FDA Finds Link Between Avandia, Heart Problems

The Food and Drug Administration released a series of reports Friday on the controversial diabetes drug Avandia. The reports summarize all that is known about the drug's safety, and on balance, they paint a negative picture: The drug increases the risk of heart attacks, strokes and death. The documents come in advance of a meeting next week where FDA advisers will vote on whether the drug should stay on the market. Melissa Block talks with Joanne Silberner about the reports.

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MELISSA BLOCK, host:

More troubling news about the controversial diabetes drug Avandia today. The Food and Drug Administration released more than 700 pages of documents, including several new studies of the drug. They show that people with type 2 diabetes who take the drug run a higher risk of heart problems, and possibly death.

Next week, two advisory committees will vote on whether the drug should remain on the market. Reporter Joanne Silberner has been covering the ups and downs of Avandia since questions first arose about its safety back in 2007. She joins me now.

And Joanne, lots of questions, now going back several years. Why is Avandia still on the market?

JOANNE SILBERNER: Well, it is good at controlling blood sugar. That's what the company developed it for, and that's what the FDA approved it to do, and it does do that well.

BLOCK: But tell us more about these heart problems now, that these studies are showing.

SILBERNER: Well, they're getting to look more and more real. I mean, this all started back in 2007 when Steve Nissen, from the Cleveland Clinic, took a look at some data on the drug. It looked to him like there could be some heart problems going on.

And he did a study, and an advisory committee to the Food and Drug Administration looked at that study and some other data and said the drug does, in fact, cause heart problems. But they suggested back then to leave it on the market. They didn't think the evidence was strong enough, or that the problem was big enough.

Now, though, there's a lot more data coming in. There was a study just last week of 227,000 people. And all these new studies are starting to really build up.

BLOCK: And if I'm somebody with type 2 diabetes taking Avandia, how concerned should I be right now?

SILBERNER: Well, there seems to be a real risk. I think the easiest way to think about it is David Graham, a Food and Drug Administration staffer, did a he was the one who did the analysis of the 227,000 people on the drug. And the way he puts it is this. He says for every 60 people on the drug for a year, there's going to be one extra case of heart attack or stroke or heart failure or death. And that's a pretty high number.

Now, I've got say here, though, that the manufacturer, GlaxoSmithKline, is saying its analysis of some of the same data, plus six studies it's really focusing on - that looking at those two things, they say there is not any increased risk of heart attack, stroke or death.

BLOCK: Well, how do you explain that, Joanne? How can there be such wildly disparate results in these studies?

SILBERNER: The FDA staffers analyzing the data took a look at why there could be different interpretations, and they looked specifically at the company's interpretation. And they are accusing the drug company of using incomplete data. They're and using studies that weren't done all that well, where people were sort of lost to follow-up, or people stopped taking the drug after a short period of time.

And there are other issues, when you look at statistics. Now, how long did the studies last? What really counted? Did it have to be a heart attack that was directly observed or really proven, or could it be a suspected heart attack? You know, what counted?

When the FDA looked, they saw things that counted and looked real. They saw more things than the drug company did. It's really tough to tease these things apart, and that's why the Food and Drug Administration has asked this outside committee of experts to come in and come to some sort of conclusion.

BLOCK: And if their conclusion is that, in fact, Avandia should come off the market, what will people who have been taking that drug do?

SILBERNER: Well, the FDA has to decide whether to follow the advice of the committee. It held that hearing back in 2007, and that committee didn't say it should come off the market. If this committee says that it does, there's actually another drug out there.

It's in the same class as Avandia, a very similar drug. And there's no direct, head-to-head comparisons of these two drugs. But indirect comparison suggests that the second drug - it's called Actos; it's also a popular drug - that that drug does not cause the same level of problems as Avandia does.

BLOCK: Okay, Joanne Silberner, speaking with us from Atlanta. Joanne, thanks so much.

SILBERNER: Thank you. This is ALL THINGS CONSIDERED from NPR News.

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