From July, Prescribing of MDMA and Psilocybin in Australia will be Legal
Australia will be the first country in the world to legalise clinical prescribing of MDMA and psilocybin, marking a significant milestone in the field of psychedelic therapies.
The Therapeutic Goods Administration (TGA) announced that authorised psychiatrists would have the authority to prescribe MDMA (commonly known as ecstasy or molly) for post-traumatic stress disorder (PTSD) and psilocybin (magic mushrooms) for treatment-resistant depression, starting from 1 July 2023.
The decision follows applications made to the TGA to reclassify the substances in the Poisons Standard, extensive public consultation, a report from an expert panel, and advice received from the Advisory Committee on Medicines Scheduling.
Patient advocacy groups have greeted the TGA's decision with enthusiasm, citing potential benefits for individuals grappling with mental illnesses that haven't responded to conventional treatments, while an element of concern has emerged from experts in the field.
Professor Colleen Loo, a renowned clinical psychiatrist and researcher at UNSW Sydney and the Black Dog Institute, has spent decades introducing ground-breaking psychiatric therapies. While Prof. Loo has been involved in clinical trials exploring the therapeutic potential of psilocybin, she remains apprehensive about implementing these new psychedelic treatments.
"My concern is that psychedelic treatment isn't going to be rolled out in a way that represents good clinical practice and that is in the patient's best interest,” Prof Loo said.
As the discussions surrounding the TGA's decision continue, the focus shifts toward establishing comprehensive guidelines and protocols to ensure the safe and responsible integration of MDMA and psilocybin therapies into mental health treatment options.
Experts like Prof. Loo emphasise the need for cautious evaluation of potential risks, proper training for practitioners, and continuous monitoring of patients undergoing these treatments.
"While the TGA's decision has opened up novel possibilities for mental health treatments; researchers, healthcare professionals, and regulatory bodies must collaborate to prioritise patient welfare and safety in the path ahead."
Research into these substances began in the West during the 1940s, shortly after the discovery of lysergic acid diethylamide (LSD). However, progress was hindered in the 1960s as psychedelics became associated with drug abuse and party culture.
"It's not just that these substances were illegal. They were associated with party culture and the drug scene, regarded with some suspicion and fear by clinicians and the public," commented Prof. Loo, highlighting the prevailing perceptions at the time.
In the 2000s, there was a gradual resurgence of interest in psychedelic research, particularly regarding their potential to aid patients with mental illnesses that were unresponsive to conventional treatments. Ketamine, another psychedelic drug has emerged as an alternative for individuals with treatment-resistant depression.
Prof. Loo was pivotal in establishing the first ketamine randomised controlled trials in Australia in 2016 at the Black Dog Institute.
Despite its effectiveness, the high cost of ketamine treatment remains a challenge, as Medicare does not currently fund it.
With Australia leading the way in legalising the clinical prescribing of MDMA and psilocybin, the field of psychedelic therapies is poised for further exploration. The focus now turns to developing appropriate protocols and guidelines to ensure responsible and safe integration of these therapies into mental health treatments.
"Psychiatry is very complex... Treatment is not a simple protocol where everybody follows steps A, B, and C," explains Prof. Loo. "The most suitable clinical approach for a specific individual at a given time may not always involve psychedelic therapies."
This aspect holds significance, especially considering that the cost of MDMA and psilocybin treatments is anticipated to reach the five-figure range, with no intended government subsidy.
"I'm concerned about the public receiving clear information about all the factors they should consider and be aware of before investing their money. The treatment will likely be expensive—$10,000 or more for a complete course," Prof. Loo says.
"People who are desperate may be willing to pay that amount."
While the potential of psychedelic therapy to assist patients is promising, uncertainties persist regarding its availability to Australian individuals seeking treatment.
According to Professor Loo, mental illnesses such as depression and PTSD are intricate, presenting various possible treatment approaches. Psychiatrists cannot accurately predict whether a patient will respond more favourably to psilocybin, for instance, compared to alternatives like electroconvulsive therapy or ketamine.
As psychedelic therapy's potential benefits and complexities continue to be explored, individuals must make informed decisions regarding their mental health treatment options.
Transparent discussions about the range of available treatments and their associated costs are necessary to ensure patients have a comprehensive understanding before committing to any particular course of action.
Based on Professor Loo's firsthand experience treating patients with ketamine, she anticipates rapid mood shifts among individuals undergoing MDMA and psilocybin therapy. While these shifts can be transformative in a positive way, they also carry potential risks.
"With ketamine, you can go from being severely depressed to completely well within a single day. It's an unprecedented phenomenon. The treatment is incredibly potent in terms of both its effectiveness and rapidity," Prof. Loo explains.
"However, you can also experience a sudden reversal of that entire progress within a day, which can be quite astounding as people are not accustomed to such rapid mood fluctuations. Patients who have undergone both ketamine and psilocybin treatments for depression have shared that the experience is remarkably similar."
Treatment providers must be prepared for these significant mood shifts and assist patients in managing them effectively. This proactive approach is crucial to ensure that patients can fully reap the benefits of psychedelic therapy in both the short and long term.
Another vital consideration is addressing the duration of the treatment's effects and establishing a supportive framework for individuals when the benefits begin to wear off.
While recognising the need for careful implementation of MDMA and psilocybin treatment in Australia, Prof. Loo remains hopeful about the potential of these drugs to transform patients' lives.
"The more powerful the treatment, the more cautious one must be. However, it also opens up greater possibilities for positive change," Prof. Loo concludes.