107th Congress

Report: Consideration of the Nomination of Elias A. Zerhouni, M.D., to be the Director of the National Institutes of Health—Hearing Before the Senate Committee on Health, Education, Labor and Pensions—April 30, 2002

Members Present

Senators Edward Kennedy (D-MA), Chairman; Judd Gregg (R-NH), Ranking Minority Member; Barbara Mikulski (D-MD); Paul Sarbanes (D-MD); John Warner (R-VA); and Paul Wellstone (D-MN).

Witnesses

Elias A. Zerhouni, M.D., Nominee to be Director of the National Institutes of Health (NIH). Also in attendance were Ruth Kirschstein, M.D., Acting Director of NIH, and Yvonne Maddox, Ph.D., Acting Deputy Director of NIH.

Purpose of Hearing: To consider the nomination of Dr. Zerhouni to be the Director of NIH.

Summary

The Members of the Committee expressed unanimous support for Dr. Zerhouni. Senator Kennedy predicted an expeditious confirmation, including a vote by the full Senate, possibly before the end of the week. All of the Members, joined by Dr. Zerhouni, applauded the stewardship of Dr. Kirschstein. Topics discussed during the hearing included the following:

• Ensuring that NIH budget increases are well spent.
• Diabetes research.
• Increase in life expectancy.
• Human subjects protection.
• Clinical trials.
• Stem cells.
• Recruitment, training and retention of biomedical researchers.
• Cross-cutting research initiatives.
• Translational research.
• Disease prevention.
• The National Institute of Bioimaging and Bioengineering.
• Mental health research.
• A molecular library.

Opening Statements

The Members made brief opening statements expressing support for Dr. Zerhouni and recognizing the importance of the work of NIH to the American public. Chairman Kennedy said Dr. Zerhouni would be the "first NIH Director of the century." He called Dr. Zerhouni a "living example of the American dream."

Dr. Zerhouni was introduced to the Committee by his home-state Senators, Barbara Mikulski and Paul Sarbanes. They described his life and career, including his upbringing and education in Algeria and his remarkable rise to become a department head at Johns Hopkins Medical School. Senator Sarbanes quoted the President of Johns Hopkins, who said the following about Dr. Zerhouni:

"One who often sees solutions clearly when others see problems...keeps an open mind, unencumbered by the biases of others."

Dr. Zerhouni introduced his family and friends sitting in the audience. He called NIH the country's leader of biomedical science. He said his experience has taught him that he can succeed as a leader by inspiring others and involving all fields of science. Dr. Zerhouni stated three views of the future of biomedical research:

• "I have become convinced that only further fundamental discovery will allow us to meet the health care challenges facing us."
• "We need to bring the fruits of research to clinical testing more rapidly and enhance our ability to prevent and detect disease much earlier."
• "I believe that biomedical research is at an important turning point that may require new strategies."

Dr. Zerhouni cited the DNA chip as an example of the quickening pace of technological advances and how its development will speed the process of scientific discovery. He also discussed how a single cell, smaller than the tip of a needle, contains all human DNA as well as the entire molecular machinery necessary to transcribe and translate DNA into all the complex networks of molecules that make humans function the way they do. Now that these discoveries have been made, "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." He talked about the need to recruit the best talent to undertake this journey.

Dr. Zerhouni mentioned the tension between science and society as discoveries raise ethical issues. He said disease knows no politics. The Director of NIH should "not be made to be factional, but must always remain factual." In functioning this way, he will comply with Administration policy and Federal law.

Dr. Zerhouni said he was instrumental in creating an Institute for Stem Cell Engineering at Johns Hopkins "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." He called the stem cell policy implemented by President Bush an important advance because it allows Federal funding of stem cell research.

Dr. Zerhouni vowed to manage the substantial resources of NIH effectively. He concluded his statement with an impassioned observation: "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."

Questions

Senator Kennedy

• What are your goals? Dr. Zerhouni said he wanted to recruit key people to important vacancies at NIH. He also said he wanted to increase understanding of the dynamics of research.


