And now for something completely different…autism quackery. Given that discussions of COVID-19 science, pseudoscience, denialism, and grift have so thoroughly dominated this blog, I thought it would be nice to focus on a topic that has been relevant to this blog for many years and is utterly unrelated to the coronavirus pandemic. (I know, right? It’s hard to believe!) It is, however, just as horrifying in its own way, as it involves what appear to be some very questionable activities by researchers at Duke University. Paul Knoepfler pointed me to this issue on Twitter:
Let me delve into this story. 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 the quackery of “integrative medicine.” I pick on U. of M. because the embrace of quackery by some of its 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 Alternative Medicine (NCCIH), which is currently run by an acupuncture believer.
As bad as the embrace of naturopathy, traditional Chinese medicine, and even reiki and homeopathy by some institutions that would normally be expected to be bastions of science-based medicine is, there is 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,” for example. Unfortunately, what Dr. Knoepfler describes 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.
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 this.)
Dr. Knoepfler 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, even though their clinical trials 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 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.
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. 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:
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.
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:
The new Marcus Center will focus on four areas:
“This center, enabled by the generosity of The Marcus Foundation, will allow us to bring cellular therapies into 21st century medicine,” said Dr. Kurtzberg. “It represents the culmination of over 3 decades of work at Duke in transplantation and cellular biology, and it will be a catalyst to continue to accelerate the translation of these discoveries into the clinic.”
- Clinical trials to develop and evaluate cellular and tissue-based therapies;
- Learning to harness the body’s own mechanisms used for cellular repair;
- Manufacturing and delivery of cells, tissues, and biomaterials;
- Creation of non-invasive imaging to monitor cell distribution and function inside the body.
Dawson noted, “There currently are no FDA-approved biomedical treatments for autism. Our goal is to develop effective treatments that can significantly improve outcomes for individuals with autism and other developmental disorders.”
Bellamkonda added, “Duke engineers are excited to be a part of the new Marcus Center and will help develop novel technologies for cell manufacturing and scale-up, co-transplantation biomaterials designed to enhance cell survival and phenotypic stability, and novel non-invasive imaging techniques to monitor and optimize cell therapies and cures.”
All of this is well and good as far as the development of new techniques to harvest, isolate, and grow stem cells goes, but there isn’t any good evidence that autism is treatable with stem cells. It’s not even very biologically plausible, given that the assumption here is that, if you inject stem cells into the blood or the cerebrospinal fluid, they will somehow know where to go and what to do. Truly, stem cells are magic! Also, mostly unrecognized, the very assumption that stem cells can somehow “fix” autism rests on an unspoken premise that autism is some kind of brain “damage,” given that stem cells are generally assumed to be able to repair and regenerate damaged organs. No wonder antivaxxers and proponents of “autism biomed” quackery love stem cell treatments for autism.
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 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.