Could you give our readers an overview of TheraPsil? 

Absolutely.  

TheraPsil Today 

TheraPsil is a non-profit advocacy group of healthcare professionals, patients and advocates that was officially formed in 2019. We are focused on facilitating legal access to psilocybin-therapy for patients with a terminal diagnosis, who are experiencing end of life distress. We support patients who wish to apply directly to the Minister of Health, Patty Hajdu, for an exemption to section 56(1) of the drugs and substances act​.

In addition to access to treatment, TheraPsil is also working on increasing Public  Education and professional Training. We have seen first hand how the public’s perception of psilocybin containing mushrooms AKA “Magic Mushrooms”  changes when you share research and stories of those mushrooms have helped.  We hope to educate the public on the merits and limitations of psilocybin through articles, webinars, video and social media. 

As for Training, we realize that there is a huge demand for professional training as  Doctors and Therapists are both showing interest in the research and getting questions from their patients. The key to access is to have healthcare professionals qualified to deliver the treatment once legalized for medical use.  

History of TheraPsil 

The initial idea for the work TheraPsil is doing today dates back to 2016. Torn between the illegality of supervising a psychedelic therapy session, the knowledge of the potential benefits of psychedelic therapy in reducing existential distress, and a sense of duty to his patients, TheraPsil’s founder, Dr. Bruce Tobin decided to challenge the law to provide legal access to a  compassionate therapy option. 

So, In 2017, he applied for a status exemption for psilocybin under section 56(1) of  the Controlled Drugs and Substances Act in Canada, on account of it being a  useful approach to palliative care. Communication between Health Canada and  Dr. Tobin has occurred over the past three years; however, Dr. Tobin finally received a rejection notice from Health Canada stating there was “insufficient evidence for the medical need for psilocybin”. 

It seemed like Bruce’s original application was not properly heard or understood by Health Canada, because the class of ‘dying Canadians’ he was asking to treat with psilocybin were theoretical. So, in 2019, TheraPsil was born with a new strategy and optimism. We now help individual patients who are terminally-ill apply directly to the Minister of Health, Patty Hajdu, for an exemption to section  56(1) of the Canadian Drugs & Substances Act, so if approved, they may legally be allowed to undergo medically-supervised psilocybin-assisted therapy. To date we have helped 4 individuals with their applications for exemptions, and we continue to invite patients who meet our patient inclusion criteria to reach out to us.  

How did you identify the individuals who are now petitioning the Minister of  Health for access to psilocybin-assisted therapy? 

These individuals found us! Either through word of mouth or by reading articles about TheraPsil’s work, all the Canadians we have supported so far have found  TheraPsil and contacted us directly for assistance. 2 of these 4 individuals (​Laurie  Brooks of Abbotsford​, BC and ​Thomas Harle of Saskatoon​, Saskatchewan) have been very brave and at their own will have gone public with their stories and applications. They hope that by sharing their stories, more Canadians who are also facing a terminal illness may consider psilocybin psychotherapy. 

Why did you choose to begin your campaigning with a focus on those in palliative care? 

Great question. Palliative care patients are our focus for 3 main reasons: 1) The evidence is strongest, and 2) the legal precedent and moral reasoning is strongest 3) these patients need our help the most urgently. 

1. Evidence

In addition to ​stories of patients who have benefitted from this treatment​,  high-quality research supporting the efficacy of psilocybin in treating end-of-life anxiety continues to emerge. A ​2018 systematic review by Reiche and colleagues looked at three studies exploring psilocybin and end-of-life distress and concluded that evidence supports that patients with life-threatening diseases associated with symptoms of depression and anxiety benefit from the anti-anxiety and antidepressant properties of serotonergic hallucinogens, such as psilocybin. In a rigorous ​2016 study Ross and colleagues​ demonstrated that a  single moderate dose of psilocybin, in conjunction with therapy, can promote a  rapid and sustained reduction in anxiety and depression in participants struggling with end-of-life distress.  

2. Legal & Moral Reasoning

TheraPsil’s Legal Argument:

