5 ms·

As a personal data point: about 15 years ago a close relative of mine (in his 90s) was going blind (I think from MD, but not 100% sure) with no cure, at least a

by ptero 10y ago

As a personal data point: about 15 years ago a close relative of mine (in his 90s) was going blind (I think from MD, but not 100% sure) with no cure, at least at the time. He was fully self sufficient and an avid reader his whole life and knew that in 6 months his walks with grandkids, reading and in general life as he knew it would be over. He died of an acute infection (or virus) before he went blind, but I am sure that given an option with outcomes of death at 50% and keeping vision at 50% he would take it (I would, too). Regulating non-approved medical treatments out of existence might look appealing, but IMO we need to allow informed, rational people to choose unapproved treatments where no approved one exists. Much better to have full disclosure and informed consent (FDA would not approve a treatment with 50% death/health outcome, but some people would gladly take it). My 2c.

aleksei 10y ago
How do you ascertain someone is informed and rational? Where's the line between unapproved treatment and snake oil? I get your point, but the specifics are way more nuanced and difficult to get right than you make them out to be, even without getting into the ethical considerations of unproven medicine that extend beyond the individuals.
djsumdog 10y ago
But without formal studies, you can't get solid data on if treatments actually work. That's why the Japanese case stated is so different. Even if you allow this therapy for people over 90, who may feel they have nothing to lose, the data from it might not really be worth anything because you don't have the standard controls, placebos, etc. There needs to be several rounds of animals testing first, formal procedure and clear indications to the patients of the risks. Elderly people over 80 are in some ways ideal (less to lose; depending on how you measure life/quality of life) and could have treatment in only one eye, but are also less than ideal since their could be a higher rate of failure simply due to their age and the inability of their bodies to accept treatment. For something to be a treatment, it has to work consistently, with the same success rates and documented side-effects across a population. There is a reason those studies are slow and take time, because we try to be careful today when dealing with human life and not be Nazi/MKUltra scientists.
gwbas1c 10y ago
Uhhh, the idiots who performed this procedure operated on both eyes. (And I stress the word "idiots" here.) You don't perform an experimental procedure on both eyes. This is just basic common sense. Even if there was a promising experiment for your grandfather, it would only be performed on one eye.
- M_Grey 10y ago
  For that alone, everyone involved should lose their licenses to practice anything, up to and including simple musical instruments. It has to be one of the most basic concepts in modern medicine that the eye is fragile, precious, and if you must screw around with them, leave one at least.
- Elrac 10y ago
  Cynically, I'd like to counter that the procedure was not experimental but well-proven. As the quacks informed us, they've successfully performed thousands such interventions. To make my above statement true, you need only consider what defines "success" from the point of view of the quack clinics. In each case, the treatment achieved its primary goal, which was to part desperate people from their money. The treatment's effect on their vision was a side effect. For the same reason, I wouldn't dignify the procedure with the "experimental" label. When you say an approach is experimental you're implying that it's being performed under carefully controlled and monitored conditions to improve the state of medical knowledge. It sounds to me like this isn't at all what those treatments are about.
Para2016 10y ago
Injecting fat "stem cells" into the eye without any evidence behind such a procedure working is irresponsible and just quackery. Selling desperate people what amounts to snake oil for $50,000 should be criminal and definitely should be regulated.
hannob 10y ago
> but I am sure that given an option with outcomes of death at 50% and keeping vision at 50% he would take it (I would, too). Sure. But this has nothing to do with the scenario of an unproven stem cell therapy. There the chances are 99,99999% vs. 0.00001%. > Regulating non-approved medical treatments out of existence might look appealing, but IMO we need to allow informed, rational people to choose unapproved treatments where no approved one exists. This is a really bad idea, and your comment ideally shows why that's the case. You're selling people the idea that they have something like a 50/50 chance. But that's a complete illusion. Even 10/90 is an illusion. The chances of a completely unproven therapy to do any good are practically zero. It's different if you have early stage interventions that have some weak evidence behind them. But there are already mechanisms to cover that. The right thing to handle that is to add people to a study.
- stagbeetle 10y ago
  > Sure. But this has nothing to do with the scenario of an unproven stem cell therapy. There the chances are 99,99999% vs. 0.00001%. > This is a really bad idea, and your comment ideally shows why that's the case. You're selling people the idea that they have something like a 50/50 chance. But that's a complete illusion. Even 10/90 is an illusion. The chances of a completely unproven therapy to do any good are practically zero. The 50/50 is for sake of practicality, it's not the main point. The point is some people would take unproven treatments if it meant they had any chance to improve their quality of life. See: The man who's having his head transplanted. I've been in this situation before where all approved methods had failed me. I was extremely desperate to find something that would help, so I was vulnerable to con men (and they made a killing off me from "homeopathic remedies"), but when I settled down with a clear and rational head, I decided that I would be worse off if I continued living in my pathetic state. So, I did my due diligence and interviewed every treatment that looked promising (after doing research on my disease). Even though they were all "out there" I found one I was confident in and signed up. There was no guarantee I was going to be better, only that there'd be a $60k hole in my pocket. To make a long story short, it improved my condition to a manageable state and I'm very happy with the results. I've never been a proponent of restriction, only proper education. If someone is properly educated on the possible harms and how to avoid them, then why shouldn't they be allowed to take a course they believe would benefit them (without hurting anyone else)? The problem that's being discussed here, though, is that the clinic had a power imbalance (partly due to lack of proper education on the subject) and preyed against these three women. Perhaps if they were informed properly (due to regulation on full disclosure) they might have been better off.
elif 10y ago
This was for macular degeneration. My family has it, and all of my elders affected still drive cars and most read normal typeface. Maybe in reality these patients were extreme cases, but the article didn't present them as such.
bdavisx 10y ago
I don't completely disagree, but if these clinics are anything like the "nutritional supplement" racket (e.g. mannatech and others like them), then there's no informed consent. There's a lot of lies and promises about completely unproven bs that unlike the supplement market, is much more dangerous. While the field may not need full blown regulation like the regular pharmaceutical industry, I'm guessing it needs something more than what exists now.
joshmarlow 10y ago
> Regulating non-approved medical treatments out of existence might look appealing, but IMO we need to allow informed, rational people to choose unapproved treatments where no approved one exists. The difficult part is the word "..informed,...". Without regulation, how can you enforce the research and data collection and sharing needed to estimate the efficacy of the treatment? And without a good estimate of the risks and efficacy, how can you make an informed decision? Granted it's a bit of a chicken and egg scenario; you need data before you can make an informed decision, but you need experiments before you can get data. I'm actually pretty comfortable with letting people at the end of their lives try unproven experimental treatments; but we need to ensure that we as a society learn from those experiments so they won't always be unproven and experimental; so the first 100 people taking a treatment know it's a toss-up on results; the next 100 people know there's a 15% chance of improvement/10% chance of death. I fear that without adequate regulation, there would be little incentive to track what worked and what didn't.
- narrator 10y ago
  I think a good compromise for these experimental procedures is to not be able to charge patients until the technique has at least some clinical data showing that it works. The creator of the procedure would then have some intellectual property rights over the procedure for sometime afterwards.

