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Duke U.’s stem cell program for autism: The dark(er) side of quackademic medicine (revised and greatly expanded)

Despite a lack of evidence Duke University is all-in on stem cells for autism, thanks to a billionaire benefactor and a Panama stem cell clinic. This is the dark(er) side of quackademic medicine.

Given how much I’ve been writing about COVID-19 science, pseudoscience, public health policy, and crankery, I feel as though I’ve been neglecting other issues relevant to science-based medicine. So this week, I’ll take a little break from the pandemic (don’t worry—I’m sure it’ll probably be back next week to look at another bit of COVID-19 grift), and revisit another form of grift, a particularly disturbing one. I’m referring to stem cell quackery. It’s a topic that I addressed initially on my not-so-secret other blog a couple of weeks ago, but that now has a major update, along with a paper, meaning that I can summarize what happened initially and, hopefully, update in a way to make a more complete story for this blog. It all started when I saw this Tweet about Duke University, stem cells, and autism:

The above Tweet probably looks familiar to regular readers, as I referenced it nearly a month ago. This particular post is an updated, revised, and (greatly) expanded version of the original post.

I’ve often bemoaned the infiltration of what I like to refer to as “quackademic medicine” in medical academia. It’s true that I did not coin the term “quackademic medicine” (Dr. R. W. Donnell did) but I did adopt it and popularize it to the point where many mistakenly think that I coined the phrase. In brief, quackademic medicine is a term to describe the increasing study and adoption of unscientific and pseudoscientific medicine in medical academia, mainly medical schools and academic medical centers. It’s gotten so bad that even my medical alma mater, the University of Michigan, the school where I proudly earned my MD, now features acupuncture, naturopathy, and even anthroposophic medicine. The Department of Family Medicine there even invited a prominent homeopath to give grand rounds on his field! It even indoctrinates residents into the quackery of “integrative medicine”. I pick on U. of M. because the embrace of quackery by some of its personnel pains me deeply, but I could easily rattle off at least a dozen other examples without even pausing to take a breath, and then there’s the NIH’s National Center for Complementary and Integrative Health (NCCIH) (formerly known as the National Center for Complementary and Alternative Medicine, or NCCAM), which is currently run by an acupuncture believer.

The dark(er) side of quackademic medicine: Duke teaming up with a quack clinic

As bad as the embrace of naturopathy, traditional Chinese medicine, and even reiki and homeopathy by academic medical institutions that would normally be expected to be bastions of science-based medicine is, I’ve discovered that there can be an even darker side to quackademic medicine. I’m referring to when researchers and universities team up with companies selling outright quackery, such as when St. Elizabeth Healthcare in Cincinnati took money from dōTERRA, a company selling essential oils, to start a center for “integrative oncology”. Unfortunately, what Dr. Knoepfler described a few weeks ago at Duke looks even worse than that:

There is a puzzle when it comes to the controversial idea of using cord blood for autism, because two of the strongest proponents are the autism cord blood program at Duke and for-profit, unproven stem cell clinics. On first glance it seemed like this was a bit of an odd couple to me.

The links between the Duke autism program and one particular Panamanian stem cell clinic called generically enough “The Stem Cell Institute” appear to go beyond just their enthusiasm about cord blood for autism.

Those apparent connections involve a mega-donor who has given a vast sum perhaps as high as $10s of millions to Duke’s autism cord blood group. Furthermore, The Stem Cell Institute says the donor and people in his circle have also been their customers. The clinic also makes another particularly startling claim I go into later in the past [sic].

As I’ve described more times than I can remember, bogus stem cell therapies are a particularly favorite form of autism quackery. Indeed, long time readers might remember the time twelve years ago that I wrote about Kent Heckenlively and how he took his severely autistic daughter to Costa Rica for “stem cell therapies” involving injecting “stem cells” directly into her cerebrospinal fluid and even borrowed $15,000 from her grandparents to do it. Indeed, I’ve even written about Duke University’s ethically dodgy “pay-to-play” clinical trials of cord blood stem cells for autism, noting that the Stem Cell Institute was the single largest recipient of money from patients who crowdfunded their treatments. (Northwestern University was another culprit doing, as Dr. Knoepfler described, the same sort of dubious things.)

Dr. Knoepfler also notes that investigators in Duke’s autism program, led by Dr. Joanne Kurtzberg, still share major enthusiasm for stem cell therapy using umbilical cord blood for autism, despite a negative phase II randomized, double-blind, placebo-controlled clinical trial of umbilical cord blood for autism that showed no improvement in socialization skills or reduced autism symptoms. Other clinical trials also show no benefit. (Why anyone is doing these ethically problematic trials anymore is beyond me.) Despite that resoundingly negative study, these Duke researchers continue to want to bravely paddle up the river of pseudoscience, apparently rationalizing that they need to use more stem cells, rather than just cord blood:

Remarkably the Duke team has subsequently begun not one but two more new, related trials.

The first seems focused specifically on lab-amplified cord blood stem cells for kids with autism and the second is for young adults with autism.

How can they still be so enthusiastic?

I don’t know. There always seems to be some rationalization to keep them going.

Things like this pop up, “If only we had designed our trial differently and excluded some patients, we would have seen benefit”, and so on. Maybe now they think that instead of cord blood it’ll be better to use lab-grown cord stem cells?

It feels to me like they just can’t let go of their idea that cord cells must help autism despite the data generally saying otherwise so far both from their own and other trials.

The Stem Cell Institute, located in Panama, is clearly a quack stem cell clinic, although that didn’t stop Duke University researchers from partnering with it. Indeed, the first trial opened to accrual on October 1; the second is expected to open this month. Its website advertises stem cells to treat autism, cerebral palsy, heart failure, multiple sclerosis, osteoarthritis, rheumatoid arthritis, spinal cord injury, and autoimmune diseases, complete with very little actual science but a whole lot of testimonials. Its founder, Neil Riordan, has shown up with Mel Gibson on the Joe Rogan Experience (as has a Stem Cell Institute patient, welterweight champion Kamuru Usman) to tout his snake oil.

