July 21, 2010
Eighteen months ago, the Faculty of Medicine at Harvard University launched a review of its longstanding faculty policy governing financial conflicts of interest. The report and recommendations of our Faculty of Medicine Committee on Conflicts of Interest and Commitment, which I have accepted and which were released today, comprehensively address the diverse manifestations of such potential conflicts in the modern world of biomedicine. The final recommendations will result in a new policy that provides guidelines and rules to protect the interests of the public and the integrity of our faculty and institutions, while simultaneously permitting effective interactions between our faculty and industry that are essential to our mission of improving human health.
The report and new policy recommendations engage an unavoidable tension, seen in many fields but especially important in biomedicine, between the sacred professional obligations of physicians and scientists to our patients and to the integrity of science and personal and institutional financial interests that have the potential to incentivize unprofessional behavior. Although professional codes, institutional values and the integrity of our faculty serve as powerful defenses against such behavior, these alone are sometimes insufficient, and our policy seeks to codify our standards and make adverse exceptions as rare as possible.
Why is it necessary to consider academic interactions with industry? The reason is simple. Neither academia nor industry acting alone can optimally provide the new therapies that we so desperately need to attack the medical afflictions we face. Virtually all involved in the enterprise of creating new knowledge for the purpose of developing such therapies understand this and agree that new and more effective collaborations are needed. Our faculty is an extraordinary repository of creativity, knowledge and drive. Through their own work, funded by industry when appropriate, and through consultation with industry in areas of mutual interest, we have the opportunity to enhance the future health of our country.
The Faculty of Medicine at Harvard University address health across a broad spectrum of activities, from the education of medical and dental students, trainees and practicing physicians, and other healthcare providers; to research both basic and clinical; and to health care policy at all levels. As a result, potential financial conflicts of interest are a collection of distinct species that must be examined separately to be understood.
In all cases where financial interests are involved, an essential antidote to potential harm is transparency, and so disclosure of relevant financial interests internally—and, for the first time, publically—will address this concern.
Let’s first consider financial conflicts related to research. The majority of our sponsored research derives from federal sources, such as the National Institutes of Health, but research supported by industry plays an increasingly important role in our research programs. Why? Funding from federal and nonprofit sources is inadequate to support many meritorious proposals, and companies have the resources and interest and can provide reagents, techniques and expertise not otherwise available. So far, so good. Since industry-sponsored research may involve bench research or patients, the existing policy and new revisions are tailored differently for the two varieties. In both cases, however, the terms must protect the appropriate academic freedoms of our faculty.
For all industry-sponsored research we limit the financial interests that the faculty may have in the company sponsoring the research, and we prohibit such research if sponsored by a privately held company in which the faculty has equity interests. For research involving human subjects, the financial restrictions are much more severe and, under the new policy, will be further tightened. These rules limit the actual and perceived potential for financial-induced bias while permitting robust industry sponsorship of both basic and clinical research.
What about financial conflicts in the sphere of education? There is nothing more central to our mission than the integrity of our educational offerings and the excellence of our faculty as educators, and we are justifiably proud of both of these. Financial interests have received attention as potential influences over the educational objectivity of faculty in recent years, and although we see this as very rare among our faculty, new actions are justified in response to public and professional concerns and changing practices. In addition to requiring disclosure of permitted financial interests by all faculty at the time of lectures and soon on a public website, we have placed new safeguards against inappropriate influence by the marketing arms of companies during educational events involving our faculty. We will prohibit faculty participation in so called industry “speakers bureaus,” in which faculty are paid to present information prepared and provided by the company on new treatments. Although these educational materials are reviewed by industry sponsors to ensure compliance with FDA regulatory requirements, and educational benefits from such programs may well exist, we consider it inappropriate for our faculty to play such active roles in the explicit marketing efforts of pharmaceutical companies and will insist that our faculty develop and be responsible for their own educational content, as they do when teaching in all other situations.
Most of the continuing medical education (CME) that we provide to practicing physicians is tuition based, with topics and content determined by us and presented by our best faculty. In some cases, however, funding of the costs of CME programs is supplemented by industry contributions, without influence over the content. Going forward, additional protections against the possibility of such influence will be required in HMS-accredited CME.
What about gifts? Over recent years, the provision by pharma and device companies of gifts to physicians—ranging from pens and pads bearing company logos, to fancy dinners, to tickets to sporting events, to lavish junkets to discuss new therapies—has grown in prevalence. Although evidence is limited on the extent to which such gifts cause changes in physician behavior that are inimical to the best interests of patients, it is hard to see the value of such practices when compared to their negative appearance and potential harm. We will now formally preclude these practices, not only for clinical faculty, as recently mandated by Massachusetts law, but for all HMS faculty.
So where does this leave us? Having revised our policies to make financial interests of faculty transparent to academic leadership and the public, to limit questionable practices in continuing medical education and gift-giving and to safeguard the integrity of industry-sponsored biomedical research, we should focus upon the substantial benefits of well-constructed academic–industry collaborations. This is necessary, since some critics of rare but real abuses extend their criticism to practices that are important to our mission and worthy of respect.
Under our new policy, we will limit potential abuses while promoting our great capacity to do good. That is our intention, and we are proud to be judged by our success at achieving it in the coming years.