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Questions on Vytorin Mount.

WASHINGTON -- A congressional committee investigating whether the marketers of the cholesterol drug Vytorin withheld data that would hurt sales has released new evidence that critics contend supports such suspicions. The Senate Finance Committee noted that even the researcher who led a crucial study of the drug accused Vytorin partners Merck & Co. and Schering-Plough Corp. of holding back negative results to boost sales.

The Senate panel, along with the House Energy and Commerce Committee, have been examining how the two companies handled data comparing Merck's Zocor against their jointly marketed drug Vytorin, which combines Zocor and Schering's Zetia.

A letter from the committee's ranking Republican, Sen. Charles Grassley of Iowa, to the drug manufacturers states that the companies' decision to delay unfavorable results of their Vytorin study 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 two years ago. Vytorin costs about $100 a month, compared with a third of that amount for a generic version of Zocor.

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

The letter comes after top cardiologists urged doctors to go back to older, well-proven treatments for high cholesterol. The physicians spoke at a major heart specialists' conference after hearing full results of the Vytorin study--called ENHANCE--that showed it worked no better than an inexpensive generic. They concluded that Vytorin should be used only after all other cholesterol-lowering drugs fail until research proves that the medication works.

Zocor lowers bad cholesterol in the blood by blocking an enzyme in the liver; Zetia blocks absorption of cholesterol from food in the intestine.

"I am troubled to learn that after careful analysis of the ENHANCE results, medical experts are now calling Vytorin the cholesterol fighter of last resort," Grassley wrote in a letter to the chief executives of Merck and Schering.

The two drug makers once heavily advertised Vytorin and Zetia, which brought their joint venture $5.1 billion in 2007 sales. The stock prices of Merck and Schering have plunged since the congressional reports, with some analysts asserting that the damage could be long-term for Schering, the smaller of the two pharmaceutical firms. Earlier this month, it announced plans for saving $1.5 billion by 2012 through a new productivity program to respond to "dramatically intensifying pressures."

Schering has vowed to trim 10% of its workforce, consolidate plants and revamp product lines, achieving most of these goals by 2010. "No area will be exempt [from layoffs]," states chairman and chief executive officer Fred Hassan.

The long-term repercussions may also be determined by pharmacy benefits managers. They are likely to decide whether millions of patients will continue to have access to the drugs. A CVS Caremark Corp. spokesman says that company is not making any changes at this time but adds that its independent pharmacy and therapeutics committee "continually reviews new data as it becomes available."

Cigna Corp. has announced that it will no longer recommend Vytorin as an alternative therapy for patients who now use higher-price, off-plan cholesterol drugs that are not working.

By contrast, United Healthcare Group, the country's largest insurer, recommends that patients remain on Vytorin because the company says it has uncovered "no safety issues."

Medco Health Solutions Inc. has indicated that it will also examine the drugs, as has Express Scripts Inc.

A medical trial assessing Vytorin's effectiveness in warding off heart disease in an expanded patient population is not expected to be completed until 2012.
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Title Annotation:Focus; Congress. Senate. Committee on Finance accuses Merck & Company Inc. and Schering-Plough Corp. of holding back negative results to boost sales
Publication:Chain Drug Review
Date:Apr 28, 2008
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