Those Vytorin Results Will Be Right Out

Those Vytorin Results Will Be Right Out

Wall Street Journal

December 11, 2007, 9:26 pm

Usually, critics wait for a study’s results to come out before taking their shots. But in the case of a closely watched clinical test of Vytorin, a cholesterol pill marketed by Merck and Schering-Plough, the questions are already loud and pointed. They center on why the results of the study have remained a mystery for so long.

Although the study was finished in April 2006, doctors, patients and investors still don’t know how it turned out. Merck and Schering-Plough have been merrily marketing Vytorin as a potent reducer of cholesterol all along. Vytorin combines the drugs Zetia and Zocor in a single pill. But is the drug really better than plain old Zocor, now available as a cheap generic?

House Energy and Commerce Committee leaders John Dingell and Bart Stupak, both Michigan Democrats, ratcheted up the pressure on the companies today with a letter expressing their concern “with the delay…and the apparent manipulation of trial data.” (See the full text here.)

The trial at issue, called ENHANCE for short, looked at how well Vytorin slows the buildup of plaque in the arteries compared with a combination of Zocor and a placebo.

The companies said last month that the results would be presented at a meeting of the American College of Cardiology in March. But they also said then that the presentation would focus on an ultrasound measurement at only one point of the carotid artery. The study’s design called for the assessment of changes at three points of the artery as the primary endpoint. The apparent move of the carotid goal posts fueled questions about what the companies were up to.

Well, Team Vytorin has moved to placate questioning cardiologists by saying the main results will be revealed at the ACC meeting and that there will be no change in the endpoint after all.

“We have clarified today that we decided not to” change the endpoint, a Schering-Plough spokeswoman told the Health blog. The decision came after the companies got input from “leaders in the field in the U.S. and Europe,” she said. The spokeswoman said the company hasn’t formally received the letter from Congress, and she declined to comment on it.

A Merck spokesman said the company’s executives “just received and are reviewing the letter from the House Committee on Energy and Commerce and will respond in a timely manner.”