropriation of CSBG included language
regarding the use of the block grant at the state level. Many of the
states have statues regarding the use of CSBG funds, which are state,
legislated. Passing national legislation regarding the distribution of
the block grant at the state level 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 over 1,120 agencies which
coordinate nearly $7.5 billion in federal, state, local and private
resources each year. Operating in more than 96 percent of counties in
the nation and serving nearly ten 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 could 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
Leveraging capacity.--For every CSBG dollar they receive, CAAs
leverage $4.46 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 2001, the most recent year for which data are available,
the CAAs elicited more than 32 million hours of volunteer efforts, the
equivalent of almost 15,000 full-time employees. Using just the minimum
wage, these volunteer hours are valued at nearly $165 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.
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.
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.
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 2000:
--70 percent have incomes at or below the poverty level; 47 percent
have incomes below 75 percent of the poverty guidelines. In
2000, the poverty level for a family of three was $14,150.
--Only 49 percent of adults have a high school diploma or equivalency
certificate.
--35 percent of all client families are ``working poor'' and have
wages or unemployment benefits as income.
--17 percent depend on pensions and Social Security and are therefore
poor, former workers.
--Fewer than 16 percent receive cash assistance from TANF.
--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 daycare 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:
--employment and training programs
--transportation and child care for low-income workers
--individual development accounts
--micro business development help for low-income entrepreneurs
--a variety of crisis and emergency safety net services
--local community and economic development projects
--housing and weatherization services
--Head Start
--energy assistance programs
--nutrition programs
--family development programs
--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. Sixty percent (60) 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 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 2001:
--70,360 participants gained employment with the help of community
action (42 states reporting)
--17,426 participants retained employment for 90 days or more (24
states reporting)
--32,603 households experienced an increase in income from
employment, tax benefits or child support secured with the
assistance of community action (28 states reporting)
--12,662 families continued to move from homelessness to transitional
housing (23 states reporting)
--33,795 families moved from substandard to safe, stable housing (26
states reporting)
--1,861 families achieved home ownership as a result of community
action assistance (16 states reporting)
--22,903 participants achieved literacy or a GED (32 states
reporting)
--12,846 participants achieved post secondary degree or vocational
education certificate (22 states reporting)
--506,545 new service ``opportunities'' were created for low-income
families as a result of community action work or advocacy,
including 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 (28 states reporting)
All the above considered, NASCSP urges this committee to maintain
funding the CSBG grant to the states at $650 million.
______
Prepared Statement of the American Heart Association
Every 33 seconds another life is taken. Our parents, spouses,
children and friends are all potential victims of a disease that is
responsible for the deaths of nearly 40 percent of Americans. Heart
disease, stroke and other cardiovascular diseases remain America's
leading cause of death and a major cause of permanent disability.
The American Heart Association works to reduce disability and death
from heart disease, stroke and other cardiovascular diseases. We
commend this Committee for completing the doubling of the National
Institutes of Health budget and for making funding for the Centers for
Disease Control and Prevention a priority. But, we are concerned that
our government is still not devoting sufficient resources for research
and prevention to America's No. 1 killer--heart disease--and to our
country's No. 3 killer--stroke.
still number one
Cardiovascular diseases represent a continuing crisis of epidemic
proportions. Nearly 62 million Americans--1 in 5--suffer from one or
more of these diseases, including men, women and children of all ages.
More than half of those who suffer from cardiovascular diseases are
under age 65. Hundreds of millions of Americans have major risk factors
for these diseases--an estimated 50 million have high blood pressure,
42 million adults have elevated blood cholesterol (240 mg/dL or above),
nearly 49 million adults smoke, more than 129 million adults are
overweight or obese and nearly 11 million have proven diabetes. As the
baby boomers age, the number of Americans afflicted by these often
lethal and disabling diseases will increase substantially.
Cardiovascular disease costs Americans more than any other disease--an
estimated $352 billion in medical expenses and lost productivity in
2003. Heart disease is the major cause of premature, permanent
disability of American workers, accounting for nearly 20 percent of
Social Security disability payments. Heart defects are the most common
birth defect and cause more infant deaths than any other birth defect.
Stroke is a leading cause or permanent disability.
how you can make a difference
Now is the time to capitalize on a century of progress in
understanding heart disease, stroke and other cardiovascular diseases.
According to a 1999 expert panel supported by this Committee, America's
progress in reducing the death rate from cardiovascular disease has
slowed, suggesting that new strategies against these killers are
needed. The panel also reported that there are striking differences in
cardiovascular disease death rates by race/ethnicity, socioeconomic
status and geography. But promising, cost-effective breakthroughs in
treatment and prevention are on the horizon. A continued, sustained
investment in the NIH budget and appropriate funds for the NIH heart
disease and stroke budget will support promising and critically needed
new initiatives and the translation of that research into effective
clinical and community programs. For fiscal year 2004, we urge you to:
--Appropriate $30 billion (a 10 percent increase over fiscal year
2003 funding) for the NIH--to provide a continued, sustained
investment in life-saving medical research.--NIH research
provides new treatment and prevention strategies, cuts health
care costs, creates jobs and maintains America's status as the
world leader in the biotechnology and pharmaceutical
industries.
--Provide $2.5 billion for NIH heart research and $348 million for
NIH stroke research.--Researchers are on the brink of advances
to greatly enhance prevention and to provide new treatments so
you and your loved ones can be spared the pain and suffering of
heart disease and stroke.
--Allot $75 million for the CDC's State Heart Disease and Stroke
Prevention Program to elevate up to an additional 10 states
from planning to program implementation and continue to support
the other currently funded states.--Science must be made
applicable through community programs that encourage Americans
to make healthful lifestyle choices to prevent and control
heart disease and stroke.
--Support $42.5 million to continue to help our communities buy
automated external defibrillators (AEDs) and to train emergency
and lay responders to use them.--Rural Access to Emergency
Devices Act is part of Public Law 106-505 and Community Access
to Emergency Defibrillation Act is part of Public Law 107-188.
heart and stroke research benefits all americans
Thanks to advances in addressing risk factors and in treating
cardiovascular diseases, more Americans are surviving heart disease and
stroke. Heart disease and stroke research and prevention breakthroughs
are saving and improving lives. Several examples follow.
Stents.--Each year more than 1 million angioplasty procedures are
performed to widen narrowed arteries to the heart and stents (wire mesh
tubes used to prop open an artery) are now used in nearly 80 percent of
angioplasty procedures. However, within six months, 20 to 40 percent of
procedures must be repeated because the artery narrows again. The
development of stents that can deliver drugs to prevent this
renarrowing will significantly improve the subsequent course for many
individuals.
Surgery to Reduce Risk for Stroke.--Often surgeons can prevent
stroke by removing plaque buildup when one of the main arteries to the
brain is severely narrowed. Research has defined the patients for whom
this surgery is most helpful, as well as those for whom medical
treatment is the better choice. An estimated 124,000 such procedures
are performed each year.
State-of-the-Art Life-Extending Drugs.--Research has produced
amazing new drugs to help prevent and treat heart disease and stroke.
Drugs to control blood pressure and cholesterol are more effective than
ever in saving lives and enhancing quality of life for millions of
Americans. Some of these drugs can prevent heart attack and stroke.
When prevention fails, primary angioplasty, opening the blocked artery
to restore blood flow, and ``clotbuster'' drugs, such as tPA, can
greatly reduce the size of heart attacks and the resulting disability.
In stroke, the use of tPA, within 3 hours of the onset of symptoms, can
restore blood flow and reduce chances of permanent disability by 33
percent, saving health care costs. These treatments offer hope for an
estimated 1.1 million Americans who will suffer a heart attack and the
more than 600,000 who will have a clot-based stroke this year.
Life-Saving Devices.--Defibrillators have been made small enough to
be implanted and smart enough to read the heart's rhythm and restore a
normal rhythm when needed. Recent research has suggested that many
individuals at risk of sudden cardiac death after a heart attack can
have their lives prolonged by these remarkable devices.
We commend Congress for fulfilling its historic commitment to
double the NIH budget. We join other members of the research community
in advocating for an fiscal year 2004 appropriation of $30 billion for
the NIH to provide a continued, sustained investment in life-saving
medical research and encourage continued investigation into new
therapies. The NIH budget for heart diseases and stroke remains
disproportionately under funded compared to the enormous burden these
diseases place on our nation and the numerous promising scientific
opportunities that could advance the fight against these disorders.
Despite significant NIH budget increases and the fact that heart
disease, stroke and other cardiovascular diseases meet the NIH's
criteria for priority setting (public health needs, scientific quality
research, scientific progress potential, portfolio diversification and
adequate infrastructure support), NIH still invests only 8 percent of
its budget on heart research and a mere 1 percent on stroke.
We have a particular interest in individual NIH components that
relate directly to our mission. Our funding recommendations for these
institutes follow.
heart research challenges and opportunities for nhlbi
Significant advances have been made possible by more than 50 years
of American Heart Association-sponsored research and more than a half-
century of investment by Congress in the National Heart, Lung, and
Blood Institute. However, while more Americans are surviving heart
disease and stroke, these diseases can cause permanent disability,
requiring costly medical care and loss of productivity and quality of
life. Clearly more work is needed if we are to win the fight against
heart disease and stroke.
Neither the NHLBI budget nor its heart and stroke-related budget
kept pace with the campaign to double the NIH budget. We urge this
Committee to appropriate funding for the NHLBI and for its heart
disease and stroke-related budgets to support and expand current
activities and to invest in promising and critically needed new
initiatives to aggressively advance the fight against heart disease and
stroke. To accomplish this goal, we advocate a fiscal year 2004
appropriation of $3.5 billion for the NHLBI, including $2.1 billion for
heart disease and stroke-related budgets. Several challenges and
opportunities to advance the battle against heart disease are
highlighted below.
Recovery of Heart Function with Circulatory Assist.--Nearly 5
million Americans live with the effects of heart failure, which kills
more than 51,000 each year. Another 550,000 Americans will be diagnosed
with this often-disabling condition this year. Because their damaged
hearts cannot pump enough blood to meet their body's needs, victims
often suffer fatigue and breathlessness. Fluid also builds up in other
parts of their body, such as the ankles. The only treatment for
sufferers of end-stage heart failure is a heart transplant. Since there
is a severe shortage of hearts available for transplant, now mechanical
circulatory assist devices are typically used to stabilize these
patients until a suitable donor heart becomes available. With
additional funding, a planned research program would capitalize on the
amazing observation that the ``rest'' provided by mechanical
assistance, in some cases, enables the heart to recover sufficiently to
resume pumping blood on its own. Program goals include determination of
whether sustained heart recovery is achievable through circulatory
assist devices, characterization of patients who would likely benefit
and study of other therapies that may improve outcomes.
Specialized Centers of Clinically Oriented Research (SCCOR) in
Pediatric Heart Development.--Heart defects remain the most common
birth defect and cause more infant deaths than any other birth defect.
They cost an estimated $3 billion a year. About 2 million American
adults and children live with the often-disabling consequences of heart
defects existing at birth; and more than 4,300 die each year. An
additional 40,000 babies will be born this year with heart defects;
nearly 2,000 die before their first birthday. At least 35 types of such
defects have been identified, ranging from simple defects to complex
malformations. Ranging from existing at birth heart defects, disorders
of heart function and heart rhythm, and acquired heart disease,
pediatric heart disease is an important public health problem. With
additional resources, a planned SCCOR program could enhance the
prevention, diagnosis and treatment of these disorders by stimulating
and fostering multidisciplinary clinical and basic research.
Pediatric Mechanical Circulatory Support Research and
Development.--A recent NHLBI-supported study showed that circulatory
assist devices, such as left ventricular assist devices, increased
survival rates and quality of life for adult patients. But, such
devices are not available for infants and children suffering from heart
failure due to heart defects existing at birth and acquired heart
disease. Additional resources are needed for planned research that
would develop and evaluate pediatric circulatory assist devices. Such a
device could provide short, intermediate or long-term lifesaving
support for infants and children waiting for a heart transplant or
development of new surgical or other therapies.
Diagnostic Screening Test for Salt Sensitivity.--About 50 million
Americans have high blood pressure, the most critical stroke risk
factor and a leading cause of heart attack and heart failure. The cause
of 90 to 95 percent of high blood pressure cases is not known, but it
is easily detected and usually controllable. Of those with high blood
pressure, 32 percent are unaware they have it. Because excess dietary
salt is a key risk factor for high blood pressure, public health
officials caution all Americans to limit salt intake. Thus, the ability
to identify those who are likely to benefit from salt restriction would
provide strong incentives for susceptible people to heed the message.
More resources would allow the NHLBI to begin planned development of a
noninvasive or minimally invasive, rapid, practical diagnostic test for
salt sensitivity, i.e., the propensity for an individual to experience
an increase in blood pressure in response to a salt-rich diet. The
NHLBI would involve the small business community in developing such a
diagnostic test.
stroke research challenges and opportunities for ninds
A major cause of permanent disability and a key contributor to
late-life dementia, stroke is America's No. 3 killer. Many of America's
4.7 million stroke survivors face debilitating physical and mental
impairment, emotional distress and huge medical costs. About 1 of 4
stroke survivors is permanently disabled. An estimated 700,000
Americans will suffer a stroke this year; and nearly 170,000 will die.
Considered a disease of the elderly, stroke also strikes newborns,
children and young adults.
The NINDS stroke budget did not keep pace with the NIH doubling
initiative. We urge you to provide sufficient funding for the NINDS to
support and expand current activities and to invest in promising and
critically needed new initiatives to aggressively prevent stroke,
protect the brain during stroke and enhance rehabilitation. To
accomplish this goal, we advocate an fiscal year 2004 appropriation of
$1.8 billion for the NINDS, including $191 million for stroke. Some
challenges and opportunities follow.
Strategic Stroke Research Plan.--As a result of report language
provided by this Committee during the fiscal year 2001 appropriations
process, the NINDS convened a Stroke Progress Review Group. This
Group's report is serving as a blueprint for a long-range strategic
plan on stroke research. They identified critical gaps in stroke
knowledge and outlined five research priorities and seven resource
priorities that would stimulate stroke research. Increased resources
are needed to implement the first year of this plan.
Emerging Stroke Risk Factors.--More Americans are controlling major
stroke risk factors, such as high blood pressure and smoking, yet the
number of people falling victim to stroke continues to rise. Scientists
are defining new stroke risk factors, re-examining existing ones and
reconsidering the long-held belief that no difference exists in risk
between young and older patients with similar risk factors. Researchers
are studying heart valve disease, irregular heartbeats, the role of
inflammation in clogging of arteries, and the long-term effects of
previous high blood pressure. Increased funding to study these areas
may lead to new ways to prevent stroke.
Therapeutic Strategies for Stroke.--Several major clinical trials
have identified new methods for preventing and treating stroke in high-
risk populations. However, with the increased number of strokes, and
with the disparities evident in the treatment of stroke, new ways to
prevent strokes, to raise awareness and to better treat strokes need to
be developed and evaluated. Funding for new clinical studies is crucial
for developing cutting-edge stroke treatment and prevention.
Stroke Education.--Less than 5 percent of patients eligible for
tPA--the only FDA approved emergency treatment for clot-based stroke--
receive it. As a member of the Brain Attack Coalition, organizations
committed to fighting stroke, we work with the NINDS to increase public
awareness of stroke symptoms and to call 9-1-1. Together, we launched a
public education campaign, Know Stroke, Know the Signs. Act in Time,
and we are striving to develop systems to make tPA readily available to
appropriate patients. When these measures are implemented, stroke
treatment will change from supportive care to early brain-saving
intervention. More funding is needed to educate the public and health
professionals about stroke.
research in other nih institutes benefit heart disease & stroke
Critical research seeking to prevent and find better treatments for
heart disease, stroke and other cardiovascular diseases is supported by
other NIH institutes and centers such as the National Institute on
Aging, the National Institute of Diabetes and Digestive and Kidney
Diseases, the National Institute of Nursing Research and the National
Center for Research Resources. It is important to provide sufficient
additional resources for these entities to continue and expand their
critical work.
agency for healthcare research and quality
The lead health care quality agency, the AHRQ acts as a ``science
partner'' with public and private health care sectors in improving
health care quality, reducing health care costs and broadening access
to essential services. The AHRQ is an active participant in developing
evidence-based information needed by consumers, providers, health plans
and policymakers to improve health care decision making. We join with
the Friends of AHRQ in advocating an appropriation of $390 million for
the AHRQ to improve health care quality, reduce medical errors and
expand the availability of health outcomes information.
centers for disease control and prevention
Prevention is the best way to protect Americans' health and ease
the huge financial burden of disease. Commitment cannot stop at the
laboratory door. Resources must be made available to bring research to
places where heart disease and stroke live--the towns and neighborhoods
of America.
The CDC sets the pace on prevention. It builds a bridge between
what we learn in the lab and how we live in communities. We advocate an
fiscal year 2004 appropriation of $7.9 billion for the CDC, with a $350
million increase for state-based chronic disease prevention and health
promotion programs.
Thanks to this Committee's support since fiscal year 1998, the
CDC's State Heart Disease and Stroke Prevention Program covers 30
states, including the District of Columbia. But, only 8 states receive
funding for program implementation. The other 22 states receive funding
for program planning. This initiative allows states to design and/or
implement programs to meet specific needs to prevent heart disease,
stroke and other cardiovascular diseases. The CDC's 1997 report
Unrealized Prevention Opportunities: Reducing the Health and Economic
Burden of Chronic Disease states, ``strong chronic disease prevention
programs should be in place in every state to target leading causes of
death and disability . . . and their risk factors.'' Since
cardiovascular diseases remain the No. 1 killer in every state, each
state needs funding for basic implementation of a State Heart Disease
and Stroke Prevention Program. With fiscal year 2003 funding, the CDC
will add two states to the program and elevate, after a competitive
process, two states from planning to program implementation. An fiscal
year 2004 appropriation of $75 million for the State Heart Disease and
Stroke Prevention Program would allow the CDC to elevate up to an
additional 10 states from planning to program implementation and
continue to support the other currently funded states.
The Paul Coverdell National Acute Stroke Registry is designed to
track and improve delivery of care to stroke patients. The CDC is
developing and testing prototypes for this registry in 8 sites in
California, Georgia, Illinois, Massachusetts, Michigan, North Carolina,
Ohio and Oregon. An appropriation of $5 million would allow the CDC to
implement a statewide model registry and data-based intervention plans
among three state health departments to enable them to monitor and
improve stroke emergency transport response times, delivery of acute
care and use of treatments to prevent recurrent stroke.
Also, we recommend the following fiscal year 2004 funding levels
for the following CDC programs:
--$210 million for the Preventive Health and Health Services Block
Grant;
--$65 million for the Nutrition, Physical Activity and Obesity
Program;
--$83 million for the School Health Education Program; and
--$130 million for the Office of Smoking and Health to expand a
national program to curb tobacco use.
Coupled with a nationwide comprehensive State Heart Disease and
Stroke Prevention Program, these initiatives will help fight these
diseases. Please make heart disease and stroke prevention a top
priority.
health resources and services administration
About 250,000 Americans die each year from sudden cardiac arrest.
About 95 percent of the victims die before reaching a hospital. With
each minute the heart beat is not restored to its normal rhythm, the
victim's chance of survival drops about 10 percent. Within ten minutes,
death is almost certain. Small, easy-to-use devices, AEDs can shock a
heart back into normal rhythm and restore life. The Rural Access to
Emergency Devices Act, part of Public Law 106-505, and the Community
Access to Emergency Defibrillation Act, part of Public Law 107-188)
authorizes funds to local first responders, school districts and other
local government bodies to establish public access defibrillation
programs. Cities and towns nationwide eagerly await funds from these
important public health service grant awards, applying in droves for
resources made available last year. An fiscal year 2004 appropriation
of $42.5 million is required to support these authorized programs.
department of education
Physical inactivity is a major risk factor for heart disease and
stroke. Unfortunately, our nation's youth have fewer opportunities for
physical education. Congress has appropriated significant funds for the
Carol M. White Physical Education for Progress Act over the last two
years. PEP provides critical funding for school-based physical
education programs, which teach life-long physical activity habits and
thereby prevents the onset of chronic disease, such as heart disease
and stroke. We advocate a fiscal year 2004 appropriation of $100
million for PEP.
action needed
Increasing funding for research, prevention and treatment programs
will allow continued strides in the battle against heart disease,
stroke and other cardiovascular diseases. Our government's response to
this challenge will help define the health and well being of Americans
for decades to come.
______
Prepared Statement of the Community Medical Centers Fresno, CA
Mr. Chairman and Members of the Subcommittee: My name is Dr. Philip
Hinton and I am the Chief Executive Officer of Community Medical
Centers in Fresno, California. Community Medical Centers is a not-for-
profit, locally owned healthcare corporation that is committed to
improving the health of the community. I am pleased to provide the
subcommittee with a request for assistance in securing federal monies
for a critical project in the Central San Joaquin Valley that would
improve access to healthcare to the residents of Fresno County.
These are challenging times for those providing healthcare across
the country. Recent events have highlighted the crisis that the
healthcare system in this country is facing:
Recently, the week of March 10, 2003 was designated as national
``Cover the Uninsured'' week, publicizing the plight of over 41 million
people across America lacking health insurance and resulting in the
introduction of several initiatives in Congress to address the
situation.
The recent introduction of S. 412, the Local Emergency Health
Services Reimbursement Act of 2003, recognizing the need for the
federal government to reimburse counties in southern and central
California for emergency health care to undocumented residents.
Recent news articles reporting that emergency departments in
hospitals across the country are overcrowded by uninsured and Medicaid
populations. In the last 10 years, there has been an average increase
in hospital emergency department visits by 33 percent while over 500
hospital emergency departments have closed. Due to a lack of health
insurance, many are forced to resort to treatment at hospital emergency
rooms rather than access primary care physicians.
It is clear that this crisis requires bold initiatives and
leadership.
Community Medical Centers, located in Fresno, took over the County
of Fresno's obligation for indigent healthcare in a 1996 landmark
agreement. Since that time, Community has been providing inpatient and
outpatient services to the residents of this community--regardless of
their ability to pay. The availability of healthcare to all in Fresno
County is a challenge at best. With a county boasting a population of
800,000, Fresno has some sobering statistics:
--An unemployment rate at 15 percent (almost three times the national
average)
--Over 25 percent of the residents in the county living below the
poverty line
--Over 30 percent of the residents in the county without health
insurance (almost double the national average)
--The third highest asthma mortality rate in the nation
--The highest rates of teen pregnancy in the state
--The highest incidence of diabetes among the Hispanic population
--Late or no prenatal care for pregnant women
--Some of the lowest immunization rates in the nation (62 percent at
age 2 versus 79 percent nationally)
These statistics point to the need to aggressively address the
healthcare needs for the county in a comprehensive manner and offer an
opportunity for Fresno County to serve as the perfect laboratory for
such an experiment. Community has developed the concept of a primary
healthcare network comprised of a local healthcare providers, Federally
Qualified Health Centers, county health and human services agencies,
schools and churches. A critical link to this network is the Community
Caremobile, a doctor's office on wheels that travels to communities
with no access to healthcare. The network will work to deliver both
preventive and primary healthcare to the residents of Fresno County.
Key to this network is a hub known as the Ambulatory Care Center to
be located on the campus of the Regional Medical Center in downtown
Fresno. We are requesting $17.5 million in funding for the Ambulatory
Care Center and have identified the following program for this $17.5
million request: the HHS Health, Resources and Services Administration
(HRSA) Buildings and Facilities earmark in the fiscal year 2004
appropriations bill for Labor/HHS/Education. Because this program is
specifically designated for buildings and facilities, we request your
assistance in securing as much of the $17.5 million as possible through
this program for the Ambulatory Care Center.
Although the challenges facing the healthcare community at the
national level are significant, these challenges are magnified in the
Central Valley beginning with the 30 percent of the residents of Fresno
County lacking any form of health insurance. The result is the need to
become creative and innovative in one's approach to providing health
care. The concept of creating a hub, the Ambulatory Care Center in
downtown Fresno, to be linked to a vast network of clinics and
healthcare providers throughout the county is the only possible way to
address the great need for accessible primary healthcare. By your
providing significant funding for the Ambulatory Care Center, we can
begin to address a severe crisis and improve the lives of many in
Fresno County.
______
Prepared Statement of the National Association of Children's Hospitals
The National Association of Children's Hospitals (N.A.C.H.) is
pleased to have the opportunity to submit the following statement for
the hearing record in support of the Children's Hospitals' Graduate
Medical Education (CHGME) Payment Program in the Health Resources and
Services Administration (HRSA).
On behalf of the nation's 60 independent children's teaching
hospitals, we thank the Subcommittee for the remarkable achievement
that Congress made last year in continuing to provide full, equitable
GME funding for these hospitals, giving them a level of federal support
for their teaching programs that is comparable to what all other
teaching hospitals receive through Medicare. We urge the Subcommittee
to continue to provide equitable funding for Children's Hospitals GME
in fiscal year 2004 so that these institutions will have the resources
to train and educate the nation's pediatric workforce.
N.A.C.H. is a not-for-profit trade association, representing more
than 120 children's hospitals across the country. Its members include
independent acute care children's hospitals, acute care children's
hospitals organized within larger medical centers, and independent
children's specialty and rehabilitation hospitals.
N.A.C.H. seeks to serve its member hospitals' ability to fulfill
their four-fold missions of clinical care, education, research, and
advocacy devoted to the health and well being of all of the children in
their communities. 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 they serve as the major training centers for future
pediatric researchers, as well as a significant number of our
children's doctors. These institutions are major safety net providers,
serving a disproportionate share of children of low-income families,
and they are also advocates for the public health of all children.
background: the need for children's hospitals gme
While they account for less than 1 percent of all hospitals, the
independent children's hospitals train nearly 30 percent of all
pediatricians, half of all pediatric specialists, and a majority of
future pediatric researchers. They also provide required pediatric
rotations for many other residents. They train about 4,000 residents
annually, and the need for these programs is even more heightened by
the growing evidence of shortages of pediatric specialists around the
country.
Prior to initial funding of the CHGME program for fiscal year 2000,
these hospitals were facing enormous challenges to their ability to
maintain their training programs. The increasingly price competitive
medical marketplace was resulting in more and more payers not covering
the costs of care, including the costs associated with teaching.
The independent children's hospitals were essentially left out of
what had become the one major source of GME financing for other
teaching hospitals--Medicare--because they see few if any Medicare
patients. They received only \1/200\th (or less than 0.5 percent) of
the federal support that all other teaching hospitals received under
Medicare. This lack of GME financing, combined with the financial
challenges stemming from their other missions, was threatening their
teaching programs, as well as other important services.
In addition to their teaching missions, the independent children's
hospitals are a significant part of the health care safety net for low-
income children. On average, they devote nearly half of their patient
care to children who are assisted by Medicaid or are uninsured. More
than 40 percent of their care is for children assisted by Medicaid, and
Medicaid covers only about 84 percent of the cost of that care. Without
the Medicaid disproportionate share hospital (DSH) payments, Medicaid
would cover only about 76 percent of children's hospitals' patient care
costs. Further, these hospitals provide many important services from
dental care to child abuse programs that are either uncovered or very
underpaid.
The independent children's hospitals also are essential to the
provision of care for seriously and chronically ill children in this
country. They devote more than 75 percent of their care for children
with one or more chronic or congenital conditions. They provide more
than 40 percent to 75 percent of the 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, they are the only source of pediatric specialty care. The
severity and complexity of illness and the services and resources that
these institutions must maintain to assure access to this quality care
for all children are also often inadequately reimbursed.
The CHGME program, and its relatively quick progress to full
funding in fiscal year 2002, came at a critical time. Between 1997 and
2000, independent children's hospitals on average experienced declining
operating margins and total margins. By fiscal year 2000 more than a
quarter of the hospitals were not able to cover their operating costs
with operating revenues, and nearly 20 percent were not able to cover
their total costs with total revenues. Thanks to the CHGME program,
these hospitals have been able to maintain and strengthen their
training programs.
Continuing this critical CHGME funding is more important for these
hospitals than ever in light of serious state budget shortfalls in
virtually every state in the country and the resulting pressures for
significant reductions in state Medicaid programs. Further, unless
Congress intervenes, cuts in the Medicaid DSH program that became law
on October 1, 2002, plus additional federal cuts called for in the
House-passed fiscal year 2004 Budget Resolution, will force states to
make even more substantial reductions in their Medicaid programs with
devastating results for children's hospitals and many other safety net
hospitals in many states.
The pediatric community, including the American Academy of
Pediatrics, Association of Medical School Pediatric Department Chairs,
and others, has recognized the critical importance of the GME programs
of the independent children's teaching hospitals, not only to the
future of the individual hospitals and their essential services but
also to the future of the nation's pediatric workforce and the
provision of children's health care and advancements in pediatric
medicine overall.
Lastly, many of the independent children's hospitals are a vital
part of the emergency and critical care services in their communities
and regions. They are part of the emergency response system that must
be in place for bioterrorism other public health emergencies. Expenses
associated with preparedness will add to their continuing costs in
meeting children's needs
congressional response
In the absence of any movement towards broader GME financing
reform, Congress in 1999 authorized the Children's Hospitals' GME
discretionary grant program to address the existing inequity in GME
financing for the independent children's hospitals and ensure that
these institutions could receive equitable federal support to sustain
their teaching programs. The legislation was reauthorized in 2000
through fiscal year 2005 and provided for $285 million through fiscal
year 2001 and such sums as may be necessary in the years beyond.\1\
Congress passed both 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'').
---------------------------------------------------------------------------
\1\ The Lewin Group, an independent health policy analysis firm
calculated in 1998 that independent children's teaching hospitals
should receive approximately $285 million in federal GME support for
nearly 60 institutions to achieve parity with the financial
compensation provided through Medicare for GME support to other
teaching hospitals.
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With the support of this Subcommittee, Congress appropriated
initial funding for the program in fiscal year 2000, before the
enactment of its authorization. Following that 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 and $292 million in fiscal year 2003. This represents an
extraordinary achievement for the future of children's health care as
well as for the nation's independent children's teaching hospitals.
The $285 million appropriated in fiscal year 2002 was distributed
at the end of the fiscal year through HRSA to 59 children's hospitals
according to a formula based on the number and type of full-time
equivalent (FTE) 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
has begun to allocate the $292 million appropriation--minus an across-
the-board reduction of 0.65 percent million enacted as part of the
omnibus fiscal year 2003 appropriations bill--in bi-weekly periodic
payments to eligible independent children's hospitals.
fiscal 2004 request
N.A.C.H. respectfully requests that the Subcommittee continue
equitable GME funding for the independent children's hospitals by
providing $305 million for the program in fiscal year 2004. This would
continue the fiscal year 2002 appropriation of $285 million--the
original full funding authorization level--and provide for an
adjustment for inflation by the consumer price index to recognize
higher wages and costs, building on the fiscal year 2003 appropriation
of $292 million. The authorization, which provides for such sums as may
be necessary in fiscal year 2002 and beyond, would allow for such an
adjustment, and it would be in keeping with the provision of such
adjustments in Medicare.
An fiscal year 2004 appropriation of $305 million for the federal
Children's Hospitals GME Payment Program enjoys board support in the
Senate. For example, on March 25, during debate on the Senate's fiscal
year 2004 Budget Resolution, the Senate passed by voice vote S. Amdt.
354 to S. Con. Res. 23, a Sense of the Senate Resolution by Senator
Michael DeWine that the Children's Hospitals GME should be funded at
$305 million.
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 congressional support they have received, including the attainment
of the program's authorization in fiscal year 2002 and continuation of
full funding with an inflation adjustment in fiscal year 2003. Now,
N.A.C.H. asks Congress to maintain this progress in fiscal year 2004.
Support for a strong investment in GME at independent children's
teaching hospitals is 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. It also is consistent with the Subcommittee's repeated
emphasis on the importance of enhanced investment in the National
Institutes of Health (NIH) overall, and in NIH support for pediatric
research in particular, for which we are very grateful.
The CHGME funding has been essential to the ability of the
independent children's hospitals to sustain their GME programs. At the
same time, it has enabled them to do so without sacrificing support for
other critically important services that also rely on hospital subsidy,
such as many specialty and critical care services, child abuse
prevention and treatment services, poison control centers, services to
low-income children who have inadequate or no coverage, mental health
and dental services, and community advocacy, such as immunization and
motor vehicle safety campaigns.
In conclusion, the Children's Hospitals GME Payment 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, could not be assured without it.
Again, N.A.C.H. thanks this Subcommittee and Congress for your
continuing leadership and support.
For further information, please contact Peters D. Willson, vice
president for public policy, N.A.C.H., at 703/797-6006 or
pwillson@nachri.org.
______
Prepared Statement of the American Society for Microbiology
The Centers for Disease Control and Prevention (CDC) is at the
frontline of public health with a mission to prevent disease, illness,
and injury. CDC works to ensure the well-being of Americans by
detecting disease, providing accurate and timely information used in
health decisions, and cooperating with partner groups likewise involved
in health promotion. The recent release of the Institute of Medicine
Report, ``Microbial Threats to Health: Emergence, Detection, and
Response,'' recognizes the ``need for a new level of attention,
dedication, and sustained resources to ensure the health and safety of
this nation--and of the world.'' The $6.5 billion proposed for the CDC
in fiscal year 2004 does not sufficiently address the complex health
risks that confront the agency from within this country and throughout
the world. Events just within the past month--possible bioterrorism
against U.S. combat troops overseas and the emergence of yet another
apparently new infectious threat--SARS (severe acute respiratory
syndrome)--urgently underscore the need for increased funding for the
CDC. The American Society for Microbiology (ASM) recommends that
Congress appropriate $7.9 billion for CDC in fiscal year 2004, which is
the recommendation of the CDC Coalition.
Fighting Infectious Diseases
The ASM is concerned about the adequacy of the proposed fiscal year
2004 funding of $332 million for CDC's infectious disease control
program, which is a decrease of $3 million from fiscal year 2003. This
level of funding is counter to the reality of infectious diseases,
which continue to be the third leading cause of death in the United
States and the cause of nearly one-third of deaths worldwide.
Persistent complications such as antimicrobial resistance, newly
identified pathogens like West Nile virus, newly emerging diseases such
as SARS, and global human migration certainly are not evidence in
support of decreased funding.
The CDC's complex and costly mission is to prevent the ravages of
infectious disease here and around the world, whether familiar threats
such as influenza or newly discovered, emerging diseases like SARS.
Here and abroad, CDC personnel conduct surveillance, investigate
epidemics, support both intramural and extramural laboratory research,
and provide training and public education programs to many millions.
During the past decade, more than 35 new infectious diseases were
identified; the current push to identify the source of SARS may add
another emerging disease to this deadly list. In response to the
initial overseas SARS cases, the CDC activated its Emergency Operations
Center to manage what is a complicated, international and
multijurisdictional disease outbreak. The CDC also conducts intensive
studies of other emerging diseases such as hantavirus; for instance,
last year it provided funding to four academic institutions to study
hantavirus transmission.
The CDC is expected to be at the forefront of any new infectious
disease outbreak, providing epidemiological expertise and state-of-the-
art laboratory assistance. The CDC recently established International
Emerging Infections Programs in Thailand and Kenya and developed seven
domestic and global sentinel surveillance networks to link health care
providers facing these newly emerging diseases. Much of the fieldwork
depends on the CDC's Epidemic Intelligence Service (EIS) Program. In
fiscal year 2002, EIS officers participated in Epi-Aids missions to
more than 70 outbreaks worldwide, at the request of local, state, and
foreign health officials.
Old enemies also endanger America's public health, in spite of
available prevention methods. In this country alone, an influenza
pandemic would cause an estimated 89,000 to 207,000 deaths, 314,000 to
734,000 hospitalizations, and economic losses between $71 billion and
$167 billion. Aware of this potential catastrophe, the CDC in the past
year expanded U.S. sentinel surveillance sites for influenza. ASM
recommends that an additional $10 million be allocated within the
infectious diseases budget in fiscal year 2004, to prepare for a
pandemic flu outbreak.
There have been great successes throughout years of immunization
programs, forcing vaccine-preventable diseases to or near historically
low incidences in the United States. Measles, for example, is no longer
endemic and the CDC estimates that measles immunization saves this
country both thousands of lives and $7 billion each year. Only two
cases of rubella were reported to CDC in 2001, compared to 1,401 cases
a decade ago. However, weaknesses persist in our immunization barricade
against preventable infectious diseases. Nearly one million two-year-
old Americans have not received one or more of the available
recommended childhood vaccines. Vaccine-preventable diseases in adults
is an even greater challenge: as many as 50,000 adults die each year of
hepatitis B, influenza, and pneumococcal infections. The annual cost of
these diseases exceeds $10 billion.
The fiscal year 2004 budget request includes more than $1.2 billion
to continue CDC campaigns against HIV/AIDS, sexually transmitted
diseases (STDs) and tuberculosis. This is more than $46 million above
the President's fiscal year 2003 budget for these ongoing programs.
Approximately 900,000 Americans are HIV-infected; unfortunately, the
number of new HIV infections reported each year has been about 40,000
for the past decade, without showing any decline. STDs caused by
chlamydia are the most commonly reported infectious disease in the
United States (more than 700,000 cases in 2001). Non-HIV STDs cost the
U.S. economy at least $10 billion in direct and indirect costs each
year, due to an annual estimated 15 million new cases.
Prevention of disease is the CDC's primary mission--the ASM urges
Congress to provide an additional $93 million in fiscal year 2004 to
enable CDC to complete its strategic plan for the 21st century,
``Preventing Emerging Infectious Diseases.''
Global Infectious Disease
Disease outbreaks anywhere in the world put U.S. citizens at risk;
American health has become intertwined with global health. In 2002, the
CDC announced its Global Infectious Disease Strategy, to create
effective collaborations with international partners against the
emergence and spread of infectious diseases. International efforts can
make impressive progress: the number of polio-endemic countries dropped
from 125 in 1988 to only eight today. But if ignored, infectious
disease anywhere could spread into disaster, as have periodic influenza
outbreaks and HIV infection. The current SARS outbreak of just a few
reported cases in China in November has increased to more than 1,600
worldwide, today. The suspected number of cases in the United States
has grown to fifty-nine, across twenty-two states. CDC recognizes that
protecting the well-being of Americans is now impossible without
supporting global strategies. The Administration recognized this as
well, in its recently announced International Mother and Child HIV
Prevention Initiative, to be administered in part by the CDC and meant
to reduce HIV transmission from infected mother to child by 40 percent.
At the end of 2001, 2.7 million children younger than 15 were living
with HIV/AIDS worldwide, nearly all of them infected by their mothers.
The ASM recommends that Congress allocate $9 million over the
appropriated fiscal year 2003 level, for global infectious disease
activities.
Antimicrobial Resistance
Antimicrobial resistance among pathogenic microorganisms is a
frightening trend found in a widening range of disease agents. The
pathogenic agents of tuberculosis, malaria and gonorrhea are among
those that have developed mechanisms to disarm their standard drug
treatments. A recent study at Harvard concluded that by the summer of
2004, as many as 40 percent of the strains of Streptococcus pneumoniae
could be resistant to both penicillin and erythromycin. This
streptococcus causes thousands of cases of ear infections, pneumonia,
meningitis, and sinusitis every year. The CDC estimates that as many as
100,000 are hospitalized each year with methicillin-resistant
Staphylococcus aureus infections, bacteria capable of causing many
different illnesses including bloodstream and skin infections. In
addition, antimicrobial-resistant tuberculosis bacteria, which have
evolved new strains immune to drugs typically used to treat the
disease, has also emerged. Government agencies joined the CDC in 2001
to address this trend under the Public Health Action Plan to Combat
Antimicrobial Resistance. This past year, the CDC initiated a research
grant program focused on antimicrobials in the environment and in rural
areas and on ways in which resistant genes spread among pathogens. In
recent weeks the agency launched a topic-specific education campaign
for physicians, on using antimicrobials wisely and preventing the
spread of resistant pathogens. The ASM recommends that an increase of
$13 million be appropriated for antimicrobial resistance programs and
activities implemented by the CDC.
Ensuring National Security and Public Health
As events in late 2001 sadly demonstrated, this nation and its
citizens abroad are at high risk from possible terrorist attacks,
including the intentional release of pathogenic microorganisms. The CDC
responded immediately and aggressively to those events with personnel,
information, and financial support. CDC requires adequate resources to
optimally prepared to meet such tragedy, to join with state, local, and
international agencies in a well-coordinated defense.
The proposed fiscal year 2004 budget for CDC includes $1.1 billion
for the agency's multi-faceted Bioterrorism Preparedness and Response
Program, equal to the fiscal year 2003 bioterrorism-related request.
Within this sum are $940 million to improve state and local
preparedness, $158 million to improve CDC's internal preparedness, and
$18 million to continue anthrax research. This steady-state sum total
reflects the creation of the new Department of Homeland Security and
subsequent shift from CDC to the new department of the smallpox vaccine
program and the Strategic National Stockpile (SNS) designed to
warehouse counterterrorism vaccines and pharmaceuticals. Despite these
two recent program shifts, the CDC responsibility for homeland security
remains immense. The ASM supports the Administration's request of $940
million for state and local capacity. We also support and strongly
encourage CDC efforts to quickly assess the cost of the smallpox
immunization program, including an evaluation of the impact of the
program on human resources and the redirection of resources from other
state and local public health activities and broader bioterrorism
preparedness, as recommended in a March 27 report by the Institute of
Medicine's Committee on Smallpox Vaccination Program Implementation.
The IOM recommendation was based on state and local health department
concerns that resources are being diverted from other public health
services to respond to smallpox preparedness and that cost issues
constitute a difficulty in program implementation. The assessment
should also focus on the human resources needed, training issues and
the allocation of resources to state and local health departments.
Understanding and responding to the cost implications is critical for
the safe and effective implementation of the program and for funding of
ongoing public health services and broader bioterrorism preparedness.
Following the attacks of September 11, 2001, and the intentional
release of anthrax shortly thereafter, the CDC refocused its priorities
to be ready against all types of terrorism, whether chemical,
biological, radiological or conventional. In partnership with the
Agency for Toxic Substances and Disease Registry (ATSDR), the CDC
reinforced its capability to respond rapidly, having learned along with
the nation that the public health system is central to any conflict
with terrorism. The ongoing, integrated effort includes improving state
and local laboratory capacity to detect possible biological and
chemical agents, as well as upgrading surveillance and reporting
systems nationwide.
Over the past year the CDC established a national Emergency
Communication System, to quickly and accurately include all groups
involved in defending public health. This system already has been
utilized during the West Nile virus outbreak, the initial distribution
of smallpox vaccine, and recently, to track the SARS outbreak. At the
same time, the agency trained more than 1.5 million health
professionals in terrorism-specific areas through its online Public
Health Training Network. In 2002 the CDC released its National Public
Health Performance Standards for state and local systems, part of its
strategy to strengthen public health practice as called for by the 2002
Bioterrorism Act. This January, the CDC began distributing to state and
local governments shipments of smallpox vaccine, which had been
deposited by the agency at the centralized national vaccine stockpile.
The CDC and ATSDR recently joined with the FBI in a renewed
investigation of the 2001 anthrax contamination in Florida. CDC
scientists have examined reputed anthrax-containing parcels/letters
submitted by many state health departments.
What is learned about the epidemiology of infectious diseases in
general also applies to potential weapons of bioterrorism, making all
aspects of CDC infectious disease activities important to homeland
security. Biological agents can be difficult to identify in advance of
and even during an attack, and infectious disease can spread quickly
through a population. The CDC is able to respond within minutes of
receiving infectious outbreak reports, but strives to improve its own
and others' counterterrorism capabilities. To upgrade its own
responses, the CDC is revamping the Rapid Response and Advanced
Technology (RRAT) laboratory at the agency's National Center for
Infectious Diseases (NCID). NCID also is distributing millions of
dollars to non-CDC investigators for basic research in biodefense and
emerging infectious diseases, with emphasis on the A list of potential
biological agents--those causing anthrax, botulism, plague, smallpox,
tularemia, and viral hemorrhagic fevers, all easily disseminated and
capable of high mortality rates. Through the government's Select Agent
Program, the CDC and the Department of Agriculture register facilities
that use these and other agents for legitimate purposes.
Reinforcing CDC Infrastructure
The total funding for CDC buildings and facilities in the fiscal
year 2004 proposed budget is $114 million, which is $70 million less
than the President's fiscal year 2003 request. CDC's priority items are
security upgrades and construction of a new building for agency
headquarters and the Emergency Operations Center. The CDC utilized last
year's funding to open two new research laboratories, to investigate
toxic chemicals in the environment and parasitic diseases,
respectively. But the physical component of the CDC remains greatly
inadequate, out-of-date and scattered. Some of CDC's laboratories
continue to have leaking roofs, rotted floors, and cramped conditions.
Newly emerging diseases and today's greater risk of terrorism can
overload an already strained communications system. The CDC tracks more
than 60 notifiable infectious diseases in the United States, while
watching worldwide for new and old diseases. Within the proposed fiscal
year 2004 budget, CDC priorities include building a Public Health
Information Network that goes beyond the many existing CDC surveillance
systems. It will guarantee secure and accurate information-sharing in
emergency and non-emergency situations. Last year the agency improved
public access to its Internet information, increasing the average
monthly visits to 3.6 million. It educated on-line thousands of health
care providers about emerging critical issues such as smallpox and
anthrax vaccines. The ASM recommends that Congress appropriate $250
million for the critical infrastructure needs at CDC.
______
Prepared Statement of the National Treasury Employees Union
Chairman Specter, Members of the Subcommittee: My name is Colleen
M. Kelley and I am the National President of the National Treasury
Employees Union (NTEU). NTEU represents more than 150,000 federal
employees across 28 agencies and departments of the federal government,
including employees in a number of agencies within the Department of
Health and Human Services.
NTEU is proud to represent employees in the Health Resources and
Services Administration (HRSA), Substance Abuse and Mental Health
Services Administration (SAMHSA), Administration for Children and
Families (ACF), Administration on Aging (AoA), Office of the Secretary
(OS), Office for Civil Rights (OCR), Program Support Center (PSC) and
the National Center for Health Statistics (NCHS). NTEU also represents
employees in the Social Security Administration's Office of Hearings
and Appeals.
As you know, Mr. Chairman, for entirely too long now, most federal
agencies and departments have been strapped for adequate funding. When
federal agencies are denied the resources they need, services the
American people expect and deserve are effectively denied. Front line
federal employees feel this lack of resources directly and are
frustrated by the continuing necessity of doing more with less.
The human capital crisis the federal government faces will only
begin to turn around when we take the appropriate steps to treat our
employees like assets to be valued instead of costs to be cut. Adequate
and stable agency funding coupled with appropriate federal pay and
benefits are the keys to ensuring that the government is able to
attract and retain the federal employees it needs.
The need for the federal government to hire and maintain a highly
trained and skilled workforce has never been more clear. Federal
employees protect our Nation's medical supplies, they help secure our
borders and they provide valuable information to their fellow citizens
every day. They deserve to have the agencies they work for properly
funded.
Unfortunately, this is often not the case. Agencies are frequently
unable to provide appropriate training to their employees or even hire
the necessary number of employees to accomplish their missions because
of budgetary restrictions. The fiscal year 2004 budget request for
agencies within the Department of Health and Human Services and the
Social Security Administration is no different.
The Administration's fiscal year 2004 request for program
management funding at the Health Resources and Services Administration
(HRSA) is $157 million. Although this figure represents a $3 million
increase in administrative funds over the fiscal year 2003 funding
level, it is important to remember that HRSA's 2003 funding level
represented a reduction of $2 million from the prior year. For an
agency charged with insuring access to quality health care, especially
to underserved populations--services that are in desperate need of
expansion--a considerably larger increase in program management funding
is called for. HRSA cannot effectively accomplish its mission without
additional resources.
The President proposes a $1 million reduction in funding for the
National Center for Health Statistics (NCHS) for fiscal year 2004,
dropping the agency from its $126 million funding level in 2003 to $125
million. If this funding level were enacted, it would be the second
year in a row that funding for the NCHS has been reduced. As you know,
the work NCHS undertakes is critical to ensuring that national health
care initiatives are effective and the agency deserves a more
appropriate funding level.
The budget request for program management funds at the Substance
Abuse and Mental Health Services Administration (SAMHSA) is $85
million, an increase of $8 million over the fiscal year 2003 funding
level for this agency. SAMHSA is the federal agency charged with
improving the quality and availability of treatment and intervention
programs for those suffering from substance abuse and mental illness.
NTEU is pleased to see this request, especially in light of the
reduction in funding this agency suffered between fiscal year 2002 and
2003 when more than $14 million in program management funds were
stripped from SAMHSA's budget. However, we are troubled by the proposal
the President has made to reduce full time equivalent employment at the
agency and contract out some current SAMHSA functions. NTEU strongly
objects to this proposal and urges the Subcommittee to review this
request carefully.
After static funding levels the past two years, the President's
budget proposal for fiscal year 2004 for the Administration for
Children and Families (ACF), represents an increase of $8 million for
federal administration of the programs ACF oversees. Funding
restrictions in past years have hampered this agency's ability to
accomplish its missions and NTEU strongly supports increased funding
for the federal administration of ACF programs.
However, at the same time, we must register our strong opposition
to the budget's recommendation that the Head Start Program,
administered extremely successfully by ACF for many years, be moved
from the Department of Health and Human Services to the Department of
Education. As the Chairman knows, Head Start is much more than a stand
alone education program; it provides a comprehensive range of effective
social services to low income families and at risk children. Proposals
to transfer oversight of this premiere program risk destroying what
most experts agree is one of the finest programs the federal government
has ever operated. The founding principles of the program are as valid
today as they were when the program was implemented almost 40 years
ago.
Instead of proposing to move Head Start from the Department of
Health and Human Services to Education, Congress should be focusing on
providing the necessary resources to ensure that Head Start can serve
more needy children and their families and be even more successful in
the future. In NTEU's view, moving Head Start from HHS to Education is
effectively a move to dismantle the program. While reading skills are
an essential component of Head Start, they are by no means the only
component. A child without enough to eat, a child suffering from abuse
or depression or a child with difficulties in hearing or seeing is not
a child likely to read well absent intervention. The program was placed
under the Department of Health and Human Services in the first place
because that agency was best equipped to help resolve the range of
issues that may impact a child eligible for the Head Start program.
That is no less true today.
Congress considered and soundly rejected a proposal to move Head
Start out of the Department of Health and Human Services and into the
Education Department during the Carter Administration. The principles
Congress adhered to at that time are equally true today and NTEU urges
this Subcommittee's strong opposition to the proposal to move Head
Start to the Department of Education.
