<DOC>
[109th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:22987.wais]
LEGISLATION TO REAUTHORIZE THE NATIONAL INSTITUTES OF HEALTH
=======================================================================
HEARING
before the
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED NINTH CONGRESS
FIRST SESSION
__________
JULY 19, 2005
__________
Serial No. 109-40
__________
Printed for the use of the Committee on Energy and Commerce
Available via the World Wide Web: http://www.access.gpo.gov/congress/
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COMMITTEE ON ENERGY AND COMMERCE
JOE BARTON, Texas, Chairman
RALPH M. HALL, Texas JOHN D. DINGELL, Michigan
MICHAEL BILIRAKIS, Florida Ranking Member
Vice Chairman HENRY A. WAXMAN, California
FRED UPTON, Michigan EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida RICK BOUCHER, Virginia
PAUL E. GILLMOR, Ohio EDOLPHUS TOWNS, New York
NATHAN DEAL, Georgia FRANK PALLONE, Jr., New Jersey
ED WHITFIELD, Kentucky SHERROD BROWN, Ohio
CHARLIE NORWOOD, Georgia BART GORDON, Tennessee
BARBARA CUBIN, Wyoming BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois ANNA G. ESHOO, California
HEATHER WILSON, New Mexico BART STUPAK, Michigan
JOHN B. SHADEGG, Arizona ELIOT L. ENGEL, New York
CHARLES W. ``CHIP'' PICKERING, ALBERT R. WYNN, Maryland
Mississippi, Vice Chairman GENE GREEN, Texas
VITO FOSSELLA, New York TED STRICKLAND, Ohio
ROY BLUNT, Missouri DIANA DeGETTE, Colorado
STEVE BUYER, Indiana LOIS CAPPS, California
GEORGE RADANOVICH, California MIKE DOYLE, Pennsylvania
CHARLES F. BASS, New Hampshire TOM ALLEN, Maine
JOSEPH R. PITTS, Pennsylvania JIM DAVIS, Florida
MARY BONO, California JAN SCHAKOWSKY, Illinois
GREG WALDEN, Oregon HILDA L. SOLIS, California
LEE TERRY, Nebraska CHARLES A. GONZALEZ, Texas
MIKE FERGUSON, New Jersey JAY INSLEE, Washington
MIKE ROGERS, Michigan TAMMY BALDWIN, Wisconsin
C.L. ``BUTCH'' OTTER, Idaho MIKE ROSS, Arkansas
SUE MYRICK, North Carolina
JOHN SULLIVAN, Oklahoma
TIM MURPHY, Pennsylvania
MICHAEL C. BURGESS, Texas
MARSHA BLACKBURN, Tennessee
Bud Albright, Staff Director
David Cavicke, Deputy Staff Director and General Counsel
Reid P.F. Stuntz, Minority Staff Director and Chief Counsel
(ii)
C O N T E N T S
__________
Page
Testimony of:
Zerhouni, Elias A., Director, National Institutes of Health.. 10
Additional material submitted for the record:
Zerhouni, Elias A., Director, National Institutes of Health,
response for the record.................................... 65
(iii)
LEGISLATION TO REAUTHORIZE THE NATIONAL INSTITUTES OF HEALTH
----------
TUESDAY, JULY 19, 2005
House of Representatives,
Committee on Energy and Commerce,
Washington, DC.
The committee met, pursuant to notice, at 2 p.m., in room
2318 of the Rayburn House Office Building, Hon. Nathan Deal
(acting chairman) presiding.
Members present: Representatives Barton, Bilirakis, Deal,
Wilson, Buyer, Pitts, Walden, Ferguson, Rogers, Myrick, Murphy,
Burgess, Blackburn, Waxman, Markey, Towns, Brown, Rush, Eshoo,
Stupak, Engel, Wynn, Green, DeGette, Capps, Allen, Solis,
Inslee, and Baldwin.
Staff present: Chuck Clapton, chief health counsel; Cheryl
Jaeger, majority professional staff; Eugenia Edwards,
legislative clerk; Brandon Clark, health policy coordinator;
John Ford, minority counsel; and Voncille Hines, minority
research assistant.
Mr. Deal. I call this hearing to order. I need to explain
to our witness, and to the rest of the committee that our
chairman and some of our members of this committee are engaged
in the Energy Conference, and therefore, they may come in, and
they may have to leave. So--and the fact that they are meeting
right now--we decided to proceed on with this hearing today,
and I believe we have enough to proceed.
I recognize myself for a very brief opening statement.
First of all, I want to welcome Dr. Zerhouni to this hearing,
and it is a hearing in our continuing effort to reauthorize the
National Institutes of Health, and we appreciate you for
joining us again, as you have in the past. This is an area of
jurisdiction that is important to this committee, and many of
you are aware that this is actually the eleventh hearing we
have had on NIH in the last 2\1/2\ years, and all of us are
hopeful that the result of those hearings and the work of our
staffs will allow us to achieve the very important function of
reauthorizing NIH.
We have been working on the issue of reauthorization of NIH
for longer than many people on this committee have actually
been in--serving in Congress, and some of us are of the opinion
that now is the time to finalize that issue, and we are hopeful
of doing that in the very near future. One of the issues that
is important, I think, to all of us on this committee,
regardless of our party affiliation, is the fact that in the
absence of reauthorizing NIH, this committee basically cedes
its jurisdiction to another committee, namely, the
Appropriations Committee, and we believe that it is appropriate
for us to reclaim that issue of jurisdiction, and this effort
to reauthorize will do that.
Times have changed, and certainly, as times change, the
necessity of looking at organizations such as NIH, and whether
or not it, too, should change is indeed appropriate. Dr.
Zerhouni, again, we welcome your attendance today, and look
forward to hearing your testimony and working with you as we
proceed with NIH reauthorization.
I am now pleased to recognize my ranking member of our
subcommittee, but I presume standing in also for the full
committee, Mr. Brown of Ohio.
[The prepared statement of Hon. Nathan Deal follows:]
Prepared Statement of Hon. Nathan Deal, Chairman, Subcommittee on
Health
Thank you, Mr. Chairman.
I want to start off by welcoming Dr. Zerhouni to this hearing on
our efforts to reauthorize the National Institutes of Health. We
appreciate your joining us again this afternoon to talk about one of
the most important priorities under the jurisdiction of this Committee.
As you are well aware, this will be the Energy and Commerce
Committee's eleventh hearing on the NIH in last two and a half years,
and we are hopeful we can all continue to work together to achieve some
much-needed improvements to this vital component of our federal
government.
As many of you know, we have been working on reauthorizing the NIH
longer than most of the Members of this Committee have been serving in
Congress, and it is well past time for this Committee to get something
done.
Indeed, Mr. Chairman, it is time for Authorizers to be Authorizers
again, and I applaud you for your leadership on this very important
issue.
Times change and organizations must adapt to this change. We must
modernize the organizational structure of the NIH so that we can
advance scientific discovery for the benefit of all mankind.
Again, Dr. Zerhouni we appreciate your attendance and expertise,
and we look forward to working with you as we strive to improve one of
the most important agencies in our government.
Mr. Brown. Thank you, Mr. Chairman, and thank you, Dr.
Zerhouni, as always, for joining us with your wisdom and your
knowledge. It is our responsibility to ensure that agencies
under our jurisdiction have the resources and statutory
authority they need to advance the public good. NIH represents
half the discretionary budget at HHS, and the chairman has
rightly assigned a high priority to its reauthorization.
As we know, NIH is a complex agency. Its work affects the
lives of millions of Americans. I want to make it clear that
passing a consensus, a consensus bill, requires that all
parties have the necessary time to contribute their ideas,
perspective, and insight into the final product, and I would
reiterate, have the necessary time to contribute these ideas
and perspective.
Well, this committee has had numerous hearings on NIH. The
devil, of course, is in the details. Members of Congress and
stakeholder groups have had less than a week to review
legislation that translates general concepts into concrete
operational changes in a very complicated structure, as I have
seen from both committee hearings and individual personal
conversations with Dr. Zerhouni. We need time to make sure the
bill does what we think it does, and that those changes are
beneficial. However, given the right timeframe, and with the
right input from inside Congress and outside Congress, I am
confident we can pass a bill that represents true progress for
NIH and for all of the American public.
Thank you.
Mr. Deal. Thank the gentleman. Does anyone else wish to
make an opening statement?
Mr. Bilirakis. Just a very brief one.
Mr. Deal. Mr. Bilirakis.
Mr. Bilirakis. Just a very brief one, Mr. Chairman.
I am one of those people who will probably have to be
called upon at a moment's notice to go downstairs for a vote on
the conference, but I did want to join you and the others in
welcoming Dr. Zerhouni here, and to thank you for your part in
the preparation of this legislation.
We must reauthorize NIH. I think we all agree to that, to
increase transparency and accountability at the agency, and to
ensure that it is operating as effectively and efficiently as
possible. And I would also like to say, and really emphasize,
Mr. Chairman, that we must make certain that any changes that
we make to NIH will not harm its various institutes. I am
always concerned about the unintended consequences of our acts.
Haste sometimes makes waste. We are all--have our minds made up
that we are going to reauthorize this time around. We are
working with the minority, which is just great in that regard,
but let us make sure that we are concerned that our--whatever
we do do, and whatever changes we do make will not cause more
harm than good.
So having said that, Mr. Chairman, I would yield back, and
thank you.
Mr. Deal. Thank the gentleman. Anyone else. Mr. Rush?
Mr. Rush. Thank you, Mr. Chairman. Mr. Chairman, I also
want to thank you for holding this hearing, and I will be
brief, since my time in short, and we want to really get to
hear Dr. Zerhouni.
Mr. Chairman, I truly appreciate your leadership in this
committee reasserting its jurisdiction over the National
Institutes of Health. For too long, the appropriators have had
way too much authority over NIH, and it is time that this
committee put an end to that reign. With all due respect to
that other committee, we are the committee of expertise, and it
serves this Congress, the NIH, and the American people well
when we utilize that expertise.
Having that said, I have two key issues that I would like
to--the draft legislation before us to address. First, I remain
concerned that the issue of racial disparities, an old,
shameful problem that has not gone away, and Dr. Zerhouni, in
his statement, agrees with this point, that the issue of racial
disparities is not adequately addressed by this bill. We need
stronger mandates for our premier medical research institute to
aggressively address an inexcusable and unconstitutional
problem in our country here. Specifically, I want to hear what
NIH can do to include more people of color and women in
clinical trials, both as researchers themselves, and as
subjects in the private sector.
Second, I am concerned that medical research in this
country is not adequately incorporating children in their
research and medical deliberations. I believe that NIH needs to
consider the pros and cons of including children in clinical
trials, and use its leverage and Federal dollars accordingly.
As always, I welcome the Director to this hearing, and I
look forward to his testimony. And Mr. Chairman, I look forward
to working with you and the rest of the members of this
committee, so that we can come up with a truly bipartisan,
cooperative, and deliberative piece of legislation that
reauthorizes the National Institutes of Health.
I yield back the balance of my time.
Mr. Deal. Thank the gentleman. I recognize Ms. Wilson for
an opening statement.
Ms. Wilson. Thank you, Mr. Chairman, and thank you for
holding this hearing.
I think there are some concepts in this draft legislation
that are worth supporting, certainly in prioritizing the
research in the most promising areas, and allowing greater
flexibility to manage research roadmaps across the various
institutes of the National Institutes of Health, and second, to
give the Director authority over a certain percentage of
funding to direct particular research--and there is a precedent
in this area, with the Department of Energy Laboratories, where
a certain percentage is set aside for lab-directed research and
development, to put money toward the most promising research.
There are a couple of areas I think we need to be attentive
to. One is that this legislation tries to move forward on
establishing an electronic data base of research projects,
which is very helpful to those who are looking for clinical
trials, and information about research ongoing. I think we need
to make sure that that data base is publicly available, not
just to people who are researchers or medical doctors, but
accessible to the public, who are paying for this research,
that it is searchable, and it really does enhance access to
clinical trials.
The second area where I have some concerns has to do with
public/private coordination or collaboration. The legislation
does anticipate some partnership in high risk and high reward
areas of research, but I wonder whether we should limit those
collaborative mechanisms to just the high risk research, and
whether we should expand those mechanisms and encouragement to
include basic research, because there is a lot more research
that is done outside of the NIH than is done inside of the NIH,
and collaboration and coordination could, I think, help both.
And with those two caveats, I look forward to the testimony
today. Thank you, Mr. Chairman.
Mr. Deal. Thank the gentlelady. Mr. Waxman, do you have an
opening statement?
Mr. Waxman. Yes, Mr. Chairman.
The National Institutes of Health is, without doubt, one of
the premiere agencies in the Federal Government. It is widely
respected throughout the world. It is an agency with a mission
critical to the Nation's health; and it is an agency that few
would dispute is working well.
Can it do better? Of course. Where it can be strengthened,
we want to do that. All of us want to provide the necessary
tools to enhance its ability to perform its mission. But this
is not an agency which is broken. The changes we make to
improve it must be thoughtful and measured, and we must be
certain that we are not unintentionally taking actions which
reduce the very features that have made it strong.
Our goal, as authorizers of this institution, should not be
to restrict the resources the agency receives, but to provide
fully for its support and growth now and into the future. Our
goal should be to maintain and defend the peer review process
which is at the heart of its strength, and to give the
Institutes the tools to stay at the forefront of medical
research.
I look forward to hearing from Dr. Zerhouni today, and from
any other persons and institutions who support and benefit from
the work of this agency. And I hope and trust this committee
will move forward with caution and care and deliberation.
Thank you.
Mr. Deal. Thank the gentleman. Anyone on this side have--
Dr. Burgess, recognized for an opening statement.
Mr. Burgess. Thank you, Mr. Chairman, and I, too,
appreciate your holding this hearing today, and I know that
this reauthorization is one of your highest priorities, and I
think we can see the fruits of your labor before us today, and
of course, welcome again the Director of the NIH, Dr. Zerhouni,
and I am looking forward to his comments on the draft bill.
On my review, I think the draft does strike a balance of
achievable reforms. Granting the Director greater budgetary
authority will go a long way in redirecting research priorities
at the NIH. With additional oversight and authority, the NIH
director can plan, in a more strategic manner, and respond to
emergencies as they occur.
I have visited the NIH. I have visited with the Director,
and you really get a sense of how precious that organization is
to this country. In fact, it is my visit to the NIH that is one
of the few things of the last 2\1/2\ years that have really
made me optimistic about the future of this country that we are
leaving to our children and grandchildren.
The research conducted by the NIH is truly groundbreaking,
whether it is additional treatment for cancer or a greater
understanding of the human genome, the NIH has a proven record
of innovation. Improvements can be made in its managerial
structure, and that is, in fact, how we will improve the
quality of research conducted at NIH and the health of all
Americans.
Thank you, Mr. Chairman. I will yield back.
Mr. Deal. Thank the gentleman. Anyone else? Mr. Engel.
Mr. Engel. Thank you, Mr. Chairman. At the outset, I would
like to say that I like sitting on this side of the committee.
I want to thank you for----
Mr. Deal. You have to act accordingly.
Mr. Engel. I want to thank you for convening this hearing
today. I am very pleased to welcome Dr. Zerhouni back for his
seventh appearance before our committee.
It is always good to see you, Doctor. It is disappointing,
though, that none of the stakeholders that will be affected by
the proposed restructuring of the NIH were invited to give
their reaction to these proposals. I certainly support
initiatives to improve coordination and increase transparency
among the NIH institutes and centers. The proposed
concentration of budget, management, and grant making authority
in the office of the NIH, though, may go further than necessary
to achieve these goals.
I am concerned that the discussion draft establishes four
specific authorizations of appropriations line items, which may
dramatically impact the ability of the constituencies of the 27
research institutes and centers from having a place at the
table in the appropriations process. I am not certain that
authorizing the virtual elimination of these important
relationships is the best policy proposal.
I appreciate the commitment of the chairman to open and
amend the proposed legislation based on feedback from members
of this committee and the many stakeholders who work with and
benefit from NIH research. As we move forward, it is my sincere
hope that we can pass legislation that strengthens the
management of the NIH without sacrificing the voices of these
important groups.
I thank you, and I yield back.
Mr. Deal. Thank the gentleman. Mr. Ferguson.
Mr. Ferguson. Does that mean we have to act accordingly on
this side, Mr. Chairman?
Mr. Deal. You are excused.
Mr. Ferguson. Thank you, Mr. Chairman. I certainly thank
Dr. Zerhouni for being here again with us today, and certainly
looking forward to the reauthorization process.
