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Vytorin Makers Defend Drug Following Cancer Findings

Jul 24, 2008 | Parker Waichman LLP

Vytorin makers Merck and Schering-Plough are preparing to send a letter to thousands of physicians in an attempt to address cancer concerns raised by a recently published study.   While the companies acknowledge that Vytorin users enrolled in the SEAS study had higher rates of cancer than those taking placebo, the letter characterized the finding as an "anomaly".

This latest Vytorin study - known as SEAS - was presented Monday 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 Vytorn 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.

In a letter being sent to doctors, Merck and Schering-Plough state that  "the cancer finding in SEAS is likely to be an anomaly that, taken in the light of all the available data, does not support an association with Vytorin".   The companies said they have made the Food & Drug Administration (FDA) aware of the SEAS findings, " we do not believe that changes in the clinical use of Vytorin are warranted."

Vytorin has been under fire 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.

In March, the full ENHANCE study was vetted during the annual meeting of the American College of Cardiology (ACC). A panel of four doctors concluded that Vytorin should be used only as a last resort, considering that the expensive drug did not provide any added benefits. “Our strongest recommendation is that people need to go back to statins,” said panel member Dr. Harlan Krumhotz.


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