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79–502 PDF 2002

S. HRG. 107–433

NOMINATION

HEARING

BEFORE THE

COMMITTEE ON HEALTH, EDUCATION,

LABOR, AND PENSIONS

UNITED STATES SENATE

ONE HUNDRED SEVENTH CONGRESS

SECOND SESSION

ON

ELIAS A. ZERHOUNI, OF MARYLAND, TO BE DIRECTOR OF THE

NATIONAL INSTITUTES OF HEALTH

APRIL 30, 2002

Printed for the use of the Committee on Health, Education, Labor, and Pensions

(
(II)

COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

EDWARD M. KENNEDY, Massachusetts, Chairman

CHRISTOPHER J. DODD, Connecticut

TOM HARKIN, Iowa

BARBARA A. MIKULSKI, Maryland

JAMES M. JEFFORDS (I), Vermont

JEFF BINGAMAN, New Mexico

PAUL D. WELLSTONE, Minnesota

PATTY MURRAY, Washington

JACK REED, Rhode Island

JOHN EDWARDS, North Carolina

HILLARY RODHAM CLINTON, New York

JUDD GREGG, New Hampshire

BILL FRIST, Tennessee

MICHAEL B. ENZI, Wyoming

TIM HUTCHINSON, Arkansas

JOHN W. WARNER, Virginia

CHRISTOPHER S. BOND, Missouri

PAT ROBERTS, Kansas

SUSAN M. COLLINS, Maine

JEFF SESSIONS, Alabama

MIKE DeWINE, Ohio

J. MICHAEL MYERS, Staff Director and Chief Counsel

TOWNSEND LANGE MCNITT, Minority Staff Director
(III)

CONTENTS

STATEMENTS

TUESDAY, APRIL 30, 2002

Page

Kennedy, Hon. Edward M., a U.S. Senator from the State of Massachusetts ... 1

Gregg, Hon. Judd, a U.S. Senator from the State of New Hampshire ................ 3

Mikulski, Hon. Barbara, a U.S. Senator from the State of Maryland ................ 4

Prepared statement .......................................................................................... 5

Sarbanes, Hon. Paul, a U.S. Senator from the State of Maryland ...................... 6

Warner, Hon. John W., a U.S. Senator from the State of Virginia ..................... 8

Zerhouni, Elias A., M.D., nominated to be Director, National Institutes of

Health, Bethesda, MD ......................................................................................... 9

Prepared statement .......................................................................................... 23

(1)

NOMINATION

TUESDAY, APRIL 30, 2002

U.S. SENATE, COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS, Washington, DC.

The committee met, pursuant to notice, at 10:02 a.m., in room

SD-430, Dirksen Senate Office Building, Hon. Edward M. Kennedy

(chairman of the committee) presiding.

Present: Senators Kennedy, Mikulski, Wellstone, Gregg, and

Warner.

The CHAIRMAN. The hearing will come to order.

This is a very special day for our committee. There are a lot of

important matters that this committee concerns itself with, but I

think that every member of this committee and all Americans take

a great sense of pride in our National Institutes of Health, and the

one who serves as head of that institution has a very special responsibility and a very special honor.

So we are looking forward to considering someone today who has

been extremely highly recommended and is very highly qualified,

and we are looking forward to having that hearing in just a few

moments.

My friend and colleague, Senator Gregg, has an extremely important conflict and wanted to be here at the opening, so I would ask

him if he would be good enough to say a word, and then we will

move ahead and recognize my colleagues, and I will make a brief

comment, and then we will get on with the hearing.

OPENING STATEMENT OF SENATOR KENNEDY

The CHAIRMAN. We are glad they are all here. Very good and

very impressive that they are all here.

I have just a few comments on the importance of this hearing

and the position to which Dr. Zerhouni has been nominated.

If confirmed, he will become the first NIH Director in this new

century of the life sciences. The NIH budget increased to more than

$27 billion this year. These funds support research and training in

thousands of research institutions across the Nation and around

the world. Leading the NIH is an awesome responsibility that will

determine the quality of life for millions and millions of Americans

for many years to come.

NIH research ranges from studies of microscopic structures in

living cells to investigations of patterns of disease in entire populations. NIH research not only gives us information about what

keeps us healthy or makes us sick, but it reveals new insights into

who we are as human beings.
2

The advances made by NIH research in just the first 2 years of

this new century are extraordinary, and the future promises still

greater wonders. Already in this century, NIH research has helped

map the human genome. No less important than these basic genetic studies are recent findings from NIH scientists that structured lifestyle changes can significantly reduce the risk of diabetes,

sparing millions of Americans from this deadly disease.

The impact of NIH research on human health is incalculable.

Life expectancies have risen dramatically over the last century, and

some scientists believe that the first human being to live to be a

productive 150-year-old is already alive today.

Never before have the challenges for NIH been greater. The anthrax attacks of last fall taught the Nation what many of us knew

already—that powerful techniques of modern biology can be used

not only to heal, but to harm. Just this week, The Brookings Institute published a risk assessment showing that one million Americans could die in a major biological attack.

NIH must provide the leadership required to develop new medical weapons in the battle against terrorism. I know that good

progress is already being made in the race to develop better vaccines against smallpox, anthrax, and other dangerous pathogens.

We should give our full support to those vital research projects.

As clinical research has grown in size and complexity, the challenges it poses for human subject protection have likewise increased. Many members of our committee have been concerned by

the strains in the current system. NIH will have an important role

to play in restoring confidence in clinical trials, and I look forward

to making progress on this important issue in a bipartisan way.

Today we have the opportunity to hear from Dr. Zerhouni his vision for meeting the challenges and seizing the opportunities of

this new century of life sciences.

Elias Zerhouni is a living example of the American dream. He arrived from Algeria with little else but his medical training—and a

desire to help his fellow human beings facing disease. I believe that

all of us on this committee can agree that his contributions have

been extraordinary.

As a researcher, Dr. Zerhouni has contributed new methods for

imaging living tissues that are in use in hospitals around the Nation. As a skilled administrator, he has demonstrated leadership

and vision time and time again at Johns Hopkins. He has revitalized the medical school’s Clinical Practice Association. He has

worked skillfully with scientists, business leaders, and elected officials to create a thriving biotechnology park.

Most recently, he established the groundbreaking Institute for

Cell Engineering. At this remarkable new facility, scientists are exploring the potential of stem cells to alleviate some of the most

deadly diseases we face as a Nation. The stem cell research conducted at the new institute is already providing new insights into

therapies for Parkinson’s disease, spinal injury, diabetes, and other

serious illnesses.

I would like to extend my thanks and the thanks of this entire

committee to Dr. Ruth Kirschstein who has served so effectively as

acting director since the departure of Harold Varmus. She has
3

served in this important position with great dedication and skill,

to the great benefit of NIH and the Nation.

It is a pleasure to welcome Dr. Zerhouni to this committee, and

I look forward to working closely with him in the days to come.

OPENING STATEMENT OF SENATOR GREGG

Senator GREGG. Mr. Chairman, let me first thank you for expediting this hearing on this nomination and for your willingness to

move the nomination through in such a prompt manner, which I

think is extremely important.

It is a pleasure to have the doctor here today before us. As the

chairman has alluded to, the NIH is the flagship agency in the

area of health, not only for our Nation, but for the world. There is

no question that the National Institutes of Health is the institution

that everyone around the world looks to as the source of ideas,

thoughts, and a legitimate, fair arbiter of what is right in the area

of science and especially in the area of health science.

