Julia Neubauer · Mind Medicine Australia
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Exploring Emerging Therapies: Understanding the Role of Psychedelic-Assisted Treatments in Mental Healthcare

At Mind Medicine Australia, we are dedicated to transforming the treatment of mental illness by expanding access to evidence-based psychedelic-assisted therapies. As a leading charity in the field, we support the development and clinical implementation of innovative therapies involving psilocybin and MDMA. These treatments, supported by international research, offer renewed hope to Australians experiencing persistent mental health challenges.

Why We Need New Solutions

In Australia today, one in four people live with a mental illness, and current treatments are often insufficient. We understand the frustration and despair that can arise when conventional options don’t work. Research shows that over 50% of individuals do not respond to existing therapies such as SSRIs or talk therapy alone. This underscores the urgent need for innovative solutions that address the root causes of suffering more effectively and compassionately.

What Are Psychedelic-Assisted Therapies?

Psychedelic-assisted psychotherapies involve the use of psychedelic compounds, such as psilocybin and MDMA, combined with psychotherapy. These treatments follow a three-phase model: preparation, experience, and integration. These sessions are held in safe, therapeutic environments under the supervision of trained professionals. Patients are carefully screened and supported throughout the process to ensure safety and maximise outcomes.

 

Image: Increased communication between brain networks (based on fMRI scans)​: Brain imaging comparison before (left) and after (right) psilocybin treatment. Source: Beckley Foundation, United Kingdom. Based on clinical trials at Imperial College, London​

Clinical trials at leading institutions—including Johns Hopkins University and Imperial College London—have consistently shown that these therapies can lead to remission in patients with treatment-resistant conditions, such as depression and PTSD. In fact, international studies have found that psilocybin and MDMA-assisted therapy has resulted in 60-80% remission rates after 2-3 medicinal treatments in combination with a short course of psychotherapy for the treatment of PTSD and depression. They are often rated by patients as among the most meaningful experiences of their lives.

How Mind Medicine Australia Made History

In 2023, following advocacy efforts by Mind Medicine Australia, the Therapeutic Goods Administration (TGA) approved the rescheduling of psilocybin and MDMA for controlled clinical use. This landmark decision makes Australia the first country to formally allow treatments in clinical environments.

Since January 2024, 100+ patients have been treated in clinics across Australia as part of the Therapeutic Goods Administration’s (TGA) Authorised Prescriber (AP) program with medicines and training supplied through Mind Medicine Australia.

This milestone builds on six years of sector leadership, during which we’ve trained over 500 clinicians through our globally recognised Certificate in Psychedelic-Assisted Therapies (CPAT)™ program, secured $15 million in federal research funding, supported the launch of clinics nationwide, and funded groundbreaking trials for conditions like OCD and PTSD. With over 3,500+ individuals educated through workshops and courses and public outreach reaching hundreds of thousands, we’re not just supporting individual healing—we’re transforming mental healthcare in Australia and beyond.

World-Leading Training

We offer professional education through our Certificate in Psychedelic-Assisted Therapies (CPAT)™, training clinicians in best practices. This hybrid program (online + face-to-face) is for registered healthcare professionals—psychiatrists, psychologists, psychotherapists, counsellors, and more—who want to deliver psychedelic-assisted therapy using psilocybin and MDMA in clinical settings. The training is delivered by a world-class faculty made up of global leaders in the field including Dr Gabor Maté CM (Canada), Dr Bessel van der Kolk (USA), Dr Rick Doblin (USA), and many more. We’ve received outstanding feedback for the program:

“One of the things I’ve been doing a lot in the last year is teaching on the Mind Medicine Australia training course, which I think is the best course in the world for educating people about how to use psychedelics and how to develop, through that, in Australia, several hundred people who have the competencies and knowledge to potentially be therapists for this kind of treatment.”Professor David Nutt (UK), ABC News

Read more testimonials here.

How You Can Help

Our vision includes establishing more clinical programs, making therapies accessible, and ensuring long-term safety and effectiveness through continued research and community engagement. We believe these treatments have the power to revolutionise mental health care in Australia, but only when delivered safely, ethically, and responsibly. We are committed to supporting access to treatments that can truly make a difference, which is why we have created our Patient Support Fund (PSF).

The Patient Support Fund (PSF) subsidises treatment costs for Psychedelic-Assisted Therapies in Australia to support equitable access. The total amount committed so far is over $100,000 AUD. We have also received further funding requests for 2025. Please help us to make psychedelic-assisted therapies accessible for all Australians who need them by donating today.

Together, with continued research, compassionate care, and community support, we can bring these life-changing therapies to those who need them most—offering not just treatment, but hope for healing and brighter futures.

 

Disclaimer: This post is provided by Mind Medicine Australia for educational purposes only. It does not constitute medical advice. Psychedelic-assisted therapies are available only through approved clinicians in accordance with the Therapeutic Goods Administration guidelines. Always consult with a qualified health professional regarding your treatment options.

Mind Medicine Australia’s Achievements in the First Six Years

Over the past six years, we’ve helped position Australia as a global leader in psychedelic-assisted therapies. From rescheduling MDMA and psilocybin to training over 500 clinicians and supporting groundbreaking research, our work is driving real change for mental health. Here are some of the milestones we’ve reached so far.

 

Key Achievements

 

Other Achievements

 

Training & Education

Public Awareness & Engagement

Sector Leadership & Stakeholder Engagement

Research, Events & Policy

 

Support our work and help make psychedelic-assisted therapies accessible to all Australians who need them.

 

Donate to our Patient Support Fund today: https://mindmedicineaustralia.org.au/psf

 

 

Integration Experience Filled with Love, Compassion and Harmony with Dr Bessel van der Kolk and Licia Sky, hosted by Mind Medicine Australia

I am immensely grateful to have been invited by Tania and Peter from Mind Medicine Australia to join a three-day workshop with Dr. Bessel van der Kolk and Licia Sky. This experience became a profound and inspiring journey in a beautiful setting, surrounded by the most compassionate people. Together, we co-created a beautiful dance of healing, learning, and transformative energy—a sacred space where wounds could be witnessed and transformation could unfold.

Photo: Workshop Participants

Within this sanctuary of compassion—a carefully crafted safe container—everyone was invited to truly see their authentic selves through genuine connection, psychodrama, and the practice of living fully present. The atmosphere itself became a healing element, allowing vulnerability to transform into strength through collective witnessing and support.

About Psychodrama…

For me, witnessing the profound impact of psychodrama directed by Dr. van der Kolk and Licia was nothing short of revelatory. Like skilled conductors of human experience, they guided wounded healers to see and feel alternative realities beyond the traumas and stories that had consumed and limited their ways of being. This wasn’t merely talking about healing—it was embodied experience. Through fully present, ongoing deconstructed experiences, and the gentle, compassionate, authentic direction of Dr. van der Kolk, participants began seeing new possibilities that catalyzed the formation of new neural pathways. In these sacred moments, they experienced alternative possibilities and genuinely felt what had previously remained unfelt and unintegrated. What struck me most was how the common challenge in psychotherapy—dependency—dissolved naturally through the very essence of psychodrama, as participants became active creators rather than passive recipients of their healing journey.

Visualization

This transformation connects deeply to the power of visualization—a bridge between imagination and physical reality. Research extensively documents this power, from athletes imagining muscle growth to achievers mentally rehearsing their goals. Even Nikola Tesla used visualization to experiment with his inventions before physically creating them, testing and refining them in the laboratory of his mind before bringing them into material form. Similarly, in psychodrama, visualization places the protagonist into a vivid and compelling alternate reality—a reality where healing principles of forgiveness, release, and reconnection to one’s true self naturally unfold, not as intellectual concepts but as lived experience.

Photo: Licia Sky, Yatong Wen and Dr Bessel van der Kolk

The Body keeps the score

The genius of this experience lay in its integration of multiple healing modalities. When combined with somatic experiences, traumas stored in the body—those wordless memories held in muscle and tissue—surfaced into awareness. This integration allowed protagonists to recognize the interconnectedness of their reality: how body holds what mind cannot express, how present reactions echo past wounds, and what had remained hidden behind their conscious awareness—particularly childhood trauma (This is also what Dr Gabor Maté emphasized significantly) and inappropriate parenting experiences. The body and mind began working together rather than remaining fragmented and at odds.

Dance together, self-compassion

Through this integrative approach, the creation of ideal characters profoundly empowered participants. These embodied representations served as bridges between pain and possibility, enabling participants to recognize what had been missing in their original experiences and to reveal their ever-existing capacity for self-compassion and self-healing. What was once fractured began forming new constellations of wholeness.

Seeing Beyond

This journey revealed a profound truth: true liberation from suffering emerges through unconditional acceptance and compassion toward oneself. Yet this liberation requires self-realization of the fundamental roots beneath surface-level experiences—a seeing and knowing that penetrates beyond symptoms to sources. As clarity dawned for participants, freedom followed naturally, like morning light dissolving night shadows without effort or struggle.

Safe Container

What made all this possible was the foundation established by the lovely people in the room: a safe container, holistic understanding of human suffering, shadow work by the people themselves, and genuine compassion and curiosity. These elements weren’t just techniques but embodied principles—essential not just to accompany a person temporarily but to serve as living examples of the love and presence we all seek. This approach allows people to eventually walk independently, guided by their ever-present inner light that we help illuminate rather than claiming to create.

Science

Dr. van der Kolk also talked about MDMA’s huge potential in treating deep-rooted trauma.

MDMA creates a unique neurobiological state by releasing serotonin, dopamine, and oxytocin while reducing amygdala activity (fear center) and increasing prefrontal cortex engagement. This combination allows patients to access and process traumatic memories with less emotional overwhelm.

It helps break entrenched neural patterns formed by trauma. By creating a temporary state of increased emotional openness and reduced fear, MDMA therapy provides an opportunity for the brain to form new, healthier connections around traumatic experiences.

Photo: Dr Bessel van der Kolk and Yatong Wen

Conclusion

By the workshop’s conclusion, something remarkable had occurred: The light within ourselves illuminating profoundly —not as a concept but as a felt reality—like a river that had always been flowing through our hearts but had been covered by ambiguity and debris of past pain. In this rediscovery, we unearthed abundant self-love strong enough to prevent us from falling back into the depths of old patterns. Now carrying this inner illumination like torches, we continue our journey beyond the workshop—up metaphorical mountain tops and through life’s valleys—forever changed by having experienced our own capacity for transformation. And so our stories continue to unfold, branching out to touch others with the same healing presence we received, creating ripples of transformation far beyond the three days we shared together.

Great Love to Tania & Peter and Tribe at Mind Medicine Australia. There’s so much sense of belonging flowing through my heart. ❤

 

Learn more about Dr van der Kolk’s workshop here.

Learn more about our Certificate in Psychedelic-Assisted Therapies (CPAT)™ here.

 

“Out beyond ideas of wrongdoing and right-doing, there is a field. I’ll meet you there.” – Rumi

Photo: Peter Hunt AM, Yatong Wen and Tania de Jong AM

 

Mind Medicine Australia’s First Six Years: Progress and Achievements

In our first six years, we have made remarkable progress in growing public awareness of and creating access pathways for Psychedelic-Assisted Therapies in Australia. With the success of our rescheduling applications in early 2023, we are now seeing patients being treated with psilocybin and MDMA-assisted therapies for treatment-resistant depression and PTSD respectively. This is an important and historic moment for these therapies and for mental health treatment in Australia.

The TGA decision provides access to these innovative treatments for Australians suffering from treatment-resistant mental illness and paves the way to treat other illnesses such as addictions, obsessive-compulsive disorder, anorexia, cognitive decline and end-of-life stress in the future. In January 2024, the first patients were treated with psychedelic-assisted therapies in Melbourne, Australia. These were the first psychedelic medicine dosing sessions in clinical settings in 50 years. We estimate that 80 patients received psychedelic-assisted psychotherapy in Australia in 2024. We project that this number will increase dramatically in 2025 as the number of psychiatrists authorised to deliver PAT continues to increase.

Our goal is to build the ecosystem for these treatments in Australia. Everyone meeting the medical criteria should be able to access psychedelic-assisted therapies in medically controlled environments. Please see our key strategic objectives below.

What we have achieved in six years with your support:

 

Awareness and Knowledge Building

• 230+ webinars including FREE Global Webinar Series with the leaders in the field, numerous documentary screenings and a range of special events attracting 42,000+ participants

• Facilitating Professor David Nutt’s incredibly successful Australian tour in November 2022, where he presented to public audiences, clinicians and decision makers. This tour included a presentation to over 130 people at the TGA in relation to the rescheduling of MDMA and psilocybin.

• Launch of free online Global Webinar Series where World-leading experts provide illuminating presentations and conversations about the ground-breaking opportunity psychedelic-assisted therapies offer and other related topics.

• Launch of Mind Medicine Australia Podcast series featuring 56 podcasts with leaders in psychedelics

• Launch of MMA Weekly Meditation Sessions

Video animation explaining the mental illness epidemic in Australia and the benefits of psilocybin and MDMA-assisted psychotherapy with 80,000+ views

• Created a short documentary, Science vs Stigma, to dispel some of the myths associated with these important medicines with over 29,000+ views

•  Over 155,000+ views of Shroom Boom, a light-hearted music video

• Implemented a Board Observership program in conjunction with VMIAC

• Appointed as Member of peak body, Mental Health Australia

• Launch of MMA online shop selling a range of unique merchandise including Australia’s first book of Psychedelic Healing Stories

• Initiated Australia’s first Essential Research poll to gauge the sentiment of the Australian public on the issue of access to psychedelic medicines in medically controlled environments as treatments for key classes of mental illness. 67% agreed that ‘People experiencing terminal illness should have the choice to use psychedelic-assisted therapies to ease end of life distress’.

