TGA approves psychedelics for mental health treatment

The Therapeutic Goods Administration (TGA) has announced that, from 1 July this year, medicines containing the psychedelic substances psilocybin (found in magic mushrooms) and MDMA can be prescribed by specifically authorised psychiatrists for the treatment of certain mental health conditions. The TGA said it will permit the prescribing of MDMA for post-traumatic stress disorder and psilocybin for treatment-resistant depression — the only conditions where there is currently sufficient evidence for potential benefits in certain patients.

The decision acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses and follows applications made to the TGA to reclassify the substances in the Poisons Standard, extensive public consultation, a report from an expert panel and advice received from the Advisory Committee on Medicines Scheduling. It means that psilocybin and MDMA can be used therapeutically in a controlled medical setting.

Prescribing will be limited to psychiatrists, given their specialised qualifications and expertise to diagnose and treat patients with serious mental health conditions with therapies that are not yet well established. To prescribe, psychiatrists will need to be approved under the Authorised Prescriber Scheme by the TGA following approval by a human research ethics committee.

There are currently no approved products containing psilocybin or MDMA that the TGA has evaluated for quality, safety and efficacy. This latest 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. For these uses, psilocybin and MDMA will be listed as Schedule 8 (Controlled Drugs) medicines in the Poisons Standard; for all other uses, they will remain in Schedule 9 (Prohibited Substances), which largely restricts their supply to clinical trials.

Reactions to the announcement have been mixed. Adjunct Professor Peter Duggan, a Senior Principal Research Scientist at CSIRO, said the news is “really promising” for patients living with these difficult-to-treat conditions, and it will “also be great encouragement for a number of local Australian companies whose goal is to commercialise psychedelic therapies based on psilocybin or MDMA”.

University of Sydney PhD student Sarah-Catherine Rodan meanwhile thinks the new allowance doesn’t go far enough. She noted, “Safety and efficacy has been demonstrated in other indications such as nicotine/alcohol dependence, obsessive compulsive disorder and end-of-life distress. Further, depression is often co-occurring with these psychiatric disorders. The TGA clearly acknowledges that it does have therapeutic value and states that these substances are relatively safe when administered in a medically controlled environment.

“In Australia, there are clinical trials investigating psilocybin in substance abuse, generalised anxiety disorder, end-of life anxiety, anorexia nervosa as well as depression. Currently, researchers will have to go through the process of handling psilocybin as a Schedule 9 drug and this approval does not change this. I hope that the TGA will consider re-scheduling psilocybin for all treatment-resistant psychiatric disorders so there is greater capacity for researchers to explore its therapeutic potential.”

Professor Richard Bryant, from the School of Psychology at UNSW, said there is still much we do not know about MDMA as a treatment for PTSD, particularly when compared to proven treatments which are much cheaper and simpler to administer. He said, “The science is at a point where we can say it is too early to be prescribing MDMA for PTSD patients; instead, we should be investing in research to understand how MDMA can be used in relation to proven treatments.”

Professor Susan Rossell, a cognitive neuropsychologist at Swinburne’s Centre for Mental Health, added that the new treatments are not well established for a sufficient level of broad-scale implementation. “Substantial further research needs to be done,” she said, “first to confirm efficacy to international standards for all psychotropic medications and to understand which conditions are best treated and which formulations will best serve the patients and minimise risks. We’ve got no data on long-term outcomes at all, so that worries me a lot.”

Mike Musker, an Enterprise Fellow at the University of South Australia, was more optimistic. He said, “The reluctance to using these potential medications is associated with them being used as drugs of abuse where agencies often report on the harm they cause. All psychiatric drugs have some level of side effects which can be harmful and these mind-altering drugs … are no different.

“They do, however, offer hope to thousands of people across Australia where traditional medications have not helped their condition. With the advent of the threshold for these two drugs being reduced to ‘controlled drugs’, we can now start new research trials for their effectiveness in treatment.

“These drugs alter the mind and reduce inhibitions whereby the person being treated may be able to cope with some of the difficult images, memories or thoughts which are accessed more readily and potentially with reduced associated feelings of anxiety.”

Dr David Caldicott, an Emergency Consultant and Senior Clinical Lecturer at the Australian National University, concluded, “MDMA was being used as medication in 1985, when it was banned by executive order of the President of the USA and against the advice of medical professionals and administrative agencies. In the last decade, with advances in functional neuroimaging, it has become abundantly clear that a controlled supply of known doses of both MDMA and psilocybin can have dramatic effects on conditions often considered refractory to contemporary treatment.

“Perhaps most excitingly, many of the treatments that are emerging with these previously banned products require only a brief exposure to facilitate therapy, and not the lifelong prescription of drugs that do little more than dull the edge of psychological trauma.

“The safe ‘re-medicalisation’ of certain historically illicit drugs is a very welcome step away from what has been decades of demonisation.”

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