Earlier this year, researchers raised eyebrows when Australia's traditionally conservative medicines regulator approved the use of psychedelics to assist therapy sessions. The decision will see psilocybin, found in magic mushrooms, used for treatment-resistant depression. It will also allow MDMA, known as ecstasy in tablet form, for post-traumatic stress disorder (PTSD). The changes come into effect on Saturday, making Australia the first country to classify psychedelics as medicines at a national level. While initial access to the drugs will be limited and costly, many experts and patients are hailing it as a landmark moment. But major health organizations have also urged caution. 'Shining again' Marjane Beaugeois was diagnosed with severe depression in 2017. "Within two months, I lost my mother, grandmother, beloved pet dog and my romantic relationship," she recalls. She couldn't eat, shower, or leave her house in Melbourne -- but says prescription antidepressants left her "zombie-like, unable to cry, self-soothe or feel better". "I'd still go to bed praying not to wake up," the 49-year-old says. When her research for alternative therapies led her to a psilocybin clinic in Amsterdam, she was hesitant. "I have no history of drug or alcohol use. As an addiction counsellor, I was always very against it," she says. But she was also desperate to escape her treatment-resistant depression, so in 2018, she booked herself in. The psilocybin was taken in tea. "Colors became more vivid. I felt powerfully reconnected to the world; warm and fuzzy. I'm getting emotional just talking about it... it was a massive, beautiful experience of unconditional love." Three sessions later, she felt healed. "I could smile, feel joy, go about my daily routine with clarity," she says. "When I got home, friends said they saw my eyes shining again." When Glen Boyes suggested microdosing psychedelics to treat his crippling depression, his therapist was skeptical. "He explained it wasn't something he does, but he couldn't stop me, and would do brain scans to track my progress," he says. The 33-year-old veteran says he began experiencing "lingering PTSD" from his time in the army, during Covid-19 lockdowns in Sydney. But after 10 weeks of microdosing and therapy sessions, red areas on his initial brain scans showing blockages had cleared. "My brain fog evaporated. I could think clearly again." Due to no other country rescheduling these substances for clinical use on a national level, the cohort who've experienced psychedelic therapy is small. Professor David Nutt, Head of Neuropsychopharmacology at the UK's Imperial College, congratulated Australia on "leading the world in this vital treatment innovation". Psychedelic researcher and psychiatrist Dr Ben Sessa described the approval as pioneering. "This is where the global psychedelic spotlight now shines," he told the BBC. Dr Sessa has resigned from his job running the UK's primary psychedelic clinical organization and will spend the next 18 months traveling to Australia to deliver a bespoke psychedelic prescribing training program. Other countries have explored psychedelics for compassionate use, including Switzerland, Canada, and Israel -- where regulators have made similar decisions, although not nationally like in Australia. Psychedelic clinics also operate legally in countries including Jamaica and Costa Rica. But how Australia rolls out clinical prescriptions for both drugs, and at what price tag, will be closely watched. First developed as an appetite suppressant in 1912, ecstasy was used in therapy sessions in the US until the mid-1970s when it was outlawed. It entered Australia in the 1980s as a party drug due to its reported effects of increased energy, empathy, and pleasure, and was criminalized in 1987. In the 2000s though, research slowly started up again — with recent trials finding that both MDMA and psilocybin can quickly improve symptoms of severe depression, though little is known about how they do this. Mind Medicine Australia (MMA), a charity which lobbied for psychedelic treatments, is helping to train health professionals tasked with procuring and prescribing the drugs. To become an authorized prescriber, psychiatrists must apply to an ethics committee and to Australia's drugs regulator — the Therapeutic Goods Administration (TGA). They'll then need to source and supply both MDMA and psilocybin. Once all expenses are factored in -- including the drugs themselves, supervision from multidisciplinary teams, psychiatrist sessions and hiring a private clinic -- costs could spiral to A$30,000 (£15,700, $20,000) per treatment, according to one psychedelics expert. Due to the prohibitive price tag, Dr Stephen Bright, senior lecturer at Edith Cowan University, says he doubts these treatments "will be very widely available at all" for the first 12-18 months. Philanthropist Peter Hunt, chair of MMA, disputes those estimates, telling the BBC patients should expect to pay between A$10,000 for two psilocybin assisted therapy sessions, and A$15,000 for three MDMA assisted sessions. "We costed the treatments with a mental health clinic," he said. But with no planned government subsidies, the five-figure treatments are expected to remain unaffordable for most patients. Not a miracle cure Australia's major medical and mental health bodies are among the loudest voices pushing back against psychedelic treatments. "There's been considerable caution from the scientific and medical community," said Kristen Morely, a professor of addiction medicine at the University of Sydney. According to MMA, the "weight of submissions from thousands of Australians whose current mental health treatments just aren't working" helped get the TGA approval over the line. But the Australian Medical Association (AMA) and the Royal Australian and New Zealand College of Psychiatrists (RANZCP) have expressed serious concerns. Both groups have called for larger-scale studies and better research into psychedelic treatments, warning of unknown risks, long-term side effects and "potentially very limited benefits" from their use in therapy. "Psychedelic-assisted therapy may offer hope to a small number of people where other treatments have been attempted without success. But it's not a miracle cure," warned Professor Richard Harvey, who chairs the RANZCP's Psychedelic-Assisted Therapy Steering Group, warned. He urged a "cautious, considered and informed" approach, due to the "potential for psychedelic substances to cause fear, panic and re-traumatization". "Vulnerable people can understandably feel distressed if their experience doesn't match their expectations of this therapy," he said. It's also unclear, he argued, whether the results from psychedelic treatments stemmed more from the substances themselves, or the psychotherapy. "Put simply, psychedelic-assisted therapy is in its infancy. There is more we need to know." — BBC
