1. Pink Sheet

Expert Sparring over Xarelto: Califf and Nissen Clash

An intriguing subplot in the September 8 advisory committee review of FDA’s Xarelto review was the verbal jousting between two high-visibility figures in the world of cardiovascular drug testing and drug therapy: Robert Califf (Vice-chancellor-clinical research at Duke and a principal investigator on the key Xarelto study, ROCKET-AF) and Steve Nissen (chair-cardiovascular medicine at the Cleveland Clinic).

On paper, Steve Nissen and Robert Califf have a lot in common. Both are prominent cardiologists at leading institutions: Nissen is chair of cardiovascular medicine at the Cleveland Clinic, while Califf is the Vice-Chancellor of clinical research at Duke.

Both are frequent participants in the FDA advisory committee process and also frequent commenters on

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