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NIH REFORM ACT OF 2006: PROGRESS, 

CHALLENGES, AND NEXT STEPS 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED TENTH CONGRESS 

SECOND SESSION 

SEPTEMBER 9, 2008 

Serial No. 110–144 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

JOHN D. DINGELL, Michigan, Chairman 

HENRY A. WAXMAN, California 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

EDOLPHUS TOWNS, New York 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chair 

LOIS CAPPS, California 

MIKE DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JAN SCHAKOWSKY, Illinois 

HILDA L. SOLIS, California 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

DARLENE HOOLEY, Oregon 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

BARBARA CUBIN, Wyoming 

JOHN SHIMKUS, Illinois 

HEATHER WILSON, New Mexico 

JOHN SHADEGG, Arizona 

CHARLES W. ‘‘CHIP’’ PICKERING, 

Mississippi 

VITO FOSSELLA, New York 

ROY BLUNT, Missouri 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PROFESSIONAL STAFF

DENNIS B. FITZGIBBONS, Chief of Staff 

GREGG A. ROTHSCHILD, Chief Counsel 

SHARON E. DAVIS, Chief Clerk 

DAVID CAVICKE, Minority Staff Director 

(II)

(III) 

SUBCOMMITTEE ON HEALTH

FRANK PALLONE, JR., New Jersey, Chairman 

HENRY A. WAXMAN, California 

EDOLPHUS TOWNS, New York 

BART GORDON, Tennessee 

ANNA G. ESHOO, California 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

Vice Chair 

TOM ALLEN, Maine 

TAMMY BALDWIN, Wisconsin 

ELIOT L. ENGEL, New York 

JAN SCHAKOWSKY, Illinois 

HILDA L. SOLIS, California 

MIKE ROSS, Arkansas 

DARLENE HOOLEY, Oregon 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

JOHN D. DINGELL, Michigan (ex officio) 

NATHAN DEAL, Georgia, 

Ranking Member 

RALPH M. HALL, Texas 

BARBARA CUBIN, Wyoming 

HEATHER WILSON, New Mexico 

JOHN B. SHADEGG, Arizona 

STEVE BUYER, Indiana 

JOSEPH R. PITTS, Pennsylvania 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

JOE BARTON, Texas (ex officio) 

(V) 

C O N T E N T S 

Page 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 1 

Hon. Nathan Deal, a Representative in Congress from the State of Georgia, 

opening statement ................................................................................................ 3 

Hon. Anna G. Eshoo, a Representative in Congress from the State of California, prepared statement .................................................................................. 4 

Hon. Joe Barton, a Representative in Congress from the State of Texas, 

opening statement ................................................................................................ 5 

Hon. Marsha Blackburn, a Representative in Congress from the State of 

Tennessee, opening statement ............................................................................ 7 

Hon. John D. Dingell, a Representative in Congress from the State of Texas, 

prepared statement .............................................................................................. 7 

Hon. Jan Schakowsky, a Representative in Congress from the State of Illinois, opening statement ....................................................................................... 8 

Hon. Tim Murphy, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 9 

Hon. Tammy Baldwin, a Representative in Congress from the State of Wisconsin, opening statement ................................................................................... 10 

Hon. Michael C. Burgess, a Representative in Congress from the State of 

Texas, opening statement .................................................................................... 11 

Hon. Jim Matheson, a Representative in Congress from the State of Utah, 

opening statement ................................................................................................ 40 

Hon. Gene Green, a Representative in Congress from the State of Texas, 

prepared statement .............................................................................................. 54 

WITNESSES

Elias A. Zerhouni, M.D., Director, National Institutes of Health ....................... 12 

Prepared statement .......................................................................................... 19 

Questions for the record ................................................................................... 75 

SUBMITTED MATERIAL

Hearing slides, submitted by Dr. Zerhouni ........................................................... 55 

(1) 

NIH REFORM ACT OF 2006: PROGRESS, 

CHALLENGES, AND NEXT STEPS 

TUESDAY, SEPTEMBER 9, 2008 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON HEALTH, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittee met, pursuant to call, at 10:05 a.m., in room 

2123 of the Rayburn House Office Building, Hon. Frank Pallone, 

Jr. (chairman) presiding. 

Members present: Representatives Pallone, Eshoo, DeGette, 

Baldwin, Schakowsky, Matheson, Deal, Myrick, Murphy, Burgess, 

Blackburn, and Barton (ex officio). 

Staff present: Melissa Sidman, Jessica McNiece, Carly Hepola, 

Lauren Bloomberg, Chad Grant, and Aarti Shah. 

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY 

Mr. PALLONE. The meeting of the subcommittee is called to 

order, and today we are having a hearing on NIH reform, ‘‘NIH Reform Act of 2006: Progress, Challenges, and Next Steps,’’ and I will 

recognize myself initially for an opening statement. 

First, I guess I would like to welcome back all my colleagues 

from the 5 week district work period. I have to say, to me it felt 

like we were here yesterday but I know it was a busy time, hopefully a productive time. 

The subcommittee, as I said, is meeting to discuss the progress, 

the challenges, and the work that still needs to be done to meet the 

expectations outlined in the NIH Reform Act that was passed in 

2006, and I know that our ranking member of the full committee, 

the gentleman from Texas, Mr. Barton, was very much involved in 

that legislation and specifically requested that we have the hearing 

today. 

For over a century, the National Institutes of Health has played 

a fundamental role in the advancement of biomedical, behavioral 

and population-based research. NIH translates cutting-edge research into practical applications. This work has led to the development of new diagnostic tools which have permitted early detection 

of numerous diseases and have produced innovative treatments 

that have saved millions of lives and profoundly improved the lives 

of many others. Federal investment in NIH research has led to 

groundbreaking discoveries in the fight against cancer, diabetes, 

heart disease, and numerous other conditions that impact the lives 

2 

of all American families. For the most part there is a mutual understanding of the importance of this research and public education, which up until recent years was reflected in a bipartisan effort to double funding for the NIH. Democrats and Republicans 

were united in ensuring NIH had the resources it needed to continue its mission. This, however, or unfortunately is no longer the 

case as the priorities of this Administration have shifted towards 

broad tax cuts and increased funding for defense and the war in 

Iraq. There is not enough money to fund domestic priorities including the vital research conducted by the NIH. 

The President’s fiscal year 2009 budget proposal was no different. He has yet again requested flat funding for the NIH, which 

if adjusted for inflation, would represent a 14 percent cut in funding, and has threatened to veto any domestic spending bill that exceeds his request. This Administration is willing to spend $12 billion each month on the conflicts in Iraq and Afghanistan but has 

abandoned the commitment, in my opinion, to the medical research 

that will help provide lifesaving treatment to our returning veterans and millions of other Americans. While one-third of veterans 

returning from Iraq and Afghanistan suffer from debilitating mental illness and while the rate of suicide among our national heroes 

is now double that of the general population, mental health research has remained relatively flat for years. I have to say, during 

the Democratic Convention, our New Jersey delegation had a visit 

during one of our breakfasts by Congressman Patrick Kennedy 

from Rhode Island, and he specifically talked about how the 

amount of funding for mental illness and suicide prevention has 

really effectively gone down. 

We also have a great need for further research into traumatic 

brain injury. It is estimated that 10 to 20 percent of Iraq and Afghanistan veterans have experienced traumatic brain injury from 

exposure to roadside bomb blasts but show no outward signs of the 

condition, and this coupled with our current limited understanding 

of the condition and its symptoms is resulting in many of our military personnel suffering with little hope of getting better. We have 

an obligation, in my opinion, to our war heroes and to all Americans to ensure that this lack of investment in medical research 

ends. We must increase the funding levels for NIH to improve diagnosis and treatment of these debilitating injuries and diseases. 

I think we are in danger of losing ground to other nations that 

are making medical and biotechnical research more of a priority, 

and this cannot continue without devastating results. We must recommit to provide the NIH the funding it needs to continue the innovative research that has brought hope to so many Americans. 

Now, in the 2006 Act, Congress asked the National Institutes of 

Health to report on their work and required them to reorganize 

and use limited funds in a more effective and efficient way. We also 

required them to release a biannual report detailing this activity 

and laying out the Institute’s progress. The first report was just released a few weeks ago and today we will be hearing from Dr. 

Zerhouni, director of the NIH, on how the requirements laid out by 

Congress in 2006 are being implemented. I am eager to hear about 

the organizational changes and strategic planning activities that 

3 

have taken place at NIH since the passage of the Act as well as 

the cross-institute initiatives that have been implemented. 

As we discuss the next steps in our continued effort to improve 

NIH, it is vital that we all work together to make sure it is strong 

and effective, not only through organizational change but also 

through a renewed commitment to providing the funding necessary 

to continue the great work of the agency, and I hope that we can 

all work together to further this mission. 

I do want to specifically mention, as I already have, the efforts 

of Mr. Barton and also Mr. Deal. I know that they worked on this 

quite a bit and Mr. Barton was actually the sponsor of it when we 

were in the Majority and so I note he cares a great deal and that 

is really the reason that we are having the hearing today. 

I yield now to our ranking member of the subcommittee, Mr. 

Deal. 

OPENING STATEMENT OF HON. NATHAN DEAL, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF GEORGIA 

Mr. DEAL. Thank you, Mr. Chairman, for holding this very important hearing to examine the NIH Reform Act of 2006 and its implications on biomedical research at the National Institutes of 

Health, and thank you, Dr. Zerhouni, for being with us today. We 

look forward to your testimony. 

As we all agree, the NIH is a critical component of the puzzle 

in the healthcare delivery mission of our Nation. They lead research, paving the road for biomedical developments of our future 

and actively engage in preserving the health of all Americans 

through research and innovation. I am looking forward to hearing 

what Dr. Zerhouni will say regarding the NIH Reform Act of 2006 

and the improvements at NIH which have subsequently resulted. 

I believe this legislation laid an appropriate foundation to fund 

trans-NIH research, revolutionizing the way interdisciplinary 

science shares information of common interest. The Common Fund 

authorized by this Act laid the groundwork for transformational 

healthcare research at the National Institutes of Health. Additionally, the Act called for great transparency so taxpayers know exactly how their hard-earned dollars are being spent. It also required greater accountability on the part of NIH to ensure that 

these needed dollars are being spent appropriately. 

While NIH has modernized its structure and operational objectives, there is still much yet to be accomplished. For example, how 

does the Institute determine a fair share of research dollars for certain disease-specific issues? Do appropriators account for the outside private revenue-generating capacity which some enjoy while 

others fall very short. Even last week, celebrities banded with 

three major television networks to host a nationwide telethon in 

support of the fight on cancer. Musicians, actors, reporters and 

businesspeople alike joined forces and managed to raise over $100 

million for the American Cancer Society. This is fantastic and represents the power of the American people when we all come together for a common cause. 

There are, however, many research-worthy conditions which do 

not enjoy this type of support, many of which whose budgets are 

modest yet critically underfunded, are forced to abandon research 

4 

due to monetary constraints. How are these specific circumstances 

mitigated to ensure every disease is given at least some degree of 

scrutiny through their NIH dollars? Furthermore, research is only 

beneficial to the public when information is shared among scientists and healthcare professionals. How do we stimulate crossdisciplinary sharing of this critical research data, which is so critical to our fight against disease? As we move forward, I am hopeful 

we can address these apparent concerns and continue to push NIH 

toward innovation and development and not back to the ways of 

our past. 

Again, I am encouraged by the developments made since the implementation of the NIH Reform Act of 2006 and foster an appreciation of the cross-cutting innovative research at NIH upon which 

we, our families, and our constituents depend as a result of the 

passage of this legislation. By giving the director the tools to implement strategic research planning and to promote cross-institutional 

research, barriers to medical innovation are being broken, and I 

thank you, Mr. Chairman, and I thank Dr. Zerhouni for being with 

us today and we look forward to this hearing. 

Thank you. I yield back. 

Mr. PALLONE. Thank you, Mr. Deal. 

I next recognize for an opening statement the gentlewoman from 

California, Ms. Eshoo. 

Ms. ESHOO. Good morning, Mr. Chairman. It is good to be back. 

Welcome, Dr. Zerhouni. I am going to submit my statement for the 

record and reserve the time for questions. Thank you. 

[The prepared statement of Ms. Eshoo follows:] 

PREPARED STATEMENT OF HON. ANNA G. ESHOO

Thank you Mr. Chairman for holding this hearing on the NIH Reform Act. As the 

first reauthorization of the NIH in 13 years, it’s a significant piece of legislation that 

will transform the way the NIH operates for years to come. 

Our oversight NIH, which I call the ‘‘National Institutes of Hope,’’ is, I believe, 

the crown jewel in the jurisdiction of the Energy and Commerce Committee. The 

legislation we’re discussing today was endorsed by some of the most important 

stakeholders and experts in healthcare, including Dr. Zerhouni. 

Last February, Dr. Zerhouni flew to my Congressional District to participate in 

a Healthcare Forum at Stanford University, to join Speaker Pelosi, John Chambers, 

CEO of Cisco, and leading experts to discuss innovations in healthcare. Dr. Zerhouni 

spoke to our tendencies to manage the short term when it comes to medicine. What 

we need is a clear vision, to look into the future 15 and 20 years from now. He gave 

us a wonderful analogy of our efforts to combat polio more than 50 years ago. It 

could have been our strategy in 1954 to improve the iron lung, to make it very productive, very effective, and very efficient and forget about a vaccine for polio. If that 

were the case, we’d have terrific iron lungs today and no vaccine for polio. 

The NIH serves a crucial mission to the American people. We trust the NIH to 

acquire new knowledge and conduct basic research that will enable us to prevent, 

detect, diagnose, and treat diseases from the rarest genetic disorder to the common 

cold. We make investments in the NIH because it represents hope for the future. 

