While much noise has been made in the media about the TGA’s decision, there are currently no approved products containing psilocybin or MDMA that the TGA has evaluated for quality, safety, and efficacy.
From 1 July 2023, medicines containing the psychedelic substances psilocybin (found in magic mushrooms) and MDMA (3,4-methylenedioxy-methamphetamine) can be prescribed by specifically authorised psychiatrists for the treatment of certain mental health conditions: MDMA for the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression.
The TGA stated that these are the only conditions where there is currently sufficient evidence for potential benefits in certain patients but noted that as the new therapies are not yet well established, this amendment will allow authorised psychiatrists to access and legally supply a specified ’unapproved’ medicine containing these substances.
For these specific uses, psilocybin and MDMA will be listed as Schedule 8 (Controlled Drugs) medicines in the Poisons Standard and for all others, they will remain in Schedule 9 (Prohibited Substances) which restricts their supply to clinical trials.
These drugs alter the mind and reduce inhibitions whereby the person being treated may be able to cope with some of the difficult images, memories or thoughts which are accessed more readily and potentially with reduced associated feelings of anxiety.
However, according to the TGA, only one clinical trial of MDMA is currently taking place, by Edith Cowan University, testing the feasibility of “safely and effectively providing MDMA-assisted psychotherapy in Australia by treating four WA adults with chronic treatment-resistant PTSD.”
The only other trial dealing with the substance, by the University of Sydney, is evaluating mental health professionals’ attitudes on using MDMA as a treatment.
In November 2020, the TGA knocked back approval of psychedelics, noting that there remain many unknown factors and risks, especially in the long term:
The risks of developing psychosis, especially in vulnerable populations, must be established in a clinical trial setting
The potential adverse effects, particularly relating to multi-drug toxicity, are unknown
the dosage, formulation, labelling, packaging, and presentation of a substance
A typical dose in the context of psychotherapy is 25 – 35 mg, depending on subject weight, and although optimal therapeutic dosage has not been established, though the lethal dose is thought to be 6 g
There is a considerable risk of diversion for misuse, even in conjunction with Schedule 8 controls
Psilocybin-assisted psychotherapy may eventually prove to be safe and efficacious, but the evidence does not yet suggest this
It will take years to develop a curriculum and accredited training process for psychiatrists. To protect public health and prevent misuse, psilocybin should not be down scheduled until all necessary safeguards have been established and implemented.
The new decision acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses and follows numerous applications made to the TGA to reclassify the substances in the Poisons Standard, extensive public consultation, advice from the Advisory Committee on Medicines Scheduling, and a detailed investigation and report by an expert panel.
Expert panel members included Professor Mark Connor, a molecular pharmacologist and Associate Dean of Higher Degree Research at Macquarie University’s department of Biomedical Sciences; psychiatrist Professor Steve Kisely from the University of QLD, who is also an accredited member of the faculties of adult psychiatry, addiction, and consultation psychiatry of the Royal Australian & New Zealand College of Psychiatrists; and Professor Andrew Somogyi, an expert in clinical and experimental pharmacology with the University of Adelaide.
The panel noted that although there have been several recent systematic reviews, studies and participants have been limited, and the field is rapidly evolving with the publication of more research.
As such, the team reviewed eight of the latest randomised controlled trials for MDMA and six dealing with psilocybin, concluding that MDMA was a suitable medication for PTSD following four to 12 weeks of treatment, and psilocybin was more effective at dealing with treatment resistant depression than a popular antidepressant.
“MDMA was well tolerated in all the studies, with anxiety, restlessness, fatigue, jaw-clenching, headaches and transient increases in blood pressure reported as the primary side effects; while psilocybin was also well tolerated and resulted in anxiety, headaches and similarly transient increases in blood pressure,” the panel said.
“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.”
They reported that both agents were also 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,” the panel said.
Associate Professor Petra Skeffington, a clinical psychologist from Murdoch University said that this is a major step for psychedelic-assisted therapies in Australia, but one that should be taken with caution.
“With the potential for increased access to MDMA and psilocybin-assisted therapies, it is now critically important that high-quality therapist training be made available to promote safe therapeutic conditions when working with these medications,” she said.
Patients may be vulnerable during psychedelic-assisted psychotherapy and to prescribe, psychiatrists will need to be approved under the Authorised Prescriber Scheme by the TGA following approval by a human research ethics committee.
The TGA noted that currently, psilocybin-assisted psychotherapy sessions typically last 6 – 8 hours, relying on two trained specialists. The regime consists of 1 – 3 psychedelic-assisted therapy sessions, usually supplemented with ‘integrative’ therapy sessions where psilocybin is not used.
Dr Paul Liknaitzky, the head of Clinical Psychedelic Research at Monash University, one of only a few sites in Australia that is already delivering psychedelic-assisted therapies to clinical patients, also stressed the importance of improving professional capacity to provide high quality care and safe environments for participants.
“We have witnessed up-close the potential of our treatment to change people’s lives for the better; yet the safety and effectiveness of psychedelic therapies depends on a unique set of professional competencies and considerations that are in scarce supply within mental healthcare,” Dr Liknaitzky said.
“For clinical psychedelic services to be sensible, safe, and useful, considerable professional and public education will be needed, and questions of affordability, eligibility, oversight, and standards of care should be addressed.
“With this schedule change coming in a matter of months, Australia has very little time to get across this.”
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