Mind Medicine Australia Wins Psychedelic Rescheduling

In 2015, a blog post by Tim Ferriss detailing his $100,000 donation to Imperial College for psilocybin research on depression led the speaker to Michael Pollan's New Yorker article, "The Trip Treatment." This article ignited her interest in psychedelic-assisted therapy. After convincing her husband to read it, they decided to pursue a trial.

They contacted Robin Carhart-Harris, who informed them they did not qualify for European trials due to lacking a mental illness diagnosis. Eventually, they found a guide in the Netherlands and embarked on an "extraordinary experience" with a large dose of psilocybin. The speaker, initially terrified, even wrote an email to her accountant with her last wishes, fearing loss of control and sanity.

The experience was profound, connecting them to themselves, others, and the planet. It transformed their perception of nature and brought them closer as a couple. The integration of this experience took about a year, which the speaker described as letting a "snow globe settle" after a "huge fireworks display."

Initially, she thought she would never repeat the challenging experience, but a year later, they returned to the same Dutch guide for an even higher dose, which proved "even more profound." This led them to realize the healing potential of these "magic mushrooms."

Having already founded five charities, they began to consider how these therapies could help people suffering from homelessness, domestic violence, unemployment, disabilities, and depression, recognizing that mental illness and trauma often underpin such disadvantages. They started attending conferences, meeting researchers worldwide, and learning everything they could about psychedelics.

Founding Mind Medicine Australia

In 2018, Rick Doblin, a key figure in the psychedelic movement through MAPS (Multidisciplinary Association for Psychedelic Studies), encouraged them to establish a charity in Australia. Doblin, known for his work on MDMA-assisted psychotherapy for PTSD since the 1970s, was a significant inspiration, as were Roland Griffiths, Robin Carhart-Harris, and Professor David Nutt.

In Australia, there was limited activity in the psychedelic space, with only one trial for end-of-life stress and anxiety. Believing Australia could become a leader in this field, they launched Mind Medicine Australia (MMA) in February 2019. Their goal was to make these medicines available to Australians as quickly, safely, accessibly, and cost-effectively as possible.

Engaging with the Therapeutic Goods Administration (TGA)

In late 2020, MMA approached the Therapeutic Goods Administration (TGA), Australia's equivalent of the US FDA, to request the rescheduling of psilocybin and MDMA. These substances were classified as Schedule 9 (prohibited substances) in Australia, similar to Schedule I in the US. MMA aimed to move them to Schedule 8 (controlled medicines) for use in clinical environments.

Their initial application, though encouraged by the TGA, was rejected at both the interim and final stages. Undeterred, the speaker's husband, leveraging the TGA's requirement to provide reasons for rejection, meticulously addressed their concerns in a new application. This application, focused on psilocybin and MDMA for depression and trauma, was again rejected at the interim stage.

During the subsequent public consultation period, MMA launched a massive campaign, educating politicians, health professionals, business leaders, and the public through thousands of presentations and webinars. Over 13,000 Australians submitted their support for rescheduling, representing over 98% of submissions and the largest volume ever received by Australian regulators for any medicine.

Building a Movement and Overcoming Obstacles

By this point, MMA had grown into a massive movement with over 30 chapters across Australia and even in New Zealand. These chapters, comprised of dedicated volunteers, were provided with templates and precedents to facilitate public submissions.

In addition to public support, MMA began training clinicians through their "world-leading certificate in psychedelic-assisted therapy," which started in 2021. They have since trained over 750 clinicians, including psychiatrists, psychologists, doctors, nurses, and social workers, who then advocated within their professional bodies.

The speaker also highlighted the importance of engaging with key figures and policymakers. She mentioned recruiting lobbyists and organizing a roadshow with Professor David Nutt in 2022. Nutt, a renowned neuropsychopharmacologist, addressed packed town halls and black-tie events, raising awareness and support.

The speaker explained that their strategy involved persistence and overcoming every roadblock. Their advisory panel, comprising about 75 leaders in the field, was crucial. She met many of these experts, including Nutt, at conferences like the Erowid Center (Erowid) conference in Madison, Wisconsin, where she spoke and sang, connecting with them on a personal level.

A Pivotal Meeting with the TGA

A critical moment occurred in November 2022 when MMA arranged for David Nutt to present to the TGA. The head of the TGA anticipated only 10-15 attendees, but 140 people from the Department of Health and TGA showed up.