There are many, many important elements to this law. The establishment of the 

common fund should serve to stimulate trans-NIH research in areas of emerging scientific opportunities. The creation of a new infrastructure at NIH to evaluate and 

report on the research portfolio will make it easier for the public to gain access to 

all the work that’s being done under NIH grants. 

What the bill does not address is the very real issue of funding. While the bill 

authorizes a 5% increase a year, we have not seen this happen, and after adjusting 

for inflation, the NIH is actually losing money. After years of significant funding increases for NIH, we’ve come to a complete halt in growth, with President Bush requesting a $5 million decrease for Fiscal Year 2009. 

5 

I look forward to learning more about how the NIH Reform Act has been implemented, what barriers and successes have been discovered, and how we can continue to improve the National Institutes of Health. 

Mr. PALLONE. Thank you. 

Our ranking member of the full committee, Mr. Barton, is recognized. 

OPENING STATEMENT OF HON. JOE BARTON, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BARTON. Thank you, Mr. Chairman, and I thank the full 

committee, Chairman Dingell for holding this hearing. You know it 

is important to me if I am actually here on time, so I am here 

today and I was here, let the record show, at a little before 10:00. 

I want to thank Dr. Zerhouni for his attendance. He has done an 

outstanding job as director of the NIH. 

I did request both informally and formally to Chairman Dingell 

that we hold an oversight hearing on the NIH Reform Act of 2006 

and I am very pleased and honored that Chairman Dingell and 

Chairman Pallone would honor that request. 

The law that we are reviewing today represents the first thorough, complete reauthorization of NIH in over 13 years at the time 

it was done in 2006. Reforming NIH was a top priority of mine as 

the chairman of this illustrious committee and the writing of this 

specific legislation proved to be a very long and arduous process. 

The bill that we are reviewing today or the law that we are reviewing today was literally the last act of the last Congress. It passed 

at, my recollection, about 3:00 in the morning and Congress adjourned about 3:15. So it took to the very last to get this done. Having said that, I think the last 2 years have shown that passing this 

Act was the right thing to do. Changes are being made. I think the 

NIH and the research community that it represents are better 

today because of the law that we are reviewing today. 

In some respects, I think it is safe to say now in hindsight that 

the old NIH was stuck in the past. This law gave it the flexibility 

to adopt new research opportunities. It actually gave the director, 

in this case, Dr. Zerhouni, some real clout. It made him more than 

a figurehead. It gave him the ability to do oversight within the 

NIH. It gave the director’s office the ability to coordinate research 

responsibilities that spanned a very many number of institutes and 

centers that constitute in total the NIH. The division of program 

coordination, planning and strategic initiatives was established 

under this Act to give focus to new areas of emerging scientific opportunity, allowing the NIH to coordinate and plan in a cross-NIH 

way new research initiatives that had not been allowed to do and 

able to do in the past. 

As we all know, much of the research that the NIH does is disease-specific, and that is as it should be, but we know that if we 

focus only on one disease, sometimes researchers were blinders to 

advances in other areas that might be of help to them. Under the 

old NIH system, the director presided over this type of research but 

had no ability to systematically inform other scientists of other researchers’ discoveries in other areas in a different institute. That 

was a major problem. Everyone who has looked at the new system, 

6 

the new coordination role that we have under the new law, agrees 

that this new system gives enhanced opportunities to make new 

and necessary medical advances in a more timely fashion. 

I am particularly proud of what is called the NIH Roadmap for 

Medical Research. This is funded through another of the new funds 

that we now have, a fund that is called the Common Fund. The 

roadmap is a set of trans-NIH research activities designed to support high-risk, high-impact research in emerging areas of scientific 

or public health areas. The new law requires transparency so that 

Congress and the public can know what the NIH is doing, how the 

dollars are being spent and what the results of those spending decisions are. 

There is one thing that I hope we can explore today, Mr. Chairman. As we all know, the very structure of the NIH, these institutes that are somewhat isolated, kind of the silo style approach, 

lends itself sometimes to pigeonholing new knowledge. If this is not 

managed correctly, the NIH centers, as good as they are on an individual basis, not only do they not share information, sometimes 

they actually fight other institutes for high-priority funding. That 

is understandable if unfortunate. That is why I think it is so important and why I fought so hard in the last Congress to put in 

this Common Fund approach to get it its own line item and to encourage the Appropriations Committee to actually fund the Common Fund, which they are doing and I am very pleased about that. 

I feel very strongly that the Congress should not micromanage the 

NIH by dictating which disease or which disorder gets the highest 

priority in funding. I want scientists, not politicians, as well intentioned as we can be, and not advocates, as well intentioned as they 

can be, to figure out who gets the most money for the newest disease on the block that is the highest priority. I am proud to say 

that so far this Common Fund approach appears to be working. 

Having said that, there are some of the stakeholders with the 

best of intentions that don’t understand the new system or perhaps 

they don’t want to understand the new system. In any case, once 

again in this Congress, this committee has numerous disease-specific bills before it, all clamoring with some justification that they 

should be the newest highest priority for Congress to fund. The 

whole purpose of the NIH reform bill in some ways was not to say 

we should never fund new research or give a higher priority to a 

different area but that we should let the experts, let the people 

who are most responsible to actually do the research in collaboration working within this new structure decide where to put the 

highest priority. 

Mr. Chairman, again, I want to thank you for holding this hearing. I look forward to participating to the fullest degree possible 

and trying to make sure that the Congress and the people of America understand what the NIH is doing. 

Mr. PALLONE. Thank you, Mr. Barton. 

I next recognize the—well, first I have to thank the gentlewoman 

from Colorado for such a nice convention that we had, and I had 

a chance to go look at the Colorado Springs and Golden and Boulder. It was really nice, I have to tell you. I recognize the gentlewoman. 

7 

Ms. DEGETTE. Thank you. I hope you spent large amounts of 

money when you were in Colorado. 

Mr. PALLONE. I did, unfortunately. 

Ms. DEGETTE. Mr. Chairman, I want to thank you for having 

this hearing on the NIH Reform Act of 2006, of which I was also 

a strong supporter. I want to welcome Dr. Zerhouni and his senior 

staff, who worked so hard. I will waive my opening statement in 

favor of more time for questioning. Thank you. 

Mr. PALLONE. And next is the gentlewoman from Tennessee, Ms. 

Blackburn. 

OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TENNESSEE 

Ms. BLACKBURN. Thank you, Mr. Chairman. I want to thank you 

for holding the hearing. I want to say welcome to our guest. We 

are so glad that you are here. I will put my full statement in the 

record, but briefly, I was pleased with provisions in the NIH Reform Act that cut bloated administrative costs and ordered to focus 

more on funding on research activities. In addition, the legislation 

aimed to improve best practices at NIH, and I am looking forward 

to learning how the NIH has cut the bureaucracy, has increased 

the transparency, has streamlined the interagency communication 

since the NIH Reform Act became law. And I know that communication component was one that had kind of stumbled, so I am 

looking forward to hearing about that. 

NIH must have the autonomy and tools with which to set and 

develop the Nation’s biomedical and behavioral research priorities. 

Often this committee considers disease-specific legislation which directs research funding and activities instead of allowing NIH to do 

the job, and I will continue to urge Congress to move away from 

cherry-picking research dollars since it is the responsibility of the 

NIH, and I do not believe it is the responsibility of Congress to dictate those research priorities. 

I also want to say thank you for giving us the report. Nice way 

to receive that, and I hope that this is an indication of the transformation that we have seen in your communication and your technology capabilities, and I yield back. 

Mr. PALLONE. Thank you. 

I would like to ask unanimous consent that the statement of our 

chairman, Mr. Dingell, be included in the record. Without objection, 

so moved. 

[The prepared statement of Mr. Dingell follows:] 

PREPARED STATEMENT OF HON. JOHN D. DINGELL

I commend Subcommittee Chairman Pallone for holding this hearing today. In the 

109th Congress, under the Chairmanship of my good friend Joe Barton, this Committee worked in a bipartisan and diligent fashion to move legislation which reauthorized and reorganized the National Institutes of Health (NIH). When Congress 

passed, and the President subsequently signed into law, the ‘‘NIH Reform Act of 

2006’’, it was only the third omnibus reauthorization in NIH’s history. 

Passage of the ‘‘NIH Reform Act of 2006’’ was a major accomplishment for the 

Congress and was achieved, thanks in large part to the dedicated work of Representative Barton. It was my sincere pleasure to work with Representative Barton 

and his staff on that legislation. 

8 

As with any major legislation, it is important that the committee of jurisdiction 

exercise its responsibility to oversee and evaluate the programs and activities created. That is why I am so pleased that the Subcommittee on Health is examining 

the implementation of the ‘‘NIH Reform Act of 2006’’. And I welcome Dr. Zerhouni, 

Director of the NIH, who has been an invaluable resource to the Committee. Thank 

you, Dr. Zerhouni. 

The ‘‘NIH Reform Act of 2006’’ enhanced the authority and tools available to the 

NIH Director’s Office to conduct strategic planning and to facilitate and fund transdisciplinary, cross-Institute research initiatives. In addition, the law created more 

budgetary, organizational, and programmatic transparency at the NIH and standardized data and information management systems. 

Although this law was a significant step in the right direction, the NIH still faces 

many hurdles. Challenges facing the agency—such as attracting and keeping young 

scientists, creating opportunities for trans-disciplinary research that cut across Institute boundaries, and managing the portfolio of extramural and intramural research—are only being compounded by insufficient funding. 

After years of significant funding increases for NIH in its fight against disease, 

this Administration has consistently chosen to flat fund or decrease NIH’s budget. 

For instance, the President’s FY2009 budget requested a decrease of $5 million 

below the FY2008 program level. This budget decrease could significantly harm the 

country’s principal medical research agency. This is simply unacceptable. 

I look forward to hearing Dr. Zerhouni’s testimony about the implementation of 

the NIH Reform Act and I welcome his views about how to respond to challenges 

that lie ahead. 

Mr. PALLONE. And the next recognized for an opening statement, 

the gentlewoman from Illinois, Ms. Schakowsky. 

OPENING STATEMENT OF HON. JAN SCHAKOWSKY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS 

Ms. SCHAKOWSKY. Thank you so much, Mr. Chairman, and thank 

you, Dr. Zerhouni. I wanted to give you a personal thank you for 

being helpful to me and my family when we needed help, and I appreciate the opportunity to discuss the direction and priorities of 

the NIH, ensuring that the agency continues to expand its lifesaving research in the interest of all Americans. I want to applaud 

your leadership on these issues as well as the other issues designed 

to advance the cause of biomedical research and improve 

healthcare quality. 

The NIH is our Nation’s leading research institution and we look 

to it to develop cutting-edge cures for debilitating diseases like 

heart disease, diabetes, cancer, and so many other illnesses that 

are families are struggling with every day. And yet over the past 

5 years the Administration has refused to make NIH funding a priority. From fiscal year 2003 to fiscal year 2008, the NIH budget 

has steadily declined. Yet President Bush proposed another reduction in NIH dollars in his fiscal year 2009 budget, representing a 

14 percent decrease from the fiscal year 2003 levels. We are on the 

verge of many breakthroughs in treating and preventing serious illnesses and yet it seems we are moving backwards. 

When we passed the NIH Reform Act, I and many of my colleagues were on record expressing our concerns with the annual 5 

percent increase in NIH funding as provided for in the legislation, 

saying that it was insufficient to keep pace with the rate of inflation. We tried to include an amendment that would authorize the 

NIH with a real 5 percent increase that accounted for inflation and 

rising costs of conducting this invaluable work and were defeated 

despite having the backing of numerous research and patient advoVerDate Nov 24 2008 14:18 Jan 06, 2011 Jkt 037690 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 P:\MY DOCS\HEARINGS\110-144 CHRIS
9 

cacy organizations. We never imagined that we would be fighting 

back gradual cuts to the program and it is time that we corrected 

the focus of this committee and of the Congress. 

NIH budget cuts damage the agency’s ability to support dynamic 

new research projects and recruit talented and creative new investigators. A report authored earlier this year by prominent university presidents and professors highlighted a long list of adverse effects of the flat NIH budget including an 8 percent decrease in the 

overall success rate for vital NIH research projects. We can’t possibly maintain our standing as the world’s leader in first-rate innovative medical research with statistics like those. 

So Dr. Zerhouni, I commend you for continuing to move forward 

with our research priorities on a diminishing budget, and it is my 

sincere hope that the President and this Congress will step up to 

the plate and provide NIH with adequate resources to continue 

your work. Thank you so much for being here again. I appreciate 

it. 

Mr. PALLONE. Thank you. 

I next recognize the gentleman from Pennsylvania, Mr. Murphy. 

OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA 

Mr. MURPHY. Thank you, Chairman Pallone and Ranking Member Deal for this hearing today, and thank you, Dr. Zerhouni, for 

the testimony we are going to hear today. 

The research conducted at the National Institutes of Health is 

critical to improving healthcare for Americans and funding through 

medical research. As an adjunct faculty member myself on the University of Pittsburgh School of Medicine and the University of 

Pittsburgh School of Public Health, I witnessed firsthand many of 

the collaborative efforts that take place and much of the 

groundbreaking research. 

I also want to make sure we thank Chairman Barton during his 

tenure as chairman for the work he did in moving this bill forward 

before and the ongoing work that Mr. Dingell and Mr. Barton have 

pushed for with NIH reforms. I think they paid off. 

