Response to the Delegate of the Secretary’s Decision Not to Amend the current Poisons Standard in Relation to Psilocybin

Introduction

The purpose of our response to the Delegate of the Secretary’s decision not to reschedule psilocybin under the Current Poisons Standard is to request further examination of regulatory models that currently exist in comparable countries.

Our response, researched by top Canadian academics and experts in the Canadian psychedelics space, addresses some of the misconceptions and inconsistencies outlined in the Delegate’s interim decision. As Canada moves towards a fully regulated psychedelics framework, we hope our submission gives the Therapeutic Goods Administration (TGA) an opportunity to understand the compassionate measures being undertaken to provide breakthrough therapy for Canadians, and more importantly, how similar policy decisions may benefit Australians.

Thank you for your consideration.

Ronan Levy, Founder & Executive Chairman, Field Trip Health Inc.

Michael Kydder, Founder, Kydder Management Group Inc.

About Field Trip Health Inc. & Kydder Group Inc.

Field Trip is leading the medical and scientific re-emergence of psychedelics and psychedelic-enhanced therapies. Through Field Trip Health’s intentionally-designed, technology-empowered clinics providing psychedelic therapies, Field Trip Digital’s apps and resources scaling our protocols globally, and Field Trip Discovery, our drug development division developing the next generation of psychedelic molecules, we help people through an integrated, evidence-based approach to healing and thriving.

Kydder Group is a multi-service public affairs and relations firm based in Canada specializing in legislative and regulatory affairs, government relations, and public opinion polling. We work with established tech entrepreneurs, mental health organizations and advocates, and social entrepreneurs focused on changing the world through their own inspiring stories.

1. TGA — Delegate of the Secretary Statement (Pg. 16):

“Currently, no comparable country has down-scheduled psilocybin to a category equivalent to

Schedule 8, and at present, there is no international framework for how to handle psychedelic-assisted therapies.”

Incorrect. Under Canada’s Controlled Drugs and Substances Act (CDSA), a phased approach to the regulation of psilocybin for pure therapeutic purposes is currently in place (Section 56 of the CDSA) and in review for re-classification via the Special Access program (SAP).

Canadian Regulatory Status

Psilocybin is a pro-drug to psilocyn, the psychoactive compound found in psycho-active mushrooms. Under Schedule 3 of the Controlled Drugs and Substances Act (CDSA), both are illegal to possess, obtain or produce unless authorized for clinical trial or research purposes.

Authorization for manufacturing or other private work can be requested under the Food and Drug Regulations through a Dealer’s License from Health Canada. Numinus, a private firm in British Columbia, has obtained a Dealer’s License from Health Canada and is authorized to cultivate magic mushrooms and extract its psychoactive alkaloids; Numinus has recently completed the first flush of legal magic mushrooms production in Canada[1]; Calgary-based PsyGen Labs Inc. is similarly in application for a Dealer’s License and is scheduled to supply domestic researchers with synthetic psychedelics, including psilocybin[2].

Exemptions to the prohibition of controlled substances may be requested under subsection 56(1) of the CDSA, if the Minister of Health believes the exemption is “necessary for a medical or scientific purpose or is otherwise in the public interest.”[3] To date, 30 Canadians with terminal illness have been approved for Schedule 56(1) access (exemption from narcotics legislation for compassionate reasons) in partnership with TheraPsil, the Canadian non-profit initiative that originally filed an application with Health Canada seeking a section 56(1) exemption to allow therapists to legally practice psilocybin-assisted psychotherapy in the compassionate treatment of certain cancer patients suffering from end-of-life distress (EOLD)[4].

Multiple jurisdictions in the United States have decriminalized magic mushroom use, including Denver, Oakland and Santa Cruz[5]. In November, a state-wide vote in Oregon — Measure 109 — was successful and will soon allow for the therapeutic use of psilocybin[6]. The states of Florida and California have also recently submitted legislation for the approval of psilocybin-assisted therapy for those suffering with treatment-resistant mental health illnesses.

Precedents for Reclassification

In Canada, the previous medical cannabis regulatory framework may prove a good fit for therapeutic access to psilocybin as decided between a medical practitioner and patient.[7]

Legal access to cannabis began with section 56(1) exemptions in 1999, followed later by appellate courts ruling affirming the right to possess marijuana for medical purposes[8] and the subsequent creation of Marihuana for Medical Purposes Regulations.[9] Charter challenges argued the limits on those regulations contravened constitutionally-protected rights, and the Government of Canada legalized cannabis before those challenges were escalated to the Supreme Court.

Special Access Program (SAP)

Health Canada, through the SAP can reclassify drugs from prohibition to regulatory approval, and as of February 10, 2021, they are now reviewing public submissions in response to a call to amend regulations under the Controlled Drugs and Substances Act (CDSA), which would allow certified medical practitioners (only) to prescribe psilocybin and MDMA-assisted therapy for patients with “serious or life-threatening conditions.”

