The Therapeutic Goods Administration (TGA) in Australia has approved the use of MDMA (ecstasy) and psilocybin (magic mushrooms) for certain medical conditions. However, the decision has received mixed responses. Australia’s peak psychiatric body believes that further evidence is needed to determine the long-term safety and efficacy of these drugs. From July 1, authorised psychiatrists will be able to prescribe these drugs for post-traumatic stress disorder (PTSD) and treatment-resistant depression, following their reclassification in February.
The TGA states that both drugs have been reclassified from a schedule nine listing to a schedule eight listing, allowing them to be prescribed by authorised psychiatrists with control measures in place. These control measures include obtaining approval from a human research ethics committee and using treatments in conjunction with psychotherapy. However, the TGA acknowledges that there are currently no established treatment protocols for these drugs.
Professor Susan Rossell, a cognitive neuropsychologist and professorial research fellow, expressed concerns about the rushed approval process. She is currently conducting a phase 2 trial on the use of psilocybin-assisted psychotherapy and believes that more research is needed to determine the appropriate treatment protocols.
Associate Professor David Caldicott and Dr. Paul Liknaitzky have expressed support for the reclassification, highlighting the potential benefits of these treatments. However, they emphasize the need for professional and public education, as well as considerations of affordability, eligibility, oversight, and standards of care.
Richard Harvey, chair of the Psychedelic Assisted Therapy Steering Group, was surprised by the TGA’s reclassification and believes that more time and resources are necessary for the implementation of these treatments. Martin Williams, a mental health researcher, raised concerns about the limited scope of previous studies and urged further exploration of the drugs’ efficacy in broader population groups.
Psychiatrist Nigel Strauss cautioned against overhyping the benefits of psychedelic-assisted therapy and emphasized the need for a thorough examination of risks and limitations. He mentioned potential adverse effects such as fear, panic, psychological damage, and worsening depression.
Swinburne University in Melbourne will conduct a significant research trial on the use of psilocybin in treating treatment-resistant depression. This trial, involving approximately 160 patients, aims to assess the effects of psilocybin-assisted psychotherapy versus a placebo.
Overall, the approval of MDMA and psilocybin for medical use in Australia has sparked a range of opinions within the psychiatric community, with some calling for more evidence and cautious implementation, while others emphasize the potential benefits and the need for education and proper standards of care.