Australia Legalizes Psychedelics for Use in Depression, PTSD Therapy

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In a move that excited some and concerned others, Australia’s Therapeutic Goods Administration (TGA) earlier this year approved the use of MDMA and psilocybin as adjuncts in the treatment of posttraumatic stress disorder (PTSD) and treatment-resistant depression, respectively, effective July 1. (The TGA performs a similar function to that of the U.S. Food and Drug Administration.) The move makes Australia the first nation to legalize the therapeutic use of psilocybin and MDMA in a controlled medical setting.

“Psychedelics have gone from fringe to fashionable,” said Fernando Espi Forcen, M.D., Ph.D., a psychiatrist at Massachusetts General Hospital who has had an interest in psychedelic medicine for years. “Today, wealthy individuals can arrange for a psilocybin retreat in Jamaica or have an authentic ayahuasca experience in Peru.” Given the growing global psychedelic therapeutic market and a groundswell of citizen advocacy in the United States and abroad, Espi said he is not surprised that some country took the leap to legalize these products.

Beneath the hoopla surrounding this “first” status, Espi and other psychiatrists who work with psychedelics in the United States said there are multiple steps Australia will need to work through before patients there can access the therapy.

Legal, But Likely Out of Reach

“Well, the horse is finally out of the barn,” said David Hellerstein, M.D., a professor of clinical psychiatry at Columbia University Irving Medical Center, who like Espi was not particularly surprised by Australia’s decision to approve MDMA. “Phase 3 clinical trials of MDMA for PTSD have already been completed, so there is robust data out there, though it hasn’t all been published yet,” he said.

Hellerstein said that the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) is in the process of submitting a new drug application for MDMA with the Food and Drug Administration (FDA), and he expects MDMA will be approved for PTSD in this country within a year.

He noted he was more surprised by Australia’s approval of psilocybin because, as he put it, “the phase 3 trials for depression have just started.”

Until last year, he noted that the combined randomized, controlled trial data on psilocybin for major depression involved just over 100 subjects, taken from multiple small studies. In November 2022, the pharmaceutical company Compass Pathways published positive results in The New England Journal of Medicine from a larger phase 2 multinational study of 233 participants with treatment-resistant depression, but that trial involved only one session of psilocybin therapy and followed patients for 12 weeks.

Espi believes the available evidence supports the use of psilocybin for patients with treatment-resistant depression who have exhausted other options such as electroconvulsive therapy. In addition to the Compass study, he cited an April 2021 study that found that participants who had received two sessions of psilocybin-assisted therapy demonstrated mood improvements at six weeks that were comparable to those who took the antidepressant escitalopram. That study was also published in The New England Journal of Medicine.

“I think it’s good that Australia broke ground and made both these psychedelic treatments legal,” Espi continued. “But that is much different from their being feasible and affordable treatments.”

The MAPS model for psychedelic-assisted therapy involves three eight-hour sessions by two trained therapists (one of each sex) in which therapists guide patients through their “trip.” These are preceded by a preliminary engagement session to prepare patients for the experience. Considering average psychotherapist rates, a full treatment course could be around $25,000 (Australian dollars).

Though Australia offers basic health benefits to all citizens through the country’s Medicare, there is no indication that Australian Medicare or private insurance will pick up any significant portion of the tab, Espi said. (Australia operates a shared public-private health care system.)

“A day in inpatient psychiatric care [in the United States] also runs between $3,000 to $5,000, so if we get evidence showing that psychedelic treatment can significantly reduce hospitalization, that provides a rationale to advocate for reimbursement,” Espi said. “But that will require a lot of long-term data.” In addition, Espi said that Australia does not have a significant number of MAPS-trained therapists nor does the country have domestic manufacturers of MDMA or psilocybin.

“When you look at all these barriers, it seems psychedelic treatment will be limited to VIP clinics for a few years,” he said.

Questions About Rollout Remain

Even if patients can afford psychedelic-assisted therapy in Australia, Natalie Gukasyan, M.D., an assistant professor of psychiatry at Columbia University, said it remains to be seen how the clinics will offer this service. Gukasyan was previously at Johns Hopkins Center for Psychedelic and Consciousness Research.

She noted that the guidance documents released by the TGA leave a lot of questions unanswered. For example, there are no defined standards of care (such as how the therapy is delivered); rather, physicians seeking prescribing authorization set out their own protocols and then seek approval from their institute or center’s Human Research Ethics Committees (HREC). Once approved by the HREC, physicians then send their application to the TGA for final approval.

“It will be interesting to see, as applications get approved, what the minimum requirements are, such as how many people should be in the therapy room, what level of certification they need, and what other safety and patient monitoring rules are in place,” she said.

There are also uncertainties as to whether patients will be allowed to continue taking an existing antidepressant or other medications when receiving psychedelic-assisted psychotherapy.

Gukasyan anticipates that Australian physicians and regulators will proceed cautiously and use psychedelic-assisted therapy sparingly. She believes it is unlikely that patient data from Australia will have any bearing on the timing or decisions by the FDA on psilocybin and MDMA. If anything, she noted, the legalization may only add risk, as any publicized adverse outcomes might give FDA some pause.

Hellerstein agreed, noting that rigorous safety measures and thorough post-session assessment will be critical moving forward if psychedelic medicine is to succeed in the long term.”

In clinical practice, MDMA and psilocybin will likely be reserved for people with long-standing refractory depression along with other illnesses, he continued. However, most clinical data have focused on psychedelic efficacy in people without other complex medical issues, he explained. “It’s a vulnerable population, and there are a lot of potential risks.”

Like Gukasyan, Hellerstein thinks the ripples of Australia’s decision won’t be felt in the United States anytime soon, though he hopes the National Institutes of Health is paying attention.

“Why is NIH not funding more research in this area?” he wondered. “There are many important details about psychedelic-assisted therapy we still don’t know, and we need to be ready for when it becomes legal here.” ■