Makers of Vytorin and Zetia Agree to Pay $5.4 Million to Settle Cover-Up Claims

Merck & Co. and Schering-Plough Corp. have agreed to pay $5.4 million to settle civil claims brought by states accusing them of covering up negative study results for two of their blockbuster cholesterol-fighting drugs.

The drug companies had been charged by attorneys general in 35 states and the District of Columbia for burying the results of a study, called Enhance, which questioned the effectiveness of Vytorin and Zetia. The study found that the drugs were no more effective than an older, less-expensive drug at reducing plague blamed for hardening and narrowing arteries.

The study results were internally released in 2006, but the drug companies did not publicly disclose them for years. The states filed lawsuits in January 2008 over how the drugs were marketed.

The settlement amount announced today is designed to compensate the states for their legal costs in prosecuting the drug companies for the alleged wrongdoing. However, in paying the settlement amount, the drug companies admit no misconduct or liability, officials said.

“This agreement is consistent with our belief the companies conducted the Enhance trial in good faith and that our promotion of Vytorin and Zetia was in compliance with the law,” said Merck spokesman Ron Rogers, according to a Reuters news report.

There may be more legal rumblings stemming from the controversial Enhance study in the future, officials said.

Zetia and Vytorin are both big-time earners for the drug companies. Zetia generated about $2.2 billion in sales last year, which was down nearly nine percent largely due to studies which questioned its effectiveness.

Vytorin is a combination drug which uses Zetia and another generic drug, called Zocor. It earned about $5 billion in 2007, but there have been concerns about a possible link between the drug and certain cancers. Earlier this year, members of a Congressional panel said they want more information about clinical trials of Vytorin, which has also been linked to an increased risk of heart attack and stroke.

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