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FDA Decides Not to Register MDMA as a Medicine in the United States Pending Receipt of Further Data

As many will have seen, the FDA in the United States announced on Friday that it has rejected the MAPS registration application for MDMA when used as part of therapy. After the second Phase 3 results were announced by MAPS last year it looked like MAPS would have a straight-forward route to registration.  However, over time a lobbying campaign against registration gained momentum, and a recent campaign in support (which included Veteran associations and Members of Congress) was too slow to have any impact.

The rejection letter to the MAPS sponsoring company (Lykos) from the FDA has not yet been made public but some of the details  are starting to come out (eg. a requirement from the FDA that Lykos sponsor a new Phase 3 trial to further test safety and efficacy).  That will be challenging for Lykos to fund and will put registration back by a number of years.  Lykos has asked the FDA to reconsider its position, but any change (at least from this distance) seems unlikely.

A good summary of the FDA’s decision can be found here: https://psychedelicalpha.com/news/breaking-fda-rejects-lykos-therapeutics-mdma-assisted-therapy-for-ptsd

The arguments used by the FDA Advisory Panel (which appear to have been adopted by the FDA) look superficial and/or manageable.  For example, the challenges with blinding that were raised by the Advisory Panel have been obvious for a long time.  Using the same argument, this should also have been a problem with the registration of the ketamine nasal spray Spravato (esketamine) but in that case the sponsor – Johnson and Johnson – was a conventional pharmaceutical company better known to the FDA. Another argument raised by the Advisory Panel was the vulnerability of patients to abuse when in an altered state, a risk that we believe can be controlled by having two therapists in the room with the patient at all times, the sessions being visually recorded and the recording being available for review.  It really does seem a strange argument because the same argument could be applied to patients being given morphine for pain relief or patients being given a general anaesthetic.

We have provided a full analysis of the arguments raised by the Advisory Panel in a paper co-authored by Professor David Nutt (Imperial College London), Tadeusz Hawrot (PAREA – Europe), Peter Hunt (Mind Medicine Australia) and Dr Anne Schlag: https://www.drugscience.org.uk/allaying-the-fears-mdma

We think that this is just a setback and that MDMA will be registered as a medicine in the United States by the FDA in time and that the public campaign for registration in the United States will just keep getting stronger.  The suicide rate and suffering amongst veterans, first responders and others, which hasn’t been helped by the failure of current treatments, will continue to highlight why this treatment needs to be available (with appropriate controls in place).  Unfortunately, more people in the United States who are suffering from mental illness will continue to take their own lives or seek illegal access to MDMA-assisted therapy (with no regulatory supervision) in the meantime.

What this outcome does show is the wisdom of the TGA’s decision to reschedule MDMA and psilocybin when used as part of therapy for PTSD and treatment resistant depression by combining this with the controls in place under the Authorised Prescriber scheme. We just have to be careful that the regulatory controls don’t unfairly inhibit access for patients in Australia who satisfy the criteria, where both the prescribing psychiatrist and the patient – properly informed – agree that it’s an appropriate and much needed treatment for the patient.  We also need to carefully review any claims that are made against the use of these therapies (including through conflicts of interest and lack of proper analysis).

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 therapies to ease end of life distress’.

Developed summary of all trials taking place in Australia

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

• Over 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 therapies Research Registry at ANU, which will allow for outcome data to be collected from treatment with PAT around Australia

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

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

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

• Discussions with key University stakeholders continue

 

Noteworthy from Media Releases:

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

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

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

• An Open Letter to the Prime Minister in November 2022

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

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

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

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

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

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

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

 

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

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

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

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

In the last 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 was the lead author of Mind Medicine Australia’s successful rescheduling applications for MDMA and psilocybin, which made Australia the first country in the world to reschedule these medicines.

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

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

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.”

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 was the lead author of Mind Medicine Australia’s successful rescheduling applications for MDMA and psilocybin, which made Australia the first country in the world to reschedule these medicines.

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

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

My Awakening… by Simone Dowding

Here I was a successful entrepreneur living a millionaire lifestyle. I had made it! Or so I thought. But something was missing. I didn’t feel the happiness that I’d been promised by society. I felt lied too, that I’d been somehow tricked.  The success, I had valued and strived my whole life for, had left me empty and in a marriage that had died in the process. I don’t think anyone can describe the loss of a marriage. The loss of the family you had always wished for, the loss of everything you essentially knew, the look of despair in your children’s eyes, the dreams you had created together. Your combined friends, family and memories.  They all disappear. In the midst of all the trauma, change and never-ending tears something else dawns on you too.