As an aside, in other marketing, Ozzie Osbourne also went to the Stem Cell Institute for treatment for Parkinson’s disease:

Now here’s where the connection I was talking about comes in:

As I’ve tried to learn more about all of this over the years, I found that the Panama stem cell clinic often kept popping up in a parallel way to the Duke Autism Program on the web with different searches. Some patients mention both.

More concretely, Duke has reportedly received more than USD $10 million (media reports range from $15 million to $26 million or even $40 million) for its autism research from a philanthropic organization called the Marcus Foundation, which also has connections to The Stem Cell Institute clinic in Panama, at least according to the clinic. The Marcus Foundation is led by Home Depot founder and billionaire, Bernie Marcus.

Bernie Marcus, besides being a billionaire, is a believer in stem cell treatments and has been a patient at the Stem Cell Institute. There’s even a story about it in the News section of the Stem Cell Institute’s website:

Bernie Marcus, cofounder of Home Depot and the company’s first CEO, suffered from bronchiectasis, a chronic lung condition that caused him to have difficulty, especially when public speaking. As a prominent businessman and active philanthropist, Bernie is a sought-after speaker. When his condition worsened and interfered with his speaking ability, he knew something had to be done. “I would get hoarse and cough ten to fifteen times every hour,” he said. “It was difficult to handle and progressively getting worse.” He went to the nation’s top respiratory hospital—National Jewish Health—where the doctors told him he would have to take antibiotics for two years to address the bacterial infection in his lungs. This treatment would do a number on his digestion, however, so he sought an alternative.

His physician recommended that he try stem cell treatment in Panama. Another good friend of Bernie’s had already been down to Panama to treat a stomach disorder that completely cleared up, so he felt comfortable with the recommendation.

Bernie was treated with stem cells and shortly thereafter stopped coughing and was able to return to his work. “I was able to go back to public speaking without embarrassing myself,” he said.

The story even claims that Marcus brought his wife, who has severe osteoarthritis of both knees and needs bilateral knee replacements, to Panama for stem cell treatments and claims that she is without pain now.

So we’ve established that the Marcus Foundation, which was founded by a billionaire who believes in unproven stem cell treatments that are basically quackery, has donated tens of millions of dollars to Duke to research cord blood and now stem cell treatments for autism. As Dr. Knoepfler notes, now that cord blood therapies have resoundingly failed in Duke’s phase II clinical trial, Duke researchers are moving on to treatments based on growing stem cells in a lab to infuse into patients, treatments much more like what the Stem Cell Institute claims that it is doing. (I always say “claims” with respect to what stem cell clinics like the Stem Cell Institute say they are doing, because in many cases it is not at all clear to me that they are actually correctly isolating and expanding the needed stem cell populations.) That’s bad enough. Although it’s certainly not illegal to seek donations from a foundation that clearly promotes dubious stem cell therapies, it should raise many red flags ethically to any researcher looking at science-based therapies based on stem cells. After all, the connection between Marcus and Riordan appears real, unless Riordan is lying about it, which seems unlikely, and the Stem Cell Institute is selling stem cell snake oil.

There is also this photo on the Stem Cell Institute’s Facebook page:

Here’s where it really gets dicey. As Dr. Knoepfler describes, it appears that Dr. Riordan is one of the scientific reviewers of grant applications to the Marcus Foundation and that he reviewed Duke University’s grant application. In a response to an article critical of Duke University’s stem cell trials for autism, Dr. Riordan himself did a sort of “Q&A” about the article and questions raised. I’m going to quote a bit more than what Dr. Knoepfler quoted:

13. Did you collaborate with any researchers from Duke when designing this study? Have you collaborated with researchers at Duke in any way?

I know Dr. Kurtzberg at Duke. Bernie Marcus, who funded the Duke trials, has been a patient in Panama (public information) and saw children with autism benefitting from treatment with umbilical MSCs first hand. I was asked to review the Duke proposal for the Marcus Foundation and was at the Foundation Board meeting that led to the funding.

So, basically, it sounds as though Dr. Riordan is basically bragging about having steered some of that sweet, sweet Marcus Foundation cash to Dr. Kurtzberg and Duke University. It goes beyond that, though:

14. Do you have plans for follow-up studies, and if so, what are the goals of those studies? If you have a specific study underway now, how many children do you plan to recruit?

There is currently no follow-up study in Panama underway. We do have plans for future studies in the U.S. but there is no timeline as of yet.

“We” have plans for future studies in the US? What does this mean? Whom does Dr. Riordan mean by “we”? It could be that he means the Riordan Medical Institute, located in Texas. Or does he mean Duke University? Or both? Inquiring minds want to know!

It also turns out, unsurprisingly, that Bernie Marcus is into more quackery than just stem cell quackery and has long been using his fortune to support and promote quackademic medicine. Here’s Marcus himself in an interview:

Yes. I have a particular doctor who is an integrative medicine doctor. He has used herbs. He has used massage. He has used chiropractic, and he has taken care of my family for well over 20 years. And I have watched the things that he does, and I have watched the fact that he could give us herbs instead of medicines—medicines where we always had a serious reaction, medicines that in fact could be dangerous in some situations. And instead of that, he gave us simple remedies that worked for us.

