Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
Yes, the FDA will insert itself to regulate medicine wherever it can. For example, the FDA has been pushing to regulate diagnostic tests as medical devices.
It’s funny how Americans surrender medical autonomy to the government but draw a strict line in the sand in other issues
Would have been interesting to hear what the feeling was like 2 weeks later (ie lethargic? walking alright? breathing well?) TFA only says he's alive "with his new heart beating soundly", which could mean a lot of things.
My dad took weeks(like more than 2 months) to back to being some what confidently ok'ish with things after his coronary artery bypass graft. He needed physiotherapy. His knees were weak and he needed a knee replacement only an year later. But in the after math of bypass surgery I had to hold his hand and make him walk, even feed and took him to rest room personally, I would even bathe him.
It took like ages to let him confidently use the toilet on his own. And I'd always keep the toilet door open 'Just in case'.
The Knee replacement a year later was obviously more brutal given the bypass was only an year back and we were peak in COVID times. He was infected, and I had sleep on the road as I caught it too(couldn't go home out of fear of infecting the family). Pretty much saw hell in bare form during that(weeks in anxiety, walking in COVID wards and suffering every single minute), and of course that recovery took months, as the drugs they gave him caused a huge spillover of issues.
It might just be that as a I child I felt more for my father.
But let me tell you major surgeries like bypass grafts, or knee replacements are nightmarish experiences, even more more so in the COVID times today.
I think two weeks after heart surgery is never fun... A few days ago I noted that recovering from having your sternum broken open takes 6-8 weeks to be able to resume daily basic activities under the best circumstances.
If you want to explore the concept further, I suggest you watch the movie "Never Let Me Go" (2010). The premise is very similar, apart from the fact there's no secret or conspiracy about it, children are just grown to become sacrificial organ donors, and since it's socially accepted, there's no way out of it.
Speaking from a country with ongoing human organ harvesting, this is absolutely amazing, everyone involved in this deserves an enormous amount of praise.
A podcast called Straight Talk MD talks about several different weird transplants like this in this episode: https://pca.st/episode/1628074d-b415-477b-b1f6-81c9d81fc261 (For Fame or Money? The Dark Side of Ten Amazing Medical Firsts on Straight Talk MD)
Of note is the disastrous synthetic heart in the 90’s. I was surprised that such a thing was attempted.
Is this compassionate use or experimentation on a dying patient for the future benefit of the rest of us? I’m fine with the latter, if consensual. But only if we call it what it is.
First generation transplants are always both. David would have died soon without this (he's quite likely to die soon with it too, unfortunately, if this goes anything like other first of a kind transplant receivers). Desperate people accept desperate measures, and the hope that it may teach us how to save others helps too.
It's a way to potentially prolong a terminally ill patients life with an experimental technique, potentially advancing medical science in doing so. I fail to see why this should be cast in a negative light.
That is what a clinical trial is. There is now other way. Although with organs-on-a-chip we are working on at least getting the animal testing stages confined to a minimum. Over time we may reduce the risk to first recipients of new tech using these new technologies. Perhaps even digital models may at somepoint start playing a role. But until we have digital models, this is what we have. And it does seem to work well in this case.
It is quite clear since the first article on this topic that the recipient is very aware of the potential and risks. If I may say, he sounds like he geeks out about it. He had previously received a pig heart valve which kept him alive a long time. This probably affects his perceptions positively too.
From everything I read it was consensual. But that raises a larger moral question. Is it really consent if you're about to die? I think that almost anyone given the choice to either die or get a pig heart will choose the latter, there's a good chance you will die if you get the transplant but there is a 100% chance that you will die if you don't.
The guy would have died pretty soon without the procedure. If the choice is between dying for sure in a few weeks, or maybe dying in a few weeks but maybe not dying for another few years.... I'll take the 2nd option.
I just want to say huge respect for Dr Mohammad who despite his faith decided to do what is right. It might not be well known but most muslims are raised with strong beliefs, even in educated countries (eg 85% in Pakistan support sharia).