Health Canada acknowledged the following in its decision to amend regulations:

“While restricted drugs do not have approved medical uses, regulations under the CDSA allow for their use for scientific or research purposes, including their use in clinical trials. Since these regulatory changes were made in 2013, the science pertaining to the efficacy and safety of certain restricted drugs has continued to advance. Certain restricted drugs are now demonstrating potential therapeutic uses, including in Phase II and Phase III clinical trials.”

Their objectives for introducing the amendments clearly show that a “comparable framework” exists:

“As noted in the Regulatory Impact Analysis Statement for the 2013 regulatory amendments, the objective of those amendments was to prevent access to restricted drugs, heroin, and unauthorized products containing cocaine through Health Canada’s SAP. In 2016, these regulatory amendments were partially reversed, allowing for the consideration of applications made to the SAP for diacetylmorphine (i.e. heroin).

Based on recent scientific advancements and the potential for some restricted drugs to have therapeutic benefit, the objective of the current proposal is to restore the possibility of access to restricted drugs through Health Canada’s SAP, by reversing the remaining 2013 regulatory amendments. In practice, this would mean that practitioners could, on behalf of patients with serious or life-threatening conditions, request access to restricted drugs through the SAP in instances where other therapies have failed, are unsuitable, or are not available in Canada.”

Between the Section 56 (1) ministerial exemptions, amendments to the SAP which would allow drugs like psilocybin and MDMA to be re-classified, and Health Canada’s acknowledgement of scientific and therapeutic advancements, we encourage the TGA to consult with Health Canada officials before making a final decision. A roadmap exists, patients are reporting incredible results, and policy is being slowly integrated through step-by-step measures that puts compassion before stigma.

2. TGA — Delegate of the Secretary Statement (Pg. 16):

“I note that psilocybin is an illicit drug with a high potential for misuse and an unknown safety profile. The medium and long-term effects of psilocybin-assisted psychotherapy are unknown,

particularly in vulnerable populations, and the risk of developing psychosis may be high.”

The Delegate’s suggestion that psilocybin has a high potential for misuse with an unknown safety profile and risk of developing psychosis conflates the number of well-supported and documented evidence suggesting the opposite. Supporting documentation is listed below:

Safety Considerations

Serotonergic psychedelics possess relatively low physiological toxicity and have not been shown to lead to neurological deficits, organ damage or to cause genetic damage or birth defects (Gable, 2004; M. W. Johnson et al., 2008a; Strassman, 1984). Psychedelics have a low potential for abuse or dependence and have not been found to lead to compulsive drug seeking (Carbonaro et al., 2016; Johansen & Krebs, 2015; Krebs & Johansen, 2013a; Rucker et al., 2018)

Non-toxicity and safety of serotonergic psychedelics have been well established, though there are documented adverse experiences to mitigate, including increased blood pressure and heart rate, transient anxiety and post-session headaches (Shore, 2020).

The safety profile for psilocybin mushrooms — including established safety levels, that it is well tolerated, and that it has a low risk profile — has been well documented in the clinical trial literature over several decades (Shore, 2020, Aday et al, 2020, Ross, 2016, Barceloux, 2012). Various reviews have found no serious lasting negative side effects among participants in clinical trials (Aday, 2020, Shore, 2020), covering over n=2,000 participants who participated in trials since 2016 (Ross, 2016). Reports of long-term reactions, such as Hallucinogen Persisting Perception Disorder are negligible (Barceloux, 2012) and empirical evidence to support the existence of such a disorder is scant (Krebs & Johnson, 2015). Generally, these risks can be managed through appropriate management of set, setting, support, and participant selection, and no psilocybin clinical trial documented medically serious adverse effects (Shore, 2020).

Psilocybin-assisted Therapy for End-of-Life Distress:

Of the nine completed clinical trials investigating psilocybin for clinical application, three are specific to cancer-related anxiety and distress and total 97 participants, representing 57% of the total (n=169) of all psilocybin clinical trial participants. Of all completed psilocybin clinical trials, the EOLD trials are characterized by the most robust methodology and demonstrated the clearest, measured positive treatment outcomes, most specifically reductions in depression and anxiety, and positive attitudes and beliefs towards mortality and life purpose (Shore, 2019, Rucker 2018, Grob et al, 2011, Griffiths et al., 2016, Ross et al., 2016.). A multi-site psilocybin clinical trial proposal co-sponsored by the University of Ottawa, McGill University, University of Toronto, McMaster University and Queen’s University has been developed and awaiting funding (Psilocybin for Psychological and Existential Distress in Palliative Care (PI.: Dr. James Downer, University of Ottawa)[10].