And I can tell you that some of them were exotic. Some of them were like umbilical cord stem cells, heavy doses of vitamin C, which he uses for cancer patients, that we know anecdotally alleviates some of the side effects of chemotherapy—losing the hair, the energy, the appetite, et cetera, et cetera. And it has been used by holistic medicine/integrative doctors for the last 15–20 years. And medicine turns its nose up at it, even though it is a vitamin and it goes in and out of the body, it is very, very hard to sell to anybody.

Fortunately, we now have some rigorous clinical trials going on at leading institutions, hopefully to prove this effect, and have the data available for others to use. That is what integrative medicine is. It is trying different, non-traditional ways of dealing with ailments that people have—you might call it different strokes for different folks.

And:

So I have experienced the value of integrative medicine myself, and I am a great believer in it. We helped open this clinic at Jefferson, and hopefully we are going to prove this. I think the other thing that will happen is that medical students are going to be exposed to it, which I think is very important—that they do not have blinders on their eyes that most medical doctors have when it comes to these kinds of nutrients. For most doctors, if it is not taught in medical school, it is not kosher. So I think it is going to have a very, very important effect on medicine in the future.

Unsurprisingly, rare is the actual rigorous clinical trial that actually shows benefit from these “alternative” and “integrative” treatments. Also, how is “stem cell therapy” in any way “integrative” or “alternative,” other than in the sense that it is unproven, except for a handful of indications, and that there are a huge number of quack clinics out there profiting from it?

Lack of evidence aside, there’s a center for “integrative medicine” named after him at Jefferson University, after the Marcus Foundation donated a $20 million grant to the university to form the first full department of “integrative medicine” in a major academic medical center, after having previously donated $25 million to integrative medicine projects including the creation of the Marcus Institute of Integrative Health, which offers “functional medicine“, a make-it-up-as-you-go-along “specialty” that relies on massive overtesting and overtreatment, high dose intravenous vitamin C, “restorative” micronutrients, and more. Meanwhile, at Duke, in 2018 a Marcus Foundation donation led to the founding of the Marcus Center for Cellular Cures (“cures”?), which is dedicated to—you guessed it!—stem cell-related treatments and “cures” for autism and other neurodevelopmental disorders.

This brings us to the latest on this arrangement, courtesy of Prof. Knoepfler and a new paper in Cytotherapy by Jeremy Snyder and Leigh Turner, who previously published about crowdfunding for unproven stem cell treatments and how it induces kind-hearted strangers to pay for quackery. In previous work Turner described how crowdfunding is abused by quack cancer clinics.

Tainting science by consorting with quacks?

Last week, Paul Knoepfler continued the story he had begun about the highly ethically questionable relationship between The Stem Cell Institute and Duke University, in particular Dr. Joanne Kurtzberg. Being a stem cell researcher himself Dr. Knoepfler mentions in his post how difficult it is for him to write an article like this, asking, quite reasonably, who “wants to take the risk to be critical of the practices of a team led by a fellow academic stem cell researcher?” and noting that, after his previous discussion of the same sort of setup at Northwestern University, leader Dr. Richard Burt pushed back with a piece in Science. I fully understand his reluctance. After all, given their prominence in the world of stem cell research, researchers like Drs. Burt and Kurtzberg that Knoeopfler criticized could well be the members of NIH study sections who will be evaluating his grant applications. Moreover, before drifting into studying dubious stem cell treatments for autism, these researchers had built their reputations with solid research. So Knoepfler answers his question about why he is writing posts like these:

Given all of that, why do a post like last week’s?

The well-being of pediatric patients and their families is the primary reason I decided to pull the trigger on this particular post.

I’m also very concerned more broadly about the practice of some universities requiring large fees for patients to receive unproven cellular therapy offerings, often in ways such as via off-study or compassionate use where the data from the patients often does not end up published. These arrangements may have less chance for benefit and more risks than are portrayed.

Some universities are at the same time hyping or exaggerating on-going clinical trials as though the cell therapy drug in question is already known to work.

He’s right, too. Duke, Northwestern, and some other universities are falling into hype that sounds very much like the hype of the for-profit stem cell clinics with which they’ve gotten into bed, while risking corrupting legitimate academic research:

This Duke-stem cell clinic situation is a prime example of muddy waters between a place overall doing robust clinical science and for-profit clinics. In terms of the actual biomedical science in this case, it seems to me like this is likely the realm of stem cell “magic” where one’s hopes and ideas prevail over actual data.

I’ve frequently said the very same thing, namely that, if you believe the advertising of for-profit stem cell clinics, stem cells are magic! They seem to think that they can just isolate any old stem cells, be they from amniotic fluid, mesenchyme, or wherever, inject them into the bloodstream, and expect that they will magically home in on wherever they need to go to fix whatever problem they’re being used to fix. This might make some sense in degenerative diseases involving chronic inflammation causing damage to a structure or organ, such as for various forms of arthritis, although I’d still say there was a huge assumption being made there. The same applies to damage from an acute injury, such as spinal cord injury or a stroke, although, again, it is a huge assumption to postulate that the cells will just magically “know” where to go and “know” how to fix the damage.

I said at the beginning of my post that this alliance between Duke University researchers and the Stem Cell Clinic represents the “dark side” of quackademic medicine. Basically, through its hard-to-find ties to the Stem Cell Institute Duke University has sullied its good name by getting into bed with stem cell quacks like Neil Riordan. It’s all fun and games (and easy to laugh at and off) when academic medical centers embrace, for example, the faith healing that is reiki. It’s not so funny anymore when they start taking money from believers in quackery to run scientifically dubious clinical trials of that quackery and even set up centers dedicated to dubious treatments. Real children could end up being hurt. Without robust preclinical evidence in cell culture and animal models of the disease being treated to show that the stem cells do what you claim they will do, it is not just a leap to test them in humans. By the Declaration of Helsinki, it is unethical. It’s arguably even more unethical to require patients (or their parents or other relatives) to pay huge sums of money to participate in these clinical trials.

