Imagine Avandia safety as an old-fashioned balance scale. Data on one side upholding the contention that the benefits of the GlaxoSmithKline (NYSE: GSK) diabetes med are worth its risks. Data on the other supporting the argument that the drug isn't safe and should be withdrawn. Well, two newly published studies are adding their weight to the latter--just two weeks before the FDA's advisory panel meeting on Avandia safety.
One study concludes that Avandia boosted the risk of death, heart failure, stroke or heart attack by 18 percent compared with its Takeda-made competitor Actos. You may recall that this research was done by the FDA's David Graham, who's been a frequent critic of Avandia and of the FDA's response to safety concerns. "If you treated 60 people for a year with Avandia, you would cause one extra case of heart attack, stroke, heart failure or death," Graham tells NPR, "compared to if you had treated 60 patients with Actos."
The other, an update of the first study that found heart-attack risks associated with Avandia, found that one of every 52 patients using the drug suffered. "I think what we can say confidently is, looking at the totality of data in 2010, Avandia increases the risk of heart attack compared to other diabetes drugs by about a third," Dr. Steve Nissen of the Cleveland Clinic says.
GSK released a statement contending that data from randomized clinical trials--rather than these analyses of clinical data and records--shows that Avandia is, in fact, safe. "[T]hese trials show that Avandia does not increase the overall risk of heart attack, stroke or death," the company says. And as PharmaTimes reports, another new study hit at the American Diabetes Association meeting yesterday, showing no increased risk of death, stroke or heart attack (but does boost fracture risk).
FDA Deputy Commissioner Joshua Sharfstein tells the New York Times that the newly published studies "will be part of the discussion that FDA has as we consider the important question of Avandia's safety." The FDA is also planning to release its own research on the drug. That advisory panel meeting is coming up July 13-14.