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Comment by aresant | Hacker News Reader

The word "treatment" in the headline made me think that this was some kind of formal study.

But in reality this is literally some Florida crank lab selling a shitty third-party procedure that takes adult stem sells derived from fat tissue, and despite the fact that the "safety and effectiveness of this procedure is unknown, all three patients received injections in both eyes."!!!

To be clear: this was not a test, this was not a study, this was literally three old ladies being sold on a completely unproven "stem cell" procedure by a Florida for-profit clinic.

And apparently there are 100s of these clinics being run all over America with essentially no evidence / clinical trials / etc behind their treatments:

http://www.npr.org/sections/health-shots/2016/09/05/49137294...

I remain stunned at the things that are heavily regulated in America vs not.

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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.

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.

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.

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.

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.

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.

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.

> 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.

> 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.

In your view, though, blame will always lie elsewhere. It's either with the uneducated blind women, or, if you're a generous soul, the society that failed to properly educate them.

Somehow the back alley quack with the completely unrested remedy evades all blame for their actions.

Quackery has a supply side and a demand side. The supply side is easier to deal with. It's a smaller target. Furthermore, it's in the interest of the quack to produce misinformation that your education programs will be in competition with.

> In your view, though, blame will always lie elsewhere.

This is contrary to what I said, but I wasn't clear. Let me elaborate:

> Perhaps if they were informed properly (due to regulation on full disclosure) they might have been better off.

What statements the clinic puts out should be regulated, just like supplements. You are not allowed to say some things, but required to say other things.

> It's either with the uneducated blind women, or, if you're a generous soul, the society that failed to properly educate them.

The blind women is partly to blame (though dependent on her ability to research -- an 90 y/o alzheimer's patient is much much much less to blame than a 25 y/o office worker) for being taken advantage of. The clinic, however, holds the majority of the blame for practicing deceptive procedures and misinforming (if they indeed had misinformed, I only skimmed the article).

> Quackery has a supply side and a demand side. The supply side is easier to deal with. It's a smaller target.

This is true, but it does not bring about the best outcomes. Proper medical procedures (as accepted and enforced by regulatory agencies) are most of the time years behind in implementing new and better techniques (or not incentivized to, see: europe vs. american models of health treatment).

You hurt: the people to whom accepted practices do not offer relief, the research of "unethical" procedures that could otherwise save lives if there was no stigma (again, see: head transplant), and people's freedom of choice.

The problem with 'freedom of choice' is the assumption that you are equipped enough to handle the information. There is a general assumption among us educated that given time and energy, we can understand anything logically without our biases hurting the process.

In reality, we are not equipped. We are not even equipped to analyze day to day news that we receive (if you consider all the biases, journalistic mistakes and private interest media/websites). We just don't have the time to do the same job as a fully trained doctor / FDA certifier would. We might convince ourselves based on some outliers, but in reality - specialization has been the key to address the ever expanding scope of knowledge today.

Anecdotally, When I was a kid, there used to be pretty much a physician or a surgeon in India. They handled 99% of cases compared to today when every body part has a specialist. That's the scope of knowledge spread - It is very trivializing to assume that we can jump in and figure it all out better than the experts.

I am glad that your non-approved treatment worked out. But it is anecdotal - there are a million other equivalents where it didn't. This spans people with intelligence of all ranges. Cornered people would be will do almost anything based on how they perceive the current threat. The fact that they convince themselves that they are making the right call, doesn't make it right.

> this has nothing to do with the scenario of an unproven stem cell therapy. There the chances are 99,99999% vs. 0.00001%.

You can't just say that unproven treatments never work. Did you even read the article? There's an example of an unproven stem cell therapy that may have worked right there!

No, there is an example of a careful study showing promise. The unproven treatment is the one that made three people blind, don't mix them up.

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.

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.

> 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.

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.

> I remain stunned at the things that are heavily regulated in America vs not.

Yes. This looks like a clear example where a regulation in place, and enforced, can save lives.

> "The inaction by the FDA not only puts many patients at serious risk from unproven stem cell offerings, but also it undermines the agency's credibility," Knoepfler wrote in an email.

This is part of the goal, I guess. To cripple regulatory agencies and then close them because they aren't effective is a widely used tactic.

I hope there is a bright future for stem cell medicine, but regulations should be included in that future so it serves citizens and not just for-profit organisations.

> but regulations should be included in that future so it serves citizens

Regulations rarely serve citizens. They usually serve special interest groups.

Citation needed. I can think of quite a few food, consumer, financial, medical, and environmental regulations that directly serve me and my fellow citizens.

I don't consider my desire to live in a pollution-free environment to be a "special interest".