This brings us to the paper by Snyder and Turner, “Crowdfunding, stem cell interventions and autism spectrum disorder: comparing campaigns related to an international “stem cell clinic” and US academic medical center“. In this paper, Snyder and Turner compare and contrast “crowdfunding campaigns, identifying an international stem cell clinic marketing a purported umbilical cord blood-derived stem cell treatment for autism spectrum disorder, with campaigns soliciting donations intended to help children with autism spectrum disorder either participate in clinical studies or obtain expanded access to stem cell products provided at an academic medical center in the US”. They begin by noting in the introduction that not all clinical trials of stem cell therapies come from for-profit direct-to-consumer clinics selling unapproved stem cell interventions:

However, not all crowdfunding campaigns related to purported cell therapies are confined to the direct-to-consumer marketplace for unapproved stem cell interventions. Some campaigns solicit donations that will help individuals access investigational stem cell products provided at academic institutions, either in the context of clinical trials or outside clinical studies on what in the US is known as an expanded access (EA) basis. For example, a study of crowdfunding campaigns for unproven stem cell interventions for neurological conditions identified campaigns for participation in clinical trials conducted at academic health centers or to utilize EA pathways at those facilities. In this study, although the top three destinations for purported stem cell treatments were clinics operating on a direct-to-consumer basis, the fourth most commonly named destination facility was Northwestern University. This location was named in crowdfunding campaigns seeking experimental stem cell interventions for multiple sclerosis. The site has reportedly ceased enrolling new participants in clinical studies. The fifth most frequently named destination facility was Duke University. These crowdfunding campaigns all sought experimental stem cell interventions for autism spectrum disorder (ASD).

Online crowdfunding activity identifying academic medical facilities as intended destinations for accessing experimental interventions has largely escaped scrutiny by scholars and journalists. This lacuna is striking because many investigational products are first tested in clinical trials conducted by researchers based at academic health centers. In particular, there has been little effort to compare and contrast crowdfunding campaigns for individuals seeking access to clinical studies or the EA regulatory pathway at academic health centers with crowdfunding campaigns for persons hoping to undergo unproven stem cell procedures at clinics operating on a direct-to-consumer commercial basis. Thus, the content of campaigns for participation in clinical trials and to access unproven treatments on an EA basis is largely unknown.

So what did Snyder and Turner do? They decided to compare the pitches made for clinical trials of stem cell treatments for autism by The Stem Cell Institute (SCI) in Panama and the Duke Center for Autism and Brain Development, noting that, although a phase 1 clinical trial of intravenous infusion of autologous umbilical cord blood cells was safe and resulted in significant improvements in behavior among children with ASD, a “more recent phase 2, randomized, double-blinded and placebo-controlled study by these same researchers found no improvement in ASD symptoms and socialization skills”.

The authors then did this:

The authors searched the GoFundMe crowdfunding platform for campaigns seeking funds to access stem cell interventions at these two sites. GoFundMe was selected for study, as it is by far the largest platform for medical crowdfunding campaigns worldwide. Searches took place using GoFundMe’s internal search engine and a search tool that scraped the GoFundMe site for crowdfunding campaigns seeking donations for ASD and specifying that the subject of the campaigns would travel to either Duke or SCI for stem cell intervention. Search terms used were “Duke” and “autis*” (to capture both “autism” and “autistic”) for campaigns with Duke University as a destination facility and “autis*” and “stem cell institute” or “autis*” and “stem cell” and “panama” for campaigns with SCI as a destination. This search took place on May 25, 2020, and returned 69 campaigns referencing Duke and 92 referencing SCI.

Snyder and Turner identified and analyzed ten campaigns to obtain access to stem cell interventions at Duke, with six to participate in a clinical trial, three to access stem cells on an expanded access basis, with one unclear as to which of these funds were being raised for. There were 76 campaigns for interventions at SCI. They then categorized statements about the perceived efficacy of stem cell interventions into “definitive statements that the intervention would work in all or some specific subset of cases (including specific percentages of positive outcomes or testimonials) and no definitive statements of efficacy”. To summarize the results, campaigns connected to both sites contained inaccurate claims, but campaigns identifying SCI as the intended destination for treatment made stronger claims about efficacy and included more testimonials than campaigns associated with Duke University. However, they also noted that press releases, clinical studies, and news stories about Duke’s program played an important role in “lending the perception of credibility to the putative stem cell treatments marketed by the international clinic”. In other words, news coverage of Duke’s trials and Duke press releases not only enticed parents of autistic children seeking stem cell treatments to want to enroll in Duke’s clinical trial, but that sheen rubbed off on SCI, where campaigns also cited Duke as evidence that SCI’s intervention was efficacious.

In addition, Snyder and Turner analyzed an additional eleven crowdfunding campaigns for children with ASD seeking to take the child to someplace other than Duke or SCI, which included for-profit stem cell clinics in the US, Russia, India, and Mexico. They observed that these campaigns “discussed inadequate numbers of umbilical blood stem cells for the procedure, cost, lack of availability in the US and lack of Food and Drug Administration approval as barriers to accessing this intervention at Duke” and “mentioned news coverage of the Duke trial to support the legitimacy of the intervention being sought”. They concluded that, although there were “meaningful differences” between the claims showing up in crowdfunding campaigns for treatment at SCI versus Duke, even so:

Acknowledging these important distinctions, there nonetheless are striking ways in which the clinical trials conducted at Duke help support and sustain a market for unproven and unapproved stem cell interventions provided at Panama’s SCI. For example, campaigns seeking donations for stem cell procedures conducted at SCI frequently refer or even link to information about clinical trials conducted at Duke. Campaigns reference these studies to bolster their claims that stem cells can now be used as safe and effective therapies to treat children with ASD. Some campaigns note that members of the philanthropic family supporting Duke University’s stem cell research in the area of ASD visited SCI and had stem cell procedures there. In other cases, campaigners referred to first seeking stem cell interventions at Duke University and then deciding to travel to SCI after being unable to access stem cell procedures at Duke. One campaigner claimed that they selected SCI as their preferred destination after being referred there by staff at Duke. Such claims might be inaccurate, but they suggest that the clinical research program at Duke propels significant interest in SCI’s products and bolsters confidence in their effectiveness.

