Avandia: GlaxoSmithKline Cover-Up Turns Off Doctors
GlaxoSmithKline withheld studies that made their drug Avandia, look unsafe.
July 14, 2010— -- In the face of mounting evidence that GlaxoSmithKline withheld important safety data on their controversial drug Avandia, some doctors are abandoning use of this diabetes treatment.
Documents released Tuesday morning by the Senate Finance Committee suggested that for more than a decade, the drugmaker deliberately hid study results showing that Avandia could worsen certain risk factors for heart disease and was no better than its market competitor Actos.
The documents include several internal emails that record GlaxoSmithKline officials suggesting that certain unfavorable studies concerning the drug "never see the light of day to anyone outside of GSK."
"It's just not morally or ethically acceptable for companies to withhold data," says Dr. Steve Nissen, chair of Cardiovascular Medicine at the Cleveland Clinic and author of the original RECORD study, which raised public concern over Avandia's safety.
GlaxoSmithKline responded in an official statement that the studies were withheld because they failed to add new scientific information, but the growing evidence against the drug and the possibility of a cover-up is enough to deter some doctors from using the drug.
Release of these documents comes at the start of two days of advisory panel hearings to investigate Avandia's safety. The panel's recommendations could include keeping the drug on the market, calling for further restrictions or pulling the drug from the market altogether.
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