But I want to say that there are some areas that I think are so 

important for the future moving forward. The collaborative efforts 

or the latitude that you have or the NIH has in investing in research is vital. But one of the things that I want to make sure, at 

a time when we are concerned about the $2 trillion expense of 

healthcare in America, that NIH can and I believe should play a 

leadership role in pushing for major reforms that can come out of 

collaborative research. That is practical and applied research that 

is aimed at patient safety and patient quality that reduces cost 

such as disease management, such as integrating mental health 

care with other medical care to treat diseases faster, more effectively and less costly. We know, for example, that those with chronic illness and untreated depression have double the medical costs 

of those without depression or those with treated depression and 

yet many times, and I know researchers will get caught in a little 

box and we want to follow that linear thinking but it is important 

that in your role as the head of NIH that you push for people to 

10 

ask the people in the cubicle or the office next door, how does this 

work and how does this apply. That is where great breakthroughs 

can come through. 

One particular area is that the Centers for Disease Control and 

Prevention reported that healthcare-acquired infections in clinics 

and hospitals contribute to between 90,000 and 100,000 deaths in 

the United States each year, which adds over $50 billion to annual 

medical costs. So far this year, from January 1, this means 

1,210,000 infections, 59,891 deaths and $30,273,000,000 in costs. 

And every time Congress looks at the costs of healthcare and Medicare and Medicaid and the VA and private insurance, it is vitally 

important that we think not just in terms of who is paying but 

what we are paying for and what can we do to improve quality. 

This is an area that I hope NIH plays a strong an active leadership 

role in improving healthcare quality in America. 

With that, I look forward to hearing your testimony today and 

I yield back my time. 

Mr. PALLONE. Thank you, Mr. Murphy. 

The gentlewoman from Wisconsin, Ms. Baldwin, is recognized. 

OPENING STATEMENT OF HON. TAMMY BALDWIN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF WISCONSIN 

Ms. BALDWIN. Thank you, Mr. Chairman, and thank you for 

holding this hearing this morning. Also, I thank you, Dr. Zerhouni, 

for being here today. I really look forward to your testimony and 

the discussion that I expect will follow. 

As my fellow members of this committee have heard many times 

before, I represent south central Wisconsin in the Congress and I 

am honored to have the University of Wisconsin—Madison as one 

of the Nation’s premier research institutions as a part of the district that I represent. Much of the university’s success has been 

fueled by NIH funding, so I am eager to have a review and a discussion of the reauthorization passed last session in Congress. 

These are really exciting times for scientific research as we continue to learn more and more about the way that the world works 

and about how the human body functions. We are coupling these 

discoveries with advances in technology and the research possibilities are truly exploding. The ability to conquer a variety of different diseases is truly within our reach at this time. I am really 

continually amazed at the incredible research that is done at the 

University of Wisconsin and the depth of expertise that they house 

in so many different areas of research. From the initial discovery 

of how to grow and sustain stem cells made by Dr. Jamie Thompson in 1998 to more recent discoveries in virus transmission and 

vaccine development, the UW has been a leader in a number of 

very exciting research fields. Today the university is also paving 

the way for more goal-oriented and interdisciplinary research 

through its new Discovery Center, which will focus on nanotechnology, biotechnology and information technology, and in addition, 

through the NIH’s clinical and translational science awards, we are 

training the next generation of clinical and translational researchers. This is a type of progress that I am incredibly proud of in my 

district and I strongly feel that we as members of Congress and as 

11 

government officials should do everything that we can to aid and 

encourage these researchers and not discourage them or tie their 

hands. 

Despite this potential for amazing progress right now, the NIH 

continues to struggle with a shortfall in funding. Because federal 

funding has not kept pace with inflation since 2003, the purchasing 

power of NIH has decreased 13 percent. My colleague, Ms. 

Schakowsky, just outlined some of the consequences. I wanted to 

highlight two others. While it affects all aspects of biomedical research, it has a particularly strong effect on one group and that is 

young researchers. Since 1990, the average age at which a researcher receives his or her first major NIH grant has increased 4 

years from 39 years of age to 43 years of age. In addition, the percentage of major NIH research grants that go to first-time investigators has decreased from 29 percent to 25 percent. So I am interested to hear today how the NIH is coping in this very difficult environment. 

Dr. Zerhouni, thank you again for coming here. I welcome the opportunity to talk about the NIH and look forward to the questions 

that will follow your testimony. 

Mr. PALLONE. Thank you, Ms. Baldwin. 

Next recognized for an opening statement, the gentleman from 

Texas, Mr. Burgess. 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. Thank you, Mr. Chairman. Dr. Zerhouni, welcome 

back to our humble committee. Every time I hear you talk—and I 

have stolen this line from you and used it so many times I almost 

embraced it as my own, but you talk about medicine becoming 

more personalized, and because it is more personalized, it is going 

to be more predictive, and because it is more predictive it can be 

more preventive, and has to be more participatory, and really, 

those are the guideposts for me whenever we talk about healthcare 

policy in this Congress. I want to make certain that we do nothing 

that will deflect you from that path because I believe that to be the 

correct one. 

I was really very proud and pleased to be part of this committee 

in 2006 when we hammered out the compromise that we now know 

as the NIH Reform Act. I am grateful to Chairman Barton for putting so much emphasis on that in the 109th Congress. Part of your 

problem is us, and we come to you and say this has to be a priority 

and this has to be a priority, and when everything is a priority, 

nothing is a priority, and the Reform Act was to try to inject some 

measure of sanity into your world and I am anxious to see whether 

or not we have done that. I am interested to hear about the gains 

we have made in the translational research at the National Institutes of Health. I am interested to hear about the research that 

has been funded and the new demonstration programs that allow 

you to allocate funds and award grants and contracts and engage 

in other transactions for high-impact, cutting-edge medical research. 

And then finally, this year we lost one of the giants in medical 

research, Dr. Michael DeBakey, at the age of 99, and shortly before 

12 

his passing, I had an opportunity to talk to Dr. DeBakey and he 

talked about how the world had been transformed by the NIH, and 

when he was a young man and graduated from medical school, he 

had to go to Europe to get the credential to be a researcher and 

now the world is a different place and researchers come to the 

United States to get the credentials to go into careers in research, 

and he empathically pointed out to me that Congress did that by 

its activity in the 1940s and 1950s transforming the NIH, and if 

it was a priority for the Congress in the 1940s and 1950s, there is 

no reason that it shouldn’t be a priority for the Congress of the 

21st century. 

So I look forward to hearing your testimony today and I assure 

you that we will work with you to make certain that we all achieve 

the goals that you talk about so frequently, and I will yield back. 

Mr. PALLONE. Thank you, Mr. Burgess. 

The gentleman from Utah is recognized for an opening statement, Mr. Matheson. 

OPENING STATEMENT OF HON. JIM MATHESON, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF UTAH 

Mr. MATHESON. Thank you, Mr. Chairman. I will be very brief. 

I want to thank you for the hearing. We all certainly value the 

efforts of NIH, and Dr. Zerhouni, I appreciate your taking the time 

to be with us today. Funding is an important issue, you have heard 

a lot of people on this committee mention that, but it is also important that we know that our programs are being implemented effectively, and that is really the purpose of this hearing to get an update from you on the Reform Act and I think this is wholly appropriate that we are having this discussion today and I look forward 

to your remarks. 

Mr. PALLONE. Thank you. I think that concludes our opening 

statements by the members so we will now move to our first and 

only panel and our only witness, Dr. Zerhouni. Let me just take a 

minute here to first welcome you, and mention that you of course 

are the director of the National Institutes of Health. This is Dr. 

Elias A. Zerhouni, who is also a medical doctor. We have a 5- 

minute opening statement. Since you are the only person though, 

I am certainly not going to stick to that, and I know you said you 

would like to talk a little longer so please proceed. You know your 

statement becomes part of the record, and in the discretion of the 

committee we may submit additional brief and pertinent statements in writing for inclusion in the record. Thank you for being 

here and thank you for what you do. 

STATEMENT OF ELIAS A. ZERHOUNI, M.D., DIRECTOR, 

NATIONAL INSTITUTES OF HEALTH 

Dr. ZERHOUNI. Thank you, Mr. Chairman. First of all, I would 

like to thank you and thank Mr. Deal for this committee meeting. 

I thought it was appropriate that we met with all the members to 

really report to you on the progress of the Reform Act of 2006, 

which passed about 18 months ago. 

But before I do that, I would like to personally and publicly 

thank Chairman Barton, who at the time single-handedly led the 

effort at the beginning and then crossed the aisle and worked in 

13 

an extraordinary bipartisan fashion with Chairman Dingell and 

members in the Senate to make this happen really at the last 

minute of the last 109th Congress. I want to thank you personally 

because it has made a huge difference in the outlook for science 

and the outlook for health in the country. 

And today what I would like to do is to show you why it is important to understand what are the mega trends, what are the real 

trends in science and why is the Reform Act fitting with what is 

happening on the ground in science. So my testimony, my oral testimony will be focused on that, but I have also submitted a full 

written testimony for the record, Mr. Chairman. 

When you think about where we are in science, I would like to 

stress and direct your attention to the slides. We provided also 

hard copies for you. There are four fundamental points. First and 

foremost, I have never witnessed in my career such a rapid pace 

of new and extraordinary discoveries which truly are changing the 

way we see medicine in the future to an era of medicine that will 

be personalized. And it will affect health and the way we manage 

health, we pay for health, we pay in the 21st century, and how our 

costs are going to be affected because of the ushering in of this new 

era. This new era can only be here because scientific progress over 

the past 20 years has led us to realize that diseases as we knew 

them and disciplines of science as we knew them are actually not 

parallel to what the discoveries are. In fact, we are noticing today 

an enormous convergence of science. Fields of cancer research have 

had a huge impact on HIV/AIDS. Fields in cardiac research have 

had a huge impact on cancer research and one of the most successful treatments for cancer, Gleevec, actually came from research initially in the cardiovascular system. In addition, this convergence 

tells us that we have to cross boundaries. You cannot be bound by 

boundaries. You have to be without boundaries going forward in 

the life sciences. 

We also know that it is essential that we match our organizational changes to where the science is rather than fit the science 

into your organizational structures so that if you look strategically 

from the standpoint of the NIH director, you really have an obligation to look at how is the agency, as complex as it is, doing its work 

in the short term. What are the tools to manage the agency in the 

medium term and what are the tools that you need to manage the 

agency in the long term. Agencies don’t change every year. They 

change over several years. Where was the mechanism to do that? 

Programs don’t happen in a month. They happen over 2, 3 years. 

Where was the mechanism to make sure that those were coordinated and were strategic. That’s what the NIH Reform Act has 

done, and my testimony will essentially tell you where is the 

science, what is the rationale for this convergence of science, which 

means that our patients today are likely to suffer from more diseases and mechanisms of disease that affect them across institutes 

and across the missions of different institutes. 

The NIH Reform Act of 2006 really, in my view, solved a fundamental problem as well explained by Mr. Barton, which was to address the medium- and long-term issues and how do you adapt an 

agency as complex as the NIH for its mission. So I would like to 

just take you back for a second in terms of what has happened in 

14 

science over the past 20 years. Fundamentally, all of us scientists 

have gone from observing disease from the outside to try to go to 

the real essence of biology, so we have gone from the surface of the 

cell and then we have gone to the nucleus of the cell and eventually in 1953, the first discovery of the structure of DNA told us that 

DNA was important. But it took us about the last 20 years to unravel the chromosomes: we have 23 pairs of chromosomes, the very 

long, 3 billion basis of the DNA of humans. We had completed the 

human genome in 2003 and we had said that this would be the 

basis of a true revolution in science. Why is that? Why is that long 

stretch of DNA bases telling us that this in fact is a key to the 

mysteries of biology today? 

[Slide shown.] 

So what I would like to do is, if you will allow me, to give you 

a little bit of a sense of how we see it. On the left-hand side is 

DNA. DNA essentially is a code, an instruction book that each part 

of the DNA may code for a particular gene product which usually 

is a protein. So in this case, I am showing you five proteins, A, B, 

C, D and E, but what we didn’t understand is that all of these proteins don’t act in isolation. They all interact. For example, we now 

have what we call networks and pathways of molecules which are 

very complex. So in this case, for example, I show you molecule C, 

which has the ability, for example, with that bar that goes back 

with a stop sign to stop the production of protein A and may encourage the production of protein D, and all of that in health is 

what you need to do as a physician. You need to maintain your patient within what I call the homeostasis zone, where everything is 

in balance. 

Now, we know that disease means that all of these networks are 

out of balance. How do we unravel that complex? The human genome gave us a key and many, many other advances give us the 

ability to study proteins to study RNA and DNA in detail. But now 

let me show you what has happened in the past 3 years that has 

changed the world. Clearly, when we look at the DNA sequence, 

what we are looking for are in the disease state. Perhaps a misspelling, a mutation, as you see that star sign there, that has affected protein C. Well, that mutation is going to change the way 

the protein functions, is going to change usually its shape, and in 

this case, you can see that C is no longer functional, and look what 

happens. If C is not functional, then A is going to grow, and if C 

is not functional, D is going to go down, and all of that basically 

creates a dysfunction. So what you see all of a sudden is in the disease state you have more A than you should, more cholesterol, for 

example, more of a protein that you shouldn’t have, which is what 

we look for when we want to diagnosis a disease. We say, ‘‘Does 

this patient have high cholesterol, what type of cholesterol, how is 

it related to heart disease?’’ That is what we do. And the reason 

I am giving you this background is to now show you what has happened to me in my career here at the NIH over the past 6 years 

and to the world of science. 

On this table, I am showing you the 23 chromosomes of humans 

from one to the last chromosome. We have a pair of each one of 

these, and what we have at the NIH is a map that we developed 

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tutes, and I asked all the institutes to report to me any finding 

that they have made that may explain a dysfunction in one of these 

networks that I showed you of molecules. In 2005, there was one 

discovery which related to macular degeneration, which is a major 

cause of blindness. Then I waited and waited for the reports, and 

in 2006 I had three new reports related to heart disease, inflammatory bowel disease, very surprising discoveries actually, and we 

invested in 2005 in a large effort across all NIH to try to find out 

more of these markers of disease states. Look at what happened. 

