Terminal cancer patient has waited 440 days for federal permission to continue magic mushroom therapy

Thomas Hartle says his first psychedelic trip was life-changing.

In the summer of 2020the Saskatoon man became the first person in Canada to legally trypsilocybin the active ingredient in what are commonly known as "magic mushrooms" after an exemption from then-Minister of HealthPatty Hajdu.

Hartle, 54, was diagnosed with Stage 4 terminal colon cancer in 2016 andsays the drug helped him face his anxieties about dying.

"Before I did my first session, my most painful thought was this idea that I do a lot for my family and at some point I just won't be here when they need me for something," Hartle said in a recent interview with CBC News.

"That sentence by itself is a sentence that I would not have been able to say the night before I did my psychedelic session without breaking down emotionally."

Hartle was able to do three sessions in 2020, but his federal exemption was only good for theyear. He applied to renew it in October 2021 and has been waiting 440 days for an answer from Health Canada.

"I've had a few emails back and forth with Health Canada, but a majority of my emails have been completely ignored," he said.

"It would be, I believe, less frustrating if I was able to get some kind of a response back.I've already answered all of the questions. I've already qualified. I've already jumped through all of the hoops."

In a statement, Health Canada said itis"committed to ensuring that all people who need end-of-life care receive the best-possible, high-quality and compassionate supports available."

The department saidfurther research on psilocybin is still needed.

"Currently, the best way for patients to access psilocybin is through participation in a clinical trial," the statement said.

Psilocybinhas been at the forefront of a renaissance in psychedelic therapy in recent years, due in part to persuasive researchat institutions such as Johns Hopkins University and the University of California. Some peer-reviewed studies have found that psilocybin has antidepressant effects and can allow patients, with the help of trained therapists, to confront fears and feelings that are otherwise too traumatic.

Advocates say Hartle's situation highlights a bigger problem of terminally ill peoplenot having legal or timely access to psychedelic therapies to treat their end-of-life anxiety, and question the government's role in making decisions about patients' treatments.

Issues with 'Special Access Program'

When Hartle's federal exemption ended, he was able to do a few more psilocybin sessions under Health Canada's Special Access Program (SAP), which allows health-care professionals to request access to restricted drugs that have not yet been authorized for sale in the country.

However, Hartle and advocates say the program is flawed. Unlike a federal exemptionthat doesn't havelimits on the number of therapy sessions a patientcould have, doctors have to submit an application for each session under SAP.

And while Hartle was previously able to legally grow psilocybin and do it at home with a therapist, he now has had to spend thousands of dollars flying to British Columbia, where his doctor is, to receive the therapy.

"What on the surface seems like granting access actually puts boundaries and borders in place," Hartle said.

Hartle once travelled to Jamaica where psilocybin treatment is legal for a session when his SAP application was denied.

Hartle's doctor says an SAP representative recently told her she was submitting too many applications and must run a clinical trial.

"We're struggling with this," said Dr. Valorie Masuda, a palliative care physician on Vancouver Island, who is part ofa health-care practice that offerspsilocybin-assisted group therapy.

"Until I get this clinical trial up and running, we can't actually treat patients and any patients that require treatment will have to go through the underground."

Masudasays there are many barriers to running a clinical trial, including having to find private donors.

A clinical trial might also meanthat some people won'tgetpsilocybin and instead will receive a placebo,Masudasaid.

WATCH | Dr. Masuda explains what happens to your brain on psilocybin

What happens to your brain on psilocybin

3 years ago

Duration 1:43

Palliative care physician Dr. Valorie Masuda explains what happens inside the brain after consuming the psychedelic drug.

Doctors not bureaucrats

Masuda and Spencer Hawkswell, the CEO of TheraPsil, a B.C. non-profit working to legalize therapeutic psilocybin, saydoctors and patients should be the ones making choices about using the substance.

"These are decisions about people's health care that are being made by government bureaucrats who are unknown and they're not medical doctors. That's wrong," Hawkswell said in an interview.

The organization drafted proposed regulations for magic mushrooms based on the same ones the federal government first created about 20 years ago for medicinal cannabis.

TheraPsil also launched a legal challenge arguing that the denial of access to psilocybin is a violation of Canadian's Section 7 charter rights.

"The effect has been in essence a real extortion of the patients and a lack of ease of access. They've made it incredibly difficult for people to access this life-affirming medicine," he said.

Hawkswell says some patients who are forced to wait months to access psilocybin, or get their applications denied, resort to getting the drug illegally, which has the potential to be unsafe.

Rally in Ottawa

TheraPsil recently led a rally in Ottawa with patients who have terminal illnesses or treatment-resistant depression calling on Health Minister Jean-Yves Duclos to grant more exemptions.

Hawkswell says patients met with MPsfrom all political stripes and received "a compassionate and human response," though they disagree on how widely accessible psilocybin should be.

He says the group couldn't get a meeting with the health minister as requested, but will be back in Ottawa in February.

Health Canada said that due to the ongoing litigation,"it would be inappropriate" for Duclosto engage with exemption requests.

Thomas HartlehopesTheraPsil's legal challenge will be successful, even if he's not there to see it.

"It is my personal belief that access to this therapy really is a right of Canadians," he said.