MDMA and psilocybin approved as drugs for the first time
For the first time in the world Australia has announced that it officially recognizes MDMA and psilocybin as medicines.
February 3 The Therapeutic Goods Administration of Australia (TGA), the government agency responsible for drug regulation,announced that from 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 magic mushrooms, for treatment-resistant depression. Since the TGA has not yet approved any genuine 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 reduction of the list of drugs for medical use. “When I woke up, my email was completely overflowing with people saying, ‘Did you hear what happened?’ I was shocked by this decision,” says Simon Ruffell, a psychiatrist and senior researcher at the Institute of the Psych at the University of Melbourne.
Before advocates rejoice, experts warn that many questions remain about how many people will actually be able to access these treatments from July 1, and whether Australia was rushing before gathering enough evidence on how to effectively deploy these treatments. and safe.
“I think it will take time to pick up the pace,” says Daniel Perkins, associate professor at the Swinburne University Mental Health Center and senior fellow at the University of Melbourne. It’s wise, he says: let him gradually open up to see what works well and what doesn’t. “They probably did it that way on purpose.”
The psychiatrist’s path to drug approval can be long and winding. First, psychiatrists must be approved under the Australian Authorized Prescribing Scheme, which means approval by the Human Research Ethics Committee and then by the TGA. To do this, they will need to prove that they can clinically justify the treatment regimen, that they will have proper management of the treatment process, and that they will use appropriate measures to protect patients. Exactly how these measures look in practice is yet to be 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 how exactly these therapies will be administered, given that the evidence supporting them is based on patients receiving therapy from trained professionals along with the drugs themselves. Because of this, and because the TGA has made the psychiatrist responsible for demonstrating that their prescribing practices are appropriate, it will likely require the provision of therapy in combination with medication, says Rhys Cohen, who sits on a non-executive advisory council The Lambert Cannabinoid Therapy Initiative at the University of Sydney and advises the medical cannabis industry.
And not every psychiatrist or psychologist can safely deliver these therapies. Ruffell points out that in well-established indigenous psychedelic practices around the world, people spend five to ten years at least learning how to work with such substances. “I think it would be a serious mistake to think that psychiatric and psychological qualifications can be transferred to psychedelic substances without additional training.”