[Senate Hearing 107-433]
[From the U.S. Government Publishing Office]


                                                        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








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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

               EDWARD M. KENNEDY, Massachusetts, Chairman
CHRISTOPHER J. DODD, Connecticut     JUDD GREGG, New Hampshire
TOM HARKIN, Iowa                     BILL FRIST, Tennessee
BARBARA A. MIKULSKI, Maryland        MICHAEL B. ENZI, Wyoming
JAMES M. JEFFORDS (I), Vermont       TIM HUTCHINSON, Arkansas
JEFF BINGAMAN, New Mexico            JOHN W. WARNER, Virginia
PAUL D. WELLSTONE, Minnesota         CHRISTOPHER S. BOND, Missouri
PATTY MURRAY, Washington             PAT ROBERTS, Kansas
JACK REED, Rhode Island              SUSAN M. COLLINS, Maine
JOHN EDWARDS, North Carolina         JEFF SESSIONS, Alabama
HILLARY RODHAM CLINTON, New York     MIKE DeWINE, Ohio
           J. Michael Myers, Staff Director and Chief Counsel
             Townsend Lange McNitt, Minority Staff Director





                            C O N T E N T S

                              ----------                              

                               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


                               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.
    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 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.
    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 mission, 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.

                                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 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.
    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 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.
    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 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 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.
    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, particularly 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 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 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.
    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 pre-graduate 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 day-to-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.
    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 follow-up 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.
    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.
    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 handle 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.
    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.]

                          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.
    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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