A $5.4 million settlement has been reached by 35 states with drug makers in a dispute over two cholesterol medications. Merck & Co. and Schering-Plough Corp. will pay the money to settle claims with the states. It was alleged that the companies covered up test results that cast doubt on the effectiveness of the drugs Vytorin and Zetia.
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 failed to release a partial reporting of the negative results until January 2008. A complete reporting was not made until the following April. Prior to the release of the results, Vytorin was still being heavily marketed by the companies. As you may recall, 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. But the original Vioxx settlement did not cover the allegations related to Vytorin and Zetia, because Merck marketed the two drugs through an agreement with Shering-Plough Corporation.
While the amount of money actually to be paid is very small and will barely pay the states’ expenses incurred, fortunately there is more to the settlement. The companies must now adhere to several injunctive terms, including a requirement to obtain pre-approval from the U.S. Food and Drug Administration 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.
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 Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, West Virginia, Washington, and Wisconsin, as well as the District of Columbia.
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