Now, Two Senators Want GSK's Avandia Pulled from the Market
The report doesn't bring up new issues, but it raises important concerns, such as proper post-market drug-safety follow-ups. "There's a real problem when FDA's office that reviews drugs that are on the market is an unequal player in drug-safety efforts," Grassley says. "Both the FDA and Congress need to take every step possible to establish independence for post-market surveillance."
FDA Commissioner Margaret Hamburg says she's reviewing the senators' inquiry and awaits an advisory committee's recommendations.
Harsh Accusations Against GlaxoSmithKline
The report didn't spare the drugmaker, either. It concludes that GlaxoSmithKline knew about the "possible cardiac risks associated with Avandia years before such evidence became public." But instead of informing the FDA and patients, "GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk."
GlaxoSmithKline rejects the report's conclusions about Avandia's safety, saying they "are based on analyses that are not consistent with the rigorous scientific evidence supporting the safety of the drug." GSK adds: "Contrary to the assertions in the report ... the scientific evidence simply does not establish that Avandia increases cardiovascular ischemic risk or causes myocardial ischemic events."
Sales of Avandia topped $3 billion in 2006 but fell to $1.2 billion in 2009, after the New England Journal of Medicine published an article in May 2007 warning of Avandia's possible cardiovascular risk, which triggered the senators' investigation.
Post-Market Drug-Safety Surveillance Still Lags
If you're asking why a Finance Committee is doing a drug investigation when clearly it should be the FDA's job, reading the senators' statement offers an answer. "The FDA has been too cozy with drugmakers," has been outmaneuvered by them, and "has overlooked or overridden safety concerns cited by its own officials," they say.
Indeed, under President Obama and relatively new Commissioner Hamburg, the FDA has been trying to improve, putting more emphasis on safety and transparency. But even with new mandates, it's still behind on several issues, one of them being post-market drug safety, as a Government Accounting Office report noted not in December.
This episode has definitely tarnished the do-gooder, squeaky-clean image that GlaxoSmithKline's CEO Andrew Witty, barely two years on the job, is trying to achieve. Even if GSK is vindicated, it seems its past behavior could still present problems. But if there's truth to the accusations in the report, Witty should acknowledge them now.
The New York Times first reported the latest developments based on internal FDA reports on Friday night.