Many mental illnesses are characterized by feeling stuck, trapped, or helpless. The sufferer cannot imagine recovery. It is entirely unsurprising that recreational drugs, which people take to give themselves a different perspective, may have use in shifting this feeling of stuckness. Thus researchers have experimented with a range of psychedelics to assist in psychotherapy over the last ten years, and trials show the psilocybin from magic mushrooms can help shift depressive symptoms and MDMA can do the same for post-traumatic stress disorder (PTSD).
The Therapeutic Goods Administration (TGA), the medicines regulator in Australia, is considering rescheduling psilocybin and MDMA from schedule 9, prohibited, to schedule 8, heavily regulated but prescribable by doctors. For this we owe credit to the extraordinary folks at Mind Medicines Australia. What follows is my submission to their public consultation.
Millions of Australians suffer from treatment-resistant depression or post-traumatic stress disorder, impairing their quality of life as well as participation in our society and economy. It is an indictment on our system of medical and pharmaceutical research that our development of better treatments has been so slow. Worse still is the interference in this quest by politicians privileging culture war over the alleviation of suffering. The history of drug prohibition is clear - the restrictions on psychedelics for both recreational and therapeutic use had no evidence base as a matter of public policy or medical regulation. It is thus darkly ironic that advocates for undoing this historical wrong are now required to meet high standards of evidence to shift this cultural inertia - evidence that has been near-impossible to gather given the restrictions themselves.
Nonetheless, the need is so dire and the therapeutic potential so clear that brave researchers from around the world have indeed amassed a significant body of evidence showing promise in treating depression with psilocybin-assisted psychotherapy and particularly PTSD with MDMA-assisted psychotherapy. The phase 2 trials on the former in May and November 2021 and the phase 3 trial on the latter in May 2021, as referenced in the proposal, are only the latest additions to this research renaissance. They show these therapies are superior to existing treatments to such an extent that they prompt paradigm shifts in our conceptions of what psychiatric treatments can achieve. As well as dramatic reductions in our psychometric scores of symptom severity, patients report that their experiences are among the most meaningful and valuable moments of their lives, and help them reconnect with their loved ones and themselves.
The provisions b and c in the proposed rescheduling, which require the authorizing psychiatrist to undertake specific training in the use of the substance as part of therapy, as well as obtain approval from two independent psychiatrists, would establish an unprecedented level of oversight, greater even than regulations allowing doctors to give involuntary electroconvulsive therapy or proposals for voluntary euthanasia. It is an eminently conservative step that allows treatment of those who need it most while minimizing the potential for abuse, diversion, or improper use. In the unlikely event that diversion does occur, the public can take heart in the knowledge that these substances pose minimal acute, chronic, or social risks, especially compared to alcohol, as well documented by Professor David Nutt.
These minimal risks, the accumulation of supportive evidence, and the enhancement of regulatory protections make the overwhelming case that the benefits of rescheduling outweigh the risks. Our regulators should show that regulation can be evidence-based rather than reflexively punitive, future-focussed rather than change-phobic, and compassionate rather than coercive. Australia has the opportunity to show world leadership as a humane and pragmatic country. The TGA should help us take it.
Dr Tomas Heard
Psychiatric Registrar, Metro South Addiction and Mental Health Services, Queensland Health
Trainee of the Royal Australian and New Zealand College of Psychiatrists
Associate Lecturer, University of Queensland
NB. my opinions are my own and do not represent the official positions of the above organisations, though I believe they one day will.
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