Autism & chelation: Exploiting the fear of a toxic world
Part 4 in my series about the vaccine/autism myth
“Some of the most important research that’s been done by our intramural program is to prove that something that’s in wide use has absolutely no value or has some real safety concerns, so that we can tell people they should not be doing that,” Tom Insel, then-Director of the National Institute of Mental Health told Spectrum magazine 2008.
Insel was referring to a proposed US National Institute of Mental Health (NIMH) trial on chelation as a treatment for autism, using autistic children as subjects. Experiments on chelation for autism, based on an antivax lie, with no plausible mechanism and clear risk to the non-consenting child subjects, almost happened with the blessing of the NIMH.
Then in 2008, before the study was to begin, it was officially canceled by NIMH[1] after a paper in Environmental Health Perspectives showed that in rats, a three-week course of DMSA causes lasting cognitive issues. The announcement from NIMH stated:
“In February 2007, based on new scientific data, an NIH Institutional Review Board reassessed the risk-benefit ratio of the proposed study. The board determined that there was no clear evidence for direct benefit to the children who would participate in the chelation trial and that the study presents more than a minimal risk.”
Off label risks, non-consenting kids
Chelation, typically indicated for emergencies like industrial accidents or lead poisoning, removes metals and minerals from the blood. The process carries significant risk because it removes crucial elements such as calcium, essential for heart health. There is no plausible mechanism for researching chelation as an autism treatment. As a research review by Dr. Yashwant Sinha et al. concluded, “The potential for vulnerable families to seek this as a promised miracle cure raises ethical and professional practice questions that need international consideration.”
"Chelation is a treatment for which we have no evidence of benefit and we have evidence of harm," says Dr. Evdokia Anagnostou, a pediatric neurologist and senior autism researcher at Holland Bloorview Kids Rehabilitation Hospital in Toronto. As the US Poison Control Center states:
“The National Center for Health Statistics reported that 111,000 adults said they used chelation therapy, along with 72,000 children under the age of 18. It is highly unlikely that 183,000 US residents required chelation therapy for the limited number of approved indications. It is much more likely that therapies were received for conditions attributed to heavy metals without scientific validation.”
The NIMH study was to be led by Swedo, then a tenured professor from Northwestern University and also was the Chief of Pediatrics and Developmental Neuroscience Branch of the NIMH. (She has since retired.)[2] Her team’s trial sought to compare the “social and language skills” of children receiving the chelator DMSA against a control group of kids receiving a placebo, following the standard error-laden approach of relying on parent and providers’ subjective reporting on young children’s cognitive and behavioural development over time as signs of “success” for a treatment.
It was initially approved in 2006 by the NIH’s internal review boards, had almost made its way out of the regulatory gate, with researchers ramping up to begin testing chelation on autistic children. [3] But the National Institute of Health now states on its Complementary Medicine website:
“There’s no scientific evidence that secretin (a gastrointestinal hormone), hyperbaric oxygen, chelation, or antifungal agents help people with ASD, and they may be dangerous.”
It was a close call. One study like Swedo’s would have opened the gates for a stampede of hype (and copycats), regardless of results. As Steve Novella, an assistant professor of medicine at Yale University who had been blogging about chelation therapy, put it: “The very fact of studying things like this is used to say, ‘See, the government is taking this seriously. This is real good science, because they are studying it”,” Novella says. “If you do a risk-benefit analysis, it just doesnʼt make sense. It isnʼt ethical.”
Yet even without the NIMH study, there are still dealers claiming that chelation can treat autism. MDs have the ability to prescribe chelating agents “off label,” meaning for a use they were not intended. Some MDs will prescribe and infuse prescription chelating agents for conditions not indicated by the drug maker, such as autism, diabetes, fatigue or heart disease, charging roughly $250-$700 per infusion and often telling patients their child needs repeat infusions.
At one Ontario-based centre I phoned in 2021 as part of research for this book, I was told that a test for heavy metals in my child’s blood would be free and that IV chelation would be $250 per session, but I could save if I bought a pass for 10 infusions. They also offered me a “multipass” for $595 which would include a session of ozone therapy.