Developed summary of all trials taking place in Australia

• Over 705,000+ visits to the Mind Medicine Australia website

• Over 101,700+ followers on our social media channels

• Over 684,000+ views on our YouTube Channel and 5371+ subscribers

• Over 11,000+ visits to our e-book about psychedelic-assisted psychotherapies

• An engaged database of over 72,000+ diverse people from a range of sectors and 47,000+ people on our mailing list

• 680+ donors

• 310+ media appearances across Australia’s biggest publications including national news

• 33+ local Chapters around Australia and New Zealand with 2200+ members and growing

• 55,000+ views to our TGA How-to guide during the 2022 public submission period

• Presented and produced Mind Medicine Australia’s inaugural International Summit on Psychedelic Therapies for Mental Illness in November 2021

• Nearly 1000 people registered for our two-day workshop and Global Summit from every state of Australia and more than 15 other nations

• Over 90,000 views of our Summit sizzle reel

• Over 80,000 visits to the Summit website

• Over 5000 queries received from the Summit website

• 110 virtual breakout rooms

• 32 global leaders in the field presented on a range of topics

• 19 major Corporate partners

• Over 160 Education partners

• 17 Supplier Partners

• 15 Media Partners

• 8 Scholarship winners

• 5 Poster winners

• 1 global 4-day event with massive impact

 

Patient Access

• Successful submissions made to the TGA to reschedule MDMA and psilocybin from Schedule 9 (Prohibited Substances) to Schedule 8 (Controlled Medicines), allowing limited access to MDMA and psilocybin-assisted therapies from July 1 2023 via the TGA’s Authorised Prescriber scheme

• Granted an Innovation Patent over an improved method of synthesis of MDMA

• Successfully procured medical grade GMP standard MDMA and psilocybin for import to Australia for use in trials and as part of the TGA’s Authorised Prescriber scheme from July 1 2023. We provide equitable access to GMP quality medicine as an exclusive distributor in Australia for Optimi Health

• In January 2024, the first patients were treated with psychedelic-assisted therapies as part of the Therapeutic Goods Administration’s (TGA) Authorised Prescriber (AP) program in Melbourne, Australia with medicines and training supplied through Mind Medicine Australia. These were the first psychedelic medicine dosing sessions in clinical settings in 50 years.

• Established the Patient Support Fund (PSF). Donations into this fund provide subsidised treatment for those who otherwise could not afford it. We have supported 9 patients with a total commitment of $85.000+ in its first year.

• Collaborating with Health Insurers and Governments to broaden the funding base for these therapies

• Developing a gold standard National Care Program, clinical protocols and standard operating practices for psychedelic-assisted therapies in partnership with leading clinical groups around Australia

 

Professional Development Program

• Our highly anticipated Certificate in Psychedelic-Assisted Therapies commenced in January 2021 featuring a world class Faculty. By the end of 2024, there will be over 500 qualified therapists including psychiatrists, GPs, physicians, psychologists, psychotherapists counsellors, nurses, social workers, occupational therapists, addiction specialists, paramedics and other allied health professionals.

• Confirmed world-leading facilitators for our Certificate in Psychedelic-Assisted Therapies (CPAT) professional development course

• Engaged Dr Gita Vaid (USA) as the course’s International Course Director and Dr Eli Kotler as the Australian Course Director for our programs from 2023 onwards.

• Described as “the best course of its kind in the world” by Professor David Nutt on ABC Radio National interview (UK)

• Over 1000+ applications received since launch

• Over 1333+ people trained in psychedelic-assisted therapies across our suite of training programs

• Over $434,000 raised for CPAT grants through philanthropy to support those in regional and rural areas and therapists suffering financial hardship. Over 85 grants have been awarded so far.

• Over 183,000+ views of the CPAT highlights sizzle reels. Watch current reel.

• Launch of the Fundamentals in Psychedelic-Assisted Therapies Course

• Developed a mentoring program for graduates of PAT training, allowing ongoing professional development with global leaders in the field

Recognition by key peak/membership bodies of our professional development and training programs

• Key university student placement partnerships with University of Melbourne and a major volunteering program established

 

Research

• Successfully advocated for $15 million to support innovative mental health clinical trials utilising psychedelic-assisted therapies from the Federal Government through the Medical Research Futures Fund

• Supported the launch of Psychedelic-Assisted therapies Research Registry at ANU, which will allow for outcome data to be collected from treatment with PAT around Australia

• Launch of The Monash University Neuromedicines Discovery Centre, initially proposed by MMA and developed over a 2-year period

• 32+ current trials of psilocybin, MDMA, LSD and Ibogaine in Australia and New Zealand.

• Developed a BLOG, significant education resources and partnered with Universities to disseminate these as well as sharing these via our website

• Discussions with key University stakeholders continue

 

Noteworthy from Media Releases:

• Mind Medicine Australia, Marks 5-Year Milestone with Global Achievements in Psychedelic Therapies

• Psychiatrists give the First Psychedelic Medicine Dosing Sessions in Clinical Settings in 50 Years this Week in Melbourne Australia

• Breaking News: The TGA Announces the Delegate’s Final Decision to Reschedule the Use of Psilocybin and MDMA for Medical Purposes

• An Open Letter to the Prime Minister in November 2022

• TGA Expert Review Findings Support the Therapeutic Use of Medicinal Psychedelics in Treating Mental Health Crisis in October 2021

• Mind Medicine Australia Launched Australia’s First Book of Psychedelic Healing Stories in October 2021

• Monash University announced the establishment of the Neuromedicines Discovery Centre to Focus on Psychedelic-Assisted Therapies for the Treatment of Key Classes of Mental Illness in November 2021

• Mind Medicine Australia hosted Australia’s Inaugural International Summit on Psychedelic Therapies for Mental Illness online in November 2021

• Mind Medicine Australia joined a global coalition launched to secure a rescheduling of psilocybin under the 1971 UN Convention on Psychotropic Substances in January 2022

• New Polling by Mind Medicine Australia Revealed Over 60% of Australians Support Increased Access to Psychedelic Medicines in February 2022

• Mind Medicine Australia Lodged New Applications for the Restricted Medical use of MDMA and Psilocybin Assisted Therapies for Patients with Treatment Resistant Mental Illnesses in March 2022. The full applications can be found here.

 

The progress we are making in public education was exemplified in several headline media articles including in the Australian Financial Review, The Australian, The Age, Herald Sun, The Saturday Paper and Vogue Australia and media interviews including with Channel Nine, Channel 10, The Project, ABC and numerous other TV and radio stations and online media.

In February 2023 the TGA announced that MMA’s rescheduling applications for MDMA and psilocybin were successful. This decision allows psychiatrists to apply for Authorised Prescriber status to administer psilocybin-assisted therapy for treatment-resistant depression and MDMA-assisted therapy for PTSD.

Our primary focus over the next couple of years will be on facilitating the roll out of psilocybin and MDMA-assisted psychotherapy in light of this regulatory change. We are also interested in novel research in this rapidly emerging field to treat a variety of conditions.

Behind the scenes, we are working closely with key stakeholders to ensure that these therapies will be accessible and affordable to all Australians needing these treatments in medically controlled environments, so that cost and geography doesn’t become a barrier.

In the last six years, we have assembled a comprehensive leadership team with expertise in mental illness including psychology, neuroscience and pharmacology, non-profit development, business practices and networks, public health, events, marketing and educational development.

Mind Medicine Australia is also supported by an outstanding Board, Ambassadors, and an Advisory Panel of over 70 local and international experts in medicine, psychiatry, psychology, pharmacology, research, science more broadly, ethics, law, policy, anthropology, business and therapeutic practices. We have also developed a Lived Experience and Young Leaders Panel.

As we move through 2024, our vision and capacity continue to grow. With these medicines now legally available in Australia on a restricted basis, we turn our focus toward ensuring they are accessible and affordable to all Australians who meet the medical criteria.

We ask for your continued and expanded support so that we can fund the path for psilocybin and MDMA-assisted psychotherapy to help treat the millions experiencing key mental illnesses in Australia. This is personal for every one of us.

As Carl Jung said, “The sole purpose of human existence is to kindle a light in the darkness of mere being.”

With gratitude for your interest and generosity. There has never been a more important time to support innovation in the treatment of mental illness.

 

Peter Hunt AM and Tania de Jong AM

Tania de Jong AM

LL.B (Hons), GradDipMus

Tania de Jong AM is the co-Founder and Executive Director of Mind Medicine Australia. She regularly presents on psychedelic-assisted therapies, mental health and wellbeing at major conferences and events around the world and to Governments, regulators, clinicians, philanthropists and the general public.

Tania is one of Australia’s most successful female entrepreneurs and innovators developing 6 businesses and 4 charities including Creative Universe, Creativity Australia and With One Voice, Umbrella Foundation, Creative Innovation Global, Pot-Pourri and The Song Room.

Tania was named in the 100 Women of Influence, the 100 Australian Most Influential Entrepreneurs and named as one of the 100 most influential people in psychedelics globally in 2021. Tania’s TED Talk has sparked international interest. Tania has garnered an international reputation as a performer, speaker, entrepreneur and a passionate leader for social change. Her mission is to change the world, one voice at a time!

Peter Hunt AM

B.Com, LL.B

As an investment banker Peter Hunt AM advised local and multi-national companies and governments in Australia for nearly 35 years.  He co-founded one of Australia’s leading investment banking advisory firms, Caliburn Partnership and was Executive Chairman of Greenhill Australia. Peter was a member of the Advisory Panel of ASIC and chaired the Vincent Fairfax Family Office.

Peter is an active philanthropist involved in funding, developing and scaling social sector organisations which seek to create a better and fairer world.  He is Chairman of Mind Medicine Australia which he established with his wife, Tania de Jong, in 2018. He regularly presents to Governments, regulators, clinicians, philanthropists and the general public on psychedelic-assisted therapies and the legal and ethical frameworks needed to ensure these treatments can be made accessible and affordable. He was the lead author of Mind Medicine Australia’s successful rescheduling applications for MDMA and psilocybin, which made Australia the first country in the world to reschedule these medicines.

He founded Women’s Community Shelters in 2011. Peter is a Director of The Umbrella Foundation. Peter also acts as a pro bono adviser to Creativity Australia.  He was formerly Chairman of So They Can, Grameen Australia and Grameen Australia Philippines.

Peter was made a member of the General Division of the Order of Australia in the Queen’s Birthday Honours List in 2010 for services to the philanthropic sector.

MDMA as a Medicine. Responding to the Views of the FDA’s Advisory Panel.

This article is a joint publication by Drug Science, PAREA and Mind Medicine Australia.

 

Doubt it not, MDMA is a medicine

 

The recent rejection of MDMA-assisted therapy for PTSD by the FDA Psychopharmacologic Drugs Advisory Committee (AdCom) was surprising to many working in the field of mental illness where MDMA-assisted treatment was seen as a vital innovation for treatment-resistant PTSD, a difficult to treat mental illness where there has been little therapeutic progress in the past 30 years. The panel voted 9-2 against the evidence showing real clinical efficacy and 10-1 that MDMA-assisted therapy had a negative benefit-risk ratio. These votes were surprising given the overwhelming clinical data in leading peer reviewed journals of highly significant clinical effects in two large phase 3 trials.

This clinical data, presented by the MAPS for profit company Lykos, at face value fulfils the FDA requirement of two placebo-controlled trials demonstrating efficacy to permit marketing authorisation. The Lykos data showed this requirement was met with a between-subjects effect size of approximately 1 [a large effect size p<0.001]. This is about 3 time greater than that of the only class of licensed medicine used for PTSD, the SSRIs (fluoxetine sertraline venlafaxine and paroxetine) [Note the between subjects effect size subtracts the effect of the therapy from the effect of the therapy plus MDMA, leaving the effect only of the MDMA. A more clinically relevant effect size is the within-subjects effect size, 2.1 in MAPP1 and 1.95 in MAPP2]. The MDMA effect size is even more remarkable given that many of the patients in the MAPs trials were treatment-resistant i.e. had failed to adequately respond to both SSRIs and psychotherapy, an all-to-common situation for people with PTSD.

As one member of the panel reportedly said “It is strange to vote no when the p-value involved three zeroes,” acknowledging the clear mathematical significance of the clinical results. From a few press clippings it seems that some assessors voted against efficacy because they had doubts about other aspects of the therapy rather than because they didn’t believe the statistics.

An added benefit to the clinical efficacy data is that MDMA-assisted therapy differs from other medical treatments in psychiatry in that the drug administration is transient. In the Lykos trials just 3 doses of MDMA were given, unlike with other psychiatric medicines e.g. the SSRIs that are generally given chronically and hence carry a side-effect burden. This should be seen as a real advance in terms of reducing total exposure of the person to the pharmacological agent so reducing the risk of chronic drug interactions within the body leading to emerging adverse effects, tolerance development and possible dependence and challenges with withdrawal in addition to a reduced side-effect burden. But perhaps the very uniqueness of this reduced total exposure to a medicine worried the AdCom panel?

 

Prior national decisions on MDMA

 

What was especially surprising about the FDA panel’s vote was that other national expert groups had previously come to the opposite conclusion, i.e. that MDMA is a medicine (for some patients). In Switzerland MDMA has been allowed on a compassionate-use basis for several decades, when used by registered psychiatrists for patients with treatment-resistant mental health disorders.

