The Citizen Campaign That Made Australia First in Psychedelic Medicine

I mean, the reason why there's so many people seeking so many different alternative therapies is because the current medicines or drugs in the pharmaceutical system are not working for as many people as they need to be, and there's an enormous amount of unnecessary suffering that's occurring. And there's a range of different treatments that are safe and effective that are being discovered by citizens because we now have a worldwide web and we have many ways that people can discover these treatments. And if they can't get them legally in clinical environments, then they're going to go underground and try and get them off the black market or take their own risk. Because people at the end of the day want to get well. They want to lead a meaningful life and a happy and healthy life, which is every person's birthright.

Australia made history by rescheduling MDMA and psilocybin for therapeutic use, and it didn't happen the usual way. It came from thousands of citizen submissions, growing scientific evidence, and a recognition that current mental health treatments just aren't working for most people. In this episode, I sit down with Tanya de Jong to talk about how they made it happen, what this means for patients and psychiatrists, and why taking ownership of your own mental health might be more important than ever. This is about changing the system when the system isn't serving people.

My name is Dr. Fleet Maull, and I'm very happy to be here this morning with Tanya de Jong. How are you, Tanya?

Very good. Thank you, Fleet. It's a pleasure to be with you again.

Your career covers so many dimensions of society and it's such a, a celebrated career. It's quite amazing. And we are gonna focus on a particular aspect of your work for this interview on Mind Medicine Australia and your advocacy for psychedelic-assisted medicines and therapies as something you and your husband became very passionate about. And you've been very successful in moving that movement forward in Australia. So as we all know, about 18 months ago in Australia, the TGA, which is for those in the US, it's equivalent of the FDA more or less, and in Europe, the EMA approved and rescheduled both MDMA and psilocybin for therapeutic use. I believe this went into effect in July of last year, July 1st of last year. And so this is a decision that's been celebrated broadly internationally in the psychedelic community among advocates for psychedelic-assisted medicine. And it's also brought up some issues around the whole process of how psychedelic drugs, which are considered by some that have risks associated with them, go through a process of determining safety and efficacy and become approved by agencies and then rescheduled for prescription by medical professionals, psychological professionals. And in Australia, although your applications were based on the current scientific evidence as it stands, the process was quite influenced by more traditional lobbying and advocacy efforts. You know, some have raised some questions about where the locus of decision-making arises. Is it through those kind of efforts, is it should be solely in the purview of the scientific community, should be solely the result of a long clinical trial process and so forth, like what's going on here in the US. So I'm just curious about your thoughts about how you managed to create this amazing success. I mean, really the first country in the world to do this, and quite inspiring. I remember when I first saw it in the news, I was like, wow, you know, it's amazing. So your thoughts about that and what's currently going on in the US, we have this pending decision of the FDA here this month and so forth. So just your thoughts on the overall process of how this works and how it might work going forward for other countries.

Sure. Well, I mean, obviously, you know, we're all delighted, not just the psychedelic community, but the broader community in general is very excited about the rescheduling of these medicines. And at first we couldn't believe it when we read the announcement. I kept saying to my husband, are you sure? Are you sure? And then I read it for myself and we started dancing around the kitchen, but I would just preface this by saying that there is confusion between rescheduling of an unregistered medicine, which is what occurred in Australia, as compared to the registration of, of a medicine, which is what's currently in process in the US with MDMA. So with the rescheduling of an unregistered medicine, you still need to present an enormous amount of scientific data to support safety and efficacy to the regulator. So that was all provided to our Therapeutic Group, and these submissions are available on our website so people can see they're very long and detailed documents. And the rescheduling applications wouldn't have succeeded if the TGA had not agreed with the scientific arguments that we put forward. And then we combined those scientific arguments with a major campaign to drive it home to the TGA and the government more broadly that the levels of suffering in our community are so very high. And current treatments for mental illness don't work for the majority of patients. So in other words, given the system failure for many people, unregistered medicines, providing they satisfy the safety and efficacy requirements for unregistered medicines, are seen as a way of balancing the need for innovation to reduce human suffering against the long, arduous, and expensive process involved with more trials and registration. So the Australian government was provided with existing trial data to make their decision. And of course, much of that data is extremely compelling and that supported their rescheduling decision. Now, of course, we are seeing that similar campaign is being used by MAPS as part of its registration application for MDMA currently in the US. But at the end of the day, bureaucrats have to weigh up their understanding of the scientific data available with the enormous levels of unnecessary suffering in the community. Which are unacceptable in my opinion.

