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Unproven Stem Cell Treatments Blind 3 Women (npr.org)
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.
Technological salvation is a faith based proposition.
"Tempers are wearing thin. Let's just hope some robot doesn't kill everybody." --Bender
Pro tip, don't look at laser err have injections in the remaining eye.
One at a time it people!
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 humble crowd. (don't worry, there is no reason why one wouldn't be able to "upload" themselves to more than one provider. Heh, this means some of your virtual selves will resent your for their placement. Hopefully, "self-delete" will always be an option.
This issue is a bit more complicated than you think.
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.
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...
Post may contain irony: discontinue use if experiencing mood swings, nausea or elevated blood pressure.
Many US states have "right to try" 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.
Quattuor res in hoc mundo sanctae sunt: libri, liberi, libertas et liberalitas.
We already know what happened here. Some people in Florida injected mesenchymal stem cells 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.
[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.
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.
Anons need not reply. Questions end with a question mark.
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!
Those who do not learn from commit history are doomed to regress it.
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.
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.
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."
...you're going to go blind.
I've calculated my velocity with such exquisite precision that I have no idea where I am.
Shouldn't they have at least tested on one eye first before messing with the other one?
sed -e 's/Chuck Norris/Rajnikant/g' joke > fact
Somebody should tell them to fly to Australia to find a church in Dandernon(sp?) where I've heard this fellow Sam's mom got cured by God because she went to that church and they prayed for her and there was this singer who was so moved by the tale it was if he had an eye chart in front of him and the first five letters read I C G O D. I mean, what are the odds?
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.
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.
Those who do not learn from commit history are doomed to regress it.
Accountability only exist if there are regulations in place that define it. And it's not the Left who fight regulations.
http://www.bbc.co.uk/programmes/p04wyzk9/
Seems some guy in US without any real qualifications is offering stem cell treatments for eye problems.
I want a list of atrocities done in your name - Recoil
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 hair fall out.
Where are the lawyers suing these scam clinics? Aren't these lawyers ostensibly suing companies for the good of the public? Or do these clinics not make enough money to be worth suing?
My Other Computer Is A Data General Nova III.
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, not only will these sorts of problems continue to occur, but they are *encouraged* to continue.
I would encourage this to help weed out the stupid people, however these people tend to take down others with them (looking at you, anti-vaxxers), and it's not fair to them.
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?
But back in the day, you used to have to go to some third-world country to get your medical quackery like GOAT TESTICLE GRAFTS
Hell, they used to advertise that stuff on Mexican radio "border BLASTER" radio stations, like where Wolfman Jack got his start.
Restore your vitality with GOAT TESTICLE GRAFTS
the preceding comment is my own and in no way reflects the opinion of the Joint Chiefs of Staff
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.
"When you have eliminated the unacceptable, whatever is left, however improbable, must be the truthiness" - Holmes
"For profit" is significant in that it brings up the possibility of fraud (lying for profit) and a possible conflict of interest (the clinic was doing it for the money, and had a financial interest in finding suckers). If the clinic were non-profit, and didn't accept payment, it couldn't be fraud and there would be less (not zero) possibility of a conflict of interest.
"When you have eliminated the unacceptable, whatever is left, however improbable, must be the truthiness" - Holmes