New Scientist: Humans placed in suspended animation for the first time
November 20, 2019 11:17 AM Subscribe
"Doctors have placed humans in suspended animation for the first time, as part of a trial in the US that aims to make it possible to fix traumatic injuries that would otherwise cause death." [New Scientist]
The technique, officially called emergency preservation and resuscitation (EPR), is being carried out on people who arrive at the University of Maryland Medical Centre in Baltimore with an acute trauma – such as a gunshot or stab wound – and have had a cardiac arrest. Their heart will have stopped beating and they will have lost more than half their blood. There are only minutes to operate, with a less than 5 per cent chance that they would normally survive.
EPR involves rapidly cooling a person to around 10 to 15°C by replacing all of their blood with ice-cold saline. The patient’s brain activity almost completely stops. They are then disconnected from the cooling system and their body – which would otherwise be classified as dead – is moved to the operating theatre.
Cool now figure out how to upload my consciousness into a quantum computer and then let me live in robot host bodies via a nanocomputer mesh.
posted by nikaspark at 12:20 PM on November 20, 2019 [20 favorites]
posted by nikaspark at 12:20 PM on November 20, 2019 [20 favorites]
This looks an awful lot like medical experimentation on a historically oppressed population. Letting people in the community "opt out" online is not really enough IMO.
posted by muddgirl at 12:29 PM on November 20, 2019 [18 favorites]
posted by muddgirl at 12:29 PM on November 20, 2019 [18 favorites]
What's cooler than being cool? Ice cold.
posted by bleep at 12:31 PM on November 20, 2019 [33 favorites]
posted by bleep at 12:31 PM on November 20, 2019 [33 favorites]
It's exciting that this is finally happening - I remember hearing about it maybe 10 years ago at this point.
Here's an article from 2015 that talks in more detail about the consent procedures they're following, which is based around the concept of "community consent".
posted by vibratory manner of working at 12:41 PM on November 20, 2019 [9 favorites]
Here's an article from 2015 that talks in more detail about the consent procedures they're following, which is based around the concept of "community consent".
posted by vibratory manner of working at 12:41 PM on November 20, 2019 [9 favorites]
This article from the New Yorker back in 2016 answers a few questions I have, like why an earlier trial at UPMC failed - it was reportedly because UPMC (in Pittsburgh, PA) does not get enough gunshot victims to qualify for the trial. It also talks a lot more about ethical considerations including a quote from a public health professor and a medical ethicist.
Now I wonder has it taken 3 years to find one patient at the center in Baltimore?
posted by muddgirl at 12:43 PM on November 20, 2019 [4 favorites]
Now I wonder has it taken 3 years to find one patient at the center in Baltimore?
posted by muddgirl at 12:43 PM on November 20, 2019 [4 favorites]
This looks an awful lot like medical experimentation on a historically oppressed population. Letting people in the community "opt out" online is not really enough IMO.
Restating from the article: There are only minutes to operate, with a less than 5 per cent chance that they would normally survive. I guess they could opt to only try it out in the Hamptons?
posted by Abehammerb Lincoln at 12:55 PM on November 20, 2019 [3 favorites]
Restating from the article: There are only minutes to operate, with a less than 5 per cent chance that they would normally survive. I guess they could opt to only try it out in the Hamptons?
posted by Abehammerb Lincoln at 12:55 PM on November 20, 2019 [3 favorites]
How does this sort of experiment work in the America with its very expensive medical care? Who pays that initial ER bill? Who pays for the long term care of any patients they manage to revive, but with lasting brain damage? If they manage to develop this treatment to the point that it is no longer experimental, who will pay for it then? Will the same communities it was tested on be able to afford it then?
If the only real use case is gunshot wounds, testing it on the primary communities that will benefit from it might make sense. But if it's also useful for car accident victims, then this tends to look an awful lot like using a black community to test the procedure that may significantly or even primarily benefit non-black communities.
posted by jacquilynne at 1:02 PM on November 20, 2019 [7 favorites]
If the only real use case is gunshot wounds, testing it on the primary communities that will benefit from it might make sense. But if it's also useful for car accident victims, then this tends to look an awful lot like using a black community to test the procedure that may significantly or even primarily benefit non-black communities.
posted by jacquilynne at 1:02 PM on November 20, 2019 [7 favorites]
They could make the program opt in, for one, but they know they'd never get enough enrollment from the general population.
The fact that these cases are generally terminal is not an ethical justification. As youarenothere demonstrated in this very thread, people have opinions on what should be done with their dead and dying bodies. "There's not enough time" is again a poor justification given the history of medical experimentation on black Americans.
posted by muddgirl at 1:04 PM on November 20, 2019 [5 favorites]
The fact that these cases are generally terminal is not an ethical justification. As youarenothere demonstrated in this very thread, people have opinions on what should be done with their dead and dying bodies. "There's not enough time" is again a poor justification given the history of medical experimentation on black Americans.
posted by muddgirl at 1:04 PM on November 20, 2019 [5 favorites]
If it’s ‘almost certainly die due to traumatic injury’ or ‘much better chance of saving life’ I would opt in, at least for now. You should be able to change that kind of thing, much like organ donor status.
posted by SaltySalticid at 1:09 PM on November 20, 2019 [2 favorites]
posted by SaltySalticid at 1:09 PM on November 20, 2019 [2 favorites]
That community consent article mentions the Army's role in funding this research, which raises a number of obvious questions. (Like, wouldn't soldiers be a more suitable test population here?) Given the ethical concerns raised above, I have to wonder if this would have gotten IRB and FDA approval without government backing.
OTOH, for better or worse we have ample precedent for the idea that unconscious people in mortal peril are deemed to consent to lots of treatment that conscious people might reject. Is the requirement to e.g. opt out of resuscitation through a DNR that different from the Baltimore scenario?
posted by Not A Thing at 1:19 PM on November 20, 2019 [8 favorites]
OTOH, for better or worse we have ample precedent for the idea that unconscious people in mortal peril are deemed to consent to lots of treatment that conscious people might reject. Is the requirement to e.g. opt out of resuscitation through a DNR that different from the Baltimore scenario?
posted by Not A Thing at 1:19 PM on November 20, 2019 [8 favorites]
If only these people could have just signed a form to opt out of being shot.
posted by L.P. Hatecraft at 1:20 PM on November 20, 2019 [8 favorites]
posted by L.P. Hatecraft at 1:20 PM on November 20, 2019 [8 favorites]
Restating from the article: There are only minutes to operate, with a less than 5 per cent chance that they would normally survive.