by ptero 10y ago

aleksei 10y ago

How do you ascertain someone is informed and rational? Where's the line between unapproved treatment and snake oil? I get your point, but the specifics are way more nuanced and difficult to get right than you make them out to be, even without getting into the ethical considerations of unproven medicine that extend beyond the individuals.

djsumdog 10y ago

But without formal studies, you can't get solid data on if treatments actually work. That's why the Japanese case stated is so different. Even if you allow this therapy for people over 90, who may feel they have nothing to lose, the data from it might not really be worth anything because you don't have the standard controls, placebos, etc. There needs to be several rounds of animals testing first, formal procedure and clear indications to the patients of the risks. Elderly people over 80 are in some ways ideal (less to lose; depending on how you measure life/quality of life) and could have treatment in only one eye, but are also less than ideal since their could be a higher rate of failure simply due to their age and the inability of their bodies to accept treatment. For something to be a treatment, it has to work consistently, with the same success rates and documented side-effects across a population. There is a reason those studies are slow and take time, because we try to be careful today when dealing with human life and not be Nazi/MKUltra scientists.

gwbas1c 10y ago

Uhhh, the idiots who performed this procedure operated on both eyes. (And I stress the word "idiots" here.) You don't perform an experimental procedure on both eyes. This is just basic common sense. Even if there was a promising experiment for your grandfather, it would only be performed on one eye.

M_Grey 10y ago
For that alone, everyone involved should lose their licenses to practice anything, up to and including simple musical instruments. It has to be one of the most basic concepts in modern medicine that the eye is fragile, precious, and if you must screw around with them, leave one at least.
Elrac 10y ago
Cynically, I'd like to counter that the procedure was not experimental but well-proven. As the quacks informed us, they've successfully performed thousands such interventions. To make my above statement true, you need only consider what defines "success" from the point of view of the quack clinics. In each case, the treatment achieved its primary goal, which was to part desperate people from their money. The treatment's effect on their vision was a side effect. For the same reason, I wouldn't dignify the procedure with the "experimental" label. When you say an approach is experimental you're implying that it's being performed under carefully controlled and monitored conditions to improve the state of medical knowledge. It sounds to me like this isn't at all what those treatments are about.

