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

In our first five 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.

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 five years with your support:

 

Awareness and Knowledge Building

• 250+ webinars, screenings and special events attracting 50,000+ 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

• 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 therapy 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 63,000+ followers on our social media channels

• Over 650,000+ views on our YouTube Channel

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

• Over 47,000+ people in our database incl. over 15,000 health professionals and over 1000 psychiatrists

• 670+ donors with 4000+ donations and 80% returning donations

• 200+ media appearances

• 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 will provide subsidised treatment for those who otherwise could not afford it

• 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 $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 with over 480+ participants so far

• 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 Therapy 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 five 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 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 Therapy’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.

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.

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 therapy, 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 therapy 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!

Will Australia take a lead in psychedelic therapy? By Kevin Ke

Papercut head

By Kevin Ke

On September 30th 2021, the Therapeutic Goods Administration (TGA) of Australia published an eagerly awaited report on the use of psychedelics in treating mental health conditions. It is an independent review of the evidence surrounding two particular substances: MDMA and psilocybin, commissioned by the regulatory agency in order to inform its decision making process towards these substances. Currently, these substances are placed in ‘Schedule 9’ of the ‘Poisons Standard’ – the most restrictive classification which includes other substances like heroin. The TGA is in the midst of evaluating a proposal to move them into ‘Schedule 8’, a less restrictive category. Schedule 9 substances are considered ‘Prohibited substances with high potential for abuse and misuse’, and are only accessible for purposes of medical research, in order to severely limit access. Although we are in a time of increasing awareness and interest in psychedelic substances, the history of psychedelic research in the modern era is complex. The current restrictions on psychedelic use for recreational and medical purposes are closely intertwined with US government anxieties about counterculture movements in the Vietnam War era.

The proposal to reschedule is led by an Australian nonprofit, Mind Medicine Australia (MMA), and has the support of world leading experts in psychedelic research. If successful, it will lead to a situation where Australian patients suffering from mental illness can access psychedelic substances for use in therapy. There are no proposed changes to the status of recreational use of psychedelics, which will remain in Schedule 9. A range of safeguards will be in place – for example, prescription will be restricted to being prescribed by psychiatrist or specialist addiction physician. MMA has been training cohorts of qualified psychotherapists specifically in psychedelic-assisted therapy in anticipation of future demand. Access is envisioned to occur in a medically controlled environment with the patient never taking the substances home. As unregistered medicines, prescribers will still require approval on a per patient basis from both the TGA (under Special Access Scheme B) and the State or Territory Government where the treatment is to occur. Mental health conditions like post-traumatic stress disorder (PTSD) and depression are frustratingly difficult to treat, with debilitating impacts on patient’s lives and those around them – and it is envisioned that these patients stand to benefit from a psychedelic experience given in a controlled and supervised setting.

 

What’s the evidence for psychedelic-assisted therapy?

In recent years, psychedelic research has reached an inflection point, with accelerating recognition worldwide of its therapeutic value in a range of mental health conditions. A landmark phase 3 trial evaluating MDMA for the treatment of PTSD read out earlier this year, sponsored by the pioneering US based nonprofit MAPS. A total of 91 patients with severe PTSD were randomised to two groups, with the average patient having carried the diagnosis for 14 years. A large majority (92%) of patients had experienced suicidal ideation during their lifetime, and 1 in 3 had attempted suicide in the past.

Both groups received a structured program of therapy over 18 weeks, but only one group received MDMA across three sessions, with the other receiving an inactive placebo in its place. The group that had received MDMA-assisted therapy responded considerably better than the group without – with 67% (28/42) of patients no longer meeting the criteria for PTSD diagnosis, compared to 32% (12/37) in the therapy-only group, as measured 18 weeks after initiation of treatment. In a patient group with such severe and intractable disease, these results are remarkable – clearly demonstrating the potential of psychedelic assisted therapy to heal patients who may otherwise never respond to conventional treatment regimes.

 

How does psychedelic assisted therapy work?

