I've frequently written about bogus stem cell clinics that use hard sell techniques to sell unproven and expensive "stem cell treatments" to desperate patients. For instance, I deconstructed the story claiming that hockey great Gordie Howe improved so markedly after a severe stroke, thanks to stem cells offered to him for free (because of his celebrity) by a dubious stem cell company (Stemedica) through its Mexican partner (Clínica Santa Clarita). The whole incident basically opened my eyes to just how unethical the for-profit stem cell clinic industry is, as clinics use hard sell techniques more akin to used car salesmen to peddle potentially dangerous therapies even right here in the good ol' USA. The level of corruption and lack of ethics are truly astounding. Indeed, some stem cell clinics have followed the Stanislaw Burzynski model in getting patients to pay to be on dubious clinical trials that are designed primarily to sell product rather than to answer any sort of scientifically important question.
The problem, of course, is that very few stem cell therapies have compelling evidence for efficacy and safety. Yet that doesn't stop dubious stem cell clinics all over the country from selling treatments claiming to improve or cure everything from heart disease to lung disease to cancer to even autism, all with minimal evidence that what these clinics are doing can do anything of the sort. That's why I view it as very much a good thing that the FDA has recently made noises about cracking down on stem cell clinics, a move that's long overdue. I hope it continues.
Regardless of whether the FDA's new loving attention to stem cell clinics is sustained or not, yesterday I learned of something very, very disturbing. Let's just put it this way: What's scarier than an unregulated, dubious stem cell clinic selling "stem cell"-related "cures" for lots of money? I'll tell you. It's an unregulated, dubious stem cell clinic selling "stem cell"-related "cures" for lots of money run by naturopaths. I kid you not. there's a clinic in Park City, Utah, the Docere Clinics, in which a naturopath is advertising stem cell therapies that it offers. The naturopath, Harry Adelson, ND (Not-a-Doctor) is described thusly:
Stem cells, specifically mesenchymal stem cells (MSCs), have been called “patient-specific drug stores for injured tissues” because of their broad range of healing abilities. MSCs are directly responsible for healing damaged tissues after injury. Upon encountering damaged tissue, they release proteins that decrease inflammation, kill invading microbes, and trigger the growth of new connective tissues and blood vessels. In the case of severe damage and cell death, MSCs have the ability to turn into healthy versions of damaged or destroyed cells that they encounter.
When we take MSCs from your own bone marrow, from your own fat, or from both, concentrate and/or isolate them, and then inject them directly into your problem area, we ‘trick’ your body into thinking that there has been a new injury without actually causing any tissue insult, and you get a second chance at healing. In the case of advanced osteoarthritis where the population of stem cells has been depleted, we are repopulating the area with stem cells, and thereby restoring the body’s natural ability to heal itself.
The only good thing I can say about this is that Docere Clinics don't claim to be able to treat spinal cord injury, autism, or cancer. Believe me, that isn't saying much. Because, quite strategically, Docere Clinics does treat all manner of musculoskeletal pain syndromes, some of which stretch the imagination as conditions that would need something like stem cell therapies. For instance, like many "regenerative medicine" stem cell clinics, Docere claims it can treat osteoarthritis and avascular necrosis. It also claims that it can treat back pain of various etiologies and bone spurs. (One wonders why on earth one would need a treatment as expensive and radical as stem cell therapy in order to treat bone spurs.) Ditto carpal tunnel syndrome, whose pathophysiology is pretty well understood and which is treated quite effectively by carpal tunnel release surgery. (I know. I've that surgery 15 years ago and it basically cured my carpal tunnel syndrome, other than a minor twinge every now and then.)
