Speech delivered
May 26, 1994 By
Harold Varmus, M.D.
Director, National Institutes of Health
A few days ago, I celebrated (if that is the word) the 6-month anniversary of my swearing-in as Director of the NIH. The occasion reminded me of a significant moment during my brief confirmation hearing before the Senate Committee on Labor and Human Resources. Earlier in the hearing, in an opening statement, I had outlined briefly but in lofty terms what I thought I could accomplish with the unusual credentials I was bringing to this political and administrative position in difficult times. I promised to use my knowledge of how science is done to inform debates about science policy, my personal experiences with the study of cancer viruses in the defense of open-ended basic science, my sense of fairness in efforts to improve education and the careers of women and minority scientists, and my clinical training in the exploitation of biological discoveries.
Near the end of the hearing, knowing that politics are played on a much shorter field, Senator Barbara Mikulski of Maryland asked me to define some objectives that might realistically be met within the next 6 months, 1 year, or 3 years. The transcript shows that I had time to name goals only for my first 6 months. These were, first, recruitments into several key positions, including the engagement of a distinguished scientist to serve as ombudsman for the extramural community; second, an evaluation of the NIH intramural program; third, improvements in equal employment opportunities at NIH; and, fourth, a rethinking of the peer review process.
I would like to use this event to give my 6-months report to the Senator, and to all of you.
1) Recruitments
There have been dramatic changes in the leadership at the NIH and in the organization of the Director's Office. Since the lives of many if not most of you are strongly influenced by what NIH does, I will take a few moments to mention some of the new faces, not a few of which are familiar to you as members or friends of the ASM.
First among these is Ruth Kirschstein, hardly a new face, but now serving as the principal deputy director after extended service as a virologist and as the Director of the National Institute of General Medical Sciences. Michael Gottesman, who has consented to serve as Acting Deputy Director for Intramural Research, is himself only a molecular geneticist but he is married to a distinguished bacteriologist. Wendy Baldwin, formerly of the National Institute of Child Health and Human Development and probably less well known to you since she is a behavioral scientist, is now the Deputy Director for Extramural Research.
A crucial new office, established by last year's NIH reauthorization bill, is now responsible for formulating NIH AIDS policy and distributing AIDS revenues, $1.3 billion as requested for 1995, among the institutes. I was lucky to have persuaded a renowned immunologist, Bill Paul, to take on this challenge and he has done so with gusto. After being without a director for several years, the NIH Clinical Center is now run by John Gallin, the former Scientific Director of the National Institute of Allergy and Infectious Diseases, who has a successful research program to study chronic granulomatous disease and other immune disorders. Before the year is out, I will have named new directors for at least six institutes: Alan Leshner, previously Deputy Director of the National Institute of Mental Health, is now in charge of the National Institute on Drug Abuse; I expect to announce a new director for the National Institute of Neurological Disorders and Stroke in the very near future; and searches are in progress for new directors of the National Institute of Dental Research, the National Institute of Nursing Research, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and NIMH.
Along with these appointments have come changes in the way the NIH functions in Bethesda and in the way it interacts with the Department of Health and Human Services. I have found, somewhat to my surprise, that I do have an administrative style, and that it is horizontal, rather than vertical. Many people in the Director's Office now talk directly to me or Ruth, not through intermediate deputies. And I keep in close touch with the institute directors through regular group gatherings and periodic individual discussions. In this sense, I feel as though I have been well-trained for administrative activity by running a lab: the only way to know what is going on is to talk with the people who are doing the work, regardless of whether they are post-docs or institute directors.
Our relations with the Department are also excellent, in contrast to what I am told has been the experience of most former NIH directors. Both Phil Lee, the Assistant Secretary for Health, and Donna Shalala are strong supporters of universities, of all forms of biomedical research, and of NIH. Not only have I had full access to their offices and energies, but they have accorded me the coin of the realm in Washington by delegating to me the authority to make many decisions--particularly about hiring--that have traditionally required departmental approval, usually at multiple levels. (Incidentally, the frustrations that such approvals can incite are well described in a year-old speech by Bernadine Healy that is reprinted in this week's New England Journal of Medicine.)
It is now widely known that my search for an ombudsman, someone to solicit and represent the views of the extramural scientific community in NIH policy making, has been especially successful, thanks to the willingness of Howard Schachman of the University of California, Berkeley, to take on this job. Howard is, of course, a well-known physical chemist, enzymologist, and public spokesman on many contentious issues. He has plunged into this new role with enthusiasm, shuttling between Washington and many of your campuses, gathering views on varied topics from a diverse constituency, and influencing policy on indirect costs, grant management, and peer review, among others. (Howard has asked me to say, however, that it is not his job to try to improve any individual priority scores.)
So I think we are making good progress towards reshaping NIH leadership.