“Our clinic is very reasonable,” the receptionist assured me, before directing me to an intake form required before an appointment.[4]
In other cases, DIY chelation, substances are sold to parents by naturopathic MDs or online vendors. Melissa Eaton documented and shared links and screenshots with me, saying:
“Oral chelation products can be purchased on Amazon. There’s plenty of moms that have YouTube channels where they’re showing you how to cut up these doses, how to divide them out, how to put them in the syringes and medical droppers. Some of these parents…their children are sleeping and they just squirt these doses in their mouth while they’re asleep.”
Whether by off-label prescription or DIY products, marketers claim that chelation will detoxify autistic children of “toxins” they were exposed to during their routine childhood vaccinations and thus treat/cure their autism.
No evidence of benefit and clear evidence of harm
In 2005, Abubakar Tariq Nadama, age 5, died of cardiac arrest in the office of Pennsylvania doctor Dr. Roy E. Kerry after receiving chelation therapy. His family, who was told that chelation would treat his autism, had travelled with him from the UK to the US for the treatment. Abubakar suffered cardiac arrest immediately after undergoing chelation and Kerry was charged with involuntary manslaughter, with his medical license was suspended for six months with two years’ probation. In 2008, Tariq Nadama’s family sued the doctor.
As of 2018, the US FDA had documented more than 30 recent cases of death from off-label chelation, including children. Death, dehydration, hypocalcaemia, kidney injury, liver enzyme elevations, hypotension, cardiac arrest, allergic reactions, essential mineral deficiencies, neurodevelopmental toxicity and teratogenicity are all risks of chelation.
As a 2015 Cochrane Review concluded:
Given prior reports of serious adverse events, such as changes to calcium levels in blood, kidney impairment and reported death, risks of using pharmaceutical chelating agents for ASD currently outweigh proven benefits.
Elements of a scam
Chelation for autism has all the elements of an autism scam, as I discuss in Chapter 1: myth-making, upselling, desensitization and upselling.
1. Sellers creates a myth—that autism is caused by vaccine injury.
2. Upselling is common among chelation-autism providers, with products including supplements and hyperbaric oxygen treatments that were sold as a complement to the chelation therapy, as well as heavy metal testing through associated labs.
3. The desensitization process is also clear. Repeat visits, using different types of chelator are, at the core, dehumanizing to the child, who is suffering from the process and does not want to be there.
4. Families are isolated when using chelation. Not only is it a therapy outside of the mainstream standard of care, but it can end up replacing standard, evidence-based autism therapy like speech and occupational therapy and psychotherapy.
One thing that got me interested in the problem of chelation for autism was when a friend of mine who is a psychotherapist told me that the parents of an autistic client had begun to explore chelation for their child. Soon, they were solving meltdowns by taking their child for chelating sessions and the psychotherapy contract was ended. Not only was chelation replacing an established standard of care, but the chelation provider had created repeat business for himself.
Typically, a chelation-for-autism marketer will charge $500-$1000 per session, with multiple sessions. (If one session “worked”, it would not lead to the same lucrative revenue stream). They typically diagnose heavy metal toxicity through a so-called toxic metal test, where patients are given a chelating agent and then their urine is tested for levels of metal—and of course excreted levels of metal are likely going to be high in the urine if a chelating agent has recently been administered.
Marketers may also sell multiple forms of chelation, arguing that it is a trial-and-error process. As one marketer wrote: “Often a series of challenges is performed with different agents and routes, and the one that is chosen for ongoing detoxification therapy is the one that brings the most metal excretion with the least (if any) side effects." The Talk About Curing Autism website stated in 2019:
An interesting observation made by physicians who work with children undergoing chelation is that there is no single chelating agent or route of administration that is superior. One patient may show the most excretion with DMPS, while the next person will excrete more with DMSA or CaNa2EDTA. And one person may excrete more metal using oral chelation, and another may excrete more using suppositories, even when using the same agent and the same dose.