The NIH is a place where groundbreaking research occurs
daily, research that might lead to a cure for many of the
diseases that affect people throughout our world. Recently,
Congress has set out on an ambitious path to increase funding
for NIH, and we have seen the budget double in the last number
of years. We have not seen NIH reauthorized in 12 years, since
1993, and recent hearings have pointed to a need for
interagency cooperation and coordination to help maximize the
resources of the Institutes.
We must give the Director the ability to manage the NIH
portfolio to focus on research that yields results, cures to
diseases that are within reach. In the January 2004 edition of
Health Affairs, Dr. Zerhouni said: ``We need to be able to plan
across NIH. We need some funds in common. If you have 27
fingers out there with no palm, you don't have a hand.''
I look forward to this hearing, to hear Dr. Zerhouni's
impressions of the hand that you have been dealt, and what we
can do to give you the upper hand as we go through the
reauthorization process, and as we try to enable NIH to find
the cures to diseases which affect so many people throughout
the world.
Thank you, Mr. Chairman. I yield back.
Mr. Deal. Oh, well, at least we don't have a paradox today.
Recognize Ms. DeGette.
Ms. DeGette. Thank you, Mr. Chairman, and I would like to
add my welcome to Dr. Zerhouni.
The last time we authorized the NIH was 12 years ago in the
House, and when you think about the status of medical research
12 years ago, you really realize why reauthorization of this
important agency is well overdue. The nature of medical
research and, frankly, the integration of research that we are
seeing among the 27 Institutes has grown dramatically in the
last 12 years.
I agree with Mr. Waxman. The system is not broken, and that
is why it is such a pleasure to be reauthorizing the agency at
this juncture. But I think it is important that we discuss what
the balance is between the 27 fingers and the palm of the
agency, and we really try to figure out how we can keep the
autonomy and the important research that is happening among
those 27 agencies, but at the same time, use the Director's
Office to ensure that cross-fertilization happens in the
important way that it can, because that is the only way that we
will really see medical research advance in the 21st Century.
Thank you, Mr. Chairman.
Mr. Deal. Thank the gentlelady. Anyone else on this side
have an opening statement? If not, anyone on the top row here?
Yes. Mr. Stupak.
Mr. Stupak. Thank you, Mr. Chairman. Dr. Zerhouni, thanks
for coming here today. I look forward to your comments.
Since I have 1 minute, I am going to focus on one area of
this draft legislation that I find troubling. The draft strikes
a section of the Public Health Service Act that authorizes
pediatric drug studies at NIH. This Section, 409(i)(d), was
added in 201 as part of the Best Pharmaceuticals for Children
Act. The BPCA reauthorized a law that gave drug companies
patent extensions in exchange for testing the drugs on
children. The incentive doesn't work if the drug has no patent
protection left, therefore Congress created a research fund
within NIH to study drugs that are off patent.
It is one of only a few provisions in law that actually
mandates FDA and NIH to work together on drug safety. This
draft would strike that provision. The sad fact is that
Congress has never funded this provision, but it does not mean
it is not important. It is more important than ever. Off-label
use by children of drugs approved and labeled only for adults
is rampant. The FDA has no power to restrict off-label use, and
the list of drugs that need to be studied continues to grow. If
the FDA cannot or will not enforce drug companies to do these
studies, then at the very least, we should not eliminate a
safeguard that gives parents some assurance that their
children's drugs will be tested for safety and efficacy.
I look forward to working with this committee on this
issue, and will be submitting additional questions to the
record. Thank you, Mr. Chairman.
Mr. Deal. I thank the gentleman. I might tell him that due
note has been made of your concerns, and will be addressed in
the next draft.
Mr. Allen.
Mr. Allen. Thank you, Mr. Chairman. Welcome, Dr. Zerhouni.
I hope you enjoyed your brief visit to Maine, and I want to
thank you for your leadership at NIH.
I just wanted to mention several concerns about this draft.
First, the committee needs adequate time to consider this
legislation, and to obtain input from stakeholders. Second, a
question. To what degree should the Director have the authority
to add, remove, and transfer Institute responsibilities without
ensuring a transparent public process? I do worry that the
concentration of so much power in the office of the Director
could result, could, in ideological and political
considerations trumping good science.
Third, this draft legislation appears to create an
arbitrary ceiling of Federal investment in biomedical research.
Establishing a ceiling would seem to directly contradict
Congressional success in doubling the NIH research budget, and
imposing a ceiling could also hamper the agency's ability to
deal with new public health threats. We just passed an
appropriations bill with the smallest increase for NIH in 36
years, so at least now, the budget is growing slower than the
costs of inflation and new research.
Finally, I believe that legislation to reauthorize the NIH
should address the violations of NIH scientists engaging in
outside consulting agreements with pharmaceutical companies,
and I want to commend Chairman Barton and Ranking Member
Dingell for their leadership on this particular issue.
I look forward to hearing from you, and with that, Mr.
Chairman, I yield back.
Mr. Deal. I thank the gentleman. Ms. Solis.
Ms. Solis. Thank you, Mr. Chairman, and welcome, Dr. Elias
Zerhouni. I am very interested in hearing what your testimony
will reveal to us today.
But one of the concerns I have is, I happen to represent a
very diverse district in Southern California, where we are
finding that access to health care, as you know, is a crisis--
it is in a crisis stage for many of the constituents I
represent. But more importantly, the diverse communities, not
only in Southern California, but across the country, we
increasingly see that there is a lack of research being done in
these different racial and ethnic minority communities. We are
trying to combat chronic illnesses, asthma, diabetes, obesity,
and other related illnesses that affect, at a higher degree,
more minority populations. We would like to see, I believe,
more research done, not in a vacuum, not in just one office,
but spread out throughout NIH, so that there are different
calibers of individuals and researchers that can provide new,
innovative information, so we can combat these illnesses, and
hopefully, look at ways of prevention, and making that service
available in languages and culturally competent, meaningful
ways that will actually make a difference for our populations.
There are no party lines when you talk about healthcare
access in communities of color that many of us represent in the
House, so I would hope that you would keep an open mind, and
work with us, the Members of the Congress, to see that we
really achieve parity, in terms of eliminating disparities
amongst our communities that currently are faced with some
severe challenges and a crisis in healthcare.
So thank you very much.
Mr. Deal. I thank the gentlelady. Anyone with opening
statements? Yes, Ms. Baldwin.
Ms. Baldwin. Thank you, Mr. Chairman, and thank you, Dr.
Zerhouni, for joining us again. I enjoyed our discussion when
you appeared before this committee's Health Subcommittee back
in March, and look forward to it continuing today.
Biomedical and behavioral research that is conducted at or
coordinated by the NIH is of utmost importance to all of
America, and particularly, in my district, which includes one
of the Nation's leading research institutions. I applaud the
chairman's focus on this important part of our government, and
I hope that, given the size and the importance of NIH, that we
do take a thorough, thoughtful, and measured approach to NIH
reauthorization.
Now, I have some concerns surrounding NIH reauthorization,
and some of those concerns have been amplified with the
circulation of the discussion draft last week. As I expressed
at the subcommittee's hearing in March, I have observed ongoing
and recently heightened efforts to politicize science and the
conduct of research, and I believe that we have to insist upon
safeguards to prevent this, and certainly, the time tested peer
review process must be protected at all costs.
I just want to end by noting that, while it is a delight to
have you return to the committee, I do hope that we will have
further hearings on this important topic with some of the other
stakeholders that are involved in NIH reauthorization,
especially researchers, research institutions, and patient
groups.
Thank you, and I yield back, Mr. Chairman.
Mr. Deal. Thank the gentlelady. Any other opening
statements?
[Additional statements submitted for the record follow:]
Prepared Statement of Hon. Paul E. Gillmor, a Representative in
Congress from the State of Ohio
Thank you Mr. Chairman for holding this hearing and bringing before
us a discussion draft aimed at reauthorizing the National Institutes of
Health (NIH).
Very briefly, our last NIH revamp bill was enacted 12 years ago,
and we must continue to focus carefully on the current organizational,
funding, and management structure of the NIH in order to make
significant headway in reauthorizing and improving its 27 medical
research institutes and centers. We must ensure that the NIH continues
to meet our public health needs as well as embrace cutting-edge
scientific opportunities.
I welcome Director Zerhouni, and again applaud Chairman Barton's
initiative. I yield back the remainder of my time.
______
Prepared Statement of Hon. Joe Barton, Chairman, Committee on Energy
and Commerce
Thank you, Dr. Zerhouni, for testifying once again before the
Committee. And I thank all of the organizations and Members who have
expeditiously responded with constructive feedback to improve the first
discussion draft we distributed last week.
It's time for us to do our job and have the Energy & Commerce
Committee reauthorize the National Institutes of Health. This job is
critically important and long overdue. With great fanfare, we doubled
the budget of NIH. Unfortunately, NIH did not have the mechanisms in
place to either account for the increases or strategically apply them.
It still doesn't, and that must change.
To date, NIH continues to lack the capability to track dollars
across institutes and centers for particular types of research or by
disease categories. Only authorizing legislation can put in place the
long overdue management tools that NIH needs to provide rational
accountability to an agency that needs efficiency as much as it needs
money.
I strongly believe that the NIH could be better organized to
achieve its mission. This sentiment is shared by many. Nearly two
decades ago, the Institute of Medicine reported, when NIH was 10 units
smaller and had a budget of $4.5 billion--less than 15 percent of the
size of the President's FY06 budget request for NIH--that there should
be a presumption against the creation of new research institutes. The
alarm bells sounded and Congress ignored them. NIH has grown like
topsy-turvy and now there are 27 Institutes and Centers.
Let me be clear. I don't have a problem with the research programs
at the institutes and centers. I'm not looking to cut the budget of
NIH, nor weaken the fundamental role that the individual institute and
center directors play in fulfilling their research agendas. But someone
needs to be in charge of strategic planning for the agency. No one in
his right mind would ever design a $28.5 billion agency that is
fragmented 27 ways with a director with only limited control.
Dr. Zerhouni is certainly to be commended for the job he is doing
with the power he can currently exercise. In three years time, he has
put in place new management mechanisms to advance cross-cutting,
interdisciplinary science. Congress can help Dr. Zerhouni to move
forward with these initiatives by moving forward a reauthorization
bill.
It's time for this Committee to recognize that it has serious
responsibilities with respect to this agency. We can't simply require
NIH to conduct more research by spending more money; we must demand
that NIH achieves more with taxpayer funds. The status quo is simply
unacceptable. On that note, I would like to personally thank Mr.
Dingell and Mr. Brown for their help in moving forward this
legislation. As I said months ago, the NIH enjoys bipartisan support,
and the bill to reauthorize it should be bipartisan as well.
The bill that is the subject of this hearing today was drafted with
two key policy principles in mind: no institute or center at NIH would
be favored, nor would the bill pick and choose disease winners and
losers. I ask my colleagues to keep these important principles in mind
as we move forward to improve the bill.
Instead, the bill provides a framework for NIH scientists, not
politicians, to identify areas of emerging scientific opportunity and
take action to improve public health outcomes. The discussion draft
creates a new, comprehensive electronic reporting system that will, for
the first time, catalogue all research activities of the NIH in a
standardized format. Instead of thousands of pages of reports from each
of the research institutes and centers, the NIH Director will compile
biennially a report that comprehensively lays out the strategic plans
and research activities of the agency.
The bill will let the NIH Director direct by establishing a formal
strategic planning process for the entire research portfolio of the
agency that transcends the research planning activities of individual
Institutes and Centers.
And finally, the legislation streamlines how we fund research
activities at the NIH. Science has changed, and so too must the agency
that funds it.
By reauthorizing the NIH, we are once again recognizing the
critical importance of the biomedical research enterprise that will
lead to the next generation of medical breakthroughs and therapies. I
look forward to working with Members of this Committee to see that this
long overdue bill moves not only through the Committee, but is enacted
into law.
Mr. Deal. If not, we will then proceed with Dr. Zerhouni.
We are, once again, pleased to have you here, and look forward
to your testimony.
STATEMENT OF ELIAS A. ZERHOUNI, DIRECTOR, NATIONAL INSTITUTES
OF HEALTH
Mr. Zerhouni. I am very honored to be here, Mr. Chairman,
and members of the committee. I think this is probably a
defining moment for NIH. There are transitions that are
occurring in science as we speak. There are transitions in the
way science is conducted, and this topic requires the attention
that you have exerted over the past 2 years with 11 hearings.
This is my seventh appearance. I have submitted a written
statement, and to leave ample time for both comments and
questions, what I would like to do is summarize my comments
through a slide presentation, if I may.
Clearly, what we are trying to do here, all of us, is to
find a better way for NIH, a way that in no way implies that
NIH has not been a highly performing organization. In every
measure, whether it be GPRA plans or progress in science, or
breakthroughs, or impact on public, I think we can say that NIH
has been a remarkably successful organization over many, many,
many years.
It is important to also remember that our basic authority
comes from the PHS Act, Section 301, which states that the
Secretary shall conduct in the service and ``encourage,
cooperate with, and render assistance to other appropriate
public authorities, scientific institutions, and scientists in
the conduct of, and promote the coordination of, research,
investigations, experiments, demonstrations, and studies
relating to the causes, diagnosis, treatment, control, and
prevention of physical and mental diseases and impairment of
man.''
And I think what the committee is doing is to reinforce
this fundamental authority. We are the primary Federal agency
authorized by this committee to conduct and support medical
research, and I think the efforts that we are seeing have also
been, in many ways, summarized in this list, where, in fact,
the basic authorities do allow us to prioritize research at NIH
through fundamentally an organizational structure, Institutes,
Centers, that are created for special purposes related to
perceived scientific opportunities or public health priorities.
It mandates biomedical research, it provides grant-making
authority. It mandates a system of peer review which is the
envy of the world. It is a world-renowned system that ensures
that quality science is funded on a competitive basis. It
mandates training for the workforce that we need to address the
problems we are dealing with. It also mandates dissemination of
information, that the information we generate be made public,
and be made available to the public who funds that research,
even subject to protections as well, as a wide solicitation of
the public advice.
And I think the draft that is being circulated reinforces
these authorities, and maintains them, and I want to comment
and say that, to me, this is the most important set of
reaffirmation of the success of the agency by reaffirming its
fundamental authorities. It is clear, however, as the Institute
of Medicine study, entitled ``Enhancing the Vitality of the
National Institutes of Health: Organizational Change to Meet
New Challenges,'' said that ``while the NIH is to be
celebrated, success alone does not answer fully the question of
whether there is a better way to proceed.''
Particularly, as one faces a future where the world of
biomedical science is being rapidly transformed in virtually
all its dimensions. I would like to take a second. There is a
quote on the wall there that says: ``Where there is no vision,
the people perish.'' Proverbs 29:18. And I think this is what
the IOM and your committee, and our own community, have been
indicating. If, indeed, there is a transformation, and there
are different priorities, how do we set those priorities? What
is the organizational challenge we need to tackle as we go into
an era of biomedical and behavioral and social science research
that is characterized by much more complex problems, problems
that affect an entire population at times, problems that affect
an aging population, conditions that have become more chronic,
more long-term, than the conditions we dealt with 30, 40 years
ago. You can survive cancer today. You can live with cancer as
a chronic disease. You can live with AIDS as a chronic disease.
You can live and survive heart disease for many, many years.
The landscape has changed, and I think we need to adapt as
well.
Now, at the March 17 hearing, this chart was highlighted by
Chairman Barton as illustrating both the opportunity and the
challenge that we have. Clearly, as any successful
organization, we have grown in size, we have grown in
complexity. To the same extent, the complexity and scale and
scope of the public health problems we have to deal with have
also grown. And as I said, the organization of NIH is primarily
an organization driven by structure. So how did we evolve the
structure; 27 Institutes and Centers represent the operating
arms of NIH, what I refer to as the fingers, if you will. The
palm, on the other hand, is represented by some of the
coordinated offices, which you see at the top left hand corner,
the offices that have been created for the purpose of better
coordination, the Office of Research on Women's Health, the
Office of AIDS Research, the Office of Behavioral Social
Sciences Research. So as you can see, as time has gone by, more
structures have been created. But at the same time, we have
attempted to create what Representative Ferguson mentioned as
the palm. And I think the balance between the palm and the
fingers is really our challenge. A strong palm with no good
fingers is not a good hand. Strong fingers without a palm is
not a good hand either.
So I think going forward and analyzing the proposed
circulation draft, these are some of the observations that we
can make. I think if you really look not in the structural way
at NIH, but in the functional way, what you find is you have
Institutes that are specifically directed to research and
science that addresses either a disease or a disease process,
or an organ, the Heart and Lung Institute, or a particular
disease, like diabetes, or a life stage, childhood, or the
aging population. These are what I call vertically oriented
institutes that integrate all of the components of research
needed to address a particular problem, as identified through
our public health priority stance.