In the first quarter of 2007, all of a sudden I got more reports of 

discoveries than I had in the previous 2 years. Second quarter, it 

doubled. Third quarter, it increased again. 

By the fourth quarter of 2007, I knew I had a real problem because all of these discoveries meant a complete rethinking of how 

NIH was going to address these problems. But thanks to the Reform Act, we had a mechanism with the Common Opportunity 

Fund to get together and say how are we going to tackle this. We 

had a retreat of all the directors and we talked about our new 

strategies, and sure, we should have because look at what happened in 2008, first quarter, and the second quarter. This, members of the committee, is an explosion of knowledge. I have never 

witnessed such an explosion in my entire career. I didn’t think that 

we would witness this so fast. 

I will give you an example. We spent years of research trying to 

find out, as Mr. Murphy was pointing out, the complex causes of 

chronic diseases because chronic diseases like diabetes and heart 

disease are the main diseases, and we never found out. Ten years 

ago we had no inkling as to exactly what was wrong in diabetes. 

Today we have 16 genes that we know we are going to investigate 

like detectives. These are clues. We are going to go after them. Autism is another disease that is very worrisome in terms of its presence, its increase, the impact it has on families. We were searching 

around and we decided to invest in a project where we would go 

around the world and do a comparison of patients with autism and 

patients without autism, using these modern methodologies, and 

guess what? We discovered just last month six new genes. Those 

are clues. 

What happens after you have made these discoveries is, you need 

to explore them and you cannot sit back. You have to be nimble. 

The pace of change is so fast that we needed the instruments to 

react quickly and the NIH Reform Act frankly, has done that for 

me and for the NIH and for all of science because it allows us to 

have a conversation that is proactive rather than reactive. So if you 

look, for example, at the plan, what is the NIH plan? The NIH plan 

is after these discoveries are made, these are clues. We are going 

to study more populations, more genes. We are going to try to understand how these complex networks work. That will give us 

leads, real leads, and those will lead to targets once we prove that 

they are indeed, like cholesterol being high, that is a real target, 

and that will then be translated through centers like the Centers 

for Clinical and Translational Science and other things we are 

doing into either diagnostics to be more predictive or prevention to 

preempt disease or treatments. That is the fundamental trend of 

science. But that tells you I have not used the word of any one disVerDate Nov 24 2008 14:18 Jan 06, 2011 Jkt 037690 PO 00000 Frm 00021 Fmt 6633 Sfmt 6633 P:\MY DOCS\HEARINGS\110-144 CHRIS
16 

ease, any one institute, any one organization. You are going to 

have to cross borders and to fertilize across borders, across disciplines, across all types of sciences, physical as well as biological 

sciences. 

So how is that embedded in the future? It means that medicine 

will have to become much more personalized, much more predictive, much more preemptive, but it will require us to go from a 

system of healthcare to a system of health. That is the fundamental change going forward. 

Now, how has that worked for us? Let me just describe for you 

what has happened at the NIH and how the institution has responded to this. First, as I said, all the directors, myself included, 

sat together and said we need to be more nimble, we need to 

streamline the way we make decisions. We had 63 committees, 24 

appropriations, institutes. Everybody had to get their OK, and 

frankly, it wasn’t as functional and we wanted it to be in an era 

where everything is converging. It was fine 20 years ago. It is not 

fine today. So the first thing we did is, we streamlined governance. 

And this is essentially the governance of NIH with a central steering committee of 10 directors that have the authority to basically 

advise the NIH director, and once those decisions are made, they 

are really decisions that we all abide by. That has created a level 

of coordination that we didn’t really have but this only takes care 

of short-term issues and we have five management committees. We 

eliminated 63 separate committees that had a say in the affairs of 

the NIH. That has streamlined things, made it more functional. 

But in 2006 we were able to add, through the Reform Act, the element that allows you to manage in the medium term, and that is 

this Division of Program Coordination, Planning, and Strategic Initiatives. It allows us to have resources to look at what is happening 

in science, where are the gaps, where are the opportunities. Let us 

move quickly in that direction. This is really what I think the Reform Act has given us. 

Let me show you the impact of that. So I would like to show you 

what the mechanisms would have been before the Reform Act. If 

you had an idea, you would have to convince 24 separate institutes 

that this was important to them. But you know in science, bold 

ideas don’t get adopted by 24 people at once. It doesn’t happen this 

way. So typically what happens is, you get convinced when the 

game is over basically, yes, we have already made that, it is pretty 

clear that it is a good investment, like the genome. The Human Genome Project was one of the most controversial projects started at 

the NIH. It was opposed by large majority of individuals who said 

this is just a lot of mechanics but not science. Once it became successful, there is not an institute that doesn’t have a genomics program. So science can’t wait for the consensus of so many. It needs 

to be bold. It needs to be gutsy. It needs to move fast. In the past 

we had obviously the ability to do that but it would take longer because you have to go through the process, then accumulate the dollars. 

Now, in good times when the budgets are rising, there are more 

dollars to give to bold initiatives but what happens when budgets 

are not so generous as they have been generous over the past 5 

years. You have to really make priority decisions. How do you 

17 

make those priority decisions? Well, do you take away from cancer 

and give to something that may not have anything to do with cancer? That is a difficult proposition, and that is where the system 

really slowed down in an era where convergence occurred. We tried 

an experiment. We said, look instead of having this, let us use a 

small percentage of the NIH budget and put it in a common fund 

and let us discuss then about the most exciting opportunities in 

science, and that is what the roadmap prototype was and I was 

really pleased to see that in fact it was adopted and the directors 

contributed and we had some projects that were initialled immediately and implemented in a way that a lot of people said we 

couldn’t have done it without a Common Opportunity Fund, if you 

will. And that was enshrined in the Reform Act and this is what 

I think as an institutional mechanism this committee has done. 

You have enabled us to separate the question of monies, opportunities and 24 different opinions about where science is, to a more 

nimble organization where now the appropriators have appropriated a Common Opportunity Fund which allows us to basically 

function in a very different way. Now if you have an idea, it goes 

through this very high-level analysis with lots of experts across all 

fields. It doesn’t relate to one institute or one disease. They look 

at the entire portfolio. They invite scientists from all areas of 

science and then they make a priority call, and if there is a priority 

call, it goes through this NIH Common Opportunity Fund, 1.8 percent of the budget, and then it goes back to an institute that says 

I am going to take the lead. So we are supplementing the institutes’ budgets depending upon science, not depending upon an appropriation process that is not related to the scientific priorities. 

So I am just going to give you one example of a breakthrough 

that occurred because of that. When we had the Common Opportunity Fund, we decided to provide what we call molecular libraries, compounds that only pharmaceutical companies had in the 

past. Scientific researchers in academia did not have access to that. 

And we did it because we had advances in robotics and advances 

in basic technologies that allowed us to test 1.5 million compounds 

against a disease target in less that a week. It would have taken 

a year and a half before. 

Now, let me just show you just one example of how that has 

changed one disease, schistosomiasis. It affects 200 million people 

around the world. We had a scientist, Dr. Williams at the University of Illinois, who for 20 years had been researching it and was 

hoping that he could test a compound that he thought would work. 

Within a week, he worked with the NIH center and he has the first 

compound that the WHO is saying is the number one discovery in 

tropical diseases in the last 50 years. So this is what has happened 

thanks to the Reform Act. 

But going forward, what we are going to do is to continue what 

the other part of the Reform Act that I don’t think is well understood that is written in law. And that is that NIH has to continue 

to innovate despite all of the environmental difficulties, challenges, 

budgets. America has to invest in high-risk, high-impact research. 

So we did. We have committed over $1 billion, in these budget 

times, trust me, it is not so easy to do, $1 billion to what we will 

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search. This could not have happened before the implementation, 

the passing of the Reform Act. Trust me. We couldn’t have done it. 

For example, we have implemented what we call the Transformative RO1, what we call Discoveries Without Boundaries, and 

I am showing you a little cartoon about what Discoveries Without 

Boundaries is not, and that is, ‘‘I will be happy to give you innovative thinking, just give me the guidelines.’’ No guidelines. That is 

what we wanted. This allowed us to, for the first time, establish 

a program with no boundaries, and it is implemented now. We will 

see what happens. We will learn from it. 

Last but not least is transparency. You have asked us to be more 

transparent. We intend to be. We have implemented an automated 

system to report to you exactly what we spend on what disease, 

how much we spend on it, and you will have the basis of that information. We are distributing this electronically. You can search it 

on your computer. If you have any question, you can go back to this 

and find out what NIH is doing. 

This is the first biennial report. We decided that this was a lot 

tougher to understand and nowadays you can plug that into your 

computer, put the words you want, and you will find out exactly 

what NIH is doing. Now, it is not perfect. Let me just make sure 

we don’t oversell this. This is new technology. It is knowledge management. It is looking at all of our data. We are going to learn from 

it, but at least we are biting the bullet of transparency and we 

want to do it in a way that I think will satisfy you and satisfy the 

Act. 

Last but not least is the sense that ‘‘long term’’ needs to be taken 

care of and long term means continuous improvement to look at the 

agency over years. We never had a mechanism to do that. Every 

time Congress wanted to reform, they would form an ad hoc committee that didn’t really know what happened before and had no 

stake in what would happen next. So the idea, and I want to credit 

again Chairman Barton for that, was to create a very empowered 

Scientific Management Review Board and this Board has been 

impaneled and the role of this Board is to advise the NIH Director 

to conduct continuous, and the world ‘‘continuous’’ is important. 

Comprehensive organizational reviews of NIH and report these 

findings no less than every 7 years to the HHS and Congress, so 

that you have a mechanism that is accountable about understanding these changes and proposing changes that are buttressed 

by facts. 

Mr. Chairman, I know I have abused the time and I apologize 

for going over time but I thought it was important to see the connection between why the Reform Act was important in the context 

of science that is changing so fast. Again, thank you very much, 

Mr. Chairman. 

[The prepared statement of Dr. Zerhouni follows:] 

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Mr. PALLONE. Thank you. I did want to hear a full statement 

from you. That is why we had you as the only witness today, so 

thank you. And now we will have some questions and I will start 

with myself. 

You mentioned in the Reform Act there were multiple changes 

in the administration, organization, and they created new initiatives and responsibilities for the agency including increased transparency, accountability, the trans-NIH research activities, which 

you said were so important, and in your testimony you outlined the 

progress NIH has made implementing these new provisions. However, as I mentioned in my opening statement, we know the funding for NIH has been decreasing in real terms in recent years. So 

can you elaborate on the challenges you face implementing these 

new initiatives, given the lack of funding increases? 

Dr. ZERHOUNI. Right. So we have to be modest. The purchasing 

power of an agency depends obviously on its budget relative to inflation. So there is no doubt that you have to manage relative to 

inflation. Costs don’t go down. The cost of oil doesn’t go down. The 

cost of food doesn’t go down. Everything has a certain ratio of inflation. So the way we have managed this is by truly identifying what 

are essential priorities of the agency. For example, one essential 

priority of the agency is the funding of the next generation of scientists. I think Mrs. Baldwin mentioned the fact that early stage 

investigators are funded later and later. We have initiatives to prevent that: high-risk, high-impact research. I showed you $1 billion 

committed to pioneer awards and new innovator awards so that we 

can sustain—— 

Mr. PALLONE. So tell me, that was another one of my questions, 

this new innovator award because, I mean, I know we hear a lot 

about the importance of ensuring that NIH attracts these young investigators. Why is that so important and what does this new innovator award do to accomplish that? 

Dr. ZERHOUNI. So it is an award for really deep innovation by individuals who are less than 10 years from their doctoral degree. So 

it is the individual between 30 and 40 who is really trained, understands the issues and has a new idea. What happens if you do not 

do this in a period of constrained budgets, people become very conservative. They really don’t want to present high-risk ideas because 

they are afraid that there won’t be enough basis to be supported. 

So we want to dedicate dollars to those individuals. That is what 

you have to do in periods of stress when less than 20 percent of 

our applicants get funded. 

Mr. PALLONE. And then one of the concerns I always have, even 

constituents will mention this if they are familiar with NIH, is that 

the translation from discovery to patient care. In other words, you 

have the basic biomedical research, which is what we think of NIH 

doing, but it has to translate into, you know, research to the patient’s bedside. Do you want to comment on that at all? And again, 

given the new changes and the lack of funding how you deal with 

that. 

Dr. ZERHOUNI. That is a crucial question, Mr. Chairman. You are 

putting your finger on probably the weakest, most difficult link to 

manage that we have. Let me show you, let me just tell you that 

if you look at the productivity of the pharmaceutical industry in 

34 

terms of new discoveries, it has gone down even though the pharmaceutical industry spends twice as much as NIH on research. 

What really needs to happen is an integration and a reinforcement 

both of our basic research according to what I showed you, which 

is understanding these complex connections, but understanding 

these complex connections cannot be just understood in the lab, 

they have to be understood in patients. Well, over the years what 

has happened is that it is more and more difficult to connect the 

basic scientists with the translational scientist who is going to do 

this and vice versa. So that response has been one that came from 

the ability to have a Common Opportunity Fund to make sure that 

the system does not come apart. It is not funding bench to bedside 

research alone. It is really to fund all of it. We believe that at NIH, 

about 60 percent of our budget should really be dedicated to basic 

discoveries but 40 percent should be applied research, and that applied research needs to focus on that translation in addition to all 

of the other things we do, for example, in vaccine development and 

so on. It is the connectivity that is the issue between those fields 

and the disciplines, unless you break the barriers, are not going to 

work with each other. And NIH’s programs are designed to glue 

these components of the discovery process. 

Mr. PALLONE. Is there anything that you suggest that we do? I 

mean, obviously today is not just about the past but about the future. Do you have any ideas for what we could do to deal with that 

problem or to make it easier? 