You really don't seem to remember or have been alive before a lot of these regulations were put into effect. Ever look at a food nutrition label? That one was fought tooth and nail.

Still being fought. Trans fats can be listed as 0g as long as it's <=0.5g. Sugar still has no % DV. Many other things the industry fights against.

> Sugar still has no % DV.

Because medically, that's a complicated question.

The 25-40mg/day number that's often cited is for added sugar, not inclusive of all sugar in food. That's something that's a little trickier to evaluate for processed food[0], and it varies a lot more between people than other substances for which a recommended daily value is listed.

[0] For example, fruit juice can have no sugar added, but still contain what are likely unhealthy levels of sugar depending on the serving size

> Because medically, that's a complicated question.

That fine, but with all the misdirection around sat/trans fats, and the current global obesity epidemic, I find it hard to believe the industry is solely concerned about reducing consumer confusion (IIRC, that's their stated reasoning) around a % DV for sugar.

That is, we need some kind of yard stick for sugar, because what we have now is not sufficient for the problems our society has. It may not be % DV, but off the top of my head, say relative sugar ratio to other food products in the same category. But that can be gamed as well since there're only a handful of independent companies in the industry.

> It may not be % DV, but off the top of my head, say relative sugar ratio to other food products in the same category. But that can be gamed as well since there're only a handful of independent companies in the industry.

Right now, there isn't sufficient medical consensus to require labeling. A metric that is trivial to game can be far worse than not having one at all, as is picking a metric that ultimately turns out to be incorrect and counterproductive.

We know that, broadly, "too much added sugar isn't good". But we don't know exactly how much, or what the tradeoffs are with "replacing" added sugar with natural sugar (by substituting foods in diets), or with replacing added sugar with various sugar substitutes, or even if there is a meaningful difference between the different kinds of sugar (sucrose, glucose, fructose, etc.). There are speculations with some evidence to suggest reasonable hypotheses, but prematurely acting on those hypotheses has very far-reaching consequences.

I'm always gobsmacked when anyone fights against labeling requirements. If you don't want people knowing what's in your stuff, should you really be selling it to them?

It's been really interesting to watch the fight over GMO labeling. A lot of people who I'd normally consider to be on "my side" in this (pro-GMO) are strongly against labeling requirements.

Granted, GMO labeling requirements are essentially a "give an inch" scenario. Since there is no logical reason why GMO would be the deciding factor between safe and unsafe versions of a plant (especially since the resulting plant is tested in the same way as common produce), it really seems asinine to require the labeling. Requiring GMO labeling legitimizes hooplah; and opens the door to labeling requirements for almost any dumb, irrelevant characteristic of the product. This also introduces tonnes of new requirements up and down the supply chain, it's not just about labeling at that point, because now you have to be able to prove that you don't need the label.

Then there's the problem of the commercial code. If you say it's GMO, so that you don't get sued by GMO paranoids, then you could be sued by sane people for selling goods of a different description than the one on the label (by just saying it's GMO to be safe).

if it is GMO, is it not reasonable to assume it is likely to have more herbicide/pesticide particles?

I don't think that assumption can be made, no. My understanding is that the purpose is generally not to be able to put more pesticide on the crop, but for the crop to react less to the amount of pesticide necessary to provide the desired environment for the plant; and this is only in the case of pesticide-resistance modifications. There are, for example, GMO rice strains which are intended to increase yield in pesticide-free crops, and in cooler climates than typically desired for rice.

Regarding herbicide: "By 2016 there was a 100-fold increase from the late 1970s in the frequency of applications and volumes of glyphosate-based herbicides (GBHs) applied, partly in response to the unprecedented global emergence and spread of glyphosate-resistant weeds.[5]:1"

[0] https://en.wikipedia.org/wiki/Glyphosate

But i was mistaken on pesticides, the GM for plants to create Bacillus thuringiensis bacteria leads to a reduction in the requirement of pesticide.

EDIT: but this is not about what two HN commenters believe to be right or wrong, it's about the ability for consumers to discern for themselves what is right or wrong.

I agree with your closing point, but I think there's a distinction to be drawn between labeling for pesticide/herbicide residue rates, and labeling for GMO. There's nothing about GMO that requires the use of pesticide, and some GMOs are intended to eliminate the need for pesticide application. If they change the microbiome or gross chemical composition of the plant, then that's a different matter altogether.

So why these "special interest groups" do everything they can to avoid regulations laws being passed?

"If all men were angels, no government would be necessary." -James Madison

Hence effective, nuanced regulation is absolutely vital and libertarianism is an illusionary utopia like communism, with sensible and practical being somewhere in the middle.

Libertarianism comes from the left, first used by an anarcho-communist. Between libertarianism and communism there's nothing....