In 2023 the Australian equivalent of the FDA [the TGA] decided to down-schedule MDMA to allow its use for treatment-resistant PTSD by authorised psychiatrists. Very recently the Dutch State Commission on MDMA, established by the government and comprised of experts from psychiatry, medicine, criminology, prevention and law, issued its recommendations two days before the AdCom decision. In a lengthy report the Commission concluded that “with what is currently known, there appears to be sufficient scientific evidence for the effectiveness and safety of this form of therapy” and “the government must act expeditiously to enable the therapeutic use of MDMA”. It concluded that until MDMA-assisted therapy is registered in the Netherlands, the best way to provide state-of-the-art treatment is through a large naturalistic study.

It is unclear if the AdCom knew of these decisions and the full FDA hearing in August may well come to a different conclusion to that of the panel. It should be noted here that the FDA is not obliged to follow the views of the AdCom Panel and frequently doesn’t. The final positive Australian TGA decision was preceded by negative opinions on some of the same key issues, which were exposed as flawed by expert feedback.

 

What were the key FDA AdCom concerns?

 

From the FDA hearing these appear to have been

  1. How to regulate a combination of medicine + psychotherapy?
  2. Failure of blinding of patients to the active MDMA arm and/or patient expectancy of positive effects bias affecting the results?
  3. MDMA has a significant abuse risk.
  4. It would be difficult to train enough psychiatrists and other therapists to allow generalisability of treatment efficacy outside of clinical trials?
  5. Risk of misbehaviour of therapists – the breaking down of professional boundaries encouraging sexual abuse.

Each of these issues is addressable and none alone should debar MDMA-assisted therapy, though it seems an accumulation of doubts over each might explain the advisory committee votes. As Oreskes and Conway point out in their book “The Merchants of Doubt” the creation of doubt is a common way scientific facts become undermined in peoples’ minds and so policy decisions become less straightforward. A detailed review of each of these concerns by the authors will appear shortly.

 

The impact of prior professional bodies opinions

 

Both the original Australian and the current FDA opinions were probably swayed by less-than-positive comments by the national professional psychiatry bodies [the APA and RANZP respectively]. These lukewarm psychiatry expert opinions on MDMA contrasted with the same body’s earlier positive support for the licensing of another psychedelic drug esketamine. MDMA was assessed as having a weaker clinical evidence base and being more prone to abuse than esketamine.

In the Australian case a detailed critique of the arguments made by the RANZCP concluded that a degree of bias had been applied against MDMA when compared with esketamine and that if anything the evidence base for MDMA safety and efficacy was the stronger of the two. It is likely that these comparative assessments contributed to the TGA revising its decision to approve MDMA.

In addition to the unsupportive APA letter the FDA hearing was preceded by a negative report by the Institute for Clinical and Economic Review (ICER). This raised the concerns listed above and concluded that MDMA therapy would not be cost-effective so was unlikely to be reimbursed by health insurers. A competitor company – Otsuka – which has just submitted its own combination therapy product for the treatment of PTSD [a daily dose of sertraline and brexpiprazole] – was supportive of the ICER analysis – in what is clearly a major conflict of interest.

Also, one of the members of the FDA Advisory Panel was an employee of Janssen, the company that had recently gained marketing authorisation for the fast-acting psychedelic, esketamine, which would generally be seen as a significant conflict of interest: even though esketamine is licensed for treatment-resistant depression, it is being used off-label for other disorders including PTSD.

For as yet unknown reasons Lykos did not take the opportunity to respond to these issues let alone choose to publicly rebut them. This may have consolidated them as important negative facts in the minds of some on the AdCom panel.

 

Binary decision making

 

The AdCom was asked to make a binary yes-no vote on both the efficacy and benefit-risk of MDMA, with scores of 9-2 and 10-1 against for each question. Is this an appropriate way to make such important decisions? How did they assess benefit-risk across so many different variables? At the very least there should have been some estimates of confidence in each person’s decision. Much better one of several modern validated benefit-risk approaches could have been used or a full Multi Criteria Decision Analysis could have been carried out as developed for the EMA for these kinds of issues.

One hopes that the full FDA hearing will take note of our critique of the AdCom decision-making process and outcomes.

We also hope that the FDA will engage in a much more thorough analysis of the issues that the Advisory Committee referred to which caused the panel to have doubts about MDMA. We will shortly be publishing our own detailed analysis on each of these issues.

 

Prof David Nutt, Prof Jo Neill, Drug Science

Tadeusz Hawrot, PAREA

Peter Hunt, Mind Medicine Australia

 

Prof David Nutt (UK)

BA, MB BChir, MRCP, MA, DM, MRC Psych, FRCPsych, FMedSci, FRCP, FSB

Renowned researcher, policy advisor and author, Professor David Nutt, is currently Head of Neuropsychopharmacology at Imperial College London and the Chair of Drug Science.

Under the leadership of Professor Nutt, the Psychedelic Research Group at Imperial College is one of the world’s foremost psychedelic research laboratories, publishing landmark research on psychedelic therapies and neuroimaging studies of the psychedelic state.

Professor Nutt has also held many leadership positions in both UK and European academic, scientific and clinical organisations, including presidencies of: the European Brain Council, the British Neuroscience Association, the British Association of Psychopharmacology, the European College of Neuropsychopharmacology.

He was previously Chair of the UK Advisory Council on the Misuse of Drugs.

Prof Joanna Neill (UK)

Jo Neill is a Professor of Psychopharmacology at the University of Manchester. She is Chair of the Medical Psychedelics Working Group at Drug Science, a Trustee for Heroic Hearts UK, and a scientific advisor for the Conservative Drug Policy Reform Group. She is co-founder of b-neuro, a University based Contract Research Organisation developing new treatments for mental illness through animal models and past President of the British Association for Psychopharmacology (President 2016-2018).

Tadeusz Hawrot

Tadeusz has 15 years of policy and advocacy experience with the European Union institutions and at the global level. He maintaince strong focus on brain health and evidence-based advocacy. He played an instrumental role in setting up a number of civil-society led coalitions: over 10 national brain councils, Portuguese Societal Impact of Pain Platform, the OneNeurology Partnership.

Peter Hunt AM

B.Com, LL.B

As an investment banker Peter Hunt AM advised local and multi-national companies and governments in Australia for nearly 35 years.  He co-founded one of Australia’s leading investment banking advisory firms, Caliburn Partnership and was Executive Chairman of Greenhill Australia. Peter was a member of the Advisory Panel of ASIC and chaired the Vincent Fairfax Family Office.

Peter is an active philanthropist involved in funding, developing and scaling social sector organisations which seek to create a better and fairer world.  He is Chairman of Mind Medicine Australia which he established with his wife, Tania de Jong, in 2018. He regularly presents to Governments, regulators, clinicians, philanthropists and the general public on psychedelic-assisted therapies and the legal and ethical frameworks needed to ensure these treatments can be made accessible and affordable. He was the lead author of Mind Medicine Australia’s successful rescheduling applications for MDMA and psilocybin, which made Australia the first country in the world to reschedule these medicines.

He founded Women’s Community Shelters in 2011. Peter is a Director of The Umbrella Foundation. Peter also acts as a pro bono adviser to Creativity Australia.  He was formerly Chairman of So They Can, Grameen Australia and Grameen Australia Philippines.

Peter was made a member of the General Division of the Order of Australia in the Queen’s Birthday Honours List in 2010 for services to the philanthropic sector.

New Horizons in Healing: Psychedelic-Assisted therapies’s Bold Leap Forward

This article was originally published by Dr David Reiner here. Connect with David on LinkedIn here.

A New Chapter in Mental Health Care

On January 19, 2024, the landscape of mental health care was changed forever. In an unprecedented move, MDMA was given to a patient not as part of a trial but as a prescribed treatment. This bold step came less than a year after the Therapeutic Goods Administration’s (TGA) decision to sanction MDMA for the treatment of PTSD.

As we acknowledge the weight of this moment, it is fitting, as many of us are, to be celebrating. The patient under the care of Ted Cassidy and Monica Schweickle, grappling with chronic treatment-resistant PTSD, reportedly experienced profound therapeutic gains. Writing on LinkedIn, Dr Cassidy said, “one day with MDMA-assisted therapy achieved more than is usually achieved in a year.”

This event should fuel our optimism for the future of psychiatric treatment. Yet, it also serves as the perfect point for us to pause and ponder the journey that has brought us here, and to balance our enthusiasm with the right amount of caution.

As we stand on the cusp of a new era in mental health intervention, one that could promise great leaps forward in healing, it’s vital we remember our commitment to patient safety and evidence-based practice.

The Mavericks of Medicine

The trajectory of medical science has been and continues to be a journey into the unknown. The strides forward that we now accept as conventional thought first required someone to view things unconventionally, sometimes at great risk to their personal and professional reputations.

Consider Dr Ignaz Semmelweis, the tragically marginalized pioneer of antiseptic procedures, who was branded a charlatan and met his end in a Viennese asylum. While it is the mavericks and iconoclasts who have propelled science forward, his story is a sobering reminder of the price paid for radical thought.

Overlooked or not, some of the greatest scientists in history started as outsiders and rebels. In medicine, the field of psychiatry perhaps best exemplifies this spirit of rebelliousness, with unconventional figures such as Freud littered along its annals of fame. It seems fitting, then, that psychedelics—long associated with counter-culture—have found a niche within this rebellious lineage.

Rigour in the Face of Revolution

Yet, in the pursuit of progress, we should anchor ourselves with a healthy level of scepticism – the vital counterbalance we use in science to ensure that our optimism does not outpace the evidence available.

It is our duty, as doctors within the psychedelic space, to rigorously scrutinize, research, and refine our methods. So, as we congratulate Ted Cassidy and Monica Schweickle for conducting the first MDMA dosing session beyond a research setting, let’s also commit to the meticulous study that this new frontier demands.

The initiation of MDMA in clinical therapy is a significant leap, yet our journey is far from complete. Continued research is essential to refine our treatment protocols and to validate the efficacy of our work with patients. Though the road ahead is promising, it will be long and filled with complexity and controversy, just as the road to this point has been.

Navigating Complex Currents

The journey toward the TGA decision in 2023 to approve MDMA and psilocybin as medicines was a complex one. Just a year before the decision, a proposal to down-schedule these substances was rejected, with major professional bodies like the Royal Australian and New Zealand College of Psychiatrists and the Australian Psychological Society supporting this stance.

The eventual shift in policy seems to have been catalysed by advocacy from groups like Team Mind Medicine Australia and notable scientists such as Professor David Nutt, despite little new scientific evidence at the time. This pivot highlights the nuanced dynamics at play in the landscape of psychedelic medicine.

As a result, reactions to the TGA’s decision have been polarized, with some such as Professor Nutt embracing it as a beacon of hope for patients with few alternatives, while others voice apprehension. Prominent psychiatric professionals, including Orygen CEO Patrick McGorry , have voiced concerns about the potential implications of “intense private lobbying” on regulatory decisions.

Decisions in the medical field ought to be grounded in rigorous scientific evidence and to be made with the utmost integrity. As we continue to explore the therapeutic potential of psychedelics, we must maintain balance. However, there are patients out there suffering from chronic and treatment-resistant conditions. For them, waiting for new treatment options risks prolonged suffering and the pace of governments and bodies is overly risk-averse.

The Cultural Catalysts

Psychedelic medicine is currently at a pivotal crossroads, experiencing a shift propelled by a diverse cohort including clinicians, researchers, and, notably, entities from the med-tech sector, venture capitalists, and investors. The entrance of for-profit interests into this sphere inevitably prompts scrutiny over the motivations steering the field.

Amidst this transformation, cultural contributions such as Michael Pollan’s “How To Change Your Mind: The New Science of Psychedelics,” now a successful Netflix series, have catalysed public curiosity and piqued demand for psychedelic-assisted therapies. The resultant surge in public interest has significantly outpaced the more measured approach traditionally taken by established medical bodies.

This disparity in pace has been highlighted by the actions of the Royal College of Psychiatrists, which has only recently begun to actively engage in establishing a dedicated working group on psychedelics and forming a committee to write clinical guidelines for psychedelic treatment.

The slow response from such established institutions has left a void, now being filled by non-traditional actors. Their readiness to step in reflects a broader trend where, in the face of pressing public demand and the potential for profound therapeutic benefits, the impetus for innovation emerges from outside the medical establishment.

Toward a Future of Healing

We can hope that this pioneering first case of MDMA as a medicine in a clinical setting could catalyse a broader movement towards accessible and affordable mental health treatments. As evidence supporting psychedelic therapies grows, so too does the potential for government support and integration into healthcare systems

The broadening of the evidence base is a crucial factor that could pave the way for psychedelic treatments to be integrated into mainstream healthcare systems. If these therapies can continue to demonstrate efficacy and safety in clinical use, it stands to reason that they might soon be considered for inclusion in national healthcare schemes like the Pharmaceutical Benefits Scheme and Medicare.

The potential for reducing the financial burden on patients and increasing the availability of innovative therapies is a hopeful prospect, one that could transform the landscape of mental health treatment and offer new hope to those for whom traditional therapies have fallen short.

A New Dawn with Due Diligence

As we stand at the cusp of what could be a revolution in mental health care, our shared mission must be to proceed with informed enthusiasm and cautious optimism. Let us embrace the new dawn of MDMA-assisted therapy with diligence, ensuring that every step forward is taken with care for those we serve and respect for the science that guides us.

