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Marcia Angell correctly points out that financial conflicts of interest in academic medicine can seriously distort medical education and research, as well as the delivery of optimum medical care. They are a genuine concern for the academic medical community, the medical profession, and the public writ large.
Some commentators address these issues by demonizing pharmaceutical and related vendor industries and advocating for marked reduction or even total elimination of interactions between them and academic medicine. Such uncompromising rhetoric has its own adverse consequences. Angell, for her part, has forcefully and judiciously argued for the reduction of industry influence while maintaining those relationships between academia and industry that do not “threaten the independence and impartiality essential to medical research.” Angell and I are in agreement on this point.
I advocate distinction of those industry relationships that are largely gratuitous, distracting, self-indulgent, and corrupting, and should be eliminated, from those that have value and serve important public functions. Diligent enforcement of federal and state regulations, reaffirmation of medicine’s professional codes, and vigorous implementation of clear institutional policies in academic medicine are critical to this approach, which would wean the medical profession from the perverse culture of entitlement that in recent decades has flourished and sapped its integrity. And where better to start this process than in academic medical centers?
I applaud the efforts now being made by leading academic medical institutions to eliminate most of the industry relationships that I characterize as gratuitous and corrupting, and to manage strictly the few that may remain. To be eliminated are the excessive role of industry in subsidizing continuing medical education and the development of influential clinical practice guidelines, as well as the many varieties of industry gifting. The vast majority of these activities are funded by industry marketing budgets and have no acceptable role in medicine. Here again, I believe that Angell and I are in close agreement.
But when it comes to research, there is some distance between us. Many of the conflicts Angell rightly denounces are unfortunate responses to public expectations that cannot be fulfilled without close interactions between academia and industry. In seeking to eliminate excesses, we must take care not to undermine beneficial interactions.
In the last six decades, the size of the biomedical research and training enterprise has grown enormously, fueled mainly by funds competitively awarded by the National Institutes of Health. (It is important to recognize that even with the recent growth in research relationships with industry, industry funding comprises, in aggregate, less than 10 percent of academic biomedical research funding.) Along with the remarkable growth of federal investment in biomedical research has come an equal growth in public impatience and insistence upon tangible benefits: new diagnostics and treatments, cures.
These public expectations create a dilemma. On the one hand, academic medical institutions, like the research universities in which they are often situated, are expected to serve the public as trustworthy “independent arbiters of knowledge” by producing research that is unbiased and untainted by financial self-interests. On the other hand, NIH does not fund, and academic institutions do not manufacture, products. In our society that is the role of the commercial sector, of venture capital and industry. There must be some interface between the very different cultures and values of industry and academia if the products that people demand are ever to become available.
Attempts to deal with the dilemma occasionally result in failures, but this does not mean that relationships between academia and industry should be abandoned. Every major research university has policies that protect the freedom of its faculty to choose and pursue their research endeavors without interference from sponsors, including industry sponsors. This means that the faculty researchers, whether in biomedicine or any other discipline, must be free to design their studies, collect and analyze their data, and interpret and publish their findings in scholarly literature. These institutions as a rule do not accept external funding from any sponsor, whether federal agencies or corporations, that would impose conditions that contravene these policies. I note that during my 29 years at Stanford, the only time the university had to sue a sponsor to protect a researcher’s freedom to communicate his findings, the defendant was a federal agency.
It is clear that not all universities and medical schools have behaved this way consistently. Some have accepted pharmaceutical-industry funding for research that was unduly controlled by the company, and leading medical faculty have put their names as first authors on papers describing research they did not perform. These are deplorable practices, universally condemned. But they are failures of academic institutions, not grounds for denouncing all pharmaceutical industry-funded research.
University policies also address financial conflicts of interest of individual faculty members and senior institutional officials with respect to research. The central feature of these policies is the requirement that faculty annually report to their institutions their outside financial interests that are in any way related to their academic responsibilities, and that these reports be critically reviewed by an institutional official or faculty committee. The committee evaluates the magnitude of the financial interest, its relationship to the research, its sensitivity to the results of that research, and the nature and inherent risks of the research. Based on this review, the institution may prohibit the faculty member from proceeding with the research unless the conflict of interest can be eliminated, reduced to a tolerable level, or managed, generally by restricting the conflicted researcher’s participation, and/or by appointing independent monitors.
Vigorous implementation of these policies heightens institutional consciousness of and sensitivity to financial conflicts of interest and protects the integrity of research, the well-being of human or animal research participants, and the reputations of both the researchers and the institution. By the adroit deployment of policy and education, institutions can create in their faculties, students, and research staff a culture of responsibility and conscience.
Even with committed enforcement, however, the policies are under constant strain. The relentlessly increasing public pressure on universities and medical centers to commercialize the fruits of publicly funded research is generating ever more diverse and complex financial relationships between faculty, institutions, and commercial partners. New mechanisms of conflict-of-interest oversight and strategies of management will evolve, and given the enormous federal investment in university research and public sensitivity to financial interests, more expansive and intrusive federal regulatory regimes are inevitable.
But the fact remains that it is the public that has laid these conflicting expectations on research universities and academic medical institutions, and whatever new approaches are adopted must satisfy both prongs of the dilemma: promoting the efficient translation of research discoveries and protecting research integrity.
Money can indeed buy many things, but it must never be permitted to buy scientific integrity. It is the solemn duty of our academic institutions to ensure that it does not.
Relationships between academic institutions and biotechnology companies create conflicts of interest that undermine the goals of academic medicine and harm the public.
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