Dr. ZERHOUNI. I think that if you really analyze the issue, NIH 

has taken the lead in terms of creating a home for translational 

science in conjunction with basic sciences. It is not exclusive of 

each other. In fact, we are trying to build the bridges here. But if 

you really think about new, young physician-scientists who are critical to this process, they are being run ragged, let us say, because 

the clinical service demands in their institutions are high, their 

training demands are high. They don’t have the time to dedicate, 

and Dr. Burgess probably knows that very well, to 100 percent research at the translational edge. It is important if we are going to 

do this to find a way of funding these early-stage investigators not 

just through NIH but through Medicare, through Medicaid, 

through whatever R&D source we need to sustain that class of individuals, Ph.D.s and M.D.s who are dedicated to accelerating our 

discoveries in the human population. It is at risk. If you go to academic health centers, you will see that many departments are losing their best talent because we don’t have the ability to sustain 

them at the right level. So that is what I would do. I would say, 

you know, preservation of the clinician scientists of the future, the 

next generation of scientists is a fundamental issue. 

Mr. PALLONE. OK. Thank you very much. 

Mr. Deal. 

Mr. DEAL. That was a very impressive presentation. I am glad 

that we got to hear the full explanation of how you linked all this 

together. I think that is one of the best presentations explaining 

complex matters that I have heard. 

Let me ask you this. Given that certain disease-specific research 

proposals receive significant private funding, and I use the example 

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cessful for the cancer society last week, does NIH consider this fact, 

that is, the amount of privately raised revenue in making a decision as to what proposals will be funded within the NIH budget? 

In other words, how do you reconcile those two streams of funding? 

Dr. ZERHOUNI. Right. So this is a very good question. The real 

question is, is that extra funding sustaining something that is very 

critical or is it just duplicative? That is the issue. And when we 

look at it in different fields, we realize—for example, cardiovascular 

research. If you look at all of the impact we have had on mortality, 

which has dropped 70 percent both for heart disease and stroke, 

you realize that we spend, every one of us, every American spends 

about $4 a year on cardiovascular research. If you look at cancer 

research, all of us spent about $9 over the past 30 years in the war 

on cancer, $9 a year. Everybody will tell you that even with philanthropy plus private funding, that we are still below where we need 

to be, particularly in cancer, because of the growth of—I mean, it 

is becoming the number one, it is the number one cause. So what 

we are trying to do is coordinate with the private foundations. For 

example, now we share our databases on what grants were accepted, what grants were not accepted so that we don’t duplicate efforts. We have a transparent system with not just the cancer society but all funding agencies now. We open up through this transparent process our own databases for grants. That is one. The second is, we believe that because of this issue of early-stage investigators, that these private efforts are very important to maintain 

the next generation of scientists to be able to work on cancer, work 

on other things. I don’t have that ability at the scale I would like 

it and so that is very important. So we work on two things: creating new talent, innovative talent, new people, new scientists and 

making sure we don’t duplicate. Let me just assure you that with 

all of that, if you look at the productivity of pharma-spending twice 

as much as we do and not coming up with many, many targets, it 

tells you that more science according to the lines of what I described is going to be the key and that means more investments in 

people, talent, resources. 

Mr. DEAL. I am sure that every other member of this subcommittee, like I, continue to receive requests from disease-specific 

groups for targeted legislation that would fund their particular disease, recognizing that some diseases obviously receive more outside 

funding than others. In order to balance your research among all 

disease-specific research proposals, would it be beneficial to establish a separate fund for less privately funded research proposals to 

ensure that they get adequate representation in the overall process 

of both private and publicly funded research? 

Dr. ZERHOUNI. I think so. I think it is a good idea to have more 

open communications with the patient advocacy groups. I don’t 

think it is a good idea to basically through different pressures to 

say, well, X goes to Y and Z goes to Z. Disease specific—what you 

understand as a disease today may be completely different 5 years 

from now, and diabetes is a good example. What we understood the 

disease to be 10, 15 years ago, a lack of insulin, now we understand 

in type 2 diabetes that it is really not the lack of insulin that is 

the problem, it is the resistance to insulin. Things change. So my 

sense would be that through this new division that we are impleVerDate Nov 24 2008 14:18 Jan 06, 2011 Jkt 037690 PO 00000 Frm 00041 Fmt 6633 Sfmt 6633 P:\MY DOCS\HEARINGS\110-144 CHRIS
36 

menting to have that conversation of coordination and 

prioritization openly and transparently and not just through back 

channels and try to get separate legislation for each one. That only 

fragments the effort and it really, I think, disequilibrates the scientific progress. 

Mr. DEAL. Well, I know that all of us are under that pressure 

and I think the fact that you have done such a good job of using 

the tools that are at your disposal under the 2006 Act has made 

it easier for many of us to resist those private groups saying we 

want you to just focus on us, and I wish that many of them could 

hear the explanation you have given us about how integrated all 

of the research really is. I think it would make them feel better if 

they really thought that they weren’t totally being left out of the 

equation. 

Thank you very much for your testimony today, and I yield back. 

Mr. PALLONE. Thank you, Mr. Deal. 

For questions, Ms. Eshoo. 

Ms. ESHOO. Thank you, Mr. Chairman, and Dr. Zerhouni, thank 

you for your outstanding presentation—cogent, highly instructive, 

encouraging, and it is an eloquent statement about your leadership 

at the NIH. I have always thought that this committee’s jurisdiction of NIH is really the crown jewel of Energy and Commerce and 

I am very fond of saying to my constituents that NIH stands for 

the National Institutes of Hope, and I think that what you have 

presented to us today in detail is that much hope is being realized 

as a result of the legislation and so kudos to you, certainly to the 

ranking member of the committee when he was chairman as well 

as the rest of the committee for far-reaching legislation that ha 

brought us to what you presented to us today. 

Now, earlier this year Dr. Zerhouni came to my congressional 

district, flew across the country to come to Stanford University 

where we had really an inspiring forum on technology and innovation and healthcare. At that time you reiterated many, many times 

the importance of a really clear vision for the future of healthcare 

and medicine, looking beyond managing the present and really protecting the future. I hope I am bringing some credit to the breadth 

of what we were attempting to examine that day, and I think that 

you said at the forum that we can’t be short-term wise and longterm foolish. When 75 percent of our healthcare expenditures are 

related to chronic diseases, it raises the question of how do you 

think the NIH Reform Act addresses these long-term goals. That 

is my first question. 

My second question is, having examined the efficiency now of 

being able to bring translational interpretation to what NIH is 

doing, I also know, we all know that it isn’t any secret that the 

NIH needs more funding. The dollars will have the potential of 

fueling what you are doing. The fewer dollars there are, the harder 

it is to make progress even under the best of reorganization, and 

I think this is the best of reorganization. You gave us a statistic 

in February that for every year the NIH falls behind in terms of 

inflation and deinvestment decouple the NIH by $1 billion. We lose 

6,000 scientists. I think these figures are correct. If they are not, 

I want you to correct them. It takes 20 years to train these 6,000 

scientists. That is 120,000 years. I mean, that just takes my breath 

37 

away. It should take all of our breaths away. It takes $100,000 to 

train scientists effectively and that is $12 billion. So taking two 

steps forward and one step back I don’t think is an effective way 

to fund the NIH. So my question is, when so much of our 

healthcare costs go toward managing chronic diseases, do you think 

that increasing—I guess it is a softball question, but it is the big 

question because I would like to see, as we have decoupled the bureaucracy from what needs to be done and gotten rid of the silos, 

and you have made the most magnificent presentation to us of the 

overall funding at the NIH is not where it should be. Tell us where 

you think we should go from there and how we do it. 

So those are my two questions, and thank you again for your 

leadership. It isn’t very often that we come to a hearing and leave, 

I think, on a high. But what you presented today is so encouraging 

and so hopeful for humanity, so thank you. Congratulations on 

your grandson’s first birthday and taking his first steps on his own 

in life. 

Dr. ZERHOUNI. Thank you. It happened just after the NIH Reform Act. 

Ms. ESHOO. Well, good for us. 

Dr. ZERHOUNI. First of all, thank you for having really a very 

good recall of our conversation there. I think what is essential is 

to understand the long-term impact of short-term decisions in 

something like science and health, which really goes over a long 

time. You don’t train a scientist overnight. You train them over a 

long period of time. Once you have lost them, you have lost them. 

So the point I was making is sustainability and predictability of 

funding is essential, to have the talent to tackle the problems of 

chronic diseases. That is number one. So having these ups and 

downs, and the number I gave you is correct. In other words, if you 

really look at the impact, at the end of the day some people will 

have to leave the scientific workforce and they are. So we have 

young people right now who choose other careers because of the unpredictability. So predictability and reasonable inflation corrected 

rate of growth, is essential for anything. And that in science is 

even more important because you are talking about a 20-year cycle 

to train someone. And you have made all that investment and all 

of a sudden they go. So you need to sustain that. 

Second, I have to give credit to my colleagues at the NIH. They 

all realize what is happening in science. They are the best of the 

best and truly have come together. So I will give you some examples beyond the Reform Act. Neural sciences and mental health 

issues are going to be very important to the chronic-disease burden 

of the country. Depression, as Mr. Murphy mentioned, is going to 

be a real challenge in the age between 25 and 44. So all the institutes that have to do with neural sciences came together for what 

is the NIH Neurosciences Blueprint. They came together spontaneously and said let us just work across that. As an example, they 

came then to the Common Opportunity Fund and said, the key to 

chronic-disease management is going to be behavior change, how 

do you change the behavior and how do you comply—— 

Ms. ESHOO. It operates like a venture capital fund, doesn’t it? 

Dr. ZERHOUNI. Exactly. It is a venture capital fund. So they came 

in and guess what? We have an initiative called the Science of BeVerDate Nov 24 2008 14:18 Jan 06, 2011 Jkt 037690 PO 00000 Frm 00043 Fmt 6633 Sfmt 6633 P:\MY DOCS\HEARINGS\110-144 CHRIS
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havioral Change, because we realized we don’t really know how to 

change people’s behavior. So that is an investment that came from 

that concept of, how do you manage chronic diseases. The second 

is obesity. There is a trans-NIH obesity research plan. As you 

know, if we do not tackle this issue as a society, it is likely that 

life expectancy will decrease again. So we really want to work on 

these issues. But that is not just a NIH topic, it is a societal topic. 

But how do you get the people who are going to do that in a time 

where every year you tell them, well, your chances of getting funded are 20 percent, 15 percent, 10 percent. If you are a smart 25- 

year-old and you say I am going to work 10 years to finish my 

training in science, by age 35, like my son, have a child and try 

to get a job and then I am told, well, next year the budget may 

be this, may be that, you may get it, you may not, and then you 

don’t get your first grant by age 42, it becomes daunting. So we 

have a fundamental issue. If you want to tackle chronic diseases, 

which are 80 percent of the cost, you have to have the workforce 

for it. Look at the issue of geriatrics. These are specialists who take 

care of the aged population. The number of geriatricians trained is 

actually going down at a time when the aging population is exploding. This is something that needs to be thought about and this 

committee really needs to look at the intricacies of how that happens. NIH is just the head of the fountain, but if there is no water 

in the fountain, trust me, you won’t be able to solve the downstream problem. 

Ms. ESHOO. Dr. Zerhouni, I want to work with you on legislation 

that is going to address this so that it is shaped and modeled to 

appeal regardless of what side of the aisle members may be on because this is, I think, one of the major areas for us to address and 

it is for future generations. We cannot have the spigot shut off. The 

costs are too high. We know what the challenges are. The best 

news today is, is that we can seize these challenges and really leapfrog way into the future. But we have to make sure that we have 

the appropriate funding stream that sustains and that it is not 

stop-start. So I want to work with you and with all of my colleagues on this, and thank you again for your brilliance and your 

leadership. This is a terrific hearing. Thank you. 

Mr. PALLONE. Thank you. 

Mr. Barton. 

Mr. BARTON. Thank you, Mr. Chairman. 

Thank you, Dr. Zerhouni. I appreciate the biennial report. I had 

it in the old form, the book, and I just got this. I need a port to 

put this in my brain. My problem is, my brain is analog and this 

is digital, so if you will have your scientists work on a way to input 

this directly, then I will see if we can’t get funding for it. I do appreciate it. 

I also want to compliment you on your kind words for me in your 

opening statement. You would think that you and I are related because you say nice things about me and I say nice things about 

you. As far as I know, there were no Zerhounis in Hill County, 

Texas, and I doubt there were very many Bartons in your neck of 

the woods, so we are not related, so this isn’t a brother-in-law deal 

where we—like county commissioners sometimes get involved with. 

39 

You have done an outstanding job in implementing this Reform 

Act and it truly is reform and it truly is transformational. You 

paint such a positive picture. If you are even 60 percent correct, it 

is amazing what has happened in the last 2 years. I mean, it is 

really stunningly amazing what this Act has done. I wish that 

Chairman Dingell were here and hopefully he is watching and I 

know how busy he is and hopefully he is watching in his office on 

television the hearing because we intentionally set up the Act when 

we passed it 2 years ago to be a 3-year authorization. It has been 

2 years so next year, 2009, we need to reauthorize the NIH if we 

want to continue the progress. So it is important that we have this 

hearing. 

Now, my first question is, we required in the Act the establishment of an electronic system of coding to uniformly code research 

grants and activities so that they would be transparent, not only 

within the NIH but also to the public. This is a mandatory coding 

requirement and it is not voluntary. Could you comment on the implementation of this mandatory coding system and how it is being 

received and what the status is of it being fully implemented NIHwide? 

