More Bad News For GSK and Avandia
Tuesday, July 13, 2010 at 12:31PM As if the controversies surrounding GSK's clinical trials for Paxil were not enough, in February of this year, the U.S. Senate Committee on Finance released a report based on a two-year inquiry of Avandia. According to the report, GlaxoSmithKline was aware of the possible cardiac risks associated with Avandia years before such evidence became public. The Senate report also alleges that the company intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug Actos might reduce cardiovascular risk.
These actions began in 1999 when GSK, who depended heavily on sales of Avandia because its laboratories were not producing any new discoveries or products, undertook a clinical trial to see if Avandia was safer for the heart than its leading rival, Takeda's Actos. The results were catestrophic - Avandia was found to be much riskier, which (ultimately) signals the end of the drug and financial disaster. According to the New York Times, the drug giant spent the next 11 years trying to cover up the trials' results, and were forced to come clean in 2007 when a cardiologist from the Cleveland Clinic, using documents GSK was forced to release as part of a lawsuit, discovered the risks.
The documents directly contradict the statements by GSK officials, who claim that the company only hid the risks starting in 2005, and not 1999 (as if this is much comfort).