These are the 15 Institutes that support research specific
to either a disease, an organ, or a life stage. Now, any
complex organization cannot work when there is only a vertical
orientation of each structure. In fact, other Institutes have,
for function, research, and science that is just as valuable as
the what we call mission specific Institutes, but it supports
what applies to all diseases, all organs, all life stages. For
example, every discovery at the National Human Genome Research
Institute applies to the entire aspect, the entire spectrum of
challenges NIH has. We were talking about cross-cutting issues.
These Institutes really perform the function of cross-cutting
science, and cross-cutting issues like minority health, for
example. Basic science, the National Institute of General
Medical Sciences, performs science that applies to the entire
set of diseases, ages, conditions, organs of the human body.
At the same time, as I mentioned, in the top left corner,
there are five program coordination offices that are specific
to particular areas of the portfolio. When you think about
organizations like this, you also have to realize that as the
landscape has changed, what also happened is that with chronic
diseases, patients are not affected by one disease at a time,
or one organ at a time. They are often affected by multiple
failures involving multiple organs. Diabetic patients may have
a vascular problem, a neurological problem, as well as a
problem of metabolism. So, it is important to realize that
barriers and silos become, in themselves, both instruments of
effectiveness, but also, instruments by which you lose
effectiveness, if you are not able to create that glue.
So I think the concept, the committee's conceptual
framework, is a good one. It is truly going from structure, and
enhancing that by a functional analysis of what NIH does.
However, the one piece that I believe is important is to create
the ability for the NIH, on a prospective basis, to analyze its
portfolio, to have a real radar as to what is it that is being
done within the agency, what is it that needs to be done, that
no single institute can do, and what kind of coordination can
you accomplish, and how do you accomplish it? And how does it
impact budgets? Do you want to direct all research from such an
office? No. Centralization is counterproductive in science,
excessive centralization, too much top down research. Do you
want to have no coordination? Well, the answer is no. Somehow,
somewhere, I think the committee is proposing a structure that
will accomplish this goal, which is very parallel to what the
IOM recommendations have been, and very parallel to what my own
actions have been on the ground, when we try to develop trans-
NIH programs, such as the Roadmap for Medical Research, or the
Blueprint for Neuroscience, or the Trans-NIH Obesity Plan. This
OD division would be essentially supporting the glue
mechanisms, the coordination--not dictate, but enhance and
synergize research. It will include the five specific program
coordination offices, which will continue their roles, because
they were created to fulfill a gap, which was coordination, and
I think they need to continue to do that job.
So in summary, I think you can see that going from a
structural organization to a more functional organization does
make the case that an authorization structure that would
encourage, rather than discourage, integration, that it would
encourage synergy, while not losing the autonomy and the
ability for the most significant part of the activities of the
Institutes and Centers, to be focused on their mission. I think
we do see, in my personal view, a great wisdom in what the
committee is proposing.
I would like to mention, fundamentally, that NIH and its
directors have tried to facilitate cross-cutting collaborations
over time. I think it is true that science has changed over the
past 12 years, and we have tried to adapt to it. We have
adapted to it by an ad hoc process, which I don't think is
codified or formalized, and we have shown that it can work, so
when we say let us go forward, and make a change, I think I
resonate with those who say make sure you don't break the
agency. Make sure that what you are proposing works. And I
think we have shown that it can work. The Roadmap for Medical
Research is one example where all the Institutes have come
together, and pooled funds, admittedly, at a time of generous
budgets, and have put those funds together to work over a 5-
year period, and continue to see this as a valuable initiative.
The Strategic Plan for Obesity, or the NIH Neuroscience
Blueprint, I think this will accelerate the progress, and make
sure that there is, at least, an exploration of a better way.
When you look at the role of this division, I think it will
provide consistent analysis across Institutes. It will provide
streamlined reporting to Congress. It will provide prospective
analysis of emerging areas, either scientific opportunities,
like nanotechnology, or proteomics, rising public health
challenges, like obesity or any other knowledge gaps can be
addressed objectively, on the basis of a transparent and
publicly available analysis. I think in conjunction, it should
not be done separately from the ICs, in conjunction with the
ICs, we should identify the areas that require strategic
coordination, where no single Institute can really accomplish
the goal that we would like to achieve. And it should launch
initiatives that are beyond the purview or resources of any one
Institute or Center. High risk, high reward research is
difficult to launch when you don't have a common pool of funds
that allow you to share the risk. This is, I think, what will
serve NIH as a whole.
So we need to make sure that whatever we do does not
supplant what has worked, or dictate IC-specific plans. I don't
think it is the role of this division to go to the Institute
for Cancer and say, ``You shall do so.'' I think it is more
important that we stimulate explorations for a part of the
portfolio of NIH, to make sure that no stone goes unturned,
that if there are opportunities to treat, to make progress,
that those are prospectively, in a formalized process,
evaluated.
This institutionalized mechanism for allocating a
percentage of the total NIH budget for greater synergy is, I
think, the core, to me, of the reauthorization concept that I
see, which I think would be very valuable. Essentially, it will
be a common fund for common needs, with a process that would
be, obviously, transparent, that will call for consultation,
that will have the right checks and balances for oversight, but
at the end of the day, in an era where science has become
interdisciplinary, collaborative, and converging in many cases.
Most of the research we do at one Institute applies to another.
The first treatments for HIV/AIDS actually came from research
that was done at the National Cancer Institute. There is no
firm separation of good science. There is only good science and
good public health.
So in summary, I think that it is clear that the bill, as
drafted, does provide, in my view, a higher level of
coordination. And I, again, should say that it should not bleed
into centralization. I think it should provide input from NIH
Institutes and Centers, outside scientists, and the public. It
should assess, like I said, a radar of the public health
landscape, look at the scientific landscape on a regular and
organized and disciplined basis, and manage the NIH portfolio
for maximum return on the investment, if you will.
But it will also, in my view, allow something that is
always difficult to accomplish in a complex organization,
nimbleness, the ability to be dynamic and responsive to quickly
emerging opportunities, not wait for the 3 year or 4 year
cycle, to be able to address a question, but to be there, on
time, with the right amount of money, the right amount of
resources, when we need it.
So in summary, I think I am indicating to you a willingness
to work with the committee. I think I hear the need for us from
the standpoint of policy and national interest, to look
carefully at the reauthorization of NIH. We will work with the
committee and the staff, in any capacity, to provide the
technical assistance that you may wish to have, but, in my
view, I think the committee, after 2 years of work, is
proposing something that has a functional component to it that
does make sense.
[The prepared statement of Elias A. Zerhouni follows:]
Prepared Statement of Elias A. Zerhouni, Director, National Institutes
of Health, U.S. Department of Health and Human Services
Mr. Chairman and Members of the Committee, today is my seventh
appearance before the Energy and Commerce Committee or one of its
Subcommittees. I have testified about a variety of topics, including
research priorities, the organization of Institutes and Centers,
scientific peer review, the shift of the Nation's health care burden
from acute to chronic diseases, and the need to revolutionize the
methods and systems we use to conduct and manage biomedical research.
Each time I testified, I noted the remarkable achievements made in
the course of biomedical research, ranging from mapping the human
genome to reducing mortality from cancer, AIDS, and heart disease to
the rapid progress in the development of vaccines. But I tempered the
stories of success by describing the daunting journey that lies ahead
of the scientific community as we grapple with the remaining obstacles
impeding progress towards the prevention, diagnosis, or treatment of
the many causes of human suffering. Much more needs to be learned about
human biology and behavior. Emerging and reemerging infectious diseases
continue to threaten the world. Chronic diseases are growing in terms
of their impact on quality of life and the economic future of America
and other countries. The threat of bioterrorism continues to loom.
Health disparities remain a widespread problem.
As the Institute of Medicine (IOM) has observed, ``While NIH's
success is to be celebrated, success alone does not answer fully the
question of whether there is a better way to proceed, particularly as
one faces a future where the world of biomedical science is being
rapidly transformed in virtually all its dimensions.''
This quest for the ``better way,'' as the IOM describes it, is also
at the core of insuring continued scientific progress in an era when
the scale and complexity of the problems we are facing require constant
innovation, increased interdisciplinary efforts, and a balanced
portfolio of basic, translational, and clinical research investments
across all NIH Institutes and Centers. Based on my own interactions
with the Members of this Committee, I know you too strive to find the
``better way.''
The IOM had several key recommendations worth recalling in the
context of today's hearing. It recommended that the ``Director of NIH
should be formally charged by Congress to lead a trans-NIH planning
process to identify major crosscutting issues and their associated
research and training opportunities and to generate a small number of
multi-year, but time limited, research programs.'' The IOM proposed
that NIH present the justification for trans-NIH budgeting to Congress
and that the funding for such research should be held in an escrow
account. It recommended that such research be included in the
President's budget request to Congress for NIH.
The IOM suggested that NIH have a formal process for reorganizing
offices and programs.
The IOM also recommended standardizing data and information systems
at NIH to enhance management, accountability, and transparency.
The IOM report was followed by three years of analysis by the
Committee and its staff. I think it is noteworthy that the IOM and the
Committee reached similar conclusions about NIH. Many of these
conclusions are manifested in the reauthorization concepts offered by
the Chairman and Ranking Member.
In thinking about NIH reauthorization, I want to begin with the
core research authorities embodied in Title III of the Public Health
Service Act, which authorize the Public Health Service to ``encourage,
cooperate with, and render assistance to other appropriate public
authorities, scientific institutions, and scientists in the conduct of,
and promote the coordination of, research, investigations, experiments,
demonstrations, and studies relating to the causes, diagnosis,
treatment, control, and prevention of physical and mental diseases and
impairments . . .''
I believe this core authority is the fundamental reason why NIH has
been so successful in its mission. I applaud the Chairman and Members
of the Committee for maintaining these and other vital authorities,
such as peer review, the pursuit of scientific opportunity through
investigator-initiated grants, human subjects protections, and the
requirement to disseminate research findings to the public. In its own
search for the better way, I think the Committee is correctly focused
on organizational efficiency and effectiveness, which is the principal
challenge for an increasingly large and complex organization.
I agree with the Chairman that we should first and foremost
carefully reconsider how the organizations of NIH can collectively and
effectively support the core missions of the agencies. The challenge is
to accomplish this goal through enhanced coordination and partnerships
across the NIH Institutes and Centers while avoiding the pitfalls of
centralization or top-down research. Achieving the right balance
between the necessary autonomy and diversity of approaches represented
by the various Institutes and Centers while avoiding the silo effects
that can reduce the effectiveness of the whole Agency is the central
question. How can the whole be greater than the sum of the parts? As I
said in the past, twenty-seven fingers without a palm is not a strong
hand. Likewise a strong palm without strong fingers is also
ineffective.
I agree with the Chairman that NIH needs an organization, such as
the proposed division of program coordination, planning and strategic
initiatives, that will serve as a coordinating office for evaluating on
a regular basis the progress of science in the context of public health
priorities. It will be responsible for analyzing and reporting with
consistent methods the portfolios of NIH research that cross the
boundaries of multiple Institutes and for identifying trans-NIH
research needs that no single Institute can address but that all of NIH
needs to support. This structure should be able to conduct appropriate
strategic planning for emerging areas of scientific opportunities or
challenges and to develop important data and intelligence to support a
more comprehensive and informed priority setting process. As you know,
the Administration has proposed such an office. I support the concept
that this office be able, through a codified process that includes
participation from all of the Institutes and the scientific community
at large, to allocate resources to initiatives that serve the common
good, subject to review by an advisory committee. However, I do not
think this office should actually conduct the research resulting from
any initiatives it identifies. I believe that this research is more
appropriately conducted by the existing Institutes and Centers.
The Chairman also proposes to clearly define the roles of NIH
Institutes and Centers. I agree that each Institute and Center should
have a defined purpose in support of the overall mission of NIH. The
Chairman has proposed categorizing Institutes and Centers into either
mission-specific or science-enabling responsibilities. This has
resulted in the perception that one category is more significant than
another. I understand that this is not the intent. All of the
Institutes and Centers support vital research. Some engage in broader
areas of science that are useful to all of NIH's organizations while
others are involved in more specific areas of research, focusing, for
example, on cancer, heart disease, or infectious diseases. Their
research is of equal value to the scientific community.
I will work with the Committee to clarify the roles of each of
NIH's Institutes and Centers. I agree with his goal of clearly defining
how each of these organizations serves the overall mission of NIH and
ensuring that the Agency does not consist of 27 silos that do not work
in coordination.
In further pursuit of the ``better way,'' the Chairman has proposed
consistent coding and reporting of research and a more transparent,
efficient mechanism for reporting the results of NIH research to
Congress and the general public. I agree that these steps are
necessary, and I will work with the Committee to accomplish these goals
in a way that will enhance the public's understanding of how NIH works,
while not unduly inhibiting the Agency's ability to conduct and
translate research quickly.
In conclusion, I pledge my cooperation to work with the Committee
as it considers reauthorizing the NIH provisions of the public health
Act. I look forward to answering any questions that you might have.
Mr. Deal. Thank you. I will begin with the questions.
As you know, we are considering in this proposal to divide
the various Institutes and Centers into two big categories, one
that is mission specific Institutes, and two, the science
enabling Institutes and Centers. What do you think about this
approach to that two major divisions?
Mr. Zerhouni. I think functionally, you can see that the
mission is actually different for the two groups. It is really
important to have the ability to coordinate planning between
these. As I said, for example, you may have conditions and
diseases that affect multiple organs. Diabetes affects the
cardiovascular system, affects the brain. So you want more
coordination around diseases, for example, that go across
multiple Institutes that are focused on diseases.
At the same time, in the cross cutting Institutes, that are
just as important, you may see an emerging discipline. You may
see something that--a methodology, or you may actually want to,
for example, develop computational biologists. Well, that
cannot be done by any one of them in isolation. So there is, I
think, merit to--from the planning standpoint, to have these
Institutes make sure that they get coordinated in a way that is
strategically directed.
Mr. Deal. I am sure most of us have heard from groups that
feel like they are not adequately represented within the silos
that currently exist, and one of the complaints is that they
get shuffled from one to the other, that this is not that
institute's responsibility, it is somebody else's.
One of the ways that we have anticipated trying to deal
with that is through the reporting system that is in the draft
legislation. Do you believe that this reporting system is a
good way to let the public know what is or is not being done
and by whom, and is this an important ingredient in setting
priorities for you within the NIH itself?
Mr. Zerhouni. First of all, I would like to commend the
committee, for looking at this issue of reporting. It is a
consuming activity that consumes a lot of resources and staff
time, for a benefit that is not necessarily there. So I think
streamlining reporting would be of great value to us, and
strategically reporting, in an appropriate way, would be
important. But think about it. If you had a division like this,
that had consistent ways of recording data and information,
that across all activities, the NIH had a way, a consistent
way, of reporting it dynamically, if you had an issue, you
wouldn't have to create a report, or a need for a report. What
you would do, you would say this division should be charged to
look at, for example, in the case of autism, we developed an
autism plan, called an autism matrix, and the case of
Parkinson's disease. And the question should be what is in the
portfolio, and what is science telling us, or public health
telling us, that we are not doing. That sort of dynamic
reporting is, I think, the future, but you can't do it unless
you have the tool to do it. And I think, with the tools, we
could streamline it.
However, I think mandated reports of a very large size,
basically, in my view, would be counterproductive. We need to
be more nimble. We need to be more accessible. I think someone
said accessible public information. That, I think, will solve
the problem eventually. So I am in favor of streamlining
reporting.
Mr. Deal. Thank you. Mr. Brown.
Mr. Brown. Thank you, Mr. Chairman. Dr. Zerhouni, I just
have a series of short questions, and I hope that, if possible,
you can give pretty quick answers to them.
One of the questions before the committee is whether we
include specific authorization levels in a bill reauthorizing
NIH. Do you support the committee legislating a hard ceiling,
or--a hard ceiling on NIH funding?
Mr. Zerhouni. Well, you are creating a real conflict in my
mind here. As the Director of an Agency, there is no ceiling
that is good enough, but I do understand the necessity for the
authorizing committees to look at that issue, and clearly, I
think it--like we said, it really depends on the total
structure of the authorization bill, and the specific amounts,
and so on, over what time. I think the details need to be
worked out, and would be happy to talk about the consequences.
It needs to be done carefully, if it is to be done.
Mr. Brown. Well, if we have ceilings or caps, let me push
it a little further. If we have ceilings or caps, what is an
appropriate percentage increase? What is an appropriate number,
if there are those caps or ceilings?
Mr. Zerhouni. I think you need to really look at the
planning process, and you need to look at the opportunity well.
I mean, you can't tell what emergencies will occur, what
opportunity will come. So it is very, very important to leave
yourself a significant amount of flexibility.
