Opinion //

Why the TGA should down-schedule psilocybin and MDMA

The Therapeutic Goods Administration should lead the way in destigmatising psychedelics.

On 3 February 2021, the Therapeutic Goods Administration (TGA) handed down their interim decision to not down-schedule psilocybin and MDMA to Schedule 8 (Controlled Drug) when used clinically with psychotherapy. Currently, both drugs are found on Schedule 9 (Prohibited Substance) which heavily restricts their supply and use in Australia. In their decision, the Secretary’s Delegate determined that both drugs had a high potential for misuse and not enough research to back their efficacy and safety. I will argue that this assessment is misguided.

Many natural psychedelics, including psilocybin, commonly known as magic mushrooms, have been used extensively in many cultural and religious settings for their ‘healing’ benefits. Thus, whilst there is generally limited but promising research in the form of clinical trials concerning the use of natural psychedelics and MDMA, there is plentiful anecdotal and survey-based evidence that speaks to the efficacy and safety of natural psychedelics. For example, previous studies have found that ayahuasca use including in shamanic and religious settings resulted in a higher reported quality of life and clinical improvement especially of minor psychiatric symptoms.

In relation to their safety specifically, both drugs have been shown to be safer than many other currently prohibited drugs, and even controlled pharmaceuticals. According to the The Australian drug harms ranking study in 2019, almost all other drugs listed, including cocaine, alcohol, cigarettes, cannabis and prescription opioids, had significantly higher instances of harm to both the user and others. While MDMA (as ecstasy) is known to have significant risks and harms in non-clinical settings, these harms tend to increase when partnered with other drugs. Moreover, psilocybin is generally considered to be safe having a high therapeutic index. According to James J H Rucker, a UK psychiatrist, psilocybin has a therapeutic index of around 1000 compared to cocaine (15) and heroin (6). 

Given this, it seems that there is prima facie evidence supporting the safety and efficacy of psilocybin and MDMA that warrants potential down-scheduling in spite of the Delegate’s claims.

Yet, the Delegate and Mind Medicine Australia, who applied for the schedule changes, seem to contradict each other with regards to what exactly the current research says about the clinical use and safety of these drugs. In a media alert, Mind Medicine Australia contested the RANZCP Clinical Memorandum (CM) on psychedelic drugs which formed a basis of the Delegate’s interim decision. The RANZCP which is currently opposed to the down-scheduling of both drugs, claimed safety concerns and unknowns in the CM, which was critiqued as being misinformed and outdated. This contention, I argue, is rooted in stigma that still prominently influences the science and policy of psychedelic drugs.

Part of the reason for the limited body of clinical research on the potential effects of psilocybin and MDMA is decades of restrictive drug policies rooted in conservative moral panic and the war on drugs. This, in turn, led to the scapegoating of many drugs which were and are still labelled as particularly susceptible to being abused rather than credited for their potential medical uses. Even today, many of the positions taken by medical organisations in relation to both Oregon Measure 109, which regulated and legalised psilocybin service centres, and the proposed down-scheduling continue to claim opposition to these changes by using the guises of ‘limited’ research and unknown/high risks of abuse. This raises questions about the substantive that is used to back up these claims.

Ultimately, I firmly believe that both drugs, particularly psilocybin, should be down-scheduled for controlled medical use. In reality, this is a modest change from the status quo, but one that attempts to break down the stigma that has persistently painted these drugs in a negative light. According to AOD Media Watch, the only practical effect of down-scheduling these drugs would be an increased ease of access through a Special Access Scheme Category B (SAS-B) application, a system that is presently overly complex despite already being possible under the current schedule. However, most importantly, down-scheduling would show that the medical community and the TGA are ready to move on from the unwarranted stigmatisation of psychedelic drugs.

Submissions to the TGA’s interim decision on psilocybin and MDMA are still open on their website until 4 March 2021. Please see Mind Medicine Australia’s Submission Guide if you would like some assistance.

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