FDA probing GSK over Avandia disclosures
More hot water for Avandia--and the FDA. The agency is investigating whether GlaxoSmithKline (NYSE: GSK) broke the law by failing to fully inform the agency about the heart risks associated with the now-controversial diabetes drug, Time magazine reports, citing Deputy FDA Commissioner Joshua Sharfstein.
The Time article details the drug's steps toward FDA approval, suggesting that the company defended the drug's safety to the agency and the public while debating internally about data and analyses pointing to increased cardiac risks. Later, after the drug was approved, GSK produced two separate analyses of new data, finding that heart side effects jumped by 29 percent and 31 percent in Avandia patients.
But the company didn't disclose that data to the FDA until early May 2006, Time reports. The big brouhaha over Avandia's heart risks didn't really begin until the following May, when a now-infamous study by cardiologist Steve Nissen (photo) found a significant increase in heart attack risk for patients using Avandia.
And the FDA isn't blameless, either, Time suggests. The agency didn't inform the public about the new Avandia data in 2006; it charged its own people with a re-analysis. Indeed, Time uses the Avandia mess to suggest that the agency is simply too close to the pharma industry, just as Sen. Charles Grassley (R-Iowa), who did his own Avandia investigation, has alleged.
- read the Time piece
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