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AAMC Reporter: March 2005
A Word from the President:
"Restoring Public Trust in the NIH: Lessons for Academia"
Last month, NIH Director Elias Zerhouni took what he called a "drastic" step. He tightened dramatically the rules governing financial relationships between NIH employees and outside entities that are in a position to gain from dealings with the agency. Was he right to do so? Given what had recently come to light, I think he had no choice.
Revelations in the media about financial conflicts of interest involving some top NIH scientists were troubling enough. To make matters worse, a careful internal review of recent practices at the agency uncovered additional examples of serious financial conflicts that had not previously been disclosed.
It doesn't matter that the number of NIH scientists who had financial conflicts may have been quite small relative to the thousands of investigators employed there. And, sad to say, it doesn't matter that future problems of this sort might have been avoided by robust enforcement of less draconian measures. What does matter is that the reputation of the NIH, the cathedral of medical research here and around the world, was suffering a body blow. Trust in the integrity of NIH science was threatened as never before. And longstanding congressional support for biomedical research at NIH and elsewhere was being shaken.
A less drastic response would not have sufficed to staunch the growing anger and sense of betrayal that these seemingly egregious conflicts elicited. We can't have it both ways. We can't expect the NIH to maintain its preeminent standing in the world while permitting such ostensible impropriety to persist.
Now, to be sure, the new NIH conflict of interest rules are extremely stringent. Virtually all compensated activity with any outside entity, commercial or otherwise, that could benefit from a relationship with the NIH is now prohibited. Mindful of the unintended consequences that could result from this sharp departure from the previous conflict of interest regime, the NIH wisely announced its intention to review within one year the impact of the new rules, especially on recruitment and retention of top scientists. No one wants to undermine the effectiveness of this uniquely important institution any more than one wants to see its credibility tarnished. If the consequences of the new rules prove damaging to the NIH's essential functions, modifications will certainly be made.
In the meantime, not surprisingly, some in the media and elsewhere are now asking why these extremely stringent rules should be limited to the intramural scientists at NIH? If it's appropriate for them to be heavily insulated from financial temptation, they ask, why not apply the same rules to university scientists? After all, they also conduct research with NIH money.
The answer is that university scientists operate in a much different environment than their NIH counterparts, and play a much broader societal role. Which is not to suggest, by any means, that stringent conflict of interest rules are not critically important for investigators working in academic settings, but only to acknowledge that those rules need to be tailored to accommodate different circumstances. The principal difference centers on the public's interest in fostering productive partnerships between academia and industry. Beginning long before the enactment of Bayh-Dole Act of 1980 gave recipients of federal research funds the right to patent their discoveries, such partnerships have been widely recognized as essential, not only to the vitality of university science and science education, but also to fulfilling a critical public purpose, namely, to accelerate the translation of new knowledge into useful products and services. To that end, lawmakers have put strong financial incentives in place to encourage academic institutions and their faculty to team up with for-profit entities in order to harness their unique capacity to fully develop promising ideas into actual benefits for people. It makes no sense to sacrifice the enormous public benefits stemming from this policy by totally prohibiting the financial interactions that fuel it.
Accordingly, both the federal government and the academic research community have determined that the public's interest in gaining rapid access to the benefits of medical research would best be served by carefully monitoring and managing, rather than by banning, all financial interactions between academia and industry. Research universities have had long experience at managing faculty conflicts of interest across the broad range of scholarly disciplines. Conflicts in biomedical research have received special attention, particularly since the issuance of mandatory federal regulations for the extramural community in 1995, and their enhancement by comprehensive federal guidelines in 2004.
Recognizing the importance of maintaining public trust and protecting the safety of human subjects who participate in medical research, the extramural community has used these federal regulations as the basis for embracing even more robust standards. Notable in this regard are the AAMC's guidelines for managing individual and institutional financial conflicts of interest, which were developed in recognition of the unique challenges faced by medical schools and teaching hospitals as they attempt to fulfill their congressionally sanctioned role as partners with industry. This guidance is exceedingly stringent; its touchstone is the rebuttable presumption that no one with a significant financial interest in the outcome of a study can be allowed to conduct that research. The AAMC recommendations were directed specifically at research involving human subjects but are equally applicable to all academic research. A survey conducted last year revealed widespread adoption of all or substantial portions of the AAMC recommendations, indicating that our community has strengthened its conflict of interest standards significantly beyond those set by federal regulations.
Rules can never be made stringent enough to prevent a determined individual from violating them. But the guidance already being adopted by academic medical centers, if scrupulously implemented, can avoid the indignity recently suffered by the NIH. Indeed, the critical lesson to learn from the NIH experience is that strict compliance with appropriate conflict of interest standards is a sine qua non for preserving public trust in the integrity of our research.
Jordan J. Cohen, M.D.
AAMC President
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