This type of argument gives an excellent excuse for marketers to charge for multiple chelation sessions on the children.
It is difficult to find out which agents a doctor uses or their effects on autistic patients due to patient confidentiality laws. But one lawsuit revealed some of the types of products and the way they are marketed. In 2010, James Coman sued doctors Dr. Anjum Usman and Daniel Rossignol[5], who had performed chelation on his seven-year-old son 37 times and prescribed more than 30 different health supplements, which they sold directly to the family. According to the lawsuit, Usman treated the boy at her clinic and Rossignol, who had never met the child, prescribed treatments via phone.
A complaint by Illinois health regulators also noted that “Over the next five years, Usman allegedly diagnosed the child with a calcium-to-zinc imbalance, yeast, dysbiosis, low zinc [and] heavy metal toxicity” and treated the child with “dietary restrictions; …supplements; two antifungal drugs; four chelators or detoxifying drugs; a hormone suppressor; and hyperbaric oxygen treatments, in which the child is shut inside a pressurized bag filled with extra oxygen.”
“It’s fraud, pure and simple.” said Coman, who is divorced from his son’s mother who had taken the child for the treatments, “They made a lot of money off my family and they're making a lot of money off other families."
The regulatory challenge
It is hard to gauge the level of influence by off-label chelation proponents lobbying to stop regulation in the US. But it is clear that trade associations for compounding pharmacies lobbied hard to stop regulation. As Jack Pitney points out in his book The Politics of Autism, when Senator Edward Kennedy proposed a bill to limit the scope of drug compounders in 2007, lobbyists encouraged parents to become advocates for compounders: “Parents of autistic children flooded Kennedy’s office, arguing that compounding pharmacies were the sole source of treatments such as chelation. The bill never came up for a vote.” (Pitney, 60).
Since that time, in the absence of other regulation, chelation for autism has been banned by the US Food and Drug Administration, with the agency issuing warning letters to companies promoting it. In 2010, the US FDA warned consumers about the use of chelation as a treatment for autism (as well as for heart disease). After issuing warning letters to eight companies marketing chelation products without a prescription, it advised patients: "FDA is concerned that patients will delay seeking proven, sometimes essential medical care, when relying on unproven OTC chelation products to treat serious conditions,” for which there already are standards of care.
US, medical boards of professional conduct have conducted hundreds of investigations and disciplinary actions involving practitioners of off-label chelation. This case of a physician using off-label chelation involved action by two Boards of Medical Examiners as well as three civil suits. After ten years of suspensions and other disciplinary actions, the Boards revoked the physician’s license. (The lawsuits were settled for undisclosed amounts.)
In 2014, the FDA issued a warning that companies are making false claims about products or therapies that claim to treat or cure autism. The FDA stated in its warning that chelation therapy or mineral treatments, carry “serious and life- threatening outcomes.” In 2016, the FDA again issued warning letters to companies marketing OTC chelation for autism products, writing in its press release: “Consumers who use OTC chelation products for detoxification are exposed to all the risks associated with chelation. These risks are not acceptable, given that there is no proof that ‘detoxification’ using these products is effective to prevent or treat any condition or disease.”
In 2012 and 2014, the US Advertising Standards Authority (ASA) also investigated complaints about false advertising by chelation-for-autism providers. In both cases, the ASA concluded that the ads were misleading and could not be run again.
As well the National Institute of Health identifies it as both “unproven” and “dangerous”.
Chelation is on the UK’s Do Not Use For Autism list, per its National Institute for Health and Care Excellence (NICE). Similarly, the National Health Service in the UK banned the off-label use of chelation on autistic children and included chelation on its list of Fake and Harmful Autism “Treatments”.
The UK’s National Institute for Health and Clinical Excellence (NICE) recently published A guideline on the diagnosis and management of autism in adults and a guideline on the management and support of children and young people on the autism spectrum. Both documents address the health risks of a number of biomedical interventions for autism including chelation, stating: “Do not use chelation to manage autism in any context in children and young people.”
