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Witness Testimony
Dr. Harold Varmus M.D.
NIH Ethics Concerns: Consulting Arrangements and Outside Awards.
Mr. Chairman and Members of the Committee: Thank you for an opportunity to speak with you about rules governing the outside activities of scientists employed by the National Institutes of Health (NIH) and about my views of the recommendations recently made to the NIH Director by the panel he established to review practices related to conflicts of interest. I welcome the public discussion of these topics, because the NIH is of such importance to the future of biomedical research and health care, and the conduct and management of its research program are therefore matters of general concern. My current opinions about the complex issues being addressed at your hearing today are based on my experiences in three phases of my career---first, as a faculty member at the University of California, San Francisco, Medical School from 1971 to 1993; second, as the Director of the NIH, from 1993 to the end of 1999; and, third, as the current head of the Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City. Each of these phases offered lessons that are pertinent to our important discussion here today. Phase 1: Birth of the biotechnology industry It helps to begin with some history. During the 1970's and 1980's, biomedical research was transformed by advances in molecular biology and genetics that led to the development of recombinant DNA technology. Once the government and the scientific community reached agreement about reasonable means to monitor the safety of these new methods, an industry based on them---the biotechnology industry---was born and grew rapidly, especially in the Bay Area, where I was working. Soon this new enterprise generated and began to manufacture some of its now numerous products---such as human insulin, hepatitis B virus vaccine, and hormones that protect the bone marrow after cancer chemotherapy---major advances in health care that help to justify to the public the major investment that our country has made in basic biomedical sciences. The growth of the biotechnology industry was also remarkable because it depended heavily on an unusually intimate relationship between the industry and the non-profit sector, especially scientists in academic institutions. These academic scientists, largely supported by public funds (often salaried by state universities and nearly always beneficiaries of Federal research grants), were not only the authors of the published knowledge on which the biotechnology industry was built; they were also the founders, the consultants, the board members, the collaborators, and the sources of newly trained employees for the companies. Different academic institutions displayed a wide range of attitudes towards these activities, without consensus on the nature or seriousness of any potential conflicts and often without clear guidelines for preventing or governing them. One indisputable feature of this change was the enhanced fertility and frequency of relationships between the academic and industrial sectors. In contrast, government scientists, such as those working in the intramural program (IRP) of the National Institutes of Health, were more likely to be subject to limitations to their participation in these productive and interesting interactions, despite the fact that they were neither regulators of non-government research nor responsible for awarding grants and contracts. In fact, in most ways, the government scientists in the IRP could be viewed as having position descriptions very similar to those of academic scientists at universities, health centers, and research institutes: to perform not-for-profit research, largely with public funds, with the intention that the findings will be useful for the control of disease. (The major differences between IRP and academic scientists are related to funding mechanisms, review procedures, and the speed of the IRP's response to new health threats.) Phase 2: Strengthening the NIH IRP The governmental restrictions, however, on industrial interactions and other "outside activities" (such as bans on honoraria for speaking, editing, and writing), combined with less generous salary scales and many concerns about the management of research activities in the Federal agency, contributed to the relatively low esteem in which the IRP was held by outside scientists and to the low morale in the program when I arrived at the NIH as Director in the fall of 1993. Worrisome consequences of these attitudes included ineffective recruiting of new staff from the external scientific community (it was reported that 70% of recently recruited staff had been trained in NIH laboratories) and the recent loss of some of NIH's most prominent scientists to the academic or industrial sectors. (Some of these issues are discussed in a lengthy news article that appeared in Science magazine in August, 1993; J.Cohen, "Is NIH's Crown Jewel Losing Luster," Science 261: 1120, 1993.) As a proud product of the NIH intramural training program in the late 1960's, when it was considered to be in an extraordinarily productive phase, I was intent on trying to return the IRP to its earlier stature in my new position. To achieve this, my colleagues and I energetically and successfully followed the recommendations made by a panel of distinguished investigators that we convened to address concerns about management, evaluation procedures, and facilities in the IRP (Report of the External Advisory Committee of the Director's Advisory Committee and Implementation Plan and Progress Report, November 17, 1994). I sought permission from the DHHS, again successfully, to expand the use of alternative pay scales, including the Senior Biomedical Research Series, and alternative hiring authorities, such as Titles 38 and 42. When advised by the Office of Government Ethics in 1995 that NIH had dramatically improved its oversight of outside activities, following a critical appraisal in 1991, and should come into compliance with the less restrictive policies employed at other Federal agencies, I lifted the restrictions as another step towards making the NIH IRP more welcoming to outstanding scientists, with the explicit understanding that all outside activities would be carefully reviewed by ethics