Dr. ZERHOUNI. Right. Dr. Krensky, who is the head of the Office 

of Portfolio Analysis and Strategic Initiatives, is here and has 

worked almost 2-and-a-half years. The first question that we resolved was, do we use manual coding, do we use an army of coders 

and then provide that to Congress like we have in the past in the 

260 categories. We consulted widely, and it was very clear that in 

the age of Google, where you can have a search engine that can go 

in millions and millions of pages, that can extract information and 

present it to you, we thought we should adopt as a federal agency 

something that is the wave of the 21st century, and that is what 

we call knowledge management software. So all of the NIH system 

has been developing around this concept that you develop software 

and then you go into all of the grants and you identify through 

these automated search engines what it is that relates to diabetes 

or cancer or whatever you are looking for, and then you post it. In 

the past we had a judgment staff. People would say, well, this 

grant is 10 percent this, 20 percent that, and that is why advocacy 

groups were very frustrated with us and that is why you heard 

about the complaints of the advocacy groups saying we are not getting good information here, we don’t know where the information 

is coming from, how is it analyzed. So we decided to embrace the 

21st century for information management and it is a real, real 

breakthrough in terms of our ability to manage our portfolio. It is 

new, it is novel. The problem is that it doesn’t give you the exact 

same results you used to see, and for institutes that had a long history of coding their own data according to their own priorities, it 

does present a problem, and how do you reconcile the new information with the old information the way you used to and how do you 

manage the coding that was there. 

Obviously the new system is going to be evolving and it is not 

going to be perfect the first day. But how do you explain, for example, that an institute would have said, well, I am spending $100 

million on this and our system searches this and says well, no, it 

is $80 million. How do you do the transition? So some institutes 

40 

have had difficulty with that, especially when you realize that the 

Reform Act gives the obligation to NIH to report on everything. 

Mr. BARTON. Well, is it a technology difficulty or a human reluctance to implement? 

Dr. ZERHOUNI. I think it is both. I think it is obviously cultural 

and control of information but also the sense that what these results are, this is a new system, knowledge management. What is 

that? Google search of your grant portfolio and then you are going 

to make that public and everybody can go in and say, gee, why is 

this grant here and not here? So you end up with a tremendous 

cultural change of—— 

Mr. BARTON. Would it be helpful if we gave some incentives to 

those institutes that meet the coding requirements sooner than 

others, or if you want to be punitive, disincentive to those that 

don’t so you get more money next year if you are fully coded and 

implemented or less if you are not? 

Dr. ZERHOUNI. I think this is so new, what I would do is, I would 

get the Scientific Management Review Board to look at that and 

to say, well, are we achieving our goal. Now, I will give you the 

statement that says don’t think you are going to be happy day one. 

No one is going to be happy day one. But over time we will improve 

that. 

Mr. BARTON. But if you had to put a percentage in terms of 

meeting the mandatory requirement for coding, would you say that 

overall the NIH has 70 percent implemented it, 50 percent implemented it, 25 percent? 

Dr. ZERHOUNI. Right now? 

Mr. BARTON. Yes, sir. 

Dr. ZERHOUNI. Oh, 90 percent. 

Mr. BARTON. Ninety percent? 

Dr. ZERHOUNI. Ninety percent, yes. We have absolutely no issue. 

The only issue is when you want to go deeper in an area, how do 

you do it. So my decision was, look, you can report your coding as 

your coding. It doesn’t comply with the Act but for the transition 

period I am find to see how you would walk the community 

through what the RCDC numbers are and what yours are as long 

as you are transparent. The problem is, in the past, we have had 

an issue, for example, in health disparities. Three, 4 years ago we 

had a scathing report from the National Academy of Sciences and 

when they re-looked at the source of the coding, they disagreed 

with our coding. So that is why the RCDC exists. That is why you 

have mandated it. And we are embracing it. I think at this point 

it is a matter of watching it for a while. I wouldn’t decide to be punitive until I see it a little more. But I think the Committee and 

you as the governing oversight board have to stick to the line that 

we need an accountable, transparent automated system that can be 

followed over the years. Don’t change the rules on me every 6 

months, which is what the problem was. You cannot manage something you don’t reliably know. This is the attempt to have the portfolio understood consistently and reliably. 

Mr. BARTON. Mr. Chairman, I know my time has expired. Are we 

going to be allowed to ask additional questions? 

Mr. PALLONE. I wasn’t planning on having an additional round, 

Mr. Barton. I mean, if you want to ask—— 

41 

Ms. DEGETTE. Mr. Chairman? 

Mr. BARTON. No, I know the other people have waited a long 

time so I would just hope that after everybody asks one round, I 

am going to ask unanimous consent at that time if I could ask a 

few additional questions because this is my one shot to really focus 

and I appreciate the hearing but I don’t want to abuse the prerogatives of the other members here. 

Mr. PALLONE. OK. Ms. DeGette. 

Ms. DEGETTE. Thank you, Mr. Chairman. I was going to ask 

unanimous consent to give Mr. Barton 5 more minutes, but I will 

just go ahead. 

Dr. Zerhouni, I always hate to use cliche ́s about elephants but 

there is an elephant in the room and it is really the level of funding 

for the NIH. I want to explore that a little bit more in depth with 

you than just obviously the NIH could use substantially more resources. But I want to drill down a little bit with that, because 

what really struck me with your presentation, aside from the overall brilliance, were these two slides you had about the genome-wide 

association discoveries, how in 2005 you got this little blip and then 

by the second quarter of 2008 you had an explosion of discoveries. 

And I am wondering if you can describe for me if, for example, Congress made the kind of commitment that we had back in the 1990s, 

which was to double the NIH budget, if we made that kind of real 

commitment in the next term of Congress, what could we do from 

a concrete research standpoint to take those genome discoveries 

and move those along in your next matrix towards translation 

diagnostics, prevention strategies and therapeutics? 

Dr. ZERHOUNI. I think personally that there are three priorities 

that need to be taken care of. First is the issue of the workforce. 

I think Congresswoman Eshoo was saying we should have a conversation about this. I think we need to have a conversation about 

that. I am very concerned. We have made projections. We are seeing the aging of the scientific workforce and we are seeing the absolute number of new investigators who come in not growing at the 

rate I would like it to grow. So the first thing we need to address 

is, how do we sustain the new generation of scientists who are 

going to solve these problems when we know the scope of the problems and also the scope of opportunities is much greater than it 

was before, and that is—— 

Ms. DEGETTE. Well, and just to interrupt you, the other problem, 

you know, I have a daughter who wants to potentially go into research who is a sophomore in college, and I look at her peers 

around her—it is not just the labor pool, it is the amount of debt 

burden these kids are going to have when they come out of their 

postgraduate programs. 

Dr. ZERHOUNI. That is right. So you need to almost have a conversation that is way beyond NIH, the United States science and 

technology workforce trends and strategies to make sure we are 

competitive as you see the growth outside of the United States. We 

need to tackle that at the early entry stage. You don’t have the 

bright minds to solve the problems if you don’t take care of them 

at the beginning. So that I think is priority. 

Ms. DEGETTE. And what do you mean concretely by that? Do you 

mean debt relief from loan relief and also salaries? 

42 

Dr. ZERHOUNI. I am not sure that I would be willing to say it is 

X, Y, or Z. I think we need to—it is a systems approach. You really 

need to look at it from science education all the way to funding. 

But you need to focus on that issue and perhaps you need to identify resources that are unrelated to whether or not inflation you 

say we have to invest in the talent pool first. 

Ms. DEGETTE. I just might say on that, you might get your staff 

to work on some ideas more concretely around what those funding 

levels would look like and what we need to do. 

Dr. ZERHOUNI. We have, and I am happy to share that for the 

record, if you wish, to tell you what our projections are. We have 

had long conversations across all institutes on this issue. The second is the issue that Chairman Pallone was raising and that is, 

you know, how do you sustain over time. I think predictability is 

very important there. So you can’t in this sort of environment make 

ad hoc decisions. You need to really have a long-term plan, and the 

problem that we have is that it is hard to make long-term plans 

for anything. So one of the issues that I see in science management, not just NIH, is how we decide strategic investments that 

are more than 1 year or 2 years at a time, and how do you sustain 

that. 

The third is very simple. As you think about it and you say what 

is it that really would stabilize the system, it is the success rate. 

And if the success rate goes way below a number, then you have 

a difficulty in sustaining the effort. People adapt to the new 

science. We have changed the kind of science we do all the time. 

NIH has been terrific at doing that. The problem is that if you do 

not have a reasonable success rate, you lose your talent pool. So 

what is a reasonable success rate, right? You are going to ask the 

question. I have thought about this for 6 years and I will tell you 

what the answer is. On average, we give a grant for 4 years, which 

means that if you are going to get renewed and maintain that research, you need a 25 percent success rate because you are going 

to renew it every 4 years, and if you don’t have a quarter success 

rate, that is the bare minimum to just stay level. If you don’t ensure that, you are losing. Ideally, you would want to sustain what 

you have and then fund those new ones, right? 

Ms. DEGETTE. Right, right. 

Dr. ZERHOUNI. Which means that your success rate has to be 

above 25, and historically, we have done extremely well in terms 

of adapting to new science when we are around the 30 percent 

range. So that is my technical opinion. Obviously that has implications. But those are the three things: new investigators, sustained 

success rate, and a predictable long-term path to investing in longterm issues that we deal with. 

Ms. DEGETTE. I think as we move into the rest of the fall and 

since Congress will be leaving soon, it would be extremely helpful 

if your team could start to put some thought on price tags for that 

because when we come in to the next Congress, I think one thing 

we are going to be trying to look at is how we can commit ourselves 

to really making progress with these exciting new research breakthroughs that we are seeing, and in large part I think because of 

the Reform Act. 

43 

I just want to ask, you know I couldn’t have you come here without talking to you about stem cell research, so I had my staff pull 

the budgets for stem cell research, and you know this as well as 

I do, the total stem cell research budget at the NIH for fiscal year 

2007 was $650 million. Forty-two million dollars of that was for 

human embryonic stem cell research and the rest of it was for 

adult stem cell research, placenta, umbilical cord, et cetera. I am 

just wondering if that level of research dollars is really enough to 

sustain robust research, given some of the discoveries we have seen 

both in the private sector and around the world, or if it would really be helpful to get more dollars and of course less conditions? 

Dr. ZERHOUNI. I asked myself that question, and as you know, 

we do not have a cap on dollars to fund human embryonic stem cell 

research. There is absolutely no limit. If you have a good proposal, 

they come in, we fund them if they pass review. What you see out 

there is, we fund pretty much all the good proposals that we get 

in human embryonic stem cell research but they have to do them 

with the stem cell lines that we have, and some researchers just 

don’t feel that those lines are now appropriate for looking at the 

issues. What are the issues they are looking at? As you know, we 

have made great progress in induced pluripotent stem cells, adult 

stem cells. The other $610 million is invested in those areas. But 

let us remember one thing: Dr. Thompson from Wisconsin could not 

have made his breakthrough in understanding how to create induced pluripotent stem cells that are not human embryonic stem 

cells without the human embryonic stem cell research he has done. 

That is how we discovered the factors that take an adult cell and 

transforms it into pluripotent stem cells. So a lot of researchers are 

saying look, I understand the very first step to make something 

pluripotent, I still need to understand how it becomes a neuron or 

heart cell—I am simplifying—and a diabetes cell. We have had 

great breakthroughs over the past months and year so a lot of scientists are focusing on that. They are not really looking at embryonic but they are going to come back and say now, next step, I 

found the first four factors, what are the next five or the next 10 

that do that. So I think you are going to see an up-and-down requirement for that funding but a lot of them fund that through private sources obviously. 

Ms. DEGETTE. A lot of them, they think that pre-2001 cell lines 

are not effective so they are funding their funds for that research 

somewhere else. 

Dr. ZERHOUNI. I have a diversity of opinion on that. Some people 

still use NIH stem cells and say that they are useful. Others say 

no, I really want to study new stem cells with new methods to look 

at the genes, how they are expressed so I can learn what factor. 

The goal right now is that people don’t want to use embryonic stem 

cells in the long term. They want to really find the factors and then 

reprogram adult cells in the individual. That is the dream. It is not 

to take human embryonic stem cells. So I think that we need to 

fund all avenues of research. I think the $42 million is just the fact 

that you have that many researchers making good proposals. We 

have no bias in terms of one or the other. 

Ms. DEGETTE. No, no, I know. Thank you. 

Mr. PALLONE. Thank you. 

44 

Next for questions, Mr. Murphy. 

Mr. MURPHY. Thank you, Mr. Chairman. 

A couple areas here that I just want to let you know, a lot of my 

constituents have been talking lately about multiple sclerosis and 

cystic fibrosis and hoping that those areas are recognized, that a 

lot of major breakthroughs are coming through, and my hat is off 

to you and NIH and people who are doing the important research 

in that, and as those are chronic conditions, it leads me back to the 

discussion I had in my opening comments, and that is, in the areas 

of neural science and human development, which are part of the 

categories we look at here. You mentioned the key to disease management is behavior change. Could you elaborate on what you are 

finding with that? 

Dr. ZERHOUNI. Right. So as we analyze the issue, we have deep 

conversations within the Office of Portfolio Analysis and Strategic 

Initiatives, this process that we now have, and there was a consensus that although we fund behavioral sciences, that we needed 

to have a more basic understanding of the science of behavioral 

change. We had papers that came out showing that if you understood that, you could actually change the proper level of control of 

blood sugar, for example, in diabetes. How do you maintain that? 

How do you encourage that behavior change and sustain it? Clearly, it is the key to chronic-disease management in what you could 

call non-communicable emerging diseases like obesity and heart 

disease and so on. We basically decided to invest in more fundamental research. I don’t have the answer. I can tell you some anecdotes of what we are thinking about. We know, for instance, that 

if you look at public health measures, typically a passive public 

health measure works a lot better than an active public health 

measure. Let me be specific. If you look at seat belts, that is a public health measure. It took 50 years to get to 85 percent compliance. I mean, we knew about seat belts in the 1950s. That is an 

active act. It is a very simple one. It doesn’t cost you anything, it 

is in the car, and yet you have difficulties in implementing it. 

