FDA’s Graham Says Avandia Should Go
3 CommentsBy Ed Silverman // July 30th, 2007 // 9:11 am
David Graham, the controversial FDA medical reviewer who criticized the agency’s handling of Vioxx, believes an FDA advisory panel should urge that Glaxo’s Avandia get pulled off the market, Reuters reports. The meeting gets under way momentarily.
In slides prepared for his remarks, Graham states that Avandia increases the risk of cardiovascular problems such as heart attacks, while a rival drug, Takeda’s Actos, doesn’t. There is “no evidence of major clinical health benefits” from Avandia and leaving it on the market may “cost thousands of lives,” according to slides for a presentation to be given today by David Graham, a Food and Drug Administration safety scientist.
In briefing documents, senior FDA officials say they don’t know if Avandia increases the risk of heart attacks and are asking the advisory panel if the drug should come off the market or stay with stronger warnings or limits. Panel recommendations are expected this afternoon.
Glaxo, meanwhile, issued this statement in defense of its diabetes drug. “Patients have been scared enough by a lot of snippets of information here and there,” Chris Viehbacher, Glaxo’s president of US pharma, tells Bloomberg News. “The advisory committee’s going to hear a lot of people, including Dr. David Graham, and I think what you’re going to find is that the weight of scientific evidence continues to support the safety of Avandia.”
You can read the panel roster, agenda, FDA documents and Glaxo documents here.
Hank
David Graham’s track record is pretty stellar - more than 80% of the time when he’s advocated a drug withdrawal, FDA has ended up agreeing (even when it took years, as with Rezulin).
If I were Glaxo, I’d consider getting a paper route.
Harry
So sorry Hank. Swing and a miss.
Sad day for Pharmalot.
Simon Passanante - FDA maverick advocates Avandia ouster
[...] to Reuters, Dr. Graham has now turned his focus on Avandia. He urged an FDA advisory panel to pull the diabetes drug from the [...]