So just so I'm clear about this, so in Australia then, were MDMA and psilocybin already previously registered drugs?

No. So the rescheduling enables unregistered medicine. So this has happened as well with medicinal cannabis in the past few years.

Okay. I understand that. Yes.

Yeah. So that's the sort of process that, that we achieved, and that was a world first. Because Australia was the first nation to reschedule those medicines, but that's entirely different from the registration process taking place in the US.

Yeah, I think—

That's not to say though that registration will not occur in Australia. It's very likely to occur for both medicines in the coming years.

I see. I think generally the language, at least that most people are using here in the US, is FDA approval, which is the same thing as registration. So I suppose it would've been possible for to get the DEA to reschedule MDMA without the FDA approval process, but very unlikely, I think, in this country. It seems to be that those processes are pretty deeply embedded. And it does look like if the FDA approves MDMA as now a registered drug with medical purposes, that by the DEA's own policies, it'll almost be de facto that it will reschedule it. We'll find out about that soon because the decision is pending. You're probably aware of the not so wonderful recommendations from the DEA Advisory Committee— sorry, the FDA Advisory Committee. I wonder if you have any thoughts on that. Some people felt that, you know, they were expressing reasonable caution and pointing to some reasonable questions about the protocols, but the research protocols, but others just seemed, myself included, it seemed very ill-informed and didn't acknowledge that the FDA was involved in the protocol design to begin with. So it seems a little bit—

Exactly, and provided the breakthrough therapy status to begin with, right? I mean, yes, I mean, it would be very disappointing if this was not registered at this time because the scientific data demonstrably does support registration. These Phase 3 trials are very compelling and the remission rates are so, so high, and I'm sure you'll be covering that in the summit. Now we'll have to wait and see what the FDA actually says. For example, they may require more information. I believe it's highly unlikely they'll straight out reject. We've read the transcript of the FDA advisory hearing and we don't believe the advisory members were well-informed and nearly all of them were from different unrelated fields of expertise. And we have to get beyond the blinding argument. We need to focus on those who are suffering rather than expecting a perfect system to begin with, which hasn't actually been invented yet. The whole point is really to bring these therapies into practice, develop real-world evidence, and then work out what are the most effective therapies that create the longest lasting remissions for patients.

Mm-hmm. So all this kind of brings up some really important issues in our healthcare systems worldwide altogether, and especially in the West around the empowerment of patients, the role of citizen advocacy and so forth. Here in the US, there was a lot of suppression of alternative medicines for a long time, including by the FDA, in some ways even criminal criminalization of it. And it was really the citizenry just, I mean, at one point it was discovered that the US citizens were spending something like 60% of their healthcare dollars on alternative treatments and alternative medicines. And I think that woke up the establishment. But this is clearly, people want things that work and they want access to things that are going to provide healing. And I think they want a greater voice. There's, there's this effort around the world of microdosing of kind of citizen research, the work of James Fadiman and Paul Stamets, uh, they would collected a lot of direct report data from citizens. And now in Paul Stam's case, that is gonna lead to some clinical trials. But you know, there's, I think it's just interesting as we see this whole landscape moving and changing, the role of the scientific community, the role of the citizenry and advocates, the role of the patient and the physicians, as well as the political implications. So, but anyway, the, it's great news that, that you were successful in Australia. So now that it happened, and I guess it's actually been in maybe to prescribe it for about a year now. So how are things unfolding there?

Well, Fleet, I wouldn't mind just coming back to just your point on citizen, you know, advocacy and things like that just for a moment, because I didn't mention, but there were more than 10 times as many submissions supporting the MDMA and psilocybin applications that we put into the TGA than ever received for any other medicines, including medicinal cannabis. And the bulk of the public submissions came from people who were direct stakeholders in the mental health system. So for example, researchers, clinicians, patients, and their carers. So these are the people who directly see the level of suffering in communities. And in the case of researchers and clinicians, they're very capable of analysing currently available scientific data. And in the case of patients, there is a human right that, you know, anyone should have access to safe and effective medicines. And that at the end of the day, these decisions of what is prescribed to a patient should be a decision that is made by the doctor and their patient, not by governments and other bodies. It really is up to an individual doctor and patient to make that decision. And to your point about alternative therapies, yes, I mean, the reason why there's so many people seeking so many different alternative therapies is because the current medicines or drugs in the pharmaceutical system are not working for as many people as they need to be, and there's an enormous amount of unnecessary suffering that's occurring. And there's a range of different treatments that are safe and effective that are being discovered by citizens because we now have a worldwide web and we have many ways that people can discover these treatments. And if they can't get them legally in clinical environments, then they're going to go underground and try and get them off the black market or take their own risks because people at the end of the day, want to get well. They want to lead a meaningful life and a happy and healthy life, which is every person's birthright.

