Congress: Vytorin Makers Held Bad News

Apr. 1, 2008— -- A congressional committee, investigating whether the makers of cholesterol drug Vytorin withheld data that would hurt sales, released new evidence supporting such suspicions Monday.

The Senate Finance Committee said even the researcher who led a crucial study of the drug accused Vytorin makers Merck & Co. and partner Schering-Plough Corp. of withholding negative results to boost sales.

A letter from the committee's ranking Republican, Sen. Chuck Grassley of Iowa, states that delaying the results affected medical decisions and put financial burdens on patients and the federal government, which has paid hundreds of millions of dollars for Vytorin since the study ended nearly 2 years ago.

Spokespeople for both drugmakers said the letter is just one in a series from Grassley's committee and that their companies are cooperating fully.

The letter comes as shares of Merck and Schering-Plough tanked after top cardiologists urged doctors to go back to older, well-proven treatments for high cholesterol. The doctors spoke at a major heart specialists' conference after hearing full results Sunday of the Vytorin study, called ENHANCE, that showed it worked no better than an inexpensive generic.

"This is the last thing that Schering and Merck need, especially in a political year," said analyst Steve Brozak of WBB Securities Ltd. "This can become brutal."

For months, the Senate Finance Committee and the House Energy and Commerce Committee have been investigating how Merck and Schering-Plough handled data from a study comparing Vytorin with Merck's older cholesterol drug, Zocor. Vytorin, which costs $100 a month or more, combines Zocor — available as a generic for about one-third as much — and Schering-Plough's cholesterol drug Zetia.

Between the two committees, congressional staffers have been probing everything from who knew what when to whether executives of Merck and Schering-Plough sold large amounts of stock based on insider knowledge.