PIERRE, S.D.-  Attorney General Larry Long today announced a settlement with Merck & Co. Inc, Shering-Plough Corporation, and a joint venture of the two companies, MSP Singapore Company, LLC.  The Assurance of Voluntary Compliance resolves an investigation into the companies’ lengthy delay releasing negative  results from the clinical trial called Ezetimibe and Simvastatin in Hypercholsterolemia Enhances Atherosclerosis Regression (ENHANCE).  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 Assurance of Voluntary Compliance applies the extensive injunctive relief from Merck’s 2008 Consent Judgment with the States regarding Vioxx to Zetia and Vytorin which had been carved out from the Vioxx settlement because Zetia and Vytorin are promoted by Merck as a joint venture with Shering-Plough.  Among the injunctive 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 ensuring the safety of participants in clinical trials; and,

• Comply with detailed rules prohibiting the deceptive use of clinical trials.

In addition to agreeing to these injunctive terms, the companies agreed to pay the States investigation costs of $5,400,000.  For its work on this investigation, South Dakota will receive $100,000. The companies cooperated fully in the States’ investigation.  For any additional information about this settlement contact Sara Rabern at 605-773-3215.

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