Edmonton company to produce psychedelic drugs for clinical use
'It’s not just a bag of mushrooms,' founder says
A new Edmonton-based company is planning to grow magic mushrooms for potential use in medical clinics.
Dr. Peter Silverstone, a long-time faculty member with the department of psychiatry at the University of Alberta, is hoping to facilitate access to the psychedelic drug through his new company, PsiloTec Health Solutions.
In a release, the company bills itself as the first fully integrated psychedelic drug development company in North America.
The company is currently in the process of securing a 23,000 square-foot facility to produce psilocybin in the Edmonton area.
Silverstone says psychedelic drugs could be a new option for people who are struggling with severe mental health issues who have been unable to find relief through currently available therapies.
"It's a combination of talk therapy and psychedelics," Silverstone said. "It's not just a bag of mushrooms. With those combinations there have been some striking results."
Psilocybin, the active drug in magic mushrooms, has shown promise in relieving end-of-life distress for palliative cancer patients, though it is still undergoing clinical trials.
Silverstone said psilocybin is a low-risk drug but it is important to ensure those undergoing treatments are safe and supported.
"Certainly I am not advocating that people get high doses of anything and then go home and take them. I think we need to figure out for individuals what is the risk-benefit."
Since August 2020, Health Canada has granted exemptions under subsection 56(1) of the CDSA to a number of patients to possess and consume mushrooms containing psilocybin, while undergoing psilocybin-assisted psychotherapy, for the treatment of end-of-life anxiety and psychological distress associated with a cancer diagnosis.
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One Calgary company has already been approved by Health Canada to conduct legal psychedelic-assisted therapy for patients in palliative care.
On Sunday doctors with the ATMA Journey Centers guided their second patient through a treatment session according to its co-CEO, David Harder.
"Most people don't fit the criteria right now that Health Canada has set up," Harder said.
"Once [approved] we have a psychiatrist, doctors, nurses, psychologists. Depending on the situation, if it's palliative care then obviously we work more with the palliative care doctor. If it's more mental health we would work more with the psychologists and psychiatrists."
Health Canada's Special Access Program (SAP) enables drugs that have not yet been approved as marketed drugs to be requested by practitioners for the treatment, diagnosis, or prevention of serious or life-threatening conditions in instances where conventional therapies have failed, are unsuitable, or unavailable.
Recently, Health Canada consulted on a proposal to reverse the regulatory amendments made in 2013 and restore potential access to restricted drugs through the SAP.
Currently Health Canada is considering feedback on the consultation, though in the interim, access to restricted drugs through the SAP remains prohibited.
The proposed amendments are not intended to bypass the well-established clinical trial and drug review process, nor to promote or encourage the early use of unapproved drugs.
Harder hopes to one day be allowed to use psychedelic treatments to treat depression, anxiety and possibly even post-traumatic stress disorder.
Harder said he's also noticed a major shift in attitudes toward psychedelics as a treatment option.
"I couldn't get doctors, nurses, psychiatrists, psychologists to talk to me a year ago and now it is overwhelming."
Founder of Multidisciplinary Associations for Psychedelic Studies (MAPS) Canada, Mark Haden, said he's also noticed a change in attitudes.
"I started MAPS Canada in 2011," Haden said. "I had a couple of doctors who whispered in the corridor that they were interested … and ten years later I have about 60 on my list who are eagerly enthusiastic to get involved. Both from a research perspective and also providing the treatment."
Haden also credits the legalization of cannabis with helping move the process along.
"Politicians who just talk about the evidence seem to be supported. So, the politics and the taboo and the stigma around drug policy generally, but certainly around psychedelics is being reduced as well."