Mr. Brown. I am not going to get a specific--answers that I
want here, am I?
Mr. Zerhouni. I am willing to work with the staff and the
committee. I think it is something that needs to be looked at
in greater detail.
Mr. Brown. The draft contains several different authorities
for the Director to transfer funds within the National
Institutes of Health. One of these follows the Institute of
Medicine's recommendation that each Institute and Center set
aside a percentage of its budget into an escrow type account to
be applied toward trans-NIH initiatives, as we discussed, a
sort of common fund. What is an appropriate percentage that we
should set aside, if we do it in the authorizing language for
trans-NIH authority?
Mr. Zerhouni. Well, clearly, I think, it wouldn't be
meaningful if it is not a meaningful percentage. I think--and I
think the IOM recommended beginning with 5 percent of the
overall NIH budget, and I think that this is a good way of
making sure that the NIH Institutes come together on a regular
basis, because this is not transferred away from the
Institutes. I think it should stay within the Institutes, but
allocated dynamically over a period of time, and the
initiatives to which it is allocated should not be permanent
initiatives. They should be time limited. If you do that, I
think, obviously, you need to have a significant portion, 5
percent is, in my view, a good recommendation as a minimum.
Mr. Brown. As a minimum.
Mr. Zerhouni. For a common fund.
Mr. Brown. Yes.
Mr. Zerhouni. Now, there is a difference between----
Mr. Brown. You are saying a minimum----
Mr. Zerhouni. [continuing] a minimum----
Mr. Brown. [continuing] or the optimal number, 5 percent.
Mr. Zerhouni. I am reading you the----
Mr. Brown. What do you think?
Mr. Zerhouni. I think 5 percent should be a minimum.
Mr. Brown. Okay, a minimum. Okay. And you want to set it up
so that it is not an entitlement, so that it doesn't ultimately
lead to another Institute, in effect.
Mr. Zerhouni. That is right. I think the idea of creating
another structure that has funds, and allocates that to--over
an infinite period of time is not the concept. The concept here
is to create an organization that will identify what areas to
incubate better, what emerging areas need to be supported, what
emerging areas need to be funded. But it shouldn't be forever.
It should be time limited, and we can discuss how to do that,
technically, but I don't believe that those initiatives should
live there forever.
Mr. Brown. And what other kind of transfer authority that
the Director, that allows the Director to transfer funds from
one Institute or Center to another Institute or Center. My
understanding of current law is that you have the authority to
transfer 1 percent of any of the Institutes' or Centers' budget
in this way. In that 1 percent, that--my understanding, that is
what the appropriators have done, have allowed. I am not sure
that we have addressed that. Have you made use of that 1
percent transfer as Director?
Mr. Zerhouni. Okay, historically, if you look at the use of
the transfer authority, because it is an authority that comes
post facto, it is not planned ahead of time, and if you know
the reality of the budget process, you have to plan at least 2
years ahead of time. We are currently dealing with the 2007
budget, while the 12006 is not done. So what you really need,
transfer authority is only used in cases where your planning
missed something. Something happened where you need to quickly
react to a--something on the ground that is happening in real
time, so you transfer small amounts. So historically, the
transfer authority has never been used for a prospective,
strategic purpose. It is usually reactive and post facto. So
the transfer authority doesn't have to be a large authority.
The common fund concept, however, needs to be real and
significant.
Mr. Brown. Last question, real quick, Mr. Chairman. On the
transfer authority, not the common fund, but the transfer from
one Institute to the other. Is the--should the 1 percent number
be in the authorizing language? Should it be 2, should it be a
half? I understand that you haven't used it--you have used it
very infrequently, if at all. What should we do there? Give us
a specific number.
Mr. Zerhouni. There is no doubt in my mind that it should
be in the authorizing language, because not being in the
authorizing language makes it unsure.
Mr. Brown. What should be in the authorizing language, 1
percent, 2 percent, .5 percent, what?
Mr. Zerhouni. Again, I will have to think through what the
topics are, but 1 to 3 is usually what people recommend, the
AAMC says up to 3, the IOM says up to 3. One to me--it depends
on what else you have. If you have a common fund that is in
law, in authorization, where everybody knows that they have to
come to the table, and plan jointly, then the transfer
authority can be smaller. If you don't, then you have to rely
on the transfer authority, like we did for the Roadmap, for
example. The first year of the Roadmap, I used the transfer
authority.
Mr. Deal. Mr. Bilirakis.
Mr. Bilirakis. Thank you, Mr. Chairman. Doctor, you have
spoken, and I would say pretty fondly, of the committee draft.
Obviously, in your remarks, you didn't go into the dollars of
it. Mr. Brown did, and I would sort of like to maybe hitchhike
on his questioning.
In my opening statement, I was concerned that we not cause
any harm, basically, the old doctor's education adage, ``Do no
harm.'' In that connection, thinking in terms of multi-year
commitments in research portfolios, thinking in terms of longer
range planning, which is, I guess, basically the same thing.
Thinking in terms of--or politics. Politics sometimes in NIH
would be maybe even heavier than politics in Capitol Hill.
Ultimately, it is the real world is, I guess, is what I am
talking about, the ability to shift funds. Talk about that, in
general.
Do you feel that the areas that you have not mentioned,
such as the four specific authorizations or appropriations, the
competition which is envisioned there, the transfer authority,
the increased transfer authority that would be given to your
office. I think, even though the legislation is blank, it
leaves it open in terms of what that percentage would be. It
certainly envisions considerably higher than what your office
now holds.
So in terms, again, of the things that concern the--tell us
a little--take the rest of my time, and tell us a little about
that.
Mr. Zerhouni. I think it is a very good area to focus on.
From my standpoint, what is really important here is to
establish the proper checks and balances, just like our system
of government works on checks and balances. There is always the
possibility of misdirecting decisions at the executive level,
if you don't have the proper checks and balances. And I think
the same is true, that you could also have such an
entanglement, and such a limitation on what the executive can
do that you are not getting an efficient organization. So the
answer to that, I think, is what I believe in very strongly.
No. 1, complete preservation of the peer review process. No. 2,
relying on the input from the Institutes and Centers who are
closest to the action, understand the research, and have a
process that is formalized, where in fact, that consultation
occurs. And third, an outside oversight mechanism such as the
Advisory Council of the Director, which is, in law, the
mechanism by which all Institutes, really, are overseen, with
public members and scientific members.
I don't think it is as big a problem as I think some people
are afraid of, but I think it will depend on the details of how
you establish the proper checks and balances, so that there
isn't excessive authority being exercised on a discretionary
basis without reporting back to Congress, and to the
appropriate members.
Mr. Bilirakis. Well, but excessive authority, sir, and
checks and balances and whatnot, I mean, that is pretty darn
subjective. It is in the eyes of the beholder, I guess.
Mr. Zerhouni. Right.
Mr. Bilirakis. And so here, we put ourselves in the shoes
of these research facilities out there, and from the
standpoint, again, of the multiyear planning, and whatnot.
There still would be, in the hands of--basically, right now, of
course, they are in the hands of the Appropriations Committee's
up here.
Mr. Zerhouni. Right.
Mr. Bilirakis. They would be in the hands of the Director
to a very large degree.
Mr. Zerhouni. I think they would be balanced, because no
project that the Director can come up with will not--will be
accepted without peer review. So all of those will go through
that two level of peer review process. Second, if you predicate
the ability of having an allocation done for a particular
purpose, on the need for a consultation with the Institutes, so
that the scan that I am talking about is done, and remember
that we are only talking about trans-NIH areas of concerns,
where the palm has to be stronger than it is today. I think it
is doable. I don't think--it is an achievable goal. Complex
organizations do that all of the time. As long as you have a
proper oversight structure and the corporate board structures
to have enough input.
Mr. Bilirakis. You know, over the years, when I chaired the
subcommittee, I guess the most terrible times that I had was
when I had people coming in to me in wheelchairs or whatnot,
and they wanted increases in research funding for that
particular, specific disease, and having to tell them that we
have a policy here of not basically telling NIH how they should
spend that money. So I guess you are making this--if this were
to go forward, it probably makes it easier on us, in the sense
we would pass the buck on to, I guess, to you, if you--is that
correct?
Mr. Zerhouni. Well, I hope it is not the intent here,
because I would definitely see that as not a good evolution. I
think, in fact, the reason our American science is as good as
it is, and NIH science is as good as it is, is because of the
wisdom of Congress in avoiding specific earmarks independent of
the peer review process, independent of that check and balance
system that is really the envy of the world. So I would prefer
to preserve that, rather than have more coordination, to be
honest with you.
Mr. Bilirakis. Well, thank you, sir. Thank you, Mr.
Chairman.
Mr. Deal. Thank you. I know that you cannot see the timer.
The only thing you can see is probably when the red light goes
off at Dr. Zerhouni's table there. And we have a timer up here.
The Science Committee is just not as advanced as we are in our
committee, but if you would try to watch that timer there, so
we can get everybody with questions. Mr. Waxman.
Mr. Waxman. Thank you, Mr. Chairman, Dr. Zerhouni, I want
to ask you about advisory committees at NIH. The National
Research Council of the National Academy of Sciences recently
recommended that appointments be made on the basis of
scientific and technical knowledge and credentials, and
professional and personal integrity. Do you agree with that
statement?
Mr. Zerhouni. Yes.
Mr. Waxman. The National Research Council also stated that
it is inappropriate to ask potential candidates for advisory
committees about non-relevant information, such as voting
record, political party affiliation, or position on particular
policies. Do you agree with that view as well?
Mr. Zerhouni. Yes, I agree.
Mr. Waxman. In recent years, there have been serious
allegations made that advisory committee appointments were
dictated by politics, and not science. In one well publicized
case, an advisor to a panel on drug abuse was asked whether he
had voted for President Bush, and whether he supported abortion
rights. In another case involving the Fogarty Center on
International Health, numerous proposed experts were rejected
by the Department for apparently political reasons, and those
rejected included a Nobel Prize winner. Would you support clear
language adopting the National Research Council's standards as
guiding advisory committee appointments at NIH, and essentially
saying the NIH Director would make appointments without
political interference by the Department, these appointments
should be based on scientific merit, not political litmus
tests, and Congress should remove any temptation to meddle with
this process?
Mr. Zerhouni. Well, when I became Director I looked into
them. The NIDA case, for example, that was not a department
selection with NIH. You are talking about a Nobel Prize
Committee member. I understand that same person is now an
advisor to the Office of Science and Technology Policy. I have
heard a report from one member, who had been asked questions
like this. So----
Mr. Waxman. Whatever happened in the past--in the future,
do you think it would be a good idea to write that into the
language?
Mr. Zerhouni. Let me just say this, Congressman, that to my
knowledge, since I was aware of that one case, and I intervened
no one on any NIH council, peer review or advisory, is
unqualified to be on that council. So I want to make sure you
know, my commitment is to, in fact, achieve that. And during my
tenure, there has not been----
Mr. Waxman. Dr. Zerhouni, I am not really being critical of
you. I am just asking for questions on this legislation. Do you
think we ought to write that in?
Mr. Zerhouni. By and large I think NIH is--should be
apolitical. I think it is apolitical, I think disease knows no
politics. I think we should really advise and inform, and do
the research that serves the entire country, and do it in the
most objective way possible.
Mr. Waxman. You have been a strong advocate for NIH's
system of peer review of grants, and its independence from
political pressures. Do you believe the NIH Director should be
able to defund a grant that has passed peer review by an
Institute?
Mr. Zerhouni. I think there would have to be really, a
very, very scientifically justified reason to defund it. We do
have cases where there are issues of integrity of the science,
misconduct, where we have to defund. So the NIH Director needs
the authority to defund, but not on the basis of a political
decision.
Mr. Waxman. Well, the reason I ask is that the idea has
been floated to make the NIH Director responsible for
eliminating unnecessary, duplicative research, and for ensuring
balance in research. I understand the need to constantly----
Mr. Zerhouni. Well----
Mr. Waxman. [continuing] review NIH's research portfolio,
to make sure it is responding to the challenges facing the
American people, but I am concerned about giving any Director,
a political appointee, you know, broad authority to second
guess the scientific experts to rate the grants in their
fields. What should be the NIH Director's role in assessing the
portfolio----
Mr. Zerhouni. I think priorities, in my view, should be
allocated and priorities means resource allocation, at the end.
I think----
Mr. Waxman. But not micromanaging.
Mr. Zerhouni. Not micromanagement. You should really do it
on a prospective basis. For example, we allocated resources,
greater resources, to the obesity issue, that you know well,
prospectively. Once it goes to that level, I think the Director
should trust the peer review process, and not second guess a
two level process. The peer review process, two levels of
independent review is the cornerstone of NIH, and why it has
been successful. So prospectively, doing priority setting,
absolutely. Changing the relative weights, because science
changes, and public health priorities, absolutely.
Retrospectively, I don't think it is a good idea.
Mr. Waxman. Thank you. Thank you, Mr. Chairman.
Mr. Deal. Chairman Barton, do you have questions?
Chairman Barton. Mr. Chairman, I am going to defer at this
point in time, to kind of get a feel for the hearing, but--the
Energy Conference is in recess for 30 minutes, so before I go
back downstairs, I would like to be called on. But I want to
study up a little bit right now.
I am glad to know where all my energy conferees are,
though. They are all up here at the NIH hearing. But I am going
to defer at this point in time.
Mr. Deal. All right. Ms. Wilson.
Ms. Wilson. Thank you, Mr. Chairman, and thank you, Doctor,
for being here to testify.
I had a couple of questions. I had a particular interest in
this issue of managing research portfolios, which I think is
very different than a lot of the other things that we manage in
government. And I am interested not in what are the best
opportunities for research and science, but how do you
determine what are the best opportunities? What tools do you
have as a Director, or within and across your Institutes, for
determining what the best opportunities are?
Mr. Zerhouni. Of how it is done. So fundamentally, about
60, 65 percent of the budget is allocated to what we call
scientifically-initiated proposals, so it is investigator-
initiated proposals, a scientist out there has a great idea.
They submit the idea to the peer review process, which is the
first step at the top, is the NIH grant proposal. It then goes
to a scientific review panel. And only 25 percent of these get
ranked to be funded, and it goes through the program officer.
Now, the program officer in each Institute follows a particular
strategic plan, that has been usually developed over a period
of years by the Institute, to look at program importance and
program relevance. And that officer will determine whether or
not the grant fits with the program relevance of that
Institute. And then, it goes to the second level of review,
which is the Institute National Advisory Council, and that
Institute has, in law, in statute, the authority to fund this
research or not fund it, and sometimes, they will change the
priorities at that level. And this goes to the Institute
Director, reported back to Congress, obviously. This is the
issue of reporting that we cover.
So this is done at the level of the Institutes, and the
ability of the NIH in total to combine all these portfolios is
limited. This is why, I think, this reauthorization strategy
will provide the ability to look across Institutes and across
portfolios. And Institutes have done that on their own, and
many Institutes have come together to look at areas that are
common. Usually, with a lead Institute serving as the disease-
specific need. So the process seems complex, but there is no
doubt that within each Institute, planning is done, has always
been done, in a very effective way, and the Program Directors,
in conjunction with the Advisory Councils, will then determine
what the portfolio will be for that Institute.
What you don't have, as effectively as we--what I believe
we should have, is a look across all portfolios, with
analytical tools that tell you how much are you spending in
this area of research versus that one. And duplication is not
necessarily bad in research. You need to confirm findings. You
want to have that. But it is the balance, is the issue of what
is the right balance.
[GRAPHIC] [TIFF OMITTED] 22987.001
Ms. Wilson. I find that interesting, that it seems to be driven
from the bottom up, from the researchers. There may be some value to
that. At the same time, you as a Director need to be----
Mr. Zerhouni. Right.
Ms. Wilson. [continuing] looking at what are the biggest problems.
Mr. Zerhouni. Right.
Ms. Wilson. [continuing] that we need to identify research
roadmaps, and gaps in research in order to fill. And that is--is there
anything that you currently have that does that kind of an assessment
of here are the biggest health problems, whether it is the cure for
diabetes, which is driving health costs, or aging problems? Do you have
any mechanisms to do that?
Mr. Zerhouni. Actually, my answer was incomplete. Sixty-five
percent of the budget is allocated to investigator initiated proposals,
and about 30 percent is allocated to what we call requests for
applications, or requests for proposals, or contracts, where we
identify, ourselves, an area where further investments are needed, or
an action is needed, or new Centers are created. We put those
announcements for competition to the field, and that is how we balance
the portfolio between what comes from the bottom up, and what we want
to get accomplished. I am sorry, I missed that.
