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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."
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.
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).
Actually, there are several strains of HIV, and newer research is showing that the possibility of getting more than one is extremely severe.
Also, it may be for the safety of medical personel, as harvesting and working with such organs may be more dangerous in some situations (situations that shouldn't come up anyway, but people like to have mulitple security levels).
Actuall, looking at TFA you see that it hasn't been totally rejected yet:
... The FDA is not bound by its advisers' recommendations but usually follows them
Slashdot title:
FDA Rejects Artificial Heart
Washington Post title:
FDA Panel Rejects Artificial Heart
In article text:
the panel voted 7-6 that the heart's probable benefit didn't outweigh the risks
There is still hope, and writing a letter to people like Tom DeLay or George Bush might help (only in that they may get together and pressure the FDA). Kinda ironic that I might actually take their side on this sort of issue - assuming that they would support it due to their right to life/culture of life stance.
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Imagine walking around knowing you had no heart? Spooky.
Actually, you generally don't have your own heart taken out for these devices. Instead it is placed alongside your normal heart.
This has the advantage if you have some cardiac reserve that even if the device fails you don't necessarily die, as your own heart may have enough strength to keep you alive till the problem is fixed.
Your heart can actually recover if given a "rest" by these devices, which is another reason to not take it out. These devices have a strong role to play in end stage heart failure when there is a prospect of recovery.
Also, this is only one of many devices being trialled. I have been involved with many assist devices and some of them are more promising than the abiomed. I think that we will be seeing alot more of them in the future. I personally* know of one person in our unit who went nearly two years on a similar device whilst awaiting a heart transplant.
Michael
* For what its worth, I am an anaesthetist who works in a heart transplant unit, and we use these things alot - the surgeons put them in at the business end, but we run the controls on the slightly less biological end of things. I guess its something like IAACA (I am a cardiac anaesthetist).
There is no cryptographic solution to the problem where the intended receiver and the attacker are the same entity.
We aren't talking about bringing back 110 year old people from near death.
In this case, it's precisely what we're talking about. Abiomed was applying for a "humanitarian device exemption", to be used only in cases where the person had less than a month to live. They weren't expecting you to live long on it; just long enough to say a few extra months of goodbyes.
They were rejected anyway. The numbers were just too much against them. Two people out of 17 died almost immediately.
The rejection was narrow, 7-6, and it seems a little unfair to blame those deaths on the procedure since it was only done in people who were about to die anyway. These are not the best candidates for surviving massive surgery.
You can't do it in children, even though their young systems might handle it better, because they'd have to make tiny devices for them, with attendant research issues.
The best choice might be those otherwise healthy middle-agers. I'm not certain why Abiomed hasn't looked into those, except that they're presumably reluctant to try an experimental device on somebody who's a potential candidate for a life-saving heart transplant.
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.
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.
I'm sure you can't find the article because it probably doesn't exist. Artificial hearts (and the associated machinery) are quite noisy. As a matter of fact, artificial heart valves, which are quite common, are noisy enough that you can hear them from several feet away in a quiet room. I have an artificial valve and it sometimes keeps me awake at night. It's like having an old school wind-up wrist watch parked next to your ear. But it certainly beats the alternative....death. Cheers,
I work for a medical device company (though not the one in the article nor one who competes with them).
Simplistically, the basic difference between the FDA standards and the European ones is that to get a CE mark (Euro approval) you only have to show safety (doesn't hurt people), but in the US to get FDA approval you must show both safety and efficacy (actually helps people). This means you must show that the device does what you say it does and provides some measurable benefit. Generally you design a study with the endpoint chosen to demonstrate some statistically significant benefit. This means that if a company is making a claim about a regulated drug or device, you can trust that the FDA has validated that claim (note that this is not true for herbs/supplements). You can't market a device to people if you can't show that it will help them.
In this case, there is not enough evidence that the device actually helped anyone; maybe the device needs redesign, maybe they need a better-designed study, maybe they need a larger data set (try it on more patients). With this data, it is difficult for them to convince the FDA that you should be allowed to market the product. Even for a humanitarian use case, there must be some benefit to balance the risk. If they do another study where they are able to demonstrate some benefit, they can reapply for approval.
I have a spooky side effect from my implanted mechanical mitral valve. Whenever it is quiet I hear a steady click-click as my heart beats, one click for each beat. People with good hearing can hear it a short distance away. This really startled my 16 year old nephew who heard it as we were working a computer together. I'm sure he has spread the story among his friends.
I find the clicking sound reassuring, it is a sign that everything is working well.
While valve and my pacemaker (which gives no sign of its presence) is comforting for me, I hear that others are disturbed as they make them feel not whole and reminds them of thier mortality.
A psychotherapist friend of mine tells me that he has a patient being driven crazy by the clicks. I feel sorry for the patient, as there is no way to avoid them.
Either way, these devices are very noisy, even if they don't have mechanical valves (and use porcine valves or polymer valves instead).
MJC
No kidding, I know a guy with an artificial valve. It's noisy as hell. I can hear it from 6-8 feet away in an office setting. Then again, I can hear an analog wristwatch in the same environment.. That's the main reason I don't wear a watch around anymore, it's damned annoying.
Hope I don't have some kind of Captain Hook syndrome going on. Eck!
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