"Sorry, It's Nap Time at FDA ... Call Back Later"

Friday, February 11, 2005

"Sorry, It's Nap Time at FDA ... Call Back Later"

Back on Nov. 4, the Food and Drug Administration (FDA) estimated that the drug Vioxx may have contributed to 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003. The estimate came from a study conducted by FDA official David Graham. But the news of these 27,785 deaths was largely missed by a nation that was still hungover from the just completed national election.

Since news emerged this week that the FDA knew the dangers of Vioxx back in 2002, it would be interesting to see an estimate of deaths occurring between the point at which the agency first learned of the danger to public health and the point at which the FDA finally went public -- late September of '04.

Was the FDA's silence shaped by the deregulatory ideology that is pervasive in the Bush administration? (Except, of course, for those drugs produced in the banana republic of Canada -- we can't allow a free market for them. There's no telling what might happen if we permitted Americans to buy their prescription drugs from Canada.)

If those Canadians are so lax at regulation and oversight of pharmaceutical drugs, then what explains this story from this morning's newspaper?
A day after Canadian officials came to an opposite conclusion, FDA regulators said Thursday that there is insufficient evidence to pull an attention deficit disorder (ADD) drug from the market.

The drug, called Adderall and Adderall XR, has been linked to 20 reports of sudden death worldwide, most in children, according to Health Canada. None of the deaths were in Canada.

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