Healthy Skepticism Library item: 7900

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Houston Business Journal.
Bayer reaches settlement over drug disclosure
Houston Business Journal 2007 Jan 23
http://houston.bizjournals.com/houston/stories/2007/01/22/daily29.html

Full text:

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 (NYSE: BAY) 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.

“Texans deserve to be fully informed about the adverse effects of their medications,” said Texas Attorney General Greg Abbott. “This agreement ensures that patients have access to the information they need to make educated health care decisions.”

The terms of the judgment require that Bayer (NYSE: BAY) 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.

In 1997, the U.S. Food and Drug Administration approved Baycol, a “statin” cholesterol-lowering prescription drug, which Bayer began marketing in May 1998. While patients who take statin drugs frequently experience muscle-weakening side effects, Bayer failed to disclose that its product posed significantly greater risks than did statins produced by other drug companies.

Because of Bayer’s failure to disclose risks exacerbated by its product, patients who were prescribed Baycol were not informed of its potential side effects. Concealing risks in the name of profit violates the Texas Deceptive Trade Practices Act.

Bayer Corp. USA is a subsidiary of Bayer AG, part of the Bayer Group of companies based in Germany. The company has facilities across the U.S., including Channelview and Baytown.