The ethics of being on a pharmaceutical advisory board

While diligently perusing a stack of unread journals, a piece in the July 25, 2011 issue of Modern Healthcare caught my attention.

Titled “What’s the Agenda?” this special report deftly navigated the murky waters of “physician participation on advisory boards” and managed to present an accurate appraisal of the issues.

Here is a brief recap.

Back in the days before “medical ethics” issues were commonplace, 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.”

Often this meant asking physicians to give their impressions of promotional materials in terms of their likely influence on other physicians.

In essence, the lines were a little fuzzy. Was the advisory board really about marketing? If so, who was the intended audience — the physicians themselves or the ultimate consumers?

For pharmaceutical and medical device manufacturers, the case for physician advisory boards is clear cut and very practical.

Obviously, making physicians aware of a particular product in the course of board discussions may steer them toward using it in their practice.

However, consulting arrangements with physicians are considered to be essential for developing and, more importantly, improving upon technologies.

True, there may be no way to completely avoid influencing decisions. The question is one of how a physician advisory board can remain objective and how to minimize 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.

It is a delicate balance, but 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.

There has been a lot of conversation and a great deal of background noise on this topic for years. So, I asked myself why Modern HealthCare would decide to devote two full pages and a couple of charts to this topic at this particular time.

Whatever the reason, the timing couldn’t be better!

In the wake of intense scrutiny – and equally intense criticism – 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.

The rationale 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.

Second is the fine work of the Accreditation Council for Continuing Medical Education (ACCME) in issuing 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 of the Department of Health and Human Services 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.

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, my personal rules are pretty much set in stone … and they work.

  1. Define a goal (or goals) and set an agenda centered on a policy related discussion that is unrelated to a specific product.
  2. Recruit appropriate physician advisory board participants with transparency.
  3. Pay physician participants a reasonable fee to accomplish the specified goal or goals.

Back in 2003, I wrote an editorial for the Health Policy Newsletter entitled, “Seeking Middle Ground.” At the time, there was a slew of adverse publicity with regard to perceived conflict of interest with regard to advisory boards.

Controversy will remain and the debate is likely to continue but, for me, the wisest place to chart a course is somewhere in the middle ground.

David B. Nash is Founding Dean of the Jefferson School of Population Health at Thomas Jefferson University and blogs at Nash on Health Policy.

Originally published in MedPage Today. Visit MedPageToday.com for more health policy news.

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  • http://www.twitter.com/alicearobertson Alice Robertson

    Interesting…sorta like finding out Murdoch’s son was on a BigPharma board….add journalists and publishers to the red flag list.  Can’t have regular old patients on the boards….why…they wouldn’t recognize a pea if it was under one mattress far less 20+…..no Princesses among us:)  Sigh…yet, patients think the boards are run by frogs…we are still kissing them hoping one will be a Prince…ha!

  • Anonymous

    Big Pharma has no ethics! Look at the commercials!!!!

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