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Vytorin Cancer Controversy Far from Over

Aug 28, 2008 | Parker Waichman LLP

News earlier this summer that Vytorin had been tied to a higher risk of cancer by a newly published  study quickly faded from the headlines.  Merck and Schering-Plough's reassurance that the cancer finding in the SEAS study was an anomaly apparently squashed much discussion of the issue - at least in the media.  But a new report on Fortune.com seems to indicate that a change is coming, and Vytorin could face new scrutiny next week

The SEAS study investigated the effects of Vytorin in patients with partial blockages of the aortic valve of the heart, known as aortic stenosis. Left untreated, it can progress to death from heart failure or cardiac arrest. According to the SEAS findings,  Vytorin did little to help patients with aortic stenosis avoid other heart problems.

But even more disturbing, a subsequent 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.

Such news should have created a firestorm.  But according to Forbes, the way Merck and Schering-Plough released the SEAS data helped mitigate fallout.  According to Forbes, "Researchers involved in the study put together a hastily organized, company-funded press conference on July 21 to release the data."

There, Richard Peto, an Oxford University statistician, "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',” according to Forbes.

But some experts say Peto's analysis doesn't stand up to scrutiny, and that might become apparent when the full SEAS study is released next week.  For its article, Forbes surveyed more than dozen top experts about SEAS.  While none were yet convinced that Vytorin increased cancer risk, at least 8 said that Peto was wrong to completely dismiss the possibility. Ten thought there was at least some chance that Vytorin increases the risk of death for patients who have cancer.  Peto's analysis did not even address that possibility. 

Several experts interviewed by Forbes said that there is just not enough information available to reach conclusions about Vytorin's cancer risks.  The data "are not definitive at all," says James Stein, a cardiologist at the University of Wisconsin, Madison. He told Forbes that Vytorin should remain "a third-line drug" until more data can be collected.

Next week, when the entire SEAS study is vetted, it is likely that many more experts will voice similar concerns.


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