Australia has become the first country in the world to permit the use of MDMA and mushrooms for medical purposes.
The psychedelics were approved as a new option for treatment-resistant cases of mental illness.
Australia’s drug regulator, the Therapeutic Goods Administration, announced that there is “sufficient evidence for potential benefits in certain patients” who have been diagnosed with post-traumatic stress disorder and psilocybin for treatment-resistant depression.
“The decision acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses. It means that psilocybin and MDMA can be used therapeutically in a controlled medical setting,” said the TGA in a Feb. 3 statement. “However, patients may be vulnerable during psychedelic-assisted psychotherapy, requiring controls to protect these patients.”
MDMA and psilocybin-containing mushrooms will still be classified as prohibited substances but will be legally permitted to be used as part of clinical trials.
“There are currently no approved products containing psilocybin or MDMA that the TGA has evaluated for quality, safety and efficacy,” said the administration. “However, this amendment will allow authorised psychiatrists to access and legally supply a specified ‘unapproved’ medicine containing these substances to patients under their care for these specific uses.”
Professor Susan Rossell of Swinburne University conducted the nation’s largest research trial on the effects of psilocybin on depression. She told Perth Now that more research is needed before mushrooms are offered to mental health patients.
“These treatments are not well established at all for a sufficient level of broad-scale implementation,” she told the outlet. “We’ve got no data on long-term outcomes at all, so that worries me a lot, which is one of the reasons why I’m doing my very large study.”
Monash University’s Dr. Paul Liknaitzky stressed the new treatment options must be overseen by knowledgeable professionals. Liknaitzky leads clinical research that offers psychedelic-assisted therapies to patients.
“We have witnessed up-close the potential of our treatment to change people’s lives for the better, yet the safety and effectiveness of psychedelic therapies depend on a unique set of professional competencies and considerations that are in scarce supply within mental healthcare,” he said. “For clinical psychedelic services to be sensible, safe and useful, considerable professional and public education will be needed, and questions of affordability, eligibility, oversight, and standards of care should be addressed.”
An Independent Expert Panel was formed in August of 2021 to review the proposal to downgrade MDMA and psilocybin from schedule 9 (prohibited drug) to schedule 8 (controlled drug). In December of 2021, the panel published its finding and announced that “that MDMA and psilocybin may show promise in highly selected populations but only where these medicines are administered in closely clinically supervised settings and with intensive professional support.”
“Although there have been several recent systematic reviews, studies and participants have been limited, and the field is rapidly evolving with the publication of more studies,” noted the panel.
Only authorized psychiatrists will be able to prescribe both MDMA and mushrooms on July 1.