Before Nutt's scientific presentation, a woman named Vanessa shared her tragic story. Her husband, Franco, developed severe depression and, despite trying numerous treatments, including SSRIs and institutional care, ultimately took his own life. Vanessa believed that access to psychedelic-assisted therapies could have saved him. Her emotional testimony, coupled with Nutt's scientific evidence, deeply impacted the TGA attendees.

Rescheduling and its Impact

On February 3, 2023, the TGA announced the rescheduling of psilocybin and MDMA. The speaker described the moment of receiving the news as surreal and a cause for celebration. Australia became the first country to take this step, leading to global headlines.

A few months later, rules were implemented allowing psychiatrists to treat patients in clinics. Psychiatrists can apply for "authorized prescriber status" by submitting detailed protocols to the TGA and an independent ethics committee.

Currently, over 20 clinics across Australia, largely staffed by MMA-trained clinicians, are offering psychedelic-assisted therapy. Approximately 400 patients have been treated, with 60-80% achieving remission rates, mirroring international trial results. Importantly, no serious adverse events have been reported.

The speaker emphasized that the TGA's decision was influenced by the "risk of not doing anything," recognizing that denying access to these treatments could lead to more tragedies like Franco's.

Challenges and Future Directions

Despite the progress, challenges remain. The cost of treatment, ranging from $8,000 AUD for one session to $25,000 AUD for a 3-4 month course, is a barrier for many. MMA has established a patient support fund and secured funding from the Department of Veterans Affairs, the National Disability Insurance Scheme, and Medibank (Australia's largest health insurer) to help cover costs.

The speaker also highlighted the importance of data collection. MMA funded a registry at the Australian National University to collect real-world evidence on treatment outcomes, which will be crucial for demonstrating the effectiveness and cost-saving potential to the government.

Regarding the therapeutic approach, while not standardized, clinicians are encouraged to use various modalities, including Internal Family Systems (IFS) therapy. The speaker also stressed the importance of nutrition and exercise in integration, recognizing that these therapies open a "critical window" for behavioral change.

She also touched upon the use of Syrian rue with psilocybin, which was part of her initial experience. This combination, containing MAO inhibitors, amplifies and extends the psychedelic experience. While some find it nauseating, she found it beneficial for relaxation and deeper exploration.

The speaker acknowledged that the group dynamic in therapy is highly valuable, not only for cost-effectiveness but also for improved outcomes and deeper experiences.

Lessons Learned

Reflecting on mistakes, the speaker noted the unexpected resistance from some researchers who prioritized continued research over immediate patient access. She also mentioned the challenges of working with individuals who had unresolved mental health issues, emphasizing the need for a resilient team when driving significant change. The personal attacks she faced were also difficult, highlighting the emotional toll of pioneering work.

She underscored the importance of the durability of psychedelic-assisted therapy, where remission rates can increase over time, unlike traditional antidepressants. This durability, coupled with the potential for significant cost savings, makes these treatments particularly compelling.

The speaker concluded by emphasizing the ongoing dialogue with the TGA to address bureaucratic roadblocks and ensure that these treatments remain accessible and effective for those who need them most.

Cost of Psychedelic-Assisted Therapy

The cost of psychedelic-assisted therapy in Australia is a significant consideration. A single treatment, including screening, starts at approximately 8,000 Australian dollars (around 5,000 US dollars). A course of three doses with integration can reach up to 15,000 Australian dollars. MDMA-assisted therapy might be slightly more expensive due to potentially requiring up to three doses, compared to psilocybin's two doses. This cost includes three to four months of integration following the medicine treatments, making it a three to four-month course that can cost up to 25,000 Australian dollars (around 15,000 US dollars).

The high cost is primarily due to the extensive therapeutic time involved, not the medicine itself. The medicine constitutes a tiny percentage of the overall cost. The therapy often involves two therapists, further increasing the expense. A single dosing session can last five to six hours, requiring significant professional time.

Alternative Compounds and Approaches

The discussion touched upon methylone, described as a "softer, gentler cousin of MDMA," with a shorter duration of effect (45-60 minutes compared to 4-6 hours for MDMA). This shorter duration could significantly reduce therapeutic time and, consequently, the cost. The idea of non-psychotherapy coupled dosing was also raised, referencing Transcend Therapeutics' approach with methylone. This approach focuses on the effects of the medication alone, potentially simplifying regulatory hurdles, as agencies like the FDA struggle with standardizing psychotherapy.