So your willingness to take this post over is something that we

very much appreciate. You have a tremendous background, and

certainly Johns Hopkins’ loss is the Nation’s gain. I notice that you

are joined by your wonderful Senators from Maryland who will obviously reflect on Maryland having such a fine son, but I just want

to say that I strongly support your nomination, and I look forward

to working with you.

You have a big challenge. You have a unique challenge, as we

were mentioning earlier, in the process of the Federal Government.

Most Government agencies do not have enough money. Your agency is getting so much money so fast, the question is how to most

efficiently use it, because the Congress has made a commitment to

double the funding for NIH, and it will be doubled as of this year,

and those new dollars need to be placed where they can do the best

for our country.

I happen to have always been a supporter of the belief that you

folks should be making the decisions, not the Congress, on where

those dollars should be going. We give you the dollars, and we

know that with your leadership, they will be well-spent, and it certainly would be my goal to give you the freedom and flexibility to

effectively use these resources to better the health of not only the

American people but, really, of the world population.

I thank you.

The CHAIRMAN. Thank you very much, Senator Gregg.

I have a comment, but I will withhold for just a moment, recognizing that you are accompanied by two of our colleagues who

are very highly regarded and respected by this committee and by

all of our members.

Senator Mikulski is a very energetic member of our committee

who spends a great deal of time and effort and energy on many

matters, but none is closer to her than the NIH.

And our friend and colleague of many years, Senator Sarbanes,

has been a strong supporter and an eloquent spokesman on the

floor of the Senate for ensuring that we are going to be able to take

advantage of the great breakthroughs in prescription drugs and

other matters and make sure that they will be accessible and available to people.
4

So you have two very good friends who understand the importance of the NIH, believe in it, and are here to add a word of support.

I would recognize Senator Mikulski.

Senator MIKULSKI. I would be happy to defer to the senior Senator.

Senator SARBANES. No. Please go ahead.

OPENING STATEMENT OF SENATOR MIKULSKI

Senator MIKULSKI. Good morning, Senator Kennedy, and thank

you very much for convening this hearing in such an expeditious

way.

Mr. Chairman, I am so proud that Maryland is home to the National Institutes of Health and home to some of the best and

brightest researchers in the world. I am also pleased that Maryland is the home of Dr. Elias Zerhouni, the President’s nominee to

lead the National Institutes of Health.

Dr. Zerhouni has been a member of the Johns Hopkins University Medical School team since 1975. He was a radiology resident,

a faculty member, and then went on to become chair of the department of radiology.

Born in Algeria, he trained as a radiologist at the University of

Algiers School of Medicine. He is currently executive vice dean of

the Johns Hopkins Medical School. He recently led an effort to create the Institute of Cell Engineering at Hopkins to explore the

promise in that very important area.

Dr. Zerhouni has had a most impressive career already. He has

the skill and the technical and scientific expertise to turn medical

research into tools and treatments that actually improve patients’ lives. He has developed techniques that are used to diagnose cancer

and cardiovascular disease. His research has given radiologists a

way to tell the difference between benign and cancerous masses in

the lungs. He invented a biopsy technique to diagnose suspicious

lumps found on mammograms and replaced painful, invasive surgery.

He is an innovative thinker and a successful entrepreneur who

has turned his scientific discoveries into successful businesses that

translate his high-intake radiology research into new services for

patients.

Now he has the opportunity to bring his scientific capability, his

managerial expertise, and his entrepreneurial spirit to the public

sector.

I look forward to hearing Dr. Zerhouni’s vision for the direction

of the NIH and then for the committee to move in a deliberative

way.

Before I yield to my senior colleague, I would also like to take

this opportunity to thank Dr. Ruth Kirschstein for the outstanding

job that she has done as Acting Director of the National Institutes

of Health. For over 2 years, she has guided this agency during its

transition time of not only more funds, but how to make wise use

of taxpayers’ dollars to turn that into the basic research that then

adds promise in finding cures and ways of dealing with disease.

Dr. Kirschstein and her team have served with steadfastness, tenacity, and have really been very good stewards of the NIH mis-
5

sion, and I believe that as we move through this transition, this

committee, this Congress, and this Nation owe Dr. Kirschstein a

debt of gratitude for her stewardship.

Thank you, Mr. Chairman.

[The prepared statement of Senator follows:]

PREPARED STATEMENT OF SENATOR MIKULSKI

Thank you for calling this prompt hearing on the vitally important nomination of Dr. Elias Zerhouni (e-LEE-as zer-HOON-knee)

for Director of the National Institutes of Health (NIH).

The position of NIH Director is critically important to the public

health of the United States but it has been vacant for over 2 years.

I also want to acknowledge the excellent work of Acting Director,

Dr. Ruth Kirschstein who has done an outstanding job. I am

pleased that Maryland is home to the NIH.

I am proud to be part of the bipartisan effort to double NIH’s

budget over 5 years. Investing in cutting-edge research saves lives.

Bringing new discoveries from the lab to the patient’s beside, helps

Americans live longer and better.

The NIH Director oversees this life-saving medical research.

CRITERIA

My criteria for looking at each nomination are competence, integrity, commitment to the mission of the agency. I look forward to

hearing from Dr. Zerhouni today about his vision and qualifications.

COMPETENCE

As head of the largest biomedical research organization in the

world the NIH Director must be respected by the research and scientific communities. Management expertise is essential for the next

NIH Director. NIH will fund almost 35,000 research project grants

this year. Congress has almost completed the doubling of NIH’s

budget over 5 years. NIH has a budget of $23.3 billion and about

18,000 employees. The NIH Director must have strong management skills and leadership to manage this investment wisely.

Translating research from the lab to the patient.

INTEGRITY

Highest standards for transparency, honesty, and accountability

especially as NIH deals with complex, potentially lifesaving research. Serving the public good.

COMMITMENT TO THE MISSION OF THE AGENCY

Understanding new knowledge that will lead to better health for

everyone. Cutting edge research that leads to new treatments and

potential cures. Training researchers for today and tomorrow. Communicating medical information to the public so that the public can

take advantage of NIH’s discoveries.
6

CLOSING

I know Dr. Zerhouni as a dean at the Johns Hopkins University.

We met again recently to talk about his vision for the NIH. Dr.

Zerhouni is a dynamic and entrepreneurial person who brings significant experience from his years at Johns Hopkins University. I

am looking forward to hearing from Dr. Zerhouni today. I will

evaluate Dr. Zerhouni—as I do each and every nominee—based on

his competence, integrity, and commitment to the mission of the

agency.

Thank you again, Mr. Chairman, for convening this hearing on

this critically important nomination to the health of this country.

The CHAIRMAN. That is certainly true. I see the doctor here in

the audience, and I think all of us are very well of the professionalism and the many courtesies that have been extended to all of us

who are interested, and we thank her very much.

Senator Sarbanes.

OPENING STATEMENT OF SENATOR SARBANES

Senator SARBANES. Thank you very much, Chairman Kennedy.

First, I would like to echo the comments of my colleague Senator

Mikulski with respect to Dr. Kirschstein. We very much appreciate

the really very significant contribution she has made and the great

skills she showed in her tenure as acting director of NIH.

I am very pleased to come this morning and have this opportunity to help present Elias Zerhouni to the committee.

This really encapsulates the American story, I think. Dr.

