Two years on from Australia’s bold psychedelic experiment, here are our concerns

A 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. They 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.

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. Others withdrew for a number of reasons unrelated to the treatment, including their medical condition worsening, leaving 25 people to complete the trial.

Several clinical trials in Australia and New Zealand are testing psychedelic drugs for a range of conditions. For example, trials have focused on depression, anxiety, prolonged grief, anorexia and addiction.

Psychedelic-assisted therapy offers promise. But in other new research, which has been accepted for publication, we show that the path to safe and equitable access is complex.

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 do this. They’ve been allowed 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 (depression that hasn’t responded to other treatments).

The TGA’s decision to allow psychedelic-assisted therapy was controversial. Its own expert panel concluded the available evidence to support its use was of low quality.

One panel member later criticised 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 signal they may fast-track the approval of psychedelics for psychotherapy. This includes backing from Secretary of Health and Human Services, Robert F. Kennedy Jr.

Slow uptake in Australia

These treatments are still rare in Australia. In the scheme’s first six months, only one patient was prescribed MDMA, and none received psilocybin.

At that time, up to six psychiatrists were authorised to prescribe them. By early 2024, at least ten psychiatrists had been.

Mind Medicine Australia, which advocates for psychedelic-assisted therapy, estimates about 80 patients had the therapy in 2024.

But we don’t have official data.

Unlawful promotion is a major concern

Promoting prescription drugs directly to the public is illegal in Australia.

Yet, 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 remove or amend their advertising.

In the US, however, direct-to-consumer drug advertising is legal, pervasive – even celebrated. So medicalising psychedelics in the US would likely fuel online promotion that would inevitably influence Australian attitudes.

Misconduct and patient risk

A deep concern internationally is professional misconduct surrounding psychedelic-assisted therapy, especially sexual boundary violations. This is any form of sexualised behaviour by a practitioner towards a patient – a profound and harmful betrayal of trust.

Our research, and that of others, suggests the risk of boundary violations is higher in psychedelic-assisted therapy.

The substances can make patients suggestible, lowering social inhibitions while fostering intense bonds with their therapist.

Evidence of therapist misconduct – including allegations of sexual abuse in the US clinical trials – was a key factor in the FDA’s decision to reject MDMA therapy.

Based on the same unethical conduct, the journal Psychopharmacology retracted three pivotal papers analysing the MDMA trial data.

While there have been no public reports of such misconduct in Australia, the international reports raise a serious red flag.

A patchwork of regulations creates barriers

Differences have emerged in how different states and territories apply psychedelic-assisted therapy regulations.

In New South Wales, practitioners need a separate approval from the state’s health department for every patient. Treatment must also occur in a licensed private mental health facility, yet none is licensed for the required day-stay procedure. This has forced NSW patients to travel to Victoria for treatment.

South Australia defines these substances as “drugs of dependence”, and practitioners need special authorisation from the state health minister to prescribe them a full treatment course.

In Victoria, authorised prescribers notify the health department before they treat a patient, with no restrictions on the type of facility.

This inconsistency between jurisdictions creates a “postcode lottery” for care.

A cautionary lesson?

Australia’s decision to medicalise psychedelics was a bold step. But the scheme’s flaws show that legalisation is not a simple switch.

It requires a robust, nationally consistent framework that prioritises patient safety and confronts the unique ethical risks of these powerful medicines.