The President's budget recommends no new funding for program
administration for the Administration on Aging (AoA), instead opting to
keep the agency's program administration funding level at $18 million
for another year. With our country's rapidly growing older population,
this is particularly troublesome. The AoA helps older Americans remain
independent and productive and offers nutrition, caregiver support and
preventive health programs. These are precisely the type of programs
desperately in need of expansion, yet the fiscal year 2004 budget
proposal, like the 2003 budget before it offer no new funding for these
critical areas. The AoA funding level, too, requires the careful
scrutiny of this Subcommittee.
The Office of the Secretary (OS) of the Department of Health and
Human Services is also slated to receive no new funding in fiscal year
2004. Federal employees working in the Office of the Secretary help
administer all of the programs operated by the Department of Health and
Human Services. It is critical that this office be effectively funded
and NTEU urges a significant funding increase for this division.
The President's budget recommends a small increase in program
funding for the Office for Civil Rights (OCR). The recommendation would
increase this agency's resources from their 2003 funding level of $33
million to $34 million in 2004. The HHS Office for Civil Rights helps
to ensure that individuals have proper access to all the services and
programs the Department offers. Moreover, this agency helps promote the
privacy of medical information. In past years, OCR has been woefully
underfunded and NTEU urges this body to carefully review their funding
needs for 2004.
The Department of Health and Human Services' Program Support Center
(PSC) offers a range of administrative services both to HHS agencies
and other federal departments. The President's budget, which requests a
$10 million increase in expenses for this key agency over their fiscal
year 2003 funding level, deserves to be adopted by this body.
NTEU also represents employees in the Office of Hearing and Appeals
(OHA) of the Social Security Administration. As the Chairman knows very
well, OHA's mission is to assist those claimants who have been found
ineligible for Social Security disability benefits by providing an
impartial review and hearing on their cases. The growing backlog of
cases before OHA prevents a fair and timely hearing for these
individuals. One of the problems facing OHA is that it lacks sufficient
decision makers to handle its rapidly growing workload.
For almost a decade, SSA's disability program has been in crisis.
In 1995, SSA introduced a program called the Senior Attorney Program
that was instrumental in reducing the backlog and improving processing
times. In every respect, the Senior Attorney Program was a success. The
agency's experienced staff attorneys were given the authority to decide
and issue fully favorable decisions--without the time and expense of a
full hearing--in those cases where the evidence clearly identified an
individual as disabled. It materially improved both the quality and
timeliness of service to the public. The OHA backlog fell from over
550,000 pending cases to a low of 311,000 at the end of fiscal year
1999.
Unfortunately, SSA chose to terminate this innovative program as it
undertook its Hearings Process Improvement (HPI) plan, a plan SSA now
admits was unsuccessful. The Senior Attorney Program benefited more
than just those claimants who received their disability benefits sooner
than would have otherwise been the case. Administrative Law Judge time
was more wisely spent on cases that required a hearing, thereby
reducing processing times for those cases as well.
NTEU urges the Committee to closely review the original Senior
Attorney Program. Not only was it a huge success, it materially
improved the quality of service to the public and resulted in
administrative and program cost savings. With the inevitable increase
in disability applications that is expected to occur as our population
ages, the time to address the situation is now. The Senior Attorney
Program worked. It did not consume additional resources, not did it
require the hiring of new Administrative Law Judges. The Senior
Attorney Program provides an answer with proven results and its
termination was shortsighted. I hope this Subcommittee will carefully
consider this as a potential solution to the growing backlogs facing
the OHA.
Although the President's fiscal year 2004 budget for OHA would
provide some additional funds to the agency, it appears to be little
more than a down payment. The agency will continue to be unable to
improve processing times for disability cases until it is provided with
the appropriate resources for its mission. NTEU strongly urges both
additional funding--and additional decision makers--for the Office of
Hearings and Appeals.
Mr. Chairman, thank you very much for the opportunity to comment on
the fiscal year 2004 budget proposal for agencies within the
jurisdiction of your Subcommittee.
______
NATIONAL INSTITUTES OF HEALTH
Prepared Statement of the National MPS Society, Inc.
Mr. Chairman and members of the Subcommittee: My name is Les
Sheaffer, I serve on the Board of Directors of the National MPS Society
and as Chairman of the Committee on Federal Legislation. My 10 year old
daughter Brittany suffers from MPS III. I am submitting this testimony
for the purposes of expressing the views of the National MPS Society
with respect to congressional appropriations for the National
Institutes of Health in 2004 and biomedical research priorities and
issues of importance to the MPS, ML and rare disease community.
I wish to offer my thanks to Chairman Specter and the members of
the LHHS Subcommittee for their continuing support for enhanced
investment in genetic and biomedical research, training and
infrastructure at the National Institutes of Health.
There are 11 primary types of Mucopolysaccharidosis (MPS) and
Mucolipidoses (ML) are genetic Lysosomal Storage Disorders caused by
the body's inability to produce certain enzymes. Normally, the body
uses these enzymes to break down and recycle dead cells. In affected
individuals, the missing or insufficient enzyme prevents the normal
breakdown and recycling of cells resulting in the storage of these
deposits in virtually every cell of the body. As a result of the
storage, cells do not perform properly and cause progressive damage
throughout the body including the heart, bones, joints, respiratory
system and central nervous system. While the disease may not be
apparent at birth, signs and symptoms develop with age as more cells
are damaged by the accumulation of deposits. The most unfortunate
result of these disorders is childhood mortality in many cases.
MPS research has gained momentum in recent years, private sector
investment, funding of research by non profit organizations, improved
technology, increasing collaboration and the essential federal
investment in valuable MPS and ML related research on the part of the
National Institutes of Health have all contributed to a better
understanding of these disorders. The recent (January 2003)
recommendation by a FDA advisory committee to approve the enzyme
replacement therapy product ``Aldurazyme'' is a testament to the
continued progress in development of MPS and Lysosomal Storage Disorder
(LSD) therapeutics and promise for future advancement.
The average MPS researcher obtains approximately 80 percent of the
funding they utilize for MPS and ML research projects from the National
Institutes of Health. These statistics are based upon the results of a
poll of the Scientific Advisory Board of the National MPS Society in
2000. Clearly, strong federal funding of MPS related research is
essential to ensure investigators have resources needed to perform
critical research pursuing development of effective therapies for MPS
and ML disorders.
The primary institutes supporting MPS related research include the
National Institute of Diabetes Digestive and Kidney Diseases (NIDDK),
National Institute of Neurological Disorders and Stroke (NINDS),
National Heart Lung Blood Institute (NHLBI) and National Institute of
Child Health and Human Development (NICHD), additionally resources for
development and maintenance of LSD animal models is supported by the
National Center for Research Resources (NCRR) and the Office of Rare
Diseases (ORD) plays an important role in facilitating communication
and coordination.
In September of 2002 the NINDS sponsored a scientific conference
titled ``Mucopolysaccharidosis--Therapeutic Avenues in the Central
Nervous System'' supported by NIDDK, NICHD and ORD. Bringing key
investigators in the current MPS research community together with
outside professionals in relevant fields of study contributed to
greater interest in MPS related research and collaborative discussion
on the critical issue of how we may treat the brain in MPS disorders.
We look forward to the growth and enhancement of NIH efforts to
employ all available and appropriate mechanisms to support research
that contributes to the development of therapeutic approaches for the
CNS in Lysosomal Storage Disorders like MPS, ML and other deadly
diseases that rob the quality of life and future of thousands of
children every year. The progression of neurological damage in MPS
disorders is profound and has yet to effectively treated or managed in
any MPS or ML disorder.
As you know Requests for Applications (RFA) are a valuable tool for
stimulating research in a targeted area. For example we are hopeful the
now expired RFA soliciting proposals for Gene Therapy for Neurological
Disorders (NS-02-007) will provide knowledge so valuable to better
understanding how we may one day treat these multi systemic disorders.
RFA's issued in 2003 supporting Rare Diseases Clinical Research (RR-03-
008) and Drug Screening in Animal Models (NS-03-003) are promising and
represent an enhancement to efforts to better serve the rare disease
research community.
In this context we wish to express in the strongest possible way
our support for the employment of a targeted funding mechanism with a
focus on addressing Central Nervous System (CNS) issues. This intuitive
with appropriate focus, particularly on the Blood Brain Barrier (BBB)
as an impediment to treating Lysosomal Storage Disorders will in our
view will present a meaningful contribution to filling the gaps in
important current research and embark on the path that will lead to
development of effective therapies for MPS and many other disorders.
In light of these facts it is clear that investment allowing the
NIH to fulfill its mission to support intramural and extramural
research is essential to ensuring current MPS and ML related research
is supported and resources are available to take advantage of the
promising research we expect to see continue to develop.
I have reviewed the Presidents proposed budget for the NIH for
fiscal year 2004 and respectfully disagree with the approximate 2
percent increase in the NIH budget for fiscal year 2004. The Board of
Directors and the membership of the National MPS Society I wish to
express our support for a minimum increase in the budget of the
National Institutes of Health budget of approximately 8 percent for
fiscal year 2004. This funding level will ensure that current
commitments are fully met and provide resources necessary to ensure the
growth and enhancement of federally supported quality biomedical
research, valuable research that will continue to solidify the position
of the United States as the world leader in health research.
The Board of Directors and members of the National MPS Society
fully recognize the many challenges we face as a nation with respect to
maintaining of security and homeland defense as well as the significant
demands placed on public resources required to support or military
efforts to secure our national security and global interests. Like all
Americans we have an interest in providing the resources needed to
ensure our way of life.
The unique perspective provided in caring for a child with a
serious and most often fatal disease grants a clear vision of multiple
aspects of protecting our children, some are quite tangible including
effective and affordable health care and related services for our
children. When considering research, we steadfastly maintain the
belief, founded in fact, that strong funding of the NIH remains
essential to ensure the continued advancement of basic research science
and understanding of thousands of diseases affecting society, diseases
that like MPS and ML rob the quality of life, financial stability and
ultimately the lives of millions of American children and adults.
In closing I wish to again thank the members of the Labor Health
and Human Services Subcommittee for your continued dedication to
medical research and the completion of the Congressional commitment to
double the budget of the National Institutes of Health in 2003.
Please carefully consider the information presented here, it is our
sincere hope that future budget and appropriations decisions continue
to reflect the advancement of and investment in medical research as the
highest possible priority for years to come. Our children and those of
future generations deserve nothing less.
______
Prepared Statement of the American Thoracic Society
summary of funding recommendations
[In millions of dollars]
National Institutes of Health................................. 30,000.00
National Heart, Lung, and Blood Institute................. 3,287.57
National Institute of Allergy and Infectious Disease...... 3,237.96
National Institute of Environmental Health Sciences....... 727.32
Fogarty International Center.............................. 72.93
National Institute of Nursing Research.................... 153.67
Centers for Disease Control and Prevention.................... 7,900.00
National Institute for Occupational Safety and Health..... 307.00
Office on Smoking and Health.............................. 130.00
Environmental Health: Asthma Activities................... 70.00
Tuberculosis Control Programs............................. 528.00
The American Thoracic Society (ATS) is pleased to present its
recommendations for programs in the Labor Health and Human Services and
Education Appropriations Subcommittee purview. The American Thoracic
Society, founded in 1905, is an independently incorporated,
international education and scientific society which focuses on
respiratory and critical care medicine. The Society's members help
prevent and fight respiratory disease around the globe through
research, education, patient care and advocacy. The Society's long-
range goal is to decrease morbidity and mortality from disorders and
life-threatening acute illnesses.
magnitude of lung disease
Each year, an estimated 344,500 Americans die of lung disease. Lung
disease is America's number three killer, responsible for one in every
seven deaths. More than 30 million Americans suffer from a chronic lung
disease. In 2002, lung diseases cost the U.S. economy an estimated
$144.9 billion in direct and indirect costs.
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:
chronic obstructive pulmonary diseases, lung cancer, tuberculosis,
pneumonia, influenza, sleep disordered breathing, pediatric lung
disorders, occupational lung disease, sarcoidosis and asthma.
The ATS is pleased that the Administration and Congress fulfilled
its commitment to double the National Institute of Health (NIH) budget
in fiscal year 2003. However, we are extremely concerned with the
President's fiscal year 2004 budget that proposes a mere 2 percent
increase for NIH. We thank the Senate for approving a 10 percent
increase for NIH and hope that the final appropriations numbers will
reflect the Senate number. In order to stem the devastating effects of
lung disease, research funding must continue to grow to continue with
the medical breakthroughs made over the past five years. While our
statement will focus on selected parts of the Public Health Service,
the American Thoracic Society is firmly committed to appropriate
funding for all sectors of our nation's public health infrastructure.
copd
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 is an umbrella term used to describe
the airflow obstruction associated mainly with emphysema and chronic
bronchitis. COPD is the fourth leading cause of death and disability in
the United States and the third leading cause of death worldwide.
While the exact prevalence of COPD is not well defined, it affects
tens of millions of Americans and can be an extremely debilitating
condition. It has been estimated that 10 million patients have been
diagnosed with some form of COPD and as many as 24 million more are
undiagnosed.
In 2001, 13.3 million adults in the United States were estimated to
have COPD. In addition, according to the new government data based on a
2001 prevalence survey, three million Americans have been diagnosed
with emphysema and 11.2 million are diagnosed with chronic bronchitis.
In 2000, 122,009 people in the United States died of COPD, with the
death rate for women with COPD surpassing the death rate of men with
COPD. COPD costs the U.S. economy an estimated $30.4 billion a year.
Medical treatments exist to address symptom relief and slow the
progression of the disease. Today, COPD is treatable but not curable.
Fortunately, promising research is on the horizon for COPD patients.
Research in the genetic susceptibility underlying COPD is making
progress. Also, there are promising research leads on medications that
might be able to repair damage to lung tissue caused by COPD.
Additional research is needed to pursue these leads.
Despite these promising research leads, the ATS feel that research
resources committed to COPD are not commensurate with the impact COPD
has on the United States and the world. The best approach to stem the
growth of COPD is through prevention, education and more public
awareness. The ATS strongly recommend that the NIH and other federal
research programs commit additional resources to COPD research and
educational programs.
asthma
Asthma is a chronic lung disease in which the bronchial tubes of
the lungs become swollen and narrowed, preventing air from getting into
or out of the lung. A broad range of environmental triggers that vary
from one asthma-sufferer to another causes these obstructive spasms of
the bronchi.
Asthma is on the rise and is a serious public health concern. The
following statistics tell of how devastating asthma is to our nation.
It is estimated that 12 million people suffer from asthma, including
over 4 million children. Rates are increasing for all ethnic groups and
especially for African American and Hispanic children. While some
children appear to out grow their asthma when they reach adulthood, 75
percent will require life-long treatment and monitoring of their
condition.
Asthma is expensive. The growth in the prevalence of asthma will
have a significant impact on our nation's health expenditures,
especially Medicaid. The direct medical costs and indirect costs for
asthma are estimated to exceed $14 billion annually. In fact, the value
of reduced productivity due to loss of school days represented the
largest single indirect cost at $1.4 billion and asthma represents the
most common cause of school absenteeism due to chronic disease. In
2000, there were 9.3 million physician office visits, and 1.8 million
emergency room visits due to asthma.
Asthma also kills. In 2000, 4,487 people in the United States died
as a result of an asthma attack. Approximately, 65 percent of these
deaths occurred in women. A disproportionate share of these deaths
occurred in African American families.
Addressing the Growing Asthma Epidemic
As the prevalence of asthma has grown, so has asthma research.
Researchers are developing better ways to treat and manage chronic
asthma. Research supported by National Heart, Lung and Blood Institute
(NHLBI) has discovered genetic components as well as how infectious
disease contributes to asthma.
Basic research is also learning more about asthma. Researchers
supported by NHLBI have developed better animal models to allow
expression of selected asthmatic genetic traits. This will allow
researchers to develop a greater understanding of how genes and
environmental triggers influence asthma's onset, severity and long-term
consequences.
The ATS also feels that Centers for Disease Control and Prevention
(CDC) must play a leadership role in the ways to assist those with
asthma. Currently, there are national statistical estimates that
document that asthma is a growing problem in the United States.
However, we do not have accurate data that provide regional and local
information on the prevalence of asthma. To develop a targeted public
health strategy to respond intelligently to asthma, we need locality-
specific data. CDC should take the lead in collecting and analyzing
this data.
Last year, Congress provided approximately $35 million for the CDC
to conduct asthma programs. CDC will use these funds to conduct asthma
outreach, education and tracking activities. The ATS recommends that
CDC be provided $70 million in fiscal year 2004 to expand programs and
establish grants to community organizations for screening, treatment,
education and prevention of childhood asthma.
In the past, Congress enacted legislation that directs the National
Asthma Education and Prevention Program at NHBLI to develop a plan for
the federal government to respond to the growing asthma epidemic in the
United States. This plan should bring together key public and private
organizations to develop a national asthma plan to coordinate the many
elements of an effective public health response to asthma. Components
of a national plan should include research, surveillance, patient and
provider education, community awareness, indoor and outdoor air
quality, and access to health care providers and medication.
tuberculosis
Mr. Chairman, the first lung disease research began with the
treatment of those who had tuberculosis or consumption, as it was
called at the turn of the 20th century. Tuberculosis (TB) is an
airborne infection caused by a bacterium, Mycobacterium tuberculosis.
TB primarily affects the lungs but can also affect other parts of the
body, such as the brain, kidneys or spine.
TB is spread through coughs, sneezes, and close proximity to
someone with active tuberculosis. People with active tuberculosis are
most likely to spread TB to others they spend a lot of time with, such
as family members or coworkers. It cannot be spread by touch or sharing
utensils used by an infected person.
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 2002, there were 15,678 cases
of active TB reported in the United States.
The Institute of Medicine (IOM) recently published a report,
entitled: ``Ending Neglect: The Elimination of Tuberculosis in the
United States.'' The report documents the cycles of attention and
progress toward TB elimination, the periods of insufficient funding and
the re-emergence of TB. The IOM report provides the United States with
a road map of recommendations on how to eliminate TB in the United
States. The IOM report identifies needed detection, treatment,
prevention and research activities. The ATS have endorsed the IOM
report and its recommendations.
The ATS is pleased to note that, for the time being, TB rates in
the United States are declining. From a high in 1992 of 26,673 new
cases, we have seen 10 straight years of decline. To help maintain
control and accelerate the decline of TB in the United States, engage
in the global effort to control tuberculosis, and develop new tools for
the diagnosis, treatment and prevention of TB, the ATS recommends $528
million for the CDC to fund TB research in fiscal year 2004.
While declining overall TB rates is good news, the emergence and
spread of multi-drug resistant TB poses 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.
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. The National Institutes of Allergy and Infectious Disease have
developed a Blueprint for Tuberculosis Vaccine Development. ATS
encourages the subcommittee to fully fund the TB vaccine effort.
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. The goal is to
develop a cadre of health professionals in the developing world who can
begin controlling the global AIDS epidemic.
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. This supplemental program has been highly successful in
beginning to create the human infrastructure to treat the nearly two
billion people who have TB worldwide.
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 ATS recommends Congress provide an additional $3
million for FIC to expand the TB training grant program from a
supplemental grant to an open competition grant.
NIOSH--Researching and Preventing Occupational Lung Disease
The ATS is extremely concerned that the president's budget proposes
to cut the National Institute of Occupational Safety and Health (NIOSH)
extramural research program. The ATS strongly encourage this
subcommittee to reject the Administration's proposed cut to the NIOSH
research program. Occupational safety and health research are valuable
and deserve additional funding.
Protecting the health of our nation's workforce will require
research, training, tracking and new technologies. The ATS recommend
that the subcommittee provide a $60 million increase for the NIOSH
budget including $20 million for the NIOSH National Occupational
Research Agenda (NORA). NORA represents a partnership research plan for
occupational disease. The NORA agenda was developed with input from
labor, business and the health community.
The ATS recommend an additional $20 million for NIOSH Emergency
Preparedness agenda including activities at the National Personal
Protective Technology Laboratory. In addition to improving workers
safety, investments in protective technology will help our nation
respond to the growing threat of bioterrorism. The ATS also recommend
an additional $10 million for NIOSH-sponsored prevention, intervention
and information programs. These programs respond to existing workplace
health programs, conduct prevention education programs and work with
labor and industry groups to lower the risk of workplace injury and
illness.
A recent IOM Report, Safe Work in the 21st Century: Education and
Training Needs for the Next Decades Occupational Safety and Health
Personnel, identified a growing shortage of trained occupational health
professionals in the United States. Unlike the majority of medical
subspecialties, occupational health professionals do not receive
Medicare training support. We recommend $10 million for Capacity
Building for Worker safety and health including training opportunities
for occupational health professionals at NIOSH-sponsored Centers of
Excellence. The ATS believe more funds are needed to track the
incidence of serious work-related illnesses and injury.
Physician Workforce Supply
The ATS is also concerned about the supply of physicians in the
United States. A recent study published in the Journal of the American
Medical Association predicts that there will be an acute shortage of
physicians trained to treat patients with critical care illness and
lung disease starting in 2007.\1\ While the study focuses on supply of
pulmonary/critical care physicians, what is driving the shortage is the
predicated increase in demand for physician services caused by the
aging of the U.S. population.
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\1\ D. Angus, et al. Current and Project Workforce Requirements for
Care of the Critically Ill and Patients with Pulmonary Disease: Can We
Meet the Requirements of an Aging Population? JAMA 2000; 284:2762-2770.
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Policy makers have given much thought and attention to how the
aging population will effect Social Security and other programs for the
elderly. Significant attention has been given to the acute shortage of
nurses. However, such forward thinking does not seem to be applied to
our physician workforce.
We are pleased that Bureau of Workforce Analysis at HRSA will be
conducting a study on physician workforce supply in the United States.
The ATS is hopeful that HRSA study will confirm the looming shortage of
physicians in United States and make policy recommendations on how best
to add physicians to the workforce before it becomes a serious crisis.
lung-disease opportunities and advances
Pulmonary researchers have made significant advances in lung
disease research. NHBLI has identified areas of lung disease research
that they will be exploring in the next year. One area of focus will be
with acute lung injury (ALI) and acute respiratory distress syndrome
(ARDS). NHLBI created Specialized Centers of Clinically Oriented
Research (SCCOR) in translational research in acute lung injury.
Patients experiencing ALI and ARDS suddenly develop severe lung
inflammation that results in hypoxemia, loss of lung compliance and
possibly multi-organ system failure. The SCCOR program will foster
multi-disciplinary basic and clinical research related to ALI and ARDS,
which will eventually have a positive impact on their prevention,
diagnosis and treatment.
Another area of focus is COPD and lung cancer research. As
mentioned earlier, COPD is the fourth leading cause of death and
disability in this country. Nearly a quarter of a million Americans die
each year of either COPD or lung cancer. NHLBI hopes to address the gap
in knowledge that a common pathogenetic mechanism may be involved as a
risk factor for COPD and lung cancer. The research will focus on a
search for the similarities of the cellular and molecular mechanisms
that lead to COPD and lung cancer. This new research could have
important implications for the prevention and management of both
diseases.
In conclusion, lung disease is a 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. Overall,
lung disease and breathing problems constitute the number one killer of
babies under the age of one year. Worldwide, tuberculosis kills three
million people each year, more people than any other single infectious
agent. The level of support this committee approves for lung disease
programs should reflect the urgency illustrated by these numbers.
______
Prepared Statement of the Cystic Fibrosis Foundation
introduction
On behalf of the Cystic Fibrosis Foundation, I am pleased to submit
this statement to the Appropriations Subcommittee for Labor, Health and
Human Services, and Education. The CF Foundation appreciates the
opportunity to share with you the latest advances in cystic fibrosis
(CF), and a recommendation for a strong federal role in the fight
against this disease. The CF Foundation is committed to finding a cure
and believes our efforts will be accelerated, with your support, by
encouraging a more expansive partnership with the National Institutes
of Health (NIH).
We are truly grateful for the leadership of this Subcommittee in
doubling the appropriations for the NIH over the past five years. With
the doubling of the budget complete, we urge the Subcommittee to
maintain its diligence to ensure that the NIH continues to flourish and
that we reap the benefits of our world leadership in biomedical
research.
Congress and the NIH have an opportunity now to impact CF research.
We urge you and your colleagues to encourage the NIH to support the
mission of the CF Foundation in its tremendous undertaking to translate
basic research advances into new treatments. Because CF is an
``orphan'' disease, the role of the NIH in translating basic research
into treatments is even more critical. The CF Foundation was pleased
with the passage of The Rare Disease Act of 2002, as this new law
focuses the NIH on supporting clinical trial networks for rare
diseases. Recognizing the importance of clinical research in future
treatments, the CF Foundation established a clinical trials program,
the Therapeutics Development Network (TDN), in 1998. It includes strong
patient protections and a centralized data management system. It has
been acknowledged by NIH staff and others as a model for conducting
clinical trials, especially for rare diseases.
To help move CF clinical research forward, we ask the Subcommittee
to urge the NIH to partner with the CF Foundation to strengthen and
expand the Therapeutics Development Network. We believe an expanded
collaboration between the NIH and the CF TDN would have two clear
benefits: (1) it would accelerate the pace of research on new CF
treatments; and (2) it would provide valuable information to the NIH
regarding the optimal structure of clinical trials networks for other
rare genetic or metabolic diseases. By encouraging the NIH's support of
CF research, this partnership offers Congress the opportunity to
champion promising, mission-driven research.
We ask the Subcommittee to specifically recognize the National
Center for Research Resources (NCRR) for its leadership in supporting
innovative clinical trials networks to test new therapies and to
accelerate the translation of basic research findings into new
treatments. NCRR has fostered the development of networks, such as the
TDN. To meet the growing opportunities for CF clinical trials, we urge
the Subcommittee to encourage the NIH, through NCRR or the Office of
Rare Diseases, to commit $5 million per year for the next five years to
expand its support for clinical trials networks for new cystic fibrosis
therapies. This contribution will allow additional clinical trials to
be initiated and more therapies to be tested thereby meeting the urgent
needs of people with CF for the development of new therapies.
cystic fibrosis: the disease
We have come a long way in the battle against CF. When a child was
diagnosed with CF in 1960, that child had a life expectancy of less
than 10 years. Today, children who are diagnosed with CF have a
predicted life expectancy of more than 30 years. Despite this
tremendous progress, it is obviously not the cure we seek. Thirty years
represents less than half of the average American lifespan. More must
be done if we are to give all people with CF hope for a healthy future.
CF is a genetic disease that affects approximately 30,000 children
and adults in the United States. An individual must inherit a defective
copy of the CF gene from each parent to have the disease. CF causes the
body to produce abnormally thick, sticky mucus, due to the faulty
transport of sodium and chloride to the outer surfaces of the cells
that line organs, such as the lungs and pancreas. Individuals with CF
experience persistent coughing and wheezing and are particularly
susceptible to chronic lung infections, including pneumonia. A
bacterial or viral infection that minimally slows down a person without
CF could be devastating and potentially life-threatening to someone
with the disease. Individuals with CF also may have excessive appetite
but poor weight gain because the pancreas is obstructed and digestive
enzymes cannot reach the intestines.
Treatments for CF vary based on the severity of the disease. Most
people with CF are treated by chest physical therapy, which requires
vigorous percussion on the back and chest manually or with the use of
mechanical devices to dislodge the thick mucus from the airways.
Powerful antibiotics, which may be administered intravenously, orally,
and by aerosol, may be used to treat lung infections to prevent life
threatening lung damage. Individuals with CF cannot absorb enough
nutrients; to maintain their health and avoid malnutrition, they need
to eat an enriched diet and take both replacement vitamins and
pancreatic enzymes. Eventually, lung transplantation may be necessary,
which offers the few patients who successfully receive donated organs a
new chance for a healthy future.
advances in cf research
With the fiftieth anniversary of the discovery of DNA by Watson and
Crick upon us this month, we must pause to appreciate the knowledge and
dedication of the scientists who opened the doors to genetic research.
We continue to marvel at the complexity of medical science and the
elusiveness of unlocking the mysteries of genetic disease. With the
discovery of the gene that causes CF in 1989 by scientists supported by
the CF Foundation, there continues to be great optimism about new
therapies that can result from this groundbreaking genetic research.
Just last year, researchers supported in part by the CF Foundation
announced progress in applying gene therapy to CF. This latest
application resulted in a fruitful but transient effect of the gene in
the cells of patients with CF. We continue to believe in the promise of
gene therapy and explore multiple avenues to develop this field of
research.
Another advancement last year showed the effectiveness of
azithromycin, a commonly prescribed antibiotic, in reducing
inflammation in the airways, and improved lung function. This trial was
conceived of and supported by the CF Foundation. It confirmed anecdotal
reports that this drug might benefit the overall respiratory health of
CF patients.
Despite these recent successes, the fate of compounds in the lab
today, and the future of people with CF, lie in the hands--still--of
the CF Foundation. With the economy flagging, more biotech companies
find it difficult to raise venture capital funds. And those who are
interested in CF are coming to the CF Foundation for financial
assistance. Although they bring exciting research that promises to make
a difference in this disease, many of these compounds--and many of
these companies--will disappear in the current economic environment.
The CF Foundation is being asked to do more that it can possibly do
to treat and cure this disease. It is difficult to say no to any
project that might be ``the one'' that saves these individuals lives.
However, it is not possible for the CF Foundation to take up the
faltering reigns of the biotech industry alone. We must build a
stronger partnership with the NIH if we are to save lives of people
with CF today.
benefits of partnership to nih
Why should the NIH join forces with the CF Foundation? With our
dedication to curing this disease, we have taken it upon ourselves to
pursue promising research leads in rapid fashion and to support
national standards of care to assist those with the disease. Many
generous individual and corporate donors and successful special fund-
raising events have joined our efforts. Supporters in the past few
years include the Bill and Melinda Gates Foundation and Tom and Cydney
Marsico. However, with the current state of the economy, and the
uncertainty it brings to our continued fund-raising successes, we
cannot achieve this goal alone. We believe a broader partnership with
NIH will inure great benefits to both partners.
Founded in 1955 by parents who wanted to cure this disease in their
children, the CF Foundation today supports a broad array of CF research
and health care initiatives. These initiatives include:
--Accrediting and supporting more than 115 CF care centers at major
teaching hospitals and community hospitals across the country.
These care centers offer comprehensive diagnosis and treatment
services to individuals with CF, improving the lives of
patients with CF at these centers.
--Maintaining a national registry with data on patients with CF and
their health status, a database that remains vitally important
to ongoing efforts to improve the quality of health care for
individuals with CF.
--Sponsoring a Therapeutics Development Program to pursue CF drug
development, from the discovery of promising compounds through
clinical evaluation. This program applies cutting-edge
technologies to the screening of potential drug candidates,
their evaluation in the laboratory, and their testing in pre-
clinical studies and clinical trials, including large-scale
studies involving patients with CF. In essence, a virtual
pipeline for the development of drugs to treat CF is now
underway.
--Funding grants to scientists to conduct CF research. The CF
Foundation's awards include new investigator research grants,
pilot and feasibility grants, clinical research grants,
research fellowships, clinical fellowships, and student
traineeships.
--Supporting 10 Research Development Program centers for basic
research projects at leading universities and medical schools
that focus on CF.
--Maintaining a centralized laboratory dedicated to identification of
Burkholderia cepacia complex, a species of bacteria found in
agricultural and consumer products that can be lethal to
individuals with CF.
Exploring Clinical Research: The Therapeutics Development Network
All of the promising basic research advances in the nation cannot
lead to new therapies without being tested in clinical trials. In 1998,
the CF Foundation built an outstanding clinical trials program, the
Therapeutics Development Network (TDN), to conduct clinical trials to
evaluate new therapies. The TDN provides access to top CF researchers
to conduct trials, and to numerous patients who can enroll in trials.
It plays a pivotal role in accelerating the development of new CF
treatments to improve and save the lives of individuals with CF.
The clinical research within the TDN is focused on five types of
treatment strategies: gene therapy, protein-assist therapies, chloride
channel treatments, anti-inflammatory therapy, and anti-infection
therapy. The comprehensive approach of the TDN is dictated by the fact
that a cure for CF will probably be a combination of gene therapy,
protein repair therapy, and drug or other therapies. Through the
network, ten trials have been completed, and as many as ten more have
been undertaken in recent months.
With the discovery of multiple drug compounds that must be tested
before becoming new CF therapies, the CF Foundation has increased the
number of medical institutions in the TDN. This past fall, we increased
the network from eight centers to 14 around the country, which now
includes centers at the University of Iowa and the Children's Hospital
of Pittsburgh as well as ten other states. This expansion will help to
speed up the examination of more potential therapies--speed that is
essential to improve the health of these young people. They cannot wait
half of their lifetime to obtain new treatments--which is the average
time, 14 years, that it takes industry to develop a new drug.
Furthermore, this speed does not compromise patient safety, because of
the establishment of a data safety monitoring board, ethical advisors,
patient safety committees, and other safeguards.
Today, the most significant challenge facing the CF Foundation is
to ensure that we have the financial resources necessary for the
expansion of the clinical trials network in order to pursue all the
promising translational and clinical research opportunities before us.
An Opportunity for a Promising Partnership
The NIH has always made an incredible impact on our nation's basic
research accomplishments. Now, it is important that the NIH join forces
with the private non-profit sector to take the next step to translate
this basic research into treatments. With the interest of Congress, and
the passion of the new NIH director, we feel great confidence that the
NIH is making clinical research a priority. Many NIH institutes have
clinical trials networks or collaborate with the private sector in
undertaking clinical trials. These partnerships are making a difference
in the lives of millions of Americans.
We request that the Subcommittee encourage the NIH to enter into a
renewed partnership with the CF Foundation to support a rejuvenated CF
clinical trials network. The Subcommittee has placed great faith in the
biomedical research enterprise by providing significant boosts in NIH
funding. We hope that the Subcommittee will now urge a robust public-
private partnership in CF clinical trials to promote the goal of all
basic research findings--helping patients to overcome disease and live
longer, healthier lives. By working together, we can continue adding
tomorrows every day.
Thank you again for the opportunity to submit this statement. The
CF Foundation looks forward to working with Congress in continuing to
support this biomedical research enterprise--one of the remarkable
assets of this great nation.
______
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 2004 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 would like to thank the Subcommittee for its continued strong
support for increased funding for the National Institutes of Health
(NIH) over the last several years, particularly the additional funding
you have provided for the National Institute of Mental Health (NIMH),
the National Institute on Aging (NIA), the National Institute on
Alcohol Abuse and Alcoholism (NIAAA), and the Center for Mental Health
Services (CMHS) within 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.
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
--despite recent significant increases in appropriations for support
of research in mental health, the allocation of NIMH and CMHS
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.
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.
Current and projected economic costs of mental disorders alone are
staggering. The direct medical expense to care for a patient with
Alzheimer's disease ranges from $18,000 to $36,000 a year per patient,
depending on the severity of the disease. In addition, there are
substantial indirect costs associated with caring for an Alzheimer's
disease patient including social support, care giving, and often
nursing home care. 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 five million suffer from depression, resulting in
increased disability, general health care utilization, and increased
risk of suicide. Older adults have the highest rate of suicide rate
compared to any other age group. Approximately 30 percent of older
persons in primary care settings have significant symptoms of
depression; and depression is associated with greater health care
costs, poorer health outcomes, and increased mortality.
The enormous and widely underestimated costs of late-life mental
disorders justify major new investments. The personal and societal
costs of mental illness and addictive disorders are high, but advances
in research and treatment will help save lives, strengthen families,
and save taxpayer dollars.
The Benefits of Research on Public Health
The U.S. Surgeon General's Report on Mental Health (1999) and the
Administration on Aging Report on Older Adults and Mental Health (2001)
underscore the prevalence of mental disorders in older persons and
provide evidence that research has lead to the development of effective
treatments. These reports summarize research findings showing that
treatments are effective in relieving symptoms, improving functioning,
and enhancing quality of life. Preliminary findings suggest that these
interventions reduce the need for expensive and intensive acute and
long-term services. However, it is also well demonstrated that there is
a pronounced gap between research findings on the most effective
treatment interventions and implementation by health care providers.
This gap can be as long as 15 to 20 years. These reports stress the
need for translational and health services research focused on
identifying the most cost-effective interventions, as well as creating
effective methods for improving the quality of health care practice in
usual care settings. A major priority (neglected to date) is the
development of a health services research agenda that examines the
effectiveness and costs of proven models of mental health service
delivery for older persons.
Special attention also needs to be paid to inadequately or poorly
studied, serious late-life mental disorders. Illnesses such as
schizophrenia, anxiety disorders, alcohol dependence and personality
disorders have been largely ignored by both the research community and
the funding agencies, despite the fact that these conditions take a
major toll on patients, their care givers, and society at large. Many
of AAGP's members are at the forefront of groundbreaking research on
Alzheimer's disease, depression, and psychosis among the elderly, and
we strongly believe that more research funds must be focused in these
areas. Improving the treatment of late-life mental health problems will
benefit not only the elderly, but also their children, whose lives are
often profoundly affected by their parents' illness.
While the funding increases supported by this Subcommittee in
recent years have been essential first steps to a better future, a
committed and sustained investment in research is necessary to allow
continuous progress on the many research advances made to date.
National Institute of Mental Health
Fiscal year 2003 marked the end of the five-year, bipartisan effort
in Congress to double the NIH budget. In his fiscal year 2004 budget,
the President proposed an increase of $498 million over fiscal year
2003, which would bring the entire NIH budget to a level of $27.7
billion. This 1.8 percent increase pales in comparison with previous
double-digit annual increases. A decline in budget increases could have
a devastating impact on the ability of NIMH, and NIH as a whole, to
sustain the ongoing, multi-year research grants that have been
initiated over the last two to three years.
For NIMH, the President is proposing $1.382 billion for scientific
and clinical research, an increase over the agency's fiscal year 2003
appropriation of $1.349 billion. It is important to note that from
fiscal year 1999 through fiscal year 2003, NIMH received increases that
lagged behind the increases of other institutes. The 8.4 percent
increase that NIMH received for fiscal year 2003 was far below the
average 12 to 13 percent increases received by other institutes from
fiscal year 1999 through fiscal year 2002. This fall-off for fiscal
year 2003 is the result of disproportionately large increases for bio-
terrorism research at the National Institute for Allergy and Infectious
Diseases and a reallocation of funds from across NIH to the Centers for
Disease Control. As Congress moves forward with deliberations on the
fiscal year 2004 budget, AAGP believes that NIMH should receive a
percentage increase that, at the very minimum, is at least equal to the
average percent increase for the other NIH institutes.
Commendable as recent funding increases for NIH and NIMH have been,
AAGP would like to call the Subcommittee's attention to the fact that
these increases have not always translated 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).
AAGP is pleased that in recent months NIMH has renewed its emphasis
on mental disorders among the elderly, and commends the creation of an
intra-NIMH consortium of scientists concerned with mental disorders in
the aging population. However, funding for aging mental health research
is still not keeping pace with that of other adult mental health
research, and is actually decreasing proportionally when considered in
the context of anticipated projections in growth of mental disorders in
older persons. For example, the proportion of total NIMH newly funded
extramural research grant funding devoted to aging research declined
from an average of eight percent from fiscal years 1995 to 1999 to a
low of six percent in fiscal year 2000. To reverse this trend, it will
also be important to constitute grant review committees with
specialized expertise in geriatrics to ensure fair review of research
proposals. Review committees must take into account knowledge of the
unique biological factors associated with the aging brain, the high
prevalence of co-occurring medical illnesses, and the specific systems
for financing and health services delivery for older Americans.
In addition to supporting research activities at the NIMH, AAGP
supports increased funding for research related to geriatric mental
health at the other institutes of the 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),
and the National Institute of Neurological Disorders and Stroke.
Center for Mental Health Services
It is also critical that there be adequate funding increases for
the mental health initiatives under the jurisdiction of the 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 both fiscal year
2002 and fiscal year 2003 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 first step in addressing the mental health
needs of the nation's senior citizens.
Funding for the dissemination and implementation of evidence-based
practices in ``real world'' care settings must be a top priority for
Congress. Despite significant advances in research on the causes and
treatment of mental disorders in older persons, there is a major gap
between these research advances and clinical practice in usual care
settings. The greatest challenge for the future of mental health care
for older Americans is to bridge this 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 2003 be increased to $20 million for fiscal year 2004.
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 be a collaborative effort, actively involving family
members, consumers, mental health practitioners, experts, professional
organizations, academics, and mental health administrators. With $10
million dedicated to a program to disseminate and implement evidence-
based practice in geriatric mental health, there will be an assured
focus on facilitating accurate, broad-based sustainable implementation
of proven effective treatments, with an emphasis on practice change and
consumer outcomes. Such a program should include several development
phases including identification of a core set of evidence-based
practices, development of evidence-based implementation, and practice
improvement toolkits and field-testing of evidence-based
implementation. 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.
Agency for Healthcare Research and Quality
One of the most valuable resources in our efforts to improve access
to and the quality of geriatric mental health services is the Agency
for Healthcare Research and Quality (AHRQ). In recent years the Agency
has supported important research on mental health topics including
studies on children's mental health issues, the impact of mental health
parity on consumers' share of mental health costs, improving care for
depression in primary care, and cultural issues in the treatment of
mental illness in minority populations. This work has led to important
contributions to the mental health literature, and the advancement of
effective diagnosis and treatment of mental illness. We applaud these
efforts and urge the Committee to increase support for the critical
work of this Agency.
However, we are concerned that the research agenda of the Agency
has not given more attention to geriatric mental health issues. The
prevalence of undiagnosed and untreated mental illness among the
elderly is alarming. Conditions such as depression, anxiety, dementia,
and substance abuse in older adults are often misdiagnosed or not
recognized at all by primary and specialty care physicians. There is
accumulating evidence that depression can exacerbate the effects of
cardiac disease, cancer, strokes, and diabetes. Research has also shown
that treatment of mental illness can improve health outcomes for those
with chronic diseases. Effective treatments for mental illnesses in the
elderly are available, but without access to physicians and other
health professionals with the training to identify and treat these
conditions, far too many seniors fail to receive needed care.
AAGP believes there is an urgent need to translate findings from
aging-related biomedical and behavioral research into geriatric mental
health care. By utilizing the resources of the evidence-based practice
centers under contract to AHRQ, results from geriatric mental health
research can be evaluated and translated into findings that will
improve access, foster appropriate practices, and reduce unnecessary
and wasteful health care expenditures. We urge the Committee to direct
AHRQ to support additional research projects focused on the diagnosis
and treatment of mental illnesses in the geriatric population. We also
believe a high priority should be given to the dissemination of
scientific findings about what works best, to encourage physicians and
other health professionals to adopt ``best practices'' in geriatric
mental health care.
Conclusion
Based on AAGP's assessment of the current need and future
challenges of late life mental disorders, we submit the following
fiscal year 2004 funding recommendations:
The current rate of funding for aging grants at NIMH and CMHS
is inadequate. Funding for NIMH and CMHS aging-related research
grants should be increased to be commensurate with current
need--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.
A fair grant review process will be enhanced by committees
with specific expertise and dedication to mental health and
aging;
Infrastructure and reporting mechanisms within NIMH and CMHS
are essential to support the development of 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. Those
individuals in the Office of the Director of NIMH and in the
Office of the Director of CMHS who are designated to oversee
the aging research agendas and initiatives for these two
agencies should provide regular reports to Congress to ensure
accountability;
AHRQ should undertake additional research projects focused on
the diagnosis and treatment of mental illnesses in the
geriatric population, and dissemination of information on best
practices; and
Funding for NIAAA must be increased by at least 20 percent to
enable it to undertake more research and collect more data
focused on issues such as the link between alcohol use and
late-life suicide and the impact of alcohol use across the
lifespan.
AAGP strongly believes that the present research infrastructure,
professional workforce with appropriate geriatric training, health care
financing mechanisms, and mental health delivery systems are grossly
inadequate to meet the challenges posed by the expected increase in the
number of older Americans with mental disorders. Congress must support
funding for research that addresses the diagnosis and treatment of
mental illnesses, as well as programs for delivery of geriatric mental
health services that increase the quality of life for those with late-
life mental illness.
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 NIMH, CMHS, AHRQ and NIAAA.
______
Prepared Statement of the Hepatitis Foundation International
summary of fiscal year 2004 recommendations
Continue the great strides in research and prevention at the
National Institutes of Health (NIH) by providing a 10 percent budget
increase for fiscal year 2004. Increase funding for the National
Institute for Allergy and Infectious Diseases (NIAID) and the National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) by 10
percent.
[In billions of dollars]
NIIH.............................................................. 29.8
NIAID............................................................\1\ 3.9
NIDDK............................................................. 1.7
\1\ Non-bioterrorism.
--Provide $7.9 billion in fiscal year 2004 for the Centers for
Disease Control and Prevention (CDC).
--Provide $41 million in fiscal year 2004 for a hepatitis B
vaccination program for high risk adults at CDC as recommended
by the National Hepatitis C Prevention Strategy.
--Provide $40 million in fiscal year 2004 for CDC's Prevention
Research Centers.
--Provide continued support of the National Viral Hepatitis
Roundtable.
Chairman Specter and members of the subcommittee thank you for your
continued leadership in promoting better research, prevention, 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), representing members of 425 patient
support groups across the nation, the majority of whom suffer from
chronic viral hepatitis.
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 all types of
hepatitis, individuals with chronic viral hepatitis (types B, C, and D)
represent the majority of liver failure and transplant patients.
Treatment options and immunizations are available for most types of
hepatitis (see below), however, all types of viral hepatitis are
preventable.
hepatitis b
Hepatitis B (HBV) claims an estimated 5,000 lives every year in the
United States, even though we have therapies to both prevent and treat
this disease. This disease is spread through contact with the blood and
body fluids of an infected individual. Unfortunately, due to both a
lack in funding to vaccinate adults at high risk of being infected and
the absence of an integrated preventive education strategy transmission
of hepatitis B continues to be problematic.
hepatitis c
Infection rates for hepatitis C (HCV) are at epidemic proportions.
Unfortunately, as many do not become ill with the disease until several
years after infection, we are dealing with an ``epidemic of
discovery''. This creates a vicious cycle, as individuals who are
infected continue to spread the disease, unknowingly. Hepatitis C is
also spread through contact with an infected individual's blood. The
CDC 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, new
research is undertaken, and case-finding is enhanced and more effective
treatments are developed. As there is no vaccine for HCV, prevention
activities serve as the only tool in halting the spread of this
disease.
prevention is the key
Only a major investment in immunization and preventive education
will bring these diseases under control. All newborns, young children,
young adults, and especially individuals that 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 helping children avoid the ravages of health
problems resulting from viral hepatitis infection.
--Training educators and health care professionals in effective
communication and counseling techniques.
--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.
--Expansion of screening, referral services, medical management,
counseling, and prevention education for individuals who have
HIV/AIDS, many of whom may be co-infected with hepatitis.
HFI recommends an increase of $41 million in fiscal year 2004 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. Additionally, HFI
recommends that $10 million be used to train and maintain hepatitis
coordinators in every state.
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 $40 million
for the Prevention Research Centers program in fiscal year 2004.
investments in research
Investment in the National Institutes of Health (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 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.
--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.
The Hepatitis Foundation International supports a 10 percent
increase, which would provide $29.78 billion for NIH in fiscal year
2004. HFI also recommends a comparable increase of 10 percent in
hepatitis research funding at the National Institute of Diabetes and
Digestive and Kidney Diseases and the National Institute of Allergy and
Infectious Diseases.
national viral hepatitis roundtable
Victims of hepatitis suffer emotionally as well as physically. They
experience discrimination in employment, strained personal
relationships and severe depression when treatments fail to control
their illness as well as during their treatment. Traditionally,
however, there has not been an organized effort to periodically convene
all stakeholder organizations that play a role in hepatitis prevention,
education, treatment and patient advocacy. Successfully addressing
viral hepatitis will require a comprehensive and strategic approach
developed by all key stakeholders.
In order to fill this void, HFI and CDC co-founded the ``National
Viral Hepatitis Roundtable''. HFI believes that a National Viral
Hepatitis Roundtable will enhance and assist CDC's viral hepatitis
mission for the prevention, control, and elimination of hepatitis virus
infections in the United States, as well as the international public
health community. It will provide an infrastructure for the sharing of
information and education of all stakeholders.
The ``National Viral Hepatitis Roundtable'' is a coalition of
public, private, and voluntary organizations dedicated to reducing the
incidence of infection, morbidity, and mortality from viral hepatitis
in the United States through research, strategic planning,
coordination, advocacy, and leadership.
This organization acts in an advisory capacity to all parties
interested in topics pertaining to viral hepatitis. The Roundtable
first convened on January 13, 2003.
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 our testimony.
the hepatitis foundation international
The Hepatitis Foundation International (HFI) is dedicated to the
eradication of viral hepatitis, a disease affecting 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.
Our mission has four distinct parts:
--Teach the public and hepatitis patients how to prevent, diagnose,
and treat viral hepatitis.
--Prevent viral hepatitis by promoting liver wellness and healthful
lifestyles.
--Serve as advocates for hepatitis patients and the related medical
community worldwide.
Support research into prevention, treatment, and cures for viral
hepatitis.
______
Prepaed Statement of the FacioScapuloHumeral Muscular Dystrophy Society
Mr. Chairman, it is a great pleasure to submit this testimony to
you today.
My name is Daniel Paul Perez, of Lexington, Massachusetts, and I am
testifying as President & Chief Executive Officer of the
FacioScapuloHumeral Muscular Dystrophy Society (FSH Society, Inc.) and
as an individual who has this devastating disorder.
Facioscapulohumeral muscular dystrophy (FSHD) is the third most
prevalent form of muscle disease. FSHD is a neuromuscular disorder that
is transmitted genetically to 1/20,000 people. It affects up to 37,500
persons in the United States. FSHD can occur at any time by new
mutations in the chromosome. 20-30 percent of people affected by FSHD
are believed to be new mutations. For men and women, the major
consequence of inheriting FSHD is progressive and severe loss of
skeletal muscle. The usual pattern is of initial noticeable weakness of
facial, scapular and upper arm muscles and subsequent weaknesses of
other skeletal muscles. Retinal and cochlear disease can often be
associated with FSHD although the pathogenesis and causative
relationship to FSHD remains unknown. FSHD wastes the skeletal muscles
and gradually but surely brings weakness and reduced mobility. Many
with FSHD are severely physically disabled and spend the last 30 years
of their lives in a wheelchair. The toll and cost of FSHD physically,
emotionally and financially are enormous. FSHD is a life long disease
that has an enormous cost-of-disease burden and is a life sentence for
the innocent patient and involved persons and their children and
grandchildren as well.
People who have FSHD must cope with continuing, unrelenting and
never-ending losses. The most unlucky, those who are affected from
birth, are deprived of virtually all the ordinary joys and pleasures of
childhood and adolescence. No matter at which stage of life the disease
makes itself known, there is never after that any reprieve from
continuing loss of physical ability or ever for a moment relief from
the physical and emotional pain that FSHD brings in its train. Every
morning, FSHD sufferers wake up to face the reality that neither a
cause for their disease nor any treatment for it has yet been found.
