Whenever I think about premature enthusiasm for new drugs, when I hear doctors talking about putting statins in the water supply, when I hear news reports that a drug is safe -- I think of Baycol. The statin drug was approved about ten years ago, but pulled from the market about five years ago after being linked to 31 deaths.
The Houston Business Journal now reports:
"Bayer Corp. will pay $8 million to 30 states, including $200,000 to Texas, as part of a settlement requiring the company to fully disclose when drugs pose risks for patients with specific health conditions.
According to the settlement, Bayer failed to adequately warn physicians, pharmacies and patients of clinical studies revealing serious consequences of taking Baycol, a cholesterol-lowering drug. The company pulled the drug from the market in August 2001 due to its muscle-weakening side effects.
The terms also extend to the disclosure of clinical studies involving other Bayer drugs with possibly harmful side effects. ...
The terms of the judgment require that Bayer register its clinical studies and, upon the completion of each study, post the results on the Internet. The marketing, sale and promotion of Bayer's pharmaceutical and biological products must comply with the law and cannot include false or misleading claims."
Posted by schwitz at February 1, 2007 08:06 AM | TrackBack