I expect your attitude about this depends in large part on your feelings about "Congratulations! Without your consent, we've given you severe brain damage instead of just letting you die! Enjoy your symptoms and have a great day, Mr. SomebodyElse'sProblem!"
The article doesn't mention it, but I have to wonder why they aren't trialing this with the military, where I'd have thought that the odds of there being enough of an opt-in pool to be useful would be higher?
posted by GCU Sweet and Full of Grace at 1:20 PM on November 20, 2019 [24 favorites]
I expect your attitude about this depends in large part on your feelings about "Congratulations! Without your consent, we've given you severe brain damage instead of just letting you die! Enjoy your symptoms and have a great day, Mr. SomebodyElse'sProblem!"
The article doesn't mention it, but I have to wonder why they aren't trialing this with the military, where I'd have thought that the odds of there being enough of an opt-in pool to be useful would be higher?
posted by GCU Sweet and Full of Grace at 1:20 PM on November 20, 2019 [24 favorites]
Ugh, Peter Thiel is going to plague us forever, isn't he.
posted by longdaysjourney at 1:30 PM on November 20, 2019 [1 favorite]
posted by longdaysjourney at 1:30 PM on November 20, 2019 [1 favorite]
Referendum supermajority would be a plausible basis for claiming community consent. Putting an ad in the newspaper and holding a few lightly-attended meetings is not.
posted by justsomebodythatyouusedtoknow at 1:32 PM on November 20, 2019 [6 favorites]
posted by justsomebodythatyouusedtoknow at 1:32 PM on November 20, 2019 [6 favorites]
Like, wouldn't soldiers be a more suitable test population here?
There is considerable overlap between populations who live in high-crime areas and those who enter the Armed Forces to escape them. Most or all of the same issues of consent would still seem applicable, unless the starting position is that enlisted forfeit those rights, by virtue of enlisting.
posted by They sucked his brains out! at 1:40 PM on November 20, 2019 [8 favorites]
There is considerable overlap between populations who live in high-crime areas and those who enter the Armed Forces to escape them. Most or all of the same issues of consent would still seem applicable, unless the starting position is that enlisted forfeit those rights, by virtue of enlisting.
posted by They sucked his brains out! at 1:40 PM on November 20, 2019 [8 favorites]
Imagine losing your son in a car crash or a shooting, and finding out that there was a procedure that the doctors could have used to save his life, but they didn't because your son had not ever anticipated being shot or being in a car crash and bothered to fill out the necessary paper work in advance. Would you feel satisfaction from knowing that his consent had been respected or angry that he died when he could have lived?
Also, where consent for a procedure is opt-in in advance, does the rate of uptake differ between groups in society and where the procedure improves survival does this contribute to disparities in medical outcomes between groups?
Without your consent, we've given you severe brain damage instead of just letting you die!
Wouldn't this be the case for the current crack-your-chest-open-and-massage-your-heart procedure too? Aside from the absence of a DNR, is any special consent required for that?
posted by L.P. Hatecraft at 1:41 PM on November 20, 2019 [9 favorites]
Also, where consent for a procedure is opt-in in advance, does the rate of uptake differ between groups in society and where the procedure improves survival does this contribute to disparities in medical outcomes between groups?
Without your consent, we've given you severe brain damage instead of just letting you die!
Wouldn't this be the case for the current crack-your-chest-open-and-massage-your-heart procedure too? Aside from the absence of a DNR, is any special consent required for that?
posted by L.P. Hatecraft at 1:41 PM on November 20, 2019 [9 favorites]
That said, I would not be surprised to see this funded by or even implemented to some degree within the medical service in the military, especially in high-risk war zones.
posted by They sucked his brains out! at 1:42 PM on November 20, 2019 [1 favorite]
posted by They sucked his brains out! at 1:42 PM on November 20, 2019 [1 favorite]
The article doesn't mention it, but I have to wonder why they aren't trialing this with the military, where I'd have thought that the odds of there being enough of an opt-in pool to be useful would be higher?
An interesting question. Perhaps the setup needed to pull this off effectively is difficult to replicate in areas where troops are most likely to get wounded.
posted by Conrad Cornelius o'Donald o'Dell at 1:42 PM on November 20, 2019 [1 favorite]
An interesting question. Perhaps the setup needed to pull this off effectively is difficult to replicate in areas where troops are most likely to get wounded.
posted by Conrad Cornelius o'Donald o'Dell at 1:42 PM on November 20, 2019 [1 favorite]
From the article:
EPR involves rapidly cooling a person to around 10 to 15°C by replacing all of their blood with ice-cold saline. The patient’s brain activity almost completely stops. They are then disconnected from the cooling system and their body – which would otherwise be classified as dead – is moved to the operating theatre.
A surgical team then has 2 hours to fix the person’s injuries...
I am stunned that a person can be kept like this for two hours without complications.
posted by Thorzdad at 1:45 PM on November 20, 2019 [2 favorites]
EPR involves rapidly cooling a person to around 10 to 15°C by replacing all of their blood with ice-cold saline. The patient’s brain activity almost completely stops. They are then disconnected from the cooling system and their body – which would otherwise be classified as dead – is moved to the operating theatre.
A surgical team then has 2 hours to fix the person’s injuries...
I am stunned that a person can be kept like this for two hours without complications.
posted by Thorzdad at 1:45 PM on November 20, 2019 [2 favorites]
Imagine losing your son in a car crash or a shooting, and finding out that there was a highly experimental procedure that the doctors could have used to try and save his life, but they didn't because your son had not ever anticipated being shot or being in a car crash and bothered to fill out the necessary paper work in advance.