Zerhouni was born in a small mountain town on the then-French

Algeria western border. In a family of eight children, he moved

with his father, a teacher of mathematics and physics, to the suburbs of the capital city of Algiers, where he obtained his education

through medical school at the University of Algiers School of Medicine.

At 24, he came to the United States, to Johns Hopkins Medical

Center in Baltimore, where he began as a radiology resident in

1975, just over a quarter-century ago. He became chief resident in

1978, a member of the faculty, conducted research on computer tomography, which led to the development of CT densitometry, a

technique to give radiologists a way to distinguish accurately between benign and malignant nodules in the lungs. It was a major

step forward.

He then went on to do a number of other very important scientific advances, actually combining his medical ability with his interest in mathematics and physics.

He became eventually the head of the Department of Radiology

at Johns Hopkins, after doing some very impressive research. In

early 1977, he was asked to serve as executive vice dean for clinical

affairs and president of the Clinical Practice Association while continuing as director of radiology.

In this position, he showed tremendous administrative ability,

and I want to underscore that because obviously, the NIH directorship involves or requires tremendous administrative skills.

He led efforts at Johns Hopkins, which we regard as the premier

medical institution actually in the world, to restructure the School
7

of Medicine’s Clinical Practice Association. He developed a comprehensive strategic plan for research. He helped reorganize the

school’s academic leadership. And he has worked with the local

community and elected officials to develop a biotechnology research

park and urban revitalization project near the Johns Hopkins medical campus.

Anyone who has made any effort to do something of that sort

knows the kinds of skills that are required to build a consensus in

order to move forward in an endeavor of that sort.

So I think we have a rare find here, a very highly skilled medical

researcher, one committed to science and yet with these very impressive human skills in terms of being able to organize complex

operations, draw people to work together in a consensus way to

carry out important projects.

Bill Brody, the president of Johns Hopkins University, and actually, Dr. Zerhouni’s predecessor as chairman of the department of

radiology, said about him, and I quote: ‘‘One who often sees solutions clearly where others only see problems.’’ We can use somebody like that in the Government at any time, if I may say so.

Brody went on to say about him that: ‘‘He keeps an open mind

unencumbered by the biases of others.’’ So I think we have a rare opportunity here to put in at NIH as

its director, and of course, we all deeply appreciate the important

tasks at NIH; we know there are now a number of institutes without directors that need to be filled. As has been pointed out by Senator Gregg, there has been a significant infusion of money into NIH

by the Congress, and of course, we are very anxious that this

money be put to good use. So I am very pleased to join with Senator Mikulski.

I might just add a personal note. My wife had the pleasure of

teaching one of the Zerhouni children, and I have to tell you of the

very positive impression she formed about the Zerhounis on the

basis of that experience. So I guess I am here also to tell you that

he has been an extraordinary—he and his wife, who is, of course,

a pediatrician—that they have been extraordinary parents as well.

So I strongly urge his confirmation to the committee. I think that

NIH will be in very good hands, and we are looking forward to NIH

continuing to make the significant progress which it has over the

recent years.

The CHAIRMAN. Thank you, Senator Sarbanes.

Was it Adam whom your wife taught?

Senator SARBANES. No. It was their daughter, Yasmin.

The CHAIRMAN. Very good.

Let me say a word, and then I will ask Dr. Zerhouni to introduce

his family. I spot his mother here, too, which is a very, very special

honor for us. We know how proud she must be.

Would you be good enough to stand, Mrs. Zerhouni, so we can

recognize you and welcome you?

[Applause.]

The CHAIRMAN. We all know how important mothers are.

Before I ask Dr. Zerhouni to introduce the other members of his

family, I will just make a very brief comment, and I would invite

my colleagues to remain, although I know they have other responsibilities.
8

But while they are here, Dr. Zerhouni, maybe you could introduce your family. The Senators might have to leave, and I think

it is important, so if you would be good enough to do that.

Dr. ZERHOUNI. It is my pleasure to do that, Senator.

First, I would like to introduce my wife, Nadia, who is a pediatrician and works in the International Adoption Clinic at Johns Hopkins actually helping international adoptions from the medical

standpoint.

The CHAIRMAN. Very good.

Dr. ZERHOUNI. This is my son Will, who is a second year medical—that is, law student—I wish he were a medical student.

[Laughter.]

The CHAIRMAN. I do not know how you escaped, Will.

Dr. ZERHOUNI. He is at Harvard, and he is in his second year.

The CHAIRMAN. He is also in the Institute of Politics at the Kennedy School, which he reminded me of, which is a wonderful thing

to take an interest in public policy.

Dr. ZERHOUNI. Yes.

And then, my son Adam, who is a junior at Severn High School

and still looking at what he is going to do in the future.

The CHAIRMAN. Thank you very much for being here, Adam.

Dr. ZERHOUNI. And my daughter Yasmin, who just graduated

from Columbia, and is actually going for her master’s in education.

She is very interested in teaching young children, so this is what

she is going to be doing.

The CHAIRMAN. There is a great need, and that is a wonderful

ambition. Good for you, Yasmin.

Thank you very much, Dr. Zerhouni.

Dr. ZERHOUNI. Senator, if I may, I would like to also introduce

two other people. Mr. Rusala is my best friend from sixth grade onward. We have been keeping in touch for the longest time, and he

decided to come here from Algeria to be with us for this opportunity.

The CHAIRMAN. You are very welcome.

Dr. ZERHOUNI. And Marion is my son’s fiancee, and she is from

Memphis, TN.

Senator MIKULSKI. Mr. Chairman, if I might, before Dr. Zerhouni

begins, could we give Dr. Kirschstein a round of applause.

The CHAIRMAN. Certainly. Would you be kind enough to stand,

Dr. Kirschstein?

[Applause.]

The CHAIRMAN. I see my friend and colleague Senator Warner

has joined us. Would you like to say a word, Senator?

OPENING STATEMENT OF SENATOR WARNER

Senator WARNER. Thank you, Mr. Chairman.

Just a brief word. As a matter of fact, the question is often put

to me: What is that part of Senate life that you find most enjoyable? It is the reward that we have by the opportunity to meet individuals like yourself, Dr. Zerhouni.

You very thoughtfully came to my office, where we shared a long

and in-depth discussion on a wide range of subjects. My interest,

of course, stems from my father, who devoted his life to medicine
9

and to research, and coincidentally, Johns Hopkins was an institution with which he had an affiliation.

Mr. Chairman and others, this individual, if I may say is Exhibit

A regarding America’s immigration policies, and you come to us at

a time when we are looking at those policies. You came to this Nation not familiar with its language and have now risen to the very

top of those who have goals and seek to achieve them.

It is so refreshing, Mr. Chairman, to have this opportunity. I

have been in the Senate now for some 24 years and have been a

strong supporter of the institution to which I am sure you will be

confirmed to take over, and I have often viewed it as sort of the

‘‘Supreme Court.’’ It is the court of last resort for those individuals

who have not been given any hope for life because of the complexity or the unusual nature of their afflictions and their disease.

To have an inspirational person like yourself leading that institution, giving that hope, and hopefully in some instances, finding an

answer to preserve life and continue it—I suppose, Mr. Chairman,

if I had to summarize this remarkable American in one word, it

would be ‘‘humility.’’ He reflects that characteristic.

I wish you luck, Dr. Zerhouni, and I have only one word of advice—do not exhibit too much humility when you deal with the

Congress—just go at it with both fists and get everything you can

get.