Well, I think that's one of your strongest arguments for rescheduling is not pushing people into the underground where there's a lot less regulation and a lot more risk because people clearly want to make use of medicines. They're going to be— so we have to figure out how to do this. Quite extraordinary. You also submitted as part of that process, thousands of individual citizen submissions, right, of their own experience with psychedelic medicines.

Well, they submitted them. I mean, there was over 13,000 submissions from researchers, clinicians, patients, and their carers, and 98% of those submissions were in favor of the rescheduling. So at the end of the day, when you have that many people demanding change, it's very difficult for anybody to then say no, given the levels of suffering. And you know, many of these people are veterans and first responders, people who've served the nation. And have gone through terrible traumas and they, they deserve the chance to heal. And current treatments, as you'd be well aware in the case of antidepressants, you know, only about 15 to maximum 30% of patients going to remission. And in the case of post-traumatic stress disorder, as few as 5 to 10% of patients are going to remission from existing treatments. Now you compare that against the 60 to 80% remission rates after just 2 to 3 treatments of psilocybin or MDMA with a short course of psychotherapy. And why wouldn't your citizen who's suffering demand and request and be given access in a clinical environment to these sorts of treatments with trained clinicians? That seems fair enough to me.

I would have to agree. So it's been about a year. How's it being rolled out?

Yeah, you know, look, it's slow, but these treatments are taking place. So since January this year, January 2024, psychiatrists who have achieved what's called authorized prescriber status, which is given to psychiatrists who've done training either in our CPAT course or other professional training in psychedelic-assisted therapies, then present to a human research ethics committee and for their particular protocols of treatment. And once they receive those approvals, then they put that submission into the TGA, who then gives them permission to be an authorized prescriber if they're, if they believe that their protocol's right. And they've got the approval of the ethics committee. And so far, anyone that I'm aware of who's applied for that status under those conditions has received authorized prescriber status. And so now those psychiatrists with their therapeutic teams, multidisciplinary therapeutic teams, are providing psychedelic-assisted therapy treatments to patients with treatment-resistant depression and for psilocybin and post-traumatic stress disorder with MDMA. And there's been a number of psychiatrists given that status. I think there's something like maybe around 15 or so in Australia so far, spread out around Australia. And that might not seem like a lot, but they can do quite a lot of treatments. And slowly, slowly, more and more treatments are taking place. We've also set up a registry with the Australian National University to collect real-world evidence and data so that this data can be collected and we're getting real-world evidence coming into the field. From these psychiatrists about their patient's progress and so on. So they have to report to the Registrar. So that's very exciting and we are hearing very promising reports of, you know, outstanding and transformational healing with some of the patients that have already gone through these treatments.

So in terms of the combination of the treatment with psychotherapy, are the psychiatrists also doing the therapy? Are they the prescriber and then they work with psychotherapists who are doing— so is there a combination? Can psychotherapists who maybe have master's level and licensing a psychotherapist that works with a prescriber?

Yes. So, you know, some of the psychiatrists at the moment are choosing to do the therapy themselves. I don't think that will be for the long term because it's very time-consuming, expensive, but I think they're learning and they're wanting to just do it. But they're working with psychologists primarily, and some are working with mental health nurses and others and psychotherapists and so on to ensure that they do have this multidisciplinary team that has this vast range of therapeutic skills to sit with the patients and make sure that these experiences can be the most meaningful and healing possible.

So in Australia, are there limitations on who can work with a psychiatrist prescriber and do the therapy? I'm asking this because when people are talking about bringing this to scale in the US, they're talking about there's such a need and they're talking about not only having licensed clinicians, psychotherapists with master's level licensing and so forth, but even, uh, beginning to develop maybe guides who work under the auspices of a prescriber or something, but who are not licensed clinicians themselves.

