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Psychedelic Drug Therapy for Mental Disorders?

DOI: 10.4236/ojmp.2023.123010, PP. 150-171

Keywords: Psychedelic Drugs, Psychotherapy, Mental Disorders, Clinical Trials

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Abstract:

Objective: Psychedelic drug therapy is banned in all countries of the world except Australia, where the government regulatory watchdog, the Therapeutic Goods Administration, is planning to allow approved psychiatrists, as of July 1, 2023, to prescribe psilocybin to treat depression and MDMA to treat post-traumatic stress disorder, a move precipitated by the U.S. Food and Drug Administration’s designation of these two drugs as “breakthrough therapy”. The objective of the present article is to demonstrate that the evidence on which the FDA and then the TGA relied is irretrievably flawed and should be dismissed. Method: Expert review of psychedelic therapy clinical trials and specifically of the methodology and measures used. Results: The present review demonstrates that the studies the U.S. FDA and the Australian TGA relied on to approve these two psychedelic drugs for therapy are irretrievably flawed. All future trials will follow the same procedure and are therefore bound to be flawed as well. Conclusions: Psychedelic drug studies have so far provided no trustworthy evidence of their effectiveness for treating mental disorders and are not likely to produce this evidence in the future. Psychedelic drug therapy is in any event impractical because of its specialized training requirements and very high treatment costs. It is also dangerous because false publicity about its effectiveness will almost certainly lead to unsupervised self-dosing with drugs that not only are illegal but have an unacceptably high addiction rate.