Thank you very much.

The CHAIRMAN. Dr. Zerhouni, we will hear from you now, please.

STATEMENT OF ELIAS A. ZERHOUNI, M.D., NOMINATED TO BE

DIRECTOR, NATIONAL INSTITUTES OF HEALTH, BETHESDA,

MD

Dr. ZERHOUNI. Thank you, Mr. Chairman.

It is a great pleasure for me to be here, and I want to thank Senator Mikulski and Senator Sarbanes for the nice introduction.

Senator Kennedy and members of the committee, I am honored

to appear before you today as President Bush’s nominee for the directorship of the National Institutes of Health.

If confirmed, I am looking forward to working with Secretary

Thompson and Congress to best serve the institution that has

made our country the undisputed leaders in the biomedical

sciences.

You have heard about my background, and I will not repeat that.

I worked hard, I was amply rewarded, and I ended up being in a

position at Johns Hopkins where I was able throughout my career

to interact with biomedical scientists from the most basic to the

most clinical.

Through that, and through my research and the developments

that I did and the interactions that I had, I learned two things.

One was that I could not succeed unless I was able to inspire and

lead groups of multidisciplinary scientists, because in my field, you

could not succeed unless you had biologists, physicians, and physical scientists working together.

I also gained some new perspectives about what it is that research should be in the 21st century, and I would like to share that

with you.
10

First, I have become convinced that only further fundamental

discoveries will help us meet the challenges of the health care system that we face today and the challenges facing us in that system.

That is an important point, because it means that we still have to

make discoveries to perhaps facilitate the way we deliver health

care.

Second, we need to bring the fruits of our research to clinical

testing more rapidly and enhance our ability to prevent and detect

disease much earlier than in the past.

Third, I believe that biomedical research in 2002 is at a turning

point that may require new strategies. To illustrate that point, I

would like to show you a device here that has been developed

through the use of robotics technology, imaging technology, molecular chemistry, and computer chip-making technology.

This device is known as a DNA chip. Amazingly, with one experiment, a scientist using this device can identify which of the thousands of human genes are active in any one biological sample.

Only a few years ago, it would have been impossible to ask the

questions that we are able to ask with these revolutionary technologies at a rate and on a scale that is unprecedented in history.

You might think that this is great progress, and it is. But now

let me show you the challenge that we face and how much more

we have to do.

I have here a very tiny needle, and I would like you to think

about the tip of this needle. The tip of this needle is actually several times larger than any one, single cell in the human body. Yet

that single cell contains all of the human DNA—not just a subset,

as in this DNA chip. It also contains the entire molecular machinery that translates that DNA into all the complex molecules and

networks of molecules that are interacting within our body to make

us what we are.

Today we have discovered the component parts of that cell. The

real challenge for the 21st century is to understand how all these

parts fit together on a microscopic scale. This is by far the most

formidable scientific problem ever faced by mankind, and I believe,

as you said, Senator, that it will define the 21st century.

Progress will increasingly depend on multidisciplinary teams of

scientists. The future team will have to encourage cross-cutting initiatives. We need to continue to train, recruit, and retain the best

talent in biomedical research, because in the final analysis, it is always that creative spark of the unique individual that leads to new

knowledge and real progress.

Sometimes, this new knowledge will raise deep moral issues.

Throughout history, tensions have always developed between

science and society whenever a scientific discovery challenges our

deeply-held beliefs. The resulting debates can be polarizing, and I

have the interesting privilege of coming before you at just that

time, Senator.

What, then, should be the role of the NIH Director in that regard?

I have told several of you Senators during my visits my thoughts

about that. First and foremost, I believe that disease knows no politics. The NIH, as a public agency at the vanguard of the fight

against disease, is to serve all of us. I believe that the NIH and
11

its director should not be or be made to be factional, but must always remain factual.

My role as NIH Director will be to inform the debate by developing and communicating the most objective scientific data. The NIH

Director should actively promote the necessary research within the

policy guidelines laid out by the President and in strict compliance

with all laws passed by Congress.

As executive vice dean at Johns Hopkins, I was instrumental in

creating an institute for cell engineering, primarily because I was

concerned about the lack of any Federal funding to advance the

fundamental research needed in this new and fledgling field.

This is why I believe that in the current state of science, the August 9 policy set by the President was an important advance. For

the first time, it allowed NIH funding for stem cell research, something which had not been done under previous administrations.

We still have to go on, but there is another important topic that

all of you have raised. That is, after years of effort from you, Senators, and the rest of the Members of Congress, the doubling of the

budget is almost here, to be completed, as proposed by President

Bush. This occurred despite all the difficulties faced by the Nation.

And during my visits with you, I was impressed by your strong

support for NIH, but I also heard loud and clear your wish to see

these resources managed effectively.

I will work hard to develop the information necessary to put to

best use the hard-earned resources of American taxpayers. I will do

my best to work with Congress to accomplish this goal.

I also would like to take this opportunity to acknowledge the outstanding service of Dr. Ruth Kirschstein, who is with us today, the

acting director of NIH; and also that of Dr. Harold Varmus, the immediate past director. Both have been very helpful to me during

this process.

I would like to especially thank my wife and family for their constant and understanding support.

Finally, Mr. Chairman, as an immigrant, I am very touched by

being here today, because it says something about our great country that no other country can say about itself.

Thank you, Mr. Chairman.

[The prepared statement of Dr. Zerhouni may be found in additional material.]

The CHAIRMAN. Thank you very much for an excellent statement.

Obviously, once you gain the responsibility for leadership at the

NIH, you will have a good deal more information in terms of the

strengths and challenges presented. But what can you tell us about

what you hope to be able to achieve as director, based upon your

own views about the agency now?

Dr. ZERHOUNI. Senator, I think the most important role of the director right now is to reestablish morale and momentum and the

vision and energy to recruit NIH institute directors and recruiting

to key positions that will make the agency even more effective than

it has been.

The second, I think, is to try to work with Congress and with all

parties to understand better the dynamics of research and research

resources and try to match the research resources that we are

given with the capacities of the system and the opportunities in
12

science and the priorities that are set at the same time. I think this

is probably the biggest challenge for the new director, that is, to

learn how to set priorities properly, Senator.

The CHAIRMAN. So it is obviously important to get the talent into

the agencies, into places where that is necessary, where the vacancies are. Do you have any broader sense about changes or directions in which you would like to take the agency now, or are you

waiting until you get out there? What can you tell us about any

changes that you might want to see at the agency?

Dr. ZERHOUNI. I can tell you some, Senator. I obviously do not

know all the ins and outs of the agency at this point, but one thing

that is clear is that science is evolving at such a pace and in such

a way that cross-cutting initiatives need to be encouraged.

Science has converged whereby many fields of science now apply

to many diseases, and I think it will be important for the new director to find ways of enhancing that interaction.

The second thing that I believe is important is to identify what

are the bottlenecks for science today, both at the fundamental

level—one of them, for example, is access to the new technologies

that I described in my opening statement. We need to have our scientists throughout the country have access to national resources

that will facilitate their research.

The other is in the translation of that research into clinical reality.

Those are probably the most important priorities that we need to

look at early on. I do not have a specific plan of action, Senator,

but I certainly will look along those lines.

