Trying to stop off-label chelation for autism in Canada: My journey through the regulatory wilderness
This is part 5 of my 5-part series on the autistic community, antivax & the movement to ban chelation as an autism “treatment”. Jump to Part 1
In 2018, my family was roadschooling. As part of that, we took ViaRail across Canada from Toronto to Vancouver. It took us a few weeks, with stops to explore various regions on foot. One day, as our train rumbled through the microdesert in Kamloops, British Columbia, a letter from the College of Physicians and Surgeons arrived for me back home: their decision on my complaint about an MD who had been using off-label chelation to allegedly treat autistic children’s “vaccine injuries”.
When my neighbour asked if I wanted him to open the letter, I said no. I think I knew, deep in my heart, that the College would take no action on the complaint. I wanted to give myself a few more weeks of believing it might be possible that they would do the right thing for kids.
Back in 2017, when I’d first alerted CPSO to this off-label prescribing, I had thought it would be reviewed quickly, without prejudice. As days, weeks and months passed, my hopes faded. With the MD (Dr. Gannage) having also served on CPSO complaint review boards and with the College’s generally taciturn approach towards me, I began to feel almost embarrassed of my earlier optimism.
The CPSO letter did contain bad news--for the children of Ontario, for autism families and indeed for all patients in the province. In fact, the committee had refused to even read the resources I’d sent, nor investigate the issues outlined in complaint (which met all of the College’s stated requirements for a complaint). In reading it, I got my first glimpse the underbelly of the strange, bureaucratic world of institutions that, in some ways, survive as they do by dehumanizing people.
Three years and two appeals later, it was all the more clear that we need a paradigm shift within these structures.
While my last post focused on the history and the risks of off-label chelation-for-autism, here I will focus mostly on my case, in relation to the regulatory landscape.
Context of the complaint: Canceled drug trials, risks and a ban by FDA
As detailed in my last post, chelation can be life-threatening and is typically reserved for acute poisoning; it is not indicated at all for autism, nor is there a plausible mechanism for its use for autism.
The most well-publicised case of a death related to chelation-for-autism was that of Abubakar Tariq Nadama, age 5, who died of cardiac arrest in the office of Pennsylvania doctor Dr. Roy E. Kerry after receiving chelation therapy in 2005. His family, who was told that chelation would treat his autism, had travelled with him from the UK to the US for the treatment. Kerry was charged with involuntary manslaughter.
In 2008, a study on chelation as a potential autism treatment was pitched to the National Institute for Mental Health in the US. The study was briefly approved but quickly canceled before it started[1] after a paper in Environmental Health Perspectives showed that in rats, a three-week course of chelation (with DMSA) causes lasting cognitive issues. The announcement from NIMH stated:
“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.”
The NIMH cited risks as its reason to stop the trials of this off-label use.[2]
A decade later, as the US FDA documented more than 30 recent cases of death from off-label chelation, including children, it called for a ban on the off-label use of chelation as an autism “treatment”. Criminal complaints and civil lawsuits against MDs for this off label use, and other off-label use of chelation, have continued with the context of the FDA’s ban.
Like US regulators, UK regulators also banned off-label chelation as an autism treatment But Canada had not caught up.
The complaint
In late 2017, I learned about an Ontario-based MD, Dr. Gannage, using chelation to treat autistic children’s “vaccine injury”.[3] I’d first heard about it from another autism mom who had visited the clinic but decided against it. She described seeing rows of chairs, as in a chemo lab, for chelation for a various conditions. I then heard about the clinic again from a psychotherapist friend who was concerned about the risks for a young client whose parents were taking him for chelation. Neither the therapist nor the parent wanted to be part of any regulatory complaint, so I was on my own.
I put together a report using the doctor’s own case study on chelation for autism and his website materials. Both sources suggested autism was related to MMR vaccines and could be healed with chelation. Dr. Gannage described autism as “a unique form of chronic mercury poisoning”. In his case study, which was a white paper, Dr. Gannage had claimed that chelation therapy for children had “the ability to dramatically improve the life (and remove the label) of an autistic child.” He describes his patient, “T,” this way:
His parents provided a clear history of regression in speech development at 18 months, after the DPTP vaccine and influenza vaccine were administered two weeks apart. He described T as experiencing “major improvements” after chelation, to the degree that he lost his autism diagnosis altogether, concluding: “I am optimistic that in the future vaccine injury will be studied, reported and disclosed, and genetic information will be available to parents about the risk of specific vaccines to their child.”
