By Joanne Silberner
With the release over the weekend of results from an investigation of a once-popular diabetes drug by the Senate Finance Committee, the new regime at the Food and Drug Administration has quite a mess on its hands.
At 342 pages, the Senate report presents quite a bit of detail on the drug Avandia and heart risks. Sure, the FDA has already addressed the potential problem with a black-box warning--the strictest at its disposal--on the drug's label.
But critics of Avandia say that's not enough and the drug needs to come off the market now. Cleveland Clinic cardiologist Steven Nissen told Shots the case against Avandia, which he helped get rolling three years ago, continues to build and that the drug's maker, GlaxoSmithKline, has had a hard time discrediting his work. In an interview with CNBC today, he called again for the drug to be withdrawn.
So the FDA has a Senate committee questioning its judgment on allowing Avandia to stay on the market as well as broader questions about how the agency responds to questions about the safety of drugs on the market.
What's the agency to do? For starters, the FDA issued a statement Tuesday saying it's not doing anything right away. Instead, the agency is looking at the data it got last summer from a Glaxo-sponsored safety trial of Avandia. And the agency is planning a July hearing to present the analysis and to get input.
For its part, Glaxo staunchly defends the drug. The company points out that in July 2007, an FDA advisory committee considered the evidence of an elevated heart attack risk, and the committee failed to vote in favor of removing the drug from the market. But it doesn't note that the advisory committee did acknowledge the increased risk of heart attacks.
Glaxo also says the big safety trial, called RECORD for short, ultimately showed "Avandia was not associated with an overall increase in cardiovascular hospitalization or death" compared with some alternative diabetes medicines--metformin and sulfonylureas.
But there are even more layers to the mess, including claims Glaxo wasn't as forthcoming with the FDA as the agency expected.
The Senate committee report also chronicles how a reviewer for the New England Journal of Medicine provided a copy of the meta-analysis by Dr. Nissen highly critical of the drug before the manuscript was published--directly against the journal's editorial policy. (Check out that CNBC video for a little more on that.) Furthermore, the Senate investigation reveals that the company used the time between when the publication was submitted and when it was published to pressure several diabetes experts to drop their criticisms of the drug, and to prepare a response to the study.
So stay tuned. The Avandia saga won't be over until at least July.
Update: Forbes added an editor's note to Mintz's blog post about potential conflicts on the subject after learning that he had received money for speaking and consulting from Glaxo.