Yes. So the TGA has recently said that the second therapist can be an allied health professional, like it doesn't have to be a psychiatrist or a psychologist. Um, so that's great news. And we are training a broad range of therapists and allied health professionals ranging from obviously psychiatrists. To psychologists, GPs, specialists, physicians, and addiction specialists and so on, psychotherapists, counselors, nurses, social workers, occupational therapists, even, you know, naturopaths and Chinese doctors and so on, uh, choosing to do this training because I think that many therapists are seeing this as a very prospective future career for them and they're very interested in this field because of the remission rates and the chances, the higher chances to get their patients well.

Well, let's talk a little bit about your training program. So I'm curious about the scale of it to begin with, how many cohorts you have going, how many people you're able to train a year, how long your training programs are. But then also maybe talking about what do you think some of the more important principles involved in the training. What if transformation isn't just about thinking differently but feeling differently? Science shows us that true change happens when we align not just our minds but also the neural networks in our hearts and guts. This heart-mind connection is the key to deeper healing, resilience, and expanded awareness. That's why I created the HeartMind All Access Membership and Community, a space designed to help you rewire your nervous system, cultivate heart intelligence, and live with greater clarity and purpose. With over 1,000 hours of transformational teachings, specifically curated to meet your needs. You'll learn from world-renowned meditation teachers, neuroscientists, and experts in neuroplasticity, all sharing powerful tools to help you shift your mindset and heartset, regulate your emotions, and unlock your full potential. You'll also gain unlimited access to every summit and course we've ever produced, a treasure trove of wisdom worth over $10,000 and growing, plus live gatherings and an inspiring global community to support your journey. If you're ready to step into a more heart-centered, connected, and conscious life, I invite you to join us. Click the link to learn more and start your journey today.

So we started our training at the beginning of 2021, our certificate in psychedelic-assisted therapies, which, by the way, Professor David Nutt has named on Radio National ABC as the world's leading psychedelic-assisted therapy training. And you will have seen extraordinary faculty, which is led by Dr. Geeta Vaid, a psychiatrist in New York. She's the international course director, and then Dr. Ali Kotler, a psychiatrist in Australia, who's the national course director. And then we have this extraordinary faculty, including people like Professor Nutt and Rick Doblin and Bessel van der Kolk, Gabor Maté, and many, many of the leading experts in the field who have vast experience in training clinicians and working with these therapies, both in trials and in practice, in clinical practice, where they can, obviously. So Guido has vast experience working with ketamine, particularly in New York. But essentially we've trained, I think by the end of this year we'll have trained 500, over 500 clinicians and therapists from all the professional disciplines that I mentioned earlier. And our course combines our online training. So we have a 14-week online training program, which includes assessments and lectures and so on. People like Dr. Bill Richards, who's extraordinary as well, giving these wonderful lectures. And then there's a 1-week intensive where they go through a lot of the actual practical ways of how to hold space for patients and work with patients using holotropic breathwork as the medium to work with one another in altered states and support one another in those. So it's all about combining the theoretical with the practical and by being trained by people with real-world expertise in these therapies in clinical environments. You know, we're seeing a lot of courses emerging around the world, some of them with teachers with limited expertise. So I just say to everyone out there, do your due diligence on the caliber of teachers for any courses and make sure that you are working with the best courses you can. In fact, we have people registering for our course from Europe and the UK and the US, as well as Australia, which is wonderful to see. And the UK as well. I keep forgetting that the UK is no longer in the EU, but yeah.

So around training, one, one of the issues is if you're providing training in psychedelic-assisted psychotherapy as a specialty to a therapist who's already been clinically trained, that's one thing. If you're training others who have not had that training, You know, I can— the reason I bring that up is, for example, if someone's been thoroughly trained as a psychotherapist, a psychologist doing direct therapy, you know, they understand a lot of the ethical frameworks of psychotherapy. They are— they understand transference and countertransference, not just academically but experientially. And I think the bar for these things is raised with psychedelic drugs because the possibilities of those things do become somewhat heightened under the effects of psychedelic medicines. So I'm wondering if, for example, if someone's coming into your program who's an allied therapist or you mentioned some of the other professions that might not have had that kind of psychotherapeutic clinical training, is there the opportunity for them to get that? So, I mean, this is a moving landscape within the US as well with all the different trainings, but there's kind of a core set of clinical skills that I think are fundamental even in a broader world of, you know, not to take anything away from the genuine world of South American and international shamanic traditions and their their deep training and their experience. But Western shamanism here in the US, some may have been thoroughly trained in other countries, but yet they may not have had any training in traditional psychotherapy or understand really those psychological dynamics and so forth. So the importance of really good clinical psychological or good clinical training to understand, you know, how to safely engage in a psychotherapeutic process with a client where there are a lot of vulnerabilities on both sides.

