The Role of Medical Communications in the GlaxoSmithKline SettlementPosted July 2, 2012 by Jim Schweitzer / Pharma
As has been widely published in the media, GlaxoSmithKline has settled crimincal and civil complaints with the US government for fraudulent marketing of Paxil, Wellbutrin, and Avandia, to the tune of $3 Billion in fines. While no individuals are facing criminal penalties for the errors, ommissions, and improper behavior reported, should the Medical Communications and Information department at GSK shoulder some of the responsibility for the mistakes made at the time?
Medical Information and Communications departments exist to be the central source of scientifically well-balanced information and data about a company’s drug products. In the case of Avandia, GSK admits “inadvertent omissions from certain reports” of study status results for that drug. GSK MedComm likely knew of these studies and was not consulted by marketing or investor relations, or dropped the ball themselves. This seems like one area of the complaint that would have been prevented by better-designed operational controls and processes within the organization.
In terms of Paxil and Wellbutrin, the purported malfeasance involves willful disregard of balanced efficacy data by sales staff and consultants. A Medical Information representative cannot control the behavior of company reps in the field, so as long as they maintained the proper balance of information in their standard response letters and marketing promos, then GSK MedComm is in the clear for these violations.
The lesson from all of this is that information, or the withholding of it, is a powerful thing. GSK, as a company, will be repaying the American government for reckless and selective use of available, scientificly well-balanced Medical Information. The question remains as to whether this could have been prevented with more process checks and balances, and the heavier inclusion of the Medical Communications in corporate operations.