On Unsubstantiated Yet Prevalent Therapeutic Interventions for Autism [Part I]
July 9, 2018
A highly variable neurodevelopmental disorder characterized by social and communication challenges and restricted repetitive behavior and interests, the range of conditions classified as autism spectrum disorder (ASD) is thought to affect 1-3% of the population. In just the past century, autism has progressed from poorly grasped—what was considered “autism” in the 1950s was then blamed on psychological harm inflicted by mothers— to better defined as a spectrum of disorders caused by a complex interaction of genetics and environment. But our understanding of the complexities of ASD and its causes remains in flux, and there is no known single cause. Like any area of health study with substantial unknowns, the gaps in knowledge are ripe for exploitation.
A frightening spectre to many a parent, the American Academy of Pediatrics recommends that all children be screened specifically for ASD at their regular 18- and 24-month-old well-child visits. Adding to parents’ worries is the commonly-held misconception that rates of autism are skyrocketing— often referred to as an “epidemic”—which maintains the myth that the cause must be environmental toxins. Recent CDC data suggesting that prevalence has increased from 1 in 150 in 2007, to 1 in 68 in 2014, to 1 in 59 today can seem alarming, but it isn’t actually evidence of an “epidemic.” Rather, the changing numbers are thought to most likely represent increased surveillance, improved diagnosis, changes in diagnostic criteria, increased awareness and educational support, and reduction in stigma, so that more of the population falls under the ASD umbrella (even as controversy continues to brew over DSM-5 autism criteria, the elimination of Asperger’s syndrome from the criteria, and whether the latest criteria could do a disservice to girls.) It’s also important to note that slow progress with racial and ethnic disparities in healthcare have also contributed to perceived changes in ASD prevalence, with diagnosis among black and hispanic children improving with better surveillance. Once these factors are accounted for, it becomes clear that the prevalence of autism as we define it today is not actually increasing, let alone skyrocketing.
Although our understanding of autism is changing at a rapid pace—the DSM changed its nomenclature from “infantile autism” to three unique autism disorders in 1987, and again to one umbrella diagnosis of autism spectrum disorder in 2013—there remains an iceberg of unanswered questions beneath what we understand about the condition.
For one, distinguishing the subtypes of autism across the spectrum poses an ongoing challenge for researchers, especially with regard to mode of inheritance and type of genetic variation. The body of evidence overwhelmingly points to autism being influenced by a complex interaction of inherited variations distributed across the genome, with some autistic people carrying a strong acting de novo (arising in a germ cell or fertilized egg) variant. These genetic variants are thought to interact with environmental factors to influence autism phenotypes. Environmental risk factors associated with ASD include advanced parental age at conception, having a sibling with ASD, low birth weight, premature birth, certain prescription drugs taken during pregnancy, and certain viral infections during pregnancy, although causal relationships have not been established. The most convincing association between viral infection and ASD is with congenital rubella.
Despite the powerful, popular narrative that vaccines cause autism, rooted in the discredited, fraudulent, retracted paper by Andrew Wakefield linking the measles, mumps and rubella (MMR) vaccine to the disorder, any links between vaccines and ASD, including thimerosal, a mercury-based preservative used to prevent contamination of multidose vials, have been thoroughly discredited. Wakefield was stripped of his medical license in 2010 after The Lancet retracted the paper, discovered to be an elaborate and deliberate fraud.
Given that ASD has no single cause, there is also no existing cure and no treatment that helps everyone. According to Mayo Clinic:
“Treatment options may include:
- Behavior and communication therapies. Many programs address the range of social, language and behavioral difficulties associated with autism spectrum disorder. Some programs focus on reducing problem behaviors and teaching new skills. Other programs focus on teaching children how to act in social situations or communicate better with others. Applied behavior analysis (ABA) can help children learn new skills and generalize these skills to multiple situations through a reward-based motivation system.
- Educational therapies. Children with autism spectrum disorder often respond well to highly structured educational programs. Successful programs typically include a team of specialists and a variety of activities to improve social skills, communication and behavior. Preschool children who receive intensive, individualized behavioral interventions often show good progress.