No, absolutely. I mean, that is the real strength of our course. And in actual fact, I mean, quite often it's doctors themselves and psychiatrists themselves who actually lack a lot of that therapeutic training because they're, they've mainly been prescribers.

Right.

And so they're the ones often who need more of that guidance. And our course seems to be ticking those boxes. If people go and have a look at our CPAP website, they'll see the testimonials. From students ranging from psychiatrists and doctors who've described the course as life-changing regardless of just the psychedelic-assisted therapies. I think they're developing skills that they otherwise wouldn't have developed through this training, which is extremely important. And we're finding that the intakes for our course, we have two intakes each year, one in, I think it's the start of February and one in July and each year. And those intakes are traditionally oversubscribed. Prescribed because there's so much demand, especially for this very high level of training with a faculty like the one that, that we're working with.

So let's talk a little bit about, you know, how this goes to scale, accessibility and equity and access for people. I'm curious to begin with, was ketamine already prescribable and was there ketamine-assisted therapy being practiced in Australia?

Yes, it's, I think it might be Schedule IV. I, I'd have to check on that, but It's been available. It hasn't been used that much. There are some ketamine clinics in Australia and psychiatrists who are specializing in ketamine-assisted therapy. It's becoming more and more of interest now, and we're deliberately including units of it in our various development courses in our CPAT. And we've also just launched a new course called Fundamentals of Psychedelic-Assisted Therapies in partnership with Drug Science in the United Kingdom. And I think there's also a unit on ketamine in that course. So we feel it's important to focus on absolutely psilocybin and MDMA, but ketamine is, in some cases can be easier to use, but the problem of ketamine from what I have heard is that it needs to be used more regularly and it's, the remission rates don't seem to be quite as successful. In other words, it's something that maybe needs to be used over and over, whereas in the case of psilocybin and MDMA, the remission rates are occurring after just 2 to 3 treatments.

I think there's a distinction between— here in the US anyway, there's a fairly broad infrastructure already for ketamine-assisted psychotherapy. But there's a distinction between the infusion clinics where people are going in and just getting an infusion of ketamine without psychotherapy, which has shown some positive effects for people suffering from depression. But nonetheless, I think if you look at the data with the combination of psychotherapy and ketamine use like Dr. Geeta Vaid is doing in her practice. I think the results are pretty compelling. But the reason I bring that up is, so the infrastructure that exists here in the US for ketamine-assisted psychotherapy is fairly widespread. A lot of clinics. It's still not going to answer the need or really there's still a lot of questions about how to take it to scale. You know, so how do you imagine, you know, for example, is there all one-on-one therapy? Is there any notions of any kind of group therapy? How do you imagine this going to scale in Australia? From where you are now?

Yeah, so it's interesting about the group therapy. So we part-funded, um, a trial at Australian National University, which was for healthy persons, and it was for people who had done professional training. So it was for therapists, and they actually did it in a group therapy environment. And we're very supportive of that sort of environment for the integration part of the experience, because it can offer enormous cost savings, but it can also offer a, uh, you know, I'm not in this alone, you know, the fact of being in a group. And learning from the group is very powerful, as I think a lot of your listeners will know, and I know that you, you would appreciate that in your field. And so being in a group can be a very powerful way, and I'm hoping, and I believe that we're going to see elements of group therapy coming into this field, if not only for the cost, but for other reasons as well, but certainly to save money. And we're also starting to see in terms of costs in Australia, we're seeing a lot of interest now emerging from health insurers. And there's also the potential for government subsidies in Australia. But in the meantime, at Mind Medicine Australia, we've started a patient support fund where we're providing up to 50% of the upfront costs of a treatment program, which is around about, in Australian dollars, $20,000 to $25,000, $30,000. And we're providing half the cost to patients who demonstrate real need. Who otherwise wouldn't be able to afford the cost of treatments. And some of those are veterans and first responders again, that we've already supported to have these treatments.