Looking at the list, I see no condition for which stem cell therapies have been shown to be efficacious or safe, but I do see conditions that are primarily ones of chronic pain, which means that they are likely to be particularly susceptible to placebo effects. Without rigorously designed randomized, placebo-controlled, double blind clinical trials, it would be very difficult to determine whether any therapy has a significant impact on these conditions. Is there any RCT data supporting what Not-a-Dr. Adelson does? Nope. None of that stops him from doing what naturopaths love to do and cosplaying a real doctor by wearing scrubs in all his videos and pictures on the clinic website:
Dr. Adelson began his training in regenerative injection therapy (prolotherapy) in 1998 while in his final year at The National College of Naturopathic Medicine, in Portland, Oregon after having been cured of a rock-climbing injury with prolotherapy. During his residency program in Integrative Medicine at the Yale/Griffin Hospital in Derby, Connecticut, he volunteered after hours in a large homeless shelter in Bridgeport, Connecticut, providing regenerative injection therapies to the medically underserved while gaining valuable experience. He opened Docere Clinics in Salt Lake City in 2002 and from day one, his practice has been 100% regenerative injection therapies for the treatment of musculoskeletal pain conditions. In 2006 he incorporated platelet rich plasma and ultrasound-guided injection into his armamentarium, in 2010, bone marrow aspirate concentrate and adipose-derived stem cellls, and in 2013, fluoroscopic-guided injection (motion X-ray).
Prolotherapy, of course, has been around a long time but lacks convincing evidence for clinical efficacy. The same can be said of platelet-rich plasma (PRP). Neither have particularly compelling evidence for utility in the conditions for which they are commonly used. It's possible that PRP might have an effect in some conditions, but there really isn't much in the way of decent evidence to show that it does.
But wait! Did you do a double take when you saw that last sentence, wherein a naturopath is using fluoroscopy to guide his injection of stem cells. Just let that sink in a moment. How on earth could he ever be qualified as a naturopathic quack to use fluoroscopy for anything? Get a load of where he injects the cells, too:
Of the fluoroscopically-guided injections that we perform, one that stands out is the injection stem cells into the intervertebral disc. Discs are structures that are rich with nerves, but are the least vascularized tissue in the body. The way discs maintain hydration is through movement; as the disc moves, hydration comes from the vertebral bodies (bones) above and below. When we lead sedentary lifestyles or suffer traumatic injuries, the discs can become ‘desiccated’, meaning dehydrated. A dry disc is an extremely painful disc. Being able to inject a dry disc with stem cells is the primary reason we became interested in fluoroscopically-guided injection.
That's right, Not-a-Dr. Adelson is injecting "stem cells" of unclear provenance into cervical discs because he thinks the stem cells will somehow un-desiccate them and turn the old, atrophied cervical disks to shiny new ones. Here he is cosplaying a real interventional radiologist:
Yes, he's injecting into cervical and lumbar disks. What could go wrong? Well, there are nerve roots nearby that could be damaged. One can damage the disks themselves. There's a reason why becoming a board-certified interventional radiologist takes as many years as becoming a surgeon does. Perhaps what's most disturbing about this is that Not-a-Dr. Adelson trained at Yale's integrative medicine program. I wonder if Steve Novella knows his school's quackademic medicine program admits naturopaths. It led me to find that the Director of the Yale Adult and Pediatric Integrative Medicine Program is a naturopath. Although the Yale/Griffith Hospital integrative medicine program appears to exist no more, in its day it did have naturopaths as residents, as evidenced by this advertisement for a talk on naturopathic approaches to pain management, given by one of the naturopath residents.
So does Not-a-Dr. Adelson have any evidence to back up his treatment? Well, he has a TEDX talk:
It's basically an anecdote about a veteran of the Iraq/Afghanistan wars named Chris who had severe chronic low back pain due to a degenerated L4/L5 disk, suffered as a result of injuries due to his bad luck of being too close to two two different IED explosions. Apparently this veteran came to him asking him to inject stem cells into his disc. At about the 1:20 mark, you see how Adelson justifies his unethical actions. He basically portrays the options, but paints the ethical option (not using stem cells) in the worst possible light, as abandoning the patient. He portrays the other best option, enrolling the patient on a clinical trial, in an equally bad light, dismissing it saying that, well, you know, you have to be aware that you might bet a placebo. The next option he jokes about, namely taking the patient to "my offshore stem cell clinic" to treat him. Then, he portrays what he did, using an unproven technique that hasn't been validated scientifically or in clinical trials on a single patient, as the best option, the heroic option, the "can do" option. He even brags about how doing an autologous stem cell transplant is no different than doing a hair transplant. He also justifies his action by his own "conversion experience" using prolotherapy to treat his shoulder injury from rock climbing. I also learned the name of the surgeon who taught him how to do injections. Not surprisingly, it was a doctor, an orthopedic surgeon, who runs a dubious stem cell clinic in Florida.
