Watson, Ngaire; Kotler, Eli --- "Psychedelic medicine and the law" [2022] PrecedentAULA 9; (2022) 168 Precedent 34

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PSYCHEDELIC MEDICINE AND THE LAW

By Ngaire Watson and Dr Eli Kotler

If the latest clinical research holds true, psychedelic-assisted therapy (PAT) will quickly become the most powerful treatment we have for many mental health conditions. It may revolutionise our understanding of, and our treatment paradigms for, mental illness. Legal issues have limited the opportunity to access this treatment, but psychedelic medicine is currently undergoing regulatory reconsideration and may therefore be able to offer hope to many with persistent mental illnesses.

Psychedelics are psychoactive compounds which impact subjective experiences in ways that can allow people to work through emotional conflicts and traumas underlying and fuelling mental illness, and form new patterns of thinking and feeling. Brain imaging studies of psychedelic use show large scale collapse of hard-wired neurological patterns and a concomitant increase in neuroplasticity, with new connections formed between neural networks.

Psychedelic substances have been deeply embedded in different cultures, yet in modern times are associated with conflicting attitudes and controversy. In this article we focus on two psychedelic substances, psilocybin and MDMA.^[1] Psilocybin is a classic psychedelic found in fungi; the non-rarefied form is colloquially referred to as the ‘magic mushroom’. MDMA is not a classic psychedelic but, due to overlapping structure and function, is often referred to as a psychedelic. These two substances have been selected for discussion due to their therapeutic effects, and the similar issues they have faced with respect to their legal status in Australia.

A HISTORY

Humans have been using psychedelic substances for thousands of years. Rock shelters with Neolithic carvings dating back 7,000 to 9,000 years, depicting the use of psychoactive mushrooms, were found at Tassili n'Ajjer on the southern edge of the Sahara Desert in Algeria.^[2] Psychedelic substances have been deeply embedded in different cultures ever since, yet in modern times are associated with conflicting attitudes and controversy.

Originally, psychedelic compounds were found in nature: in fungi, plants and a few animals. More recently, MDMA and another psychedelic, LSD,^[3] were synthesised in laboratories (MDMA in 1912 and LSD in 1938). In 1943, Swiss chemist Albert Hofmann, who originally synthesised LSD, intentionally ingested the drug to examine its effects. In the following decades, LSD formed the basis of therapy and research conducted by psychiatrists, including Dr Stanislav Grof,^[4] who used the chemical to assist thousands of patients and gain a deeper understanding of the human psyche, in a therapy coined ‘psycholytic psychotherapy’. In the early 1960s, a group of Harvard University professors conducted experiments, sometimes involving graduate students, to study the effects of psychedelics. Psychiatrists and therapists used psychedelics (most commonly LSD and MDMA) to help their patients with intractable psychiatric disorders. It has been estimated that MDMA was used therapeutically 500,000 times before 1985.^[5]

VICTIM OF THE ‘WAR ON DRUGS’?

LSD became politically controversial in the 1960s and 1970s. At the time of the Vietnam war and the counter-culture social protest movement, US President Richard Nixon announced a ‘war on drugs’.^[6] This led to the passing, in the US, of the Controlled Substances Act, which classified various psychedelic substances and other drugs as Schedule 1 controlled substances; this meant they were considered dangerous and illegal. In turn, other countries adopted the same view of psychedelics and other ‘illicit’ drugs in general.

The war on drugs has now been waged for decades across the globe, with varying degrees of success. It is this history of psychedelics, as well, perhaps, as their ability to profoundly alter human experience, that has resulted in resistance to mainstream research on and use of psychedelics. This resistance has created numerous legal barriers for researchers, and for doctors wishing to use these medicines for treatment.

Recently, however, there has been a worldwide groundswell of support for re-examining these controversial chemicals, due to their beneficial effects on otherwise treatment-resistant psychiatric conditions. The search for further synthetic psychedelics with clinically useful properties has begun in earnest.