End-of-Life Distress

EOLD is identified as a primary reason why individuals pursue medical assistance in dying (Watt et al., 2017, Salt et al, 2017, Hendry et al., 2018) Psychological suffering and existential distress are common among cancer patients approaching end of life as well as others experiencing terminal illness. Patients report feelings hopelessness, loss of autonomy, poor relationships, and general lack of purpose. (Kissane, 2000, Bauereiss et al., 2018). End-of-life distress is associated with poor treatment and psychological outcomes, including decreased medication adherence (Colleoni et al, 2000, Skarstein et al., 2000), diminished quality of life (Colleoni et al, 2000, Oregon Health Authority, 2016), an increased desire for hastened death and higher rates of suicide. identified as a primary reason why individuals pursue medical assistance in dying (Watt et al., 2017, Salt et al., 2017).

Public Health Gap in Palliative Care

Up to 80% of patients with advanced cancer are likely to suffer distressing thoughts around death (Grossman et al, 2017) and up to 50% of patients with generally incurable conditions are likely to have psychiatric diagnoses (Asghar-Ali et al, 2013). Symptoms include depression, anger, hopelessness, fear of suffering and loneliness (Swift et al, 2017, Grossman et al, 2017). Death anxiety may be a normal part of the human life cycle, but the current medicalized model (Dyck, 2019) can make it difficult for palliative patients to focus on their holistic and spiritual well-being, which palliative nurses consider to be of top concern (Rosa, 2019). The literature suggests a gap between current palliative care offerings and the current and expected future demand; the literature suggests this gap is driven by a lack of reliable pharmacological interventions for palliative dread (Bernstein, 2020, Rosenbaum et al, 2019) and an ageing population (Dyck, 2019). If left unaddressed, death anxiety may lead to more palliative patients seeking medical assistance in dying (MAID) (Grossman, 2017).

Psychedelics may be effective supportive agents for patients experiencing end of life distress and considering medical assistance in dying. While medical assistance in dying is a protected right in Canada, patients approaching death may be underserved if promising therapies are withheld. Psychedelic-assisted therapy can promote patients to safely surface concerns about mortality and face death, our “primordial fear” (Dutta, 2012) while simultaneously enabling resolution of those these concerns (Moreton et al, 2019). They can also help patients find meaning in death, embrace mortality, and appreciate their lives (James, 2020, Swift, 2017, Ross, 2016, Grob, 2013).

Modelling the Need

Combining prevalence data, Canadian demographics, selection criteria for psilocybin for EOLD and estimation methodology, TheraPsil forecasts 2800 new Canadians each year may benefit from access to psilocybin-assisted therapy (TheraPsil, 2020). The estimate range is 1200–5900, with a projection that ~80% of this population experiencing clinically meaningful improvements in EOLD, with ~60% in full remission even 6 months after treatment. Inclusion criteria establish medical necessity and include: a) patients facing serious and life-threatening illness, cancer; b) patients suffering from serious end-of-life psychological distress, and c) other treatment options have proven unsuccessful. (TheraPsil, 2020). TheraPsil further estimates that 25 hours of therapist time accompany each psilocybin dosing session, in preparation, support and integration[11].

Conclusion

Clinical research has established the safety, tolerability and efficacy of psilocybin in the treatment of End-of-Life Distress and mental health anguish. Regulatory channels are currently providing legal access on compassionate, humanitarian grounds while jurisdictions consider broader regulatory changes. Precedents exist for reclassification of Schedule 3 drugs in Canada. Previous regulations allowing medical access to cannabis offer a regulatory model to expand access.

Twenty-eight hundred Canadians with terminal illness per annum could potentially benefit from expanded access. Expanded regulatory access and re-scheduling is justifiable given the established safety of psilocybin, its putative therapeutic benefits, Canada’s and Australia’s aging population and the prevalence of EOLD.

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[1] https://www.truffle.report/numinus-landmark-psilocybin-announcement/

[2] https://www.greenmarketreport.com/psygen-labs-to-supply-neonmind-with-psilocybin-for-weight-loss-study/

[3] https://www.canada.ca/en/health-canada/services/health-concerns/controlled-substances-precursor-chemicals/exemptions.html

[4] https://www.thestar.com/news/canada/2020/10/25/mental-illness-is-on-the-rise-due-to-covid-19-could-psychedelic-drugs-be-the-game-changer.html

[5] https://www.forbes.com/sites/davidcarpenter/2020/02/01/santa-cruz-is-third-us-city-to-decriminalize-psilocybin-plant-medicine-as-advocacy-expands/#45dd58805d0d

[6] https://www.kgw.com/article/news/politics/elections/oregon-measure-109-psilocybin-therapy-election/283-8805ddb6-7a61-4182-95ae-640fda00235f

[7] personal communication, Dr. B. Tobin, TheraPsil, October 2020.

[8] https://www.canlii.org/en/on/onca/doc/2000/2000canlii5762/2000canlii5762.html

[9] https://medicalmarijuana.ca/patients/marijuana-laws/

[10] Personal communication 10/15/2019

[11] personal communication, B. Tobin, Oct. 22, 2020