Slashdot Mirror
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.
LOAD "SIG",8,1
I'm glad that the FDA is looking out for people who are terminally dying and have no further treatment options and are about to experience imminent death by making sure nobody tries to sell them a treatment that, you know, might kill them.
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.
I'm doing my cardiology clerkship for medical school right now, and I can say that although it does suck that this is being rejected, and yes - the US's FDA is notoriously stricter than other countries (certain great chemotherapy drugs are only available to europeans), sometimes this is a good thing. Famously, some years ago the FDA was a little reluctant about this miracle drug sweeping across europe. Turns out that this miracle drug ("Thalidomide")caused babies to be born without limbs. Yeah - sorta bad. So, it's like an innocent-until-proven-guilty system. Sure, we miss nabbing a lot of criminals, but, the tradeoff is that this system is ultimately made with the idea that it's very hard for an innocent person to be convicted.
yeah, that reminds me also how they wont transplant an organ from an HIV infected person into another HIV infected person who needs an organ... wtf??
Two reasons
- Safety of the people and equipment that will come into contact with the infected blood during the procedure.
- There's more than one strain of HIV. Having two of them is worse than having one.
My Karma: ran over your Dogma
StrawberryFrog
So much for living in a free country.
It's just a local ordinance. If you can afford a new heart, you can afford a plane ticket to a free country. Are there any?
I've been wondering this generally in relation to, for example, sale of organs (illegal in US), sale of blood (illegal in US), medical marijuana (illegal in US), recreational cloning (illegal in US), certain forms of political speech (illegal in US.)
Outsourcing would seem to be the way to go.
Who the fuck are you to get in the way?
Person A is dying. Person B has a device that can prolong person A's life. They willingly make the trade.
That's no one else's business.
Yeah.
'Cause that guy's family sure deserves to get money that they didn't actually earn in the first place. Inheritance is a gift, not an entitlement. I don't have to leave your lazy ass one damn cent if I feel like it.
The Jungle, by Upton Sinclair, then think about the FDAs usefulness. Like any government agency they do screw up, but they do, by far, more good than harm.
"Sic Semper Tyrannosaurus Rex."
I support developing technology to improve health, of course; but sometimes I wonder if as a society (talking about the USA here) we shouldn't spend some time figuring out how we're going to pay for this unbelievably expensive treatment before we continue funding this kind of research. The skyrocketing cost of medical care is the biggest fiscal problem facing the US, in my opinion.
Well, here's an original idea: how about you develop the artificial heart, then the people who can afford to pay for one can have it. Others don't have the unconditional right to have it given to them for free. Halting development until you can provide it to everyone for free is among the most ridiculous ideas I've heard. Just because the poor can't afford something doesn't mean the wealthy should be denied it. Plus, when you take a *free market* approach to it, eventually the cost of the artificial heart will drop, making it available to those less wealthy, where otherwise no one would have it because it's impossible to fund initially.
Answer: All of it.
There is still hope, [...] assuming that they would support it due to their right to life/culture of life stance.
And why would that be "hope"? Why would you place your uninformed judgement, or that of DeLay or Bush, above that of people who have studied the data, know medicine, and have thought about this long and hard?
Implanting an artificial heart in a sick patient is a painful, dangerous, and costly procedure with (apparently, according to the panel) little benefit to either the patient or research. Those are just the facts of life: as it is, the technology isn't ready. Therefore, it doesn't make sense to subject patients to it, and we can save more lives by spending the money on other procedures.
When companies come up with devices that do work, then they will get approved. And they can still implant new designs as experimental devices.