FDA under fire as reports of risky medicines grow

? Drug maker Bayer was slow to report the risks of its cholesterol-lowering drug Baycol and to remove it from the market in 2001, according to an forthcoming report in the Journal of the American Medical Assn.

The findings, based in part on internal company documents revealed in a recent court case, raise new questions about the Food and Drug Administration’s effectiveness in monitoring the safety of drugs after it has approved them for sale.

The report on Baycol appears in the journal’s Dec. 1 issue, along with five other papers on problems with drugs after they have been approved for sale. An accompanying editorial in the journal recommends that a new federal regulatory office be established, independent of the FDA, to monitor drugs once they are on the market.

“In effect, what happens is that some companies may treat scientific data as if it is a marketing problem,” said report co-author Dr. Curt Furberg, a professor of public health sciences at Wake Forest University in Winston-Salem, N.C.

“Selective publication of favorable articles … misrepresents the evidence for physicians and patients who need complete and accurate information to make informed decisions about therapies,” the study said.

The journal’s editorial board joins lawmakers, consumer advocates and others in urging the creation of an independent agency to monitor the safety of drugs on the market.

The Baycol study concluded that Bayer officials knew four months after the drug hit the market in February 1998 that it was more likely than other cholesterol-lowering drugs, known as statins, to cause a rare and sometimes fatal muscular disorder.