The recipient is a non-Muslim, so no Sharia-related problems in his case.
AFAIK it is not forbidden for a Muslim to touch pigs, only to eat them. Pigs and dogs are impure, but you can perform ablution afterwards. Muslims normally own hunting and guarding dogs. That would actually be a common problem for Coalition soldiers in Iraq when they tried to enter a village by stealth - lots of barking.
"This impureness nevertheless doesn't imply that one might not touch a pork, but that one might need to wash his hands and maybe even re-do the ablution to be able to pray after touching it."
I don't know how many Muslims you're friends with but I wouldn't assume without some indication that this was difficult for him. There is a huge variety of beliefs in a population of over a billion adherents. Most of the ones I know have no issue with, for example, picking up a pack of bacon from the store as long as they're not the one expected to eat it.
Can anybody offer some insight into what people mean by that? I know that in the 19th century, sharia was basically just a legal tradition, that drew on Islam (just as western legal traditions draw on Christianity, or eastern ones Confucianism). Is it more extreme these days?
For a layman like me on medical matters, it seems very strange that a pig's heart is used. Would it more logical idea to use a primate, our closest "cousin"?
"While it is true that pigs are less compatible with humans than monkeys, they can be genetically manipulated to produce organs less likely to be rejected on transplantation. Pigs quickly grow to full size, produce larger litters and can be more easily reared by biotechnology companies."
Pigs have a lot of physiological similarity to us (thus why fetal pig dissections are often done in high school/undergrad biology). Plus there are fewer ethical concerns around using an animal we already use for food.
I imagine there's also a consideration for ease of raising. These pigs had to be kept separate from others and tested frequently for disease because of having some aspects of their immune system weakened to reduce rejection risk. This would probably be easier to do ethically for pigs compared to primates.
Pigs are not too far off when it comes to the overall body. I believe the idea to use a pig's heart is one off availability (and maybe ethics). A ton of pigs are slaughtered each and every day, we already use several parts of a pig's body (which is a good thing, waste as little as possible). If we can successfully use it's heart for transplantation, even better. This means there is a good supply of hearts to be used.
A good test. The guy is older and wanted to remain alive, despite the wishes of his family. And pigs are so close to humans anyway -- which is why I have the theory of why humans love bacon so much.
Best wishes to Mr. Bennett, and hope that whatever happens, it will be a good leap for humanity.
I've said this before here and got downvoted for it, but bioethicists as a profession are responsible for more death than pretty much anything else I can quickly think of.
People are dying from heart disease all the time, very often in predictable conditions. Literally millions every year. Statistically this means we should hear about such failed procedures many many more times than we do now - there is literally no downside from doing this much more often, and a strict upside: a chance to live longer and a definite advance in medicine leading to other lives saved. Sure, it may mean more stress for a dying patient, but quite a few would prefer their death have some meaning. But they can't chose this because it's not "ethical".
Moderna had the mRNA vaccine for Covid ready in about 3 weeks. This means the tech was already there - I'd really like to see an argument where we had three major companies create mRNA vaccines, only one failed (harmlessly!) but we shouldn't have used this technology a few years early. mRNA tech is incredibly versatile - it should have applications from curing cold to curing cancer. But no, we needed a pandemic and 10 months of testing to start using it, because it wasn't "ethical".
We knew from month 1 that the young and healthy are not hit hard by Covid. Mortality in those groups was always comparable to flu, more or less. But we didn't do challenge trials. We wasted ... I have to take a break from typing, tbh, I'm overwhelmed. We wasted almost a year while literal millions died while wondering if Covid is transmitted by touch, aerosols or airborne when we could have fixed this in two weeks with a bunch of 25 year olds. We spent half a year before even realizing masks help, and we still don't know for sure how much and what's the difference between each kind. We had Omicron - we knew it was different, we had good reason to think it's not significantly worse from the start, but we still had a _lot_ of questions. But two years from the start of the pandemic we STILL didn't put a bunch of healthy volunteers through a completely harmless study to find out things early. Because it wouldn't have been "ethical".
