Expanded access to psychedelic treatments: comparing American and Canadian policies

• Published in: General psychiatry Vol. 38; no. 1; p. e101894
• Main Authors: Richard, Jérémie, Garcia-Romeu, Albert, Henningfield, Jack E
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group Ltd 19.02.2025; BMJ Publishing Group LTD; BMJ Publishing Group
• Subjects: Anxiety; Clinical trials; Commentary; Depressive Disorder, Treatment-Resistant; Drug therapy; FDA approval; Health care access; Health Care Quality, Access, and Evaluation; Mental depression; Post traumatic stress disorder; Principles; Psychedelic drugs; Psychopharmacology; Psychotherapy; Stress Disorders, Post-Traumatic; Veterans; Canada; United States > US; Psychotherapy; Stress Disorders, Post-Traumatic; Depressive Disorder, Treatment-Resistant; Health Care Quality, Access, and Evaluation; Psychopharmacology
• ISSN: 2517-729X; 2096-5923; 2517-729X
• DOI: 10.1136/gpsych-2024-101894

In February 2024, 176 Canadians were authorised to access psilocybin via the SAP, with Health Canada approving 78% of applications for the drug.2 Comparatively, 41 authorised requests were granted for MDMA.3 Due to the difficulties associated with accessing MDMA as a treatment option for PTSD via the SAP (predominantly due to difficulties procuring pharmaceutical-grade MDMA), the Canadian Senate’s Subcommittee on Veterans Affairs has advocated for a large-scale research programme on psychedelic-assisted psychotherapy to help expand the range of available treatment options for the 10% to 15% of Canadian veterans diagnosed with PTSD experiencing significant psychological distress and severe functional impairment.4 Beyond veterans, it is also important to acknowledge that the number of civilian refugees and asylum seekers due to armed conflicts is increasing on a global scale, with estimates indicating a pooled prevalence rate of 23.70% for PTSD among those living in war-afflicted areas.5 The increasing public health burden of PTSD6 calls attention to the need to develop and expand access to evidence-based interventions including novel pharmacologically assisted psychosocial interventions for the treatment of PTSD.7 In the United States of America (USA), the FDA has a similar programme to Health Canada’s SAP, known as expanded access, which serves as a potential pathway for patients with a serious or life-threatening condition to gain access to an investigational treatment outside of clinical trials when there is no comparable or satisfactory alternative therapy. Preliminary data among a small segment of SAP patients (n=8, 50% female, Mean age=52.3 years (SD=10.7)) who received psilocybin treatment for cancer-related existential distress demonstrated significant improvements in anxiety, depression, pain, quality of life and spiritual well-being 2 weeks post-treatment.10 No serious adverse effects were noted outside of common transient side effects including nausea/vomiting (4/5), headache (3/5), sweats/chills (3/5) and crying (3/5). The benefits experienced by SAP patients are consistent with clinical trial data, with multiple studies showing significant and persisting reductions in depression and anxiety after high-dose psilocybin administration in patients with cancer-related psychosocial distress.11 Moreover, the limited adverse events reported in Canada appear to be consistent with meta-analytic findings indicating that classic psychedelics such as psilocybin are generally well tolerated in clinical settings.12 At present, the SAP continues to provide access to psilocybin or MDMA to patients who have been unresponsive to available treatments. [...]the range of conditions within the SAP scope of the approval is actively expanding (eg, access to psilocybin for cluster headache was granted in June 2024).13 In contrast, only 50 patients have had access to MDMA in the USA via the FDA’s expanded access pathway from the initial approval of MDMA for PTSD in 2020 to the present day. Access was only granted to 10 approved sites, greatly limiting access to individuals living outside of California (3 sites), Colorado (1 site), Connecticut (1 site), Maine (1 site), Maryland (1 site), New Mexico (1 site), North Carolina (1 site) and Oregon (1 site). [...]with a population of over 340 million compared with Canada’s 41 million, the fact that Canada has already provided services to more than four times the number of patients in the USA in half the time raises questions of equitable access to care and the restrictions to the controlled and closely monitored medical use of these drugs by qualified and licensed healthcare practitioners.