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More Vytorin fallout for Merck, Schering-Plough

Pharma Compliance Alert, January 30, 2008

Merck and Schering-Plough are facing a lawsuit over their cholesterol drug Vytorin, according to Business Week.

Lawsuits have been filed in federal courts in California, Florida, Louisiana, Minnesota, Mississippi, New Jersey, New York, and Ohio. Additional suits are pending in other states, according to the article.

The suits allege the companies falsely represented the drug's effectiveness and withheld information in approval submissions and filings with the U.S. Food and Drug Administration.

In addition to the lawsuit, the companies are facing a continuing Congressional investigation into the ENHANCE study, according to a press release from the House Committee on Energy and Commerce.

Rep. John D. Dingell (D-MI) and Rep. Bart Stupak (D-MI) plan to continue looking into the study, which compared Vytorin to generic simvastatin. The trial ended in April 2006, but the results showing Vytorin had the same effectiveness as simvastatin were not released until this month.

According to a New York Times article, the House Committee on Energy and Commerce also plans to investigate Merck and Schering-Plough's relationship with the American Heart Association and the American College of Cardiology. Both groups advised patients not to stop taking Vytorin without consulting their physicians and both receive money from the pharmaceutical industry.

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