Break The Needle
Why psychedelic therapy is stuck in the waiting room
There is mounting evidence of psychedelics’ effectiveness at treating mental disorders. But researchers face obstacles conducting rigorous studies
In a move that made international headlines, America’s top drug regulator denied approval last year for psychedelic-assisted therapy to treat post-traumatic stress disorder.
In its decision, the U.S. Food and Drug Administration cited concerns about study design and inadequate evidence to assess the benefits and harms of using the drug MDMA.
The decision was a significant setback for psychedelics researchers and veterans’ groups who had been advocating for the therapy to be approved. It is also reflective of a broader challenge faced by researchers keen to validate the therapeutic potential of psychedelics.
“Sometimes I feel like it’s death by 1,000 paper cuts,” said Leah Mayo, a researcher at the University of Calgary.
“If the regulatory burden were a little bit less, that would be helpful,” added Mayo, who holds the Parker Psychedelics Research Chair at the Psychedelic and Cannabinoid Therapeutics Lab. The lab develops new treatments for mental health disorders using psychedelics and cannabinoids.
Sources say the weak research body behind psychedelics is due to a complex interplay of factors. But they would like to see more research conducted to make psychedelics more accessible to people who could benefit from them.
“If you want [psychedelics] to work within existing health-care infrastructure, you have to play by [Canadian research] rules,” said Mayo.
“Therapy has to be reproducible, it has to be evidence-based, it has to be grounded in reality.”
Psychedelics in Canada
Psychedelics are hallucinogenic substances such as psilocybin, MDMA and ketamine that alter people’s perceptions, mood and thought processes. Psychedelic therapy involves the use of psychedelics in guided sessions with therapists to treat mental health conditions.
Psychedelics are generally banned for possession, production and distribution in Canada. However, two per cent of Canadians consumed hallucinogens in 2019, according to the latest Canadian Alcohol and Drugs Survey. Psychedelics are also used in Canada and abroad in unregulated clinics and settings to treat conditions such as substance use disorder, post-traumatic stress disorder (PTSD) and various mental disorders.
“The cat’s out of the bag, and people are using this,” said Zachary Walsh, a professor in the Department of Psychology at the University of British Columbia.
Within Canada, there are three ways for psychedelics to be accessed legally.
The federal health minister can approve their use for medical, scientific or public interest purposes. Health Canada runs a Special Access Program that allows doctors to request the use of unapproved drugs for patients with serious conditions that have not responded to other treatments. And Health Canada can approve psychedelics for use in clinical trials.
Researchers interested in conducting clinical trials involving psychedelics face significant hurdles.
“There’s been a concerted effort — and it’s just fading now — to mischaracterize the risks of these substances,” said Walsh, who has conducted several studies on the therapeutic uses of psychedelics. These include studies on MDMA-assisted therapy for PTSD, and the effects of microdosing psilocybin on stress, anxiety and depression.
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The U.S. government demonized psychedelic substances during its War on Drugs in the 1970s, exaggerating their risks and blocking research into their medical potential. Influenced by this war, Canada adopted similar tough-on-drugs policies and restricted research.
Today, younger researchers are pushing forward.
“New ideas really come into the forefront when the people in charge of the old ideas retire and die,” said Norman Farb, an associate professor in the Department of Psychology at the University of Toronto.
But it remains a challenge to secure funding for psychedelic research. Government funding is limited, and pharmaceutical companies are often hesitant to invest because psychedelic-assisted therapy does not generally fit the traditional pharmaceutical model.
“It’s not something that a pharmaceutical company wants to pay for, because it’s not going to be a classic pharmaceutical,” said Walsh.
As a result, many researchers rely on private donations or venture capital. This makes it difficult to fund large-scale studies, says Farb, who has faced institutional obstacles researching microdosing for treatment-resistant depression.
“No one wants to be that first cautionary tale,” he said. “No one wants to invest a lot of money to do the kind of study that would be transparent if it didn’t work.”
Difficulties in clinical trials
But funding is not the only challenge. Sources also pointed to the difficulty of designing clinical trials for psychedelics.
In particular, it can be difficult to implement a blind trial process, given the potent effects of psychedelics. Double blind trials are the gold standard of clinical trials, where neither the person administering the drug or patient knows if the patient is receiving the active drug or placebo.