FTFY
I wouldn't be satisfied, but I'd certainly think it was appropriate not to experiment on my son in one of the few major metropolitan areas primarily comprised of people of color. Especially given, you know, this country's history of using people of color in medical experiments without their consent.
Maybe this time it's a coincidence. That part of the calculus was not the lack of political capital held by the people of Baltimore because of the white supremacist life-blood of the U.S. In that case it's just tasteless, and not Nazi level experimentation.
Because if it wasn't a complete coincidence that it was Baltimore, it is Nazi level experimentation.
posted by avalonian at 1:51 PM on November 20, 2019 [5 favorites]
FTFY
I wouldn't be satisfied, but I'd certainly think it was appropriate not to experiment on my son in one of the few major metropolitan areas primarily comprised of people of color. Especially given, you know, this country's history of using people of color in medical experiments without their consent.
Maybe this time it's a coincidence. That part of the calculus was not the lack of political capital held by the people of Baltimore because of the white supremacist life-blood of the U.S. In that case it's just tasteless, and not Nazi level experimentation.
Because if it wasn't a complete coincidence that it was Baltimore, it is Nazi level experimentation.
posted by avalonian at 1:51 PM on November 20, 2019 [5 favorites]
There is a huge difference between assuming consent to an accepted standard of trauma care and assuming consent for human trials of a new medical procedure with unknown outcomes.
Would you feel satisfaction from knowing that his consent had been respected or angry that he died when he could have lived?
This framing begs the question. There are a myriad of undesirable outcomes where the patient is technically alive.
posted by muddgirl at 1:51 PM on November 20, 2019 [1 favorite]
Would you feel satisfaction from knowing that his consent had been respected or angry that he died when he could have lived?
This framing begs the question. There are a myriad of undesirable outcomes where the patient is technically alive.
posted by muddgirl at 1:51 PM on November 20, 2019 [1 favorite]
Imagine losing your son in a car crash or a shooting, and finding out that there was a procedure that the doctors could have used to save his life, but they didn't because your son had not ever anticipated being shot or being in a car crash and bothered to fill out the necessary paper work in advance. Would you feel satisfaction from knowing that his consent had been respected or angry that he died when he could have lived?
The outcomes here aren't binary. It's not 'death, but just a short time later than it would have happened' vs. 'life pretty much back to normal'.
Imagine your son only sort of waking up after a car crash with permanent and completely incapacitating brain damage resulting from doctors performing a science experiment in which they deliberately killed him and then tried to bring him back to life an hour later. Would you feel satisfaction from knowing at least they tried or anger because a bunch of doctors decided to torture your son for science?
posted by jacquilynne at 1:53 PM on November 20, 2019 [11 favorites]
The outcomes here aren't binary. It's not 'death, but just a short time later than it would have happened' vs. 'life pretty much back to normal'.
Imagine your son only sort of waking up after a car crash with permanent and completely incapacitating brain damage resulting from doctors performing a science experiment in which they deliberately killed him and then tried to bring him back to life an hour later. Would you feel satisfaction from knowing at least they tried or anger because a bunch of doctors decided to torture your son for science?
posted by jacquilynne at 1:53 PM on November 20, 2019 [11 favorites]
The resuscitation of very cold drowning victims is probably the origin of this technique, though I did not notice it mentioned in the article. It seems like a promising technique, though the ethics of trialing it are quite fraught. On the other hand the ethics of any new unproven emergency intervention are fraught.
It's sad, but we are the beneficiaries of a lot of medical research that happened when ethical concerns were not particularly important, at least when applied to marginalized groups. Heart transplants, anyone?
posted by sjswitzer at 1:57 PM on November 20, 2019 [2 favorites]
It's sad, but we are the beneficiaries of a lot of medical research that happened when ethical concerns were not particularly important, at least when applied to marginalized groups. Heart transplants, anyone?
posted by sjswitzer at 1:57 PM on November 20, 2019 [2 favorites]
I am alternately amazed and horrified by this development.
Mostly horrified.
posted by MissySedai at 2:02 PM on November 20, 2019 [1 favorite]
Mostly horrified.
posted by MissySedai at 2:02 PM on November 20, 2019 [1 favorite]
I'm amazed by the science of it - and it's very timely, as I've just been reading a book all about cryogenic preservation.
The ethics is another issue. I think it's really complex. They probably should have gone for an opt-in rather than opt-out, but that would have also required quite a bit community outreach and education for people to make informed consent yes or no.
I'm not at all horrified - maybe that's because I don't think disability is always a fate worse than death. But what are the rates and the severity of disability?
posted by jb at 2:08 PM on November 20, 2019 [4 favorites]
The ethics is another issue. I think it's really complex. They probably should have gone for an opt-in rather than opt-out, but that would have also required quite a bit community outreach and education for people to make informed consent yes or no.
I'm not at all horrified - maybe that's because I don't think disability is always a fate worse than death. But what are the rates and the severity of disability?
posted by jb at 2:08 PM on November 20, 2019 [4 favorites]
Congratulations! Without your consent, we've given you severe brain damage instead of just letting you die! Enjoy your symptoms and have a great day, Mr. SomebodyElse'sProblem
That'd be my beef with this. What are they going to do with/for the people on whom it doesn't work, but whom it also doesn't kill? If they can't get off vent or feeding, then who's going to feed them? Who's going to pay for it? How long are they going to pay for it?
posted by spacewrench at 2:11 PM on November 20, 2019
That'd be my beef with this. What are they going to do with/for the people on whom it doesn't work, but whom it also doesn't kill? If they can't get off vent or feeding, then who's going to feed them? Who's going to pay for it? How long are they going to pay for it?
posted by spacewrench at 2:11 PM on November 20, 2019
that would have also required quite a bit community outreach and education for people to make informed consent yes or no.
The study supposedly did this as part of their "community consent" model, so why not make it opt-in?
posted by muddgirl at 2:13 PM on November 20, 2019 [1 favorite]
The study supposedly did this as part of their "community consent" model, so why not make it opt-in?
posted by muddgirl at 2:13 PM on November 20, 2019 [1 favorite]
I don’t think emotionally appealing to our hypothetical sons or using words like ‘torture’ are very useful when discussing bioethics.
