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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."
psychological. Imagine walking around knowing you had no heart? Spooky.
James Buchanan
Zombie Chief Executive/15th President of the USA
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 never understood 'cure for death' type devices getting shot down. Like, your heart is going to stop and you will die, but we could perform $risky_medical_proceedure and there's a 10% chance you'd live. That's pretty lousy survival for say, cough drops, but not all that bad when faced with certainty of death.
"Because Science" is one step from "Because old book". Try "Because of my experiment testing my falsifiable assertion".
so does that mean, 'no heart, no soul'?
I heard a report on this earlier in the week on NPR. The interview (sorry, RealAudio is the only option for listening to the report) seemed to indicate that all the recipients up to this point had really really serious health problems besides just having bad hearts. I wonder what choice someone has if they are deemed too unhealthy/high risk for a heart transplant? Sit and wait to die? Serious bummer...
The Right Reverend K. Reid Wightman,
The source claims the heart has been tested by 14 men. Two died directly, one never regained consciousness, ten died within five months and one died after 17 months.
It costs $250,000 and at best it gives the patients a few months extra life. I believe it should be approved, but only if the patient wants to take the risk and pay for it.
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.
Nonetheless, the real answer to the organ replacement problem is goading adult stem cells into growing a human heart. It would not suffer the negative effects of rejection (caused by donor hearts) and blood clots (caused by mechanical hearts).
That explains that whole General Grevious thing.
I was wondering why he was built like a toaster except for the gizzards.
- This was a manually created sig. Take THAT robot overlords. -
Can't find the article now, but people who lived in the trials had something very spooky happen once their new "hearts" were installed - their life became really quiet.
Usually you don't notice your heartbeat, or have other things going on to drown out the noise. But with an artificial heart, you aren't spending as much time in bars and so forth - you get more quiet time. The man who lived the longest compained that once the artificial heart was installed he could no longer hear the beating of his heart and it was eerie. The heartbeat is something every human knows, and many cultures have played on it in their music (trance, drums).
So yes it is spooky, but for more problematic reasons. It just needs a virtual drum machine or something...
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As has been mentioned, this _is_ a bit of a step backward. However, the Abiomed device is an actual artificial heart.. This is much more complicated than the accepted alternative, the left ventricle assist (LVAS). The idea is, they stick this motor in the side and bottom of your heart, and turn it on. No chambers required, no pulse necessary. Constant Flow. Makes me wonder how well the brain would operate without a pulse though.. Would it effect your moods? I'm not sure, but as this is a press release, I don't _think_ it violates my NDA. http://www.terumo.co.jp/English/press/2004/04_01.h tml/
Each processor would proceed sequentially as if it had been better for them not to rise against Saul.
... piss off a Naussican, and you have nothing to worry about.
it's right here in the article text...
sufferers... are likely to die within a month
I am a biomedical engineer for Cardiology at a top 25 hospital in the US, and a trained LVAS engineer for the WorldHeart Novacor LVAS system. We see 3-4 implants a year with this system*. The patients who are referred for implant come in literally with one foot over the threshold of death. It's amazing any of them survive the surgery at all. Doctors are scared to death of the devices. We have had attendings refuse to admit a patient once they learned the patient had a LVAD. Yes, some of the side effects can be severe. You have about as great a chance of dieing from a stroke caused by a massive clot in the device as you do of heart failure, but the reason to take that risk is quality of life. This man here is one of our patients. He has been on pump for four years this month. That's four years of quality life, enjoying his grand- and great grandkids. Hell, we have photos of him putting a roof on his barn while standing in the front end loader on his tractor. Our other patients go back to work, or at least can live on their own in their home, without 24/7 nursing care or constant hospital stays like patients who do not get a pump.
These devices are mostly used for "bridge to transplant" meaning it is used to keep them alive and healthy until hopefully they get a heart transplant. Unfortunately there are like 2,000 donor hearts a year and 50,000 people who need one. So many of these companies are aiming to be certified "destination therapy" which means the person gets a pump and that's it. If/when it wears out, they get a replacement, but they won't get a donor heart. Which is fine, because the patients who get donor hearts are back constantly for biopsies and caths to check that their donor heart is healthy (since only arteries/veins get connected between the person and donor heart and not nerves, they can't feel chest pain if they have a heart attack) and are on anti-rejection medication regimens.
* - Our hospital also does the Abiomed AB5000 and Thoratec HeartMate, but these are short term (days to weeks) support devices where the patient does not leave the hospital and are supported by the Perfusion team (the people who run the heart/lung bypass machines during surgery). The Abiomed device sits on the freakin' outside of your body and it's clear so you watch your own blood pump through it. It's actually clear so the clinician can look for a "flash" which is when the device completely empties of blood after a stroke and you see the white membrane inside. The console used during surgery is roughly the size of a dishwasher and the "travel console" is like a piece of carryon luggage. The Thoratec HeartMate I is approved for destination therapy, but we don't use it as such. Their HeartMate II is going into clinical trial, and is totally implantable. Hopefully it will pass the FDA's approval for destination therapy and we can save 48,000 lives a year...
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."
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.
OK, remove the 30% of hispanic, black, and asian from your study, and you have a population whose genetic makeup is quite close to the EU.
In terms of diets and exercise habits, I think the differences are small enough - both EU and USA are industrial countries with similar culture (lots of mutual influences).
I guess doing such a study is easier than you suggest.
C - the footgun of programming languages