Health Canada also requires researchers to meet strict trial criteria, such as demonstrating that the benefits outweigh the risks, that the drug treats an ongoing condition with no other approved treatments, and that the drug’s effects exceed any placebo effect.
It is especially difficult to isolate the effects of psychedelics. Psychotherapy, for example, can play a crucial role in treatment, making it difficult to disentangle the role of therapy from the drugs.
Mayo, of the University of Calgary, worries the demands of clinical trial models are not practical given the limitations of Canada’s health-care system.
“The way we’re writing these clinical trials, it’s not possible within our existing health-care infrastructure,” she said. She cited as one example the expectation that psychiatrists in clinical trials spend eight or more hours with each patient.
Ethical issues
Psychedelics research can also raise ethical concerns, particularly where it involves individuals with pre-existing mental health conditions.
A 2024 study found that people who visited an emergency room after using hallucinogens were at a significantly increased risk of developing schizophrenia — raising concerns that trials could harm vulnerable participants.
Another problem is a lack of standardization in psychedelic therapy. “We haven’t standardized it,” said Mayo. “We don’t even know what people are being taught psychedelic therapy is.”
This concern was underscored in a 2015 clinical trial on MDMA in Canada, where one of the trial participants was subjected to inappropriate physical contact and questioning by two unlicensed therapists.
Mayo advocates for the creation of a regulatory body to standardize therapist training and prevent misconduct.
Others have raised concerns about whether the research exploits Indigenous knowledge or cultural practices.
“There’s no psychedelic science without Indigenous communities,” said Joseph Mays, a doctorate candidate at the University of Saskatchewan.
“Whether it’s medicalized or ceremonial, there’s a direct continuity with Indigenous practices.”
Mays is an advisor to the Indigenous Reciprocity Initiative, which funnels psychedelic investments back to Indigenous communities. He believes those working with psychedelics must incorporate reciprocity into their work.
“If you’re using psychedelics in any way, it only makes sense that you would also have a commitment to fighting for the rights of [Indigenous] communities, which are still lacking basic necessities,” said Mays, suggesting that companies profiting from psychedelic medicine should contribute to Indigenous causes.
Despite these various challenges, sources remained optimistic that psychedelics would eventually be legalized — although not due to their work.
“It’s inevitable,” said Mays. “They’re already widespread, being used underground.”
Farb agrees. “A couple more research studies is not going to change the law,” he said. “Power is going to change the law.”
This article was produced through the Breaking Needles Fellowship Program, which provided a grant to Canadian Affairs, a digital media outlet, to fund journalism exploring addiction and crime in Canada. Articles produced through the Fellowship are co-published by Break The Needle and Canadian Affairs.
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By Alexandra Keeler
B.C.’s push to replace coercive care with community models never took hold — and experts say province isn’t fixing that problem
Two decades ago, B.C. closed one of the last large mental institutions in the province. The institution, known as Riverview Hospital in Coquitlam, had at its peak housed nearly 5,000 patients across a sprawling campus.
There, patients with mental illnesses were subjected to a range of inhumane treatments, city records show. These included coma therapy, induced seizures, lobotomies and electroshock therapy.
When the province transferred patients out of institutions like Riverview during the 1990s and early 2000s, it promised them access to community-based mental health care instead. But that system never materialized.
“There was not a sustained commitment to seeing [the deinstitutionalization process] through,” said Julian Somers, a professor at Simon Fraser University who specializes in mental health, addiction and homelessness.
“[B.C.] did not put forward a clear vision of what we were trying to achieve and how we were going to get there. So we languished.”
Today, amid a sharp rise in involuntary hospitalizations, experts say B.C. risks repeating the mistakes of the past. The province is using coercive forms of care to treat individuals with mental health and substance use disorders, while failing to build community supports.
“We’re essentially doing the same thing we did with institutions,” said Somers, who began his clinical career at Riverview Hospital in the 1980s.
“[We’re] creating a system that doesn’t actually help people and may make things worse.”
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ECT machines and electrodes from the Riverview Hospital Artifact Collection. | City of Coquitlam
Riverview’s legacy
B.C.’s push for deinstitutionalization was driven by growing evidence that large psychiatric institutions were harmful, and that community-based care was more humane and cost effective.
