This article, authored by Christopher Rudge and Reeve McClelland, first appeared in The Conversation here.
A recent small Australian trial that used psychedelic-assisted therapy to improve the mental health and wellbeing of terminally ill patients is in the news today.
The results are based on research conducted in Melbourne involving 35 people. All had an advanced, life-threatening illness, such as cancer or motor neurone disease, and also had anxiety and/or depression. In the first part of the trial, they took either a synthetic version of psilocybin (usually found in magic mushrooms) or a placebo. In the second part, all participants took psilocybin. Patients had psychotherapy with trained clinicians before and after taking the drugs. The benefits included reduced symptoms of anxiety and depression, and improved spiritual wellbeing and quality of life. One person withdrew from the trial due to anxiety during dosing, while others withdrew for reasons unrelated to the treatment, including their medical condition worsening. This left 25 people to complete the trial.
Several clinical trials in Australia and New Zealand are testing psychedelic drugs for a range of conditions, including depression, anxiety, prolonged grief, anorexia, and addiction. While psychedelic-assisted therapy shows promise, other new research, which has been accepted for publication, highlights the complex path to safe and equitable access.
What is psychedelic-assisted therapy?
Psychedelic-assisted therapy, also known as psychedelic-assisted psychotherapy, involves a patient taking a psychedelic substance in a clinical setting, guided by trained health professionals. For about two years, Australian psychiatrists have had a legal pathway to prescribe MDMA and psilocybin for specific mental health conditions. When the scheme began in July 2023, Australia became the first country to establish a national, regulated clinical model for these therapies.
‘Too fast and too soon’?
In Australia, a human research ethics committee must approve a psychiatrist’s treatment plan. The psychiatrist then applies to the Therapeutic Goods Administration (TGA), Australia’s medicines regulator, to become an “authorised prescriber” of MDMA for post-traumatic stress disorder (PTSD) or psilocybin for treatment-resistant depression.
The TGA’s decision was controversial, with its own expert panel concluding the available evidence was of low quality. One panel member later criticized the decision as “too fast and too soon”. These concerns were echoed in June 2024, when a US Food and Drug Administration (FDA) advisory committee voted against approving MDMA for PTSD. Now, officials in the new US administration have signaled they may fast-track the approval of psychedelics for psychotherapy, with backing from Secretary of Health and Human Services, Robert F. Kennedy Jr.
Slow uptake in Australia
These treatments remain rare in Australia. In the first six months of the scheme, only one patient was prescribed MDMA, and none received psilocybin. At that time, up to six psychiatrists were authorized to prescribe them, and by early 2024, at least ten psychiatrists had been. Mind Medicine Australia, an advocacy group for psychedelic-assisted therapy, estimates about 80 patients had the therapy in 2024, but official data is not available.
Unlawful promotion is a major concern
Promoting prescription drugs directly to the public is illegal in Australia. The TGA has already issued more than a dozen warning letters for the unlawful promotion of MDMA and psilocybin, compelling clinics, researchers, and media outlets to change their advertising. In contrast, direct-to-consumer drug advertising is legal, pervasive, and even celebrated in the US. This means the medicalization of psychedelics in the US could fuel online promotion that influences Australian attitudes.
Misconduct and patient risk
A significant international concern is professional misconduct in psychedelic-assisted therapy, particularly sexual boundary violations. This involves any form of sexualised behaviour by a practitioner towards a patient, which is a profound betrayal of trust. Our research, and that of others, suggests a higher risk of boundary violations in this type of therapy. The substances can make patients more suggestible, lowering social inhibitions and fostering intense bonds with their therapist.
Evidence of therapist misconduct, including allegations of sexual abuse in US clinical trials, was a key factor in the FDA’s decision to reject MDMA therapy. Based on this unethical conduct, the journal Psychopharmacology retracted three pivotal papers analyzing the MDMA trial data. While there have been no public reports of such misconduct in Australia, these international reports are a serious red flag.
A patchwork of regulations creates barriers
Different states and territories have applied psychedelic-assisted therapy regulations inconsistently. In New South Wales, practitioners need separate approval from the state’s health department for each patient. Treatment must also occur in a licensed private mental health facility, but none is licensed for the required day-stay procedure, forcing NSW patients to travel to Victoria for treatment. South Australia defines these substances as “drugs of dependence”, requiring practitioners to get special authorization from the state health minister to prescribe them a full treatment course. In Victoria, authorized prescribers simply notify the health department before they treat a patient, with no restrictions on the type of facility. This inconsistency creates a “postcode lottery” for care.
A cautionary lesson?
Australia’s decision to medicalize psychedelics was a bold move. However, the scheme’s flaws demonstrate that legalization is not a simple solution. It requires a robust, nationally consistent framework that prioritizes patient safety and addresses the unique ethical risks of these powerful medicines.
Sydney Health Law 
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