Ms. Wilson. I will be interested in pursuing that, as we move along
here on reauthorization. And finally, I just ask for your thoughts on
how to structure a system to give access to research, and whether you
think it should be public, or only to medical practitioners. Should it
include the successes as well as the failures? What are your thoughts
on how you would pursue this?
Mr. Zerhouni. This is a topic that we discussed entirely with NIH
Directors as well as scientists, and it is a very major component of
the Roadmap for Medical Research, where in fact, we think that we
should make investments in information technology that would be
accessible at the community level. We think that we need to train
community practitioners in research methods, and have a core of 50,000
community practitioners that would have access to our data base, called
clinicaltrials.gov, where we are listing about 14,000 clinical trials.
I think we need to enhance the ability for us to link those trials to
the results of those trials.
So my view is more openness, more transparency, more access, to
community physicians in particular, because chronic diseases are seen
in the community much more so than they are in academic health centers.
And we have an initiative, which will start this year, called Clinical
and Translational Science Awards, which we are going to announce at the
end of August, September.
Mr. Deal. Ms. Eshoo, you are recognized for questions.
Ms. Eshoo. Thank you, Mr. Chairman, for holding this very important
hearing, and welcome, Dr. Zerhouni.
This is a very large undertaking. I have been in the Congress, this
is my thirteenth year, and I am always thrilled when we get to
reauthorize NIH, which I always like to refer to as the National
Institutes of Hope, and I think that is the way the American people
view the NIH, and it is in that spirit that I ask the following
questions.
First, on transfer authority. This transfer authority is thought to
allow you, the Director, and succeeding Directors, more flexibility to
run projects and to streamline the budget decisions, but of course, we
don't want flexibility to undermine any accountability. And I raise
this because last year, broad transfer authority was given to the NASA
Administrator, and I think with devastating consequences. I have a
major NASA Ames, maybe it is good that we are the science hearing
room--someone may come off the walls on this. I have a NASA facility in
my district, NASA Ames, right in the heart of Silicon Valley, and we
saw that budgets were being realigned not to spur progress and
development, but to cover funding shortfalls in other areas.
So it was--that transfer authority was being completely, I think,
misused, and I know that there isn't anyone here that wants to see
transfer authority misused. What would you suggest that could be built
into the reauthorization, with these proposed changes, that would not
allow the NASA, you know, the--what I just described happening at NASA,
to happen within the NIH?
I want to ask my questions, then you can answer. I mean, I agree
that NIH scientists are, by and large, more equipped than Congress on
where--maybe so, you know, as a partner, on how best to spend the
money, where it should be directed. But I am concerned that scientists
would not have any kind of role in the transfer authority. I think when
the--let me just summarize it by making this observation. I think NIH
works best when it is collaborative. I don't think it was ever meant to
be an institution that has such a powerful Director that there is only
one conductor of the orchestra. You have to have someone that leads,
but I do think that the collaboration needs to be built, and so that it
is enjoyed across the board. As you explained, I mean, we have entered
a new era. So this transfer authority business is a bit troubling to
me, if it is not handled right.
And I have concerns that dividing the NIH Institutes and the
Centers into two categories will not necessarily make NIH function more
effectively, or improve Congressional oversight of appropriations. And
on that key word of, in terms of appropriations, I know it is a tough
call for you to make, but you know what the needs of the agency are. I
am highly skeptical of doing reforms anywhere, when they are meant,
they are really--it is really dressing the issue up to cut or to not
fund properly. And you know, one doesn't take the place of the other.
In fact, reforms, many reforms can't be carried out unless you have the
necessary resources. I see where the FDA is having a very tough time.
FDA has not been funded properly by the Congress, and yet, we have so
much that we expect from the agency. So if we are going to live up to
National Institutes of Hope, and the changes that are afoot, what would
you instruct us about transfer authority, so that it is what it should
be, and not what I described happening in another agency.
And also, on the organization of Institutes, you know, there was
one that I helped to found. I don't know if it is--with this plan, it
is going to be wiped. I mean, I have had people come to me and say it
is working very, very well, the Biomedical Imaging and Bioengineering
Institute. So if you would comment on my observations also my
questions, I would like to see a good, healthy appropriation for NIH.
It is only to help to make the changes, but we have to--this century is
going to be the--is going to be known, I believe, as the century of the
biomedical changes. And if NIH is not embraced by the Congress, in
terms of an appropriate appropriation, then it is going to be--we are
going to be talking about out of both corners of our mouth.
So take it away.
Mr. Zerhouni. Well, very important points. I think the----
Mr. Deal. You have 30 seconds to respond.
Mr. Zerhouni. Okay. That is----
Ms. Wilson. He can respond--for the committee as well.
Mr. Zerhouni. Yes, I can certainly respond, but I don't think----
Ms. Wilson. They are serious questions.
Mr. Deal. Just looking for the question mark.
Mr. Zerhouni. As a Director I think it is important to remember
what I said before, and that is, it is the balance that is key. A
dictatorial counselor authority wouldn't work, and I would like to just
read, I think, one of the recommendations of the IOM report, which
captures what I think is trying to be accomplished here.
``The Director of NIH should be formally charged by Congress to
lead a trans-NIH planning process''--everybody is at the table--``to
identify major cross cutting issues in their associated research.''
That is collaboration, because think, not having any such authority
removes the accountability of the Director to be able to direct the
agency to what it needs to do. So there is a balance between the two.
The question is where you find that balance. And it does instruct the
Director to present the scientific rationale for trans-NIH budgeting to
the relevant committees of Congress, including a proposed target for
investments in trans-NIH initiatives. So it is not a transfer. It is a
common fund for common good, for common needs. That is the concept. And
I don't think it should be deviated from that, provided we put the
right checks and balances and transparency in it. That, I believe, is
needed by the NIH.
Mr. Deal. Dr. Burgess.
Mr. Burgess. Thanks, Mr. Chairman. I will be glad to yield to the
full committee chairman, if he----
Chairman Barton. If the gentleman doesn't mind, I appreciate that.
First, Dr. Zerhouni, thank you for testifying today, and thank you
for you and your staff's efforts working with us the last year, as we
have worked with the stakeholders to come up with the legislation, the
draft legislation, that we are looking at today. I want to let the
committee know that this is a very high priority for me as chairman. If
we wish to reestablish the authorizing committees in a meaningful way,
when overseeing the agencies that we theoretically have jurisdiction.
Under the current environment, we haven't reauthorized NIH in 12 years,
and in all--to be totally true about it, most of the oversight that is
being done is being done by the appropriators. So this effort, while
you can argue with the specifics of the draft, is an attempt to
reassert the jurisdiction of the authorizing committees in general, and
the Energy and Commerce Committee specifically over one of the more, if
not the most, one of the more important agencies in the Federal
Government.
We have--as well as we all know, we have doubled the budget of NIH,
but we have not done anything to try to help their management
structure, or help them come up with a mechanism for allocating all
these new grants and funds that we have provided them. Nothing in the
current draft legislation in any way denigrates the peer review
process, the two step solicitation, the grant process at NIH. Nothing.
We keep our hands off of that. We are not trying to micromanage. What
the draft does do is collapse the 26 line items to four, No. 1, give
the Director, in this case, Dr. Zerhouni, more direct authority, by
empowering him, and enlarging the--his direct discretion, and then two,
creating this trans-NIH fund, that is multi-agency with NIH, and give
it real budgetary authority, and real dollars, so that as we have these
cutting edge ideas come forward, they are looked at across the NIH,
concurrently, as opposed to individually within each of the 27
Institutes.
I think that is a very good idea. So my first question to you, Dr.
Zerhouni, the general concept of going from multiple line items, in
this case 26, down to a more, a smaller number, in this case, four, at
least in approach, do you support that? If you don't maybe support the
exact numbers, do you support the principle?
Mr. Zerhouni. Again, I think, as I testified while you were busy
with the other committee, Mr. Chairman, I believe that the approach,
the conceptual approach you have taken in bringing functional
integration, through the mechanism of identifying what is the function,
relative to the structure is, in my view a good approach. The details,
obviously, of how you implement that on the ground, and how do you play
that, it is obviously something we need to work on. But I think the
fundamental concept, that the agencies become more complex and larger,
and needs to be more efficiently managed through a transparent process
that makes people have a common good, a common fund for a common good,
overall, this is, in my view, a good contribution to the agency.
Chairman Barton. What about the line item that we would create,
that is trans-agency, that we give direct authority, with a discrete
amount of money, that it would allocate funds across the different
Institutes.
Mr. Zerhouni. My comments to that are, Mr. Chairman. I think you
need what I call an opportunity fund. When something comes up that is
actually critical, you need the ability to house it somewhere, so that
you can implement it quickly at the time of the budget request, and
that it be authorized. So that is what I call the opportunity fund.
Then, I would say that it is important to have a trans-NIH fund of
some sort, called, what I call the common fund, where everybody is
incentivized to come around the table and discuss, without being afraid
of, essentially removing from their own specific mission resources,
because they are mandated by the authorization language to say you
need--you shall come together, and you shall identify what is cross
cutting, and what needs to happen. So the authority for having an
opportunity fund is important, because you never know what comes up.
For example, biodefense came up, and we need to react to that.
A trans-NIH fund is certainly a necessity, and some transfer
authority. It doesn't--if you have those two, you don't need large
transfer authorities, because they are different in nature. Transfer
authority is post facto. A trans-NIH fund is prospective. So I think
the combination of these three is really what would make the agency
work well.
Chairman Barton. My--I see my clock has expired. I want to ask one
more question. As we put the draft out for review, there appears to be
a lot of concern about where we would set the baseline, the first--if
we--if this bill were to become law, where we would set the baseline.
Now, my preference would be that the first year, if this bill were to
become law as-is, the baseline for each Institute would be whatever the
funds that it received in the prior year. So we would guarantee every
Institute, you know, that--100 percent as the baseline, and then, we
would start from there, and you could go up, and--or they could go
down, but the very first year, every Institute would be held whole, and
then we would begin this internal review and internal competition, and
with your discretionary fund, and the trans-NIH fund, in terms of the
first year's baseline, is that your view, too, that each Institute
would start at 100 percent of last year's funding?
Mr. Zerhouni. Well, clearly, as you know, the process of science is
not something you can do over 3 months, stop, and start again. So it
would be very important to make sure that you don't disequilibrate the
system, I mean, the agency does work relatively well. To the extent
that you--and I would certainly echo what you just said. I mean, it
would be very important to preserve the, you know, the momentum that
many of these Institutes and Centers have undertaken. What I think is
important, also, is to realize that the--depending on how we--you
technically settle on what is common fund, what is opportunity fund,
what is--then, the answer will affect, obviously, what you wish to
accomplish through that mechanism of putting, I think, a floor.
I think it depends on that planning process.
Chairman Barton. Okay. And I want to thank you, Dr. Zerhouni. I
also want to thank the chairman of the Science Committee, Mr. Boehlert,
for allowing us to use his hearing room, the Science Committee hearing
room, so that we could continue our markup at the Energy Conference
downstairs. And if we have energy conferees here, not to name names,
but Mr. Stupak and Mr. Bilirakis, to name a few, we are--and Mr. Wynn,
we are reconvening in 10 minutes downstairs.
Thank you, Mr. Chairman.
Mr. Deal. Mr. Wynn came in late. We are still confused as to why he
is sitting over here, Mr. Chairman.
Ms. DeGette, I believe you are next.
Ms. DeGette. Thank you very much, Mr. Chairman.
Dr. Zerhouni, we have been told by the leadership of this committee
that what they are really trying to do with this NIH reauthorization
bill is to look at the organizational structure, and see if there are
ways--in a bipartisan manner, that we can reauthorize the bill by
looking at the structure, and looking at some of what I think are your
very wise suggestions. I agree with that approach for the most part. I
think--I mean, I have many fabulous pieces of legislation which are
bipartisan, that I would like to see included in this bill, but I am
going to try to work with the leadership. But there are some questions
I have been sitting here mulling over, listening to the testimony, and
listening to the questions of my colleagues on the panel, and I am
wondering if you can comment a couple of these. It is not about do we
need more research for this or that, or--tempting as--though it may be,
stem cell research.
Instead, I was thinking about when you talked early in your
testimony, and it is this slide here, which your staff kindly provided
me with, the key authorities that the NIH has, prioritizing research,
mandating biomedical research, providing grant-making authority,
mandating peer review, mandating training, mandating dissemination of
information, mandating human subject protections, and mandating the
solicitation of public advice. Do you think all of those areas should
be included in a reauthorization of the NIH?
Mr. Zerhouni. Yes. I think those are the basic authorities, and
they have served NIH very well.
Ms. DeGette. And I would agree with that. But really, in your view,
when we do this reauthorization in the committee, we should try to work
in a bipartisan way to look and see if the NIH current mandate is
adequate in all of these areas, and whether it can be beefed up or
expanded or improved, correct?
Mr. Zerhouni. The privilege of the committee, absolutely.
Ms. DeGette. Okay. The reason I ask that is, I have a particular
interest, which you know. In this list of items, in the human subject
protections, and as you know, Dr. Zerhouni, I have been working
previously for many years with Jim Greenwood, who was the previous
chairman of the Health Subcommittee, and also, I have talked with Mr.
Barton and other members about human subject protections. I am
wondering if, in the draft legislation, you or your staff expanded the
human subject protection authority that the NIH currently have, as--or
have you addressed this at all in the draft? I haven't had time to
really delve into it.
Mr. Zerhouni. Not to my knowledge, but I certainly will check. I
have not personally focused on that issue, but certainly, we would be
more than happy to share with the committee staff what the status of
human subject protection is, and--in the context of what I know you are
interested in.
[The following was received for the record:]
The NIH has a long-standing commitment to the protection of human
subjects of research that dates to the first formal policies it
developed for its intramural program when the Clinical Center opened in
1953. Since then, through Congressional directive and Executive
initiative, the agency has developed a comprehensive network of
standards and requirements so that NIH-sponsored research, both
intramural and extramural, meets the highest levels of human subjects
protections.
The legal authority for NIH oversight of human subjects protections
in research supported or conducted by the NIH derives from the Public
Health Service Act, which at 42 USC 289 directs the Secretary of Health
and Human Services to establish oversight of research conducted or
supported by HHS and its agencies. In accordance with this legal
authority, research supported or conducted by NIH is subject to federal
human subject protection regulations, known as the Common Rule, found
at 45 CFR part 46, subpart A. These regulations require informed
consent and IRB review. HHS regulations that specifically concern
protections and considerations for pregnant women, fetuses and in vitro
fertilization, as well as prisoners and children can be found at 45 CFR
part 46, subparts B, C, and D. These regulations are referred to as the
``Common Rule'' because the federal government, in June 1991, published
them as a common policy for federal agencies conducting or supporting
research with human subjects. Today, it governs seventeen agencies and
most federally-supported research. Additionally, when NIH-funded
research is regulated by the Food and Drug Administration (FDA), it is
subject to FDA's human subjects regulations incorporated at 21 CFR
parts 50 and 56.
NIH has measures in place to help ensure that NIH-funded clinical
research complies with the ethical guidelines and regulatory
requirements for research involving human subjects and that the rights
and welfare of human subjects participating in NIH funded studies are
protected.
For the NIH intramural program, a distinct office is charged with
helping intramural investigators understand and comply with ethical and
regulatory requirements for research involving human subjects. In the
extramural program, NIH has regulations and policies in place to help
NIH-funded clinical research comply with the ethical guidelines and
regulatory requirements, including 45 CFR part 46, for research
involving human subjects.
Pursuant to its authority to set the terms and conditions for
research that it funds, and consistent with the requirements of 45 CFR
part 46, the NIH has implemented specific requirements for the
protection of human subjects in research that it funds or conducts (see
generally 42 CFR part 52). These include:
A requirement that applicants or offerors describe and justify the
risks to the subjects, the adequacy of protection against these
risks, the potential benefits of the research to the subjects
and others, and the importance of the knowledge gained or to be
gained;
The evaluation of proposed human subjects protections by peer
reviewers and NIH staff, and appropriate resolution of human
subjects issues before the study can be initiated;
Confirmation that the institution has a current Office for Human
Research Protections (OHRP) ``Assurance'' on file attesting to
its compliance with 45 CFR part 46;
Certification of review and approval of the research by an
Institutional Review Board (IRB) registered with OHRP under the
institution's Assurance.
Education in the protections of human subjects for research study
personnel designated as ``Key'' to human subjects research so
that they understand the underlying philosophy and specific
requirements of human subjects protections when engaged in
clinical research; and
A plan for data and safety monitoring for all NIH-funded clinical
trials; the NIH policies specify that the level of monitoring
should be commensurate with the risks and the size and
complexity of the clinical trial. For certain types of studies
(phase III and many multi-center trials), the monitoring must
involve a group of independent experts called a data and safety
monitoring board (DSMB). The role of the DSMB is to review
accumulating safety and outcome data in order to help ensure
the continuing safety of current trial participants and those
yet to be recruited.
