FDA Panel Votes to Keep Dangerous Drug on the Market
Call to action! There’s still time to press the FDA to pull a dangerous and unneeded drug off the market—and let them know that their protection of Big Pharma must come to an end.
Evidence be damned! Diabetes drug Avandia offers no benefit over a rival drug, but causes significantly more deaths. In a panel vote that sees no reason to remove the drug from the market, the FDA reveals its true allegiance: Big Pharma.
Theheart.org’s Shelley Wood has produced revealing reports from the site of the FDA’s meeting addressing Avandia’s safety.(1,2) In spite of vocal and outraged comments by anti-Avandia doctors inside the FDA and no legitimate documentation to support its safety, only 12 of 33 panel members voted to remove Avandia from the market. A full 21 voted for a variety of other options. The most positive thing that can be said is that none of them voted to leave it on the market and remove label warnings.
Ten panel members voted to leave Avandia on the market with more label warnings and limitations on its use. (Keep in mind that doctors can prescribe without regard to such warnings.) Seven felt that only additional warnings are needed. Three said no changes should be made. One panelist abstained.
The vote on the TIDE trial, a GlaxoSmithKline (GSK) sponsored study that is currently in operation, was 20-10 in favor of its continuation. Two people abstained and one was absent.
At issue is the lack of good data on Avandia’s safety. Those in favor of leaving it on the market claim that studies showing its dangers are flawed.
That, though, is the real issue. The safety of any drug can be determined only by knowing its dangers. Yet, though Avandia has been on the market since 2002, the first trial to determine its safety, TIDE, is just now being done. Worse, it’s being reported that its manufacturer, GSK has hidden data documenting the dangers.
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