This isn't ethics we're talking about. It's pure and unadulterated cowardice. We as a society shy away from doing things which we _know_ would save more lives in the aggregate because we'd have to risk causing much less harm, but harm which we'd be directly responsible for. Joe from the street would be excused from making these decisions, but when you deal with the people directly charged by the society from making these decision, it's just failure to do their job. And in a supermajority of case we're dealing with volunteers anyways.
I'm a full on speciesist. let's do more of this. since we're already eating them I feel like this even a more reasonable usage of their lives. can we do kidneys next please? we can basically shut down most dialysis clinics after that.
[+] [-] phnofive|4 years ago|reply
Not a huge update but an interesting discussion of FDA approval; can the FDA actually stop or sanction experimental procedures like this?
[+] [-] hprotagonist|4 years ago|reply
They explicitly permitted this operation, by means of https://www.fda.gov/news-events/public-health-focus/expanded...
Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
[+] [-] jostmey|4 years ago|reply
It’s funny how Americans surrender medical autonomy to the government but draw a strict line in the sand in other issues
[+] [-] oneepic|4 years ago|reply
[+] [-] kamaal|4 years ago|reply
It took like ages to let him confidently use the toilet on his own. And I'd always keep the toilet door open 'Just in case'.
The Knee replacement a year later was obviously more brutal given the bypass was only an year back and we were peak in COVID times. He was infected, and I had sleep on the road as I caught it too(couldn't go home out of fear of infecting the family). Pretty much saw hell in bare form during that(weeks in anxiety, walking in COVID wards and suffering every single minute), and of course that recovery took months, as the drugs they gave him caused a huge spillover of issues.
It might just be that as a I child I felt more for my father.
But let me tell you major surgeries like bypass grafts, or knee replacements are nightmarish experiences, even more more so in the COVID times today.
P.S: This is in Bangalore, India.
[+] [-] sdenton4|4 years ago|reply
[+] [-] __s|4 years ago|reply
[+] [-] henryw|4 years ago|reply
[+] [-] Valgrim|4 years ago|reply
Fair warning: it's pretty depressing.
[+] [-] lvass|4 years ago|reply
[+] [-] userbinator|4 years ago|reply
[+] [-] taf2|4 years ago|reply
[+] [-] dmead|4 years ago|reply
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[+] [-] anonymousiam|4 years ago|reply
They seem to have forgotten about this baboon-to-human heart transplant from 1984.
https://en.wikipedia.org/wiki/Baby_Fae
[+] [-] kdtop|4 years ago|reply
[+] [-] dqv|4 years ago|reply
Of note is the disastrous synthetic heart in the 90’s. I was surprised that such a thing was attempted.
[+] [-] threshold|4 years ago|reply
[+] [-] ovi256|4 years ago|reply
[+] [-] dtech|4 years ago|reply
[+] [-] teekert|4 years ago|reply
[+] [-] Karawebnetwork|4 years ago|reply
[+] [-] _fat_santa|4 years ago|reply
[+] [-] albrewer|4 years ago|reply
[+] [-] voldacar|4 years ago|reply
why does it need to be? What if Mr. Bennett just wants to live longer? What obligation does he have to you or me or anyone?
[+] [-] wonderwonder|4 years ago|reply
[+] [-] goodguyamericun|4 years ago|reply
God bless Dr mohammad
[+] [-] inglor_cz|4 years ago|reply
AFAIK it is not forbidden for a Muslim to touch pigs, only to eat them. Pigs and dogs are impure, but you can perform ablution afterwards. Muslims normally own hunting and guarding dogs. That would actually be a common problem for Coalition soldiers in Iraq when they tried to enter a village by stealth - lots of barking.
"This impureness nevertheless doesn't imply that one might not touch a pork, but that one might need to wash his hands and maybe even re-do the ablution to be able to pray after touching it."
https://islam.stackexchange.com/questions/48791/is-it-haram-...
