Tuesday, March 24, 2009

Wolfe Defanged at FDA Advisory Committee Meeting on J&J's rivaroxaban

Some see the glass half full -- eg, the In Vivo Blog's post "Fighting Like a Wolfe Against Johnson & Johnson" (image on left) -- while others see it half empty -- as in this post (image on right).
"During the March 19 Cardiovascular-Renal Drugs Advisory Committee review of Johnson & Johnson’s anticoagulant rivaroxaban, Wolfe, the acting consumer representative, took the unusual step of calling out to an FDA drug safety reviewer—Office of Surveillance & Epidemiology associate director for science John Senior, who was sitting in the audience—to ask him point-blank the very question the committee was being asked to deliberate: whether rivaroxaban should be approved based on the available data," reported In Vivo. "Sidney Wolfe isn’t one to stand on protocol."
Would a real wolf call upon a sheep to be its ally?

I don't know much about John Senior except a comment I found on Pharmalot: "John Senior the reviewer who let Lotronex on the market" once said the public has to "realize that drugs aren’t safe and that we have to wait until post marketing" (see comments to "FDA To Post List Of Drugs With Safety Issues").

I have no idea if Senior is a sheep or fellow wolf(e). In the end it didn't matter. Wolfe's breach of protocol had little effect on convincing the committee to see things his way. Wolfe was effectively defanged.

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