"A Cautionary Tale of 'Stem Cell Tourism'" [SLNYT]
June 24, 2016 5:31 AM   Subscribe

 
I am often irritated here on MetaFilter when there is a story about someone experiencing misfortune and people come in to say "they should have known better" or "why was it not obvious to them that this was a bad idea?" because it's so easy to see with hindsight and from the outside.

This one, though. Let me be the first to say What The Hell Was He Thinking?

At the same time, I give Gass credit for letting his story be told. Perhaps it will do some good as a cautionary tale.
posted by not that girl at 6:18 AM on June 24, 2016 [2 favorites]


It would take very little editing to change this into a compelling horror novel. With the strange mass of foreign cells growing and mutating, confused doctors, and sketchy clinics, all the key pieces are there.

It's a horrible story, but probably inevitable with experimental and unlicensed clinics facilitating desperate patients.
posted by Dip Flash at 6:49 AM on June 24, 2016 [5 favorites]


We had the same spate of scare stories over the implanting if monkey and goat glands back in the 1890s. Did we end us with great armies of monkey/goat people ravaging the land?

Well, yes. You think we would have learned something from that, honestly.
posted by GenjiandProust at 6:54 AM on June 24, 2016 [37 favorites]


My impulse is to be sympathetic in stories about weird alternative treatments. We as Americans have this cultural idea that death can be defeated with enough ingenuity, can-do spirit, and, of course, money. Gass was a high-level attorney, and clearly he thought he could beat his disability the same way he'd beaten other things in life, by bringing the best minds and the most resources to bear on the problem. But the central tragedy of human existence is that our bodies do not obey our wills.
posted by Countess Elena at 6:55 AM on June 24, 2016 [21 favorites]


That assumes he, in fact, had the best minds and ingenuity. It seems more like he was suckered into paralyzing himself by opportunists preying on the desperation of a sick man.
posted by Punkey at 6:57 AM on June 24, 2016 [10 favorites]


Exactly. He was fooled by charlatans because there are no quick smart ways to do this yet.
posted by Countess Elena at 6:58 AM on June 24, 2016


For a second there, before reading TFA, I worried this might be about William Gass. After reading the article, I realized it might have been written by William Gass. Except it's too short.
posted by chavenet at 7:02 AM on June 24, 2016 [4 favorites]


The way the science-illiterate media has been trumpeting "miracle cures from stem cells just around the corner" stories for years surely doesn't have any role in this man's bad decision. That would make for a good story.
posted by GenjiandProust at 7:06 AM on June 24, 2016 [11 favorites]


... Where do the clinics get the stem cells? Are they culturing them themselves? Where do the lines come from?
posted by maryr at 7:06 AM on June 24, 2016 [1 favorite]


Well, here's the challenge. The US is so fucked up about who sues who and everything must be run through umpteen thousand trials, and here is a man who feels cognitively functional, has disposable income, and US medical care says "no". He says, "I won't sue". Hospitals say "We know you might not, but someone did and we've been this route that's why there are safety measures in place for us to say no". So he, being of sound mind but wanting to reclaim his life that he had before he dies takes what anyone else would perceive as an extreme measure.

And if the same treatment or effort or test was allowed or produced in the US with actual US safeguards, one would assume that the US would be using his stem cells instead of a strangers. Maybe it would have worked, maybe it wouldn't have, maybe he'd still have a mass of flesh growing inside him - at least it would be his own cells and not someone else's.

But here's reality. There isn't enough research to give something like this a broad thumbs up, and there aren't enough researchers, and research needs to be done properly, and the researchers who would do this - well, they're hopefully doing stuff to get us to this point properly, and not just taking the cash grab from a desperate man to get his life back. And when the doctors tell you an outcome of of no treatment is bad, and the internet tells you that there might be something - at even a sub 10% chance of success... and you're crazed from a failed body - there are plenty of people who will roll those dice. They'd roll them for themselves, they'd roll them for someone they love.

