Drug News
Minutes or no minutes, that is the question for Vytorin makers to answer
By Sue Mueller
Apr 15, 2008 - 12:16:22 PM

TUESDAY April 15, 2008 (foodconsumer.org) -- Two democrats have reportedly raised questions about how Merch & Co Inc and Schering-Plough Corp documented a key meeting about a controversial study of their cholesterol drug Vytorin.

John Dingell, House of Representatives Energy and Commerce Committee Chairman and Rep. Bart Stupak said company documents showed minutes from a November meeting of outside experts were actually "created after the fact".

An study revealed that Vytorin, a drug made of both simvastatin and Ezetimibe, is no better than a cheaper generic drug at reducing cardiovascular disease.

Experts at the meeting were informed that no minutes would be created, Reuters cited the company spokeswoman as saying.  But the FDA later requested and the company prepared minutes based on notes.

Dr. James Stein, a cardiologist at the University of Wisconsin, was cited as complaining to Schering-Plough that the minutes did not present a full picture of the panel discussions.

For more details on the story, read Vytorin's Man In The Middle and Lawmakers question makers on key Vytorin meeting