World-first: Magic mushrooms and ecstasy get the thumbs up for clinical use

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In a world first, the Therapeutic Goods Administration has approved the use of psychedelics for mental health treatment in Australia.

It’s surprising that Australia is the first country take this step, given our long-standing conservatism on the use of what are otherwise illicit drugs.

From July 1, medicines containing the psychedelic substance psilocybin, which are found in magic mushrooms, will be approved as a therapy for treatment-resistant depression.

“Prescribing will be limited to psychiatrists, given their specialised qualifications and expertise to diagnose and treat patients with serious mental health conditions,” a TGA statement read.

In cases where all else has failed

Psilocybin has been found to serve as a breakthrough drug in patients that have otherwise been held hostage by severe depression.

The approval of psilocybin is probably not a great surprise, with the research (many, many studies in hospital settings) being well reported in news media.

MDMA, also known as the party drug ecstasy, will be allowed for the treatment of post-traumatic stress disorder.

Again, research shows it has had success as a breakthrough drug in clinical studies.

Even so, it’s possibly the more controversial approval.

Expert reaction is mixed

Professor Susan Rossell is a cognitive neuropsychologist at Swinburne’s Centre for Mental Health. She is the lead researcher on Australia’s biggest research trial examining psilocybin for treatment-resistant depression.

Professor Susan Rossell.

Professor Rossell is concerned the approval of psilocybin for clinical use is premature.

“I have a significant degree of caution about this decision because these treatments are not well established at all for a sufficient level of broad-scale implementation,” she said.

“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.”

A change in government allowed the ‘inevitable’

Associate Professor David Caldicott is a clinical senior lecturer in Emergency Medicine at the Australian National University.

Dr Caldicott described the approval of MDMA and psilocybin as “an inevitable outcome for a process that in different political circumstances, might have occurred at least five years ago”.

Professor David Caldicott.

He said the data that supports this move “has been in play for some time”.

He noted that MDMA was being used as medication in 1985, when it was banned by executive order of the US President, 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,” he said.

He said one of the key groups “that stand to benefit in Australia are returned service men and women from the ADF”.

Do we have enough specialist training?

Dr Stephen Bright, senior lecturer at Edith Cowan University, says his concern is that “the safe provision of these treatments requires extensive training, which is why they have been limited to clinical research in Australia to date”.

He said it was important the TGA provides “a clear expectation regarding the minimum training standards required for psychiatrists who the TGA approves to prescribe these drugs”.

Dr Paul Liknaitzky.

Dr Paul Liknaitzky, as head of Clinical Psychedelic Research at Monash University, leads one of the few sites in Australia that is already delivering psychedelic-assisted therapies to clinical patients.

Although he had witnessed up close “the potential of our treatment to change people’s lives for the better”, the safety and effectiveness of psychedelic therapies depended on a unique set of professional competencies and considerations “that are in scarce supply within mental health care”.

He said with the TGA approval coming on line in a matter of months, Australia has very little time to prepare.

Existing therapies have more certainty

Professor Richard Bryant is with the School of Psychology at the University of New South Wales. He noted there is evidence that MDMA can be beneficial in treating PTSD but said there was much we do not know.

Professor Richard Bryant.

“We currently have strong evidence-based treatments for PTSD, and to date, we do not know how MDMA compares relative to these proven treatments, which are much cheaper and simpler to administer,” he said.

Instead, he said, “we should be investing in research to understand how MDMA can be used in relation to proven treatments”.

On the other hand

Professor Kim Felmingham is chair of clinical psychology and director of the Brain and Mental Health Research Hub, at The University of Melbourne.

Professor Kim Felmingham.

She said the approval for MDMA-assisted therapy for PTSD is a promising and exciting development, based on positive results in initial clinical trials.

Professor Felmingham said that developing novel treatments for PTSD is “sorely needed, particularly for PTSD patients for whom our gold-standard treatments have failed”.

However, further rigorous research is required to understand the mechanisms underpinning MDMA-assisted therapy, so we can address the critical question of what therapy works for each individual with PTSD.

“No one PTSD treatment is a panacea that will treat everyone with PTSD effectively, and MDMA is not an exception.” she said.

The expert commentary was provided by the Science Media Exchange.

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