Back in the day this was done just by evangelicals and faith healers promising miracles on the sliding scale of your retirement - now we can slap on some white coats instead of robes, talk to a shill while holding a clipboard, make a seemingly sanitary OR, and the person will fork over huge sums of cash - mortgage their life, and otherwise let you poke at them, jam stuff in, pull stuff out, and otherwise do whatever you want in the name of a cure.
posted by Nanukthedog at 7:25 AM on June 24, 2016 [2 favorites]


That was a great and valiant attempt by his sister in law though to get him to question the clinics in question. But for reasons noted by Countess Elena he went ahead anyhow. I commend him for putting his name and story out there.
posted by biggreenplant at 7:39 AM on June 24, 2016 [3 favorites]


Back in the day this was done just by evangelicals and faith healers promising miracles on the sliding scale of your retirement...

I think its telling that Mr. Gass thought that the "worst" thing that would happen was no improvement.

That's the thing about faith healers and homeopathy, as long as they not being used in lieu of actual treatment, at least they are harmless. And if some desperate person wants to spend their savings in the hope of a miracle that, at worst, won't hurt them, I can harrumph about it but it's their money, you know.

This though... the downside risks are just so insane. And it's not like these clinics have an incentive to inform their patients about them.

I'm glad Mr. Gass agreed to come forward.
posted by sparklemotion at 7:40 AM on June 24, 2016 [6 favorites]


I would think that if the clinic just wanted his money, they'd inject something harmless. If you're pure scam, why bother to source stem cells? That's a lot of work. But these clinics are a weird amalgam of scammers and what are probably well-intentioned scientists, unfettered by any ethical rules.
posted by elizilla at 9:12 AM on June 24, 2016 [6 favorites]


I've been reading 'The Emperor of All Maladies' by Siddhartha Mukherjee, its a history of cancer treatment. He discusses the development of an experimental approach to treating breast cancer in the 1980s, so called "High-dose chemotherapy and bone marrow transplant" (HDC/BMT).

---

The idea was simple - the amount of chemo you can give people is limited mainly by the toxic effect on the bone marrow. HDC/BMT involved first harvesting the bone marrow, giving people humungous doses of chemo which wipe out their bone marrow and would normally be fatal, then giving them their marrow back. Genius idea, allows you to use massive doses of chemo which could treat more advanced cancers, but without killing people in the process.

Early phase I trials showed promise, and whilst some doctors advised caution, large numbers of private clinics and hospitals started offering HDC/BMT. Demand was huge, the waiting lists were long, and the money made funded entire wards and hospital wings dedicated to the procedure.

Sure, the procedure wasn't FDA approved and hadn't been formally tested in a large clinical trial. But the logic of the approach was so clear, and the need was urgent - people were dying of cancer now. The problem was that the medical establishment and the FDA were delaying getting new treatments to sick people, that their bureaucracy and fussiness were costing lives.

When Nelene Fox, a Californian teacher with advanced breast cancer, applied to her insurance provider for funding to get HDC/BMT she was denied as it was an 'investigational' procedure. Her brother, an attorney, took the insurance company to court. In the meantime a large public fundraising campaign managed to raise enough for Fox to get HDC/BMT. Sadly, whist the treatment was briefly effective, she relapsed a year later and died. A posthumous verdict on the lawsuit led by her brother awarded Fox's family $89 million in damages in 1993. In 1993 Massachusetts passed a bill requiring insurers to cover HDC/BMT.

Between 1991 and 1999, roughly forty thousand women around the world underwent marrow transplantation for breast cancer, at an estimated cost of between $2 billion and $4 billion (at the higher estimate, about twice the yearly budget of the NCI). And yet it was almost impossible to run clinical trials - who would possibly volunteer for a clinical trial when there was a 50% chance they'd be in the control group and not get the new wonder-treatment?

And yet a few trials did manage to get sufficient recruits, and when presented at the 1999 annual cancer meeting in Atlanta they all basically said the same thing: HDC/BMT didn't give any survival benefit, and around 10% of patients developed horrible complications - infections, blood clots, organ failure. But one man, Bezwoda, a doctor from Johannesburg, had presented remarkably different results - massive improvements in survival with few serious side effects. How to rectify these differences?

Some American investigatory asked Bezwoda if they could review his records. He agreed, and they found chaos - incomplete and missing records, patients who had died recorded as 'alive', no followup of the patients. Bezwoda admitted research fraud, resigned, and has disappeared from the world of cancer medicine. HDC/BMT was quickly forgotten and is no longer used in hospitals.

