A majority of the advisory panel of the Food and Drug Administration voted today to restrict the sales of Avandia, a controversial diabetes drug, because of its potential risk for causing heart attacks. The 33-member advisory committee was deeply divided. Twelve voted to remove Avandia from the market altogether; ten voted for continued sale but with new label revisions and possible restrictions; seven voted to add more warnings and three voted for no change at all. But the votes can also be viewed as a decision by a majority, 21, to continue allowing sales of Avandia with more restrictions. A final decision will be made by the FDA at a later date.
At the end of the meeting, Dr. Janet Woodcock of the FDA said that the agency took the panel’s advice seriously, and that the agency would examine a transcript of the hearing as well as its regulatory options. “We will come to a decision as soon as possible and we will announce that publicly,” Dr. Woodcock said.
After a few closing remarks from the panel’s chairman the meeting was adjourned, two minutes before its scheduled end.
The committee voted 19-to-11 in recommending continuation of the so-called Tide trial, the one intending to compare Avandia and its rival Actos.
A little update here: Yet another mistake has been noted in the voting. The committee actually voted 19 to 11, not 20 to 10 as had been originally reported, with two abstentions and one member who left before the vote was taken.This vote almost certainly reflects wishful thinking on the panel members’ part. The Tide trial was already having difficulty getting patients to agree to take part in the trial because of worries about Avandia’s risks. Now that the panel has decided those risks are substantial enough to require that the drug either be withdrawn or restricted in sales, those enrollment problems will certainly worsen.
Dr. Marvin Konstam explained that he voted to withdraw the drug but then voted to continue the Tide trial because, if Avandia stays on the market, it needs to be studied. Still, he said that the trial might not be ethical. “I voted yes, but I really don’t understand how you can do it,” he said.
This is the committee’s final vote.
14 July 2010
That's the sound of people losing their jobs
Rico says the article by Gardiner Harris in The New York Times explains why Avandia is in trouble, but some of his friends from the old days at GSK are undoubtedly polishing their resumes:
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