The view from Australia: 5 Questions for psychedelics researcher Paul Liknaitzky
Liknaitzky discusses the future of psychedelics in Australia.
As of July 1, Australia has a new drug policy allowing psychiatrists with special approval to prescribe MDMA as a treatment for PTSD and psilocybin as a treatment for depression. Australia’s Therapeutic Goods Administration announced the rule change in February, which came as a surprise to many in Australia’s psychedelics scene. Some psychedelics researchers have expressed concern about insufficient evidence for psychedelic therapy and the number of unanswered questions around treatment protocols.
But what, if anything, has changed on the ground? The Microdose spoke with Paul Liknaitzky, the head of the Clinical Psychedelic Lab at Monash University, for his perspective from Australia. Liknaitzky has led clinical trials studying the safety and efficacy of psilocybin-assisted therapy in treating anxiety and MDMA-assisted therapy in treating PTSD. According to Liknaitzky, he was the only full-time psychedelic researcher in the country up until about a year ago, but there will be around two dozen active psychedelic studies running by the end of the year, alongside the government’s new authorized prescriber program. “The country’s gone from 0 to 100,” Liknaitzky says.
What's the mood among psychedelics researchers and clinicians in Australia right now?
It’s very mixed. There seem to be some very strong voices that are very excited about and in favor of the changes, while others are skeptical verging on cynical, and deeply opposed to them. This is in contrast to the sense I’ve gotten from the international community of clinicians and researchers, which is almost entirely positive. They say that Australia is taking the lead — “How lucky are you!” — whereas here it feels like there is a lot more negativity. It’s a very new topic in Australia and there are not a great number of people who know what they're talking about in a deep way.
There are a number of factors in the mix: there’s the question of whether these regulatory changes had good rationale behind them, questions about whether professional communities are well equipped and ready to support these changes, and then questions about the motivations of the people who are getting involved in the authorized prescriber context. These are almost entirely private clinics, so there’s corporate motivation in the mix. Also, I see plenty of motivation to make a real difference in mental healthcare.
Australia’s Therapeutic Goods Administration’s policy change took effect July 1. Are there any discernible changes yet on the ground — have any psychiatrists gotten approved to prescribe psychedelics? Have any patients been treated?
Not yet. The steps that need to be taken will take at least a couple of months — and in the case of getting authorized prescriber approvals, it may be much longer than that. For instance, psychiatrists applying for authorized prescriber status first have to submit a protocol to an ethics committee for approval. Only then can you apply to become an authorized prescriber. Then, only after approval can you start to screen your first clients or patients; that could take many more months. And that’s just the permitting and administrative side of things; there are still required steps to procure and store drugs, to build or renovate facilities, to train teams.
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Australia’s Therapeutic Goods Administration requires clients undergoing psychedelic-assisted therapy to be accompanied by a trained facilitator. What is the psychedelic workforce like in Australia — are there enough people trained to support increased demand for psychedelic therapy?
It’s very thin on the ground. There’s a scarcity of adequately trained and experienced clinicians that can responsibly support treatment. The College of Psychiatry issued a guidance document that is quite conservative, and it recommends that prescribers either have prior experience using a psychedelic for that indication in a clinical trial or clinical setting, or that they are supervised by someone who has that experience. We expect that ethics committees will tow that line as well. However, in terms of psychiatrists who have directly delivered MDMA for PTSD in Australian trials, there have been zero. There are two psychiatrists who have directly delivered psilocybin for treatment resistant depression (TRD). And of the active clinical trials in the country, there are only a few, and most are not for PTSD or TRD, so what is going to happen is that there will be a slow process of training and supervision.
As for other facilitators, there are just a small number of mental healthcare workers who have been trained and have experience with patients in trials: there are 25 on my team, and less than an additional ten in the rest of the country. There are probably an additional few hundred mental health care workers who have had exposure to some type of psychedelic training, but I can’t speak to the credibility of training. And in terms of available options for training in Australia, there is very little available so far.
In response to that need, our lab will be setting up therapist training at Monash that will hopefully begin early next year. We are sorely in need of more credible options for training in this country and access to experienced psychedelic supervisors and ability to have placements in these clinics and clinical trials. We’re working with colleagues here in Australia and also in Germany to build an international network for clinical psychedelic supervisors to oversee and assist in that training.
Will these changes affect researchers’ ability to find participants for clinical trials?
It’s hard to say, but I don’t predict there will be difficulty finding participants; the number of spots in a clinical trial is typically a drop in the ocean compared to the number of people who apply. We typically deny something like 90% to 95% of applicants. Plus, the cost of treatment from an authorized prescriber would be an out of pocket cost, which can be avoided if you're a participant in a clinical trial. And, of course, the authorized prescriber program only allows MDMA for PTSD and psilocybin for TRD, so anyone seeking treatment for any other indication would need to be treated within a clinical trial.
Clinical science is fundamentally focused on developing and testing treatments that can have real impact in the world, but the exciting aspect of this change is taking psychedelics out of the ivory towers and into the real world. We are setting up a clinic so we’ll be able to deliver a more patient-centric treatment that is not constrained by some of the realities of clinical trials. That will give us the opportunity to try things we haven't done in clinical trials, like tailoring treatments for patients. Trials take a one size fits all approach, usually with a brief intervention alongside substantial assessment. But now we have the opportunity to do things far more flexibly, like increasing the number of doses or dose levels, altering amounts and types of psychotherapy, or even dual diagnoses combining psilocybin and MDMA.
A lot of treatments look good in a lab but may not translate into the real world. In this case, there's potential for us to get outcomes that outstrip the best outcomes we’ve seen in clinical trials. Our emphasis will be on augmented psychotherapy; our default treatment protocol being something in the order of nine months in duration. My read on the research to date is that the promise of psychedelics treatments may only be fulfilled at scale if we consider it to be an augmented psychotherapy and not just a drug.
What other steps will Australia need to take before MDMA and psilocybin are accessible?
We often think about the approval of the medication as being the pivotal moment in that medication being available. But particularly for expensive or complex interventions, it's actually the reimbursement of that medication or treatment that is pivotal. Cost effectiveness is going to determine whether this actually has an impact at a population level. If it is not cost effective in the terms that insurers and Medicare can see it, then it's going to remain limited to people who can afford it. And that's not what we're after.
At this moment, Australia has a wonderful opportunity and an impressive challenge ahead. We’re very new to this line of treatment, in terms of capacity, training, and experience. The outcomes in these early clinics are incredibly important, not only for the clients that are accessing these treatments, but also for access to future clients, as the data we gather will contribute to cost effectiveness analyses over the coming years. I encourage all my colleagues in to apprentice themselves to those who have a longer track record, to be open and transparent in their conduct and how they monitor their activities, and to take a learning approach to the whole enterprise. We need to be both cautious and curious, learning from precedent and adapting our treatment models and training approaches so over time we get better and better outcomes.
This interview has been edited and condensed for clarity and length.