MEDICAL CHARACTERISTICS OF PSYCHEDELICS

Psychedelics appear to work through serotonin-2A receptors in the neo-cortex. These receptors radically increase the connectivity between cortical neural networks which do not usually talk to each other. The collapse of patterned network connections leads to increased entropy in the brain, and a dissolution of previously hard-wired and rigid connectivity. Particular focus has been placed on disruption by psychedelics of the default mode network, a ‘resting-state’ neural network correlated with self-referential thoughts and musings, and therefore associated with concepts such as the ego. Researchers have also determined that 5HT2A receptors^[7] in the brain trigger neuroplastic changes, both functional and structural, which appear to facilitate improvements in mental health conditions. These neurological shifts appear to represent the underlying brain changes which accompany the subjective experiences of patients taking psychedelics.

These subjective experiences include ego-dissolution (the breakdown of the thought-filled, controlling and rigid aspects of our minds), mystical-type experiences, a sense of connection and empathy, access to emotions, memories and conflicts and to unconscious material, and a reorganisation of previously firmly held beliefs about oneself and the world. Experiences of this kind can be difficult and challenging initially. However, as with any good therapy, it is through the challenging aspects of the psyche, including fear and pain, that true healing can be found. The subjective experiences mentioned are correlated with therapeutic efficacy and hence appear to be a fundamental aspect of psychedelics’ mechanism of action. This underlines the paradigm-shifting potential of psychedelic medications to offer a form of treatment for mental illness that combines the biological effects of a medication with the subjective effects of therapy.

Psychiatric disorders, unlike other medical diseases, are conceptually complicated. For example, renal physiology and dysfunction are complex, but we don’t find philosophers and doctors debating what a kidney is. Not so in the case of the mind and mental illness. In fact, humanity has been struggling with the relationship between brain (objective structure and function) and mind (subjective experience) for millennia. Psychiatry, as a discipline, tends to sway uncomfortably and often unconsciously between these two poles,^[8] with psychoanalysis (the mind) as the focus being replaced by cognitive, behavioural and biological models (the brain). This reductive shift has more recently occurred in parallel with the ‘decade of the brain’, 1990–1999,^[9] ushering in a new era of neuroscientific understanding. These approaches are not merely academic, as they also tend to influence research paradigms and treatment approaches.

Psychedelics are attractive to both explorers of the ‘mind’ and ‘brain’ researchers, creating a dialogue between the humanists and the scientists. This may forge a new balance within mental health treatment regimes in general, and psychiatry in particular.

Often, psychiatric medications treat the symptoms – fear, anger, sadness, and disturbing thoughts and behaviours – by removing them.^[10] Psychedelics appear to work not by removing a negative experience, but by giving those who take these medications the courage to face disturbing parts of themselves and work through them.

Current treatment approaches tend to focus on unitary diagnoses (for example, DSM diagnoses), resulting in the use of terms such as ‘dual diagnosis’ for individuals with, say, an addiction and a mental health diagnosis such as depression. Psychedelics, on the contrary, tend to be transdiagnostic in their approach, working on the psychological issues underlying most chronic mental illnesses irrespective of the specific diagnosis – developmental trauma, for example.

PSYCHEDELIC-ASSISTED THERAPY

A new paradigm

PAT is a new paradigm in which psychedelic medication enhances good therapy, creating a powerful modality of treatment that allows people to work through the underlying emotional conflicts and traumas which may have triggered their mental illness, and also enables the benefits of the treatment to be maintained. As many patients comment, having PAT can be akin to having a decade of therapy in a single month.^[11]

Treatment sessions

Much of the contemporary research records treatment where a participant has two pre-medication therapy sessions; in these sessions, the therapist and participant gain trust in each other, and the therapist gains an understanding of the participant’s issues. The ‘set’ and ‘setting’ are discussed – the former is the focus of the participant entering into the psychedelic session, and the latter the physical environment in which the participant is couched (this could include music). The environment is usually non-medicalised, with most people preferring relaxing, spiritual or personally meaningful surrounds –they may bring in objects of personal significance.