These requirements are included in the NIH Grants Policy Statement,
which is a standard term of award for grants and cooperative
agreements. These requirements are also incorporated into research
contracts. An NIH Institute or Center also has the authority to include
additional conditions on the award for specific studies (see 45 CFR
part 52.9). Also, because of special risks and societal concerns,
trials involving human gene transfer that are conducted at or sponsored
by institutions receiving NIH funding for recombinant DNA research must
be registered with the NIH. Investigators responsible for those trials
must report adverse events and other pertinent information to the NIH,
as outlined in Appendix M of the NIH Guidelines for Research Involving
Recombinant DNA Molecules.
Ms. DeGette. Yes, because a couple of things I am
interested in with the legislation, I am interested in, for
example, the common rule, which now applies in all research
that is funded by the NIH, but does not necessarily apply in
other types of research. Am I correct?
Mr. Zerhouni. I am not totally briefed on this, and----
Ms. DeGette. Okay.
Mr. Zerhouni. [continuing] current, but I think you are
right.
Ms. DeGette. And I am wondering if this might be an area
that we could explore in a bipartisan way, beefing up the
application of the common rule more broadly, into research that
is either directly or indirectly affected by the NIH
activities.
Mr. Zerhouni. Be happy to, you know, to work with the
committee----
Ms. DeGette. Okay.
Mr. Zerhouni. [continuing] and the staff, your staff, to
look at that. Obviously, the Office of Human Research
Protection at the Department also has jurisdiction over that.
Ms. DeGette. Exactly. Right.
Mr. Zerhouni. So you have to look at that issue.
Ms. DeGette. Okay. But that is certainly a topic that you
think would be appropriate in the NIH reauthorization bill.
Thanks, Doctor, and I yield back.
Mr. Deal. Thank the gentlelady. Dr. Burgess.
Mr. Burgess. Thank you, Mr. Chairman.
Dr. Zerhouni, when you were here earlier this year, I think
one of the things that came up was the--when we restructured
the intelligence agencies last year, one of the big discussions
around town was if you don't have the budgetary authority, then
you don't have the authority.
Do you feel that this reauthorization that we are doing
currently, does it provide you with the budgetary authority
that you need in order to exercise the appropriate authority
over the NIH?
Mr. Zerhouni. I think the important component of the
reauthorization is this ability for the Director to have an
instrument by which all of NIH comes together, for at least a
small portion of the total budget, and looks at what I call the
glue areas, the synergy areas. That is an important
institutionalized process that needs to happen for any complex
agency. That would provide that.
In terms of budget area, currently, obviously, the Director
can always make an administration budget, and through
interaction with the department and OMB, present a budget to
Congress. That authority is there. But typically, what happens
is everything goes in lockstep, and the reason it goes in
lockstep is because of all of the stakeholders and different
pressures and programs that you have, unless there is an
emergency, or something that changes the equilibrium. What I am
talking about is instead of having this, is to look at a small
layer of the budget, and plan it together, not dictate or
direct it. I don't think the NIH is an agency--it is a
knowledge organization. You really need to manage it according
to that.
So I think the reauthorization will provide marginal budget
authority for a very specific purpose, but overall, the budget
authority in the current authorization does allow you to make
some marginal changes, but not a lot.
Mr. Burgess. I must admit, when I first looked at that
organizational chart that you showed us early in the year, and
knew that we were coming to this reauthorization, my feeling
was that there would be significant consolidation between the
various departments, and I guess I won't say that I am
disappointed that there is not some consolidation, because
after having been onsite, and watched some of the great work
that you do, I realize how little Congress should, in fact,
meddle in the system that you have. But do you feel that there
is enough along the lines of consolidation in the
organizational chart that you maintain with this
reauthorization?
Mr. Zerhouni. I think this allows for a greater degree of
functional consolidation that is not there today. I don't think
it allows for structural consolidation. I think structural
consolidation does happen over time, as science will--changes.
I think a reauthorization, in my view, should be done
regularly. It shouldn't be a one time event every 12 to 15
years. So I think we should really look at this, and see how it
works, and adjust in 3 years time. I don't think this is an
impractical proposal, but I do believe you need to show that
you have the mechanisms of functional integration, before you
can go ahead and destroy structure, and combine structures in a
way that may not be productive.
Mr. Burgess. The--Ms. Wilson, who was here a minute ago,
talked about the ability to get information to the public, and
I must admit, after 20 odd years in clinical practice, I did
not know about clinicaltrials.gov. Maybe there is an
opportunity there to do some public service announcements to
medical societies across the country. I thought I saw the AMA
here earlier today. That would be, I think, a good thing,
because I can remember times, being in the treatment room and
being absolutely baffled about what do I do next. It would have
been great to know that I could have gone online and gone to
clinicaltrials.gov, and gotten that rare cucumber virus tended
to.
And then, finally, I just can't help myself. What do you
see on the horizon, looking over the horizon, as some of the
new scientific areas of study that your organization may be
working on in the near future?
Mr. Zerhouni. Dr. Burgess, you should see the progress we
are making. Every month, there is a new discovery, a new
breakthrough. Recently the National Cancer Institute reported
on a research study that showed that by looking at 16 cancer-
related genes, in women who have breast cancer sensitive to
estrogen hormones--you know, in the past, we had about 100,000
women with that, and all of them underwent surgery and
chemotherapy. By looking at that--those 16 cancer-related
genes, you can see that 70,000 of these women will not benefit
from chemotherapy, whereas the other 30,000 do. So that
research is going to completely transform the way we practice
medicine in the next year or 2, and we will save about $8,000
per year of treatment, because we will avoid chemo, unnecessary
chemotherapy. And I think that is the trend. We--a month before
that, we reported in Science and PNAS, three of our grantees
discovered a gene for age related macular degeneration, which
will affect 7 to 10 million Americans over time, that will lose
vision because of this. We never knew what the cause was until
this research, but it has to do with a blood protein called
Factor H, and no one had any clue that this could have come
from not your eye but your blood. So this is a breakthrough
that is going to make it possible for us to prevent blindness
in the aged population. The acceleration and the momentum that
I think we have been able to demonstrate with the funding that
you have provided us is, in my career, remarkable, my own
personal experience. I have never seen such a rapid fire of
discoveries that can really change the way we practice
medicine.
Mr. Burgess. I appreciate that. Could you give the
committee just a little flavor of what is the magnitude of
scientific throughput that is required to come up with one of
these genetic determinations?
Mr. Zerhouni. I see--I can see you really enjoyed the
briefing, sir. Basically, that is the key. The key, for
example, the cancer research, they looked at 250 genes in
thousands of patients, put that into a large data base,
analyzed the data base through a high throughput system, come
down on to 16, then did trials on thousands of women. So it
really is a scale and complexity that required more than the
NCI itself could do, but multiple collaboration. So that is the
trend, interdisciplinary, collaborative, large scale, but yet,
still, coming from the scientists, and bottom up, rather than
control and--command and control.
Mr. Deal. Ms. Baldwin, would you defer to Mr. Stupak. He is
just dying to get back to the conference committee, I can tell.
I will come back to you, if you will do so. Mr. Stupak.
Mr. Stupak. Thank you, and thank you, Ms. Baldwin, for
yielding.
Dr. Zerhouni, you mentioned that the need to ensure
clinicaltrials.gov is accessible as possible, and that results
of trials are also accessible as possible. Do you support the
making the results mandatory, having them published?
Mr. Zerhouni. Basically, we do believe that it is important
to connect clinicaltrials.gov to what we have been trying to do
through public access publishing, so that any report that comes
out in the public domain be linked, so that when someone looks
at clinicaltrials.gov, they know what that trial, what the
results of that trial eventually were. So I think we are in
favor of more transparency and more reporting, and more
registration of all trials. The issue of whether or not you can
do reporting on the fly about adverse events or other things,
that needs to be looked into, because it goes beyond our
jurisdiction. That is an FDA issue, but yes, we are in favor of
trials being connected to their results in some fashion, and
accessible to the public.
Mr. Stupak. Do you have subpoena power to information that
you might find interesting in these trials?
Mr. Zerhouni. No, I do not.
Mr. Stupak. You talked a lot about the fingers and the palm
of a hand, and how do you get the information you need from
these trials that raise a flag with you, if you don't have
any----
Mr. Zerhouni. If it is a trial that is----
Mr. Stupak. Yes, I am sorry. Enforcement power.
Mr. Zerhouni. If it is a trial that is funded by NIH, we
have, obviously, the mechanisms to look to what we call a data
monitoring and safety board, which is an independent board that
looks at what the investigators and what we are funding. That
is how, for example, we reported on the issue of Celebrex in a
trial of the National Cancer Institute, and other trials that
we were looking at. So for NIH funded trials, we have
authority----
Mr. Stupak. Well, how about non-NIH funded?
Mr. Zerhouni. With non-NIH funded trials, we have no
authority. We are not a regulatory agency. The FDA does.
Mr. Stupak. So you may be aware of clinical trials that may
be detrimental to human health, but if they are not published,
you really can't have access to them, to check the credibility,
or their--any evidence.
Mr. Zerhouni. We have access to our own, and when--and as I
said publicly, our threshold for stopping a trial is,
obviously, greater than--I mean more sensitive than others,
because we are doing research, so we never know that there is a
defined benefit. The FDA is the agency charged for regulatory
oversight of other trials.
Mr. Stupak. Right. Well, as I said in my opening, both you
and the FDA have this responsibility to make sure we have sound
clinical trials to protect the health and safety of the
American people, but neither one of you have any kind of
subpoena power, so how do you enforce it? What----
Mr. Zerhouni. NIH----
Mr. Stupak. Well, take Celebrex. You mentioned it yourself.
There were other trials out there you knew of, but you didn't
have access to them, because they weren't your own. So how do
you obtain that information?
Mr. Zerhouni. NIH does not have subpoena power, but I am
not an expert on the regulatory----
Mr. Stupak. FDA doesn't either--that is fine.
Mr. Zerhouni. I think that is--I haven't thought about that
question, of how you connect the enforcement powers with the
oversight powers. I would be happy to come back on record for
you.
[The following was received for the record:]
NIH has access to safety information for the clinical
trials we fund. In addition, NIH policy requires data
monitoring in all clinical trials and, for certain types of
studies, depending on stage, level of risk, design, and
organization, the monitoring must involve a group of
independent experts, called a data and safety monitoring board
(DSMB, see NIH Guide for Grants and Contracts, June 10, 1998
and June 5, 2000). The DSMB's role is to review accumulating
safety and outcome data in order to help ensure the continuing
safety of current trial participants and those yet to be
recruited as well as the continuing validity of the trial.
Safety information on clinical trials funded by the private
sector must be reported to the FDA when those trials are
conducted as part of the development of drugs, devices, or
biologics and data is intended to be submitted to FDA for
regulatory approval purposes (see 21 CFR parts 312 and 812).
NIH does not have direct access to adverse event information
about such private sector trials. However, we work closely with
FDA and are able to factor information FDA makes publicly
available into our own decision-making about the continuing
safety of clinical trials we support and conduct. In this
regard, our work will be aided by FDA's efforts to ensure that
established and emerging drug safety data are quickly available
in an easily accessible form. In addition, we have established
a working group to help consider and, if necessary, make
improvements in our assessment and response to emerging safety
information from clinical trials or in post-marketing product
surveillance that has implications for NIH clinical studies and
study participants. The goal of the effort is to ensure that
NIH's response to such events is timely, coordinated and well
considered.
We are also working on longer term efforts to promote
greater transparency and awareness through enhanced clinical
trial registration and access to published articles and results
summaries in ClinicalTrials.gov, NIH's database of clinical
trials. In establishing ClinicalTrials.gov, Congress mandated
the registration of all treatment trials subject to FDA
regulation, regardless of funding, that address life-
threatening and serious diseases and conditions (see 42 USC
282(j)).
Mr. Stupak. Sure. It has always amazed me that the--some of
the regulatory agents, like FDA and--not that you are
necessarily a regulatory agency, but when you are responsible
for basic health needs, you have no power to get the
information you need to help make the decisions.
Mr. Zerhouni. Except for what we fund.
Mr. Stupak. Except for what we--you fund, right. And while
we wish you had more money, it is not all the money that is
going into research. There is a lot of research out there.
I mentioned in my opening the importance of one program,
pediatric research, and the consequences of striking its
authorization. Is there anything else in the committee draft
that may have been stricken that you would like to see? What is
missing in this committee draft that you would like to see,
besides subpoena power?
Mr. Zerhouni. Any special authorities that were removed,
you mean?
Mr. Stupak. Yes.
Mr. Zerhouni. Well, that is--I haven't really thought about
what was removed that would be of critical importance. I
think--I am not sure what it is that I would--I am just
thinking through as--think, but----
Mr. Stupak. Sure. Sure.
Mr. Zerhouni. Can I get back to you, and look at that,
specifically?
Mr. Stupak. One more, since my time is just about up. How
are we doing on the flu vaccine for next year?
Mr. Zerhouni. We, just last week, had the results of the
first phase of our clinical trials. As you know, NIH has gone
forward in developing a vaccine on H5N1, which is the variant
of the virus that we suspect will be the--if it mutates to the
point of becoming transmissible. We have good results. There is
a dose response we know we have a vaccine. Now, we need to go
to the other phase, but we are very, very pleased with the
Phase I results.
Mr. Stupak. Thank you, and thank you, Mr. Chairman, for
your courtesy.
Mr. Deal. Thank you. Mr. Ferguson.
Mr. Ferguson. Thank you, Mr. Chairman. Dr. Zerhouni, I
apologize. I have been out, as I know a number of other members
have been. So I may have missed if you have addressed some of
these questions.
Mr. Deal. Well, we have all been here. We have all been
here.
Mr. Ferguson. Yes. You, Mr. Chairman, I know, have been
here. We talked--I talked a little bit about, and you have
referred to the 27 fingers--you need the palm. In your review
of the draft, do you feel like we have--the draft adequately
addresses your need, as the Director, or the need of any
Director to properly coordinate what is going on, to provide
the adequate palm, if you will, for management purposes?
Mr. Zerhouni. I think it is a good draft, and I think we
need to clarify some details. As I said, I don't know if you
were here, I said 27 fingers without a palm is not a good hand,
but a strong palm with no fingers is not a good hand, either.
Mr. Ferguson. Right. Right.
Mr. Zerhouni. So we need to find the balance between the
two, but I think we are getting there, and I think the
committee staff and the committee draft are going in the right
direction.
Mr. Ferguson. And if you have, obviously, as you are
talking about, some of this, specifics or the details, I am
certain that we will be talking with you further as you have
advice or thoughts, input for us as we continue to go through
the process. I hope you will.
Mr. Zerhouni. I will certainly do that.
Mr. Ferguson. Wouldn't you share that with us? Like Mr.
Stupak, I am particularly interested in childhood diseases, as
well, and I think it is--I feel strongly that we need to make
sure that our agencies are really working together properly,
and working toward research on diseases for, frankly, one of
our, probably our quietest constituency is our kids. How do you
feel like this draft, and as we are--the direction that NIH may
be heading, and how will that improve your ability, with regard
to the cutting edge research, and translating that research
into actual cures, for some of the childhood diseases that we
have talked about?
Mr. Zerhouni. As you know, the fundamental authority of NIH
allows NIH to do research in every field, including pediatric
research. I believe that having an instrument like this
division of program coordination is going to allow all of us to
prospectively, rather than retrospectively or after a lot of
lobbying, to understand what disease process is doing what, to
truly prospectively look at the evolution of childhood diseases
of particular concern. I think that, to me, will be the result
of a modern reauthorization bill that would institutionalize
not only the mechanism but the obligation to look at the
landscape of public health for children, or for any other
population.
Mr. Ferguson. And will further enable the agencies to, and
the Institutes to kind of get out of their silo, to get out of
their, perhaps, more narrow, necessarily narrow view?
Mr. Zerhouni. Well, I think the Institutes have done a good
job when it came from their specific mission needs. I think we
should really not think that the Institutes have not
collaborated. The Roadmap is a collaboration. What I think I am
talking about is when there is an area of science or public
health where no Institute has either the resources or the
expertise, or the ability, if you will, to look across, and
this is where, I think, that would be very helpful.
Mr. Ferguson. Well, I--these are just a couple of the
points that have been kicking around in my head.
Mr. Zerhouni. Right.
Mr. Ferguson. And I think a number of the points that some
of the others on the committee have raised today are equally
important. So I appreciate very much your insights and your
advice, and not only your work at NIH, but as we go through
this process, looking to the future, your continued input is
going to be very important for us, so we appreciate very much
your time today, and----
Mr. Zerhouni. Thank you.