The experience of increased empathy and connection appear to be central to the way that MDMA seems to produce these results. Pharmacologically, the drug increases levels of serotonin in the brain, also acting to increase noradrenaline and dopamine to lesser degrees. Modulation of serotonin neurotransmission is the primary proposed mechanism by which both MDMA and psilocybin are able exert psychological effects. On one hand, an increased level of serotonin binding to the 5HT-1A receptor is thought to lower anxiety, while action on the 5HT-2A receptor increases neuroplasticity and the capacity for learning. In this state of lowered barriers and heightened flexibility of thinking, the individual is able to confront and reprocess their trauma with the assistance of their therapist. Unlike MDMA, psilocybin is a ‘classic psychedelic’ as it predominantly acts on the 5HT-2A receptor like LSD, DMT and mescaline. Experiences of psilocybin have been demonstrated to be effective for conditions like depression, even when the patients are resistant to other therapies. When 5HT-2A receptor activation increases, patients enter into a state of cognitive flexibility and creative thinking where enduring patterns of thought are able to be rewired. Individuals often rank it as among the most challenging and meaningful experiences of their lives – undergoing intense emotional realisations which persist long after the therapy has ended. In this way, psychedelics represent a different approach to treating conditions characterised by fixed mindsets and beliefs like depression and anxiety. Treatment is considerably shorter in duration (a few sessions), and may have more durable results than other treatment modalities. This is quite significant because conventional antidepressants and psychotherapy are known to take several weeks to months to achieve effect, requiring considerable resources. Psychedelics therefore represent a novel modality with distinct therapeutic benefits.

According to proponents of psychedelic assisted therapy, the therapy itself is a crucial part of healing. Also, it is emphasised that the substances are medical grade, produced to purity and stability specification – reducing risks of contamination and adulteration. Theoretical risks that arise from overdose or drug interactions can further be mitigated when given in a supervised setting. While the history of psychedelic research is intricately linked to diverse fields including psychoanalysis, consciousness, religion, and anthropology, the current movement is seeking first to focus on the medical applications, and this stands to reason. It has been reported that the growing acceptance of recreational cannabis use stems largely from its recent medicalisation, with cannabis being explored for a range of diverse applications ranging from anxiety and stress to autism and seizures. In medical cannabis, the TGA also has an important precedent for psychedelic regulation. In February this year, low doses of cannabidiol (the non psychoactive component of cannabis), were rescheduled to Schedule 3, the category for over the counter sale. In practice, it will be some time before pharmaceutical companies achieve registration of their medicines – requiring demonstration of efficacy and safety through clinical trials, a process that can take years. Nonetheless, similar arguments can be drawn between ‘psychedelics’ and medical cannabis, and the shifting tide of public opinion towards this group of substances is also self-reinforcing.

 

An independent expert review

The original TGA submission from MMA dates back to July 2020, and from there, the original decision of the regulatory agency was to retain the status quo and to not reschedule. Some groups have a different perspective of the benefits and risks of this psychedelic assisted therapy. Medical bodies like the Australian Medical Association and the Royal Australian and New Zealand College of Psychiatrists emphasised a need for clinical trial processes, including careful assessment of efficacy and safety, under strict protocols and ethical oversight. For these groups, psychedelic research is still in its infancy, with ‘limited but emerging evidence that psychedelic therapies may have therapeutic benefit’, and emphasis is placed on their status as illicit substances. The initial decision was challenged by MMA, prompting an independent review of the evidence, bringing us to the recent report.

The expert panel was tasked with reviewing the available evidence on MDMA and psilocybin for the treatment of mental health conditions. Benefits and risks, therapeutic value, and applicability to the Australian healthcare system, were all aspects that were considered. For MDMA, a total of 8 randomised controlled studies were found to be relevant and pooled together, and their results analysed. The rationale is that looking at the results in totality may provide us with better estimates than looking at these studies individually. Results are collated and compared using the statistical quantity ‘standardised mean difference’, or ‘effect size’ – calculated by taking the difference in mean severity scores between groups relative to the standard deviation in these scores. This can be helpful when a range of different severity scores are used between trials, as ‘effect size’ allows for comparisons between different disease scoring systems. However, comparing interventions indirectly through looking only at ‘effect size’ can also be misleading, as different trials inevitably recruit patient populations which are heterogenous or homogenous in their own ways. Trials involving more homogenous patient populations will inevitably have higher effect sizes, while the converse is also true, with all else being equal. With that said, in our report, MDMA assisted therapy was found to have an effect size of -0.86 compared against the control arms, considered generally as a large effect size (almost one standard deviation). This is a promising result considering that the controls also received placebo medication, and the same course of intensive psychotherapy. In other words, patients will experience a large benefit from this treatment, beyond what you might expect from psychotherapy alone. The importance of these results are highlighted when we consider that the only two FDA-approved drugs for PTSD are the SSRI drugs sertraline and paroxetine, which both have modest efficacy, being 2-3 times less effective than MDMA, when compared using absolute change in the CAPS-2 score (and effect size). For psilocybin, six studies were identified by the panel as relevant to their evaluation. Their main findings were that psilocybin was better than placebo for treatment resistant depression, and that it showed efficacy for treatment of anxiety. It was also compared to escitalopram, a common antidepressant – and no ‘statistically significant’ differences were observed, although there is a good argument to be made that this is due to limited statistical power. A closer, critical read of an important recent trial comparing psilocybin with escitalopram would be worthwhile for any interested reader, as the data itself is promising (additional data is in the article appendix).  The authors of our TGA report conclude: “MDMA and psilocybin may show potential as therapeutic agents in highly selected populations when administered in closely supervised settings and with intensive support. Evidence appears strongest for MDMA.”

