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Vytorin - Cancer Link Draws Congressional Scrutiny

Aug 1, 2008 | Parker Waichman LLP Lawmakers on a congressional committee want to see the results of a new study that indicated patients taking Vytorin might be at a higher risk of cancer.  That study, known as SEAS, was given to the Food & Drug Administration (FDA), but has yet to be turned over to the House Energy and Commerce Committee, which has been investigating Vytorin for months.

Vytorin, which was developed and marketed jointly by Merck and Schering-Plough, was approved for use in 2004. Since it came on the market, Vytorin sales have reached $5 billion per year. Vytorin is a combination of cholesterol-lowering Zetia (ezetimibe) and the statin Zocor (simvastin). Statins like Zocor reduce the amount of cholesterol produced by the liver, while Zetia lessens the amount of cholesterol in food that is absorbed in the intestines.

SEAS was presented last month in London by its primary researcher, Dr. Terje Pedersen of Ulleval University Hospital in Oslo, Norway. The study, which involved 1873 patients, investigated the effects of Vytorin in patients with aortic stenosis. Aortic stenosis involves partial blockage of the aortic valve in the heart. Left untreated, it can progress to death from heart failure or cardiac arrest. Aortic valve replacement for severe symptoms is the second most frequent type of heart surgery. Apart from surgery, there is no medical therapy known to prevent or heal this condition.

In addition to failing to show that Vytorin did much to help patients with aortic stenosis avoid other heart problems, a safety analysis of 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. Researchers conducting the study said that while those numbers don’t prove a definitive cancer link, they were “statistically significant”, meaning the odds were less than 5 percent that they were the result of chance.

Both Merck and Schering-Plough have called the cancer findings an "anomaly", but members of the House Energy and Commerce Committee aren't so sure.  According to The Wall Street Journal, in a letter to the FDA, Rep. John Dingell (D-Mich), Chairman of the committee, said that based on the study's finding, "Vytorin may not be safe. Its potential for cancer and cancer deaths may be a significant cause for concern among physicians and patients."

Dingell has asked the FDA to turn over an assessment of the SEAS study that was written by Dr. Richard Peto, an epidemiologist at Oxford University, and related records within two weeks.  Dr. Peto's analysis, which was funded by Merck and Schering-Plough, said SEAS' cancer findings were largely due to chance and "implausible."

The House Energy and Commerce Committee has been investigating Vytorin 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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