The CHAIRMAN. One of the essential functions of NIH, as you

mentioned, is to provide the best scientific information to Congress

and the public, and you reiterated that in your comments. Nowhere

is this more important than on the complex issue of stem cells and

cloning. We are all aware that you must carry out the administration’s policy, but can you assure the committee, the Congress, and

the American people that you will provide the objective scientific

information on cloning and other scientific issues regardless of

whatever political winds may be blowing?

Dr. ZERHOUNI. I think my statement reflected that. I mean, I

have lived by that principle before, and I will continue to live by

that principle. I think science is to be open and transparent. It has

to fit certain quality standards such as peer review and replication

by others, but all of that should be shared transparently and with

everyone, as I told you in our visits.

The CHAIRMAN. We heard in this committee a few days ago about

the serious gaps in our current protections for human subjects in

research, and we are working on bipartisan legislation to fill those

gaps. Volunteers simply will not participate in essential research

without the confidence that their rights and their safety are protected.

Can you tell us what you believe should be the role of the NIH

in strengthening human subject protections?

Dr. ZERHOUNI. I think, Senator, that you are touching on a very,

very important issue. I think this issue can really slow down medical progress if not handled well. It has, as you said, been generated

by the marked increase in clinical trial needs that we have.
13

The NIH, in my personal view—and we had a tragic experience

at Hopkins where we unfortunately lost a volunteer during a clinical trial—the one thing I learned about that is that in human research protection, we have to change the emphasis from research

to protection. And to do that, we need to change the culture more

than just the regulations and how to cross the t’s and dot the i’s.

That is something that we found at our institution, and the NIH

should play a major role in the training and the development and

the qualifications of those engaged in clinical trial research to almost ingrain that culture of safety within the conduct of clinical research—within the context, obviously, of the regulations.

The CHAIRMAN. Well, we want to work closely with you on this.

We are working through these policy issues, and we will certainly

value your insight.

On the issue of clinical research, you have been a leader throughout your career in translating breakthroughs in the laboratories

into advances in patient care. Have you given thought to how NIH

can strengthen its role in this kind of patient-oriented clinical research?

Dr. ZERHOUNI. Clinical research is a challenge. It is actually

more difficult than most people think it is. I have been a clinical

researcher, and I have worked with clinical researchers, and one of

the things that is not always appreciated is that clinical research

evolves into a full ecosystem that relates to the health of academic

health centers independent of their research activities. And in academic health centers today, the clinical scientist is challenged because there is a need for productivity and not necessarily the support that they need to engage in the clinical research that we

would like done.

So I think that in clinical research, Senator, maybe we need to

take a step back and look at the total ecosystem to make sure that

we encourage young people to find major satisfaction in conducting

clinical trials.

Again, I do not have the specific answer, but certainly I look at

it at that level.

The CHAIRMAN. If my colleague would yield, I just have a few

other areas that I would like to touch on. One is on disease prevention. While the NIH has made astonishing progress in diagnosing

and treating diseases, millions of American still suffer from diseases that are preventable.

Do you think that the NIH has any role in researching disease

prevention?

Dr. ZERHOUNI. It has to have a role, Senator. If you look at the

statistics, for instance, on diabetes, the fast rise in incidence should

be characterized as a pandemic. This is not something that we can

ignore, and in many ways, many of the diseases that we suffer

from are often almost self-inflicted because of lifestyles and dietary

intake and other characteristics.

How we do the research to address these aspects of behavioral

modification, a better match between what we know about the genetics of disease in the environment in which we live, the better

we will be able to prevent these preventable diseases. There are

diseases that we cannot prevent for sure, but in regard those that

are preventable, we need to do a lot more than we are doing, par-
14

ticularly in terms of the drivers of behavior that lead people to

really hurt themselves.

The CHAIRMAN. I think this is an enormously important area

that we do very little on, and we are interested in finding ways of

working with you in this area as well.

There is a final area that I would like to get your reaction on.

Throughout your distinguished career, you have made many contributions in biomedical imaging and engineering. As you know,

there is now a new NIH institute devoted to these disciplines. I do

not know if you have any vision for the new institute; do you believe that to be effective, the new institute will have to be connected to the existing NIH institutes? Do you have a view about

that?

Dr. ZERHOUNI. I certainly do, Senator. I was also a radiologist

and participated in trying to create a structure at NIH that would

respond to the needs of imaging sciences.

I think that what we are facing here is a profound issue that is

not specific to imaging in my mind, and that is the issue that

whenever you develop an area that is cross-cutting across all the

different institutes, you have difficulties in in fact promoting and

developing that area of science.

Obviously, the answer is creating an institute, and in many

ways, what I have been saying all along is that the Nation has one

need, and that is that typically at NIH in the past, we have done

what we call hypothesis-driven research; unless it had an application to a particular disease, you could not really get funded. But

in many ways, these new areas, these emerging technologies, not

just imaging, by the way—and I do not consider imaging to be just

clinical imaging; I look at it at the most fundamental level, for example, imaging cells and imaging molecules and finding out how

they interact with each other—but there are other technologies like

this that are emerging in bioengineering, like nanotechnology. I described to you the minute world of the cell. Well, we are going to

have to develop minute technologies in order to observe that world.

To me, that is the role of these institutes.

If I had a choice, I could call it the ‘‘Institute for Emerging Technologies’’ or ‘‘Emerging Biomedical Technologies,’’ imaging being a

very, very important part of it. So it fits within the greater context,

Senator.

The CHAIRMAN. Senator Mikulski.

Senator MIKULSKI. Thank you very much, Mr. Chairman.

I ask unanimous consent that my full opening statement be included in the record.

The CHAIRMAN. Without objection.

Senator MIKULSKI. I would like to go on to some questions, but

before I do, one point. While I have been very active, Dr. Zerhouni,

in promoting the doubling of the NIH budget, I have also been active in doubling the National Science Foundation budget. And Senator Kit Bond, my Republican counterpart, and I have had a particular focus on nanotechnology—you and I have had some discussions on this—and we see that this is a big breakthrough.

Dr. Zerhouni, I would like to go to page 2 of your testimony, in

which you talk about three areas from your perspective on the biomedical sciences. You are convinced that ‘‘only further fundamental
15

discovery will allow us to meet the health care challenges, bring

the fruits of our research to clinical testing more rapidly,’’ and that ‘‘the new century calls for new strategies.’’ Could you elaborate on each of those and perhaps give some examples of what you mean and how you would like to operationalize

this perspective, including also the extramural aspects of NIH.

Dr. ZERHOUNI. Sure. Thank you for this important question, Senator.

First of all, when I talk about ‘‘fundamental discovery will allow

us to meet the health care challenges,’’ I start there because of my

personal experience at Johns Hopkins. I was really involved in

looking at all aspects of the delivery of health care, and it became

very apparent to me that many of the things that we do today can

be improved at the margin. With managed care or better performance improvement, engineering, reengineering methods, we could

improve the delivery of care by may 10 or 15 percent—I do not

know what the number is—but it is not revolutionary.

The only thing that would revolutionize health care in my mind

would be if you were able to find ways of limiting the amount of

time anyone has to go to the hospital. After all, good health is not

seeing the doctor.

In that context, when you look back and you say, well, let us

think about science, I will give you one example of why fundamental discoveries will be needed. Cancer—we already know, for example, that many genes are affected in a cell becoming cancerous. The

fundamental discoveries that I am talking about will be those related to finding what are the multiple pathways that you need to affect at once to change the outcome of cancer.