Nationally, advances in antipsychotic medication, rising civil rights concerns and growing financial pressures were also spurring a shift away from institutional care.
A 2006 Senate report showed community care could match institutional care in both effectiveness and cost — provided it was properly funded.
“There was sufficient evidence demonstrating that people with severe mental illness had better outcomes in community settings,” said Somers.
Somers says people who stay long term in institutions can develop “institutionalization syndrome,” characterized by increased dependency, worse mental health outcomes and greater social decline.
At the time, B.C. was restructuring its health system, promising to replace institutions like Riverview with a regional network of mental health services.
The problem was, that network never fully materialized.
Marina Morrow, a professor at York University’s School of Health Policy and Management who tracked B.C.’s deinstitutionalization process, says the province placed patients in alternative care. But these providers were not always well-equipped to manage psychiatric patients.
“Nobody left Riverview directly to the street,” Morrow said. “But some … might have ended up being homeless over time.”
A 2012 study led by Morrow found that older psychiatric Riverview patients who were relocated to remote regional facilities strained overburdened and ill-equipped staff, leading to poor patient outcomes.
Somers says B.C. abandoned its vision of a robust, community-based system.
“We allowed BC Housing to have responsibility for mental health and addiction housing,” he said. “And no one explained to BC Housing how they ought to best fulfill that responsibility.”
Somers says the province’s reliance on group housing was part of the problem. Group housing isolates residents from broader society, instead of integrating them into a community. A 2013 study by Somers shows people tend to have better outcomes if they get to live in “scattered-site housing,” where tenants live in diverse neighbourhoods while still receiving personalized support.
“All of us … are influenced substantially by where we live, what we do, and who we do things with,” he said.
Somers says a greater investment in community care would have emphasized better housing, nutrition, education, work and social connection. “Those are all way more important than medical care in terms of the health of the population,” he said.
“We closed institutions having no [alternative] functioning model.”
Reinstitutionalization
Despite B.C.’s efforts to deinstitutionalize, the practice of institutionalizing certain patients never truly went away.
“We institutionalize way more people now than we ever did, even at peak Riverview population,” said Laura Johnston, legal director at Health Justice, a B.C. non-profit focused on coercive health laws.
Between 2008 and 2018, involuntary hospitalizations rose nearly 66 per cent, while voluntary admissions remained flat.
In the 2023-24 fiscal year, more than 25,000 individuals were involuntarily hospitalized at acute care facilities, down only slightly from 26,600 the previous year, according to B.C.’s health ministry. These admissions involved about 18,000 unique patients, indicating many individuals were detained more than once.
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In September 2024, a string of high-profile attacks in Vancouver by individuals with histories of mental illness reignited public calls to reopen Riverview Hospital.
That month, B.C. Premier David Eby pledged to further expand involuntary care. Currently, B.C. has 75 designated facilities that can hold individuals admitted under the Mental Health Act. The act permits individuals to be involuntarily detained if they have a mental disorder requiring treatment and are significantly impaired. These existing facilities host about 2,000 beds for involuntary patients.
Eby’s pledge was to add another 400 hospital-based mental health beds, and two new secure care facilities within correctional facilities.
Johnston, of Health Justice, says Eby’s announcement merely continues the same flawed approach. It “[ties] access to services with detention and an involuntary care approach, rather than investing in the voluntary, community-based services that we’re so sorely lacking in B.C.”
Kathryn Embacher, provincial executive director of adult mental health and substance use with BC Mental Health & Substance Use Services, says additional resources are needed to support those with complex needs.
“We continue to work with the provincial government to increase the services we are providing,” Embacher said. “Having enough resources to serve the most seriously ill clients is important to provide access to all clients.”
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θəqiʔ ɫəwʔənəq leləm’ (the Red Fish Healing Centre for Mental Health and Addiction) is for clients with complex and concurrent mental health and substance use disorders. | BC Mental Health and Substance Use Services website
Inertia
If B.C. wants to avoid repeating the mistakes of its past, it needs to change its approach, sources say.
One concern Johnston has is with Section 32 of the Mental Health Act. Largely unchanged since 1964, it grants broad powers to medical professionals to detain and control patients.
“It grants unchecked authority,” she said.
