Conflicts of interest in biomedical research.

FINANCIAL CONFLICTS OF INTEREST IN ACADEMIC BIOmedical research first entered the public consciousness during the 1980s, along with a series of widely publicized episodes of scientific misconduct. In some of these episodes, faculty investigators were accused of having fabricated or falsified research data on therapeutic products in which they had substantial financial interests. The linkage was unfortunate because it has imprinted indelibly in the minds of members of Congress and the media that financial conflicts of interest in biomedical research are inherently wrong and often accompanied by scientific misrepresentation or misconduct. These issues are again before us, in a context of increasing administration, congressional, and public concern about the adequacy of the current system of protections of human subjects in general, and more specifically, in response to recent tragic events that occurred in gene transfer experiments in settings in which both investigators and their institutions are alleged to hold financial interests have been linked to the deaths of several research participants. Once again, there are calls for increased federal interposition into the conduct of academic biomedical research and strengthened federal guidance, if not regulation, of faculty researchers’ behaviors and privileges. In the early 1990s, both the Association of American Medical Colleges and the Association of Academic Health Centers published monographs that provided guidance to academic centers for the management of individual and institutional financial conflicts of interest in research. The guidelines were well received at the time, and their insights and wisdom are worth recalling as academic medicine again finds itself on the defensive in the face of renewed public concern about financial conflicts of interest in research and demands for expanded governmental oversight. At times like these, it becomes easy to lose perspective about conflicts of interest and forget the reasons the public is so generous in its support of biomedical research and the public policy that shapes the process that creates new products to ease suffering and disability. Absence of context can lead to proposed remedies that could damage both the scientific process and the translation of scientific discoveries into public benefit. On the other hand, it is of equal concern that the nation’s medical schools and teaching hospitals, which remain the fount of new medical knowledge from which most novel diagnostic methods and treatments derive, may have been insufficiently responsive to the profound changes that have transformed the culture of academic medicine since the birth of recombinant DNA technology in the early 1970s and the passage of the Bayh-Dole Act in 1980, and thereby allowed themselves to become vulnerable to corrosive public skepticism. This Commentary addresses both of these issues in the hope of providing perspective and context that will help inform the renewed public debate.