For Canadian Patients, Therapeutic Psychedelics Beset by Red Tape
In January of 2022, Janis Hughes was told she had two years to live. After two prior bouts of cancer, she was now told she had stage 4 breast cancer, which had already spread to her sternum, ribs, and right lung. The news devastated her, making her feel “a great weight” pressing on her chest, robbing her of any joy. One day, she came across a documentary about how psilocybin mushrooms, commonly known as magic mushrooms, combined with therapy could help people with terminal cancers get relief from their existential dread. Hughes, now 66, was not one for taking what she considered “hard drugs,” but she was intrigued.
“I had nothing to lose at this point, and it just resonated with me — oh, that’s what I need,” she said.
Getting access to these drugs, however, was not going to be easy. In Canada, where Hughes lives, it is generally illegal to use psychedelics outside of a research setting. But since 2020, the government has allowed a small number of patients to seek medical exemptions. More recently, in January 2022, Canada reversed a regulatory restriction that had prohibited patients from accessing restricted drugs, including psychedelics, through its Special Access Program. The SAP, which is overseen by Health Canada, the nation’s public health agency, allows patients with serious or life-threatening conditions to obtain emergency access to unapproved medications when conventional therapies have failed or are otherwise unsuitable.
Canada’s recent policy change makes it among the few countries in the world to explicitly offer psychedelics on a compassionate or emergency use basis.
Hughes applied through the SAP, but soon ran into a hurdle: She had to find a doctor willing to fill out an eight-page form; administer psilocybin, the psychoactive compound in magic mushrooms; and oversee the entire process. The doctor would also have to take responsibility in case anything went wrong. She asked two oncologists at her cancer center and her family physician, but all of them declined. One oncologist had never heard of psilocybin-assisted therapy for terminal cancer patients, Hughes said, and the other told her that she preferred not to get involved because of the amount of paperwork. Her family physician was open to helping with her application, she said, but didn’t want to be responsible for overseeing her use. When Hughes finally found a willing doctor, she would have to travel more than 1,000 miles across Canada to an unfamiliar city to be treated. She decided against it.
Frustrated, Hughes shared her experience with the media and soon received offers of help from underground psychedelic therapists. Hughes found one who worked in her area and took psilocybin on two occasions. The experiences were transformative. “It’s beyond happiness. It’s beyond contentment,” said Hughes. “It’s those things and more.”
This happy outcome is out of reach for too many patients, say the SAP’s critics, which include a mix of drug advocates, palliative care physicians, and scientists. While the SAP was intended to serve as a fast route to grant desperate patients access to restricted drugs, applicants have been left waiting weeks, sometimes months, backlogged by what these experts describe as a highly administrative and arbitrary process. Contributing to the bottleneck is the fact that few physicians in Canada are specially trained in psychedelic treatment, and the nation’s specialists do not have space in their schedules to meet the demand. Even when they do have an opening, it might not be possible for faraway patients to meet with them.
As of early February, only 100 patients — a small fraction of those who are eligible and interested — have even applied to the SAP to access psilocybin, palliative care physicians say, and some have died before getting approval.
“This SAP process is really a horrible process for getting patients access to experimental drugs like psilocybin,” said Spencer Hawkswell, CEO of TheraPsil, a nonprofit psychedelic advocacy group based in British Columbia that currently works on assisting patients in applying through the SAP. “It just doesn’t work.”
Not everyone sees the SAP so bleakly. While the program may be slow, some medical ethicists and physicians say the application form asks perfectly legitimate questions and should help ensure that the drugs are prescribed safely and effectively. Psychedelics hold a lot of promise, they argue, but the evidence surrounding their use is still preliminary, so safeguarding against misuse is critical.
These experts also say that the best way to get access to these drugs is through a clinical trial, a type of study that tests how well a treatment works in humans. Such trials guarantee a certain level of safety and help health regulators compile data to rigorously identify the benefits of the drugs. “Then all patients could ideally have access to them without going through these pathways,” said Holly Fernandez Lynch, an assistant professor of medical ethics and health policy at the University of Pennsylvania.
Clinical trials specific to these patients are rare, however, and conducting one is costly. And according to the SAP’s critics, patients are often left with few legal options.