Data obtained by Health Justice show one in four involuntarily detained patients in B.C. is subjected to seclusion or restraint. And even this figure may understate the problem. B.C. only began reliably tracking its seclusion and restraint practices in 2020, and only collects data on the first three days of detention.
A B.C. health ministry spokesperson told Canadian Affairs that involuntary care is sometimes necessary when individuals in crisis pose a risk to themselves or others.
“It’s in these situations where a patient, who meets very specific criteria, may need to be held involuntarily under the Mental Health Act,” the spokesperson said.
But York University professor Morrow says those “specific criteria” are applied far too broadly. “We have this huge hammer [involuntary care] that sees everything as a nail,” she said. “Involuntary treatment was meant for rare, extreme cases. But that’s not how it’s being used today.”
Morrow advocates for reviving interdisciplinary care that brings psychiatry, psychology and primary care together in community-based settings. She pointed to several promising models, including Toronto’s Gerstein Crisis Centre, which provides community-based crisis services for those with mental health and substance use issues.
Somers sees Alberta’s recovery-oriented model as a potential blueprint. This model prioritizes live-in recovery communities that combine therapeutic support with job training and stable housing, and which permit residents to stay up to one year. Alberta has committed to building 11 such communities across the province.
“They provide people with respite,” Somers said.
“They provide them with the opportunity to practice and gain confidence, waking up each day, going through each day without drugs, seeing other people do it, gaining confidence that they themselves can do it.”
Johnston advocates for safeguards on involuntary treatment.
“There’s nothing in our laws that compels the health system to ensure that they’re offering community-based or voluntary based services wherever possible, and that they are not using involuntary care approaches without exhausting other options,” she said.
“There’s inertia in a system that’s operated this way for so long.”
This article was produced through the Breaking Needles Fellowship Program, which provided a grant to Canadian Affairs, a digital media outlet, to fund journalism exploring addiction and crime in Canada. Articles produced through the Fellowship are co-published by Break The Needle and Canadian Affairs.
Subscribe to Break The Needle.
Our content is always free – but if you want to help us commission more high-quality journalism,
consider getting a voluntary paid subscription.
Addictions
Man jailed for trafficking diverted safer supply drugs, sparking fresh debate over B.C. drug policies
Nanaimo drug trafficker’s case is further evidence of safer supply diversion. But some sources say even diverted drugs reduce harm
In early May, 68-year-old Ronald Schilling of Nanaimo, B.C., was sentenced to three years in prison for trafficking street drugs such as fentanyl and meth — as well as government-supplied opioids.
When authorities had arrested Schilling two years earlier, they had found him in possession of more than 80 government-supplied opioid pill bottles labeled with other patients’ names.
Those pills had been dispensed to patients under B.C.’s “prescribed alternatives” program, more commonly known as safer supply. The program aims to reduce overdose deaths by dispensing pharmaceutical opioids to drug users as an alternative to toxic street drugs.
In Schilling, patients of this program had found a drug dealer who was willing to give them harder drugs — such as fentanyl — in exchange for their prescription opioids. Schilling would in turn sell their prescription opioids to others.
“Mr. Schilling preyed upon people who were taking the safe supply drug,” Provincial Court Judge Karen Whonnock said during the sentencing hearing.
Schilling’s case is further evidence that safer supply opioids are making their way to the streets — and having unintended negative consequences. However, some sources say even diverted pills reduce harm if they flood the market with safer drugs.
‘Upside Down’
Schilling, a former charity worker, developed a cocaine addiction after the sudden death of his partner. He ultimately turned to drug trafficking to fund his addiction, according to his lawyer.
In court, the prosecution described Schilling as operating a mid-level drug trafficking scheme that exploited B.C.’s safer supply program.
Schilling coordinated with multiple dealers to source both illicit and prescription drugs, and had at least three individuals working under him. His text messages showed he would arrange to meet clients near Nanaimo’s Outreach Pharmacy to trade potent street drugs for the prescribed medications they had just received.
He operated under the name “Upside Down Inc.” — “down” being a street reference to fentanyl — and had business cards to match. To reassure users that the street drugs were safe, he would have them tested at a local overdose prevention site.
‘Predatory behaviour’
While Schilling’s case is unusual, it adds to the growing body of evidence that provincial safer supply programs are not always being used as intended.