My complaint, submitted via email, contained a report containing hyperlinks to case studies and reports (such as a Cochrane Review that found no evidence for chelation as an autism treatment[4]), warning statements from US and UK regulators and reports of deaths and injury from off-label chelation.
I also relied on the CPSO’s own Complementary and Alternative Medicine (CAM) policy, a guiding document for physicians that listed criteria for the use of CAM. According to the CPSO’s policy:
“Any CAM therapeutic option that is recommended by physicians must be informed by evidence and science, and it must: Have a logical connection to the diagnosis reached; Have a reasonable expectation of remedying or alleviating the patient’s health condition or symptoms; Possess a favourable risk/benefit ratio based on the merits of the option, the potential interactions with other treatments the patient is receiving, the conventional therapeutic options available.”
I submitted the report to Dr Gannage’s health regulating college—the first step in Canada for a complaint of this nature. When someone contacts the College with a concern (typically called a “complaint”),[5] the College is then responsible for investigating, then making a recommendation as to whether the doctor should be allowed to continue the practice and whether any actions are in order.
Problems in Canada’s health regulatory system
This was my first time reporting to a health regulatory college and I assumed it would be a quick and easy process. I was totally unprepared for what would actually happen. As bioethicist Carl Elliott documents in The Occasional Human Sacrifice: Medical Experimentation and the Price of Saying No, people are rarely aware of the onslaught of denial, gaslighting, character assassinations and professional reprisals that will be brought upon them by the individuals and institutions that they have reported. As he said on my podcast:
“What a lot of people think is ‘if just everybody else could see what I’m seeing and they knew what I know, they would be as outraged as I am’. And they simply assume, or at least have a reasonable hope that when they do that, that’s what’s going to happen.”
I’d expected the College to follow its own guidelines its own guidelines for investigation, but this did not happen. Instead, CPSO would lead me on a years-long legal tussle that ended at the Ontario Superior Court.
I didn’t know this at the time, but Canada’s health regulatory have been plagued by problems; in fact, a series of scandals within medicine, chiropractic and naturopathy had raised the issue of whether relationships, bias or other factors could be influencing college decisions and putting patient safety at risk. For example, British Columbia’s colleges were the subject of a report (2019) that led to changes, including reducing the number of its colleges, redefining the guidelines for college board representation, building transparency into the complaint process and creating an oversight body for audit and review.
The CPSO’s response
About six months after submitting my report, I received the CPSO’s response letter, which claimed the College did not need to investigate at all and that they were confident that chelation for autism was “valuable and evidence-based.” Their argument was that I had not supplied patient-specific information (despite the fact I had shared a case study of a patient) and that Dr. Gannage “conforms to the expectations of the CAM policy.” They had not consulted any experts on autism and in fact, they claimed to have not read any of the citations that had been summarized and linked in my report.
What the committee had done was to request a short letter from Dr. Gannage which defended chelation for autism as “valuable and evidence-based,” the phrase that CPSO had cribbed in its response letter to me. He also told CPSO:
“Given the goal of chelation therapy which is to reduce toxic heavy metal burden, it can be a useful treatment for select children with ASD.”
Rather than investigate his claims or follow up with further questions, the CPSO declined to investigate.
A first appeal
The CBC ran a story about my report a few weeks later and I decided to appeal the CPSO’s decision to the Health Professions Arbitration and Review Board (HPARB), a provincial body of appeal. Working pro bono on my appeal was lawyer Stephen Aylward, an expert in health regulation law at Stockwoods, a law firm in the same Bay Street corridor as the CPSO’s legal team.
I re-submitted my complaint to the appeal arbitration board, including letters from autism experts in Toronto, such as Dr. Evdokia Anagnastou of Holland Bloorview Children’s Hospital, which specializes in autism and childhood disability, as well as large autism-related organizations, all of whom opposed chelation as an autism treatment.