It is almost like fighting a war. There is no magic bullet. You

cannot just go in and destroy the bridges one day and the harbors

and the airports; you have to attack all of that at once.

How to do that is becoming the challenge.

Senator MIKULSKI. I have only five minutes, so could you go on

to the clinical research and requiring new strategies? I think we

understand that there has to be emphasis on the basic research as

well as disease-specific and that there is a continual interaction between the two; isn’t that right?

Dr. ZERHOUNI. Absolutely.

Senator MIKULSKI. Do you want to talk about the move to clinical testing more rapidly and how you see that, if you can, and also

the new strategies. What would be some of the new strategies?

Dr. ZERHOUNI. Well, on clinical testing, I think we talked about

the challenges of clinical trials and clinical research, and clearly,

we need to find a quicker pathway from discovery to clinical testing, and I really believe that the number of discoveries that are

made, the number of molecular targets that we have identified over

the past 5 years, requires us to think through how we get to that,

in particular if we are going to test multiple drugs at once.

In terms of new strategies, as I described, science is changing.

There is a convergence of science, and that convergence will require

us to rethink what are the basic infrastructure needs of this new

science. For example, access to biological samples is a very important part of research today. You need to have access to these cells.

You need to have access to these molecularly well-characterized
16

samples of cells or other biological materials. And the NIH has

started to do this because it realizes that it is stumbling block.

I will give you another example of new strategies. Scientists in

the laboratories today suffer from one limitation, and that is not

having access to molecules easily to test against their biological

problems. It would be very helpful, Senator, if we could develop

rapid access to our scientists to be able to have that.

Senator MIKULSKI. First of all, those are very interesting scientific strategies. One of my areas of concern is the ability to think

across institutes, and today is not the day to go into that level of

detail, Doctor; I think it is more broad-brush. But NIH is composed

of 27 institutes and centers, and some offices. The reason that we

have an Office of Research on Women’s Health and not a center

was so that women’s health is in every center and institute. So we

are going to also look for new management strategies. As gifted

and talented as our scientific community is at NIH, there is a tendency to think smokestack—this is my area, and somebody else

should go to the meetings. So that is something that we will come

back to on another day.

Let me go to the issues around staff. There are about 18,000 people who work at NIH. You have everything from your own fire department to Nobel Prize winners. It is a very important challenge.

In terms of the scientific as well as the support staff, I am interested in what thoughts you might have at this time, both for recruitment and retention of outstanding people, and I am also very

concerned about the whole issue of the ability to recruit minorities.

This has been a big issue just in terms of the scientific community

generally. I chair the subcommittee that funds NSF, and this has

been a significant challenge of encouragement.

So on recruitment and retention, how do we get new people, a

new demographic profile, and how do we get new thinking. When

I came over to Hopkins to talk to the newly-endowed chair on

breast cancer that Harriet Lagam and others did, I also talked

with some of the young scientists, more the upstart crowd, the new

start crowd, about the difficult time they had getting research

money because they were not established.

So if you could comment on all of the above—knowing that this

is the first of what I hope will be many conversations. You will face

it if confirmed; Dr. Kirschstein, Dr. Varmus, and Dr. Healy faced

it. We have had ongoing conversations in this area.

Dr. ZERHOUNI. Senator, this is a very appropriate and important

point that you make. Even in medical schools we face the same

issue, as you know. I am looking forward to working with you on

these issues. There is no easy answer, but there are answers.

Senator MIKULSKI. So you do not have any today.

Dr. ZERHOUNI. I do not have any today, Senator. I would be willing to comment, but I was just mindful of your time, Senator.

Senator MIKULSKI. And I think the White House has also told

you do not break new ground and do not break any knuckles today.

[Laughter.]

Dr. ZERHOUNI. No—I can certainly comment if you give me the

time; absolutely.
17

Senator MIKULSKI. Yes. Why don’t you take just a few minutes

and then we will turn to my colleague, and I will wait for a second

round.

Dr. ZERHOUNI. That would be fine, Senator. I did not mean to not

respond; I just wanted to be careful of the time.

First of all, let me say this. I think the issue of diversity is a very

important issue. When you look at the statistics—and we looked at

our statistics at Johns Hopkins—what you find is that in the pregraduate and graduate training programs, the composition is more

diverse than what you see later on. That loss of talent is to me the

number one problem we have to look at—why is it that even

though we train, we do not retain?

So one thing that I will focus on is the retention mechanisms

that we use, because as you said—and you are right—it is difficult

to break in. It took me 5 years to break into being funded at NIH.

That issue of retention—because we have the means and we have

the slots to train people—the problem we have is that they get

trained, and then there is a selection process that occurs, and that,

Senator, I think is the first step. If you do not have role models

who will entice newer scientists to come into the field along with

those role models, you will never get that pump primed.

So I have a very specific sense about it, and that is that we need

to absolutely understand why it is that we can, to an extent, create

more diversity up front and less at the back end.

Managing a complex organization between fire trucks and Nobel

Prizes is very difficult, as you know. It is essentially combining corporate management with academic cultures, and that is very hard

to do. I do not think anyone has the answer, by the way, Senator,

in terms of how to best manage an enterprise like this. It is a dayto-day fight, finding the right people to manage those enterprises.

Senator MIKULSKI. Thank you, Dr. Zerhouni.

I am going to now yield to my colleague, Senator Wellstone. But

you see, you are exactly what I am talking about, and even going

to our own beloved institution of Johns Hopkins, when I was a

young social worker at Catholic Charities, I knew that there were

no African American physicians at Johns Hopkins. Fifty years ago,

Hopkins had a quota in terms of Jewish physicians being on their

faculty. Now that is gone. We see Levi Watkins and Ben Carson

and Dr. Vogelstein and so on—and you, as a man of the Muslim

faith and an immigrant from a medical school in Algiers. You know

how snobby our medical establishment can be. The fact that you

were able to do this shows that we are making progress.

I really believe, as you—I know from our one-on-one conversations your passion for an opportunity ladder and an open door to

talent and your own experience. Even our own beloved institution

had to eliminate barriers for people to participate and to bring

their talents to the clinical and research table.

I would hope, presuming you are confirmed, that this could be

one of the challenges that we really look at—not only for new

ideas, but for that new talent where everyone is welcome and everyone is supported to be able to bring the new ideas.

With that, Senator Wellstone, let me turn to you.

Senator WELLSTONE. Thank you, Madam Chair, and welcome,

Dr. Zerhouni.
18

Dr. ZERHOUNI. Thanks, Senator.

Senator WELLSTONE. I followed your questions, and I personally

think the last question or comment that you made may have been

the most important, and I would like to associate myself with the

words of Senator Mikulski.

Welcome, and I enjoyed having a chance to meet with you as

well, Dr. Zerhouni.

I want to ask three specific questions that we covered when you

came by the office. We passed the Muscular Dystrophy Care Act,

and I talked with you some about Duchenne’s disease. It has been

very moving work, and I have found that when you work with the

parents of these children, and they are so hopeful, and you pass

something, my fear is that you pass it, and there is not the followup or the follow-through, and for them, of course, time is not neutral.

The House Energy and Commerce Committee predicted that if

you implemented the provisions of the legislation—the Muscular

Dystrophy Care Act—it would require about $56 million additionally, and that was for fiscal years 2003 to 2006. I was disappointed

to learn that the NIH estimates for fiscal year 2003 on all muscular dystrophy was only $25.4 million, which is only $2 million

more than 2002 funding—and this was before the passage of this

Act.

