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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
Still alive after all these years? I knew it!
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".
in this case I must agree with teh FDA panel that the risk's realy don't outwiegh the benifit. though it is not all that surpising that it was rejected given its track record. Though on the other hand the increased studies, and it seems the willingness of the ambiocor to train doctors and follow up to "improve" the technology might have been more beneficial in the long run
so does that mean, 'no heart, no soul'?
Comment removed based on user account deletion
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.
Because instead of giving you an artificial heart that might save your life (in x% of cases, where x is low) we aren't going to do anything.
OTOH there are too many humans already on this planet.
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.
Oh no.. what will happen to my hollow tin chest!!!
SOB! FDA ! SOB!! (pun intended!)
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.
Oh, and its FDA, not FDR. FDR's been dead for a while. Even us Canucks know that.
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).
Jean Luc Picard needs an artificial heart! How can the FDA stop him from getting one? Those bastards, they killed picard!
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. -
Only a heartless bastard would pay $300,000 (where do you think that money comes from? Inheritance money of course!) to get a new heart just to live a few more weeks. The guy should just die already to let his family have $300,000 more to fight over after the funeral. Then again, maybe you don't have to be a heartless bastard. If you're having the heart replaced, your old one must be broken. I guess that's the same. Or something. Damn egoists.
All future soldiers will have their brains replaced with a computer... after all, no brain, no pain...
If the people who has died from heart-failure could object to the FDAs opinion I think most of them would..
Those people who fear cyborgs can rest easy.
Motoko Kusinagi is unimpressed with these pathetic, childish attempts at so-called "cyborg" technology.
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...
Get your Unix fortune now!
Crap! I better cut back on my drinking. I was counting on that artifical liver 20 years from now.... well there's always stem cells to hope for.
--aiee
Here are the true facts of the thalidomide case. It wasn't that the FDA heroically saved us from thalidomide. It was bureaucratic bungling.
How is this a setback to artifical organs? The submitter of this article obviously doesn't know anything about the process behind recieving validation. The only item this effects is the artifical hearts in question, it isn't like they would take acl replacements off the market now that artifical hearts dont work. Sensational journalism? Yes.
But wait, what about those people who need artificial heart or they'll die?..
1's and 0's should be free.
Actually, the FDA hasn't totally rejected the use of the device yet (as I already pointed out).. but otherwise you are very correct. At that point I misread the article.
I don't see the problem if someone makes a conscious decision to use this or any other device. If some people want the right to die, then others should have the right to live.I argue constantly with my friend who is fresh out of medical school (and pretty close to Kevorkian's views medically/politically speaking) - but he always seems to argue that doctors would know best. I think the issue is a lot less medical and a lot more personal/religious/whatever...
I hate to see anyone push their beliefs on another (especially Tom Cruise's religious view of psychiatry, but that is another story).
Get your Unix fortune now!
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.
News moves at such a slow rate on this site, that it's often aliased against other sites, losing details..
Still a good site for discussion, however.
"Victory means exit strategy, and it's important for the President to explain to us what the exit strategy is." G.W.Bush
My grandmother took Thalidomide for a time in the 1950's and it has been assumed that is the reason my uncle sufferes from Meniere's disease...
http://en.wikipedia.org/wiki/Meniere's_disease
Get your Unix fortune now!
Now the researchers and developers who created this have to do more now to make it successful and profitable, instead of just doing what they've done so far and leaving it like that. I wouldn't call a forced "Make it better" a setback. And this signals to others that they have to do a better job to get their stuff approved in the future.
;) Where's my damn datajack, cyberdeck, cybereyes, and sleep regulator?
Still, I can't wait until the world of shadowrun, at least the tech stuff.
If that is the case, and their only choice is to die, screw the FDA..
I can see an issue if its NOT the last resort. But if this is the last and only way to stay alive, i dont think the FDA has any right to say no.
Besides, if they wont approve it, another country will. And we miss out on yet another medical advancement..
---- Booth was a patriot ----
The bottom line is, to borrow a phrase, "my body, my choice." The FDA's charter should be revoked, or else their rulings should be made purely advisory.
it does seem like a setback towards replacing failing organs with fully artificial ones
I wouldn't look at it as a setback. A bigger setback would be hundreds of people dying from heart implants that weren't quite ready for the market, and a public afraid to use future implants as a result.
No, I don't like our "Digital" solution to "Analog" life.
Makes me wanna watch PI again. Wtf is wrong with people. Work with organics, not metal and plastic and such.
We will eventually have a symboitic relationship with some cybernetics, but meat carries soul.
So what you're really saying is that Slashdot has the same editorial standards as the Washington Post...:)
"Lack of technical competence coupled with the arrogance of power, as usual, leads to no good end."
but not artifical hearts? I guess rich old men getting boners will spend more money in the long run for more viagra.
by TheSpoom (715771) Uncaring Linux user here. I have nothing to add to this but please continue. *munches popcorn*
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.
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 FDA stated that there was too little gain
Like avoiding death?
with too many adverse side effects.
Like, er, death?
This article explains a bit more about the CEO's explaination for what happened and what he hopes to happen for the future. An important note is that without this artificial heart all of the test subjects would have died slowly one organ failing at a time in a hospitol. The artificial heart allowed one patient to move back home. While others were allowed leave briefly for out of hospitol visits. Two died on the operating table. 42% eventually died from stroke. The reason why they died of stroke is because they were not given blood thinners which is common when a large non-tissue device is inserted into the body. The reason for not giving blood thinners was because all the patients had internal bleeding as a result of their failing heart. So its either bleed to death a few days after surgery or live for 6-18months more or less instantly from a stroke. IMHO I think that if the device has been found to work for 5-6 months minimum then it is worth making available to those who want to live just a little while longer. It should be the patients right to choose when and how to die if they can.