Snyder and Turner conclude by urging universities to be more aware of how they’re being used:

The authors urge clinicians, institutional leaders and media relations or communications staff members at academic health centers and similar medical facilities to anticipate that their research can be used and, in some cases, abused in this manner.

And:

Researchers at academic institutions and comparable health care facilities cannot prevent representatives of businesses engaged in direct-to-consumer marketing of unlicensed and unproven stem cell interventions from making misleading or otherwise problematic promotional claims. However, they can play an important role in shaping how their own research is depicted in press releases and on institutional websites. Wherever and whenever feasible, stem cell researchers need to emphasize the preliminary nature of early-stage clinical studies and avoid making claims about efficacy until convincing evidence is available to support such assertions. Connections to direct-to-consumer sellers of unproven and unapproved stem cell products—no matter how fleeting—should also be avoided due to the documented propensity of these facilities to exploit these connections and of patients, their caregivers and their social networks to interpret these connections as endorsements.

From my perspective, the question boils down to: Are stem cell researchers at universities like Duke who consort with dubious for-profit stem cell clinics useful idiots for those quack clinics, or are they aware of what they’re doing? From my perspective, the two explanations are not mutually exclusive. There could be elements of both. Having observed quackademic medicine for nearly 16 years, I’ve come to realize that there really is an ivory tower, and many academics really are that naïve, although that doesn’t rule out an element of mutually beneficial grift. It’s basically impossible to say without a lot more in-depth knowledge of the arrangement and situation, although Knoepfler notes:

It is surprisingly easy to fall into the trap of viewing your favorite particular kind of stem cells as some kind of medical magic. I actively try to avoid this with one of my favorite types of stem cells, IPS cells. Over the years I’ve posted many times about limitations and even setbacks to clinical IPS cell research along with the milestones and stepwise successes.

Stem cells in a general sense are remarkable cells with unique qualities, but that doesn’t mean that any particular kind of stem cells can treat or cure a wide array of diseases.

These are wise words. Not only is it unlikely that stem cells, of whatever type, will be the panacea that quack stem cell clinics portray them as (and that even reputable stem cell researchers sometimes imply that they are), but scientists and physicians are human, too. They’re just as prone to all the cognitive biases and shortcomings hardwired by evolution into our primate brains. Scientists and physicians have a similar all-too-human tendency to become so enamored of their pet hypothesis or pet treatment that they have a hard time being objective about it and can sometimes, when sufficiently in love with their idea, rationalize getting help to study it from sources that they would normally dismiss as too tainted.

Is that what’s going on at Duke? Who knows? What I do know is that, from my perspective, SCI has all the hallmarks of a quack stem cell clinic. No reputable academic medical center or researcher at such a medical center should have anything to do with a clinic like SCI. While it may be amusing to see academic medical centers embrace, for example, the faith healing that is reiki, it’s not so funny any more when they start taking money from believers in quackery to run scientifically dubious clinical trials of that quackery and even set up centers dedicated to dubious treatments. Real children could end up being hurt.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

47 replies on “Duke U.’s stem cell program for autism: The dark(er) side of quackademic medicine (revised and greatly expanded)”

“Real children could end up being hurt”.

In what way? Immune rejection? Are you SURE it is quack medicine? It can’t be any worse than the merry-go-round of Trazadone, Clonidine, Prozac, Abilify etc; some all at the same time, being used more & more frequently to chemically restrain autistic children. Is it worse than the windows they put their heads through or the ponds they drown themselves in? My friend & her 280 lb autistic son just died in a house fire last month. He wouldn’t run to safety with her, she couldn’t carry him & she wouldn’t leave him. The firefighters found them dead; with him in her arms. Understand the stakes before calling judgement on what “hurts”.

Stem cells reduce inflammation. Autism is an immune-mediated disorder. It’s worth researching, when you understand the stakes.

What about the man who went to Central Asia for “stem cell” treatments to address the side effects of a stroke and ended up with a debilitating tumor in his spine? That is real harm.

What if these stem cells haven’t been processed correctly and are contaminated by bacteria? Or viruses?

For what it is worth, I deal with the processing of cells for use in humans for a living. It is very hard to process them safely. It is distressingly easy to mess up. There’s contamination, there’s getting the wrong cells, and those are with a very well-characterized cell population.

Stem cells aren’t well characterized. There is still no consistent way to program what kind of cell you want a stem cell to become. Bone marrow isn’t even programmed: we’re just lucky that it homes to bone marrow and replaces the cells that have been killed.

The risk is injury, disability or death. That is the risk.

I’m sure once a 200+ lb kid gets a spinal tumor and ends up with, at best, severely limited mobility, Christine will be signing her kid right up, since she’d much have a child with gross motor impairment than a child with autism. Her life will be so much easier.

Could be worse; could be teeth (and a mouth).

{The fire story is sad but at 280 lbs I’m guessing that diet does not take precedence over bleach enemas (gut-brain hypothisis might even be on to something)}

since she’d much have a child with gross motor impairment than a child with autism

Since the stem cell treatment is not working at “curing” autism, she will only get an autistic child with gross motor impairment.

@Athaic, given that her go to estandards for “real” autism are elopement and aggressive behavior, and since significant motor impairment would eliminate those, she might consider him no longer “really” autistic.