- Family therapies. Parents and other family members can learn how to play and interact with their children in ways that promote social interaction skills, manage problem behaviors, and teach daily living skills and communication.
- Other therapies. Depending on your child's needs, speech therapy to improve communication skills, occupational therapy to teach activities of daily living, and physical therapy to improve movement and balance may be beneficial. A psychologist can recommend ways to address problem behavior.
- Medications. No medication can improve the core signs of autism spectrum disorder, but specific medications can help control symptoms. For example, certain medications may be prescribed if your child is hyperactive; antipsychotic drugs are sometimes used to treat severe behavioral problems; and antidepressants may be prescribed for anxiety. Keep all health care providers updated on any medications or supplements your child is taking. Some medications and supplements can interact, causing dangerous side effects.”
Early intervention for children less than 3 years of age, aimed heavily at training parents or caregivers, has been shown to have long-term effects on social communication and “severity” of autism symptoms. Considered a primary intervention, Applied Behavior Analysis (ABA) (which has applications outside of autism) involves up to 40 hours a week of a therapist working one-on-one with a child to develop social, language, and other skills, and is the most widely used therapy for ASD. ABA is controversial, however—critics say the drills are cruel and force autistic people to hide who they truly are.
It’s important to note that a growing movement calls for autism acceptance, rather than awareness, toward an equitable, neurodiverse society. In his Neurotribes blog, science writer Steve Silberman, author of NeuroTribes: The Legacy of Autism and the Future of Neurodiversity, explains that awareness isn’t enough, and includes the ideas of a group of self-advocates, parents, and teachers, posing the question, “Obviously, even a month of acceptance will not be enough to dramatically improve the lives of people on the spectrum. What could be done to make the world a more comfortable, respectful, and nurturing place for millions of autistic kids and adults—now, starting today?”
As with other emerging bodies of science, the gaps in knowledge on ASD have allowed profiteers to creep in. It’s not surprising that vulnerable parents of autistic kids want simple solutions to complex problems, even though scientists largely believe that there will never be a definitive “cure” for autism. As the science streams in, a number of organizations, movements and leaders have encroached, promoting the ideology that autistic children and adults are somehow defective and must be fixed. While research on interventions for ASD continues, these so-called “cures,” unsubstantiated therapeutic interventions, and supplements that we can safely chalk up to woo have thrived. Part 1 of this column will examine DAN! protocol, chlorine dioxide, secretin, chelation therapy, hyperbaric oxygen therapy, lupron, GcMAF, and stem cell therapy, all of which have been purported to treat or even cure autism.
A project of the Autism Research Institute (ARI), a nonprofit organization founded in 1967 by Bernard Rimland, Ph.D. (1928-2006), Defeat Autism Now! (DAN!)—the most broad school of ASD cure thought, with several discredited and harmful interventions under its umbrella—was launched in 2005 and shut down in 2011. Based on the belief that autism is caused by lowered immune response, external toxins from vaccines and other sources, and problems caused by certain foods, proponents claimed that the treatments were “a way of addressing individuality in the context of an epidemic that has environmental causes." Dubbed “the father of modern autism,” Rimland is credited with overturning the once accepted “refrigerator mother” theory— that uncaring mothers’ lack of warmth triggers the onset of the condition—ultimately helping end that specific form of mother-blaming for autism. But that does little to undo the damage that DAN! inflicted, including the administering of harmful treatments, including chelation, nutritional interventions, and hyperbaric oxygen treatments (described later in this article). Despite DAN! being suspended in 2011, a quick Google search turns up several practitioners offering the protocol.
Retired psychiatrist and Stephen Barrett, co-founder of the National Council Against Health Fraud (NCAHF) and founder of Quackwatch wrote in a 2015 critical look at DAN!:
“To determine effectiveness, variables must be isolated and tested in controlled experiments. The DAN! protocol" as a whole was never validated or even tested, and was untestable. It was derived from observations that were not structured to determine effectiveness. It was a hodgepodge of everything DAN!'s founders speculated might be useful. Many of its promoters seem to believe that:
If a child improves or is reported to have improved following the administration of a treatment, that outcome would support the diagnosis, the treatment, and the alleged underlying theory.