The case for psychedelic assisted therapy is strong, and the high quality evidence which has been generated to date cannot be ignored for long. The recent independent review highlights the clinical efficacy of this treatment, and the TGA is well placed to enact regulatory changes that will encourage the development of the field. In the midst of our current mental health crisis, patients with intractable conditions stand to benefit considerably from a rescheduling of these medicines.

It’s Time To Give Our Military The Medicine They Need by Scott Leckie and Tania de Jong AM

Military

Following the American decision to bring their troops home from Afghanistan after some 20 years in that troublesome country, Australia will also soon do the same. After losing 41 Australian lives, 261 wounded in action, facing war crimes allegations and billions of dollars of expense, thousands of our country’s bravest men and women will soon be coming home. Sadly, many of the more than 39,000 soldiers who served in Afghanistan will have varying degrees of post-traumatic stress disorder. This is nothing unique to the ADF. All soldiers everywhere suffer from PTSD. It’s just a question of degree; whether they know it or not.

Imagine the trauma then, when they come to learn that upon their arrival back in the lucky country, how unlucky they are that they still cannot access medicine with an incredibly successful track record in treating PTSD, that is cheap, plentiful and, most importantly, that works.

More than 150 recent empirical studies have shown the remarkable success that the therapeutic use of either psilocybin (the naturally occurring active ingredient in what are colloquially known as ‘magic mushrooms’) and MDMA (known more commonly as ecstasy) can have with people suffering from PTSD. These medicines can assist them in dealing effectively and permanently with the traumas of war. Yet when they return home, our soldiers will not have legal access to these medicines.

Both psilocybin and MDMA remain illegal in Australia and cannot legally be prescribed by doctors for patients, even though more and more people realise that such substances can be of great benefit in dealing with a range of mental disorders including PTSD. They cannot be grown or manufactured in Australia, cannot be imported and cannot be medically prescribed for patients in need, including returning military personnel. Yet they are available through Expanded and Compassionate Access pathways in many of our closest allies, including the United States, Israel, Switzerland and Canada.

Among other critics of the status quo, Dr Simon Longstaff AO, Executive Director of The Ethics Centre says that it is unethical and inhumane to withhold these treatments from those who are suffering. Existing treatments for PTSD lead to remissions in only 5% of patients compared to remissions for 60–80% of those receiving 2–3 medicinal doses of MDMA or psilocybin combined with a short course of psychotherapy.

In a recent trial supervised by the U.S. Food and Drug Administration (FDA), 105 participants (many of whom were veterans and first responders) had been suffering from treatment-resistant PTSD for an average of 18 years. Just three medicinal doses of MDMA with a short course of psychotherapy led to remission in 52% of cases immediately and in 68% of cases at the 12 month follow up.

Brigadier General Sutton, New York City’s Commissioner of Veteran Services said: “If this is something that could really save lives, we need to run and not walk toward it. We need to follow the data.” This same approach should be taken in Australia and inform the recently announced Royal Commission into Veteran Suicide.

Former Defence Force Chief, Admiral Chris Barrie has repeatedly confirmed that psychedelics offer the “only possibility of a cure for post-traumatic stress disorder”.

The Icahn School of Medicine at Mount Sinai in New York has launched a new Centre for Psychedelic Psychotherapy and Trauma Research (one of 6 similar Centres recently launched in the UK and USA), to discover novel and more efficacious therapies for PTSD, depression, anxiety, addiction and other stress-related conditions in the veteran and civilian population. The Centre will focus on studying MDMA, psilocybin and other psychedelic compounds.

