FDA not pulling Avandia from shelves

Steve Henn Jul 30, 2007

FDA not pulling Avandia from shelves

Steve Henn Jul 30, 2007


Kai Ryssdal: Another government agency now, also best known by its initials, the Food and Drug Administration. An advisory panel there has been holed up all day weighing the fate of the diabetes drug Avandia. The New England Journal of Medicine published a study earlier this year that linked the drug to an increased chance of heart attack.

Late this afternoon, the panel helped manufacturer GlaxoSmithKline dodge a multibillion-dollar bullet when it ruled Avandia can stay on the market despite the risks. Marketplace’s Steve Henn reports.

Steve Henn: Until this year, the diabetes drug Avandia was a blockbuster for GlaxoSmithKline, bringing in about $3 billion a year.

But a highly-publicized study linking the drug to an increased risk of heart attacks has taken a toll on Glaxo’s profits. Avandia-related sales fell 22 percent in the last three months.

But this morning, Glaxo was still standing behind the drug. Melinda Stubbee is the company’s spokesperson:

Melinda Stubbee: We disagree that the product should be withdrawn from the market.

Stubbee says Avandia is no more likely to cause heart attacks than other commonly prescribed diabetes drugs.

But at a meeting today, a prominent FDA scientist begged to differ, saying the drug should be taken off the shelves.

And Senator Charles Grassely, an Iowa Republican and longtime critic of the FDA, says that for more than a year, FDA scientists were sounding the alarm about problems with Avandia to no avail.

Sen. Charles Grassley: We’re having scientists inside suppressed.

He believes the FDA routinely fails to quickly respond when it’s confronted with evidence that drugs already on the market may be dangerous.

Grassley: These scientists have not been listened to until the information gets out in the public. And then they do something about it.

The FDA will make its final decisions on the panel’s recommendations soon.

In Washington, I’m Steve Henn for Marketplace.

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