Australia’s pharmaceutical regulator, the Therapeutic Goods Administration (TGA), has approved an application by Melbourne-based, not-for-profit, Mind Medicine Australia (MMA) to use psychedelic therapy in a therapeutic setting. The application, which was originally made by MMA in 2020 but was rejected at that time, took a further three years, and a long consultation process involving an independent expert panel to legalise these drugs for psychiatric treatment.
Ethical concerns have previously been raised about the legalisation of MDMA and psilocybin for use in the treatment of psychiatric conditions. Clinicians have argued that there is a lack of research and regulation that proves either are safe to prescribe. However, a phase II trial conducted in late 2022 showed that psilocybin – which is the active ingredient of so-called ‘Magic Mushrooms’ – is twice as effective in a 25mg dose than a 1mg dose for treatment of depression.
Other conditions that it has been proposed the drugs can be used to treat include anxiety, anorexia and substance addiction. This ground-breaking legalisation is a world’s first making Australia the only country to allow the use of the drugs as medications. Other countries, such as Canada and the USA, have only approved psilocybin and MDMA on compassionate grounds or in clinical trials.
Doctors in Australia have been warned that not every patient will have a good experience with the drugs. Susan Rossell, a psychiatrist working on a clinical trial testing psilocybin-assisted psychotherapy said: “It’s not for everybody.” Adding that there is a potential for these drugs to be abused which could lead to other psychological problems. While it is difficult to determine who would react badly to their prescription, Rossell’s research suggests that between 10 and 20% of trial participants experience negative effects from MDMA or psilocybin.
Psychiatrists will have to sign up to the TGA’s Authorised Prescriber Scheme to treat their patients with either MDMA or psilocybin. They will also need to seek approval from an expert panel and provide the TGA with six monthly reports on patient numbers and any serious adverse effects. The Medical Board of Australia will also provide a code of conduct that psychiatrists will be required to follow.
Meanwhile, in June 2023, the FDA published its first draft guidance on psychedelic drugs, suggesting that more research must be carried out to determine the efficacy, dosage and toxicity of these drugs. Tiffany Farchione, director of psychiatry at the FDA, said that: “these are still investigational products.”