Medical Ethics Revisited

Harvard Medical School has decided for now not to liberalize its rules...

Harvard Medical School has decided for now not to liberalize its rules governing faculty members’ economic stake in company-sponsored research conducted in their laboratories. The issue, under study by a committee appointed in 1998 by Dean Joseph B. Martin, was scheduled for debate at a faculty meeting on June 1. Instead, on May 25, Martin announced that “we will not recommend any new exceptions in our policy” and canceled the June 1 debate.

The school’s “Policy on Conflicts of Interest and Commitment” permits only minor exceptions to financial conflicts. A researcher may own up to $20,000 in publicly traded stock in a company whose technology is being studied, or may receive consulting fees or honoraria of up to $10,000 annually from such companies. Those limits, considered the tightest in American academic medicine, were being reevaluated by the committee for two reasons. One is concern that the guidelines might unduly stifle fruitful industry-medical school collaborations. Another is that Harvard’s stringent criteria might cause talented researchers to work elsewhere.

The medical school’s self-examination did not take place in a vacuum. Martin recently served on an independent panel that reviewed the University of Pennsylvania’s Institute of Human Gene Therapy. The death there last September of a teenaged research subject has prompted federal safety reviews and changes in procedures, practices, and personnel. While endorsing the promise of gene therapy,  the panel’s report, issued April 27, questioned the institute’s organization, training, and allocation of responsibilities, and urged that Penn “review its policies on conflict of interest.” It noted that “the avoidance of conflict of interest that even remotely might detract from putting the needs of patients first becomes paramount” because “new therapies differ from...other ventures, such as computer technology, which involve no responsibilities for patient care.”

On May 18 the New England Journal of Medicine ran a sharply worded editorial by outgoing editor Marcia Angell titled “Is Academic Medicine for Sale?” Angell cited bias among researchers with ties to drug companies. “Academic medical centers,” she declared, “should be wary of partnerships in which they make available their precious resources of talent and prestige to carry out research that serves primarily the interests of the companies.” For Harvard’s faculty to consider “[s]oftening its conflict-of-interest guidelines is exactly the wrong thing for Harvard Medical School to do.”

The June 1 medical-school faculty meeting was to have been attended by outside experts. Among them, David Korn ’54, M.D. ’58, senior vice president of the Association of American Medical Colleges, and Kenneth I. Shine ’57, M.D. ’61, president of the Institute of Medicine of the National Academy of Sciences, both supported Martin’s decision. Shine expressed the hope that more schools would move toward Harvard’s standard, rather than vice versa.

A few days later, Jeffrey M. Drazen—Angell’s successor at the New England Journal—was embroiled in the kind of conflict she editorialized about. An asthma expert, Drazen has been Francis professor of medicine and professor in the School of Public Health’s department of environmental health. As editor, he said, he would recuse himself from reviewing manuscripts involving any of nine companies from which he had received research support or fees. Late in May, it was reported that a 1999 press release from Sepracor had quoted Drazen, then a paid consultant, who hailed a new drug’s efficacy—but the Food and Drug Administration found that the quotation misleadingly went beyond the uses for which the drug had been approved.

Given heightened public concern over the relationship between private research sponsors and academic medical centers, the federal government in May proposed further oversight of clinical trials and research. In that context, Martin told his colleagues, the medical school faculty’s deliberations “should await a national forum for dialogue.” He continued, “[T]he most important role academic medicine can have in clinical research today is to try to bolster the public’s faith in the veracity and ethical underpinnings of this noble endeavor….at the same time that we try to move science forward as eficiently as possible to the benefit of mankind.”

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