Vytorin’s Effectiveness Questioned, Debate over Cancer Risk Continues

By Alice Carver
14:23, September 2nd 2008
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Vytorin’s  Effectiveness Questioned, Debate over Cancer Risk Continues

The debate over Vytorin’s cancer risk continues as results of a controversial Vytorin study, called SEAS, and the analysis conducted by Oxford University’s Richard Peto, one of the world’s top statisticians are presented at the annual congress of the European Society of Cardiology. The opinions about the results differ.

An editorial published in the New England Medical Journal, which contained the full data from the SEAS study questions the drug safety and effectiveness. The full data from the Vytorin study showed a total of 105 cancer cases among patients taking Vytorin compared with 70 cancer cases among patients taking a placebo. Several prominent cardiologists also expressed concern about the safety of the drug.

The Food and Drug Administration approved the new type of cholesterol-lowering drug in 2002.

On the other hand, according to Peto’s analysis, “There is no credible evidence of any side effect.” Peto also says that few drugs could survive in a world where they are constantly tested against any possible risk.

The cholesterol-lowering pill produced by Schering-Plough Corp. and Merck & Co. was prescribed 20 million times last year. But there is still no strong evidence that Vytorin helps patients live longer or avoid heart attacks. More than that, studies are conducted to see if the cholesterol drug causes cancer. The companies which make Vytorin and Zetia say that Zetia showed no cancer risk in animal trials and claimed that cancer finding is probably the result of chance. Douglas Weaver, a cardiologist at Henry Ford Hospital in Detroit and president of the American College of Cardiology says he is almost certain the increase in cancer deaths is due to chance.

Previous studies compared Vytorin with an older cholesterol drug. The difference between the two drugs is that Zetia, the component found in Vytorin, prevents cholesterol from being absorbed from food, while older cholesterol drugs prevent cholesterol from being made in the liver. Studies found that Vytorin does not work better than older cholesterol drugs, which are sold for a fifth of Vytorin’s price.



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