First in the world, Australia has announced it will officially recognize MDMA and psilocybin as drugs.
On February 3, the Australian Medicines Regulatory Authority (TGA)—the government agency responsible for drug regulation—announced Starting July 1, 2023, authorized psychiatrists will be able to prescribe MDMA for the treatment of post-traumatic stress disorder (PTSD) and psilocybin, the active ingredient in ghost mushrooms. surgery, to treat treatment-resistant depression. Since the TGA has yet to approve any actual drugs containing MDMA or psilocybin, patients will initially receive “unapproved” drugs containing these substances.
The decision came as a big surprise. At the end of December 2021, the same regulator decided against rearrangement of drugs for use in medical contexts. “When I woke up, my email was flooded with people saying: ‘Do you know what happened?’ I was shocked by this decision,” said Simon Ruffell, a psychiatrist and senior research fellow at the Psychae Institute at the University of Melbourne.
Before advocates celebrate, experts warn there are still questions surrounding how many people will actually be able to access these treatments on July 1, as well as whether Australia will jump the gun before gathering enough evidence on how to deploy these treatments effectively. and safely.
Daniel Perkins, an associate professor in the Center for Mental Health at Swinburne University and a senior research fellow at the University of Melbourne, said: “I think it’s going to take some time to get up to speed. Here’s the wisdom, he says: Let it gradually unfold to see what works well and what doesn’t. “Perhaps they did it on purpose.”
The path to a completely clear psychiatrist to drug withdrawal can be long and tortuous. Psychiatrists will first need to be approved under the Australian Authorized Prescriber Scheme, which means endorsed by the human research ethics committee and then the TGA. For this, they will need to demonstrate that they can clinically justify the regimen, that they will have appropriate management of the treatment, and that they will use the suitable for patient protection. Exactly what these measures look like in practice has not yet been detailed by the TGA.
In addition, the TGA has yet to provide any details regarding the minimum training standards required for psychiatrists to become authorized prescribers. This makes it ambiguous exactly how these treatments will be prescribed, considering the background of evidence to support them in relation to patients receiving treatment from trained professionals. along with the drugs themselves. Because of this—and because the TGA has delegated the responsibility to psychiatrists to demonstrate that their prescribing methods are appropriate—the provision of combination therapy may be required, said Rhys Cohen, who on the TGA’s non-executive advisory board. Lambert Initiative for Cannabinoid Therapy at the University of Sydney and consulting for the medical cannabis industry.
And not just any psychiatrist or psychologist can safely perform these types of therapy. Ruffell points out that in long-standing indigenous psychedelic practices around the world, people spend at least five to 10 years training to be able to work with these substances. “I think it is a serious mistake to assume that the mental and psychological level can be converted to hallucinogens without further training.”
