TGA's psychedelics approval welcomed but experts urge caution

Monday, 06 February, 2023

TGA's psychedelics approval welcomed but experts urge caution

The Therapeutic Goods Administration has announced that from 1 July this year, authorised psychiatrists can prescribe medicines containing the psychedelic substances psilocybin (found in magic mushrooms) and MDMA for mental health treatment.

The prescribing of MDMA will be permitted for the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression. These are the only conditions where there is currently sufficient evidence for potential benefits in certain patients, said the TGA.

Effects and benefits

Dr David Caldicott, an Emergency Consultant and Senior Clinical Lecturer in Medicine at the Australian National University said the TGA approval represents an inevitable outcome for a process that, in different political circumstances, might have occurred at least five years ago.

“The data that supports this move has been in play for some time, and it is perhaps a reflection of a change in the policy ecosystem that has seen changes being introduced at this late stage, rather than when the evidence to support the move originally became available.

“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 life-long prescription of drugs that do little more than dull the edge of psychological trauma. One of the key groups that stand to benefit in Australia are returned service men and women from the ADF. Their parlous situation is currently the subject of a Royal Commission into Defence and Veteran Suicide.

“The safe ‘re-medicalisation’ of certain historically illicit drugs is a very welcome step away from what has been decades of demonisation. In addition to a clear and evolving therapeutic benefit, it also offers the chance to catch up on the decades of lost opportunity in delving into the inner workings of the human mind, abandoned for so long as part of an ill-conceived, ideological ‘war on drugs’.”

The TGA said the decision acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses. This means psilocybin and MDMA can be used therapeutically in controlled medical settings, but patients may be vulnerable during psychedelic-assisted psychotherapy, requiring controls to protect them.

Safety considerations

Dr Paul Liknaitzky, Head of Clinical Psychedelic Research, Monash University, is leading ‘one of only a few sites in Australia’ already delivering psychedelic-assisted therapies to clinical patients.

Liknaitzky and his team 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 depends on a unique set of professional competencies and considerations that are in scarce supply within mental healthcare”.

“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. With this schedule change coming in a matter of months, Australia has very little time to get across this,” Liknaitzky said.

Professor Susan Rossell, a cognitive neuropsychologist and Professorial Research Fellow at Swinburne’s Centre for Mental Health, who is leading “Australia’s biggest research trial” examining psilocybin for treatment-resistant depression warns caution about the TGA decision because these treatments are not well established for broad-scale implementation and silubstantial further research still needs to be done.

“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, which is one of the reasons why I’m doing my very large study.”

Training requirements

To ensure that people accessing these treatments are not harmed, Dr Stephen Bright, Senior Lecturer of Addiction at Edith Cowan University, suggests it will be important that TGA provides a clear expectation regarding the minimum training standards required for psychiatrists who the TGA approves to prescribe these drugs.

“Further, given people are already accessing the treatments illegally in Australia, this announcement has the potential to create further awareness among the public resulting in more people accessing these treatments illegally through desperation. It will be important that resources are provided by the government to minimise these unintended effects of the legislation change,” Bright said.

Image credit: Imago

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