Posted on 07/30/2007 11:09:59 PM PDT by neverdem
GAITHERSBURG, Md., July 30 — A federal drug advisory committee voted overwhelmingly on Monday to recommend that the diabetes drug Avandia remain on the market, even after finding that it raised the risks of heart attacks.
Panel members said that studies concerning Avandia were too murky to merit drastic regulatory action and that other diabetes medicines might have similar risks...
The votes — 20 to 3 on the heart attack risk and 22 to 1 on the marketing — were cast after an extraordinary meeting in which officials from the Food and Drug Administration, which brought the committee together, openly disagreed with one another on the course to take.
Dr. David Graham, a drug safety officer at the federal agency, called for withdrawing the drug and estimated that its toxic effects on the heart had caused up to 205,000 heart attacks and strokes, some fatal, from 1999 to 2006. For every month that Avandia is sold, Dr. Graham said, 1,600 to 2,200 patients will suffer more of those problems.
Dr. Robert Meyer, director of the F.D.A. office that approved the initial Avandia application, immediately disagreed.
“I think it’s important that the committee understand there’s a fundamental disagreement” within the agency, Dr. Meyer said.
Other diabetes drugs also have risks, he added, and doctors and patients need a variety of options.
After the votes, Rebecca Killion of Bowie, Md., a patient representative on the advisory panel, said, “My feeling here is that we’re being asked to take a very draconian action based on studies that are very inadequate for us to make that kind of decision.”
(Excerpt) Read more at nytimes.com ...
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I’ve been on Avandia for about three years and it hasn’t killed me yet. I told my sister the good news is that now if I drop dead she has somebody to sue.
I do have a problem with these studies that have dire warnings about the sort of thing the drug is designed to offset - such as the psychotropic drugs that they claim make you more prone to suicide. To which I ask “how do they know? They’re already giving it to depressed people. Wouldn’t those patients already be more prone to suicide than the average placebo-user?”
Diabetes weakens you circulatory system and makes you more prone to heart attacks. So it should be no surprise that people who take diabetes drugs have a higher percentge of heart attacks. Maybe it’s because... they have diabetes!
Anyway, I’m more concerned with Avandia’s propensity to make you gain weight than I am about heart attack risks.
Hey, we all have to die of something.
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