Autism case highlights urgent need to reform Ontario’s regulatory colleges
A case in Ontario Superior Court about an MD using a risky “treatment” on autistic children may be the wake-up call Ontario health regulators need.
Canada’s health regulatory colleges were designed to set standards of conduct among health professionals, to investigate and sanction practitioners for misconduct and to protect patients. But a series of scandals within medicine, chiropractic and naturopathy have raised the issue of whether self-regulatory colleges are doing enough to ensure patient safety – or whether relationships, bias or other factors could be influencing college decisions and putting patient safety at risk.
British Columbia’s colleges were the subject of a report last year 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 changes are an effort to remedy what international professional regulation expert Harry Cayton described in his report as “a lack of relentless focus on the safety of patients in many but not all of the current colleges.”
The problem isn’t just limited to B.C. According to Ryan Armstrong of Bad Science Watch, a grassroots watchdog group, Ontario has also had a series of problems with its health regulatory colleges.
“Our provincial colleges are not fulfilling their mandate to protect the public. Some have a tendency to protect their members over the public,” says Armstrong. “These issues would be best addressed by a provincial or national body focussed on standards across regulated health services.”
On Oct. 27, the Ontario Superior Court of Justice held a judicial review of a College of Physicians and Surgeons of Ontario (CPSO) decision on a physician who has been performing off-label chelation on autistic children, a practice that is banned in the U.S. and U.K.
I am the complainant in the case, represented by lawyer Stephen Aylward. Since the CPSO refused to investigate my complaint, it has made its way through the appeals process for nearly three years, including a ruling by the Health Professions Arbitration and Review Board (HPARB) that upheld the CPSO’s refusal to investigate the physician’s use of chelation on autistic children.
At the time of the HPARB appeal, Tim Caulfield, Canada Research Chair in Health Law and Policy at the University of Alberta, told the Globe and Mail that the HPARB and CPSO decisions cast doubt on the idea that health profession regulatory bodies were adequately protecting patients. “If they can’t act in this kind of situation,” he asked, “what is their role?”
The Superior Court is now deciding whether it will require the College to do a meaningful investigation. Meanwhile, the case raises questions about the role (and practices) of the health regulatory colleges.
Chelation for autism: Banned in the U.K. and U.S.
The idea of using chelation to treat autism comes from a false belief among anti-vaccine advocates that autism is caused by metals from vaccines and that autistic children should be “detoxed” through the off-label use of chelating drugs. There is a lucrative market in some countries where MDs use prescription chelation drugs on autistic children, selling the false promise to parents that it will cure their children’s autism.
Chelation, typically reserved 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. The Food and Drug Administration (FDA) in the U.S. has documented more than 30 recent cases of death from off-label chelation, including children such as 5-year-old Abubakar Tariq Nadama, who died after his parents travelled with him from the U.K. to the U.S. for “autism chelation” treatment. Abubakar had received his third treatment of chelation therapy at a doctor’s office shortly before going into cardiac arrest, according to Pennsylvania Deputy Coroner Larry Barr.
After Abubakar’s death, the FDA and the National Health Service in the U.K. banned the off-label use of chelation on autistic children. The NHS has included chelation on its list of Fake and Harmful Autism “Treatments” and the FDA has been issuing warning letters to those marketing/selling chelating products as an autism treatment for more than a decade, citing deaths and injury. 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.”
Off-label use in Canada is in the jurisdiction of the provinces and territories. In Ontario, that means that the safety of a physician’s off-label use of a drug is determined only if challenged – and consequences, if any, are decided by a health professions regulatory board. (The current case was reviewed by a panel of two MDs and a community member.)
The CPSO: Declining to investigate
In contrast to regulators in the U.K. and US, the CPSO ruled in July 2018 that chelation should be allowed as an autism treatment, describing it as “valuable and evidence-based.” This is a stunning declaration since autism experts are unanimous that there is no evidence of benefit and clear evidence of harm in using chelation on autistic children. I had documented that in my submission to the CPSO. The complaint, about an Ontario MD using chelation on autistic children, included letters from autism researchers (Holland Bloorview Children’s Hospital), case studies and reports (a Cochrane Review that found no evidence for chelation as an autism treatment), FDA and NHS warning statements and reports of deaths and injury from off-label chelation. I also documented that the Ontario MD performing chelation described autism as “a unique form of chronic mercury poisoning” and had generated his own research that consisted of a single case study with one child based on anecdotal evidence.
After receiving my complaint, the CPSO did not contact any outside experts, nor did it consider data I had presented. The only step the review board took was to solicit a letter from the MD, who wrote that chelation for autism was “valuable” and in keeping with the CPSO’s Complementary Medicine policy. The CPSO committee took no investigative steps to independently verify his claim even though the treatment appears to violate three principles of the CPSO’s Complementary Medicine policy that states a treatment “must have a logical connection to the diagnosis, a reasonable expectation of clinical benefit and a favourable risk/benefit ratio.”
A year or so after that, Ontario’s HPARB dismissed my appeal. While the HPARB acknowledged that there were “legitimate concerns” about using chelation as an autism treatment, it nonetheless declined to send it back to the CPSO for an investigation. For those unfamiliar with health provider regulation in Ontario, the HPARB is typically the end of the line for complaints. Patients, caregivers or patient advocacy groups have little recourse other than the health regulatory college (save a costly battle in civil court). Although I considered letting the complaint go, I decided that a judicial review might bring the kind of investigation the complaint warranted.
A new regulatory framework?
This case highlights two issues. The first is the conflict between the official role of health regulatory colleges versus the reality of their practices. “The colleges do not belong to the professions,” reminds B.C. Health Minister Adrian Dix. “They belong to the public … they have a public protection mandate.” If the CPSO or any other health profession regulator has shown a pattern of refusing to investigate certain cases adequately (or if any bias is found in the approach), then it has not been doing the job it needs to do to protect public health and safety.
The case also brings up broader issues around the protective role of the state in the lives of vulnerable patients such as children or intellectually disabled people. In a case like this, where children are being put at risk for a procedure that has been widely discredited, there is no clear mechanism for the government to act, unlike in the U.S. and the U.K., where bans are enforced.
As well, Health Canada does not regulate the off-label use of medications, leaving the issue solely to the regulatory colleges on a case-by-case basis. This adds extra weight to the responsibility of a college: When it receives a complaint of this nature and does not fulfill its responsibility to investigate, it’s likely no one else will.
This raises several questions: If the state has a role to protect the vulnerable, why are autistic children in Canada not being protected from chelation “treatment”? If a jury-of-peers system cannot be trusted with the responsibility of protecting vulnerable patients, who can? And what would a more robust regulatory framework look like?
In searching for answers, policymakers can look to best practices in other countries as well as consulting with policymakers in B.C. My hope is that Ontario will follow B.C.’s lead and shift Ontario’s health regulatory process from a relationship-driven network of “self-regulation” toward clearer mandates, as we have seen in the U.S. and U.K. This shift is crucial, both for patient safety and to improve public trust in our health professionals.
As our society continues to face a pandemic coupled with an onslaught of health misinformation, the public’s trust in the health system is already in jeopardy. Rather than hunkering down into defensive positions, Ontario’s regulatory colleges would do well to acknowledge their weaknesses and make way for a new regulatory framework of which we can all be proud.