The approval was given even though the grapefruit-size device was implanted in just 14 patients at four hospitals from 2001 to 2004. All of the patients, who agreed to receive the heart as an experimental device, were men, and all have died.Did I read that right? Fourteen patients in a four year period? All who received the device eventually died? If this was a medication, then it would be laughed out of the room instead of being approved.
Two died from the implant operation. A third never regained consciousness, and the rest survived an average of five months. The longest survivor lived 512 days, when the mechanical heart failed.
The company is approved to sell 4,000 a year. But, in all likelihood will only be about 25-50. The cost? A cool $250,000. The company is not even sure if it will receive insurance coverage for the device yet.
For me, this is under the category of "just because we can do something, doesn't mean we have to do something." Granted, I realize that there are thousands of people who die each year waiting for a donor heart. The article also states that in the last six months of live, the slowing dying heart patient incurs an average of $1 million in ICU expense alone.
But, 14 patients in a four year period? Fourteen months ago, according to the article, the FDA voted to deny this same device because of concerns of complications like bleeding, strokes, and infection. Like the FDA is not embroiled in enough controversy with Plan B, Vioxx, Bextra, and other medications in the news.
In my opinion, these are just lawsuits waiting to happen. And, there are attorneys salivating out there just waiting for something to go wrong so that they can swoop in to defend these "victims" against the evil entrepreneur doctor who is seeking fame and fortune at the expense of a patient with a failing heart.
Update: I didn't realize the New York Times site only has limited access. Here's the article from The Washington Post. Hopefully, there are no access problems with this.
Yep, watch out for the lawsuits. the scary part is that patients who need a heart replacement will want to have this, even if they know the odds.
When it comes down to "positive death" vs "probable death", guess which one most will choose?
Did you know that Mary Gohlke lived 5 years after being the (USA's) first successful heart and lung transplant recipient?
Her chances certainly wern't good, but she chose it anyway. For the exact reason I mentioned above.
It is a poor commentary on our medical priorities. Clearly the FDA does not speak to CMS. The Wall Street Journal this morning reported that "the company says it is working with the government and private insurers to develop reimbursement guidelines."
In my view, any government agency or insurer approving reimbursement for this device should be legally liable for manslaughter of the thousands of others unable to afford health care.
im with cathy on this one.. i have been doing research into the way the FDA goes through it's stuff.. and sometimes.. they gotta go with progress... someday.. this could be a long term solution if you give it half a chance now...unfourtanly that dosn't always mean the greatest outcome now.. but maybe some day in the future.. however these people know the chances they are taking when they agree to the procedure.. they have to that is the law and if they make this choice that is for them to make and not us to second guess...a lot of times when you see articles like that and the flake the FDA gets for making there decisions you don't know all the workings and all the reasons for the decisions.. that is the joy of the media.. they share only the information they want to.. the stuff that is shocking.. and going to get your attention.. not the inside story that really counts.. but thats just one peon's lowly opinion:)
This kind of device was bound to come along one day or another, as their is such a shortage of organ transplants these days.
In Britain now, if a person dies, and they have put their name on the oragn donor register, relatives are not allowed to object to them having organs removed, as their is such a shortage of organs being donated.
Science will always be ahead of ethical and legal discussions. There is no getting around that. It's just frustrating.
It's true that we don't know the entire story from the FDA. But, using the examples of Vioxx and Baycol (meds removed from the market), the FDA was eventually compelled by Congressional investigations to tell the entire story.
If and when this device is removed from the market, I think that we're going down the same road. And then, more questions will arise, "Why was this device approved in the first place, especially 14 months earlier it was rejected," etc. Patients will be used as pawns for attorneys and legislators, and physicians will be caught in the middle somewhere.
That's what frustrates me, because it doesn't have to play out like this.
For argument's sake, it would seem to me that if I were in the position of end-stage heart failure, anxiously awaiting a suitable donor, and knowing I might have 512 extra days beyond the capacity of my own failing heart, I would see no reason not to do it.
For argument's sake, you can continue to wait for a donor heart. Or, I have a device which may extend things 512 days. It also may decrease things considerably. Of the 14 people it was tried on, two died on the operating table. There is also risk of stroke, bleeding, and infection which may decrease the 512 day number. While you're waiting for a donor heart.
I'm not criticizing, this is just a lot of information for a patient to process. There's no perfect solution.
I don't think people give the patients enough credit for thinking for themselves.. they know the risk when explained.. there not stupid..the family is grieving.. and honestly it isn't right that they second guess there family members decision.. a pt in that kind of a situation will most likely think.. if im going to die at least let me die fighting.. at least let my death give someone else the oportunity to possibly live longer.. while they work out the bugs on this.... they know.. and i really don't feel it's right of us.. to say.. ohh you didn't know what you were doing when you made this dicesion.. doc A i get your concerns.. the docs shouldn't be in the middle of it at all..and if they fully disclosed the information then they most definetly should not get sued or anything like that.. can you remember what they were saying about the first heart transplants???? was it something similar to this???
The late Crocodile Hunter would have said, "CRICKEY!"
I don't know. I have many mixed feelings. How many heart transplants do they do now. So many I think that we don't have near enough donors. When Mary Gohlke had hers it had never before been successful. She lived 5 years and set the way for many to have it done. Yet going into it her chances were so bad that Dr. Reitz was bound by moral and ethical values that he couldn't operate, until she was so close to death, that if she died, it really wouldn't have mattered.
Won't these people be aware of how risky this can be? Won't they also be able to make an informed decision. If it goes bad how could they (family members) then turn around and sue? If it is all done in the name of research how can that happen?
My concern also is that family members might try to force their loved one to have this done. Satisfying their own selfish needs of not wanting to say goodbye.
Also is the money. Where will it all come from? People do not have a quarter of a million dollars laying around. Look at the condition medicare, medicaid and all other ins are in...Who will pay for these procedures? Noone likes to talk about the money but it is a fact that has to be talked of.
My point was to emphasize that ethics lagging behind technology is hardly unusual.
Imagine we have two patients in the same room, terminally ill with MDS. One of them happens to be Susan Sontag, the author of Illness as Metaphor. The first patient says, "I don't want to be in pain. Keep me comfortable, but I wish to die in peace." Sontag, on the other hand, demands anything and everything in an attempt to "save" her life. She has survived cancer twice, and at her near last breath is attempting to swallow an experimental medication. Her doctor knew it was a frivolous intervention. But this is what she wanted. Was the doctor acting ethically in providing a cognizant, terminally ill patient a "last shot" (at least in her own mind)? And who will decide when enough technology & resources have been thrown at futility? The physician? The insurer? The government? I agree with drwes that it is, indeed, a poor commentary on priorities.
But these watershed technological innovations have become "routine" in patient's minds, and this profession is on the receiving end of this sense of "entitlement"; and thus my question, factor analysis be damned, "Why would I not do it?" I heartily recommend a read of a medical student's take on the matter, and the anonymous excoriation he took in response. We should not be left responsible for these decisions.
Well said. Interesting medical student post.
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