Therapeutic Psilocybin for Canadians in End-of-Life Distress

We are a group of seven health professionals who seek to make the psychedelic medicine psilocybin legally available to Canadians in need of compassionate treatment for severe psychological distress.

Following an interruption of 40 years, psychedelic medicine is now back in research labs and in the news.  Recent studies point to promising treatments for some of the most pressing mental health challenges of our age: anxiety, depression, addiction, post-traumatic stress disorder (PTSD). Protocols are now being developed using psychedelic medicines in conjunction with ongoing psychotherapy by a specially trained clinician.

It is heartening to see some of this research taking place in Canada.  In Vancouver B.C., a federally approved clinical trial funded by the Multidisciplinary Association for Psychedelic Studies (MAPS) has completed a Phase 2 clinical trial exploring the value of methylenedioxymethamphetamine (MDMA) in the treatment of PTSD, and is now beginning their part in a much larger Phase 3 trial that will involve hundreds of subjects.

Psychedelics are not yet ready for “prime time”.  But we are now to the point where a clinician’s belief in the value of psychedelic medicine and a desire to support its accessibility to certain Canadians can be solidly defended. Indeed, it seems increasingly clear that ongoing research is more likely to further confirm the promise of psychedelic medicine than diminish it.

Psychedelic research appears to be most robust and mature in the treatment of end-of-life distress: the psycho-spiritual depression and “existential anxiety” that often accompany the diagnosis of a life-threatening illness such as cancer. Recent research at Johns Hopkins Medical Centre and New York University indicates that treatment of end-of-life distress with psilocybin-assisted psychotherapy is safe and effective.  It led to immediate, substantial, and sustained decreases in depression, death anxiety, cancer-related demoralization and hopelessness. It resulted in increases in quality of life, life meaning, and optimism.  These changes were sustained at 6-month follow-up: most participants continued to show clinically significant decreases in depressed mood and anxiety.  Participants attributed improvements in attitudes about life/self, mood, relationships, and spirituality to the psilocybin experience, with most endorsing moderately or greatly increased well-being/life satisfaction, and improved attitudes toward death.

But a clear-eyed look at the foreseeable future for Canadians who could benefit from this ground-breaking therapy is not especially rosy; at our current rate of progress, it may well be ten years before psilocybin successfully completes Phase 3 trials and becomes available as an orthodox prescription medicine.

In the meantime, several thousand Canadians are suffering severely from end-of-life distress, and are in dire need of relief NOW.

  1. They face a serious and life-threatening illness: cancer. Their condition is terminal, so concerns about long-term effects of psilocybin are not relevant;

  2. They suffer from serious end-of-life psychological distress (anxiety/depression) as a result of their disease and diagnosis;

  3. They suffer end-of-life-distress to the point that it interferes with their other medical treatments;

  4. Their emotional distress has not successfully responded to other treatments.

Our intent is to provide compassionate treatment for these Canadians. We fully agree with the Canadian medical establishment that, in ordinary circumstances, new medicines should be made available to Canadians only when they have successfully completed Phase 3 clinical trials. But the Canadian government itself acknowledges, through Health Canada’s Special Access Programme (SAP), that certain patients who are suffering and have unsuccessfully exhausted all other treatments should rightfully have access to still-experimental medicines on compassionate and humanitarian grounds.  SAP, however, does not permit patient access to psilocybin.  We contend that the exclusion of psilocybin from SAP is out of step with current scientific understanding of psilocybin, and that the end-of-life patients we describe above should be eligible for compassionate access to psilocybin. Because of their extraordinary medical straits, psilocybin, even at its current stage of development, represents a reasonable medical choice for them; it is necessary to them for a medical purpose, and it is in the public interest that they receive permission to receive treatment with psilocybin.

We began our advocacy for end-of-life patients by filing an application on March 4, 2019 with Health Canada, seeking an exemption pursuant to the Controlled Drugs and Substances Act section 56 that will permit our clinicians to provide psilocybin-assisted psychotherapy with certain patients suffering from end-of-life distress, and to legally import psilocybin for that purpose.

In the event that our application is denied, we intend to file a lawsuit in Federal Court challenging that denial, and seeking a declaration that prohibition of access to psilocybin for medical purposes violates a citizen’s Canadian Charter of Rights and Freedoms Section 7 right to “life, liberty, and security of person”. This clause has already been interpreted by the Supreme Court to imply that a citizen has the right to autonomy in making “reasonable” health care decisions.  Our initiative will advance the successful Charter-based arguments that have led to access to cannabis for medical purposes in the landmark Parker, Smith and Allard cases. We argue that what applies to cannabis also applies to psilocybin:

The prohibition of … cannabis “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”.

Supreme Court of Canada, R. v. Smith, 2015

We are pleased and honored to have the support and encouragement of three eminent American scientists who have contributed significantly to the research literature on which we base our application.  Dr. William Richards, of the Johns Hopkins Medical Center’s Psilocybin Research Project team, Dr. Anthony Bossis, of the New York University research team, and Dr. Charles Grob, of the Harbor-UCLA team, have agreed to serve as expert witnesses for us in the event of litigation.

Click on the Research button at the top to review scientific evidence supporting our application to Health Canada.  Our scientific argument is supplemented with carefully developed legal and ethical arguments to create a compelling case for compassionate treatment NOW.

We hope you will join with us in this venture.  Let’s move forward together with psilocybin-assisted psychotherapy for the Canadians who most need it – beginning with those suffering from end-of-life distress.

Could you – or a loved one – benefit from psilocybin-assisted psychotherapy for end-of-life distress?  We would like to hear from you.