Psilocybin & MDMA might be known to most as recreational drugs, but experts say they can treat mental health disorders and should be considered medicines.
Many may not know what the word psilocybin or MDMA acronym mean. How about magic mushrooms and ecstasy? More familiar now, aren’t they? “Magic mushrooms” is the colloquial name given to a class of fungi that contain psilocybin, the psychoactive compound responsible for the infamous “shroom trip”. Meanwhile “ecstasy”, is the street name given to pressed pills containing 3,4-Methylenedioxymethamphetamine (MDMA), which has been a popular club drug since the 1980’s and is famous for producing in users feelings of elation, energy, and compassion.
Last year, an application to amend the current Poisons Standard of psilocybin and MDMA was made to the Australian Therapeutic Goods Administration (TGA). The application requested both psilocybin and MDMA be down scheduled from schedule 9 (prohibited substances) to schedule 8 (controlled medicines). Schedule 9 substances are those considered to have a high propensity for dependency and abuse and should only be prescribed for analysis and medical or scientific research. Meanwhile, schedule 8 substances are available for use but with stringent restrictions. The rescheduling applications for psilocybin and MDMA received 575 and 478 public submissions respectively.
Whilst psilocybin and MDMA are currently schedule 9, they are also both on the Special Access Scheme (SAS-B), which allows health practitioners to apply to prescribe a substance not authorised for supply. However, the TGA itself admits these applications are unlikely to gain approval outside of a clinical trial setting. Further, both Queensland and the ACT have regulations that disallow approval of these substances regardless of TGA approvals. Should psilocybin and MDMA be placed on schedule 8, they will however remain unregistered medicines hence still require SAS approval and be held under the strictest of regulations.
The move to apply for rescheduling comes following emerging evidence in psychedelic science that displays both psilocybin and MDMA have significant positive effects on varied mental, behavioural, and developmental disorders including PTSD, treatment-resistant depression, anxiety disorders, substance use disorders, and end-of-life distress, among others. Following the application and public submissions late 2020, the TGA released an interim decision in February 2021 rejecting the proposed change for both substances. The primary reasons supplied for the decision cited:
- limited (but emerging) evidence of the therapeutic benefits
- unknown long-term side effects
- possibility of psychosis
- high risk for misuse
In response to the interim decision, further submissions were made that refuted many or all of these claims. In April 2021, the TGA responded by commissioning an independent review into the therapeutic value, risks, and benefits to public health outcomes of psilocybin and MDMA. This meant the long-awaited final decision due later that month would be postponed. Soon after, the panel responsible for this review was announced; it included Professor Mark Connor from Macquarie University, Professor Steve Kisely from The University of Queensland, and Professor Andrew Somogyi from The University of Adelaide.
In the afternoon of 30th September 2021, the panel’s review was published online. Those with interest in the field scoured over it at pace, hoping the words they read were synonymous with what they themselves believed. Those in favour of rescheduling might have found the most salience within lines such as “effect sizes were large in all MDMA comparisons”, and “Psilocybin and MDMA were well tolerated in all studies”. Whereas those holding more cautious attitudes may well have focused upon statements discussing the limited amount of studies published thus far, small sizes of these studies, the highly structured environments in which they were conducted, and limited generalisability of findings.
- Both MDMA and psilocybin were well tolerated in all studies
- There were no related serious adverse effects, suggesting these therapies may be safer alternatives to some currently available options.
- Evidence was strongest for MDMA, especially in doses of over 100 mg
- There were only 8 eligible MDMA studies and 6 eligible psilocybin studies included in analysis
- Number of participants ranged from 6 to 90, the average being just 29 people per study.
The authors of the review concluded by stating “MDMA and psilocybin may show potential as therapeutic agents in highly selected populations when administered in closely supervised settings and with intensive support. Evidence appears strongest for MDMA.”
In light of the recent changes in public attitudes towards psychedelics, Dr Stephen Bright of Edith Cowan University and psychedelic research charity PRISM provided ABC’s Hack with a sobering warning: “For people that have a pre-existing mental health condition, adding the drugs on top of that without proper psychotherapy is actually quite dangerous and could lead to their condition becoming worse rather than better.” Meanwhile, Professor at Black Dog Institute and School of Psychiatry UNSW Colleen Loo described the current stage of research development as “still very early” and reminded listeners that more evidence would be needed before these promising treatments can be confidently approved.
The TGA is expected to publish a final decision on the application to reschedule psilocybin and MDMA in December 2021.