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More Vytorin Questions from Congress

Sep 5, 2008 | Parker Waichman LLP

A Vytorin probe in Congress is expanding in scope.  The House Energy and Commerce Committee has been investigating the safety and effectiveness of the controversial cholesterol drug for months, and now it wants to hear from the statistician who analyzed data on cancer cases and deaths in the SEAS study and two other ongoing Vytorin studies.

The latest Vytorin controversy followed the release of the SEAS study, which was designed to see if the drug prevented heart attacks in people with aortic stenosis.  Not only did SEAS show that Vytorin offered no additional heart attack prevention, but Vytorin patients enrolled in the study had higher rates of cancer than those taking a placebo. In the trial 102 patients taking Vytorin developed cancer, compared with 67 taking the placebo. Of those, 39 people taking Vytorin died from their cancer, compared with 23 taking placebo.

Researchers conducting the study said that while those numbers don’t prove a definitive cancer link, they were “statistically significant, meaning the odds were less than 5 percent that they were the result of chance.

Merck and Schering-Plough, the makers of Vytorin, have called the cancer findings an anomaly.  The companies base that claim on an analysis of the SEAS cancer findings that was conducted by Richard Peto, an Oxford University statistician.  Peto pooled data from two much larger ongoing studies of Vytorin and said they showed that the cancer risk was a statistical fluke. He called the contention that Vytorin could cause cancer "bizarre".

But Peto's conclusions have come under fire.  This week, when SEAS was published in the New England Journal of Medicine, the editors of the journal also published a strongly worded editorial criticizing Peto's findings.  The authors of the editorial wrote that a link to cancer deaths “should not be assumed to be a chance finding until further data are in,”, adding that doctors and patients “are unfortunately left for now with uncertainty about the safety and efficacy of the drug.”

In a letter sent to Merck CEO Richard T. Clark and Schering-Plough CEO Fred Hassan this week, the  House committee directs the companies to answer questions about the SEAS cancer findings, and Peto's report. The letter states that the committee had expected "a complete assessment of Vytorin's association with cancer in the SEAS study," but only got a five-page report, relayed by the Food and Drug Administration on Aug. 21, that contained little more information than what Peto already had released publicly."

According to a report in the Associated Press, a spokesperson for Schering-Plough indicated that while the company has not responded to the Committees Aug. 21 request for more information, it plans to do so, and is preparing a response.  As far as Peto appearing to answer the committee's questions, the spokesperson said that he does not work for Schering-Plough, and the company does not control his activities. 

The House Energy and Finance Committee has been investing Vytorin since late last year, when questions were raised about Merck and Schering-Ploughs handling of another key Vytorin study.  That study, ENHANCE, which was finally released in January, showed Vytorin was ineffective in preventing clogged arteries, and might actually increase plaque in some users.  Some  Vytorin critics have compared the companies' decision to delay the release of ENANCE for over a year to fraud.

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