Nobody expected this one: the Australian government has issued authorization for specially licensed psychiatrists to prescribe two psychedelic substances to patients. They are MDMA, the basis of the recreational drug ecstasy, and psilocybin, originally extracted from so-called “magic” mushrooms, of the genus psilocybe.
The authorization from the TGA, the acronym in English for Administration of Therapeutic Goods, the equivalent of Anvisa, is valid only in particular situations. Only ethics-approved psychiatrists with an authorized specialist license will be able to prescribe the two compounds.
Additionally, prescribing will be viable for only two diagnosed mental conditions: MDMA for post-traumatic stress disorder (PTSD) and psilocybin for treatment-resistant depression. The drugs will have to be administered in a controlled environment, such as hospitals and research centers.
Despite the restrictions, it is a pioneering step towards the regulation of psychedelics as medicines. The TGA decision takes effect in July, when some psychiatrists will probably have already obtained the special license.
From there, the first effect will be to greatly facilitate clinical research with these compounds, in the understanding of psychiatrist Luís Fernando Tófoli, a professor at Unicamp involved in studies of ayahuasca, ketamine and LSD. This is a field in which Australia has intensified activity, and the measure seems designed to encourage more studies.
Australian regulations apparently do not preclude patients from taking MDMA or psilocybin on a one-off basis outside of research protocols. So much so that the agency has already published a question and answer guide with items dedicated to professionals and consumers interested in psychedelics.
“For two or three years the Australian government has been releasing a lot of money for research with psychedelics”, says Nicole Galvão-Coelho, a psychedelics researcher at the Federal University of Rio Grande do Norte (UFRN) who collaborates with Australian researchers.
“We already see psilocybin clinical trials going on in several hospitals, like in Melbourne. They invest in what they believe in.”
The authorization came as a result of a review of the psychiatric use of MDMA and psilocybin commissioned from three experts, Steve Kisely, Public Health System in Brisbane, Mark Connor (Macquarie University) and Andrew Somogyi (University of Adelaide). They evaluated that there is good statistical evidence of benefits of the two substances in the highlighted conditions, mental disorders for which there are few efficient therapeutic alternatives at the moment.
The active principle of ecstasy is closer to approval, as two phase 3 clinical trials of MDMA for PTSD have been completed that should support a license application to the FDA (US drug agency) this year. If the US agency gives its approval, which could happen in 2024 or 2025, ex-combatants and victims of violence could undergo psychedelic-assisted psychotherapy, possibly covered by health insurance.
Psilocybin for depression goes in the same vein. Phase 2 trials have already been published, such as the one by the British company Compass Pathways with 233 patients, and phase 3 trials are in preparation. Its biggest competitor is the Usona Institute (USA).
“It is extremely important that Anvisa removes these compounds from the list of prohibited substances for the group of controlled substances, as the Australians did”, says Tófoli. “That would make Brazilian research immensely easier. And I would go further, also putting DMT [dimetiltriptamina, psicoativo da ayahuasca] in that rating.”
Brazil appeared in third place, in a 2021 survey, as the country with the highest number of scientific articles of great impact on psychedelics. This has happened, in large measure, because of the tradition of ayahuasca studies, including a much-cited UFRN trial that tested the tea against resistant depression.
“I don’t think it’s so easy for this to happen in Brazil, a more conservative, more bureaucratic country,” says Galvão-Coelho.
In the United States, the regulation of psychedelics has been taking place at the initiative of state and municipal governments. Oregon and Colorado voted in referendums for access to psilocybin by licensed “facilitators,” who need not be health professionals. A dozen other states, including California, are debating similar legislation.
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NOTICE TO NAVIGATORS – Psychedelics are still experimental therapies and certainly do not constitute a panacea for all psychic disorders, nor should they be the object of self-medication. Speak with your therapist or doctor before venturing into the area.
To learn more about the history and new developments of science in this area, including in Brazil, look for my book “Psiconautas – Viagens com a Ciência Psychedelica Brasileira”.
On the tendency to legalize the therapeutic and adult use of psychedelics in the US, see the article “Cogumelos Livres” in the December 2022 issue of Piauí magazine.
Be sure to also see the articles in the series “A Ressurreição da Jurema” in Folha:
https://www1.folha.uol.com.br/ilustrissima/2022/07/reporter-conta-experiencia-de-inalar-dmt-psicodelico-em-teste-contra-depressao.shtml
https://www1.folha.uol.com.br/ilustrissima/2022/07/da-caatinga-ao-laboratorio-cientistas-investigam-efeito-antidepressão-de-psicodelico.shtml
https://www1.folha.uol.com.br/ilustrissima/2022/07/cultos-com-alucinogeno-da-jurema-florescem-no-nordeste.shtml
I have over 8 years of experience in the news industry. I have worked for various news websites and have also written for a few news agencies. I mostly cover healthcare news, but I am also interested in other topics such as politics, business, and entertainment. In my free time, I enjoy writing fiction and spending time with my family and friends.