By the way, this Act set up a center of excellence with a focus

on Duchenne’s disease, because it had fallen between the cracks.

Given the provisions of this legislation as well as the significant

number of families and individuals afflicted by one of the nine

muscular dystrophies, do you believe that NIH’s commitment to

this disease is as balanced as it should be, and what additional resources do you envision NIH investing in properly implementing

the provisions of this legislation?

I do not want to pin you down specific by specific; I just want

to get some sense for these families as to whether you—because I

believe you will be the director—will have a very strong commitment to the resources for the research.

Dr. ZERHOUNI. Well, Senator, as I said during our discussion, my

instinct is always to try to understand the total requirements for

advancing the research in that field, and I think the Act provides

for that.

I am not familiar with the details of implementation. I understand that the NIH is trying to implement the MD Care Act. I will

certainly look into that and get back to you as I get into this job

if confirmed. But I have to tell you that my heart is where you are.

Senator WELLSTONE. Well, it starts with the heart, and I appreciate that. Maybe what I would ask you is if, at the appropriate

time, perhaps there could be a meeting with some of these parents,

if you would be willing to meet with the community and sit down

at the table. I think that would mean everything to them.

Dr. ZERHOUNI. Certainly.

Senator WELLSTONE. Could I get that commitment from you?

Dr. ZERHOUNI. Certainly, Senator.

Senator WELLSTONE. That would be very helpful.

You know, some of this work truly translates into personal

terms, and I appreciate it.
19

Quickly on this one, because we touched on it, all the research

that is being done in the mental health—and for that matter, also

substance abuse—NIMH, NIAA—I want to just find out whether

you see yourself as active in promoting the additional research. The

President said yesterday that he was committed to full mental

health parity, and I believe that we are going to move on that. I

think part of the reason for that is the citizen groups, but part of

it has been the research that has really broken through some of the

stigma, saying this is really an identifiable, diagnosable, and treatable disease.

So can I get some sense from you—and we covered this, but—

Dr. ZERHOUNI. Actually, as I indicated to the committee before,

I do believe that in fact, the impact of mental health in itself is a

significant burden on society, and many times, the burden is hidden, as you know.

But in addition to that, I think that all the sciences of behavioral

modification, behavioral sciences, social evaluation of the milieu

into which we evolve as individuals and human beings and in relation to diseases that are in many ways driven by our own behavior,

we need to really understand better, because as I mentioned,

epidemics like diabetes are profoundly related to mental processes,

and we need to do more research in that; there is no question that

we need to do that.

Senator WELLSTONE. I appreciate that, and on a personal note,

I have one other quick question.

I would say to Senator Mikulski and you that, actually, years

ago, my brother had a severe mental breakdown and wound up at

Johns Hopkins, and probably that first year of treatment was what

saved him—although it took my parents 20 years to pay off part

of the bill, which is part of the problem; there is not the coverage,

which we are hoping to change.

My last question is on Parkinson’s disease, and I do not think

you will disagree. Scientists tell us—and when I say us, this community—that it is perhaps the most curable brain disorder, that

there is a lot of potential here, and that with adequate research,

in 3 to 5 years, we could have a cure. They also say that discoveries

in Parkinson’s also spill over to Alzheimer’s, spinal cord injury,

ALS, Huntington’s disease—you name it. So I am interested in the

question of stem cell research, because this is key.

Researchers have argued that the 78 stem cell lines available

through the President’s policy are not sufficient to pursue the

therapies for diseases such as Parkinson’s and diabetes and spinal

cord injury. They say that greater diversity in the number of lines

will be needed for them to meet the promise of research.

In your capacity as director, how will you ensure that researchers have the necessary supply of stem cell lines to develop treatments and cures, and if necessary, will you recommend that the

President’s policy be broadened to include additional lines?

Dr. ZERHOUNI. Well, in terms of where the science is today—and

I know a little bit about stem cell research; I organized the institute at Hopkins—there is no question that there is a lot of fundamental research that needs to be done before even considering

which pathways we are going to take for cures.
20

Fundamentally, the process by which DNA is programmed and

reprogrammed is not well-known, and that needs to be done. Now,

when you talk about the 78 cell lines, let me point out to you, for

example, that a lot of research can be done on the limited number

of cell lines when they are well-characterized. In fact, what I am

saying is the same in other fields of research. For example, if you

look at the human genome, how many DNAs do we have in the

human genome that we are using to do our research? It is a closely-held secret, but we know the number is two to six individuals,

and actually, in the last New York Times, one of the individuals

said ‘‘I am one of them.’’

So you can do a lot when you have these lines, and in embryonic

stem cell research in mice for 20 years, there have been a number

of cell lines—about 20—that have been used for fundamental research for understanding the mechanism to know where you go

next.

Now, to the second part of your question, it becomes evident

through this research that there are pathways to develop cures and

so on. I will be the first one to assemble that information, to get

the experts to give that information, to provide that in the sense

of well-established scientific facts, and share that with everyone.

Senator WELLSTONE. I appreciate it. I am not sure whether it

was a ‘‘yes’’ or ‘‘no’’ answer, and I am not a scientist, so I appreciate it—I am in politics and public affairs—but I do not think it

was quite the commitment that I was hoping to hear, but I will follow up with you on it; okay?

Dr. ZERHOUNI. That would be fine.

Senator WELLSTONE. Thank you.

The CHAIRMAN. Dr. Zerhouni, you talked about establishing a national molecular library at NIH. Why is that important? What will

that mean for researchers?

Dr. ZERHOUNI. Again, this is a concept that we discussed in our

interview, and it is an idea that has evolved from my experience

at Hopkins. I do not know all the ins and outs of how to do it, so

with that caveat, let me describe to you what I believe is needed.

When we look at our research and our researchers, we have tremendous ability, through technologies like this one, to identify

which proteins and which genes are actually affected by disease,

but we do not have the molecules to affect those pathways. And scientists have a difficult time accessing molecules for research—not

for therapy, not for drugs, but for research—out of the molecular

libraries that are available in the world.

One step that I know that our scientists at Hopkins, basic scientists, have mentioned to me as an important step forward—and

I agree—would be to have a national resource where any scientist

with a catalog of the appropriate molecules that would be known

to affect genetic pathway ‘‘X’’ or biological pathway ‘‘Y’’ in such a

way that over time, we will build a library that will allow us to go

from fundamental discovery to clinical testing much faster. That is

the idea, but again, this is my own and not tested and vetted by

other colleagues.

The CHAIRMAN. It is enormously interesting, and I could listen

to your answer two or three more times to try to get a better han-
21

dle on it, but I think it is very exciting and something that deserves a good deal of thought.

Senator Mikulski, is there anything further?

Senator MIKULSKI. Just one other issue. As you can see, we liberal arts graduates are trying to hang in there. [Laughter.] Just a

question on page 3 of your testimony, Dr. Zerhouni, about the Institute for Stem Cell Engineering at Hopkins.

If we go to the third paragraph from the bottom on page 3, you

say, ‘‘I was instrumental in creating an Institute for Stem Cell Engineering primarily because I was concerned about the lack of Federal funding to advance the fundamental research still needed in

this promising, but fledgling, field.’’ Question: What was and is the Institute for Stem Cell Engineering? You cite in its creation the lack of Federal funds to advance

fundamental research. In your perspective, are Federal funds still

lacking, and should Federal funds be available?

