The U.S. Food and Drug Administration has approved the sale of the world's first totally implanted artificial heart -- the AbioCor, pioneered in Louisville.
The decision runs against the advice of an advisory panel last year, which essentially said the risks of the AbioCor heart were greater than the benefits. The panel's vote in June 2005 was 7-6.
So let me make sure I have this right. The advisory panel says no (close vote though) to the plastic heart, and the FDA approves it over their objection. A previous advisory panel voted 23-4 to approve Plan B for over the counter sale with no restrictions, and just to make sure there wasn't an issue, also noted 27-1 that there is no medical reason to restrict it based on age.
I am goddamn sick of money, politics and religion sticking in on basic medical decisions. Vioxx is safe, at least it looks like it is because we covered up some of the studies. Plan B gets held up for 3 years because some pinhead wants to force his religion on the rest of us.
I'm not opposed to a plastic heart, I think it could be great. But if the advisory board thinks it's not ready and wants more testing done, what's the issue?
FDA approves AbioCor heart