For immediate release – Tuesday, January 23, 2007.
Contact Bob Brammer – 515-281-6699.
Bayer Corp. to Post Results of Clinical Trials, and Pay $8 Million
States alleged the company failed to adequately disclose risks of cholesterol drug.
Des Moines. Attorney General Tom Miller said today that Bayer Corporation has reached a settlement with Iowa and other states, resolving the states’ concerns that Bayer failed to adequately disclose safety risks associated with “Baycol,” a cholesterol-lowering drug.
Under judgments filed today in Iowa and 29 other states, Bayer must register most of its clinical drug studies and post study results. Bayer also will pay $8 million to the states, including $200,000 to Iowa for use in consumer protection litigation and education.
“Baycol was introduced in May of 1998, and it was effective,” Miller said. “However, we alleged that Bayer failed to adequately warn prescribers and consumers about serious adverse effects it knew about.”
The states alleged that Baycol and all cholesterol-lowering “statin” drugs carry a known risk of “myopathy” (a weakening of the muscles) and “rhabdomyolysis” (a more serious muscular disease.) But the states argued that Bayer learned through post-marketing surveillance of the drug that the risk for Baycol turned out to be significantly higher compared to other statins, particularly at high doses and when combined with “genfibrozil,” another cholesterol-lowering drug.
The State Attorneys General alleged that, while Bayer informed the US Food & Drug Administration about the adverse effects, Bayer failed to adequately warn prescribers and consumers about them. Bayer withdrew Baycol from the market in August 2001.
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Additional Background and Details:
Thirty states participated in today’s settlement with Bayer: CT, MI, OR, PA, and VT (executive committee states), and AZ, AR, CA, DE, FL, ID, IL, IA, KS, KY, ME, MD, MA, MS, MT, NV, NC, OH, SC, SD, TN, TX, VA, WA, and WI.
To resolve the matter in Iowa, both a lawsuit and a consent judgment were filed today in Polk County District Court. The Attorney General’s Office filed the lawsuit and presented the Consent Judgment, which was approved by Polk County District Court Judge Robert A. Hutchison.
Bayer denies any wrongdoing in the Judgment.
Under terms of the judgment and court order, Bayer:
∙ Must register most of its clinical studies in advance -- and then post the results at the end of each study. (Studies must be registered at www.ClinicalTrials.gov and results must be posted at www.ClinicalStudyResults.org.)
∙ Must comply with the law in the marketing, sale, and promotion of its pharmaceutical and biological products.
∙ Must not make false and misleading claims relating to any such product sold in the United States.
∙ Must pay a total of $8 million to the 30 participating states to settle the concerns of those states' Attorneys General.
On the Web: www.IowaAttorneyGeneral.org.