AG Van Hollen: Announces multi-state settlement with Merck & Co. Inc, Schering-Plough Corporation and joint venture concerning slow disclosure of negative drug study results

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Bill Cosh 608/266-1221

MADISON – Today, Attorney General Van Hollen, together with 35 other State Attorneys General announced a settlement with Merck & Co. Inc, Shering-Plough Corporation, and a joint venture of the two companies, MSP Singapore Company, LLC. The parties signed an Assurance of Voluntary Compliance, which resolved a multistate investigation into the companies’ lengthy delay in releasing negative results from a clinical trial of the companies’ cholesterol lowering drug Vytorin®.

The study showed that Vytorin® was no more effective at reducing the formation of plaque in carotid arteries than the cheap, generically available cholesterol lowering drug simvastatin. Although the study ended May 2006, no results were released until January 2008 and the complete results were not published until April 2008. However, prior to the release of these negative results, Vytorin was heavily promoted in direct-to-consumer advertisements.

The Assurance of Voluntary Compliance requires the companies to comply with the following terms when marketing Vytorin®:

* 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, Wisconsin will receive $100,000. The companies cooperated fully in the States’ investigation.

The investigation was led by Oregon Attorney General John R. Kroger and an Executive Committee including the Attorneys General of Arizona, California, Florida, Illinois, New Jersey, Ohio, Pennsylvania, South Carolina, Texas, and the District of Columbia.

The 36 States participating in today’s agreement are Arizona, Arkansas, California, Colorado, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, New Jersey, Nevada, New Mexico, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, West Virginia, Washington, and Wisconsin and the District of Columbia.

Assistant Attorney General Lara Sutherlin represented the State of Wisconsin in the matter.