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E-mails allegedly show GSK concerns about Avandia

Pharma Compliance Alert, January 21, 2009

E-mails between GlaxoSmithKline (GSK) researchers allegedly show they were concerned about the possible increase in cardiac risks associated with the company’s diabetes drug Avandia at the same time GSK publicly refuted similar conclusions in a New England Journal of Medicine article, according to a Wall Street Journal article.

In 2007, Cleveland Clinic cardiologist Steven Nissen conducted a meta-analysis that showed patients taking Avandia had a 43% higher risk for a cardiac incident. The internal e-mails allegedly show GSK scientists reached similar conclusions. The company said it did not hide the fact that its analysis reached similar conclusions and provided that information to the FDA.

In response to Nissen’s article, GSK released preliminary results of its own study called Record. According to the GSK study, Avandia might increase cardiac risks, but did not increase the likelihood of a heart attack or death.

The article prompted congressional investigations into GSK’s marketing of Avandia and the FDA’s response to the safety concerns. Senator Charles Grassley (R-IA) wants the FDA to request that GSK withdraw Avandia from the market and is preparing a report containing excerpts from the company e-mails, according to the Wall Street Journal. That report could be used to bolster lawsuits filed by approximately 1,000 people who claim to have suffered heart related problems after taking Avandia.

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