FSHD denies a person the full range of choices in life. FSHD
affects the way you walk, the way you dress, the way you work, the way
you wash, the way you sleep, the way you relate, the way you parent,
the way you love, the way and where you live, the way people perceive
you, interact with you and treat you. You cannot smile, hold a baby in
your arms, close your eyes to sleep, run, walk on the beach or climb
stairs. Each new day brings renewed awareness of the things you may not
be able to do the next day. This is what life is for tens of thousands
of people affected by FSHD worldwide.
Through the FSH Society, FSHD patients have found ways to be useful
to medical and clinical researchers working on their disease. The FSH
Society acts as a clearinghouse for information on the FSHD disorder
and on potential drugs and devices designed to alleviate its effects.
It fosters communication among FSHD patients, their families and
caregivers, charitable organizations, government agencies, industry,
scientific researchers and academic institutions. It solicits grants
and contributions from members of the FSH Society, and from
foundations, the pharmaceutical industry, and others to support
scientific research and development. It makes grants and awards to
qualified research applicants. In less than six years, the FSH Society
has raised more than $1.1 million for research and has invested it in
more than two dozen innovative research programs internationally. One
of the FSH Society's key assets, its Scientific Advisory Board, is
composed of international experts whose awareness of current FSHD
research ensures both that new research is not duplicative but
complementary and that it will fill gaps in existing knowledge. The FSH
Society's work in education, advocacy, and training has led to
increased funding in the United States and abroad. It was a key
participant in drafting the Muscular Dystrophy Community Assistance
Research and Education Act of 2001 (MD CARE Act) which in the United
States mandates research and investigation into all forms of Muscular
Dystrophy.
A decade of progress in FSHD has led to the discovery of many novel
genetic phenomena never seen before in human disease and genomics.
Despite remarkable genetic insight and immense progress by a small team
of scientists worldwide, the nature of the gene products remain
enigmatic and the biochemical mechanism and cause of this common muscle
disease remains unknown and elusive. The same is true for any
treatment--none exist.
More than a decade ago, we appeared before this Committee to
testify for the first time. Ten years ago, I walked with some
difficulty. Today, I sit in a wheelchair because of this disease called
FSHD. Over the same ten years, the Appropriations Committees in both
the U.S. House and the U.S. Senate have repeatedly instructed the
National Institutes of Health (NIH) to enhance and broaden the
portfolio in FSHD and muscular dystrophy in general. The NIH accounting
for the total overall NIH and the subset of muscular dystrophy
appropriations in millions of dollars for the past five years follows:
NATIONAL INSTITUTES OF HEALTH (NIH) APPROPRIATIONS HISTORY
[Dollars in millions]
----------------------------------------------------------------------------------------------------------------
NIH MD MD FSH FSHD FSHD
Fiscal year overall research percent research percent percent
dollars dollars of NIH dollars of MD of NIH
----------------------------------------------------------------------------------------------------------------
1999.......................................... $15,629 $16.7 0.107 $0.4 2.39 0.0026
2000.......................................... 17,821 12.6 0.071 0.4 3.18 0.0022
2001.......................................... 20,458 21.0 0.103 0.5 2.38 0.0024
2002.......................................... 23,296 27.6 0.118 1.3 4.71 0.0056
2003.......................................... 27,067 31.4 0.116 1.5 4.78 0.0055
----------------------------------------------------------------------------------------------------------------
Source: NIH/OD Budget Office & NIH CRISP Database On-line.
Despite major initiatives from the volunteer health agencies and
the extramural community of researchers, FSHD research at the NIH and
funding through the NIH is negligible in muscular dystrophy.
Notwithstanding these positive changes at the NIH as well as major
cooperative initiatives from the volunteer health agencies and the
extramural community of researchers, we realize that major changes are
slow but we are hopeful that this year the NIH will initiate new and
increased funding for FSHD.
NATIONAL INSTITUTES OF HEALTH (NIH) R21, R01, P01 GRANTS FOR FSHD
------------------------------------------------------------------------
Total No. Total No. Total No.
Fiscal year(s) of FSHD P01 of FSHD R01 of FSHD R21
grants grants grants
------------------------------------------------------------------------
1972-1998....................... ........... 3 ...........
1999............................ ........... 1 ...........
2000............................. ........... 1 ...........
2001............................ ........... 1
2002............................. ........... ........... 6
2003............................. ........... ........... 7
------------------------------------------------------------------------
Source: NIH CRISP Database On-line.
Our concern is that the funding increases for facioscpaulohumeral
muscular dystrophy (FSHD) have been abysmal. In the last eighteen
months, four grants directly and specifically pertaining to FSHD were
submitted. One of the four, a small R21 style grant, was funded by the
NIH Committee for Scientific Review (CSR). Despite the Congressional
mandate to accelerate research on FSHD, FSHD grant applications are
still not making it through the peer review process. FSHD grant reviews
have been a constant source of frustration for FSHD researchers
submitting grant applications to the program and review staff of CSR.
Submitting R01, P01, R21 grant applications calls/contracts has been a
frustrating and time consuming endeavor for most researchers in the
FSHD community since it bears little fruit. Since 1994, not a single
R01 or P01 grant application focusing directly on a critical aspect of
FSHD has survived the peer review process at CSR despite the high
quality of researchers and the leading edge of scientific thought and
opportunity involved with FSHD. We choose not to disagree with the peer
review process at NIH nor do we seek to change the peer review
requirement. However, we strongly emphasize that there is a shortage of
reviewers with the required expertise to guarantee the review deserved
by grant submissions in the muscular dystrophy area. Review of FSHD
proposals, with novel genetic phenomena and mechanisms and a leading
edge of scientific thought, are particularly needful of that expertise.
This should be addressed through training, development and mentorship
programs by the NIH. We also emphasize that the NIH must offer ways to
ameliorate the difficulties in this aspect through targeted programs,
training scientists and short and long term outreach efforts to produce
the desired input to its own NIH process.
Congress has been very generous with the NIH. Congress has
repeatedly mandated more effort in muscular dystrophy research in
general and FSHD research in particular. But this is not happening.
We ask Congress to investigate why this is happening and request an
explanation from the NIH accounting for the failure to do better in the
area of FSHD despite repeated Congressional requests. Three R01
research grants funded on FSHD (two of them only peripherally FSHD-
related at best) in four decades is not enough. We implore Congress to
request the NIH to specifically build the research portfolio on FSHD
through all available means, including re-issuing specific calls for
research on FSHD at an accelerated rate, to make up for historical
neglect.
Mr. Chairman, we trust your judgment on the matter before us. We
believe the Committee should explore why muscular dystrophy in general
and FSHD in particular has been left behind in the great rise in
research support at the NIH. Frankly, we are extremely frustrated that
amid a huge increase in funding and strong unambiguous expressions of
Congressional support, the NIH commitment in facioscapulohumeral
muscular dystrophy (FSHD) is so weak. Only you can answer that
question.
Mr. Chairman, again, thank you for providing this opportunity to
testify before your Subcommittee.
______
Prepared Statement of the International Foundation for Functional
Gastrointestinal Disorders
summary of fiscal year 2004 recommendations
--Provide a 10 percent increase, to $29.8 billion, for fiscal year
2004 to the National Institutes of Health (NIH) budget. Within
NIH, provide proportional increases of 10 percent to the
various institutes and centers, specifically, the National
Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK). We request NIDDK's budget to be increased by 10
percent to $1.7 billion.
--Continue to accelerate funding for extramural clinical and basic
functional gastrointestinal research at NIDDK.
--Provide funding for NIDDK to conduct a prevalence study on and to
increase public and professional awareness of irritable bowel
syndrome (IBS).
--Provide funding for NIDDK to work to develop a strategic plan
setting research goals on IBS and functional bowel diseases and
disorders.
--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 research.
My name is Nancy Norton, and in 1991, I founded the International
Foundation for Functional Gastrointestinal Disorders (IFFGD), in
response to my own experiences as a patient. I'm proud to say that 12
years later my organization serves hundreds of thousands of people in
need each year, providing information and support to patients and
physicians. The largest organization of its kind in the world, IFFGD
works with consumers, patients, physicians, providers and payers to
broaden understanding about fecal incontinence, irritable bowel
syndrome (IBS), gastroesophageal reflux disease (GERD), pediatric
disorders and numerous other gastrointestinal disorders. Additionally,
it has been my personal vision and goal to see a greater investment in
research on functional gastrointestinal and motility disorders.
IFFGD continues to speak about and raise awareness for disorders
and diseases that many people are uncomfortable and embarrassed to talk
about. The prevalence of fecal incontinence and irritable bowel
syndrome, 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 the burden of illness and human toll has not
been fully recognized.
Given that we have been diligently working for the past twelve
years it is an exciting time to lead the IFFGD, not only are we serving
more and more people, but we are beginning to be able to privately fund
research. Our first research awards were made on April 6, 2003.
Since its establishment the IFFGD has been dedicated to increasing
awareness of functional gastrointestinal disorders and motility
disorders, among the public, health professionals, and researchers.
Last November, we hosted a conference on fecal and urinary
incontinence. During the first week of April 2003 we also hosted the
Fifth International Symposium on Functional Gastrointestinal Disorders,
which was a great success in bringing scientists from across the world
together to discuss the current science and opportunities on irritable
bowel syndrome and other functional gastrointestinal and motility
disorders. The IFFGD has become known for our professional symposia. We
consistently bring together a unique group of international
multidisciplinary investigators to communicate new knowledge in the
field of gastroenterology.
The majority of the diseases and disorders we address have no cure.
We have yet to 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, conservative estimates range 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.
fecal incontinence
I have had IBS most of my adult life and due to an obstetrical
injury 17 years ago I now live with bowel incontinence. Incontinence in
particular is often thought of as something that affects us when we are
frail and elderly--perhaps something that is part of the aging process.
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, let alone a complication of an episiotomy with vaginal
delivery.
Fecal incontinence can be caused by: 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. 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, so they withdraw from friends and family.
The social isolation is unfortunate but may be reduced because
treatment can improve bowel control and make incontinence easier to
manage.
irritable bowel syndrome (ibs)
Irritable Bowel Syndrome affects approximately 30 million
Americans. This chronic disease is characterized by a group of
symptoms, which can 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 treatment.
Similar to fecal incontinence and depending on severity, 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.
gastroesophageal reflux disease (gerd)
Gastroesophageal reflux disease, or GERD, is a very 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. 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.
Periodic heartburn is a symptom that many people experience. 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.
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 only 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 to $29.8 billion or 10 percent for NIH
overall, and a 10 percent increase for NIDDK, or $1.7 billion. 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 (FGI) and motility disorders, this increased funding
will allow for the growth of new research, a prevalence study and a
strategic plan on IBS, and increased public and professional awareness
of FGI and motility disorders.
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.
the international foundation for functional gastrointestinal disorders
The International Foundation for Functional Gastrointestinal
Disorders is a nonprofit education and research organization founded in
1991. IFFGD addresses the issues surrounding life with gastrointestinal
(GI) functional and motility disorders and increases the awareness
about these disorders among the general public, researchers, and the
clinical care community.
______
Prepared Statement of the NephCure Foundation
summary of recommendations for fiscal year 2004
1. A 10 PERCENT INCREASE FOR THE NATIONAL INSTITUTES OF HEALTH AND
THE NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
(NIDDK).
2. ENCOURAGE NIDDK TO PROVIDE HIGH PUBLIC VISIBILITY FOR GLOMERULAR
DISEASE AS PART OF THE FORTHCOMING NATIONAL KIDNEY DISEASE EDUCATION
PROGRAM.
3. ENCOURAGE THE NATIONAL CENTER FOR MINORITY HEALTH AND HEALTH
DISPARITIES (NCMHD) TO INITIATE STUDIES INTO THE INCIDENCE/CAUSE OF
FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) IN THE AFRICAN-AMERICAN
POPULATION.
4. PRIORITIZE, AT NIDDK, A PROGRAM FOR COLLECTION OF TISSUE SAMPLES
AND SCIENTIFIC RESEARCH INTO THE CAUSE OF FSGS, BUILDING ON THE CURRENT
FSGS CLINICAL TRIALS UNDERWAY. THUS, HEIGHTENING THE ATTRACTION OF
GLOMERULAR INJURY RESEARCH FOR TALENTED RESEARCHERS.
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 blue-ribbon panel of respected medical
experts and a dedicated band of patients and families working for a
common goal--to save kidneys and lives.
I also include a letter from Melanie Stewart, one of tens of
thousands of young Americans struggling with an insidious disease of
the kidney's filtering mechanism. Now living with the aid of daily
dialysis, Melanie relates just a little of her courageous battle with
focal segmental glomerulosclerosis, or FSGS.
Treatment Trials Beginning, But No Cure in Sight
Mr. Chairman, FSGS is one of a cluster of glomerular diseases that
attack the one million tiny filtering units contained in each human
kidney. These filters are called nephrons and the diseases attack the
portion of the nephron called the glomerulus, scarring and often
destroying the irreplaceable filters. Scientists don't know why
glomerular injury occurs and they are not sure how to stop its
destruction of the kidney.
We are thankful that an NIDDK-funded clinical trial will begin this
year to study the efficacy of the current treatments for FSGS. But
these clinical trials hold out no particular hope for patients such as
my 18-year-old daughter, Christine, who also suffers from FSGS. Chrissy
has been treated with most of the drugs that will be tested in the
upcoming clinical trial. Thus far, none have stopped the proteinuria;
the spilling of protein in the urine that characterizes glomerular
injury.
Christine has experienced the facial swelling and disfigurement
that periodically comes and goes with glomerular disease. She has
suffered the depression and mental ravages of heavy steroid treatments.
Nothing has worked. Last year her kidneys showed scarring and today she
is one of thousands of young people who are in a race against time,
hoping for a treatment that will save her kidneys. The NephCure
Foundation today raises its voice to speak for them all, asking you for
specific actions that will aid our quest to find the cause and the
cure.
First and foremost, we support a 10 percent increase for the
National Institutes of Health and the National Institute of Diabetes
and Digestive and Kidney Diseases (NIDDK).
Too Little Data About a Growing Problem
When glomerular disease strikes, the resultant Nephrotic Syndrome
causes loss of protein in the urine and symptoms such as edema, a
swelling that often appears first in the face. The Antosh family
physician mistook Christine's puffy eyelids as an allergy symptom.
Stories of similar misdiagnosis are common at our Foundation. With
experts projecting a substantial increase in Nephrotic Syndrome in
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,
including patient education seminars, the most recent of which is
slated for Seattle in May. News of our activities can be found on our
web site at www.nephcure.org. But our efforts are not enough.
As NIDDK plans a major federal outreach--the National Kidney
Disease Education Program--we seek your support in urging NIDDK to
assure that glomerular disease receives high visibility in this
important program.
Glomerular Disease Strikes Minority Population
Nephrologists tell us that glomerular diseases such as FSGS affect
a disproportionate number of African-Americans and, according to NIDDK,
``the worst prognosis is observed in African-American children.''
NephCure officials have described this situation in a meeting with Dr.
John Ruffin, director of the National Center for Minority Health and
Health Disparities (NCMHD).
As the NCMHD becomes fully operational and plans programs, our
Foundation will continue to work with the Center to encourage the
creation of programs to study the high incidence of glomerular disease
within the African-American population.
We ask the Committee to join with us in requesting that the
National Center for Minority Health and Health Disparities seize the
opportunity to establish research into the phenomenon of glomerular
disease with in the African American community.
More Basic Science is Needed
The current FSGS clinical trials, which will cover an estimated 400
patients over a three year period, are limited, according to the RFA,
to examining the ``impact of immunomodulatory therapy on proteinuria.''
While the trials may lead to safer or more efficient care for children
with FSGS, no one is suggesting that they will bring us closer to
finding the cause and cure. Science has yet to prove that FSGS is an
immune-mediated disease.
Scientists tell us that much more needs to be done in the area of
basic science, beginning with collection of tissue and fluid samples
from a large number of patients on which years of important scientific
research can be founded. NephCure is collaborating with the NIH in a
major way to work for such progress.
The National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) will match, dollar-for-dollar, funds raised by
NephCure that will allow researchers to obtain DNA samples from
hundreds of FSGS patients in upcoming clinical trials. The NIDDK will
match up to $300,000 raised by NephCure for a combined total of
$600,000.
We urge you to prioritize a program for a comprehensive study of
such tissue samples and other new programs of scientific research into
the cause of FSGS at NIDDK, actions that will enhance the attraction of
glomerular injury research for talented researchers.
We sincerely believe that the recommendations we make here today,
if implemented, will give hope to the thousands of young people whose
kidneys and lives are threatened by this terrible disease, and give
meaning and honor to the heroic story of Melanie Stewart.
Hello, my name is Melanie Stewart. I'm 15 years old and have been
fighting FSGS since I was seven. Over the last 8 years, I've spent most
of my time in the hospital or hooked up to a dialysis machine, while
trying to keep up my schoolwork. It hasn't been easy.
Three years ago, FSGS destroyed both of my kidneys. On April 21,
1999, my dad gave me one of his kidneys. The year after the transplant
was one of the hardest. Over that time I had Apheresis procedures done
three times a week. As a result of the high doses of immune suppressant
drugs, PTLD, a form of cancer, was found on my head. In November of
2000, I almost died because of a blood infection and a blood clot in my
heart caused by the Apheresis catheter.
In March of 2001, I had my donated kidney removed. I am now on
dialysis again, every day, and am forced to start over.
There are thousands of people, mostly young, like me who would like
a chance for a cure and a normal life.
For everyone, I'm asking for your help to help me meet my goal of
finding a cure.
Thank you for allowing me to share my story and thank you for
listening.
______
Prepared Statement of the Charles R. Drew University of Medicine and
Science
summary of recommendations for fiscal year 2004
--10 PERCENT INCREASE FOR THE NATIONAL INSTITUTES OF HEALTH AS WELL
AS A 10 percent INCREASE FOR ALL INSTITUTES AND CENTERS,
SPECIFICALLY THE NATIONAL CENTER FOR RESEARCH RESOURCES (NCRR),
THE NATIONAL CENTER FOR MINORITY HEALTH AND HEALTH DISPARITIES
(NCMHD), AND THE NATIONAL CANCER INSTITUTE (NCI).
--URGE NCRR, NCMHD, AND NCI TO WORK TOGETHER TO SUPPORT THE
ESTABLISHMENT OF A NATIONAL MINORITY HEALTH COMPREHENSIVE
CANCER CENTER AT A HISTORICALLY MINORITY INSTITUTION.
Mr. Chairman and members of the subcommittee, I am Dr. Charles
Francis, President of Charles R. Drew University of Medicine and
Science. Charles R. Drew University is one of four predominantly
minority medical schools in the country, and the only one located west
of the Mississippi River.
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, 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 the King-
Drew Medical Center and 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.
a response to health disparities
Racial and ethnic disparities in health care have long been
established as a major barrier to successful prevention and treatment
of a multitude of diseases in minority and underserved communities. As
recently 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 fifteen 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 are still not doing enough to
try to combat cancer in our communities.
In response to these findings and the high cancer rate in their own
community, Charles R. Drew University of Medicine and Science proposes
that a Minority Health Comprehensive Cancer Center be built 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.
support for this initiative
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 in our underserved community would be impossible without
the resources of NIH.
To help facilitate the establishment of a Minority Health
Comprehensive Cancer Center 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).
First, the facility must be constructed. Drew University does meet
the Public Health Service Act eligibility requirement for facilities
construction grants which maintains that the institution ``is located
in a geographic area in which a deficit in health care technology,
services, or research resources may adversely affect health status of
the population of the area in the future, and the applicant is carrying
out activities with respect to protecting the health status of such a
population.'' Therefore, the university is seeking Extramural
Facilities Construction grants through NCRR in the amount of $4 million
per grant cycle for build-out of the first floor of the research
facility, and subsequent build-out of the second floor.
The University is also seeking $8 million from NCMHD for the
research building shell to house the Charles R. Drew University of
Medicine and Science Minority Health Comprehensive Cancer Center.
In addition, the Minority Health Comprehensive Cancer Center cannot
become a reality without programmatic funding. Drew University, in
collaboration with UCLA, is seeking support from NCI in the amount of
$10 million over five years to support the health care and research
activities conducted by the Center.
conclusion
Despite our knowledge about the disparities in diseases and health
care, the ``gap'' continues to widen. 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.
Even though institutions like 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 lack of appropriate research facilities.
With your help, this cancer center will facilitate translation of
insights gained through research into greater understanding of
disparities in cancer incidence, morbidity and mortality and ultimately
to improved outcomes.
Mr. Chairman, with your support and the financial resources of NIH,
Charles R. Drew University of Medicine and Science can not only be the
nation's first Historically Black College or University (HBCU) to have
a Comprehensive Cancer Center, but also the first minority medical
school in the country to have a comprehensive cancer center focused
exclusively on minority health and health disparities.
We look forward to working with you to lessen the burden of cancer
for all Americans through greater understanding of cancer, its causes,
and its cures.
Mr. Chairman, thank you for the opportunity to present on behalf of
Charles R. Drew University of Medicine and Science.
______
Prepared Statement of First Candle/Sudden Infant Death Syndrome
Alliance
summary of fiscal year 2003 recommendations
--Continue to fund the third Sudden Infant Death Syndrome (SIDS)
Five-Year Research Plan at NICHD, which focuses on research and
educational opportunities on SIDS Stillbirth.
--Re-examine the third Five-Year Research Plan to determine the
appropriateness of including research planning on stillbirth
and miscarriage as components of the plan.
--Continue to fund the SIDS and Other Infant Death Program Support
Center at the Maternal and Child Health Bureau, within the
Health Resources and Services Administration.
--Fund 3 SIDS death scene protocol demonstration projects through the
Centers for Disease Control and Prevention (CDC) in rural,
urban, and suburban settings to provide a nation-wide protocol
for dealing with SIDS death scenes.
Chairman Specter, thank you for again allowing First Candle/SIDS
Alliance the opportunity to submit testimony to this Subcommittee and
explain issues involving Sudden Infant Death Syndrome (SIDS), the
importance of federal funding for SIDS programs and research, and
exciting changes currently transforming the SIDS Alliance. Mr.
Chairman, we still need your help, commitment, and support to help
solve the mystery that is SIDS and ensure healthy pregnancies and that
every child lives.
Despite the fact that SIDS cases have been documented for years,
organized scientific research into SIDS only began in the mid 1970's.
In the three decades since, scientists are now beginning to make
significant progress in unraveling this enigma of SIDS, which robs
families of their infant children. As an example of this progress, we
now know that in many SIDS related deaths there is an abnormality or
under-development in a region of an infant's brain, which is thought to
control the heart and lung functions. In these cases, this irregularity
may hamper normal respiratory activity. While this may not be the sole
cause of SIDS, it may have contributed to a larger respiratory problem
leading to death when combined with other circumstances.
As a direct result of SIDS research and the ``Back to Sleep''
educational and awareness campaign on infant sleep positioning, SIDS
deaths have been reduced by 42 percent since 1992, leading to the
greatest decline in infant mortality rates in over 20 years.
Despite this exceptional news, our research and educational
campaign is far from finished. There are still more than 2,500 SIDS
deaths in the United States each year and SIDS continues to be the
number one cause of death for children between one month and one year
of age. SIDS is a major component of the United States infant mortality
rate. In spite of these facts, we still do not yet understand the
causes of SIDS nor do we possess any guaranteed method for its
prevention.
However, because of the decreasing rates of SIDS, in 2002, the SIDS
Alliance moved to expand our mission and changed our name to First
Candle/SIDS Alliance. First Candle/SIDS Alliance exists to promote
infant health and survival during the prenatal period through two years
of age. We will concentrate in this arena through advocacy, education,
and research not only in the area of SIDS, but also branching out in
the areas of Stillbirth and Miscarriage.
The primary federal agency responsible for conducting SIDS research
and the ``Back to Sleep'' public awareness campaign is the National
Institute of Child Health and Human Development (NICHD) at the National
Institutes of Health (NIH). In addition to federal funding of SIDS
research, there are other federal agencies involved in the SIDS effort.
Since 1975, the Maternal and Child Health Bureau (MCHB) within the
Health Resources and Services Administration (HRSA) has supported
specific programs for SIDS bereavement services such as family
counseling and for public and professional education about SIDS. The
Centers for Disease Control and Prevention (CDC) has established a
standardized death scene investigation protocol for SIDS incidents.
Additionally an Interagency Panel on SIDS has been established, which
includes: NIH, HRSA, CDC, Indian Health Services (HIS), Food and Drug
Administration (FDA), U.S. Consumer Products Safety Commission,
Department of Defense, Administration for Children and Families, and
the Department of Justice to help coordinate all federally funded SIDS
activities.
First/Candle SIDS Alliance is grateful for the Subcommittee's past
support of SIDS activities, especially the support of NICHD. We urge
you to again provide the additional funding necessary for the third
year of the third Five-Year SIDS Research Plan to ensure that NICHD can
continue to address critical SIDS research initiatives. Specifically
the SIDS Alliance is supporting a funding increase to $29.8 billion or
10 percent for NIH overall, and a 10 percent increase for NICHD to
$1.33 billion. We respectfully ask that the increases for NIH do not
come at the expense of other Public Health Service agencies. Further
research is essential to find the reasons for and means of preventing
the tragedy of SIDS as well as providing research to understand the
causes of Stillbirth and Miscarriage.
First Candle/SIDS Alliance urge the Subcommittee to support SIDS
educational, awareness, and counseling activities that take place at
the MCHB, and the death scene investigation protocol demonstration
projects at the CDC. These programs are a vital companion to the
research conducted at NICHD. Without prevention, awareness, counseling
and standardized investigation procedures, competent scientific
research does not translate into meaningful advances for SIDS victims
and their families.
highlights of federally funded sids activities
National Institute of Child Health and Human Development (NICHD)
Childcare has become increasingly important in the social fabric of
the United States, so have child care centers and homes. To address
this issue the NICHD has initiated the ``Back to Sleep Child Care
Project,'' sending publications and other ``Back to Sleep'' materials
to over 280,000 child care centers and licensed homes throughout the
United States. Response to these mailings has been overwhelming,
resulting in a 20 percent increase in the volume of requests for Back
to Sleep materials. 20 percent of all SIDS deaths occur in a childcare
setting. First Candle/SIDS Alliance and NICHD, as well as other
coalition partners such as the American Academy of Pediatrics (AAP),
have joined in a collaborative initiative launched by MCHB. This
initiative calls attention to this problem and works to further educate
policy makers and day care providers regarding infant sleep positioning
with the goal of further decline in the number of SIDS deaths every
year.
Studies on the risk factors for SIDS among African American and
American Indian populations conducted in collaboration with the CDC and
the Indian Health Service have yielded valuable information for
targeted interventions to reduce infant mortality in these communities.
SIDS among minority populations continues to be a top priority for the
NICHD. Surveys show that the proportion of African Americans placing
their infants to sleep on their stomachs continues to decrease,
however, African Americans are still twice as likely to place infants
on their stomachs as compared to other populations. Discussion groups
are underway in African American communities across the country to
assess the ``Back to Sleep'' campaign message, and to improve message
delivery. In addition, during fiscal year 2001, the NICHD established
new initiatives on health disparities in minority populations. SIDS and
related fetal and infant deaths are part of the initiatives targeted at
eliminating health disparities in infant mortality.
A new component of the ``Back to Sleep'' campaign focusing on
reducing SIDS among African American's was launched in late 1999. The
goal is to develop and implement a community-based initiative. The
National Black Child Development Institute (NBCDI) joined with the
NICHD, the campaign sponsors, and several other organizations in the
outreach initiative. A culturally appropriate resource kit, which
includes a training guide, has been developed, and the first national
training workshops have been held.
The mechanism of SIDS is still unknown; there are no clinical or
biologic tests to identify a newborn at high risk of succumbing to
SIDS; and more work is needed to increase the implementation of ``Back
to Sleep'' among all caregivers and in communities with high rates of
infant death. To address and focus its efforts on these challenges, the
NICHD has developed and is implementing its third SIDS Research Five-
Year Plan. The plan is divided into five parts: Introduction, Etiology/
Pathogenesis, Prognostics and Diagnostics, Prevention, and Health
Disparities. Because of our expanded mission, First Candle/SIDS
Alliance is asking the Subcommittee to direct NICHD to review the third
SIDS five-year plan to investigate the appropriateness and scientific
viability of including Stillbirth and Miscarriage in current Five-Year
Research Plan for SIDS.
Research initiatives in fiscal year 2004 include (1) continued
research on mechanisms of pathogenesis through studies in animal
models, postmortem tissue, and high-risk infants. This includes a
prospective study to define a battery of physiologic and genetic
markers that will predict SIDS and to determine whether SIDS is part of
a larger family of autonomic nervous system disorders; (2) analysis of
epidemiological and physiological data collected during the second five
year research plan to improve our understanding of environmental and
intrinsic risk factors; (3) a community-linked health disparities
initiative to investigate related aspects of mortality from late fetal
life through early childhood; (4) improve risk reduction and efficacy
of ``Back to Sleep'' through continued research, monitoring, and
outreach in at risk communities.
Maternal and Child Health Bureau (MCHB)
Recently, First Candle/SIDS Alliance has entered into a
collaborative effort with MCHB to kickoff the ``Healthy Child Care
America Back to Sleep Campaign''. This initiative builds on the success
of the ``Healthy Child Care America'' and ``Back to Sleep'' campaigns
to unite child care, health, and SIDS prevention partners across the
country to reduce the number of SIDS-related deaths in child care
settings.
The MCHB continues to support a number of SIDS and Other Infant
Death related services and programs, including the following
activities:
--National SIDS Resource Center, a major source of current
information about SIDS.
--Maternal and Child Health Service Block Grant (MCH), which grants
funds to states providing a range of services to SIDS families.
Block grant funds support activities like: contact families
immediately after death, discussion of autopsy results with the
family, and support and counseling through the first year of
bereavement. Unfortunately, in many jurisdictions across the
country, funds for these services have been decreased or
eliminated due to budgetary difficulties.
--Field training and curriculum to health care providers for case
management of families who have experienced an infant death,
and the development of model programs, particularly for the
underserved and minorities. Demonstration grants have been
established and are continuing in four states to target
services for specific populations: California, Massachusetts,
Missouri, and New York.
--National SIDS & Infant Death Program Support Center to address SIDS
service issues at the federal level on an ongoing basis. First
Candle/SIDS Alliance was chosen to run this center, which
opened in 1999, and has experienced notable success. The
support center is working to expand bereavement services to
family members of those you experience stillbirth and
miscarriage.
Centers for Disease Control and Prevention (CDC)
To develop a better statistical figure on SIDS cases, Congress
recommended in 1993 the establishment of a standard death scene
protocol to offset discrepancies on unexplained infant deaths between
states. It was hoped that this protocol would be adopted by states not
only for statistical measure, but to help avoid what can become awkward
and emotionally charged misunderstandings at the death scene. In 1996,
CDC published the protocol, and since that time several states have
adopted the standard. It is First Candle/SIDS's Alliance long term goal
to ensure that all states fully adopt and implement the protocol. To
help realize this goal, First Candle/SIDS Alliance would like Congress
to appropriate funds for CDC to heed Congress' recommendations for the
past several years and implement the demonstration projects that follow
these guidelines in several community settings nationwide. We recommend
a demonstration project in each of the following, a rural community
setting, an urban community setting, and a suburban community setting.
We would also encourage CDC to implement a nationwide survey to measure
how many locales have already implemented the protocol independently
and to analyze the results thus far.
In conclusion, we are all too painfully aware that SIDS has
historically been a mystery, leaving in its wake devastated families
and bewildered physicians. Not only have there been no answers on the
cause of SIDS, but there have been no answers on how to effectively
prevent its occurrence. Today we are beginning to find some of the
answers on cause and prevention, and therefore reduce the risk of SIDS.
Because of the ``unknown'', however, babies are still vulnerable even
when parents and care givers take the cautionary steps to prevent SIDS
deaths. This tragedy will continue if research efforts are stalled or
halted, especially when we are at the point where so much progress has
been made. Now is the time for a re-energized effort against this
tragic syndrome.
On behalf of the thousands of families who have been devastated by
the loss of a baby to SIDS, and the millions of concerned and
frightened parents, we ask for your support, and thank you again for
allowing us to submit this testimony. If you have any questions, please
do not hesitate to contact us.
first candle/sudden infant death syndrome alliance
First Candle/SIDS Alliance is an organization of parents and
friends of SIDS victims along with medical, business, and civic groups
who are concerned about the health our this nation's children. The
Alliance is engaged in ongoing efforts to expand its scientific
program, strengthen services for families, and provide public education
and advocacy opportunities. An important goal is to improve community
understanding and elevate SIDS to the level of societal concern
appropriate to one of our nation's major causes of infant mortality.
______
Prepared Statement of the Crohn's and Colitis Foundation of America
summary of fiscal year 2004 recommendations
--A 10 PERCENT INCREASE FOR THE NATIONAL INSTITUTE OF DIABETES, AND
DIGESTIVE AND KIDNEY DISEASES, AND THE NATIONAL INSTITUTE OF
ALLERGY AND INFECTIOUS DISEASES AND A CORRESPONDING INCREASE
FOR INFLAMMATORY BOWEL DISEASE RESEARCH AT BOTH INSTITUTES.
--$1 MILLION FOR THE NATIONAL INFLAMMATORY BOWEL DISEASE
EPIDEMIOLOGICAL PROGRAM AT THE CENTERS FOR DISEASE CONTROL AND
PREVENTION.
--$25 MILLION FOR CDC's NATIONAL COLORECTAL CANCER SCREENING
AWARENESS PROGRAM.
introduction
Mr. Chairman, thank you very much for the opportunity to present
the views of the Crohn's & Colitis Foundation of America (CCFA). I am
Rodger DeRose, President and Chief Executive Officer of CCFA and I am
honored to represent the people of this country who suffer from Crohn's
disease and ulcerative colitis.
Crohn's disease and ulcerative colitis are chronic disorders of the
gastrointestinal tract which represent a leading cause of morbidity
from digestive illness. Because they behave similarly, these disorders
are collectively known as inflammatory bowel disease (IBD). IBD can
cause severe diarrhea, abdominal pain, fever, and rectal bleeding.
Moreover, IBD related complications can include; arthritis,
osteoporosis, anemia, liver disease, and colon cancer. Crohn's disease
and ulcerative colitis are not fatal, but they can be devastating. We
do not know their cause, and we have no cure.
CCFA is a non-profit, voluntary organization dedicated to finding a
cure for Crohn's disease and ulcerative colitis. Throughout its 36-year
history, CCFA has sponsored basic and clinical research of the highest
quality. The Foundation also offers a wide range of educational
programs for patients and healthcare professionals, and provides
support services to assist people in coping with these chronic
intestinal diseases.
We are very grateful Mr. Chairman, for your support of IBD research
and epidemiology programs in the Fiscal Year 2003 Labor-HHS bill.
Furthermore, we applaud the leading role that you played in the
successful effort to double the NIH budget and your recent amendment to
the budget resolution providing for an increase in NIH spending in
fiscal year 2004.
recommendations for fiscal year 2004
National Institutes of Health
CCFA has developed highly successful research partnerships with the
NIH. We are particularly proud of our longstanding collaborations with
the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) which sponsors the majority of IBD research at NIH, and the
National Institute of Allergy and Infectious Diseases (NIAID).
In 2001, a team of investigators from NIDDK, CCFA, and the private
industry announced that they had identified the first gene for Crohn's
disease. This historic breakthrough opens up exciting new pathways of
research focused on the development of improved therapies for Crohn's
disease patients. The research which led to the discovery of the gene
would not have been possible without the strong support that Congress
has provided to the NIDDK in recent years.
Some of the most promising IBD research supported by the NIH has
focused on translating findings from studies conducted on animal models
to humans with IBD. These animal models have enabled researchers to
form the current hypothesis that Crohn's disease and ulcerative colitis
are caused by a malfunctioning immune system, wherein components of the
patient's immune system overreact to normal intestinal bacteria. We
know that people are susceptible to this malfunction because of their
genetic makeup but further research is necessary to determine which
bacteria are responsible, how these bacteria interact with the
intestine's immune system, and which immune system components are
involved.
Mr. Chairman, IBD patients and their families are pinning their
hopes for a better life on medical advancements made through NIH
sponsored research. For this reason, CCFA strongly supports the goal of
the doubling the NIH budget and recommends a 10 percent increase for
NIDDK, NIAID, and NIH overall in fiscal year 2004. Moreover, CCFA
encourages the subcommittee to increase IBD research funding within
NIDDK and NIAID at the same rate as NIH overall.
centers for disease control and prevention
IBD Epidemiology Program
CCFA estimates that ``up to one million'' people in the United
States suffer from IBD. Unfortunately, we do not have an exact number;
due to the complicated nature of those diseases, patients may remain
undiagnosed or misdiagnosed for several years. One of CCFA's main
public policy objectives is to establish a nationwide IBD
epidemiological program in partnership with the Centers for Disease
Control and Prevention. This much-needed program will further our
understanding of both the prevalence of IBD in the United States, and
the demographic characteristics of this unique patient population.
The cultivation of patient demographic information is critically
important to our biomedical research efforts given that environmental
factors are believed to play a major role in the development and
progression of IBD. 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.
As a result, CCFA entered into a partnership last year with the CDC
to establish an IBD epidemiology program. Specifically, CCFA has funded
a grant that CDC submitted to the Foundation to initiate this important
study. We greatly appreciate your support of this collaboration as
outlined in the Committee's fiscal year 2003 Labor-HHS bill. We are
looking forward to reviewing a report on the progress CDC is making in
this area, as requested by the Committee. Moreover, we are pleased that
the Committee has strongly encouraged CDC to provide financial support
for this study now that it has been initiated with funds from our non-
profit organization.
For fiscal year 2004, we are requesting that the Committee provide
CDC with a specific appropriation of $1 million to continue this
important initiative.
Colorectal Cancer Prevention
Finally, Mr. Chairman, in addition to coping with either Crohn's
disease or ulcerative colitis, many IBD patients are at high risk for
developing colorectal cancer. As you may know, colorectal cancer is the
third most commonly diagnosed cancer for both men and women in the
United States and the second leading cause of cancer-related deaths.
Because people who have suffered from IBD for more than eight years are
susceptible to this disease, CCFA has a long history of actively
promoting the benefits of colorectal cancer screening.
Although colorectal cancer is almost entirely curable when detected
early, studies have shown a tremendous need to: (1) inform the public
about the availability and advisability of screening and (2) educate
healthcare providers about screening guidelines. CDC's National
Colorectal Cancer Roundtable is actively working to address these
challenges by partnering with organizations like CCFA to implement a
national public awareness campaign emphasizing the importance of
screening and early detection. Moreover, CDC's ``Screen for Life''
awareness campaign is actively promoting the importance of colorectal
cancer screening via television, radio and print media. CCFA encourages
the subcommittee to provide CDC with $25 million in fiscal year 2004 to
support its colorectal cancer prevention activities.
Once again, Mr. Chairman, thank you for the opportunity to present
the views of Crohn's and Colitis Foundation of America. We look forward
to continuing to work with you on these important issues.
______
Prepared Statement of the Dystonia Medical Research Foundation
summary of fiscal year 2004 recommendations
--Provide increased funding for the National Institute of Health at
10 percent for fiscal year 2004. 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 10 percent.
Fiscal year 2004 recommendations for NIH
[In billions of dollars]
NIH...............................................................29.800
NINDS............................................................. 1.610
NIDCD............................................................. 0.409
NEI............................................................... 0.700
--Continue to accelerate funding for extramural dystonia research at
NINDS.
--Provide funding for NINDS to conduct an epidemiological study and
to increase public and professional awareness of dystonia.
--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 again allowing me the opportunity
to submit testimony to the Subcommittee on behalf of the Dystonia
Medical Research Foundation (DMRF). I want to take this opportunity to
describe for the Subcommittee how dystonia has affected the lives of
many Americans and to provide for you our recommendations for fiscal
year 2004 federal funding with regards to dystonia research.
My name is Rosalie Lewis, I am currently president of the Dystonia
Medical Research Foundation (DMRF). 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.
I have a very personal connection with this disorder because I am
the mother of four sons, three of whom suffer from the complications of
dystonia, and a fourth who is a carrier of the DYT1 gene which is
responsible for generalized early onset childhood dystonia. 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 370
grants, and 5 fellowships, totaling more than $18 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. Additionally, in
October 1996, the NIH was one of our co-sponsors for an international
medical symposium, which featured 60 papers on dystonia and 125
representatives from 24 countries. 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 3,000 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 October 14 through 20. 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.
The Dystonia Foundation has over 200 chapters, support groups, and
area contacts across North America. In addition, there are 15
international 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. In 2000, we held over eight regional
symposiums reaching approximately 2,000 affected families. Eight more
regional symposiums are scheduled throughout 2003 and 2004.
dystonia and the national institutes of health
The Dystonia Medical Research Foundation recommends an increase to
$29.8 billion or 10 percent for NIH overall, and a 10 percent increase
for NINDS, NIDCD and NEI or: $1.61 billion, $409 million, and $700
million respectively. Now that the NIH doubling is complete, NIH still
must have the adequate resources to continue the research it has begun
during the period of the doubling. We at DMRF request that this
increase for NIH does not come at the expense of other Public Health
Service agencies. 2002 was a banner year in the field of dystonia
research with the release in August of the NIH Program Announcement:
Studies in the Causes and Mechanisms of Dystonia. This program
announcement is a historic collaboration for research on behalf of the
dystonia community throughout the NIH and it serves as an example of
the success of the NIH doubling of funding to make this possible. If
NIH is not adequately funded then many of the grant proposals
associated with the program announcement could go unfunded hindering
the scientific progress we in the dystonia community have made in the
past few years.
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.
We also urge the Subcommittee to recommend that NINDS provide the
necessary funding for additional extramural research and a large-scale
dystonia epidemiological study. 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 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 though NIH, NINDS, NIDCD and NEI 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.
the dystonia medical research foundation
The Dystonia Medical Research Foundation was founded 25 years ago
and has been a membership-driven organization since 1993. Since its
inception, the goals of the Foundation have remained the same: to
advance research for more effective treatments of dystonia and
ultimately a cure; to promote awareness and education; and support the
needs and well being of affected individuals and their families.
______
Prepared Statement of the Medical Library Association and the
Association of Academic Health Sciences Libraries
summary of recommendations for fiscal year 2004
(1) A 10 PERCENT INCREASE FOR THE NATIONAL LIBRARY OF MEDICINE AT
THE NATIONAL INSTITUTES OF HEALTH AND SUPPORT FOR NLM'S URGENT FACILITY
CONSTRUCTION NEEDS.
(2) CONTINUED SUPPORT FOR THE MEDICAL LIBRARY COMMUNITY'S ROLE IN
NLM'S OUTREACH, TELEMEDICINE, AND MEDICAL INFORMATICS PROGRAMS.
Mr. Chairman, thank you for the opportunity to submit testimony on
behalf of the Medical Library Association (MLA) and the Association of
Academic Health Sciences Libraries (AAHSL) regarding the fiscal year
2004 budget for the National Library of Medicine. I am Logan Ludwig,
Associate Dean for Library and Telehealth Services at Loyola University
Strich School of Medicine in Maywood, Illinois.
Established in 1898, MLA is a nonprofit, educational organization
of more than 1,100 institutions and 3,600 individual members in the
health sciences information field, committed to educating health
information professionals, supporting health information research,
promoting access to the world's health sciences information, and
working to ensure that the best health information is available to all.
AAHSL is comprised of the directors of libraries of 142 accredited
U.S. and Canadian medical schools belonging to the Association of
American Medical Colleges. Together, MLA and AAHSL address health
information issues and legislative matters of importance to the medical
community through a joint task force.
Mr. Chairman, the National Library of Medicine, on the campus of
the National Institutes of Health in Bethesda, Maryland, is the world's
largest medical library. The Library collects materials 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. The collections stand at 5.8 million items--books, journals,
technical reports, manuscripts, microfilms, photographs and images.
Housed within the library is one of the world's finest medical history
collections of old and rare medical works. The Library's collection may
be accessed in the reading room or requested on interlibrary loan. NLM
is a national resource for all U.S. health science libraries through a
National Network of Libraries of Medicine. Increasingly, it is becoming
an international resource for world-wide research collaboration.
On behalf of the medical library community, I would like to thank
the subcommittee for its leadership in securing a 12 percent increase
for NLM in fiscal year 2003. With respect to the Library's budget for
the coming fiscal year, I would like to touch briefly on four issues;
(1) the growing demand for NLM's basic services; (2) NLM's outreach and
education services; (3) NLM's telemedicine and informatics activities;
and (4) NLM's facility needs.
the growing demand for nlm's basic services
Mr. Chairman, it is a tribute to NLM that the demand for its
services continues to steadily increase each year. An average of 500
million Internet searches are performed annually on NLM's MEDLINE
database, which provides access to the world's most up-to-date health
care information. MEDLINEplus, NLM's extensive electronic information
resource for the general public, is viewed approximately 200 million
times a year. This activity dwarfs previous usage of NLM's
bibliographic services, whether electronic or print. Moreover,
researchers, scholars, librarians, physicians, healthcare providers
from around the world, and the general public rely heavily on NLM and
its National Network of Libraries of Medicine to deliver health care
information everyday that is necessary to improve the quality of our
nation's healthcare system.
NLM also plays a critical role in maintaining the integrity of the
world's largest collection of medical books and journals. Increasingly,
this current and historical information is in digital form. This has
fundamentally changed how the library operates--how and what it
collects, how it preserves information, and how it disseminates
biomedical knowledge. NLM, as a national library responsible for
preserving the scholarly record of biomedicine, is developing a
strategy for selecting, organizing, and ensuring permanent access to
digital information. Regardless of the format in which the materials
are received, ensuring their availability for future generations
remains the highest priority of 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 come to expect.
Recognizing the invaluable role that NLM plays in our health care
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 10 percent increase for NLM
and NIH overall in fiscal year 2004.
outreach and education
NLM's outreach programs are of particular interest to both MLA and
AAHSL. These activities, designed to educate medical librarians, health
care 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. We were pleased that the
Committee again last year recognized the need for 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 publishing concept proposed by former NIH Director Dr.
Harold Varmus. The site houses articles from some 100 journals
including the Proceedings of the National Academy of Sciences and
Molecular Biology of the Cell.
The medical library community believes that health sciences
librarians should continue to play a key role in further development of
PubMed Central and we are pleased that medical librarians are members
of the NLM 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 our
community can assist NLM with issues related to copyright, fair use,
and information classification on the PubMed Central site. We look
forward to continuing our collaboration with the Library as this
exciting project continues to evolve this year.
MEDLINEplus
NLM estimates that the public conducts 30 percent of all MEDLINE
searching. 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 of health and its usage by the public. In January 2003,
two million unique users searched more than 600 ``health topics'' that
contain detailed consumer-focused information on various diseases and
health conditions. Recent additions to MEDLINEplus include illustrated
interactive patient tutorials, a daily news feed from the public media
on health-related topics, and the NIHSeniorHealth site [http://
nihseniorhealth.gov/], a collaborative project between NLM and the
National Institute on Aging.
Clinical Trials
Mr. Chairman, I also want to comment on another relatively new
service offered by NLM--its clinical trials database [http://
www.clinicaltrials.gov]. This listing of more than 7,000 federal and
privately funded trials for serious or life-threatening diseases was
launched in February of 2000 and currently logs more than 2 million
page hits per month. 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.
Mr. Chairman, we applaud the success of NLM's outreach initiatives
and look forward to continuing our work with the Library again in
fiscal year 2004 on these important programs.
telemedicine and medical informatics
Mr. Chairman, telemedicine continues to hold great promise for
dramatically increasing the delivery of health care to underserved
communities across the country and throughout the world. NLM has
sponsored over 50 innovative telemedicine related projects in recent
years, including 21 multi-year projects in various rural and urban
medically underserved communities. These sites serve as models for:
--Evaluating the impact of telemedicine on cost, quality, and access
to health care;
--Assessing various approaches to ensuring the confidentiality of
health data transmitted via electronic networks; and
--Testing emerging health data standards.
It is clear that telemedicine and medical informatics program such
as the Visible Human Project [http://www.nlm.nih.gov/research/visible/
visible_human.html]--male and female data sets consisting of MRI, CT,
and photographic cryosection images totaling 50 gigabytes and licenses
to scientists at more than 1,700 institutions around the world--will
play a major role in the delivery of health care and research in the
21st Century.
We are pleased that NCM has begun a new program to support
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 we encourage Congress and NLM to
continue their strong support of telemedicine and other medical
informatics initiatives.
nlm's facility 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.
This increase in the volume of biomedical information as well as
expansion of personnel (NLM currently houses over 1,100 people in a
facility built to accommodate 650) has resulted in a serious shortage
of space at the Library. In addition, NLM's National Center for
Biotechnology Information [http://www.ncbi.nlm.nih.gov] builds
sophisticated data management tools for processing and analyzing
enormous amounts of genetic information critical to advancing the Human
Genome Project.
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 last year appropriated the necessary architectural and
engineering funds for facility expansion at NLM.
We encourage the subcommittee to continue to provide the resources
necessary to acquire a new facility and to support the Library's health
information programs.
Mr. Chairman, thank you once again for the opportunity to present
the views of the medical library community.
______
Prepared Statement of the American Psychological Society
summary of recommendations
--As a member of the Ad Hoc Group for Medical Research Funding, APS
recommends $30 billion for NIH in fiscal year 2004.
--APS requests Committee support for increased behavioral and social
science research and training at NIH in order to: better meet
the Nation's health needs, many of which are behavioral in
nature; realize the exciting scientific opportunities in
behavioral and social science research, and; accommodate the
changing nature of science, in which new fields and new
frontiers of inquiry are rapidly emerging.
--Committee support is requested for specific behavioral science
activities at a number of individual institutes. This testimony
provides examples to illustrate the exciting and important
behavioral and social science work being supported at NIH.
Mr. Chairman, Members of the Committee: On behalf of our members, I
want to thank the Committee for your leadership in the bipartisan
effort to double NIH budget. As a member of the Ad Hoc Group for
Medical Research Funding, the American Psychological Society recommends
$30 billion for NIH in fiscal year 2004. After the historic doubling of
NIH budget, thanks to the efforts of Congress and both the Clinton and
Bush administrations, the rationale for these aggressive increases
remains as compelling today as it was in fiscal year 1999, the year
that you and your colleagues in Congress embarked on this path. NIH has
experienced a period of unparalleled growth in the past 5 years, and
the progress achieved as a result of research funded by NIH will lead
us into a new era of discovery and innovation.