Not-a-Dr. Adelson makes the claim that the outcomes were "so much better" than PRP that stem cell treatments "instantly became 100% of my practice," bragging about how he traveled to various Central and South American stem cell clinics. One man he mentioned was Carlos Cecilio Bratt, MD, who, it turns out, runs a stem cell clinic in Venezuela, and runs what sounds like an assembly line doing stem cell treatments. (One wonders why he hasn't published his results.) He also went to the infamous Stem Cell Institute in Panama City. He also went to Ecuador. Finally, he found MDs and DOs willing to teach him how to use a C-arm and do fluoroscopy. Naturally, Adelson finished his story by bragging about how much Chris claims his pain has improved and how good his results are. Did he mention any clinical trials? No, of course not. He does have an unrandomized, highly dubious clinical "trial," though. Unfortunately, what he doesn't have is any mention of whether he had institutional review board (IRB) approval to do that retrospective chart review and to publish it. Worse, he doesn't have anything resembling real informed consent:
Patients presenting to Docere Clinics in Park City, Utah, between July 15, 2014, and November 15, 2014, who were deemed candidates for autologous stem cell therapy, were asked to choose between being treated with BMAC [bone marrow aspirate concentrate] or SVF/ PRP [stromal vascular fraction suspended in platelet rich plasm]. e conversation can be summarized as follows: “I can do a bone marrow aspiration and treat you with BMAC, with which I have ve years of experience and am aware of data supporting its use, or I can do a lipoaspiration and a blood draw and treat you with SVF suspended in PRP, which has the potential to provide us with a far greater yield of stem cells and, theoretically, a superior outcome. However I have little experience with it and there are very few data supporting its use.” Patients then self-selected into the BMAC or the SVF/PRP group.
Then, he changed the protocol:
During this period and during preliminary follow-up with patients, I began to notice a trend that many SVF/ PRP patients reported higher satisfaction than those in the BMAC group, but the remainder were experiencing no improvement at all. Beginning November 16, 2014, I be- gan o ering patients SVF prepared as described above but suspended in BMAC rather than PRP, hypothesizing that the combination could o er the consistency of BMAC with the augmented outcomes of SVF.
This is half-assed, "make it up as you go along" clinical research at its most dubious. Adelson then looked at his outcomes using a retrospective survey. Basically, everyone appears to have done roughly the same. Given that there wasn't a hint of a whiff of a statistical analysis or power calculation, that's basically that can be said. As for the lack of IRB involvement, Adelson appears to be taking advantage of the fact that the IRB requirement, strictly speaking, only applies to human subjects research funded by the federal government, carried out at an institution (e.g., a university) that receives federal funding, or when a clinical trial is being done as the basis to seek FDA approval. True, some states have their own laws requiring that any research inside their borders have IRB approval according to the Common Rule, but I don't know if Utah is one of them.
Not surprisingly, Adelson seems utterly oblivious to what we already know about invasive surgical procedures: There can be a significant placebo effect any time you inject anything into the spine or discs. I like to use the example of vertebroplasty for lumbar spine fractures due to osteoporosis. It's been shown convincingly in at least a couple of good randomized, placebo-controlled trials to be no better than placebo. The usage of vertebroplasty has even declined as a result, albeit not nearly as much as it should have. (Yes, doctors sometimes share something in common with not-a-doctors; the unwillingness to give up treatments that science has shown to be ineffective.) Without a good RCT, it's impossible to tell if Not-a-Dr. Adelson is getting the results he gets due to placebo effects or not. Yet he just cruises along, using an unproven therapy. Worse, who knows what Adelson is actually injecting? He's described his technique for isolating stem cells, but one thing I see lacking is any characterization of the cells to demonstrate that they are what he claims they are. I also see a lack of followup images to demonstrate that the concoctions injected into the discs have had any effect at all biologically in rehydrating and renewing them. Basically, Adelson's clinical "evidence" is a joke, and a bad one at that. Yet, Docere Clinics continue to offer the treatment, and even offer a 10% discount per patient to current patients who refer new patients. Capitalism!
