Toth et al. v. Minister of Health

• Decision: Toth et al. v. Minister of Health 2023 FC 1283

• Notices of Application

  • Original Notice of Application (July 11, 2022)

  • Amended Notice of Application (September 14, 2022)

• Decisions Under Review

  • Final Decision re Jeff Toth (June 9, 2022)

• Health Canada’s Evidence and Analysis

  • Memorandum for Decision - Notices of Intent to Refuse (January 10, 2022)

  • Memorandum for Decision - Final Decisions (May 26, 2022)

  • Summary of call with Office of Clinical Trials (August 19, 2020)

  • Summary of call with Health Products and Food Branch (November 3, 2020)

  • Psilocybin - A Summary of Safety and Efficacy Data

  • Summary Report - Psychedelics: Clinical Use and Risks

• Applicants’ Submissions

  • Cover Letter (February 28, 2022)

  • List Healthcare Practitioners Represented (February 28, 2022)

  • Cover Letter (March 25, 2022)

  • List Healthcare Practitioners Represented (March 25, 2022)

• Legal Representations

  • Written Representations (February 28, 2022)

• Affidavits and Exhibits

  • Affidavit of Julia Joyes (February 11, 2022)

    • Ross S, et al - Psilocybin Treatment for Anxiety and Depression (2016)

    • Griffiths R, et al - Psilocybin Produces Decreases in Depression in Patients with Cancer (2016)

    • Carhart-Harris, R.L., et al - Psilocybin with Psychological Support for Treatment-Resistant Depression (2016)

    • Davis, A. K., et al - Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder (2021)

    • Carhart-Harris, et al - Trial of Psilocybin versus Escitalopram for Depression (2021)

    • Pisano, V.D., et al - The Association of Psychedelic Use and Opioid Use Disorders in the United States (2017)

    • Johnson, M. W., - Pilot Study of Psilocybin in the Treatment of Tobacco Addiction (2017)

    • Johnson, M. W., et al - Long-term Follow-Up of Psilocybin-Facilitated Smoking Cessation (2017)

    • Nutt, D.J., et al. - Drug Harms in the UK (2010)

    • Rucker, J.J. - The Effects of Psilocybin on Cognitive and Emotional Functions in Healthy Participants (2022)

    • Brown, Nicholas, C.R., et al. - Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults (2017)

    • Studerus, et al - Acute, Subacute and Long-Term Subjective Effects of Psilocybin in Healthy Humans (2011)

    • Amsterdam, et al. Harm Potential of Magic Mushroom Use (2011)

    • Jones, & Nock, M.K. - Psilocybin Use is Associated with Lowered Odds of Crime Arrests in US adults (2022)

    • Roberts, et al - Perceived Harm, Motivations for Use and Subjective Experiences of Recreational Psychedelic "Magic" Mushroom Use (2020)

    • Johnson, et al - The Abuse Potential of Medical Psilocybin According to the 8 Factors of the Controlled Substances Act (2018)

    • Rochester, J., et al - Entheogens and Psychedelics in Canada (2021)

    • Phelps J. - Developing Guidelines and Competencies for the Training of Psychedelics Therapists (2017)

    • Johnson, M., et al - Human Hallucinogen Research: Guidelines for Safety (2008)

  • Affidavit of Natasha Fearnley (February 21, 2022)

    • TheraPsil Clinical Protocol

    • Table of Patients who Contacted TheraPsil (May 2020 - February 2022)

    • Table of Healthcare Practitioners in TheraPsil's Roster of Practitioners Able to Support Treatment

  • Affidavit of Yasmeen Sadain (February 23, 2022)

    • Affidavit of Yasmeen Sadain (February 25, 2022) & ATMA Training Program Website

    • Affidavit of Yasmeen Sadain (February 27, 2022)

    • TheraPsil Training Program Syllabus

    • TheraPsil Clinical Protocol

    • List of Psilocybin Exemption Applications and Statuses (October 1, 2021)

    • Notice of Intent to Refuse (January 31, 2022)

    • Email from Spencer Hawkswell to OCT (January 31, 2022)

    • Emails from Nicholas Pope and Jennifer Saxe (February 11-18, 2022)

    • ATMA News Release (January 7, 2022)

    • Email from Carole Legare (OCT) to Nicholas Pope (February 21, 2022)

    • Email from Yasmeen Sadain to David Harder (February 8, 2022)

