Well, right up to the big vote this afternoon, it was pretty hard to say how a 33-person panel of experts would come down on Avandia, the diabetes drug under scrutiny for heart risks.
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An expert panel voted to keep Avandia on the drug with beefed-up warnings and restrictions. But the FDA has the final say.
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Not long after 3 p.m., we found out. A majority of the panel members — 20 in all — voted to tell the Food and Drug Administration to keep the drug on the market with various new restrictions and warnings. Those votes were split among three choices, but taken together they supported continued availability of Avandia.
The single biggest vote-getter, though, was the choice to withdraw Avandia from the market. Twelve panel members essentially said the risks of heart trouble from the drug aren't worth it. As Wake Forest's Dr. Curt Furberg, a nay, put it: Avandia "has serious adverse effects that overwhelm any benefits." What's more, he said, safer alternatives are available.
Actos, a rival to Avandia that hasn't shown the same sorts of heart risks, was the option discussed the most.
The panel meeting made public an internal battle simmering at the FDA, some agency scientists have been calling for the withdrawal of Avandia for years.
Among the experts who supported the continued sales of Avandia, made by GlaxoSmithKline, a big issue was a lack of definitive data about the medicine's hazards.
Cardiologist Sanjay Kaul of Cedars-Sinai in Los Angeles, who voted to keep Avandia on the market but not as a first choice for diabetics, asked if there is "clear and convincing evidence that incriminated this drug?" His answer: "No."
The ultimate decision on Avandia's fate will rest with the FDA. The agency generally, though not always, follows the guidance of these expert panels.
The split decison from the experts leaves the agency with an unclear message on exactly which path to take to beef-up warnings and restrictions on its sale. It's also possible the agency could push to have the drug removed from the market.
Nobody voted to keep Avandia for sale without making significantly strenghtening risk protections. There was one abstention in the voting.
A draft list of the questions considered by the panel can be found here. The key question is No. 8. The final wording for the key questions and vote tallies are in this spreadsheet.
Update: After the meeting ended, Glaxo issued a statement saying results of a half-dozen clinical trials available in the last three years "show that Avandia does not increase the overall risk of heart attack, stroke or death." Therefore, the company said, it believes that "when used in the appropriate patient and in accordance with labeling, Avandia is a safe and effective treatment option for type 2 diabetes."