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ADUC – Article – Legal psychedelic therapies in Australia. Problems and reflections

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A few days ago, the Australian drug regulatory authority – the Therapeutic Goods Administration (TGA) – surprised experts from all over the world when announced the approval of some psychedelic treatments.

Starting July of this year, the TGA will allow licensed psychiatrists to prescribe psilocybin (found in “magic mushrooms”) for treatment-resistant depression and MDMA (found in “ecstasy”) for the disorder from post-traumatic stress.

I direct the first psychedelic clinical laboratory in Australiawhere we develop psychedelic-assisted therapies to treat various mental illnesses, test their safety and efficacy, explore how the treatments work, and train therapists.

I have witnessed, up close, the rapidly accelerating developments within the field, and in positive public sentiment, over the course of just a few years. But this surprising announcement may have devils — and angels — in the details.

From the desert
Just a few years agoAustralia had no psychedelic research, almost no professional interest, and negligible public awareness of the clinical potential of these treatments.

The first psychedelic experimentation in Australia was approved in 2019. We have set up the first psychedelic clinical laboratory of the country in 2020. And by the end of 2023, there will be more than 15 active psychedelic clinical trials nationwide.

While the TGA announcement was hailed as groundbreaking, there are actually a handful of places where psychedelic-assisted therapies have been approved for very limited clinical use outside of research studies (e.g., access programs compassionate or enlarged over United States, Canada e Israel and a version of authorized prescribers in Swiss).

But this is the first time a government has changed the way these drugs are formally classified (“scheduled”). This may turn out to be a distinction without differences, as only so-called “licensed prescribers” will be allowed to use these drugs outside of trials; or instead, it could prove to be a watershed moment with dramatic effects on the ground globally.

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Emerging evidence
Emerging evidence shows that, when used in conjunction with psychotherapy, some psychedelic drugs can be safely administered and produce large, rapid and long-lasting benefits for a range of addictions and mental health conditions. These include post-traumatic stress disorder, depression, end of life anxiety, use disorder alcohol and addiction to nicotine.

While there are some important research limitations associated with these studies, the results were compelling.

Cautious optimism
Since the announcement, I have spoken to numerous doctors and researchers working in psychedelic studies in Australia, and all have expressed mixed reactions to the TGA news.

There is enthusiasm: for drug policy progress; on the potential access for more people in need; on the prospect of being able to offer patients more suitable and tailor-made treatments without the constraints imposed by clinical trials and rigid protocols.

And then there are concerns: the evidence remains inadequate and the transition to clinical service is premature; that incompetent or poorly equipped doctors could flood the space; that treatment will be untenable for most; that formal oversight of education, treatment, and patient outcomes will be minimal or ill-informed.

Many professionals working at coalface fear that future prescribers, therapists, and decision makers probably don’t know that they don’t know some of the essentials of safe and effective psychedelic therapy.

Angeli o diavoli
TGA ad quotes promising evidence as a basis for your decision. However, his approach does not appear to take into account factors that may be critical to this evidence base and leaves some critical questions unanswered. Here are some things to look out for:

Who treats?

The TGA decision allows only licensed psychiatrists to administer this treatment e he claims that “the product should not be supplied to other professionals who prescribe or administer the product”.

While psychiatrists are an important part of a collaborative care model, they will need substantial psychedelic training to deliver this complex form of drug-enhanced psychotherapy. What will constitute adequate psychedelic training is unlikely to be clarified, nor is it necessary for practitioners to be supervised by psychedelic experts.

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Psychedelic therapies are so different from general psychiatry that simply trusting psychiatrists”they have the training
and competence […] to treat appropriately”
patients who use psychedelics is misinformed.

In addition, any requirement to have psychiatrists present at all treatment sessions (dosing days typically last eight hours and a typical treatment model involves approximately 40 hours of therapy) will make this even less convenient.

Any potential licensed prescriber will need thorough training and ongoing supervision by credible professionals who are experienced in providing psychedelic therapies and should establish collaborative care teams with qualified psychologists and psychotherapists.

Who is treated?

Evidence for safe and effective psychedelic treatments comes from studies with very strict eligibility criteria. More than 90% of candidates for these tests are generally excluded.

Testing is cautious, in part because we know these treatments can destabilize people, exacerbate some symptoms and increase suicide. The excellent track record of safety in nearly all modern psychedelic tests was established in the context of extensive screening.

Authorized prescribing will open eligibility to a greater diversity of people seeking help. This is a good step, but it should be well informed and taken with caution and transparency.

What does the treatment involve?

Since 1999, clinical trials of psychedelics have provided psychotherapeutic support before, during, and after drug administration, one to three dosing sessions. The TGA’s decision mandates none of this, advising “at present there appear to be no established treatment protocols.”

This is a misunderstanding. Although the treatment protocols in the different studies are not all the same, they certainly exist and there is considerable overlap in the treatment approaches used. Improved protocols will be developed over time, but a sensible approach is to start with an approximation of what has been done in trials that have shown safe and effective results.

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Are patients informed before they consent?

Practitioners must make informed decisions about any deviations from precedent and be transparent about those details with patients.

For example, if a prescriber does not provide therapy, does not have psychedelic training or supervision, or offers more than three dosing sessions, patients need to know which aspects of their treatment are outside the evidence base.

Wider prescribing will effectively result in a ‘community-based experiment’ and a basic right of all patients is that they are able to make informed decisions about their treatment.

A brave new world?

There are many more questions worth addressing over the next five months, including those surrounding adequate patient supervision and protection, affordability and reimbursement, and public expectations and awareness.

I feel cautiously optimistic that many more Australian patients may be able to access safe and effective psychedelic treatments and that the Australian mental health sector has an opportunity to learn how best to deliver them.

To those intending to work in this space in Australia, I urge you to curiously begin or continue to climb the steep learning curve, arrange for reliable training, support and resources from those already doing the work, and establish appropriate governance systems , control and transparency.

There is so much potential here, a lot at stake and work to be done.

(Paul Liknaitzky – Head of Clinical Psychedelic Research, Monash University -, su The Conversation del 07/02/2023)

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