[+] [-] causality0|4 years ago|reply
[+] [-] FDSGSG|4 years ago|reply
[+] [-] kybernetyk|4 years ago|reply
[+] [-] pasabagi|4 years ago|reply
Can anybody offer some insight into what people mean by that? I know that in the 19th century, sharia was basically just a legal tradition, that drew on Islam (just as western legal traditions draw on Christianity, or eastern ones Confucianism). Is it more extreme these days?
[+] [-] unknown|4 years ago|reply
[deleted]
[+] [-] unknown|4 years ago|reply
[deleted]
[+] [-] thegabriele|4 years ago|reply
Is this true? How would these manipulations be carried out?
[+] [-] yitchelle|4 years ago|reply
[+] [-] gavinflud|4 years ago|reply
They do cover this point.
[+] [-] ColinWright|4 years ago|reply
[+] [-] dotnet00|4 years ago|reply
I imagine there's also a consideration for ease of raising. These pigs had to be kept separate from others and tested frequently for disease because of having some aspects of their immune system weakened to reduce rejection risk. This would probably be easier to do ethically for pigs compared to primates.
[+] [-] Schinken_|4 years ago|reply
[+] [-] eps|4 years ago|reply
[+] [-] bawolff|4 years ago|reply
[+] [-] eric4smith|4 years ago|reply
Best wishes to Mr. Bennett, and hope that whatever happens, it will be a good leap for humanity.
[+] [-] radu_floricica|4 years ago|reply
People are dying from heart disease all the time, very often in predictable conditions. Literally millions every year. Statistically this means we should hear about such failed procedures many many more times than we do now - there is literally no downside from doing this much more often, and a strict upside: a chance to live longer and a definite advance in medicine leading to other lives saved. Sure, it may mean more stress for a dying patient, but quite a few would prefer their death have some meaning. But they can't chose this because it's not "ethical".
Moderna had the mRNA vaccine for Covid ready in about 3 weeks. This means the tech was already there - I'd really like to see an argument where we had three major companies create mRNA vaccines, only one failed (harmlessly!) but we shouldn't have used this technology a few years early. mRNA tech is incredibly versatile - it should have applications from curing cold to curing cancer. But no, we needed a pandemic and 10 months of testing to start using it, because it wasn't "ethical".
We knew from month 1 that the young and healthy are not hit hard by Covid. Mortality in those groups was always comparable to flu, more or less. But we didn't do challenge trials. We wasted ... I have to take a break from typing, tbh, I'm overwhelmed. We wasted almost a year while literal millions died while wondering if Covid is transmitted by touch, aerosols or airborne when we could have fixed this in two weeks with a bunch of 25 year olds. We spent half a year before even realizing masks help, and we still don't know for sure how much and what's the difference between each kind. We had Omicron - we knew it was different, we had good reason to think it's not significantly worse from the start, but we still had a _lot_ of questions. But two years from the start of the pandemic we STILL didn't put a bunch of healthy volunteers through a completely harmless study to find out things early. Because it wouldn't have been "ethical".
This isn't ethics we're talking about. It's pure and unadulterated cowardice. We as a society shy away from doing things which we _know_ would save more lives in the aggregate because we'd have to risk causing much less harm, but harm which we'd be directly responsible for. Joe from the street would be excused from making these decisions, but when you deal with the people directly charged by the society from making these decision, it's just failure to do their job. And in a supermajority of case we're dealing with volunteers anyways.
If you feel like reading more about how stupid the whole system is: https://slatestarcodex.com/2017/08/29/my-irb-nightmare/
[+] [-] jb1991|4 years ago|reply
[+] [-] drenvuk|4 years ago|reply
[+] [-] benatkin|4 years ago|reply
PETA doesn't like that anyone got a pig heart transplant. https://www.peta.org/media/news-releases/first-heart-transpl...
[+] [-] notjustanymike|4 years ago|reply
[+] [-] amelius|4 years ago|reply
[+] [-] unknown|4 years ago|reply
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[+] [-] nikkinana|4 years ago|reply
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