Para2016 10y ago

Injecting fat "stem cells" into the eye without any evidence behind such a procedure working is irresponsible and just quackery. Selling desperate people what amounts to snake oil for $50,000 should be criminal and definitely should be regulated.

hannob 10y ago

> but I am sure that given an option with outcomes of death at 50% and keeping vision at 50% he would take it (I would, too). Sure. But this has nothing to do with the scenario of an unproven stem cell therapy. There the chances are 99,99999% vs. 0.00001%. > Regulating non-approved medical treatments out of existence might look appealing, but IMO we need to allow informed, rational people to choose unapproved treatments where no approved one exists. This is a really bad idea, and your comment ideally shows why that's the case. You're selling people the idea that they have something like a 50/50 chance. But that's a complete illusion. Even 10/90 is an illusion. The chances of a completely unproven therapy to do any good are practically zero. It's different if you have early stage interventions that have some weak evidence behind them. But there are already mechanisms to cover that. The right thing to handle that is to add people to a study.

stagbeetle 10y ago
> Sure. But this has nothing to do with the scenario of an unproven stem cell therapy. There the chances are 99,99999% vs. 0.00001%. > This is a really bad idea, and your comment ideally shows why that's the case. You're selling people the idea that they have something like a 50/50 chance. But that's a complete illusion. Even 10/90 is an illusion. The chances of a completely unproven therapy to do any good are practically zero. The 50/50 is for sake of practicality, it's not the main point. The point is some people would take unproven treatments if it meant they had any chance to improve their quality of life. See: The man who's having his head transplanted. I've been in this situation before where all approved methods had failed me. I was extremely desperate to find something that would help, so I was vulnerable to con men (and they made a killing off me from "homeopathic remedies"), but when I settled down with a clear and rational head, I decided that I would be worse off if I continued living in my pathetic state. So, I did my due diligence and interviewed every treatment that looked promising (after doing research on my disease). Even though they were all "out there" I found one I was confident in and signed up. There was no guarantee I was going to be better, only that there'd be a $60k hole in my pocket. To make a long story short, it improved my condition to a manageable state and I'm very happy with the results. I've never been a proponent of restriction, only proper education. If someone is properly educated on the possible harms and how to avoid them, then why shouldn't they be allowed to take a course they believe would benefit them (without hurting anyone else)? The problem that's being discussed here, though, is that the clinic had a power imbalance (partly due to lack of proper education on the subject) and preyed against these three women. Perhaps if they were informed properly (due to regulation on full disclosure) they might have been better off.

elif 10y ago

This was for macular degeneration. My family has it, and all of my elders affected still drive cars and most read normal typeface. Maybe in reality these patients were extreme cases, but the article didn't present them as such.

bdavisx 10y ago

I don't completely disagree, but if these clinics are anything like the "nutritional supplement" racket (e.g. mannatech and others like them), then there's no informed consent. There's a lot of lies and promises about completely unproven bs that unlike the supplement market, is much more dangerous. While the field may not need full blown regulation like the regular pharmaceutical industry, I'm guessing it needs something more than what exists now.

joshmarlow 10y ago

> Regulating non-approved medical treatments out of existence might look appealing, but IMO we need to allow informed, rational people to choose unapproved treatments where no approved one exists. The difficult part is the word "..informed,...". Without regulation, how can you enforce the research and data collection and sharing needed to estimate the efficacy of the treatment? And without a good estimate of the risks and efficacy, how can you make an informed decision? Granted it's a bit of a chicken and egg scenario; you need data before you can make an informed decision, but you need experiments before you can get data. I'm actually pretty comfortable with letting people at the end of their lives try unproven experimental treatments; but we need to ensure that we as a society learn from those experiments so they won't always be unproven and experimental; so the first 100 people taking a treatment know it's a toss-up on results; the next 100 people know there's a 15% chance of improvement/10% chance of death. I fear that without adequate regulation, there would be little incentive to track what worked and what didn't.

narrator 10y ago
I think a good compromise for these experimental procedures is to not be able to charge patients until the technique has at least some clinical data showing that it works. The creator of the procedure would then have some intellectual property rights over the procedure for sometime afterwards.