“The SEAS study provides no evidence to support the use of Vytorin, and raises a concern that is hard to dismiss,” Dr. Krumholz said in a separate interview. “For me,” he added, “the bottom line is this: If you can take a statin and be treated adequately, you should not be on this drug.”
Although Dr. Krumholz said he awaits the two larger trials to settle questions of benefit and safety, an added concern for Dr. Steingart is that these trials may not resolve the issue. The approval and ensuing widespread use of ezetimibe based on surrogate end points may make it impossible to determine clinical end points, he warned.
Moreover, the cancer data in SEAS could discourage patients from enrolling in IMPROVE-IT. “If I were recruiting for this trial, I would think these issues would make it very difficult,” he said.
The unusual reporting of results by Webcast instead of peer review also is an issue. “I don't think this is a great precedent,” Dr. Steingart said, adding that although he found the cancer analysis reassuring, it would not deter inquiry into a possible cancer link.
“How could they be so confident?” Dr. Krumholz asked, agreeing that Vytorin's causing cancer is unlikely but not ruled out by the hasty analysis. “I just don't know why they rushed as opposed to deliberating.”
Lee A. Davies, director of global product communications and advocacy relations for Schering-Plough, said that fuller results may be presented as soon as the European Society for Cardiology convenes this month. “Nonetheless, given the confluence of our earnings release, the findings in the study, and the importance of restoring confidence in the transparency of the pharmaceutical industry, we felt strongly that it was important to disseminate the results now and to provide our view of them,” he said.
The company has posted a letter to physicians at www.msppharma.com