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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."
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".
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,
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!
The US was certainly fortunate to be spared the horrible results of Thalidomide. But the stricter rules in the US have (rough estimate) caused hundreds of thousands of premature deaths, not to mention untold suffering.
The problem with comparing this to an "innocent until proven guilty" legal system is that with such a legal system the government is refraining from doing harm. In the case of the FDA their are interfering in private choices about medical care and killing more people than they save.
It is true that the FDA's prudency has been good in certain cases, but the FDA's rejection of Thalidomide was something of luck. It turned out that the lady who was in charge of evaluating Thalidomide had refused to pass any drug or device whatsoever -- that is, she pretty much said no to anything. Did this lady's conservatism save lives? Yes. Overall was she responsible? Not completely.
You are describing a Left Ventricular Assist Device (LVAD). That's not what this is.
The Abiomed device is a Total Artificial Heart (TAH). They cut out your existing left and right ventricles and install this in their place. If the device fails, you die instantly.
For what it's worth, I participated in the first calf trial of this device at Louisville.
Fair enough, but you can usually get a similar effect by doing a BiVAD type approach. (in the less common situation where the right heart is failing).
For what its worth we have been putting alot of ventricor's in lately, and they seem to work really well as a LVAD device (they are a bit unusual as they are a non pulsatile device with a centrifugal drive similar to ECMO devices). They are still pretty experimental here - just trial status but the initial results look very good (including the longer term complication rates)
Michael
There is no cryptographic solution to the problem where the intended receiver and the attacker are the same entity.
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...
Yeah, I know - When something good happens, it is God's will, but when something bad happens, it is just bad luck...
God hates meddling with His procreation efforts, but he's okay with ancouraging his destruction efforts as long as it doesn't involve a fetus. Makes sense.
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