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 ...
