Three Women Blinded by Unproven Stem Cell Treatments
npr.org
npr.org
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.
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.
Regulations rarely serve citizens. They usually serve special interest groups.
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
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.
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.
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.
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).
[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.
Hence effective, nuanced regulation is absolutely vital and libertarianism is an illusionary utopia like communism, with sensible and practical being somewhere in the middle.
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
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.
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).
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.
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.
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.
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.
Thus once again illustrating the advantages of regulation for sellers, not just buyers.
And yet tobacco-companies still exist.
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.
3 blind women would disagree.
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.
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
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.
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.
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.
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.
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.
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.
> 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.
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.
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.
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.
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!
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.
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.
The headline is a bit misleading because the 3 ladies in question were already going blind. The treatment was supposed to reverse the disease but failed. You could write the same headline about other treatments that are considered safe enough to try: "3 patients killed by chemotherapy treatments that failed to eliminate their cancer."
Other treatment mentioned != the "treatment" these 3 ladies got. Those clinics are, for want of a better phrase, peddling stem cell snake oil.
>In one report, researchers document the cases of three elderly women who were blinded after getting stem cells derived from fat tissue at a for-profit clinic in Florida. The treatment was marketed as a treatment for macular degeneration, the most common cause of blindness among the elderly. Each woman got cells injected into both eyes.
This doesn't sound like an experiment however, it sounds like they told these women it was a valid tested treatment. Why else would they get both eyes done simultaneously?
They're touting the use of adult stem cells [edit: from a separate source in the body] which have never been shown to provide the kind of results that embryonic stem cells have. That is snake oil. At best it wouldn't have made anything worse but also not made anything better. When your best case scenario is "you won't be any worse off than you started" you lose the right to call that a treatment.
Of course I somehow doubt it was explained to those women that way.
> Sometimes we have good reason to think a treatment might work, but it fails upon trial.
Given the nature of the source of the stem cells, no one would have had good reason to expect this to work.
Actually that is false. As someone who is currently losing their eyesight due to retinal degeneration (and in their 20's no less), I've done quite a bit of reading on this subject. Most of the stem cell treatments and gene therapy that I've seen rely on the patient's own cell cultures in order to prevent autoimmune rejection. Normally the retina has immune privilege, but as it breaks down it becomes vulnerable to attack by the immune system, which adds an extra level of complication.
Honestly, this whole thread has me pretty worried that I might be cut off from access to experimental treatments just because they're not guaranteed. I know you all mean well, but going blind with your whole life ahead of you and no treatment whatsoever is a really scary thing. These women made a fair trade, and honestly I would accept the same risks that they did. Having a chance at not being blind is better than for sure going blind.
Sure, it only lasts a couple of years. But, when you are 80+ years old, that may be all you need.
My mother has macular degeneration and the only thing they even said was possible so far is injections with Eylea, Lucentis or Macugen.
I guess she manages currently, but it's interesting to see that there are other options
True. But not before scientific due diligence is performed. Animal studies, toxicology studies, efficacy studies, safety studies etc etc etc.
Not just injecting stem cells into old ladies eyes to see what happens and make some cash while doing so.
There is such a thing as medical experimentation under informed consent.
Not that any proper risk assessment existed in the first place.
That's very likely what these "doctors" were thinking.
My reasons are that (as others have pointed out), one does not start medical trials on humans; I am unaware of any plausible reason for why this would help in the first place (stem cells are not magic); they apparently did not follow proper protocols for eye treatments (start with one eye instead of both); the women were clearly not informed of the risks; and finally, this was a paid treatment.
For more, see these two blog posts I pointed out in another comment: http://theness.com/neurologicablog/index.php/alzheimers-and-... and http://theness.com/neurologicablog/index.php/more-stem-cell-...
Any a layman could make it through?
I cannot identify any statement or section within the article where the journalist themselves makes a claim or assertion as to the validity of the treatment, but instead just numerous citations and reports from other agencies and persons who are qualified to comment on it.
Can you please clarify what you are discussing?
It's safe to say a child could evaluate that blinding someone is an invalid outcome.
THAT'S how you do "you don't really know whether it will work until you try it" on humans.
The clinic in Florida used a different type of cell: https://en.wikipedia.org/wiki/Mesenchymal_stem_cell These are far easier to obtain (centrifuge and wash liposuctioned fat -- voila!), but have more limited uses. They can become muscle, fat, bone, cartilage, and blood cells, among a few other things, and they help repair injury -- awesome stuff! They CANNOT become eye cells. We already know that. Do not inject them into your eyes. You will go blind. Those stem cells do not belong in eyes.
What the clinic did was tremendously irresponsible. This is not a matter of "someone has to be the first" There's just no evidence at all that this would work.
Off the top of my head:
- One of the researchers had his medical license revoked
- Some patients paid up to $20,000 for the treatment.
- Very few, if any, patients had any improvement. Many had decreased eyesight after the treatment.
It's not like some unrelated treatment was used and caused them to go blind.
These women need to sue for a quackery and shut them down.
Gross incompetence. Why would you ever do both at the same time? Had they done one first, these people would at least have sight in one eye and know not to mess with it.
The bad thing is that news items like this will likely cause some damage to the field of stem cell treatments and related research.
For me, this is where the arguments based on the idea that everyone should be free to decide for themselves and take responsibility for their own decisions really falls apart. A market that is unregulated w.r.t adventurism is a market that is unprotected against fraud.
It's the same concept as the argument for safe and legal abortions.
Also worth mentioning is the fake "emergency rooms" and "urgent care" fly-by-night shops which have sprung up on the side of roads in much of the Southern US. People will inevitably die because of the confusion and misrepresentation caused by these shoddy scammers.
What are these?
I wonder if he's talking about those homeless health clinics on wheels. I always thought that they were staffed by volunteer or non-profit funded Doctors, Nurse Practitioners, etc.
Anecdotally I was sent to one by my primary care doctor because she thought I was having a heart attack as a result of month long strep/sinus infection. They gave me a bag of saline and charged me $1000 (insurance ER rate) for the privilege. I think these places exist only to bilk parents with crying children in the middle of the night and people who don't know any better.