Even if her death is guaranteed by leaving it in (and I’m not sure it is without more information), does that make it ethical to remove? Perhaps the patient would prefer a shorter life with greater quality in regards to her seizures. After all, don’t we allow and accept cancer patients to forgo treatment and enjoy the time they have left?
Frankly the articles I’ve found all use a mix of really weird language. In some places it says she was ‘advised’ to remove it by doctors, which makes a lot of sense. In others they talk about finances and purchasing the implant from the company.
My guess is that it was a combination of factors and while she ultimately did not want to give up the device despite being urged by doctors (she accepted the risk of leaving it in), but she was robbed of the possibility by capitalism and the fact that the company was forced to liquidate assets as terms of going bankrupt or being bought by another company. But we might have to wait for a court case or proper reporting to find out.
I hope we are able to enshrine some rights over forced explantation in the future. As soon as a device is implanted in you, you should own it 100%, no matter the cost of the device. To encourage making this possible even for extremely expensive devices, we should probably offer huge write offs or some other incentive to these companies lest they decide to restrict their purchase to only rich clients.
It doesn’t say that. It says she was willing to pay to keep it in, which means she was willing to pay for long-term maintenance. But there was nobody willing to provide maintenance, because the company dissolved. That is why she was advised to remove the device.
the company was forced to liquidate assets
Implants generally go in the garbage after removal.
Implants that failed to gain FDA approval definitely go in the garbage after removal. Nobody else wants them, in fact the company will end up having to pay for proper disposal of medical waste.
Yes I very clearly stated what my *guess *was. Nothing says enough to determine what truly happened here. As someone who works in the medical field, I’m making an educated guess based on my knowledge of how medical devices, elective surgeries, and governing bodies work.
I mean, we should protect against that too by requiring a certain level of service. But at the very least they need to own the device and have the right to leave the device in, even if it would fail or potentially cause them harm. I pointed that out because it sounds like they wanted to leave it in and not listen to the doctors advice to remove it, but could not for some reason. The only reason I can imagine would involve someone paying for the surgery to remove it against her will is one in which she does not own the device and the alternative is being burdened with a massive debt to pay off the device.
How do you require a certain level of service when the company that made it goes out of business? Or when employees with essential knowledge leave the company? I’ve been working in software for a long time, and everywhere I’ve worked, losing someone knowledgeable about a product is a big blow to future development because a lot of important knowledge is only in their head, leaving future maintainers to do a lot of reverse engineering. Requiring documentation wouldn’t work because any company that had strict enough requirements would have a very hard time hiring engineers willing to spend so much time documenting every little thing.
You require them legally to budget and plan these things and give them harsh penalties if they fail. That they need to set aside money in a way that it can’t be touched if they go under. You’ll likely need to hire teams at the government to help fill gaps and coordinate.
I don’t think you have any idea how much money you’re talking about. The fact that you’re proposing it in the context of an experimental device that was probably never even marketed is just deranged. We’d still be stuck with 1950s-level technology if you had your way because nobody could afford to develop any new products that can’t be made in a basic machine shop.
The whole point of a clinical trial is to enroll volunteers who are willing to undergo a treatment that might not work at all and might not be available in the future even if it does work. Not only that, but you might expect to get a potential cure and end up with only a sugar pill.
If you think any of that is unreasonable, then don’t enroll in a clinical trial.
This, right here, is really important. We already have otherwise useful things being bricked because the software is no longer updated, or worse, the company goes bankrupt. If that’s our future with brain implants, that’s going to be a big problem.
Doctors remove unsafe implants and/or replace them with safer versions all the time, including devices like deep brain stimulators. I don’t see why you consider this to be a big problem.
There was a medical reason, the device was considered unsafe. Any experimental device is considered unsafe without monitoring, and monitoring was no longer available. That’s why she chose to have it removed.
Anyone who signs up for a clinical trial knows that their treatment can be discontinued at any time, even if it is helping them. For example, if an implant is helping you but is found to be harming other people, it may be considered unsafe and you may be advised to remove it. In fact, a different article suggested that other patients were experiencing adverse effects from this experimental implant. This might even be why the company couldn’t get their product approved and eventually lost funding.