In our Submission of Applicant, we argued that CPSO, by not investigating, had ignored crucial issues such as whether chelation for autism complied with the CAM policy as well as CPSO’s Drug Policy, which states:
“There must be a logical connection between the drug prescribed and the diagnosis… Physicians must consider the risk/benefit ratio for prescribing that particular drug for that patient.[6]”
We also noted that in a previous decision, the CPSO’s Discipline Committee had rule that it was “contrary to the standards of practice for a physician to prescribe a drug off-label where its use had been ‘discredited and rejected by the medical community.” In fact, the committee had concluded that the MD in that case had “violated the physicians oath of ‘do no harm’” and that “patient care was compromised.”
Then we waited many months for the HPARB hearing.
The appeals board hearing
These kind of hearings are a lonely, dull affair. One would scarcely know that sometimes they are about life-and-death matters. This particular hearing happened on an upper floor of some grayish building, with folding tables seating counsel for the two sides, some chairs for observers and a Canadian flag wilting in the corner. The day’s hearing was devoid of emotion, save a few infuriated, hand-written Post-It notes passed over to me by one MD in attendance who’d been following the case. As a “complainant,” I was instructed not to speak at all, according to HPARB protocol.
Months later, an email came in from Aylward’s office: news of a decision. I again waited to read this decision, this time for a few days. As I’d expected the HPARB had upheld the CPSO’s refusal to investigate, concluding that the CPSO had done an “adequate” job with the complaint--even though the CPSO had done nothing to investigate it, save solicit a letter from the MD himself. The HPARB also claimed that it was onerous to expect the CPSO committee to read the research I’d summarized and included in the original report.
Tim Caulfield, Canada Research Chair in health law and policy at the University of Alberta, spoke with the Globe and Mail after the decision. Seeing cases like this one, he wondered whether health professional regulatory bodies in Canada were capable of ensuring patients were safe from treatments that could pose risks to their health. He said:
“That is their mandate. Not protecting their members, but protecting the public. If they can’t act in this kind of situation, what is their role?”
Stephen Aylward advised we had one more pathway of appeal; to the Superior Court of Ontario. His commitment to continue gave me hope to continue on myself, and we prepared for a new hearing. It’s important to note I had many more resources at my fingertips than the average complainant and this led me to wonder if the College merely sought to exhaust and impoverish its complainants as a way to make them—and their concerns—just go away. With that thought, I felt a stronger drive to keep going with mine.
Appeal to the Superior Court
In 2021, the hearing came, on what was already a particularly low day in my life. I had just finished my final rounds of radiation after undergoing chemo and surgeries for cancer. I was tired, bald and in no mood for nonsense. The hearing was held virtually and I was invited to attend but--as with the HPARB hearing--only my lawyer was allowed to speak. The weirdness of being a spectator at my own compliant hearing was amplified by the on-going technical difficulties the judges had in logging in from their homes, cottages or wherever they may have been.
There was some reason for optimism, I suppose. In the midst of the pandemic, the threat of the antivaccine movement seemed to finally have more general relevance. In fact, the CPSO had sanctioned a female doctor for tweeting her vaccine skepticism. If doctors were being disciplined for something like a tweet, perhaps the judges would have the wisdom to understand that actually treating autistic children for fake “vaccine injury” through a potentially deadly off-label procedure that is banned in the US and the UK should not be permitted.
Aylward presented a clear-cut case, based on Dr. Gannage’s claims in the single case study and the broader risks and impact. He quoted the CPSO’s own CAM policy [59 a,b,c] and wrote:
“There is no logical connection between chelation therapy and ASD. The basis on which Dr. Gannage purports to use this treatment, as stated in the Case Study, is that ASD is a form of mercury poisoning caused by ‘vaccine injury.’”
Aylward also cited a relevant precedent: “In the R.N. decision, the HPARB upheld a decision of the [CPSO] committee holding that the use of chelation as a treatment for chronic pain did not comply with the CAM policy because it was not ‘informed by evidence and science.’” [60].
The CPSO lawyer’s arguments were different. She claimed that even looking into the claims would have set a dangerous precedent for the College. She claimed that reading a patient file during an investigation, although part of the College’s mandate, was as an invasion of privacy and the reviewing of the case as an undue hardship for the review committee.