Within NIH budget, my testimony today focuses on the behavioral and
social science research activities of NIH.
overview: basic and applied psychological research related to health
The effects of behavior on health are indisputable.--Many leading
health conditions--heart disease, lung disease, diabetes, developmental
disabilities, brain injury, AIDS, and so many more--are behavioral in
origin. Consider, for example, the devastating health consequences of
smoking, drinking, taking drugs, engaging in risky sexual behaviors.
None of these conditions can be fully understood without an awareness
of the behavioral and psychological factors involved in causing,
treating and preventing them.
APS members include thousands of scientists who, with NIH support,
conduct basic, applied, and clinical research related to physical and
mental health at our Nation's leading universities and colleges.
Virtually every institute at NIH supports some amount of psychological
science. Examples include: The connections between the brain and
behavior; research into how children grow and develop; management of
debilitating chronic conditions such as diabetes and arthritis as well
as mental disorders; and the behavioral aspects of smoking and drug and
alcohol abuse, so that science may find ways for people to escape
addiction.
The new director of NIH, Dr. Elias Zerhouni, has expressed strong
support for behavioral science at NIH, and sees this research as
critical to our nation's health. ``We are aware of the challenge in
social and behavioral science. It's going to be front and center,'' he
has stated. He went on to add, ``The bill for the nation will be
unbearable in health and social costs without a recognition of the role
of behavior.''
Twenty-four of the 27 institutes at NIH fund behavioral science
research, and seven institutes commit over $100 million to this
enterprise. Six institutes commit over 20 percent of their resources to
behavioral science research. That places these pursuits squarely at the
forefront of the most pressing health issues facing this Congress, this
Administration, and this Nation. We ask that you continue to help make
behavioral research more of a priority at NIH, both by providing
maximum funding for those institutes where behavioral science is a core
activity, and by encouraging NIH to advance a model of health that
includes behavior in deciding its scientific priorities.
behavioral science research training: a guaranteed investment
The outcomes of science are unpredictable.--Yet there is one aspect
of science where the time and money invested is guaranteed to pay off:
the training of our future scientists. We know that if we provide
support now for a young investigator, we will have a well-trained,
highly-qualified scientist as a result. This is a serious issue in
behavioral science at NIH, where the demand for behavioral science
investigators at NCI, NIMH, and other institutes outpaces the current
supply of behavioral science researchers. In order to meet the future
needs of research in health and behavior, NIH must have a comprehensive
training strategy in place today, one that focuses on training young
investigators in the core disciplines of behavioral and social science
research as well as in multidisciplinary perspectives.
The National Academy of Sciences is currently conducting its
congressionally authorized study of research personnel needs with
regard to the National Research Service Awards. In recent years, NIH
has chosen to only implement the recommendations of NAS selectively, if
at all. NAS produces unbiased, highly analytical reports, and they
should receive more attention from all of the NIH institutes. This
Committee has expressed interest in this study in the past. We hope
that this committee will follow theses developments closely, and take
an active role in the enforcement of these recommendations.
We ask the Committee to support the development, in consultation
with the relevant scientific community, of a comprehensive training
strategy for behavioral and social science research at NIH. This
strategy should include all training mechanisms, and should be balanced
between interdisciplinary research and traditional core disciplines in
the behavioral sciences.
I would now like to turn my attention to the behavioral science
research that is taking place at the individual institutes.
national institute of mental health (nimh)
Strengthening Clinical Science.--Under the leadership of its new
director Dr. Thomas Insel, NIMH is working with the Academy of
Psychological Clinical Science to explore the development of training
models for clinical science in psychology. The goal is to establish
training for clinical scientists who will go on to create new ways to
diagnose, measure and treat mental disorders, and new ways to evaluate
how those treatments translate from the lab to the real world. We ask
the Committee to support the efforts of NIMH as the institutes takes
this very complex first step in the on-going fight against mental
illness.
Basic Behavioral Research at NIMH.--NIMH is to be commended for
promoting the transfer of knowledge into application. At the same time,
basic behavioral research at NIMH must continue to receive the same
strong support it traditionally receives there. This is crucial, as
NIMH is a de facto source of basic behavioral knowledge that is tapped
by many other institutes. Until other institutes begin to support
larger amounts of basic behavioral science research connected to their
respective missions, it is essential that NIMH's programs of research
into behavioral phenomena such as cognition, emotion, psychopathology,
perception, development, and others continues to flourish. We ask the
Committee to encourage NIMH's continued efforts to strengthen the ties
between basic and clinical behavioral research, and to encourage NIMH's
basic behavioral science portfolio in order to ensure continued
progress in our understanding of the causes, treatment, and prevention
of mental illness and the promotion of mental health.
Adherence and Behavior Change.--NIMH supports studies of factors
that influence decisions about adopting and adhering to treatment and
prevention interventions, including individual personality or disease-
related factors and type of treatment, as well as factors that may
enhance or interfere with adherence to prevention, treatment, or
rehabilitative regimens. This research is critical to increasing the
effectiveness of vaccines, drug therapies, smoking and substance abuse
cessation and relapse prevention programs, and other advances in public
health treatment and prevention.
national institute of general medical sciences (nigms)
NIGMS is the only National Institute specifically mandated to
support research not targeted to specific diseases or disorders. That
legislative mandate also extends to behavioral science research.
Unfortunately, NIGMS does not now support behavioral science research
or training. This is an enormous oversight, given the wide range of
fundamental behavioral topics with relevance to a variety of diseases
and health conditions. Congress addressed this issue for the past four
years in the reports on the fiscal year 2000, fiscal year 2001, fiscal
year 2002, and fiscal year 2003 appropriations for NIH. Specifically,
this Committee said: ``The Committee is concerned that NIGMS does not
support behavioral science research training. As the only Institute
mandated to support research not targeted to specific diseases or
disorders, there is a range of basic behavioral research and training
that NIGMS could be supporting. The Committee urges NIGMS, in
consultation with the Office of Behavioral and Social Sciences, to
develop a plan for pursuing the most promising research topics in this
area.''
The institute's response in their fiscal year 2003 budget
justification was inadequate. ``The Institute's research training
programs mirror the areas of science that fall within the mission of
the National Institute of General Medical Sciences (NIGMS). Except for
a few fields of inquiry, behavioral studies largely fall outside of the
Institute's research mission, and are instead deemed to be within the
missions of other institutes at the National Institutes of Health. ``
NIGMS is mistaken. Their research mission encompasses ``general or
basic medical sciences and related natural or behavioral sciences
[emphasis added] which have significance for two or more other national
research institutes'' (TITLE 42, CHAPTER 6A, SUBCHAPTER III, Part C,
subpart 11, Sec. 285k)
Basic behavioral research in addiction (significance for NIDA,
NIAAA, NCI and NHLBI), obesity (significance for NIDDK, NHLBI, and
NICHD) and neuroscience (significance for NIMH, NINDS, and NHGRI) just
to name a few, are all within the NIGMS mission. Once again, we ask the
Committee to direct NIGMS to develop a plan for establishing a basic
behavioral science research program at NIGMS.
national institute on drug abuse (nida)
NIDA's National Prevention Research Initiative.--NIDA's new
Prevention Research Initiative integrates basic science with prevention
research. NIDA-supported investigators will draw on basic behavioral,
cognitive, developmental, social and neurobiological research to inform
the development of innovative and novel prevention interventions. NIDA
will focus on preventing the initiation of drug abuse by better
understanding basic cognitive processes, such as the decision to use a
drug. This basic research component is just one of three components
(along with establishment of transdisciplinary prevention centers and
community multi-site prevention trials) that NIDA will use to enhance
national prevention efforts. Understanding behavior will not only aid
in the development of prevention strategies, it will also aid in the
development of new therapies for those addicted to drugs.
NIDA Clinical Trials Network (CTN).--To date, the efficacy of new
treatments for drug addiction has been demonstrated primarily in
specialized research settings, with somewhat restricted patient
populations. To address this problem, NIDA has established the National
Drug Abuse Treatment Clinical Trials Network (CTN). The mission of the
CTN is to conduct studies of behavioral, pharmacological, and
integrated behavioral and pharmacological treatment interventions of
therapeutic effect in rigorous, multi-site clinical trials to determine
effectiveness across a broad range of community-based treatment
settings and diversified patient populations; and then transfer the
research results to physicians, providers, and their patients to
improve the quality of drug abuse treatment throughout the country
using science as the vehicle. There are currently 17 networks in place,
up form 5 in 1999. We ask this Committee to increase NIDA's budget in
proportion to the overall increase at NIH in order to reduce the
health, social and economic burden resulting from drug abuse and
addiction in this Nation.
national institute on alcohol abuse and alcoholism (niaaa)
NIAAA has broadened its behavioral science portfolio in order to
understand the underlying psychological and cognitive processes that
lead people to drink, and the impact of chronic alcohol abuse on those
processes. As one example, NIAAA convened a workshop of national
experts on social identification and alcohol research to examine ways
that group peer pressure and group norms concerning drinking influence
drinking. The Institute also convened a group of experts in cognitive
research to explore the effects of alcohol abuse on memory, decision-
making, cognitive development to begin looking at issues of cognitive
rehabilitation.
Advancing Behavioral Therapies for Alcoholism Behavioral, non-
pharmacological therapies currently are the most widely used method of
treating alcohol dependence and alcohol abuse. To advance the
effectiveness of behavioral therapies, NIAAA is examining approaches to
improving clinicians' abilities to engage and retain adults and
adolescents in treatment. NIAAA plans to expand research on the
mechanisms of action of successful behavioral therapies, behavioral
therapies for alcohol-abusing patients who have psychiatric disorders,
which significantly complicates therapeutic interventions, and
combinations of new medications with behavioral therapies to sustain
recovery. We ask this Committee to increase NIAAA's budget in
proportion to the overall increase at NIH in order to reduce the
health, social and economic burden resulting from alcohol abuse and
addiction.
national cancer institute (nci)
Having already established itself as a leader among NIH Institutes
in many fields of research, NCI has made enormous advances in the
behavioral sciences.
NCI's Behavioral Research Program.--NCI's comprehensive behavioral
science research program ranges from basic behavioral science to
research on the development, testing and dissemination of disease
prevention and health promotion interventions in areas such as tobacco
use, diet, and even sun protection. Focusing on transdisciplinary and
collaborative research, NCI's Behavioral Program has expanded to five
branches, including a basic biobehavioral research branch, a health
communication and informatics research branch, and the tobacco control
research branch. The transdisciplinary research conducted by NCI is an
example of the new path for science, as disciplines are only made
stronger when complimented by others. With every new discovery that
arises, we see more and more that no branch of science is complete if
it stands alone.
Health Communications.--Recognizing the central role of effective
communication in addressing issues of health and behavior, NCI has also
undertaken a major effort to develop science-based communications
strategies for disseminating information and persuasive messages about
cancer prevention and treatment to the public. Researchers are
exploring innovative strategies for communicating cancer information to
diverse populations, looking at various communication approaches such
as message tailoring and framing with application in multiple
communication channels. These messages draw from a foundation of basic
behavioral and social science research into such issues as how people
learn and remember health information, how they perceive health risks,
and how they are persuaded to adopt healthy behaviors.
Theories Project.--The goal of the Theories Project is to identify
and carry out activities that will help develop improved theories of
health behavior. Its focus is on actions that individuals can take to
prevent cancer and speed its early detection. Among the activities that
may be considered are training in theory development and testing for
health behavior researchers who lack such training; recruiting
scientists with strong theory orientations to cancer behavior research;
development of state-of-the-art summaries of theory-relevant topics
when these are lacking; and better communication of opportunities for
theory-focused research among current types of NCI grants. We ask
Congress to support NCI's behavioral science research and training
initiatives and to encourage other institutes to use these programs as
models.
I would now like to turn to some cross-cutting initiatives in which
behavioral research plays a critical role.
Translational Research in Behavioral Science.--Several institutes
have demonstrated enormous leadership in promoting translational
research in behavioral science, aimed at bringing knowledge from the
laboratory into clinical research and application. In simplest terms,
this is the result Congress was looking for when it chose to double NIH
budget: the results of research being used to treat patients with
complex disorders in an effective and efficient manner. At NIMH, for
example, they will develop research centers that support the transition
of basic behavioral science research to patient-oriented studies
regarding new interventions and delivery of services for patients with
mental disorders. The goal is to develop more effective, theory-based
interventions and service-delivery models for mental disorders through
increased applications of the garnered data. At NIDA, the translational
research branch (TRB) identifies basic research discoveries in the
field of drug abuse research, and related disciplines, that have
potential practical impact in the treatment and prevention of disease
or the development of new research technologies. Once findings with
practical applications are identified, the TRB actively facilitates the
translation of these basic research data into clinical and research
tools, medications and treatments. And at NIAAA, investigators funded
by the institute have been learning a great deal about the neuroscience
and biology of the problem, for example charting the brain activity of
binge-drinking laboratory animals to discover what changes in
neurotransmitter pathways affect the craving and reward systems that
contribute to at-risk drinking behaviors.
It's not possible to highlight all of the worthy behavioral science
research programs at NIH. In addition to those I've discussed here,
many other institutes play a key role in NIH behavioral science
research enterprise. These include the National Institute on Aging, the
National Heart Lung and Blood Institute, the National Institute of
Child Health and Human Development, the National Institute of
Neurological Disorders and Stroke, and within NIH Director's office,
the Office of Behavioral and Social Sciences Research. Behavioral
science is a central part of the mission of each of these, and each
deserves the Committee's support.
Obesity.--Obesity is a health problem all too often overlooked, yet
recently it has begun to receive the attention it is warranted. We are
glad to see Congress take up the issue in such pieces of legislation as
H.R. 716, which is directed at fighting obesity and promoting improved
nutrition and increased physical activity in the United States. As the
legislation notes, behavior will play an important role in this effort.
Motivation, counseling, marketing and communication are all important
tools if we are to create a healthier nation led by healthier children.
If we are to see results, the message that we communicate must be
rooted in science and research. Evidence based research, translated
into practice, will ensure safe and effective messages. The use of
science in promoting behavioral changes should not and cannot be
ignored. It has shown us that obesity leads to increased risk of
diabetes, heart disease, and even cancer.
The National Heart, Lung and Blood Institute concluded that a
significant proportion of coronary heart disease is caused or
exacerbated by behavioral factors, including high-risk behavior. But
preventing obesity could save $50 billion a year in health care costs,
and recommended treatments for over-weight individuals begins with
behavioral programs that include diet, exercise and training in
behavioral techniques. The behavioral and physiological changes that
occur during high-risk periods for weight gain must be clarified. This
information can then be used to design individualized interventions, in
order to prevent future weight gains and obesity. Research in this
field benefits not only NHLBI, but other institutes as well, such as
NICHD, NIDDK, and NCI.
This concludes my testimony. Again, thank you for the opportunity
to discuss NIH appropriations for fiscal year 2004 and specifically,
the importance of behavioral science research in addressing the
Nation's public health concerns. I would be pleased to answer any
questions or provide additional information.
______
Prepared Statement of the Society of General Internal Medicine
The Society of General Internal Medicine (SGIM) is pleased to
present the Senate Labor, Health and Human Services and Education
Subcommittee with testimony regarding fiscal year 2004 appropriations
for key programs within the Department of Health and Human Services.
SGIM is an international association of 3,000 physicians and other
health professionals who combine treating patients with teaching and
conducting research. SGIM is dedicated to improving patient care,
medical education, and research in primary care and general internal
medicine. SGIM believes it is uniquely positioned to recommend
appropriate funding levels to continue the important work of the Title
VII and VIII Health Professions Programs and the Agency for Healthcare
Research and Quality (AHRQ).
title vii and viii health professions programs
As healthcare professionals, researchers and teachers, we are
concerned that sufficient, stable funding be directed towards the
important work of the health professions and nursing education programs
under Title VII and VIII of the Public Health Service Act. These
programs help ensure that health care professionals are trained to
provide quality care, represent the diverse makeup of the general
population, and are available to communities across the country,
particularly those in underserved areas.
SGIM recommends a 2004 budget of $550 million for the Title VII and
VIII health professions programs, of which at least $40 million should
be directed to general internal medicine and general pediatrics
training.
By providing support to students, programs, departments, and
institutions, the health professions program improves the
accessibility, quality, and racial and ethnic diversity of the health
care workforce. These programs help combat health professional
shortages in rural and underserved areas by educating and training
primary care providers who are more likely to serve in such areas.
Title VII grants provide the only federal funding dedicated to the
education and training of the primary care workforce. Well-trained
primary care physicians are a necessity to provide care to the
uninsured and underinsured, particularly in underserved areas. Data
proves that one half of primary care providers trained through Title
VII programs go on to work in underserved areas, compared to ten
percent of those not training through a program funded by this cluster.
Within primary care, funding for general internal medicine and
general pediatrics training supports medical student training,
residency training, faculty development, and development of academic
administrative units. Aside from increasing the number of physicians
choosing general internal medicine, these programs have also proven to
increase the diversity and cultural competency of the workforce. Title
VII general internal medicine residency programs graduate two to five
times more minority and disadvantaged students than programs that do
not receive such support.
SGIM is disappointed that the Administration's budget plan for
fiscal year 2004 virtually eliminates the entire Title VII program and
provides no funding for the Title VII primary care cluster, which
includes general internal medicine. The President's plan increases
funding for community health centers and the National Health Service
Corps to meet the health care needs of the uninsured and underinsured.
While these programs are important, the President's budget provides
little to no funding to train the health professionals who could enter
the corps and serve at these health centers. SGIM commends the Senate
for approving the Specter-Harkin amendment to the budget resolution,
which provides further funding for the Health Resources and Services
Administration (HRSA) specifically for the health professions programs.
SGIM urges the subcommittee to not just restore the President's
proposed cuts to these programs, but to increase their funding due to
the vital need for a well-trained health professions workforce.
agency for healthcare research and quality (ahrq)
SGIM strongly supports AHRQ's mission and work to support, conduct,
and disseminate research that improves access to and outcomes and
quality of health care services. SGIM consequently believes a fiscal
year 2003 budget of at least $390 million is necessary for AHRQ to
fully carry out its congressional mandate to improve health care
quality, including reducing errors in medicine and advancing health
outcomes information.
The agency's health services research complements the biomedical
research of the NIH by helping clinicians, patients, and health care
institutions make choices about what treatments work best, for whom,
when, and at what costs. AHRQ is the only federal agency that
explicitly looks for ways to improve the delivery of health care
services, in terms of increased effectiveness, increased quality,
increased cost-effectiveness, and with fewer errors. The agency's
research on error reduction addresses an important public concern,
saves lives, and saves money by reducing costs of mistreatment and
medical malpractice expenditures. Much of AHRQ's research addresses the
cost-efficiency of new modalities or interventions and the
appropriateness of their application for large patient sub-populations
such as those served by Medicare and Medicaid.
AHRQ supported the development of ``cardiac predictive
instruments,'' which predict patients' probability of having an acute
cardiac ischemia (a heart attack or unstable angina pectoris, that
leads to heart attack) and outcomes (e.g. death or cardiac arrest). An
AHRQ-supported clinical effectiveness trial of the ACI-TIPI diagnostic
predictive instrument built into electrocardiographs reduced
unnecessary hospitalizations the equivalent of 200,000 people per year
in the United States, with an estimated savings of $728 million per
year. An error reduction version of the ACI-TIPI, also built into
electrocardiographs, shows promise to reduce the equivalent of $1.2
billion per year in malpractice costs for missed heart attack
diagnoses. The use of an AHRQ-supported predictive instrument, the
Thrombolytic Predictive Instrument, improved the use of thrombolytic
(``clot-buster'') therapy and angioplasty for heart attacks, especially
for patients more often missed and in community and rural hospitals.
Another example is the finding by an AHRQ Evidence-based Practice
Center that children suffering from uncomplicated acute otitis media
(AOM), a middle ear infection, and treated with amoxicillin fared just
as well as those treated with more expensive antibiotics. This research
represents large cost savings to the Medicaid program since
pediatricians can prescribe the less expensive medication and achieve
the same result.
To the extent that it's budget allows, AHRQ collaborates with other
Department of Health and Human Services (HHS) agencies, particularly
the National Institutes of Health (NIH) and the Centers for Disease
Control and Prevention (CDC). These collaborative efforts are critical
in the translation of the fruits of the NIH biomedical research into
effective clinical practice. The combination of the specific applied
focus of the AHRQ with NIH research remains an opportunity for
increased benefit from greater investment.
The private sector cannot replace the work of AHRQ. The private
sector puts a relatively small amount of financial resources toward
initiatives similar to AHRQ research, focused primarily on products
developed by the specific company. Moreover, the agenda of those
sectors selling health care services and goods is to increase the use
of their product, not to look for the most cost-effective solution. And
while health plans indeed do have motive to improve cost-effectiveness,
because they are in a competitive market with enormous fiscal
constraints, they do not cooperate in making cost-effective high
quality care generally available to the public as AHRQ does.
The President's proposed budget for AHRQ for 2004 would be an eight
percent decrease from the agency's 2003 funding level. It would allow
for no new grants, and would cause current, non-patient safety grants
to be cut by 15 percent. Reductions in the AHRQ funding stream will
result in lost opportunities for research projects currently in the
middle of a two- or three-year grant cycle. Mid-course interruptions
will halt some projects just as these initiatives are about to bear
fruit in the form of improved patient health outcomes and reductions in
healthcare expenditures. Such reductions will also have a chilling
effect on individual, investigator-initiated research, a competitive
process through which applicants that receive modest levels of grant
funding develop initiatives with financial implications far beyond the
original investment. Congress must sustain ample funding for
investigator-initiated research to encourage sufficient numbers of
researchers to enter and remain in this field.
SGIM sincerely appreciates the opportunity to provide testimony to
the subcommittee, and would like to thank you for the subcommittee's
past support of Title VII and AHRQ.
______
Prepared Statement of the Society for Neuroscience
Good morning Mr. Chairman and members of the Subcommittee. I am
pleased to be here today to testify before the subcommittee. I am Dr.
Huda Akil and I serve as the President of the Society for Neuroscience.
Our organization has a membership of over 31,000 basic and clinical
researchers. We are the largest scientific organization in the world
dedicated to the study of the brain, spinal cord and nervous system.
Aside from my work at the Society, I am the Gardner Quarton
Distinguished University Professor of Neuroscience in Psychiatry at the
University of Michigan. I am also the Co-Director of the Mental Health
Research Institute in Ann Arbor. I study the biology of the emotional
circuits in the brain along with the impact of the environment on these
circuits. My work focuses on stress, mood disorders, and substance
abuse.
Psychiatry, neurology and neurosurgery are the better-known medical
specialties that have their basis in neuroscience, but this research
has an impact on numerous other medical specialties. Understanding the
development and function of the brain is essential to understanding the
impact of a wide variety of other diseases and disorders. For example,
there is ample evidence that depression increases the likelihood of
heart disease and that in turn heart disease can trigger severe
depression. Obesity is a major health issue in our country, and the
control of feeding behavior and metabolic activity is controlled by the
brain. Therefore, the science of the brain can have great impact on the
overall mental and physical health of this nation.
We are pleased that Congress included funding in the fiscal year
2003 omnibus spending bill to complete the final phase of doubling for
the National Institutes of Health (NIH). We recognize that the advances
in basic research would not be possible without this subcommittee's
strong commitment to biomedical research. Doubling the NIH budget
provides an excellent foundation to continue progress in understanding
and providing cures for diseases.
neuroscience research center
The Society for Neuroscience is also pleased that the conference
agreement includes language granting authority for the construction of
the first and second phases of the John E. Porter Neurosciences
Building. The Neuroscience Research Center will house research programs
conducted by intramural neuroscience researchers from nine institutes.
While all disciplines benefit from collaborative research,
neuroscience, in particular, thrives on it. Different types of
neuroscience research are currently conducted at various NIH
institutes. Thus, the Neuroscience Research Center provides a forum for
collaboration amongst leading researchers at different institutes to
work together, and with the extramural research community, to further
neuroscience research discoveries.
funding recommendation
We appreciate this subcommittee's commitment to significant budget
increases for the NIH, especially in light of the difficult budget
allocations imposed on the subcommittee.
The Society is concerned that the Administration's request for
fiscal year 2004 funding for NIH may not provide adequate resources.
The fiscal year 2004 budget would provide $27.9 billion for NIH, a net
increase of $549 million, or 2.0 percent, over the fiscal year 2003
request. We are concerned that the progress that has been made in the
years of doubling will cease its momentum. As the Chairman and members
of the committee understand, scientific research builds on previous
discoveries. To maintain this nation's world-renowned excellence, we
must maintain the commitment exemplified in the years of doubling. This
research will help us understand the biological basis of disease and,
in turn, develop strategies to prevent, diagnose, treat, and finally
cure such diseases.
The relatively new threat of bioterrorism has added another
dimension to biomedical research. In addition to curing already
existing conditions, researchers have to plan for the contingency of an
induced plague or influx of disease inducing germs. This not only
exhausts resources, but also affects the nation's mental well-being.
Individuals who already suffer from psychiatric diseases are profoundly
affected by the added stress from the threat of bioterrorism. As
importantly, individuals who are healthy but are vulnerable to stress
can become ill, either physically or psychologically, as a result of
threats to their safety. Understanding how to cope with these
psychosocial factors can be scientifically based and can become part of
our national effort to combat terrorism and its long-term effects.
incidence and economic burden of neurological and psychiatric diseases
Each year, we try to convey the importance of biomedical research
in terms of longer, healthier lives for those who suffer from
debilitating neurological and psychiatric disorders. It is in the
economic costs and burdens that the impact of these diseases is
measurable. For example:
--All Depressive Disorders affect 18.8 million Americans and cost $44
billion per year
--Hearing lost costs the United States $56 billion per year, on the
28 million Americans affected
--Alzheimer's Disease affects 4 million Americans and costs $100
billion a year
--4 million people are affected by stoke, which costs the United
States $30 billion per year
--$32.5 billion per year is spent on the 3 million Americans that
have schizophrenia.
--1.5 million Americans are affected by Parkinson's Disease at a cost
of $15 billion per year
--Multiple Sclerosis affected 350,000 Americans at a cost of $7
billion per year
As you know, the federal government, particularly the National
Institutes of Health, is the nation's leading supporter of biomedical
research. We need only look at recent history to see the progress of
biomedical research. Where a disease like epilepsy or cancer once meant
a death sentence, today we have an arsenal of methods to manage these
disorders.
Recent achievements in neuroscience made through NIH-funded
research demonstrate that our nation's commitment to biomedical
research has been worth the investment. I would like to discuss some of
the research being done in my area of expertise.
recent advances in understanding and treating mental disorders
My research group works on the brain basis of mood disorders--major
depression, manic-depressive illness (also called Bipolar Disorder),
anxiety, panic, obsessive-compulsive illness and other mood disorders.
These are brain illnesses that affect the patients' mood and shape
their view of themselves and the world around them. For example, a
severely depressed individual can see himself or herself as worthless,
feel a sense of hopelessness and despair and suffer from intense
psychological pain. This illness can be fatal as the suffering leads
many to suicide and devastates entire families, wreaking havoc across
generations. Even for those who survive, the illness can produce
indelible changes in the brain. Repeated episodes of severe depression
can lead to changes in brain structure and function that may be
irreversible, and have been likened to ``scarring''. It is therefore
critical to avoid repeated episodes to minimize either the fatal
consequences or the long-term impact on brain function.
It should be noted that there is a close link between mood
disorders and substance abuse. Many people use drugs because they are
struggling with anxiety or other dark moods, or are unable to deal with
stress. They seek alcohol and other drugs to alleviate these feelings.
In turn the use of drugs, even if first triggered by other causes such
as thrill seeking or peer pressure, can often lead to mood disorders.
Stimulants such as cocaine, or narcotics such as heroin, alter mood.
The body becomes dependent on their presence, and when they are
withdrawn, severe changes in mood occur, sometimes leading to serious
psychiatric consequences. Thus, understanding the brain biology of mood
disorders is relevant across many arenas, including alcoholism and
substance abuse.
Until recently, we thought of mood disorders as a sign of weakness,
a problem that can be remedied by ``toughening up'' or ``looking on the
bright side''. But neuroscience research has taught us that moods are
the results of intricate activity in the brain, and therefore have a
physical basis. Depressed individuals are literally trapped in a
chemical imbalance that disrupts how they feel, think and judge. This
insight has led brain scientists to re-frame the question of mood
disorders very differently, not in terms of strength of will, but in
terms of biological causes and drug treatments. Not only is this a non-
judgemental and more humane approach to human suffering, but it has
spurred significant scientific advances that are helping millions of
people all over the world.
Neuroscientists have worked for many years to elucidate the
chemical mechanisms in the brain that underlie emotions such as anxiety
and whose malfunction may be at the root of depression. For example,
many studies have implicated the transmitter serotonin in the chemical
imbalance of depression. This view has resulted in the development of
drugs like Prozac, a so-called Specific Serotonin Reuptake Inhibitor
(SSRI). Prozac and other SSRI's are now widely used for the treatment
of depression and help a large proportion of patients with the illness.
These drugs also help with a number of other disorders including
anxiety and obsessive-compulsive disorders and chronic pain.
However, some depressed individuals are ``treatment resistant'', in
that they do not respond to SSRI's or other classes of antidepressant
drugs. Our research group has discovered that this treatment resistance
is typically related to a disturbed stress system. The body has a
complex set of brain molecules and blood hormones that help it cope
with stress. Huge demands on this system can have severe consequences
on the brain, including remodeling of the brain in an adverse manner.
We have shown that those individuals that have a highly disrupted
stress system often do not respond to antidepressant treatments.
Therefore, there are numerous pharmaceutical company efforts aimed at
discovering new classes of antidepressant drugs, many of which are
aimed specifically at ``resetting'' the stress system. New
antidepressant drugs that are in various phases of testing include
blockers of the brain stress hormone CRH and of the brain receptor that
recognizes the steroid stress hormones that circulate in the blood and
bathe the entire body (the Glucocorticoids).
In addition, we are exploring exciting research frontiers for
discovering the causes and devising new treatments for mood disorders,
especially the more genetically based bipolar illness. These efforts
take advantage of the results of the Human Genome Project. They aim to
uncover specific genes that are active in the emotional parts of the
brain and may contribute to the cause and the course of mood disorders.
New technologies, including a tool known as a microarrays or ``Gene
Chips'', are helping in this undertaking. A gene chip allows scientists
to examine the activity of tens of thousands of genes at the same time
and determine whether the pattern of activity in a particular brain
region is altered under certain illnesses. Recent work, funded by the
NIMH, as a large collaborative project between my laboratory and
several other laboratories in Michigan, Stanford and the University of
California, is providing exciting new insights on genes whose activity
is altered in the brains of severely depressed individuals, and another
set of genes altered in the brain of bipolar individuals. Thus, this
research is leading us to the identification of patterns of gene
activation that associate with specific mental disorders. More
importantly, this research is generating a host of new ideas on how to
understand the causes and improve the treatment of mental disorders.
These and many other efforts from numerous talented scientists
working both with animals and with humans give us hope that we will
continue to make great strides the huge proportion of Americans that
suffer from a brain disorder at some point in the course of their
lives.
somatic cell nuclear transfer
I would also like to mention an innovative therapy that offers hope
to the millions of people who are affected by neurological diseases.
Somatic cell nuclear transfer (SCNT), also referred to as therapeutic
cloning, is one of the most promising medical research procedures on
the horizon. SCNT involves removing the nucleus of an egg and replacing
it with the material from the nucleus of a ``somatic cell.'' This could
be a cell from the skin, the heart, or a nerve. The egg is never
fertilized by sperm. The sole purpose of this technology is to develop
treatments for disease. With this research, scientists may find cures
for diseases and disabilities ranging from juvenile diabetes to
Alzheimer's disease.
Ethical scientists would agree that human cloning for the purpose
of reproduction is reprehensible. The Society for Neuroscience supports
a ban on reproductive cloning complete with criminal and civil monetary
penalties. However, we strongly believe that the promise of SCNT is too
compelling to be ignored. Permitting critical therapeutic cloning
research will keep hope alive for millions of Americans with crippling
and life-threatening diseases.
conclusion
We have made great strides. Basic researchers know more today than
scientists twenty years ago could even dream of understanding. Yet
millions still suffer. We are committed to eradicate more diseases and
ease suffering of individuals with these diseases and those who care
for them. With this subcommittee's help, we hope to continue to make
extraordinary inroads to understanding diseases and successfully curing
them
Thank you again, Mr. Chairman, for the opportunity to testify.
______
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 7 million supporters nationwide, we appreciate the
opportunity to provide testimony on our top funding priority for the
Labor, Health and Human Services, and Education Subcommittee in fiscal
year 2004.
pain and distress research
An estimated 40 percent of the National Institutes of Health (NIH)
budget--or currently more than $11 billion--is devoted to some aspect
of animal research. At this time, no funding is set aside specifically
for research into alternatives that replace or reduce the use of
vertebrate animals in research or that reduce the amount of pain and
distress to which research animals are subjected. NIH may receive $27.7
billion in fiscal year 2004 if Congress fulfills the President's budget
request. Out of this funding, we seek $2.5 million (.009 percent) for
research and development focused on identifying and alleviating animal
pain and distress. We recommend that this R&D be conducted under the
National Center for Research Resources (NCRR, responsible for NIH
extramural funding). We also urge the Committee to specify in report
language that NCRR should conduct this research in conjunction with, or
``piggy-backed'' onto, ongoing research that already causes pain and
distress. No pain and distress should be inflicted solely for the
purpose of this research, given the volume of existing research (we
estimate a minimum of 20-25 percent of all animal research) that is
believed to involve moderate to significant pain and/or distress.
In 1987, NIH announced a program to award grants for ``research
into methods of research that do not use vertebrate animals, use fewer
vertebrate animals, or produce less pain and distress in vertebrate
animals used in research.'' Many of the 17 program awards made from
1987 to 1989, totaling approximately $2.4 million, involved research on
non-mammalian models, including projects on frogs, mollusks, and
insects. Other awards included mathematical modeling and computer
studies. This program, which was managed out of the Division for
Research Resources (the precursor to NCRR), no longer exists at NIH,
and it has not been replaced by any similar program.
A 2001 survey conducted by an independent polling firm indicates
that concern about animal pain and distress strongly influences public
opinion about animal research in general. Public support for animal
research declines dramatically when pain and distress are involved: 62
percent support animal research when pain and distress are minimal,
only 34 percent when moderate, and an even smaller 21 percent when
animal suffering is severe. Despite this public concern, NIH has not
continued to sponsor R&D exploring how to minimize animal suffering and
distress in the laboratory.
During the past five years, HSUS has been reviewing institutional
policies and practices with respect to pain and distress in animal
research. We have found that research institutions have inconsistent
policies due to the lack of information on this subject, and that
standards vary greatly from one institution to another. Painful
techniques, such as the use of carbon dioxide to euthanize rats and
mice, are widely practiced and approved even though studies indicate
that carbon dioxide exposure for only a few seconds causes acute
distress to humans. The federal standard for determining laboratory
animal pain specifies that, if a procedure causes pain or distress to
humans, it should be assumed to cause pain and distress to animals.
While human experience can and should provide a useful guide in some
cases, there are others in which humans are never subjected to the
conditions facing laboratory animals. Information on pain and distress
that animals themselves actually experience is important. For many
accepted laboratory practices there is no scientific data regarding the
painful or distressing effects on either people or animals.
A lack of data on the recognition, assessment, alleviation, and
prevention of pain and distress in laboratory animals is commonly cited
by scientists as a rationale for either not reporting pain and distress
or not acting to mitigate it. This lack of data is obviously
detrimental to the welfare of animals used in research, but it is also
detrimental to the quality of science produced. Uncontrolled,
undetected, and unalleviated pain, physical distress, or psychological
distress result in alterations in physiologic and behavioral states,
and confound the outcome of scientific research. 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 pre-clinical animal research results are applied to humans in
clinical trials. It is worth noting that researchers themselves often
comment publicly at scientific meetings about the urgent need for
funding in order to properly understand and mitigate pain and distress
in research animals.
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. For example, the United Kingdom,
Sweden, Switzerland, Germany, the Netherlands and the European Union
all have committed funds specifically for the ``three R's'' (replacing
the use of animals, reducing their use, and refining research
techniques to minimize animal suffering).
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 for the National Center for
Research Resources 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.''
Again, we appreciate the opportunity to share our views and top
priority for the Labor, Health and Human Services, and Education
Appropriation Act of fiscal year 2004. We hope the Committee will be
able to accommodate this modest request that will benefit animals in
research and the quality of the research. Thank you for your
consideration.
______
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. The Society is the world's largest
private voluntary health organization devoted to the concerns of all
those affected by MS. Throughout our 57-year history, we have
maintained a commitment to research to help us better understand MS and
to apply this knowledge to the development of new treatments and
ultimately a cure. The Society awarded its first three research grants
in 1947, and our commitment to research has steadily grown. This year
we will invest $30.1 million in research.
Multiple sclerosis is a chronic, unpredictable and often disabling
disease of the central nervous system. Symptoms range from numbness in
the limbs, to loss of vision, 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.
To this end, basic and clinical research conducted at NIH and
research supported by NIH throughout the country is of critical
importance to all people with chronic illnesses and disabilities--such
as MS. Since MS is considered both a neurological and autoimmune
disease, two NIH institutes are of particular relevance to our
patients: The National Institute of Neurological Disorders and Stroke
(NINDS)--which funds 75 percent of the MS-specific research at NIH--and
the National Institute of Allergy and Infectious Diseases (NIAID)--
which funds about 25 percent.
In this year's testimony, we wish to bring the following issues to
the Subcommittee's attention:
--The Society's gratitude for the large fiscal year 2003 NIH increase
and hope for continued balanced, increased funding for
biomedical research at all NIH institutes in fiscal year 2004
and beyond.
--The cooperation and responsiveness of NINDS to the Society's
inquiries concerning the coding system that tracks grant
expenditures.
--Increased collaborative research efforts between NIH and the
Society.
nih funding
On behalf of people with MS, the Society wishes to express
gratitude for the Subcommittee's commitment to doubling the NIH budget
from $13 billion in fiscal year 1999 to $27 billion in fiscal year
2003. However, to maintain this current research momentum, the Society
firmly believes NIH needs an 8-10 percent increase in fiscal year 2004
funding. This increase is required to sustain critical biomedical
research at NIH and to keep pace with inflation. With regard to
bioterrorism research, the Society urges the Subcommittee to weigh
carefully the funding allocation at NIH institutes to assure that our
national security needs are met, but to still allow biomedical disease
research at all institutes to grow in fiscal year 2004 and beyond.
The President's fiscal year 2004 budget request, under which NIH
would receive about a 2 percent increase, is of great concern to the
Society. NIH-funded research has led to advances in critical areas of
discovery, such as human genetics, diagnostic testing and more targeted
and effective treatments. If NIH receives a small fiscal year 2004
increase, significant pending and future scientific gains will be
limited and perhaps altogether missed--potentially undermining the
intent of doubling the NIH budget. Furthermore, a 2 percent increase
essentially would constitute a reduction in funding as it would render
NIH unable to keep pace with inflation.
The Society recognizes that new discoveries and breakthroughs could
come from any area of biomedical research and could apply to the
primary concern of our members: ending the devastating effects of MS.
Knowing that a well-funded federal research enterprise is of great
public benefit, we encourage Congress to focus on NIH as a whole, with
balanced consideration given to the two institutes of direct relevance
to people with MS--NINDS and NIAID.
grant recoding process at ninds
In 2000, NINDS changed its procedures for coding and tracking of
grants and consequently, the Society was surprised that reported fiscal
year 2000 expenditures on MS research dropped about 46 percent (to
$40.3 million). The Society is pleased to report to the Subcommittee
that in 2002, the Society worked closely with NINDS leadership to
understand, correct and improve the institute's coding system. As a
result of this effort and after close review, we have determined that
the NINDS actual fiscal year 2002 support of MS-related research was
$65.6 million, a figure that now better represents the institute's
investment in MS. We will continue our efforts to ensure optimal
procedures are used to track the federal investment in MS-related
research at NINDS, NIAID, and NIH-wide.
collaboration with nih
Last year, we raised concerns to the Subcommittee about our
experience with the lead NIH institute in MS research with regard to
joint collaborative research projects in MS. We are pleased this year
to report increased interest in collaborative research and other
activities by NINDS and NIAID.
ninds
The Society currently is working closely with NINDS on a joint
workshop to foster the development of a collaborative and international
MS genetics network. Titled ``Genetics and Multiple Sclerosis: Future
Prospects,'' this workshop will bring together leaders in the field of
MS genetics along with the Society's senior scientific advisors. This
workshop will provide an opportunity to review the state of the art in
the field and to discuss strategies for small and large-scale studies
utilizing the latest technology and cost-effective approaches to
finding the genes that confer susceptibility to MS.
niaid
In 2001, the Society entered into a collaborative agreement with
NIAID to research ``Sex-based Differences in the Immune Response.''
Such collaboration extends the reach of the Society's own targeted
research initiative on gender differences in MS by encouraging basic
and clinical investigation of disparities in immune responses between
men and women and provides wider visibility of the problem and
opportunities. Initiated as an effort of the NIAID, other NIH
institutes, including NINDS, came on board to provide co-funding for a
one-time request for applications. Together, our agencies co-funded six
research projects relevant to MS, as well as projects related to other
autoimmune diseases and to the immune function in general.
Collaborative activity leverages the resources of all parties
engaged in the effort. In the current environment of fiscal constraints
and numerous national spending priorities, collaborative research
across public and private sectors and scientific disciplines presents a
significant opportunity to leverage the research investment of all
involved parties. We ask the Subcommittee to encourage continued
collaboration among NIH institutes as well as outside the boundaries of
the federal government, and we look forward to continuing our
collaborative efforts with NIH institutes.
We thank the Subcommittee for this opportunity to comment and
applaud your steadfast commitment to advancing the health and well-
being of all Americans through substantial investment in biomedical
research.
______
Prepared Statement of the American Association of Immunologists
The American Association of Immunologists (AAI), a non-profit
professional association of more than 6,500 research scientists and
physicians dedicated to understanding the immune system--resulting in
the prevention, treatment, and cure of disease--appreciates this
opportunity to express its views on the fiscal year 2004 Budget for the
National Institutes of Health (NIH). Before we do, we would like to
express our deep appreciation to the members of this subcommittee and
to its chairman and ranking member, Senators Arlen Specter and Tom
Harkin, for your extraordinary support for biomedical research and the
NIH. AAI was very proud to present Senators Specter and Harkin with our
2001 Public Service Award, ``in recognition of their outstanding
leadership, achievements, and advocacy on behalf of biomedical research
and the National Institutes of Health.'' We are grateful for your
continuing leadership and unwavering dedication to government sponsored
biomedical research and the scientists this funding supports.
immunology
The study of immunology spans a wide range of diseases and
conditions which affect the lives of every American. Our scientists use
grants from the NIH, and in particular from the National Institute of
Allergy and Infectious Diseases (NIAID),\1\ to understand the workings
of the immune system. This information allows for delineating the
causes of disease and discovering treatments and potential cures.
Immunologists are currently engaged in many such activities, including:
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\1\ Many AAI members also receive grants from the National Cancer
Institute (NCI), the National Institute on Aging (NIA), the National
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS),
the National Heart, Lung, and Blood Institute (NHLBI), the National
Institute of General Medical Sciences (NIGMS), and other NIH Institutes
and Centers.
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--developing effective vaccines against HIV/AIDS, influenza, and
other infectious and chronic diseases;
--discovering new defenses against emerging and re-emerging bacteria
(such as tuberculosis) and drug resistant bacteria (including
antibiotic-resistance);
--regulating autoimmune diseases such as diabetes, myasthenia gravis,
rheumatoid arthritis, and lupus;
--discovering the causes of cancer and promising new treatments; and
--developing treatments to prevent the rejection of transplanted
organs and bone marrow.
With all of this research ongoing, immunologists have also recently
begun important work on urgently needed biodefense research, much of
which was funded in the fiscal year 2003 appropriations bill. Because
AAI members include the nation's preeminent immunologists, many of our
members are already conducting research that is at the forefront of the
nation's urgently needed vaccine development and related biodefense
research efforts. The work of immunologists will be critical in
understanding both the mechanism of infectious diseases and recovery
from them.
As we discuss this year's budget, we would also like to discuss the
unique role that we believe immunologists are playing in the national
effort to combat bioterrorism.
the nih budget in the post ``doubling'' era
AAI is immensely grateful to Chairman Specter and Senator Harkin,
and to the members of this subcommittee, for initiating and shepherding
the successful effort to double the budget of the NIH over five years,
an effort which was completed during the fiscal year 2003
appropriations process. We cannot emphasize enough the importance of
this extraordinary commitment to the research enterprise, both in terms
of securing additional research dollars and for the ``shot in the arm''
to biomedical researchers all over this nation. Just as our troops
overseas depend on both financial and emotional support from home to
succeed in their mission, so do those on the ``home front'' who are
fighting a war against illness and disease--whether caused by natural
agents or by man-made agents of bioterror. The recent boost in NIH
funding has put NIH and the scientists it funds on a trajectory for
rapid progress and ultimate success.
general biomedical research
AAI strongly believes that future NIH budgets must continue to
recognize the critical importance of biomedical research funding both
as a tool to prevent and treat disease and as an urgent defense against
the threat of bioterrorism. We believe that--to capitalize on the
momentum that has resulted from doubling of the NIH budget--NIH must
now receive increases that are sufficient to support this large
bipartisan investment in biomedical research. In this regard, AAI
recommends a 10 percent increase in funding for NIH for fiscal year
2004. Such an increase--if properly allocated--will allow more quality
research to be funded, leading to more translational opportunities and
swifter clinical application; help attract young Americans to research
careers; and help retain young, promising scientists (who might
otherwise leave academia or government for better rewarded
opportunities with pharmaceutical or biotech companies).
As you know, the President's fiscal year 2004 budget proposes a
budget of $27.893 billion, a 2 percent increase over the fiscal year
2003 budget. According to the Administration, the actual increase in
funding for ``research programs and support'' will be 7.5 percent ``as
a result of converting approximately $1.4 billion from one-time non-
recurring costs in fiscal year 2003 for facilities construction and
anthrax vaccine procurement. . . . [Department of Health and Human
Services Fiscal Year 2004 Budget Summary (``HHS Budget Summary''), page
31] Administration officials concede, however, that with biodefense
research growing at a faster rate, non-biodefense research will
increase only 4.3 percent.\2\ [National Institutes of Health, Summary
of the President's Budget, February 3, 2003 (``NIH Budget summary''),
p.1] AAI is very concerned that this increase is too small to both
support ongoing research and permit funding of a sufficient number of
new and competing continuation grants. In addition, this increase will
not support the continued enhancement of pre- and post-doctoral
stipends (see p. 5).
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\2\ The President's fiscal year 2004 proposed budget indicates that
the average cost of research project grants will increase in the
aggregate by only 2.7 percent. (NIH Budget summary, p. 5)
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biodefense research
The Administration proposes a slight decrease in NIH biodefense
funds, requesting $1.6 billion in fiscal year 2004. Once again,
Administration officials consider this $121 million reduction a result
of ``significant one-time, non-recurring biodefense expenses in fiscal
year 2003 . . .,'' resulting in an increase of $875 million in fiscal
year 2004. (HHS Budget summary, p. 32) AAI supports this level of
biodefense funding, and in particular (as described below), strongly
supports the request for 125 FTEs for biodefense research activities.
While the infrastructure funding provided in the 2003 appropriation
was both needed and welcome, it does not provide all of the needed
facilities for biodefense research (see p.3), nor does it provide
funding for the additional security costs mandated by the Patriot Act
both as one time costs and for ongoing security required at facilities
which conduct research on select agents. In addition, this important
research cannot get done without adequate NIH intramural staff to award
the grant funding and to provide necessary administrative and oversight
functions. It is vitally important, therefore, that the NIH
professional staff be increased to oversee the biodefense research and
that they be provided with sufficient administrative and fiscal support
personnel. We urge the Congress to provide NIH with these and any other
resources it needs to ensure the expedited distribution, efficient use,
and sound stewardship of federal biodefense funds.
Project BioShield.--While we have not yet had an opportunity to
review the details of the proposed Project BioShield, we look forward
to working with the Administration and the Congress on this program.
Construction of New High Containment (BSL3/BSL4) Laboratories.--
Work on many select agents as well as other pathogenic bacteria,
viruses, and fungi require biological and physical containment. One of
the limiting factors in the ability of the research community to
perform critical work relating to the cause, treatment, and cure of
these disease-causing organisms is the relative scarcity of physical
laboratories that are equipped to allow a safe working environment for
both the investigator and the community.
BSL4 laboratories provide the highest level of containment. While
there is currently a shortage of BSL4 labs, several new facilities are
coming on line and will certainly ease the cues of experiments to be
performed in the existing BSL4 facilities. There does, however, remain
a need for additional BSL3 facilities that are adequately secured for
use with select agents. These labs, while used for less dangerous
select agents, have many advantages: they can be used for experiments
on many biohazardous agents; they can be accommodated in many different
physical buildings; and their operational costs are much lower than for
BSL4 facilities. AAI supports the construction of additional BSL3
facilities at institutions around the country to allow access of
investigators who have important projects requiring this standard of
protection.
Just as important as the construction of new high containment
laboratories is ensuring adequate training in their use. AAI urges the
Congress to support programs which enable graduate students, post-
doctoral fellows, and senior investigators to obtain proficiency
training to allow them to work in biohazard labs. Such programs could
be in the form of brief training periods or as supplements to existing
training grants.
the role of immunologists in the national response to bioterrorism
Because immunologists study the immune system in health and
disease, we have both a special interest and expertise in the nature of
infections. We have a unique ability to study the normal immune
response to the bacteria and viruses which could be used as weapons of
bioterrorism. An important aspect of the normal immune response is
defining the ``targets'' (i.e., antigens or epitopes) the immune system
uses to recognize and destroy invading pathogens. In immunologic terms,
this means defining the chemical nature of the epitopes recognized by
the major defenders of the immune system--T and B lymphocytes. The
mechanisms of defining epitopes are well known, but have not been
applied to some pathogens which could be used as weapons of
bioterrorism; these will need to be defined in the test tube, in animal
models,\3\ and finally, in humans. Once we understand the human immune
response, we will be prepared to develop life-saving therapies and
preventive vaccines. Collaboration between microbiologists, who
understand the biology of infectious agents, and immunologists, who
understand how the immune system recognizes and fights infectious
agents, is critical.
---------------------------------------------------------------------------
\3\ Immunologists depend heavily on the use of animal models in
their research. Without the use of animals, 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, people and organizations that oppose such research
are threatening scientists who use animal models. The legal and illegal
methods used by these 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 that is underway.
