MARY LOUISE KELLY, host:
The Obama administration is facing its first big decision about whether to remove a drug from the market. Hundreds of thousands of Americans with diabetes take a drug called Avandia.
Yesterday, researchers published two new studies that add to evidence that Avandia raises the risk of heart attacks, stroke and cardiovascular death. And next month, the Food and Drug Administration will hold a public debate about the safety of the drug. NPR's Richard Knox reports.
RICHARD KNOX: One of the new studies is the largest done so far on Avandia. It was commissioned by the Food and Drug Administration and published by the Journal of the American Medical Association. It looks at what happened when nearly 230,000 Medicare recipients took either Avandia or a related drug, Actos. Dr. David Graham of the FDA says the results were alarming.
Dr. DAVID GRAHAM (Food and Drug Administration): If you treated 60 people for a year with Avandia, you would cause one extra case of heart attack, stroke, heart failure or death, compared to if you had treated 60 patients with Actos.
KNOX: This is a substantial difference. Graham says it means nearly 50,000 elderly Americans have died or had heart attacks, strokes or heart failure due to Avandia since the drug came on the market in 1999. Add in those under 65 and the number is probably 100,000.
A second new study appears in the "Archives of Internal Medicine." It updates an analysis done three years ago that concluded Avandia greatly raises the risk of heart attacks and deaths.
Study author Steven Nissen, of the Cleveland Clinic, says the new analysis pools results from 52 studies and it comes out pretty much the same way.
Dr. STEVEN NISSEN (Chairman, Department of Cardiovascular Medicine): I think what we can say, confidently, is looking at the totality of data in 2010, Avandia increases the risk of heart attack compared to other diabetes drugs by about a third.
KNOX: Nissen started the whole debate in 2007 with his first analysis. Before that, Avandia was the world's most popular diabetes drug. Afterward, the number of prescriptions dropped by half but Avandia still brings in more than a billion dollars a year for drug's maker, GlaxoSmithKline.
Company Vice President Jia Patel says the critics are just wrong about the dangers of Avandia. He says a six high-quality studies have been done since Nissen's first bombshell three years ago.
Dr. JIA PATEL (Vice President, GlaxoSmithKline): Taken together, these trials do not show any increase in overall risk of heart attack, stroke or death with Avandia.
KNOX: Patel says studies that find otherwise, all have fatal flaws.
To sort out the conflicting claims, the FDA has scheduled a two-day hearing in mid July. Then the agency will have to decide whether to pull Avandia from the market.
Again, Steve Nissen of the Cleveland Clinic.
Dr. NISSEN: We approach what will be I think a defining moment for the new administration and the FDA: what to do with this drug thats now been around for 11 years, for which the cloud of suspicion has gotten greater and greater and greater.
KNOX: Some think the FDA should have taken action months or years ago. David Graham, the agency's most vocal inside critic, says the agency failed to learn the lessons from the disaster involving the pain killer Vioxx in 2004. It was withdrawn from the market after studies indicated it raised the risk of heart attacks.
Dr. GRAHAM: Vioxx and Avandia, what they represent is a failure of FDA decision-making; a failure to place patient safety first, ahead of corporate profits.
KNOX: But one of Graham's bosses says the agency has not been dragging its feet. Joshua Sharfstein is the FDA's principal deputy commissioner. He says the agency has been busy lately gathering new data that have come out since 2007.
Dr. JOSHUA SHARFSTEIN (Principal Deputy Commissioner, FDA): A lot has changed since then, so we feel that this is a very good time to do a serious assessment of Avandia's safety.
KNOX: The FDA has its defenders. Dr. David Kessler, now at the University of California at San Francisco, is a former FDA commissioner known for tough stands on public safety.
Dr. DAVID KESSLER (Former Commissioner, FDA): It's not that the agency has been dithering. The fact is, these are very hard questions.
KNOX: Still, Avandia has changed Kessler's mind about how the FDA makes decisions on drug safety. He used to think it was okay for the same people who approve a drug to decide if it should be taken off the market when problems arise.
Dr. KESSLER: For the first time, I have questions whether somebody who has put their name on an approval letter, that somehow makes it harder to say - boy, I might have made a mistake.
KNOX: FDA leaders say they're looking at whether the regulators who decided the drug should stay on the market ought to be walled off from those who let it on in the first place.
Richard Knox, NPR News.
KELLY: You are listening to MORNING EDITION from NPR News.
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