She claimed reports like mine amounted to a “fishing expedition” and seemed to suggest my report reflected someone else’s agenda (I’m not sure who?) and that it would set a bad precedent if it was investigated. She said I’d expected too much of the review committee by asking them to take time for my report.1 After a while I stopped listening to her attack my character and at one point even muted her on my screen.
The judgement came out a few days later. I didn’t wait to read it this time. I stood in the kitchen with my phone, skimming through a decision that repeated the defense’s talking points.
While I reached out to my media contacts, they did not cover the story this time--because it wasn’t Covid-related.
Making sense of “failure” & continuing to advocate
In filing the complaint to the College of Physicians and Surgeons, I’d held out hope that someone would understand the importance of addressing the serious risk to children of using chelation to “treat” autism, and to stop clinics in Ontario from this off-label use. I also expected the College would use a reasonable protocol for adjudicating the complaint. The CPSO failed in both regards. In the appeals process, the HPARB team and the Superior Court judges also failed. They all failed to protect children.
The case decisions do not erase the fact that many individuals do understand the importance of stopping chelation as an autism “treatment”. We see this support from health regulators in other jurisdictions who’d banned chelation for autism, to toxicologists and Cochrane reviewers who studied and provided evidence to support the bans, to journalists who covered stories around this issue, to the pro-bono legal team and supportive autism organizations, to people like the doctor who slipped me the Post-It notes at the hearing.
I’ve learned that some health regulatory teams have a strategy designed to cover up for their peers and stop changes that would protect patients. I’ve learned from others that it is fairly normal to be gaslit and degraded by lawyers when one makes a report to a College—and that peers will often close ranks rather than act in the public interest. What happened in this case is the norm. We need to reform our broken reporting systems by building in accountability and oversight.
Since 2017 I’ve reported many scammers to regulatory bodies including other Colleges, Health Canada and FDA with mixed results. It all comes down to the culture at the agency or division. There needs to be at least one person there who sets a tone tha patients matter, that accountability matters. (I talk about some of those cases in my book.) But it’s all too common that a regulatory body is either extremely ignorant or essentially rigged. We need to fix regulation and enforcement. And where it doesn’t work, we need to get much better at educating consumers.
I realize too that I’d unconsciously found ways to cope with the stress of reporting. I’d waited to open those CPSO letters right away as a self-protective measure, to keep a sense of control. And when I spaced out as the CPSO lawyer was saying silly things about me, it helped separate me from her world. I kept my talk about the case amongst certain supportive colleagues and tried to keep other parts of life free from reminders of it. All of these things helped me to not be engulfed by disappointment and gave me energy and hope to keep going.
We should never feel ashamed of having hope. Remember the cascade effect! There are many examples of reporting that did lead to changes that helped children, sometimes after many decades. In my next series here, I look at the ABA system and the many individuals who’ve shed light on abusive practices in the field, working for a paradigm shift in autism services that—finally—has begun. I hope they all knew that these changes were coming. And if you work in advocacy, I hope you know how much your work matters, too.
This is part 5 of my 4-part series on the autistic community, antivax & the movement to ban chelation as an autism “treatment”. Jump to Part 1
[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] The term off label refers to the use of a prescription product in a way that is not prescribed by the company that makes the product.
[3] In addition to Dr. Gannage’s clinic, there are numerous clinics in my province that offer chelation for a range of unproven or fraudulent uses. For example, one clinic in Vaughan, Ontario offers chelation for conditions including cardiovascular disease, slow healing wounds, diabetes, memory disorders and peripheral neuropathy. None of these are evidence-based uses.
[4] The Cochrane Review notes: “Currently no clinical trial evidence suggests that pharmaceutical chelation is an effective intervention for ASD. 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.”
[5] In the case of the College of Physicians and Surgeons of Ontario, the complaints review committee has generally consisted of two doctors and one person who is not a doctor.
[6] CPSO, “Prescribing Drugs,” Policy No. 7-16 at page 4. (cited in Applicant’s Book of Documents, Tab 5, page 94, submitted to HBARB Jan. 29, 2019. File# 18-CRV-0478)
I don’t have direct quotes, because we were not allowed to record the hearing.