When it comes to prescription drugs, people rely on government authorities to ensure their safety. Even doctors count on regulators to make proper decisions when approving drugs, assuming that those agencies will correctly weigh the risks and benefits and advise them about both. Which makes the story of GlaxoSmithKline's (GSK) diabetes drug Avandia all the more disturbing. In a 342-page report, two senators are questioning the drug's safety, renewing concerns that it increases the risk of heart attack, and challenging both regulators and the drugmaker. Avandia has been on the market since 1999, so episodes like this can shake the public's confidence in the whole process, regardless of who is to blame.Sens. Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) of the Senate Finance Committee investigated the issue for two years. The report (here in its entirety) questions the Food and Drug Administration's conduct and concludes that GlaxoSmithKline knew about the drug's risks. The senators recommend that Avandia be pulled from the market because its risks seem to outweigh its benefits, especially compared to other diabetes drugs, such as Takeda's Actos, which lower blood-sugar level but don't affect the heart as much, according to studies.
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.
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