In one example, a B.C. government report released in February revealed that more than 60 pharmacies were involved in a kick-back scheme, offering patients cash or rewards to fill safer supply prescriptions they did not need. Some of those drugs were then sold on the black market.
Collen Middleton, a co-founder of the Nanaimo Area Public Safety Association, refers to safer supply drugs as the “perfect consumer product.”
“They are a product that produces its own demand, because it’s addictive,” said Middleton, whose neighbourhood association is a vocal critic of safer supply.
One of Middleton’s concerns is that safer supply drugs are presented as safe, despite being addictive themselves. He says this makes them an effective gateway to more dangerous street drugs like fentanyl.
“Those drugs are being marketed as safe to kids … [so] you’re bringing more people into using addictive drugs, more abuse, more predatory behaviour toward a vulnerable segment of the population,” he said.
The B.C. Ministry of Health told Canadian Affairs in an emailed statement that it takes the “diversion of prescription medications … very seriously.”
“The unauthorized distribution is illegal and puts the public at risk,” it said.
In response to the B.C. pharmacy scandal, the province tightened its protocols for dispensing prescription opioids. All new and most existing patients must take prescription opioids under the supervision of health-care professionals, a protocol known as witnessed dosing. In rare cases, existing clients may continue to take their doses offsite if the prescriber views the risk of diversion as low.
Mixed evidence
In its statement to Canadian Affairs, B.C.’s health ministry also said its safer supply program “plays an important role in reducing substance use-related harms” and can lower overdose risk by as much as 91 per cent.
This figure comes from a 2024 B.C. study published in the British Medical Journal. That study found individuals prescribed pharmaceutical opioids early in the pandemic were 91 per cent less likely to die from any cause in the week after receiving at least four days of safer supply opioids, compared to a control group.
The study only tracked outcomes during the week following prescription fills. It did not verify whether individuals took the opioids as prescribed.
A study published in April in The Lancet Public Health shows B.C.’s safer supply programs are linked to improved short-term health outcomes, including fewer overdoses and hospital visits.
However, a population-level study in JAMA Health Forum found no significant reduction in overdoses or mortality associated with B.C.’s safer supply and decriminalization policies. It also suggested possible increases in emergency department visits and hospitalizations.
Comprehensive long-term research on the health impacts of Canadian safer supply programs is limited.
Creating a market
Some sources say the diversion of prescription opioids may be less harmful than the alternatives.
“If you could replace [street] drugs with safer pharmaceutical alternatives, people’s needs would be met,” said Perry Kendall, B.C.’s former provincial health officer and a long-time harm reduction advocate.
“They wouldn’t have to turn to the illicit market, and their risk of a toxic drug overdose would be significantly reduced.”
In Kendall’s view, Schilling was in some ways functioning as a harm-reduction worker.
“[Schilling] was kind of offering a harm reduction service, as well as supplying people with the drugs they wanted,” Kendall said.
Kendall’s views are echoed in a 2023 B.C. government review that notes diversion of safer supply drugs to people already at risk of drug poisoning may be beneficial. But the review also acknowledges that diversion to users who would not otherwise use unregulated drugs is harmful.
Still, Kendall acknowledged a fundamental issue: “[Safer supply opioids don’t] really give you the same high [as fentanyl]. So if you can trade [them] to … get what you’re looking for, which is fentanyl, then that’s what you will do.”
Leonard Krog, the mayor of Nanaimo, says it is clear that, within Nanaimo, B.C.’s policies to help drug users are making it easier for dealers to sell their toxic drugs.
“We have a safe injection site next to City Hall, and there’s no question dealers are coming down here and they’re selling their stuff, because the market’s right here,” said Krog.
But Kendall warns that pulling back on decriminalization and safer supply programs creates a dangerous gap.
“The daftest thing you can do is create a market of desperate people and then fail to fill it,” said Kendall. “Somebody’s going to meet those needs — and they’re not going to be law-abiding citizens.”
Krog is unconvinced.
“If we make it easier for the wolves to successfully exploit the sheep, is that a good thing?”
This article was produced through the Breaking Needles Fellowship Program, which provided a grant to Canadian Affairs, a digital media outlet, to fund journalism exploring addiction and crime in Canada. Articles produced through the Fellowship are co-published by Break The Needle and Canadian Affairs.
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