There have several lawsuits filed against Merck & Co. and partner Schering-Plough Corp., related to their marketing of cholesterol drug Vytorin. Also, the U.S. Department of Justice is investigating the drug makers’ conduct, according to a regulatory filing. The Justice Department’s Civil Division notified Merck by way of a September 10th letter that the Department is investigating whether the drug makers’ promotion of Vytorin resulted in false claims to federal health care programs. If so, federal health programs could seek to recover money they have spent on the drug.

A group of 35 state attorneys general are jointly investigating whether the partners violated state consumer protection laws in their marketing of Vytorin, Merck reported. And, since January, Merck has been served with or become aware of about 140 civil class action lawsuits alleging consumer fraud claims in connection with two cholesterol drugs sold and promoted by the partners’ joint venture. Some lawsuits allege personal injuries or seek medical monitoring for people who used the drugs.

Vytorin and one of its components, Zetia, have been blockbusters in the lucrative cholesterol market, with a combined $5.2 billion in 2007 revenue. But repeated bad news about the drugs this year has cut revenue by about 15% since last fall – they brought in only a combined $1.1 billion in the third quarter – contributing to new rounds of layoffs at both Merck and Schering-Plough. In January, under pressure from Congressional investigators, the companies released results of a long-delayed study showing that the very expensive Vytorin was no better at reducing plaque buildup than its second component, a generic cholesterol drug called Zocor costing about one-third as much.

Those revelations led to the investigations by Congressional committees as to whether the companies deliberately delayed releasing the study’s results to boost sales of Vytorin and Zetia. The companies have denied the charge. The investigations are being conducted by the Senate Finance Committee and the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations. They have sought witness interviews, documents and information related to the companies’ promotion of Vytorin, the delayed release of results on the patient study, called ENHANCE, and stock sales by officers of the companies.

The Oversight and Investigations subcommittee has also made requests for documents and information related to another patient study, called SEAS, that linked Vytorin to a possible increased risk of various cancers and showed it didn’t prevent deterioration, surgery or death in patients with diseased heart valves, as the companies had hoped. If you need more information on Vytorin issues, contact Frank Woodson at 800-898-2034.

Source: Forbes

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