If enough reports are pooled, they will reveal what works—so try lots of things and and attribute any improvement to what you tried rather than other things such as a good teacher or the natural tendency of children to mature over time.
Even though well-designed studies might demonstrate that something (such as chelation or secretin) doesn't work, these studies can be ignored because each child is an individual and may still respond positively to any intervention.
I do not believe that science works that way. And neither should you.”
David Gorski, surgical oncologist and Managing Editor of Science Based Medicineaddressed DAN! in his Orac blog:
“[I]t is big business to be bilking the parents of autistic children of considerable sums of money to use pseudoscientific “treatments” based largely on the scientifically discredited idea that autism is some form of “vaccine injury” or “toxicity” due to a combination of vaccines and environmental “toxins” (almost always vaguely defined or completely undefined). As a result, children are subjected to potentially dangerous treatments like chelation therapy, which can kill when it goes wrong, designed to “detoxify” the heavy metals that are supposedly causing the child’s autism.”
Chlorine Dioxide (CD/MMS)
Often called Miracle Mineral Solution (MMS) or CD Protocol, the impetus for administering active ingredient chlorine dioxide is the belief that autism is caused by parasites which can be eradicated by these glorified bleach enemas, oral solutions, and baths. Made by mixing sodium chlorite and citric acid, parents who administer MMS to their autistic kids often share photographs of the “parasites” that they believe they’ve removed from their children’s bodies. The heartbreaking fact is that the images actually depict the lining of the intestines sloughing off from the bleach.
In 2010, Health Canada issued a warning “that using this product as directed may cause serious health problems” and that consumers should stop using it immediately.
The U.S Food and Drug Administration issued a safety alert on MMS in 2010, since removed from its website (but with excerpts published in several news articles) stating that:
"The product, when used as directed, produces an industrial bleach that can cause serious harm to health. The product instructs consumers to mix the 28 percent sodium chlorite solution with an acid such as citrus juice. This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment. High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration."
Thought to now reside in Mexico, Kerri Rivera, one of the leading proponents of MMS as an autism cure, was brought to task by the state of Illinois in 2015, which barred her from selling it to Illinois residents or speaking at conferences in the state.
As of publication, online video consultations with Rivera may be purchased through the CD Autism Shop website at $120, with follow up consultations running $70.
In a 2012 post in Science Based Medicine, Gorski wrote:
“[W]e’re seeing quacks douse autistic children in bleach, pump their colons full of it, and feed it to them until they start to have fevers and diarrhea, believing that the diarrhea and fever are evidence that the bleach is working to reverse autism. The diarrhea and fever might well be working to do something, but reversing autism is not part of that something. Making children sick is.”
Barrett covered CD/MMS in a Quackwatch article updated in 2016:
“MMS contains a 28% solution of sodium chlorite. which, when mixed with an acid such as citrus juice, produces chlorine dioxide (ClO2), a potent bleach used for stripping textiles and industrial water treatment. High oral doses, such as those recommended in MMS labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration. Sodium chlorite is not legal to sell for human consumption, and legitimate suppliers of the chemical include a warning sheet stating that it can cause potentially fatal side effects if swallowed. MMS's discovery is attributed to Jim Humble, a former "research engineer."”
Neuroscientist and blogger Alison Bernstein admonished readers in a 2015 post at the It’s Momsense blog:
“Parents who are carrying out this protocol share their stories online. They share stories about their children crying in pain as they are held down and an industrial strength bleaching agent is forced into their rectums. They share pictures of the lining of their children’s intestines falling out, toenails falling off, and hair falling out. They share that their children stop showing emotion and have a loss of appetite. These are all signs of chronic poisoning and chronic abuse, but in these groups parents are congratulated for “curing” their children of autism. When parents post about disturbing symptoms their children are having in response to this “treatment”, the answer from the leaders is always – give more enemas. These children are in pain but children trust their parents. This is an utter betrayal of that trust.”
