FDA Rejects Artificial Heart Bid

Well this seems straightforward enough to me. If you're testing this machine and almost half of the test patients either die or suffer dire medical complications--then perhaps it shouldnt be made available for use, except as a last resort (IE, one would die anyway). Perhaps that's just me.

Let people with heart problems make this decision for themselves! For what reason should FDA not allow this? They might die? And even under the situations where they live a worse life: people are rational, they can make the decision. Allowing thousands of people, who would otherwise die, to get the AbioCor annually would be such an amazing boost to the industry; not just because of the money flowing to AbioMed, but because of the wealth of knowledge and data to be taken from thousands of patients. The 14 patients who got the AbioCor is such a small pool to really guage much from. Think of the one guy (maybe two or more, forget) who survived for months afterward, and the scientists struggling to figure out what made the difference between them and the ones who died early, who got infections, or just the ones who died during surgery. And you want to study the AbioCor based on 14 people? That's ridiculous. If the FDA would just get out of this, allow the Federal Government just to make sure corporations keep promises, hundreds, maybe thousands of people would be living amazing lives with the AbioCor and giving us so much more knowledge on the AbioCor itself to help future generations.

Oren,

You're absolutely right. As far as I can tell, some government agency is keeping people who are dying from trying a treatment that will perhaps save them. No one is saved, and hope is crushed. This is absurd.