A little bad press from the FDA can be devastating for drug manufacturers – just ask the the folks at GlaxoSmithKline, the makers of the diabetes drug Avandia.
It all started with a 2007 study led by Dr Steven Nissen, the head of cardiology at the Cleveland Clinic; Dr Nissen and his team determined that Avandia significantly elevated risk for cardiovascular problems by a whopping 43%.
The drug didn’t fare much better in a 2010 study published in the Archives of Internal Medicine that reported a 28%-39% increased risk for heart problems in patients taking Avandia. In that particular study, patients who were not given Avandia were taking Actos instead. As a result of these and other studies, the FDA placed severe restrictions on Avandia – the agency required physicians who prescribed the drug to register their patients into a Risk Evaluation and Mitigation Strategy (REMS) program.
But if a news release issued by the FDA Monday is an indicator, the Avandia controversy may have been much ado about nothing – the agency announced that the restrictions will be lifted.
This news comes three years after the FDA contracted Duke Clinical Research Institute to critically analyze data from the study RECORD and concluded that the data did NOT support Nissen’s findings of an elevated risk for cardiovascular events.
Just how much this will ultimately affect GlaxoSmithKline’s bottom line remains to be seen – the world of pharmaceuticals isn’t akin to pop culture, an arena where negative press can boost a bedraggled or fledgling career. Indeed, redirecting public perception regarding Avandia won’t be easy. At the height of its popularity, 120,000 patients were prescribed the drug. In July of this year, only 3,000 used it to manage their Type 2 diabetes.