FDA Advisory Panel Considers Avandia's Future
MARY LOUISE KELLY, Host:
NPR's Richard Knox reports.
RICHARD KNOX: Dr. Philip Home, who led the study, insists it shows that Avandia, which is known generically as rosiglitazone, is actually safer than other drugs for diabetes.
PHILIP HOME: And Murray Stewart of Glaxo stressed that rosiglitazone keeps blood sugar down.
MURRAY STEWART: Overall, when used appropriately, rosiglitazone has a positive benefit risk profile and should remain a treatment option for patients with Type 2 diabetes.
KNOX: But the company ran up against strong critics within the FDA - more than when the agency decided three years to keep the drug on the market. This week's hearings, in fact, reveal a sharply divided FDA. Staffer Thomas Marciniak says one faction is pushing to keep the drug on the market - another faction maintains it's killing thousands of people.
THOMAS MARCINIAK: And then, I think, you have me. I have not been involved with rosiglitazone prior to fall of last year. I have this clean slate there. So I think I amount(ph) to, I think, is a tiebreaker in terms of whether this is a good or bad drug.
KNOX: Marciniak proceeded to savage Glaxo's biggest study. When he delved into it, he found serious flaws, including whether or not patients had died and when.
MARCINIAK: In 2002, a patient, as reported, has died and the investigator says he doesn't even know the year. No one checks up on this. This is all we know about this patient.
KNOX: Marciniak found eight heart attacks among rosiglitazone patients that had never been recorded. He told the advisory panel they shouldn't rely on Glaxo's big study.
MARCINIAK: You really can't depend upon it for safety. It does confirm the problems of heart failure and extends them regarding heart failure deaths and in fact does suggest that rosiglitazone increases the risk for MI.
KNOX: Other FDA staffers defended the record study and questioned other data that seemed to indict the drug. But clearly, many within the FDA and its expert panel are troubled by the larger issue that this case represents.
ELLIS UNGER: The issue here is really truth.
KNOX: That's Dr. Ellis Unger of the FDA.
UNGER: The question is: Is there a malfeasance here? Can we trust the results or not? And maybe the only way is to audit the whole trial. I don't know.
KNOX: Richard Knox, NPR News.
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