References

[1]  Hansen, C., Alas, H. and Davis Jr., E. (2023) Where Is Marijuana Legal? A Guide to Marijuana Legalization. U.S. News. https://www.usnews.com/
[2]  Lukianoff, G. and Haidt, J. (2018) The Coddling of The American Mind. Penguin Books, London.
[3]  Henriques, G. (2014) The College Student Mental Health Crisis. Psychology Today.
https://www.psychologytoday.com/sg
[4]  Rossiter, J.R. (2022) The DEP-6: A Brief Multi-Diagnostic Measure of Depression. Psychology, 13, 853-871. https://doi.org/10.4236/psych.2022.136058
[5]  Rossiter, J.R. (2022) The ANX-8: A Brief Multi-Diagnostic Measure of Anxiety Disorders. Psychology, 13, 1711-1726. https://doi.org/10.4236/psych.2022.1312107
[6]  Cross, J. (2023) Fit for Their Future. The Sunday Telegraph, 18-19.
[7]  Gusmaroli, D. (2021) Kids in a Race to See Who Is Sickest. The Daily Telegraph.
[8]  Bilton, R. and Nutt, D. (2022) Psychedelic Drug Researcher. The Weekend Australian Magazine.
[9]  Leckie, S. and de Jong, T. (2022) Drug of Choice: Support Is Growing for Greater Use of Psychedelic-Assisted Therapy. The Daily Telegraph.
[10]  Center for Drug Evaluation and Research (2019) Fact Sheet: Breakthrough Therapies. Food and Drug Administration, Washington DC. https://www.fda.gov/
[11]  Carboni, L.P., Patel, D. and Rosen, D.L. (2022) Psychedelic Drugs—Easing the Regulatory Hurdles for Development. Health Care Law Today.
https://www.foley.com/en
[12]  Therapeutic Goods Administration (2023) Change to Classification of Psilocybin and MDMA to Enable Prescribing by Authorized Psychiatrists.
https://www.tga.gov.au/
[13]  Dean, L. (2023) The People Getting Rich from the Psychedelic ‘Renaissance.’ Australian Financial Review, 1-3.
[14]  Department of the Prime Minister and Cabinet, Ministers Media Centre (2021) $15 Million for Development of Innovative Therapies for Mental Illness.
https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/15-million-for-development-of-innovative-therapies-for-mental-illness
[15]  Lynch, J. (2022) Psychedelic Studies Mushroom. The Australian.
[16]  Boreham, T. (2023) Psychedelic Shares Edge Closer to Reality. The Daily Telegraph, 71.
[17]  Royal Australian and New Zealand College of Psychiatrists (2022) Clinical Memorandum: Therapeutic Use of Psychedelic Substances. https://www.ranzcp.org/
[18]  Rossiter, J.R. (2002) The C-OAR-SE Procedure for Scale Development in Marketing. International Journal of Research in Marketing, 19, 305-335.
https://doi.org/10.1016/S0167-8116(02)00097-6
[19]  Rossiter, J.R. (2011) Measurement for the Social Sciences: The C-OAR-SE Method and Why It Must Replace Psychometrics. Springer, New York.
https://doi.org/10.1007/978-1-4419-7158-6
[20]  Rossiter, J.R. (2022) Aripiprazole and Cariprazine for Bipolar Disorder? Open Journal of Medical Psychology, 11, 254-273.
https://doi.org/10.4236/ojmp.2022.114019
[21]  Dawes, R.M. (1994) House of Cards: Psychology and Psychotherapy Built on Myth. Free Press, New York. https://doi.org/10.1097/00005053-199509000-00011
[22]  Aiken, L.S., West, S.G. and Millsap, R.E. (2008) Doctoral Training in Statistics, Measurement, and Methodology in Psychology: Replication and Extension of Aiken, West, Sechrest, and Reno’s (1990) Survey of PhD Programs in North America. American Psychologist, 63, 32-50. https://doi.org/10.1037/0003-066X.63.1.32
[23]  Rossiter, J.R. (2022) Learning Theory Principles for Psychotherapy. Psychology, 13, 743-766. https://doi.org/10.4236/psych.2022.135049
[24]  Carhart-Harris, R.L., Bolstridge, M., Rucker, J., et al. (2016) Psilocybin with Psychological Support for Treatment-Resistant Depression: An Open-Label Feasibility Study. The Lancet Psychiatry, 3, 619-627.
https://doi.org/10.1016/S2215-0366(16)30065-7
[25]  Wikipedia (2022) Psilocybin.
[26]  Sadock, B.J. and Sadock, V.A. (2007) Kaplan & Sadock’s Synopsis of Psychiatry. 10th Edition, Lippincott Williams & Wilkins, Philadelphia.
[27]  American Psychiatric Association (2013) Diagnostic and Statistical Manual of Meental Disorders, Fifth Edition: DSM-5TM. American Psychiatric Publishing, Washington DC. https://doi.org/10.1176/appi.books.9780890425596
[28]  Rossiter, J.R. (2017) Optimal Standard Measures: Comment on Matthews et al. (2016). American Psychologist, 72, 489-490. https://doi.org/10.1037/amp0000131
[29]  Rush, A.J., Trivedi, M.H., Ibrahim, H.M., et al. (2003) The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), Clinician Rating (QIDS-C), and Self-Report (QIDS-SR): A Psychometric Evaluation in Patients with Chronic Major Depression. Biological Psychiatry, 54, 573-583. https://doi.org/10.1016/S0006-3223(02)01866-8
[30]  Carhart-Harris, R., Giribaldi, B., Watts, R., et al. (2021) Trial of Psilocybin versus Escitalopram for Depression. The New England Journal of Medicine, 384, 1402-1411.
https://doi.org/10.1056/NEJMoa2032994
[31]  Feduccia, A.A., Jerome, L., Yazar-Klosinski, B., et al. (2019) Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline. Frontiers in Psychiatry, 10, Article 650.
https://doi.org/10.3389/fpsyt.2019.00650
[32]  Eysenck, H.J. (1994) Meta-Analysis and Its Problems. British Medical Journal, 309, 789-792. https://doi.org/10.1136/bmj.309.6957.789
[33]  Mitchell, J.M., Bogenschutz, M., Lilienstein, A., et al. (2021) MDMA-Assisted Therapy for Severe PTSD: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study. Nature Medicine, 27, 1025-1033.
https://doi.org/10.1038/s41591-021-01336-3
[34]  Mitchell, J.M. (2022) A Psychedelic for Trauma. Scientific American, 326, 56-61.