A digestive system hormone that regulates the secretion of digestive fluids from the stomach, pancreas, and liver, secretin caused a buzz and generated false hope after three autistic children reportedly improved significantly after taking the hormone in the late 90s. As Spectrum News reported in a 2016 feature:
It’s difficult enough to separate placebo from drug effects when participants report their own experiences, says Karin Jensen, a placebo researcher at the Karolinska Institute in Stockholm, Sweden, but it’s nearly impossible when other people are in the mix. The excitement in the media and the autism community over the secretin trials is a perfect example of this phenomenon, she says. “Most of [autism research] is based on subjective ratings,” she says. “Expectations were sky high, and so that was transferred to patients via parents and caretakers.”
Subsequent studies, including a 2012 Cochrane review of 16 studies of secretin administered intravenously to a total of 900 children with ASD concluded that “[t]here is no evidence that single or multiple dose intravenous secretin is effective and as such currently it should not be recommended or administered as a treatment for ASD. Further experimental assessment of secretin's effectiveness for ASD can only be justified if there is new high-quality and replicated scientific evidence that either finds that secretin has a role in neurotransmission in a way that could benefit all children with ASD or identifies important subgroups of children with ASD who could benefit from secretin because of a proven link between the action of secretin and the known cause of their ASD, or the type of problems they are experiencing.”
Rooted in the thoroughly-refuted notion that mercury exposure from vaccines causes autism, proponents of chelation for ASD purport that this treatment strips the element, along with other heavy metals, from the body. Chelation therapy involves intravenous or orally-administered chelating agents like EDTA and DMSA, which bind to metals, allowing them to be excreted in urine. It’s approved for use exclusively by prescription for true cases of heavy metal poisoning only. The FDA warns consumers against the use of OTC chelation products:
“These companies marketing unapproved OTC chelation products commonly target patients with serious and incurable diseases who may have limited treatment options. Two common conditions that these products claim to treat are autism spectrum disorders and heart (cardiovascular) conditions, including treatment of high blood pressure, high cholesterol, clogged arteries, angina, prevention of heart attack or stroke, and even as an alternative to coronary bypass surgery. Some companies also claim their products can prevent or treat Alzheimer’s disease, Parkinson’s disease, complications of diabetes, and many more diseases and health conditions that may be unrelated to one another.
FDA is concerned that patients will delay seeking proven, sometimes essential medical care, when relying on unproven OTC chelation products to treat serious conditions such as heart and blood vessel disease. FDA is also concerned that chelation can result in serious side effects such as dehydration, kidney failure, and death.”
Though the theory that thimerosal—a mercury-containing compound used as a preservative in some vaccines—causes autism has been thoroughly refuted, data suggest that around 7% of individuals with ASD have received this treatment. A 2015 Cochrane systematic review concluded that “no clinical trial evidence was found to suggest that pharmaceutical chelation is an effective intervention for ASD. Given prior reports of serious adverse events, such as hypocalcaemia, renal impairment and reported death, the risks of using chelation for ASD currently outweigh proven benefits. Before further trials are conducted, evidence that supports a causal link between heavy metals and autism and methods that ensure the safety of participants are needed.”
Quackwatch features information on inappropriate testing, clinical studies, lawsuits, and regulatory actions, explaining that:
“Chelation therapy is a series of intravenous infusions containing EDTA and various other substances. It is falsely claimed to be effective against cardiovascular disease, autism, and many other diseases and conditions. Because chelation has valid use in some cases of heavy metal poisoning, many practitioners falsely diagnose lead, mercury, or other heavy metal toxicity to trick patients into undergoing chelation. The articles linked from this page explain why doctors who advocate the general use of chelation therapy should be avoided.”