Torture is intended to cause pain; this procedure is intended to save lives. Likewise, imagining your family in a near-death scenario is not going to help you better rationally gauge the appropriateness of any medical technique or human subject research.
posted by SaltySalticid at 2:16 PM on November 20, 2019 [11 favorites]
Torture is intended to cause pain; this procedure is intended to save lives. Likewise, imagining your family in a near-death scenario is not going to help you better rationally gauge the appropriateness of any medical technique or human subject research.
posted by SaltySalticid at 2:16 PM on November 20, 2019 [11 favorites]
Eh. This has been around for a (relatively) long time.
This is not "suspended animation - in the popular scifi sense.
This is a method to protect the brain from glutamate excitotoxicity and requires measure so minimize ischemia-reperfusion injury.
When a neuron dies, say during a stroke (lack of oxygen), the neuron is chock full of glutamate sequestered away in vessicles. Once the glutamate gets released, it agonizes a whole bunch of glutamate receptors on nearby neurons, the neurons are overwhelmed, dies, and releases their sequestered glutamate stores, etc.
By reducing the temperature globally in the brain (by perfusing a cold liquid through the circulatory system), this slows the brain damage caused by ischemia. With a good anti-reperfusion injury protocol, this gives surgeons a little bit more time to deal with the trauma before "starting up" the patient again.
posted by porpoise at 2:22 PM on November 20, 2019 [28 favorites]
This is not "suspended animation - in the popular scifi sense.
This is a method to protect the brain from glutamate excitotoxicity and requires measure so minimize ischemia-reperfusion injury.
When a neuron dies, say during a stroke (lack of oxygen), the neuron is chock full of glutamate sequestered away in vessicles. Once the glutamate gets released, it agonizes a whole bunch of glutamate receptors on nearby neurons, the neurons are overwhelmed, dies, and releases their sequestered glutamate stores, etc.
By reducing the temperature globally in the brain (by perfusing a cold liquid through the circulatory system), this slows the brain damage caused by ischemia. With a good anti-reperfusion injury protocol, this gives surgeons a little bit more time to deal with the trauma before "starting up" the patient again.
posted by porpoise at 2:22 PM on November 20, 2019 [28 favorites]
Cool now figure out how to upload my consciousness into a quantum computer and then let me live in robot host bodies via a nanocomputer mesh.
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posted by jquinby at 2:29 PM on November 20, 2019 [4 favorites]
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posted by jquinby at 2:29 PM on November 20, 2019 [4 favorites]
I consider this suspended animation because the heart is stopped. What I understood that they have done before is slowed down the heart a lot...but I am no scientist.
posted by agregoli at 2:33 PM on November 20, 2019
posted by agregoli at 2:33 PM on November 20, 2019
Because if it wasn't a complete coincidence that it was Baltimore, it is Nazi level experimentation.
From the Wikipedia Trauma Center article:
The concept of a shock trauma center was also developed at the University of Maryland, Baltimore, in the 1950s and 1960s by thoracic surgeon and shock researcher R Adams Cowley, who founded what became the Shock Trauma Center in Baltimore, Maryland, on July 1, 1966.
I don’t need to consult crime rate statistics to state with confidence that Baltimore sees a far higher than usual number of violent crime victims, both relative and absolute. I don’t need to consult a history book to know the reason for that higher violent crime rate is a century and a half of economic discrimination piled upon human slavery.
So, no, it’s not a coincidence: it is the direct result of systemic racism in the United States, past and present. It’s also not Nazi experimentation: shock trauma / modern triage was in large part pioneered in Baltimore in response to an ongoing human health crisis brought about by shitty gun laws, shitty narcotics policy, horrific municipal law enforcement and segregationist tactics deliberately employed by our predominately white ruling sociopaths.
As far as policy goes, I’d say the ethics are entirely correlated with who is footing the bill. If the trauma center is - as part of research funding for developing a new standardized technique - then that’s fine. The patients who are disproportionately likely to have been victims of the aforementioned economic discrimination? Absolutely not.
If it were me? Do it, take whatever readings/perform whatever tests needed to get useful data from the experience, and once some utility has come of it immediately pull the plug. I lived like a pissed-off Vulcan and I fully intend to die like one.
posted by Ryvar at 2:48 PM on November 20, 2019 [8 favorites]
From the Wikipedia Trauma Center article:
The concept of a shock trauma center was also developed at the University of Maryland, Baltimore, in the 1950s and 1960s by thoracic surgeon and shock researcher R Adams Cowley, who founded what became the Shock Trauma Center in Baltimore, Maryland, on July 1, 1966.
I don’t need to consult crime rate statistics to state with confidence that Baltimore sees a far higher than usual number of violent crime victims, both relative and absolute. I don’t need to consult a history book to know the reason for that higher violent crime rate is a century and a half of economic discrimination piled upon human slavery.
So, no, it’s not a coincidence: it is the direct result of systemic racism in the United States, past and present. It’s also not Nazi experimentation: shock trauma / modern triage was in large part pioneered in Baltimore in response to an ongoing human health crisis brought about by shitty gun laws, shitty narcotics policy, horrific municipal law enforcement and segregationist tactics deliberately employed by our predominately white ruling sociopaths.
As far as policy goes, I’d say the ethics are entirely correlated with who is footing the bill. If the trauma center is - as part of research funding for developing a new standardized technique - then that’s fine. The patients who are disproportionately likely to have been victims of the aforementioned economic discrimination? Absolutely not.
If it were me? Do it, take whatever readings/perform whatever tests needed to get useful data from the experience, and once some utility has come of it immediately pull the plug. I lived like a pissed-off Vulcan and I fully intend to die like one.
posted by Ryvar at 2:48 PM on November 20, 2019 [8 favorites]
I don't see this mentioned upthread in response to GCU Sweet and Full of Grace:
IIRC, the Armed Services are very, very, very good at getting wounded soldiers into surgery. There was a Metafilter post on this years ago now but someone did a re-org on how triage and transport function and the fatalities dropped considerably.
