Thread by @rhyscohen

How accessible will MDMA and psilocybin be, following the Australian government's decision to make them available as Schedule 8 controlled drugs?

Probably not very accessible at all, for a bunch of reasons:

First, the Therapeutic Goods Administration has determined that from July 1 2023, MDMA to treat PTSD and psilocybin to treat treatment-resistant depression may be approved for patient use by a qualified psychiatrist.

tga.gov.au/sites/default/…

However, before treatment is permitted, the psychiatrist must become an Authorised Prescriber for the drug and medical condition in question. This requires them to seek the endorsement of a Human Research Ethics Committee or specialist College, and the TGA.

To get that endorsement, the psychiatrist must satisfy the HREC/College that they have sufficient processes, procedures and expertise to safely use the drug in clinical practice, including a detailed treatment protocol. Then do the same thing for the TGA to get AP approval.

The TGA's statement clarifies that "there does not currently appear to be any established treatment protocols", leaving the "onus and opportunity with a prospective prescriber" to develop, justify, and seek HREC and TGA approval for their protocol.

tga.gov.au/sites/default/…

That is a significant hurdle. But not as big as this: the Royal Australian and NZ College of Psychiatrists stated in July 2022 that, "clinical use of psychedelic substances should only occur under research trial conditions".

ranzcp.org/files/resource…

So any psychiatrist who wants to pursue this treatment option for their patients will have to develop a new treatment protocol and get that approved by an HREC, or by their College, which formally opposes what the psychiatrist will be seeking permission to do.

Based on very similar events that occurred with the legalisation of medicinal cannabis, I predict that, at first, access will be non-existent. HREC/College endorsements will be declined. People will blame the TGA, who will say it's not up to them, there's a process, so follow it.

This will go on for months while the media runs stories featuring desperately sick people who can't get the treatment they want, and a small number of psychiatrists who don't care about painting a professional target on their backs.

Eventually the political pressure will get too much, and the TGA will be forced to expand access, possibly to include the SAS-B pathway which does not require HREC/College endorsement. This will give rise to psychedelic clinics, which will proliferate.

Access will be massively expanded, and hopefully this results in better treatment outcomes for more people. But we should do everything we can to ensure that potential harms are minimised, especially for vulnerable populations.