2) The NIH Intramural Program
But what about the second goal of reevaluating and reenergizing the intramural scientific program at NIH? As many of you know, in 1993 the House of Representatives demanded that the new NIH Director report to them about the future of this large scientific program, with a budget of 1.2 billion dollars, over 6000 scientists and 2000 trainees. This mandate reflected the concerns of many in the extramural environment that the intramural program was excessively protected from the fiscal stringency others were facing--as well as concerns that the Clinical Center Complex, home to half of the clinical research beds in the nation and 40% of the intramural laboratories, was in physical decline and slated for demolition or decay.
I have recently received a remarkable report on the intramural research program (to be officially presented to the Director's Advisory Committee next Thursday). Written by ten outstanding biomedical scientists, including (as co-chair) your society's president, Gail Cassell, the report makes many important recommendations about the ways in which we should train, recruit, evaluate, and promote our scientists, about procedures for allocating funds in each Institute between intra- and extramural programs, and about reconstructing a Clinical Center as a hospital of about 250 beds with associated laboratories at different removes from it. (A more detailed plan for the new buildings, which are likely to cost in the range of $1 billion over the next decade, will be produced with funds in the President's NIH Budget for 1995.)
Time forbids a detailed account of these recommendations, but I want to emphasize a few aspects that are likely to affect the careers of some of you. Most importantly, the process by which we attract new scientists to the NIH should become increasingly accessible and attractive to well-trained fellows from all parts of the country seeking their first independent jobs. Tenure-track positions will be widely advertised and filled by open competition. A new tenure track policy has already been put in place by Michael Gottesman and the scientific directors, and it will make use of a multi-institute tenure committee composed of outstanding basic and clinical scientists. Even before we received the most recent report, NIH investigators had begun to develop the trans-institute special interest groups--in cell biology, genetics, neurosciences, structural biology, molecular biology, and other fields--as suggested earlier by an intramural committee headed by Rick Klausner and Bill Paul. In addition, we are taking several measures to strengthen our post-doctoral training programs on campus, in both laboratory and clinical settings, deferring for the moment my long-range aspirations to develop a graduate program that emphasizes disease-oriented basic research.
I would like to believe--and I hope I can convince you and Senator Mikulski--that there is a renewal of spirit on our campus, that there will be more direct collaboration with the extramural community, and that the nation's scientists will move bidirectionally between these two communities with greater ease, despite their different modes of operation.
3) Equal opportunity
I have greater difficulty claiming major progress towards the third goal of achieving equal opportunity for all at NIH (or, for that matter, in NIH-supported science elsewhere). A recent review of minority representation among our intramural scientists by a committee headed by Bruce Chabner reveals that only 2 percent of our tenured scientific staff is black or hispanic, statistics that are, of course, not too different, though a bit worse, than observed elsewhere in the academic community. We have a respectably large cohort of women on our scientific staff, but analysis shows that they have received less pay and resources for equal status. And both women and minority scientists tend to be especially under represented in our upper ranks. Furthermore, to my dismay, NIH has been criticized over the past few years--in the press, by Congress, and by activist groups--for alleged discriminatory practices.
Dealing with these issues is an inherently difficult challenge, and one made harder by a current hiring freeze; by imposed reductions in NIH staff positions, especially at the senior scientist levels; and by the sometimes acrimonious tone of the debates. But there are some signs of progress, nevertheless. With the help of an NIH task force, I have put in place new means for processing and resolving complaints; in cooperation with our women scientists, Michael Gottesman is correcting historical inequities; we have obtained a few exemptions from the hiring freeze to appoint women and minority employees; and we have initiated a new program for clinical associates that will provide loan forgiveness to six M.D.'s from disadvantaged backgrounds this year. (We should not underestimate the importance of training a racially diverse cadre of clinical investigators, especially now that new congressionally-mandated NIH guidelines will augment the inclusion of minorities in clinical studies.)
The goal of achieving equal opportunity cannot be solved solely by such programs. In the longer run, we will have to depend on many efforts to make scientific careers more attractive to underrepresented groups--either in early schooling, as Bruce has emphasized, or at college. The remarkable success of some programs, such as the Meyerhoff Scholars Program at University of Maryland, Baltimore County, gives me hope that such preaching is not in vain.
4) Peer review
Merit review by peers is among the central tenets of biomedical science in this country, and it is a major source of our strength and our prestige. Yet we all recognize that peer review has become increasingly difficult as the budget fails to keep pace with inflation, as success rates fall, and as reviewers become dispirited by a process that seems excessively laborious and sometimes capricious. With budgets unlikely to improve in the near future, so long as we are operating under congressional caps on discretionary spending, it is important to try to improve the review process. This is one of several ways that we can hope to increase our chances of making the best possible use of the money we have.
With the help of Wendy Baldwin, Jerry Green, Director of the Division of Research Grants, and others, I have been looking at a number of ways to change various aspects of mechanisms by which NIH awards grants. Indeed, to carry out this evaluation, NIH has been awarded the status of a Reinvention Laboratory, in which government is reinvented under the guidance of the Vice-President's campaign for National Performance Review.