I'm going out on a limb now: this same re-org is not "cost efficient" or funded or some such thing in the States proper, doesn't exist here, and so there are more, uh, near-death subjects for this research project.
posted by Slackermagee at 3:23 PM on November 20, 2019
IIRC, the Armed Services are very, very, very good at getting wounded soldiers into surgery. There was a Metafilter post on this years ago now but someone did a re-org on how triage and transport function and the fatalities dropped considerably.
I'm going out on a limb now: this same re-org is not "cost efficient" or funded or some such thing in the States proper, doesn't exist here, and so there are more, uh, near-death subjects for this research project.
posted by Slackermagee at 3:23 PM on November 20, 2019
Lets say this saves lives, but causes brain damage that requires a lifetime of care by the victim's family.
Does the study pay for that, in addition to all medical care? If the person still dies, do they pay for the funeral and all medical costs such that the family isn't burdened?
Because that's the only way that this would be ethical in my view. If they were in a drug trial, they would likely be compensated for participation, and if the drug had bad side effects they'd be able to sue. But it's damn hard to sue hospitals.
I remember an article about it on metafilter, about a woman left at the wrong hospital entrance. I think it was this one. I believe Maryland has a similar cap.
posted by gryftir at 3:26 PM on November 20, 2019
Does the study pay for that, in addition to all medical care? If the person still dies, do they pay for the funeral and all medical costs such that the family isn't burdened?
Because that's the only way that this would be ethical in my view. If they were in a drug trial, they would likely be compensated for participation, and if the drug had bad side effects they'd be able to sue. But it's damn hard to sue hospitals.
I remember an article about it on metafilter, about a woman left at the wrong hospital entrance. I think it was this one. I believe Maryland has a similar cap.
posted by gryftir at 3:26 PM on November 20, 2019
Suppose your son is placed in suspended animation after a shooting incident, and eventually they cure him and release him from hospital and as he’s leaving he sees a group of people waving at him and then he notices they’re standing on trolley tracks and then he looks down and notices that he is also standing on trolley tracks and then he’s suddenly run over by a trolley BECAUSE SOMEONE JUST HAD TO DO ETHICS DIDN’T THEY and they rush him to hospital but the surgeon refuses to operate because he’s her son and you’ve never met the woman and you don’t even have a son.
What then?
posted by Grangousier at 3:38 PM on November 20, 2019 [7 favorites]
What then?
posted by Grangousier at 3:38 PM on November 20, 2019 [7 favorites]
It took me way too long to realize the other danger which is not discussed in any of the articles I've read - the procedure is attempted and is botched in some way. Easy for this death to go essentially unreported (as death unrelated) without pretty rigorous reporting that is difficult in emergency situations.
I want to be clear that I am not passing any judgement on the science behind this, the intentions of the lead scientist/the hospital, etc. Good intentions alone on the part of doctors do not mitigate ethical concerns.
posted by muddgirl at 3:40 PM on November 20, 2019
I want to be clear that I am not passing any judgement on the science behind this, the intentions of the lead scientist/the hospital, etc. Good intentions alone on the part of doctors do not mitigate ethical concerns.
posted by muddgirl at 3:40 PM on November 20, 2019
The resuscitation of very cold drowning victims is probably the origin of this technique...
Or, y’know, waking up in a bathtub full of ice, missing a kidney.
posted by Thorzdad at 4:19 PM on November 20, 2019 [4 favorites]
Or, y’know, waking up in a bathtub full of ice, missing a kidney.
posted by Thorzdad at 4:19 PM on November 20, 2019 [4 favorites]
Not new. From 2007: Medical experiments to be done without patients' consent.
As a Baltimore resident, I'm concerned about the idea of local ER's experimenting on patients without consent. That said, Baltimore is where a lot of emergency medicine gets developed, and has been since the 1950's. The military actually sends its doctors here to Shock Trauma (University of Maryland Medical Center) and Johns Hopkins Hospital before sending them overseas. CBS story from 2008: Intense Training For Military Surgeons.
Returning to the ethics question, we can also look at this as the latest chapter in the Baltimore medical community's history of racist medical decisions. Henrietta Lacks cells were taken from her at Johns Hopkins. JHU supported government experiments in Guatemala in the 1940's that infected hundreds with syphilis, gonorrhea and other sexually transmitted diseases. PBS NewsHour: Baltimore hospitals work to repair frayed trust in black communities. From 2001, U.S. Investigating Johns Hopkins Study of Lead Paint Hazard; the study was done in the 90's and gave some poor families more help removing lead from their homes than others. Here's more info about the patient death mentioned as an aside in that last article.
posted by postel's law at 7:03 PM on November 20, 2019 [2 favorites]
As a Baltimore resident, I'm concerned about the idea of local ER's experimenting on patients without consent. That said, Baltimore is where a lot of emergency medicine gets developed, and has been since the 1950's. The military actually sends its doctors here to Shock Trauma (University of Maryland Medical Center) and Johns Hopkins Hospital before sending them overseas. CBS story from 2008: Intense Training For Military Surgeons.
Returning to the ethics question, we can also look at this as the latest chapter in the Baltimore medical community's history of racist medical decisions. Henrietta Lacks cells were taken from her at Johns Hopkins. JHU supported government experiments in Guatemala in the 1940's that infected hundreds with syphilis, gonorrhea and other sexually transmitted diseases. PBS NewsHour: Baltimore hospitals work to repair frayed trust in black communities. From 2001, U.S. Investigating Johns Hopkins Study of Lead Paint Hazard; the study was done in the 90's and gave some poor families more help removing lead from their homes than others. Here's more info about the patient death mentioned as an aside in that last article.
posted by postel's law at 7:03 PM on November 20, 2019 [2 favorites]
This model of emergency medical care research is standard in multiple cities. I've sat on some IRB committees (not in Baltimore) that have voted to approve experimental emergency medicine research. I'm pretty sure it's always been federal research, though not always Army funding.
