Feds Probe GlaxoSmithKline over Avandia Disclosures

Time Magazine’s most recent investigation into the behavior of big pharma GlaxoSmithKline and their diabetes drug Avandia may have lead to further investigations by the FDA. Time’s investigation found that GSK officials weren’t entirely truthful when they told FDA officials that research on Avandia was inconclusive regarding an elevated risk of myocardial ischemic attacks. They revealed this five days before an article linking Avandia to a 43% increased risk of heart attacks compared to its competitors was to be published in 2007 by the New England Journal of Medicine. According to Time, “What GSK didn’t tell the FDA was that on May 14, 2007, two days before the White Oak meeting, GSK’s Global Safety Board had noted that a new assessment of Avandia studies “strengthens the [cardiac-risk] signal observed in the [previous] analysis.” Or that eight days earlier, the company’s head of research and development, Moncef Slaoui, had sent an e-mail to its chief medical officer saying Avandia patients showed an “increased risk of ischemic event ranging from 30% to 43%!” Or that the day before the meeting, the company had produced a preliminary draft report that showed patients on Avandia had a 46% greater likelihood of heart attack than those in a control group.”
This misdirection allowed GSK to continue to make huge profits at the expense of unsuspecting patients. Time estimates that the lack of full disclosure made the company billions in added revenue while putting millions at further risk of an increased risk of heart attacks.