Thus far, the most effort and the most press ink has been devoted to the triaging of grant applications. In this process--which was used on an experimental basis, and mostly successfully, by four study sections in February, and is being extended to another twelve in the current round of reviews--the reviewers (not the staff) identify those applications, expected to be about half, that do not merit the full-throated presentation and discussion that should be reserved for those applications that are truly competitive. The disappointed applicants profit from being told early and clearly that a different approach is required, and the reviewers benefit from being required to write much less about the low priority applications and from having more time to rank the better applications fairly.
Other changes in peer review are also under consideration.
- We would like to defer submission of many of the forms currently required for all applications, until we know which are likely to be funded. This just-in-time procedure could save millions of dollars both at NIH and at sponsoring institutions.
- We have recently begun to reclassify the study sections and are thinking about further adjustments in name and composition to more accurately align them with current disciplinary interests.
- We are seeking ways to reduce paperwork by making better use of computers and electronic mail in the review process.
- We are hoping to enrich the membership of study sections by identifying individuals who have been successful beneficiaries of the system but have not done community service as a study section member. (Some of these people--you know who you are--will soon receive an encouraging letter from me.)
- Finally, we are contemplating other, more radical moves, that might make the grants dollars go further. These might include caps on awards, more grants of predetermined size, limits on salary supplementation, and other ideas. These possibilities and others will soon be aired in a discussion on grants and peer review in July, by a group that includes representatives of study sections, science review administrators, extramural scientists, and NIH leadership.
Other (long-term) issues:
I have been trying to convince you--and Senator Mikulski--that some real progress has been made on each of the fronts I pledged to work on during my first six months: appointments, the intramural program, equal opportunity, and peer review. Now I would like to conclude with a few comments about the central theme that brought me to Washington--the hope of helping to protect the basic science enterprise from the erosion I had sensed was occurring as a result of budget cutting, earmarking of funds, and demands for more socially relevant and applied research.
Here there is a certain irony. Doubtless we are all threatened by the deficit and by the limited supply of money currently available for science of many kinds. But I have not felt that there is a troubling shortage of love for the fundamental research that most of us do, especially for work done under the large umbrella of health and the NIH. We can see this from several perspectives.
- Recent proposals to reemphasize basic research in the fight against AIDS--for example the highly publicized article by Bernie Fields in Nature--have been greeted with general enthusiasm.
- Newspapers and magazines have been exclaiming over recent successes in basic biology, sometimes reaching levels of hyperbole--hyperbole for which we ourselves are often responsible--that could have negative repercussions in the future.
- The Office of Science and Technology Policy has taken an active interest in the welfare of fundamental science, having staged an important 2-day forum on the topic at which Vice President Gore and other dignitaries spoke and from which is expected to emerge an administration endorsement of the goals we share.
- Many members of Congress, especially those familiar with NIH, have displayed strong sympathies for and understanding of our work. Listen, for example, to Senator Mikulski herself, as she spoke at the Forum, describing the term "strategic research" for which she had last year been criticized by many scientists:
"By strategic research I do not mean only applied research ... (or) project-based research .... I mean investments in science that are focused around important national goals .... I believe the best model for what I am talking about ... is in the NIH. NIH is grouped around strategic areas to treat and cure diseases .... We do not have the National Institute for Molecular Biology; we have the National Cancer Institute, in which the most stunning research is going on in molecular biology and cellular biology, from the basic stuff of life itself all the way up to applied research.
"You and I know that science is not a linear process; it's like sailing--the difference between sailing and a power boat. A power boat you get in and guide your boat into the next marina. When you sail in Chesapeake Bay, first of all you make sure you have good ballast in your keel and a navigational chart, then you zig and you zag because you have to go where the winds of opportunity take you ...."
Such friends and their statements should, of course, encourage some optimism, but not complacence, about the regard in which basic science is held. To my surprise, the component of biomedical science that most needs help at the moment is clinical, applied, and even targeted in nature. The two most publicized crises I have had to confront were the deaths of five patients undergoing a clinical trial at NIH for eradication of hepatitis B virus with a nucleoside inhibitor, FIAU, and then the failure of the NCI's National Surgical Advujant Breast and Bowel Project to publicize swiftly the fraudulent practices that afflicted important studies of breast cancer treatment.
One of the things I have learned in Washington is the danger of distinguishing too forcefully between clinical and basic sciences. In the minds of Congress and the public, we are part of the same culture, recipients of the same funds, pointed towards the same goals. Some of the issues raised by current dilemmas in clinical science are closely related to questions that have afflicted basic science in recent years--particularly questions about integrity, disclosure, public trust, and even the scientific ego. Some of the remedies--through scientific training, information services, new kinds of oversight and investigation--may also be similar. It seems likely that we, as biomedical scientists of many kinds, will profit from working more closely with each other to solve shared problems and build an enterprise that benefits us all.
