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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.
Pro tip, don't look at laser err have injections in the remaining eye.
One at a time it people!
Good thing we're cutting funding for the sciences so we can find out what happened.
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.
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.
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."