I saw this thread just before I have to sign off for the night so I can't stick around right now and offer to talk about what the community consent model/process looks like from inside an IRB committee, but if that's of interest, I can come back tomorrow and talk about it.
posted by Stacey at 7:04 PM on November 20, 2019 [10 favorites]
I saw this thread just before I have to sign off for the night so I can't stick around right now and offer to talk about what the community consent model/process looks like from inside an IRB committee, but if that's of interest, I can come back tomorrow and talk about it.
posted by Stacey at 7:04 PM on November 20, 2019 [10 favorites]
Stacey, I'd be interested in hearing about what it looks like from an IRB perspective.
posted by postel's law at 7:09 PM on November 20, 2019 [2 favorites]
posted by postel's law at 7:09 PM on November 20, 2019 [2 favorites]
I am stunned that a person can be kept like this for two hours without complications.
If they were certain this could be done without complications, we could handwave past the majority of the ethical issues.
It's (relatively) new, and very experimental, which means they don't actually know what kind of long-term results are standard, even if a notable number of short-term results have been "we're pretty sure this was going to be a death, and now it's not."
posted by ErisLordFreedom at 8:38 PM on November 20, 2019
If they were certain this could be done without complications, we could handwave past the majority of the ethical issues.
It's (relatively) new, and very experimental, which means they don't actually know what kind of long-term results are standard, even if a notable number of short-term results have been "we're pretty sure this was going to be a death, and now it's not."
posted by ErisLordFreedom at 8:38 PM on November 20, 2019
Hypothermic surgery isn't new, and the technique of "deep hypothermic circulatory arrest" has been routine for decades when required for aortic and brain surgery. The EPR-CPT study protocol says all equipment is FDA approved, and the only off-label part of the use is in emergency surgery. Apparently having your heart stopped for 30 minutes intentionally is normal, but stopping it for an hour in an emergency is suspended animation?
It's clear that they put a lot of thought and time (nearly a decade) into this trial. They've set the study population to a narrow group where there's strong evidence they'd make a rapid and complete recovery instead of near-certain death. The total study population is 20 individuals, with 10 in the control group.
The history of racist scientific exploitation can't be undone. Nothing here will fix systematic racism that's killing young black men every day. The people at Shock Trauma push back that tide one life at a time.
posted by netowl at 8:54 PM on November 20, 2019 [6 favorites]
It's clear that they put a lot of thought and time (nearly a decade) into this trial. They've set the study population to a narrow group where there's strong evidence they'd make a rapid and complete recovery instead of near-certain death. The total study population is 20 individuals, with 10 in the control group.
The history of racist scientific exploitation can't be undone. Nothing here will fix systematic racism that's killing young black men every day. The people at Shock Trauma push back that tide one life at a time.
posted by netowl at 8:54 PM on November 20, 2019 [6 favorites]
Also - cumulative ischemic brain damage after emergency trauma surgery - wasn't that one of the main story arcs in the later/ last season of 'Homeland'?
posted by porpoise at 8:58 PM on November 20, 2019
posted by porpoise at 8:58 PM on November 20, 2019
The good intentions of doctors don't matter when dealing with a population that rightly doesn't trust doctors. How does an IRB factor this into their review?
posted by muddgirl at 9:12 PM on November 20, 2019
posted by muddgirl at 9:12 PM on November 20, 2019
Okay, so: What this looks like from inside an IRB committee. I'll say up front that I'm conflicted about the entire model for emergency trauma research. I also don't know how to do it better, and do feel that it needs to be done. And so my approach is generally to work within the processes and practices that have been approved by the government and the universities I've worked with, and do what I can to ensure autonomy/beneficence/justice (the three principles of ethical research) within that framework. Sometimes I leave commiteee meetings feeling better about achieving that goal than other times. I also haven't seen a ton of these studies; maybe a dozenor so, over as many years. I'm smooshing experiences together in this post from multiple universities/hospitals where I've done IRB service.
Process first: A study like this is always going to come to a full IRB committee for review, rather than go through one of the shortcut pathways for less risky research. First the full-time IRB staff are going to work with the researcher to get it to a state where they think it's potentially approvable and are comfortable sending it to committee. Then one committee reviews the study and sends it back with a list of required changes including directives to change the community plan if they think it's insufficient. Then the community consultation process happens. Then the researchers go back to a committee (could be the same or a different committee) and say "here's a report on what we did and what the community comments were, here's how we have changed our study plan to address them, now can we do our study?" And then maybe it gets approved or maybe it goes through multiple more rounds of review and/or community consultation. These things can kick around for a long time.
The committees are required to have relevant medical expertise. They are also required to include non-scientists, and to include people from "the community" rather than just faculty/staff of the university/hospital in question. In theory that's one of the ways that the review board can be sure it's considering what an average non-medical non-research person might think about the study. This sort of works - the community members' thoughts are given a lot of weight, and in the times when I've been in a community role, I've been able to make positive changes in studies related to things like mental health, sexual orientation, and gender by bringing perspectives that otherwise wouldn't have been at the table. That said, I will be the first to say that if I work at one university up the street, and am a "community" member at the university IRB three blocks away, I'm not exactly bringing a wealth of demographic and experiential difference to the table. (Shameless plug here: most IRBs are *desperate* for community members. If you're curious about how this stuff works and you'd find it interesting to have a hand in research that affects your community, and you might be able to volunteer a few hours a month to the cause, if you call up your local IRB you could probably get involved, and maybe help broaden that community member experience pool a bit!)
So, all that happens and you're in a committee room and one of these studies hits your agenda. In my experience, committees devote a lot more time to these emergency trauma studies than most studies. Typically the people with the medical expertise will lead the discussion since they are the ones who can vouch to the rest of us for whether this study meets the medical criteria for this kind of approval - for example, studies like this can't be denying anyone an known effective treatment. We rely on the medical expertise (and the researcher's documentation, but more so the expertise in the room) to convince us that the situation in the study is one where there is no proven effective treatment or where the research to be done doesn't seriously increase the participant's risk over what's already being done to them in a trauma setting. (That last one obviously doesn't apply in the study we're talking about here, but does in some studies.) The medical expert also walks the committee through the data supporting the study (there needs to be some reasonable basis for believing it will work, like pilot work or animal studies, for this kind of study to be approved, it can't be "have a trauma research idea, jump straight into large-scale testing it on people."). The researchers may be called in to justify their study plans or answer questions.
