A Cancer Patient Just Received Legal Psilocybin Therapy At A Toronto Clinic—Accessing It Wasn’t Easy
A woman in her mid-40s with life-threatening cancer has become the first patient to be treated with psilocybin-assisted therapy at Field Trip Health (Toronto). While psilocybin is still an illegal substance in Canada, the Special Access Program allowed medical director Dr. Michael Verbora to apply for the drug on the patient’s behalf. The result was the woman receiving her first session in August.
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What Is The Special Access Program?
In Canada, healthcare professionals can submit requests on behalf of their patients to access non-marketed drugs to treat, diagnose or prevent serious or life-threatening conditions through the Special Access Program (SAP). The program is intended to streamline access to restricted drugs for patients, in cases where conventional treatments have failed, are unsuitable, or are unavailable.
The SAP was amended in January 2022 to allow physicians to request access to restricted drugs, including drugs that have shown promise in clinical trials (like psilocybin or MDMA), or are approved in other countries but not available in Canada.
Verbora’s patient, Mio, suffers from stage four pancreatic cancer and sought the help of Field Trip to obtain access to psilocybin to come to terms with her diagnosis. Psilocybin has been shown to decrease symptoms of depression and anxiety in patients suffering from life-threatening cancer, improving their attitudes about life, mood, relationships, and spirituality.
“She’s surprisingly very optimistic compared to how I think most people would handle the news,” Verbora told Healing Maps about his patient, who underwent a ketamine-assisted therapy session at Field Trip a few weeks prior to her treatment with psilocybin. These were Mio’s first-ever psychedelic experiences.
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Special Access Program Proves Onerous
It’s certainly progressive on Canada’s part to provide a route of access to restricted drugs for patients with severe and life-threatening conditions, but make no mistake: seeking approval to use psilocybin is a massive undertaking, and can be a “treacherous process,” according to Verbora, even when the patient is an ideal candidate for psilocybin treatment.
Requests to the SAP are considered on a case-by-case basis, and while the federal health agency “[tries] to process requests within one working day of receipt,” Dr. Verbora, who was initially optimistic about the program, says it took two weeks before his patient was granted access.
Other patients with similar cases required more back-and-forth with Health Canada, but were ultimately denied.
“I said, ‘this is great, it’s a step in the right direction,’ but now that I’m actually going through the process, my perspective is different,” he said about the Special Access Program.
Verbora noted that there aren’t many physicians in Canada who are both willing to spend the extra time completing applications and knowledgeable about psychedelic therapy. A patient without a supportive physician may seek out a clinic like Field Trip: “Very few doctors are going to do these applications, so they’re going to come to a doctor like myself, who is familiar with the process and indications.”
Even when a physician has the knowledge, getting to know a new patient, collecting and reviewing their past records, and completing the necessary paperwork to apply takes several hours, additional work that physicians cannot bill for — another thing Verbora says excludes physicians from even considering use of the program.
“It’s a little bit too onerous on physicians to do the work,” he said.
Physicians applying to the Special Access Program are also required by Health Canada to find a partner to produce the medicine they are applying for. Verbora can leverage the relationships Field Trip has with other companies in the psychedelic sector to source psilocybin safely and legally, he said, “but the average doctor isn’t going to have a clue.”
Health Canada Cautious With Approvals
Based on her life-threatening diagnosis, short timeline, and several previous failed therapies, Verbora assessed Mio to be a great candidate for psilocybin treatment and assumed she would be granted access quickly. He was frustrated when Health Canada came back with some unexpected questions.
“It was invasive and almost condescending. I have a stage-four pancreatic cancer patient, and they wanted to know if she could tie her shoes,” he said. “It seemed like they weren’t going to approve her unless she had bad functioning day-to-day, even though her timeline is short.”
Verbora said that now that close to 30 Canadians in total have been approved for psilocybin access through the Special Access Program, it would be helpful for patients and physicians if Health Canada published criteria for applicants seeking psilocybin access.
“They’ve worked with me, but it’s been really, really frustrating,” he said, noting that he’s had to adjust his own criteria for patients because of limited bandwidth. “We dose our patients for free, and I’m volunteering my time. It’s great learning for me, and it’s an important thing that I want to do for others, but we need to figure out a process to streamline this.”
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Treatment at Field Trip
Mio was eventually approved for 25 grams of psilocybin and will undergo her second treatment at the Toronto clinic in a few short weeks. Verbora and team follow the psilocybin treatment program created at Field Trip’s Amsterdam clinic, where truffles are legal.
While Field Trip will continue to offer to help Special Access Program applicants, Verbora said that effectively scaling psilocybin treatment through the program might require creative solutions, such as offering treatment in group settings, or charging a fee and working with insurance companies to subsidize the cost of treatment.
In the meantime, the medical director said treatment with another drug could be an option for patients who may not have the time to wait for an approval from Health Canada.
“Ketamine already works for treatment-resistant depression, it’s got great evidence in a whole host of mental health conditions, and it’s extremely safe to use — we have tens of thousands of data points, and zero adverse outcomes,” he said. “At this point, rather than jump through all these hurdles, we think that it’s much easier to offer ketamine up front.”
Stay tuned next week for an interview with Mio.
