Drug policy change to MDMA welcome

Welcomed by many in the medical community, the Federal Government recently announced the rescheduling of MDMA and psilocybin for treating PTSD and treatment-resistant depression, writes David McIlveen.

IN CONTRAST to recent news on the scourge of pokies in Australia and the increasing flow of money from the gambling and alcohol lobby into the major political parties – $2.165 million invested ("donated") in 2021-22, up 40 per cent on the previous year – we’ve just seen Australia take a very slight step towards a more rational and enlightened approach to the regulation of two drugs: MDMA (3,4-methylenedioxy-methamphetamine) and psilocybin.

Last week, the Australian Therapeutic Goods Administration (TGA) announced the rescheduling of MDMA and psilocybin for specific medical use — from Schedule 9 (prohibited substances) to Schedule 8 (controlled drugs) of the Poisons Standard.

From 1 July this year, both substances can legally be prescribed by authorised psychiatrists for treating PTSD (post-traumatic stress disorder) and treatment-resistant depression.

In making the decision, the TGA recognised:

'... there is a need for access to new therapies for treatment-resistant conditions.'

The drugs will be accessible under strictly limited circumstances via the Authorised Prescriber Scheme (AP) – under theTherapeutic Goods Act 1989 – in contrast to cannabis, which is accessible via both the Special Access Scheme and the AP.

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Like cannabis, both substances will remain in Schedule 9 for all other uses (for example, recreational, spiritual and personal), where they have languished for many years as a consequence of the pure politics and ideology of a notoriously irrational and expensive "drug war" that is now over half a century old.

It’s valid to ask how the TGA can classify compounds differently based on indication – that is, the use of that drug for treating a particular illness – when their chemistry and pharmacology is the same.

Progress in other areas of drug regulation and law reform remains painfully slow. For example, in the state of Queensland, even a recent push from Queensland Labor members to simply legalise the possession of small quantities of cannabis for personal use was rejected by the state Labor Government. This, despite a major 2019 report from the Productivity Commission finding criminalisation of drug possession in Queensland has: repeatedly failed to reduce drug use and supply; caused the state’s prisons to overflow and wasted hundreds of millions of dollars.

Criminalisation, certainly of cannabis and other lower-risk drugs such as MDMA, is undoubtedly senseless, irrational, uneconomic and unscientific, but presumably still politically useful… somehow.

Even with the coming rescheduling of MDMA and psilocybin, it should be emphasised that this will, at most, permit those who would benefit from psilocybin or MDMA-assisted therapy to access these drugs under strict supervision without breaking the law.

And even then, this is likely to be slow and expensive. Furthermore, the rescheduling will not extend to all treatment-resistant psychiatric disorders nor be accessible to those suffering from alcohol dependence, obsessive-compulsive disorder, general anxiety and depression, anorexia nervosa or end-of-life distress — where MDMA/psilocybin have proven, at the very least, very promising.

And there will still be material hurdles for researchers trying to obtain these drugs for use in clinical trials, who will need to go through the lengthy and difficult process of obtaining a Schedule 9 drug. These drugs, of course, are in Schedule 9 by default; there is no body of scientific or medical evidence supporting this scheduling.

But back to the positive news at hand. Huge credit is due to the diligent and persistent efforts of Mind Medicine Australia (MMA), which made the original application for the complete rescheduling of MDMA and psilocybin (without the "for restricted medical use only" caveat) back in 2020, which ultimately failed.

The charity launched a new application in March 2022 for the same rescheduling: ‘retaining psilocybin and MDMA In Scheduling 9, but also having a Schedule 8 Entry for Restrictive Medical Use only’, according to specific conditions. In October 2022, the TGA made an interim decision — still against rescheduling.

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Following the interim decision, however, it seems that with a final push from MMA and overwhelming public support in favour of rescheduling (constituting over 98% of the nearly 12,000 submissions made during the processes by researchers, healthcare professionals and consumers), the weight of evidence and reasoning was simply irrefutable.

In announcing its final decision, the TGA stated:

'... they were satisfied that sufficient controls on access to the substances as Schedule 8 drugs could be included in the Poisons Standard to ensure the benefits… would outweigh the risks'.

MMA’s cautious and strategic approach appears to have paid off.

What may have also helped significantly is the authority and expertise of Professor David Nutt, former chief drugs advisor to the UK Government and now professor of neuropsychopharmacology at Imperial College London.

As part of its application process, MMA engaged Nutt who came to Australia following the interim decision in October last year and presented to the TGA on the rescheduling application in November. Notably, Nutt was specifically recognised by the TGA’s delegate in the final decision.

Commenting on the recent positive outcome from the UK, Nutt has said that it would be a

“... denial of science and patient need [if the UK failed to do the same]... In the UK, we should support this new approach for compassionate use in patients who have failed other treatments."

MMA is, as expected, jubilant.

In a media release, executive director and founder of Mind Medicine Australia Tania de Jong AM commented:

'We want to express our enormous gratitude to the tens of thousands of people who have made this breakthrough possible including the TGA, the delegate… and all of the people who put in submissions of support.'

Added de Jong:

'Finally, our hearts go out to all those Australians suffering from treatment-resistant depression and PTSD. They now have the opportunity of accessing this breakthrough treatment with their mental health professionals, which has shown such positive safety and efficacy results internationally.'

Good news indeed.

David McIlveen studied science and environmental engineering at the University of Queensland and now works as an environmental consultant in Brisbane.