An article in Modern Healthcare discussed physician participation on advisory boards. According to a recent commentary on the article written by David B. Nash, the Founding Dean of the Jefferson School of Population Health at Thomas Jefferson University, the article “managed to present an accurate appraisal of the issues.”
Background
The article in Modern Healthcare gave a brief history of physician-industry interactions in the days before “medical ethics” issues were commonplace. These days were described as a time where pharmaceutical and medical device manufacturers were accustomed to inviting physicians to a nice hotel or resort ostensibly to “answer questions that would help improve cutting edge therapies.”
Nash noted that, “often this meant asking physicians to give their impressions of promotional materials in terms of their likely influence on other physicians.” However, did this mean that a physician was marketing, and if so, were they marketing to physicians themselves or the ultimate consumers?
For pharmaceutical and medical device manufacturers, Nash asserts that, “the case for physician advisory boards is clear cut and very practical.”
While he noted that, “making physicians aware of a particular product in the course of board discussions may steer them toward using it in their practice,” Nash recognized that, “consulting arrangements with physicians are considered to be essential for developing and, more importantly, improving upon technologies.”
Consequently, although it may be difficult to “completely avoid influencing decisions,” Nash noted the best way to ensure that a physician advisory board minimizes the risk of bias– for example, a physician participant being predisposed to use a product or device regardless of what might be in the best interest of the patient—is to “chart a course is somewhere in the middle ground.”
Nash recognized that while it may be “a delicate balance, the key is to develop agendas and design consulting and advisory agreements so as to ensure that the physician’s focus is always on the best interest of each patient.”
Interestingly, the timing of this discussion about physician-industry relationships on advisory boards comes “in the wake of intense scrutiny – and equally intense criticism.” Today, Nash noted that, “we are seeing a paradigm change around interactivity among physicians and industry.”
First and foremost is evidence of the industry’s commitment to ethical practices. The Pharmaceutical Research and Manufacturers Association (PhRMA) developed a voluntary “Code on Interactions with Healthcare Professionals” that includes strict limits on how drug makers reimburse physicians for advice. The code is now endorsed by 55 biopharmaceutical companies. AdvaMed, which represents medical device manufacturers, also implemented a voluntary Code of Ethics similar to PhRMA’s.
The rationale underlying these policies is that it is reasonable to pay physicians to consult if the advisory board’s mission is narrowly defined to address a specific problem and the fees are “at fair market value for the services provided.” Posh resorts and lavish entertainment are now taboo, as are pens, notepads and other freebees.
Second is the fine work of the Accreditation Council for Continuing Medical Education (ACCME) in issuing Standards for Commercial Support and guidelines and updating policies to ensure that CME developed with financial grant support from PhRMA is certified and delivered without bias.
Finally, there is public sector oversight. Since 2003, the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) has required pharmaceutical organizations to separate their sales/promotional activities from educational activities.
And, on the horizon is the Physician Payment Sunshine Provisions, included in healthcare reform act, that requires drug and device manufacturers to track payments to physicians (over $10) beginning in 2012. In 2013, these disclosures will be posted on a publicly searchable Web site.
Conclusion
After more than a decade of working closely with multiple stakeholders including pharmaceutical and medical device companies to convene physician advisory boards here at Jefferson School of Population Health, Nash explained that his personal rules are pretty much set in stone … and they work.
- Define a goal (or goals) and set an agenda centered on a policy related discussion that is unrelated to a specific product.
- Recruit appropriate physician advisory board participants with transparency.
- Pay physician participants a reasonable fee to accomplish the specified goal or goals.
Ultimately, Nash noted that while “controversy will remain and the debate is likely to continue,” the wisest place for physicians who work with industry to go is “the middle ground.”