Merck says Justice Dept. is probing Vytorin marketing
The U.S. Department of Justice has begun investigating the conduct of Merck & Co. Inc. and Schering-Plough Corp. in the marketing of the cholesterol drug Vytorin, according to a regulatory filing.
The U.S. Department of Justice has begun investigating the conduct of Merck & Co. Inc. and Schering-Plough Corp. in the marketing of the cholesterol drug Vytorin, according to a regulatory filing.
Lawsuits against the companies related to Vytorin marketing also are piling up, Merck said in a filing late Monday to the Securities and Exchange Commission.
Merck, of Whitehouse Station, N.J., has extensive operations around West Point, Montgomery County.
The Justice Department's Civil Division notified Merck in a Sept. 10 letter that the agency was investigating whether the drugmakers' promotion of Vytorin resulted in false claims to federal health-care programs, Merck noted. If so, federal health programs could seek to recover money they have spent on the drug.
Thirty-five state attorneys general are jointly investigating whether the partners violated state consumer-protection laws in marketing Vytorin, Merck said.
And, since January, Merck has been served with or become aware of about 140 civil class-action lawsuits alleging consumer fraud 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, the filing said.
"We take this matter very seriously," Skip Irvine, a spokesman for the joint venture, said yesterday. "We're cooperating with the request for information that the Justice Department is seeking."
Merck also said in the SEC filing that it was cooperating with the other investigators.
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 about 15 percent since last fall - they brought in only a combined $1.1 billion in the third quarter - contributing to new rounds of layoffs at Merck and Schering-Plough.
In January, under pressure from congressional investigators, the companies released results of a long-delayed study showing that pricey Vytorin was no better at reducing plaque buildup than its second component, a generic cholesterol drug called Zocor costing about one-third as much.
That led to the investigations by congressional committees as to whether the companies deliberately had delayed releasing the study's results to boost sales of Vytorin and Zetia - an accusation the companies have denied.
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.