We talk about the community consultation plans. From what I can tell, the basics are pretty similar in various cities - community meetings, newspaper notices and articles, bus ads, radio ads, billboards, advertisements in community centers. In my city, this always involves consultation with the city humans rights commission to develop and carry out the plan. If the research is on a specific condition where you can identify community expertise - say, a support group or a clinic - you might go and give a presentation to that group. There's usually some sort of opt-out bracelet, although honestly I personally can't imagine that piece of it is terribly effective.
Assuming you get through all that and the study approved, you're also going to have at least three levels of oversight on an ongoing basis. One, your study sponsor is going to require periodic reports. Two, the IRB will require the researchers to establish a data monitoring committee that's independent of the research team, that will do periodic review of the study. Three, the IRB itself will do ongoing review. By regulation this has to happen at least yearly, but in practice, at least in the first year it's definitely going to be more often. I've seen this look like "we want to see you back here every three months" or "we want to see you back here with a report after each of the first five patients" or whatever the committee thinks is appropriate. The researcher then has to report back on how many people were enrolled, where they are in the process and what the outcomes were, whether the researchers were able to get consent afterwards, whether they've lost contact with any participants or any have died and if so details on what happened, etc.
That's generally how it works. To some specific topics:
- Payment for e.g. lifelong disability: This isn't discussed enough, in my view. I haven't seen one of these cross my desk in a while but my recollection is that the sponsor is generally on the hook for costs associated with the intervention and any resulting injury. Generally speaking, sponsor and hospitals *really* don't want the bad press of having someone get injured in their research and then getting bankrupted by medical bills from it, and will waive a lot of fees. But I can imagine a situation where the sponsor might balk or try to limit their exposure in some way if this actually happened. There's no way I'd find out about it unless the person or their family came back and filed an IRB complaint, so all I can say is I'm not aware of any case where this has been tested. This is an area where an IRB committee doesn't hold a lot of sway; generally, universities and hospitals and sponsors all have standard language that's been lawyered to death about what injuries will and won't be covered, and IRBs can't do much to budge them. I'd like to see this change.
- History of racist and ableist medical experimentation: I don't think IRBs get enough training on this. This may have improved in recent years as it's been a long time since my onboarding, but my experience is generally that if you join up with an IRB you get a broad "history of research ethics" intro training, plus occasional ongoing refreshers. They're not in depth. If you know about Nazi medical experimentation, Tuskegee, Willowbrook, and the Tearoom Trade study, you probably know about as much as IRB committee members are required to know. In my city, I'm not aware of any training that specifically addresses the racist history of *this* city. Personally, I'm both deeply interested in this topic and also think it's a matter of personal responsibility to learn as much as I can about it if I'm going to be in the professional positions I'm in, so I do a lot of reading on my own and suspect I know more than most of my fellow committee members about a lot of really bad shit. I'd say that these topics come up a lot when we're talking about doing research in different cultures, like foreign countries or Native American reservations, but it rarely comes up when we're talking about this kind of research being done in our city. We do talk about the researcher's expected participant demographics and whether they're substantially different from the people we would expect to benefit from the research results if they work out, but I don't honestly get the feeling that a lot of researchers put enough time into that section of their applications For example, in our extremely white city, if you say that you expect your study population to be 90% black because of the neighborhoods you're going to work in or the condition you're studying, that will get attention and discussion. But that requires the researcher to be cognizant enough of the issues involved to answer that question accurately and not just hand-wave it, or for the committee to recognize that the three hospitals the study is happening at are the hospitals in poor black neighborhoods, and to ask the right questions about that.
I don't know that any of this is the right answer. I do know that it's one of the most serious things I run into as an IRB member. I wasn't prepared for it the first time I ran into it in a committee; it wasn't something I was trained for in advance or understood the nuances or process for, it was just sort of "oh, here is how we do this." I'd have liked some focused training on what the process looks like and what the laws are and what the ethical considerations are. And actually, this has been a really good thread in making me verbalize that, and I think I'm going to go off and suggest to my committee that they make this a focused topic for one of the mini-education sessions they do at the beginning of each meeting.
Ugh. Sorry. This got so long. Apparently we've hit one of those things I care a lot about and don't know how to shut up about . But I will shut up right....now.
posted by Stacey at 7:42 AM on November 21, 2019 [23 favorites]
Process first: A study like this is always going to come to a full IRB committee for review, rather than go through one of the shortcut pathways for less risky research. First the full-time IRB staff are going to work with the researcher to get it to a state where they think it's potentially approvable and are comfortable sending it to committee. Then one committee reviews the study and sends it back with a list of required changes including directives to change the community plan if they think it's insufficient. Then the community consultation process happens. Then the researchers go back to a committee (could be the same or a different committee) and say "here's a report on what we did and what the community comments were, here's how we have changed our study plan to address them, now can we do our study?" And then maybe it gets approved or maybe it goes through multiple more rounds of review and/or community consultation. These things can kick around for a long time.
The committees are required to have relevant medical expertise. They are also required to include non-scientists, and to include people from "the community" rather than just faculty/staff of the university/hospital in question. In theory that's one of the ways that the review board can be sure it's considering what an average non-medical non-research person might think about the study. This sort of works - the community members' thoughts are given a lot of weight, and in the times when I've been in a community role, I've been able to make positive changes in studies related to things like mental health, sexual orientation, and gender by bringing perspectives that otherwise wouldn't have been at the table. That said, I will be the first to say that if I work at one university up the street, and am a "community" member at the university IRB three blocks away, I'm not exactly bringing a wealth of demographic and experiential difference to the table. (Shameless plug here: most IRBs are *desperate* for community members. If you're curious about how this stuff works and you'd find it interesting to have a hand in research that affects your community, and you might be able to volunteer a few hours a month to the cause, if you call up your local IRB you could probably get involved, and maybe help broaden that community member experience pool a bit!)
