In an article in the May 2014 issue of Compliance Today, Bill Sacks, Vice President and co-founder of HCCS, a HealthStream company, describes how new NIH regulations are forcing academic medical centers (AMCs) to examine and update their conflict-of-interest policies. He lists the 15 best practices for management of conflicts of interest that have been proposed by the Pew Charitable Trust and discusses how some of these recommendations are enjoying wide acceptance, as others are being met by serious objections. The Pew “Best Practice” recommendations are summarized below.
1. No gifts or meals should be accepted from industry sales representatives. Recognizing that even small gifts can influence the behavior of physicians and that accepting gifts looks bad, accepting no gifts is the best option for academic medical center staff.
2. Faculty must disclose all conflicts of interest. All academic medical centers must have a process in place to manage conflict of interest (COI) disclosures.
3. Industry-funded speaking should not be allowed. To avoid any appearance of impropriety, it is preferable to limit or prohibit industry funding of speaking engagements directed toward other faculty, students, patients or the public.
4. Industry-funding of continuing medical education (CME) should be severely limited or prohibited. Industry funding of CME tends to bias topic choices and content in favor of the sponsors’ products and therapeutic areas.
5. Faculty, students, and trainees should not attend industry-supported promotional or educational events. As another way to avoid any appearance or possibility of bias, clinical staff should be prohibited from attending events that are not primarily for education and are directly funded by industry.
6. Limit or prohibit pharmaceutical sales representative access in academic medical centers. Most academic medical centers restrict the presence of pharmaceutical reps. To avoid bias or the appearance of bias, this presence should be very limited or even prohibited.
7. Limit medical device representative presence in academic medical centers to what is necessary. Academic medical centers should restrict medical device manufacturer reps access to what is required for successful implementation and use of devices and equipment that have already been bought.
8. Conflict-of-interest education should be required for all clinical staff and students. Given its increased importance, conflict of interest training must be a mandatory and periodic requirement for everyone teaching, learning, and working at an academic medical center.
9. Conflict-of-interest policies should apply to everyone with a relationship to the academic medical center—paid, volunteering, affiliated, etc. To avoid any appearance of impropriety mandated conflict-of-interest policies should apply to everyone involved with the academic medical center.
10. Industry-supported clinical fellowships should be available for scientific training only. Industry-sponsored fellowships for clinical training should not be accepted by academic medical centers, but they may accept funding for scientific training under certain circumstances.
11. Ghostwriting and honorary authorship are strictly prohibited. Companies funding research should have no influence over the test of articles or determining which results get published in academic journals.
12. Faculty and trainees can engage in consulting relationships for research and scientific activities with pharmaceutical and device companies about research and scientific matters. Consulting arrangements must require written contracts with clear deliverables, to ensure that inappropriate payments are not involved. All research faculty must report any consulting payments on their annual Conflict of Interest Disclosure Forms.
13. Consulting relationships for marketing purposes are prohibited. Academic medical centers must establish policies that prohibit faculty involvement in developing promotional material or marketing strategies.
14. Pharmaceutical samples can be accepted and used only when they don’t become marketing tools. Academic medical centers must develop policies that guide clinicians’ ability to accept and distribute pharmaceutical samples in ways that do not constitute marketing of the product.
15. Members of pharmacy and therapeutics committee cannot vote on formulary or treatment changes involving a company or product in which they have a financial interest. The pharmacy and therapeutics committee of a healthcare organization must make decisions based on the best interests of the institution and not be unduly influenced by the financial relationships or other considerations of members.
Academic medical centers face multiple challenges and serious considerations in their efforts to address potential conflicts of interest. These recommendations by the Pew Charitable Trust provide a resource to AMC’s as they formulate policies and procedures to identify and manage real and potential conflicts of interest.
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