Mr. Ferguson. Chairman, I yield back.
Mr. Deal. Thank the gentleman. Ms. Baldwin.
Ms. Baldwin. Thank you, Mr. Chairman.
I have, first, a narrow question, and then some broader
questions on reauthorization. In your testimony, you talked
about the mission specific division relating to research around
disease or organs or life stages, versus what has been called
the science enabling division, having more cross cutting
issues. And I just looked at the list of Institutes that would
be congregated, as proposed in the draft, I noticed that the
National Institute of Environmental Health Sciences, is under
the disease, organ, and life stage specific grouping. I wonder
if you could tell me a little bit more about what is happening
in that Institute, so I could derive whether that is an
appropriate placement of that institute, versus the other
divisions that it could be possibly placed under?
Mr. Zerhouni. I have to say that you are very observant,
and I--we have been----
Ms. Baldwin. Well, thank you.
Mr. Zerhouni. [continuing] actually, thinking about the
NIEHS being, again, as--if you look at the fundamental
definition, does research in NIEHS apply to all organs, all
disease, all life stages, and the answer is yes, so you could
think of NIEHS being a cross cutting Institute.
Ms. Baldwin. We will take--I am sure we will take a closer
look at that, and have greater discussion.
On some broader questions, with the establishment of four
specific appropriation line items for NIH, that we have gone
over what those are, I am concerned about the impact that
lumping the Institutes and Centers, most of them in two line
items, will have, in terms of pitting them against each other
for the available funding. In a worst case scenario, you would
see a competition that would result in the loss of cross-
institutional collaboration and cooperation that we have
recently enjoyed. I wonder if you could comment on that, and
talk about ways to prevent the pitting of institutions against
each other, what we might want to have as safeguards in this
legislation to prevent that.
Mr. Zerhouni. That is a very good question. The way you
structure a reauthorization structure drives culture. Structure
drives culture, and therefore, you can't really look at that
issue in isolation. You really look at the total structure that
I think is being envisioned here. There is no doubt that losing
the identity of a mission is not necessarily a good thing, so
you need to find balance between the two, and clearly, you
don't want to have a zero sum game that occurs. You really want
to, therefore, have what I call a common fund for common good,
for funding when there is a need to do it. But again, I mean
you have programs that sometimes don't need to move out of a
particular Institute to be coordinated with another Institute.
So to me, the most important thing is to keep the planning
process, the ability to present a logical plan to Congress, to
the--I mean to Congress in general, and the appropriators in
particular, that keeps that identity for the mission.
Otherwise, what you end up with is no one is responsible for
anything. So you need to strike that balance between the two.
Ms. Baldwin. Are you comfortable with legislation that
places a limit on the number of Institutes in each division?
Right now, I think they are looking at 15 in the mission-
driven, and nine----
Mr. Zerhouni. There is no doubt that, you know, the way
Institutes and Offices and Centers have been created has been,
I wouldn't say haphazard, but frankly, driven by factors other
than pure science. I do believe that, you know, there is a
particular law in--that every time you add one, you double the
complexity, and every time you add another one. I think it is
not a good idea to have so many structures, and I do believe we
need to have a limit, and if anything, think about
reorganizing. I was just reading the New York Times this
weekend, and General Electric went from 11 divisions to six.
And obviously, it is a completely different environment,
completely different, but we do need to have a limit to the
number of direct reports and units that are independent, that
duplicate their own administrative structures and so on. So
yes, I think every observer, including the IOM, by the way,
would say you need to be very careful in adding any. I think we
should subject all of this to a public process, as recommended
by the IOM, but I do believe that limits are a good thing. If--
we need to have the discipline of recognizing a mission, but
not at the expense of complexity of management, and
unwieldiness of the agency.
Ms. Baldwin. Dr. Zerhouni, I see that amber light, which
means my time is almost done, in fact, I think it is done, but
there are two questions that I want to pose, and you don't have
to answer right now. They are both following on questions
previously asked by Mr. Waxman and Mr. Brown.
First, there is the blank by the authorized appropriation
level. Any guidance you can provide us, in terms of how we
should be considering opportunities as we deliberate over what
the optimum rate of increase for NIH is appropriated, and
second, following up on Mr. Waxman's questions, whether we
should have specific language in this draft, or in the final
bill, for the next Director of NIH, who will be a political
appointee, to direct them in terms of composing the advisory
committees and the institutes?
Mr. Zerhouni. I will submit my answer in the record.
Ms. Baldwin. Thank you.
Mr. Deal. Thank the gentlelady. Mr. Buyer.
Mr. Buyer. I want to cover a couple of questions. One, in
particular, that deals with your Roadmap, and a followup off of
Mr. Ferguson's question that he had to you about how this
legislation, will it really permit you to implement your
Roadmap? And so that I can understand that better, I think
anyone that wants to take on an organization like--that you
have--functional consolidations of an organization, to
integrate activities, to meet strategic goals based on
priorities, that is noble. I--that is your job. That is what
you want to be able to do. And as I was listening to you
testify, I was thinking about a couple years ago, you came up,
and you testified about your Roadmap. A lot of us got pretty
excited. I remember asking you a question about sexually
transmitted diseases in America, and I was pretty stunned--
correct me if I am wrong, but I thought your testimony was that
there are 80 million Americans, is that about right? Or 65
million?
Mr. Zerhouni. Sixty-five million, growing by 4 million a
year.
Mr. Buyer. Wow. Sixty-five million Americans have been
infected with a sexually transmitted disease. If you actually--
take of our population of 295 million people, and say of that
population, then, what is the highest in sexual activity, you
are almost looking at a one in three, one in four perhaps.
Mr. Zerhouni. This is--lifetime, yes.
Mr. Buyer. Yes, in a lifetime, have dealt with a sexually
transmitted disease. And the reason I remember that is because
you, then, said Congressman, this is an epidemic. All right. It
is an epidemic. I would think that is an epidemic. If you think
about it, our society, and this is a problem that--it is sort
of the problem in the closet. It is sort of the problem in the
basement, a problem that nobody really wants to talk about
somehow, until we have to deal with it. So I look at this, and
you could pick a disease. It doesn't have to be a sexually
transmitted disease, but I brought that up, because I
remembered you talking about it, and I look at you now trying
to do this consolidation. You have got your Roadmap, and--so my
specific question for you would be can you give us some actual
examples from your experience on how the current individual
Institute and Center-oriented structure of NIH, or limited
authorities results in missed opportunities, or significantly
impeded your ability to respond to opportunities and public
health challenges, such as the one that you called the
epidemic?
Mr. Zerhouni. Right. That is a very good question. You have
seen the example of the Roadmap. The Roadmap was not designed
to address any particular public health challenge--it was
really the first time that all Directors said, ``We really need
to do better in cross-investment.'' So they came together, and
if you look at, I think I have this--this is the investment of
the Roadmap.
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Mr. Zerhouni. We decided to have three topics, pathways to
discovery, research teams, clinical research, things that we
identify as gaps in our investment, and commit to a 5-year
process. Now, at the time, funding was a lot easier. It is
about 1 percent of the NIH budget, over time. But when you were
done with this, what you realize is that you hadn't been
necessarily responsive to obesity, for example. So the next
year, we asked Dr. Allen Spiegel, from the National Institute
of Diabetes and Digestive and Kidney Diseases, Dr. Nabel from
the National Heart, Lung and Blood Institute--at the time, Dr.
Lenfant, to come up with a trans-NIH plan on obesity. That is
how it works, but you know what? We never really had the
mechanisms or the idea of having a process that would be
prospectively looking at that. And I have been trying to
instill this in my interactions with the agency, because I do
believe, from my previous experience in the private sector,
that science requires that now. It is too complex, but you need
to have a crosscut of exactly what you are doing.
So what other opportunities? Neuroscience. If you look at
the disease burden in patients from 25 to 44, mental health
becomes the major problem that affects the population, drug and
addiction, alcohol abuse, behavioral problems,
neurodegeneration, and mental health. You take those five, it
is a $500 billion healthcare cost. So we decided to have a
Neuroscience Blueprint this year, which we are presenting in
2006, but guess what? You couldn't fund it, because there was
no prospective mechanism by which you would say here is a set
aside fund. This is our opportunity fund. This is our common
fund. Let us just make sure that every time there is an
emergency out there, that we react to it. So the question you
are asking is, this will provide you a mechanism to look at
public health burden, what is rising, what is not rising. We
knew about obesity all these years, but we really didn't have a
mechanism to A, plan for it, and then, allocate resources. The
mechanism that usually happens is an office is created in law,
like the Office of AIDS research, because there is a public
health emergency, or this is more language that is put in the
bills, because a particular disease process or constituency
wants that served. I think having this process would
continuously allow NIH to be responsive, nimble, and proactive.
Mr. Deal. Thank the gentleman. Mr. Rush.
Mr. Rush. Thank you, Mr. Chairman.
Dr. Zerhouni, the last time that you appeared before our
committee, the question that I asked was what could NIH do to
better promote the inclusion of minorities and women in
clinical research, both as subject and researchers. And can you
tell us now how exactly NIH dollars are being used to promote
racial and gender inclusion, and also, include in your answer
whether or not NIH dollars are being used to promote minorities
and women as researchers themselves, and also, included in your
answer, would you give us some idea about how can NIH encourage
private sector companies, such as pharmaceutical firms and
medical device manufacturers to include minorities and women in
their clinical research, as both subjects and also, as
researchers? Can you give me a quick answer on those, please?
Mr. Zerhouni. Well, first of all, let me say that if you
have attended some of my presentations, health disparities is
one of our top five priorities, and remains one of our top five
priorities. No. 2, there are two parts to your question. One is
what are we doing in terms of having a scientific workforce, a
medical workforce, that is able to study and research these
conditions? Our basic philosophy is that, from the scientific
standpoint, it is very clear that the diversity of those who
conduct the research has to mirror the diversity of those who
participate in the research as subjects. So we have this
philosophy that to penetrate communities, you have to be there,
and you have an interaction that is constructive with a
diversity that reflects that population. That is a challenge,
because when you look at the number of women or minorities in
science careers, what you find is difficulties there. I mean,
it is an opportunity issue. Young African-Americans, for
example, who are very successful, may not necessarily see
science as a maximizing opportunity for their own career. On
the other hand, I think NIH has been consistently proactive in
building minority training programs. The new Center on Minority
Health and Health Disparities spends quite a bit of resources
on building the infrastructure for that, and you can see it is
paying off.
The other issue is participation. That is an issue that
relates to the Roadmap, and the concept that you need to
conduct research at the community level. So we funded, for
example, the Jackson Heart Study. The National Center for
Primary Care that Morehouse has funded, with 136 community
centers, having a presence in the communities. That is the
answer. The answer is you have to be on that ground, with
trained people that are connected to all the trials that are
ongoing, if you really want to have participation.
Mr. Rush. I want to quickly move to another one of my
interests. A Newsweek magazine that highlights the problem of
uncertainty within the medical profession when it comes to
prescribing drugs for children. According to the article,
because drug companies have not invested in clinical research
involving children, apparently, it is not very profitable, the
doctors are basically flying blind with nothing but speculation
when prescribing drugs to children. The results can lead to
both inadequate treatment and even death, and Mr. Chairman,
there is an article that I would like to submit for the record,
a Newsweek article that I would like to submit for the record.
Dr. Zerhouni, what should NIH do to correct this problem,
and what can Congress do to ensure NIH is addressing the
problem, and is the solution including children in clinical
trials?
Mr. Zerhouni. Well, as you know, the BPCA, the Better
Pharmaceuticals for Children Act, mandates that we look and
rank all of the medications that need testing in children,
because we do believe that we need, there is a need for making
sure that we understand how--what is the dose, what are the
side effects, which may be different. So we have a process
through the National Institute of Child Health and Human
Development, that looks at the drugs. There is a committee that
meets at the departmental level, and in conjunction with the
Foundation for NIH and the FDA, essentially prioritizes the
trials that need to be undertaken in particular--adult drugs
that are used for children. So we have a mechanism, and I think
that mechanism leads to----
Mr. Rush. Well, how effective is that mechanism? Because we
still have a very serious issue, and a serious problem with
children who are getting inadequate dosage, or maybe too much
dosage?
Mr. Zerhouni. I know it is, can I get back to you on that,
because I know we have about 11 drugs that are being tested, or
on the list of being tested, but I don't know the specifics at
this point.
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Mr. Deal. The gentleman's time has expired. Ms. Blackburn.
Ms. Blackburn. Thank you, Dr. Zerhouni. If you get down to
me, you know you are getting pretty close to the end. I am the
only one left over here.
Just a couple of quick things, and you--Mr. Ferguson and
Mr. Buyer both talked a little bit about your organization, and
you mentioned where you would have put some focus this year if
you had had funding. But I want to go back to something that
Dr. Varmus, who was your predecessor, had said in 2001. He
mentioned that he felt like you could add 10 Institutes a
decade, and what I am hearing from you is you probably would
opt not to that--not to do that, but would work within your
framework, and use the flexibility from the proposed
legislation to allow you to meet those needs. Is that a correct
understanding?
Mr. Zerhouni. Right. I know Dr. Varmus well, and what he
was referring to, what he told me, is that unless we have a
mechanism to prevent proliferation, we will end up with 10 per
decade, and then make the agency less manageable. He has
advocated, actually, consolidation of all Institutes into five
Institutes. So he is clearly one who has been very concerned
about the rapid growth of the number of Institutes.
Ms. Blackburn. Excellent, and thank you for the
clarification on that. A little bit on flexibility and
collaboration, and let me use, to make the point, use the SARS
outbreak, because I have read that you all did some research
and some work on SARS in 2003. Now, we are hearing about avian
flu, and the possibility of avian flu. So using SARS as our
real life example, and our experience, talk to me just a little
bit about how quickly you were able to put funding into the
Institute for Allergy and Infectious Diseases, and the old
structure, what your turnaround was on meeting the need for
research, and then, the new structure, how you would plan to do
that, and if St. Jude's, which is right in Shelby County,
which--one of the counties I represent--is doing some avian flu
work. So how quickly would the new legislation allow you to
respond, and how would it make it easier than the old
legislation?
Mr. Zerhouni. Very important points. In the SARS case, we
had invested NIAID, the National Institute of Allergy and
Infectious Diseases, invested in Asia years ago, in having
laboratories in Asia, to, in fact, be our sort of warning
stations for flu. We actually thought it was flu at the
beginning. When we identified, CDC identified that this was a
different disease, we then collaborated with CDC, and very
quickly, were able to identify the virus. Now, you are asking
what did you then do to develop a vaccine to--for SARS? The
Institute then reallocated resources, because of the doubling,
we have built a Vaccine Research Center, which is extremely
capable, so that the fundamental investment was there, and then
the Director of the Institute reallocated dollars within its
Institute to develop the early prototypes of two, and now,
three SARS vaccines, one of which is in trial.
In the case of pandemic flu, this is a much larger problem.
The Secretary Levitt has appointed a taskforce that is being
coordinated across the government. There is no doubt that we
need to be able to move resources. In the current context, it
is not that easy to do. I can use transfer authority if I need
to. It is 1 percent of that. We can also, obviously, use a 1
percent transfer authority the Secretary has, to be able to
move dollars in that category. You can use contracts. So in the
case of flu, we have been able--over a year ago, we knew that
there was a risk of flu, to develop a prototype vaccine, and we
have a prototype vaccine. We have 2 million doses, and it has
been tested last--this past few months.
Ms. Blackburn. And under your existing structure, how
quickly were you able to do that, and under the proposed
structure, how quickly would you anticipate being able to do
that?
Mr. Zerhouni. The current structure that is being proposed
is really to be more strategic and proactive in known public
health problems----
Ms. Blackburn. Okay. So it would not affect that. One quick
thing, one last question. I like your mission statement, and
basically, what it is saying is science in pursuit of knowledge
to improve health. So as you look at your mission, and we talk
about the proposed legislation, does the legislation improve
your ability to meet your mission?
Mr. Zerhouni. I believe so. I think improvements in our
ability to coordinate and synergize the 27 Institutes and
Centers is very important to science today. If you look at the
key elements of science today, one, it has become
interdisciplinary. You need people from physical sciences,
computer science, mathematics, working with biologists. So they
cannot be locked into silos.
Second, the scale of experiments that we do is larger, and
there is--and when I started research, we had three members of
my team, myself and two co-investigators. You go to any
scientific meeting today, or look at a publication in any
journal, you will have 15 collaborators. So collaboration is
very important as well. This means that Institutes and NIH in
general needs to be more nimble and more aggressive in
stimulating and incubating these sorts of approaches, and I
think it will do that.
