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Unproven Stem Cell Treatments Blind 3 Women (npr.org) 108

An anonymous reader quotes a report from NPR: Scientists have long hoped that stem cells might have the power to treat diseases. But it's always been clear that they could be dangerous too, especially if they're not used carefully. Now a pair of papers published Wednesday in the New England Journal of Medicine is underscoring both the promise and the peril of using stem cells for therapy. 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. In a second report, a patient suffering from the same condition had a halt in the inexorable loss of vision patients usually experience, which may or may not have been related to the treatment. That patient got a different kind of stem cell derived from skin cells as part of a carefully designed Japanese study. The Japanese case marks the first time anyone has given induced pluripotent stem (iPS) cells to a patient to treat any condition. The report about the three women in their 70s and 80s who were blinded in Florida is renewing calls for the Food and Drug Administration to crack down on the hundreds of clinics that are selling unproven stem cell treatments for a wide variety of medical conditions, including arthritis, autism and stroke.
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Unproven Stem Cell Treatments Blind 3 Women

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  • Technological salvation is a faith based proposition.
    • by SeaFox ( 739806 ) on Thursday March 16, 2017 @10:54PM (#54055899)

      Good thing we're cutting funding for the sciences so we can find out what happened.

      • by Xenographic ( 557057 ) on Thursday March 16, 2017 @11:47PM (#54056105) Journal

        We already know what happened here. Some people in Florida injected mesenchymal stem cells [wikipedia.org] into the eyes of three people. Mesenchymal stem cells are multipotent, but we already know that they do not form eye tissue. There was a different Japanese study that used induced pluripotent stem cells, which actually showed some promise. Those stem cells actually can become any type of tissue and are much more difficult and expensive to obtain.

        So, I don't know about you, but I have a lot of questions about how injecting cells that might turn into bone, cartilage, fat or muscle into someone's eyes is supposed to help prevent blindness. And I would expect a lot of good answers and prior studies before having them do that to people.

        • by mysidia ( 191772 )

          And I would expect a lot of good answers and prior studies before having them do that to people.

          Yeah.... Injecting ANYTHING into somebody's Eye is dangerous business.
          You need more than a hunch to do that.

          It's not as the article's author suggested a justification for a FDA 'Crack down' on potential stem cell treatments for things that don't
          involve doing something ridiculous --- like injecting the cells directly into a vital organ such as the eyes, brain, heart, spine, kidneys, etc.

          • by ShanghaiBill ( 739463 ) on Friday March 17, 2017 @01:50AM (#54056419)

            Injecting ANYTHING into somebody's Eye is dangerous business.

            Sure, but these women had macular degeneration and were going blind anyway. MD causes the vision to deteriorate first in the center of the visual field, and then expand outward, so the most important part of sight is lost first, leaving only peripheral vision. So it's not like 3 women with perfect vision suddenly lost their sight.

            • This would be reasonable in a controlled study, but this appears to have been a rogue clinic doing something that made no sense at all.

            • by Raenex ( 947668 ) on Friday March 17, 2017 @03:23AM (#54056669)

              Sure, but these women had macular degeneration and were going blind anyway.

              They had enough vision to read and drive. There's no guarantee they would have gone completely blind, or at what rate they would have lost their vision. And they paid $5,000 for the privilege of going blind while being irresponsibly injected into both eyes instead of one. All while thinking they were taking part in legitimate research, because the "study" was advertised on a government site.

              The whole thing is a horror show of profit-seeking irresponsibility.

            • Sure, but these women had macular degeneration and were going blind anyway. MD causes the vision to deteriorate first in the center of the visual field, and then expand outward, so the most important part of sight is lost first, leaving only peripheral vision. So it's not like 3 women with perfect vision suddenly lost their sight.

              Well when you put it like that it sounds much more reasonable, they should really be grateful for the opportunity to go blind earlier. Now they have an opportunity to pull themselves up by their own walking sticks.

            • by mysidia ( 191772 )

              Sure, but these women had macular degeneration and were going blind anyway. MD causes the vision to deteriorate

              By this logic, we should just let murderers go free, because the victim was suffering from a disease called Aging that was eventually going to kill them, anyways.

              MD has a very gradual progression, and it is by no means certain that the person would still be alive by the time it resulted in near total blindness.