---------------------------------------------------------------------------
Some exciting work in the area of biodefense is already underway.
Immunologists, working in conjunction with infectious disease
specialists, are using cutting edge technology to ``immunize'' people
against agents of bioterror. Rather than using the traditional ``active
vaccination'' approach, which requires injection of attenuated microbes
or inactivated toxic molecules and a period of some weeks to months
before the individual is protected from the disease and/or infectious
agent, immunologists are working to develop passive antibody therapies
(i.e., developing human monoclonal antibodies that can be used in vivo
to neutralize and remove bioterrorist microbes and their toxic
products) for prevention and treatment of infections or the toxic
effects caused by selected bioterrorism agents. In many instances, this
approach would be far preferable to active vaccination as it has few,
if any, of the potential side effects that can occur as a result of
active vaccination and provides immediate protection that will last for
months. Such a therapy could be used to protect first responders and
others prone to exposure in the event of a bioterrorism incident. This
developing therapy has the potential to be used as protection against
anthrax, plague, botulinum toxins, and smallpox, among others.
Another example of important biodefense work is research being
conducted on vaccinia virus, which is used as the vaccine for smallpox.
Immunologists have demonstrated through mouse models that the immune
response to vaccinia virus is greatly altered when the host has
previously had infections with other, completely unrelated viruses. As
a result, immunologists are now studying whether adult humans who
receive the smallpox vaccine for the first time may respond in
different ways than children, as the adults have had a history of more
infections by other viruses that could account for differences in the
side effects of adult vaccination that are now being seen.
research, management and services (rm&s) budget
AAI is very concerned about the Administration's plans for the
Research, Management and Services (RM&S) budget, and in particular, for
the ``outsourcing'' portion of that plan. The significant new funding
appropriated to NIH requires additional administrative staff to ensure
that the money is well and properly spent. While the RM&S budget
supports the management, monitoring, and oversight of intra- and extra-
mural research activities (including ensuring the continuation of NIH's
excellent and highly regarded peer review process), it has not kept
pace with the increasing size and complexity of the NIH budget.
While the President's fiscal year 2003 budget included an overall
increase of 17 percent (with an average 9 percent increase for most
Institutes and Centers and a larger increase for NIAID and NCI), the
President's fiscal year 2004 budget recommends an increase of only 5.3
percent. (NIH Budget summary, p. 9) As a result, only 3 percent of the
NIH budget will be devoted to RM&S, continuing a decline in funding
(from the 4.8 percent that RM&S received in fiscal year 1993) which has
occurred even as the NIH budget--and programs supported by that
budget--increase.
AAI is also very concerned about the Administration's proposal for
``outsourcing.'' While certain jobs within NIH 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 the programs and policies of NIH.
Outsourcing such positions will undoubtedly result in the loss of a
dedicated and capable workforce, reducing efficiency in the long run.
AAI believes that proper stewardship is the best guarantee the
taxpayer and the Congress have that appropriated funds will support the
highest quality research and lead to the most promising results. We
urge Congress to increase the RM&S budget, restrict outsourcing to non-
programmatic activities, and permit streamlined hiring procedures to
assist in the expeditious awarding of grant funds.
salary cap
The President's fiscal year 2004 budget request includes a
provision which was rejected by the Congress for the last two years to
lower the existing salary cap for extramural researchers. As we
understand this year's provision, it again proposes to ``roll back''
current law and result in a 10 percent reduction in salary support for
some extramural researchers. This would cause serious administrative
and budgetary problems within research institutions, medical schools,
and universities that are preparing or have already prepared budgets
based on the higher salary cap previously permitted by the Congress. We
urge this subcommittee and the Congress to reject this provision and to
retain current law.
attracting bright students to biomedical research and retaining young
researchers
AAI has long been concerned about science's ability to attract
bright young students to careers in biomedical research to ensure the
future supply of biomedical researchers. In particular, we have worked
to advance the plight of post-doctoral fellows who are significantly
underpaid and under-compensated for their critical work. We were very
pleased, therefore, when the NIH announced in March of 2001 that it
intended to implement recommendations of the National Academy of
Sciences' Committee on Science, Engineering, and Public Policy
(COSEPUP) regarding the need for better compensation and employment
benefits for post-doctoral fellows. (See NIH NOT-OD-01-027). The final
NIH plan included increasing the stipends for the Ruth L. Kirschstein
National Research Service Awards (NRSA) recipients over a five year
period by 10 percent per year or until entry level post-doctoral
fellows reach $45,000 per year (from its fiscal year 2002 level of
$31,092). During fiscal year 2002 and fiscal year 2003, the NIH did
raise stipends by 10 percent. The President's fiscal year 2004 budget,
however, permits only a 4 percent increase for pre-doctoral fellows
(from the current stipend level of $19,968), and from 4 percent to 1
percent, based on years of experience, for post-doctoral fellows. We do
not believe that this increase, which would result in an annual stipend
of $35,560 for first year post-doctoral fellows (and includes few, if
any, fringe benefits), provides adequate support for post-doctoral
scientists, many of whom are in their thirties, are married, have
children, and are trying to buy homes, save for their children's
college educations, and save for their own retirement.
We strongly urge this subcommittee to enable NIH to proceed with
its plan to increase NRSA post-doctoral stipends and to further explore
ways to provide important employment benefits--including health
insurance, pensions and Social Security, and vacation and sick leave
time--to both NRSAs and the post-doctoral fellows supported by NIH
extramural grants. While we understand that this may result in the
hiring of fewer post-doctoral fellows, we believe that it is essential
to provide a living wage and basic employment benefits if we are to
attract and retain the best and brightest students who often encounter
multiple job opportunities with significantly more attractive
compensation packages. NIH and the National Science Foundation have
both recognized this reality facing the nation's scientific community
and have attempted to address this problem directly--we urge the
Congress to enable NIH to move forward with its post-doctoral stipend
plan.
scientific advisory committees
AAI has been concerned about reports we have read in Science and
Nature magazines as well as anecdotal evidence suggesting that various
federal scientific advisory panels have been dismantled or reorganized
in an effort to ensure political compatibility with specific positions
of this Administration. AAI believes strongly that it is in the best
interests of the public, the government which serves them, and the
advancement of science that members of government scientific advisory
panels be selected on the basis of the excellence of their science, and
not on the basis of their political affiliations, voting history, or
religious views. In short, 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 that is
available. We hope that the members of this subcommittee might address
this concern in report language to reassure the scientific community
that the Federal Government values receiving independent scientific
advice, not based on conformity with specific litmus tests.
conclusion
At this writing, the Senate is just beginning consideration of
fiscal year 2004 appropriations for NIH. We look forward to the hearing
process, to learning more about the plans the Administration and the
Congress have for advancing biomedical research at and through the NIH,
and to commenting on those plans as they unfold. We will continue to
embrace the many familiar research areas that are open to our
scientists and to working with NIH to help educate bench scientists
about the newer urgent scientific needs--and the ever-increasing
scientific opportunities--that lie before us. We hope that the members
and staff of this subcommittee--and the Senate--will look to us as a
resource on any matters involving the immune system, vaccine
development, or biomedical research in general. We appreciate having
this opportunity to express our views.
______
Prepared Statement of the American College of Cardiology
introduction
The American College of Cardiology (ACC) is a 29,000-member,
professional medical society and educational institution whose mission
is to foster optimal cardiovascular care and disease prevention through
professional education, promotion of research, and leadership in the
development of standards and guidelines and the formulation of health
policy. The ACC submits for the record this statement in support of
fiscal year 2004 funding for the National Heart, Lung, and Blood
Institute (NHLBI).
Due largely to the medical research and education programs
supported by the NHLBI, many Americans who suffer from or are at risk
for cardiovascular disease now have access to a greater variety of
diagnostic tests, medical treatments, and information about prevention.
Even with these advances, cardiovascular disease continues to claim
almost as many lives each year as the next five leading causes of death
combined. With the aging of the so-called baby boom generation, the
number of people at risk for cardiovascular disease is only likely to
grow, making it critical that recent and future discoveries be
translated into practice as quickly as possible. The ACC urges the
subcommittee to continue its long-standing support for the NHLBI and,
specifically, for its heart-related research.
The advances in the treatment of cardiovascular disease achieved
over the last several decades have saved millions of lives and improved
the quality of life for many who otherwise would not have had access to
the life-saving treatments they desperately needed. But because
cardiovascular disease continues to afflict millions of Americans, and
because researchers are on the brink of exciting new discoveries that
will help prevent and treat cardiovascular disease, it is critical that
the NHLBI be funded at the highest possible level.
In addition, the work of the Agency for Health Care Research and
Quality has emerged as a critical partner of the research community in
working to ensure the effective migration of relevant clinical research
results into practice. AHRQ sponsors and conducts research designed to
provide evidence-based information on health care outcomes--that is,
quality, cost, use and access. The information has the potential to
help health care decisionmakers--patients and clinicians, health system
leaders, purchasers, and policymakers--make more informed decisions and
ultimately to improve the overall quality of health care services.
the cost of cardiovascular disease
The total cost of cardiovascular disease in the United States in
2003 is estimated to be $351.8 billion. This figure includes direct
costs, such as the cost of physicians, hospitals, nursing home
services, medications, and home health care. Of the $351.8 billion,
$142.5 billion is attributed to the indirect costs of lost productivity
resulting from morbidity and mortality.
Cardiovascular disease claimed 945,836 lives in the United States
in 2000--that is 39.4 percent of all deaths, or one of every 2.5
deaths. More than 2,600 Americans die of cardiovascular disease every
day, an average of one death every 33 seconds. In addition, 150,000
Americans under the age of 65 are killed by cardiovascular disease each
year. Contributing to these staggering numbers is the fact that, people
who have had a heart attack run a risk of sudden death that is four to
six times greater than that of the general population.
For the past five years, Congress has demonstrated its deep
commitment to medical research by completing a five-year plan of
doubling funding for the National Institutes of Health (NIH) by 2003.
The ACC commends this dedication to medical research funding,
especially in light of the constraints placed on the federal budget and
competing funding priorities. The ACC believes that the completion of
the doubling of the NIH budget has been an excellent down payment on a
strong medical research infrastructure. Despite all that has been
accomplished, the federal government should not rest on it laurels. Now
is the time for Congress to demonstrate that medical research truly is
a priority by continuing to increase federal support of the NIH.
translating research from ``bench to bedside"
The ACC believes that the expansion of large-scale clinical trials
is critical if we are to translate ground-breaking research into useful
practice. Clinical trials can also be an important tool for identifying
early therapeutic strategies and pharmacological agents that have the
potential to reduce health care costs. Many of these trials require
thousands of patients to be studied over several years. In addition to
expanding the number and scope of clinical trials, additional resources
must be dedicated to train the next generation of clinical
``trialists'' in the areas of biostatistics, trial design, outcomes
research, and bioethics.
High blood pressure, also known as hypertension, is a major
contributor to and indication of cardiac diseases. According to recent
estimates, one in four U.S. adults has high blood pressure, but because
there are no symptoms, nearly one-third of these people don't even know
they have it. Compared to the general population, patients with
hypertension are three times more likely to develop coronary heart
disease and six times more likely to develop congestive heart failure.
A very recent clinical trial has shown that relatively inexpensive
traditional diuretics are just as effective as newer medicines like
calcium channel blockers and ACE inhibitors when attempting to prevent
heart attack, stroke, and heart failure.
A recently concluded clinical trial demonstrated that patients who
have normal levels of harmful low-density lipoprotein (LDL)
cholesterol, known as ``bad'' cholesterol, can see significant benefit
from drug treatments that raise the levels of high-density lipoprotein
(HDL) cholesterol, or ``good'' cholesterol. The HDL Atherosclerosis
Treatment Study (HATS) was designed to study the effect of lowering LDL
and raising HDL levels on the progression of atherosclerosis in
coronary disease patients. HATS found that patients who were
administered a combination of the drugs simvastin and niacin not only
had a significant reduction in the progression of atherosclerosis, but
they also experienced a significant reduction in incidences of heart
attacks, strokes, and deaths. This was important work because while the
health benefits of lowering LDL levels are understood and applied in
the medical community, the beneficial effects of raising HDL levels and
improving the balance between LDL and HDL was not previously well
understood.
The NHLBI is also currently funding a clinical trial designed to
test public access to automated external defibrillators (AEDs)--devices
that automatically analyze heart rhythms and deliver an electric
current to the heart of a cardiac arrest victim. Researchers already
know that AEDs save lives. The Public Access to Defibrillation (PAD)
program is designed to measure the life-saving potential and cost
effectiveness of putting AEDs in the hands of trained lay individuals.
For every minute that the heart is not shocked back into rhythm, the
cardiac arrest victim's chances of survival decrease by 10 percent.
About one-fourth of the 300,000 annual deaths from sudden cardiac
arrest occur outside the home in public areas, making it critical that
more people are trained so the time between cardiac arrest and
defibrillation is shortened.
Knowing the critical importance of early defibrillation, the ACC
asks the subcommittee to reaffirm its support for public access to
emergency defibrillation by funding community AED programs at $42.5
million for fiscal year 2004. Continued funding will be used to help
communities buy AEDs and train first responders and the public in their
use.
Almost 62 million Americans suffer from one or more types of
cardiovascular disease. Contrary to society's belief that men are more
likely to suffer from cardiovascular disease than women, 32.1 million
women, compared to 29.7 million men currently suffer from one or more
forms of cardiovascular disease. Women also typically develop
cardiovascular disease later in life than men.
As women age, one of the most important health decisions they face
is whether to use post menopausal hormone therapy. Until recently,
studies have yielded conflicting results about the hormone therapy's
effects on breast cancer, heart disease, and other conditions. Research
being conducted through the Women's Health Initiative (WHI), provides
new important information that women and their physicians should
consider when making that choice. The NIH established the WHI in 1991
in an effort to address the most common causes of death, disability and
impaired quality of life in postmenopausal women. This 15-year, multi-
million dollar endeavor is important to research being done on
cardiovascular disease and women and is one of the largest prevention
studies of its kind in the United States. In summer 2002, WIS halted
its hormone therapy study after it was found that the risks of long-
term estrogen plus progestin therapy outweighed its protective
benefits. The researchers found increased risks of heart attack,
stroke, invasive breast cancer, and blood clots. And although the
increased risks are small, when applied to the entire population of
women on hormone therapy and over several years, the potential public
health impact could be considerable.
If clinical research is to benefit patients, resources must be
available to facilitate the transmission of clinical trial data to the
general medical community. The ACC asks the subcommittee to designate
funds for clinical research training and for the translation of
research into practice, through the NIH and other federal agencies.
future research and development initiatives
With adequate funding, the possibilities of medical research are
endless. Each advance in cardiovascular research opens the door to
other new and exciting initiatives. Increased funding for medical
research through the NHLBI is needed not only so current research
initiatives can continue, but so that the NHLBI can pursue new research
opportunities. The ACC encourages Congress to provide funding for these
and other research initiatives which NHLBI hopes to pursue in fiscal
year 2004:
DNA Research
Because of the size and complexity of the human DNA puzzle,
currently there are very few laboratories which are sufficiently
staffed and equipped to tackle the work of narrowing long sequences of
genetic code down to useable information. Genetic predisposition to
certain diseases can be placed within a certain region of DNA, but
narrowing the focus down to be able to pinpoint the causative gene
requires highly specialized equipment and personnel. The NHLBI plans to
fund a handful of laboratories to pursue the work of accurately
identifying the specific genes that predispose an individual towards
the development of cardiovascular disease. Research of this type has
already proven effective. Last year researchers were able to identify
first in mice and later in humans the gene which associated with the
levels of triglyceride (a type of fat) in a person's blood. This is
important because triglyceride levels are associated with a risk of
coronary heart disease.
Overweight and Obesity Prevention and Control at the Worksite
Nearly two-thirds of the adult U.S. population is overweight or
obese. As a result, more Americans are at risk of developing various
cardiovascular problems ranging from atherosclerosis to total heart
failure. Among its research opportunities for fiscal year 2004, the
NHLBI plans to develop a new program that will support the design and
testing of innovative worksite interventions for preventing and
controlling overweight and obesity in adults. Because of the risks
associated with unhealthy body weight, it is important that the current
approach of appealing to individuals to control their weight is
expended to include the workplace, which is a promising location to
encourage healthy lifestyle changes.
Recovery of Heart Function with Circulatory Assist
The only proven treatment for end-stage heart failure is heart
transplantation, but the waiting list for transplants is long. While
waiting for an appropriate donor heart to be found, a mechanical
circulatory assist device is utilized to stabilize a patient. There is
some some evidence that the ``rest'' that mechanical assistant provides
to the heart may actually enable the heart to recover function. The
NHLBI hopes to initiate a study that will capitalize on this
observation and determine the potential for sustained myocardial
recovery through the use of external circulatory assistance devices,
identify the kinds of patients most likely to reap reparative benefits
from temporary assistance, and investigate collaborative treatment
protocols which will promote cardiac tissue repair.
Mechanisms of HIV-Related Cardiopulmonary and Hemostatic Complications
``Drug cocktails'' and anti-viral therapies have begun to transform
the lives of individuals infected with HIV. HIV-positive individuals
who receive modern treatment have seen greatly lengthened life
expectancies. While these new treatments are exciting, HIV patients are
now beginning to present secondary effects of infection, including
serious cardiopulmonary and hemostatic complications. The NHLBI will
initiate a research initiative aimed at furthering understanding the
relationship between HIV infection and other diseases such as
opportunistic infection of the heart, emphysema, and coagulation
disorders. It is important that health care providers are given the
tools to deal with both the primary effects of HIV infection and also
the secondary complications which are becoming more prevalent.
Cultural Competence Academic Award
Cultural, linguistic, and social differences in populations can
present barriers to effective diagnosis and treatment of cardiovascular
disease. To promote the design of materials specific for cultural or
ethnic groups and their dissemination throughout the medical community,
the Cultural Competence Academic Award will be established as a
medical-training curriculum development initiative.
the value of prevention and education
While the ACC stresses the continued need for increased funding for
NHLBI research, new treatments and therapies are not enough to win the
fight against cardiovascular disease. If we are to turn the corner in
our battle, efforts must be strengthened to reduce the incidence of
heart attacks, coronary heart disease, heart failure, and high blood
pressure through increased patient and physician education. We know
hypertension, high cholesterol, obesity, diabetes, smoking, and
physical inactivity are definitively associated with heart disease.
Current education programs funded by the NHLBI include the National
Cholesterol Education Program, the National High Blood Pressure
Education Program, the Obesity Education Initiative, the National Heart
Attack Alert Program, and the Women's Heart Health Initiative. These
programs are designed to make information readily available to
physicians, patients, and their families.
Lipid Reduction
The leading indicator of heart disease is high cholesterol.
Although many people know that high cholesterol is bad, they tend to be
unaware of which levels of cholesterol are considered high or
dangerous. In 2001, the NHLBI released new guidelines redefining
healthy and unhealthy cholesterol levels. As a result of these new
guidelines, the ``Third Report of the National Cholesterol Education
Program Expert Panel on Detection, Evaluation, and Treatment of High
Blood Cholesterol in Adults'' (also know as the Adult Treatment Panel
III [ATP III]) released in spring 2001 calls for more aggressive
cholesterol-lowering treatment and for better identification of those
at high risk of contracting heart disease. To inform people about these
new guidelines, the NIH developed several resources to get the
information out to physicians, including an ``ATP III at-a-Glance''
desk reverence and a Palm-OSR interactive tool. And as a way of
encouraging patients to be more active partners in their care, the NIH
released a new patient booklet titled, ``High Blood Cholesterol--What
You Need to Know,'' a simplified 10-year heart disease risk calculator
for the public, and an updated Web site, ``Live Healthier, Live
Longer,'' that includes all the information in the ATP III study.
Statins, drugs that play a key role in lowering cholesterol, while
gaining popularity, are still underused. It is especially important,
now that the NHLBI has lowered the levels at which cholesterol is
considered high or dangerous, that people know their cholesterol levels
and their options for treatment.
Obesity Prevention
One of the greatest health threats in this country and in the
battle against heart disease is obesity. Over the past 20 years,
obesity rates among adults and children have skyrocketed. Last year,
the U.S. Surgeon General issued a ``call to action'' to prevent and
decrease overweight and obesity. We must heed this call, otherwise we
risk turning back the clock on the gains made in areas such as heart
disease, several forms of cancer, and other chronic health problems. At
the core of the obesity problem is poor diet and physical inactivity,
which are cross-cutting risk factors that contribute significantly to
deaths from heart disease, stroke, and diabetes. This country must
dedicate the resources necessary to encourage more Americans to have a
healthier diet and to be physically active. The ACC encourages the
subcommittee to support a funding level of $65 million in fiscal year
2004 for the Division of Nutrition and Physical Activity, and $125
million to restore the Youth Media Campaign at the Centers for Disease
Control and Prevention.
Promoting Heart-Healthy Lifestyles
In another effort to promote heart-healthy lifestyles in
communities around the country whose residents have higher than normal
mortality rates from coronary heart disease and stroke, the NHLBI has
created and funded twelve Enhanced Dissemination and Utilization
Centers (EDUCs), doubling the number of EDUCs in existence. The EDUCs
are expected to form the foundation of a nationwide network to reduce
the burden of cardiovascular disease by changing the behaviors of
health care providers, patients, and the general public. The EDUCs are
just one element of a larger heart-health agenda that the NHLBI
launched as part of its efforts to meet the federal government's
Healthy People 2010 report goals. Healthy People 2010 are the federal
government's plan for building a healthier nation over the next 10
years. Its two major goals are to end racial and ethnic disparities in
the burden of disease and to increase the years and quality of life for
every American.
AHRQ--Moving Research into Practice
The research and education developments the federal government has
facilitated are remarkable and exciting. However, the best research is
of no value if it never reaches the patient. The Agency for Healthcare
Research and Quality (AHRQ) is charged with ensuring that advances in
medicine become the baseline for medical care. By fulfilling the
mission of placing today's breakthroughs in the hands of physicians
tomorrow, AHRQ injects up-to-the-minute research into day-to-day
medical decisions and treatments. AHRQ has become an increasingly
important partner to both the clinical research community and to the
ACC and other private sector organizations as we work to develop
continuous quality improvement initiatives. In addition to funding
cardiovascular outcomes effectiveness research, AHRQ recently announced
the funding of a coordinated set of projects to test different
mechanisms for accelerating the health system's adoption of research
findings that demonstrate ways to improve quality of care. These
include financial incentives and rewards for providers, and innovative
team-oriented educational programs. AHRQ also funds evidence-based
practices to review the latest scientific evidence and draft summary
reports such as a recent one on Blood Pressure Monitoring. The ACC
urges Congress to support the work of the AHRQ and to provide a funding
increase for AHRQ in fiscal year 2004.
conclusion
Beyond better public awareness and the translation of research into
practice, reducing the number of cardiovascular-related deaths is
greatly dependent on research sponsored by the NHLBI. The ACC hopes the
subcommittee shares its optimism and urgency about the unique
opportunities that our scientists and clinical investigators now have
to achieve their long-standing goal of conquering the nation's number-
one killer. In summary, the ACC encourages the subcommittee to provide
a funding level of at least $3.5 billion for the National Heart, Lung,
and Blood Institute within the National Institutes of Health for fiscal
year 2004. It is a wise investment in the future health of our nation.
______
Prepared Statement of the National Breast Cancer Coalition
introduction
Thank you, Mr. Chairman and members of the Subcommittee for your
dedication and leadership in working with the National Breast Cancer
Coalition (NBCC) to help in our fight to eradicate breast cancer.
As you know, the National Breast Cancer Coalition is a grassroots
organization dedicated to ending breast cancer through the power of
action and advocacy. The Coalition's main goals are to increase federal
funding for breast cancer research and collaborate with the scientific
community to design and implement new models of research; improve
access to high quality health care and breast cancer clinical trials
for all women, and; expand the influence of breast cancer advocates in
all aspects of the breast cancer decision making process. Nearly 600
NBCC advocates will be on Capitol Hill on Tuesday, May 6, to lobby
their Senators and Representatives on a legislative agenda that
reflects these goals. NBCC truly believes that with our extraordinary
determination and unbelievable spirit, combined with your continued
support for high quality breast cancer research, this deadly disease
will someday be eradicated.
continued funding for breast cancer research is critical
The Coalition would like to emphasize the advancements in breast
cancer research that have come about as a result of your longstanding
support for this issue. Developments in the past few years have begun
to offer breast cancer researchers fascinating insights into the
biology of breast cancer and have brought into sharp focus the areas of
research that hold promise and will build on the knowledge we have
gained. We are at a point where we are now able to target genes and
begin to know how to address one woman's breast cancer in a different
way from another woman's. This knowledge is leading us forward in
finding the answers to prevention of breast cancer, as well as how to
detect it earlier, and treat it more effectively. Now is precisely the
time to continue your support for this important research.
the breast cancer and environmental research act
NBCC asks for your support for increased appropriations for breast
cancer research at the National Institute of Environmental Health
Sciences (NIEHS). During the 107th Congress, Senators Chafee, Reid,
Hatch and Leahy introduced S. 830, the Breast Cancer and Environmental
Research Act. (Representatives Lowey and Myrick introduced the House
companion bill, H.R. 1723.) This legislation will be reintroduced in
the 108th Congress with the goal of establishing Breast Cancer and
Environmental Research Centers at the National Institute of
Environmental Health Sciences to support research on environmental
factors that may be related to the etiology of breast cancer.
It is generally believed that the environment plays some role in
the development of this disease, but the extent of that role is not yet
understood. NBCC believes that a strategy must be developed and more
research done to determine the impact of the environment on breast
cancer. It is only when we understand what causes this disease that we
will have a better idea of how to prevent it, how to treat it more
effectively, and how to cure it.
Women want to do all they can to reduce their risk of breast cancer
or a recurrence. However, little is known about how the millions of
environmental exposures we encounter each day impact the incidence of
breast cancer. While there have been isolated studies looking at the
suspected environmental links to breast cancer, overall, the issue of
what causes breast cancer and the association between the environment
and breast cancer has been chronically underfunded and understudied.
The Coalition believes the Breast Cancer and Environmental Research
Act is the appropriate strategy to examine this question. Many Members
of Congress from across the political spectrum agree with this approach
as well. NBCC specifically appreciates this Subcommittee's
recommendation in CR 107-84 regarding the need for additional research
in the realm of breast cancer and the environment. We thank the
Subcommittee for taking these important first steps in endorsing the
goals set forth in this legislation. The time is right for the
Committee to move forward in the fight to eradicate this disease by
providing $30 million to fund up to eight breast cancer and
environmental research centers, which would make grants using a peer
review and programmatic review process that involves consumers. NBCC
urges the Committee to use the tremendously successful Department of
Defense (DOD) Peer-Reviewed Breast Cancer Research Program (BCRP) as a
model for the structure of this research program.
accountability at nih
Finally, NBCC believes the issue of accountability at NIH is an
especially timely one with respect to the completion of doubling the
NIH budget. We would like to see collaboration among consumer
advocates, NIH and Congress, to create mechanisms to ensure a higher
level of accountability for federally funded breast cancer research.
The National Breast Cancer Coalition understands that the level of
funding is meaningless unless the funds are allocated appropriately.
The Coalition believes that the call for increased accountability
should be a collaborative effort, and wants to work with the Committee
and with NIH and NCI. The Programmatic Review Group (PRG), which Dr.
Klausner convened in 1998 to provide an account of NCI's plan to
eradicate breast cancer, was a good beginning; however, a more
comprehensive strategy is necessary.
We know that NIH and NCI are as committed as we are to finding
prevention and cures for this disease. However, there needs to be
outside oversight of NIH to monitor this process. NBCC believes that it
is inappropriate for a government agency to design its own oversight;
rather, the public must design and participate in a process that can
review decisions without bias. The time is right for Congress to
request an independent audit of research funding at NIH--using breast
cancer research funding as a model. The question of whether changes may
be needed in the grant mechanism and research structure at these
Institutes should be explored. This outside evaluation is necessary to
update processes or to uproot outmoded or duplicative efforts that no
longer make sense.
The Coalition also seeks answers to the questions that remain. For
instance, how is breast cancer research funding currently being spent?
Who sets priorities and what criteria are applied? And, how can we, as
consumer advocates, seek to influence how the money is being spent?
NBCC believes that some of the answers to these questions lie in
the model of accountability in the Department of Defense (DOD) Army
Peer-Reviewed Breast Cancer Research Program (BCRP). While the DOD BCRP
is significantly smaller and more focused than NCI and NIH, it has an
effective infrastructure of accountability that serves as a good model
for other research programs to follow.
The DOD Integration Panel has outside members that include
advocates on both levels of peer and programmatic review. Also, the DOD
Breast Cancer Research Program has reported the progress of the program
to the American people during two public meetings called the ``Era of
Hope.'' These meetings have been the only times a federally funded
program reported back to the public in detail not only on the funds
used, but also with regards to the research undertaken, the knowledge
gained from that research and future directions to pursue. These
meetings allowed scientists, consumers and the American public to see
the exceptional progress made in breast cancer research through the DOD
Peer-Reviewed Breast Cancer Research Program.
As we are all aware, these are taxpayer dollars. We owe it to all
of our constituencies to assure them that this investment is spent
wisely. The National Breast Cancer Coalition supports increased
appropriations for breast cancer research so that we can eradicate this
disease as soon as possible, however, it is vital that the public
understand how the funds are being spent. NBCC would like to work with
Members of this Subcommittee on this issue.
conclusion
Chairman Specter, Senator Harkin, and members of the Subcommittee,
thank you again for the incredible investment you have made in helping
us work to eradicate breast cancer. NBCC looks forward to continuing to
work with you to end this disease.
______
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 19 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; Association of Black
Cardiologists Citizens for Public Action on Blood Pressure and
Cholesterol, Inc.; Compliment; Congress of Neurological Surgeons;
International Society for Cardiovascular Surgery; Mended Hearts, Inc.;
National Stroke Association; North American Society of Pacing and
Electrophysiology; Society of Interventional Radiology; Society of
Vascular Surgeons; and WomenHeart.
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 Forcasting
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.
Several 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 heart and stroke
research funding.
I am proud to say I traveled to 18 communities and met personally
with 28 members of our delegation or their staff. Nearly half of our
congressional delegation is now members of the Congressional Heart and
Stroke Coalition.
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, his livelihood, and marriage,
I remain a statistician at heart. I couldn't resist calculating and
telling that part of my story. But please remember my story is not
dissimilar to that of many of the 4.7 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 over $600,000.
--Subsequently, the cost to the federal government in lost income and
other taxes, early Medicare payments and Social Security
disability payments is over $320,000.
--My HMO spent approximately $150,000 to respond to and treat my
stroke.
--One man, over one million dollars.
About 700,000 Americans will suffer a stroke this year costing this
nation an estimated $51 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'm 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. I appreciate the
support of Congress in the past for eliminating restrictions on access
to rehabilitation services essential to those who have experienced a
stroke. Unfortunately, caps on reimbursement will be re-implemented in
July. I urge you to act on this important issue.
______
Prepared Statement of the American Society for Microbiology
The American Society for Microbiology (ASM) strongly recommends
continued strong growth for the National Institutes of Health (NIH) to
sustain and expand on the extraordinary progress in medical research
that has been set in motion during the past 5 years as a result of the
substantial increased funding provided by Congress for the nation's
biomedical research enterprise. The Administration has proposed $27.9
billion for the NIH in its fiscal year 2004 budget request, an increase
of $549 million over fiscal year 2003 funding. The 2 percent increase
is greatly inadequate and will undoubtedly decrease and slow promising
areas of biomedical research. The ASM recommends that Congress approve
a 10 percent increase in the fiscal year 2004 budget for the NIH to
bring the level of funding to $30 billion. A 10 percent increase for
the NIH budget will improve its ability to capitalize on the
substantial achievements of the past 5 years and enhance its ability to
seize scientific opportunities to advance national health and security.
Fortunately, the robust levels of budgetary support for the NIH
over the past 5 years have produced medical and technological advances
that serve public health as well as the defense of the nation and the
world. These significant benefits include discovery of the mechanisms
by which anthrax toxin destroys cells, which will speed development of
anthrax therapies; the finding that available doses of licensed
smallpox vaccine can be ``stretched'' by dilution to provide protection
for more people; collaborative efforts to develop a new and safer
smallpox vaccine; and new anthrax vaccine candidates that will soon
enter clinical trials. NIH has also been responsible for a number of
improved HIV/AIDS treatments, vaccines against pneumococcal disease and
hepatitis A and B, potential vaccines against the West Nile and Ebola
viruses, and genomic sequencing of more than 60 medically important
microbes, including the bacteria that cause tuberculosis. Significant
health challenges remain for the 21st century to find treatments and
preventions for microbial threats worldwide. NIH plays a pivotal role
in research efforts to combat old and new infectious diseases that
undermine health and well being and cost this country more than $120
billion annually. The multiple threats of emerging, re-emerging, and
drug-resistant infections mandate increased biomedical research.
The ASM, representing more than 42,000 members in the
microbiological sciences, is particularly concerned with the threat
from infectious diseases and bioterrorism in the United States and
worldwide. The proposed fiscal year 2004 NIH budget includes $4.3
billion for the National Institute of Allergy and Infectious Diseases
(NIAID), an increase of $354 million over the fiscal year 2003 request.
The NIAID supports research and training on all aspects of infectious
diseases, their causative agents and transmission, host responses to
infection, advanced therapeutics and vaccines, and rapid diagnostic
technologies. The NIAID over the past five years has contributed
greatly to U.S. public health; for example, an impressive reduction in
blood-transfusion transmission of HIV and hepatitis viruses, a 70
percent reduction in AIDS-related deaths since 1995, and the near
eradication of Hemophilus influenzae infections in children.
biodefense research
The nation looks to the NIH and to the NIAID for safe and effective
countermeasures against biological agents to defend against
bioterrorist attacks. This threat presents urgent challenges and new
responsibilities for the biomedical community and heightens the
importance of NIAID supported research on the rapid diagnosis,
prevention and treatment of potential agents of bioterrorism. The ASM
supports the fiscal year 2004 NIH budget request of $1.6 billion for
biodefense research resources. The NIAID has a strategic plan and
research agenda for potential agents of bioterrorism, which has been
developed in collaboration with experts in the scientific community.
The plan builds on NIAID funded biomedical research programs that hold
promise in the defense against bioterrorism and against naturally
occurring deadly infectious diseases. The NIAID is mounting an historic
initiative to bring the full capability of science to bear on advances
in knowledge and products to counter biological pathogens. NIAID
expertise used with great success against conventional disease
outbreaks will significantly enhance the effort to combat bioterrorism,
and vice versa. This response to bioterrorism will require a long-term
dedication of financial resources and scientific talents.
In his recent State of the Union address, President Bush proposed
implementing a new initiative against biological warfare, Project
Bioshield. This comprehensive plan calls for a more rapid development
of state-of-the-art drugs and vaccines to target biothreat agents.
Project Bioshield is intended to nurture cooperation among NIAID
researchers, medical experts, and private industry to form a more
focused counterterrorism defense. The Secretary of Homeland Security
and the Secretary of Health and Human Services will collaborate to
identify the most critical research needs. The Director of NIAID will
have increased authority and flexibility to award grants for the
research and development of high-priority defenses such as next-
generation smallpox vaccines.
Although the NIAID has always worked to protect Americans against
infectious diseases, current global and domestic affairs have forced
the Institute to reevaluate and refocus its considerable expertise. Its
efforts against biothreat agents have been and will continue to be
rooted in solid scientific evidence acquired through basic research.
But the expedited translation of basic research findings into
practical-use interventions has become more central to NIAID's mission.
NIAID investigators will approach potential agents of bioterrorism with
new, more efficient strategies, such as the development of broader-
spectrum therapeutics and vaccines. More productive cooperations with
biotechnology and pharmaceutical companies likewise are expected to
streamline the development of countermeasures. The NIAID plan against
bioterrorism comprises two complementary components: basic research on
the biology of potential microbial agents and the mechanisms of host
response to infections, and applied research for the development of new
or improved diagnostics, vaccines, and therapeutics.
Biodefense research is the first priority for the program increases
within the proposed fiscal year 2004 budget. The NIAID is supporting
more than 50 initiatives in biodefense research. In fiscal year 2004,
it expects to add 17 new and expanded initiatives, including the
acquisition and storage of standardized reagents and other materials
related to the study of Category A, B, and C priority pathogens, for
eventual use by investigators and laboratories engaged in biodefense
research. Also in fiscal year 2004 NIAID will refocus on current
immunology and genetics programs that might provide information useful
against biothreat agents. This includes the Pathogen Functional
Genomics Resource Center and a to-be-established Cooperative Centers
for Translational Research on Human Immunology. Other planned fiscal
year 2004 initiatives include developing novel therapeutic strategies
for blocking the effects of the botulinum toxin.
infectious disease research
Bioterrorism threats should not diminish the NIH/NIAID mission to
detect, prevent and control infectious diseases. Globally, infectious
diseases are the leading cause of death, killing an estimated 14.9
million per year. In the United States infectious diseases cause
millions of illnesses and cost the economy billions of dollars, despite
our relatively high public health standards. We cannot be complacent
about infectious diseases because of the persistence or re-emergence of
old diseases and the emergence of new ones such as hantavirus, West
Nile virus, which has spread to 39 states infecting thousands of
people, Hepatitis C virus (HCV), which has infected almost 4 million
people in the United States and about 9,000 people die annually from
HCV, and Severe Acute Respiratory Syndrome (SARS), an atypical
pneumonia of unknown etiology that has caused approximately 60 known
deaths to date. There also is growing evidence that infectious agents
cause or contribute to many chronic diseases and cancers. Antimicrobial
resistance represents a major threat to increased mortality and
morbidity from untreatable disease and the risk from the spread of
drug-resistant pathogens.
Infectious diseases represent a global risk for nations and
individuals. There is greater risk that Americans overseas will become
exposed to serious infectious diseases like SARS, and international
travel can serve as a mode of disease transmission. The NIAID has a
long-standing commitment to stop the principal international killers
like HIV/AIDS, tuberculosis, and malaria. The heaviest medical and
economic burdens from these diseases exist outside the United States,
but they endanger this country as well. Of the estimated 40 million
HIV-infected persons worldwide, over 70 percent live in sub-Saharan
Africa. Yet the United States has its own challenges: The annual number
of new cases is not declining and perhaps one-third of those living
with HIV/AIDS are unaware of their infection. The NIAID has in place a
global research plan against these infections that includes significant
research funding inside and outside the United States and the creation
of strong alliances with foreign and international health
organizations. This funding continues to produce promising candidate
vaccines for prevention and therapeutic intervention, as well as
breakthroughs in understanding HIV biology and host immune responses.
The Administration recognizes the strategic importance of halting the
HIV pandemic, evidenced in its fiscal year 2004 budget request to fund
the Emergency Plan for AIDS Relief, a five-year, $15 billion initiative
that triples international HIV/AIDS funding.
Tuberculosis and malaria have been health disasters for centuries
of human history. The emergence of antimicrobial-resistant strains of
these pathogens, aided by increased global travel and trade, have made
it difficult to stop these diseases. Among the world's populations,
16.2 million currently have active tuberculosis while malaria strikes
an estimated 300 to 500 million new victims each year. If governments
do not learn how to better control tuberculosis, by 2020 an additional
1 billion persons worldwide will be newly infected and 35 million of
those will die, according to World Health Organization estimates. The
NIAID estimates that 10 to 15 million in the United States currently
have tuberculosis, and the Institute invests heavily in research on
diagnostics, therapeutics and vaccines. Using a newly developed strain
of tuberculosis bacterium that carries a mutated gene, NIH-funded
scientists in the United States and India are learning how the pathogen
protects itself and how it stimulates inflammation. In fiscal year 2002
the NIAID established the Millennium Vaccine Initiative to search for
novel vaccines against tuberculosis and malaria. Although the latter
disease remains relatively rare in this country, malaria around the
world causes an estimated 300 to 500 million new cases and more than 1
million deaths each year. There still is no malaria vaccine, but NIAID-
supported research has accelerated vaccine development.
Global events can also affect the threat from newly emerging
infectious diseases, whether through travel or trade that carries
pathogens from place to place. In the past few years, several
frightening diseases have found their way into various human
populations, including neurodegenerative disease caused by
transmissible spongiform encephalopathies (TSE, e.g., ``mad cow
disease''), West Nile virus (WNV) infection, hantavirus infection and
SARS. There will certainly be more of these unexpected outbreaks, as
new microorganisms evolve and old ones develop greater virulence
through resistance to standard drug therapies. NIAID research
encompasses these and other emerging diseases, within strategic plans
designed to anticipate more mysterious infections in the future. The
NIAID is supporting WNV vaccine development and participates in the
Interagency Task Force on West Nile Virus established in 2002. Studies
at NIAID suggest that TSE diseases may be more widespread than
believed, and scientists there plan future studies to understand its
transmission from animal species to humans.
New infectious diseases attract headlines, but less dramatic
diseases cost excessively in lost human and economic resources. NIAID
resources are also needed to address ``everyday'' diseases such as
hepatitis, sexually transmitted diseases, and food- and water-borne
illnesses. The NIAID has made significant investments to blunt the
impact of these and similar diseases, which account for many millions
of illnesses each year. For example, there are an estimated 15 million
new U.S. cases of STDs annually. NIAID-supported researchers have,
among other discoveries, recently determined that the bacterial agent
of gonorrhea binds to different molecules in the male and female
genital tracts. Such detailed understanding of microbial biology and
pathogenesis traditionally leads to successful therapies and prevention
strategies. In 2000 an estimated 2.1 million people died worldwide from
diarrheal diseases, often transmitted through food and water. At NIAID,
development of a vaccine against rotavirus, a major cause of diarrhea
in children, is a high global health priority.
The recently released Institute of Medicine report, ``Microbial
Threats to Health: Emergence, Detection and Response,'' reports that
``Today's outlook with regard to microbial threats to health is bleak
on a number of fronts. AIDS is out of control in much of sub-Saharan
Africa, India, China and elsewhere; bioterrorism has become a reality;
the relentless rise of antimicrobial resistance continues . . .
microbial threats present us with new surprises every year.'' Research
is the underpinning of the nation's capacity to prevent and control
infectious diseases. A strong, stable biomedical research and training
infrastructure is needed to investigate the mechanisms of molecular
pathogenesis, or the cause of infectious diseases, the evolution of
pathogeneses, drug resistance, and disease transmission. Fundamental
scientific knowledge is needed to design new vaccines, discover new
classes of antimicrobial compounds and devise new preventions and
treatments for infectious diseases.
The ASM urges Congress to add 10 percent in fiscal year 2004 to the
doubled budget of the NIH to bring the total to $30 billion. Continued,
sustained investment in NIH and NIAID is critical to dramatically
reduce the threat from both naturally occurring infectious diseases and
intentional use of biological agents.
______
Prepared Statement of the Upper County Branch, Montgomery County,
Maryland Stroke Club
a stroke survivor: a personal story
Hello. My name is Susan Emery. I am the presiding officer of the
Upper County Branch of the Montgomery County Stroke Club and I'm a
stroke survivor.
Our club conducts education and support activities for stroke
survivors, their family members, and caregivers. We serve people in the
Maryland suburbs of Washington, DC, 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 about their
research into stroke prevention and treatment with us.
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's 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'm here, more than 36 years later, and
I've 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 under age 14. 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 following four months in
intensive physical therapy. My tenth 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'm still smiling. During the four 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 four months, and would never wish to repeat it.
I've 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 six 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 didn't
even notice. But I noticed. I went in for two or three 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 cornucopias, unicorns
instead of fruit baskets. Instead of the word being the same, I picked
a word that sounded the same. These therapists in Colorado worked with
my mind and my body and I will forever be in their debt.
Close to fourteen years ago, I made a new life for myself in
Maryland. Here, I've 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've seen numerous physiatrists, all
of whom are excellent in their field. I've also seen my fair share of
therapists. Since I've had therapy off and on for most of my life, I
can honestly say that the first few times you go in to see a therapist,
you'll 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 there for more than five years. I've done
more than survive. I've 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 moved 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 ten 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. About an estimated 4.7 million Americans live
with the consequences of stroke and about 1 of 4 is permanently
disabled. Yet, stroke research receives 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 Mended Hearts, Inc.
I am Robert H. Gelenter, the legal representative for the Mended
Hearts Inc, a national heart disease patient support group of 25,000
members across the country. We visit patients in about 450 hospitals
throughout the United States. I have been appointed by the group to
assist in this lobbying effort--a volunteer position.
More than 27 years ago, I was diagnosed with a rare heart disease.
After having severe chest pains and trouble breathing for more than two
years, I was diagnosed with hypertrophic cardiomyopathy, a disease in
which the heart enlarges. The heart muscle eventually thickens so much
that it can't pump blood effectively and does not grow in the normal
parallel patterns. More than 36 percent of young athletes who die
suddenly die from this disease. But, it affects men and women of all
ages. It is sudden and one of the things known about this disease is
sudden cardiac death. There is no cure for this disease. Medication may
work and there is surgery that may or may not alleviate the pain. If
that doesn't work a patient may need a heart transplant, yet spare
organs are scarce. The doctor who made my diagnosis was trained at the
National Heart, Lung, and Blood Institute of the National Institutes of
Health.
Initially, I received several medications which allowed me to
engage in most activities. But, some activities, such as walking up
hills, gave me problems like shortness of breath and severe chest
pains. But, generally I could function normally. However, after about
11 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 great that I would
almost double over in the middle of the street. My wife told me that my
face would become gray. The perspiration would pour off by body. If I
was lucky I could find a chair to sit on. The quality of my life had
deteriorated so drastically that I knew I needed some treatment.
Finally in 1988, I went to Georgetown University Medical Center for
an angiogram--the gold standard for diagnosing heart problems. The
cardiologist who performed the angiogram 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--the so-called ``widow makers
spot.'' The worse news was that I had a major chance of having a major
heart attack with a less than a 5 percent chance of surviving that
heart attack because of the hypertrophic cardiomyopathy. At this point,
my wife was quietly crying and I was perspiring profusely. Since
Georgetown University Medical Center did not have the expertise to
operate on me, they called the NIH to see if they would accept me as a
patient. I was sent home pending notice from the NIH.
My parents begged me to go to New York or San Francisco for second
opinions. But, I knew that I had run out of alternatives. No matter
what the result, I needed treatment and I needed it immediately.
I was accepted by the NIH. After entering the National Heart, Lung,
and Blood Institute on February 6, I was operated on February 11, 1988.
No matter how trite the expression--that was the first day of the rest
of my life. The surgery, considered drastic and rare, is still
considered the gold standard throughout the world for the treatment of
hypertrophic cardiomyopathy. The Murrow Procedure, in honor of the
creator, was developed and improved at the NIH.
Although this surgery is no longer performed at the National Heart,
Lung, and Blood Institute, there is another experimental ongoing
protocol in which the same effect is being attempted by using alcohol
to deaden the excessive heart tissue.
Now, I am on medication for the rest of my life. My condition is
progressive. Seven years ago, I was fitted with a pacemaker to insure
that my heart beats at the correct rate. I am 100 percent dependent on
this pacemaker. Without the pacemaker, there are times when my normal
heart beat is so slow that I would die.
I am eternally grateful to the physicians funded by the National
Heart, Lung, and Blood Institute, particularly to Dr. MacIntosh and his
staff, for the gift of life. Because of this marvelous research
supported by the NHLBI, I have lived 15 years pain free. I have seen
two children graduate from college and three grandchildren born, I have
shared these years with a wonderful wife. I have been able to work at
my profession--an attorney at law.
I have had the gift of life restored to me. So to express my
gratitude for that gift, I visit patients recovering from heart
episodes at two hospitals, Washington Hospital Center and Washington
Adventist Hospital.
I ask for an fiscal year 2003 appropriation of $3.5 billion for the
NHLBI, including $2.1 billion for its heart disease and stroke-related
budget.
My experience is the proof that the research supported by the
National Heart, Lung, and Blood Institute benefits not just the
patients at the NIH Clinical Center, but throughout the United States.
The benefits go worldwide as well.
Heart attack, stroke and other cardiovascular diseases remain the
No. 1 killer and major cause of disability of men and women in the
United States. Nearly 40 percent of people who die in the United States
die from cardiovascular diseases. This year, nearly 950,000 Americans
will die from cardiovascular diseases, including almost 150,000 under
the age of 65.
Thank you for your support of National Heart, Lung, and Blood
Institute's heart research.
______
DEPARTMENT OF EDUCATION
Prepared Statement of the NCB Development Corporation
On behalf of NCB Development Corporation, I am pleased to submit
written testimony to the United States Senate's Committee on
Appropriations Subcommittee on Labor, Health and Human Services and
Education on the subject of charter school facility finance. I am Terry
D. Simonette, president and chief executive officer of NCB Development
Corporation located in Washington, District of Columbia and I would
like to thank Chairman Specter for the opportunity to submit this
written testimony today on fiscal year 2004 funding for Charter School
Facility Finance which addresses the needs of the underserved and
displaced communities under the jurisdiction of the Subcommittee. At
the outset, let me share with you some background information on NCBDC
and our approach to address the charter school facility finance
problem. Then I would like to share our thoughts on why charter schools
could be easily looked at as community development strategy.
NCB Development Corporation (NCBDC) was founded as a 501(c)(3) non-
profit affiliate of the National Cooperative Bank pursuant to the
National Consumer Cooperative Bank Act (Public Law 95-351). NCBDC is a
national mission-driven non-profit organization that for 25 years has
provided innovative financial and development services to improve the
lives of low-income individuals, families, and communities. By
creatively investing in our neighborhoods, advocating elected officials
around public policy, and collaborating with other national and local
community-based organizations, NCBDC helps charter schools finance and
develop facilities; creates a policy environment that supports strong,
self-sustaining communities; enables community health centers to expand
to serve more patients; preserves and creates affordable housing; and
helps socially responsible businesses thrive.
NCBDC's solutions are based on the cooperative principles of self-
help, democratic control, and open participation. NCBDC targets
community needs nationwide that have not been adequately addressed by
traditional approaches. In its 25 years of existence, NCBDC has grown
from a provider of high-risk development finance to a multifaceted
national organization engaged more broadly in pursuing solutions to
some of the most urgent problems facing under-served communities today.
Mr. Chairman, as you may already know, there are currently about
2,700 charter schools in 36 states and the District of Columbia, giving
nearly 684,000 children an opportunity to receive a quality education.
Unlike traditional public schools, charter schools are not given a
public building in which to operate. Instead, it is up to the charter
school to find and fund an appropriate location. Operators, who are
often concerned parents, teachers, or nonprofit organizations,
typically have little experience with planning, zoning, and building
code regulations, let alone finding affordable space and adequate
financing. And very few financing organizations are willing to lend to
charter schools.
