Glaxo Settles with States on Avandia

GlaxoSmithKline agrees to pay $229 million to nine states to settle claims over Avandia, its once-popular diabetes drug. At the same time, the FDA loosens restrictions on the drug.



Commentary

The course of diabetes drug development never did run smooth, but GlaxoSmithKline continues to ride one heck of a roller coaster with Avandia, its once popular drug.

News outlets report that the drug manufacturer has agreed to pay $229 million to settle a legal action with a group of eight states and a separate set of accusations from the state of Louisiana. This is on top of a $90 million settlement with 37 other states over allegations that Glaxo misled consumers on the safety and prescribed use of Avandia. (In both settlements, the drug company admitted no wrongdoing.) It’s a dizzying plummet for a drug that once was the toast of the town.

The trouble began in 2007 when a cardiologist unveiled an analysis of studies on Avandia showing that taking the drug increased the likelihood of heart attack by more than 40%. Sales plummeted and the U.S. Food and Drug Administration severely restricted its use.

But just in case you think the Avandia saga couldn’t have any more twists and turns, an FDA advisory panel met recently in June to loosen some restrictions on the drug’s use, according to a New York Times report. It’s a bit like closing the barn door after the cows have gotten out. While the FDA decision, which only loosens restrictions somewhat, may provide a bit of vindication for Glaxo, it probably will do little to boost Avandia sales, at this point.

The recent settlement may be the company’s way of trying to get off the ride, but the legacy of the controversy surrounding Avandia has fundamentally altered the landscape of the diabetes drug approval process, for better or worse. From now on, no new diabetes drug will pass muster unless it has been thoroughly vetted for complications of heart disease. This lengthens the time and increases the costs of clinical trials, and is one reason why so few new diabetes medications have been approved in recent years.

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Craig Idlebrook is chief editor for Insulin Nation and Información Sobre Diabetes, and was founding editor for Type 2 Nation. You can reach him at cidlebrook@selfrx.com.