Steven L. Dubovsky, MD, professor and chair of the Department of Psychiatry at the University at Buffalo, along with four other professors in the Department of Psychiatry at Buffalo, and one drug company representative, conducted a study to answer the following question: “Can Academic Departments Maintain Industry Relationships While Promoting Physician Professionalism?” The study itself contains a disclosure statement as well, and acknowledges that “a large number of clinical investigations at the University at Buffalo were supported by industry-sponsored projects.”
The Policy
To answer this question, “the authors describe the development of a comprehensive policy that approaches relations with academia and industry, which emphasizes objective outcomes and asserts that internal change will be more effective than rote restrictions on behavior that assumes that physicians cannot learn new behaviors and that are impossible to enforce.” The policy was created by a new standing committee on industry relations, made up of faculty and residents, which continues to meet regularly to review progress and discuss modifications. The new policy:
– Eliminates industry-supplied meals, gifts, and favors and integrates industry-sponsored and academic research;
– Educates faculty and residents about the ways in which industry marketing influences clinical decision making, although representatives no longer have any direct access to residents, and they must make appointments to see faculty members;
– Includes a comprehensive disclosure by faculty, including to patients, of financial interests in industry that the faculty has been paid by in the past year if a physician recommends any product of a company he or she has worked with;
– States that items with potential use in patient care, such as unbranded informational brochures, must be given to a faculty “industry liaison” for distribution as determined by the department; and
– States that all support of educational activities must be in the form of unrestricted educational grants, and no recommendations of speakers by industry representatives can be accepted.
With regards to faculty speaking on behalf of industry, the study noted that “restricting and policing the participation of faculty members in legal activities on their own time not only was impractical but also implied that intelligent adults are not capable of changing their behavior in the light of new data.” Faculty is not prohibited from attending such events, but residents must report their attendance to the residency director.
For investigator-initiated research, faculty “felt that industry support is an important source of funding for preliminary studies and that participation in multicenter trials is a source of support for the research infrastructure.” Consequently an existing committee was charged with supporting industry sponsored research by “protocols and budgets to make sure that industry-supported research does not involve development of a product that has no potential for meaningful advantage over existing products and to ensure that funds generated by the research are used to support independent research rather than additional faculty income.”
The authors also wanted to prohibit direct industry support of continuing medical education, participation in speakers’ bureaus, and accepting drug samples, while leaving paid consultation as acceptable if a specific work product was identified.
The new policy also discusses the psychopharmacology curriculum and a departmental “pharma symposium,” in which “industry representatives or industry sponsored guest speakers are allowed to present peer-reviewed articles followed by comments by a faculty member with relevant expertise about aspects of the presentation that are accurate or misleading and by a general discussion of research and clinical implications of the research and the manner in which it is presented.”
Although some of these ideas need further consideration, ones that preserve the “collaborative relationship with industry that maintains appropriate boundaries between industry and academia” are a great start.
Discussion
While recent reports from media about changes in medical schools and teaching hospitals policies “regarding the potential influence of “big pharma” on research” have grown, many doctors are concerned about these restrictions (as we previously wrote). Although the authors cite “a recent national survey of physicians in six specialties, which found that 94% of respondents had some sort of relationship with industry,” many fellowships and residency’s are dependent (in fact would not exist) with such relationships.
In addition, the fact that “half of practicing physicians and a third of residents acknowledge that pharmaceutical representatives are moderately to very important in influencing their prescribing habits,” suggests that industry is doing the right job: giving clinical data and information to doctors to help treat patients.
Prohibiting the kind of involvement of industry-sponsored symposia or accepting drug samples, as some medical schools have begun to do, “may raise First Amendment issues” as the authors themselves note. Perhaps just as serious, the authors noted that “restricting all interactions with industry would not necessarily promote internal change or provide for teaching the next generation of physicians how to interpret and respond to the many forms of marketing they will inevitably encounter in practice.”
Instead, the authors asserted that “a truly effective policy should integrate the urgent need to define the boundaries between industry and medicine with the academic missions of the medical school.” Such a policy recognizes the importance of maintaining the relationship with the proper boundaries, instead of abandoning it.
Further support of maintaining this relationship is that the authors believe that although physicians may be unaware of the influence marketing has on them, physicians are capable “learning new approaches to industry relations.” This belief is exemplified by the fact that the Department of Psychiatry itself used “industry sponsored clinical trials to support aspects of the research infrastructure and to support exploratory academic research.”
Still, the authors believe that the “pervasive presence of industry sponsorship has created among faculty and trainees a sense of entitlement to food, educational and personal items, and access to national experts.” This so called sense does not exist for one simple fact, which the authors also acknowledge: “limited resources” have led to “a long history of reliance on industry to support a variety of activities.” So it’s not that faculty and trainees feel entitled, rather, they do not have anywhere else to go.
Conclusion
The authors noted many concerns and debated issues that occurred when developing the new policy, including worries from residents with large debts who appreciated having industry-sponsored meals, and faculty who worried about hurting resident morale or recruitment. In fact, “the decision to eliminate all industry sponsored meals engendered substantial initial concern.”
Since the authors acknowledge that the impact of these policies on the field is “not known,” it is important that the committee consider the new policy further, and conduct follow-up research. Specifically, the authors must answer how eliminating industry support will impact society. For example, “students who do not learn how to interact with and critically interpret information from industry, may be more likely to be influenced in practice.”
In the end, the authors viewed the new policy as a way to “promote a more enduring sense of medical professionalism” by placing limits, not prohibitions, of interactions with industry. Accordingly, they believe that their experience of using faculty more “directly to develop policies directed toward a professional partnership with industry” is essential.