Back to Front PageVOLUME 6, NUMBER 4
 

Tragic events often bring to light troublesome issues that need sober reflection. The recent publicity surrounding unexpected deaths during gene therapy trials is certainly a case in point. One of the more troublesome of the issues surfaced by these tragic events is the matter of conflict of interest in the conduct of clinical trials.

One might gather from some of the accounts in the popular press that investigators who have a "conflict of interest" of any kind are, ipso facto, guilty of fraud. Such a naïve view is at best misleading and at worst devastating to sustaining public trust in the integrity of science. Conflicts of interest in medical research are neither new nor are they avoidable. Medical scientists routinely labor under conditions rife with conflicting interests.

Maintaining one's scientific objectivity is in perpetual conflict with one's interest in career advancement, in being recognized by peers, in garnering the next NIH grant, in publishing one's work in the best journals, and, now more than ever, in gaining financial rewards from commercializing one's intellectual property. The latter source of conflict, which actually may be less corrupting than the others, is never-theless the most problematic from the public's point of view-and, hence, most urgently in need of our attention.

The challenge to investigators has always been to recognize that conflicts are inevitable and that keeping one's own interests in check is the essence of scientific integrity. The challenge to research institutions is to monitor and help manage those inevitable conflicting interests their faculty face.

In today's moneyed world of joint ventures, in which medicine and business, research and commerce, and science and investment are so intricately interconnected, many investigators find themselves entangled in a web of unprecedented temptation. Obtaining stock options, licensing one's patents, and securing equity positions in promising new firms now compete with amassing a lengthy bibliography, achieving tenure at a young age, and being elected to a prestigious professional society.

This is clearly a time for sober reflection-reminiscent of a decade ago when we were in the midst of public concern over conflict of interest nearly as intense as the current one. At that time, the AAMC published a monograph titled "Guidelines for Dealing with Faculty Conflicts of Commitment and Conflicts of Interest in Research."

In an era when your new computer is obsolete before you take it out of the box, you will find it reassuring to review this document. The principles espoused by this monograph remain-as principles should-perfectly attuned to today's dilemmas.

One of the keys to preventing conflicting situations from tarnishing trust, says the guide, is "full disclosure." Few would deny that full disclosure of financial interests by investigators is an absolute requirement for maintaining research integrity and public trust. Yet, as reported in the press, the failure to disclose existing financial entanglements lies at the root of many of the recent conflict-of-interest controversies. I have no way of knowing whether those press reports were accurate, but I do know how damaging the resulting appearance of impropriety has been.

Is conscientious adherence to the principle of "full disclosure" sufficient to obviate perceptions of impropriety, or worse yet, of fraud? Emphatically no. Limitless financial interest in the outcomes of one's own research, no matter how fully and widely disclosed, is a brazen assault on public confidence in science. The public's willingness to believe in the objectivity of science has understandable limits. So, too, should an investigator's financial interests.

A heartening development on this score was a recent announcement by Joseph Martin, the dean of Harvard Medical School. He reaffirmed Harvard's long-standing and stringent limits on the financial arrangements permitted to its faculty members: a maximum investment of $20,000 in any for-profit enterprises for which they do work and a maximum of $10,000 per year in income from such work.

Those limits, it seems to me, strike a reasonable balance between the need to motivate investigators to move their discoveries as quickly as possible from bench to bedside and the danger of undermining people's trust in medical science by making our research enterprise look to the outside world more like a bazaar than a public service.

I sincerely hope our community will recognize the current public angst about conflicts of interest as a plea for us to reexamine and strengthen our safeguards. Conflicts of interest are unavoidable realities to be managed. Breaches of public trust are unacceptable transgressions to be forestalled.

 

Jordan J. Cohen, M.D.
AAMC President

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