Think of the immense suffering, mental illness and suicides that could be prevented if our veterans could finally get well through having access to all medicines that could potentially help them. Wouldn’t it be wonderful if they could lead meaningful and healthy lives contributing their skills and courage to our community?

Our health care system and the services it provides is in many respects the envy of the world. Medicare and private health services provide immediate access to both care and medicine for everyone in need. No one falls through the cracks in this country and no one has to show up in an Emergency Department just to access a doctor, as is the case in one of our closest allies, in particular. We should be justifiably proud of this, but also open to how this remarkable system could be improved.

After all, international laws, including those that have been ratified by Australia clearly recognise the right of everyone to “the enjoyment of the highest attainable standard of physical and mental health”. This must mean that everyone needing effective medical treatment should have access to all medicines that work, including psilocybin and MDMA which are proven to be safer and more effective than existing treatments, particularly when given under professional medical supervision.

The Therapeutic Goods Administration is currently considering rescheduling these medicines, which if successful, will mean that this medicine could then be prescribed by professionally trained doctors for patients that they feel will benefit from its use. It does not mean that these substances will be legal in a recreational sense. However, they will be part of the full medicinal arsenal available to all trained doctors to provide to all people in need, including our soldiers. With mounting pressure, the TGA recently announced an Independent Review on rescheduling both psilocybin and MDMA. A final decision is expected within months, and there is a large and growing chorus of voices who are calling on the TGA to provide medical access to these treatments to prevent further avoidable suicides and suffering.

Mind Medicine Australia and a rapidly growing global network will soon be releasing a short and, what we hope will be widely applied, Declaration on the Right to Universal Access to All Forms of Safe and Effective Medicine which calls upon governments everywhere to make available, to all persons, every reasonably accessible form of safe and effective medicine — regulated only for reasons of safety and efficacy, and then only to the extent strictly necessary.

Many people, and especially our soldiers, simply cannot afford to wait any longer.


Scott Leckie is an international human rights lawyer. Tania de Jong AM is a social entrepreneur and the Executive Director and co-Founder of the charity, Mind Medicine Australia.

This article was originally published by The Spectator on 6th May 2021.

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!

A Mother’s Prayer To The TGA by Annie Mason

Woman on boat

I am writing this as a mother, in the hope that my words may open the closed minds of our politicians, the TGA and the RANZCP, who we rely upon to ensure every Australian has access to the latest medical therapies.

Our 26-year-old daughter suffers from treatment resistant PTSD and severe depression as a result of a trauma when she was only 11.  Rape at any age is devasting, but for a child the impact is profound. We live with the daily fact that with the current treatment of anti- depressants and anti- psychotic drugs available to her in Australia, there is only a 5% chance of her getting well. We also live with the fear that we could lose her. We have journeyed with her for the past 15 years and have seen her suffering as she has tried every treatment available to her. We have all been profoundly impacted by her illness. Our current mental health system has failed our daughter. We need answers. We need treatment. And, we need it now. Tomorrow our daughter may not be here.

Unless you have lived with the fear of your child taking their own life, you will never truly know how it feels. Thousands of mothers, live with that fear every day. Our journey has taken us to countless specialists and across the world. We have watched the work with treatment resistant PTSD using Medicinal MDMA, which is often confused with the recreational drug Ecstasy, Ecstasy is frequently adulterated with more dangerous substances and taken in unsafe environments. We learnt about the outstanding remission rates from Medicinal Psilocybin (which in its natural form comes from certain mushrooms) for treatment of depression. We are confident that these medicines offer real hope. We know that no treatment, even the current ones advocated by our government, is without risks and that the answers are not simple. But we deserve hope.

Clinical trials with medicinal MDMA conducted overseas demonstrate remission rates between 60-80% for treatment resistant PTSD. We were confident Australia would embrace this research in an applied way. Surely, we would act when potentially one of the greatest shifts in psychiatric medicine is knocking on the door? You can imagine our dismay when the TGA refused to reschedule MDMA in its recent Interim Decision. The news was heartbreaking.

The irony is that the TGA is already authorising individual requests from psychiatrists to use these medicines with therapy under its Special Access Scheme, but their listing as prohibited substances in Schedule 9 of the Poisons Standard means that there is no ability to get State and Territory Government approval which is also required so that patients can be treated and have a chance to finally get well.  All this will change if they become Schedule 8 Controlled Medicines.  What a cruel system we have. Providing hope with one hand and taking it away with the other.