Stem cells does not reduce inflammation, and autism is not immune mediated. Autism is not brain damage, which could be corrected by stem cells.

“brain damage, which could be corrected by stem cells.” Could it really? I’m not asking to be snarky, I am genuinely curious if you think (and if there’s research out there) to suggest that brain damage can be “fixed” with stem cells.
Is this a theoretical, in the future kind of thing, or a near-er term treatment?

TBI or cerebral palsy? Would it have to be done as soon as the damage is identified, or could it be done years later? And how would that impact the patient’s personality and sense of self?

In my mind, there are as many thorny ethical questions as there are difficult technical questions about re-wiring the brain.

“brain damage, which could be corrected by stem cells.” Could it really? I’m not asking to be snarky, I am genuinely curious if you think (and if there’s research out there) to suggest that brain damage can be “fixed” with stem cells.

That is not how I read the comment. I read it as meaning “Autism is not brain damage and cannot be corrected by stem cells”.

I guess if “that” had been used instead of “which” it would have been less ambiguous.

I didn’t see anything in the comment suggesting brain damage can be fixed with stem cells.

” as there are difficult technical questions about re-wiring the brain.”

asked Elon Musk if he had considered the possible heat transfer problem that could result from the overclocking happening in the brain. She then stated that most likely, this has already been thought of and continued to share her thoughts.

https://www.techtimes.com/articles/253970/20201108/elon-musk-defends-neuralink-against-neuroscientists-concerns-of-chips-overheating.htm

so. many. haters.

@Justatech
There is an interesting paper:
Thored P, Arvidsson A, Cacci E, Ahlenius H, Kallur T, Darsalia V, Ekdahl CT, Kokaia Z, Lindvall O. Persistent production of neurons from adult brain stem cells during recovery after stroke. Stem Cells. 2006 Mar;24(3):739-47. doi: 10.1634/stemcells.2005-0281. Epub 2005 Oct 6. PMID: 16210404.
Stroke definitely causes brain damage.

I forgot to add above; life expectancy in autism is 36 years.

“One study, published in the American Journal of Public Health in April 2017, finds the life expectancy in the United States of those with ASD to be 36 years old as compared to 72 years old for the general population. They note that those with ASD are 40 times more likely to die from various injuries. About 28 percent of those with ASD die of an injury. Most of these are suffocation, asphyxiation, and drowning. The risk of drowning peaks at about 5 to 7 years old. As 50 percent of those with ASD wander, water safety and swim lessons are a must. GPS trackers are also available for purchase should a child wander or get lost. This makes finding the child or adult much easier and faster.”
https://www.psychologytoday.com/us/blog/caring-autism/201810/early-death-in-those-autism-spectrum-disorder

That’s more years lost than a 50 year old diagnosed with cancer.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5672926/#:~:text=Estimates%20for%20loss%20in%20expectation,of%20age%20lose%20%3C10%20years.

We need more research, not less.

Christine Kincaid: “ We need more research, not less.”

Exactly right. No patient should be enrolled in a treatment program until research trials (adequate and well-controlled) demonstrate that the treatment works.

Assuming that poorly-substantiated high-risk therapies work just because they contain some magic incantation in their name (“stem cell”) is bad medicine. And accepting open-label case reports for outcomes in a subjectively rated condition is foolish.

The causes of autism are not fully understood, and maybe some cases are due to an immune mediated response. I think it will be found, as testing gets better, that this cause will be the exception and that the majority will have a genetic imbalance.

Though they are learning about the causes of autism. Which is not just one disorder but dozens, or even hundreds. Remember, it you have met one autistic person you have met exactly one autistic person. It is like cancer, there several different kinds, even when you use a descriptor like breast cancer.

It is not a genetic “imbalance”, but just genetics. Many are de novo mutations, many are not… and the research is ongoing: https://sparkforautism.org/discover/

Thanks for the link Chris. I should have said a Genetic cause rather than imbalance, although there are already many documented cases of deletions and duplications (imbalances) causing autistic behaviour.

“there are already many documented cases of deletions and duplications …”

Still they are genetic sequences. Just like there is an additional chromosome for Down Syndrome, also known as trisomy 21.

@ Fergus Glencross:

There is genetic research as Chris notes and we also know that events that happen during gestation can affect brain ‘architecture’ resulting in ASDs. Meds, lack of particular nutrients, infections etc during the second trimester especially are associated with ASDs. Other variables that point to prenatal influences include age of parents ( affecting genes), overweight mothers, environmental conditions etc. We know that autism can be detected months before most vaccines through MRIs, EEGs, observation. Researchers to look at : Courchesne, Ozonoff. Aldridge, Miles..

. .

The facebook group “Stem Cell Therapy for Autism” is riddled with references to the Duke and Panama locations and how they are connected–as in if you can’t get into one, go to the other. I see posts from parents saying they’ve done multiple stem cell transplants and still have seen nothing but are going back for more. If this stem cell nonsense for autism is so great, why put it in Panama? I worry most about unethical unapproved experimentation being done in Panama for the purporse of finding potentially promising protocols that then get secretly passed along to Duke to form the basis of their next “ethical” study.

Charging patients to be in a clinical trial always suggests to me that quackery and corruption are afoot. I really can’t see the rationale for doing this if you are running a proper clinical trial. It will undoubtedly skew the trial, making it useless. It strikes me as method to make money; win, lose or draw.

