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July 15, 2009

Drug Companies Pay for Delaying Release of Negative Results of Cholesterol Drug Study

States investigated Merck and Schering-Plough for delayed release of results regarding Vytorin, a cholesterol-lowering drug

Iowa and several dozen other states have reached a settlement with Merck & Co. and Schering-Plough resolving the states’ investigation into the drug companies’ lengthy delay in releasing negative results of a clinical trial of their cholesterol-lowering drug, “Vytorin.”

The clinical study, which ended in May 2006, concluded that Vytorin was no more effective in reducing formation of plaque in carotid arteries than a less-expensive, generic cholesterol-lowering drug, “simvastatin,” but the companies didn’t report the negative results for Vytorin until 2008. Meanwhile, the companies promoted Vytorin heavily in advertising to consumers.

In a settlement with 35 states and the District of Columbia, the companies agreed to pay investigation costs of $5.4 million, including $100,000 to Iowa, which will be used for consumer protection enforcement and education.

The settlement, in the form of an Assurance of Voluntary Compliance, also requires Merck and Schering-Plough, for Vytorin and Zetia, to register clinical trials and post their results, obtain pre-approval from FDA for all direct-to-consumer television advertisements, comply with FDA suggestions to modify drug advertising, comply with detailed rules prohibiting the deceptive use of clinical trials, and other measures. (Vytorin is a combination of Zetia and simvastatin.)

The companies cooperated fully in the States’ investigation.

Thirty-five states and the District of Columbia entered the settlement with Merck & Co. Inc., Schering-Plough Corporation, and a joint venture of the two companies, MSP Singapore Company, LLC. The 35 states are AZ, AR, CA, CO, DE, FL, HI, ID, IL, IA, KY, LA, ME, MA, MI, MS, MO, MT, NE, NJ, NV, NM, NC, ND, OH, OR, PA, SC, SD, TN, TX, VT, WV, WA, and WI.

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