Mr. MURPHY. I would like to sit down with you, if I could, and 

spend a lot of time on this. With my background in psychology, I 

would like to follow up on that. I have a lot of questions, and I will 

submit more for the committee too. I would also like to know if it 

is OK with the chairman, I would like to yield the remainder of my 

time to Mr. Barton so he could follow up on some questions with 

you too. 

Mr. BARTON. I will wait until the end. I will let every member 

ask their questions. 

Mr. MURPHY. In that case, then I yield back, because I would like 

to follow up in excruciating detail with you. 

Dr. ZERHOUNI. That is great, but I think you are on the most important issue, Congressman. 

Mr. MURPHY. Thank you very much. I yield back now, Mr. Chairman. 

Mr. PALLONE. Next for questions, Ms. Schakowsky. 

Ms. SCHAKOWSKY. I have a question that is about a couple of spe- cific programs. There was a $52 million cut to end the national 

children’s study over Congress’s objections and I have heard from 

medical researchers and academics as well as families that are 

45 

very concerned about this study, and I wondered if you know why 

the Administration wants to end this funding, what kind of data 

would be eliminated if the President succeeds in cutting the funding. 

Dr. ZERHOUNI. Again, this is an issue of priorities. We looked at that study 3 years ago. It is a $3.2 billion study. Because of the 

other issues that we had to deal with and the flat budget, we 

thought that allocating that much money in these days, including 

the support of the National Institute of Child Health and Human 

Development, that the timing was not right and the priorities were 

different in terms of what we needed to dedicate dollars to. 

Ms. SCHAKOWSKY. It just seems like it is so in line with the kind 

of priorities that you said doing this kind of longitudinal study beginning now of children, the environmental impact that cause disease. It seems like a real missed opportunity to get started in this 

kind of comprehensive look at what is affecting our children. It is 

disappointing. 

I wanted to ask you about brain drain, about some researchers. 

I talked to one that was going to Dubai to look for funding, and 

if there is the feeling because not only the ability to recruit new 

investigators but we have heard that—it is not just not getting 

grants but that the grants have been cut in size, that some important research is going overseas to various countries. 

Dr. ZERHOUNI. I hear that. On an anecdotal basis, yes. Then we 

look at the tracking of the numbers, we are not seeing an exodus 

of major scientists leaving. I mean, they would stay here. But it is 

true that we have had to be very stringent on increases in the 

budget so we have had, for example, no inflation for several programs, and when you look at that, the scientist has a choice: find 

new sources of funding, either through the private sector, or in 

many cases let people go. That is where the number 6,000 scientists leaving the workforce comes from at a time when the pharmaceutical industry is not expanding. It is also downsizing. And 

that gives an opportunity for other countries to take some of the 

talent that we had developed here. I don’t see it today as a major 

exodus of talent but I am very concerned about it, and we cannot 

go on hoping that that won’t happen. It will happen if we do not 

pay attention. Other countries are increasing their investment in 

research. China, for example, has a program specifically designed 

to recruit scientists from the United States to China. It is good for 

science. I mean, it is great that those scientists are not leaving 

science, but I don’t think it is good for the integration that we described here as necessary to make progress. 

Ms. SCHAKOWSKY. And the kind of continuity, I think that—— 

Dr. ZERHOUNI. That kind of continuity, yes. 

Ms. SCHAKOWSKY. Tom Friedman wrote an article in the Sunday 

New York Times about innovation and promoting innovation as 

really being the future competitive comparative edge for the United 

States of America. You emphasize that as well, and I think a lot 

of us are concerned that we are losing these opportunities by a 

shortsighted view about the funding at NIH. I wanted to ask one 

other specific question. A few years back there were reports of senior officials at NIH receiving cash gifts from some of the same companies that received NIH funding. I wonder if you could tell us 

46 

what ongoing measures your office has implemented to safeguard 

against unethical practices. 

Dr. ZERHOUNI. Right. Let me make sure that the record is clear. 

There were no senior officials getting money from anybody that 

was receiving grants. The issue—— 

Ms. SCHAKOWSKY. Some researchers? 

Dr. ZERHOUNI. Researchers. 

Ms. SCHAKOWSKY. OK. Sorry. 

Dr. ZERHOUNI. At NIH, as you know, there is a firewall between 

the scientists who do research at NIH and the scientists who decide 

what grants get given. We have always maintained that firewall. 

I am not aware of a case in that—and Mr. Barton was actually 

overseeing that at the time where there was an official decisionmaking person who was getting that. 

Ms. SCHAKOWSKY. I appreciate the distinction. 

Dr. ZERHOUNI. Right. So now, in terms of scientists, we had undisclosed relationships that were not known to us that related to 

interactions with the pharmaceutical companies or others where, in 

fact, knowledge acquired through government resources, acquired 

through government employment, where it was used to gain private consulting fees and so on. We really tackled that in a very direct way. We just say that is just off limits. You can do it, we want 

you to work with industry, but on an official basis with a fully 

transparent agreement that know exactly all of the data. My philosophy is this: It is not all bad to work with industry. I mean, 

there are some good things that come out of it, especially when you 

are talking about new discoveries. The problem is the secrecy. So 

I want more sunshine in these relationships. You cannot manage 

what you don’t know. So if it is not disclosed, how do you manage 

it? So that has been our philosophy. I think it has really not damaged NIH. Everybody predicted that our scientists would leave in 

droves. I think it has actually improved the ability to work with 

industry on a fair basis, understanding exactly what is given, what 

is received for what through formal overseeable agreements and 

peer reviewed through an independent conflict of interest committee. 

So I feel that actually the NIH internally has done a terrific job. 

I would like to thank Dr. Kingston, who is the deputy director and 

is the director of ethics. It is been hard. He has been unpopular. 

It has been difficult, but now people as they see what is happening 

in the rest of the world, which is moving real fast, are actually 

thankful to have more clear rules that they can employ without 

preventing them from interacting but it has to be on an official 

duty basis, not a private basis. 

Ms. SCHAKOWSKY. Thank you. 

Mr. PALLONE. Mr. Burgess. 

Mr. BURGESS. Thank you, Mr. Chairman. 

Again, Dr. Zerhouni, thank you for spending so much time with 

us this morning. This has really been a pleasure to have a hearing 

that is based on success and achievement and to hear one of the 

rare good news stories that we hear come out of a federal agency, 

so I thank you for your presentation this morning. 

You know, the subject of appropriations comes up, and I understood the philosophy of the Reform Act was to provide you with a 

47 

stable source of funding over the 5-year authorization of the bill. 

There was a lot of discussion as we did the bill, was a 5 percent 

increase year over year satisfactory or would the rate of biomedical 

inflation erode that. But the sad fact of the matter is, I don’t know 

what you got in the appropriations process last year. I think it was 

about half of what we had authorized, and then this year of course, 

we have done no appropriations work at all so I presume that 

means we write our IOU in a few weeks. You will get what you 

got last year. So that activity has undermined the intent of the Reform Act of 2006, has it not? 

Dr. ZERHOUNI. Well, in terms of priorities and choices to make, 

they were a lot harder, and as I said, there are still remaining 

areas of concern. The good thing is that the appropriators, after 

you passed the Reform Act in 2006 and the joint resolution, decided 

to fund entirely the Common Opportunity Fund. So that is no 

longer coming out of institutes. It really removed the friction there. 

But since then, things have been relatively flat for everyone. So it 

is really managing and making tough calls and priorities that has 

happened. Clearly, we would really be much better served not to 

have enormous increases one year and nothing the next, but have 

a predictable curve. 

Mr. BURGESS. And again, it is a shame with all of the work we 

did on that that we didn’t manage to follow through with the appropriations process. For your sake, I hope we do our job better in 

the future because I think that is so important. 

You know, you talked about some of your templates for success, 

your benchmarks for success, and I just can’t help but wonder, because in this committee we deal with the FDA, we deal with HHS 

and the Center for Medicare and Medicaid Services, are there any 

templates that would work in your world that would also work in 

other words of federal agencies? Are there going to be ways to 

apply what you have learned with this very great story that you 

presented to us today to be able—you talk about paying for health 

and not just healthcare. Are there going to be ways that we can 

real world, real time translate that to other federal agencies and 

make it a two-translational process, not just within your world but 

other areas where you intersect with other federal agencies? 

Dr. ZERHOUNI. That is a very interesting question. I think the 

lesson that I learned is this: that typically Congress for good reasons makes decisions and appropriates in buckets. What is lacking—that makes strong fingers. Every bucket is a really strong finger. Everything you do is really justified. The problem is, you have 

these fingers but you have no palm. The mechanism that was created at NIH is a very experimental, innovative, new and working 

mechanism to create the glue. How you can translate that to other 

issues will resolve the issue that I hear all the time, in meetings 

with members, private and non-private, about how do we get more 

coordination, how do we get more synergy between the different 

areas of FDA, CDC, and frankly, that issue is inherent to the structure of how Congress authorizes agencies. I think thinking about 

mechanisms of gluing through maybe a common pool of resources 

that is managed jointly. That might be an experiment to expand, 

I believe. That is my personal belief. This is not an Administration 

view. 

48 

Mr. BURGESS. It is just a phenomenally interesting concept. One 

other thing, I just have to offer the observation, your slide where 

you showed the explosion of new information on the human genome, and of course, there are actually commercial applications out 

there that someone can go on the Internet today and have their genome sequenced for under $1,000. I mean, it is a phenomenal 

amount of information that we are putting at people’s fingertips, so 

much so that the New England Journal of Medicine in one of its 

perspective articles a few months ago sort of talked about how does 

the average clinician now deal with a patient coming in and saying 

this is what I got, doc, what are you going to do. But it is truly 

a transformational time in medicine and I congratulate you for 

being able to be transformational in what is inherently a transactional process which is what we do here in the House of Representatives. I think we can all afford to be optimistic because of 

the work that you do, so thank you, sir. 

Mr. PALLONE. Ms. Baldwin. 

Ms. BALDWIN. Thank you, Mr. Chairman. 

You have had quite a few questions about the challenges of dealing with tight NIH budgets. I want to focus on one particular category of awards, the clinical and translational science awards, because that is a program that really leverages the academic expertise found in particular institutions to shorten the distance between 

the clinical research and the patient care. I have heard anecdotal 

information that some of the grants have been or the awards have 

been much lower than anticipated, and of course, a factor of tight 

budgets, but recognizing that you are working with those tight 

budgets, can you tell me a little bit about the strategy of continuing 

to find more sites with smaller grants rather than contracting a 

number of sites and having a more adequate award amount? And 

I know these are tough decisions, but I would just like to hear your 

thinking in making those decisions. 

Dr. ZERHOUNI. Yes, this was a tough set of decisions, and again, 

you have to balance what I believe is the mainstay of where discovery comes from, and that is investigator-initiated research. The 

real issue here is that we, through this process of analysis, that we 

go through now regularly, identified the need for re-engineering 

how clinical research and translational research is done. So the 

new program brought the investment from about $300 million a 

year to about $500 million in 2011–12 when we get to full spending. The idea there is that these CTSAs will have access to other 

sources of dollars from the institutes. So that the fact the CTSA is 

leveraging investment, you give the ability to the institute to really 

play at a different level, and some institutes have done it. You will 

see that, for example, University of Wisconsin is a terrific example. 

They have the facility to do translational science better than many 

other institutions. So the question is, do you look at this as a 

leveraging investment that will then accumulate other investments 

on a competitive basis or not. It is basically a resource grant that 

you give with no questions asked. We had to make the cut and we 

said $500 million is the envelope because of the budget being so 

flat. We had to set that tone. Now, the number of institutions is 

another issue and this is going to depend on our analysis of the effectiveness of the networks as we have them. As you know, we 

49 

funded 38. The number 60 came from the fact that we had a transition to manage between the old system to the new system. That decision is not fully made that we will go to 60. We will analyze it 

now that we have had 2 years of experience and that decision may 

be different downstream. 

Ms. BALDWIN. You were just talking a little bit about in response 

to Dr. Burgess’s questions about the palm that connects the fingers, and I know when we were discussing the NIH Reform Act 

last session, we were talking about the establishment of the new 

division of program coordination, planning and strategic initiatives, 

and there was some pushback from some advocates about how this 

would affect offices that were already conducting programs that 

crossed institutes and centers. So I am wondering with a little bit 

of experience now if you can talk a little bit about how the creation 

of this division has affected the operations of the program of offices 

such as the Office of AIDS Research and the Office of Research on 

Women’s Health. 

Dr. ZERHOUNI. Very good question, and remember the time the 

controversy occurred. You know, some people said no, we want to 

keep this, and people want to keep their thing and it is a very difficult transition to go from what you have to a new world that may 

be better but you have no proof that it will be better. So we have 

been very careful. We have moved in steps. And remember the Act 

says to preserve the authority of these offices. So the Office of 

AIDS Research is so large, so intertwined already that there is not 

a lot of need. I mean, they are doing a good job and it is 10 percent 

of NIH budget, AIDS research, so they need to continue to do this. 

We don’t want to disturb that. Other institutes, other offices that 

are smaller, then found this to be a great way of leveraging their 

institute so the Office of Behavioral and Social Sciences Research, 

OBSSR, has been a real participant, bringing new ideas and trying 

to leverage what they have and try to push the Opportunity Fund 

to go into the behavioral sciences area, which his what we have 

done. So you see a difference there. I think it needs to evolve slowly. You don’t want to break what isn’t broken sort of philosophy, 

but over time, it will from the bottom up. We have the Office of 

Portfolio Analysis and Strategic Initiatives. Dr. Krensky is the director and is working real hard. We are trying to over a period of 

18 months, 2 years then get to better integration, which will happen. So we have not touched the authorities of the existing offices 

of coordination because they are doing a coordination job that is decent in most cases. 