But how can this be legal? Apparently, in Utah, it is. Britt Hermes contacted the Utah Division of Occupational and Professional Licensing and received this reply:
Naturopath Harry Adelson who harvests and injects stem cells (using fluoroscopy!) got the approval of Utah authorities.
This is bullshit. pic.twitter.com/c6DaYVZHJe
— Britt Marie Hermes (@NaturoDiaries) August 31, 2017
Yes, in Utah, naturopathic quacks can basically do anything, science be damned. Or so it would seem. Worse, Not-a-Dr. Adelson is not alone. There are quite a few naturopaths out there offering prolotherapy and "stem cell" therapies. Be afraid. Be very, very afraid.
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I wouldn't trust this person to inject roadkill with a Ron Popeil Flavor Injector, yet somehow he's allowed to inject "stem cells" into humans in his "clinic" in the US? Good grief. I guess all these emails I get about learning to do "stem cell therapy" at weekend hotel conferences truly have no restrictions on who they'll "train".
Well, at least the website is honest that they are a "cash-only" practice and the procedures are NOT covered by insurance. While he's probably making money hand over fist from his marks...er...patients, they are not putting up any kind of fuss.
I wonder if his patients do try to submit to insurance, anyway? I've known (and overheard) a lot of calls from people who become furious that they spent thousands on faux medical care and can't get insurance reimbursement. (Pro-tip - in the US, most, if not all of the big insurance companies have their policies regarding medical procedures posted on the internet . Look things up before you pay out of pocket for dubious procedures).
I don't see how the fact Adelson is an ND has much significance, or how his stem cell clinic is any scarier than other stem cell clinics – the whole terrain seems equally bogus and frightening. I'd say the lead here is that in Utah, "quacks can basically do anything, science be damned," and the rationale appears to be exactly "Capitalism!". That is, this all of a piece with "Free To Choose Medicine", and the decades-long efforts of Milton-Friedmanite ideologues to do away with the FDA. "The market can serve as the sole arbiter of utility: if a medicine is selling well, it must be delivering value." And, of course, the invisible hand will provide all the protection anyone needs. Bad medicine will, they think, "be identified quickly after [it goes] on sale," fail in the market, and disappear. (Never mind anyone who gets hurt in this process.)
But if the market did filter out the crapola, not one would believe the market filters out crapola, since the material evidence is entirely to the contrary. I've worked in and studied the advertising industry, the output of which is rooted in ubiquitous and relentless magical thinking, and is extraordinarily successful in selling stuff that can't possibly fulfill the magical promises, over and over and over, cha-ching, cha-ching, cha-ching. Medical woo is just the tip of the iceberg.
The credentials of the quacks (MD, ND, DC, AC/DC, LSMFT...) hardly matter in the libertarian laissez faire paradise (or, apparently, Utah) since 'we don't need no stinkin' badges' as the market will take care of everything. Regulation? No, we don't want the nanny state crushing the freedom of potential healthcare John Galt visionaries just because they didn't get a degree from the right school. What is (bogus) stem cell therapy but the medical version of Galt's magic engine that powered vehicles using nothing but air? Just let the visionaries work their magic without restriction, and we will all reap the benefits once a truly free market separates the wheat from the chaff!!!
@ Chris Hickie
The meat of this story isn't Adelson, who at least learned his tricks with Popeil's Stem-Jector at Yale and from the most cutting-edge stem-cell MDs in all the Americas. No, the meat is that it seems you don't even have to attend a weekend hotel conference 'training' to do intraspinal placebo injections in Utah.
Platelet-rich plasma injections (dubious treatments as noted by Orac) are used by mainstream medical providers.
Put it in the hands of a quack with fluoro and other additives and you have amplified risks still without benefit.
This is horrifying.
It's also exploitative. He basically took advantage of these people's poverty to let them be his guinea pigs upon whom he could practice his skills.
A 50-50 chance of placebo on a trial is far lower than the odds you will get placebo with a naturopath.
Damn. That's a line I should have used! :-)
As I understand it, insurance companies usually don't pay for experimental treatment of any kind. Which is why ethical doctors participating in clinical trials don't charge, or only charge minimally, patients who participate in those trials.
Chronic pain is especially pernicious. Many of the people who get addicted to opioids got there because of prescriptions for their chronic pain. People who quite reasonably want to avoid that fate are often willing to spend lots of money on treatments that won't lead to opioid addiction. People like Adelson are taking advantage of these patients.