I contacted the TGA for answers and found their response deeply disturbing. Their justifications were not based on data or science, but rather demonstrated deep bias and misrepresentation (for example, calling these medicines ‘illicit substances’ when they would, in fact, be used only in clinical medical environments). Their responses were offensive to sufferers and their families.

I contacted the RANZCP in the hope that they would show the capacity to lead us out of this crisis. It was clear that they cannot accept the facts which are undeniable and globally supported by leading experts, that these treatments are a viable and safe treatment option.

These bodies MUST begin to rely upon the validated data generated by the wider medical community. Do they suggest the outstanding research done at the leading Universities around the world is not valid or sufficient? Do they believe that countries that have enabled psychiatrists to use these therapies under Expanded Access Schemes have done so without high levels of regard?  These therapies have been granted Breakthrough Therapy Designation by the USA regulator and my daughter should be given the chance to access these therapies in Australia. Sadly, the Australian community is losing trust in the ability of our institutions to lead us forward. They risk becoming irrelevant as more and more Australians seek treatments conducted illegally by underground therapists.

I contacted every Australian Senator and the common response I have received was “we are sorry for your suffering but it is in the hands of the TGA and RANZCP”. These responses reveal that the TGA and RANZCP have too much power; beyond that of even my elected representatives. I elected my politicians to speak for me and lead us forward, and, as yet, few seem willing to ask if these bodies are advising them correctly and acting in the best interests of Australians. Who will challenge them on my behalf? Has my government forgotten they are here to serve my daughter?

This is so much bigger than my daughter. I speak also for those who don’t have a voice. For the lives already lost and for the families too enmeshed in simply surviving to speak out. Our nation is in a mental health crisis where 1 in 5 Australians have a chronic mental health condition and at least 1 in 8 are on antidepressants including 1 in 4 older adults and 1 in 30 young children.

Anxious adult

Australia should be leading the world in treatment, but instead our system is on its knees, bogged down by regressive thinking that places us as one of the poorest performing countries. We need innovation and leadership from our politicians and our medical establishment.  We can make Australia a leader in this field.  I imagine a day when the world looks to us. A day when no Australian suffers unnecessarily or dies from a treatable mental health illness.

I have NO doubt that the tide is turning and we will see these medicines rescheduled. The push from Australians like myself, WILL bring about this change. I believe the government knows this too.  They know they WILL lose the battle but don’t seem to care about those that will die in the final days of this “war”.

So, it’s time. Enough procrastination, posturing and politics. Our representatives MUST do the job that we have a right to expect of them.

I am praying that the TGA’s announcement this week, that it will be seeking further advice before making the final rescheduling decisions for MDMA and psilocybin will at last mean that the data and facts will come to the surface and block out the bias and stigma. Then finally, change will happen. The TGA has promised an Independent Expert Review into the therapeutic value, risks and benefits to public health outcomes for these medicines. My daughter and so many other sufferers need this so urgently, but I am not holding my breath.

If our government and health agencies continue to fail us, we will be forced to re-mortgage our house and attempt go overseas for treatment. To countries that lead the world in the treatment of mental health. To countries that care in actions, not just words. I will then shout from the roof tops, that my government has failed me and I am deeply ashamed of the country we have become.

Annie Mason

Annie Mason is an educator with a wide range of experiences including classroom teaching K-12, Special Education and Student Wellbeing. She was a Principal for over 15 years and has a special interest in Gender Equity, Social Justice and Women in Leadership. She is a strong advocate for the legal and ethical rights of those with mental health issues.

Healing A Troubled Mind: A Personal Perspective On Victoria’s Stagnant Mental Health System by Dr Eli Kotler

Person standing near lake

The Royal Commission’s report on the Victorian mental health system sent shockwaves throughout the State, one of which landed squarely on a patient of mine. They noted that Victoria’s mental health system is “not geared for…change”. Just to ensure we got the message, and despite a Federal Government TGA approval, my request to treat my traumatized patient with MDMA-assisted therapy was declined by our state’s regulatory authority.

To be clear, my disappointment lies not with the state government regulators, nor with the medical opinions suggesting MDMA-assisted therapy should not be used for treatment of traumatized patients (despite excellent emerging evidence that it works with little risk). I understand these opinions, though I certainly do not agree with them.

