September 2, 2008

Merck and Schering-Plough, the makers of the popular cholesterol drugs Zetia and Vytorin, were dealt a huge blow in the world’s most prestigious medical journal today.

In a strongly worded editorial, the New England Journal of Medicine criticized a study conducted by the drug companies that had dismissed a link between the cholesterol pills and cancer. According to the editors, a link to cancer deaths “should not be assumed to be a chance finding until further data are in.” The editors also added that doctors and patients “are unfortunately left for now with uncertainty about the safety and efficacy of the drug.”

Zetia, unlike most other cholesterol drugs which work in the liver, helps block cholesterol absorption in the digestive track. Vytorin is a combination of Zetia and the long trusted generic drug Zocor. Last year, Merck and Schering-Plough sold $5 billion worth of Zetia and Vytorin. But a study released in January led prominent cardiologists to question Zetia’s ability to help prevent heart attacks and strokes. As a result of the study, prescriptions for both Zetia and Vytorin dropped by a third.

Last month, Merck and Schering-Plough released the results of an important clinical trial that indicated that Zetia and Vytorin might be linked to cancer in a spontaneous press conference. According to the study results, patients taking the drugs got 50% more cancers than those on a placebo. But Oxford University’s Richard Peto, one of the world’s top statisticians, presented an analysis of two ongoing Vytorin studies that he said showed the apparent cancer risk was a fluke. “There is no credible evidence of any side effect,” he says.

Today, that Vytorin study, called SEAS, and Peto’s analysis are being published in the New England Journal of Medicine and presented at the annual congress of the European Society of Cardiology. Although doctors are divided over exactly how the cancer data should be interpreted, there seems to be a consensus that Merck and Schering-Plough were wrong to make the results of the SEAS study public via a news conference.

Doctors say that Merck and Schering-Plough should have instead published their study in a medical journal where a team of outside medical experts could have analyzed it.

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Published November 17, 2011 by