Independent Expert Panel on MDMA and psilocybin

[Black Rainbow]

Systematic literature review of the therapeutic value, benefits and risks of MDMA and psilocybin for the treatment of mental health conditions

 

5 August 2021

 

The Therapeutic Goods Administration (TGA) Scheduling Delegate (decision maker) has deferred the final decision on applications to down-schedule MDMA and psilocybin from schedule 9 (prohibited drug) to schedule 8 (controlled drug) pending a review into the therapeutic value, risks and benefits to public health outcomes for these substances. The Independent Expert Panel to undertake this review has now been established.

 

 

Terms of Reference

 

The Independent Expert Panel has been established to undertake a systematic literature review of the roles of MDMA and psilocybin for the treatment of mental health conditions.

The Review will report findings on the current state of the evidence of therapeutic value, benefits and risks of MDMA and psilocybin for the treatment of mental health conditions, including the size of effect, the quality of evidence and the applicability of the evidence to real-world use in Australia, currently and into the future.

The Review excludes pre-clinical trials (i.e. experimental pharmacology studies in test tube or animal models).

The Panel is not a decision making or approval body, and their role is to provide a publicly available report which will be considered by the delegate and the Advisory Committee for Medicines Scheduling.

 

 

 

Panel Members

 

Professor Mark Connor

Professor Mark Connor is a molecular pharmacologist with expertise in analgesics and psychoactive drugs, particularly cannabinoids and opioids, with extensive research experience in the USA, UK, and Australia. Currently, his work focuses on the pharmacology of synthetic cannabinoids and the molecular effects of phytocannabinoids.

Professor Connor holds a Bachelor of Science (Hons) and PhD in Pharmacology. He is currently the Associate Dean, Higher Degree Research, Department of Biomedical Sciences, Macquarie University.

 

Professor Steve Kisely

Professor Steve Kisely is a psychiatrist and public health physician with health services research experience in the UK, Australia, and Canada. He obtained fellowship of the relevant Colleges in the UK, Australasia and Canada, as well as of the Australasian Chapter of Addiction Medicine. He is also an accredited member of the faculties of adult psychiatry, addiction (FAP) and consultation psychiatry (FCLP) of the Royal Australian & New Zealand College of Psychiatrists.

Professor Kisely holds a Doctor of Medicine (Research Doctor of Philosophy and Doctor of Medicine. Professor Kisely is currently Professor of Psychiatry, School of Medicine, The University of Queensland.

 

Professor Andrew Somogyi

Professor Andrew Somogyi Professor Somogyi is Professor in Clinical and Experimental Pharmacology. He is a practicing pharmacist and has a research program centred on elucidating the mechanisms and factors contributing to altered human drug response in pain therapeutics, infectious diseases, depression, and transplantation through pharmacokinetic, metabolism, pharmacodynamic and pharmacogenomic studies. He is a member of the Editorial Advisory Committee and Company Director of the Australian Medicines Handbook.

Professor Somogyi holds a Certificate of Pharmacy, Diploma of Hospital Pharmacy, Master of Science, and a PhD (Clinical Pharmacology). Professor Somogyi is currently a Professor of Pharmacology, Adelaide Medical School, Faculty of Health and Medical Sciences, The University of Adelaide.

 

 

Timing

 

The Panel's Report will be published on the TGA website on 30 September 2021 ahead of consideration by the Advisory Committee on Medicines Scheduling.

 

 

Contact details

 

For enquiries regarding the Review or to contact the Panel please email  [email protected]

https://www.tga.gov.au/independent-expert-panel-mdma-and-psilocybin

Edited August 6, 2021 by Wile E. Peyote

[Halcyon Daze]

Looking forward to hearing the outcomes of the report

[Black Rainbow]

Report released today. Available here: https://www.tga.gov.au/independent-expert-panel-mdma-and-psilocybin

[-RC-]

 

 

In summary:

 

 

 

 

 

 

 

By combining the effects of small and possibly underpowered studies, meta-analyses can help to establish the relative efficacy of interventions such as MDMA and psilocybin where large studies may be impractical. Although we were only able to combine results from 9 studies for either beneficial or adverse effects, we did demonstrate statistically significant differences of the two psychedelic agents between both inactive and active treatments for either continuous scores or dichotomous responses. However, it is important to note that this was in highly supportive and structured environments including intense psychotherapy sessions in many cases.

 

 

 

Both agents were well-tolerated in supervised trials with or without additional use of psychotherapy. However, trial quality including blinding and follow-up was variable and only a small proportion of potential participants were included in the randomised phase.

 

 

 

We conclude that MDMA and psilocybin may show promise in highly selected populations but only where these medicines are administered in closely clinically supervised settings and with intensive professional support.

 

 

 

 

 

 

 

 

 

 

[fyzygy]

I think the psychiatric lobby should be satisfied with that last clause, only where these medicines are administered in closely clinically supervised settings and with intensive professional support.

 

MDMA before psilocybin, hints the ABC: https://www.abc.net.au/triplej/programs/hack/mdma-and-magic-mushrooms-could-be-downgraded-by-tga/13563076

 

If the TGA reclassified these, how could stiff criminal penalties for unauthorised use and possession be maintained? Not without a degree of cognitive dissonance, and wilful discrimination (against poor people, for example). That said, it wouldn't surprise me if penalties were actually increased under the new regime. 

Edited September 30, 2021 by fyzygy

[SayN]

"in highly selected populations"  

 

its a start I guess.

 

 

[-RC-]

Geez, it looks like they only want to open that door a crack aye?

[Black Rainbow]

PRISM's response to the report:

https://www.prism.org.au/prisms-response-tga-expertreview/