---

The message I took from this sad tale is that if it seems too good to be true, it probably is; and that when considering a potential treatment, especially one with significant side-effects, it pays to be cautious. It is certain that a large number of women suffered horrible side effects with the false promise of hope, and that their last few months of life were made much less comfortable as they received massive doses of highly toxic drugs.

But when I think about how it would feel to be a young person faced with imminent death or horrible disability, and to hear about a potential new miracle cure which the FDA and your insurance company won't let you have, I can't imagine how awful that must be.
posted by DrRotcod at 9:19 AM on June 24, 2016 [20 favorites]


Sometimes, when the FDA won't let you have a "miracle" cure, there's a good reason for it.
posted by Anne Neville at 9:55 AM on June 24, 2016 [6 favorites]


There are reasons why treatments have to be proven to be safe before the FDA will approve them. It's really not all about red tape and an eeeevul government trying to keep sick people from being cured. See also: thalidomide.
posted by Anne Neville at 10:07 AM on June 24, 2016 [4 favorites]


Laetrile sure seemed to work better in the 1970s than it does now.
posted by Fupped Duck at 10:33 AM on June 24, 2016


Some people die. Charlatans get rich. Life goes on.
posted by BlueHorse at 10:57 AM on June 24, 2016


These stories have been trickling out for 20 years now. The most famous example dates back to 1996, when a man with Parkinson's traveled to China for fetal tissue allografts. He died when the cells began to differentiate into a haploid fetus, essentially a teratoma/mutated siamese twin forming inside his skull (an autopsy found bone, skin, and hair growing in his brain, but no new neurons).

http://www.neurology.org/content/46/5/1219.abstract

I can't fault desperate people for going to extreme lengths in hopes of regaining some of their functioning or quality of life. It seems like these clinics are getting more and more common, and there are even popular ones catering specifically to pets (one called "PetStem" opened up a few miles away from me, here in LA). Hopefully more will be done to make people aware of the potential dangers.
posted by prosopagnosia at 11:50 AM on June 24, 2016 [8 favorites]


It is certain that a large number of women suffered horrible side effects with the false promise of hope, and that their last few months of life were made much less comfortable as they received massive doses of highly toxic drugs.

As someone who's taken enough chemo drugs to actively endanger their bone marrow/immune system, I shudder to think of the suffering these women went through. Efficacy must be proven, or else you're poisoning someone while promising you're curing them.
posted by Existential Dread at 12:00 PM on June 24, 2016


Back in the day this was done just by evangelicals and faith healers promising miracles on the sliding scale of your retirement...

People from the U.S. have been going to Mexico for sketchy medical treatment for a long time. Steve McQueen comes to mind, for example.
posted by The World Famous at 12:13 PM on June 24, 2016


Laetrile sure seemed to work better in the 1970s than it does now.

Ah yes, good ol' vitamin B17. Chock full of delicious cyanide.
posted by maryr at 12:33 PM on June 24, 2016 [3 favorites]


These stories have been trickling out for 20 years now. The most famous example dates back to 1996, when a man with Parkinson's traveled to China for fetal tissue allografts. He died when the cells began to differentiate into a haploid fetus, essentially a teratoma/mutated siamese twin forming inside his skull (an autopsy found bone, skin, and hair growing in his brain, but no new neurons).

Christ, this sounds like the plot of a Japanese horror manga. *shudder*
posted by schroedinger at 2:39 PM on June 24, 2016 [4 favorites]


There was a story on Risk about a woman in the African-American trans community who was convinced to get some back-room plastic surgery done by someone in the group. Apparently this other woman had a good short-term success record, so the narrator went for it.

She got silicone injections that gave her the face she'd wanted, and she was a satisfied customer until things started shifting downward, and then got very badly infected. Ultimately she had to go to a doctor, who removed hardened silicone caulking sealant. That's right, hardware-store bathroom sealant injected under the skin.

So yeah, this "just inject some random stem cells" stuff always reminds me of that, only instead of your face being full of infected cement, you lift up your eyelid to find fingernails growing in there.