Dr David Reiner

B.Med, F.A.N.Z.C.A, PG Dip Echo

Dr David Reiner graduated medical school in 2003 and completed his anaesthesia training at the Prince Of Wales Hospital in Sydney, Australia.

He has been working as a Anaesthesiologist at The Canberra Hospital (public) since 2011. He was the quality and safety officer for the Australian New Zealand College of Anaesthetists in the ACT for 3 consecutive years – during this time he activated the WEBAIRS platform in the ACT – the Adverse Incident Reporting System. He has administered anaesthesia to over 16,000 patients. The majority of his clinical practice involves anaesthesia for neurosurgery. Anaesthesiology by definition involves using mind altering drugs. Every medication has side effects/complications including the ones we are trialling – Dr David Reiner is skilled at managing drug disturbances to physiology. Having an anaesthesiologist during the clinical administration of novel drugs increases safety of that trial. Anaesthesiologists are capable of basic life support and advanced life support. Acute circulatory, neurological and respiratory disturbances due to drugs are part of Dr Reiner’s everyday practice. Like all anaesthesiologists he alters consciousness, blood pressure and breathing patterns of every single patient under his care.

Top Takeaways from Mind Medicine Australia’s Psychedelic Public Lecture with Dr. Ben Sessa

 

By Natasha Baer

A full hall gathered at St Kilda Town Hall to hear Dr. Ben Sessa present a lecture on Psychedelic-Assisted Therapies: The New Frontier in Mental Health Treatments. Dr. Sessa spent much of October and November in Australia co-leading the Intensives for Mind Medicine Australia’s Certificate in Psychedelic-Assisted Therapies (CPAT) course and presenting public lectures and workshops.

Hosted by Mind Medicine Australia (MMA), a charity that aims to alleviate the suffering and suicides caused by mental illness, the event saw MMA founders Tania de Jong AM and Peter Hunt AM give an update about the charity’s progress in the space. There was also a Q&A panel with Psychiatrist Dr. Eli Kotler and Psychotherapist Marjane Beaujeois, both graduates of MMA’s acclaimed Certificate in Psychedelic-Assisted Therapies course.

The headliner of the event was speaker Dr. Ben Sessa, a UK-based Psychiatrist and Resarcher, at the forefront of psychedelic research. Dr. Sessa highlighted groundbreaking research in the field and shared his ideas for progress in psychedelic treatment. Without further ado, here’s a wrap-up of the talking points and takeaways, so you can find out what’s what, whether you were lucky enough to be in the room or not.

 

Australia is ahead of the curve

Australia has often been criticized abroad for not being agile or on the bleeding edge of innovation. However, in the field of psychedelic treatment for mental health issues, following the successful rescheduling of psilocybin and MDMA, Australia is now in a unique global leadership position.

On July 1, 2023, Australia became the world’s first country to legalise MDMA and psilocybin officially. Other countries and territories Australia has outpaced include Canada, the USA, the UK and Switzerland.

Dr. Sessa notes that even if any country were to submit an application for legalisation today, it would take about three years for it to be confirmed into law.

Psychedelic drugs are safe…

…in a clinical setting. MMA is solely focused on clinical and legal use only, supported by emerging science, clinical data and legislative processes.

Dr. Sessa said, “A lethal dose is over 1000 times the typical intoxication dose, which equates to consuming 17 kg of fresh mushrooms”. That’s one heck of a beef wellington.

When safely using classical psychedelics clinically, the following outcomes are assessed as low risk:

Psychological risks: Low

Psychosis and suicide: Low

Dependency risks: Low

Hallucinogen Persisting Perception Disorder: Rare

Psychedelic therapy works for many mental disorders
Research studies spanning from 2006 to 2022 show that psilocybin, MDMA, and ketamine have successfully treated:

One way Dr. Sessa described this broad treatment was: “Psychedelics are non-specific amplifiers of psychotherapy”. The results have been so positive that on a chemical construction level, Dr. Sessa said, “If someone were to invent a cure for PTSD, they would invent MDMA.”

Treatment is drug-based AND talk-based
MMA does not condone simply taking a dose of these medicines. Instead, the Therapeutic Goods Administration’s (TGA) decision to reschedule MDMA and psilocybin grants Authorised Prescriber status to psychiatrists trained in psychedelic-assisted therapies who are approved by Ethics Committees to treat their patients with these therapies.

Psilocybin, MDMA, and ketamine create neuroplasticity, which biologically allows more flexibility and a window of opportunity for healing stuck and rigid thought patterns and programs. Then when paired with bespoke focused clinical psychotherapy, patients can tackle rigid narratives and allow for psychological change.

 

 

The time to act is now

There’s no better time to get involved, Dr. Sessa concludes, “We are in the midst of a global mental health crisis epidemic. We’ve had 100 years of sub-standard treatment. Psychedelics represent the newest technology in psychiatry in the last 50 years — and also the oldest!”

Dr. Sessa calls industry professionals to get involved. Psychiatrists can apply to the ethics boards and the TGA to become Authorised Prescribers. For psychiatrists and other health professionals (e.g., doctors, nurses, therapists, clinical psychologists, psychotherapists, counsellors, social workers, pharmacists and others, robust training is available and required.

 

Mind Medicine is ramping up activities!

Wherever you are, you can attend an MMA online event and listen to the MMA podcast series. And importantly, donate to MMA so they can continue to establish safe and effective psychedelic-assisted treatments to treat a range of mental illnesses. Together we can all help to relieve the immense suffering in our families, communities, workplaces and world.

Grateful for the Dead

 

The life and legacy of the late, great Augustus Owsley Stanley III. Why he was a key figure in the 1960’s counterculture movement, and responsible for ultimately altering the collective consciousness of a generation.

The tropical Cairns of Far North Queensland is the last place you’d expect to see someone with such celebratory status as Owsley Stanley. Yet, this is where he’d chosen to live for the last two decades of his life. A climate change refugee, Australia became his home after he predicted that the northern hemisphere would be ruined by uncontrollable storms causing a new ice-age. It was here he died, a citizen of the country, in a car accident in March 2011.

Owsley Stanley neighboured with the untouched vastness of the Daintree rainforest, the oldest rainforest in the world — which is where our journey begins. Likewise, this is too where I called home for the past year of my life. A music and psychedelic enthusiast myself, my path and Owsley’s met when I had the great pleasure of meeting and speaking to his daughter Redbird Ferguson, who is also Chief Financial Officer of the Owsley Stanley Foundation.

The more I learnt about Owsley Stanley’s life, the more I realised why we have him to thank for paving part of the way for the psychedelic resurgence. His legacy only validates and unveils the unique psychedelic tapestry that links creativity and culture. His story reflects the connection between the psychedelic experience and its impact on human consciousness and cognition in ways that influence innovation, scientific inquiry, and philosophical exploration.

 

EARLY LIFE

Known to many under his life-long nickname ‘Bear’, the pioneering sound man for the Grateful Dead was born in 1935. His father was a prominent government attorney, and his grandfather was elected as Governor of Kentucky in 1919. Even without graduating high school, he was admitted to the University of Virginia, where he studied engineering for a year. Although he eventually dropped out of college, his lack of formal education didn’t hinder him. Bear ultimately secured a position in the United States Air Force in 1956 as an electronics specialist, serving for 18 months.

He was first introduced to psychedelics when he was enrolled at the University of California, Berkeley for a semester in 1963. After consuming the original Sandoz LSD, he became determined to learn how to synthesise it himself. Using his Berkeley lab, he ordered 500 grams of lysergic acid monohydrate, the basis for LSD, which was legal at the time. Bear went on to perfect and produce a staggering 300,000 doses of LSD in his home laboratory.

 

THE ACID TESTS

It was Bear’s acid behind the infamous ‘Acid Tests’ conducted by the novelist Ken Kesey and his Merry Pranksters, the group of psychedelic devotees. The tests were essentially a series of parties held during the mid 1960’s. They comprised of musical performances along with strobe lights, fluorescent paint and of course, LSD. The Acid Tests are notable for their influence on the counterculture of the San Francisco area and subsequent transition from the beat generation to the hippie movement. As bands such as the Dead played, the audience drank Kool-Aid laced with LSD.

Bear eventually used the money he generated selling acid to help fund the early days of the Grateful Dead. Guitarist Jimi Hendrix sampled his product, as did the Rolling Stones’ Brian Jones, Pete Townshend of The Who, Jefferson Airplane, Frank Zappa, and The Beatles among others.

John Lennon had apparently developed an appreciation for LSD in England and wanted to obtain enough high-quality acid to fuel his creative endeavours. According to legend, Lennon approached Bear about a lifetime supply. The effects of the Beatles’ psychedelic experiences on Bear’s acid likely contributed to the band’s trippy ‘Magical Mystery Tour’ film. It is said that even Albert Hoffman, the first synthesiser of LSD, was quite impressed with the product Bear created, as he was the only one who had ever got the chemistry correct.

Some people view LSD as the prime catalyst of the hippy counterculture. It couldn’t be confined to research and government-led projects. By 1966, “Turn on, tune in, drop out” was the catchphrase popularised by LSD enthusiast Timothy Leary, who credited Bear for his contribution. In his ‘Sixties anthology of essays, Politics of Ecstasy’ Leary predicted, “The television folk heroes of today are the merry outlaws of the past. The Television Robin hoods of the future, the folk heroes of the twenty-first century, will be the psychedelic drug promoters, A.O.S. 3, acid king, LSD millionaire, test-tube Pancho Villa, is the best-known of a band of dedicated starry-eyed crusaders who outwitted the wicked, gun-toting federals and bravely turned on the land of the young and the free to the electronic harmony of the future.” A.O.S.3. was Leary’s acronymic code for the name that Bear was given at birth — Augustus Owsley Stanley III.

 

 

When he wasn’t making the colourful acid tabs known on the street as “White Lightning,” Bear served as the sound engineer for the Grateful Dead. An early and enthusiastic fan, he worked for years to develop the Dead’s “wall of sound,” a 40-foot-tall bank of more than 600 speakers whose output could be controlled by the musicians on stage. This system redefined concert sound reinforcement and set new standards for immersive live experiences. Additionally, he designed the band’s symbol of a lightning bolt inside a skull, known as the “Steal Your Face” logo.

Bear’s use and distribution of high-quality LSD had a significant impact on musicians and their creative processes. Many artists credited LSD with expanding their consciousness and influencing their musical compositions. The psychedelic experience often found its way into the lyrics, sounds, and imagery of the music produced during that era.

BLENDING OF SENSES

“Psychedelics seemed to give me access to my head in some way… I got involved with it because the first time I did it, I realised it opened a door and it was a place I wanted to explore. I wanted to know what I was doing… I guess I’m a good cook. It was the introduction to magic. I’m sure it was the root source of my ability to manipulate sound” (Stanley, 1991).

Bear continued “I was looking at sound coming out of the speakers…” describing an LSD induced trip and added that he’s never met anyone else who’s had the same experience. Interestingly, again this is where Bear and my story intertwines. A high school dropout myself, I eventually went on to study Music at University and too became profoundly transformed by psychedelic revelations. During a psylocibin trip in Joshua Tree, I and the two other women who partook in the ceremony witnessed similar visions to Bear. A phenomenon known as ‘synesthesia’, is where you experience one of your senses through another. For us, it occurred after strumming a guitar and physically seeing the vibrations being fashioned from the strings. The science of how and why this happened fascinates me.

 

 

There have now been numerous accounts of synesthesia being experienced during psychedelic trips. With a study being done by David Luke, a London-based researcher at the University of Greenwich. Luke and colleagues found that, a diverse set of drugs can cause synesthesia. LSD and other tryptamines, such as DMT and psilocybin, are more commonly able to induce the phenomenon. These drugs predominantly affect the serotonin systems which aligns with past research suggesting that synesthesia follows a serotonergic pathway. Luke believes research on psychedelic produced synesthesia could be “a back-door way to understand synesthesia,” as 57% of LSD users surveyed experience it.

Luke adds that research about synesthesia can shed light on what neurobiology researchers call the “binding problem.” This is how items that are encoded by distinct brain circuits can be combined for perception, decision, and action. How do humans take different pieces of sensory input that are processed in distinct regions of the brain, such as the motion of a car or the colour red, and bind them cognitively into one coherent perceptual experience? It helps us understand and navigate the world, and it’s a process that’s not yet deeply understood on a neurobiological level. Research on synesthesia and how it relates to the binding problem, may point toward a relationship between psychedelics and human cognition. According to Luke, his work “goes a long way to substantiating or shoring up the stoned ape hypothesis of Terence McKenna… synesthesia induced by psychedelics may have been important in the development of language.”

PSYCHEDELIC AND ALCHEMY INTERTWINE

Another link between psychedelic and human consciousness is one that is more commonly dismissed as a pseudoscience but was frequently referred to by Bear. He was “a savant with an obsession for quality, but his rigor was influenced by spiritual concerns as much as scientific ones” (Jarnow, 2001). “Since LSD itself modulated the mind, Owsley assumed that it was profoundly sensitive to the atmosphere in which it was made, and he approached making it as an alchemical act, with a fanatical concern for purity of both heart and chemistry. His standards were so exacting that he rejected a significant proportion of his yield” (McNally, 2001).

Bear openly spoke about alchemy and psychedelics. These seemingly unrelated realms of human exploration share a captivating connection that spans across time, geography, and cultural contexts. Both fields delve into the depths of transformation and transcendence, whether it be of matter or of consciousness. By recognising these connections, we gain a deeper understanding of the human drive to explore the unknown and to seek transformation in both the external and internal realms.

