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Vytorin Study Release Criticized

Sep 3, 2008 | Parker Waichman LLP

The behavior of Vytorin makers, Merck and Schering-Plough, in releasing the results of an important clinical trial that indicated the cholesterol drug might be linked to cancer has many cardiologists up in arms.  According to a report on Forbes.com, while doctors are divided over exactly how the cancer data should be interpreted, there seems to be a consensus that the companies were wrong to make the results of the SEAS study public via a news conference, rather than first publishing them in a medical journal were they would have been vetted by a team of outside medical experts.

The SEAS study investigated the effects of Vytorin in patients with partial blockages of the aortic valve of the heart, known as aortic stenosis. According to the SEAS findings, Vytorin did little to help patients with aortic stenosis avoid other heart problems. But in a real stunner, SEAS also 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.

In an attempt at damage control, 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".

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.”

The full SEAS study was finally  published in the New England Journal of Medicine (NEJM) this week.  An editorial in the same NEJM issue sharply criticized Peto's analysis, with the editors writing 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.”

This is not the first time that Merck and Schering-Plough have come under fire for a Vytorin study.  The drug has been a subject of controversy since January, when Merck and Schering-Plough finally released the long-delayed ENHANCE study. ENHANCE showed Vytorin were ineffective in preventing clogged arteries, and might actually increase plaque in some users. In spite of the findings, Merck and Schering-Plough delayed releasing ENHANCE for more than a year – something critics of the company have likened to fraud.


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