My issue is a more troublesome one. Underlying these opinions is a problem with how we practice psychiatry, which in turn reflects the alienated community in which we live. Mental health paradigms are always a reflection of the society which supports them. You see, us Australians are alienated both intra-personally (from our own emotional worlds) and inter-personally.

Our current paradigms tend to view mental illnesses in a biologically reductive way. In other words, mental illnesses are both understood and treated primarily as biological diseases (which they are not). The posters at your doctor’s rooms will teach you – depression is just like any other medical disease, such as heart-failure or emphysema. In this paradigm, entities such as addictions and depression are seen as distinct phenomena. They are treated in our current system as totally different diagnoses by entirely different teams. The alienated individual who suffers from depression and addiction is labeled with the alienating and erroneous term ‘dual-diagnosis’, which enshrines the division. Furthermore, if addictions are understood (as they are) as inherited conditions (which they are not), and primarily as brain diseases based in dysfunctional dopamine rewards circuits, they will be primarily treated as inherited brain diseases, by doctors with medications.

But what if we have got it all wrong (which we do). You see, addictions are heritable but not inherited (there is a big difference, I recommend looking it up), and the chemical dopamine in no-way explains addictions. Rather, it is the human experience of dopamine (along with numerous other chemicals) which explains addictions, suggesting that addictions are rooted in difficulties with the human experience of life, rather than the neural correlates of those experiences.

The events which lie at the root of illnesses such as addictions and depression are those which overwhelm the mind’s ability to process and integrate. We know that the presence of adverse childhood experiences is present in the majority of (if not all) people with addictions and chronic depression. But rather than seeing these conditions as consequences of trauma (which they are) and treating the underlying emotional issues (which would help), our society mistakes the symptoms (depression and anxiety) for the disease itself. We treat depression as depression and addiction as addiction and all the while we are missing the forest for the trees. The real disease is the high prevalence of trauma, alienation, and neglect in our society. After all, it is these conditions which twist and distort the mind into the contortions which fill the latest catalogues of mental illnesses.

Which brings me back to my patient. Traumatized when young, she has suffered from every diagnosis a psychiatrist’s finger can point at. She has had every treatment a medical guideline can fathom. Yet her trauma remains in place, because no-one has been able to reach it. Suddenly, on the horizon, a change is coming. Treatments like MDMA-assisted therapy appear to touch the root of the trauma, allowing individuals to process the unintegrated parts of their minds, and offer the chance of real healing. But we don’t change. Our outlooks have ossified, our diagnoses have desiccated. And all the while we suffer in our own blindness. People continue to kill themselves, and my patient will continue to suffer in silence until the Victorian Government allows me to access a new treatment which may finally bring peace to a troubled mind.

Dr Eli Kotler

MBBS MPM FRANZCP Cert. Old Age Psych. AFRACMA

Eli is a consultant psychiatrist and psychodynamic psychotherapist. He is the Medical Director of Malvern Private Hospital, an addiction and trauma hospital in Melbourne. Eli completed the inaugural CPAT course, and has since been on its faculty. He was appointed as the course’s Australian Course Director in 2023.

As a psychiatric trainee, Eli was awarded the Royal College of Psychiatrists Trainee Prize for his Scholarly Project on Depression, as well as a Research Committee Trainee award for his work on Philosophy of Mind. As an adjunct lecturer at Monash University, he oversees medical students on their addiction medicine rotation. He has been invited as a key-note speaker to several conferences and meetings to discuss addictions, trauma and psychedelics. Eli sits on the Committee of the ANZMHA to help organise their yearly addiction conference. He also sits on the inaugural Clinical Advisory Group for the Victorian Responsible Gambling Foundation. Eli is an Associate Fellow of the Royal Australasian College of Medical Administrators, and is a member of the Australasian Professional Society on Alcohol and other Drugs. He also has extensive research experience with novel therapeutics for neurodegenerative diseases.

Due to his interest in trauma, Eli has been appointed an Independent Medical Examiner by WorkSafe Victoria. He has been appointed by the Minister for Workplace Safety to sit on the Victorian Medical Panels, and is an expert witness in historical abuse cases.

Clinically, Eli works in a psychodynamic framework, and attempts to help his patients find freedom from their addictions and trauma through relational experiences, and experiential self-awareness. He is part of the AFL Player’s Association referral network for addiction issues, and his interests in depth-psychology and neuroscience led him to found the Melbourne Neuropsychoanalytic Group.

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