I am now…alone.

In my aloneness, I grew afraid. The world had lost all meaning and I felt completely disconnected from everyone and everything. Nothing bought me joy and I was trapped in extreme suicidal ideations that left me unable to work and be social. My family was unable to understand me, and I was gradually losing all my friendships. Leaving me more disconnected and isolated. For 3 years I struggled through, tortured by my thoughts and grief. I went to every western Doctor and tried various medications that made my symptoms worse. Then I tried yogis, naturopaths, psychics, body somatic work, acupuncture, counselling, hypnosis and meditation. I even went vegan and moved to the beaches of Byron Bay. You name it, I did it. I was desperate!

Synchronistically, in a yoga class, I met a girl that had just come back from the Amazon and said she had been healed of her depression.  She told me that what I was experiencing, in shamanic terms, was what can only be described as a ‘dark night of the soul’ and that the mystics before me spoke of an experience that is likened to a deep spiritual depression or existential crisis that was necessary to live an authentic life.  They saw it as an initiation. A rebirth. A transformation from the old self into a profoundly liberated state and new way of being in the world. Could this explain my intense and prolonged suffering? The reason why I’d divorced, why I’d lost everything?  At last, I felt understood, I felt hope, I felt called into something greater.

Within 3 months, I was sitting in the Peruvian jungle at the feet of a renowned and very powerful shaman.

The Amazon is not an easy place to be. But It’s hauntingly beautiful with the most ancient lush green trees. The tallest I’ve ever seen. With beautiful hummingbirds and colourful butterflies that land on your arms. You are also dangerously aware that there’s anacondas, tarantulas and piranha around too. But I had nothing to lose, because I already felt dead. So what was there to be afraid of?

I was wrong.

I was living with an indigenous tribe in very poor conditions. The shaman spoke no English but was so welcoming and kind. He told me in Spanish that my spirit was very sick and my energies needed to be realigned. I had ceremonies in which he sung icaros (their magical songs) and gave me various plant medicines including Ayahuasca (the vine of the soul). The first night was one of the most frightening nights of my life. I was confronted with all my grief and trauma and challenged to find my power within it. I felt the shaman and medicine, training me to be strong, resilient and face all my fears. I’d had an initiation that was sacred and profound.  I felt new, clean, strong. Most importantly, I had been given the ability to dream again. I could actually see a future. I had direction, I had hope. I was ready to dream my new life into being.

But the greatest gift of all was that I wanted to live.

Words can’t describe the sense of freedom and possibilities that I now felt. I realised the key to my mental and spiritual health was the complete letting go of my old life, past, ancestral history, culture, trauma and subconscious programming.  It was more than a psychological healing though. I had awakened into something new. It was like choosing the red pill in the matrix.

“You take the blue pill—the story ends, you wake up in your bed and believe whatever you want to believe. You take the red pill—you stay in Wonderland, and I show you how deep the rabbit hole goes. Remember: all I’m offering is the truth. Nothing more”. Morpheus

I’d chosen a different path to others. I wanted the TRUTH. It was a far cry from Western medicine and taking a pill to fix things quickly.  I don’t believe in a happiness pill. There is no such thing. I’d worked hard for my mental health. I’d fought hard for my life. And it was all without a doubt for my 2 boys. I had to get well for them. The greatest loves of my life.

My way is not for everybody. I’d searched for my own truth, and worked out what was true for me. In the process, I was profoundly connected with something greater than myself. The realisation had dawned on me that I was never ……alone. It really was a divine journey that had been orchestrated by a divine force to lead me back to my authentic self, to bring me home.

How lucky am I, how blessed to have taken this path that others would traditionally interpret as a descent into mental illness. It was far from that!! I’d reconnected with life, humanity, my divine purpose. I guess it’s in times of crisis that we finally yield and discover who we really are.  I have a peaceful acceptance of my past now, as painful as it was, and I realise that nothing happened by accident. I see clearly now why I had to go through that suffering. I felt like a warrior returning from war into a bright, new world filled with possibilities.

On my return from the Amazon I worked for World Vision Australia as Head of Social Enterprise, which enabled me to economically empower women globally.  I was then voted in the top 50 Business People of the Year in Australia by Inside Business magazine for my contribution to humanity. I am currently CEO of a national organisation and a guest lecturer for Monash University. Most importantly I am a loving and present mum to my two gorgeous boys.