• Do you plan any changes in the direction of NIH? Dr. Zerhouni said cross-cutting initiatives should be encouraged, that he wanted to identify obstacles to science, and that translational research should be widened. He has no specific plans of action at this time.


• In light of the political debate about stem cells and cloning, can you assure the Committee that you will be objective? Dr. Zerhouni said he believes science should be "open and transparent."


• There have been problems in protecting human subjects. How do you see the role of NIH in human subjects protection? Dr. Zerhouni said this was an important issue. He noted that there had been a tragedy involving a volunteer at Hopkins. He said there needed to be a change in the culture of clinical trials and that it should begin with the training of physicians.


• How can NIH strengthen clinical research? Dr. Zerhouni said this was an important challenge. He remarked that clinical trials are more difficult than people realize and that clinical science does not get enough support. He will look at the total system at NIH. He believes a pool of clinical researchers is needed.


• What is NIH's role in the area of disease prevention? Dr. Zerhouni said NIH must have a role. He said many diseases are self-inflicted. He used the example of diabetes, which he called a pandemic. "How we research behavior modification will be a key," he said.


• What is your vision of the new NIBIB? Dr. Zerhouni noted that he is a radiologist. He called the work of the new Institute profound and crosscutting. He said disease-driven research needs to be rethought in light of new technologies, such as nanotechnology. He said a more appropriate name for the new Institute might be the Institute for Emerging Biotechnology.


• I understand you have thought about the establishment of a molecular library. Tell us about it. Dr. Zerhouni said the lack of access to molecular material limits the pace of research. He suggested that a national resource for molecules is needed. A library is an idea he has thought about.

Senator Mikulski

• How will you "operationalize" NIH? Dr. Zerhouni said he believes research can be improved at the margin. He suggested that one way of improving health care is prevention. He said he was interested in funding research that identified the pathways to disease and cited cancer as an example.


• Do you have any strategies for clinical research that would result in more rapid testing of potential products? Dr. Zerhouni said we need to identify faster pathways from discoveries to clinical testing. He said the convergence of science requires rethinking about how to proceed. He noted that access to biological samples is an impediment to research.


• How do you improve the recruitment and retention of top scientists, particularly minorities? Dr. Zerhouni said statistics show the composition of scientists to be more diverse at the educational and training levels. He said we train but do not retain. He said we need role models to attract a more diverse staff at NIH.


• I understand that you established the Institute for Stem Cell Engineering at Johns Hopkins because you were concerned about the lack of Federal funding for stem cell research. Are Federal funds now sufficient? Dr. Zerhouni responded that scientists were shying away from promising research because of the lack of funding. "I think Federal funding is needed because, without it, progress wasn't taking place."

Senator Wellstone

• The Muscular Dystrophy Care Act was based on an estimate that NIH should spend $56 million a year on muscular dystrophy research. Yet, NIH is spending only $25.4 million. I am disappointed. Do you believe NIH is committed to this area of research? Dr. Zerhouni said he wanted to understand the total requirements of the Act. He said, "My heart is where you are."


• Will you meet with the parents of children with muscular dystrophy? Dr. Zerhouni said he would.


• Are you committed to research on mental health and substance abuse? Dr. Zerhouni said the impact of mental health problems is a significant burden to society. He said all social sciences need to be better understood.


• I understand that Parkinson's disease is potentially the most curable brain disorder and that stem cell research could lead to a cure. Are the 78 lines available for federally funded research under the President's policy sufficient, or should there be greater diversity? Will you recommend changes in the President's policy if you determine that the lines are not sufficient? Dr. Zerhouni responded that a lot of fundamental research on stem cells needs to be conducted, and this will be possible under the President's policy. Dr. Zerhouni made assurances that if it becomes evident that pathways are available for treatment using stem cells, he would be the first to compile the information and distribute it to the public.

Prepared by Marc Smolonsky, OD/OLPA, May 1, 2002