The first studies specifically looking at how psychedelics could help patients with existential distress took place in the late 1960s in the United States. While the studies mostly focused on drugs other than psilocybin, they generally seemed to suggest that psychedelics could help terminal cancer patients relieve deep-seated feelings of anxiety. But those studies came to a halt in 1970, when the country’s Controlled Substances Act banned psychedelics and classified these and other drugs as “Schedule I,” meaning they were now considered to have “no currently accepted medical use” and “a high potential for abuse” by federal law.
It was only about 30 years later that scientists picked up where they had left off. Of particular importance were two seminal studies published in 2016 by researchers at Johns Hopkins University and New York University, respectively, showing that terminally ill patients experiencing distress exhibited significant improvements in mood, anxiety, quality of life, and depressive symptoms after a single high dose of psilocybin. The studies had notable limitations: The sample sizes were relatively small, about 90 percent of participants were White, and about half had post-graduate education. But, for most of the NYU study participants, the drugs had quick and positive effects that lasted at least four and a half years.
End-of-life anxiety is not an official clinical diagnosis, however, so there was no pathway to approval by the U.S. Food and Drug Administration. Scientists soon pivoted to other conditions, including treatment-resistant depression. One of the latest studies on these patients found that psilocybin alleviated depressive symptoms as well as escitalopram, an often-used antidepressant. Last November, the biggest study on this group of patients to date, with more than 200 participants, showed that a high dose of psilocybin significantly reduced depression scores.
Psychedelics help tamp down feelings of anxiety and distress, while simultaneously helping people flourish as human beings, said Justin Sanders, director of palliative care at McGill University in Montreal. “There’s no other medicines to date that can promote these kinds of experiences in the way that we see with psilocybin,” he said. “And that’s so really powerful.”
Some have expressed reservations about treating terminally ill patients with psychedelics. In a small 2020 study, physicians cited several concerns, including potential adverse effects such as delirium and worsened distress, as well as reluctance to recommend illegal drugs to patients. Some practitioners have also raised the possibility that patients might experience stigma for using drugs with a complicated history. Another small study, published in 2021, found that some palliative care providers view existential distress as a social and spiritual problem that transcends medicalization.
And questions about how the drug actually works in the brain still remain. Scientists are just starting to map the specific receptors, pathways, and brain regions that seem to be altered when patients are on psychedelic drugs; there is currently no consensus on what biological mechanisms might explain the drugs’ anxiety-relieving or mood-boosting effects.
“The really quick answer,” said Albert Garcia-Romeu, an assistant professor and researcher in the psychedelics research center at Johns Hopkins: “We don’t know.”
Until recently, Canadian patients seeking legal access to psychedelics needed to join a clinical trial or request an exemption under a federal law known as Section 56, which allows select individuals to use controlled substances for medical purposes. In August 2020, Thomas Hartle, a 52-year-old man diagnosed with stage 4 colon cancer, was the first to get access to psilocybin through this exemption. He took the treatment under the supervision of a TheraPsil psychotherapist and emerged with a newfound comfort in the prospect of death. When his story made headlines, scores of patients in similarly dire circumstances turned to Health Canada for exemptions.
“Health Canada’s exemption office got a flood of requests and they just couldn’t cope,” said Valorie Masuda, a palliative care doctor who has treated several patients using psilocybin on approval by the SAP, and is a medical lead for Roots to Thrive, a nonprofit involved in group psychedelic therapy and research based in British Columbia. To manage the rapidly escalating situation, Health Canada restored access to restricted drugs, including psychedelics, through the SAP, she said.
When Undark asked Health Canada about this version of events, the agency did not respond directly. Instead, the agency sent a link to a government webpage, which states that Health Canada initiated a 60-day public-comment period in late 2020 to assess whether the agency should restore access to restricted drugs like psychedelics. The analysis of the proposed regulations notes that there is a “growing scientific interest” in the therapeutic use of the restricted drugs.
The proposal got overwhelming support and the SAP was officially amended about a year later. According to the program’s website, “every effort is made to contact the practitioner within 24 hours to discuss the process for handling new products.” Since then, some psychedelic centers, including Roots to Thrive, have been able to gain access to psychedelics for 30 patients without any rejections or huge delays, said Pamela Kryskow, another medical lead for the nonprofit.
