Government
Proposed ethical guidelines viewed as overkill
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November 27, 1989 C&EN
So far, the National Institutes of Health has received only 40 some comments on its proposed guidelines for policies on financial conflict of interest in research. But given the rumblings in the research community, the agency is likely to be inundated with negative reaction by the time the comment period closes Dec. 15. No one quarrels with the professed goal of the proposed guidelines, which were published in the Sept. 15 issue of the NIH Guide for Grants and Contracts (C&EN, Oct. 2, page 14). Who wouldn't agree that research supported by NIH and the Alcohol, Drug Abuse & Mental Health Administration (ADAMHA) should be carried out objectively and that the results should not be influenced by the possibility of financial gain? But the specific proposals—especially the rule that would prohibit NIH-funded investigators, their assistants and consultants, and the spouses and children of any of those involved from owning stock in any company that might be affected by the outcome of the research—are widely viewed as overkill. Another controversial section forbids scientists from sharing information or research products derived from federally funded research with companies with which they have financial ties until the results are publicly available. And researchers would have to disclose all sources of funding—including honoraria and consulting relationships as well as laboratory support—when applying for NIH and ADAMHA grants. "Blanket prohibitions don't work/' says Benjamin R. Ware, professor of chemistry and vice president for research at Syracuse University. "The current proposal will limit our ability to utilize research to strengthen the nation's economy." Jerold Roschwalb, director of federal relations for the National Association of State Universities & LandGrant Colleges, says, "In 1989 there are all kinds of interrelationships between university and business. Many people have apparent conflicts of interest—the problem is how to deal with it. The fact that a
research scholar is working with a corporate body is not inherently a problem, although it could be." Says Mark S. Wrighton, chairman of Massachusetts Institute of Technology's chemistry d e p a r t m e n t : "We're very concerned about the development of guidelines that will have the effect of precluding the opportunity to pursue the very research that is most interesting." Disclosure is needed and entirely proper but any prohibition that would not be examined on a caseby-case basis is ridiculous, according to George C. Levy, professor of chemistry at Syracuse. "If you take away anybody with a conflict of interest, you take away all the experts." Most people in the academic community recognize that NIH is under pressure from Congress to address the issue. The House Government Operation's Subcommittee on Human Resources & Intergovernmental Relations, chaired by Rep. Ted Weiss (D.-N.Y.), has held two hearings in the past 14 months that have focused on the potential for private gain biasing researchers. That subcommittee's September 1988 hearing aired some disquieting examples of medical doctors who had distorted results in clinical evaluations of new drugs in which they had financial stakes. But NIH's effort to limit such abuses, many of the guideline's critics argue, will have a detrimental impact on other research activities. "These guidelines assume the whole research community is engaged in large, multisite clinical ' trials," says Carol Scheman, the Association of American Universities' director of federal relations, "while in reality it is university scientists collaborating with industry—at the direction of the federal government." Scheman, Roschwalb, Ware, and others are disturbed that the guidelines would inhibit the transfer of the results of federally funded research to the industrial sector—a goal that Congress was actively encouraging very recently. "A few years ago the issue was 'competitiveness,' " Roschwalb says,
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Government "and we worked to secure closer relationships with business. Now we're getting the message that the relationships we thought were good are turning out to be suspect." Association of Biotechnology Companies (ABC) is alerting its members to the proposed guidelines, urging them to file comments with NIH. "The proposed prohibitions would eliminate the possibility of compensating researchers with stock," writes Bruce F. Mackler, ABC's general counsel. "New startups by fledgling biotechnology companies will be affected adversely. The ability of scientists to participate in and direct commercial development of new biotechnology products will be severely limited. Ultimately, it will be more difficult and more costly to bring basic research to the marketplace." Similarly, Syracuse's Levy fears that ventures such as a company he founded, New Methods Research Inc., would be stifled under the proposed guidelines. The business de-
velops software for data reduction ion for nuclear magnetic resonance— e— both medical imaging and chemical ical spectroscopy. Federal funding has supported 10 to 18% of the software are development, Levy estimates. Levy started the company about out five years ago with the knowledge ige and approval of both NIH and the Syracuse administration. Since then, en, Levy says, there has been a tremenendous synergy between the resources •ces of the company and the university. y. "It would be totally impossibleî to do that under the prohibitions of ich the proposed guidelines, in which payou can't own a piece of the compaanny," Levy says. Without the finanire, cial stake in the company's future, ted he says, he would not have invested ley the time, energy, sweat, and money necessary to get it off the ground. naTwo weeks ago Levy sold a maich jority interest in the firm, which ich now has 35 employees, to a French •.A. company called Digital Design S.A. im. of Paris for an undisclosed sum. When pressed as to whether itl. is
proper for him to profit from the sale of a company that grew at least partly out of an investment of publie funds, Levy points to the benefits the public has garnered. "The company has brought in 10 to 15 scientists to the Syracuse community from all over the world," he says. "The 20 people in my academie lab, although they don't work for the company, get exposed to what's going on." And the company is even helping with the U.S.'s balance-of-trade problem, he points out, as it is directly responsible for $3.5 million worth of exports to Japan. NIH's Janet Newburgh, chief of the institutional liaison office, says the agency has no preconceptions as to how it will proceed once the comment period closes. "We will evaluate the comments and then decide what to do," she says, adding that they would not become final regulations without going through a formal rule-making process. Pamela Zurer
'89 Special Symposium Announcement: PACIFICHEM F
Chemical Frontiers in Magnc Magnetic Resonance of Living Syster Systems Sheraton Waikiki Hotel - Waianae Waianai Room 20 7:30-9:30, Wednesday evening, December De< 7:30
8:00
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THE USES OF MOLECULAR PARAMAGNETISM FOR IN VIVO NMR Charles S. Springer, Jr.; State University of New York, Stony Brook, NY HIGH RESOLUTION 1H AND 13C NMR STUDIES OF BRAIN METABOLISM Robert G. Shulman, D. L. Rothman, E. J. Novotny, O.A.C. Petroff, C. C. Hanstock, and J. W. Prichard; Yale University, New Haven, CT
8:30
THE MOLECULAR BIOLOGY OF NUCLEAR MAGNETIC RESONANCE IMAGE CONTRAST Roberts. Balaban, D. D. Wolff, T. Fralix, and J. Eng; National Institutes of Health, Bethesda, MD
9:00
NEW INSIGHTS INTO CELL ENERGETICS: MECHANISMS OF CONTROL AND REGULATION OF OXIDATIVE PHOSPHORYLATION Kàmil Ugurbil; University of Minnesota, Minneapolis, MN
9:30
Reception - Niihau Room
November 27, 1989 C&EN
Corporate Sponsors: Bruker, Doty Scientific.General Electric Medical Systems, Merck Isotopes, Siemens Medical Systems, Spectroscopy Imaging Systems, Wilmad Glass Organizers, Presiding: J. J. H. Hackerman (ACS), Washington University, St. Louis, MO; L. W. Jelinski (ACS), AT&T Bell Laboratories, Murray Hill, NJ Co-Organizers: I. C. P. Smith (CIC), National Research Council, Ottawa, Ontario; H. Wateri (CSJ), National Institute of Physiological Sciences, Okazaki