        • by omaha393 ( 4864053 ) on Friday March 17, 2017 @12:43AM (#54056249)
          They didn't use mesenchymal, they used indued pluripotent stem cells derived from fat cells. [scientificamerican.com]. There's different ways cells can be induced to pluripotency (the Yamanaka method is the favorite) but the one of the biggest trouble with iPSCs is their epigenetic profiles [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3760008/]. Basically just because you activate the genes you need for iPSCs to form doesn't mean their epigenetic profiles are the same as naturually occuring pluripotent cells, so unexpected growth and differentiation can occur. Also, iPSCs have a tendency to become cancerous, so even if you run the same treatment there's still a risk of tumor formation.
          • Wrong paper (Score:4, Informative)

            by omaha393 ( 4864053 ) on Friday March 17, 2017 @02:32AM (#54056515)
            Well looks like I clicked on the wrong NEJM abstract in the link, you were right, they did use adipose derived stem cells. But the entire thing is much, much worse than iPSCs. First, the method they used wasn't the same one in clinical trials. But secondly, the patients thought they were receiving the clinical trial procedure (which they weren't) AND the procedure they thought they were getting had already been revoked from clinical trials by the time they got this shady one. From the paper: "A distinction has been made between clinical studies of stem-cell therapies that are founded on solid preclinical research with strong scientific design and programs that lack preclinical research justification. These programs are often funded by patients at nonacademic centers, and they may not receive FDA oversight if these procedures are performed without the filing of an investigational new drug application with the FDA, which requires extensive safety data. At least one of the patients thought the procedure was performed within the context of a clinical trial (NCT02024269). However, the consent forms signed by all three patients do not mention a clinical trial. The patients paid for a procedure that had never been studied in a clinical trial, lacked sufficient safety data, and was performed in both eyes on the same day."
        • by Anonymous Coward

          You and your "science"! What we need to Make America Great Again is less science, less regulation and more opportunity for entrepreneurs like this Florida company to make profit.

      • I know what happened: they blinded them with science!
      • by zifn4b ( 1040588 )

        Good thing we're cutting funding for the sciences so we can find out what happened.

        That, unfortunately, does not have an impact on the prevalence of pseudo-science.

    • Salvation is a faith-based proposition. Technology has nothing to do with it.

  • Pro tip (Score:5, Insightful)

    by Anonymous Coward on Thursday March 16, 2017 @10:48PM (#54055887)

    Pro tip, don't look at laser err have injections in the remaining eye.
    One at a time it people!

    • by Anonymous Coward

      Some companies advertise that they can do laser treatment of both eyes in a single procedure. I would do the worst eye first, then wait a couple months before risking the second eye, and if the second eye is still better than the first eye, I would also not do the second one. Eyes are much more difficult to replace than arms and legs.

  • by Notabadguy ( 961343 ) on Thursday March 16, 2017 @11:05PM (#54055931)

    Medical flimflammery has been around ever since the first witch doctor howled at the moon. The ingenuity of salesmen for nostrums is matched by the gullibility of those yearning for cures for whatever ails them.

    Lee's Anti-bilious pills: excellently adapted to carry off superfluous bile and prevent its morbid excretions -- to restore and amend the appetite -- produce a free perspiration, and thereby prevent colds ... celebrated for removing habitual costiveness -- sickness of the stomach and severe headaches -- and ought to be taken by all persons on a change of climate . . .

    Lee's elixir: a sovereign remedy for colds, obstinate coughs, catarrhs, asthma, and approaching consumptions . . .

    Lee's grand restorative: an invaluable medicine for the speedy relief and permanent cure of the various complaints that arise from dissipated pleasure ... the diseases peculiar to females at a certain period of life, bad lyings-in, & . . .

    Lee's worm-destroying lozenges: which have within seven years past, cured upward of one hundred thousand persons, of both sexes, of every age and of every situation, of various dangerous complaints, arising from worms and from obstructions or foulness in the stomach or bowels.

    Lee's genuine essence and extract of mustard: a safe and effectual remedy for acute and chronic rheumatism, gout, palsy, lumbago, numbness, white swellings, chilblains, sprains, bruises, pains in the face and neck, etc.

    Lee's infallible ague and fever drops: for the care of agues and intermittent fevers . . .

    Lee's sovereign ointment for the itch: an infallible remedy at one application, and may be used with the most perfect safety by pregnant women, or on infants a week old, not containing a particle of mercury or any dangerous ingredient . . .

    Lee's corn plaster: an infallible remedy for removing corns, root and branch, without giving pain.

    The Indian vegetable specific: for the care of venereal complaints.

    And now...

    Lee's Stem Cell Therapy: an unparalleled surgical injection that will heal whatever ails you, regenerate your skin, cure your cancer, turn back the ravages of time in your body, and even replenish the shine in your hair.

    • Yeah, we're all gonna die.

      Some day, you may be able to perform a very altruistic act, and donate your personality to the "singularity" (e.g. "upload yourself").

      I say altruistic, since, YOU, of course, will still be dead.

      If your virtualized self doesn't recognize the fact that it is not really you, I wouldn't want my avatar to have to deal with you, even virtually.

