Merck, Schering-Plough metabolic news

Reps. John Dingell (D-Mich.) and Bart Stupak (D-Mich.) said the Committee on Energy and Commerce and the oversight and investigations subcommittee are investigating the "withholding" of data from the Phase III ENHANCE trial of Vytorin/ Inegy to treat heterozygous familial hypercholesterolemia (HeFH). In a Dec. 11 letter to MRK and SGP, the lawmakers said they are concerned with alleged delays in making complete data available and in registering the trial on clinicaltrials.gov, as well as the "apparent manipulation of data." Dingell is chairman of the committee, and Stupak is chairman of the subcommittee.

The trial, which completed in April 2006, compared the highest approved dose of Vytorin/Inegy (10 mg ezetimibe/80 mg simvastatin) to 80 mg simvastatin alone in 720 patients with HeFH. In November, MRK and SGP said they had convened an independent panel to offer advice about analyzing the data because of "observations of variability in some of the data" detected as part of the review process. The panel recommended focusing the primary endpoint on the carotid artery instead of measuring change in ultrasound-determined average carotid artery intima-media thickness (IMT) at the internal carotid, the carotid bulb and the common carotid. ...