The speaker noted that methylone or MDMA do not cause the same level of perceptual distortion as psilocybin, meaning patients are generally able to have conversations and maintain a degree of awareness. This could potentially allow for group therapy settings, where one or two therapists could manage several patients, further reducing costs.

Ketamine: Benefits, Risks, and Personal Experience

Ketamine was discussed as another therapeutic option, particularly for depression. However, it often requires repeated use and carries a very high addiction potential. While it has a place in treating acute suicidality, its ease of abuse is a major concern.

The speaker shared a personal experience with ketamine infusions, undertaken to understand its subjective effects firsthand. Despite having no anxiety or depression, the experience was negative, leading to increased anxiety, short-term memory issues, and physical discomfort. However, a surprising and significant benefit emerged: the ketamine treatment resolved chronic back pain that had plagued the speaker for 15 years. This highlighted ketamine's utility for certain types of chronic pain, where a few rounds can provide durable benefits.

The speaker also acknowledged ketamine's role in rapidly alleviating suicidal ideation, allowing individuals to gain a more detached perspective on their emotional state. Despite these benefits, ketamine would not be on the speaker's top five list of preferred treatments due to its subjective effects and addiction potential.

The Future of Psychedelic-Assisted Therapy in Australia and Beyond

There is optimism for significant global shifts in the accessibility of psychedelic-assisted therapies. Psilocybin, potentially through Compass Pathways, and MDMA, possibly through an organization like Resilience (formerly MAPS), are expected to gain wider registration. Australia's recent changes are seen as a potential catalyst for other countries to follow suit, leading to less bureaucracy and increased patient access.

Australia is recognized as a favorable location for conducting clinical trials, attracting companies globally due to its regulatory environment.

Advice for Advocates and the Power of Persistence

The speaker, Tania, reflected on the advocacy efforts of Mind Medicine Australia (MMA). While acknowledging that her persistent approach sometimes drew criticism, she believes that nothing less would have been sufficient to achieve the regulatory changes in Australia. She emphasized that the success was driven by data and science, not personal favors.

Tania highlighted the importance of advocating for safe and effective medical options that are currently withheld from the public. She encouraged individuals to become their own "chief medical officers," seeking out treatments that promote healing and well-being. Her personal journey into psychedelic advocacy was inspired by an article, demonstrating how a single piece of information can spark a movement.

Calls to Action

Mind Medicine Australia has two primary asks for the public:

1. Patient Support Fund: MMA is a registered charity aiming to raise 2.5 million Australian dollars to help veterans, first responders, single mothers, and others who cannot afford the upfront costs of these treatments. Donations are tax-deductible in Australia and accepted from overseas. More information can be found at mindmedicineaustralia.org.au.
2. Clinician Training: For clinicians and therapists interested in working in this field, MMA offers a Certificate in Psychedelic Assisted Therapy. The program features a global faculty including prominent figures like Bessel van der Kolk, Gabor Maté, Bill Richards, David Nutt, and Rick Doblin. Intakes are in February and July of 2027, with current intakes fully booked. Clinicians from around the world, including Switzerland, Europe, the US, Canada, UAE, and Asia, are participating. The website mindmedicineaustralia.org.au also offers a comprehensive learning section and a free webinar series on various topics, including eating disorders, featuring experts like Peter Levine, Gabor Maté, and Bessel van der Kolk.

Tania also extended an invitation for the interviewer to join MMA's advisory panel.

The Importance of Curiosity and Inner Exploration

The speaker emphasized the importance of curiosity, especially in an age dominated by AI. She suggested that these medicines can awaken people's curiosity, encouraging them to ask questions of themselves and the world around them, rather than solely relying on chatbots and external sources.

She shared that the greatest gift of these medicines was teaching her to explore her "inner terrain," transforming her from an extroverted individual to someone who regularly engages in introspection. This inner exploration is a common theme among many who have used psychedelics, often leading to a deeper understanding of self and a greater appreciation for meditation.

The conversation concluded with a reference to Ram Dass's teaching, "We're all walking each other home," highlighting the interconnectedness and shared human journey that these medicines can illuminate.

Final Thoughts and Contact Information

The speaker expressed gratitude for the interviewer's work, crediting his articles with inspiring her journey and ultimately contributing to Australia's leading role in psychedelic-assisted therapy. She encouraged listeners to be persistent, ask for help, and pursue their dreams, emphasizing that "you never know until you ask."

Mind Medicine Australia: mindmedicineaustralia.org.au Tania De Jong's personal website: taniadejong.com Social Media: LinkedIn is a preferred platform for contact.