    • ATIP Confirmation Email (February 21, 2022)

    • Health Canada Clinical Trials Query Results

    • ClinicalTrials.gov Search Results

    • Health Canada Notice to Stakeholders - Requirements for Clinical Research with Psilocybin (January 11, 2022)

    • Letter from Numinus to Minister Duclos (February 11, 2022)

    • US NIH Ethics in Clinical Research

    • TCPS2 - Canada Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans

  • Affidavit of Valorie Masuda (February 20, 2022)

    • Curriculum Vitae

    • Special Access Program Guidance Document

    • Special Access Program Form A - Patient Specific Request

    • Special Access Program Form B - Future Use Request Patient Identity Unknown

    • List of References

  • Affidavit of Thomas Hartle (February 25, 2022)

    • Letter from Dr. Watler (June 2, 2020)

    • Section 56 Application (June 2, 2020)

    • Letter from Dr. Watler (July 13, 2020)

    • Letter from Thomas Hartle (July 30, 2020)

    • Section 56 Exemption (August 4, 2020)

    • Demoralization Scale-II (August 12, 2020)

    • Demoralization Scale-II (August 13, 2020)

    • Hamilton Anxiety Rating Scale (August 12, 2020)

    • Hamilton Anxiety Rating Scale (August 13, 2020)

    • Beck Depression Inventory (August 12, 2020)

    • Beck Depression Inventory (August 13, 2020)

    • Physician Support Form (September 29, 2021)

    • Section 56 Renewal Request (October 4, 2021)

  • Affidavits from Waitlisted Patients

    • Affidavit of Katherine Leda Marykuca (February 24, 2022)

    • Affidavit of Kathleen Phyllis Westlake (February 26, 2022)

    • Affidavit of Jessica Marie Pietryszyn (February 23, 2022)

    • Psychedelic Clinical Trials Database (February 22, 2022)

    • Affidavit of Melissa Slade

    • Affidavit of Ryley William McCafferty (February 26, 2022)

    • William Alves (February 25, 2022)

    • Jeremy Isaac Moore (February 24, 2022)

    • Affidavit of Thaddeus Conrad (February 25, 2022)

    • Affidavit of Matthew Douglas Hunter (February 25, 2022)

    • Affidavit of Shawn Dustin McLaren (February 25, 2022)

    • Affidavit of Alisen Michaud (February 26, 2022)

    • Affidavit of Shannon Elizabeth McKenney (February 24, 2022)

    • Affidavit of Solange Martin (February 24, 2022)

  • Letters from Experts

    • Letter from Dr. Lindsay Farrell, Dr. Evan Wood & Payton Nyquvest (February 11, 2022)

    • Letter from Drug Science Advisory Committee (February 9, 2022)

    • Letter from Dr. James Fadiman

    • Letter from Dr. William A. Richards

    • Letter from Dr. Roland R Griffiths (February 5, 2022)

    • Letter from Dr. Duncan Grady (February 4, 2022)

    • Letter from Dr. Erika Dyck (February 3, 2022)

    • Letter from Mark Haden (February 16, 2022)

    • Letter from Dr. Paul Grof (November 30, 2021)

    • Letter from Dr. Phil Wolfson

    • Letter from Dr. Bruce Tobin

    • Letter from Dr. Charles S Grob (November 11, 2020)

    • Letter from Dr. Michael Mithoefer (November 11, 2020)

    • Letter from East Coast Healthcare Practitioners (February 7, 2022)

    • Letter from British Columbia Healthcare Practitioners (February 8, 2022)

  • List of Videos with Hyperlinks

  • Health Canada's Summaries of Applicant's Submissions

    • Summary of Submission Documents

    • Quick Summary of Submissions on Behalf of TheraPsil HCPs

    • Summary of Articles from TheraPsil About Need for Experiential Training

    • Summary & Transcripts of Video Submissions

  • Email Correspondence

    • Expert Letters Emails - Spencer Hawkswell & Health Canada (February 11-17, 2022)

    • Extensions Emails - Nicholas Pope & Jennifer Saxe (February 11-14, 2022)

    • ATMA Trial Emails - Nicholas Pope, Office of Clinical Trials, & Jennifer Saxe (February 11-18, 2022)

    • Submission Emails - Nicholas Pope & Jennifer Saxe (March 25, 2022)

  • Certificate of Record (October 6, 2022)

Header photo created with the assistance of DALL·E 2.