So currently it's a private pay situation, but there is some interest from the insurance groups that there could be third-party reimbursement to providers. And in the meantime, you're raising money to do some funding to support accessibility.

Yeah, true. But government subsidies may very well become possible. Too. So, you know, it's just step by step.

And yet still, you know, even with all those different possibilities, a course of treatment costing $20,000 or so is still a pretty high bar. It's an expensive—

Australian. So that, that's a lot less than US dollars. If you look at some of the economic modeling that's been done, the cost savings are really enormous. I mean, like, I know, you know, I was speaking to Rick Doblin about this even a few years ago, and he was saying that the, you know, average cost savings would be well over $100,000 US per patient for those with post-traumatic stress disorder from these treatments over a period of, you know, years and decades that the patient would otherwise remain unwell. And then all the lost opportunities of that person, their suffering, their family suffering, the extra care needed and so on. So if we can get people well and out of the system in, you know, a 3-month, 4-month treatment protocol, well, isn't that wonderful? And give people their lives back.

Yeah, the arguments for long-term cost savings and benefit to patients seem very compelling, and it's more in the short term, how do we get it out there to people? And it sounds like you're taking a number of different strategic approaches. That's wonderful. So My Medicine Australia, were you also involved in advocating for medical cannabis use?

No, we weren't involved in that. It was before Peter and I'd even had any drugs in our lives. Our first experience with anything. I mean, like we'd never had drugs until 2016 when we, when I read this article about psychedelic assisted therapies and we went to the Netherlands and we undertook this treatment with a, you know, professional guide and it was really life-changing. But so a lot of the work on medicinal cannabis had taken place by then or was taking place. And now in Australia, over 1 million prescriptions have gone through for medicinal cannabis. So that just goes to show, you know, we only have a population of about, well, I think 25, 26 million. So 1 million prescriptions. I mean, sure, some of them are repeat prescriptions, but that's still a growing body of people having access to these important medicines.

Yeah, and those are changes certainly here in the US that were driven by citizen advocacy and citizen demand. Really, people wanted it and it still actually has not been approved by the federal government, but it's been approved in most of the states. And so it's just happening. And fortunately, I don't— it doesn't look like the federal government's going to step in to block it, but they haven't changed the scheduling of cannabis yet. So the reason I ask that though is other psychedelic medicines, whether Mind Medicine Australia is involved in a process of research and possibly bringing along other medicines that are under research, like LSD and DMT as a synthetic drug, but then there's also plant medicines like ayahuasca and others and that whole larger world. So is there an ongoing interest or intention in terms of broadening this in terms of the availability of plant medicines in general?

I mean, at the moment we're focused on the 3 we've talked about because they're the ones that can be used in clinical environments at the moment. So we're focused on those, but it's likely, you know, given the research that's taking place around the world with a number of these other medicines that you've just mentioned, that more and more of those will come to be available, hopefully in clinical environments. So people don't have to go underground to get them or to go overseas, which is what commonly happens in Australia. And of course we have, you know, a large population of people, I think microdosing is the, and, um, that's happening in Silicon Valley too. You know, they say that any entrepreneur who's not microdosing is going to fall behind the other entrepreneurs. Entrepreneurs. So I think we also have that amongst entrepreneurs and also just general, you know, mums and dads in Australia and even grandmums and granddads who are learning about microdosing and starting to just take this into their own hands because they want to feel better, or perhaps they want to explore more of their creativity and become more productive. There's many reasons why people might choose to microdose that may not relate to a mental illness. It could be all about creativity. And look, at the end of the day, I think as human beings, you know, if we can unlock more of our creativity, we can solve more of the wicked problems that we're facing. Humanity is, you know, facing the worst and most difficult wicked challenges right now.

Well, let me ask you a question about the whole microdosing movement. Psilocybin is one of the more common plant medicines that's used in microdosing, often in combination with other mushrooms, lion's mane and others, in some kind of microdosing stack, as they call it. So has the approval of psilocybin for prescription, does that have any impact on, for example, the government's view around people incorporating psilocybin as part of a microdosing regime, which are using in very small, not psychoactive, I mean, microdosing by definition is not psychoactive.