Ms. BALDWIN. Thank you. 

Mr. PALLONE. Thank you, Ms. Baldwin. 

The gentlewoman from North Carolina is recognized for questions. 

Ms. MYRICK. Yes, thank you very much, Mr. Chairman, and 

thank you, Doctor, for what you presented today but also what you 

do in thinking outside the box all the time. We appreciate it, and 

I think you have pretty much heard everybody agrees and supports 

your efforts in looking for ways to make it better. 

Kind of following up on what Dr. Burgess was saying, you half 

answered what I was going to ask because I am curious about how 

the coordination between Department of Defense and Centers for 

50 

Disease Control because we know money goes into those areas that 

is not actually NIH money, but you know when you are talking 

about research-related activities between the two, is that pretty 

much the palm when you said the bucket is in the palm? 

Dr. ZERHOUNI. Right. 

Ms. MYRICK. And that is an area that we really need to take 

more seriously and see where we can expand on that relative to the 

value of the dollars. 

Dr. ZERHOUNI. So again, I am glad that you bring that up because I have had internal conversations about what we can learn. 

I think there are two things that I would share with you, and 

again, this is my personal opinion, it doesn’t represent the NIH 

view. 

Ms. MYRICK. I understand. 

Dr. ZERHOUNI. Two important components to this. One, don’t create another layer. It is a mistake to create another layer, another 

institute that is going to coordinate everybody else or another agency that is going to coordinate everybody else. That is not the right 

thing to do. What I found very important is to understand the 

problem, allocate the dollars to it, but then have a streamlined decisionmaking process. But once you have made that decision, give 

the money to the agency best capable of accomplishing the task. So 

if we have a food safety issue, there should be some pool that 

doesn’t get argued over for 24 months while we have a food safety 

issue. Give the money to the FDA to solve that problem, then you 

recirculate those dollars. That is what we have. You know, the 

money in the Common Opportunity Fund is never allocated forever 

to one goal, it is every 5 years you have to rotate. That is the beauty, I think, of the Reform Act. It gave us, for the first time, the 

ability to just put money in a bucket and never get it out, which 

is the typical problem with federal programs: it never sunsets. So 

this gives you, I think, a more traditional mechanism to keep 

adapting and responding in record time. I have to tell you, some 

of the programs we launched this year, the Microbiome to look at 

microbes in all humans, A.P. Genome to understand how the genome is controlled, those happened in a matter of months. In the 

old days it would take 4 years to get that. So that is my observation, Congresswoman. 

Ms. MYRICK. Well, we appreciate it, and I think most everybody 

would be willing to work with you on that to try and bring about 

change because it is most important that we keep it moving, and 

I also share the other concerns that were raised, some that Anna 

raised and especially the ones with young people going into science 

and how we coordinate all of that because we are so far behind the 

rest of the world, and you mentioned China. I mean, China is 

just—they are doing everything they can in every area to move 

their country forward and we are going the other direction, and 

that is very scary to me, but thank you very much. 

Thank you, Mr. Chairman. I yield back the balance of my time. 

Mr. PALLONE. Thank you. Mr. Barton. 

Mr. BARTON. Well, first of all, Mr. Chairman, thank you for the 

hearing again and thank you for allowing me the courtesy of asking a few questions. Dr. Zerhouni, I want to kind of go right at 

what would be the $64,000 question, if you remember that old quiz 

51 

show from the 1960s. There are not many of us that watched it, 

but I can remember it. Three years ago, the big push for a new institute and a new funding priority was autism. We had major bills 

in both the House and the Senate and we did pass an authorization 

bill creating some new specific structure for autism and we also enhanced the funding but we did subjugate the overall reprioritization to the NIH Reform Act. In this Congress, the big 

push seems to be breast cancer and environmental research. There 

is a bill that the majority of this committee has sponsored and 

there is a major push to add some specificity of prioritization for 

that very high-profile and high-interest disease. My question to 

you, and hopefully we are at the stage where we are now as a Congress working to funnel these heartfelt requests for high-priority 

increases or at least re-prioritization to this new framework within 

the NIH. How would you think this new structure accommodate a 

Congressional and a stakeholder supported request for some sort of 

a re-prioritization of a specific disease or condition? Do you have 

an interagency task force mechanism or some sort of a mechanism 

with one of these new committees that instead of the Congress 

passing legislation, we can work within this new system to funnel 

this concern, which is legitimate. I am not downplaying the autistic 

concern of the last Congress or the breast cancer and environmental research concern of this Congress. 

Dr. ZERHOUNI. Right. These are valid concerns, I agree with. I 

think if you pay attention, I mean, autism—I have a friend with 

an autistic child—you know the pain, you know it is hard, you 

know it is difficult, and you know we need a solution and we need 

to understand it better. So the human response is typically a positive one. You want to help, whether it be breast cancer or—the 

problem is, how do you do it in a way that does not create a lockedin sort of self-fulfilling concept of research that really never leads 

to that progress. In the past, as you know, you create a new unit, 

you create a new structure that never, never adapts to how science 

really evolves. That was the past. I think the Reform Act capped 

the number of institutes and issues, which was a good thing. I 

think in the next situation we really need to think better about 

how to take into account valid aspirations of disease groups and fit 

them into a process at the NIH where we can really analyze that. 

So in the case of autism, as you know, there is an interagency coordinating committee that is going to come up with a strategic plan 

in November. Once we have that, that will fit in the discussion of 

these program coordination and strategic initiative group that we 

now have. The downside is, we only have 1.8 percent of the budget 

in that Opportunity Fund. It is hard to do when you have to commit grants to 4 years, 5 years to an initiative. You can’t change initiatives every other year, so you have to be steady. But at the end 

you recirculate the money in new priorities. That would be my recommendation, that maybe in the next situation or somehow that 

when a problem like this is identified, Congress will say look, we 

want you to develop a strategic plan, submit it to the priority-setting process of the entire agency if need be, or if it is very focused 

we can recommend, come back to you and say this really needs to 

be funded as a separate program. 

52 

Mr. BARTON. Under your current structure at the NIH, does the 

NIH have the ability if directed by the Congress either legislatively 

or informally through a letter signed by the chairman and members of the committee in the House and the Senate to create an 

interagency task force to focus on a high-priority need that hasn’t 

been as focused on in the past? 

Dr. ZERHOUNI. Absolutely. We do this informally. 

Mr. BARTON. You have that—— 

Dr. ZERHOUNI. It is not a formal process. It is an informal process. So autism, for example, we had already without the Act what 

we call the autism matrix where we identified what needs to be 

done. The real issue though is, how do you get to implementation 

but then you don’t get into an implementation. We have created an 

entitlement forever in an area of research that will never be productive because things change. That flexibility is what I think the 

problem is in mandating things. I see the legislation that is coming 

down. Normally they mandate that we plan and we coordinate but 

they say oh, no, now we are going to appoint a committee that is 

going to tell NIH where to spend the money. That is an absolute 

mistake if we would go that route. Let me just be as clear as I can 

be. You should not separate the accountability and the authority. 

Mr. BARTON. Now, as I said in my opening statement and as you 

have alluded to, this is a 3 year authorization bill. We are in the 

second year so we have got one more year. If Congress does its job, 

we should in the next Congress in the first year reauthorize for X 

more years so that we continue what we have done. What is the 

one thing when we do the reauthorization hopefully next year that 

we didn’t do 3 years ago that we could do or should do next time 

around? If you had to point to one unfinished piece of business, 

what would that be? 

Dr. ZERHOUNI. OK. First of all, this issue that you raised, we 

need to do a little more thinking about how to help Congress and 

help NIH tackle this issue of valid rising concerns of any one kind 

or another. How do we do this without trapping ourselves in a rigid 

system where, fundamentally, if you do this then the NIH is going 

to look like special interests at the end, and that is not what you 

want. So that I think is a very good question. We need to think 

more about it. The second is clarification. Authorities across the institutes are different and it is sometimes ambiguous and I think 

the Act has to, I think, in my view, equalize all the authorities 

across the institutes. I mean, why would an institute have authority X and not another institute. I think those authorities are good. 

I am not saying take anything away. I think you need to really 

equalize them and so that you don’t end up with games that really 

prevent one institute from doing something and another one—I 

think a level playing field in terms of authorities would be a good 

idea. I don’t believe that any one disease is superior to another, 

and all of them are really integrated now. You know, you don’t 

have a patient that suffers just one thing at a time so we have to 

really take into account the fact that health has changed and level 

playing field and look at that. 

The other is, I have to tell you, Mr. Chairman, I learned one 

thing. The way the process works does not allow us to do good 

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ments. I am going to take an example from a non-NIH institute. 

The United States invests in long-term projects with other countries in fusion research, energy research, and with the process that 

we have, we have become an unreliable partner worldwide when 

we need to make long-term investments that are significant. That 

process, in my view, needs to be rethought. How do we make investment at NIH over 10 years’ time for new capital, new resources, expensive resources? I can’t do this if the next year I am 

going to be having a budget that is unpredictable so we need to 

have a management of long-term issues separately. 

Mr. BARTON. I appreciate the chairman’s patience with me. I 

want to end up on a very high note, so I want to ask this final 

question. You alluded in your comments to some breathtaking 

breakthroughs in research on diabetes. Do you believe it is possible, given the progress that is being made, that we could either 

cure diabetes in people that have it or prevent it for future populations? 

Dr. ZERHOUNI. Absolutely. I am totally positive about this. 

Mr. BARTON. What about Alzheimer’s? 

Dr. ZERHOUNI. That is a harder one for me to call. Diabetes, we 

can—— 

Mr. BARTON. Would you care to predict a time frame for a breakthrough on diabetes? 

Dr. ZERHOUNI. That is dangerous to do, not advisable. If I was 

beginning my tenure, I would absolutely refuse to do that. Now I 

can probably do it and get away with it. I would definitely say that 

in diabetes, we will have ways of preventing, if implemented, the 

development of type 2 diabetes in a large number of individuals. 

Mr. BARTON. In how many years? 

Dr. ZERHOUNI. Ten years. Yes, I think it is clear. Alzheimer’s disease, I have to tell you, I believe in the preemption approaches. I 

think it will take longer. It is not possible for me to see how we 

would reverse the progress of Alzheimer’s disease. We can stop it. 

I don’t think we will prevent it any time soon, 10, 15, 20 years 

maybe. 

Mr. BARTON. Well, we are fortunate to have you as a public servant in the role that you play and we very much appreciate your attendance. 

Again, Mr. Chairman and Chairman Dingell, I really appreciate 

the scheduling of this hearing and the way it has been conducted, 

and I yield back. 

Mr. PALLONE. Thank you, Mr. Barton. 

And of course, we are done today but I do want to thank you, 

Doctor, for first your presentation and answering the questions, 

and I think we did get the insight that we wanted to into what was 

happening at NIH and hopefully we can make some changes, although I still think the biggest problem is money and I guess I 

could say that about so many issues here. But thank you again. I 

guess I will mention that members may submit additional questions in writing. The way it works is, they are supposed to submit 

them to the clerk within the next 10 days and then we would notify 

you so you may get additional questions to answer and we appreciate the response. 

54 

Thanks again, and without objection, this meeting of the subcommittee is adjourned. 

[Whereupon, at 12:20 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

STATEMENT OF HON. GENE GREEN

Mr. Chairman, thank you for holding this hearing today so we may revisit and 

assess the progress of the NIH Reform Act of 2006. 

The NIH, the world’s leading biomedical research institution, is one of the great 

success stories of the federal government. Our investment in this life-saving research has led to advances that have profoundly improved the length and quality 

of life for millions of Americans. 

Information gained from NIH research is revolutionizing the practice of medicine 

and future directions of scientific inquiry. 

Without a doubt, the work performed at the NIH is invaluable. The 

groundbreaking research supported by NIH has provided a lifeline of hope to countless Americans living with diabetes, cancer, HIV/AIDS and many other illnesses. 

In 2006, this committee was led by a fellow Texan, Mr. Barton, who worked diligently on the NIH Reform Act of 2006. At that time Congress had not reauthorized 

the National Institutes of Health in more than a decade. 

The bill created a Common Fund, through which the Director of the NIH could 

support the important research that involves several institutes and centers at the 

NIH. 

The NIH Reform Act also ensured that this new Common Fund did not overshadow the important research being performed at the individual institutes and centers by stipulating that only 50 percent of funding increases appropriated by Congress each year can be dedicated to the Common Fund. 

Unfortunately, nearly every year since the passage of the NIH Reform Act of 

2006, the President has chosen not to adequately fund the NIH. Instead he has 

opted to ask Congress for meager increases in FY07 and FY08 and for flat level 

funding in FY09. 

These funding levels do not even cover the cost of inflation and show a lack of 

commitment to research at the NIH. 

I was proud to support the NIH Reform Act because my hometown of Houston 

is home to the world-class Texas Medical Center, which houses many facilities that 

conduct groundbreaking NIH research. 

The Baylor College of Medicine and Texas Children’s Hospital conduct more NIH 

pediatric research than any other NIH grantee. 

The University of Texas’s MD Anderson Cancer Center also conducts critical NIH 

research and is frequently recognized as the top cancer center in the country. 

I believe it is crucial that the NIH be appropriated adequate funding level by Congress so that NIH research performed at the Texas Medical Center—and other impressive research facilities across the nation—will yield continued contributions to 

our understanding of disease and the development of effective treatments to improve the health and well-being of all Americans. 

I want to thank Dr. Zerhouni for appearing before the Committee today. It is good 

to see you again. 

Thank you Mr. Chairman, I yield back my time. 

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