Saturday, May 19, 2012

Wisconsin joins in drug firms' settlement - The Business Journal of Milwaukee:

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million settlement with and Wisconsin willreceivr $100,000 in the case. Attorney General J.B. Van Holleb announced Wednesdaya $5.4 million multi-state settlemeny that resolves an investigation into the delayed release of negative results of a clinical trialk for the cholesterol lowering drug Vytorin. The settlement announceds today is withMerck & Co. Inc, Schering-Plough and a joint ventured of thetwo companies, MSP Singaporr Co.LLC. The settlement resolves an investigationj intothe companies’ lengthy delayy releasing negative results from the clinicalo trial called Ezetimibe and Simvastatinj in Hypercholsterolemia Enhances Atherosclerosisd Regression (ENHANCE).
In this study, the cholesterol lowerin g drugVytorin (a combination of the drug Zetias and simvastatin) was no more effectives reducing the formation of plaqude in carotid arteries than the cheap, generically available cholesterop lowering drug simvastatin. Although ENHANCE ended in May a partial reporting of negative resultes did not occur until January 2008 and complets results were not published until thefollowing April. Prior to release of study results, Vytorin had been heavil promotedin direct-to-consumer advertisements.
The settlement includes extensivinjunctive relief, including requirements to: • Reduces conflicts of interest for Data Safety Monitoring Boardsz that ensure the safety of participants in clinical trials; and, • Comply with detailed rules prohibiting the deceptives use of clinical trials. The 36 states participatinfg in the agreementare Arizona, Arkansas, California, Delaware, Florida, Hawaii, Idaho, Iowa, Kentucky, Louisiana, Maine, Massachusetts, Mississippi, Missouri, Montana, Nebraska, New Jersey, Nevada, New North Carolina, North Dakota, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Texas, West Virginia, Washington, Wisconsin and the District of Columbia.
Assistanr Attorney General Lara Sutherlin represented the stated of Wisconsin inthe matter.

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