Many rejoice as Australia takes a groundbreaking step towards embracing psychedelic therapies, yet concerns linger regarding their accessibility.

Australia’s landmark decision

On February 3, Australia’s Therapeutic Goods Administration (TGA), the regulatory authority overseeing medicines, announced a historic move.

From July 1, 2023, authorised psychiatrists gain the ability to prescribe MDMA for post-traumatic stress disorder (PTSD) and psilocybin, the active component in magic mushrooms, for treatment-resistant depression.

However, as the TGA has yet to greenlight any specific medicines containing MDMA or psilocybin, patients will initially receive “unapproved” medications containing these substances.

Unexpected turn of events

The decision caught many off guard. Previously, in December 2021, the same regulatory body had opted against loosening restrictions on these drugs for medical use.

Simon Ruffell, a psychiatrist and senior research fellow at the Psychae Institute at the University of Melbourne, recalls his astonishment, stating, “When I woke up, my email was flooded with people asking, ‘Have you heard what’s happened?’ I was shocked by the decision.”

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Challenges ahead for accessing psychedelic therapies in australia

Before advocates rejoice, experts caution about lingering questions regarding the accessibility of these treatments post-July 1. There are concerns whether Australia has acted prematurely without sufficient evidence to ensure effective and safe implementation.

“I think it will take a while to ramp up,” says Daniel Perkins, adjunct associate professor at the Centre for Mental Health at Swinburne University and senior research fellow at the University of Melbourne.

He advocates for a gradual approach to assess what works and what doesn’t. “They’ve probably intentionally done it this way.”

The process for psychiatrists to obtain clearance to administer these drugs may be arduous. Firstly, they must gain approval under Australia’s Authorised Prescriber Scheme, necessitating endorsement by a human research ethics committee and subsequently by the TGA.

They must demonstrate clinical justification for the treatment regimen, ensure proper governance over the treatment process, and employ suitable measures to safeguard patients. However, the specific details of these measures are yet to be fully articulated by the TGA.

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Training standards and therapy requirements for prescribing psychedelic treatments

The lack of specific training standards outlined by the TGA adds to the ambiguity surrounding the prescription process for these treatments.

The effectiveness of these therapies relies heavily on patients receiving therapy from adequately trained professionals alongside the drugs themselves.

Rhys Cohen, a member of the non-executive advisory board of the Lambert Initiative for Cannabinoid Therapeutics at the University of Sydney, highlights the need for therapists to provide concurrent therapy with the drugs.

The TGA places the responsibility on psychiatrists to demonstrate appropriate prescribing practices, indicating that therapy alongside medication is likely necessary.

Moreover, not every psychiatrist or psychologist is equipped to administer these therapies safely. Simon Ruffell underscores the extensive training required in established Indigenous psychedelic practices worldwide, which typically spans five to ten years.

He warns against assuming that conventional psychiatric and psychological qualifications automatically translate to competency in working with psychedelic substances, emphasizing the need for additional training.

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Challenges and uncertainties surrounding access to psychedelic treatments

One significant obstacle to access is likely to be the cost, as these treatments will not be covered by health insurance. “So it’s probably initially going to be a therapy for relatively well-off people who have these conditions,” says Perkins.

Concerns also arise regarding the safety and long-term effects of these treatments. “We haven’t even looked at any longer-term data yet,” says Ruffell. “The longest data that we have is 12 months. We don’t really know what happens later down the line.”

However, there is optimism about the potential benefits, particularly for treatment-resistant conditions such as PTSD and depression. “The benefit could be really huge,” adds Perkins.

Australia’s pioneering move raises eyebrows globally. While Oregon became the first US state to allow adult use of psilocybin under supervision, the substance remains unapproved in the US.

Predictions suggest the US FDA will approve MDMA for PTSD treatment in 2024. Switzerland permits a limited number of psychiatrists to use LSD and MDMA for psychotherapy.

The outcome in Australia will likely influence other countries’ decisions on offering these drugs for therapeutic purposes in the future. “I think the eyes of the world will be watching Australia now,” concludes Ruffell.

Ruffell expresses both excitement and caution regarding the progress of psychedelic medicine. “The optimist in me is thrilled that psychedelic medicine is finally making strides,” he says. “But the pessimist wonders about potential negative outcomes. I hope not, but only time will tell.”

 

Disclaimer: The information provided on this page is for educational purposes only and should not be considered medical advice. Always consult with a healthcare professional before using any THC product.