Since the mid-1990's, NCBDC has been considered an expert in the
small community of organizations in the forefront of designing and
implementing innovative financing strategies to meet charter schools'
demand for capital. To date, between our lending and technical
assistance programs, NCBDC has assisted over 200 schools in 17 states,
provided more than $30 million in facilities financing, and helped
leverage more than $100 million in additional funds. Major partners in
these initiatives have included the U.S. Department of Education, the
National Charter Schools Alliance (formerly Charter Friends National
Network), the Florida Consortium of Charter Schools and the Midwest
Charter Facilities Coalition.
In the initial round of the highly competitive U.S. Department of
Education's Charter School Facilities Financing Demonstration Program,
NCBDC partnered with The Reinvestment Fund, a leading community
development financial institution based in Philadelphia, and
Foundations, Inc., a leading technical assistance provider. We were
successful in receiving a $6.4 million grant to create the Charter
School Capital Access Program (CCAP). CCAP is in the process of
creating a $40 million loan pool that will be leveraged with capital
from investor types including banks and other financial institutions
like PNC Bank located in Pennsylvania. This is a leverage ratio of
nearly seven private dollars for every one public dollar. Through CCAP,
we will focus on schools located in the Mid-Atlantic States including
New York, New Jersey, Pennsylvania, Delaware, Virginia and the District
of Columbia.
In addition, in partnership with the National Charter Schools
Alliance (formerly Charter Friends National Network), NCBDC is a
recipient of a U.S. Department of Education National Activities Grant
that establishes a pilot program of on-the-ground technical assistance
and workshops in facility development and financing. NCBDC's receipt of
the grant is a testament to its combination of financing acumen and
commitment to community revitalization. We are working with the Florida
Consortium of Charter Schools and the Midwest Charter Facilities
Coalition to provide professional support to charter schools seeking to
develop new facilities. As part of the 18-month technical assistance
program, NCBDC and its partners make available on-site resource
specialists who are capable of providing assistance to charter schools
in all aspects of facilities development and financing. On a national
level we are working with grassroots charter support groups to conduct
workshops around the country that help charter schools manage the
challenges of facilities development and financing.
In the past six months, NCBDC has had the opportunity to provide
technical assistance in Pennsylvania. In November 2002, NCBDC, along
with The Reinvestment Fund, conducted training in Philadelphia on
charter school facility financing, sponsored by the Northwest Regional
Education Laboratory. In January 2003, NCBDC, again in partnership with
The Reinvestment Fund, conducted a training given by the Pennsylvania
Charter School Resource Center in Harrisburg, Pennsylvania, discussing
charter school facilities financing and our new joint venture, the
Charter School Capital Access Program or CCAP.
Because we have seen firsthand the dire need for charter school
facility finance, NCBDC supports the continuation and expansion of the
Charter School Facilities Financing Demonstration Program by increasing
appropriations levels as authorized by the United States Congress in No
Child Left Behind (NCLB or Public Law No. 107-110) signed by President
George W. Bush into law on January 8, 2002.
A United States General Accounting Office (GAO) report ``Charter
Schools: Limited Access to Facility Financing'' (GAO/HEHS-00-163,
September 2000) states that facilities financing issues pose a
formidable obstacle for the vast majority of start-up and established
charter schools. Each of the three major financing approaches--
municipal bonds, per pupil allocations, and conventional financing--
offer only limited opportunities for charter schools that seek funds to
lease, acquire, construct, or renovate a facility. There is no more
serious challenge facing charter schools nationally than obtaining
upfront and ongoing financing for facilities. Despite the difficulty in
securing credit, charter schools are remarkably resourceful in
addressing their facilities needs, yet are generally unable to take
advantage of the financing that is available to school districts and
typically pay for facilities out of their regular operating funds. As a
result, finding and funding a building impacts limited operating funds
which in turn impacts teachers, administrative personnel and the
purchase of everyday supplies.
Not finding a suitable home has delayed school openings, and forced
schools to scale back their programs or shut down altogether. According
to the Center for Education Reform, a survey of 84 charter schools that
never opened showed that 27 percent were due to the inability to find
adequate facilities. Of 194 charter schools that were closed, 9 percent
stopped operations due to facility issues. Charter schools are usually
distinguished by their relatively small size, perceived instability of
revenue streams, short operating track records, and political
uncertainty. These characteristics pose formidable obstacles for the
private sector, which has a low-risk tolerance and is often reluctant
to lend in an ``emerging'' market. Consequently, charter schools also
require new, creative financial models to address their growing demand
for capital.
NCBDC applauds the President and the United States Congress in
their commitment to charter education. Following the fiscal year 2003
appropriations process, the President supported and the Congress passed
legislation that provided $25 million dollars for the new Credit
Enhancement for Charter Schools Facilities Program within the
Department of Education's Office of Innovation and Improvement to
assist charter schools in acquiring, leasing, and renovating school
facilities. This is done through a competitive grant process to public
and non-profit entities for loan guarantees, debt insurance, and other
activities that facilitate private lending. Much like the Charter
Schools Facilities Financing Demonstration Program, this program will
award an estimated 3-5 awards to be given within a range of $2.5-$10
million.
While the demand for charter school facility finance is estimated
nationally at $2 billion, $25 million falls far short of the $200
million authorized in No Child Left Behind, as outlined in the Carper-
Gregg Amendment in the act. The bipartisan Carper-Gregg Amendment
authorized substantial funding for the continuation and expansion of
the demonstration program by providing not only $200 million yearly in
grants to entities that help charters leverage private financing for
facilities and start-up costs, but it also expanded the Public Charter
Schools Program to provide $200 million in matching grants to states
that establish or enhance programs of per pupil facilities funding
assistance to charter schools.
With our long history of a strong commitment to community
development, particularly as it relates to underserved urban
populations, NCBDC believes that strong schools are a cornerstone of
any thriving community. Good schools keep families involved in
neighborhoods, and this involvement is essential to community
revitalization. Public charter schools encourage stability by offering
parents a tuition-free choice outside the traditional public school;
charter schools can keep families in communities with under-performing
public schools. In addition, NCBDC has found that in the process of
developing a facility, charter schools can be an effective tool for
urban renewal and neighborhood revitalization. Finally, NCBDC believes
that strong school-community partnerships, which are encouraged by
charter schools, help strengthen neighborhoods.
An example of a charter school that has affected the community
around it is the Universal Institute Charter School, started by
Universal Community Homes (UCH), in Philadelphia, Pennsylvania. UCH is
a community development corporation that provides housing, economic
revitalization, and training and social services to the area's low-
income residents. UCH started the school due to unfortunately high
rates of violence and disgraceful test scores in local public schools.
In partnership with The Reinvestment Fund, NCBDC made two loans to the
school. Together, NCBDC and The Reinvestment Fund provided more than $2
million in financing for the school's building, when it opened in 1999
and again in 2000 when it needed additional financing for expansion and
renovations. Today, the Universal Institute Charter School is a Title I
school, filled at maximum capacity, with a waiting list of more than
400 children. In March of 2003, its charter was renewed for another
five years. The school has come to be considered an integral part of
the community.
During this time of budget deficits and the rise in domestic
security costs with the aftermath of war, fiscal constraints make
efforts to fulfill Congress' commitment to education, especially
charter school facility finance, far more difficult then it has been in
years past. Charter advocates, including NCBDC, have long been
supportive of the efforts by the Administration and Congress to provide
adequate appropriations for the charter school facilities initiatives
set forth in the landmark bipartisan NCLB. We are hopeful that this
Subcommittee, and ultimately this Congress, will provide appropriate
charter school funding at the authorized levels, as charter schools are
continuously faced with the lack of funding or expertise to purchase,
build, or renovate a building and other physical plant requirements.
NCBDC appreciates this opportunity to reinforce the critical need
served by supporting expanded funding for charter school facility
finance. With your assistance, the charter school community can
continue to make a difference in the lives of our most vulnerable
children, families, and communities. In summary, NCBDC requests a NCLB
authorized fiscal year 2004 appropriation level of $200 million to help
charters leverage private financing for facilities and start-up costs--
an increase of $100 million over the President's fiscal year 2004
request and $175 million over the fiscal year 2003 appropriation level.
In addition, NCBDC supports the continued expansion of the Public
Charter Schools Program by supporting the President's request of $220
million to provide matching grants to states that establish or enhance
programs of per pupil facilities funding assistance to charter schools.
Thank you again for allowing NCBDC to present its concerns
regarding fiscal year 2004 appropriations provision of charter school
facilities financing in testimony before the Subcommittee.
______
Prepared Statement of Americans for the Arts
request
Americans for the Arts is pleased to submit testimony in support of
fiscal year 2004 appropriations at a level of $53 million for the Arts
in Education program of the U.S. Department of Education (USDE).
Americans for the Arts is one of the leading national nonprofit
organizations for advancing the arts and arts education in America.
With a 40-year record of objective arts industry research, it is
dedicated to representing and serving local communities and creating
opportunities for every American to participate in and appreciate all
forms of the arts.
As members of the Subcommittee know, the Elementary and Secondary
Education Act provides that funding up to $15 million be directed to
the John F. Kennedy Center for the Performing Arts and VSA arts. Prior
to fiscal year 2001, funding never exceeded the floor level. Beginning
in fiscal year 2001, however, Congress has consistently appropriated
funding exceeding the floor in order to fund a broader array of arts
education programs. For fiscal year 2003, Congress appropriated $33.7
million. This new funding has allowed the Department of Education to
add three significant programs:
--a competitive grants competition to further develop established
arts education models;
--support for professional development for arts educators in four
arts disciplines; and
--a program establishing partnerships between schools and community
cultural organizations to serve at-risk children and youth.
We ask the Subcommittee to appropriate $53 million for fiscal year
2004, with the bulk of the increase to be allocated to the Arts in
Education Model Development and Dissemination Program, Professional
Development training in music, theater, dance and the visual arts, as
well as Cultural Partnerships for At-risk Children and Youth.
three reasons to increase arts education funding
The reasons for increasing arts education funding are many and
varied, but we will begin with the most important: arts education works
for children. An increasing volume of research confirms that arts
education has substantial beneficial effects in several areas,
including but not limited to academic achievement. We refer the
Subcommittee to a recent research compendium Critical Links: Learning
in the Arts and Student Academic and Social Development, released by
the Arts Education Partnership, 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. Of special importance, given USDE's core
function of providing support to those most in need, the studies
suggest that arts education may be especially useful for students in
economically disadvantages and/or in need of remedial instruction. The
arts sometimes succeed when everything else has failed.
The second reason is that schools desperately want it. Even now,
when the accountability and testing regimens of the No Child Left
Behind Act have focused schools' attention on what some call ``the
basics,'' many schools understand that the arts are a core academic
subject, as stipulated by No Child Left Behind, that they are
essential, and that they work. The Department of Education's first
model grant competition generated overwhelming interest despite the
tiny number of awards. A larger amount of funding, coupled with a
smaller grant size, will at least begin to address the demand.
The third reason is that while there is tremendous interest in arts
education, substantial improvements need to be made to delivery
systems, including promoting cooperation and joint programming between
community cultural organizations and schools for afterschool arts
education programs for at-risk youth; better professional development
training for arts teachers, artists, and classroom generalists;
developing authentic and practical assessments of arts learning; as
well as much more research on effective programs. USDE's model grants
program aims to further develop established programs that improve arts
education, to evaluate these programs, and to disseminate the results.
Thus, it is absolutely in accord with a central principle of the
federal role in education: to find out what works and to disseminate
this information to states and local school districts so that they may
select and tailor programs to fit their own needs and circumstances.
This is the reason that we urge the Subcommittee to recommend that
funding include at least $1 million for evaluation and dissemination.
We note that each of the projects funded under this program include a
substantial research component. It is particularly important to add
this modest amount of funding because the USDE's existing and planned
research efforts, including the What Works Clearinghouse, do not
include substantial work on arts education.
case example: mississippi's whole schools initiative
In order to show in more detail how the model grants program
further develops programs for improving arts education, we turn to the
Mississippi Whole Schools Initiative. In 2001, Mississippi's Whole
Schools Initiative was awarded a $1 million grant from USDE's Arts in
Education Model Development and Dissemination Program. The program's
roots go back to 1991, when as a response to ``back to basics'' school
reform and the lack of arts instruction in Mississippi, the Mississippi
Arts Commission (MAC) commissioned a study of the Mississippi
environment, appropriate national models and relevant research. The
resulting paper called for a pilot program characterized by the
involvement of every student and teacher in arts-infused learning; the
integration of the arts into daily classroom instruction for all
students; and sequential, comprehensive instruction for all students in
dance, drama, visual arts, and music by certified arts specialists that
would be documented and evaluated. The pilot program began in 1992.
In 1996, MAC and the Mississippi Alliance for Arts Education
commissioned the Mississippi State University to conduct a survey on
the status of arts instruction in Mississippi public schools. Among the
findings: (1) one full-time music teacher for every 840 students,
including high school band programs, (2) one full-time visual arts
teacher for every 3,150 students, (3) one full-time drama teacher for
every 17,848 students, and (4) one full-time dance teacher for every
31,235 students. Research conducted recently revealed that, in 1999,
the ratios of arts teachers to students remain little changed.
The Whole Schools Initiative was launched in 1998 with a core
belief that art is an essential part of every child's education,
speaking to students in language that demonstrates concepts, reveals
symbols, forges connections, and helps prepare them for life. It is the
first comprehensive statewide arts education program in Mississippi.
Its goals are to improve student academic achievement through infusing
arts into the basic curriculum, to enrich students by increasing their
skills and knowledge in all arts disciplines, to assist the
professional and personal growth of teachers and administrators through
arts experiences, to use the arts to increase parental and community
involvement in schools and to assist schools in building a sustainable
system for supporting arts infusion.
Not only does the program improve the quality of arts education
being offered in participating schools, it is often the only chance
that Mississippi children, in poorly funded schools and from families
living below the poverty level, will ever have to receive any arts
instruction. Nineteen of the 26 schools involved in the initiative
serve student populations where 35 percent or more of the students
qualify to receive free/reduced lunches, fourteen schools have at least
70 percent and seven schools have at least 90 percent.
Eleven schools involved in the initiative are located in rural
communities and others serve them. Six of these schools have the lowest
per pupil expenditure in the state. In 2001, the Commission responded
to the critical teacher shortage and educational disparities in the
Mississippi Delta Region by locating the summer institute in the Delta,
recruiting Delta schools and partnering with Delta State University on
pre-service and in-service training of teachers for this region. This
weeklong institute serves to inform, empower and motivate school teams
and gives them the tools to successfully infuse the arts into their
school curriculum. Schools attend in teams of eight, including the
principal, project director, classroom and arts teachers and a
community representative. District superintendents are required to
participate in a one-day program planned with their needs in mind.
Attendance by this team and superintendent is mandatory in order to
receive grant funds from MAC.
Twenty-six schools now participate in the Whole Schools Initiative,
representing the economic, racial and geographic diversity of
Mississippi. Each designs an arts-based, school-wide program, with a
five-year strategic plan appropriate to its resources, demographics,
philosophy, and school culture. MAC provides the tools necessary for
planning and implementation and requires the inclusion of two essential
components: the use of arts teachers and visiting artists in the areas
of dance, drama, music, visual art, creative writing and folk arts to
strengthen the place of the arts as a core academic subject in its own
right; and infusing the arts in all academic subjects in order to
increase student success in these subjects. Each school receives grant
funds, technical assistance, mentoring and professional development for
six years, as long as it shows progress towards the goals of its
strategic plan and re-applies to the grant program each year. The
schools partner with various education and arts-based entities and
other community resources to carry out the activities of the
initiative. Partnerships include local arts councils, Institutions of
Higher Learning, the Mississippi Alliance for Arts Education,
professional artists, local school districts and art museums.
In 2001, the Whole Schools Initiative was one of eleven successful
applicants for a grant from USDE's Arts in Education Model Development
and Dissemination Program. This $1 million grant is allowing MAC to
expand its role with universities, encouraging the development of pre-
service courses that would strengthen arts infused instruction and aid
arts majors in becoming effective instructional leaders. The grant will
also enable MAC to expand and refine its evaluation model, a model
based on both sociological and statistical data. A final component of
the USDE funding will allow MAC to develop training materials and
procedures that can be used to replicate the program in other settings.
At the end of the three-year grant period, the project will
``blueprint'' a model built on a research base, field-tested in a
diverse set of schools, evaluated internally and externally, and which
has already produced substantive results.
This funding has made possible extensive professional development
opportunities for teachers and administrators. More than 15,000
students and 800 educators benefit annually from activities at a
weeklong summer institute, two retreats and field advisor visits. Other
ways in which it is strengthening the program include a course for
education majors that is being developed at the Delta State University,
a ``teacher friendly'' and ``teacher useful'' interactive web site, and
the designation of model schools in the north, central, and southern
regions of Mississippi where the initiative's work may be observed.
Other states will benefit from the documentation and dissemination
of the initiative. Many states have a strong interest in implementing
this model but lack the resources, knowledge and experience to do so.
States that have approached MAC and participated in the institute
include New Mexico, Illinois, Kentucky, Florida, and Louisiana.
conclusion
As the example of the Whole Schools Initiative 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 and for educators in schools and
cultural organizations, and most important, it means a better education
for our children. We urge the Subcommittee to recommend $53 million in
funding for the USDE's Arts in Education programs in order to allow
more programs like Mississippi's Whole Schools Initiative to flourish.
______
Prepared Statement of the Thurgood Marshall Scholarship Fund
Thank you for allowing us this opportunity to submit written
testimony on behalf of the Thurgood Marshall Scholarship Fund (TMSF). I
am asking you to support a total request of $20 million in the fiscal
year 2004 Labor, Health and Human Services, Education appropriations
bill. This amount includes $10 million for TMSF's Capacity Building
Program and $10 million for Technology Expansion Programs at Public
HBCUs.
Thurgood Marshall Scholarship Fund represents 45 Public HBCUs and
five historically black law schools located in 22 states, the District
of Columbia and the U.S. Virgin Islands. TMSF is only national
organization that provides merit scholarships, programmatic and
capacity building support to the staff and students attending Public
HBCUs. Currently 215,000 students attend Public HBCUs, and many of them
are the first in their families to attend college.
To continue providing valuable and meaningful opportunities for so
many deserving students, Public HBCUs must be prepared to provide
students with an educational experience that prepares them for today's
increasingly competitive and ever-changing world. TMSF member schools
lack the financial resources to fully realize this mission. The
National Capacity Building and Technology Expansion Programs for which
we are seeking funding will help our schools to do so by focusing on
developing student and faculty leadership, increasing technology,
operations, communications and staff and student expertise, and
strengthening minority professional involvement with students in the
areas of community service and career development. Just as importantly,
increased outreach activities of Public HBCUs to high school guidance
counselors and students will help assure that those in need are aware
of and have access to opportunities available at Public HBCUs.
The National Capacity Building Program includes the following
elements:
--Leadership Development.--Consists of two national training
conferences for students attending Public HBCUs and the five
public historically black law schools. This program will
provide resume building, leadership training, strategic
planning, community service, technology training and career
development.
--Member School Training and Development.--A national program
designed to provide training and development to the executive
management team, faculty and staff at TMSF member colleges and
universities in the areas of financial management, outreach,
human resource management, and leadership development. The
second component of the program is a series of regional
training conferences that will link local businesses, state,
county and city governments and nonprofit organizations with
Public HBCUs to explore innovative partnerships to help HBCUs
survive and grow.
--Student Internship Placement Services.--A program designed to
provide training and development opportunities for placement
officers from the 45 Public HBCUs by allowing them to interact
with human resource officers from corporations, non-profit
organizations, and federal agencies, and increasing
information-sharing on career marketing.
--National College Guide.--Will provide for the development of a
national college guide and on-line directory designed to
increase college enrollment for minority students. The guide
will feature financial aid resources, descriptions of the 45
Public HBCUs and a common application that can be used at any
one of the TMSF member schools. The guide will be distributed
to the nation's 14,000 public school districts.
--Volunteer Training.--This program is designed to engage diverse
volunteers of all ages, race and religions in working with at-
risk youth. The volunteers will provide mentoring and
assistance in the areas of college enrolment, career planning
and leadership development. A national volunteer training
program will be designed and piloted with ten schools to
mobilize 1,000 volunteers.
--Post-Graduate Activism.--A national program designed to organize
and train graduates and students of Public HBCUs in the areas
of career development and community service, including national
training seminars to establish graduate and student councils to
explore ways that Public HBCU graduates can leverage their
workplace skills to benefit Public HBCUs. This program will be
complimented by an interactive website.
--Community Outreach Offices.--This program will provide for
additional support for the Mid Western Capacity Building Office
and the establishment of an office in the South and Western
States. These offices will work with local high schools to link
students and parents with college attendance; work with the
local and regional employers to link students from the areas
with internship and job opportunities addressing the local and
regional talent drain issues facing many communities.
--National Counselor Training & Youth Outreach.--The National
Counselors Training program will design, produce and provide
training to the middle and high school counselors at the
nation's 17,000 school districts on opportunities at Public
HBCUs. This program will be complemented by a web site where
counselors can access applications to the 45 member colleges
and universities along with tips on preparing families on how
to support their children who may be the first to attend
college.
--Research.--A national research program designed to collect and
present the demographical data of the 45 Pubic HBCUs, this
program will study student enrollment trends; private, pubic
and individual giving trends by institutions; enrollment by
race; enrollment by regions of the country; economic impact of
the colleges and universities; tracking of the community impact
of the schools; retention and recruitment rates.
The Technology Expansion Project is equally important, as
illustrated in the following statistics:
--Two out of five Public HBCUs are in urgent need of upgrading their
technical infrastructure.
--On only one out of forty-five campuses, do more than 75 percent of
students own computers.
--Less than one-half of TMSF member school campuses have a moderate
or high degree of sophistication providing IT and technical
support staff.
--Forty percent of TMSF member schools reported that they require
both additional computer hardware and software to conduct their
Advancement programs.
This program will make resources available to 20 of our 45 member
schools in the following areas:
Campus-wide Information Tracking System.--Development of an
intranet for each institution to improve internal and external
communication practices while ensuring consistency and eliminating
duplication. The intranet will allow the sharing of critical contact
information, which will in turn provide faculty with an efficient and
effective means for sharing best teaching practices; thus improving the
quality of Public HBCU students' educational experience.
Advancement Office IT infrastructure.--Twenty grants at an average
of $50,000 each to improve internal capacity in the Advancement
Offices. Grants could be used to upgrade hardware, software, Alumni
tracking, web presence or similar programs within the Advancement
office based on the individual needs of each school. These grants will
be administered through an RFP process.
--Information Technology Resource Center (ITRC).--The ITRC will
establish and maintain a special website accessible only to
member schools to share resources, files and ideas with the
number of uses open to the creativity of the TMSF community.
The ITRC includes the following components: distance-learning
courses, a resource database, which can be used to monitor
funding resources, technology developments and opportunities,
and to disseminate information to public sources, strategic
planning tools, a web-based forum for interactive sharing of
resources and ideas, and continuing education for faculty and
staff.
TMSF member schools are a critical source of higher education
for African-Americans. Over two million alumni have graduated
from TMSF member schools.
TMSF was created to bridge the technological, financial and
programmatic gap between public and private HBCUs. Since our
inception, TMSF has provided more than $20 million in
scholarships and programmatic support to students attending
Public HBCUs.
--Nearly eighty percent of all students enrolled in historically
black institutions attend TMSF member schools.
--Ninety percent of all students attending Public HBCU's require some
form of financial assistance.
--TMSF member law schools graduate more than fifty-six percent of the
African-American lawyers in the nation.
--TMSF schools graduate more than fifty-eight percent of the African-
American public schoolteachers across the country.
As a national resource, Public HBCUs supported by TMSF are
committed to building the infrastructure and capacity to continue to
support their students and to serve as instruments of economic growth
in their states and across our nation.
In closing, I thank you for your past funding of TMSF, and urge you
to support this request for additional funding that will allow us to
carry out our important mission--Preparing a New Generation of Leaders.
______
Prepared Statement of the American Chemical Society
The American Chemical Society (ACS) would like to thank Chairman
Arlen Specter and Ranking Member Tom Harkin for the opportunity to
submit testimony for the record on the Labor, Health and Human
Services, Education Appropriations bill for fiscal year 2004.
ACS is a non-profit scientific and educational organization,
chartered by Congress, representing more than 161,000 individual
chemical scientists and engineers. The world's largest scientific
society, ACS advances the chemical enterprise, increased public
understanding of chemistry, and brings its expertise to bear on state
and national matters.
Federal investments in research and science education are critical
to producing the technologies and scientific workforce that ultimately
determine our economic and national security. As our economy becomes
increasingly dependent on technology, the demand for scientists and
engineers during the next decade is expected to increase at four times
the rate for other occupations. Unfortunately, today's high school
students on average lag well behind their European and Asian
counterparts in math and science, and NAEP studies suggest that more
than 82 percent of 12th graders are not proficient in science. To
maintain U.S. technological leadership, the Department of Education
must do more to improve teacher quality in math and science and to
provide incentives for all students--including underrepresented
groups--to pursue degrees in these fields.
ACS is encouraged by the Department of Education's recent
Mathematics and Science Initiative, which is aimed at reversing
``waning federal attention to mathematics and science education'' in
recent decades. ACS has long supported a key goal of this initiative:
to increase the number of science and math teachers who are well
trained in the subjects they teach. Because research shows that subject
knowledge is critical to effective teaching, it is alarming that nearly
half of all science teachers did not major or minor in the field they
are teaching.
We commend Congress for seeking to improve teacher quality and
student achievement in K-12 math and science education by establishing
the Department of Education's Math and Science Partnership program in
the No Child Left Behind Act. This program, which is the sole source of
dedicated math and science funding at the Department, was authorized at
$450 million. Following scant funding in fiscal year 2002, we applaud
Congress for boosting appropriations to $100 million in fiscal year
2003--a level at which the program becomes viable by allowing the
advancement of merit-based partnerships across all states. ACS urges
Congress to work toward the authorized level by funding the program at
$200 million in fiscal year 2004. Increased investment will enable the
types of innovative partnerships between school districts, university
science and engineering departments, businesses, and educational
organizations that can produce real gains in student achievement. We
believe that partnerships that advance long-term, content-based
professional development should receive priority in this program.
ACS recognizes that economic incentives can help draw students and
provide opportunities for careers in math and science, including the
teaching field. ACS supports the administration's proposal to increase
the level of loan forgiveness from $5,000 to $17,500 for elementary and
secondary education math and science teachers who teach in high need
areas. Also, to provide graduate and doctoral students with enhanced
fellowship opportunities, we support increased funding for the Graduate
Assistance in Areas of National Need program. This program provides
fellowships to assist graduate students with excellent records who
demonstrate financial need and pursue the highest degree available in a
field designated as an area of national need, including science.
In 20 to 30 years, the United States will be a majority minority
country. We must redouble our efforts to ensure that the science and
engineering educational and professional fields adequately reflect
these changing demographics. To that end, the Society strongly supports
the Department's Minority Science and Engineering Improvement program.
This program, which provides grants to predominately 2- and 4-year
minority-serving institutions, aims to significantly increase the
number of underrepresented ethnic minorities, particularly minority
women, pursuing science and engineering careers. The program received
$8.5 million in fiscal year 2003, but additional funding is needed to
reach the larger population necessary to achieve real gains in this
area.
All students need the chance to succeed in an increasingly global
and technology-driven society. ACS looks forward to working with
Congress and the administration to improve teaching and learning in
math and science.
______
Prepared Statement of the United Tribes Technical College
Summary of Request.--For 34 years United Tribes Technical College
(UTTC) has been providing postsecondary vocational education, job
training and family services to Indian students from throughout the
nation. Our request for fiscal year 2004 funding for tribally
controlled postsecondary vocational institutions as authorized under
Carl Perkins Vocational and Applied Technology Act is:
--$8 million under Section 117 of the Perkins Act, which is $1
million over the fiscal year 2003 enacted level. This funding
is essential to our survival, as we receive no state-
appropriated vocational education monies.
--Ensure that the provision in the fiscal year 2002 and 2003 Labor-
HHS-Education Appropriations Acts that waived the regulatory
requirement that we utilize a restricted indirect cost rate is
continued.
--Funding for renovation of our facilities, many of which are
original to the Fort Abraham Lincoln army installation. A
recent study commissioned by the Department of Education shows
a facility need for UTTC of $49 million.
Restricted Indirect Cost Issue.--The fiscal year 2002 and fiscal
year 2003 Labor-HHS-Education Appropriations Act provided that
notwithstanding any law or regulation, that Section 117 Perkins
grantees are not required to utilize a restricted indirect cost rate.
We thank you for taking this action, and ask that it be continued in
the fiscal year 2004 Act.
In 2001, the Department of Education, for the first time, directed
Indian grantees (both Sec. 116 and 117 grantees) to apply a
``restricted indirect cost rate'' to their grants. This means each
tribal grantee must obtain another indirect cost rate--exclusively for
its Perkins Act grant--from its cognizant federal agency (which in most
cases is the Inspector General for the Department of the Interior.)
The Department gave two reasons for applying a restricted rate to
these Perkins Act Indian programs: (1) The 1998 Amendments to the
Perkins Act (Sec. 311(a)) prohibits the use of Perkins Act grant funds
to supplant non-federal funds expended for vocational/technical
programs. This ``supplement, not supplant'' limitation previously
applied to State grants, only; and (2) A long-standing DoEd regulation
(promulgated years before the 1998 Perkins Amendments) automatically
applies the restricted indirect cost rate requirement to any DoEd grant
program with a ``supplement, not supplant'' provision.
UTTC has no quarrel with the bases and objectives of the
``supplement, not supplant'' rule and seeks no change to this statutory
provision. The primary targets of this rule are States and possibly
local government entities that run vocational education programs with
State or local funds.
By contrast, however, UTTC has little or no ability to violate this
rule, as we have no source of non-federal funds to operate vocational
education programs. Unlike States, we have no tax base and no source of
non-federal funds to maintain a vocational education program. We depend
on federal funding for our vocational/technical education program
operations. Despite our inability to violate the supplanting
prohibition, we are, nonetheless, being disadvantaged by a DoEd
regulation intended to enforce the prohibition against States who do
have the ability to supplant.
--Impact of new requirement on grantees.--Under DoEd regulations, a
``restricted indirect cost rate'' makes unallowable certain
indirect costs that are considered allowable by other federal
programs. Primarily, these are costs that DoEd believes the
grantee would otherwise incur if it did not receive a Perkins
grant, such as the cost of the grantee's chief officer and
heads of departments who report to the CEO, as well as the
costs of maintaining offices for these personnel.
Prohibiting the Perkins grant from contributing its appropriate
share to the grantee's indirect cost pool will most likely mean that
other federal programs operated by the grantee would be expected to
pick up a great share of the indirect cost pool. This outcome may well
result in objections from the other program agencies that do not want
to bear costs properly attributable to the Perkins grant.
We are caught between conflicting federal agency requirements and
will find ourselves unable to recover the necessary share of indirect
costs attributable to each of the federal programs we operate.
United Tribes Technical College: Unique Inter-tribal Educational
Organization.--Incorporated in 1969, United Tribes Technical College is
the only inter-tribally controlled campus-based, postsecondary
vocational institution for Indian people. We are chartered by the five
tribes in North Dakota and operate under an Indian Self-Determination
contract with the BIA. This year we enrolled 645 students from 44
tribes and 17 states. Our hope is to serve 2,000 adult students by the
year 2008.
The majority of our students are from the Great Plains states that,
according to the 1999 BIA Labor Force Report, has an Indian reservation
jobless rate of 71 percent. UTTC is proud that we have an annual
placement rate (placement in jobs or in higher education) of 90
percent. In addition, we serve 147 children in our pre-school programs
and 148 children in our Theodore Jamerson elementary school, bringing
the population for whom we provide direct services to 940.
UTTC Course Offerings.--We offer 14 vocational/technical programs
and award a total of 24 two-year degree and one-year certificates. We
are accredited by the North Central Association of Colleges and Schools
and we were re-accredited in 2001 for the longest time allowable--10
years or until 2011--and with no stipulations.
We are very excited about the recent additions to our course
offerings, and the relevance they hold for Indian communities. These
new programs are: Injury Prevention; On-Line Education; Nutrition and
Food Services; Tribal Government Management, and Tourism.
Injury Prevention.--Through our Injury Prevention Program we are
addressing the injury death rate among Indians, which is 2.8 times that
of the total U.S. population. We received assistance through the IHS to
establish the only degree granting Injury Prevention program in the
nation. Injuries are the number one cause of mortality among Native
people for ages 1-44 and the third for overall death rates. IHS spends
more than $150 million annually for the treatment of non-fatal
injuries, and treatment of injuries is the largest expenditure of IHS
contract health funds (IHS fiscal year 2004 Budget Justification).
--On-Line Education.--We are bridging the ``digital divide'' by
providing web-based education and Interactive Video Network
courses from our North Dakota campus to American Indians
residing at other remote sites, including the Denver Indian
community, and plan to serve rural-based Indian tribes.
Training is currently provided in the areas of Early Childhood
Education and Computer Literacy. By the year 2005, students
will be able to access full degree programs in Computer
Technology, Injury Prevention, Health Information Technology,
Early Childhood Education, and Office Technology, and others
from these remote sites. UTTC is seeking accreditation to offer
On-Line degree programs.
High demand exists for computer technicians. In the first
year of implementation, the Computer Support Technician program
is at maximum student capacity. In order to keep up with
student demand, UTTC will need more classroom space, computers
and associated equipment, and instructors. Our program includes
all of the Microsoft Systems certifications that translate into
high income earning potential for graduates.
--Nutrition and Food Services.--UTTC will meet the challenge of
fighting diabetes in Indian Country through education. As you
know, the rate of diabetes is very high in Indian country, with
some tribal areas experiencing the highest incidence of
diabetes in the world. About half of Indian adults have
diabetes (Diabetes in American Indians and Alaska Natives, NIH
Publication 99-4567, October, 1999).
We offer a Nutrition and Food Service Associate of Applied
Science degree to increase the number of American Indians with
expertise in human nutrition and dietetics. Currently, there
are only a handful of Indian professionals in the country with
training in these areas. Future improvement plans include
offering a Nutrition and Food Service degree with a strong
emphasis on diabetes education and traditional food
preparation.
We have also established the United Tribes Diabetes Education
Center to assist local Tribal communities and UTTC students and
staff in decreasing the prevalence of diabetes by providing
educational programs, materials, and training. UTTC has
published and made available tribal food guides to our on-
campus community and to tribes.
--Tribal Government Management/Tourism.--Another of our new programs
is tribal government management designed to help tribal leaders
be more effective administrators. We continue to refine our
curricula for this program.
A newly established education program is tribal tourism
management. UTTC has researched and developed core curricula
for the tourism program with which we are partnering with three
other tribal colleges (Sitting Bull, Fort Berthold, and Turtle
Mountain). The development of the tribal tourism program was
well timed to coincide with the national Lewis and Clark
Bicentennial this year. As you may know, Lewis and Clark and
their party spent one quarter of their journey in North Dakota.
UTTC art students were commissioned by the Thomas Jefferson
Foundation to create historically accurate reproductions of
Lewis and Clark-era Indian objects using traditional methods
and natural materials. Our students had partners in this
project including the National Park Service and the Peabody
Museum at Harvard University. The objects made by our students
are now part of a major exhibition in the Great Hall at
Monticello about the Lewis and Clark expedition.
Job Training and Economic Development.--UTTC is a designated
Minority Business Center serving Montana and the Dakotas. We also
administer a Workforce Investment Act program and an internship program
with private employers.
Economic Development Administration funding has enabled UTTC to
open a ``University Center.'' The Center will help with tribal economic
development. Most states have such centers. Ours is the first such
tribal center.
Department of Education Study Documents our Facility/Housing
Needs.--The 1998 Vocational Education and Applied Technology Act
required the U.S. Department of Education to study the facilities,
housing and training needs of our institution. That report, conducted
for the Department by the American Institutes for Research, was
published in November, 2000 (``Assessment of Training and Housing needs
within Tribally Controlled Postsecondary Vocational Institutions,
November 2000, American Institute of Research'') The report identified
the need for $16.6 million for the renovation of existing housing and
instructional buildings ($8 million if some existing facilities are
converted to student housing) and $30 million for the construction of
housing and instructional facilities.
UTTC continues to identify housing as its greatest need. We have a
huge waiting list of students some who wait from one to three years for
admittance. New housing must be built to accommodate those on the
waiting list as well as to increase enrollment. Enrollment for the
2002-2003 academic year has increased by 31 percent. In order to
accommodate the enrollment increase, UTTC partnered with local renters
and the Burleigh County Housing Authority. Approximately 40 students
and their dependents were housed off campus. Increased enrollment,
while desirable, also presents challenges for transportation,
cafeteria, maintenance and other services.
UTTC is building a new 86-bed single-student dormitory on campus.
We formed a strategic alliance with the Departments of Education and
Agriculture, the American Indian College Fund, the Shakopee Mdwekanton
Sioux Tribe and other sources to build the dormitory. The new dorm will
help us address our housing shortage. Existing housing must be
renovated to meet local, state, and federal safety codes. In the very
near future, some homes will have to be condemned which will mean lower
enrollments and fewer opportunities for those seeking a quality
education.
Classroom and office space are at a premium. We have literally run
out of space. This means that we cannot expand its course offerings to
keep up with job market demands. Most offices and classrooms that are
being used are quite old and are not adequate for student learning and
success. We were able to piece together three sources of funds (EDA,
USDA, DOEd) to raise $1 million to renovate a building to create a new
student life and technology center.
Thank you for your consideration of our request. We cannot survive
without the basic vocational education funds that come through the
Department of Education.
______
Prepared Statement of the American Indian Higher Education Consortium
Mr. Chairman and Members of the Subcommittee, on behalf of this
nation's 34 Tribal Colleges and Universities (TCUs), which comprise the
American Indian Higher Education Consortium (AIHEC), thank you for the
opportunity to share our fiscal year 2004 funding requests for programs
within the Department of Education, and the Department of Health and
Human Services--Head Start program.
This statement will cover two areas: (a) background on the tribal
colleges, and (b) justifications for our funding requests.
background on tribal colleges
The Tribal College Movement began in 1968 with the establishment of
Navajo Community College, now Dine College, in Tsaile, Arizona. A
succession of tribal colleges soon followed, primarily in the Northern
Plains region. In 1972, the first six tribally controlled colleges
established AIHEC to provide a support network for member institutions.
Today, AIHEC represents 34 Tribal Colleges and Universities located in
12 states, begun specifically to serve the higher education needs of
American Indian students. Collectively, these institutions serve 30,000
full- and part-time students from over 250 Federally recognized tribes.
The vast majority of TCUs are accredited by independent, regional
accreditation agencies and like all institutions of higher education,
must undergo stringent performance reviews on a periodic basis. In
addition to college level programming, TCUs provide much needed high
school completion (GED), basic remediation, job training, college
preparatory courses, and adult education. Tribal colleges fulfill
additional roles within their respective reservation communities
functioning as community centers, libraries, tribal archives, career
and business centers, economic development centers, public-meeting
places, and child care centers. Each TCU is committed to improving the
lives of students through higher education and to moving American
Indians toward self-sufficiency.
Tribal colleges provide access to higher education for American
Indians and others living in some of this nation's most rural and
economically depressed areas. These institutions, chartered by their
respective tribal governments, were established in response to the
recognition by tribal leaders that local, culturally based education
institutions are best suited to help American Indians succeed in higher
education. TCUs combine traditional teachings with conventional
postsecondary courses and curricula. They have developed innovative
means to address the needs of tribal populations and are successful in
overcoming long-standing barriers to higher education for American
Indians. Since the first tribal college was established on the Navajo
reservation, these vital institutions have come to represent the most
significant development in the history of American Indian higher
education, providing access to under-represented students and promoting
achievement among students who may otherwise never have known
postsecondary education success.
Despite their remarkable accomplishments, tribal colleges are the
most poorly funded institutions of higher education in the country.
Chronically inadequate funding remains the most significant barrier to
their success. Funding for basic institutional operations of 24
reservation-based colleges is provided through Title I of the Tribally
Controlled College or University Assistance Act (Public Law 95-471).
Funding under the Act was first appropriated in 1981 and is still, over
20 years later, less than two-thirds of its authorized level of $6,000
per full-time Indian student. In fiscal year 2002,\1\ these colleges
received $3,916 per full-time equivalent Indian student. While
mainstream institutions have a foundation of stable state tax support,
TCUs must rely on annual appropriations from the Federal government for
their basic institutional operating funds. Because TCUs are located on
Federal trust territories, states have no obligation to fund them even
for the non-Indian state-resident students who account for
approximately 20 percent of TCU enrollments. Yet, if these same
students attended any other public institution in the state, the state
would provide basic operating funds to the institution.
---------------------------------------------------------------------------
\1\ As of this writing, the Bureau of Indian Affairs (BIA) has not
released the per Indian Student Count (ISC) funding level for fiscal
year 2003.
---------------------------------------------------------------------------
Inadequate funding has left many of our colleges with no choice but
to operate under severely distressed conditions. Many colleges are
still housed in surplus trailers; cast-off buildings; and facilities
with crumbling foundations, faulty wiring, and leaking roofs.
Sustaining quality academic programs is a challenge without a reliable
source of facilities maintenance and construction funding.
As a result of more than 200 years of Federal Indian policy--
including policies of termination, assimilation and relocation--many
reservation residents live in abject poverty comparable to that found
in Third World nations. Through the efforts of tribal colleges,
American Indian communities receive services they need to reestablish
themselves as responsible, productive, and self-reliant.
justifications
Higher Education Act
The Higher Education Act Amendments of 1998 created a separate
section within Title III, Part A, specifically for the nation's Tribal
Colleges and Universities (Section 316). The Aid for Institutional
Development programs, commonly known as the Title III programs, support
institutions that enroll large proportions of financially disadvantaged
students and have low per-student expenditures. TCUs clearly fit this
definition as they are among the most poorly funded institutions in
America, yet they serve some of the most impoverished areas of the
country. The President's proposed increase for strengthening developing
institutions programs under Higher Education Act was based on the
fiscal year 2002 budget recommendations and not on the enacted fiscal
year 2003 appropriations for these programs. The fiscal year 2003
Omnibus Appropriations bill includes $23 million for the tribal college
Title III programs. Therefore, if enacted, the President's fiscal year
2004 Budget recommendation of $19 million would not result in an
increase at all, but rather a $4 million decrease in these vital
program funds. We strongly urge the Subcommittee fund section 316 at
$27 million, an increase of $4 million over fiscal year 2003 and $8
million over the President's request, and we ask that report language
included in fiscal year 2003 be restated to clarify that funds not
needed to support continuation grants or new planning or implementation
grants be available for facilities renovation and construction grants.
The importance of Pell grants to our students cannot be overstated.
Department of Education figures show that at least half of all Tribal
College students receive Pell grants, primarily because student income
levels are so low and our students have far less access to other
sources of aid than students at mainstream institutions. Within the
Tribal College system, Pell grants are doing exactly what they were
intended to do--they are serving the needs of the lowest income
students by helping people gain access to higher education and become
active, productive members of the workforce. We urge Congress fund this
critical program at the highest possible level.
Carl D. Perkins Vocational & Applied Technology Education Act
Tribally-Controlled Postsecondary Vocational Institutions.--Section
117 of the Perkins Act provides basic operating funds for two of our
member institutions: United Tribes Technical College in Bismarck, North
Dakota, and Crownpoint Institute of Technology in Crownpoint, New
Mexico. We urge Congress fund this program at $8 million and continue
the language included in fiscal years 2002 and 2003 stating that
Section 117 Perkins grantees need not utilize restricted indirect cost
rate.
The President's fiscal year 2004 budget proposes the elimination of
the Native American Program Section 116, which reserves 1.25 percent of
appropriated funding to support Indian vocational programs. We strongly
urge Congress continue this program, which is vital to the survival of
vocational education programs being offered at TCUs.
Greater Support of Indian Education Programs Under ESEA
American Indian Adult and Basic Education.--This section supports
adult education programs for American Indians offered by TCUs, state
and local education agencies, Indian tribes, institutions, and
agencies. Despite a lack of funding, TCUs must find a way to continue
to provide basic adult education classes for those Indians that the
present K-12 Indian education system has failed. Before many
individuals can even begin the course work needed to learn a productive
skill, they first must earn a GED or, in some cases, learn to read.
According to a 1995 survey conducted by the Carnegie Foundation for the
Advancement of Teaching, 20 percent of the participating students had
completed a tribal college GED program before beginning higher
education classes at the tribal college. At some schools, the
percentage is even higher. Clearly, the need for basic educational
programs is tremendous, and TCUs need funding to support these crucial
activities. Tribal colleges respectfully request that Congress
appropriate $5 million to meet the ever-increasing demand for basic
adult education services.
American Indian Teacher Corps.--American Indians are severely
under-represented in the teaching and school administrator ranks
nationally. These competitive programs, aimed at producing new American
Indian teachers and school administrators for schools serving American
Indian students, support the recruitment, training, and in-service
professional development programs for Indians to become effective
teachers and school administrators, and in doing so excellent role
models for Indian children. We believe that the TCUs are the ideal
catalysts for these initiatives because of our current work in this
area and the existing articulation agreements TCUs hold with 4-year
degree awarding institutions. We request Congress support these
programs at $10 million and $5 million, respectively, to increase the
number of qualified American Indian teachers and school administrators
in Indian Country.
Department of Health and Human Services/Administration for Child, Youth
and Families/Head Start
Tribal Colleges and Universities (TCU) Head Start Partnership
Program.--The TCU/Head Start partnership has made a lasting investment
in our Indian communities by creating and enhancing associate degree
programs in Early Childhood Development and related fields. New
graduates of these programs can help meet the mandate that 50 percent
of all program teachers earn an associate degree in Early Childhood
Development or a related discipline by 2003. One clear impediment to
the on-going success of this partnership program is the decrease in
discretionary funding being directed to the TCU/Head Start partnership.
In fiscal year 1999, the first year of the program, six TCUs received
awards; in fiscal year 2000, seven additional colleges received 3-year
grant awards; in fiscal year 2001, new grants were extended to be 5-
year grants but only $360,000 was made available for the program,
allowing only three additional TCUs to receive grants; in fiscal year
2002 no additional grants were awarded. The extension of the duration
for new grants was a welcome change. We are hopeful that the current
(1999 and 2000 grantees) will be able to extend their existing grants
to a total of 60 months. The President's budget includes a request of
$6,815,570,000 for Head Start Programs. We request Congress direct the
Head Start Bureau to designate a minimum of $5 million for the TCU/Head
Start Partnership program, to allow current grantees to extend their
programs for two additional years and to ensure that this critical
program can be continued and be expanded so that all TCUs might offer
Head Start partnership programs.
conclusion
Tribal colleges are bringing education to thousands of American
Indians. The modest Federal investment in the tribal colleges has paid
great dividends in terms of employment, education, and economic
development, and continuation of this investment makes sound moral and
fiscal sense. We very much need help to sustain and grow our programs
and achieve our missions.
Thank you again for this opportunity to present our funding
requests. We respectfully ask the Members of this Subcommittee for
their continued support of TCUs and full consideration of our fiscal
year 2004 appropriations request.
______
Prepared Statement of the Crownpoint Institute of Technology,
Crownpoint, NM
This testimony addresses appropriations for Section 117 of the Carl
D. Perkins Vocational Education Act, ``Tribally Controlled Vocational
and Technical Institutions.''
On behalf of the Crownpoint Institute of Technology (CIT), I thank
this Subcommittee for appropriating operational funds to Section 117 in
the amount of $7 Million for fiscal year 2003. Because this
appropriation is forward funded, CIT will not know its allocation under
it until September 2003. From the fiscal year 2002 appropriation of
$6.5 Million, CIT received $3,663,331. In addition, CIT extends it
deepest gratitude to this Subcommittee for the accompanying
appropriations language that addresses the Department of Education's
use of restricted indirect cost rates to vocational grants under
Section 117. The Subcommittee's language rectifies a serious problem
wherein essential vocational education services were disallowed by the
Department through the application of extraneous regulations. CIT
endeavors to realize a long range solution to the problem of restricted
indirect cost through the reauthorization of the law. The
reauthorization is expected in 2003, but it may not occur until later.
CIT urges this Subcommittee to continue the prohibition of restricted
indirect cost by the Department if the authorizing statute is not
reauthorized in 2003. CIT also strives to have other problems
surrounding the Departmental allocation of appropriated funds corrected
through the reauthorization.
CIT is the only postsecondary vocational educational institution on
the Navajo Nation reservation. For academic year 2002-03, CIT's
enrollment is 429 headcount: 517 Indian Student Count/Full Time
Equivalency (ISC/FTE). CIT is open to all Indian and non-Indian
applicants alike who meet admissions criteria, but the preponderance of
applicants are of course Navajo Nation young adults who traditionally
have not had access postsecondary vocational education due to
geographic, cultural and economic isolation from mainstream
postsecondary educational opportunities.
The Navajo reservation is an immense and remote 26,897 square miles
extending into three States: Arizona, New Mexico and Utah. This
reservation is 2,810 square miles larger than the State of West
Virginia. The driving distance across the reservation is approximately
nine hours. Although distant from major towns, Crownpoint is a major
reservation activity center. CIT students come from throughout the
reservation as well as from the towns of Gallup, Cruet, Continental
Divide, Fruitland, Kirtland, Mentmore, Rehobeth (all in New Mexico),
Durango, Colorado, White Mesa, Utah and the Tohono O'odham and Hopi
Reservations in Arizona. Approximately 30 percent of CIT students are
from the Arizona side of the Reservation.
The population of the Navajo Nation is 225,298 (U.S. Census 2000).
The Navajo Nation is one of the very few tribes with an extant native
language. Nearly all Navajo citizens raised on the reservation not only
speak the Navajo language but also use it in their daily lives. On
trust land alone, 106,432 Navajo citizens are age 18 and over. The
decennial tribal population increase is 14 percent, as compared to only
8 percent for mainstream America. The median Native American population
age is 27.4 years, eight years younger than the median age for
mainstream America. Approximately 10,000 Navajo students graduate from
area high schools each year. The average CIT student age is 26, with
the actual age range being 18 to 64.
It is essential that appropriators understand the immense
population difference that exists among Indian tribes. In contrast to
Navajo, the sixteen tribes in the States of Montana, North Dakota and
South Dakota have a combined population of 72,835. The Navajo Nation
population is more than three-fold the population of these sixteen
tribes. These sixteen tribes each have one tribal college available to
their citizens on significantly smaller land bases. The Navajo Nation
has only one other college, Dine', based in Tsaile, Arizona with eight
small branch campuses throughout the reservation. Of the entire Navajo
population, only 4.66 percent of high school graduates go on to achieve
a bachelor's degree. Only 2 percent achieve Masters degrees, and less
than one-half percent earn doctorates. CIT has proven to offer a
realistic educational alternative that equips young adults with
meaningful employment skills as well as placing graduates in career
track employment.
