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Mind Medicine Australia’s Progress and Achievements Since 2019

In our first four years, we have made remarkable progress in growing public awareness of, and creating access pathways for Psychedelic-Assisted Therapy in Australia. With the success of our rescheduling applications in early 2023, we are seeing access open up for the use of psilocybin and MDMA-assisted therapy 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 open access to these innovative treatments for Australians suffering from treatment resistant mental illness and paves the way to treat other illnesses such as additions, obsessive-compulsive disorder, anorexia, cognitive decline and end-of-life stress in the future.

Our goal is to build the ecosystem for these treatments in Australia and ensure they are accessible to all who need them in medically controlled environments. Please see our key strategic objectives below.

 

What we have achieved in four years with your support:

 

Awareness and Knowledge Building

 

• 200+ webinars, screenings and special events attracting 41,000+ 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.

• Launch of Mind Medicine Australia Podcast series

• Over 550,000 visits to the Mind Medicine Australia website

• Over 39,000+ followers on our social media channels

• Over 500,000+ views on our YouTube Channel

• 6000+ visits to our e-book about psychedelic-assisted psychotherapies

• Over 35,000+ people in our database incl. over 15,000 health professionals and over 1000 psychiatrists

• 500+ regular donors

• 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

• 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 28,000+ views

• Over 150,000+ 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’.

• 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

 

Access to Medically Approved Therapy

 

• 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 psychedelic medicines for import to Australia for use in trials and as part of the TGA’s Authorised Prescriber scheme from July 1 2023

• Established the Patient Support Fund (PSF). Donations into this fund will provide subsidised treatment for those who otherwise could not afford it

• 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

• Key university student placement partnerships with University of Melbourne

 

Professional Development Program

 

• Our highly anticipated Certificate in Psychedelic-Assisted Therapies commenced in January 2021 featuring a world class Faculty. We have been thrilled to welcome 260 therapists including GPs, physicians, psychiatrists, psychologists, psychotherapists, mental health nurses, social workers, occupational therapists, addiction specialists, paramedics and counsellors.

• 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 2023 program.

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

• Over 700+ applications received since launch

• Over $300,000 raised for CPAT grants through philanthropy to support those in regional and rural areas and therapists suffering financial hardship. Over 50 grants have been awarded so far.

• Over 127,000+ views of the CPAT sizzle reel

• Launch of the Fundamentals in Psychedelic-Assisted Therapies Course with over 320+ 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

 

Engagement with University Sector and Novel 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

• 17+ 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:

 

• 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 Institute Launched as a Dedicated Training, Education and Clinical Services Organisation Focusing on Psychedelic Assisted Therapies for Mental Illness and the Developing Understanding of the Mind, Cognition and Human Consciousness in October

• 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 four 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 2023, our vision and capacity continue to grow. With these medicines becoming legally available in Australia, we turn our focus toward ensuring they are accessible and affordable to all Australians who could benefit from them.

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.

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 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.

Peter’s Story: Finding Acceptance, Being Generous And Healing Grief Through Psychedelic Medicines by Peter Hunt AM

Psychedelic roof

 

As a young person, I never thought that I would be an Australian. I lived in a country town in England and my family seemed secure and loving (even though relationships between my mother and my father were sometimes strained). Then when I was 13, without any warning, my father committed suicide. He hadn’t let on that his business was failing, and he dealt with the burden of impending bankruptcy by taking his own life. In his letter to my mother, he said that he thought taking his life was for the best. What he didn’t realise was the lifelong damage that he would do to all of us.

My mother was an extraordinary person. In an instant, she had lost her husband, her home, her financial security, and nearly all of her possessions. But she was incredibly determined with lots of inner strength and decided that we should start again by emigrating to Australia. At the time the Australian government paid for virtually everything; a 6-week journey by ship to Australia with my mother paying just 10 pounds (about $20 Australian dollars at the time), and with me coming for free because I was under 16 years of age.

I can remember the ship coming into Sydney Harbour on a beautiful and crisp winter’s morning with the mist rising from the water. I can remember feeling excited by this new country where the light seemed so bright compared to the pastel colours of England and where the buildings in the city seemed so high. I could feel the energy, but I also remember feeling my deep sadness. I felt deeply the loss of my father and nearly everything that I had ever known, my home and my childhood friends.

Looking back, I now realise that I dealt with this sadness by becoming incredibly good at building barriers around my heart; going inwards and working incredibly hard to succeed in my education and in my career. I was lucky to get the chance to go to a great school, which encouraged me to excel, then to go to university (which was then basically free), and then to get a job as a lawyer at a top law firm before moving into investment banking.