I wish I knew how to help stop this sort of alchemical thinking about dangerous topics. Things don't work based on language like that. You don't just combine symbols and stir them in a pot. This stuff is genuinely complicated!
posted by rum-soaked space hobo at 3:19 PM on June 24, 2016 [1 favorite]


Huh. It turns out that real body horror is immeasurably more disturbing than fictional body horror. Whoda thunk.
posted by Joseph Gurl at 7:26 PM on June 24, 2016 [1 favorite]


she was denied as it was an 'investigational' procedure. Her brother, an attorney, took the insurance company to court. In the meantime a large public fundraising campaign managed to raise enough for Fox to get HDC/BMT. Sadly, whist the treatment was briefly effective, she relapsed a year later and died. A posthumous verdict on the lawsuit led by her brother awarded Fox's family $89 million in damages in 1993.

Wait, he took people to court until she could get the procedure and then sued people when it didn't work?

Between 1991 and 1999, roughly forty thousand women around the world underwent marrow transplantation for breast cancer, at an estimated cost of between $2 billion and $4 billion (at the higher estimate, about twice the yearly budget of the NCI). And yet it was almost impossible to run clinical trials - who would possibly volunteer for a clinical trial when there was a 50% chance they'd be in the control group and not get the new wonder-treatment?


I didn't understand this either. If you are in the control group, you are no worse off than if you don't participate in the trial at all, right? I understand some people might not want the hassle of paperwork and follow up testing and so on, but I wouldn't think it's the possibility of being in the control group that would stop desperate people from participation in a trial.

Unless, I suppose, control group participants had to stop other treatments they might be carrying out.
posted by lollusc at 7:29 PM on June 24, 2016


On the gripping hand, if Jesus freaks hadn't been impeding stem-cell research in the USA for decades now because OMG ABORTIONS, there might be more legitimate research available and these shade-tree clinics might not be able to get away with claiming to be "research facilities", at least not to the same extent.
posted by adrienneleigh at 7:54 PM on June 24, 2016 [7 favorites]


I didn't understand this either. If you are in the control group, you are no worse off than if you don't participate in the trial at all, right? I understand some people might not want the hassle of paperwork and follow up testing and so on, but I wouldn't think it's the possibility of being in the control group that would stop desperate people from participation in a trial.

Unless, I suppose, control group participants had to stop other treatments they might be carrying out.


"Here, we can put you in a randomized clinical trial where you have a 50% chance of getting a treatment we're calling a miracle cure ... or you can skip the trial and just get the cure."
posted by spaceman_spiff at 8:31 PM on June 24, 2016 [1 favorite]


The sad thing is that stem cells are actually tremendously promising for chronic stroke, but this is a horrible outcome. And the extra sucky thing is that the way these clinics are structured it will probably not be possible to go back and try to figure out what happened and if there is a way to prevent it.


I didn't understand this either. If you are in the control group, you are no worse off than if you don't participate in the trial at all, right? I understand some people might not want the hassle of paperwork and follow up testing and so on, but I wouldn't think it's the possibility of being in the control group that would stop desperate people from participation in a trial.


People in general have a very poor understanding of what exactly double-blind trials, randomization, and control groups actually mean. Nobody wants to be the guinea pig.
posted by The Elusive Architeuthis at 8:51 PM on June 24, 2016 [1 favorite]


You can get stem cell transplants in the United States. I've had those stem cell transplants. My orthopedist harvested my own stem cells and then injected in the areas where I had injury. However injecting stem cells from another person has yet to prove effective enough to make me want to do it. My results are stupendous by the way. And the FDA allows this type of procedure to occur. However insurance companies don't pay for it.
posted by OhSusannah at 11:20 PM on June 24, 2016 [1 favorite]


You can get stem cell transplants in the United States. I've had those stem cell transplants. My orthopedist harvested my own stem cells and then injected in the areas where I had injury. However injecting stem cells from another person has yet to prove effective enough to make me want to do it. My results are stupendous by the way. And the FDA allows this type of procedure to occur. However insurance companies don't pay for it.

I am extremely happy that they have worked for you, but there are no approved stem cell therapies outside bone marrow transplantation. In fact, the FDA has been drafting regulations on stem cell use for exactly that reason. Providers like your doctor have evaded censure because they use the patient's own stem cells and thus claim it isn't a drug. That will--and should!--be changing. There is still an awful lot that we don't know about stem cell research and the willy-nilly injection of them into various sites in the body has the potential to go really, really wrong.
posted by schroedinger at 1:10 AM on June 25, 2016 [3 favorites]


I was just reading an article about infectious tumors. Basically, a number of species - Tasmanian devils, dogs, some molluscs - are susceptible to infection by cells that grow into tumors. They get bitten or swallow something containing live tumor cells and they "inherit" the tumor. In the case of the TDs and dogs, it's the same species, but in the case of the molluscs the tumors can actually come from different species.