 

Alchemy, a mystical and proto-scientific pursuit, emerged in various cultures across the world, from ancient Egypt and Greece to medieval Europe. It aimed to transmute base metals into precious ones and discover the elusive “philosopher’s stone” that held the key to eternal life. Turns out J.K Rowling didn’t pluck Harry Potter from thin air. While on the quest for the stone, alchemists spent a great deal of time studying properties of chemicals and how they interacted. Consequently, alchemy formed the foundation of modern chemistry and medicine.

“Let it be known there is a fountain, that was not made by the hands of men.”

– Ripple, The Grateful Dead

Similarly, indigenous cultures and ancient civilisations have long employed natural substances, often psychedelic plants, or fungi, for spiritual and transformative purposes. Shamans and mystics used these substances to access altered states of consciousness and gain insights into the nature of reality. Both alchemy and psychedelics share an underlying theme of transcendence. Alchemists sought to transform not only physical substances but also their own spiritual selves, embracing the belief that material and spiritual evolution were intertwined. This mirrors the experiences reported by individuals who have undergone psychedelic journeys, often describing a profound shift in their sense of self and connection to the universe. The seven steps of the alchemical process include: calcination, dissolution, separation, conjunction, fermentation, distillation, and coagulation. The parallels between these steps and the psychedelic experience itself is often speculated.

In today’s world, the connection between alchemy and psychotropic experiences continues to intrigue scholars, scientists, and artists alike. As research into the therapeutic potential of psychedelics gains great momentum, similarities are drawn to the alchemical pursuit of transformation and healing. The exploration of the mind’s hidden depths through psychedelics echoes the alchemical quest to unveil hidden truths within matter.

 

 

RETURN OF A REVOLUTION

Owsley Stanley was an outlier from birth. Society at the time, perceived him as a threat to the status quo. He rejected the idea of fame, expressing to Rolling Stone magazine “I’m not into being a celebrity, because I think celebrityhood has no value to anyone, least of all the celebrity.” However, in death his fame is still emerging. I believe his story is an important one to tell, as the Summer of Love might have only been an ordinary season without Bear’s pharmaceutical input. It is my objective to shine light on key figures in history that changed the trajectory of our world through the enhancement of their imagination and creativity by psychedelics.

In saying this, we need to be aware of the reasons that the 60’s went sideways. LSD Dose-for-dose tops all other hallucinogens in potency, as other hallucinogens require a much larger dose. Notorious figures such as Timothy Leary and Ken Kesey passed out the drug far and wide to anyone. Even though it was a small amount, it was blowing people out of their minds. Potency is possibly why you don’t see as much research on LSD versus other psychedelics like psilocybin. People need to be mindful of its effects and when and where to indulge. With the therapeutic use of psylocibin and MDMA now legal in Australia, I assume other countries will shortly follow suit. We are being presented with the opportunity to steer psychedelics back on the right path and use them how they should have been intended, as medicine.

I have previously written in articles about the more specific research behind psychedelic medicine, and how it can unlock creativity by quietening the default mode network, consequently creating new thought patterns in the brain. Perhaps the average person may not invent the next million-dollar idea or scientific discovery, but they have the possibility to change their life and in turn fill it with more beauty. This directly influences others around them and the world at large. With that said, in a world heading for environmental crisis, who knows what problems may be solved by having psychedelics in the right hands. As science and spirituality converge, advocates are starting to bridge the gaps and harness the potential of these compounds for societal betterment. As the legalisation of psychedelic-assisted therapies proposes solace to the terminally ill and those suffering with mental health challenges, it too offers insights into the human psyche.

Bear introduced a generation to the power of these medicines. Beyond his direct influence on music production and performances, his innovative spirit inspired a generation of musicians, engineers, and artists. Bear’s emphasis on pushing boundaries and embracing experimentation left a lasting mark on the music industry and continues to influence how music is created today.

As psychedelics start to become reintroduced into society, I trust that the world will begin to remember our ancient history. Psychedelics is the thread that weaves cultures together. We are only starting to unravel the mysteries of alchemy and psychoactive compounds. We now stand at the crossroads of ancient wisdom and cutting-edge science, seeking to unlock the keys to transformation, both within and beyond. So, thank you Bear for your countless contributions, I’m grateful our paths met in a roundabout way. In the words of the Dead, “what a long, strange trip it’s been.”

 

REFERENCES

Adams, B.M. (2023) The age of Alchemy, High Times. Available at: https://hightimes.com/culture/the-age-of-alchemy/ (Accessed: 28 July 2023).

Bannerman, M. (2019) The man who brought LSD to America invented something else that also changed music forever, ABC News. Available at: https://www.abc.net.au/news/2019-03-24/stanley-owsleys-work-with-1960s-bands-must-be-preserved/10871062 (Accessed: 28 July 2023).

Bears Sonic Journals (2022) Owsley Stanley Foundation. Available at: https://owsleystanleyfoundation.org/ (Accessed: 15 August 2023).

Brown, E. (2023) ‘Bear’ Stanley, who made the LSD on which Haight-Ashbury tripped, dies at 76, The Washington Post. Available at: https://www.washingtonpost.com/local/obituaries/bear-stanley-who-made-the-lsd-on-which-haight-ashbury-tripped-dies-at-76/2011/03/15/ABt95Ib_story.html (Accessed: 12 August 2023).

Cassandra, R. (2022) Psychedelics open opportunity to study synesthesia — lucid news, Lucid News — Psychedelics, Consciousness Technology, and the Future of Wellness. Available at: https://www.lucid.news/psychedelics-open-opportunity-to-study-synesthesia/ (Accessed: 12 August 2023).

Getlen, L. (2016) This guy made the best LSD of the ’60s, New York Post. Available at: https://nypost.com/2016/11/19/this-guy-made-the-best-lsd-of-the-60s/ (Accessed: 15 August 2023).

Kitchens, T. The Johnny Appleseed of LSD (2016) KY for KY Store. Available at: https://kyforky.com/blogs/journal/owsley (Accessed: 12 August 2023).

McNally,Dennis (2002) A long strange trip: The inside history of the Grateful Dead. Broadway Books, NY.

NonDirectionalFilms (2022) OWSLEY STANLEY INTERVIEW. [Online video] Available at: https://www.youtube.com/watch?v=vjWKNw4nKOs (Accessed: 28 July 2023).

Pierce, M. (2023) The alchemical journey: Exploring the parallels with the psychedelic experience, Medium. Available at: https://medium.com/@mikejaypierce/the-alchemical-journey-exploring-the-parallels-with-the-psychedelic-experience-ca7708ccd71d (Accessed: 15 August 2023).

Charlotte McAdam

I am a natural health consultant, globetrotter, music enthusiast and freelance writer specialising in the natural healthcare industry. A psychonaut, who draws from my life story and many experiences with indigenous ceremonies from around the world. I am passionate about the ancient teachings of these medicines and how they can help heal our relationship to ourselves, each other and mother earth.

Returning to Our Roots

Australia, we did it. The first country to formally recognise psychedelics as medicines. Which of course, is what they were and always have been. The decision to criminalise the use of psychedelics is only a recent memory. However, history paints a different picture with psychoactive plants being used as a healing tool for hundreds, if not thousands, of years.

The Therapeutic Goods Administration (TGA) announced that from July, certain psychedelics will be considered schedule 8 drugs – meaning they’re approved for controlled use when prescribed by a psychiatrist. This comes after a plethora of studies published around the healing potential of psychoactive substances to treat certain mental health conditions. The drugs include MDMA for the treatment of post-traumatic stress disorder (PTSD), and psylocibin for treatment-resistant depression. Whilst the rescheduling took many by surprise, countless advocates who have been laying the groundwork for decades are relieved, including Mind Medicine Australia, who made the successful applications to the TGA.

The momentum for psychedelic therapy has been gaining traction in recent years. The conversation around altered states of consciousness is now loud and proud, and remarkably being well received. Mainstream media is saying that we are a society becoming more progressive. Yet, ancient culture would argue that we are only starting to remember our ancestral past. The scientific data undeniably favours therapeutic use of plant medicine. It seems the typically voiceless plant intelligence, is finally speaking for itself.

It was only in 1968, that use of psychedelics was outlawed by the U.S. federal government. Whilst hippy counterculture was running rampant, use of these drugs, particularly LSD, became closely associated with anti-war demonstrations. Before this time, psychedelic therapy, based on the work by psychiatrists Humphry Osmond and Abram Hoffer, was taking off. It involved a single large dose of LSD alongside psychotherapy. Osmond and Hoffer believed that hallucinogens are helpful therapeutically because of their powerful ability to make patients view their condition from a fresh perspective.

Some 40,000 patients were prescribed one form of LSD therapy as treatment for neurosis between 1950 and 1965. As well as similar psychedelics having promising results for treating depression, PTSD, addiction, OCD, relationship issues and other conditions. During this period over 1,000 scientific papers had been produced and six international conferences were held regarding the research and potential healing effects of hallucinogens.

Research came to a halt throughout the War on Drugs, with many practitioners and researchers having to go underground. The 1990s, however, saw a renewed interest in the field. During this time, Ethnobotanist and psychedelic advocate Terence McKenna published a book called ‘Food of the Gods’. This publication explored humans’ symbiotic relationships with plants and chemicals. He surmised that Homo sapiens’ cognitive leap forward was owed to their discovery of magic mushrooms. This theory was as controversial as McKenna himself.

More recently, the ‘Stoned Ape Theory’ gained a new supporter, mycologist Paul Stamets, who suggests that McKenna was right all along. At Psychedelic Science 2017, Stamets presented “Psilocybin Mushrooms and the Mycology of Consciousness” regarding the theory. He advised that the hypothesis is a plausible answer to an age-old evolutionary riddle. “What is important for you to understand is that there was a sudden doubling of the human brain 200,000 years ago. From an evolutionary point of view, that’s an extraordinary expansion. And there is no explanation for this sudden increase in the human brain” Stamets explained. McKenna’s notion constitutes a “very, very plausible hypothesis for the sudden evolution of Homo sapiens from our primate relatives.”

Even if you believe the stoned ape theory is a bit far-fetched, it does arouse curiosity around humans and our relationship to mind-altering substances. Amanda Feilding of the psychedelic think tank Beckley Foundation states, “The imagery that comes with the psychedelic experience is a theme that runs through ancient art, so I’m sure that psychedelic experience and other techniques, like dancing and music, were used by our early ancestors to enhance consciousness, which then facilitated spirituality, art, and medicine.”

Psychoactive plants have been used by non-Western cultures as sacramental tools throughout millennia. They have shaped the course of various established religions and are still used around the world today as part of religious ceremonies. This is well documented in texts from ancient Greece, and Sanskrit texts that form the Hindu religion. Modern day practice includes the Amazonian use of Ayahuasca, the Native American traditions surrounding the Peyote cactus, and the worldwide use of psychoactive mushrooms such as some indigenous tribes in South America. Not to mention suggestibility of certain Australian Aboriginal tribes’ use of the Duboisia genus, a plant hallucinogen called Pituri.

What most of these cultures have in common is using plant medicine as part of a ceremony – usually led by a shaman. They combine techniques to alter consciousness, such as chanting and drumming, to connect to the spiritual world and induce a dreamlike state. Additionally, the ceremonies are beneficial to their communities, helping them to resist certain trappings of Western culture. These communities are largely associated with lower levels of mental illness than those who are more heavily influenced by alcohol abuse.

Furthermore, it’s not only humans that show a tendency towards inducing altered states of consciousness. Evidence shows that many species of the animal kingdom similarly consume psychoactive plants, both recreationally and medicinally. From cats, cows, reindeer and other mammals to insects and fish being attracted to hallucinogenic plants and fungi.

The rise in mental health conditions around the world has certainly been one of the catalysts for the demand of alternative options. Current treatment for many has failed. As our world gets more complex and complicated, so too does our suffering mental health. With Australia now in the limelight, what does it mean to legalise these drugs for therapeutic use?

In a recent TIME article, Rick Doblin (MAPS’ founder and executive director), commented on the rescheduling in Australia. Doblin explains “Australia’s approval of these drugs may only expedite the approval process in the U.S.” However, despite their decision to make these medicines available to patients, Australian regulators have not approved any medications. Additional adequate training for practitioners must also be undertaken. Doblin says, “The drug is not the treatment – it makes the therapy more effective, but it’s about the therapy.”

Mind Medicine Australia’s Certificate in Psychedelic-Assisted Therapies (CPAT) features a world-leading Faculty. It gives qualified clinicians the additional skills and awareness they need to facilitate psychedelic-assisted psychotherapies safely and successfully. 240 clinicians have already completed the course with many more to come. New intakes are commencing in July 2023. The 90-hour course includes a 6-day intensive utilising holotropic breathwork for all participants. This provides an effective tool for teaching therapists the power of altered states for their own healing and development. They get the opportunity to “sit” with other therapists and learn how to support the patient through these transformational experiences. It will be imperative to train as many therapists as possible over the coming years to meet the growing demand for these treatments.

An integral part of the psychedelic experience comes from its innately spiritual insights. How will therapists respond to this if they haven’t experienced it themselves or are closed off to a transcendental understanding? Dr Rick Doblin and MMA both agree that it will be important for therapists to take these medicines – resulting in a better understanding of how to integrate these experiences with other therapists in Healthy Persons’ Trials.

We need to handle this next phase with care and respectfully bridge the world of ceremony with that of psychedelic therapy. Many have voiced uncertainties around the manufacturing of these drugs. Typically, in a traditional setting there is extreme variability in dosage, which leads to drastically different experiences. This makes it difficult to measure and deal with effects for researchers and practitioners. How do you carefully create a consistent psychedelic experience? And does that perhaps take some of the magic out of it?