Ms. Blackburn. Thank you.
Mr. Deal. Ms. Capps.
Ms. Capps. Thank you, Mr. Chairman, and Dr. Zerhouni, thank
you very much for spending this entire afternoon here with us.
I appreciate your testimony.
In it, you referred several times to the report of the
Institute of Medicine, and I want to refer to the Institute's
recommendation No. 4, regarding the ability to respond to new
challenges, for enhancing and increasing trans-NIH strategic
planning, the D part of that, which designates, or they
recommend a percentage of each Institute to be preserved for
trans-NIH research. Today, in your testimony, you have spoken
several times, and have referred in some of your responses to
questions about a common fund for trans-NIH research. I would
like to give you the opportunity to spell out what you mean. Do
you see this as a standalone pot of money, or is it sufficient
to require, as the IOM suggests, and just elaborate as to how
you talk about that common fund?
Mr. Zerhouni. So effectively, you can handle it in, like I
said, in three different ways. I think what the IOM is
recommending is what I call the common fund.
Ms. Capps. Right.
Mr. Zerhouni. So in other words, you know that 5 percent of
your budget is going to be not determined by you, as NIH
Institute--I mean, as, by an Institute Director, but it will be
put in a common pool, to be jointly planned, jointly decided
for, initiatives that are important, emerging, and so on. That
is the common fund concept.
Ms. Capps. I understand. Now, that is part of the--each
Institute's budget.
Mr. Zerhouni. It is part of the mission----
Ms. Capps. That they are going to set aside for that.
Mr. Zerhouni. Yes. I don't think it is necessary, No. 1, to
take away from the Institutes.
Ms. Capps. Right.
Mr. Zerhouni. In their base. Second, I don't think it is
necessary for the Director to have grant-making authority. I
think--I don't think you need to be grant making. You don't
want to create an Institute----
Ms. Capps. That is what I wanted to really be clear about.
Mr. Zerhouni. Right.
Ms. Capps. Do you want the Office of the Director, whether
it is you or whoever it is, to have direct grant making
authority?
Mr. Zerhouni. No. I think grant coordination, resource
allocation decision, planning authorities, to be able to look
across and not be told, well, this is not really your money, it
is my money.
Ms. Capps. Right. So but you----
Mr. Zerhouni. That phenomenon needs to go away.
Ms. Capps. But what role would you play, or the Director
play, in this?
Mr. Zerhouni. Coordination.
Ms. Capps. Just coordination.
Mr. Zerhouni. Yes, strategic coordination, just what it
says, program coordination across the silos, strategic
initiatives, create a transparent process, that is based on an
analytical framework that is good for analysis, good reporting.
Ms. Capps. Okay.
Mr. Zerhouni. This is just basically decision support----
Ms. Capps. Okay.
Mr. Zerhouni. [continuing] mechanism. Not take the money
away, not--nor become, in--a twenty-eighth Institute. I don't
think----
Ms. Capps. Right.
Mr. Zerhouni. I don't think that is a good idea.
Ms. Capps. I see. It--and do you have ideas about--is it a
permanent set aside of this funding mechanism, or----
Mr. Zerhouni. If you don't make it permanent, you will
never change the culture. They don't----
Ms. Capps. So you are using this as a way of changing the
culture, getting at your ideas of responsibility----
Mr. Zerhouni. Of the margins, yes, to instill the fact, and
the need to coordinate better for scientific challenges that
have become bigger and larger.
Ms. Capps. So I want--I am going to turn to another topic,
but I wanted to make sure--this is something that you really
have pulled out of the Institute of Medicine report, and you
really want to see that as a focus of the new NIH, as your
envisioning it----
Mr. Zerhouni. Right.
Ms. Capps. [continuing] as being more flexible.
Mr. Zerhouni. Well, from my standpoint on the IOM report,
this recommendation No. 4 is critical.
Ms. Capps. All right.
Mr. Zerhouni. And I support it.
Ms. Capps. Okay. Great. Another topic, since I have a
little bit of time left, there--in the draft legislation that
the committee is preparing, there is a new division, the
Division of Program Coordination, Planning, and Strategic
Initiatives, to oversee and coordinate the offices currently
located within the Office of Director, and so forth. In other
words, in a way, you could say a new bureaucracy, but I, you
know, I don't want to cast a negative word on that.
I have heard some concern that creating a new division to
carry out these functions could weaken the authority of the
existing Office. It could make for more reporting, when you are
talking about that there is already a lot, and--so can you
comment on what you see as the ideal model for managing
coordination and strategic planning at NIH, since this is such
an important focus for the future?
Mr. Zerhouni. Again, I don't think that division should be
in charge of all strategic planning for all missions at NIH.
Ms. Capps. Okay.
Mr. Zerhouni. That should be left to the Institutes. It is
really the synchronization and coordination that this division
should be doing. As far as the Offices, remember, the Offices
were created because there was somewhere, somehow, a need, felt
by many people in the community, including Congress, for better
coordination.
Ms. Capps. Okay.
Mr. Zerhouni. That is why they were created in law. So I
think they should continue their role. They should be
coordinated, but the problem that you are talking about,
bureaucracy, is every time you create a new structure----
Ms. Capps. Yes.
Mr. Zerhouni. [continuing] you have created a new
bureaucracy, and that is what I think we need to avoid. We need
to find ways of preserving their role and continue their
mission. I mean, the Office of AIDS Research plays a very
important role.
Ms. Capps. Right.
Mr. Zerhouni. Look at the authorities of that office.
Ms. Capps. Right.
Mr. Zerhouni. I mean, OAR looks at the AIDS budget across
NIH. That should be continued.
Ms. Capps. Just to be clear, and kind of as a way of giving
us advice on designing this legislation, would existing Offices
need to report to the division? Is there a chain of command
here?
Mr. Zerhouni. Well, I think the division should be pulling
from their staff, division of the Director. So to me, the
Director should really take a role here, because he or she is
accountable. The problem is, if she is accountable, shows up at
hearings like this----
Ms. Capps. I see.
Mr. Zerhouni. [continuing] when there is a problem, but
they don't necessarily have the authority to be able to be
accountable, so I think the divisions should be part of the
Office of the Director.
Ms. Capps. And when you say coordinator, you give a lot of
authority to coordinator. I mean, that is--you are saying that
is where your responsibility lies, or the Director's
responsibility.
Mr. Zerhouni. That is right. Yes, over a----
Ms. Capps. Kind of a bottom line.
Mr. Zerhouni. Well, that is--portion of the budget that
should be jointly planned and jointly executed.
Ms. Capps. Thank you, Dr. Zerhouni.
Mr. Zerhouni. Thank you.
Mr. Deal. Mr. Green.
Mr. Green. Thank you, Mr. Chairman. I ask unanimous consent
to have a statement placed in the record.
Dr. Zerhouni, the current organization at NIH affords the
Institute in Cancer, and Center Directors, with a great amount
of autonomy in priority setting, Director of the National
Cancer Institute is arguably an even greater autonomy, since he
has the ability to take the NCI budget directly to the OMB.
This structure has enabled cancer research to develop new
therapies, and to make great strides toward cancer. Under the
organization structure proposed in this draft legislation,
would have the NIH Director have sole responsibility for
priority setting. While the draft remains silent on budgetary
bypass authority for NCI, do you envision the NCI retaining
that authority to go directly to the OMB?
Mr. Zerhouni. First of all, the NIH Director should have
the sole priority setting authority. I hope I made myself
clear, Mr. Chairman and Mr. Green, that it needs to be
balanced. It needs to be part of a coordinating effort that
should not be subject to the veto of every 27 Institutes and
Centers. That is what I mean by the reason to do that, but
beyond that percentage of trans-NIH initiatives, I think the
Institutes should retain their fundamental missions and
authorities, and in the case of the National Cancer Institute,
I think it has been very important to the NCI, and to its
community, from what I hear, this authority to go and have a
bypass budget and so on is critical to their mission. So I
think it should be preserved, provided that they also
participate in the common fund for the common good.
Mr. Green. The draft legislation strikes a number of
authorizations that are either expired or never been
appropriated. It is clear from the intent that the bill is to
strike expired authorizations of appropriations, while
maintaining authority to carry out these programs. I am
interested how the NIH views these authorizations in setting
priorities. For instance, in 2000, Congress passed the Clinical
Research Enhancement Act, which included a clinical research
loan repayment program, to encourage investigators with medical
school debt to pursue a career in clinical research. However,
during the Congressional consideration of that legislation, NIH
made clear to us that the loan repayment program needed
specific authorization in order to make the program available
to extramural researchers--NIH campus. Would the strikes
contained in this bill lead you to discontinue the Clinical
Research Loan Program, and can you speak to the overall impact,
if any, on these strikes to the NIH continuing the Clinical
Research Program?
Mr. Zerhouni. That is a good question. I really--this is
obviously a technical issue. I am not clear about the
authorities that we have, but I do know that we do have the
authority to do loan repayment in PHS, authority, as I
testified. I would--definitely would like to have my legal
people help me with that, and get back to you on the record.
[The following was received for the record:]
Removal of the ``authorization of appropriation''
provisions would not affect the NIH's ability to conduct
clinical research programs, including loan repayment programs,
authorized by statute, so long as appropriations are deemed
available. The changes and additions to the authorizing
legislation to enable extramural clinical researchers to apply
for loan repayment made by the Clinical Research Enhancement
Act were necessary because prior NIH statutory authority only
provided for a loan repayment program for clinical researchers
from disadvantaged backgrounds who agreed to conduct clinical
research as employees of the NIH.
Mr. Green. Well, the biggest concern I have about that is
their impact on the goal of attracting health professionals to
careers in clinical research.
Mr. Zerhouni. Absolutely. I understand very well.
Mr. Green. And my last question, Mr. Chairman, the bill
contains four broad authorization levels, that authorize
appropriation for individual Institutes or Centers. If this
draft bill were to become law, and the Appropriations Committee
continued to provide line item appropriations for individual
Centers and Institutes, would--the result would essentially be
unauthorized appropriations. Of course, this scenario happens
quite frequently here in Congress, that we have approved money,
but appropriation for money that is not authorized. Is it your
preference to receive four different appropriated amounts, or
would you prefer that Congress provide individual Institutes
and Centers with line item appropriations, and can you speak to
that role, that increased transfer authority plays in that
scenario? For example, I know you talked about the certain
percentage in--for example, if NIH were to receive
appropriations that mirror these four authorization groups, why
is it individual transfer necessary? You are already deviating,
or divvying up the money individually.
Mr. Zerhouni. As I mentioned in my previous, I think it is
very--from my standpoint and my experience, I think it is
extremely important that whatever we do, we do it
progressively, and whatever happens, we can't overnight make
wholesale changes at NIH. It is not possible. So whatever the
committee eventually decides to do, we need to retain the
ability to maintain the momentum, and whatever I am talking
about, in terms of transfer authorities, or common fund, or
opportunity, however it settles, we need to really, also, make
sure that there is a smooth transition from State A to State B.
And I guess I am being--I am answering both questions at once.
Mr. Green. Yes.
Mr. Zerhouni. There is value to making sure that this goes
to that mission, for that amount, and that it doesn't change
erratically from year to year, because we have to maintain
these programs over time, and second, I think it is important
to understand the difference between a transfer authority which
is post facto, a common fund, which is prospective, an
opportunity fund, which is responsive to--and this is where I
think we need to have more interactions with the committee,
which I think we have had, and refine that concept.
Mr. Green. Mr. Chairman, since my time has run out, and I
just appreciate, Dr. Zerhouni, for your patience this
afternoon. Obviously, there is a lot of interest on both sides
of the aisle, because so many of us are proud of what NIH is
doing with all the Institutes, although I understand the
organizational chart can be a nightmare. We just don't want to
lose all the success we have had.
Thank you, Mr. Chairman.
Mr. Deal. Thank the gentleman. Mr. Engel.
Mr. Engel. Thank you. Thank you, Mr. Chairman, Dr.
Zerhouni. I saw, I listened to your presentation, your
testimony, and the slideshow, and I have to say that you make a
very good case for the need for change.
I have two specific questions regarding that that I would
like to ask, but I do think that the slides and your
presentation were on the money. I mean, some of us have some
questions about some of the nuances, but I think overall, I
think the vision is a good one.
I want to talk to you first about the Office of AIDS
Research. That has been very much praised as a model for
strategic planning for many years, and for budgeting, because
the OAR has the statutory authority and responsibility to
develop a comprehensive strategic plan, with input from the NIH
ICs, and from nongovernmental scientists, and community
advocates, and everyone involved with AIDS. The OAR director
has the authority to move resources across the different
Institutes to address scientific priorities that may change
from year to year, and the draft bill, I think, and correct me
if I am wrong, implies that the NIH Director would now, and I
have a quote, ``be responsible for strategic planning and
priority setting of all research activities conducted or
supported by the NIH.'' That is the quote. Lots of people have
expressed concern to me that the expanded authority of the NIH
Director could undermine the existing statutory authorities of
the Office of AIDS Research provided by Congress, and I am
wondering if you could comment on that.
Mr. Zerhouni. A very good question. I think there is a
tremendous amount, sometimes, of anxiety about any change, so
you can hear, but I think we need to be responsive to that.
First of all, I consider the model at OAR has been a good
model. Think about it. The Director of NIH never had that
authority over any part of the portfolio of NIH. Yet, OAR has
it. OAR can look strategically, get counsel from the
Institutes, look at the portfolio, reassign the portfolio.
Like, for example, Dr. Jack Whitescarver changed the priority
to vaccines over the past 2 years, because we have now vaccines
candidates we want to try. It is changed to what drugs, at the
time; that was progressive. Likewise, I think it is
understandable, and I think the committee is sort of
paralleling my own thoughts, and the thoughts of the IOM and
others, to say why wouldn't the Director of NIH also have that
same sort of OAR type authority over a common fund--what is
wrong with that--without taking away from the important mission
of OAR?
So my view is that these are complementary, not
exclusionary of each other. I think the NIH Director needs to
have what I would call generic authority over a small portion
of the budget, just like OAR has specific authority over 10
percent of the NIH budget, which is the AIDS portfolio.
Mr. Engel. But you can certainly understand why there would
be some transition.
Mr. Zerhouni. Absolutely. Absolutely, and I believe that,
as I said in my slideshow, that those Institutes should retain
their role--I mean those Offices.
Mr. Engel. Thank you. My second question is about
translational research. It has been a major priority,
obviously, of the NIH, and I have a very specific question. How
would the legislation affect the agency's ability to promote
and conduct translational research, especially in areas such as
research on Charcot-Marie-Tooth Disorder, which has the
potential to translate into direct benefits for other--research
into other neurodegenerative disorders, such as ALS and
multiple sclerosis?
Mr. Zerhouni. I think that is a very interesting question,
of what would happen, if the only way this structure will
change, if Charcot-Marie-Tooth is obviously a disease that we
are responsible for, and we have a mission to help. But let us
suppose something new happened in either the therapeutic world,
or--and something that no single Institute could put in place.
That new structure would basically look at that, and
potentially, allocate common resources for an emerging area of
opportunity that would be relevant to that disease, but this
structure is not dedicated or designed to serve special purpose
outcomes. Diseases, organs, life stages, cross cutting science,
should be primarily done in its great majority by the
Institutes in their missions as specified. The structure should
only be the glue for things that are of common interest to all.
So it may not be relevant to a specific disease, but it could
be relevant to something that is emerging, that is affecting
the landscape of science in one way that may be relevant to
Charcot-Marie-Tooth for that particular case. So sometimes, for
example, we have in trial right now a drug, to potentially be
important for ALS. It is an antibiotic. No one knew that it
could have a role. Well, reacting quickly to that would
require, perhaps, a discussion, a coming together of all the
Institutes, and say this is something novel, this is something
we need to try. That might be impacted at that point.
Mr. Engel. Well, thank you, and let me just conclude by
thanking you for staying this long, and thanking you for the
great job you are doing. Thank you, sir.
Mr. Zerhouni. Thank you.
Mr. Deal. Dr. Zerhouni, we likewise reiterate our
appreciation for your being here today. I think you can tell
the committee has great interest in what we are doing. By our
accounts, some 29 members have spent at least some quality time
with us this afternoon, and I appreciate your patience, and if
you wish to supplement or add additional information for the
record, you may certainly be free to do so.
I would like to also pay tribute to Cheryl Jaeger, who is
our staff person primarily responsible for this major
undertaking, and express our appreciation to her for her hard
work, as we try to finalize this product, and to my colleague,
Mr. Brown, for his patience as well.
There being nothing further to come before the committee,
this hearing is adjourned.
Mr. Zerhouni. Thank you, Mr. Chairman.
[Whereupon, at 4:40 p.m., the committee was adjourned.]
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