There is or can be built a machine that can simulate any physical object. -Church-Turing principle
Startup and shutdown are the periods of lowest efficiency and with the highest chance of failure. I had a fan, it was running for about a week straight, the other day I turned it off for a while, then it wouldnt start back up, even with manual assistance. Its a lot easier to start something up and keep it running than to be constantly spinning it up and down. But yes, nobodys really sure of the complications that could arrise from living without a pulse, besides you know, sucking blood or eating brains...
"Sic Semper Tyrannosaurus Rex."
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."
, it does seem like a setback towards replacing failing organs with fully artificial ones."
Whats with the general intelligence of geekdome. Why is every attempt to keep technology up to human interface standards considered a slight to technical progress? Why not just say we are too stupid, at the moment, to build a heart that is good enought to actually work! ggrrrrr aaahhhrr
That's what they told you? Of course, he looks a little different now.
But did it run Linux?
Commence comments stating, "of course not, it ran Windows!"
When they reject something like this, it's typically because there are better alternatives. And no, death isn't considered a better alternative. When this device works better than other procedures, it'll be accepted. And given that it is a dangerous procedure itself, that probably means it'll first be approved for patients that (as you say) are starting death in the face. Once it works really well, it might be ready for ordinary people.
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And more importantly you don't have batteries to worry about. Imagine having to be careful in the shower cause you know you only have 15 minutes until the internal battery fails. :-\
I wish I had mod points for you. As disturbing as the grandparent post is, I can't count the number of times I've heard it; "if everyone can't have the device, noone should." Perhaps that's not what the grandparent meant, but it certainly sounds like what he said.
___
It's the end of my comment as I know it and I feel fine.
It works for other anti-nausea drugs, like dramamine. You cannot barf up a patch.
I'm all for more research into the ingredients of marijuana as medicine. We can't figure out what we should do without research. But once we know what works, it's best to put it into a well-measured and dosed medicine than to give someone a plant and tell them to have at it. And I feel it is best to medical experts decide what becomes medicine, not the average voter.
Ever since she got her IUD.
We Can Rebuild Him
;)
We Have The Technology but,
we don't want to spend a lot of money.
Classic Family Guy
Versus death? Come on guys... have a heart!
I'm trying to teach myself to set people on fire with my mind... Is it hot in here?
Will someone please tell me how an artificial heart qualifies as either a Food or a Drug?
Or, for that matter, how we ever allowed a single organization to both regulate distribution of broadcast frequencies *and* broadcast content? (FCC)
Solomon Kevin Chang
"Twice half-assed makes an ass whole." --Solomon K. Chang
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.
but not all that bad when faced with certainty of death.
We are all faced with "certainty of death". There are some tradeoffs we can make between comfort and quantity, but just because you are willing to accept an extreme amount of discomfort (think "medieval torture") for a small increase in quantity doesn't mean that that's the decision society has to bless or pay for.
Furthermore, these devices are hugely expensive. The $500k that are spent to extend the life of 10% of the recipients by 6 months need to come from somewhere. Unless insurance premiums go up, if money is spent on that, it means that other procedures don't get done.
People who fear American-made cyborgs can rest easy...
But like with cloning, neural engineering, gene manipulation, etc. there is research going on in the rest of the world that is just as advanced as that in the US.
That said, I have to agree with the FDA that the AbiCor does not appear ready for primetime, seeing how everyone who had one has died within 17 months.
Although it's nice to think human life is more valuable than anything, in hospitals with short funds they have to make decisions about whether a certain chance of saving a life is worth the cost, because the money that is there will save lives if used in particular ways.
I am trolling
I mean, who wants to hear "I love you with all my artificial heart"?
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
One interesting thing about this heart described by the ABIOMED page is that it appears totally self contained. No wires through the skin, no air pump console. 1/2 hour internal battery and 4 hour external batteries.
Could a non-pulsatile version be made using an impeller that would eliminate pulse-shakes and give inhumanly steady hands for microsurgeons and snipers?
Plug your microsurgeon into a wall outlet via the transcutenous energy transmission coil and they could operate pulse free all day. Likewise your long range sniper, plugged into a vehicle power pack or gas powered generator.
I was cheering for Robert Tools but it looks like his experience was by far the best of the lot.
Is a simple mechanical explanation of their mediocre results applicable? Put a new pump in a rotten circulatory system and some pipes are certain to explode into strokes? If so, the whole concept really does need refinement. It could be argued that there are otherwise healthy people who could benefit but how many people with a stake through their heart survive long enough to do the switch?
I'm sure there are exceptions who would still be willing research subjects and I assume the company will get permission to do more trials with an improved technique. That seems like an appropriate compromise at this time -- with the hope that AbioCor can survive another prolonged development phase.
I'd like to think that I should be able to spend all of -my- money (or at least all of the money I'm entitled to via the insurance I've purchased) to extend my life as long as I want (and is scientifically possible).
What really frustrates me is when legitimate (if risky) medicine like this is deemed too expensive, while insurance readily pays for non-medical (homeopathy, chiropractors, etc) services - which have no value to anyone.
A lot of the stuff that passes for medicine isn't any more "medical" than going to a day-spa.
And not be staring death in the face.
There are plenty of people who need a heart transplant who simply live with their current faulty heart until one becomes available. These people are what I referred to (somewhat stupidly) as ordinary people. These procedures would reduce their chances of survival, not increase them.
Other people's hearts begin to fail before a replacement is availble, they are candidates for these experimental procedures, as they have no other hope.
http://lkml.org/lkml/2005/8/20/95