‘Filament Health’ is one of the countless companies trying to make psychedelic therapies more accessible. For individuals who can’t make a trip to South America, the Vancouver based company is pioneering a breakthrough medical grade Ayahuasca pill. However, the challenge now lies in striking a balance between the commercialisation and medicalisation of sacred plants.

There are also questions concerning prior and informed consent from indigenous groups for the project, as well as the allocation of money for delicate and pressing issues such as natural species conservation. On one hand, a pill can provide healing for many suffering in the West. Yet on the other, indigenous intellectual property is being made profitable whilst many remain in poverty. There must be a protocol for pharmaceutical companies respecting and paying back. Why should the West get to benefit all the time?

We need to honour the indigenous roots of the psychedelic movement. As a person who had the privilege to consume Ayahuasca in its traditional setting, I recognise the shaman’s guidance as a pivotal part of the experience. Indigenous knowledge must be incorporated to better understand these medicines and altered states of consciousness. Communities also need to be a safe container and be involved.

Rescheduling psychedelics felt like an impossible hurdle, especially in Australia. Seems the hard work is paying off, but we still have a long way to go. We must create a new paradigm. For these treatments to reach as many of those suffering as possible, we will need to develop a new set of values and skillsets. Many of us got involved in the movement because we see a new way of doing things in the world. How do we continue to push against that? With all these unknowns around how the rollout will unfold, we do know one thing for certain – the rest of the world will be watching.

REFERENCES

A brief history of psychedelic psychiatry | mo costandi (2014) The Guardian. Guardian News and Media. Available at: https://www.theguardian.com/science/neurophilosophy/2014/sep/02/psychedelic-psychiatry (Accessed: February 20, 2023).

Ducharme, J. (2023) The future of MDMA, psilocybin, and psychedelics in the U.S., Time. Time. Available at: https://time.com/6253702/psychedelics-psilocybin-mdma-legalization (Accessed: February 26, 2023).

Holyanova, byM. (2023) Vancouver Company creates World’s first ever ayahuasca pill, Psychedelic Spotlight. Available at: https://psychedelicspotlight.com/vancouver-company-creates-worlds-first-ever-ayahuasca-pill (Accessed: February 15, 2023).

The human brain doubled in power, very suddenly, 200,000 years ago. why? (2022) Big Think. Available at: https://bigthink.com/neuropsych/stoned-ape-return (Accessed: February 20, 2023).

Video: Honoring the indigenous roots of the psychedelic movement (2021) https://www.instagram.com/harvardcswr. Available at: https://cswr.hds.harvard.edu/news/2021/03/18/honoring-indigenous-roots-psychedelic-movement (Accessed: February 12, 2023).

Charlotte McAdam

I am a natural health consultant, globetrotter, music enthusiast and freelance writer specialising in the natural healthcare industry. A psychonaut, who draws from my life story and many experiences with indigenous ceremonies from around the world. I am passionate about the ancient teachings of these medicines and how they can help heal our relationship to ourselves, each other and mother earth.

Psychedelic Healing Stories from Australia: Juleane’s Experiences with 5-MEO-DMT

In this blog series, we are sharing some of the healing stories from our recent book: Psychedelic Healing Stories from Australia. In this blog, we share the story of Juleane and her experiences with 5-MEO-DMT.

 

What led you to seek healing through psychedelic medicine?

It was by chance that a friend of mine was given some medicine and wanted to share the experience with me. I feel that psychedelic experiences aren’t only valuable to people with mental illness, but in fact everyone.

Although at the time I wasn’t seeking any healing, in hindsight I believe that it’s played a critical role in alleviating the pressures I felt in my everyday life.

What was your psychedelic experience like?

The anxiety I had around my life decisions and responsibilities, all changed in the months following my experience with 5-MEO-DMT. The actual experience was brief (lasting about 10 minutes) yet extremely profound.

It felt disorienting at first but once I relaxed and surrendered, I felt an intense, warm loving energy flow throughout my body. The experience is difficult for me to articulate — I felt like I was being told that I was loved, and I am safe, despite not actually hearing any spoken words. The visual distortions induced the 5-MEO-DMT were so vivid that I felt like I was living in video game, giving rise to a strong sense of wonder and awe.

How have you been able to integrate this experience? How has it contributed to your healing process?

Feeling unconditional love and safety brought about the biggest change in my life — the courage to embrace life’s uncertainties. The experience also made me realise that I was living under a lot of societal and self-imposed pressures.

It initiated a slow but steady process of healing my yearning for certainty of outcomes and recovering the people-pleaser in me. The subsequent reflections have enabled me to take bigger risks in my career, appreciate the novelty that comes from taking chances, develop a deep gratitude for life and trust my own feelings.

Curious to read more? Read the Stories of 53 Australians That Experienced Psychedelic Healing, In Their Own Words.

This book will show you the deeply human side of the effect this medicine can have, and give you hope, inspiration, and clarity around what is possible for Australians when we get fair access to these breakthrough medicines.

Three Weeks Down Under: My Mind Medicine Australia Psychedelic Lecture Tour

 

I have just come back from a 3-week lecture tour of South-Eastern Australia supporting the cause of the charity Mind Medicine Australia (MMA).

They have been raising money for psychedelic research for about 4 years with considerable success. Through their efforts, the Australia government last year put up $15 million for psychedelic research and seven grants have been funded covering either psilocybin or MDMA in disorders such as treatment-resistant-depression, PTSD, anorexia, addiction and OCD, several of which I am acting as an advisor to. So, it was good to catch up with these researchers as part of my tour. MMA have organised and paid for the importation of GMP supplies of both psilocybin and MDMA. Medical-grade psilocybin has now been imported into Australia with medical-grade MDMA ready for importation, so the research is good to go once all necessary approvals have been obtained.

But the main point of my visit was to raise awareness of the current research situation for both psilocybin and MDMA, putting it into context for donors (MMA is a charity), researchers, clinicians and most importantly regulators. I gave over 15 talks to a total of over two thousand members of the public, hundreds of academics and 130 members of the TGA and the Commonwealth Department of Health.

In a demanding schedule, I gave a public lecture in Byron Bay, Canberra, and several in Sydney and Melbourne as well as to the controller of the national drug regulatory system the TGA. In addition, I met with several State health ministers, Commonwealth and State policy advisers and lead psychiatrists. In these lectures [please see summary on the MMA website]. I exploded the long-standing myths of the harms of the medicines and shared the new clinical trials and brain imaging data.

A major reason for my visit was to support local psychiatrists who have been campaigning for several years for compassionate access to psilocybin and MDMA for patients who have failed to respond to conventional therapies. Australian Federal regulations allow these drugs for compassionate use but till now, for reasons that are unclear, not one State or Territory nor the Military medicine organisations have allowed this. After discussions with several of the State and National leads for psychiatry as well as representatives of the RANZCP it became clear that many of the historical myths of these drugs were still being used to defend the lack of action. Myths such as: they are very harmful, addictive and there are safer alternatives.

I learnt from the partner of one man with depression who was denied psychedelic therapy despite having failed to respond to 96 ECTs and 24 TMS treatments and over 40 different medicines who then killed himself in despair. One has to ask what purpose was served by denying compassionate access to this man? Is there anyone who could reasonably claim that 96 ECTs might be more effective and safer than a single dose of psilocybin? My sense is that professionals were preferring to defend decisions made decades ago on the basis of limited and often false evidence rather than accept that there is now sufficient evidence of efficacy and safety in resistant depression for psilocybin and in PTSD (many trials including a phase 3 one).

To overcome this impasse MMA has made available one million dollars for an open observational study of these treatments given for compassionate access in these treatment-resistant conditions — providing real-world evidence [RWE] data in treatment-resistant patients. The terms of trial entry are listed below. The outcome data will be curated in an independently managed Register hosted at Monash University. This will use the latest adaptive and Bayesian stats methods to provide regular updates on outcomes and adverse effects. This will be the first such RWE trial in psychedelic-assisted therapies in the world and will provide vital corollary data to support the ongoing RCTs, so allowing optimal clinical roll-out once they achieve marketing authorisation. And till then they will offer hope to hundreds of Australian with mental illnesses not amenable to current treatments.

The MMA RWE Research Proposal

Background: MMA has set up a world-leading training course that has trained several hundred potential therapists. They have many hundred psychiatrists ready to engage in the trial. They have also engaged Ambassadors and an Advisory Panel of top international experts and patients and relatives with lived experience.

MMA has arranged for the import into Australia of medicinal grade psilocybin and MDMA for compassionate use to be provided for the trial

The RWE protocol for treatment-resistant patients requires for each patient

a. approval of diagnosis and treatment plan

i. by the TGA

ii. and by an independent psychiatrist

b. The treatment administering psychiatrist has been trained in whichever medicine is to be used

c. Drug treatment is given to standard protocols including preparation and integration sessions

d. For the whole period of the drug treatment session there are two health care professionals present

e. The drug treatment session is filmed for safety reasons

In addition:

A Register of Patients who are given this therapy will be set up at Monash University:

i. Entering this register will be a requirement for treatment [though patients will be anonymised] –

ii. Patients will give informed consent as the treatment is off-licence

iii. The register will contain pre-and post-treatment data including standard measures of illness severity

iv. Data collection on any adverse effects

v. Patient-reported outcomes especially quality of life and other relevant outcomes e.g. sleep and wellness scores

The register will provide an independent report in a regular fashion on outcomes and safety data distributed to all stakeholders on a regular basis

Clinical efficacy will be evaluated using adaptive and Bayesian methods that have been shown within another compassionate-use clinical-register program to provide the most optimal statistical evidence of efficacy

We believe that with the above in place, psilocybin and MDMA can be administered safely to patients who have been failed by current treatments.

This compassionate use programme for treatment-resistant depression and PTSD with a Register which is constantly updated will be the first of its kind in the world. As well as helping many hundreds of patients who are currently failed by psychiatric medicines and/or conventional therapy, it will provide critical Real World Evidence (RWE) of the value of these treatments that will make a significant contribution to the growing clinical knowledge derived from commercial and other RCTs on these medicines.

RWE is now being acknowledged as a vital part of the overall evidential base for new medicines development and roll out. The former head of the UK NICE and MHRA Sir Michael Rawlins said this in his RCP Harvey Lecture in 2008: [1]

“Randomised controlled trials, long regarded at the ‘gold standard’ of evidence, have been put on an undeserved pedestal. Their appearance at the top of ‘hierarchies’ of evidence is inappropriate; and hierarchies, themselves, are illusory tools for assessing evidence. They should be replaced by a diversity of approaches that involve analysing the totality of the evidence base.” As a result, the UK NICE and MHRA are now asking for RWE as part of decision-making [2]. It seems likely other national regulatory authorities will follow suit.

References

  1. Rawlins, M. (2008) De testimonio: on the evidence for decisions about the use of therapeutic interventions The Lancet Dec 20;372(9656):2152–61. DOI: 10.1016/S0140–6736(08)61930–3
  2. https://www.nice.org.uk/corporate/ecd9/chapter/introduction-to-real-world-evidence-in-nice-decision-making

Professor David Nutt’s Lecture Tour – November 2022

Mind Medicine Australia was delighted that Professor David Nutt, Head of Neuropsychopharmacology at Imperial College London, could come to Australia for 3 weeks in November 2022. As a result of the discussions and following feedback from various meetings and events, the following Position Statement on Compassionate Access was confirmed by MMA.

Professor Nutt presented keynote presentations and lectures including Q&A panels with the Professor, a range of researchers, clinicians and those with lived experience. Sell-out events took place at Byron Theatre, Paddington Town Hall and the University of Melbourne with the International Keynote Topic ‘Psychedelic-Assisted Therapies: History, Neuroscience and Myths’.

Professor Nutt also presented for a large audience hosted by Professor Russell Gruen and Professor Paul Fitzgerald of the Australian National University’s College of Health and Medicine and was the Keynote Speaker at a Symposium for the Monash University, University of Melbourne and the Florey Institute Neuromedicines Discovery Centre on ‘Next Generation Medicines for Better Mental Health’ alongside Professor Arthur Christopoulos and other leading researchers in the field. VIP events included lunches and dinners with philanthropists and other interested partners and supporters at the Australian Club in Sydney and Melbourne.

He also presented to Adjunct Professor John Skerritt and over 130 staff at the TGA, a large group of clinicians and researchers from Black Dog, Federal Health Minister Mark Butler’s Advisor, Australia’s Chief Psychiatrist and the Department of Health, clinicians, researchers and parliamentarians from Canberra and the ACT Government, the Mental Health Minister and the Shadow Health and Mental Health Minister for NSW, NSW Department of Health Psychiatrists, Joint Health Command regarding Veterans mental health and suicide, the RANZCP, Professor Patrick McGorry and Professor Mal Hopwood and psychiatrists from the Albert Road Clinic in Melbourne.

There was significant media interest in his visit, and he was interviewed by many of the major media in Australia. Please be inspired by some of the articles and interviews here.

We are deeply grateful to Professor Nutt for his outstanding support and contribution to MMA. We have received wonderful feedback about his presentations and celebrate his knowledge, wisdom, warmth, compassion and wit.

Psychedelic Healing Stories from Australia: Zinevara’s Story with Changa and MDMA

In this blog series, we are sharing some of the healing stories from our recent book: Psychedelic Healing Stories from Australia. In this blog, we share the story of Zinevara and her experiences with Changa and MDMA.

 

What led you to seek healing through psychedelic medicine?

