A leading diabetes doctor sent the Food and Drug Administration a letter seven years ago that warned of the heart risks of the drug Avandia. And in the next year, the F.D.A. reprimanded the drug’s maker for playing down safety concerns, according to documents from 2000 and 2001.The documents, found in a reporter’s search of the F.D.A.’s database, indicate that the agency had been warned of safety concerns with the Type 2 diabetes treatment Avandia, and that the drug’s maker, GlaxoSmithKline, was seeking to minimize Avandia’s risks, before some of the same cardiovascular concerns were brought to public attention on Monday in an article and an editorial in The New England Journal of Medicine.
The F.D.A. has acknowledged that the company alerted the agency to concerns about a cardiovascular risk as early as 2005, based on the company’s analysis.
Glaxo has challenged the significance of the data cited in the medical journal. And, along with the F.D.A., the company has said that it was too soon to draw conclusions that Avandia raises a Type 2 diabetes patient’s risk of heart attacks. But the documents from 2000 and 2001 indicate that concerns about the drug’s safety are by no means new.
The letter in 2000 to the F.D.A. was written by Dr. John B. Buse (pic), chief of endocrinology at the University of North Carolina in Chapel Hill, who is about to become the president of the American Diabetes Association.
His letter from seven years ago sounded an alarm about Avandia, citing “a worrisome trend in cardiovascular deaths and severe adverse events” among patients using the drug.
In a telephone interview yesterday, Dr. Buse said that his opinion of Avandia had not changed since he wrote that letter. But he added yesterday that regulators should not rush to judgment by withdrawing Avandia from the market. Instead, he said, they should wait for the results of a larger study now being conducted by Glaxo that is meant to study the drug’s cardiovascular risks.
Avandia has been used by an estimated six million people in the United States since the agency approved it 1999. At the time, the company promoted Avandia as a safer alternative to a similar diabetes drug, Rezulin, which was withdrawn from the market in 2000 because it caused serious liver damage in some patients.
A Harvard professor who is a critic of the nation’s drug approval process, Dr. Jerome L. Avorn, yesterday drew parallels between the regulatory histories of Avandia (rosiglitazone) and Rezulin (troglitazone), which had been a popular drug in its day.
With both drugs, “there were signals of a very dangerous side effect that were ignored,” he said. “Then massive marketing created a tremendous uptake of the drug.”
More at NYT
5 comments:
I can't stand the hysteria over Avandia. For crying out loud people, quit bashing Pharma and use your heads! The "study" that is raising all this flack is a meta-analysis (notoriously inaccurate) that shows absolute risk increases from Avandia were .02%! For goodness sakes, a small risk compared to the numerous people Avandia has helped.
But specialists point out that the actual number of heart attacks recorded in the study was quite small: Nissen found 86 heart attacks among 14,371 patients taking Avandia (or 0.598%), compared with 72 in the 11,634 patients not on the drug (0.619%).
"There were 39 deaths from cardiovascular causes in 10,378 patients on Avandia (0.375%) vs. 22 deaths in 9,188 patients not on the drug (0.239%). In other words, though the relative risk of developing a heart attack is much higher in the Avandia group, the overall risk in all patients was relatively low."
Tired of all the nonsensical hype...
Dear anony-mouse,
with Vioxx the rates were something like 13 in 10000 MI in the placebo versus 28 in 10000 (relative risk of 2.25 or !!!!!!!! 225% in marketing speak!!!!!). IMO it wasn't the nasty side-effects of rofecoxib it was the hiding the data!
I think it's bloody hilarious that it was another GSK product though.
Jack - I have a question that no one can answer...
What about Pioglitazone? Where does that stand?
Downunder in the Antipodes, Rosiglitazone is available subsidised on the equivalent of the NHS for triple therapy, but Pioglitazone isn't, so 99.9% of the scripts for glitazones goes to the GSK product.
Benedict
But does Avandia "help" any more than any other brand-name or generic glucose lowering drug?
There is no evidence that it produces any better clinical outcomes, i.e., that it makes patients feel better, function better, better avoid complications, or live longer than any other glucose lowering drug.
Why not first try older, cheaper, and possibly safer drugs instead of Avandia, and reserve Avandia for the few patients who can't tolerate those drugs.
See our post on Health Care Renewal here:
http://hcrenewal.blogspot.com/2007/05/dream-turns-to-nightmare-avandia-and.html
Roy.
Your post on your blog is excellent.
Regarding Benedict's question about pioglitazone: I think that they will have to prove that it's different......... and in my view they haven't done that yet.
Post a Comment