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Attorney General's News Release

July 15, 2009

Attorney General Koster announces Missouri to receive $100,000 in settlement with Merck and Schering-Plough

--drug companies slow to disclose negative drug-study results--

Jefferson City, Mo. -- Attorney General Chris Koster today announced a multi-state settlement with Merck & Co. Inc, Shering-Plough Corporation, and a joint venture of the two companies, MSP Singapore Company, LLC.

"When pharmaceutical companies slow reports of negative drug-study results they are as good as lying to the public," Koster said. "It is unconscionable that a drug company would withhold information that physicians and their patients need to make good health-care decisions," Koster said. "The agreement with Merck and Schering-Plough sends a strong message that this Attorney General's office will be vigilant on public health issues and that we will not allow businesses to put profits before patients."

The settlement resolves an investigation into the companies' lengthy delay in releasing negative results from the clinical trial called ENHANCE (Ezetimibe and Simvastatin in Hypercholsterolemia Enhances Atherosclerosis Regression). In this study, the cholesterol-lowering drug Vytorin (a combination of the drug Zetia and simvastatin) was no more effective reducing formation of plaque in carotid arteries than the cheap, generically available cholesterol-lowering drug simvastatin. Although ENHANCE ended May 2006, a partial reporting of negative results did not occur until January 2008 and complete results were not published until the following April. Prior to release of study results, Vytorin had been heavily promoted in direct-to-consumer advertisements.

The settlement terms that now apply to Vytorin and Zetia are requirements to:

  • Obtain pre-approval from 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.

In addition to these terms, the companies agreed to pay the investigation costs of the 36 states participating in the settlement. Missouri will receive $100,000 for its work on the investigation.

 



 
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