Another dust-up over Vytorin

Merck and Schering-Plough delayed reporting second-quarter earnings, scheduled for before the market opened on July 21, until after the end of the trading day so they could address a cancer risk signal in the SEAS trial for Vytorin, a combination of Merck's Zocor (simvastatin) and Schering's Zetia (ezetimibe). An independent oncology review panel said that patients taking Vytorin are not at increased risk for cancer despite a troubling signal from pooled study data for the combo product. However, the only positive result from the trial was a statistically significant proportional reduction in the secondary endpoint of atherosclerotic events alone. There was no significant difference between Vytorin and placebo on the combined primary endpoint of major cardiovascular events caused by either atherosclerosis or aortic valve disease, or by aortic stenosis alone. Vytorin already suffered a major setback when it failed to affect progression of atherosclerosis in the ENHANCE trial; two more Vytorin studies, SHARP and IMPROVE-IT, are ongoing (1"The Pink Sheet," April 7, 2008, p. 4)