Big love Sim

A Magic Medicine Journey By Tania de Jong AM

Psychedelic Prism

I want to start with a snapshot of how I am possibly different from the average person. I don’t smoke or drink. Before this chapter of my life began, I’d never taken any drugs besides prescription medication (and those as rarely as possible). I live in Melbourne, the coffee capital of Australia, and don’t even drink it.

Yet today, my life revolves around psychedelic medicines – heavily stigmatised substances still illegal in most countries. This huge shift is likely confusing. However, my personal journey can hopefully provide a deeper understanding of why I co-founded Mind Medicine Australia (MMA), and how psychedelic-assisted therapies could change the face of mental health treatment.

Helping People find their Voice

Over the past two decades, I’ve founded 6 companies, 3 charities and am a Member of the Order of Australia. I’m a global speaker and an international soprano – performing both as a soloist and as part of a group and have released 12 albums.

Singing has always been a huge part of my life. This motivated me to create the charity Creativity Australia and social inclusion program, With One Voice. My mission was to bring together people from different backgrounds, generations, faiths, and cultures by forming social inclusion choirs that bring together ‘haves’ with ‘have-nots’. Singing together can help alleviate loneliness, depression, and social isolation. I explain this further in my recent TED talk, which has received over 100,000 views so far.

I’ve personally witnessed that helping people find their voice can unlock their full creative potential. Similarly, I also believe psychedelics have a monumental role in helping achieve this. I know they will allow me to scale this mission… but I’ll get back to that. First, I think it’s important to tell you about my own experiences with psychedelics.

From Sober to Psilocybin Seeker

Taking an illegal substance had never occurred to me until I stumbled across Michael Pollan’s article in The New Yorker titled ‘The Trip Treatment.’ Reading it not only made me aware of the current resurgence in psychedelic research but also helped me to understand how these ancient plant medicines were assisting people to heal from a host of mental health issues.

From that point on, my interest in trying these hallucinogenic plants began to grow. I had no idea what it was like to be drunk or out of control. Yet the majority of people expose themselves to these altered states on a regular basis. I wondered if perhaps I was missing out on an essential human experience. What could psychedelics teach me about who I am or who I could be? Through exploring my psyche, what unknown parts of myself and our cosmos could psychedelics grant me access to?

So, I recruited the support of my now-husband Peter, and set out on a quest to have a therapeutic experience with psilocybin mushrooms. Having sadly lost his father to suicide in his early teens, Peter was also interested in dealing with past traumas.

However, being able to do this in a safe and legal setting proved difficult. After first trying and failing to get into global trials for healthy patients, we were ultimately referred to a private therapist in the Netherlands, where the use of psychoactive truffles is legal. We ingested a large dose of psilohuasca – a combination of psilocin-containing fungi and Syrian Rue, a MAO inhibitor used to enhance and prolong the effects of a trip.

The Inner Journey

Fair warning – describing what it’s like when you take psychedelic substances is difficult. My first time was completely removed from anything I’d encountered before. Unless you’ve personally experienced it, there’s really no reference point for understanding what it’s like. However, I can tell you that from then on, my life veered off in a very different direction.

The combination of having never lost control before and hearing stereotypes around psychedelics, made me incredibly nervous. I believed that it was going to destroy my brain. Turns out, this is far from reality. What happened was one of the most meaningful experiences of both our lives.

Firstly, the medicine completely shot us into space and, at the same time, through the Earth, rivers and oceans. What initially overwhelmed me was this incredible sense of oneness.It was as if all boundaries dissolved and I was left with the sheer magnificence of our planet. The connectivity of everything was indescribable. I haven’t been able to eat meat or even step on an ant since.

Being confronted with personal pain is a common experience during a psychedelic trip. For myself, as the daughter and granddaughter of Holocaust survivors, I’ve lived with transgenerational trauma my whole life. I was faced with this horror during my experience and have undergone transformational healing as a result.

These realisations were profound, but it’s the deeper insights we gained about ourselves that have left a lasting impression. The self-development Peter and I dove into following that first overseas expedition was vital for us to really integrate our life-changing experience. These lessons were so powerful, we didn’t feel compelled to have another session for a whole year. Research shows that the psychedelic experience significantly decreases activity in the brain’s default mode network. However, it’s the work that’s achieved in subsequent integration that leads to lasting wisdom. Incorporating the experience into your life, is just as important as the experience itself.

