For Immediate Release
Media Contact: Bob Cooper
Date: January 23, 2007
Wasden Joins Settlement with Bayer Corporation
(Boise) – Idaho and 29 other states have reached a settlement with the Bayer Corporation. Attorney General Lawrence Wasden said the settlement resolves issues related to the marketing of a drug used to lower cholesterol. The states initiated the consumer protection investigation due to concerns that Bayer failed to adequately disclose safety risks associated with the drug Baycol. Bayer withdrew Baycol from the market on August 7, 2001.
Bayer introduced Baycol, a “statin” cholesterol-lowering drug, into the United States market in 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 is significantly higher compared to other statins, particularly at higher doses and when combined with genfibrozil, another cholesterol-lowering drug.
The states alleged that, although Bayer informed the U.S. Food and Drug Administration about these adverse effects, Bayer failed to adequately warn prescribers and consumers about them.
The judgment, filed today in Fourth District Court in Ada County, requires Bayer to register most of its clinical studies on clinicaltrials.gov and post the results at the end of each study on clinicalstudyresults.org.
“The settlement makes great strides in improving patient safety by providing increased transparency in the clinical research of one of the world’s largest pharmaceutical companies,” Attorney General Wasden said. “With the new accessibility of this important information, prescribers and patients will be better equipped to make informed decisions with regard to the risks and benefits of individual drugs.”
The judgment also requires Bayer’s future compliance with the law in the marketing, sale and promotion of its pharmaceutical and biological products. Additionally, it prohibits Bayer from making false and misleading claims relating to any such product sold in the United States. Bayer denies any wrongdoing.
As part of the settlement, Bayer will pay $8 million to the 30 participating states. The State of Idaho will receive $200,000 as a result of the settlement.
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