Well, it's crazy, isn't it? But microdosing, if it's got psilocybin or LSD or whatever in it, is illegal still. Yeah. Even though it's subperceptual and, you know, yeah, it's just these strange things in the system. I mean, like in Australia, for example, you can pick a poisonous mushroom and eat it and die, and that's not illegal. But if you happen to pick a psilocybin mushroom and put it to your lips and taste it, that is illegal. It's crazy. There's just so many anomalies in these laws, and I can't wait for the day that there's some consistency and that people actually have clarity and can have access to medicines and can clearly know what's unsafe also.

Mm-hmm. Yeah, well, I think that's the important, and I think, you know, the importance of not only having well-trained prescribers, well-trained therapists, well-trained guides involved in this movement so people who go to above-ground clinical medical settings have some confidence they're gonna be dealing with competent providers. But also the importance of educating the consumer that, you know, we need to be educated consumers and we need to know, you know, at least participate in— I mean, I think the thing of safety, some— there can be a regulatory effort, and I think it's been in this country very much that all the safety has to be created by regulation. And consumer is seen as this kind of passive, naive, you know, non-active participant, which I don't think is so helpful. I think more of a balance of where there's really efforts and requirements for consumers to be educated so they're making thoughtful, educated decisions around whether they're gonna engage in microdosing or how they're gonna do that, or if they're gonna seek out a provider, how they're gonna do that. And then there's, of course, there's this whole underground movement, both of people's personal exploration as well as underground therapy going on. So, you know, there's not a lot of guardrails at the moment, so people need to educate themselves.

They do. I mean, I read something recently that said we should all be you know, our own chief medical officer. And I really believe that. I think it's really, really important to look at any kind of treatment that you are being recommended. Do your due diligence. Same with training. Do your due diligence. You know, it's just incredibly important to learn and to learn about contraindications. But you know, every one of us is unique. And unfortunately what happens is people get prescribed a lot of allopathic medicines. They often contraindicate with one another because they have different specialists. The patient's not at the center. There's not a multidisciplinary approach. And what that really is asking each of us is to do our own research, to do our own homework, and not rely even on— I mean, sure, you know, take advice from a doctor, but you— I usually, I'd say get a second opinion anyway. And, you know, just really learn about what you're putting into your body.

There's also a movement as a beginning. Emerging movement here in the US around personalized medicine. The fact that current allopathic medicine is not to be dismissive of the important research at all, but still it's not addressing me as an individual. It's addressing this bell curve and it's saying, well, the science says that, you know, this may or may not have effect, so insurance is not gonna cover this test, or insurance is not gonna pay for this medication because, and it all has to do with statistics and it has absolutely nothing to do with me. And then the prescribing of a medicine is tailored to that statistical bell curve. It's not tailored to me as an individual.

No, that's right. I mean, I think we're going to see— we are seeing, you know, an enormous rise in personalized, customized medicine. But again, that comes down to you creating your own customized program, your own whatever it is— supplement, medicine plan, your exercise plan, your dietary plan and nutritional plan, your sleep plan— everything that's going to make you operate at your highest potential. And that's really why my husband and I sought out these medicines to begin with. We weren't particularly suffering with any specific kind of mental illness, but we wanted to be at our best. So we tried lots of different things and then we came across these medicines and they were certainly transformational and changed our lives.

Yeah. So just going a little further with that, here in the US at least, many people have described the current sort of psychedelic renaissance a bit like the Wild West, that there is the effort to, you know, create regulated delivery of psychedelic medicines through, you know, the fields of medical and psychiatry and psychology and so forth. And then there's many therapists, even very qualified therapists, who chose to not wait and operate in so-called underground. And then there's a lot of people in the underground world operating as guides and things, many who are— some may be qualified, not so qualified. And then, you know, so it's— there's so much different things going on. And people just individual experimentation with no guidance or no support. And then there's a race to kind of profit from a burgeoning new area. And I, I'm not against profit. I think, you know, regulated capitalism has shown more promise in, in widely distributing resources than any other system so far. But nonetheless, there can be profiteering and just the whole commercialization. And there's issues around plant medicines and their indigenous roots and the indigenous people's stewardship of them. And then the emerging pharma companies in the psychedelic world here in the US. So the whole thing is quite, you know, it is kind of like the Wild West and it seems like I just want to say it's definitely not the Wild West in Australia.

