November 22, 2004
New studies indicate Bayer AG was too slow to pull Baycol from the market in 2001, when some patients taking the drug developed a severe and sometimes fatal muscle disorder. In a related development, a prestigious medical journal is calling for a new independent agency to monitor drug safety.
A report in the December 1 issue of the Journal of the American Medical Association (JAMA) quotes a new study which found that Baycol's risks were far worse than had been believed at the time Bayer withdrew the drug.
Merck has been under fire recently for allegedly moving too slowly to withdraw the arthritis drug Vioxx, which has been found to raise the risk of heart attack and stroke in some patients.
In an editorial accompanying the article, JAMA's editors said it is time to recognize that the Food and Drug Administration (FDA) is unable to protect the public from dangerous drugs and to establish a new agency to fill that role.
"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," the editors wrote.
Last week, David Graham, a senior FDA safety officer told a Senate panel that at least five dangerous drugs are on the market today because of the FDA's inability to effectively monitor drugs once they have been approved.
The study cited in the JAMA article said that today's cholesterol-lowering statin drugs are very safe but can pose risks when taken with fibrates, drugs often taken by older patients with diabetes to lower triglycerides.