The much-debated Avandia safety trial is shutting its doors to new patients. After last week's advisory panel meeting, the FDA has ordered GlaxoSmithKline (NYSE: GSK) to stop enrollment in the TIDE trial, which is designed to compare the diabetes drug with its direct rival, Takeda Pharmaceuticals' Actos. The agency also wants GSK to tell the 1,300-plus patients already enrolled that Avandia may increase cardiovascular risks.
The FDA advisory panel voted 20-12 to keep the drug on the market, with most of the "yes" votes calling for additional warnings or restrictions on the drug. Even before that vote, medical ethicists and other observers--even some at the FDA--had been calling on GSK to stop TIDE, because it's comparing Avandia to a drug that data suggests may be safer. And the agency asked the Institute of Medicine to weigh in on the ethics of the situation.
The FDA now says that it's continuing to study the new evidence about Avandia's risks--and while it does so, TIDE has to stop recruiting. The agency stopped short of halting the trial altogether. "This was the right thing for the FDA to do now while we await the final decision," Ruth Faden, a bioethics professor at Johns Hopkins and chair of the IOM advisory group, tells the New York Times.
GSK says it will update the investigators and ethics boards in the huge trial next week, while a Canadian research institute will inform the trial participants, who are spread across the globe in 23 countries. "This pause in enrollment will give clinical trial investigators and patients time to learn about the data presented to the FDA Advisory Committee and the Committee's recommendations," GSK's chief medical officer Dr. Ellen Strahlman said in a statement.
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