Yes, I know what you mean, but this is a pet peeve of mine. Right-wing libertarianism differ from left-wing libertarianism in the view on property in particular.

But neither see regulation as always unacceptable, but "just" want government actions to maximize liberty. This can lead to very different outcomes depending on how you think.

E.g. food safety regulations will restrict the liberty of both seller and buyer. But at the same time if properly done they protect the buyer against potentially far worse damage to liberty - ultimately potentially costing the buyers life. The seller on the other hand at worst suffers a loss of revenue.

There are further few cases where the buyer would knowingly and willingly buy unsafe food without intending to put others at the risk of harm. As such the ultimate consumer's liberty is likely to be at greater risk than the sellers liberty in the absence of regulation.

Weighing the relative impact on liberty, some degree of food safety rules would seem to be the lesser evil. I'm not saying that's the only alternative or right intrpretation, but that libertarianism in general is more complicated than just stripping all rules.

Stripping the wrong regulation can have a greater negative than positive impact on liberty

Maybe instead of trying to write specific regulations for every little thing, we should just equalize this imbalance of damage.

If a seller's misbehavior causes a buyer's death, then consider that as murder. If it's premeditated, execute the people responsible.

OK, I don't really think this would be a good idea, but I do think it's worth at least thinking about how that would look and why we don't do it. Why is it that the alternative to regulation must always be "caveat emptor"? If a company deliberately sells a faulty product that kills a customer, they should be treated just like a common criminal who breaks into someone's house and shoots them. From this perspective, regulations are as much about protecting the sellers as it is about protecting the buyers.

When the seller knows that will be the result, that basically is what happens.

The problem is that most accidents are accidents. You can't deter someone from causing something they don't expect to happen.

And if they aren't deterred then they have to pay for the damages, but it's easy to cause more damage than you have money to pay for it. So we end up on a quest to solve that problem without destroying individuals and small businesses (which would be destroyed immediately by e.g. a large bonding requirement).

Do you have an example of someone being executed because they intentionally sold a faulty product?

We have laws against negligence as well. You absolutely can deter people from accidentally getting people killed to some extent, or at least our laws seem to think we can.

Someone guilty of involuntary manslaughter can't pay back the damage they've done, but we still punish them under the theory that this encourages people to take some care when other people's lives might be at risk.

If making sellers responsible for accidental death and injury would destroy individuals and small businesses, this just reinforces my point that regulations protect sellers as much as buyers.

> Do you have an example of someone being executed because they intentionally sold a faulty product?

If a pharmacist decides she really hates Bob and is going to swap his medicine for poison, she goes down for murder. That obviously doesn't happen very often because the penalty for murder is high and serves as a very effective deterrent to intentional killings like that.

> We have laws against negligence as well. You absolutely can deter people from accidentally getting people killed to some extent, or at least our laws seem to think we can.

It's not that you can't deter some of them, it's that you can't deter enough of them, because they aren't doing it on purpose.

> If making sellers responsible for accidental death and injury would destroy individuals and small businesses, this just reinforces my point that regulations protect sellers as much as buyers.

The problem is regulations often do the same thing. Many regulatory compliance costs are fixed -- they cost the same million dollars whether you have a billion customers or just three.

I'm not talking about an individual action like a pharmacist giving a patient poison instead of medicine. I'm talking about a corporate decision to deliberately give customers an unsafe product because it saves money. Consider the Ford Pinto for a concrete example. Or for a case where it isn't even a buyer/seller relationship, any operator of a coal power plant. They'd easily top the list of worst serial killers of all time if we counted it as murder.

> I'm talking about a corporate decision to deliberately give customers an unsafe product because it saves money. Consider the Ford Pinto for a concrete example.

The problem with those decisions is that you can't get out of them. Killing them isn't your will. It's not the same thing.

Suppose you make cars. You know that 5% of your customers will get into a serious accident, and of that 5%, if you add $1000 to the cost of each car, you can save 1% of them. So $1000/car to save one in 2000 people; two million dollars per person. If you don't do it you know that you sell 60 million cars and so 30,000 people will die. Do you do it? What if it costs $10,000/car? $50,000/car?

At some point you have to say no or a car would cost thirty trillion dollars. And if some company decides that a human life is worth 1.5 million dollars but you later decide that it should be worth 2.1 million dollars, is that really the level of mistake that deserves execution?

All you really have to do is let them know ahead of time how much money it will actually cost them in jury awards, and let the victims sue the coal companies. If you set the value right they'll either figure out how to kill fewer people, or shut down operations.

The analytic scenarios like that have never been the problem because if the company is already doing the math and you don't like the outcome then all you have to do is change the numbers. The problem has always been what to do about businesses that kill people without expecting to.