officers to insure that they did not interfere with the conduct of official duties. In my estimation---and, I believe, in the estimation of most of the scientific community---the IRP has largely regained its stature and its productivity. It competes effectively with academic institutions for outstanding job candidates at the junior level, and many of its current leaders have been brought to the NIH campus in the past decade from the extramural community. It is difficult, of course, to know how much to attribute the improved status of the IRP to changes in compensation, policies governing outside activities, new buildings, altered reputation, or improved management practices. But, to offer one example, the Director of the new Vaccine Research Center (VRC) has told me that he would have been unable to recruit most of the seven junior and three senior scientists he has hired at the VRC since his arrival in 1999 if he did not have Title 42 authorities to offer salaries competitive with those provided at outside institutions; furthermore, while his new staff members fully understand the need for careful review of their outside activities for conflicts of interest and commitment, they would have been discouraged from coming to the NIH if it were considered unethical to use their general knowledge to advance the practical use of new information by consulting for industry. Phase 3: Growing sophistication of approaches to outside activities During the nearly four and a half years since I left the NIH for MSKCC, I have closely observed and participated in the evolution of attitudes at academic health centers towards outside activities, particularly those that involve the for-profit, industrial sector. In view of the dangers posed by conflicts of interest in clinical research, many academic health centers---acting alone and through their associations---have re-examined their rules for the conduct of clinical research. They have also sought clear definitions of conflicts of interest that affect individual investigators or entire institutions, and they have applied them to the conduct of basic laboratory research as well as clinical research. As a by-product of these deliberations, more attention is now also given to the conflicts of commitment that result from the devotion of relatively extensive time to, or the receipt of relatively generous reimbursement from, an outside activity. Furthermore, academic institutions increasingly appreciate the importance of even the appearance of conflicts of interest or commitment, since a perceived potential for conflict can undermine public confidence in medical research. Importantly, the accumulated experience with a wide variety of outside activities undertaken by employees at many non-profit research institutions indicates that complicated cases are generally uncommon, but difficult to judge by a simple rule book. For this reason, many academic centers, including our own at MSKCC, have established conflict of interest committees, composed of scientists, administrators, lawyers, and informed laypersons, to review unusual and complex situations on a case-by-case basis and make recommendations to institutional leaders for the management of those cases. Advice to the Blue Ribbon Panel These more sophisticated approaches to management of outside activities in academia should also be applied to the NIH IRP, as I maintained when I testified before the Blue Ribbon Panel that Elias Zerhouni, Director of the NIH, recently assembled to advise him about conflict of interest policies. More specifically, I emphasized the continued importance of outside activities, including consulting for industry, to maintain the vibrancy of the IRP, to ensure that the talents of its members are fully utilized for the benefit of society, and to provide the tools necessary for effective recruitment and retention of outstanding scientists. I also argued that rules of engagement need to be more explicit and frequently revisited---and revised if necessary---while remaining consistent with the cardinal principle of non-interference with the performance of official duties. I applauded Dr. Zerhouni's creation of a trans-NIH conflict of interest committee and his already successful efforts to enlarge the group of IRP scientists required to provide full public disclosure, not just internal disclosure, of their compensated outside activities. I also argued that some reasonable limits should be placed on the number of hours devoted to and/or the amount of compensation received from an outside activity. Finally I recommended that senior NIH personnel, such as Institute and Center Directors, who are responsible for the award of grants or the development of extramural programs and who are unable to recuse themselves in favor of an appropriate superior should not be permitted to engage in outside activities involving potential or actual beneficiaries. (I also proposed some of these policy changes in written testimony submitted to the Labor-HHS Subcommittee of the Senate Appropriations Committee on January 15, 2004.) In general, I agree with the Blue Ribbon Panel's recommendations, as presented to your Committee last week by Bruce Alberts and Norman Augustine, with a few qualifications. I believe that exclusion of senior Institute and Center personnel from consulting for industry or academia should be based on function (namely, formulation or funding of extramural programs as opposed to direction of intramural research), rather than seniority or title. I also believe that exemptions should be permitted from the ban on reimbursement with equities if reviewed favorably by the trans-NIH conflict of interest committee. Final actions by the NIH Director on these and other matters addressed in the Panel's report should take into consideration public comments on the report, the views of NIH employees and grantees, and the opinions formed by this Committee and the Congress as a consequence of these hearings. I appreciate the efforts you and your colleagues are making, Mr. Chairman, to study these complex issues by holding this series of hearings. Your actions and views can have important consequences for one of the world's most esteemed research organizations. I would now be pleased to respond to any questions you might have. Related Documents |
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