Writing for the Mayo Clinic website, pediatrician Jay L. Hoecker described chelation therapy:
“Chelation therapy is not an effective autism treatment, and it may be dangerous.
Some doctors and parents have considered chelation therapy as a potential autism treatment. Proponents believe that autism is caused by mercury exposure, such as from childhood vaccines. Chelation therapy supposedly removes mercury from the body, which chelation supporters say cures autism — but there's no evidence of a link between mercury exposure and autism. In addition, chelation therapy can be associated with serious side effects, including potentially deadly kidney damage.
The subject of exposure to environmental toxic agents — such as mercury, lead and a host of other toxins — and links to autism spectrum disorder is complex and the quality of studies varies considerably. That's in part because of all the many variables, such as geography, genetic factors, metabolism differences in individuals and sampling sources. Studies show conflicting results with no reproducible proof.”
Clinical neurologist Steven Novella wrote at Science Based Medicine:
“Chelation therapy has a long history of quackery – not for its intended use but for other uses for which there is no evidence. The classic example of this is the use of chelation therapy to treat atherosclerosis to prevent heart disease. This claim persists despite the utter lack of evidence for efficacy and the fact that all proposed mechanisms have been shown to be flawed or false.
In the last decade the belief that mercury in some vaccines (mercury-containing thimerosal was removed from routine childhood vaccines in the US by 2002) might be linked to autism. The scientific evidence clearly shows this is not the case (as I have discussed in many previous posts). But belief persists despite the evidence, mostly among anti-vaccinationist ideologues. But many earnest parents, just wanting to help their autistic children, have been caught up in the pseudoscience and conspiracy-mongering.”
Hyperbaric oxygen (HBOT/HBO2)
Hyperbaric oxygen therapy involves breathing pure oxygen in a pressurized chamber, and is FDA approved for only 13 conditions, including “treatment of air or gas embolism (dangerous "bubbles" in the bloodstream that obstruct circulation), carbon monoxide poisoning, decompression sickness (often known by divers as "the bends"), and thermal burns (caused by heat or fire).” Proposed mechanisms by which HBOT helps autistic people include the reduction in inflammation thought to restrict blood flow to regions of the brain, and improvement in the brain’s ability to absorb oxygen.
A 2015 review found that the “evidence is weak for the use of HBO2 in ASD, with only one, likely flawed, randomized control study showing treatment benefit.” Steven Novella discussed the lone 2009 study that showed limited benefit, and his critiques boil down to four main points, summed up at Exposing Autism One:
- Inadequate blinding of subjects and parents: “The primary weakness, in my opinion, is that the parents of the children being studied were allowed in the chamber with their children. The two groups in the study either received 24% oxygen in 1.3 atmospheres, or 21% oxygen in 1.03 atmospheres. It’s probable that many of the parents knew if they were getting increased pressure or not, and this therefore could have unblinded the study.”
- Small size of the study: “The study is also on the small side, with 62 children total. However, the clinical effects were very robust.”
- Potential conflicts of interest: More than one author of the study has a potential financial conflict of interest. Rossignol and Usman offer HBOT in their practice and Usman’s husband sells the hyperbaric chambers used for HBOT. “While such conflicts are important to expose, I think they are trumped by a well-enough controlled study. The whole point of a well-designed study is to eliminate the effects of bias. But given that this study was poorly blinded, and bias was present, it certainly diminishes its impact.”
- Only measured short term outcomes: It therefore did not test if the effect of hyperbaric treatment survives much beyond the treatment itself. Even if the effect in this study is real, it may represent only a temporary symptomatic benefit – not altering the course of autism itself. Therefore longer followup studies are needed as well.
Novella concluded that “It is not impossible that hyperbaric oxygen may have some benefit in some children with autism. Although there is no established mechanism at this time, and proposed mechanisms (like the notion that hyperbaric O2 decreases inflammation) are largely speculative. But a physiological effect is not implausible. The treatment is also fairly safe. Therefore it is reasonable to study it further.
