Healthy Skepticism Library item: 13276

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Hensley S.
Vytorin Problem: Healthy Patients Meet Healthy Skepticism
The Wall Street Journal Health Blog 2008 Mar 24
http://blogs.wsj.com/health/2008/03/24/vytorin-problem-healthy-patients-meet-healthy-skepticism/?mod=WSJBlog?mod=yahoo_hs

Full text:

When cardiologists gather next weekend at the annual meeting of the American College of Cardiology, one of the hot topics is likely to be a postmortem for one of the most controversial drug studies in recent memory.

Vytorin, a combination pill to treat heart disease, performed no better than a generic statin in a trial, whose results were finally released in January. Why did it take Schering-Plough and Merck, sellers of Vytorin, so long to release results of a test whose last piece of data was collected in April 2006?

The companies say they needed the time to evaluate and correct irregular data, the WSJ reports in a front-page story today. But there were signs as early as 2005 that the data weren’t going the companies’ way, an outcome that could threaten a franchise worth billions of dollars a year. Vytorin prescriptions have fallen since the results of the trial called Enhance were finally disclosed.

A problem, according to the companies, was that patients in the study were healthier than expected, complicating the task of proving Vytorin’s superiority at slowing cardiovascular disease.

The companies embarked on a program to eliminate wayward readings in the trial and hone the study’s precision (click on image at right for a chronology of events). Dutch researcher John Kastelein, the outside scientist who led the study, has called it “a trial from hell.”

No safety risk has emerged from the Vytorin study, but the delays and special measures taken in the evaluation of the data have renewed a growing concern among medical journal editors and policy makers over “selective publication,” in which positive trial results are quickly disseminated while negative studies are delayed or buried.