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This month, the TGA announced a change to current regulations allowing some psychiatrists to prescribe MDMA and psilocybin under limited circumstances as of July this year. This change will make Australia the first country to recognise these once-vilified substances as medications, allowing their use outside of clinical trials.
The announcement was met with surprise internationally, as the TGA had signalled that it would reject the application only three months ago, and jubilation from those who have lobbied hard for this.
Psilocybin, the active ingredient in magic mushrooms, has been approved for treatment-resistant depression.Credit: Getty
On the surface, the rationale is clear. Australia (and much of the world) is experiencing a mental health crisis, with increasing numbers seeking help for mental distress. Many people can’t access evidence-based care, and some who can access care don’t get better with standard treatments.
Both psilocybin (the psychoactive substance in “magic mushrooms”) and MDMA (also known as ecstasy) are better known as recreational drugs. However, a growing body of research suggests that in carefully selected adults, in controlled settings, and combined with psychotherapy as part of psychedelic-assisted psychotherapy, both are relatively safe and may produce rapid improvements in people with post-traumatic stress disorder (in the case of MDMA) and treatment-resistant depression (for psilocybin).
To bolster their case, advocates highlighted individual tragedies to press for increased access. In the recent announcement the TGA reasoned that, given existing evidence and the immense suffering of people with PTSD and treatment-resistant depression, possible benefits of these treatments likely outweigh the risks in these groups.
We don’t agree that the current evidence justifies this conclusion.
Putting aside concerns about limitations of the methods used, effects of psychedelic-assisted psychotherapy in clinical trials have undoubtedly been promising. Yet, these trials are extremely controlled, selecting a small proportion of people who apply to participate to ensure that the treatment does not cause unintended harm.
In the largest trial of MDMA-assisted psychotherapy to date, less than 7 per cent of people who contacted the trial entered treatment. The others were excluded because they had mental illnesses like psychosis or certain eating disorders, substance use problems, or medical conditions.
This is appropriate for this early stage of research. It also means that we can’t easily extrapolate the risks and benefits of these treatments, as used in the real world, from the existing, relatively small body of evidence. It is to be expected that implementation beyond clinical trials in people with more complex needs will increase risks of negative outcomes.
Even in controlled clinical trial settings, concerns about harms have been raised. Psychedelic-assisted psychotherapy puts vulnerable people in an even more vulnerable position because of the profound mental state changes caused by the medications. The best ways to mitigate these issues have yet to be agreed upon.
Another concern is the lack of good data about longer-term effects of psychedelic-assisted psychotherapy. Where most studies only assess outcomes up to a few weeks after treatment, it is impossible to know if some people experience difficulties further down the track.
In addition to harms for patients, there is also a potential for unintended consequences for ongoing clinical research in this area (disclaimer: we are conducting clinical trials of psychedelic-assisted psychotherapy).
Psychedelic research has already undergone one period in the wilderness after the ’60s and ’70s led to widespread banning of human research into these substances. Harms occurring due to early implementation – before there is agreed upon, evidence-based clinical guidance about appropriate treatment parameters and who is most likely to benefit from these treatments – could easily generate public backlash and imperil progress made in the past 20 years.
Advocates for psychedelic-assisted psychotherapy argue that this change will build a healthier and happier Australia. We agree that Australia has a desperate need for new approaches to mental healthcare provision. A key challenge is access: although there are existing evidence-based treatments that work for many – but not all – people, access to expert clinical mental healthcare is out of reach for many. The broader social and welfare issues driving increasing levels of distress also need to be understood and addressed. Allowing psychedelic-assisted therapy access as proposed will not contribute meaningfully to addressing these broader barriers to a healthier, happier Australia.
While we hope that psychedelic-assisted psychotherapies may form part of mental healthcare in the future, we don’t believe that current evidence justifies the recent announcement. Indeed, this decision seems more in response to lobbying and public pressure than evidence. It will likely contribute to the inflated expectations and hype already building around these treatments.
We hope that sufficient safeguards can be put in place to mitigate against risks to vulnerable patients, and that investment in careful clinical research will – with time – yield robust evidence to guide safe implementation of these approaches.
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