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

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

 

Doubt it not, MDMA is a medicine

 

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

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

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

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

 

Prior national decisions on MDMA

 

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

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

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

 

What were the key FDA AdCom concerns?

 

From the FDA hearing these appear to have been

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

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

 

The impact of prior professional bodies opinions

 

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

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

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

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

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

 

Binary decision making

 

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

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

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

 

Prof David Nutt, Prof Jo Neill, Drug Science

Tadeusz Hawrot, PAREA

Peter Hunt, Mind Medicine Australia

 

Prof David Nutt (UK)

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

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

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

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

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

Prof Joanna Neill (UK)

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

Tadeusz Hawrot

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

Peter Hunt AM

B.Com, LL.B

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

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

He 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.

Professor David Nutt’s Lecture Tour – November 2022

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

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

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

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

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

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

Anyone for a Magic Mushroom Medicine? By Tania de Jong AM and Scott Leckie

In the lucky country we like to think of ourselves as free, prosperous and privileged. But is our luck running out and what might we do to get it back? Australia is now ranked as the OECD’s worst performer on tackling climate change, our vaccination rollout has by every measure been a dismal failure with Australia today ranked 113th in vaccinating its people, and we are now the nation with the second worst mental health statistics in the world, with only Iceland behind us. Something is clearly not right.

Somehow, we have created a society which promotes the consumption of all forms of alcohol, and where gambling is an addictive source of government revenue. Yet fungi that possess incredible medicinal powers and grows all by itself can, if consumed, put you behind bars.

We allow Australians to drink and smoke, eat ever-growing amounts of sugar, trans-fats and processed foods, causing an obesity epidemic of massive proportions that costs society billions of dollars a year. Doctors easily dole out anti-depressants and pain-killing opiates. Only an estimated 30-35% of depressed individuals in the general population experience remission from current pharmacotherapies or psychotherapies, with the majority experiencing ongoing symptoms, and significant side effects, and between 50% to 80% relapsing after treatment stop. To create positive change and healing, we need to be innovative and broaden the tools available to our medical practitioners and qualified therapists working in this area.

And how free are we if we don’t have access to all of the safe and effective medicines that could cure us when we are ill?

History, science and increasing amounts of data, now clearly demonstrate the enormous potential social benefits of psilocybin mushrooms (psilocybin is the psychoactive component in magic mushrooms) to our mental health, creativity and productivity. Yet digestion of psilocybin remains illegal in Australia, both for medical and recreational uses. Why do prevailing State laws make it illegal to eat completely safe, non-addictive, non-toxic and free wild mushrooms, which may just be growing right outside your door in this magic mushroom season? And yet it is perfectly legal to pick a poisonous mushroom growing nearby that may possibly kill you!

 

 

Far from making us ‘lose our minds’, it turns out that the educated, careful and responsible consumption of psilocybin mushrooms might just make us better and healthier people. And yet our minds, the cornerstone of everything we do in this short and finite life, are not as free as we may think.

There is nothing particularly radical or new about humans picking and consuming mushrooms, even those with psychoactive properties. Indeed, we would be hard pressed to find a single human culture anywhere, throughout thousands of years of recorded human history, that did not revere and use these medicinal sacraments to heal a variety of physical and mental ailments. Indeed, many now believe that the original story of our beloved Santa Claus is thought to have come from Nordic indigenous peoples who, along with their reindeer, were known to have regularly consumed the famous Amanita Muscaria mushrooms.  Their white dots against a red-capped mushroom dome became the key colours of Christmas cheer.

Though these mushrooms may have a reputation as daunting and dangerous, the science clearly shows that the individual and social dangers associated with the taking of psilocybin is far safer than almost all other drugs, even in recreational environments.

In scores of medical trials of these therapies at the world’s most prestigious Universities including Yale, Harvard, Oxford, Imperial and Johns Hopkins we are seeing remission rates of 60-80% amongst thousands of patients suffering with depression, anxiety, addictions and end-of-life distress. These results occur after just two to three medicinal doses in clinical settings, combined with a short course of psychotherapy. They have been shown to be effective, safe and non-addictive. Many patients describe the therapy as one of the top five most meaningful experiences in their lives! Whoever says that about any medicine?