But not everyone is pleased with the results. Critics maintain that while the program is meant to help people with “serious or life-threatening situations,” it does not specify which conditions meet the criteria. So far, the program has mostly approved psychedelics for physicians treating patients with end-of-life anxiety and treatment-resistant depression.
Some psychedelic advocates also criticize the SAP for requiring physicians to fill out eight pages of questions to apply. Family doctors can complete this in 1 to 2 hours, said Hawkswell, the TheraPsil CEO, but SAP’s response rate is very slow. In some cases, patients have had to wait up to four months before getting a response from Health Canada, he said.
Health Canada said that time to complete the application “will vary depending on the complexity of the patient’s medical history and the status of the drug,” but that it “can usually be done in less than an hour.” Delayed responses, a spokesperson for Health Canada said, are “usually due to missing information from the physician or from the manufacturer.” The agency added that they are aware of instances in which the drug manufacturers may not have been able or willing to supply the drugs.
Psychedelics drug manufacturer Filament Health, which has provided the drugs for the vast majority of SAP-approved applications, has not rejected any applications, according to the company’s CEO Ben Lightburn, who said he cannot speak for other licensed psychedelic manufacturers.
Several health experts who do not have direct ties to Health Canada or to psychedelic advocacy groups reviewed the SAP application form for Undark and said they do see merit in the questions. Among other things, the form asks for patient and drug manufacturer information, the rationale for prescribing the drug, and treatments the patients have tried already.
“None of those things strike me as an outrageous ask,” said Fernandez Lynch, the University of Pennsylvania professor.
Quite the contrary, these questions are a necessary vetting tool to ensure the safe distribution of unapproved drugs, said James Downar, the head of palliative care at the University of Ottawa.
Hawkswell acknowledged that many of the questions posed are legitimate but said that much of the wasted time comes from physicians having to answer “absurd” follow-up questions by Health Canada, like asking doctors why symptoms like suicidal ideation, severe depression, and hopelessness are unacceptable.
In one example, Health Canada asked a medical professional to provide reasons why two of his patients, who were applying to use psilocybin through the SAP, couldn’t seek other legal treatments, including electroconvulsive therapy.
While ECT is approved for treatment of severe depression, mania, and schizophrenia in Canada, the therapy is controversial and, in some cases, can lead to serious adverse effects, including memory loss. Eventually, after some discussions with the health agency and pressure from the media, the SAP approved psilocybin for all four of his patients.
The controversy highlights what critics see as the heart of the issue: Unlike physicians, SAP health officials are trained to “check boxes” that follow internal guidelines and not to carefully evaluate what treatment is best for patients, Masuda said. Requests passing through the U.S. equivalent of the SAP, known as expanded access, are also vetted by health officials within the FDA, but the final say rests squarely with the medical professional, said Diana Zuckerman, president of the National Center for Health Research, who was involved in finding ways to improve the U.S. program. In fact, she said, the FDA approves expanded access requests in virtually all instances and the relevant forms are designed to be easy to complete and take about 20 minutes.
The SAP could follow a similar model. It might also benefit from creating a standardized form with pre-written answers that physicians could check off and determine whether their patients are eligible for psychedelic drugs, said Garcia-Romeu, the Johns Hopkins researcher. That way, the process would be streamlined, there would be fewer ambiguities, and drugs would likely be more fairly distributed.
According to Health Canada, as of February, the SAP had received 81 applications for psilocybin and 16 for the psychedelic MDMA. Yet TheraPsil is restricted in the number of patients it can assist because the group has a limited number of fully trained therapists and the application process is too burdensome for them to assist everyone, said Hawkswell. TheraPsil is currently supporting patients to sue Canada’s Health Minister, Jean-Yves Duclos, arguing that access to psychedelics should be a constitutional right. Hughes is a plaintiff on the case, but doesn’t stand to gain any money from winning, other than compensation for legal fees.
The lack of trained therapists raises another challenge for those pushing for widespread access: At the moment, Canada does not have the resources and expertise to provide optimal care, given that psychedelic training programs are only just launching and demand seems to be booming. Therapsil, for example, has around 1,150 people requesting access for treatment, according to Hawkswell, and the organization can’t keep up.