In order to do so, CIT has broader infrastructure responsibilities.
CIT is campus-based with 153,468 square feet of facilities. The CIT
campus includes state of the art classrooms and Veterinary Clinic,
modular administrative buildings, library, efficiency apartments,
dormitory, married student housing and cafeteria. CIT has no recreation
facility. CIT has a higher proportion of students who have
developmental education needs, and longer distances to transport
students. Despite many challenges, CIT earns achievements. In 2003, CIT
received an excellence award from the U.S. Department of Agriculture
for the second time for sincere commitment to student outcomes, one of
only eight such awards nationally. Also in 2003, the CIT Culinary Arts
Program students won the Hilton Hotels-sponsored creative culinary art
award.
CIT continues to increase its student housing capacity with
assistance from the Navajo Nation HUD. In 2003, another sixteen married
and family student units were completed. Students with dependent
families are among those most in need of acquiring employment skills.
CIT opened a new 75 unit efficiency housing for 150 students, but at
the same time had to temporarily close its 110 unit dormitory for
safety-related repairs to be completed in a year. Each year, CIT has
averaged a waiting list of approximately 200 otherwise qualified
students due to residential hosing limitations. Rental housing is
scarce in the town of Crownpoint.
Daily commuting from most parts of the reservation is hindered by
poor roads, harsh weather and vast distance, although some students do
commute daily up to 70 miles each way. CIT has an eight-year average
student retention rate of 95 percent, and an average job placement rate
of 86 percent over that same period. Due to the Department's
discretionary restrictions, CIT's student job placement office is
understaffed. As a consequence, the job placement average has dropped
to 75 percent. With additional resources, CIT could increase student
job placement even further.
CIT is fully-accredited by North Central Association of Colleges
and Schools as a vocational educational institution. CIT offers two-
year Associate of Applied Science degrees in seven disciplines:
Accounting, Administrative Assistant, Applied Computer Technology,
Environmental Technology and Natural Resources, Law Advocate, Legal
Assistant and Veterinary Technician. CIT offers sixteen vocational
certificate programs: Accounting, Administrative Assistant, Applied
Computer Technology, Automotive Technology, Building Maintenance,
Carpentry, Culinary Arts, Electrical Trades, Environmental Technology
and Natural Resources, Law Advocate, Legal Assistant, Nursing
Assistant, Veterinary Assistant, Small Business Development (new),
Commercial Drivers License and Computer Aided Drafting. In the upcoming
year, CIT is ready to offer Alternative Energy to assist the many
reservation areas that still do not have access to electricity and
possibly never will.
In May 2002, CIT graduated 208 students. This reflects an increase
of 25 percent in the number of graduates over the previous year, which
was 167 graduates. Approximately 80 percent of CIT completions not
continuing their educations had secured employment placement by the
time they graduated. Of this number, 86 percent secured full-time
employment with the remaining 14 percent accepting seasonal jobs. 54
percent secured employment on-reservation and 46 percent off-
reservation. In addition, the region's economy is comprised
significantly of self-employed ranchers who by definition are not
placed in employment. Several CIT Veterinary students are self-employed
ranchers who improve their livelihoods through knowledge and skills
learned in the CIT Veterinary Program. Students continuing their
educations are considered positive terminations.
Of the above graduating classes (375 students), the CIT Placement
Office successfully tracked and job placed 82 percent (308). 92 CIT
graduates (30 percent) continued their educations. Funding limitations
inhibit the capability of the CIT Placement Office to track and place
100 percent, but indicators over time are that some graduates who do
not maintain contact with the Placement Office after graduation may do
so because they have no need for job placement services. In other
words, they find employment on their own. Of those graduates utilizing
CIT placement services the following were placed in jobs or continued
their education: Accounting 10 of 10 (100 percent): Administrative
Assistant 30 of 43 (70 percent): Applied Computer technology 24 of 44
(55 percent): Automotive Technology 19 of 20 (95 percent): Building
Maintenance 15 of 18 (83 percent): Carpentry 17 of 20 (85 percent):
Culinary Arts 9 of 12 (75 percent): Electrical Trades 20 of 22 (91
percent): Environmental Technology and Natural Resources 17 of 23 (74
percent): Legal Assistant 5 of 5 (100 percent): Law Advocate 5 of 8 (63
percent): Nursing Assistant 34 of 52 (65 percent): Veterinary Assistant
10 of 13 (77 percent): Commercial Drivers License 16 of 18 (89
percent). Other variables affect employment success rates. For example,
Nursing Assistants are in high demand. However, due to housing scarcity
and transportation obstacles, several CIT Nursing Assistant graduates
were unable to accept jobs offered.
Of all CIT graduates, the average entry level wage is $17,160 per
annum. CIT's Commercial Drivers License (CDL) program graduates earn
the highest wage at $16 to $18 an hour, or $33,280 to $37,440 annually
if employment remains stable. The next highest paid entry-level wages
average by vocational program are: Veterinary Technician/Assistant
$23,920: Legal Advocate/Assistant $21,320: Electrical Trades $20,280:
Automotive and Environmental Technology, both at $19,760. Even the
modest entry-level wages can be deceiving as to the wage once
established in that profession. For example, an electrical apprentice
will start at $9/$11 hourly. This wage will more than double to $22/$28
hourly in 3\1/2\ to 4 years.
For Associate degree students continuing their educations, CIT has
articulation agreements with University of New Mexico Albuquerque and
Gallup, New Mexico State, Ft. Lewis College, University of Arizona and
Northern Arizona University. The University of Pennsylvania and Iowa
State University interns participate in CIT's Elk Management Program.
In addition, CIT partners this program with the Tohono O'odham Tribe of
Arizona where livestock is critical to subsistence. In the Tohono
O'odham partnership, CIT addresses the very real problem of migratory
livestock disease transmission from across the Mexico border.
Partnering with Iowa State and Colorado State Universities, CIT
offers an elk and cattle artificial insemination program for the
region's ranchers. In response to overgrazing, the Elk Management
Program has proven to be a viable alternative livestock offering a
three-fold return over traditional livestock.
Less than four year ago, CIT did not yet have its own internet
access. With the generous assistance of Section 117 appropriations from
this Subcommittee, CIT is achieving state of the art technology with a
now fully-operational Distance Learning capability. Partnering with
Northern Arizona University and Window Rock Unified School District,
CIT's vocational offerings will now expand to high school students in
Two plus Two Programs in the farthest reaches of the reservation. Also,
NAU programs can now be brought to CIT students, and CIT faculty can
partake of professional development without the time and expense of
leaving the campus. In the extreme geographic isolation of the
reservation, distance learning capability holds the promise of enabling
even more educational opportunities on a par with those more readily
available in urban and suburban America. In order for CIT graduates to
be competitive for America's jobs, they must be able to acquire equal
employability skills.
In an average lifetime of employment, CIT graduates will return to
the Federal Government the cost of its investment many times over. Each
employed graduate pays an average of $2,576 of their earnings to
federal taxes in the first year of employment alone. Actual taxes paid
differ according to a number of variables, but wage earnings and
resultant tax contributions will generally continue over at least
thirty years. CIT lacks institutional resources to track all of its
graduates over the past two decades, but of those tracked 62 percent
are employed in private industry and do not rely directly or indirectly
on federal appropriations for jobs.
While CIT's CDL program graduates can earn high wages, it is an
extremely limited offering. An actual tractor-trailer must be utilized
and class size limit is four students per session. Strict State
licensing standards require a paved training lot of over 300 feet in
either direction. Until now, CIT offered the CDL course on it overflow
campus parking lot. However, the Navajo Nation's new Empowerment
Building for Temporary Assistance to Needy Families (TANF) on the CIT
campus will now utilize this space. The Empowerment Center fills a
previously unmet need and will house CIT's Adult Basic Education
Classroom for its 172 students, serve 500 Eastern Navajo area families
and employ 32 staff. This will fill the overflow parking lot to
capacity. Importantly, this same parking lot also served as the
training ground for Defensive Driving training for 102 Head Start bus
drivers from throughout the area. Now, neither the CDL nor the Head
Start bus driver training courses will have a training lot. Unless
funding is found for a replacement training lot, this highly successful
CDL program will have to be discontinued.
As is prevalent throughout the economically disadvantaged in Native
America, many high school graduates are not equipped with skills
necessary to enter postsecondary education. To rectify this deficiency
among some CIT applicants, CIT will hold its first summer session of
Developmental Studies in 2003. This session will run for five weeks for
approximately 150 entering students. Participating students will have
the opportunity to achieve readiness skills by the start of the fall
semester. To maximize the benefit to the community, CIT plans to
simultaneously conduct five one week Computer and Math Camps for K-12.
CIT continually strives to strengthen its programs. In 2003 CIT
will enhance articulation agreements with San Juan and Dine Colleges
through standardization of course offerings, particularly in the math
and sciences. Through such measures CIT can more effectively ascertain
student achievement and modify course offerings as necessary. This will
increase access to continued education at four-year institutions for
CIT graduates with the goal to further their educations. CIT will
require additional resources to retain adjunct faculty in order to
achieve this goal.
On behalf of all the CIT students whose quality of life has been
immensely improved by Section 117 appropriations; I thank this
Subcommittee for all of its assistance. CIT still faces the challenges
described above, and will deeply appreciate and maximally benefit from
any increases possible from this Subcommittee.
______
RELATED AGENCIES
Prepared Statement of the National Minority Public Broadcasting
Consortia
--National Asian American Telecommunications Association
--National Black Programming Consortium
--Latino Public Broadcasting Project
--Native American Public Telecommunications
--Pacific Islanders in Communications
The National Minority Public Broadcasting Consortia (Minority
Consortia) submits this statement on the fiscal year 2006 appropriation
for the Corporation for Public Broadcasting (CPB). Our primary missions
are to bring a significant amount of programming from our communities
into the mainstream of PBS and public broadcasting. In summary, we ask
the Committee to:
--Reject the Administration's proposal to end advance funding of the
Corporation for Public Broadcasting
--Reject the Administration's proposal to divert $100 million of
already appropriated fiscal year 2004 funds to digital
conversion and satellite interconnection
--Recommend at least $410 million for CPB for fiscal year 2006, a $20
million increase over fiscal year 2005
--Encourage CPB to increase its efforts for diverse programming with
commensurate increases for minority programming and the
Minority Consortia
--Support CPB's request of $60 million for digital conversion, but
require that some of it be made available to independent
producers, not only to stations
We are taken aback at the Administration's proposals regarding
public broadcasting, and can only conclude that they are out of touch
with the American public and with Congress when it comes to
appreciating the education, services, and entertainment brought to us
by 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. Administration proposals to end forward
funding of CPB, and to rescind funds, and to divert already
appropriated funds would dramatically reduce the development of
programming for public broadcasting.
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 two years and that the fiscal
year 2004 budget resolution assumes that CPB will remain advance
funded. Reasons to continue advance funding for CPB include:
--The production of programming for public broadcasting usually takes
several years and substantial lead time is needed for planning.
--Public broadcasting programs are supported by multiple funding
sources, and two years advance knowledge of the amount of
federal funding allows CPB to better leverage its federal funds
to bring in other sources of revenue.
--The Minority Consortia administers a significant amount of CPB
programming monies, and elimination of advance funding would
negatively affect our organizations' planning and fundraising
activities.
--Proposed Diversion of fiscal year 2004 CPB Funds.
We are extremely concerned about the Administration's proposal to
divert $100 million of already appropriated fiscal year 2004 CPB funds
($380 million) to digital conversion ($80 million) and satellite
interconnection ($20 million). Such a 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. We would be
faced with a 25 percent reduction of CPB funds should Congress approve
this proposal by the Administration.
CPB fiscal year 2006 Appropriation.--We support a fiscal year 2006
federal appropriation for CPB of at least $410 million. This would be a
reasonable, albeit modest, contribution toward our national treasure of
public broadcasting. The debate of the past several years regarding
public television and public radio has highlighted the great esteem in
which they are held.
Public broadcasting, including PBS and NPR, 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.
Digital Conversion Assistance.--We support CPB's request for $60
million for digital conversion funding for CPB.
With stations able to broadcast on multiple channels, there will be
a need for a tremendous amount of new, quality public broadcasting
programming. There are costs involved in the conversion which go beyond
the significant equipment and hardware needs of stations. It will also
take additional money to produce programming for digital broadcast. All
producers face these new, higher costs.
Part of the equation in bringing more high quality diverse
programming to public broadcasting is that independent producers be
able to transition to digital production. Federal funding for digital
conversion should include assistance for independent producers.
The Minority Consortia works closely with CPB. We value our
relationship with President Coonrod and the CPB staff and appreciate
the financial and technical assistance provided to us by that
organization. We do not doubt CPB's commitment to increasing the
diversity of programming on public television and radio but also
believe they can do more with the resources at hand. The oft-stated
commitment of CPB and Congress for increased multicultural programming
combined with six years of funding increases should translate into
significant progress. We urge this Committee to communicate with CPB
about its efforts to bring more quality multicultural programming to
public television.
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 thank you
for your long time support of our work on behalf of our communities.
______
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 over 200 community
radio stations and related organizations across the country. This
includes the new Low Power FM service that has just been authorized by
the FCC. NFCB is the sole national organization representing this group
of stations, which provide service in both the smallest communities and
largest metropolitan areas of this country. Nearly half of our members
are rural stations, and half are minority controlled stations.
In summary, the points we wish to make to this Subcommittee are
that NFCB:
--Requests $410 million CPB for fiscal year 2006, a $20 million
increase over fiscal year 2005 advance appropriation;
--Requests $60 million in fiscal year 2004 for conversion of public
radio and television to digital broadcasting. Also requests $20
million for the Public TV interconnection system;
--Requests that advance funding for CPB is maintained in order to
preserve journalistic integrity and facilitate planning and
local fundraising by public broadcasters;
--Requests report language to ensure that CPB utilizes digital funds
it receives for radio as well as television needs;
--Supports CPB activities in facilitating programming services to
Latino and Native American radio stations;
--Supports CPB's efforts to help public radio stations utilize new
distribution technologies, and requests that the Subcommittee
ensure these technologies are available to all public radio
services, not just those with the greatest resources.
Community radio fully supports $410 million for the Corporation for
Public Broadcasting in fiscal year 2006.--Federal support distributed
through the CPB is an essential resource for rural stations and for
stations serving minority communities. These stations provide critical,
life-saving information to their listeners. Yet they are often in
communities with very small populations and limited economic bases, so
that the ability of the community to financially support the station is
insufficient 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 dominated by national program
services and concentrated ownership of the media.
For the past 28 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 federal funds. Most importantly, the
insulation that forward-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 and satellite radio. We commend these
activities, which we feel provide better service to the American
people, but want to be sure that smaller stations with more limited
resources are not left out of this technological transition. We ask
that the Subcommittee include language in the appropriation that will
ensure 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 programming services to Latino stations and Native American
stations. Satelite Radio Bilingue provides 24 hours of programming to
stations across the United States and Puerto Rico, addressing issues of
particular interest to the Latino population. In the same way, American
Indian Radio on Satellite (AIROS) distributes programming for Native
American stations, arguably the fastest growing group of stations.
There are now over 30 stations controlled by and serving Native
Americans, primarily on Indian reservations.
Almost two years ago, CPB funded an historic Summit of Native
American Radio in Warm Springs, Oregon. It was an extremely important
opportunity for Native American stations and producers to strategize
(with each other, and with colleagues from Public Radio and Native
America) on ways to improve radio service to all Native Americans. CPB
funded a similar Summit for Latino Public Radio, which took place this
past September 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
both improve efficiency among stations through collaborations, and
explore new ways of reaching target audiences.
CPB plays a very important role in 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
for 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 put 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 $60 million in fiscal year 2004
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
Administration's proposal that digital money should be taken from the
fiscal year 2004 CPB appropriation would effectively cut stations'
grants by more than 25 percent. This would have a devastating impact
during these hard economic times, when stations are facing cuts from
state and institutional funds at historic levels. And it would come at
a time when the local voices of community and public radio are
especially important, both 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 more
immediate, the Federal Communications Commission has now approved a
standard for digital radio transmission. We expect that there will be
funds available for radio conversion as well as television conversion.
The initial conversion of radio stations is being concentrated in 13
seed markets. CPB is using some of the previously appropriated digital
funds to help public stations in these markets convert to digital,
conduct additional research on AM radio conversion, and work with radio
receiver manufacturers to build in the capacity to receive a 2nd audio
channel. The development of 2nd audio channels will potentially double
the public service that public radio can provide, particularly to
unserved and underserved communities. This initial funding will only
help a small number of the stations that will ultimately need to
convert or be left behind while the world goes digital.
Community Radio also supports $20 million in fiscal year 2004 for
the public television interconnection system.
Federal funds distributed by 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. 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.
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)
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 our business;
concentration of ownership in commercial radio makes public radio in
general and community radio in particular more unique, and more
important as a local voice than we have ever been. 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 major global events, culturally appropriate
information and entertainment in the language of the native culture,
and help in preserving cultures that are dying out.
During this time, the role of CPB as a convener of the system
becomes even more important. The funding that it provides will allow
smaller stations to participate along with larger stations which have
more resources, as we move into a new era of communications.
Thank you for your consideration of our testimony. If the
Subcommittee has any questions, or needs to follow-up on any of the
points expressed above, please contact: Carol Pierson, President and
CEO, National Federation of Community Broadcasters, 1970 Broadway,
Suite 1000, Oakland, CA 94612--Telephone: 510 451-8200--Fax: 510-451-
8208--E-mail: carol@nfcb.org
The NFCB is a twenty-eight year old grassroots organization which
was established by and continues to be supported by our member
stations. Large and small, rural and urban, NFCB member stations are
distinguished by their commitment to local programming, community
participation and support. NFCB's 100 Participant members and 100
Associates come from across the United States, from Alaska to Florida;
from every major market to the smallest Native American reservation.
While urban member stations provide alternative programming to
communities that include New York, Minneapolis, San Francisco and other
major markets, rural members are often the sole source of local and
national daily news and information in their communities. NFCB's
membership reflects the true diversity of the American population: 41
percent of members serve rural communities, and 46 percent are minority
radio services.
On community radio stations' airwaves examples of localism abound:
on KWSO in Warm Springs, Oregon, you will hear morning drive programs
in their Native language; throughout the California farming areas
around Fresno, Radio Bilingue programs five stations targeting low-
income farm workers; in Barrow, Alaska, on KBRW you will hear the local
news and fishing reports in English and Yupik Eskimo; in Dunmore, West
Virginia, you will hear coverage of the local school board and county
commission meetings; KABR in Alamo, New Mexico serves its small
isolated Native American population with programming almost exclusively
in Navajo; and on WWOZ you can hear the sounds and culture of New
Orleans throughout the day and night.
In 1949 the first community radio station went on the air. From
that day forward, community radio stations have been reliant on their
local community for support through listener contributions. Today, many
stations are partially funded through the Corporation for Public
Broadcasting grant programs. CPB funds represent under 10 percent of
the larger stations' budgets, but can represent up to 50 percent of the
budget of the smallest rural stations.
______
Prepared Statement of the Medicare Payment Advisory Commission
The Medicare Payment Advisory Commission (MedPAC) requests a budget
appropriation of $9.3 million for fiscal year 2004. This request for a
$1.1 million increase over the Commission's fiscal year 2003
appropriations reflects the increasing need for better understanding of
the policy issues for one of the Congress' highest priorities--and with
more than 40 million beneficiaries costing $250 billion per year--one
of the federal governments largest programs. This budget also funds
increases resulting from higher rent, benefit costs, and new MedPAC
products and services.
Legislative mandate.--MedPAC is authorized under section 1805 of
the Social Security Act (42 U.S.C. 1395 b-6), as added by section 4022
of the Balanced Budget Act of 1997 (Public Law 105-33). The Commission
consists of 17 Commissioners, appointed by the Comptroller General of
the General Accounting Office, who possess expertise in biomedical,
health services, and health economics research and who draw on their
experiences as consumers, providers, employers, and payers. An
executive director, analytic and administrative/operational personnel
staff the Commission. To produce the March, June, and other reports
mandated by legislation, the Commission meets publicly throughout the
year.
MedPAC is a small efficient operation.--The Commission works under
a staffing ceiling of 40 FTEs and outsources 40 percent of its budget
for tasks such as data analysis, programming, printing, editorial work,
and selected research projects to maintain efficiencies. Each year, our
annual appropriations provide the resources necessary to complete the
Commission's required activities, including:
--March Report to the Congress.--This report always includes
recommendations on the appropriate levels of payment for
Medicare providers and policies to address the distribution of
payments within a segment of the market (for example, our March
2003 recommendations to improve payments for certain providers
in rural areas).
--June Report to the Congress.--Previous reports have addressed
issues such as Medicare in rural America, payments for new
technologies, and a variety of other topics. The June 2003
report will address a broad range of policy concerns about
variations in the Medicare program and innovations in
purchasing.
--Reports required by other legislation.--During fiscal years 2002
and 2003, MedPAC issued 15 separate reports to Congress on a
variety of issues as required by the Balanced Budget Refinement
Act and the Benefits Improvement and Protection Act.
--Comments on administrative actions.--MedPAC is required to comment
on payment-related reports that the Secretary submits to the
Congress and other proposed rules issued by the Centers for
Medicare and Medicaid Services. These include comments on CMS's
estimate of the update for physician services, evaluation of
demonstration projects like the Medicare social health
maintenance organizations, and reviews of new payment systems
being phased in for certain types of providers.
MedPAC is expanding its services to meet growing demands for
Medicare policy analysis.--Part of the additional funds we request also
will support other analysis and education provided by the Commission.
On top of our statutorily required work, the Commission staff serve as
critical resources to the Senate Finance, House Ways and Means, and
House Energy and Commerce committees in a variety of ways. Meeting the
growing number and scope of requests for information and analysis from
congressional staff requires increases in staff time and other
resources. While some of these new initiatives will require additional
funding, we expect that distributing many of our future work products
electronically will save federal dollars.
In the 2003 fiscal year, we have stepped up the amount of
assistance provided to congressional staff at the urging of our
authorizing committees, and by extension, stretched our human and
financial resources to projects not specifically mandated in
legislation. Some of these new activities include:
--Congressional briefings.--For example, MedPAC coordinated a series
of weekly briefings for Finance committee staff on the
intricacies of the payment systems. These 90-minute briefings
detail how the payment systems work and what the major policy
concerns are in each sector of the Medicare program. We also
worked with other legislative branch agencies to provide a 2-
day briefing for all personal member and committee health
legislative staff on Medicare, Medicaid, and SCHIP issues.
--Informational memos.--At the request of committee staff or through
our own initiation, we've begun to issue briefing papers to our
authorizing committees' staff on timely issues that synthesize
the facts and present policy considerations. Previous memos
explained Medicare's outlier payment policy for hospital
services and the bankruptcy of National Century Financial
Enterprises (a financier of many health care providers). Future
memos will explain topics such as how Medicare pays for
physician's professional liability premiums and geographic
variation in Medicare spending.
--New tools and other publications.--The staff fulfill many requests
from congressional offices for data on providers' financial
performance, trends in utilization, and beneficiary
characteristics. In June 2003, MedPAC will release a data book
compiling useful facts and figures to serve as a quick
reference for personal member and committee staff. Over time,
the collection of charts in the data book will be complemented
by an expanded web-based data collection on our website.
MedPAC is expanding the scope of its analyses to include emerging
and dynamic policy issues affecting beneficiaries, providers, and
spending.--Historically, the Commission provided the Congress with a
wealth of information about existing payment systems as well as
guidance on the design and implementation of new programs. Since the
Balanced Budget Act, we have recommended annual payment updates for
Medicare providers and provided input and recommendations on
Medicare+Choice, new payment systems for home health, skilled nursing
facilities, psychiatric hospitals, long-term care hospitals, and many
other providers. Beginning with our March 2003 report, we are
highlighting the implications of these recommendations on three
important issues: spending, beneficiaries, and providers.
Along with the increased urgency over Medicare reform and possible
coverage of prescription drugs, there has been a comparable increase in
the information requests submitted to us from the Congress. Commission
staff have further responded, both orally and in writing, to numerous
requests from Congressional staff on a wide variety of topics. Not
including minor requests, Commission staff have filled over 75 direct
requests for information from Congressional staff, involving meetings,
briefings, data, and other substantive analyses.
In completing our mandated reports and providing analytic support
to the Congress, Commission staff have reached out to the public,
interested parties, and the research community for input and to further
public understanding of the Commission's work. Commission staff made
over 50 public presentations to Commissioners as well as presenting to
local, national, and even international audiences. Staff have held more
than 30 meetings with interest groups and regulated parties on a
variety of topics. Finally, staff have worked with health services
researchers and the health policy community to further the Commission's
work and encourage sharing of information that could extend our
research and analytic efforts.
Looking ahead, the Commission sees a growing need for analysis and
education on many emerging and dynamic issues. We are already receiving
requests from Congressional staff to provide them with guidance on a
broad range of issues-some of which will be addressed in our plans for
future analytic work outlined below:
--Outpatient drugs
--Coverage and payment for new technology
--Post-acute episodes of care
--Dually eligible beneficiaries
--Disease management
--Growth in the volume of physician services
--The financial performance of hospitals and other Medicare providers
--Incentives for quality in traditional Medicare
--Competition in fee-for-service Medicare
--Understanding health insurance markets and choices for
beneficiaries
--Indirect medical education (IME)
--Geographic variation in Medicare payments
MedPAC needs new resources to expand our analytic capacity.--With
each analytic year that passes, the inadequacy of the data available to
assess the Medicare program becomes more evident. To successfully
fulfill our role as adviser to the Congress, we must expand data
sources and the depth of our analysis to better understand provider and
beneficiary needs. Again, such endeavors will require increased
funding. The additional resources requested in our 2004 appropriations
will allow MedPAC to accomplish its congressionally mandated mission
and meet these emerging analytic needs by:
--Expanding the scope of our analysis.--The growing clinical
importance and cost of new technology, outpatient drugs, and
many other services for Medicare beneficiaries is clear. To
fully investigate and educate the Commission and congressional
staff about complex policy issues in a rapidly changing
environment requires an expansion of our current staff capacity
and capabilities. This expansion will improve ongoing
commission work and enable us to meet the increasing number of
inquiries from our authorizing committees for research and
analysis in a timely manner.
--Maintaining and increasing our recruitment and retention of highly
skilled staff.--MedPAC's ability to advise the Congress on the
$250 billion Medicare program hinges on our ability to recruit
and retain a talented staff who bring years of experience and
analytic rigor to bear on the important questions we address.
The skills our staff possess are sought by research firms,
other government agencies, and top consulting firms. To compete
in this market for skilled staff, particularly against the
private sector, we must be able to provide competitive salaries
and benefits.
--Enhancing our ability to supplement staff work with contracted
research.--While working under a staffing cap of 40 FTEs, the
Commission regularly outsources important analyses that inform
Commission recommendations. Research funds will be used to
conduct surveys and analyses by outside contractors, acquire
private sector data such as cost and revenue information from
hospitals to update existing files, and take advantage of new
resources. Given the rapid pace of changes in the Medicare
program, it also is critical to continue to monitor
beneficiaries' access to Medicare providers as well as other
research projects on issues such as the use of outpatient
prescription medications, the characteristics of health
insurance markets, patterns of use of post-acute care services.
--Increasing the Commission's ability to respond to requests for
technical assistance.--The volume of requests has grown this
year, and we expect that trend to continue. While fulfilling
these requests is a vital part of our service to the Congress,
this additional workload strains our ability to complete work
on statutorily required activities.
--Providing resources to meet the day-to-day needs of congressional
staff.--We plan to improve our website so resources such as
background information, additional data, and detailed policy
explanations that complement our reports can be easily
accessed. While we anticipate saving money on printing and
postage through this shift, we will incur additional
information technology costs to create this new platform.
Unavoidable new expenses are consuming a larger part of the
Commission's annual appropriations.--In August 2002, the Commission was
forced to relocate to new office space as a result of a planned
demolition of its previous office location. The rent negotiated for us
at our new location by the General Services Administration (GSA)
resulted in substantial increase over prior years and added new
overhead expenses, such as security. In addition, the growth in the
cost of employee health insurance has added a tremendous burden to our
personnel budget.
MedPAC's work informed congressional and executive branch decisions
during fiscal years 2002 and 2003.--During fiscal years 2002 and 2003,
the Commission submitted its annually mandated March and June reports,
as well as a range of reports mandated under the BBRA and BIPA. The
March 2002 and March 2003 reports focused on specific issues relating
to payment policies and presented recommendations to the Congress on
updating payments to providers of services to Medicare beneficiaries.
Again, in a program that spends $250 billion dollars, these payment
update recommendations have immense repercussions for the federal
budget.
The June 2002 report focused on the Medicare benefit package,
presenting the Congress with an assessment of the need for changes, a
description of the coverage available to supplement the basic benefit
package, and options for changing Medicare benefits. This report
provided the Congress with a crucial perspective on assessing the
Medicare benefit package, gaps in coverage of the current benefits
package, and approaches to consider in revising that package.
The June 2003 report will address conceptual issues facing the
Congress relating to mechanisms for moving the program forward in the
areas of quality, access, program efficiency, and new payment system
design. Some of the topics addressed in the report include experience
with market competition in fee-for-services Medicare; alternatives to
average wholesale price as a mechanism for paying for pharmaceuticals;
and use of quality incentives in Medicare. It will also include our
annual mandated review of the Secretary's estimate of the update for
physician services. We further anticipate production and submission of
a Medicare data book in June 2003, as requested by health committee
staff. By 2004, we plan to supplement the annual data book with a web-
based resource that can be updated to meet future requests for
information.
Reports mandated by previous legislation have been completed on
schedule, and include:
--Adjusting payments for local differences in resident training costs
--Quality improvement standards in fee-for-service Medicare and
Medicare+Choice plans
--Medicare coverage of cardiac and pulmonary rehabilitation services
--State level variation in Medicare spending
--Medicare beneficiaries' access to and use of hospice
--Medicare payment to advanced practice nurses and physician
assistants
--Medicare coverage of nonphysician practitioners
--Choice of skilled nursing facility services in Medicare+Choice
--Analysis of CMS' report on PPS for inpatient psychiatric facilities
MedPAC also commented on proposed rules for long-term care
hospitals, hospital outpatient services, revisions to the physician fee
schedule, and the hospital inpatient prospective payment system. In
addition, the Commission Chairman has testified three times before the
Subcommittee on Health, House Committee on Ways and Means during fiscal
year 2002 and 2003 on physician payment policy, adjusting Medicare
payments for local market input prices, and the Commission's payment
recommendations for fiscal year 2004. The Commission expects to provide
further testimony during the remainder of fiscal year 2003 and fiscal
year 2004.
Congress and the executive branch have used MedPAC products and
services.--MedPAC has provided both direct and indirect support to the
policy process in the Congress and the executive branch. The Congress
and the Centers for Medicare and Medicaid Services have adopted
MedPAC's recommendations on a number of issues, including on risk
adjustment, rural home health agencies and the prospective payment
system, and on productivity adjustments for physician services. In
addition, MedPAC deliberations and reports have influenced the debate
in the Congress. As described above, members and staff have sought
MedPAC's analytic support to help them better assess the issues.
Commission administration and management.--The Commission believes
that its request for an appropriation of $9.3 million is necessary not
only to maintain but also to increase the current level of analysis,
data development, and operations required to fulfill and exceed our
mandated responsibilities to the Congress. This additional funding will
also cover an increase in rental and security costs from forced office
relocation, as well as increased costs for employee health insurance.
Under contract to MedPAC, the General Services Administration (GSA)
provides payroll and accounting services, arranges for office space,
telecommunication services, and travel services at government contract
rates. The Commission obtains computer services from the National
Institutes of Health, but is attempting to move to an alternative
computing platform to minimize costs.
Issues relating to the Medicare program remain at the forefront of
Congressional deliberations. MedPAC requires a budget of $9.3 million
to adequately support the Congress in its deliberations on these
issues.
______
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 2004 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
2002, the RRB paid $8.6 billion in retirement/survivor benefits to more
than 684,000 beneficiaries, and $128 million in unemployment/sickness
insurance benefits to over 39,000 claimants.
president's proposed fiscal year 2004 budget
The President's proposed budget includes $99.82 million for RRB
administrative expenses in fiscal year 2004. This total includes $97.72
million for the ongoing costs of current agency operations, which is
the same as the amount included in the President's proposed budget for
fiscal year 2003, but $2.28 million less than our initial appropriation
of $100 million, before the 0.65 percent rescission under the
Consolidated Appropriations Act, 2003 (Public Law 108-7). In addition,
the President's proposed budget includes $2.1 million to contract with
a non-governmental disbursement agent for payment of railroad
retirement and survivor benefits in accordance with provisions of the
Railroad Retirement and Survivors' Improvement Act of 2001 (Public Law
107-90).
Our Justification of Budget Estimates, released on February 12,
2003, indicated that the proposed funding would be sufficient for a
staffing level of 1,019 full-time equivalent staff years (FTE's). The
estimate reflected guidance from the Office of Management and Budget,
which assumed pay increases of 3.1 percent in January 2003 and 2.0
percent in January 2004. The projection was subsequently updated to
reflect the January 2003 pay increase of 4.1 percent enacted under
Public Law 108-7. We now estimate that the President's proposed level
of funding will be sufficient for about 1,008 FTE's, which is 73 fewer
FTE's than the RRB plans to use in fiscal year 2003. This represents a
cumulative reduction of 41 percent in our agency's staffing since
fiscal year 1993.
In order to operate at the President's proposed budget level in
fiscal year 2004, we would need to make extremely deep cuts in funding
for administrative costs throughout the RRB. We would first attempt to
minimize any disruption in customer service by reducing costs which are
indirectly related to these activities. In fiscal year 2003, we have
already suspended most of our employee benefit programs, including
transit benefit subsidies, medical exams, and certain award programs,
which have contributed considerably to employee morale in the past.
These programs would continue to be suspended in fiscal year 2004. We
would also continue to severely limit funds allocated for variable
expenses, such as overtime, travel, training, supplies and equipment.
Further reductions would still be required in two areas directly
affecting the public: agency staffing and information technology
initiatives. Without additional funding, we will need to sharply reduce
our staffing in fiscal year 2004. In addition, due to staffing
reductions, the opportunities to achieve additional savings through
automation will be diminished.
The Administration's proposed budget assumes that the RRB, as a
trust fund agency, will continue to pay actual costs to the General
Services Administration (GSA) for rental of space and services. The RRB
has paid rent to GSA based on actual costs since fiscal year 1975.
Consistent with this practice, the Administration's budget proposal for
fiscal year 2004 includes funding based on actual costs. If GSA were to
charge rent at the commercially equivalent rate in fiscal year 2004,
the RRB's rental costs and total costs would increase by $3.7 million.
We are currently negotiating with GSA officials on a long-term
agreement that would continue the practice of paying actual costs for
rental of space and services and provide for the possible payment of a
fee to be applied against a given year's depreciation expense.
In addition to the requests for administrative expenses, the
Administration's budget includes $119 million to fund the continuing
phase-out of vested dual benefits, and $150,000 for interest related to
uncashed railroad retirement checks.
request for additional funding in fiscal year 2004
We believe the President's proposed funding level is not sufficient
to meet our statutory mission under the railroad retirement and
railroad unemployment insurance programs. In order to maintain a
minimum core of experienced staff and continue making information
technology improvements, the RRB will need at least $102.5 million for
agency administration in fiscal year 2004, excluding any costs for
contracting with a non-governmental disbursement agent. In this regard,
it appears unlikely that the transition to a non-governmental
disbursement agent will occur during fiscal year 2004 due to complex
issues which have surfaced during initial procurement actions
concerning the costs and effectiveness of services available from non-
governmental providers.
Accordingly, we request an appropriation of $102.5 million for
agency administration in fiscal year 2004, which is $2.68 million above
the Administration's proposed total funding level. This would
effectively provide an additional $4.78 million for critical needs of
this agency because our request does not include any funding for a non-
governmental disbursement agent. We would use approximately $4.1
million of the increase for compensation and benefits, and the
remaining amount for information technology investments. Even with
these additional dollars, we would only be able to fund approximately
1,058 FTE's, which is 23 fewer than we expect to be able to fund in
fiscal year 2003.
The efficient and timely administration of our Acts requires well-
trained and experienced staff. Although the RRB has already suffered
significant workforce reductions over the last few years, we have been
able to maintain and even improve customer service. This has been
accomplished using a core of experienced staff and productivity gains
through technology. However, our staff has been seriously depleted due
to the continued budget reductions and the aging of our workforce. We
need additional funding in fiscal year 2004, to mitigate the expected
loss of experienced staff by hiring and training new employees and to
increase available resources for advances in information technology.
strategic management of information technology
Information technology initiatives in recent years have
significantly improved operations and allowed the agency to reduce
staffing in key areas. Ongoing and planned projects will further
increase and enhance the efficiency and effectiveness of our systems
for benefit payments and program administration. Key initiatives, which
total $1,436,000 at the Administration's proposed budget level and
$2,111,000 at the RRB's request level, can be grouped into two major
categories, as described below.
Application design services.--Initiatives in this category focus on
automation projects that are critical to our long-range strategy to
promote better customer service through automation, while lowering the
costs and increasing the efficiency of our operations. Specific
investments planned for fiscal year 2004 include:
--Information technology task orders ($250,000 at the President's
proposed level, and an additional $150,000 at the agency
request level).--This non-capital item represents funding to
implement the President's goals for increasing private-sector
competition in commercial-type activities. Contractor resources
would be used on a task-order basis as an alternative to
filling vacant positions.
--Document imaging ($75,000).--This multi-year initiative is key to
accomplishing our objective of paperless processing for claims
operations. These funds will be used for licensing and
performance-based contractual support.
--System development tools ($25,000).--The RRB will require
additional software development tools to remain current with
the changing technologies in electronic commerce and to
participate in interagency initiatives that seek to better
coordinate data sharing among agencies.
--E-Government initiatives (no funding provided at the President's
proposed level, and $300,000 at the agency request level).--The
RRB's Government Paperwork Elimination Act strategy continues
to focus on providing electronic service options for the
highest value and volume transactions. These transactions are
core agency functions that support our primary mission of
administering the benefit provisions of the Acts.
Technology infrastructure services.--These investments are required
to establish a firm foundation for the planned technology advances and
to maintain our operational readiness. The investments in this category
for fiscal year 2004 include:
--Standard workstation infrastructure ($300,000 at the President's
proposed level, and an additional $25,000 at the agency request
level).--Funding is required to continue the agency's policy of
annually replacing and upgrading one-fourth of the agency's
desktop computers, printers and related equipment and software
needed to ensure an adequate work environment.
--Network operations ($250,000).--This amount represents replacements
and upgrades to network servers and related equipment needed to
support a stable and efficient network throughout the agency.
--Mainframe ($175,000 at the President's proposed level, and an
additional $200,000 at the agency request level).--Funding is
requested in fiscal year 2004 for a replacement mainframe
processor or enterprise server that will be supported by the
vendor for continued maintenance and updated software releases
as needed. Funding at the President's proposed level would
allow for payment for the first year of a multi-year lease of a
replacement system. Funding at the agency request level would
allow us to purchase, rather than lease, a system.
--Enterprise storage lease payment ($161,000).--After a competitive
selection process, an enterprise network storage system was
installed to support the growing use of electronic services.
This investment represents the second year of the capital lease
for this equipment.
--Information security ($150,000).--In order to support ongoing
improvement of the overall security structure, we plan to
implement intrusion detection systems and support services and
to conduct a high-level vulnerability assessment using
contractual assistance.
--Enterprise architecture ($50,000).--Contractual assistance will be
used to ensure the development of an efficient and effective
implementation plan to close the gaps between the RRB's current
and target enterprise architectures.
financial status of the trust funds
Railroad Retirement Accounts.--As a result of transfers of $1.5
billion to the National Railroad Retirement Investment Trust, the net
position of the railroad retirement accounts decreased by $1.1 billion
in fiscal year 2002, to $18.7 billion. In fiscal year 2003, we have
transferred an additional $17.75 billion to the Investment Trust.
In June 2002, 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 2002-2026 and contains generally
favorable information concerning railroad retirement financing. The
report included projections of the status of the retirement trust funds
under three employment assumptions. These indicated cash flow problems
only under a pessimistic employment assumption, and then not until
calendar year 2022.
Railroad Unemployment Insurance Accounts.--The equity balance of
the railroad unemployment insurance accounts at the end of fiscal year
2002 was $15.8 million, a decrease of $24.3 million from the previous
year. The RRB's latest annual report on the financial status of the
railroad unemployment insurance system, issued in June 2002, was
generally favorable. The report indicated that even as maximum daily
benefit rates rise 50 percent (from $50 to $75) from 2001 to 2012,
experience-based contribution rates are expected to keep the
unemployment insurance system solvent, except for small, short-term
cash flow problems in 2002 and 2003, requiring a loan from the Railroad
Retirement Account. However, projections show a quick repayment of the
loan even under the RRB's most pessimistic employment assumption. The
average employer contribution rate remains well below the maximum
throughout the projection period, but a 2.5 percent surcharge is now in
effect and a 1.5 percent surcharge is expected for calendar year 2004.
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 administrative
budget request for $102.5 million. 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 present our fiscal year 2004 appropriations request and to describe
our planned activities.
The Office of Inspector General requests funding of $6,600,000 to
ensure the continuation of its independent oversight of the RRB. The
agency is responsible for managing benefit programs which paid $8.6
billion in retirement and survivor benefits to approximately 684,000
beneficiaries in fiscal year 2002 and an additional $99 million in
railroad unemployment and sickness insurance benefits to 40,000
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 $788
million in annual Medicare benefits are paid to approximately 571,000
beneficiaries.
In fiscal year 2004, the Office of Inspector General will continue
to focus its resources on significant policy issues and 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 funds
for any audit, investigation or review of the Railroad Medicare program
and the related reimbursement funds from the Centers for Medicare and
Medicaid Services (CMS). The RRB is responsible for the administration
of Medicare program activities including enrollment, premium
collection, answering beneficiary inquiries and the monitoring of the
contractor's performance in conjunction with CMS. The removal of the
prohibition would allow us to carry out our statutory oversight
responsibilities. The prohibition is contrary to the priorities set by
the Administration and the Congress to reduce fraud in one of the
largest Federal programs.
office of audit
Auditors will perform the audit of the RRB's 2003 financial
statements and preliminary work for the 2004 financial statements to
ensure the issuance of reliable financial information. The OIG will
continue to recommend that management consider additional action to
restructure the agency organization to address the overall control
environment, a material weakness cited in the audits of the financial
statements.
We will assign a high priority to the agency's monitoring of
investment activities to ensure the statutory obligations of the
Railroad Retirement Act and the Railroad Retirement and Survivors'
Improvement Act are met. Because of our ongoing concerns on the
investment of agency trust funds, we will seek legislative change to
transfer the oversight and enforcement powers of investment activity
from the agency to the OIG.
We 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. We 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.
We will ensure that network and system security safeguards are in
place to protect the confidentiality of sensitive financial and
personal information. 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 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 that now total
approximately $57.5 million.
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 2004, 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 $13 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 continue our efforts with 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 our resources on cases with the highest fraud
losses, those related to the RRB's retirement and disability programs
as well as fraudulent reporting by railroad employers. We will continue
our investigations of railroad employers and unions which submit
fraudulent compensation and service reports to the RRB and do not
submit the required contributions after they have been deemed to be
covered employers under the Railroad Retirement Act and the Railroad
Unemployment Insurance Act. These investigations typically have a
significant impact on the RRB's trust funds.
In fiscal year 2004, 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 2004, the Office of Inspector General will continue
its oversight of agency operations to improve the delivery of benefits
to beneficiaries and their families. We will issue recommendations to
improve the quality and integrity of benefit programs. We will also
aggressively pursue individuals who engage in activities to
fraudulently obtain RRB funds.
______
MISCELLANEOUS
Prepared Statement of the Morehouse School of Medicine
Thank you for your leadership in securing $300,000 in the fiscal
year 2003 Labor-HHS appropriations bill for the planning of a new
Family Practice Center at the Morehouse School of Medicine.
As you begin to consider the Labor-HHS appropriations bill for
fiscal year 2004, I request that the Committee provide $3,000,000 for
this important project from the Health Resources and Services
Administration's Health Care Facility Construction and Renovation
Program.
Located in Atlanta, GA, Morehouse School of Medicine was founded in
1975 with the mission of recruiting, educating, and graduating students
from socially and economically disadvantaged backgrounds for service as
primary care physicians in medically underserved communities. Recent
studies reflect the need for more primary care physicians, which places
Morehouse School of Medicine on the cutting edge of needed change in
health professions education. Nationally, MSM ranks among the top
schools in the country in the percentage of graduates entering primary
care. During the decade of the 1990's, MSM ranked first among all U.S.
medical schools, in three national surveys, in the percentage of
graduates entering primary care in 1993, 1995, and 1999.
The medical school's Department of Family Medicine, which includes
both academic and clinical functions, currently occupies approximately
10,000 gross square feet at Southwest Hospital Facility in Atlanta,
Georgia. The existing facility of the department does not meet its
current space needs. The expanded space that a new family practice
facility will provide is necessary in order to maintain accreditation.
A new facility will enable our institution to further its
commitment to the recruitment and training of students from
disadvantaged communities. In addition, the new center will assist the
medical school in addressing the longstanding health status disparities
that exist among minority and medically underserved populations. Thank
you very much for your consideration of this important request If you
have any questions, please do not hesitate to contact me.
______
Prepared Statement of the University of Medicine and Dentistry of New
Jersey
Request summary.--The following is the testimony of the University
of Medicine and Dentistry of New Jersey. We are seeking support for the
following priority projects, which we believe, are consistent with the
mission of this committee. The first is to expand the state-wide
activities of the Institute for the Elimination of Health Disparities;
the second is the continued development of the Child Health Institute
of New Jersey in New Brunswick; and the third is to expand the New
Brunswick based Dean and Betty Gallo Prostate Cancer Center outreach
and cancer control programs to reach populations at risk in the Newark/
northern New Jersey and Camden/southern New Jersey regions, and to
strengthen the Center's clinical research programs. In addition,
capital and program support is requested to create dedicated geriatric
research space at our Center for Aging at the University's School of
Osteopathic Medicine in Stratford. We also seek support for two
initiatives to improve obstetrical and pre- and post-natal services in
Newark and under served communities in southern New Jersey.
The University of Medicine and Dentistry of New Jersey (UMDNJ) is
the largest freestanding public university of the health sciences in
the nation. The University is located on five statewide campuses and
contains three medical schools, and schools of dentistry, nursing,
health related professions, public health and graduate biomedical
sciences. UMDNJ comprises a University-owned acute care hospital, three
core teaching hospitals, an integrated behavioral health care delivery
system, a statewide system for managed care and affiliations with more
than 200 health care and educational institutions statewide. No other
institution in the nation possesses the resources that match our scope
in higher education, research, health care delivery, and community
service initiatives with federal, state and local entities.
We wish to express UMDNJ's appreciation to this committee for its
support of the National Institutes of Health (NIH) and the important
biomedical projects that are funded by the NIH, including those at
UMDNJ. We appreciate this committee's strong support which is essential
in maintaining the high standards of excellence in research and
training sponsored by the NIH, and thank you for you actions in fiscal
year 2003 which completed a doubling of NIH's budget over a five-year
period. However any dramatic decline in the rate of growth for the NIH,
as proposed by the Administration's fiscal year 2004 budget, threatens
the momentum gained in medical research in recent years at a time when
the nation continues to confront many health challenges. We urge the
committee to maintain adequate funding levels for the NIH that will
continue the progress of the last five years.
The University's priority projects are statewide in scope and
include collaborations with our academic and health care partners. Our
mission is focused on building ``Centers of Excellence'' that will
expand our research, enhance our educational programs and provide
access to quality health care services for all New Jerseyans. At the
very foundation of this mission is our commitment to utilize the full
strength of our research, educational and service programs in reducing
and eliminating ethnic and health disparities. For that reason, UMDNJ's
first priority again this year is the Institute for the Elimination of
Health Disparities.
Despite the dramatic improvements in the health of the general
population, the federal government has identified striking disparities
in the overall health and life expectancy of racial and ethnic
populations in the United States. Eliminating health disparities among
different segments of the population is a primary goal of Healthy
People 2010, the nation's public health agenda for this decade, as well
as that of Healthy New Jersey 2010, the companion public health agenda
for the state.
UMDNJ has long been recognized for its leadership in providing
educational opportunities and health care services to under represented
communities throughout our state. We are a leader in minority student
and faculty recruitment and in the provision of services to underserved
populations through our core and affiliated hospitals, clinics and
community-based programs.
The University has focused its commitment to achieving better
health for minority communities by creating the Institute for the
Elimination of Health Disparities.
Congressional support for the Institute has resulted in $630,000 in
directed appropriations over the last two years. With this support and
matching funds provided by UMDNJ, the Institute is bringing together
the nationally-recognized research, education and community outreach
programs aimed at eliminating health disparities that are being
conducted by UMDNJ's eight schools on five academic campuses.
The Institute is collaborating extensively with the Newark and
Camden, NJ communities, cities with the greatest health disparity
needs, to identify and implement strategies to improve community
health. It also widely distributes information about health disparities
to community law audiences, the research community, and healthcare
providers across the state.
Continued support for the Institute is requested to broaden these
initiatives and initiate new activities to address the existing gaps in
health outcomes. Requested funding will expand the Institute's network
of partnerships with grass-root organizations and agencies to provide
academic-based leadership in developing health promotion and risk
reduction strategies that respond to community needs and priorities.
Support will also be utilized to provide start-up seed funding for
faculty research projects that can be leveraged in seeking long-term
program support. The Institute's research agenda seeks to better
understand the socio-economic and medical causes for health
disparities, and is directed toward federally identified priority
areas, including infant mortality, cancer, cardiovascular disease,
diabetes, HIV/AIDS and childhood immunizations. The Institute will
continue its development of a statewide public information campaign
about health disparities to better inform researchers, healthcare
providers and the public about successful approaches to improve the
health of minority and ethnic groups.
New Jersey, with a demographic profile and patterns of disparity
that closely matches the nation's, can serve as an ideal site for
federally sponsored research and education initiatives, with results
applicable to the entire nation. UMDNJ is ideally positioned to lead
New Jersey's efforts in eliminating racial and ethnic health
disparities. We are respectfully seeking $4.5 million to continue the
development of the Institute on behalf of the citizens of New Jersey
and the nation.
Our second priority is the Child Health Institute of New Jersey.
