Another battle is brewing over Avandia, GlaxoSmithKline's diabetes drug, and it promises to be a big one. While the FDA is roiled by dissent over the drug's safety, Senate investigators have released a report accusing Glaxo of hiding unflattering data on Avandia--even as it asserted the drug was safe. Some in FDA are even calling for complete withdrawal of the drug, according to internal reports obtained by the New York Times.
The safety of Avandia has been up for debate for a few years now, ever since an infamous meta-analysis of trial data performed by Cleveland Clinical cardiologist Dr. Steve Nissen. That study suggested that the drug increased the risk of heart attack. Since then, the FDA has issued warnings and sales have dropped, though an advisory committee recommended--and agency decided--to keep the drug on the market.
There's now more data on Avandia, and another advisory committee is set to review the drug this summer. Meanwhile, Senate investigators are criticizing Glaxo for its handling of the drug, saying the company should have warned patients of the risks earlier.
"Instead, G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk," states the bipartisan report overseen by Sens. Max Baucus and Chuck Grassley. Glaxo disputes those findings and emphasizes that the FDA has elected to keep Avandia on the market. We'll keep you posted.
- get the release from Glaxo
- read the Finance Committee's report (.pdf)
- read the New York Times story
- see the Forbes piece
- check out the coverage from Reuters
- find the Wall Street Journal's take