Thursday, November 18, 2004

Double Standard On Drugs


The Food and Drug Administration just issued a warning on RU-486 – the drug used to cause medical abortions – after two women died from secondary infections after taking the pill to end their pregnancies. But the FDA waited until about 27,000 people had died from heart attacks and strokes while taking arthritis drug Vioxx before pulling that drug. Why the discrepancy?

The FDA is not exactly known as a Johnny-on-the-spot agency. "Slow" and "careful" are its middle names – slow to approve generic drugs that might cut into the profits of large pharmaceutical companies, and careful not to do or say anything that could hurt the sales of those companies' hot sellers. The bodies have to really pile up before the FDA pulls the plug on a popular drug.

Which is what made the Nov. 15 FDA announcement so unusual. The death of one woman last January prompted the FDA to issue a warning notice on the so-called abortion pill, RU-486. The woman did not die as a direct cause of the medication, but rather a secondary infection that set in afterward. It was only the second such case reported after using RU-486.

Compare that FDA response to its handling of Merck's hot-selling arthritis pill, Vioxx. Warnings on that pill have been flooding in from around the world for more than two years – warnings the FDA ignored. The pill worked fine at alleviating pain – especially for the estimated 27,000 users it killed. It seems Vioxx had some nasty side affects: heart attacks and strokes.

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