I felt disconnected from myself and from life, like I was standing on the outside looking in. I’d never felt connected to anything. I spent years being told I will never heal from my traumas, that I will always be plagued by its shadow. I could only hope to be accepted as ok, as normal both by myself and others, constantly struggling to keep my head above water. I found psychedelic medicine after doing my own research.

What was your psychedelic experience like?

It was the most life-changing experience that I am still learning from every day. During my trip, I felt safe, gentle, and loved. That’s not to say the experience wasn’t painful. It was like labour, without the physical pain, just the emotional pain. Yet throughout this birthing experience I felt held in love, gentleness, and safety, and I did not feel scared. I did try and fight the process as I didn’t want to face my trauma but the harder I fought, the more I felt loved. This experience was magical, and my deep-seated trauma was diffused in fifteen minutes.

Now I can think and speak about my trauma without the waves of pain that once devoured me, triggering PTSD. I’m no longer attached to my trauma. I feel connected to myself and to life. I experienced so much more than this, like being taken to other places and times but I hesitate to explain this part because the focus of this story is on healing.

I have also found healing through another substance, which with a gentle chat from a trusted friend has allowed me to face the less intense parts of my traumas (I have several).

I want to stress the importance of doing these medicines in a safe place with a safe and trusted guide or therapist. I once had the misfortune of being maliciously triggered by someone while under the effects of a psychedelic and it was a difficult and horrible experience. This is why I STRESS the importance of being in a safe environment with a trained therapist to help deal with any trauma, painful experience, or unforeseen reactions.

How have you been able to integrate this experience? How has it contributed to your healing process?

My experiences with psychedelic medicines have shown me I’m not a lost cause. It didn’t “fix” me in fifteen minutes, but I experienced so much healing. Even now as I unravel the whole process, I find myself smiling. I now have inner strength, and a goal to fight for… me! I have hope that I will be able to heal completely. I am more aware of myself and my triggers, and I have the energy to keep working towards my highest and whole potential.

Curious to read more? Read the Stories of 53 Australians That Experienced Psychedelic Healing, In Their Own Words.

This book will show you the deeply human side of the effect this medicine can have, and give you hope, inspiration, and clarity around what is possible for Australians when we get fair access to these breakthrough medicines.

Psychedelic Healing Stories from Australia: John’s Experience with MDMA, Psilocybin and Ayahuasca

Man in Nature

 

In this blog series, we are sharing some of the healing stories from our recent book: Psychedelic Healing Stories from Australia. In this blog, we share the story of Maree and her experiences with psilocybin and LSD.

 

What led you to seek healing through psychedelic medicine?

I was bored with life.

I had money, a decent business, good friends, good health, a great lifestyle (I lived overseas for ten years) but despite all that, I wasn’t happy. I didn’t feel fulfilled or alive. I felt like life was basically meaningless. It was empty.

As a result, I drank too much alcohol. I smoked cigarettes. I took risks with my life, like racing motorcycles through the mountains of Northern Thailand and taking recreational party drugs. Anything to feel. Anything to feel alive.

I was disconnected from myself, disconnected from the people around me and I was not making the most of my potential as a human being. I was not contributing to society and to life in any meaningful way.

What was your psychedelic experience like?

I’ve had several psychedelic experiences and every single one was incredibly healing.

They showed me that I was totally shut down emotionally. There’s a lot of trauma in my family. Sexual abuse, physical violence, emotional abuse, drug and alcohol use, depression, anxiety, and more. My parents also got divorced when I was seven years old.

All of this led me to feel incredible pain when I was a child.

As a result, I shut down emotionally without realizing it. I totally disconnected from myself. Psychedelics showed me that this was why I wasn’t happy, this was why I wasn’t fulfilled. I’d lost parts of myself, and I needed to get them back. I needed to remember who I am.

That meant I needed to feel all the pain from the past. I need to turn towards my pain instead of turning away. I needed to embrace it and work with it, and in that embrace, I realised that I had the power to liberate myself from it. I had the power to heal.

How have you been able to integrate this experience? How has it contributed to your healing process?

I’m happier than I’ve ever been. More fulfilled and more alive. I rarely drink alcohol anymore, and when I do it’s usually only one glass. I quit cigarettes. I don’t use recreational drugs like I used to. I’ve never been on better terms with my immediate family. We’ve resolved all kinds of things from the past and I feel so much closer to them now. I feel lighter, as though I’ve let go of a massive weight that was on my shoulders.

It’s impossible to put into words how powerful and how positive psychedelics have been for me and my family. I think it’s a tragedy that these substances aren’t more widely available, and I hope that more people can experience what I’ve experienced.

Curious to read more? Read the Stories of 53 Australians That Experienced Psychedelic Healing, In Their Own Words.

This book will show you the deeply human side of the effect this medicine can have, and give you hope, inspiration, and clarity around what is possible for Australians when we get fair access to these breakthrough medicines.

Psychedelic Healing Stories from Australia: Maree’s Story with Psilocybin and LSD

Healing Stories

In this blog series, we are sharing some of the healing stories from our recent book: Psychedelic Healing Stories from Australia. In this blog, we share the story of Maree and her experiences with psilocybin and LSD.

 

What led you to seek healing through psychedelic medicine?

I experienced several traumatic events in my military career, which inevitably lead to moral injury and PTSD. I was experiencing depression, flashbacks, and nightmares, which, regardless of my best efforts seemed like I could not escape. I had tried talk therapy, mindfulness, gratitude, meditation, and other healing practices. I felt hopeless, life was void of joy and meaning. I could no longer see the good in the world or the value in my life. A friend mentioned how psychedelic medicine may help me. It was the only avenue I had not explored. I was nervous and hesitant to use the compounds at first but spent several weeks conducting my own research into the experiences, their benefits, and what conditions would lead to a beneficial experience.

 

What was your psychedelic experience like?

My first psychedelic experience completely changed my life. I gained a new perspective on myself, my experiences, life, the universe, and I felt a deep sense of connectedness to everything. It has been the single most potent spiritual experience of my life. I had a sense of being held, loved, and supported by the universe as I travelled with the medicine.

Consequent experiences took me deep within myself to directly address my trauma in a gentle way, which allowed me to shift my perspective and integrate the trauma. Not only was I able to explore my consciousness, but I was able to experience deep realisations that immediately and continue to improve my life. My psychedelic journeys have been the most healing, powerful, and spiritual experiences of my entire life.

 

How have you been able to integrate this experience? How has it contributed to your healing process?

I initially struggled to integrate the realisations I had in my early experiences simply because they were so profound and so mind-expanding. Over time they were integrated seamlessly, along with the insights and realisations I had during more gentle journeys. My psychedelic experiences were the single most important part of my healing process.

I have not experienced depression, nightmares, or any other negative consequence of my trauma to date. I can now look at them with appreciation, as these challenges have only contributed to my overall growth as an individual. Not only have I healed and become a happier person, but I now have a deeper respect for all of life, a relationship with the divine, and an appreciation for all of life’s experiences. I cannot be more grateful for these compounds entering my life.

Curious to read more? Read the Stories of 53 Australians That Experienced Psychedelic Healing, In Their Own Words.

This book will show you the deeply human side of the effect this medicine can have, and give you hope, inspiration, and clarity around what is possible for Australians when we get fair access to these breakthrough medicines.

Psychedelic Healing Stories from Australia: Kerry’s Healing with DMT

 

In this blog series, we are sharing some of the healing stories from our recent book: Psychedelic Healing Stories from Australia. In this blog, we share the story of Kerry and her experiences with DMT.

Trigger warning: suicide attempts and suicide ideation


What led you to seek healing through psychedelic medicine?

I grew up with no love, experiencing “trauma by omission” as quoted by Gabor Mate. I hated myself and suffered deep self-loathing throughout my childhood until my first experience with DMT at fifty-eight years old.

When I was ten years old, I developed bulimia and when I was sixteen, I fell in love with the first boy who came along and got pregnant. I was forced to give my first child up for adoption. My self-loathing got worse and I descended into multiple addictions including alcohol, drugs, and always, food.

I eventually started a family but was still haunted by my self-loathing. I tried multiple suicide attempts until my children made me promise not to do it again, but I still wanted to die every minute of every day. I tried every medication possible and every alternative course, book, and modality without relief from the crushing and incessant wish to die. I was a chemotherapy nurse, listening to patients wanting to live one more week, one more month, while my diaries were full of longing for ‘god’ to give me cancer. By that stage, I was deep in the throes of alcoholism and drug addiction.

What was your psychedelic experience like?

I was offered the chance to take DMT by a therapist. As soon as I took the dose, I felt an instant love for self and for ‘source,’ which is something I had never felt before. This experience healed me in a profound way.

How have you been able to integrate this experience? How has it contributed to your healing process?

I gave up all my physical addictions and released my negative and destructive behaviours. I started yoga and Vipassana meditation, which developed my feelings of connection to source. I started to eat nutritious, whole foods and my health has drastically improved. My family and friends are blown away by the changes.

It took fifty-eight years of hell and truly wanting to die every day, to have my healing experience with DMT. I now appreciate life and I have a deep love for myself, and strong faith in my connection to ‘source’, ‘god’, creator.


Curious to read more? Read the Stories of 53 Australians That Experienced Psychedelic Healing, In Their Own Words.

This book will show you the deeply human side of the effect this medicine can have, and give you hope, inspiration, and clarity around what is possible for Australians when we get fair access to these breakthrough medicines.

Psychedelic Healing Stories from Australia: Charlotte’s Experience with Psilocybin

Joshua Tree

 

In this blog series, we are sharing some of the healing stories from our recent book: Psychedelic Healing Stories from Australia. In this blog, we share the story of Charlotte and her experiences with psilocybin.

 

During the summer of 2019, I once again found myself searching for answers. I was visiting Joshua Tree in the United States on a road trip I had planned with friends to see a band tour concert. At that point in my life, I had been experimenting with psychedelics for a while. For the last few years, I spent my time travelling to and from America, using cannabis recreationally. I had flown to Peru the previous year and partook in three separate Ayahuasca sessions. Shortly after, I consumed Peyote in a traditional Native American setting and picked ‘magic mushrooms’ in Australia.

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The reason I keep returning to psychedelics is the truly magical healing you receive when you use them at the right time in your life, with the proper ‘set’ and ‘setting.’ Trips, undeniably, do have the potential to go wrong. However, if these medicines are used with intention and respect, they can open people up to incredible insights about themselves and the world around them.

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I had been an avid traveller for many years and understood the power of manifestation and synchronicities. Knowing how to use your intuition and creativity are skills well-practiced when you’re a young girl exploring wild, yet potentially dangerous situations in countries, unfamiliar to your own. During my many explorations in America, I met and became very close to a group of friends. These people ended up playing a central role in my life and personal growth.

They travelled with me on this adventure, and we got to talking about our life experiences. We shared vulnerable parts of ourselves, which was therapeutic in itself. One of the women and I both suffered from anxiety and negative self-beliefs, which manifested in different health conditions. I developed an eating disorder and my friend developed trichotillomania (see Glossary). For many people with these disorders, it is a way of dealing with negative or uncomfortable feelings, such as stress, anxiety, tension, boredom, loneliness, fatigue, or frustration.

For as long as I can remember, I’ve suffered from some sort of mental health struggle. It started when I was in primary school, where I dealt with depression and anxiety because of an undiagnosed mental disorder. Feeling hopeless and alone, I developed an eating disorder, which then was followed by extremely low self-esteem and self-worth. I noticed patterns of addiction with other substances, but nothing compared to the high of a binge and purge cycle. I had very little confidence by the time I turned eighteen.

Eating disorders and trichotillomania are extremely difficult conditions to treat. Both of us had tried psychiatric medications and talk therapy which helped, but just like most recovery journeys, we found ourselves reverting back to our dysfunctional behaviours.

During this trip, we consumed a North American species of magic mushrooms. The experience was wonderful and insightful. We laughed and cried, but more importantly, we all started questioning our automatic behaviours. We spoke deeply about our body image and felt like we strengthened our relationship with ourselves, each other, and we deepened our connection with nature.

We all reported similar feelings of self-love. Instead of knowing we are worthy of love, we actually felt worthy of love and held the memory of that sense in our bodies long after the experience. We bonded over music and played tracks that helped guide our trip. Because I have researched and had many experiences with these medicines, I understood the importance of doing them correctly. We felt safe in our environment and with each other to be able to explore our inner psyches.

As a result, I better understood the impact that my inner turmoil has on my physical body. Since a major component of eating disorders is the control and restrict aspect, I was able to clearly see how damaging black and white thinking can be. That insight, coupled with a deeper admiration for nature as a result of the psychedelics, has improved how I eat. I now eat more consciously, instead of punishing myself if I eat the ‘wrong’ thing.

This experience in Joshua Tree had positive long-lasting effects on my life, as well as the lives of the other women in our group. It created a profound connection between us that I can reflect on when I start to feel my disorder symptoms returning.

Psychedelic medicines have the potential to help such a variety of mental conditions, that it’s practically criminal to not allow them to be used in a clinical setting. In saying that, psychedelics are not a ‘cure all’ — they are a crash course that can speed up recovery, which is desperately needed for those whose mental illnesses are potentially life threatening.

Integration is just as important as the experience itself. We are all in need of healing in some capacity, it is a part of being human, no one’s life is perfect. However, healing is a journey, and psychedelics with proper integration are powerful medicines that can help us lead healthier and happier lives.

 


 

Curious to read more? Read the Stories of 53 Australians That Experienced Psychedelic Healing, In Their Own Words.

