Wednesday, Attorney General Bill McCollum announced Florida,
34 other states and the District of Columbia have reached an agreement with Merck & Co. Inc, Shering-Plough Corporation, and MSP Singapore Company, LLC.
The settlement resolves an investigation into the companies’ lengthy delay in releasing the negative results of a clinical trial involving the cholesterol-lowering drug Vytorin, a combination of the drug Zetia and simvastatin, another cholesterol-lowering drug.
The states’ investigation revealed that in a clinical trial, Vytorin was shown to be no more effective in reducing the formation of plaque in carotid arteries than the cheaper generically available simvastatin.
Although the clinical trial was completed in May 2006, the companies allegedly failed to release a partial reporting of the negative results until January 2008 and a complete reporting until the following April.
Prior to the release of the results, Vytorin was still being heavily marketed by the companies.
In 2008, the states reached an agreement with Merck over allegations related to the sale of the drug Vioxx, which involved allegations similar to those made about the sales of Vytorin and Zetia.
The original Vioxx settlement did not cover the allegations related to Vytorin and Zetia, however, because Merck & Co. Inc, marketed the two drugs through an agreement with Shering-Plough Corporation.
The companies must now adhere to several injunctive terms, including a requirement to obtain pre-approval from the U.S. Food and Drug Administration (FDA) for all direct-to-consumer television advertisements; compliance with FDA suggestions to modify drug advertising; registration of clinical trials and publication of the results; and compliance with detailed rules prohibiting the deceptive use of clinical trials.
In addition to the injunctive terms of the agreement, the companies will reimburse the states $5.4 million for the cost of the states’
investigation. Florida will receive $200,000. The companies cooperated fully with the investigation.
The following states participated in the agreement: 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 Car olina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, West Virginia, Washington, and Wisconsin, as well as the District of Columbia.
A copy of the AVC can be located online at the link below.