Opinion piece: Changing the game on mental illness
Professor Simon Bell, Dr Alene Yong
Authored by Professor Simon Bell, Director of the Centre for Medicine Use and Safety (CMUS) within the Monash Institute of Pharmaceutical Sciences and Dr Alene Yong, a CMUS Research Fellow.
A landmark decision by the Therapeutic Goods Administration (TGA) in 2023 authorised psychiatrists to prescribe MDMA and psilocybin for the treatment of PTSD and treatment-resistant depression outside of clinical trials.
Finding new and innovative treatment approaches to address mental health conditions is critical, particularly for those living with conditions like PTSD whereby current treatments do not achieve clinically significant benefits in around half of patients.
However, there is a clear need for evidence-based guidance to support clinicians to deliver appropriate care and help patients make informed decisions.
So, what has changed in the two years since the TGA's ground-breaking announcement?
And, importantly, what needs to happen next to ensure clinicians are well-placed to make the best evidence-based decisions for their patients?
The evidence on MDMA for PTSD
PTSD can be a debilitating mental health condition and it's not surprising new therapeutic interventions are being explored.
Promising results in phase-two and -three clinical trials has led MDMA to being proposed as a potential pharmacological adjunct to psychotherapy on the premise that MDMA helps some people with PTSD to revisit traumatic memories with more ease.
Recent research by Monash University's Centre for Medicine Use and Safety (CMUS) published in the Australian and New Zealand Journal of Psychiatry considered existing systematic reviews of the safety and efficacy of MDMA-assisted psychotherapy compared to psychotherapy only among adults with PTSD.
The research identified substantial overall improvement in PTSD symptoms, but the evidence was of low or very low-certainty due to factors including concerns of unblinding whereby participants believed they knew whether or not they have been administered MDMA, small sample sizes in the clinical trials, and results only being directly applicable to a narrow population.
Evidence on the safety of MDMA-assisted psychotherapy was of moderate to very-low certainty due to concerns of under-reporting of adverse events and a lack of long-term safety data.
Meanwhile, over in the United States, a new drug application for MDMA was rejected by the Food and Drug Administration (FDA) in August last year, with the FDA citing the need for additional data on safety and efficacy.
How has Australia seized the opportunity?
While there is a high demand for innovative therapies such as psychedelic-assisted psychotherapy since the TGA re-scheduling, the reality of the process is complicated and expensive.
Only a small number of psychiatrists across the country have become authorised prescribers, and the cost of MDMA and psilocybin treatments, which anecdotally can be as high $20,000 to $30,000 for the medication and therapists' time, excludes the majority of the population from being able to access such treatment.
That being said, in Australia new clinics specialising in psychedelic-assisted psychotherapy have been established, with further growth in the space likely given the scale of the mental health crisis and decades-long drought in the development of new safe and effective medicines for a range of mental health conditions.
Where to from here?
Australia is continuing on its trajectory as world-leaders in this space, as we set out to become the first country to develop a clinical practice guideline for MDMA-assisted psychotherapy for PTSD.
Clinical practice guidelines support clinicians to deliver appropriate care and help patients make informed decisions.
The Royal Australian and New Zealand College of Psychiatrists has outlined the value of a cautious approach given the evidence for psychedelic-assisted treatments is limited and emerging.
The college also highlights the importance of patients providing informed consent based on a comprehensive understanding of potential risks and benefits. This is particularly the case given that PTSD often impacts people from vulnerable population groups.
The new Australian clinical practice guideline is being developed by a multidisciplinary team that includes a general practitioner, health economists, knowledge translation experts, neuroscientists, a nurse, pharmacists, pharmacologists, psychiatrists, psychologists, research methodologists, and those with lived experience of PTSD and MDMA-assisted psychotherapy.
Development of the guideline will consider evidence about benefits and harms from clinical trials, as well as data from interviews with patients, clinicians, and researchers in relation to factors such as patient preferences and values, resources, equity, acceptability, and feasibility.
The multidisciplinary team is expected to make a series of recommendations and good practice statements that will be released for public consultation by around the middle of the year.
This opinion piece was originally published by The Canberra Times.