August 5, 2015

So many of the issues facing the world today demand perspective – at least in the dictionary definition of the word, namely, “a true understanding of the relative importance of things; a sense of proportion.”When it comes to the vastly important field of medicine, regulations and guidelines are critical. A variety of structures and frameworks keep chaos at bay, regularizing treatments around accepted, clinically proven practices and delivering outstanding outcomes. These guardrails have evolved over time through regulatory agencies such as the FDA and professional organization such as the AMA, as well as through the evolution of law and practice.Sometimes, the process gets skewed. Thus, sadly, one of the most vital aspects of medical progress is now under threat; sacrificed to a well-intentioned but clumsy regulatory framework that aims to protect consumers from the presumed excesses of marketers at medical and pharmaceutical suppliers.
Because of a few seemingly egregious practices in the past that may have influenced the judgement of a small minority of medical practitioners, an entire ecosystem of vital information exchange is now clouded by suspicions and encumbered with onerous and deadening reporting requirements. Of course, the ultimate loser is the patient.
The professional events that attract practitioners encompass far more than company sponsored presentations, though company presentation are in fact extremely useful. They provide an environment for intense information exchange among practitioners. Outside of medical school, the opportunities for practitioners to spend this kind of quality time at the leading edge, sharing experiences, information, and ideas with peers, are few and far between. And they are invaluable. Sandra Raymond, CEO and president of the Lupus Foundation of America, made essentially this point in testimony to Congress when she stressed that up-to-date and detailed information is vital to patient care, especially regarding less familiar ailments and conditions.
Physician education is a vitally important cornerstone of providing great medical care, whether delivered through Continuing Medical Education (CME), office visits, or larger scale sponsored meetings, doctors thrive on abundant, quality information. Their rigorous training makes them inherently impervious to the kind of simplistic promotional strategies employed by suppliers in other industries. They are simply too smart. That’s why the public need not fear quality medical information shared through these mechanisms.
For now, the expressed desire by physicians for more and better information and for exchanges with peers has so far kept regulations from stifling this process, as explained in our AHM white paper, Promotional Programs Thriving in Open Payments. Despite the added complexities involved, physicians continue to participate in interactions with industry because they desire the education, value exchanges with their colleagues and peers, and because they have a pressing need to address key issues that their patients and their practices face.
We think the goal of ensuring practitioner objectivity is a good one. However, Congress and the regulatory community can do better. Guidelines, reasonable transparency, and above all good old fashion professionalism, are the best ways to advance medical practice and keep the lively and critical dialogue going amongst medical professionals and the enterprises that support medical advancements.
Whatever regulatory framework is devised, it needs to be clear and reasonable. Also testifying, Alan Bennett, senior counsel at Ropes & Gray and co-leader of the Medical Information Working Group, citing recent case law that could undermine the current regulations, tried to make the importance of free information clear. Bennett added, that a “patient and his or her physician should have access to the best information, for which companies are the most valuable source.”
And, whether it is in the arts, science, technology, or medicine, creativity and innovation only thrive with open communications.

Contributed by:

Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership, Demand Generation and Solution Design.