I think “forced” is doing a lot of heavy lifting here. People use it to refer to unpleasant decisions, like “I was forced to leave New York City after I lost my job”.
Others have speculated that she may have been denied health insurance coverage unless she had it removed. That’s not much of a choice when you’re an old disabled woman.
Classify them however you want, they have nothing to do with your eligibility for health insurance.
In fact, ACA health plans must enroll anyone who wants to enroll. They cannot decline an individual renewal. A premium can only be adjusted according to age and tobacco use. And they cannot charge old people more than three times what they charge young people.
They can’t deny claims based on anything in your previous history. They can’t use your history of medical conditions, history of implants, history of drug use, history of pregnancy, history of employment, history of not wearing seat belts, history of anything.
They can say, “We won’t pay for this MRI” or “We won’t pay for this drug”, but that would be true of everyone else on the same plan, regardless of whether they had an implant.
More typically, they say “We only pay for a certain number of MRIs per year” or “You have to get a cheap Xray instead of an expensive MRI” or “You have to try the cheap drug, if that doesn’t work then you can try the expensive one” or “We need to be notified 30 days prior to getting the drug, otherwise we won’t pay” or “You can only get the MRI at this other location, otherwise we won’t pay”.
None of this has to do with your medical history, though. They are simply annoying hoops that everyone has to jump through. And they can never, ever, say “We will pay for X only if you remove the implant, otherwise we won’t pay for X”. If they are paying for X for anyone else on her plan, then they have to pay for hers too.
It sits on the edge of the concept of informed consent in the realm of things like SaaS and copyright. Obviously doctors wouldn’t hold her down and pull it out, but obviously it probably was not useful to leave in. I wonder if there was a contract stating it had to be removed upon demand, like at the end of a trial or the bankruptcy that occurred. It’s something that we’re going to likely see in the future, as medical technology starts using computers to actively treat disorders.
Even if her death is guaranteed by leaving it in (and I’m not sure it is without more information), does that make it ethical to remove? Perhaps the patient would prefer a shorter life with greater quality in regards to her seizures. After all, don’t we allow and accept cancer patients to forgo treatment and enjoy the time they have left?
Frankly the articles I’ve found all use a mix of really weird language. In some places it says she was ‘advised’ to remove it by doctors, which makes a lot of sense. In others they talk about finances and purchasing the implant from the company.
My guess is that it was a combination of factors and while she ultimately did not want to give up the device despite being urged by doctors (she accepted the risk of leaving it in), but she was robbed of the possibility by capitalism and the fact that the company was forced to liquidate assets as terms of going bankrupt or being bought by another company. But we might have to wait for a court case or proper reporting to find out.
I hope we are able to enshrine some rights over forced explantation in the future. As soon as a device is implanted in you, you should own it 100%, no matter the cost of the device. To encourage making this possible even for extremely expensive devices, we should probably offer huge write offs or some other incentive to these companies lest they decide to restrict their purchase to only rich clients.
It doesn’t say that. It says she was willing to pay to keep it in, which means she was willing to pay for long-term maintenance. But there was nobody willing to provide maintenance, because the company dissolved. That is why she was advised to remove the device.
Implants generally go in the garbage after removal.
Implants that failed to gain FDA approval definitely go in the garbage after removal. Nobody else wants them, in fact the company will end up having to pay for proper disposal of medical waste.
Yes I very clearly stated what my *guess *was. Nothing says enough to determine what truly happened here. As someone who works in the medical field, I’m making an educated guess based on my knowledge of how medical devices, elective surgeries, and governing bodies work.
Owning the device doesn’t help if it requires regular maintenance and there’s nobody able to do it anymore.
I mean, we should protect against that too by requiring a certain level of service. But at the very least they need to own the device and have the right to leave the device in, even if it would fail or potentially cause them harm. I pointed that out because it sounds like they wanted to leave it in and not listen to the doctors advice to remove it, but could not for some reason. The only reason I can imagine would involve someone paying for the surgery to remove it against her will is one in which she does not own the device and the alternative is being burdened with a massive debt to pay off the device.