What's even worse is that it is difficult to prove malpractice on the part of a naturopath. How do you establish that the practitioner violated the standard of care when there is no standard of care?
There are exceptions to this rule. For instance, when I was in NJ, one of the better things the state legislature did back then was to pass a law to require insurance companies to pay for all the ancillary services of a clinical trial. They still didn't have to pay for the actual cost of the experimental drug or administering it, but all the extra lab tests necessary because of the clinical trial, if any, would be covered. It's a reasonable compromise. It's also something "right-to-try" laws eliminate, as most such laws I've read explicitly give insurance companies the right to refuse to pay for experimental therapeutic-related care, which, if interpreted in the harshest light, would include letting them refuse to pay for the treatment of complications suffered as a result of using a "right-to-try" drug.
With that kind of informed consent, if he manages to damage someone's nerves he's going to have quite the issue in trial. I don't know how Utah's law treats naturopaths - holding them to professional standards or reasonableness - but I'd expect the courts to analogize on the informed consent issue.
If this doctor of nothing is practicing in Park City, he must be doing well. Park City is not a cheap place to live.
In a couple weeks, I am having shots done in 3 levels of my c-spine. Hopefully, they work so I don't have to have a 3 level fusion.
I don't think I'll go see this quack.
Lets try this again, my post seem to be disappearing into the void.
This doctor of nothing must be doing well to be practicing in Park City which is a very expensive place to live. Also, Utah treats Park City somewhat different than the rest of the state because it is such a cash cow.
I am going to having injections done in 3 levels of my c-spine to see if I can keep from having a 3 level fusion done. I don't think I'll be consulting this quack.
Among the snake oil used in the community of people who think they have "chronic Lyme disease", stem cell therapy has become a popular choice.
Semi-celebrity Kelly Osbourne wrote in her book about being diagnosed with chronic Lyme with the assistance of a heilpraktiker/naturopath named Philip Battiade. He operates cleverly marketed but shady clinics in Frankfurt, Germany and Los Angeles under the brand name Infusio. Stem cell therapy is advertised as an option for numerous desperate conditions, including Lyme and cancer.
Osbourne flew to Frankfurt and says she was cured with stem cell therapy. Stem cell clinics have been enjoying the publicity.
US Magazine published an excerpt from Osbourne's book (that is different from the actual book content) in which she states:
There is something basically wrong here, Adelson is allowed to practice voodoo medicine but a nurse that follows the law is arrested.
By all accounts, the head nurse at the University of Utah Hospital's burn unit was professional and restrained when she told a Salt Lake City police detective he wasn't allowed to draw blood from a badly injured patient.
The detective didn't have a warrant, first off. And the patient wasn't conscious, so he couldn't give consent. Without that, the detective was barred from collecting blood samples - not just by hospital policy, but by basic constitutional law.
Rich@12: I heard about that incident via another blog I read, and I expect that the SLC police department is looking at a lawsuit or two. The reason the cop didn't have a warrant is because he did not even have probable cause--the patient in question was the victim of an accident that occurred during a high-speed chase, and was not the chasee.
As for the disappearing post issue, I've been having it, too. At least two posts of mine in the last two days (on other SB blogs, so far not RI) have disappeared into the bit bucket.
I don't know what's wrong. I just approved a whole bunch of posts over the last three days that got stuck in the spam filter. I have no idea why. They weren't just held up for moderation. They were dumped straight into the spam folder. Weird. I'll keep an eye out now that I know it's happening.
Orac: " I just approved a whole bunch of posts over the last three days that got stuck in the spam filter."
Thanks. I found it a bit frustrating yesterday. I thought it was something I said, but it never said anything about "moderation."
Of course, quack Mark Hyman, MD, endorses this naturoquack on the Docere home page, but rather painfully so does a board-certified orthopedic spine surgeon, too, who blithely says:
"As a Cleveland Clinic trained orthopedic spine surgeon, when I heard about stem cell injections being performed into intervertebral discs and epidurals, I had to see it with my own eyes. When I visited Docere Clinics and watched Dr. Adelson operate, what I discovered was pleasantly surprising. Dr. Adelson is a skilled spine injector, practices flawless sterile technique, is honest and upfront, and is completely professional. I'm happy to call Dr. Adelson a trusted colleague and a friend.".
