FDAnews Drug Daily Bulletin

Pharma R&D Succumbs to the Dark Side (Pharma Marketing Blog)
In his blog, John Mack comments on an article in the N.J.-Star Ledger describing details of the ENHANCE trial, which studied Merck and Schering-Plough’s cholesterol drug Vytorin.

According to the article, the trial was poorly designed, and there was no safety monitoring board to oversee the health of study volunteers. Furthermore, subjects enrolled in the trial did not have abnormal amounts of arterial plaque.

Mack questions the intent of the scientists involved in the trial design. “I think they designed the study to satisfy the main marketing message that the Vytorin marketers wanted to send: that Vytorin slows the progression of the buildup of plaque in people prone to this build-up. If Vytorin could claim that, then it would be more competitive with Lipitor and Crestor. It’s easier to detect a slight increase in the control group if the base level is normal rather than high,” Mack writes.