Merck Settles ‘Vytorin’ Case with 36 States

     JEFFERSON CITY, Mo. (CN) – Missouri will receive $100,000 as its part of a settlement with Merck and Schering-Plough. The 36-state settlement ends an investigation into the companies’ lengthy delay in releasing negative results from a clinical trial of the cholesterol-lowering drug Vytorin.

     The study showed that Vytorin was no more effective at reducing formation of plaque in carotid arteries than the cheaper, generic drug Simvastatin. The trial ended in May 2006, but a partial reporting of the results was not available until January 2008 and the full results were not released until April 2008.
     The settlement requires Merck and Schering-Plough to obtain pre-approval from the FDA for all direct-to-consumer television advertisements; comply with FDA suggestions to modify drug advertising; register clinical trials and post their results; prohibit ghost writing of articles; reduce conflicts of interest for data safety monitoring boards that ensure the safety of participants in clinical trials; and comply with detailed rules prohibiting the deceptive use of clinical trials.
     “When pharmaceutical companies slow reports of negative drug-study results they are as good as lying to the public,” Missouri Attorney General Chris Koster said in a statement. “It is unconscionable that a drug company would withhold information that physicians and their patients need to make good health-care decisions.”

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