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Avandia may change how FDA operates

Gregory Warner Jul 12, 2010

Avandia may change how FDA operates

Gregory Warner Jul 12, 2010


Kai Ryssdal: Tomorrow, a government advisory panel’s going to start considering the fate of GlaxoSmithKline’s blockbuster diabetes drug Avandia. It’s been linked to heart attacks and stroke. The company is facing thousands of lawsuits. What the panel decides over the next two days could set the standard for the scientific analysis the FDA uses to make its decisions.

From our Marketplace health desk at WHYY in Philadelphia, Gregory Warner reports.

Gregory Warner :The gold standard at the FDA for analyzing drugs is called the “Randomized Clinical Trial.” Flip a coin and people with heads get the drug; everybody else gets a placebo. The problem is that only big drug companies can afford to sponsor randomized trial, and they only last a year or two.

Daniel Carpenter: If you’re diagnosed as a diabetic at age 25, 30, you could be on a drug like Avandia for a period of 30 years.

Daniel Carpenter is a professor at Harvard and author of a new book about the FDA called “Reputation and Power.” He says there’s a better and cheaper way to look at health risks of drugs over time. You study the medical history of lots of people already taking the drug. Those are the kind of observational studies that linked Avandia and heart attacks.

Carpenter: And if the Avandia drug is pulled off the market, that’s going to set a precedent whereby other drugs — including drugs that are currently being sold — could be pulled off the market on the basis of observational studies.

That worries Bob Goldberg at the Center for Medicine in the Public Interest. He says observational studies are subjective and easy to manipulate.

Bob Goldberg: It speaks to the effect that unnuanced analysis of tabloid medicine has on science.

Daniel Carpenter says that observational studies probably wouldn’t be a factor at the FDA.

Carpenter: But for the fact that there are some doubts hanging over GlaxoSmithKline’s ability to run its clinical trials.

If the FDA decides to pull Avandia, it means it doesn’t trust the clinical trial research that GlaxoSmithKline has presented. And that could ripple through the industry.

In Philadelphia, I’m Gregory Warner for Marketplace.

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