The biggest risk of the treatment now is that it is expensive—costing 150-900 dollars per treatment or 14-17 thousand dollars for a chamber. It also diverts energy and emotions away from possibly more productive treatments.”
In a warning for consumers, the FDA says, “[n]o, hyperbaric oxygen therapy (HBOT) has not been clinically proven to cure or be effective in the treatment of cancer, autism, or diabetes. But do a quick search on the Internet, and you'll see all kinds of claims for these and other diseases for which the device has not been cleared or approved by FDA.”
Possible side effects and complications include oxygen toxicity, fluid buildup in the ears, sinus damage, and vision changes.
Perhaps best known for its use in chemical castration of sexual offenders, Lupron (Leuprorelin, also known as leuprolide), the synthetic version of gonadotropin releasing hormone, is also used in the treatment of advanced prostate cancer, endometriosis, some breast cancers, and to delay the early onset of puberty. “Lupron Protocol” as an autism treatment originated with a 2005 paper by father son duo Mark and David Geier (Mark’s medical license has been revoked or suspended in all states since 2011) in Medical Hypotheses, a non-peer reviewed journal aiming “to give novel, radical new ideas and speculations in medicine open-minded consideration, opening the field to radical hypotheses which would be rejected by most conventional journals.” The proposed mode of action is based on the thoroughly debunked notion that mercury in vaccines causes autism—mercury binds to testosterone, so Lupron’s action in lowering testosterone levels also helps the body eliminate mercury, or so the misguided hypothesis goes.
Despite no plausible mechanism for Lupron to treat autism, hundreds of parents began using it following the Geiers development of the protocol, as reported by the Chicago Tribune in 2009.
“Four of the world's top pediatric endocrinologists told the Tribune that the Lupron protocol is baseless, supported only by junk science. More than two dozen prominent endocrinologists dismissed the treatment earlier this year in a paper published online by the journal Pediatrics.
Simon Baron-Cohen, a professor of developmental psychopathology at the University of Cambridge in England and director of the Autism Research Center in Cambridge, said it is irresponsible to treat autistic children with Lupron.
"The idea of using it with vulnerable children with autism, who do not have a life-threatening disease and pose no danger to anyone, without a careful trial to determine the unwanted side effects or indeed any benefits, fills me with horror," he said.
Experts in childhood hormones warn that Lupron can disrupt normal development, interfering with natural puberty and potentially putting children's heart and bones at risk. The treatment also means subjecting children to daily injections, including painful shots deep into muscle every other week.”
In the 8-part in depth series “Why Not Just Castrate Them,” which followed the Geier saga and examined chemical castration as a treatment for autism, David Gorski wrote:
“[T]he parents of Geiers’ patients are largely self-selected to believe the woo and have a serious incentive, after sinking thousands of dollars into it, to believe it’s working. And they do provide [testimonials]. Heck, it wouldn’t surprise me if some of them are even true. If you shut down a child or teen’s testosterone production, they will become more docile and have a decreased sex drive. That doesn’t mean the drug is doing anything at all for the teen’s autistic symptoms.”
In 2009, Steven Novella pointed out of the Lupron protocol that, there is a “huge psychological incentive to perceive an improvement even where one does not exist. The more radical, risky, and expensive a treatment is, the more parents feel the need to justify their decision by perceiving a benefit. Plus parents want their children to improve. I have seen this result in parents (and also patients themselves) reporting a clear improvement when objective measures showed no improvement at all.”
Promoted as a cure for cancer, HIV, autism, and other conditions, GcMAF (Gc protein-derived macrophage activating factor) is a protein that occurs naturally in the blood of healthy people, with activity affecting immune system function. Infamous physician James Jeffrey Bradstreet, who believed that vaccines cause autism, treated thousands of patients around the world with quack treatments including GcMAF, which was extracted from human blood plasma, concentrated, and injected. The vials were often ordered on the internet and injected without oversight. The day before Bradstreet died in a likely suicide, more than 10,000 vials of GcMAF were seized in a raid of his facility over contamination concerns following the deaths of at least five individuals who received the treatment. The FDA and physicians made statements to the Washington Post following Bradstreet’s death:
“GcMAF treatments are considered investigational, and none are approved or licensed for use by the FDA in the U.S.,” the agency said in a statement sent to The Washington Post.
