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FDA Rejects Artificial Heart
Mad_Rain writes "Those people who fear cyborgs can rest easy. The Food and Drug Administration voted to reject Abiomed's request to sell artificial hearts to people who have suffered heart failure and exhausted their treatment options. The FDA stated that there was too little gain with too many adverse side effects in the limited trial run (17 people underwent the procedure). Although this isn't quite the same product mentioned in previous Slashdot coverage, it does seem like a setback towards replacing failing organs with fully artificial ones."
How so? It just means that they'll have to improve their technology first. That doesn't seem like a setback to me.
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Basically, it's the public and perception.
Lots of lawsuits from people who "didn't fully comprehend all the risks", hospitals, doctors, procedures getting the labeled as killers, and having bad track records. Malpractice for relatively safe procedures is astronomical. No one wants to deal with those doctors (aka "so, 75% of your surgeries end up in death, why should I work with you?").
Money. That's a lot of money in the surgery for a small chance of living.
This isn't so much people banning it though. Believe me, there's tons of new, exciting, dangerous surgeries abound. The test for this heart had 17 patients with those types of risks. There's lots of cutting edge research looking for people in the exact scenario you describe, and they usually get some for of radical new treatment. In this case, the FDA just decided that this radical new treatment hadn't matured enough yet. So, there will be a couple more studies where people can get artificial hearts if they really need them.
Basically, the FDA doesn't like to make radical treatments mainstream. It prefers to keep them in the research wings where people who need them can get them, but to keep mainstream procedures as safe and mundane as possible.