I can't say I'm being left terribly impressed with Cleveland clinic doctors of late.
I've got to wonder about this guy's sterile technique.
My MIL was telling me about her friend's sister who works at a "clinic" like this in Vegas. The doctor gave the friend's sister a free injection of "stem cells" (or who knows what) in her knee that gave her a raging staph infection that had to be surgically treated (maybe with a knee replacement?) and took 6 months to recover from.
I can't say I was surprised that a person would get an infection from a dubious clinic. Who knows what their cell processing technique looks like.
There are unfortunately many MDs doing similar stuff. I knew someone who was getting platelet rich plasma injections for severe knee osteoarthritis from Victor Ibrahim at a DC clinic called "Regenerative Orthopedics and Sports Medicine." Very expensive and prolonged her suffering because she eventually had to have a knee replacement.
Rich: tell me about it. I've been fuming about this since I heard about it yesterday.
It's not the first time something like this has happened.
Re Professional standards: Sadmar makes an interesting point about credentials and a laissez faire liberterian world. As we systematically dismantle all regulations we get to the point where credentials are meaningless. The whole reason we started licensing physicians and nurses was to ensure quality of practice, and a means of accountability.
That's going away.
Then we see someone like Nurse Wubbels who sticks to her ethical guns in the face of a bullying cop. She tells us her job is to protect the patient.
She's right. That's something legislators need to be reminded of.
Health care should not be a place where caveat emptor rules.
Some of you might want to sign this petition.
The police department apologized to her yesterday, and she said she thinks they are sincere. That was what she wanted, and I'm glad she got it. The DA opened a criminal investigation; charges may be forthcoming.
I'm writing letters to my state and federal reps demanding they protect nurses from overzealous law enforcement. I've been where she is, though it didn't escalate to the point of handcuffs thank God (it did cost me a job).
It looks like even physicians in Utah don't have to carry medical malpractice insurance. So who knows if this naturoquack is carrying any sort of malpractice insurance, and as noted above just what in the world is the standard of care for naturopathy anyways? can you hold this bozo to the standard of care for an MD?
I have a new nominee for Credulous Alt Health Reporting of The Year: the Columbus Dispatch.
Today the Dispatch business section features a "Q&A" with the founder of "Worthington Optimal Wellness", which is basically a chiropractic clinic also offering acupuncture and other woo. Among the howlers the editor/interviewer failed to catch is the suggestion that the sciatic nerve controls uterine and ovarian function, plus this gem:
"Chiropractors have shown that every adjustment takes us out of fight-or-flight and puts us into parasympathetic mode, which promotes more healing, better digestion and so on."
Of course, this interview appeared in the same newspaper that runs half-page ads for a chiro who bills himself as a "functional medicine" doc who effectively treats hypothyroidism, autoimmune disease etc.
The alties are fond of telling us, 'follow the money". In this case, they may have a point.
Late to the party, but:
"A 50-50 chance of placebo on a trial"
More and more often, trials are being done 1:3 or even more - it makes the trial bigger and more expensive, but people are a lot more likely to sign up if you tell them they have a 2/3 chance of getting into the active arm rather than 50%.
And, well - the whole reason you freaking do a trial is because you don't know if the treatment works. You might be better off being in the placebo arm and getting regular doctor visits and standard-of-care treatment. But people don't think like that. They want to be in the active arm.
I looked at your link, wondering what desk at the Dispatch might have approved this story. Turns out, it's a cross-publishing thing from a business periodical, Columbus CEO Magazine, and the chiro is the subject of a "Columbus CEO Small Business Spotlight". These are straight-up puff pieces, off course, so the 'interviewer' acts innocuous gee-whiz questions and the editor only vets the copy form style and length. So the only qualification the chiro needs to talk chiro-talk in print is operating a solvent business of some sort.
In the old days of print, I'd expect typical readers to recognize this kind of piece for what it is (a 'free' ad) based on its form and where/how it appears in the publication – that is, not to imagine it as 'news' involving any warrant of 'truth' that comes from 'objective reporting' at all. But these days, who knows?