Attorney General Terry Goddard announced on Jan. 23 a settlement with Bayer Corporation over its marketing of Baycol, a drug used to lower cholesterol that the company withdrew from the market in August 2001.
Goddard joined 30 state attorneys general in this settlement, which requires Bayer to pay the 30 states a total of $8 million. Arizona’s share of $200,000 will be used to pay for consumer education and investigation costs.
The investigation was initiated because of concerns that Bayer failed to adequately disclose safety risks associated with Baycol. The settlement requires Bayer to register its clinical trials on a national Web site and post the study results. Registration of clinical studies and timely posting of study results will ensure that all material information from clinical trials is made available to doctors and consumers, not just studies with positive outcomes.
The settlement also requires Bayer’s future compliance with the law in the marketing, sale and promotion of its pharmaceutical and biological products. It prohibits Bayer from making false and misleading claims relating to any such product sold in the United States.
Bayer introduced Baycol, a “statin” cholesterol-lowering drug, in May 1998. All statins carry a known risk of myopathy (a weakening of the muscles) and rhabdomyolysis (a more serious muscular disease).
Through post-marketing surveillance of its product, Bayer learned that the risk for Baycol turned out to be significantly higher than other statins, particularly at higher doses and when combined with genfibrozil, another cholesterol-lowering drug.
The attorneys general allege that although Bayer informed the U.S. Food and Drug Administration about those adverse effects, the company failed to adequately warn doctors who prescribed the medication and consumers about the increased risks.
The settlement does not constitute an admission of wrongdoing by Bayer. The settlement will be filed in Maricopa County Superior Court and is subject to court approval.
Assistant Attorneys General Noreen R. Matts and Dena R. Epstein handled this matter.