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Attempts to Control Vytorin Cancer Data Criticized

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Merck and Schering-Plough’s release of the SEAS study – which indicated that Vytorin might be linked to cancer – via a news conference has garnered the companies more criticism.  SEAS  found that Vytorin patients in the study had higher rates of cancer and cancer deaths. 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. The SEAS study, which was designed to investigate the effects of Vytorin in patients with partial blockages of the aortic valve of the heart, known as aortic stenosis, also concluded that Vytorin did little to help patients with aortic stenosis avoid other heart problems.

Merck and Schering-Plough quickly organized a press conference on July 21 to release the data. There, Richard Peto, an Oxford University statistician, presented data from an analysis that 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”.

It is customary to publish a study like like SEAS in a reputable medical journal, where the data can be vetted by independent medical experts.  But SEAS was only published in the New England Journal of Medicine (NEJM) this month, weeks after the press conference.

Terje Pedersen, the lead investigator of the SEAS study, told Forbrs.com that he “wanted to do this in peace and quiet” and present the full results at the annual meeting of the American Heart Association in New Orleans in November. But he had no choice but to publicize them early, because Merck and Schering-Plough told him they needed to release the results to the Food and Drug Administration. Pedersen also said the companies wanted to release a bare bones version of SEAS to investors.At least one critic of Vytorin sees Merck and Schering-Plough’s rush to release SEAS as damage control. Dr. Stephen Nissan, a cardiologist at the Cleveland Clinic, told Forbes that “they’re trying to spin the results using media relations strategies rather than the proper scientific approach.”

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