The neurogenesis and increased neural plasticity created by the medicines is truly remarkable. It’s like hitting the reboot button on your brain’s computer and defragging the faulty drives. I’ve noticed my creativity has increased tremendously. I’m able to access more moments of flow and purity in my singing, public speaking and writing. I’ve also recognised real lifts in my energy and consciousness. I feel many neural pathways have reconnected for me, new ones have formed and missing parts of myself have been found.

Psilocybin and Placebo

Creating a Movement and Making a Difference

Fast forward a few years later and Peter and I now seek out a session every four to six months. We call it our reset button. Every time we work with these medicines, we get new downloads and join more dots. Not only have we woven psychedelics into our lives, but the immense value we’ve gained from these magical medicines is what inspired us to establish our fifth charity, Mind Medicine Australia in 2019. Whilst our other charities are helping thousands of people through women’s shelters, social inclusion choirs, educational programs, poverty alleviation and microfinance, we acknowledge that at the heart of any kind of social isolation or disadvantage lies mental illness.

Mental illness keeps a person isolated. Sufferers often deal with rigid, negative thought patterns and intense feelings of despair. Every day we get emails and calls from those who’ve tried medication or therapy and are at the end of the road. We need to treat the underlying cause if people are to genuinely heal and lead more meaningful lives.

Having celebrated our second anniversary in February 2021, MMA is focused on expanding the treatment paradigm available to specialist health practitioners to reduce Australia’s terrible mental health statistics, which are worsening because of the current and ongoing COVID-19 pandemic. Of particular concern and pertinence are the high levels of mental illness, addiction, and suicide amongst the veteran, first responder and other marginalised population groups.

Before the pandemic, 1 in 5 Australians were experiencing some type of mental illness. 1 in 8 adults, 1 in 4 older people and 1 in 30 children (some as young as four) were estimated to be on anti-depressants. Their use across the country has risen by a massive 95% over the past 15 years. Still, mental health statistics continue to get worse, resulting in one of the highest rates of mental illness in the world. Recently, mental health experts announced that the COVID-19 crisis could lead to a 25% increase in suicide rates. Incidence of trauma, anxiety, depression and substance abuse are all accelerated by the pandemic.

Depression treatment methods haven’t substantially changed for decades and reversion rates are as high as 80% following medication. Side effects and withdrawal symptoms are common problems. Anti-depressants and psychotherapy lead to remission for less than 35% of suffers and the rates for PTSD are around 5%.

On the other hand, MDMA and psilocybin-assisted therapies are considered safe with remission rates of between 60-80% being achieved from over 150 current and recent trials. Evidence suggests psychedelics are low in toxicity, non-addictive, and show no signs of producing organ damage or neuropsychological side effects. These medicines are also proving to be very effective at treating various addictions. Practitioners describe them as ‘antibiotics for the mind’ due to their outstanding efficiency and short nature of treatment programs.

Research showing the benefits of these therapies are taking place at many of the world’s most prestigious universities including Johns Hopkins, Yale, UCLA, Harvard, Oxford and Imperial College London. Furthermore, these therapies are already legally available in the USA, Switzerland, Canada, Israel via Special Access Schemes. Some psychiatrists and prescribing physicians we work with have also recently received approvals for use of MDMA and psilocybin-assisted therapy for their treatment resistant patients via Australia’s SAS-B pathway.

Psilocybin-assisted therapy for depression and MDMA-assisted therapy for PTSD have achieve “Breakthrough Therapy” designation from the FDA in the USA. This designation is only granted to medicines that could be vastly superior to existing treatments to fast-track the approval process. MDMA, which is in Phase 3 trials, is likely to be a prescribed treatment for PTSD in the USA within 18 months. There are also trials underway for the treatment of end-of-life depression and anxiety, alcohol and drug addiction, dementia, strokes, anorexia and other eating disorders, cluster headaches and chronic pain.

Scaling the Mission to Set People Free

In preparation, we need to ensure that practitioners are properly trained. Our Certificate in Psychedelic-Assisted Therapies commenced in January 2021. This is the first course of its kind in this field in the Southern Hemisphere and is being designed in collaboration with the world’s leading programs and features a Faculty of global leaders in this field. Both our intakes for 2021 are proving popular with practitioners including psychiatrists, psychologists, GPs, mental health nurses and social workers.