As an investment banker, I did far better than I could ever have believed possible. I eventually started my own firm and then sold the firm 10 years later to an American investment banking group. Looking back, I now realise that the hard work, the constant need to achieve, and the financial rewards were all a way of escaping from the pain that I felt deep down. Sadly, this pain prevented me from experiencing the true intimacy in my relationships with other human beings that everyone should have.

As I got older, I started to realise how lucky I had been. I could so easily have taken a different road, unable to cope and spiraled down. Luck gave me an amazing mother with the courage to start again and gave me the intellect, health, and determination to make a go of my new life. But it all came at a cost.

My way of dealing with my sense of luck was to get more and more involved in the not-for-profit sector both as a philanthropist and as an active participant – first going on to Boards and then starting new charities to help disadvantaged people who hadn’t had the luck that I had experienced. By the time that I met my beautiful wife Tania nearly 10 years ago, I had been extensively involved across the not-for-profit sector (particularly in the areas of homelessness and poverty alleviation). I had also started the Northern Beaches Women’s Shelter (with my previous partner) and then Women’s Community Shelters (www.womenscommunityshelters.org.au). The more I dealt with people who were suffering, the more I realised that it could so easily have been me. The only difference was that I had been lucky and they hadn’t been.

About 6 years ago, I can remember Tania getting excited about a Michael Pollan article she read in the New Yorker Magazine, explaining the outstanding trial results that were being achieved by researchers at major universities in the UK and North America using psychedelic-assisted psychotherapy as a cure for key classes of mental illness. I must have been busy on other things at the time because I didn’t immediately get excited about this research, and given the outstanding results being achieved, I should have.

However, Tania is a determined person and a great connector, and she quickly developed relationships with leading overseas researchers in this field. She tried to get us enrolled in trials in London so that we could experience these psychedelic substances, but we didn’t qualify (no mental illness – at least that we know of). Tania didn’t give up though and she found a therapist in Holland (where the therapy is legal) and arranged for us to have a psychedelic experience with psilocybin.

Even then I wasn’t that excited, but I went along because I trusted Tania and this was something that she was obviously passionate about and wanted to try. I had never tried any mind-altering substances (other than alcohol) and I had no idea what I was letting myself in for.

I have to say that the experience with psilocybin was “out of this world!” The therapist helped us get into the right mindset and the setting was quiet and peaceful. Then we took the psilocybin-containing mushrooms and for the first 20 minutes, nothing happened. It felt like a bit of a let-down. Eventually, with my eyes covered by an eye mask, lying down, and eyes closed, I started to “see” the amazing psychedelic shapes and colors that people talk about.

Kaleidoscope

I was then transported into another world that was timeless and where I became an observer. The experience is impossible to explain to anyone who hasn’t taken the medicine: wondrous, confronting, beautiful, extraordinary, altogether another realm of consciousness.  I came out of the experience changed, as if the blinkers that so many of us hide behind had been removed.

The argument that these substances are addictive is complete nonsense. The experience was so deep and meaningful that it took Tania and I a year before we had a second go, and that was even more powerful.

It was now decision time for us. Tania and I could either keep the experience to ourselves or work towards making these therapies available to everyone who needed them in safe environments with trained therapists. Mind Medicine Australia was born from a deep desire to help make these therapies part of our medical system so that many more Australians suffering from debilitating mental illnesses, like depression and post-traumatic stress disorder, could get well and realise the joy of life which should be available to all human beings.

Mind Medicine Australia is a charity because we want to make these therapies – with their incredible remission rates – available to all Australians that need them, irrespective of wealth or where they live. We don’t want a need to make money to get in the way.

So how do I feel now about the impact of these medicines on me and the prospect of making them available to all Australians that need them?

The self-made “protective” barriers around me have fallen away a lot in the last 6 years since my first psychedelic experience, as my capacity for acceptance has grown. My sense of wonder in the beauty of the natural world and all human beings has increased in a profound way. It’s impossible to explain this miracle.

How extraordinary that a molecule that exists naturally in some types of mushrooms locks perfectly into a certain type of receptor in the human brain and causes that person to go inwards into another realm of consciousness and, in doing so, examine the wonder of life and the connectedness of all living things. The medicine has been an amazing gift for Tania and I, and we want this gift to be available to all Australians in need.

Along the way, I’ve learned a lot about out mental health system. I’ve learned that its full of the most inspiring health practitioners who give of themselves every day. That’s the good news. The bad news is that there is also a huge amount of entrenched thinking, vested interests and hubris shared by some participants in the mental health system, which (despite claims to the contrary) isn’t based on the available science and data and which inhibits positive change, prevents people from getting well, and leads to more suffering.

Mind Medicine Australia continues to make good progress and I am increasingly confident that these therapies will become available for Australians that need them. The big question is how long will this process take? We need to move quickly to break down bias, prejudice, ignorance, hubris, and vested interests. There are just too many people suffering needlessly.

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.

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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