A groundbreaking trial in Australia involving psychedelic-assisted therapy has shown promising results for improving the mental health of terminally ill patients. Conducted in Melbourne, the study involved 35 participants suffering from advanced, life-threatening illnesses such as cancer and motor neurone disease, all of whom also experienced anxiety and/or depression.
In the initial phase of the trial, participants received either a synthetic version of psilocybin, a compound typically found in magic mushrooms, or a placebo. In the subsequent phase, all participants took psilocybin. The therapy was complemented by psychotherapy sessions with trained clinicians before and after the drug administration. Results indicated significant benefits, including reduced symptoms of anxiety and depression, enhanced spiritual wellbeing, and improved quality of life. Despite these positive outcomes, one participant withdrew due to anxiety during the dosing process, while others exited for reasons unrelated to the treatment, leaving 25 individuals to complete the trial.
As research into psychedelic therapies expands, several clinical trials are currently underway in Australia and New Zealand, exploring their potential for various conditions, including depression, anxiety, prolonged grief, anorexia, and addiction. While the promise of psychedelic-assisted therapy is evident, recent findings highlight that the path to safe and equitable access to these treatments is complex.
Understanding Psychedelic-Assisted Therapy
Psychedelic-assisted therapy, also referred to as psychedelic-assisted psychotherapy, involves administering a psychedelic substance in a controlled clinical environment under the guidance of trained health professionals. Since July 2023, Australian psychiatrists have been permitted to prescribe MDMA and psilocybin for specific mental health issues. With this initiative, Australia became the first nation to implement a national, regulated clinical model for these therapies.
Approval for treatment requires a rigorous process. A human research ethics committee must review and approve the psychiatrist’s treatment plan. Subsequently, the psychiatrist applies to the Therapeutic Goods Administration (TGA) to become an “authorised prescriber” for MDMA in treating post-traumatic stress disorder (PTSD) or psilocybin for treatment-resistant depression. Despite the TGA’s endorsement, the decision has faced criticism. An expert panel concluded that the evidence supporting the therapeutic use of these substances was of low quality, with one member labeling the decision as “too fast and too soon.”
Concerns about the TGA’s approval were echoed internationally when a June 2024 advisory committee of the US Food and Drug Administration (FDA) voted against approving MDMA for PTSD. Recently, officials in the US have indicated a potential shift towards fast-tracking psychedelic therapy approvals, backed by Secretary of Health and Human Services, Robert F. Kennedy Jr..
Challenges and Concerns in Australia
Despite the initial promise of psychedelic treatments, their uptake in Australia has been slow. In the first six months of the scheme, only one patient received an MDMA prescription, and none were prescribed psilocybin. During this period, up to six psychiatrists were authorised to prescribe these substances. As of early 2024, the number of authorised prescribers increased to at least ten, with estimates suggesting around 80 patients accessed therapy in that year, though official data remains unavailable.
One significant issue is the illegal promotion of prescription drugs directly to the public, which is prohibited in Australia. The TGA has already issued over a dozen warning letters regarding unlawful marketing of MDMA and psilocybin, urging clinics, researchers, and media outlets to withdraw or amend their advertisements. In contrast, the US allows direct-to-consumer drug advertising, which could influence perceptions of these treatments in Australia.
Another critical concern is the risk of professional misconduct in psychedelic-assisted therapy, particularly regarding sexual boundary violations by practitioners. Such violations represent a severe breach of trust. Research suggests that the suggestibility induced by psychedelics may elevate the risk of these violations, fostering intense emotional bonds between patients and therapists. Allegations of therapist misconduct during US clinical trials contributed to the FDA’s decision to reject MDMA therapy, and three pivotal studies related to the MDMA trial data were retracted due to unethical conduct. While no public cases of misconduct have been reported in Australia, these international incidents raise significant concerns.
Regulatory discrepancies across states and territories further complicate the situation. In New South Wales, practitioners require separate approvals from the state health department for each patient, and treatments must occur in licensed private mental health facilities, none of which currently meet the necessary requirements for day-stay procedures. This regulatory burden forces patients to seek treatment in Victoria. In South Australia, these substances are classified as “drugs of dependence,” requiring special authorization from the state health minister for prescribing a full treatment course. Meanwhile, in Victoria, authorised prescribers must notify the health department before treating a patient, with no restrictions on the type of facility used.
The inconsistency in regulations across jurisdictions creates what has been termed a “postcode lottery” for access to care, leaving patients uncertain about their treatment options.
Australia’s decision to legalize psychedelic therapies marks a significant step forward in mental health treatment. However, the challenges and imperfections evident in the current system underscore that legalisation is more complex than simply permitting access. A robust, nationally consistent framework is essential to prioritise patient safety and address the unique ethical risks associated with these powerful substances.
