FDA's Handling of Diabetes Drug Reviewed

Last month, the same doctor who initially raised questions about Vioxx published an analysis indicating that the popular diabetes drug Avandia also causes heart problems. A House committee is having a hearing on how the FDA handled the drug.

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Politicians on Capitol Hill today took up a question usually handled by the Food and Drug Administration. Is a medicine that's currently on the market safe? The drug in question is the popular diabetes pill Avandia.

As NPR's Joanne Silberner reports, today's House committee hearing got mired in some of the finer points of evaluating drug safety.

JOANNE SILBERNER: This was science and politics from the outset and it was not an easy mixture. In May, in the New England Journal of Medicine, a study concluded that the popular diabetes drug, Avandia, can cause heart attacks. The drug's manufacturer, GlaxoSmithKline defended the drug.

Yesterday, a new study sponsored by Glaxo was released, showing no problems with heart attacks. Today, California Democrat Henry Waxman chaired a hearing on Capitol Hill. At the outset, he admitted to some concern about raising a safety question that may not have answers.

Representative HENRY WAXMAN (Democrat, California): I have struggled with the right tone for today's hearings. To diabetes is a serious illness and Avandia is an effective medication for lowering blood sugar. Sounding a false alarm about the dangers of the drug has a potential to cause serious harm to patients.

SILBERNER: But then, the gloves came off. Republicans attack Steven Nissen, author of the study that linked Avandia to heart attacks. Representative Darrell Issa of California said Nissen was leaping to conclusions.

Representative DARRELL ISSA (Republican, California): I believe that it is okay to look at something if it is a clear and present danger. That is not the case here. This drug is very much still effective and on the market for patients today and should not be artificially called into question as to its safetyness - safety, or side effects as a result of anecdotal information presented here.

SILBERNER: Democrats jumped on the FDA. They wanted to know why the agency hadn't demanded more company research earlier, and they asked why it hadn't publicized the safety issue last year, when it got results from a Glaxo study that also linked Avandia to heart attacks. FDA head Andrew von Eschenbach.

Mr. ANDREW von ESCHENBACH (Commissioner, Food and Drug Administration): We took the opportunity to recognize these - along with other information - were clues in any kind of detective game. But we had to look at all the clues, all the information, all the data.

SILBERNER: Von Eschenbach said he doesn't think the verdict is in yet on the drug. Even so in his prepared testimony, he announced that two days after Nissen's study was published, the agency told the drug maker to put a special warning on the drug's label.

As the hearing wore on, Republican Darrell Issa got into an argument with Nissen on how the study was done. The Congress member was bothered that Nissen left out six studies, where no heart problems were seen in either group. Nissen said he have to. It's how that type of study is done.

Rep. ISSA: You left it out, didn't you.

Dr. STEVEN NISSEN (President, American College of Cardiology): Mr. Issa, you can't calculate an effect size when there are no events.

Rep. ISSA: Okay.

SILBERNER: And the arguments over numbers went on and on. For those doctors and patients wanting to know whether Avandia is safe, Nissen said more research is needed.

Dr. NISSEN: What would need to be done is an adequately sized, long-term trial probably in fairly high-risk patients, comparing Avandia to other therapies. Now unfortunately because such a trial doesn't exist, it would not be completed for probably about another seven years.

SILBERNER: With no statistics that every one could agree on, several Republicans accuse Nissen of trying to bring down a drug company working to help diabetics. Democrats accuse Republicans of demagogueing the issue, and the FDA announced that it will ask a group of medical experts to evaluate Avandia at an advisory committee meeting, July 30th.

Joanne Silberner, NPR News, Washington.

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