FDA Criticized for Diabetes Drug Avandia

There are more demands to overhaul the Food and Drug Administration. Scientific analysis indicates the widely used diabetes drug, Avandia, raises the risk of heart attacks and possibly death. The agency is being criticized for the way the drug was initially approved, and for not reporting problems sooner.

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A widely used drug for diabetes was suddenly found to cause heart problems. This story may remind you of the incident involving the painkiller Vioxx. Once again the Food and Drug Administration has become a lightning rod for dissatisfaction with the nation's drug approval system.

NPR's Joanne Silberner reports on how a review of a diabetes drug is renewing calls for change at the FDA.

JOANNE SILBERNER: The drug in question is Avandia. It was approved in 1999 and manufacturer GlaxoSmithKline estimates that about a million Americans are taking it for their type II diabetes, the most common form of diabetes. But last year Steven Nissen of the Cleveland Clinic was looking at a new study showing the drug can not only treat diabetes, it can also sometimes prevent it. What troubled him were the side effects.

Dr. STEVEN NISSEN (President, American College of Cardiology): Cardiovascular outcome went in the wrong direction. That is, there were more heart attacks, more strokes, more cardiovascular deaths in the patients that got Avandia than those that got a sugar pill.

SILBERNER: That sent Nissen back through 42 research studies of Avandia. He pulled the data and found that the drug appears to increase the risk of heart attacks by 43 percent, and increase the rate of death from heart disease by 64 percent. Now, the reason the FDA approved Avandia in the first place was because it lowers blood sugar. Again, Steven Nissen.

Dr. NISSEN: The reason we lower blood sugar in diabetes is to prevent complications of diabetes. And the most important complication of diabetes is heart disease.

SILBERNER: So you'd think the FDA would want to see whether Avandia can prevent heart disease before approving the drug. But heart disease can take a long time to develop. You can tell quickly if blood sugar is dropping. With pressure on to approve drugs rapidly, the FDA okayed Avandia with just the blood sugar data.

Now the drug's been on the market for eight years, approved under a special program that's applied to quickly approve drugs to pick up those sorts of problems. It's called post-market surveillance. Glaxo has been tracking patients getting the drug as part of that surveillance. And so far Glaxo hasn't seen heart problems, says the company's chief medical officer Ronald Krall.

Dr. RONALD KRALL (Senior Vice President for Worldwide Development, Glaxo): Those studies, two of which were competed last fall, failed to find evidence of increased risk.

SILBERNER: But Nissen says the reason he found a problem, and Glaxo didn't, is that Glaxo's studies weren't large enough and didn't include any high-risk patients. He'd like to see tougher rules about the design of post-marketing studies and penalties to prevent companies from dragging their feet. And he thinks the FDA should have higher standards for the approval of drugs in the first place.

Meanwhile, the Avandia debate has renewed calls from Capitol Hill to keep better track of what happens to drugs once they get on the market. Those calls are coming from both Republicans and Democrats. Democratic Congressman Henry Waxman.

Representative HENRY WAXMAN (Democrat, California): I think we've got to give FDA the power to say to a company you're going to do those further studies and not that you'll promise it and not do it and FDA will be left without any authority to do anything other than pull the drug off the market, which is very draconian.

SILBERNER: The Senate just passed a bill that would allow the FDA to assess million dollars fines on companies that don't do those studies when the agency has asked them to. The House will be considering a similar bill soon.

In the meantime, Waxman will hold a hearing in early June. He wants to hear from Avandia's manufacturer and the FDA about what happened with this drug, why it happened and how Americans can be protected from drug safety surprises in the future.

Joanne Silberner, NPR News, Washington.

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