Dr. ZERHOUNI. At that time, I was aware of the progress that

was made by Dr. John Gerhart in particular at Hopkins. I also realized from talking to many scientists at the time that they were

shying away from entering this exciting field.

Senator MIKULSKI. And tell us what year you established the institute.

Dr. ZERHOUNI. We started working on establishing it in 1999,

and we succeeded by 2001, because I had to raise funds for it

through philanthropy.

At the time, basically, the scientists would tell me, ‘‘I do not

want to go into this field because there is no Federal funding. I

would have to depend on commercial funding from a company, and

there are lots of strings attached to that.’’ So I said, ‘‘Well, we need get into this field, we need to understand the fundamental mechanism of this differentiation of cells

into different tissues, and I will work to try to get an institute up

and going,’’ because I needed two things—one was the resources,

but also the multidisciplinary teams working together.

Without Federal funding, it is hard for me to see how you develop a field of science in our country. So I do believe that Federal

funding is needed.

Senator MIKULSKI. Then you go on and say that the President’s

policy is an important breakthrough and that you will work with

whatever rules the Congress passes. Hopefully, Congress will be as

forward-thinking as you have been in establishing this institute.

I think that clarifies that paragraph.

Dr. ZERHOUNI. Thank you, Senator.

The CHAIRMAN. I want to thank the doctor very much for his

presence and congratulate him and congratulate the President for

this nominee. This has been extremely interesting for all of us, and

I certainly look forward to strong support of the nominee. I think

our Nation is very fortunate, as is the world, to have his services

to lead this great institution.

It is my intention to call our committee together after the first

vote tomorrow afternoon to positively affirm and report out the

nominee, which I expect will be done tomorrow; and then, it is my

intention to urge our Majority Leader to move forthwith, hopefully

in the next day or so, to have Senate confirmation.
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I would like to insist on a vote, so that you know what overwhelming support you have. It is nice to have that once in a while.

So I thank you very much, Dr. Zerhouni, for your presence here

today and your response to our questions. We thank your family for

being here.

The committee stands in recess.

[Additional material follows.]
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ADDITIONAL MATERIAL

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

Senator Kennedy, Senator Gregg and members of the committee:

I’m honored to appear before you today as President Bush’s nominee to the directorship of the National Institutes of Health.

If confirmed, I am looking forward to working with Secretary Thompson, an enthusiastic supporter of science and Congress to best serve the institution that has

made our country the undisputed leader in Biomedical Research.

I’d like to share with you some of my background and then tell you about my vision for the NIH.

I was born in a small town in Western Algeria. My father was a math and physics

teacher who gave me a love for the sciences.

At age 22, I saw the first published image of a CT scan, and decided that medical

imaging would be the perfect field for me as it combined medicine, physics and computer science.

In 1975, a few weeks after our wedding, my wife Nadia and I came to this country, to Johns Hopkins, where I encountered an extraordinary environment for innovation and discovery and great mentors who helped me become the physician, teacher and scientist I am today.

My research led me to develop new imaging methods for lung cancer and cardiac

diseases, some of which led to less invasive surgery.

I made some inventions and had the good fortune to see a few of them translated

successfully from the ‘‘bench to the bedside.’’

Throughout my career, I realized the importance of inspiring and leading groups

of multidisciplinary scientists because, in my field, progress cannot be made without

biologists, physicians and physical scientists working together.

I built a successful clinical and research division and learned how to be entrepreneurial when necessary.

I was given progressively larger areas of responsibility, first as Chairman of the

Department of Radiology and later as Executive Vice Dean of the Johns Hopkins

School of Medicine.

Through these experiences I’ve interacted with the entire spectrum of biomedical

scientists from the most basic to the most clinical.

This led me to develop a certain perspective about where we stand today in the

biomedical sciences:

First, I have become convinced that only further fundamental discovery will allow

us to meet the healthcare challenges facing us.

Second, we need to bring the fruits of our research to clinical testing more rapidly

and enhance our ability to prevent and detect disease much earlier.

Third, I believe that biomedical research is at an important turning point that

may require new strategies.

Let me show you a device developed by combining robotics, molecular chemistry,

imaging and computer chip manufacturing technologies. In my hand, I hold what’s

known as a DNA chip. It can determine in a single experiment which of several

thousand human genes are active in a biological sample.

Only a few years ago, it would have been impossible to ask the questions we’re

now able to explore on a scale unprecedented in history.

Obviously, we’ve made great progress, but let me show you how much more we

have to do. Look at the tip of this needle; it’s several times larger than any cell in

our body.

Yet that single cell contains all of the human DNA, not just a subset like this

DNA chip does, and it also contains the entire molecular machinery necessary to

transcribe and translate that DNA into all the complex networks of interacting molecules that make us what we are.

Today, we’ve discovered most of the parts of our biological systems.

Now we need to go on a journey to understand how all these parts fit together

in health and in disease: this is, by far, the most formidable scientific problem ever

faced by mankind.

Progress increasingly will depend upon fields of science beyond medicine and biology. The scientific team of the future will be multidisciplinary. We need to encourage cross-cutting initiatives.

We need to continue to train, recruit and retain the best talent in biomedical research because in the final analysis it is always the creative spark of the unique

individual that leads to new knowledge and real progress.
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Sometimes this new knowledge will raise deep moral issues as we’re now witnessing. Throughout history, tensions between science and society have developed when

a scientific discovery challenges deeply held beliefs.

The resulting debates can be polarizing, and I have the interesting privilege of

coming before you at just such a time.

What then, should be the role of the NIH director in that regard?

As I’ve told several of you, ‘‘disease knows no politics.’’ The NIH, a public agency

at the vanguard of the fight against disease, is to serve all of us.

The NIH and its director should not be, or made to be, factional, but must always

remain factual.

My role as NIH director will be to inform the debate by developing and communicating the most objective scientific data. The NIH director should actively promote

the necessary research within the policy guidelines laid out by the President, and

in strict compliance with all laws passed by Congress.

As Executive Vice Dean at Johns Hopkins, I was instrumental in creating an institute for stem cell engineering, primarily because I was concerned about the lack

of any Federal funding to advance the fundamental research still needed in this

promising, but fledgling, field.

This is why I believe that, in the current state of science, the August 9th policy

set by the President was an important advance.

For the first time it allowed NIH funding for stem cell research, something which

had not been done under previous administrations.

On another important topic, I and many others were pleased to see the doubling

of the NIH budget you started by 1998, and soon to be completed as proposed by

President Bush. This occurred despite all of the difficulties faced by the Nation.

During my visits with you, I was impressed by your strong support for NIH.

But I also heard, loud and clear, your wish to see these resources managed effectively. I will work hard to develop the information necessary to optimize the hard

earned resources of American taxpayers. I will do my best to work with Congress

to accomplish this goal.

I’d like to take this opportunity to acknowledge the outstanding service of Dr.

Ruth Kirschstein the acting director of NIH and also that of Dr. Harold Varmus the

immediate past director. Both of whom have been very helpful to me during this

process.

I’d like to especially thank my wife and family for their constant and understanding support.

Finally, Mr. Chairman, as an immigrant, I am deeply touched by being here

today, because it says about our great country what no other country can say about

itself.

I would be pleased to answer any questions you may have for me.

[Whereupon, at 11:15 a.m., the committee was adjourned.]

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