Pharmacovigilantism – Avandia Litigation

Six and one-half years ago, I gave a presentation on the then newly emerging controversy over Avandia (rosiglitazone).  Plaintiffs’ counsel Vance Andrus chaired the program, Mealey’s™ Avandia Litigation Conference, in Chicago on July 13, 2007.  Vance was a gracious host despite my skepticism about the potential for plaintiffs to cash in on their use of Avandia.

Despite Vance’s best efforts, the program was one of those lopsided affairs, and I was the only presenter who came prepared to address the scientific evidence from a skeptical perspective.  The remaining presenters were mostly cheerleaders for their declaration of war against GlaxoSmithKline over claims of heart attack and stroke from the use of Avandia.

This week, a Food and Drug Administration announcement sent me back to my presentation slides, which were provocatively titled “Pharmacovigilantism and Avandia.” Dr. Steven Nissen had published a meta-analysis in the New England Journal of Medicine in May 2007, and it had all the appearances of a contrived effort to embarrass GSK. See Steven E. Nissen, M.D., and Kathy Wolski, M.P.H., “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes,” 356 New Engl. J. Med. 2457 (2007).  A few weeks later, Dr. George Diamond published a thorough debunking of the Nissen meta-analysis, by showing that the statistically significant result in Nissen’s meta-analysis could be achieved only by choosing an inappropriate meta-analytic method.  Any other choice resulted in a result that lacked statistical significance for the rate of heart attack among patients taking Avandia.

Litigation, of course, followed and the Rule 702 hearings and decision resulted in a serious abridgement of the scientific process.  The federal MDL trial judge denied GSK’s motions to exclude plaintiffs’ causation witnesses in an opinion that has become a model for Rule 702 avoidance.  In re Avandia Marketing, Sales Practices and Product Liability Litigation, 2011 WL 13576, *12 (E.D. Pa. 2011) (Rufe, J.).  SeeLearning to Embrace Flawed Evidence – The Avandia MDL’s Daubert Opinion” (Jan. 10, 2011)

This week, without much fanfare, the FDA announced that maybe the evidence supporting the claims that Avandia causes heart attacks is not so strong, after all.  SeeFDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines” (Nov. 25, 2011).  The Avandia MDL stands out as an expensive, negligent rush to judgment; a case more of phamacovigilantism than of pharmacovigilance.

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