How do you require a certain level of service when the company that made it goes out of business? Or when employees with essential knowledge leave the company? I’ve been working in software for a long time, and everywhere I’ve worked, losing someone knowledgeable about a product is a big blow to future development because a lot of important knowledge is only in their head, leaving future maintainers to do a lot of reverse engineering. Requiring documentation wouldn’t work because any company that had strict enough requirements would have a very hard time hiring engineers willing to spend so much time documenting every little thing.
You require them legally to budget and plan these things and give them harsh penalties if they fail. That they need to set aside money in a way that it can’t be touched if they go under. You’ll likely need to hire teams at the government to help fill gaps and coordinate.
I don’t think you have any idea how much money you’re talking about. The fact that you’re proposing it in the context of an experimental device that was probably never even marketed is just deranged. We’d still be stuck with 1950s-level technology if you had your way because nobody could afford to develop any new products that can’t be made in a basic machine shop.
You asked how it might work, you didn’t say it had to be practical lmao
The whole point of a clinical trial is to enroll volunteers who are willing to undergo a treatment that might not work at all and might not be available in the future even if it does work. Not only that, but you might expect to get a potential cure and end up with only a sugar pill.
If you think any of that is unreasonable, then don’t enroll in a clinical trial.
This, right here, is really important. We already have otherwise useful things being bricked because the software is no longer updated, or worse, the company goes bankrupt. If that’s our future with brain implants, that’s going to be a big problem.
Doctors remove unsafe implants and/or replace them with safer versions all the time, including devices like deep brain stimulators. I don’t see why you consider this to be a big problem.
Because every surgery has risks, including simple ones. In this case, there would be no direct medical reason to do so.
There was a medical reason, the device was considered unsafe. Any experimental device is considered unsafe without monitoring, and monitoring was no longer available. That’s why she chose to have it removed.
Anyone who signs up for a clinical trial knows that their treatment can be discontinued at any time, even if it is helping them. For example, if an implant is helping you but is found to be harming other people, it may be considered unsafe and you may be advised to remove it. In fact, a different article suggested that other patients were experiencing adverse effects from this experimental implant. This might even be why the company couldn’t get their product approved and eventually lost funding.
She was advised to remove it.
I think “forced” is doing a lot of heavy lifting here. People use it to refer to unpleasant decisions, like “I was forced to leave New York City after I lost my job”.
Others have speculated that she may have been denied health insurance coverage unless she had it removed. That’s not much of a choice when you’re an old disabled woman.
In the US, you can’t be denied health insurance based on your medical history. Thanks, Obama! No really, thank you.
She’s Australian. They have universal healthcare, so @MadMenace’s theory probably isn’t the case here.
I somehow doubt elective, experimental electronic implants are classified as a “pre-existing condition.”
Classify them however you want, they have nothing to do with your eligibility for health insurance.
In fact, ACA health plans must enroll anyone who wants to enroll. They cannot decline an individual renewal. A premium can only be adjusted according to age and tobacco use. And they cannot charge old people more than three times what they charge young people.
Sure, but insurance companies regularly deny claims for any reason they can find.
They can’t deny claims based on anything in your previous history. They can’t use your history of medical conditions, history of implants, history of drug use, history of pregnancy, history of employment, history of not wearing seat belts, history of anything.
They can say, “We won’t pay for this MRI” or “We won’t pay for this drug”, but that would be true of everyone else on the same plan, regardless of whether they had an implant.
More typically, they say “We only pay for a certain number of MRIs per year” or “You have to get a cheap Xray instead of an expensive MRI” or “You have to try the cheap drug, if that doesn’t work then you can try the expensive one” or “We need to be notified 30 days prior to getting the drug, otherwise we won’t pay” or “You can only get the MRI at this other location, otherwise we won’t pay”.
None of this has to do with your medical history, though. They are simply annoying hoops that everyone has to jump through. And they can never, ever, say “We will pay for X only if you remove the implant, otherwise we won’t pay for X”. If they are paying for X for anyone else on her plan, then they have to pay for hers too.
It sits on the edge of the concept of informed consent in the realm of things like SaaS and copyright. Obviously doctors wouldn’t hold her down and pull it out, but obviously it probably was not useful to leave in. I wonder if there was a contract stating it had to be removed upon demand, like at the end of a trial or the bankruptcy that occurred. It’s something that we’re going to likely see in the future, as medical technology starts using computers to actively treat disorders.