Doctors question FDA oversight

New reports accuse another drug company of being too slow to pull a dangerous medication from the market and question the ability of the federal Food and Drug Administration to protect the public from such risks.

This time it’s Baycol, a cholesterol-lowering statin that Bayer AG withdrew in 2001 after some who took it developed a severe and sometimes fatal muscle disorder. A new study found that the risks were far greater than had been believed.

The study concludes that today’s top-selling statins are very safe, but could be risky when taken with other drugs called fibrates by older people with diabetes.

It also reveals that fibrates alone can be dangerous. These drugs lower triglycerides and often are taken by diabetics.

Six papers on the issue were to be released today and will be published Dec. 1 in the Journal of the American Medical Association. Its editors called for a new, independent office separate from the FDA to monitor drugs after they’re on the market.

“It is unreasonable to expect that the same agency that was responsible for approval of drug licensing and labeling would also be committed to actively seek evidence to prove itself wrong,” they write.

Merck & Co. and the FDA have been accused of moving slowly to stop sales of the arthritis drug Vioxx, which Merck withdrew in September after revealing it raised the risk of heart attacks and strokes. Some scientists claim pain killers similar to Vioxx, especially Pfizer Inc.’s Bextra, also carry risks.

On Thursday, Dr. David Graham, associate director of science in the FDA’s Office of Drug Safety, told a Senate panel that the FDA was incapable of protecting the public, and that dangerous drugs are being sold now. Bextra and AstraZeneca PLC’s statin, Crestor, were among the five he named.