MELBOURNE: Psychedelic-led therapy is unlikely to be extended to terminally ill people experiencing end-of-life distress after Australia’s drug regulator flagged its intention to reject the proposal.
In its interim decision, the Therapeutic Goods Administration says it believes the current scheduling for psilocybin-led therapy remains “appropriate” and does not need further expansion. That’s despite 590 of the 595 submissions it received expressly supporting the proposed expansion for the terminally ill, and only two categorically opposing it.
“I am satisfied that the current scheduling of psilocybin for the proposed indication remains appropriate and that the risks and uncertainties … for this indication outweigh the benefits with the current limited evidence,” reviewers wrote of the interim decision.
Australia legalised the use of MDMA as a treatment for PTSD and psilocybin for treatment-resistant depression in 2023. However, both drugs must be used only in combination with psychotherapy under tight restrictions, and only a selection of trained and approved psychiatrists can prescribe them.
Reviewers for the proposed change noted that while clinical studies did show positive results around the spiritual wellbeing of ill patients, the studies were based on small sample sizes. They also said existential distress at end of life is not a recognised diagnostic category, which poses additional issues.
“I am not satisfied that the factors which supported the 2023 amendment apply with equal force for the current proposal,” reviewers wrote.
Not-for-profit organisation End Wise proposed psilocybin-led therapy be made available for people diagnosed with certain terminal illnesses who are suffering from existential distress. The group advocates for the integration of psychedelic-assisted therapy into palliative care.
End Wise co-founder Justine Topfer said the TGA’s decision was a missed opportunity.
“This decision denies people at the end of life access to a therapy that could bring them peace. It’s a failure to recognise suffering in its full dimension,” she said.
The group has urged the regulator to reconsider its position before it makes its final determination in coming months, and called on the federal government to fund more clinical trials into the therapies.
End Wise said it would not stop advocating for change: “Existential distress affects more than half of people facing a terminal illness. It’s not just fear of death. It’s the crushing weight of meaninglessness, isolation and emotional pain that conventional medicine can’t touch.”
The TGA said Palliative Care Australia opposed End Wise’s proposal, raising several concerns including that the therapy remained “experimental”, evidence was not robust, and training was problematic.
“They (Palliative Care Australia) raised concerns around the ambiguity of the qualifications and training required to deliver this proposed therapy,” reviewers noted.
In explaining its intent to reject the proposed expansion, the TGA agreed and went on to list therapist training and credentialling as “risks”.
Yet, just last week, the TGA announced several immediate changes to psychedelic-led therapy outside of palliative care. Some of the most significant are that the approved prescriber no longer needs to remain on site for the entire dosing day and clinics need to be within 15 minutes of an emergency department.
The TGA also broadened the rules around who can conduct the associated therapy sessions. Previously, they had to be overseen by a clinical psychologist or psychiatrist and one other therapist.
That has been expanded beyond those two professions to include at least one therapist who holds a registration with either the psychology board with endorsement as a clinical psychologist, medical board with general registration, nursing and midwifery board with mental health experience, or occupational therapy board. That is so long as they complete the appropriate training in psychedelics.
The TGA’s decision to significantly expand who can conduct the therapy sessions and then, just days later, flag that it has concerns about the quality of training provided to those therapists has been described as contradictory and confusing.
“It definitely raises some cognitive dissonance for me,” clinical psychologist Shai Hipperson said.
Ms Hipperson provides the therapies and advocates for greater access to them, but said major gaps remained around therapist training, patient safety and affordability, and she had concerns about the changes.
“The option of having a GP or a mental health nurse or an occupational therapist to maintain a primary clinician role means it is optional for a psychologist’s involvement – which is a great concern given how novel this treatment is and also the depth of treatment from a mental health perspective,” she said.
She said honest conversations were needed about what skills and qualifications should be required of practitioners. She is calling for the introduction of minimum training standards for psychedelic medicine.
“These treatments can involve intense trauma processing, emotional vulnerability and highly altered states of consciousness,” Ms Hipperson said. “If these experiences are not managed correctly, there is a very real risk of psychological harm or retraumatisation for patients.
“There are courses claiming to train psychedelic therapists in as little as two days, while others involve years of supervised clinical training. The average patient has no way of understanding the difference in skill, competency or psychological experience between practitioners.
“This is an emerging field with enormous potential, but we need to get the foundations right from the beginning.”
Some doctor groups continue to urge caution around the therapies, saying there’s too much enthusiasm from too little evidence, although data is still being gathered to try to understand the long-term effects of the therapies.
Health insurer Medibank Private last year announced it was funding a clinical study into psychedelic therapy, while the Department of Veterans’ Affairs agreed to fund MDMA and psilocybin-led therapies under strict clinical conditions for ill veterans.
Public consultations about the TGA’s interim decision remain open until July 3.