Therapeutic psychedelics: Mental health ‘magic bullet’ or expensive trip?

Mental health continues to be the most significant health issue encountered day-to-day by general practices across Australia.
 
And with the burden of disease likely to grow in the wake of the COVID-19 pandemic, so will the need for effective treatments.
 
Some of the more controversial, but nonetheless promising, potential new therapies are the psychedelic substances MDMA (active ingredient in ecstasy) and psilocybin (psychoactive component of magic mushrooms).
 
Research into their potential therapeutic use began as early as the 60s and 70s but was discontinued when they became illegal in light of misuse causing harm.
 
It is only in the past few years that research has once again taken off, with a number of large overseas studies actively using these substances as adjuncts to psychotherapy.
 
MDMA has since been trialled for people with post-traumatic stress disorder (PTSD), while psilocybin has been used in the treatment of a variety of mood disorders, including treatment-resistant depression.
 
Dr Cathy Andronis, Chair of RACGP Specific Interests Psychological Medicine, told newsGP while research into psychedelics in Australia is still in its infancy, it is definitely an ‘area to watch’.
 
‘My take on it is that it offers possibilities for quite interesting and exciting new ways of managing mental illness, particularly chronic PTSD and traumatic experiences,’ she said.
 
‘But we need to be mindful that so far, available overseas studies have shown these substances have to be used in an incredibly controlled and very specific way to be effective.
 
‘They’re really just tools to enable the best use of psychotherapy.
 
‘Psilocybin for example opens the brain up to new experiences by cutting off some of that negative internal chatter. But this needs to occur under the guidance of very experienced psychotherapists who, with the aid of these substances, can enable that person to reprocess a lot of their past trauma.’
 
Currently, these substances fall under Schedule 9 of the Poisons Standard, meaning they are prohibited substances among the likes of heroin and formerly cannabis, which was down-scheduled in 2016.
 
As Schedule 9 substances, their use is limited to medical and scientific research, and subject to strict regulatory controls.
 
In a bid to expand the treatment options for mental illness and increase patient access through pathways such as the Special Access Scheme (SAS), psychedelic advocacy group Mind Medicine Australia (MMA) submitted a request to the Therapeutic Goods Administration (TGA) back in 2020 to down-schedule MDMA and psilocybin to Schedule 8 (controlled drugs).
 
MMA co-founder and Chair, Peter Hunt, told newsGP the move was to provide better access to ‘proven and effective’ therapies for mental illness, particularly PTSD and treatment-resistant depression where remission rates are ‘low’ with current available treatments.
 
That request was denied by the TGA following an independent expert panel review just a few months ago.
 
While the TGA did acknowledge there was emerging evidence of therapeutic value in their notice of final decision, it said concerns remain about the increased risk of misuse and diversion.
 
Mr Hunt said he was disappointed by the decision and refutes claims of any serious practical risk.
 
‘We’ve got a whole range of medicines we already use [in practice] that are actually far more dangerous than these substances, if used inappropriately,’ he said.
 
‘The medical system is actually very good at controlling those substances.
 
‘You also have to ask yourself the question, why would a doctor or pharmacist risk losing their licence to divert medical grade psilocybin or MDMA into the recreational world where that synthesised substance is about 10 times more expensive than what you can purchase on the street?’


Almost $15 million has been set aside to further research into the therapeutic use of psychedelics in Australia.
 
NPS MedicineWise Medical Advisor, Dr Kate Annear, also spoke with newsGP and said she understands some of the frustration in response to the TGA’s decision. However, she added that the use of psychedelics for mental health care is still very much an area of active research both in Australia and internationally, and that there are still risks which ‘need to be better understood’.
 
‘For a medicine to be approved for use in Australia for a particular indication, the TGA must review the submission for its use as well as the available evidence, and find that the benefits outweigh the potential risks,’ she said.
 
‘For the case of the use of psilocybin or MDMA to treat mental health conditions, the TGA found that their use should remain limited to research purposes; however, the current scheduling decision may be reviewed and changed in the future if supported by new evidence.’
 
Dr Andronis agrees and says the psychedelic-assisted treatment process ‘can be very dangerous if poorly supervised or used indiscriminately’.
 
‘Some of these [psychedelic-induced] experiences take hours, so patients must be expertly observed and guided. It’s not as simple as getting a prescription for a pill to take at home,’ she said.
 
‘We’re also very much in the experimental stage and really don’t know what the longer-term effects are going to be.’
 
One of Australia’s leading psychedelic researchers is Dr Stephen Bright, a psychologist and director of the not-for profit organisation Psychedelic Research in Science and Medicine (PRISM).
 
He told newsGP that while his organisation did support the down-scheduling request by MMA, its support was only partial and subject to certain requirements, such as the accumulation of an acceptable level of research evidence and the subsequent development of an expert-led implementation framework.
 
Recent moves to improve local research and better inform future regulatory decisions include a Federal Government investment of almost $15 million into the use of ‘potential breakthrough combination therapies’, including psychedelics.
 
But aside from a lack of research, Dr Bright says two other major gaps remain in Australia that currently preclude the therapeutic use of psychedelics – a lack of appropriate training to deliver psychedelic-assisted psychotherapy, and the absence of national clinical guidelines to support best practice.
 
‘There really hasn’t been the opportunity to train many people because of the way training occurs, which at the moment is in the context of clinical trials,’ he said.
 
While MMA is currently training therapists, Dr Bright says he believes ‘training has to come from the Australian Psychological Society and the various colleges’.
 
‘Any training program also needs input from key stakeholders,’ he said.
 
‘Not only in the development of the training, but also in the regulation of how the checks and balances will be put into place to ensure appropriate quality of service provision – if psychedelic-assisted psychotherapy is indeed something that will be rolled out later down the track should down-scheduling occur.
 
‘There also need to be appropriate clinical guidelines in place, so it would be important to do some work with bodies such as the National Health and Medical Research Council [NHMRC] to develop these.’
 
The lack of training and guidance is why Dr Bright believes it is still too soon to down-schedule MDMA and psilocybin, and says such a move would make Australia the first country to recognise these substances as legitimate medicines.
 
According to Mr Hunt, MMA is working on a new submission to the TGA given the ‘growing evidence’ which ‘is far stronger than the evidence the TGA relied upon to reschedule cannabis from Schedule 9 to Schedule 8’.
 
But even if there were practitioners ready to deliver psychedelic-assisted psychotherapy, Dr Andronis says psychedelics are ‘not magic bullets’.
 
‘Mental health is very complex and has biological as well as psychosocial factors and determinants which also need to be addressed to ensure treatment success,’ she said.
 
‘It is very simplistic to think that you can easily change that through a handful of substance-induced experiences, or by having this awakening that will completely change your life.
 
‘When in fact, for change in your life to become permanent, it requires a change in those determinants as well, so that takes a lot of time, expert guidance, optimism and courage, as well as appropriate services and supports.’
 
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depression MDMA mental health psilocybin psychedelics PTSD TGA