Government

Attorney General Abbott’s settlement with company requires disclosure of drug risks

Bayer Corp. pays states $8 million, agrees to post results of studies clearly outlining any risks

From the Office of Greg Abbott, Attorney General of Texas

February 1, 2007

DALLAS—Texas Attorney General Greg Abbott Jan. 23 reached an agreement requiring Bayer Corp. to fully disclose when drugs pose risks for patients with specific health conditions. Under the multi-state agreement, Bayer will pay 30 states $8 million, including $200,000 to the state of Texas.

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.

“Texans deserve to be fully informed about the adverse effects of their medications,” said Attorney General 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 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 to the medical community 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. Additionally, Bayer did not reveal that the muscle-weakening effects were particularly acute among those patients who were also taking other statin drugs.

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.