This book will show you the deeply human side of the effect this medicine can have, and give you hope, inspiration, and clarity around what is possible for Australians when we get fair access to these breakthrough medicines.

Granny’s Trips by Kerry Soorley: How Psychedelic-Assisted Therapies saved my life

“Trauma by omission” as Gabor Mate calls it, was my childhood. I grew up feeling abandoned, rejected and with so much self-loathing and shame from the earliest of times and my memories have always been that I have been on a self-destructive personal path.

I was the last of six children from a Catholic family with about 18 years between the eldest and me. I fell pregnant at 16. I was overjoyed to be in love and having a baby of my own to love. It happened that my father died during the pregnancy, and I was forced by my family to adopt my child out, they said, “it’s for the baby’s best”. They said “if I really loved it” that’s what I should do, even though I was engaged and even went on to marry the father and have 3 more children.

The baby was never allowed to be spoken of again, as if it didn’t happen. My husband had been so devastated by the situation, that it fuelled his already burgeoning alcoholism.

I went nursing for 2 months after the adoption hoping that by helping others it would improve my self-esteem and my grief. But my addictions and self-destructive path just became worse due to the deep loss of both my father and my baby.

Despite the cigarettes and diet coke addiction, the eating disorder that I managed to keep hidden from everyone was truly eating away at my soul.

I went on to have 3 more children and tried to have a ‘normal life’ and be the best mother I could be. My first born was always in my thoughts. However, the addictions and terrible depressions combined with grief were ever present.

I went on my first anti-depressant at about age 20 which didn’t work.

After many years continuing down this destructive path I was reunited with my first born but even that did not stop the depression or addictions. Then I left my husband, and everything kicked up a notch. I really did not want to be here.

Alcohol, drugs and destructive relationships entered the picture as well. My alcohol problem became so bad I had to drink daily despite saying each day I was not going to have a drink. I would wake up after blackouts with injuries and I had no idea how they had occurred. I embarrassed my children.

Looking back over my diaries, marijuana was the only thing that stopped me having more suicide attempts. ‘Pot’, had the ability to change my state, only if I had it rarely.

I didn’t want to be this way so I tried everything that I thought could help. Every book, course, healing modality, therapist, vipassana. Multiple antidepressants were tried as well. There was no alternative.

At this stage I was working in the chemotherapy unit and listening to my patients talk about just wanting to see out one more Christmas or birthday. Meanwhile I was writing in my diaries that I just wanted to die.

I had a couple of suicide attempts and ended up in a mental hospital for a month. The place made me think there was no hope because the people I met in there were on the turnstile of in and out regularly, with no end in sight or hope to be found. Unfortunately, the pharmaceutical company that owns this hospital and many other mental hospitals are very much about customers for life. They charged $5000 per patient per week for daily visits to a psychiatrist, multiple visits to psychologists and different group therapy sessions that the clients didn’t want to go to. However, the big pharma companies get money from health funds for all of this. So, it is not in their best interests to get these people well. Sadly, many of the clients want it that way too. It’s almost seen as a party place to come to catch up with their buddies.

I was addicted to benzodiazepines, and I just wanted to sleep and not wake up from the emotional pain.

Eventually, an amazing therapist offered me DMT to smoke and my life was never the same again.

I felt instant love, joy, and the pure connection that I had been craving all my life. And like an onion, with the help of truly compassionate guides and therapists, I have been able to shed so many of the walls and layers of baggage that have built up over the years.

I was able to give up my addictions and self-destructive ways and exchange them for yoga, meditation, good food, daily swims, and nature.

I became a different person. I became the passionate advocate I now am for the healing and therapeutic possibilities of psychedelic medicines.

Over the years, I also received a Graduate Diploma in Palliative Care and worked in that area for many years. I believe the existential crisis felt by the dying could be relieved by psychedelic medicines and research has shown this to be the case.

It’s now time to reschedule these medicines and enable all Australians who are suffering with treatment resistant mental illnesses access.

We have a chance to halt the real pandemic: our terrible mental health crisis NOW.

We all know someone with either mental health issues, addictions, trauma, and abuse that may be helped by this medicine. It’s time to stand up, support Mind Medicine Australia and write to politicians. Talk to people like myself, there are so many of all ages and walks of life that are benefitting from psychedelics.

A friend’s son told me to call this blog Granny’s Trips. I hope to still be around in my mid-nineties to do be able to do this with all my grandchildren if they want.

Kerry Soorley

Nurse

Kerry Soorley is a nurse of 44 years, mother of four and grandmother to nine, specialising in palliative care. She had suffered depression, addictions and suicidal ideation all her life. “Trauma by omission” Gabor Mate calls it. Forced adoption of first child and death of her father during pregnancy at 16 just escalated her mental health issues further including suicide attempt and hospitalisation. Every antidepressant, therapy, book, course and seminar all failed and just left her feeling hopeless and wanting to die even though she was so blessed. At age 58 she had opportunity to try DMT. It reset my brain and gave me, joy, self-love and connection for the first time in my life. It’s not called the God molecule for nothing. She is committed and passionate to helping others get benefits of psychedelic therapy in a safe environment and sees great potential for palliative care as well.

A message from Dr Simon Longstaff AO

Mental health

Few measures better reveal the character of society than its approach to those who suffer.

Occasionally, the suffering we encounter is beyond our capacity to relieve. In those cases, we can be held to no higher standard than that we have responded with care and compassion. However, what is to be said of a society that could have offered relief – yet refused to do so? How might such a society be judged? Will history excuse those who plead ignorance, or prejudice, or a lack of moral courage to do what was not only possible but necessary? I think not.

Such is the case in our society’s response to those who suffer from mental illness yet are denied access to the increasingly proven benefits of psychedelically assisted clinical therapies. Too often, those who suffer have already given all in service of their society: military personnel, first responders who too often suffer from Post-Traumatic Stress Disorder (PTSD). Can we justify the continuing harm done to such people when we know that, in many cases, effective treatment options are locked away for no good reason? I think not.

Mind Medicine Australia begins and ends with scientific evidence.

The world abandoned prospective treatments not because they were unsafe or ineffective but because they were associated with the ‘wrong’ side of politics. So, what politics abandoned, let ethics restore. Let us not be a society condemned for the suffering we might have prevented – if only we had made better choices, for a better world.

Dr Simon Longstaff AO is Executive Director of The Ethics Centre and a Director of Mind Medicine Australia.

Dr Simon Longstaff AO

B.Ed., Ph.D

Dr Simon Longstaff commenced his work as the first Executive Director of The Ethics Centre in 1991. He undertook postgraduate studies in Philosophy as a Member of Magdalene College, Cambridge.

Simon is a Fellow of CPA Australia and in June 2016, was appointed an Honorary Professor at the Australian National University – based at the National Centre for Indigenous Studies. Formerly serving as the inaugural President of The Australian Association for Professional & Applied Ethics, Simon serves on a number of boards and committees across a broad spectrum of activities. He was formerly a Fellow of the World Economic Forum.

Simon’s distinguished career includes being named as one of AFR Boss’ True Leaders for the 21st century. In 2013 Dr Longstaff was made an officer of the Order of Australia (AO) for “distinguished service to the community through the promotion of ethical standards in governance and business, to improving corporate responsibility, and to philosophy.”

If the Medicine Works Shouldn’t We All Have Access to it? A Recent Poll of Australians Says Yes We Should By Scott Leckie and Tania de Jong AM

(As published in The Daily Telegraph on 16th February 2022)

The painful COVID-era will fade but it will never be forgotten. This unanticipated period will be remembered for many things – death, suffering, economic and social disruptions and words like lockdown, iso, quarantine, social distancing, Zoom, omicron…

But beyond changes in the way we live and communicate, it is the devastating toll on our mental health that will continue for generations to come. Depression, anxiety, trauma, suicide, addiction, loss of livelihoods, domestic violence and broken families are increasing. We have never felt more isolated, alone and uncertain about our futures.

Our families and communities are suffering, and we urgently need access to preventative and curative medicines and medical care that is safe and effective.

Mental health charity Mind Medicine Australia recently commissioned Essential Research to conduct a representative opinion poll of more than 1,000 Australians. It found that only a small minority was aware of the immense promise of psychedelic-assisted therapies, with just 11% of those asked aware of the medicinal properties of these substances and their potential use in controlled settings. This is despite over 160 recent studies by some of the most prestigious research institutions – Johns Hopkins University, Imperial College London, Oxford, Yale to name but a few – clearly showing the quantifiably positive impacts that these substances can have when used as medicines in combination with therapy, under the guidance of trained doctors and therapists in a clinical environment.

These ground-breaking treatments offer therapeutic access to either psilocybin (the active ingredient in ‘magic mushrooms’) or MDMA, a synthetic medicine. These therapies have been scientifically proven to be safe, non-addictive and effective cures for depression, trauma, end-of-life anxiety and addictions after a short treatment program. Remission rates range between 60-80% with no serious adverse events.

Both medicines have been granted Breakthrough Therapy Status by the Food and Drug Administration (FDA) in the United States to fast-track their approval. This designation is only given to medicines that may prove to be vastly superior to existing treatments.

Although the recent poll showed that only one in nine Australians was aware of these impacts, when they were informed about the results of recent studies, their views changed dramatically towards supporting access to these promising medicines that remain illegal under Australian law. 67% agreed that ‘People experiencing terminal illness should have the choice to use psychedelic-assisted therapies to ease end of life distress’, 63% agreed ‘People experiencing mental illness should have the choice to access them in medically-controlled environments and as an alternative option for treatment-resistant patients’’, and 60% agreed ‘The difference between medical and recreational use of psychedelic substances should be legislatively recognised’.

Trials are underway in Australia and the demand for these therapies is accelerating rapidly. As ever more legal jurisdictions legalise, decriminalise or otherwise tolerate these substances – Oregon, Washington DC, Jamaica, Canada, the Netherlands and elsewhere – support will grow further. Given our publicly funded health care system, mental health epidemic and human right to access to all forms of safe and effective medicine, huge majorities rightly believe that people should not be prevented from legally accessing medicines in therapeutic settings that can help them in ways that no other pre-existing medicines can.

An official decision by the Therapeutic Goods Authority last year refused to reschedule both psilocybin and MDMA as Controlled Medicines (Schedule 8). This rescheduling would make it easier for doctors to access these therapies in clinical environments for treatment-resistant patients through our Special Access pathways. If these legislative changes continue to be delayed, many more desperate people will seek the treatments underground. Everyone deserves the chance to get well.

A new international campaign on the Right to Universal Access to Safe and Effective Medicine is now underway seeking support for a declaration to this effect, while another initiative is seeking the international rescheduling of psilocybin under the UN drug control regime. There is a growing global movement and a trillion dollar market is emerging. Continuing the status quo not only makes little sense in terms of public health but it is also cruel. There is increasing awareness that help is available, yet these treatments are being withheld even though existing medicines don’t work for the majority.

Arguably, continuing to deny access to these medicines is also a clear human rights violation. Refusing and making illegal therapeutic access to safe medicines with a proven effect violates a whole range of internationally recognised human rights, including the right to the highest attainable level of physical and mental health, the right to access all forms of safe and effective medicines, the right to access pain medication, the right to dignity of the human person, and even the right to be free from inhumane, cruel or degrading treatment or punishment.

The COVID-19 pandemic has reminded us that we all deserve access to high quality treatment. As the pandemic becomes endemic, let’s turn our collective minds to ensuring that everyone everywhere has access to each safe and effective medicine. Medicines that are non-addictive, non-toxic, voluntarily taken, administered by trained medical professionals and implemented lawfully, without the threat of sanction for either the patient or the doctor involved.

This issue is not only relevant to conservative, progressive or ecological voters. It is personal because an estimated 50% of us will experience a mental illness in our lifetime. The people are ready and support change. It’s time for the politicians, political parties and all our Governments to follow suit and act with urgency to avoid further avoidable suffering and suicide.

Scott Leckie

Scott A. Leckie is an international Human Rights lawyer, Law Professor and Director and Founder of Displacement Solutions, an NGO dedicated to resolving cases of forced displacement throughout the world, in particular displacement caused by climate change. He also founded and directs Oneness World Foundation (www.onenessworld.org), a think tank exploring questions of world-centric political evolution and new forms of global governance.

He hosts Jointly Venturing, a podcast dedicated to the question of world citizenship, and manages the One House, One Family initiative, an ongoing project in Bangladesh building homes for climate displaced families. He regularly advises a number of United Nations agencies and conceived of and was the driving force behind more than 100 international human rights legal and other normative standards, including UN resolutions – most recently the Peninsula Principles on Climate Displacement Within States. He has written 22 books and over 250 major articles and reports.

Tania de Jong AM

LL.B (Hons), GradDipMus

Tania de Jong AM is the co-Founder and Executive Director of Mind Medicine Australia. She regularly presents on psychedelic-assisted therapies, mental health and wellbeing at major conferences and events around the world and to Governments, regulators, clinicians, philanthropists and the general public.

Tania is one of Australia’s most successful female entrepreneurs and innovators developing 6 businesses and 4 charities including Creative Universe, Creativity Australia and With One Voice, Umbrella Foundation, Creative Innovation Global, Pot-Pourri and The Song Room.

Tania was named in the 100 Women of Influence, the 100 Australian Most Influential Entrepreneurs and named as one of the 100 most influential people in psychedelics globally in 2021. Tania’s TED Talk has sparked international interest. Tania has garnered an international reputation as a performer, speaker, entrepreneur and a passionate leader for social change. Her mission is to change the world, one voice at a time!

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