Anyway these clinics are basically selecting for cells that adapt and replicate readily in foreign human bodies. It sounds like a recipe to create transmissible human tumors.
posted by Joe in Australia at 2:33 AM on June 25, 2016 [3 favorites]


Wait, he took people to court until she could get the procedure and then sued people when it didn't work?

Her brother claimed that it was the delay in getting the procedure that killed her - if the insurance company had offered it immediately she would have lived. The NYT covered the case.

I wouldn't think it's the possibility of being in the control group that would stop desperate people from participation in a trial.

You have breast cancer that will kill you. You can get a procedure performed that's all over the news because of how amazing it is at curing breast cancer. Or you can join a clinical trial where there's a 50/50 chance you'll get a placebo. Which would you go for?
posted by DrRotcod at 2:52 AM on June 25, 2016 [3 favorites]


I thought the point of clinical trials was that they happened before whatever treatment was available to the general public. Of course if you can just choose to get miracle treatment, you'd do that. But if the option is that you can either wait 10 years for the treatment to be on the market and covered by your insurance, or you can get it now while they are still trialling it, but you have 50% chance of getting a placebo, I'd go for the option that at least gives me a 50% chance.
posted by lollusc at 9:15 PM on June 25, 2016


I thought the point of clinical trials was that they happened before whatever treatment was available to the general public.

That would be true if this was a completely new drug. Instead its a protocol which uses drugs which have already been licensed and a procedure that's already in use (bone marrow transplant), but it uses them in a new way. So whilst it may be necessary to get FDA approval for a particular treatment protocol to be funded by insurance companies, doctors are entirely allowed to use drugs and treatments which are already FDA licence in whichever way they choose, providing they avoid being legally 'negligent'.

The use of drugs outside the realms of their original licence is called 'off-label prescribing'. Whilst you might imagine this is a bad idea, in reality its very useful. Drug licencing is an expensive process and a pharmaceutical manufacturer won't bother to licence a drug in a rare disease or when they no longer control the drug patent, because they're unlikely to recoup the licencing costs.

Off label prescribing is very common, an estimated one fifth of all prescriptions, and often its a perfectly sensible thing to do. Wikipedia lists a large number of drugs used off label, and often this is done safely with good supporting evidence. However as the story of HDC/BMT shows, this isn't always a the case.

But if the option is that you can either wait 10 years for the treatment to be on the market and covered by your insurance, or you can get it now while they are still trialling it, but you have 50% chance of getting a placebo, I'd go for the option that at least gives me a 50% chance.

There are many more options - you can raise the money and pay for it yourself, you can hold a public fundraiser, you can sue the insurance company. Suing the insurance company is particularly effective because of the compelling narrative - young woman killed because greedy insurance company wouldn't pay for amazing new treatment that the bureaucratic big government won't let people have.
posted by DrRotcod at 3:32 AM on June 26, 2016


This one, though. Let me be the first to say What The Hell Was He Thinking?

He was desperately trying to recover from a stroke that had left him very significantly impaired. I think it doesn't take much to conclude that the literal brain damage he was known to have was not only impairing his physical ability to control his body, it was impairing his thought processes as well.

Plus, if you are desperate enough, it is fairly easy to say "I will take chances." People with serious medical conditions are often pretty eager to sign up for medical trials, try unproven alternative treatments, etc.
posted by Michele in California at 1:53 PM on June 26, 2016 [1 favorite]


They get bitten or swallow something containing live tumor cells and they "inherit" the tumor. In the case of the TDs and dogs, it's the same species, but in the case of the molluscs the tumors can actually come from different species.

Fun fact, in rare instances (i.e. immunosuppression) that can happen to people too!

Man killed by his tapeworm's cancer
posted by Existential Dread at 9:24 PM on June 26, 2016 [1 favorite]


Urgh.
posted by Joe in Australia at 10:02 PM on June 26, 2016


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