Mind Medicine Australia is in the process of establishing an Asia-Pacific Centre for Emerging Mental Health Therapies. Its main mission is to expand the mental illness treatment paradigm in Australia and boldly position Australia as a global leader in mental health innovation, with partnerships encompassing University, philanthropic, private industry, and government sectors. MMA is also a part-funder of the nation’s first psychedelic clinical trial, currently underway at Melbourne’s St Vincent’s Hospital. We are also currently planning a Major International Summit for 2021, attracted a great Board, Advisory Panel and have support from major players in the psychedelic space. These include pioneers Roland Griffiths from Johns Hopkins University, David Nutt and Robin Carhart-Harris from Imperial College London, Rick Doblin from MAPS and many others.

What psychedelic medicines provide is an extremely effective treatment option for medical professionals who are desperately seeking innovation in the way we treat mental illness. They can help us rediscover our connection to ourselves. We can’t love others unless we first love ourselves. Psychedelics used intentionally also have the potential to help us solve other serious challenges, such as environmental and political issues, homelessness, and domestic violence.

A great deal of pain and suffering could be alleviated by introducing genuine connection back into people’s lives. If the pandemic is teaching us anything, it’s that humans are social creatures, and losing that connection can drastically affect our health and wellbeing. My first mission was to heal through the power of music, and don’t get me wrong, I’m still very dedicated to doing this. Yet today, with MMA, we’re taking that mission and scaling it in a way I could’ve never imagined possible.

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!

Mind Medicine Australia Celebrates 2-Year Anniversary by Tania de Jong AM and Peter Hunt AM

Second anniversary

 

This week Mind Medicine Australia turns two years old! In our two years, we have made remarkable progress in growing public awareness of Psychedelic-Assisted therapies in Australia. We are already seeing a paradigm shift in the curiosity, acceptance and interest into the use of medicine-assisted therapy for depression, addiction, PTSD, obsessive-compulsive disorder, anorexia and other mental and physical illnesses in our communities.

In order to help those who are suffering with mental illness we have focused on four key strategic areas. Please see our strategic objectives to build the ecosystem in Australia for these medicines here.

Strategy

What we have achieved in our two years with your support:

Awareness and Knowledge Building

Access to Medically Approved Therapy

Professional Development Program (Certificate in Psychedelic-Assisted Therapies)

Asia-Pacific Centre for Emerging Mental Health Therapies (CEMHT)

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 The Project, ABC and other stations.

Our primary focus over the next couple of years will be on psilocybin-assisted psychotherapy and MDMA-assisted psychotherapy, given their “Breakthrough Therapy Designation” with the Food and Drug Administration (“FDA”) in the United States and the strong clinical evidence that supports both their effectiveness and safety. We are also interested in developing other medicines 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 year, 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 and educational development.

Mind Medicine Australia is also supported by an outstanding Board, Ambassadors and an Advisory Panel of over 60 local and international experts in medicine, psychiatry, psychology, pharmacology, research, science more broadly, ethics, law, policy, anthropology, business and therapeutic practices.

We are currently preparing for our International Summit on Psychedelic Therapies for Mental Illness to be held at the Sofitel in Melbourne this November. We have a global line-up of world leaders in medicine-assisted psychotherapies and other outstanding thought leaders on topics ranging from medicine and anthropology to neuroscience and ethics. We are now confirming financial, endorsing and media partners and would appreciate as much support as possible to produce a brilliant event.

Our much anticipated Certificate in Psychedelic-Assisted Therapies launched in January 2021. We are thrilled to welcome a wonderful group of GPs, psychiatrists, psychologists, psychotherapists, mental health nurses, social workers, occupational therapists, addiction specialists and counsellors.

As we begin 2021, our vision and capacity continues to grow, as does the need to make medicine-assisted psychotherapy a legally available treatment through our medical system for the increasing number of individuals suffering as a result of the pandemic, environmental challenges and global trends which challenge social cohesiveness and social inclusion.

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

“Psychedelics are to the study of the mind what the microscope is to biology and the telescope is to astronomy.” – Dr Stanislav Grof

Enormous gratitude to all of our supporters, partners, Board, Ambassadors, Advisory Panel, Team, Chapters and volunteers.

This is a collective mission and we need all of you by our sides.

On behalf of Mind Medicine Australia

Peter Hunt AM, Chair & Tania de Jong AM, Executive Director

Tania de Jong AM

LL.B (Hons), GradDipMus

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

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

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

Peter Hunt AM

B.Com, LL.B

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

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

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

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

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