What's missing, too, is the number of patients versus the number of AEs. With thrombin-JMI, it's at the statistical noise level, so it's unlikely the FDA will do anything beyond the black box warning already on Thrombin-JMI:
"Topical Thrombin Products (Bovine-Thrombin JMI®, Pooled Human Plasma-Evithrom®, Recombinant Human-Recothrom®)
December 2008
VHA Pharmacy Benefits Management Services and the Medical Advisory Panel"
74.125.155.132
ZGEN has the P4 trial going for their own immunogenic AEs for repeat exposure. I was surprised to read that Recothrom was contraindicated for people with snake proteins. It mentions hamsters, too. Didn't know snakes were in the recombination game. Some weird immunological cross talk? And there is no test for bovine antibodies in humans. Probably not practical or cost effective to develop or use one. Run one on everybody going in for surgery? That's not flying. Somebody would have to do a large trial (a meta-analysis, given the small trials to date, likely wouldn't turn up anything) to find a real difference. Other than that, just the sloowww process of post marketing surveillance.
So, yes, marketing ploy. The P4 data will likely have more impact.
Cheers, Tuck |