You know, the rules are very strict. As I mentioned before, all psychiatrists have to become authorized prescribers. Ethics committees involved. There's two therapists sitting with the clients. Now, the fact there's an underground movement illustrates the desperation for treatments that could heal people. So, you know, we have to go ahead and we have to make this as efficient and effective as possible. And that's why we focused on bringing these therapists into therapies into a regulated clinical medical domain. As far as profit is concerned, you know, we have a medical system where everyone's trying to profit from pharma companies through to hospitals and individual clinicians. So we need to stop pretending that psychedelic-assisted therapy is any different to any other field of medicine. And as far as the pitfalls are concerned, we just need to ensure that these therapies take place in a sensible, ethical, and regulatory environment. Where the patient is at the center of the system and clinicians are properly trained. That's really very important.

So the reason I ask that, and maybe it is a bit wilder here in the US than Australia, I don't know, but you know, the importance, as we discussed before, of educating the consumer. So organizations like My Medicine Australia, not many other organizations, MAPS, other organizations here. And one thing that in the research I've done getting involved in this over the years, I'm a baby boomer. I came through the whole 1960s thing. There's so many thoughtful nonprofits involved now and other organizations that people really seem to be making a strong effort to do this in a better way than we did back in the '60s to prevent the kind of backlash that occurred in the 1970s. But it would seem a lot of what's going on is advocacy and training of providers, and it would seem like it would be important for some of these organizations to, to really put some of the resources towards consumer education. So that we can have a much more educated consumer.

Well, I agree. I mean, I think that goes for all kinds of medicines and, and everything to do with health. That, that again goes back to teaching people how to be their own chief medical officer.

Mm-hmm.

And I think if we could do that and we, maybe we should have a consumer course. Maybe we'll talk about doing this together, Fleet. Now become your own chief medical officer.

I love that idea. I definitely think we, let's talk about it. We need to do that. Absolutely. Yeah. So, um, you know, as this movement is unfolding and then the success you've had in getting both MDMA and psilocybin rescheduled in Australia, sort of where do you see the movement going over the next 5 to 10 years? And do you have any concerns? Do you see any potential pitfalls either on the individual patient side or politically, or, you know, what's your vision of the future? Look into your crystal ball. The ball for us.

Hopefully things will move, you know, from a trickle to more of a, you know, more and more patients being treated and more therapists being trained. The cost becoming more, more manageable through bringing in the health insurers, government subsidies, continuing to provide education programs, not only to educate clinicians, but also the public, as you've talked about just now. And we're sure that the medicines will become registered in Australia in the future. Regarding concerns, you know, all the re— pretty much all the researchers, clinicians, and patients we deal with are strong supporters. There's a small group of people with vested interests who like to maintain the status quo, or people who've not done the hard work to understand the science and data and the controls in place. And I just encourage those people to learn up. And, you know, I think the most important thing that we all need to do is to think about those suffering patients and put them at the center. And think about what's going to make their lives more bearable and hopefully happy and healthy in the long, in the short to medium term so that they don't have to suffer their whole lives. And that's the entire reason why we set up this charity is because we saw the levels of suffering. We've set up 5 charities before. We see the suffering in the community and it just creates such enormous disadvantage and such heartbreak for not only the individuals, but their families. And it's just unbearable to see that. And I just hope that together we can create a happier society and community and humanity that's not so divided and that is more compassionate and sees the one in everyone. We're all the one.

Yeah. So we're nearing the end of our time here and I know you, you need to go. I'm just curious if you're aware if with what's going on in Australia, if there's communication, ongoing communication between government and policymakers in Australia and other countries between the scientific community in both countries or advocacy organizations like your own and MAPS and others? Is there a communication going so that we're kind of can spread the benefit here?

Oh, absolutely. I mean, we have an enormous international network and, um, we work with all the great organizations in the world, including MAPS and Drug Science and the European, you know, the European groups and all over the place. I mean, we were approached recently by the Dutch government around the recent MDMA work that's been done there. And we are constantly in communication, not only with these bodies, but also with individual clinicians. And you can see our advisory panel, which has over 75 of the world's leaders in a number of different fields. So we believe it's an international dialogue. We hope that what we've done in Australia inspires everyone. We know that it has, and that we hope that, you know, everyone will continue to take it up to their governments to follow Australia's lead. And make these medicines available as soon as possible in clinical environments.

Well, Anya de Jong, thank you so much and congratulations on the success of your efforts in Australia and wishing you all the best.

Thank you for having us and supporting us.

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