In a widely-publicized case, in August 2017 Dr. David O’Connell of Chelsea (UK) was restricted from treating autistic patients by the Medical Practitioners Tribunal Service while an investigation takes place for so-called autism treatments he has used on children, including animal hormone injections and chelation.
Unfortunately, chelation for autism has not been reviewed by Health Canada and in one precedent-setting case, which I discuss later, an MD had the support of his regulating college, which refused to even review the evidence of a complaint against him.
For regulators in the US and UK, it is a constant game of whack-a-mole to stop the scammers, in large part because clinical chelation for autism is usually performed by MDs, who do not report it to regulators. This usage also lends chelation for autism a false air of credibility.
After a canceled clinical trial: Underground marketing
In 2008, when US regulators canceled Swedo’s proposed clinical trial testing chelation therapy as a treatment for autism, they explained they had “determined that there was no clear evidence for direct benefit to children who would participate in the chelation trial and that the study presents more than a minimal risk." The FDA also banned chelation as an autism treatment.
“These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options,” said Deborah Autor, director of compliance in the FDA’s Center for Drug Evaluation and Research (CDER) division. The FDA also notes, “There are likely many (other) cases of serious side effects because companies are not compelled to report adverse events to the agency.”
This has not stopped online dealers from selling “oral chelation” online and through naturopathy clinics, with MDs continuing to promote the use of EDHT and other chelating drugs, off-label, in labs that look very much like chemotherapy labs. It is a lucrative market, especially when MDs prescribed it for other condition such as insomnia, “adrenal fatigue,” headaches and heart disease.
There are also parent groups willing to do promotional work for free on behalf of the marketers. Rebecca Estepp from the group Talk About Curing Autism (TACA) claimed in 2008:
Our phones have been ringing off the hook since [Swedo’s trial cancellation] got announced. . . We are dumbfounded and saddened that this study of a promising autism treatment will not happen. The government pulled the rug out from under us with no explanation. Do we have to have thousands more before they take us seriously? When does anecdotal evidence get so large that they have to listen to us?" [emphasis added.]
Autism One, a convention focused on unregulated autism treatments, then featured Dr. Swedo as a speaker in 2016.
One group of doctors, some of whom have been practicing chelation for heart disease since the 1970s, formed the American College for Advancement in Medicine, a lobby group to pressure for research into off-label chelation. The NIH was convinced by enough practitioners to run two trials in the early 2000s, entitled the TACT studies, but these did not show clear evidence of benefit that would outweigh the risk of the procedure. Also, the treatment did not improve quality of life for patients.
Interestingly, some of the physicians involved in the TACT studies were also cross-promoting chelation for other conditions, such as autism. One was Dr. John Gannage of Ontario. I discuss my complaint to a medical college about his clinic in the next section.
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[1] A year earlier, the team had submitted an investigational new drug (IND) application to the FDA and received approval to classify DMSA, a chelating agent, as an experimental autism therapy. The IND was rescinded in 2008.
[2] Swedo and some colleagues have also been studying a set of behaviours they label PANDAS, believing they are caused by the strep virus, hypothesizing that OCD could be caused by rheumatic-fever type conditions in a child and recommending long-term antibiotic use as a treatment. Although Swedo’s theory about the mechanism for the behaviours have so far not withstood the weight of scientific inquiry, the initial hype around her PANDAS hypothesis has generated a cottage industry among some MDs and naturopaths, who prescribe long-term antibiotics and a suite of supplements they claim will fix it.
[3] Swedo has also been a speaker at Autism One.
[4] In researching this book, I was never able to go as far as intake forms, which would have required me to disclose my child’s name and his personal health information—nor, obviously, did I attend any appointments due to the ethics of involving my own child in my research. While I know that a few parents have done this for the sake of a story, my recommendation for researchers is not to rely on these accounts but rather to find accounts by parents who entered a program in good faith, then regretted it and either went public or shared on the condition of anonymity.
[5] Doctors Usman and Rossignol were also active Defeat Autism Now.