• The Canadian ​Charter of Rights and Freedoms ​ (section 7) states that everyone has the right to “life, liberty, and security of person”. 
• Canadian courts have ruled in three landmark cannabis cases [​R v. Parker  (Ontario Court of Appeal 2000), ​R v. Smith ​ (Supreme Court Canada 2015)  and ​Allard v. Canada ​ (Canada Federal Court ​2016 ​ )] that the absolute prohibition of cannabis by the ​Controlled Drugs and Substances Act (CDSA)  contravenes section 7 because it “limits the liberty of medical users by foreclosing ​reasonable medical choices​ through the threat of criminal prosecution. Similarly, by forcing a person to choose between a legal but inadequate treatment and an illegal but ​more effective​ one, the law also infringes on security of person”. (SCC: ​v. Smith, ​ 2015) These rulings have led to amendment of the ​CDSA ​ to allow for the medical use of cannabis. 
• Psilocybin, like cannabis, represents a “reasonable medical choice”, and a  “more effective” treatment for some cancer patients suffering from end-of-life distress, and for whom other treatments have failed. (See  scientific argument above) 
• Therefore, the absolute prohibition of psilocybin limits the liberty of medical users by foreclosing a reasonable medical choice through the threat of criminal prosecution. Similarly, by forcing a person to choose between a legal but inadequate treatment and an illegal but more effective one, the law also infringes on security of person for the medical psilocybin user. 
• Therefore, an exemption should be issued to allow for medical use of psilocybin for patients as described above. 

TheraPsil’s Argument For The “Right To Try”

• Canadian society now acknowledges that citizens have the “right to die”.  This right was confirmed by Bill C14, the Medical Assistance in Dying Act,  passed in June 2016. This right is subject, of course, to some important conditions: it is limited to mentally competent adults who are seriously suffering in an advanced and irreversible decline and whose natural deaths are reasonably foreseeable. 
• But, if we are prepared to acknowledge that Canadians have the right to die, surely we must also recognize their right to try: to try to achieve a  better quality of life by trying psilocybin, an experimental medicine that,  though not fully through clinical trials, can be regarded as a reasonable medical choice in certain cases. Just like the right to die, the right to try is most clearly evident within the context of certain conditions: patients’  end-of-life psychological distress is severe; other treatment options have been unsuccessful; they are facing an irreversible decline and their deaths are reasonably foreseeable. 
• Conversely, for those uncomfortable for moral/religious/practical reasons, with acknowledging Canadians’ right to die, confirmation of the right to try opens up a humanitarian alternative that could potentially decrease the number of patients choosing physician-assisted death. 

3. Urgent Need

The patients we are laser-focused on helping right now have been diagnosed with a terminal illness. They are quite literally dying, and need help immediately.  They do not have time to wait for clinical trials of psilocybin or other psychedelic drugs. Our advocacy is currently focused on helping those in most immediate need. In the future, we look forward to broadening our patient inclusion criteria to help even more Canadians who are suffering.   

How do you plan to get the attention of the Minister of Health?

It’s not us that needs the Minister’s attention. It is the ​patients who have submitted applications, and who are being ignored.   

TheraPsil is doing all we can to help these patients and has launched a  multi-pronged strategy for getting the Minister of Health’s attention and advocating for patients who need immediate access. This includes a robust communications and social media strategy. We also know that the patients have contacted their MP’s and asked them to bring their applications to the attention of the minister.

What’s the precedent (if any) for individuals obtaining a section 56  exemption of the Controlled Drugs and Substances Act, as would be needed in this case? 

Section 56(1) is a piece of legislation in the Canadian Drug & Substances act  (CDSA). It states that the Minister of Health can allow the use of prohibited therapies (such as psilocybin) if, in his or her opinion, such an exemption is necessary for a medical or scientific purpose or is otherwise in the public interest. 

Section 56 exemptions have an established history in Canada. Most notably, in  1999, Section 56 exemptions allowed ​Canadians compassionate access to medical cannabis​. Furthermore, in September 2003, Health Canada granted the  Vancouver Coastal Health Authority an exemption to open North America’s first safe injection facility, InSite.​ In addition, the ​Santo Daime Church​ was granted an exemption to import into Canada and use an Ayahuasca brew, which contains the illegal drug DMT, for religious purposes. ⠀

As such, TheraPsil is assisting patients with a terminal diagnosis to apply directly to the Minister of Health, for an exemption to section 56(1) of the CDSA on compassionate, medical grounds. If approved, this exemption would allow the applicant (patient) to use psilocybin mushrooms for medical purposes – to treat their end of life distress. ⠀ 

Where do you think public opinion is on this matter?

We recently commissioned ​a poll from Pollara Strategic Insights​ aimed at understanding the public’s opinion of psilocybin for terminally-ill Canadians. To our pleasant surprise, the survey showed that 59% of respondents agreed that psilocybin should be legal for use in end-of-life care. Knowing that the majority of Canadian’s approve of this treatment option, we urge the Hon. Patty Hajdu to respond to patients who have applied for a section 56 exemption and align with public opinion.

Furthermore, we are asking for the public’s help to spread the word about our mission and the patients who are waiting 8+ weeks for a reply from the Minister of  Health: Sign up for our newsletter on our website. Retweet our tweets and get the message out to The Hon. Patty Hajdu – ​Patty We Need Your Help.