$5.4M Paid to Settle Drug Cover-up Claims

Posted on Jul 30, 2009 in Uncategorized

Merck and Schering-Plough Accused of Covering up Test Results that Cast Doubt on Cholesterol Drugs

(AP) Drugmakers Merck & Co. and Schering-Plough Corp. said Wednesday they will pay $5.4 million to settle civil claims that the companies covered up test results that cast doubt on the effectiveness of two blockbuster cholesterol drugs.

The companies settled with attorneys general from 35 states and the District of Columbia. The investigation centered on claims the companies kept the results from unfavorable studies quiet, violating consumer protection laws. Merck, Whitehouse Station, N.J., and Schering-Plough, Kenilworth, N.J., will pay back the costs of the investigation, but don’t have to make other payments or admit wrongdoing or liability.

In January 2008, the companies released studies showing Vytorin and Zetia, sold by the Merck/Schering-Plough Pharmaceuticals joint venture, were not more effective than an older drug at reducing plaque buildup in the blood vessels of the neck. The testing was finished in 2006 and the companies faced criticism for not releasing the results sooner.

The testing compared Zetia and Vytorin to Zocor, a drug that is one of Vytorin’s ingredients. Zocor is now available as a low-cost generic drug. Later studies raised additional concerns about safety and effectiveness.

Kentucky Attorney General Jack Conway said the companies agreed to get advance FDA approval for all TV advertisements aimed at consumers and comply with FDA suggestions to modify that advertising. Additionally, the companies will register clinical trials and report results and agreed to comply with rules barring the deceptive use of those trials, avoid ghost writing of articles by physicians, and reduce conflicts of interest on boards monitoring clinical trials.

The state of Kentucky will receive $100,000 in the settlement.

Merck and Schering-Plough said they will continue to comply with laws requiring the truthful and non-misleading marketing of their drugs.

The 35 states involved in the settlement are Arizona, Arkansas, California, Colorado, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia, and Wisconsin.

Merck is in the process of buying Schering-Plough for $41.1 billion. In afternoon trading, Merck shares rose 33 cents to $27.49. Schering-Plough stock added 26 cents to $25.18.