      Sales feature for future "singularity" providers - add a virus checker to weed out such pompous personalities, and cater to a more hum
      • Well, in that case, that's okay, because I'm not reallyâ me. Sure I resemble the me from just a few moments ago, but the further out you go in time, the less I resemble me's gone by and so it goes for future me's as well. So say goodbye to any me you meet in the future, for you will never meet another me like him ever again.
      • How is the you rotting on the floor any more you than the you thinking, living, loving in a virtual world? Copy that you to another server, and which one is less you? People need to get over this idea that this meat that we walk around in has some unique spot inside that contains our soul. Rather realize that the only soul you have is the one that you have convinced yourself you have.
    • I never knew the Traitor General had a side business going on while commanding the Army of Northern Virginia.
  • You have two eyes (Score:5, Insightful)

    by Solandri ( 704621 ) on Thursday March 16, 2017 @11:27PM (#54056021)
    Always do experimental treatments on one eye. And only when you're sure that vision in that eye has stabilized (whether improved, the same, or worse) do you treat the other eye. This is how laser eye surgery (and its predecessor - radial keratotomy which made incisions in the cornea with a knife) was done before it established a statistical track record of being very safe and reliable. Even then, in extreme or risky cases they'll still do one eye at a time.

    Treating both eyes at once with an experimental procedure was beyond reckless and negligent. The idiots who decided to do it need to lose their medical licenses and face criminal charges.
    • by Anonymous Coward

      [Dilios is putting a patch over his eye]
      King Leonidas: Dilios, I trust that "scratch" hasn't made you useless.
      Dilios: Hardly, my lord, it's just an eye. The gods saw fit to grace me with a spare.

    • by TWX ( 665546 )

      Yep, be careful.

    • "Do not look through telescope with remaining good eye"
  • by hey! ( 33014 ) on Thursday March 16, 2017 @11:31PM (#54056039) Homepage Journal

    It's going to get crazier.

    The summary misses an important part of this story: Congress passed a law mandating the that federal government operate a registry of clinical trials for compassionate reasons. Then unscrupulous companies discovered this was a perfect way to market unproven treatments to potential customers. The ladies in this story paid thousands of dollars for the privilege of being a guinea pig.

    And now with the "21st Century Cures Act" the standards for collecting human subject research data have been relaxed...

    • by mysidia ( 191772 )

      We need a revision to the law, where: (A) Human guinea pigs Can't be charged a fee above nominal admin. charges if the treatment doesn't work, And,
      (B) Human test subjects as a group are automatically assigned a 20% interest in every patent, or other intellectual property related to a drug or treatment developed and demonstrated by the required clinical research distributed evenly among test subjects throughout the research, which is assigned after approval, the ownership share is protected from any

      • by AmiMoJo ( 196126 )

        We need a better system for funding and getting people on to experimental medical trials in general.

        I see various stem cell treatments for ME and the temptation to try them is credibly strong. Yes, they are pretty dodgy - mostly based in India or South America, but some people report success with them.

        ME makes life pretty miserable. Imagine waking up and feeling like you just ran a marathon and need a good week's sleep. Imagine feeling like crap all day, every day, for the rest of your life no matter what.

        • by mysidia ( 191772 )

          We are too cautious at the moment, and too reliant on for-profit groups doing the trials.

          If some trials for a treatment are government-subsidized, Then there should be no exclusive rights to the product being trialed for any 1 company.... Perhaps by the gov't using eminent domain to take necessary patents on lifesaving medication, setting a license fee for active ingredient X that all competitors will have to pay, and for Just compensation to the original patent owner --- a portion of their license

      • by jebrick ( 164096 )

        This is why you cut funding to the FDA so we can get more drugs and treatments to the patients quicker and then check to see if they work.

        • by mysidia ( 191772 )

          How does cutting funding help? The FDA will increase their backlog of drugs waiting for work required prior to approval that they don't have the manpower and resources to push through their pipeline as quickly, Since you've pulled back on funding, fewer drugs will be approved.

  • Defund NPR (Score:1, Troll)

    by Orgasmatron ( 8103 )

    Unproven Stem Cell Treatments Blind 3 Women

    In a second report, a patient suffering from the same condition had a halt in the inexorable loss of vision patients usually experience, which may or may not have been related to the treatment.

    women who were blinded after getting stem cells derived from fat tissue at a for-profit clinic in Florida

    Money shot:

    The inaction by the FDA not only puts many patients at serious risk

    Imagine that. A government mouthpiece (literally) publishes a story with the sole purpose o

    • Re: (Score:2, Insightful)

      Yeah. Let the free market solve everything! Once enough people go blind, why, these businesses will surely go down in flames because nobody will be able to find them anymore!
      • In this case, private lawsuits will provide plenty of corrective action. Despite this setback, there is a lot of promise to stem cells, and the heavy hand of government bureaucracy is likely to do far more harm than good.

