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Tuesday, July 31, 2007

Caveat emptor

It will kill you, but go ahead and take the pill anyway. We can't allow regulation to hurt a major pharmaceutical company's bottom line.

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.


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