Principled scientific collaboration between physicians and the drug and medical device industries has contributed to many of the medical advances of the past century—penicillin and implantable cardiac pacemakers, to name just two. Industry marketing efforts, however, have increasingly slipped into the educational and clinical programs of academic medical centers.
|Table: Task Force Recommendations on Relationships With Industry|
In addition, pressure from the U.S. Office of the Inspector General,1 congressional hearings,2 and lawsuits alleging deceptive marketing practices3 led the Pharmaceutical Research and Manufacturers of America to recommend that member companies cease providing noneducational gifts and certain types of free meals to physicians.4
In 2012, The Pew Charitable Trusts convened an expert task force on conflicts of interest in medicine to assist academic medical centers in identifying best practices to incorporate into their conflict-of-interest policies. The panel reviewed the literature and consulted experts in order to create an updated list of recommendations to those established by the Association of American Medical Colleges in 2008. The task force formulated recommendations in 15 areas in order to protect the integrity of education and training and the practice of medicine within the academic medical center while not standing as an impediment to research and scientific inquiry.
The best-practice recommendations are:
- Acceptance of gifts and meals: No gifts or meals of any value should be accepted by clinical faculty members and staff, medical students, residents, clinical fellows, or other clinical trainees from the pharmaceutical, biotechnology, medical device, or medical diagnostics industries or their sales representatives.
- Disclosing conflicts of interest: Faculty should be required to disclose to their institutions all industry relationships that relate to their academic activities in teaching, research, patient care, and institutional service.
- Industry-funded speaking: Faculty should not accept industry funding for speaking engagements directed toward other faculty, medical students, trainees, patients, community physicians, health professionals, or the public.
- Continuing medical education: In general, continuing medical education should not be supported by industry.
- Attendance at industry-sponsored lectures and meetings: Faculty, students, and trainees should not attend promotional or educational events that are supported directly by industry.
- Pharmaceutical sales representative presence in academic medical centers: Pharmaceutical sales representatives should not be allowed access to any faculty, students, or trainees in academic medical centers or affiliated entities.
- Medical device representative presence in academic medical centers: The access of medical device representatives to patient care areas should be limited to in-service training and technical assistance on devices and other equipment already purchased and then only by appointment and with disclosure to and consent from the patients who would be involved.
- Curriculum on conflict of interest: Conflict-of-interest education should be required for all medical students, residents, clinical fellows, and teaching faculty.
- Extension of institutional conflict-of-interest policies to community educational settings: Conflict-of- interest policies established by academic medical centers should apply to all faculty members regardless of the nature of their relationship to the institution—paid or voluntary, full time or part time, on-site or off-site— and to affiliated institutions participating in the academic medical center’s educational and training programs.
- Industry-supported clinical fellowships: In general, clinical fellows, residents, and medical students may not accept industry-sponsored fellowships earmarked specifically for clinical training but may compete for industry fellowships awarded for scientific training.
- Ghostwriting and honorary authorship: Academic medical faculty and trainees should follow the International Committee of Medical Journal Editors standards for authorship and contributorship. Ghostwriting and honorary authorship are strictly prohibited.
- Consulting relationships for research and scientific activities: Faculty and trainees should be permitted to engage in consulting relationships with pharmaceutical and device companies about research and scientific matters.
- Consulting relationships for marketing (excluding scientific research and speaking): Academic medical faculty and trainees should be prohibited from engaging in consulting relationships that are solely or primarily for commercial marketing purposes.
- Pharmaceutical samples: An academic medical center should not accept samples unless it determines that there are compelling circumstances to do so. In these cases, it should implement mechanisms for accepting samples that prevent their use as marketing tools.
- Pharmacy and therapeutics committee: Ideally, voting members of these committees should not have a financial relationship with industry. In circumstances when this standard cannot be achieved, members with such relationships should be recused from any discussion of, or voting on, a related product, whether the product is manufactured by the company, is a competitor of that product, or is in the same class as that product. All committee members should disclose financial relationships with pharmaceutical and medical device companies, as should practitioners requesting changes or additions to the institution’s formulary.
This report will discuss these best-practice recommendations and provide the reasoning behind their formation. Included will be case studies at academic medical centers and examples of conflict-of-interest policies that are currently in place.
* The term “conflict-of-interest policies” refers to policies regulating the financial relationships between health care companies and academic medical center staff and trainees in the areas of medical education and clinical care. These are also known as “clinical conflicts of interest.” Policies relating to conflicts of interest in medical research are not addressed in this report.
A shorter version of these best practice recommendations can be found in the December 2013 issue of the Journal of the American Medical Association.