𝟭𝟮 𝗦𝗰𝗶𝗲𝗻𝘁𝗶𝗳𝗶𝗰 𝗥𝗲𝗮𝘀𝗼𝗻𝘀
𝗧𝗼 𝗥𝗲𝗷𝗲𝗰𝘁 𝗩𝗮𝗰𝗰𝗶𝗻𝗮𝘁𝗶𝗼𝗻
Published on July 15, 2020
Written by Dennis Stevenson

𝗡𝗲𝘄 𝗘𝗻𝗴𝗹𝗮𝗻𝗱 𝗝𝗼𝘂𝗿𝗻𝗮𝗹 𝗼𝗳 𝗠𝗲𝗱𝗶𝗰𝗶𝗻𝗲:
𝗖𝗵𝗶𝗲𝗳 𝗘𝗱𝗶𝘁𝗼𝗿 𝗠𝗮𝗿𝗰𝗶𝗮 𝗔𝗻𝗴𝗲𝗹𝗹 𝗠𝗗.,
“It is simply no longer possible to
believe much of the clinical research
that is published, or to rely on the judgement of trusted physicians or authoritative medical guidelines.”

𝗟𝗮𝗻𝗰𝗲𝘁 𝗖𝗵𝗶𝗲𝗳 𝗘𝗱𝗶𝘁𝗼𝗿 𝗥𝗶𝗰𝗵𝗮𝗿𝗱 𝗛𝗼𝗿𝘁𝗼𝗻, “…much of the scientific literature,
perhaps half, may simply be untrue … flagrant conflicts of interest …
science has taken a turn towards darkness.”

Manufacturers list vax ingredients as mercury, aborted baby DNA, aluminium, cancer tumours, anti-freeze, cow fetus, hydrochloric acid, Simian (SV40) virus, insect cells, formaldehyde, MSG, latex, detergent. Vax contaminants include lead, cyanide, tin, arsenic, urea (urine waste).

Manufacturers warn vax cause polio, cot death [SIDS], encephalitis, bleeding, paralysis, cancer, neuritis, convulsions, death, multiple sclerosis [MS] etc.

Claiming vax protects us from disease is contradicted as authorities report that vaxed patients can catch disease from, and infect, people both vaxed or unvaxed.
Impossible if vax work.

𝗩𝗮𝘅 𝗵𝗮𝘃𝗲 𝗻𝗲𝘃𝗲𝗿 𝗯𝗲𝗲𝗻 𝘀𝗰𝗶𝗲𝗻𝘁𝗶𝗳𝗶𝗰𝗮𝗹𝗹𝘆 𝘁𝗲𝘀𝘁𝗲𝗱 (𝗱𝗼𝘂𝗯𝗹𝗲 𝗯𝗹𝗶𝗻𝗱 & 𝗶𝗻𝗲𝗿𝘁 𝗽𝗹𝗮𝗰𝗲𝗯𝗼) 𝘁𝗼 𝘀𝗵𝗼𝘄:
a) if vax work, b) safety, and
c) which group is healthier long-term.

𝗧𝗵𝗲 𝗨𝗦 𝗛𝗲𝗮𝗹𝘁𝗵 𝗗𝗲𝗽𝘁 𝘄𝗮𝘀 𝗲𝘅𝗽𝗼𝘀𝗲𝗱
𝗶𝗻 𝗮 𝗺𝗮𝗷𝗼𝗿 𝟮𝟬𝟭𝟴 𝗰𝗼𝘂𝗿𝘁 𝗹𝗼𝘀𝘀 𝗮𝗳𝘁𝗲𝗿
𝗳𝗮𝗹𝘀𝗲𝗹𝘆 𝗰𝗹𝗮𝗶𝗺𝗶𝗻𝗴 𝗳𝗼𝗿 𝟯𝟮 𝘆𝗲𝗮𝗿𝘀
𝘁𝗵𝗮𝘁 𝘃𝗮𝘅 𝘄𝗲𝗿𝗲 𝘀𝗮𝗳𝗲 𝘄𝗶𝘁𝗵𝗼𝘂𝘁 𝗲𝘃𝗲𝗿 𝗼𝗻𝗰𝗲 𝗱𝗼𝗶𝗻𝗴 𝘁𝗵𝗲 𝘃𝗶𝘁𝗮𝗹 𝘆𝗲𝗮𝗿𝗹𝘆 𝘀𝗮𝗳𝗲𝘁𝘆 𝘀𝘁𝘂𝗱𝗶𝗲𝘀 𝗖𝗼𝗻𝗴𝗿𝗲𝘀𝘀 𝗼𝗿𝗱𝗲𝗿𝗲𝗱 𝘁𝗵𝗲𝗺 𝘁𝗼 𝗱𝗼.

Vax ignores 18 critical, life-saving, medical, ethical, legal and common sense requirements.
Before any vax injection, the patient’s medical history, age, allergies, sex, weight, medications, race and illnesses should be examined.
Doctors must disclose ingredients, harmful effects & get informed consent. Prescriptions are essential and must be in writing for a specific patient (never groups), disease, vax, dose and duration.

https://principia-scientific.com/12-scientific-reasons-to-reject-vaccination/

George Alexander Trebek ( July 22, 1940 – November 8, 2020)

https://tuckbot.tv/#/watch/jsavmk

He talked about his swearing in his memoir:

“I didn’t drink, didn’t smoke, didn’t do drugs. There was no big negatives associated with me. And that caused problems, because it held me back from becoming one of the guys… I started cursing, or to be more precise, injecting curse words into my conversation. But it didn’t help me become one of the guys. It just made me look like a jerk. My bad.”

Good book, easy read, very humble man, written post-diagnosis, I would recommend.

“The Answer Is… Reflections on My Life” by Alex Trebek.

@ Tim,

Yeah, You Tube borked massively last night. Worldwide. My only warning before someone threw my phone across the room, was hearing that “someone” saying “Error message. Error message” ugh.

And it has been used by holistic medicine/integrative doctors for the last 15–20 years. And medicine turns its nose up at it, even though it is a vitamin and it goes in and out of the body, it is very, very hard to sell to anybody.

