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Congressional Committee Seeks Answers from Expert Who Dismissed Vytorin-Cancer Link

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A Congressional Committee says it wants to hear from a statistician who dismissed cancer data from a key Vytorin study. SEAS 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.

Merck and Schering-Plough, the makers of Vytorin, have called the cancer findings an anomaly based on an analysis of the data 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”.

The House Energy and Commerce Committee  has been investigating 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. The July release of SEAS has only intensified scrutiny 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.”

Peto’s conclusions have already come under fire on another front. 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.”

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