These outcomes are so promising that psilocybin-assisted therapies are now being studied for the treatment of anorexia and other eating disorders, a range of addictions, obsessive compulsive disorder, dementia, Parkinson’s disease and cluster headaches. The therapeutic use of mushrooms has been legalised in Canada and the U.S. State of Oregon, and compassionate access to these treatments for treatment-resistant patients is being granted in the USA, Switzerland, Israel, and even Australia.

Aside from the realm of mental health, mushrooms are known to fundamentally change things for the better. The pioneering work of globally well-known mushroom experts, including American Paul Stamets, demonstrates that mycelial networks from which mushrooms grow constitute a significant portion of the world’s precious topsoil. They are the neural pathways by which trees and other plants actually communicate with one another. These infinitely complex networks also have qualities that can detoxify waste and greatly enhance the strength and resilience of topsoil. Clearly, mushrooms can do extraordinary things!

Psilocybin mushrooms can intensely reconnect one’s mind and significantly alter consciousness in ways almost impossible to describe to those who have not had this experience. Psilocybin binds to a serotonin receptor called 5-HT2a and takes the brain into a state where it can flow more freely, unconstrained by prior and rigid beliefs about how the world is supposed to work. Psilocybin works through cracking open complexes of suffering contained within the body and brain. It is often said of conventional antidepressants that they merely ‘plaster over’ the root causes of suffering, whereas the defining property of psychedelic therapy is the ability to accelerate self-understanding through revelation leading to complete remission for many.

How can ingesting a mushroom that grows naturally all over Australia still be illegal? In a country that is ‘free’, how can picking a magic mushroom in your garden leave you subject to prosecution and imprisonment? Increasingly, with compassionate motivations, we allow people to use drugs to end their lives via euthanasia, yet we prevent the management of mental illness with a safe and effective medicine that could assist millions to overcome a whole range of health challenges.

As Covid-19 has shown, it is easier to treat an illness if you understand it. Mental illness is the world’s number one cause of disability, and depression is the largest contributor to this burden. Pre-Covid-19, anti-depressant medications were prescribed to one in eight of the adult population in Australia including one in four older adults and one in thirty children.  And yet our rates of mental illness and suicides continue to grow. We clearly need a better approach based on science and proven treatments that get to the root cause of our suffering.

Our hope is that professionally delivered psychedelic therapy using psilocybin mushrooms can meet the massive need for breakthroughs in mental health care.

Action is needed now to ensure that these medicines are accessible and affordable to all and prevent further avoidable suffering and suicides. The recently completed Global Drug Survey showed that thousands of people sought self-treatment for psychiatric conditions and emotional distress with psychedelic-assisted therapies:  85% of them said their conditions improved as a result. People are taking matters into their own hands because they cannot wait any longer for a legal and medically controlled pathway.

Australia was a world-leading innovator in major issues such as the eight-hour work day, women’s vote, our superannuation and healthcare system and so much more. We often initiated positive change, but now our reefs, forests, unique animals, climate and coastlines are under severe threat and our international reputation is losing its shine. We need to find a way back.

Providing safe, medically controlled and legal access to effective medicines to everyone who needs them may be one of the answers. If we want to regain our world leading stature, we all need to reassess what it means to truly be free and make choices about the medicines that may heal us.

The Therapeutic Goods Administration (TGA) is currently conducting an Independent Review to reconsider the rescheduling of MDMA and psilocybin from Schedule 9 (Prohibited Medicine) to Schedule 8 (Controlled Medicine), while the Australian Government also recently announced a $15 million grant round for research into psychedelic-assisted therapies. However, huge obstacles remain, and there is still much to achieve to ensure we catch up and heal the immense suffering.

The next step is to ensure that all Australians enjoy the right to the highest attainable level of health, a right that is recognised under a plethora of human rights treaties Australia has freely ratified. To fully possess this right, everyone needs to have access to all the medicines in the medicine cabinet, and that includes magical mushroom medicine.

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!

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.

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

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