“If you want psychotherapy — psychedelic-assisted psychotherapy — you need to have the infrastructure in place to do that,” said Downar.
There may be a shortage, but the majority of physicians who submit through the SAP eventually get approval, according to data provided by Health Canada. And most patients have had “overwhelmingly positive” experiences, said Lightburn, Filament Health’s CEO. However, psilocybin doesn’t seem to work for everyone. The exact reason isn’t known, although researchers think that the drugs patients are already taking are blunting the effects of the psychedelics. To cope with their debilitating conditions — and sometimes to stay alive — patients take psychedelics while staying on other medications, like antipsychotics and antidepressants
The SAP has some measures in place to avert these and other potential risks: For instance, the program requires licensed medical professionals to explain how they intend to use the drug, including dosage. Physicians are also required to report any adverse effects to Health Canada.
But the SAP provides no official framework detailing how patients should take the psychedelic drug, meaning that doctors administer it “however they see fit,” said Lightburn. To be sure, there is no universally accepted way of taking psychedelics. But in clinical trials, scientists tend to make sure that participants feel calm and relaxed going into the session by decorating the room with peaceful imagery, dimming the lights, and playing ambient music. Patients normally wear eye covers so they can introspect and are supervised by one or two trained practitioners who prepare the patient before the session and help them process what happened afterwards.
The lack of a framework, experts say, means that patients might not get the most out of their experience, and they run the risk of misusing the drugs. For now, most SAP-approved psychedelic experiences take place in psychedelic clinics that have specific programs, trained psychedelic therapists, and experts they can consult. But some physicians have requested the drug be sent directly to their office in remote areas, Lightburn said, suggesting the patients plan to take it outside of a specialized clinic. And while their physicians might have the best of intentions, most are not trained in psychedelic-assisted therapy.
In an emailed response to these concerns, a spokesperson from Health Canada wrote that “the credentialing of health care professionals, the setting in which a drug is administered, and other aspects of patient care (e.g., preventing drug-drug interactions) are not under federal jurisdiction” and are instead regulated by local government and provincial medical colleges. While Health Canada recently set out a best-practices outline for clinical trial settings, no provincial college or local government has yet established guidelines or standards for using of psychedelics through the SAP.
If countries around the world decide to follow Canada’s footsteps in making psychedelic drugs accessible to patients in life-threatening conditions, they will almost certainly face similar problems. The U.S., for instance, has nowhere near the number of resources, trained mental health practitioners, and services necessary to meet what could be a similarly booming demand for the drugs.
“Even if expanded access programs were to swing the door wide open for all people who wanted to try these therapies,” Garcia-Romeu said, “there would not be enough places to get the treatment.”
In Canada, Hawkswell, Masuda, and others pointed out that those who don’t get access will sometimes find illegal means, like purchasing mushroom-growing kits online or foraging for them in the wild. Occasionally, like Hughes, patients may find underground therapists to guide them through a psychedelic trip. Many of these therapists may be highly experienced, but they are not professionally licensed and there’s no oversight of their practices. That lack of regulation means patients could be at higher risk of having so-called bad trips and of being victims of misconduct. A person is especially vulnerable while taking psychedelics.
“It’s a highly suggestible state,” said Hughes. “And there are people who will take advantage of that.”
Hughes, who is now more than a year past her diagnosis, was guided through her psilocybin experience by an underground therapist, who ultimately helped her face her existential anxiety. She now reads profusely, mostly about politics, philosophy, and science, listens to podcasts, knits, and has dedicated herself to helping others in similar conditions access psychedelics. Her life, she said, has in many ways been restored.
“I am no longer preoccupied by worries about the future or regrets about the past, but pretty much just living in the now,” she said, adding that she feels as though she is merely “enjoying the show.”
UPDATE: Due to an editing error, an earlier version of this piece imprecisely described the role Diana Zuckerman played in the American expanded access program. While she was involved in trying to improve the program, she did not contribute to its development.
Jonathan Moens is a freelance journalist based in Rome. His work has appeared in the New York Times, National Geographic, and The Atlantic, among other publications.