We wouldn't accept that for an individual. If a pharmacist gets a patient killed because they're deliberately putting a poison into their medicine which they estimate will only kill 0.05% of their patients, they're going to prison.

Half the medicine pharmacists administer is poison that does kill some of their patients. Read the side effects -- liver damage, hypertension, death. They know those outcomes are possible and will happen in some percentage of patients.

There is a difference between giving someone poison for no reason, or purely out of malice, vs. doing it because there is some countervailing advantage that justifies the risk. And sometimes the advantage is just that it costs less than an alternative.

People know that an old Ford Mustang isn't as safe as a new Mercedes S-Class, but it's also less expensive.

That only works if the substance in question is approved for medical use. If it's just some random compound that the FDA has never looked at, they're going to prison.

Thus once again illustrating the advantages of regulation for sellers, not just buyers.

> We have laws against negligence as well. You absolutely can deter people from accidentally getting people killed to some extent, or at least our laws seem to think we can.

And yet tobacco-companies still exist.

> If a company deliberately sells a faulty product that kills a customer, they should be treated just like a common criminal who breaks into someone's house and shoots them

I think they should, if they knew what the consequence would be.

But the problem is not so much the extreme cases as the borderline cases where it is hard to prove intent, and hard to prove the understood the severety of the consequences.

Should I be allowed to advertise my unhealthy products in ways that implies they're good for you? Do it to a large enough audience, and it'll likely kill, but not directly. We know more than enough about human willpower to know that to drag out "free will" in those contexts is meaningless.

Now consider how long it took us to get to a consensus of the danger of tobacco, and how long it took us to start penalising the tobacco industry for their deceit in fighting regulation, and consider how much higher the stakes would be if it was not about regulating them but about locking up their executives.

>Regulations rarely serve citizens. They usually serve special interest groups

3 blind women would disagree.

Your comment is being downvoted to hell, because it utterly deserves to be.

It's not only wrong to the point of being asinine — it's also the precise propaganda concept that is most widely promoted by special interest groups in their campaigns to defeat or roll back regulations that serve citizens.

The same can be said about lack of regulation.

Dude. I mean, I broadly agree, but you can't just throw it out there on an article like this like it'll be productive in any way at all; you've got to actually make a case. Remember that even the regulators who most ostentatiously serve special interest groups usually have some excuse that they're trying to make things safer and better for people at large somehow or another: you should seek to pre-emptively overcome at least the basic entry-level apologetics for them, doubly so in a situation like this.

Things that could make your case:

- bring up the issue of regulatory capture (ideally with an example from the exact relevant bureaucracy) and complain that this is evidence that the bureaucracy is focused on the interest groups instead of on the people it claims to protect, with overreactions after the fact that do not actually serve to provide effective protection (chronically fighting yesterday's battle)

- bring up the actual negative impact of certain regulations on people and demonstrate that they are worse than this particular failure (candidate topics: insanely slow FDA approval of new manufacturing of generic drugs leading to things like the EpiPen episode, "certificate of need" legislation leading to higher prices and reduced availability of medical services in the name of protecting incumbent hospital profits, etc)

- look for other failures where medical regulatory frameworks have demonstrated that they are ineffective ways to protect people

- perhaps opine that these people are going to be ruined now anyway and that a regulatory backlash is totally redundant, thwarting none of the bad guys and burdening good guys

... in short, try a post with, like, actual content sometime, it's more effective :b

> safety and effectiveness of this procedure is unknown, all three patients received injections in both eyes

I hope this is not too cynical, but I guess they even got a discount on making their two eyes in one run. This really sounds like a "two for the price of one" mentality.

More generally, this is one of the many examples where typical marked-oriented thinking utterly fails when non-financial risks are involved.

You need either high regulation without loopholes like those described here, or you need to pipe everything through a mandatory public health care system which would simply refuse to pay for non-evident treatments.

In most countries it is a combination of both.

I doubt that insurance paid for this procedure, so I don't think the single payer conversation is relevant. I'm assuming that given a similar regulatory environment, with single payer health care, that someone could choose to pay for such a unregulated procedure out-of-pocket.

WTF. This scares me a lot. How the f* would you make people inject something in your eyes that's not a medical approved treatment????

It least these people thought that it was a medical treatment. There is also https://en.wikipedia.org/wiki/Scleral_tattooing

To be fair, as stupid as tattooing your eye is to me, those people seem well informed of just how stupid what they're doing is.

By telling/convincing them that this will work/is medically approved etc. The next question is whether or not the doctors doing this are being jailed, and if not, how to best introduce legal changes so it will lead to jail time if someone tries something similar again in the future.

Look regulations are bad, let the free market sort it out. If all of their customers go blind, they won't make money! /sarcasm

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