The Child Health Institute of New Jersey (CHI), at UMDNJ-Robert
Wood Johnson Medical School, is a comprehensive biomedical research
center focused on the health and well being of children. Located on the
New Brunswick campus of UMDNJ-Robert Wood Johnson Medical School,
research conducted by the CHI will aid in the development of new
treatments, therapies and cures for devastating and debilitating
childhood disorders. Biomedical researchers will investigate the
environmental, genetic and cellular causes of these diseases in infants
and children through basic scientific studies. Some of the disorders
that warrant immediate attention include asthma, muscular dystrophy,
diabetes, birth defects and neurodevelopmental disorders including
autism and spina bifida.
CHI has assembled more than $40 million in funding through a strong
partnership among private, corporate and government entities. Support
received for the construction of the Institute's 150,000 square foot
building includes more than $6 million in general federal
appropriations over the last four years, a $1.9 million grant from the
National Center for Research Resources of the NIH in fiscal year 2000,
and approximately $17 million from private foundations, corporations
and individuals. The State of New Jersey has provided $3.7 million with
a recurring annual appropriation of $1.7 million to support the debt
service on the bonds sold to finance the remaining building costs. The
CHI has raised an additional $15 million from corporations, foundations
and individuals to support its scientific mission and goals. The CHI
will increase the current research funding base of the UMDNJ-Robert
Wood Johnson Medical School and strengthen research efforts with
clinical departments at Robert Wood Johnson University Hospital
(RWJUH), especially those involved with the new Bristol-Myers Squibb
Children's Hospital at RWJUH.
The Child Health Institute has the expertise and the infrastructure
in place to achieve major breakthroughs and discoveries that will lead
to improvements and cures in childhood diseases. We are respectfully
requesting $2 million for the purchase of analytical equipment,
including laser scanning and photon microscopes, a mass spectrometer,
and ventilated rack systems to further the development of the Child
Health Institute of New Jersey facility.
As noted above, UMDNJ is committed to supporting activities that
will help eliminate health disparities. This is why our next priority
is the Dean and Betty Gallo Prostate Cancer Center.
The Cancer Institute of New Jersey (CINJ) was established in 1990
with a $10 million capital grant from the federal government. Over the
past decade, CINJ has grown to become one of the nations most
successful cancer institutes. As New Jersey's only NCI-Designated
Comprehensive Cancer Center, CINJ joins an elite network of 41 cancer
centers nationwide that are leaders in cancer treatment, research, and
education.
One of CINJ's most significant accomplishments is the creation of
the Dean and Betty Gallo Prostate Cancer Center, established with
funding from the federal government. The Center honors the late
Congressman Dean Gallo, who succumbed to prostate cancer in 1994.
Located at the CINJ facility in New Brunswick, the Center has programs
in public outreach, cancer control, prevention, basic and clinical
research and treatment of prostate cancer. It is the only named center
of its kind in the nation totally dedicated to the eradication of
prostate cancer. The Center has secured more than $12 million in
external public and private support in recent years.
Consistent with UMDNJ's priority goal of focusing on minority
health issues, we are seeking support to expand the Gallo Center's
public outreach and cancer control programs to regions where resources
can be focused on critical minority and medically underserved
communities who exhibit high incidence for prostate cancer.
The Gallo Center has already developed an extensive network of
effective partnerships, working with groups such as the 100 Black Men
of New Jersey, the Men's Health Network, and the Jewish Renaissance
Foundation to offer prostate cancer education and screenings in
minority communities. Additional resources are needed to expand the
Gallo Center's education and prevention services to other regions of
the state. Support will allow a major expansion of the Center's Public
Outreach and Cancer Control initiatives to the Newark/northern New
Jersey and Camden/southern New Jersey regions, and to targeted
communities in Middlesex County to increase public awareness about
early detection of prostate cancer, and to reduce its incidence among
African-American, Latino, Asian-American and other undeserved
populations most affected by this dreaded disease.
These outreach activities would also support research by CINJ
investigators interested in improving outcomes by understanding how
cultural issues affect cancer education, screening and treatment.
Additional resources are needed to accelerate the Gallo Center's
promising basic and clinical research programs that are investigating
the molecular mechanisms involved in prostate cancer initiation and
progression, and for translational studies to move laboratory
discoveries into clinical practice. We respectfully request $3 million
to expand the Gallo Center's Public Outreach and Cancer Control
initiatives, and $3 million for the expansion of basic and clinical
research programs.
Another priority initiative is the Geriatric Research Center.
The Center for Aging at the UMDNJ-School of Osteopathic Medicine
(SOM) is an inter-disciplinary Center of Excellence in geriatric
education, clinical care and research. The Center is nationally
recognized as a leader in quality care for older individuals. Located
within southern New Jersey, services are provided to the region's
growing elderly population through the Center's network of ambulatory,
acute care, long-term care and community-based programs. Attracting
more researchers to the Center is critical to achieving national
prominence as a Geriatric Research Center of Excellence.
The Center for Aging's complementary clinical service base provides
opportunities for investigators to study the application of research
findings among large cohorts of elderly individuals in varied settings
over time. Based on an understanding of biology, behaviors, social and
physical environments, policies and interventions can be developed
which will enable our elderly population to live longer, more
productive lives. The research programs of the Center will focus on
cellular, biochemical and physiological aspects of aging. Research will
be directed at the genetic determinants of both aging and diseases
common in the elderly. The Geriatric Research Center will build on
existing programs in nutrition, protein loss, injury, and Alzheimer's
disease to expand basic science research programs in support of the
established clinical and educational programs at the Center for Aging.
A major obstacle is the critical lack of dedicated research space at
the Center for Aging. We are therefore seeking $5 million in capital
and program funds to support dedicated space and faculty for a
Geriatric Research Center within the Center for Aging at the UMDNJ-
School of Osteopathic Medicine.
To address other critical healthcare disparity needs, we are
seeking support for two additional initiatives, both aimed at improving
obstetrical and pre-and post-natal services in Newark and in southern
New Jersey.
In Newark the infant mortality rate, and percentage of low-weight
births, are both significantly higher than that of the state, and is
particularly alarming among black infants. The University is seeking
support for an initiative to partner with Newark community health
centers to target women at greatest risk for poor pregnancy outcomes
for early enrollment into prenatal care. Early enrollment into prenatal
care provides the best opportunity to identify and address behavioral
practices and other maternal factors that adversely affect pregnancy
outcomes. Collaborating on this initiative will be the UMDNJ Institute
for the Elimination of Health Disparities, UMDNJ-University Hospital,
and UMDNJ-New Jersey Medical School.
Requested funding will also support renovations at UMDNJ-University
Hospital in Newark to upgrade outdated labor and delivery facilities.
Proposed renovations will improve patient flow and replace the current
multi-transfer system between the triage, labor, delivery and recovery
areas into a combined labor/delivery/recovery suite. Increased space
allocations for labor and delivery rooms, and centralized nursing
stations are incorported into the design to enhance patient comfort and
increase service efficiency. We respectfully seek support of $8.15
millon in capital and program funds for this initiative.
In southern New Jersey, a rising birthrate is creating greater
demand for expanded delivery and pre- and post-natal services at a time
when gaps in such services are growing. The UMDNJ-School of Osteopathic
Medicine is seeking support to address immediate and long-range needs
for improving access to maternity care, as well as pre- and post-natal
care and education in the region's underserved communities. University
supported medical liability insurance will be leveraged to ``seed''
underserved areas with new OB/GYN providers, and help ensure that all
hospitals in the region can provide 24/7 coverage for delivery
services. Pre- and post-natal education and awareness programs will be
conducted collaboratively with the Institute for the Elimination of
Health Disparities. Support of $2.5 million is respectfully requested
for this initiative.
Again, we thank you for this opportunity to submit testimony on
behalf of UMDNJ's priority initiatives that will advance research,
education and treatment of diseases and disabilities that most
seriously affect children, the elderly and minority populations, and
will go a long way toward eliminating health disparities in the areas
of cancer, obstetrical and pre- and post-natal care. We also thank this
committee for its leadership and its continued support for our
programs.
______
Prepared Statement of the American Museum of Natural History
about the american museum of natural history
The American Museum of Natural History [AMNH] is one of the
nation's preeminent institutions for scientific research and public
education. Since its founding in 1869, the Museum has pursued its
mission to ``discover, interpret, and disseminate--through scientific
research and education--knowledge about human cultures, the natural
world, and the universe.'' It is renowned for its exhibitions and
collections, and with nearly four million annual visitors--
approximately half of them children--its audience is one of the
largest, fastest growing, and most diverse of any museum in the
country. Museum scientists conduct ground breaking research in fields
ranging from all branches of zoology, comparative genomics, and
informatics to earth, space, and environmental sciences and
biodiversity conservation.
Today more than 200 Museum scientists with internationally
recognized expertise, led by 46 curators, conduct laboratory and
collections-based research programs as well as fieldwork and training.
Scientists in five divisions (Anthropology; Earth, Planetary, and Space
Sciences; Invertebrate Zoology; Paleontology; and Vertebrate Zoology)
are documenting changes in the environment, making new discoveries in
the fossil record, and describing human culture in all its variety. In
the Museum's Institute for Comparative Genomics, established in 2001,
researchers are mapping the genomes of non-human organisms as well as
creating new computational tools to retrace the evolutionary tree. The
Museum also conducts graduate training programs in conjunction with a
host of distinguished universities, supports doctoral and postdoctoral
scientists with highly competitive research fellowships, and offers
talented undergraduates an opportunity to work with Museum scientists.
The AMNH collections of some 32 million natural specimens and
cultural artifacts are a major scientific resource, providing the
foundation for the Museum's interrelated research, education, and
exhibition missions. They often include endangered and extinct species
as well as many of the only known ``type specimens,'' or examples of
species by which all other finds are compared. Within the collections
are many spectacular individual collections, including the world's most
comprehensive collections of dinosaurs, fossil mammals, Northwest Coast
and Siberian cultural artifacts, North American butterflies, spiders,
Australian and Chinese amphibians, reptiles, fishes, and one of the
world's most important bird collections. Collections such as these
provide vital data for Museum scientists as well as for more than 250
national and international visiting scientists each year.
Permanent and temporary exhibits--from the Rose Center for Earth
and Space to The Genomic Revolution (see below)--are among the Museum's
most potent educational tools for promoting public education, science
literacy, and lifelong learning. Science Bulletins--high definition
video wall displays--present breaking science news, images, and data in
the Museum's new Halls of Biodiversity, Planet Earth, and the Universe.
The Education Department builds on these exhibition and science
resources to offer rich programming dedicated to increasing scientific
literacy, encouraging students to pursue science and museum careers,
and to providing a forum for exploring the world's cultures. The Museum
is also reaching beyond its walls: through its National Center for
Science Literacy, Education, and Technology, launched in 1997 in
partnership with NASA, it is exploiting new technologies to bring
materials and programs into homes, schools, museums, and community
organizations around the nation.
comparative genomics initiative: research, training, education and
outreach resources
The American Museum shares with DHHS and the Department of
Education a fundamental commitment to improving the nation's health and
education and advancing the research, training, facilities, and
technology that support them. The Museum is deeply engaged in the area
of comparative genomics, and it is in this vital area that the Museum
seeks to partner with the DHHS/HRSA and the Department of Education.
Genomic Science and Training Resources
DHHS leads the nation's health-related research and genome science,
advanced sequencing technologies, instrumentation, and facilities. The
American Museum, in turn, is home to a preeminent molecular research
and training program and leading science education and outreach
efforts. In the era of genomics, museum collections have become
critical baseline resources for the assessment of genetic diversity of
natural populations; studying genomic data in a natural history context
makes it possible to more fully understand the impacts of new
discoveries in genomics and molecular biology. Genomes of the simplest
organisms provide a window into the fundamental mechanics of life, and
understanding their natural capabilities can help solve challenges in
biodefense, medicine, and health care. In the Museum's molecular
laboratories, in operation now for eleven years, more than 40
researchers in molecular systematics, conservation genetics, and
developmental biology conduct genetic research on a variety of study
organisms. The labs also nourish the Museum's distinguished training
programs that serve up to 80 undergraduates, doctoral, and postdoctoral
trainees annually.
Frozen Tissue Collection
In support of its molecular program, the Museum has launched an
expansion of its collections to include biological tissues and isolated
DNA preserved in a super-cold storage facility. Because this collection
preserves genetic material and gene products from rare and endangered
organisms that may become extinct before science fully exploits their
potential, it is an invaluable resource for research in many fields
including genetics, comparative genomics, and biodefense. Capable of
housing one million specimens, it will be the largest super-cold tissue
collection of its kind. In the past two years, 15,000 specimens not
available at any other institute or facility have already accessioned.
At the same time, the Museum is pioneering the development of
collection and storage protocols for such collections. To maximize use
and utility of the facility for researchers worldwide, the Museum is
also developing a sophisticated website and online database that
includes collection information and digitized images.
Cluster Computing
The Museum also has exceptional capacity in parallel computing, an
essential enabling technology for phylogenetic (evolutionary) analysis
and intensive, efficient sampling of a wide array of study organisms.
Museum scientists have constructed an in-house 560-processor computing
cluster, and are in the process of upgrading it to 128 dual CPU nodes
with 2 Gb/sec Myrinet interconnections. It is the fastest parallel
computing cluster in an evolutionary biology laboratory and one of the
fastest installed in a non-defense environment.
Museum investigators have taken a leadership role in developing and
applying new computational approaches to deciphering evolutionary
relationships through time and across species; their pioneering efforts
in cluster computing, algorithm development, and evolutionary theory
have been widely recognized and commended for their broad applicability
for biology as a whole. The bioinformatics tools Museum scientists are
creating will not only help to generate evolutionary scenarios, but
will also inform and make more efficient large genome sequencing
efforts. Many of the parallel algorithms and implementations
(especially cluster-based) will be applicable in other informatics
contexts such as annotation and assembly, breakpoint analysis, and non-
genomic areas of evolutionary biology as well as in other disciplines.
Education and Outreach
The Museum matches these outstanding science resources with an
ambitious genomics education and outreach capacity. The Education
Department provides standards-based curricular materials and on-site
programs for school and camp groups from throughout the region,
Moveable Museums that travel to schools and community sites, a model
after-school program, award-winning online educational resources, and
lectures, workshops, and field excursions for adult learners. Its
award-winning online professional development program for science
teachers--Seminars on Science--includes subjects in genetics, genomics,
and genethics. These and other programs attract more than 500,000
students and teachers on school visits and nearly 5,000 teachers for
special professional development opportunities. The Museum's website
(www.amnh.org) also serves to reach online audiences nationally,
offering in-depth virtual ``tours'' of exhibitions; features on
curators, expeditions, and current research; access to collections; and
links to the AMNH digital library.
comparative genomics initiative
Building on these unique strengths in genomics science, training,
and education, and in concert with the health, education, and training
goals of DHHS and the Department of Education, in 2001 the Museum
launched an ambitious initiative--The Institute of Comparative
Genomics. Equipped with the parallel computing facility, molecular labs
with DNA sequencers, ultra-cold storage units, vast biological
collections, and researchers with expertise in the methods of
comparative biology, as described above, the Institute is positioned to
be one of the world's premier facilities for mapping the genome across
a comprehensive spectrum of life forms. Working collaboratively with
New York's outstanding biomedical and educational institutions, it is
conducting research and training in such critical areas as microbial
genomics and biocomputation. Complemented by the Museum's planned
education and outreach utilizing innovative educational technologies,
the Institute will constitute a national resource of unique scope and
range.
The Institute is establishing a distinguished research and training
record. Museum scientists have pioneered theoretical and analytical
approaches and are leading major new international research projects in
assembling the ``tree of life.'' They have developed efficient software
for the interpretation of microarray data, which can be used to support
more accurate diagnosis of pathogens, and novel methodologies and
algorithms for analyzing genomic, chromosomal, and other data to
discern evolutionary relationships among organisms. Current projects
include sequencing pathogens and, with NIH and DOE support, tracing the
evolution of pathogenicity and transfer of disease-causing genes over
time and between species.
In developing the Institute, the Museum plans to expand its
curatorial range in microbial systematics and the program that now
trains dozens of graduate students every year; utilize the latest
sequencing technologies; employ parallel computing applications to
solve combinatorily complex problems involving large real work
datasets; and grow the super-cold tissue collection. It plans to expand
and renovate lab space and facilities into a state-of-the-art training
and research laboratory to accommodate additional students and
researchers.
Along with the research and training components of the genomics
initiative, the Museum is using education technologies to promote
understanding of genomics. The Museum shares the Department of
Education's commitment to improving the nation's education through
teacher quality, providing additional educational opportunities outside
of the classroom, and harnessing new technologies to enhance
instruction, and its education and outreach plans for the Institute of
Comparative Genomics will help to advance these shared goals.
Its public education accomplishments to date include the landmark
exhibition, The Genomic Revolution, open from June through December
2001. The exhibition, attended by approximately 500,000 visitors and
now touring nationally, examined the revolution taking place in
molecular biology and its impact on modern science and technology,
natural history, biodiversity, and our everyday lives. The Museum has
also hosted several conferences on important topics related to
genomics: Sequencing the Human Genome: New Frontiers in Science and
Technology, an international conference featuring leading scientists
and policymakers in Fall 2000; Conservation Genetics in the Age of
Genomics in Spring 2001; and New Directions in Cluster Computing in
June 2001, which explored how parallel computing enables genomic
science and other fields. June 2002, we hosted an international
conference examining current knowledge of life's history, Assembling
the Tree of Life: Science, Relevance, and Challenges.
Using cutting-edge education and exhibition technologies and
distance learning applications, the Museum plans to expand and
diversify the reach of our genomics related professional development,
educational materials, and exhibition-related programming.
Specifically, the Museum's plan to develop a suite of standards-based
curricular materials and programs related to genome science for online
distribution to educators nationwide; to adapt and extend our
successful Seminars on Science model of online professional development
courses for K-12 teachers nationwide in subjects related to genomics;
to enhance exhibition technologies and include a focus on genomics in
our Science Bulletins; and to pilot a distance education initiative
live from the Museum's halls and classrooms that will include a
selection of regular interactive classes, professional development
mini-series, and special live events, all designed to promote genomics
teaching and learning in New York City, the region, and the country.
genomics initiative partnership
The Museum seeks $7 million in fiscal year 2004 to partner with
DHHS/HRSA and the Department of Education in furthering its genomics
research, training, and education initiative.--In so doing, the Museum
will contribute its participatory share with funds from nonfederal as
well as federal sources, including funds raised through the Museum's
own efforts from the City and State of New York as well as private
contributions and foundations. In partnership with these agencies, the
Museum will be poised to contribute its unique resources to the
nation's health research and education missions: to advancing basic
research and training in genomics, which has its potential applications
in medicine, biomedical research, and clinical treatment; and to
promoting science education and science literacy in the era of
genomics. As a federal partnership, the Museum proposes two
interrelated approaches:
--$5 million as a facilities/instrumentation initiative, building on
our already extensive investments, to construct a NATIONAL
RESEARCH AND TRAINING LABORATORY FOR COMPARATIVE AND MICROBIAL
GENOMICS. In partnership with DHHS/HRSA, the Museum plans to
expand its existing Molecular Program facilities into a state-
of-the-art molecular laboratory for research and training
activities. The requested support will be used towards
constructing a cutting-edge laboratory and upgrading HVAC and
plumbing in 6,000 sq. feet of existing lab, office, and storage
space. The expanded facility will provide up-to-date work space
and instrumentation for graduate and postdoctoral trainees as
well as senior scientists.
--$2 million as an education technology initiative. In partnership
with the Department of Education, the Museum will expand
professional development, create K-12 curriculum materials,
enhance exhibition technologies, incorporate a focus on
genomics in the Museum's Science Bulletins, develop a distance
education initiative, and launch online learning resources to
promote teaching and learning nationwide about genomic science.
In partnership, the American Museum of Natural History and the
Departments of Health and Human Services and Education will be
positioned to leverage their unparalleled resources to advance shared
goals for improving the nation's health and welfare and promoting its
research and education in the genomics era.
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........................ 125
Prepared statement........................................... 133
American:
Academy of Family Physicians, prepared statement............. 354
Association for:
Geriatric Psychiatry, prepared statement................. 409
Immunologists, prepared statement........................ 446
Thoracic Surgery, prepared statement..................... 383
Chemical Society, prepared statement......................... 471
College of Cardiology, prepared statement.................... 451
Dental Education Association (ADEA), prepared statement...... 375
For the Arts, prepared statement............................. 467
Heart Association, prepared statement........................ 387
Indian Higher Education Consortium, prepared statement....... 475
Museum of Natural History, prepared statement................ 496
Professionals in Infection Control and Epidemiology, prepared
state-
ment....................................................... 365
Psychological Society, prepared statement.................... 434
Society for Microbiology, prepared statements..............395, 458
Thoracic Society, prepared statement......................... 402
Association of:
Departments of Family Medicine, prepared statement........... 369
Family Practice Residency Directors, prepared statement...... 369
Battey, Hon. James F., Jr., M.D., Ph.D., Director, National
Institute on Deafness and Other Communication Disorders,
National Institutes of Health, Department of Health and Human
Services....................................................... 125
Prepared statement........................................... 136
Beldon, Hon. William R., Acting Deputy Assistant Secretary for
Budget, Department of Health and Human Services................ 125
Blue Cross and Blue Shield Association, prepared statement....... 351
Byrd, Senator Robert C., U.S. Senator from West Virginia,
questions submitted by......................................... 76
Chao, Hon. Elaine L., Secretary of Labor, Office of the
Secretary, Department of Labor................................. 291
Prepared statement........................................... 293
Summary statement............................................ 292
Charles R. Drew University of Medicine and Science, prepared
statement...................................................... 423
Coalition of Northeastern Governors, prepared statement.......... 382
Cochran, Senator Thad, U.S. Senator from Mississippi:
Prepared statements....................................64, 105, 328
Questions submitted by.....................................122, 348
Collins, Hon. Francis S., M.D., Ph.D., Director, National Human
Genome Research Institute, National Institutes of Health,
Department of Health and Human Services........................ 125
Prepared statement........................................... 139
Community Medical Centers Fresno, CA, prepared statement......... 391
Craig, Senator Larry, U.S. Senator from Idaho, opening statement. 17
Crohn's and Colitis Foundation of America, prepared statement.... 427
Crownpoint Institute of Technology, Crownpoint, prepared
statement...................................................... 477
Cystic Fibrosis Foundation, prepared statement................... 406
Digestive Disease National Coalition, prepared statement......... 357
Domenici, Senator Pete V., U.S. Senator from New Mexico,
questions submitted by......................................... 272
Dystonia Medical Research Foundation, prepared statement......... 429
FacioScapuloHumeral Muscular Dystrophy Society, prepared
statement...................................................... 416
Fauci, Hon. Anthony S., M.D., Director, National Institute of
Allergy and Infectious Diseases, National Institutes of Health,
Department of Health and Human Services........................ 125
Prepared statement........................................... 143
First Candle/Sudden Infant Death Syndrome Alliance, prepared
statement...................................................... 424
Grady, Dr. Patricia A., Director, National Institute of Nursing
Research, National Institutes of Health, Department of Health
and Human Services............................................. 125
Prepared statement........................................... 147
Greenberg, Dr. Judith H., Acting Director, National Institute of
General Medical Sciences, National Institutes of Health,
Department of Health and Human Services........................ 125
Prepared statement........................................... 150
Gregg, Senator Judd, U.S. Senator from New Hampshire, opening
state-
ment........................................................... 24
Hansen, Hon. William, Deputy Secretary of Education, Department
of Education................................................... 79
Hanson, Hon. Glen R., Ph.D., D.D.S., Acting Director, National
Institute on Drug Abuse, National Institutes of Health,
Department of Health and Human Services........................ 125
Prepared statement........................................... 153
Harkin, Senator Tom, U.S. Senator from Iowa:
Opening statements...........................................14, 82
Prepared statement........................................... 83
Questions submitted by.................................73, 121, 271
Hepatitis Foundation International, prepared statement........... 414
Hodes, Hon. Richard J., M.D. Director, National Institute on
Aging, National Institutes of Health, Department of Health and
Human Services................................................. 125
Prepared statement........................................... 155
Hollings, Senator Ernest F., U.S. Senator from South Carolina,
questions submitted by........................................75, 348
Humane Society of the United States, prepared statement.......... 443
Immune Deficiency Foundation, prepared statement................. 360
Insel, Hon. Thomas R., M.D., Director, National Institute of
Mental Health, National Institutes of Health, Department of
Health and Human Services...................................... 125
Prepared statement........................................... 158
International Foundation for Functional Gastrointestinal
Disorders, prepared statement.................................. 418
Katz, Hon. Stephen I., M.D., Ph.D., Director, National Institute
of Arthritis and Musculoskeletal and Skin Diseases, National
Institutes of Health, Department of Health and Human Services.. 125
Prepared statement........................................... 161
Keusch, Dr. Gerald T., Director, The John E. Fogarty
International Center, National Institutes of Health, Department
of Health and Human Services................................... 125
Prepared statement........................................... 164
Kington, Hon. Raynard, Deputy Director, Office of the Director,
Department of Health and Human Services........................ 125
Kohl, Senator Herb, U.S. Senator from Wisconsin:
Opening statement............................................ 22
Prepared statement........................................... 167
Landrieu, Senator Mary L., U.S. Senator from Louisiana:
Opening statements...........................................20, 85
Prepared statement........................................... 87
Lenfant, Hon. Claude M.D., Director, National Heart, Lung, and
Blood Institute, National Institutes of Health, Department of
Health and Human Services...................................... 126
Prepared statement........................................... 170
Li, Hon. Ting-Kai, M.D., National Institute on Alcohol Abuse and
Alcoholism, National Institutes of Health, Department of Health
and Human Services............................................. 126
Prepared statement........................................... 173
Lindberg, Hon. Donald, A.B. M.D., Director, National Library of
Medicine, National Institutes of Health, Department of Health
and Human Services............................................. 126
Prepared statement........................................... 176
March of Dimes Birth Defects Foundation, prepared statement...... 373
Medical Library Association and the Association of Academic
Health Sciences Libraries, prepared statement.................. 432
Medicare Payment Advisory Commission, prepared statement......... 484
Mended Hearts, Inc., prepared statement.......................... 463
Morehouse School of Medicine, prepared statement................. 492
Murray, Senator Patty, U.S. Senator from Washington:
Opening statements..........................................83, 301
Prepared statements.........................................84, 302
Question submitted by........................................ 349
National:
Area Health Education Centers Organization, prepared
statement.................................................. 361
Association:
For State Community Services Programs, prepared statement 384
Of Children's Hospitals, prepared statement.............. 392
Breast Cancer Coalition, prepared statement.................. 455
Coalition for Heart and Stroke Research, prepared statement.. 457
Federation of Community Broadcasters, prepared statement..... 482
Minority Public Broadcasting Consortia, prepared statement... 481
MPS Society, Inc., prepared statement........................ 401
Multiple Sclerosis Society, prepared statement............... 445
Rural Health Association, prepared statement................. 379
Treasury Employees Union, prepared statement................. 398
NCB Development Corporation, prepared statement.................. 464
NephCure Foundation, prepared statement.......................... 421
North American Primary Care Research Group, prepared statement... 369
Olden, Hon. Kenneth, Ph.D., Director, National Institute of
Environmental Health Sciences, National Institutes of Health,
Department of Health and Human Services........................ 126
Prepared statement........................................... 180
Paige, Hon. Roderick, Secretary of Education, Office of the
Secretary, Department of Education............................. 79
Prepared statement........................................... 88
Summary statement............................................ 88
Penn, Hon. Audrey S., M.D., Acting Director, National Institute
of Neurological Disorders and Stroke, National Institutes of
Health, Department of Health and Human Services................ 126
Prepared statement........................................... 182
Pettigrew, Hon. Roderic I., Ph.D., M.D., Director, National
Institute of Biomedical Imaging and Bioengineering, National
Institutes of Health, Department of Health and Human Services.. 126
Prepared statement........................................... 185
Pulmonary Hypertension Association, prepared statement........... 367
Railroad Retirement Board, prepared statements.................488, 491
Ruffin, Hon. John, Ph.D., Director, National Center on Minority
Health and Health Disparities, National Institutes of Health,
Department of Health and Human Services........................ 126
Prepared statement........................................... 188
Sieving, Dr. Paul A., Director, National Eye Institute, National
Institutes of Health, Department of Health and Human Services.. 126
Prepared statement........................................... 190
Society for Neuroscience, prepared statement..................... 440
Society of:
General Internal Medicine, prepared statement................ 439
Teachers of Family Medicine, prepared statement.............. 369
Thoracic Surgeons, prepared statement........................ 383
Specter, Senator Arlen, U.S. Senator from Pennsylvania:
Opening statements..................................1, 79, 126, 291
Questions submitted by.......................65, 107, 228, 275, 328
Spiegel, Hon. Allen M., M.D., Director, National Institute of
Diabetes and Digestive and Kidney Diseases, National Institutes
of Health, Department of Health and Human Services............. 126
Prepared statement........................................... 193
Stevens, Senator Ted, U.S. Senator from Alaska:
Opening statement............................................ 80
Prepared statement........................................... 81
Straus, Hon. Stephen E., M.D., Director, National Center for
Complementary and Alternative Medicine, National Institutes of
Health, Department of Health and Human Services................ 126
Prepared statement........................................... 196
Tabak, Hon. Lawrence A., D.D.S., Ph.D., National Institute of
Dental and Craniofacial Research, National Institutes of
Health, Department of Health and Human Services................ 126
Prepared statement........................................... 199
Thompson, Hon. Tommy G., Secretary, Office of the Secretary,
Department of Health and Human Services........................ 1
Prepared statement........................................... 5
Summary statement............................................ 2
Thurgood Marshall Scholarship Fund, prepared statement........... 469
United Tribes Technical College, prepared statement.............. 472
University of Medicine and Dentistry of New Jersey, prepared
statement...................................................... 493
Upper County Branch, Montgomery County, Maryland Stroke Club,
prepared statement............................................. 462
Vaitukaitis, Hon. Judith L., M.D., Director, National Center for
Research Resources, National Institutes of Health, Department
of Health and Human Services................................... 126
Prepared statement........................................... 202
von Eschenbach, Hon. Andrew C., M.D., Director, National Cancer
Institute, National Institutes of Health, Department of Health
and Human Services............................................. 125
Prepared statement........................................... 142
Weems, Hon. Kerry N., Acting Assistant Secretary for Budget,
Technology and Finance, Department of Health and Human Services 126
Whitescarver, Hon. Jack, Ph.D., Director, Office of AIDS
Research, National Institutes of Health, Department of Health
and Human Services............................................. 126
Prepared statement........................................... 205
Zerhouni, Hon. Elias, M.D., Director, National Institutes of
Health, Department of Health and Human Services................ 125
Prepared statement........................................... 129
Summary statement............................................ 126
SUBJECT INDEX
----------
DEPARTMENT OF EDUCATION
Office of the Secretary
Page
Additional Committee Questions................................... 107
Adjustments to the Fiscal Year 2004 Education Request............95, 97
Administration's Proposed Income Tax Provision and Reduction of
Erroneous Student Aid Payments................................. 116
Alaska's Request for Flexibility................................. 80
Assessing Education Program Effectiveness........................ 119
Assistive Technology Act State Grant Program..................... 118
Athletic Opportunities for Women and Girls....................... 102
Budget:
Cuts and No Child Left Behind Accountability................. 84
Reductions and No Child Left Behind.......................... 85
Campus Crime and Clery Act Administration........................ 104
Continued Availability of Recreational Programs for People With
Disabili-
ties........................................................... 118
Departmental Management--Clean Audit............................. 91
Education Finance Incentive Grant Funding (EFIG) vs. Title I
Targeted Grant Formula......................................... 121
Elimination of Rural Education Programs.......................... 93
Evaluation of 21st Century Community Learning Centers Program.... 109
Federal Role in Education........................................ 100
Fiscal Year 2004:
Budget:
And Title I Formulas..................................... 121
Priorities............................................... 102
Reductions............................................... 82
Request.................................................. 95
For Education........................................ 121
For the Secondary and Technical Education Excellence
Pro-
gram............................................... 111
vs. Flexibility and Accountability....................... 120
Education Budget Request and Student Access to Postsecondary
Education.................................................. 116
Flexibility of No Child Left Behind.............................. 94
Funding for Teacher Quality Improvement.......................... 97
Gear Up.......................................................... 93
Helping People With Disabilities Achieve Independence............ 118
Historically Black Colleges and Universities and Hispanic-Serving
Institutions................................................... 91
Impact of Current Vocational Education Programs.................. 109
Implementing No Child Left Behind................................ 89
Importance of:
Arts Education............................................... 102
Reading and Reading Instruction.............................. 94
Improving America's Teaching Corps............................... 90
Javits Fellowships and Graduate Assistance in Areas of National
Need........................................................... 117
Leveraging Educational Assistance Partnerships................... 117
Loan Forgiveness for Math, Science and Special Education Teachers
in Low-Income Communities...................................... 91
Louisiana:
Accountability System........................................ 85
State Accountability Plan Under No Child Left Behind......... 85
Mentoring Initiative............................................. 93
More Choices for Parents......................................... 90
No Child Left Behind:
Provision for Annual Updates on Children in Poor Families.... 123
``Report Card'' Requirements................................. 108
Other Steps Taken to Reduce and Eliminate Erroneous Federal
Education Payments............................................. 117
Paige Approves Louisiana State Accountability Plan Under No Child
Left Behind.................................................... 86
Parental Notification of Public School Choice and Supplemental
Service Options................................................ 107
Pell Grant:
Funding History.............................................. 112
Maximum Award and Cost of Higher Education................... 116
Postsecondary Education--Grant, Loan and Work-Study Assistance... 90
Poverty Data for Fiscal Year 2003 Title I Allocations............ 122
President's Management Agenda--``Green Light''................... 92
Program:
Assessment Rating Tool....................................... 92
Eliminated in Fiscal Year 2004 Budget........................ 119
Reductions and Eliminations.................................. 79
Public School Choice Requirements................................ 99
Reauthorization Proposal for Secondary and Technical Education... 110
Recreational Programs for Individuals With Disabilities.......... 118
Rural Education.................................................. 92
In Alaska.................................................... 80
Program Cut.................................................. 82
Special Education and Vocational Rehabilitation.................. 90
State:
Accountability Plans Under NCLB.............................. 87
And Local Transferability Act Authority...................... 120
Strike up the Band (and Keep Music in Schools); Iowa View........ 103
Student Aid:
Administration............................................... 111
Appropriations and Administrative Costs...................... 112
Student Financial Assistance: Pell Applicant Growth and Projected
Pell Funding Shortfalls........................................ 112
Supplemental Services Options.................................... 107
Tax:
Credit Proposals............................................. 100
Related Assistance in Paying College Costs................... 91
Title:
I Choice and Supplemental Services........................... 107
I School Improvement......................................... 107
IX Advisory Commission Recommendations....................... 99
Total Education Budget Request................................... 95
Vocational and Adult Education................................... 90
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Access to Embryonic Stem Cell Lines.............................. 213
Acquired Immunodeficiency Syndrome (AIDS)........................ 145
Acting Directors................................................. 208
Additional:
Committee Questions.......................................... 227
Resources Required for SMA Research.......................... 248
Advanced Technologies..........................................186, 202
Aging Population................................................. 127
Alzheimer's Disease.............................................. 266
An Impressive Track Record....................................... 150
Appointment of Study Section Members............................. 242
Autism........................................................... 160
Research..................................................... 225
Basic Research: A Vital Return on Investment..................... 152
Benefits, Planning, Assistance and Outreach (BPAO)............... 279
Biodefense....................................................... 132
Bioinformatics and Computational Biology......................... 187
Bioploar Disorder................................................ 270
Blood Pressure Medications....................................... 171
Bone and Other Musculoskeletal Diseases.......................... 162
Brain Research................................................... 174
Budget:
Request...................................................... 267
Statements.................................................143, 173
Building Research Infrastructure and Intellectual Capital........ 199
Buildings and Facilities Program................................. 133
Cataract Research................................................ 192
Chronic Diseases................................................. 127
Clinical:
Implications................................................. 174
Research...................................................239, 240
And the NIH Roadmap...................................... 171
Trials:
Network Does More Than Just Treat Patients............... 155
Research in Dental and Oral Health....................... 245
Combating HIV/AIDS, Hepatitis Domestically and Internationally... 155
Comprehensive:
AIDS Research Plan and Budget................................ 206
Cancer Center Program........................................ 230
Conquering Alzheimer's Disease................................... 156
Continuing to Invest in Communicable Disease Research............ 166
Coordination of Tuberous Sclerosis Research...................... 256
Coping With Chronic Obstructive Pulmonary Disease................ 148
Corneal Disease Research......................................... 191
Debt:
Collection................................................... 276
Prevention................................................... 276
Determining the Mechanisms of Action of CAM Interventions........ 197
Diabetes.......................................................172, 195
And Hypertension............................................. 265
Duchenne and Becker Dystrophies:
Clinical Trials.............................................. 253
Pharmacologic Approaches..................................... 254
Research Initiatives......................................... 254
Steroids..................................................... 254
Duchenne Muscular Dystrophy:
Congressional Priority....................................... 249
NICHD Involvement............................................ 248
``Roadmaps''................................................. 251
Embryonic Stem Cell Research..................................... 243
Emerging Diseases................................................ 128
Enhancement of Research Capacity................................. 204
Ethical, Legal and Social Implications of Genetic Research....... 141
Evaluating CAM Therapies in Rigorous Clinical Trials............. 198
Expanding Investments in Non-Communicable Diseases............... 166
Expansion of Newborn Screening Through Microarray Technology..... 136
Expediting Progress.............................................. 183
Fiscal Year 2004:
Budget Summary............................................... 133
President's Budget Request................................... 129
Focus & Accountability on Severe Mental Illness at NIMH.......... 274
Full Utilization of FCIA Tools................................... 277
Fully Funded Grants.............................................. 242
Funding:
Commitment to Extramural Construction........................ 221
Of Research Priorities....................................... 211
Future Prospects................................................. 180
Gastrointestinal Diseases........................................ 195
Glaucoma Research................................................ 190
Gleevec.......................................................... 225
Good News in Prevention Research................................. 154
Guarding Against Infectious Diseases & Bioterrorism.............. 152
Harnessing Math & Computers to Solve Biological Problems......... 151
Health Disparities........................................127, 163, 192
Hepatitis C...................................................... 195
Immune-Mediated Diseases......................................... 147
Implementation of SMA Translational Research Program............. 246
Improving Care at the End-of-Life Care........................... 149
Increased Stipend Levels......................................... 241
Information Services for the Public.............................. 178
International Research........................................... 207
Introduction of New Institute Directors.......................... 127
Investment in Tuberous Sclerosis by Institutes................... 256
Kidney Disease................................................... 195
Loan Repayment and Scholarship Program........................... 170
MD Care Act:
CBO Estimates................................................ 249
Centers of Excellence........................................ 249
Cooperative Research Centers................................. 254
Funding.................................................. 256
Resource Cores........................................... 255
Implementation............................................... 251
MD Research Resource Cores--Access and Funding................... 255
Men and Depression Program....................................... 267
Mental Illness Research.......................................... 272
Milestones to Success............................................ 185
Model Development and Genetic Medicine........................... 203
Molecular Medicine Enters the Mouth.............................. 199
Mouse Feeder Cells............................................... 216
Multidisciplinary Research Teams of the Future................... 187
Muscle Diseases.................................................. 162
Muscular Dystrophy............................................... 224
CINRG........................................................ 250
NIAMS Efforts................................................ 251
NIH Coordination............................................. 250
Research:
Cooperation With DOD..................................... 253
Infrastructure........................................... 252
Translational Research....................................... 251
Myopathies Research--NIAMS and NASA.............................. 253
Nanotechnology: Sensors for Medicine............................. 187
National:
Library of Medicine.......................................... 272
Vaccination Program.......................................... 226
NCMHD:
Co-funded Research........................................... 189
Programs..................................................... 188
New:
And Expanded Initiatives..................................... 149
Challenges:
And Strategies........................................... 130
In Therapeutics Research................................. 207
Fragile X Centers Will Develop Treatment Options............. 135
Initiatives.................................................. 180
NHGRI Initiatives............................................ 139
Research to Address Critical Public Health Issues............ 172
Targets for Medications Development.......................... 153
NIAID:
Biodefense Research.......................................... 144
An Overview.................................................. 144
NIDA Leadership.................................................. 153
NIH:
Fiscal Year 2001 Annual Report on Health Disparities Research 188
Health Disparities Research.................................. 189
Roadmap...................................................... 170
Tuberous Sclerosis Funding................................... 256
NLM Research and Development Programs............................ 178
Obesity.......................................................... 172
Research..................................................... 193
Oral Contraceptives and Breast Cancer: No Association............ 134
Other:
Initiatives.................................................. 280
Vaccines..................................................... 146
Outreach......................................................... 176
Oversight of SMA Translational Research.......................... 247
Pain Research..................................................201, 257
Pancreatic Cancer................................................ 228
Parity........................................................... 267
Parkinson's...................................................... 271
Pediatric Research............................................... 210
Postmenopausal Hormone Therapy................................... 171
Premature Birth: New Research May Reverse a Trend................ 134
Preventing Recurrent Blood Clots................................. 172
Prevention:
And Risk Reduction........................................... 175
Diagnosis, and Treatment..................................... 203
Research..................................................... 207
Program Initiatives.............................................. 193
Progress and:
Challenges................................................... 171
Full-Time Directors.......................................... 209
Prospects for the Future..................................... 183
Promoting:
Awareness of and Research on SMA............................. 247
Professional and Public Awareness of SMA..................... 248
Protection and Advocacy (P&A) Grants............................. 280
Protemomic Patterns.............................................. 230
Psychological Impact of Bioterrorism............................. 160
Public/Private:
Partnerships................................................. 161
Venture Yields new Medication for Addiction.................. 153
Recent Scientific Advances in Genomics........................... 141
Reducing:
Disease and Disability....................................... 157
Postmenopausal Women's Risks for Cardiovascular Disease...... 148
Risk Factors for Obesity and Hypertension in Adolescents..... 148
Tobacco use by Fighting the Addiction........................ 154
Regenerative Medicine............................................ 244
Research......................................................... 268
Priorities................................................... 127
Retinal Disease Research......................................... 191
Salivary Diagnostics......................................199, 209, 244
Schizophrenia.................................................... 270
Research..................................................... 273
Science for Global Health........................................ 164
Scleroderma...............................................223, 224, 263
Research..................................................... 223
Screening for Drug Discovery Targets............................. 159
Searching for Schizophrenia Vulnerability Genes.................. 159
Services Research................................................ 269
Serving Special Communities...................................... 179
Sjogren's Syndrome.............................................200, 231
Skin Diseases.................................................... 163
SMA:
Research Budget.............................................. 246
Translational Research Budget................................ 246
SPARK II Conference.............................................. 172
Spinal Muscular Atrophy.......................................... 218
Research..................................................... 216
Standardization & Characterization of Dietary Supplements........ 196
Status and Costs of Clinical Trials for SMA...................... 248
Stem Cells:
And Mouse Feeder Cells....................................... 215
Infrastructure Awards........................................ 214
Research..................................................... 232
Strabismus, Amblyopia, and Visual Processing Research............ 192
Strategic:
Alliances With Minority Groups to Reduce SIDS................ 135
Roadmap for NIH.............................................. 128
Strengthening the Global Culture of Research..................... 165
Stress and the Brain............................................. 153
Stroke Patients Improve Function of Impaired Limb................ 134
Sustaining Research Programs on Modest Budget Increases.......... 220
Systemic Lupus Erythematosus..................................... 162
Testing Drugs to Improve Health of Children and Pregnant Women... 136
The:
Burden of:
Mental Illness........................................... 158
Neurological Disorders................................... 183
Genomics and Proteomics of Periodontal Diseases.............. 200
Need for a Strategic Roadmap................................. 131
NIBIB Research Portfolio..................................... 186
NIH Tradition................................................ 129
Office of:
AIDS Research............................................ 167
Behavioral and Social Sciences Research.................. 168
Disease Prevention....................................... 168
Research on Women's Health............................... 167
Science Education........................................ 169
President's New Freedom Commission on Mental Health.......... 159
Role of Genetics and the Environment in Addiction............ 154
U.S. Epidemic................................................ 206
Worldwide Pandemic........................................... 205
Timeline and Plan for SMA Translational Research................. 247
Tissue Engineering............................................... 200
Tools for Scientists and Health Professionals.................... 177
Training:
Nurse Researchers for the Future............................. 149
Stipends..................................................... 242
TRANS-NIH Strategic Plan and Budget.............................. 188
Traumatic Brain Injury Network for Better Treatments............. 135
Treating Atrial Fibrillation..................................... 171
Treatments....................................................... 268
Tuberous Sclerosis:
Complex...................................................... 222
Research Plan and Report..................................... 256
Under-Age Drinking............................................... 175
Understanding the Biology of Aging............................... 157
Unraveling the 3-D Structures of Proteins........................ 151
Urologic Diseases................................................ 196
Variation Holds the Answer....................................... 173
Vascular Disease................................................. 264
Vasectomy and Prostate Cancer: No Association.................... 134
Women and Minorities............................................. 207
Women's Heart Education.......................................... 266
Office of the Secretary
Abuse and Neglect in Long-Term Care Facilities................... 22
Additional Committee Questions................................... 64
Aging............................................................ 17
Bioterrorism..................................................... 58
Centers for Disease Control and Prevention....................... 24
Initiative................................................... 15
Child Care Development Block Grant............................... 73
Chronic Illness.................................................. 17
Community Health Centers......................................... 17
Compassion Capital Fund.......................................... 70
Early Learning Fund.............................................. 70
Empowering America's Families.................................... 11
Faith Based and Community Initiatives............................ 9
Fast Food Industry............................................... 61
Fighting:
Bioterrorism................................................. 8
HIV/AIDS..................................................... 7
Foster Care...................................................... 20
Head Start............................................9, 15, 21, 68, 73
Faces and Impact Study....................................... 68
Health Wellness.................................................. 72
Hospital Cost Computation........................................ 66
Improving the:
Health and Safety of our Nation.............................. 12
Nation's Health.............................................. 6
Independent Living Voucher Program............................... 74
Maintaining our Investment in Biomedical Research................ 8
Medicaid:
Drug Rebate Program.......................................... 65
Proposal..................................................... 77
Medical:
Errors....................................................... 63
Liability.................................................... 62
Reform Legislation....................................... 65
Medicare:
Drug Benefit................................................. 66
Hearings Transfer............................................ 72
Payment Policy............................................... 65
Plus Choice.................................................. 76
Prescription Drug Proposal................................... 77
National:
Health Service Corps......................................... 17
Institutes of Health funding................................. 26
New Freedom Initiative........................................... 27
NIH Grants and Contracts Awarded for the State of Louisiana...... 30
Obesity.......................................................... 17
And Lifestyle................................................ 61
Physicians' Pay.................................................. 67
Prescription Drug Cost........................................... 77
President's:
Drug Treatment Initiative.................................... 28
Management Agenda............................................ 11
Scientific Advisory Committee.................................... 78
Severe Acute Respiratory Syndrome................................12, 13
Smallpox Vaccination Program..................................... 68
Strengthening and Improving:
Medicaid and SCHIP........................................... 10
Medicare..................................................... 9
Stroke........................................................... 75
Substance Abuse.................................................. 28
Programs..................................................... 29
Supporting the President's Disease Prevention Initiative......... 5
Tax:
Credits:
For Health Insurance..................................... 62
On Malpractice Insurance................................. 62
Cuts......................................................... 20
Unaccompanied Children Transfer to ORR........................... 71
DEPARTMENT OF LABOR
Office of the Secretary
Additional Committee Questions................................... 328
Asbestos Tainted Vermiculite..................................... 338
Association Health Plans......................................... 348
Bringing DOL Into the 21st Century............................... 295
Coal:
Industry Grant to China...................................... 349
Mining Inspectors............................................ 317
Comparison of the Financial Disclosure Regimes for Labor Unions
and Privately Held Companies................................... 327
Consolidation of Employment and Training Programs................ 329
Cuts in Employment and Training Services and GAO................. 339
Dislocated Worker Assistance..................................... 302
Elimination of:
Employment Service.........................................330, 343
H-1B......................................................... 342
Employee Benefits Security Administration........................ 299
Employment:
And Training Programs........................................ 295
Standards Administration..................................... 296
Ergonomics....................................................... 311
Budget....................................................... 334
Enforcement and Guidelines................................... 335
Inspections.................................................. 323
Extended Benefits for Airline Industry........................... 337
Extension of Unemployment Compensation........................... 338
Fair Labor Standards Act......................................... 344
Farmworker Housing............................................... 348
Filling Coal Mine Inspectors Positions........................... 311
GAO Report Regarding WIA Spending................................ 306
H-1B Training Programs........................................... 331
Hispanic and Immigrant Workers................................... 328
Implementing the President's Management Agenda................... 300
International:
Child Labor.................................................. 307
Labor Affairs................................................ 300
LM-2:
Financial Disclosure......................................... 345
Proposed Regulation.......................................... 323
Reporting Requirements....................................... 324
Migrant and Seasonal Farmworkers Elimination...................306, 338
Mine Safety and Health........................................... 309
Administration............................................... 298
Inspectors in West Virginia.................................. 313
MSHA District 3 Regional Office in West Virginia................. 314
MSHA Says: ``Protecting Miners Comes First''..................... 316
National:
Emergency Grants...........................................318, 319
Labor Relations Board........................................ 334
Occupational Safety and Health Administration.................... 298
Office of Inspector General...................................... 299
One Stop Infrastructure.......................................... 342
OSHA:
Enforcement.................................................. 337
Standards.................................................... 336
Pennsylvania Trade Adjustment Assistance......................... 303
Funding...................................................... 303
Pension Operations............................................... 333
Personal Reemployment Accounts................................... 340
Proposed Plan of the Mine Safety and Health Administration
Distributing Fiscal Year 2003 Appropriations of $10 Million for
Digitizing Mine Maps and Developing Technology to Detect Mine
Voids.......................................................... 309
Protecting:
America's Workers............................................ 294
Americans' Employee Benefits................................. 294
Retirement:
Of MSHA Inspectors........................................... 315
Security..................................................... 299
Status of National Emergency Grant Requests for:
Iowa......................................................... 322
West Virginia................................................ 319
Trade Adjustment Assistance (TAA) Program......................331, 338
UI Extension for Airline Workers................................. 304
Union Audits..................................................... 326
WIA:
Formula Amendments........................................... 340
Youth Programs............................................... 332
Worker Protection..............................................293, 296
Young Offenders.................................................. 333
Youth:
Opportunity Cuts............................................. 341
Program Cuts................................................. 340
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