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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

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

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

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

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

• Launch of MMA Weekly Meditation Sessions

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

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

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

• Implemented a Board Observership program in conjunction with VMIAC

• Appointed as Member of peak body, Mental Health Australia

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

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

• Developed summary of all trials taking place in Australia

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

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

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

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

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

• 680+ donors

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

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

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

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

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

• Over 90,000 views of our Summit sizzle reel

• Over 80,000 visits to the Summit website

• Over 5000 queries received from the Summit website

• 110 virtual breakout rooms

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

• 19 major Corporate partners

• Over 160 Education partners

• 17 Supplier Partners

• 15 Media Partners

• 8 Scholarship winners

• 5 Poster winners

• 1 global 4-day event with massive impact

 

Patient Access

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

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

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

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

• Established the Patient Support Fund (PSF). Donations into this fund provide subsidised treatment for those who otherwise could not afford it. We have supported 8 patients with a total commitment of $74.000+ in its first year.

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

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

 

Professional Development Program

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

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

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

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

• Over 1000+ applications received since launch

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

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

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

• Launch of the Fundamentals in Psychedelic-Assisted Therapies Course

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

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

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

 

Research

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

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

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

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

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

• Discussions with key University stakeholders continue

 

Noteworthy from Media Releases:

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

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

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

• An Open Letter to the Prime Minister in November 2022

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

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

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

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

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

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

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

 

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

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

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

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

In the last 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.

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

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

A New Chapter in Mental Health Care

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

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

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

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

The Mavericks of Medicine

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

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

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

Rigour in the Face of Revolution

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

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

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

Navigating Complex Currents

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

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

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

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

The Cultural Catalysts

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

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

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

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

Toward a Future of Healing

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

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

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

A New Dawn with Due Diligence

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

Dr David Reiner

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

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

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

Returning to Our Roots

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

REFERENCES

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

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

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

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

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

Charlotte McAdam

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

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.

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.

A Mother’s Prayer To The TGA by Annie Mason

Woman on boat

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

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

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

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

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

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

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

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

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

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

Anxious adult

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

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

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

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

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

Annie Mason

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

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