David Graham, FDA medcal reviewer, urges rejection:

Arcoxia “probably confers a substantial increase in cardiovascular risk. What you’re talking about is a potential public health disaster. We could have a replay of what we had with” Vioxx.

Peter Kim, Merck’s chief scientist, pleads for approval:

“We at Merck believe (Arcoxia) represents a valuable treatment option for patients with osteoarthritis. We would like to emphasize there is more long-term safety data … for (Arcoxia) than any other NSAID.”

Meanwhile, many of the key panelists during the 2005 advisory committee that reviewed Cox-2 heart risks aren’t on the panel today, FDC Reports notes. The panel does include seven people who participated last time, but four of the most vocal critics are missing: Tom Fleming of the University of Washington., Curt Furberg of Wake Forest University, Steve Nissen of the Cleveland Clinic and Alastair Wood of Vanderbilt University.

Alll four have been vocal FDA critics. Nissen has also called for FDA advisory committee members to have more “courage” to recommend against approval of drugs, highlighting Furberg and Fleming as two of the most “rigorous” members of FDA’s panels. At least one, Nissen, has a potential conflict under tightened rules, since he is running an NSAID study.

Further reading…
The Associated Press;
Blooomberg News.[tags]Arcoxia, David Graham, Merck, Peter Kim, Vioxx[/tags]