In what universe??? Researchers even now continue to relentlessly throw vitamin C at things (I mean I think it’s died down a bit, vitamin D seems to be the hot new vitamin right now) despite mostly meh to negative results (correct me if I’m wrong on this btw)

And beyond that, in what universe is vitamin C or even any vitamin hard to sell to anybody??? Have you seen the supplement industry lately??? I’m sorry I just can’t get past this

This is a very common quack argument. I see it over and over again. If I see it, I immediately think “quack”.

Vitamin C is one of their cure-alls and the fact that modern medicine cannot find a use for ultra high doses of Vitamin C is due to the nefarious activities of Big Pharma.

It is an eye-rollingly stupid argument, but then most claims by quacks are.

Autism is not caused by a single-gene disorder; it is an immune-mediated, multifactorial genetic disorder; the genetic variants (and there are over 300 variants ‘associated’ with autism) load the gun but an atypical immune response has pulled the trigger.Single-gene disorders can cause autistic behaviors, however (Fragile X, Rett Syndrome, etc).

@ Terrie,

You really are an awful person.

Vaccines do not trigger autism. There is a study comparing children having autistic siblings with children having neurotypical ones:
Jain A, Marshall J, Buikema A, Bancroft T, Kelly JP, Newschaffer CJ. Autism Occurrence by MMR Vaccine Status Among US Children With Older Siblings With and Without Autism. JAMA. 2015;313(15):1534–1540. doi:10.1001/jama.2015.3077
Actually, children with autistic siblings had less ASD after vaccination than children with neurotypical siblings, though effect was not statistically significant.
I doubt that autism is immunomediated. There are many anatomical differences:
Eric Courchesne
Brainstem, cerebellar and limbic neuroanatomical abnormalities in autism
Current Opinion in Neurobiology 1997, 7:269-278
Electronic identifier: 0959-4388-007-00269

@ Aarno:

You can find recent lectures by Courchesne and other relevant authors like Ozonoff

I’m sure you know this but other readers may not, so briefly

When researches postulate how development proceeds they don’t rely only on post-mortem studies but look at prenatal occurrences ( spontaneous abortion, abortion), animal studies, imaging studies as well as research that explore prior conditions that are associated with particular results.
So the development of brain structures associated with autism comes from a confluence of evidence.
Because autism is expressed in many ways ( individuals have different strengths and weaknesses so to speak), autistics brains’ aren’t all the same: the areas that correspond to social deficits aren’t the same as those that correspond to greater attention to detail etc. People have different combinations of issues.

We know that specific time periods in gestation present heightened vulnerability to interference with average development like prenatal infections, meds, nutrient deficiency, problems with the placenta etc which are associated with autism while other periods are not. In addition, over the years, studies of infants’ first year have shown early indicators of autism prior to the time when parents notice problems ( at 3 months MRI, EEG, at 6 months observation). Because the brain and face develop in synch differences in intra- facial proportions subtly divide people with mild or severe autistic symptoms from the average, some identifiable only with computer analysis ( Aldridge; Miles).

None of this stuff is new. .

“When you disagree with someone, posting pictures of your fecal matter in the comment section WILL NOT BE TOLERATED,” Matze evidently had cause to write. Deliberately obscene usernames, pornography, and threats to kill other users are also not permitted, he added.
.
.
That’s no surprise, of course; the point of running a business—any business, in any market segment—is to generate profit. As my colleague Jim realized, however, Parler makes it particularly easy for users to hold their metaphorical hats out, with a setting that adds a “tip jar” link to any… parley.
.
.
In the wake of his electoral loss to President-elect Joe Biden, Trump has been directly challenging Fox News and is reportedly planning to launch a right-wing digital media brand of his own after he eventually leaves the White House.

Parler has been trying to court Trump since at least June, according to The Wall Street Journal. Trump currently has almost 89 million Twitter followers. If Parler managed to peel Trump away from Twitter and bring a sizable fraction of his fan base along with, it could be a major coup for the nascent platform—particularly if the reports that he plans to try launching a new media brand pan out.

https://arstechnica.com/tech-policy/2020/11/what-is-parler-and-why-is-everyone-suddenly-talking-about-it/

They sound nice. News flash; it is another racist, antisemetic dumpster fire on par [see what I did there??] with Gab and Bitchute and ( not so) innocent trumpster gran gran doesn’t even have a fucking clue.

Poor Boys inticed to go big or go home:
https://www.jpost.com/diaspora/antisemitism/proud-boys-leader-trying-to-rebrand-the-group-as-explicitly-antisemitic-648831

Well, they just installed 5G equipment on our nearest cell tower, so autism rates locally will be skyrocketing soon. And it’s only a matter of time until someone gets the new Pfizer Covid-19 vaccine and immediately becomes autistic.*

These are scary times.

*on the other hand, an alert from Dr. Martha Herbert advises that consumption of fermented vegetables substantially decreases risk of mortality from Covid-19. So I plan to hunker down in a 5G-proof shelter this weekend, alternating shots of kimchi and vitamin D. Hopefully that’ll be enough to counter deleterious effects from my flu shot.

Is Martha H implying that the low number of deaths in Taiwan, Japan, Korea etc is due to diet rather than control measures? I like Japanese soy sauce, does that count?

Glad you liked it.

I was not familiar with Biden’s cancer charity, so I looked up another link.

https://cancerletter.com/articles/20201116_1/

My cut-and-paste went wonky, so I’ll just summarize.

The Biden Cancer Initiative was focused on improving data standards and giving patients a mechanism to share data so that researchers could use it to find patterns and answers. They hired people to work and they did that work for a couple years until the Bidens stepped down to start Joe Biden’s presidential campaign. The charity suspended operations a few months later.

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