So, all that happens and you're in a committee room and one of these studies hits your agenda. In my experience, committees devote a lot more time to these emergency trauma studies than most studies. Typically the people with the medical expertise will lead the discussion since they are the ones who can vouch to the rest of us for whether this study meets the medical criteria for this kind of approval - for example, studies like this can't be denying anyone an known effective treatment. We rely on the medical expertise (and the researcher's documentation, but more so the expertise in the room) to convince us that the situation in the study is one where there is no proven effective treatment or where the research to be done doesn't seriously increase the participant's risk over what's already being done to them in a trauma setting. (That last one obviously doesn't apply in the study we're talking about here, but does in some studies.) The medical expert also walks the committee through the data supporting the study (there needs to be some reasonable basis for believing it will work, like pilot work or animal studies, for this kind of study to be approved, it can't be "have a trauma research idea, jump straight into large-scale testing it on people."). The researchers may be called in to justify their study plans or answer questions.
We talk about the community consultation plans. From what I can tell, the basics are pretty similar in various cities - community meetings, newspaper notices and articles, bus ads, radio ads, billboards, advertisements in community centers. In my city, this always involves consultation with the city humans rights commission to develop and carry out the plan. If the research is on a specific condition where you can identify community expertise - say, a support group or a clinic - you might go and give a presentation to that group. There's usually some sort of opt-out bracelet, although honestly I personally can't imagine that piece of it is terribly effective.
Assuming you get through all that and the study approved, you're also going to have at least three levels of oversight on an ongoing basis. One, your study sponsor is going to require periodic reports. Two, the IRB will require the researchers to establish a data monitoring committee that's independent of the research team, that will do periodic review of the study. Three, the IRB itself will do ongoing review. By regulation this has to happen at least yearly, but in practice, at least in the first year it's definitely going to be more often. I've seen this look like "we want to see you back here every three months" or "we want to see you back here with a report after each of the first five patients" or whatever the committee thinks is appropriate. The researcher then has to report back on how many people were enrolled, where they are in the process and what the outcomes were, whether the researchers were able to get consent afterwards, whether they've lost contact with any participants or any have died and if so details on what happened, etc.
That's generally how it works. To some specific topics:
- Payment for e.g. lifelong disability: This isn't discussed enough, in my view. I haven't seen one of these cross my desk in a while but my recollection is that the sponsor is generally on the hook for costs associated with the intervention and any resulting injury. Generally speaking, sponsor and hospitals *really* don't want the bad press of having someone get injured in their research and then getting bankrupted by medical bills from it, and will waive a lot of fees. But I can imagine a situation where the sponsor might balk or try to limit their exposure in some way if this actually happened. There's no way I'd find out about it unless the person or their family came back and filed an IRB complaint, so all I can say is I'm not aware of any case where this has been tested. This is an area where an IRB committee doesn't hold a lot of sway; generally, universities and hospitals and sponsors all have standard language that's been lawyered to death about what injuries will and won't be covered, and IRBs can't do much to budge them. I'd like to see this change.
- History of racist and ableist medical experimentation: I don't think IRBs get enough training on this. This may have improved in recent years as it's been a long time since my onboarding, but my experience is generally that if you join up with an IRB you get a broad "history of research ethics" intro training, plus occasional ongoing refreshers. They're not in depth. If you know about Nazi medical experimentation, Tuskegee, Willowbrook, and the Tearoom Trade study, you probably know about as much as IRB committee members are required to know. In my city, I'm not aware of any training that specifically addresses the racist history of *this* city. Personally, I'm both deeply interested in this topic and also think it's a matter of personal responsibility to learn as much as I can about it if I'm going to be in the professional positions I'm in, so I do a lot of reading on my own and suspect I know more than most of my fellow committee members about a lot of really bad shit. I'd say that these topics come up a lot when we're talking about doing research in different cultures, like foreign countries or Native American reservations, but it rarely comes up when we're talking about this kind of research being done in our city. We do talk about the researcher's expected participant demographics and whether they're substantially different from the people we would expect to benefit from the research results if they work out, but I don't honestly get the feeling that a lot of researchers put enough time into that section of their applications For example, in our extremely white city, if you say that you expect your study population to be 90% black because of the neighborhoods you're going to work in or the condition you're studying, that will get attention and discussion. But that requires the researcher to be cognizant enough of the issues involved to answer that question accurately and not just hand-wave it, or for the committee to recognize that the three hospitals the study is happening at are the hospitals in poor black neighborhoods, and to ask the right questions about that.
I don't know that any of this is the right answer. I do know that it's one of the most serious things I run into as an IRB member. I wasn't prepared for it the first time I ran into it in a committee; it wasn't something I was trained for in advance or understood the nuances or process for, it was just sort of "oh, here is how we do this." I'd have liked some focused training on what the process looks like and what the laws are and what the ethical considerations are. And actually, this has been a really good thread in making me verbalize that, and I think I'm going to go off and suggest to my committee that they make this a focused topic for one of the mini-education sessions they do at the beginning of each meeting.
Ugh. Sorry. This got so long. Apparently we've hit one of those things I care a lot about and don't know how to shut up about . But I will shut up right....now.
posted by Stacey at 7:42 AM on November 21, 2019 [23 favorites]
That was a wonderful insight into the meat something I only had a very loose structural understanding of (there are no trauma surgeons in my family but there are *lot* of doctors so I’d overheard shop talk but that’s it). Really encouraging to hear there’s even that much of a process although yeah more and more standardized education for these things would be awesome. Thank you, seriously.
posted by Ryvar at 9:45 AM on November 21, 2019 [1 favorite]
posted by Ryvar at 9:45 AM on November 21, 2019 [1 favorite]
Psht,
I come from a family full of conservatives, we've had suspended animation my whole life!
posted by evilDoug at 12:37 PM on November 21, 2019
I come from a family full of conservatives, we've had suspended animation my whole life!
posted by evilDoug at 12:37 PM on November 21, 2019
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I. SCIENCE IS THE COOLEST AND HUMANS ARE ASTONISHING IN THEIR BRILLIANCE!!
II. please lord promise me you will just let me die when i die
posted by youarenothere at 12:16 PM on November 20, 2019 [26 favorites]