WASHINGTON The House Committee on Energy and Commerce is investigating Merck and Schering-Plough for their handling of a critical clinical trial of Zetia, a cholesterol-lowering drug that the companies market together, according to the New York Times.
The trial, called Enhance, was completed in 2006, but the results have yet to be released. The Enhance trial covered 720 patients with very high cholesterol and was intended to prove that the combination of Zetia and an older cholesterol medicine would reduce the growth of plaque in the arteries more than the older medicine alone.
Schering and Merck were originally expected to release the results of the trial at a conference in the spring of 2007, then in the fall. Last month, after being criticized by cardiologists, they said they would release the results next March. The companies say the results are still blinded, meaning that they do not know whether the drug succeeded or failed.
In a letter to Merck and Schering, the committee’s top two members, John Dingell, D-Mich. and Bart Stupak, D-Mich., asked officials at both companies to agree to talk to investigators and said both companies should retain important documents about the trial.
The letter asked the companies to provide their records to the committee by Dec. 25.