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FDA Considers Easing Controls on Diabetes Drug

A panel of advisors says that the agency should loosen restrictions on the sale of a diabetes drug with a spotty clinical safety record.
 

By | June 11, 2013

WIKIMEDIA, TOM VARCOA US Food and Drug Administration (FDA) advisory panel recommended yesterday (June 10) that the agency loosen restrictions on the availability of the diabetes drug Avandia, which has been linked to increased heart attack risk, in light of new evidence that the drug is safe, reported Nature.

Avandia has been the subject of controversy since 2007, when a meta-analysis of clinical trial data showed that it poses a risk to the heart. Having come to similar conclusions, in 2010 the FDA severely restricted sales of the drug, allowing access only if patients had tried every other diabetes medicine and had been made aware of the risks of taking Avandia. The drug’s sale in Europe was blocked altogether.

Then things got rather murky. An FDA analysis of one the key trials assessing heart risk—a clinical trial called RECORD, which was funded by Avandia’s maker, GlaxoSmithKline (GSK)—revealed some suspicious omissions in the data that suggested it was biased in favor of the drug. What’s more, an FDA staffer argued that that GSK had a hand in the omissions.

At previous advisory panel meetings on the subject, some advisors were concerned about the alleged bias, while others argued that RECORD was the best data available, as other observational studies suggesting a risk were unreliable. When they met again last week, the panel debated whether to give more weight to individual clinical trials or meta-analyses of several trials—and whether or not the GSK-funded RECORD trial was trustworthy.

In the end, the panel voted to loosen restrictions. But they were split on exactly what measures should be taken: half of the 26 advisors said the Avandia should be made more available, 7 panelists wanted all restrictions lifted, and 5 said the restrictions should remain the same. The FDA has yet to make its decision.

One of the advisors, Charles Stanley of the University Pennsylvania in Philadelphia, told Nature that he felt restrictions should be removed. But he added that he was of two minds about whether to recommend pulling Avandia from the market anyway, partly because of its controversial past—but also because so few people take the drug and diabetics have many other options available. “This is a drug that has been severely tainted,” Stanley told Nature. “I’m not quite sure whether anybody has any great interest in seeing it continue.”

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