- The Washington Times - Monday, November 22, 2004


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 medicine that Bayer AG withdrew in 2001 after some people who took it developed a severe and sometimes fatal muscle disorder. A new study found that the risks were far greater than had been thought.

The study concludes that today’s top-selling cholesterol-lowering drugs, called 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 released yesterday and will be published Dec. 1 in the Journal of the American Medical Association (JAMA). Its editors call for a new, independent office separate from the FDA to monitor drugs after they are put 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.

Dr. Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, said concerns similar to those voiced in the JAMA articles are what prompted the agency earlier this month to seek an Institute of Medicine study examining the effectiveness of the nation’s drug-safety system.

“It needs scrutiny, and we need to determine if change is necessary,” Dr. Galson said yesterday.

In part, the new study will examine how the FDA is organized to investigate the safety of drugs on the market, and Dr. Galson said the FDA would consider recommendations for structural change.

Dr. Galson said the link between statins and muscle disease, with and without use of fibrates, is noted on the drugs’ labels. The FDA worked with Bayer in the 2001 withdrawal of Baycol, and Dr. Galson said the agency “acted on the information when it was made available to us.”

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

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