Nearly all doctors agree.
“Given there is no evidence that modulating the immune system would have any benefit for children with autism spectrum disorder – especially given ASD’s genetic or epigenetic basis – I am not sure why Dr. Bradstreet would want to use this for ASD,” Peter Jay Hotez, dean of Baylor’s National School of Tropical Medicine, told The Post in an e-mail.
It’s not even clear if GcMAF injections are safe. An initial “safety study” — the first of its kind — is still trying to recruit participants.”
“The U.S. Food and Drug Administration is clear: GcMAF is not a recognized treatment for autism.
There are still no results published for the referenced non-randomized clinical trial, which recruited a total of 24 patients.
In a blog post for Science Based Medicine, David Gorski wrote, “it’s clear that Jeff Bradstreet’s many years of applying his quackery to autistic children had finally—finally—caught up with him. I’m actually sorry that he killed himself, both for the pain it caused his family, but also because it means that Bradstreet ultimately escaped justice. It means he will never face a judge and jury for the many years he victimized autistic children with a wide variety of quackery. That saddens me, but I can still hope that Bradstreet’s co-conspirators face the justice he eluded.”
Stem cell therapies
Where there is a poorly understood condition, it’s certain that there are charlatans peddling stem cells to cure it, and it’s no different with autism. A phase I study out of Duke University tested the safety of administering a single intravenous infusion of autologous umbilical cord blood, despite well-placed skepticism due to lack of preclinical data to support it. Nevertheless, the phase II study has forged ahead, with treatment and placebo arms, to evaluate the efficacy of treating autistic children with their own cord blood. Meanwhile, the media has offered up unsubstantiated hope.
Unregulated, unsafe stem cell treatments for autism existed well before the Duke study, though, and are still being sold despite warnings against them. As of publication, a search for “stem cell therapy autism” yields over 33,000 videos on YouTube, the bulk of them discussing results of stem cell treatments obtained in Panama, Mexico, China, India, and the United States.
And even with the Duke study underway, some parents who want stem cell treatments for their autistic kids are unwilling to participate, in part because they don’t want to end up in the placebo arm of the trial. Parents discuss stem cell treatments and results in posts in the “Stem Cell Therapy for Autism” Facebook group, with over 6400 members. The group started with Sarah Collins, who credits adult stem cell injections administered in Panama City, Panama, with the “recovery” of her older son and improvement in her younger son, both of whom were diagnosed with autism, as she explained to The Atlantic in 2016. But as with other unregulated treatments for autism, testimonials for stem cell concoctions don’t mean that they’ve worked, as Gorski explained:
“The reason testimonials, which are, let’s face it, simply anecdotes about one person (i.e., and N of 1) in which there are rarely any objective, properly done clinical results examine, seem so compelling to the average person is because most people don’t realize two things about the diseases and conditions for which testimonials are common. First, it’s not a coincidence that most conditions for which testimonials are used are conditions that either have a wide degree of biological variability (i.e., breast cancer) or a course that frequently varies (i.e., autism). In the case of cancer, the difference between primary treatment and adjuvant treatment is often misunderstood, wherein people who had curative surgery for their tumors are presented as though whatever quackery they tried after surgery cured them, even though it was the surgery that cured them. In the case of a condition like autism, there is often the underlying assumption that the child will never develop–would never have developed–without whatever intervention the parents subjected him to. As I’ve pointed out many times, that assumption is erroneous; autistic children can and do develop, often in fits and starts, just like other children, and sometimes they can even develop to the point of no longer meeting the criteria for autistic spectum disorders. Not surprisingly, these are the children who are often presented as “cured.””
***Up next, part two of this column will examine CEASE therapy, facilitated communication, and a slew of dietary treatments that profiteers continue to administer, even though they’ve been thoroughly discredited ...