[35]  Wikipedia (2022b) MDMA.
[36]  Faculty of Medicine, University of Queensland (2021) More Australians Use Psychedelics to Self-Treat Mental Health.
https://medicine.uq.edu.au/article/2021/03/more-australians-use-psychedelics-self-treat-mental-health
[37]  Oehen, P., Traber, R., Widmer, V. and Schnyde, U. (2013) A Randomized, Controlled Pilot Study of MDMA-Assisted Psychotherapy for Treatment of Resistant, Chronic Post-Traumatic Stress Disorder (PTSD). Journal of Psychopharmacology, 27, 40-52. https://doi.org/10.1177/0269881112464827
[38]  American Psychological Association (2018) Understanding Psychotherapy and How It Works. https://www.apa.org/
[39]  Muthukumaraswamy, S., Forsyth, A. and Sumner, R.L. (2022) The Challenges Ahead for Psychedelic ‘Medicine.’ Australian & New Zealand Journal of Psychiatry, 56, 1378-1383. https://doi.org/10.1177/00048674221081763
[40]  Wikipedia (2022) Phases of Clinical Research.
[41]  Weathers, F.W., Bovin, M.J., Lee, D.J., et al. (2018) The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and Initial Psychometric Evaluation in Military Veterans. Psychological Assessment, 30, 383-395.
https://doi.org/10.1037/pas0000486
[42]  Sheehan, D.V. (1983) Sheehan Disability Scale (SDS). Although Copyrighted by Sheehan in 1983, This Measure Is Widely Available on the Internet. One of the Most Accurately Explained Versions Can Be Found on the Website for Stable Resources Toolkit.
https://chk.static.cigna.com/assets/chcp/pdf/resourceLibrary/educationCenter/stableToolkit.pdf
[43]  First, M.B., Williams, J.B.W., Karg, R.S. and Spitzer, R.L. (2016) Structured Clinical Interview for DSM-5, Clinician Version, SCID-5-CV. American Psychiatric Association Publishing, Arlington.
[44]  PsychonautWiki (2023) Ketamine.
[45]  Wikipedia (2023) Ketamine.
[46]  Oliver, P.A., Snyder, A.D., Feinn, R., et al. (2022) Clinical Effectiveness of Intravenous Racemic Ketamine Infusions in a Large Community Sample of Patients with Treatment-Resistant Depression, Suicidal Ideation, and Generalized Anxiety Symptoms: A Retrospective Chart Review. Journal of Clinical Psychiatry, 83, 1-7.
https://doi.org/10.4088/JCP.21m14336
[47]  Wikipedia (2023) Ketamine-Assisted Psychotherapy.
[48]  Spitzer, R.L., Kroenke, K. and Williams, J.B.W. (1999) Validation and Utility of a Self-Report Version of PRIME-MD. Journal of the American Medical Association (JAMA), 282, 1737-1744. https://doi.org/10.1001/jama.282.18.1737
[49]  Spitzer, R.L., Kroenke, K., Williams, J.B.W. and Löwe, B. (2006) A Brief Measure for Assessing Generalized Anxiety Disorder: The GAD-7. Archives of Internal Medicine, 166, 1092-1097. https://doi.org/10.1001/archinte.166.10.1092
[50]  Kroenke, K., Spitzer, R.L., Williams, J.W. and Löwe, B. (2009) An Ultra-Brief Screening Scale for Anxiety and Depression: The PHQ-4. Psychosomatics, 50, 613-621.
https://doi.org/10.1016/S0033-3182(09)70864-3
[51]  Australian Psychological Society (2021) Psychologists and Psychedelic-Assisted Therapy. Australian Psychological Society, Melbourne.
https://aps.org.au/#gsc.tab=0
[52]  Miller, P.F., Petterson, S., Burke, B.T., et al. (2014) Proximity of Providers: Co-Locating Behavioral Health in Primary Care and the Prospects for an Integrated Workforce. American Psychologist, 69, 443-451. https://doi.org/10.1037/a0036093
[53]  American Psychiatric Association (2018) What Is Psychotherapy?
https://www.psychiatry.org/
[54]  Dudley, E. (2023) Psych Cuts ‘Worst for Young Women.’ The Australian.
[55]  Dunlevy, S. (2022) Is Your Doctor Being Paid Big Bucks by Big Pharma? The Sunday Telegraph.
[56]  Maddison, M. (2021) TGA to Rule on Psychedelic Drug Access to Mental Health Problems. The Australian.
[57]  HIF: Health Insurance Fund (2022) Claiming MDMA on Health Insurance? It Could Become a Reality. https://www.hif.com.au/news
[58]  Lea, T., Amada, N., Jungaberle, H., Schecke, H. and Klein, M. (2020) Microdosing Psychedelics: Motivations, Subjective Effects and Harm Reduction. International Journal of Drug Policy, 75, Article ID: 102600.
https://doi.org/10.1016/j.drugpo.2019.11.008
[59]  Holland, I. (2023) Too Easy to Buy Drugs on Facebook. The Sunday Telegraph.
[60]  Down, R. (2021) AMA Cautions against Psychedelic Drugs. The Australian.
[61]  Halford, B. (2022) Drug Companies Are Investing Big on Psychedelics, But Can They Engineer Out the Trip? Chemical & Engineering News.
[62]  Johnson, C.S., Shadfar, Z., Allison, J.R., Walsha, K.A.J. and Partington, H.K. (2022) Controlling New Psychoactive Substances in New Zealand. Australian Journal of Forensic Sciences. https://doi.org/10.1080/00450618.2022.2067230
[63]  U.S. Food and Drug Administration (2021) Fact Sheet: FDA at a Glance.
https://www.fda.gov/
[64]  Dunlevy, S. (2023) Mentally Ill Who Can’t Afford Help Forced to Call Police. The Australian.
[65]  Addiction Center (2023) Drug Street Names.
https://www.addictioncenter.com/drugs/drug-street-names/
[66]  Newport Academy (2021) Common Street Names for Drugs.
https://www.newportacademy.com/
[67]  Substance Abuse and Mental Health Services Administration (2020) Key Substance Use and Mental Health Indicators in the United States: Results from the 2019 National Survey on Drug Use and Health.
https://www.addictioncenter.com/drugs/drug-street-names/
[68]  Australian Institute of Health and Welfare (2022) The 2019 National Drug Strategy Household Survey. https://www.aihw.gov.au/

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