        • There's a lot of promise to stem cells, which is why I don't think government should heavily regulate stem cell RESEARCH. But this isn't research. This is people making untested claims and duping people who can not possibly be informed into paying money for shonky treatment. There's no corrective action that can reverse blindness, as I understand it.
        • Only if there are regulations and laws in place that you can base a lawsuit on. If there aren't any then those lawsuits will be much harder to come by.
          • Only if there are regulations and laws in place that you can base a lawsuit on.

            In a civil lawsuit, the plaintiff does not need to show that the defendant broke any law.

            • The plaintiff has to file suit on the basis that the defendant did something that the defendant legally should not have, or failed to do something the defendant was legally required to do. In cases of contract violation, for example, the plaintiff tries to show that the defendant broke some aspect of contract law. The plaintiff doesn't have to show that the defendant broke any criminal law, but the law has to be involved somewhere.

      • That wasn't the argument. The matter was more along the lines of a conflict of interest of the reporter than a matter of what government and the free market can and should do.
  • "Right to try" (Score:4, Informative)

    by Michael Woodhams ( 112247 ) on Thursday March 16, 2017 @11:44PM (#54056085) Journal

    Many US states have "right to try" [wikipedia.org] laws, and this is the sort of thing that those laws are designed to allow.
    On the supply side you have charlatans, well meaning doctors who have a dud treatment they truly believe in, and well meaning doctors who have a working-but-unproven treatment they truly believe in. On the demand side, you have patients who want to pay for a miracle and have bought into the (often hard-sell and deceptive) sales story of the supply side. These combine to try to push politicians into allowing unproven medical treatments. The medical establishment objects, but are often drowned out.

    You can find lots of criticism of "right to try" here [sciencebasedmedicine.org].

    • by TWX ( 665546 )

      Normally though, doctors of medicine who are pledged to do no harm are treating experimentally with work that researchers have conducted studies with and gotten at least some semblance of result, or else medical doctors are working with patients for experimental treatments that won't cause any additional harm anyway.

      The eye is not something to trifle with. Unfortunately they did in this case, and it sounds like without any scientific basis.

    • by dywolf ( 2673597 )

      right to try is only for experimental procedures for the benefit of terminally ill patients.
      does not apply here.

  • Why aren't they testing this on lab animals before trying this on humans? When you skip the safety protocols, you can get a lot of horrific results.

    • Why aren't they testing this on lab animals before trying this on humans?

      There are no good animal models for age related macular degeneration. Rodents don't get ARMD, and primates don't develop it until they are several decades old. Besides, if this treatment was put off for five years while animal trials were done, these women would be blind anyway, and their retinas would have likely deteriorated too far to recover. So it was now or never.

      • Have you any idea what a chimp costs? These old ladies paid to be involved! I put those numbers into my calculator and it makes a happy face.
    • There's not that many animals around willing to pay good money to these for-profit folks.
  • Shouldn't they have at least tested on one eye first before messing with the other one?
  • http://www.bbc.co.uk/programmes/p04wyzk9/ [bbc.co.uk]

    Seems some guy in US without any real qualifications is offering stem cell treatments for eye problems.
  • Clearly we should eliminate all those nasty regulations that are holding businesses back so that they can all jump on board and begin reaping the profits from new treatments like this one!

  • Every night on TV I see ads for lawyers offering to sue pharmaceutical companies for making products that do exactly what they are supposed to do. The worst is a lawsuit against a company that makes blood thinners because they potentially cause internal bleeding. Well, yeah, they thin your blood so your heart doesn't stop, internal bleeding is more manageable side effect than your heart stopping. One law firm is starting a class action against a company that makes chemotherapy drugs because they make your h

    • Unfortunately these scam clinics don't have deep enough pockets, if they did there would lawyers line up around the block.
    • Three people does not a large class action make. Perhaps if it continues for a few more years they will have enough victims to make a worth while class action suit.
  • Why should the FDA get involved? The clinics need to make a profit, after all. They may be using Stem cells the way some places claim to use quantum mechanics, but it's all just gimmick, right?

    People go to all kinds of quack clinics every day. Homeopathy is a low-hanging-fruit example, but there are tons of ridiculous clinics with ridiculous "treatments" that, at their absolute best, do nothing at all.

    As long as profit, emotion and dishonestly are held in higher regard than prudence and rational thought,

  • Put a headline out there that states how many people prescription drug addiction has killed. Will the FDA do anything about that? Nope.
  • This seems pretty short sighted when you are trying an experimental treatment, why not treat one eye and see (or don't see) what happens?

It seems intuitively obvious to me, which means that it might be wrong. -- Chris Torek

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