The session itself runs over a full day. The participant ingests the psychedelic agent, which stimulates the physiological and psychological changes discussed above. The participant is never alone during the session – in fact, two therapists (often one male and one female) are present throughout the day, providing support as required. At times the therapists are silent, allowing the individual to process the experiences themselves. At other times, there are non-directive interactions for support and safety.

In the days and weeks after the session, intensive therapy is conducted to assist the participant to integrate the psychedelic experiences, which are often full of individual meaning for the participant. This model of PAT ensures safety, and aims to be curative (an aim sadly lost to most of the current psychiatric treatments). The medication forms part of therapy, and is generally taken up to four times, as opposed to daily ingestion over longer periods for traditional psychiatric medications. The PAT model is conducive to research, though not the only method of using psychedelics with patients (see, for example, the psycholytic therapy of Dr Stanislav Grof^[12]).

Results

This promising new paradigm has produced exceptionally positive results thus far, with over 160 current and recent trials demonstrating effect sizes well in excess of those for current treatments. While psychedelics are inherently challenging to study under our current research paradigms, and studies can be prone to certain biases,^[13] initial results are very encouraging. In a series of Multidisciplinary Association for Psychedelic Studies (MAPS) Phase II trials^[14] there were 103 participants, all with chronic PTSD (for an average of 18 years). Fifty-six per cent of patients went into remission immediately after just three medicinal sessions of MDMA combined with psychotherapy, and 67 per cent at the 12-month follow up. Most of the remaining participants had a clinically significant decrease in symptoms. As the recently published results of a Phase III trial by MAPS show,^[15] in a randomised controlled study of 90 participants with chronic PTSD, at the study end-point (18 weeks) after three psychedelic-assisted therapy sessions of MDMA, 67 per cent of the MDMA group no longer met the criteria for PTSD (as against 32 per cent in the placebo group).

Similarly, recent results of a study^[16] found that 57 per cent of patients were in remission from moderate to severe depression at 6 weeks after only two sessions of psilocybin-assisted psychotherapy, in contrast with a 28 per cent remission rate for patients taking a daily dose of escitalopram (a commonly prescribed anti-depressant medication) in combination with psychotherapy. Psilocybin had quicker effects of greater magnitude in reducing depressive symptoms. Additionally, psilocybin was better tolerated and feelings of anxiety and suicidal ideation were also reduced significantly.

Numerous smaller open-label trials have had similarly outstanding results in a broad range of conditions. A trial of 15 chronic smokers had a 60 per cent remission rate from nicotine at an average of 2.5 years after a few sessions of psilocybin in addition to basic cognitive behavioural therapy.^[17] A similar trial in Bristol was conducted with 14 subjects for alcohol use disorder. At 9 months post 8 weeks of therapy that included two MDMA sessions, only 21 per cent of participants were drinking more than the recommended daily intake, compared to 75 per cent of participants who had had the traditional treatment.^[18] Nine of the participants were abstinent. Equally impressive results have been found in death-related anxiety (up to 80 per cent positive response) in those with terminal illnesses,^[19] and the Canadian Government recently legalised psilocybin therapy for end-of-life mental health treatment.

Not surprisingly, both psilocybin and MDMA have been granted ‘Breakthrough Therapy’ status by the US Food and Drug Administration (commonly known as the FDA). This rare designation is granted to medicines which are potentially significantly superior to existing treatments, to fast track their approval. The medicines are also being made available as treatments in the US, Switzerland and Israel through expanded and compassionate use pathways – pathways that allow for the prescription of psychedelics outside of clinical research parameters for people with treatment-resistant conditions.

LEGAL STATUS OF PSYCHEDELICS IN AUSTRALIA

Several Australian doctors have received Therapeutic Goods Administration (TGA) Special Access Scheme approvals (at a federal level) for MDMA and psilocybin-assisted therapies. However, state-level regulation currently prohibits the use of these medicines for compassionate use in treatment-resistant patients.

Psychedelics and the law in NSW

In NSW legislation, the Poisons and Therapeutic Goods Act 1966 (NSW) (PTG Act) and The Poisons Standard (Cth) (Standard) are relevant because the Standard schedules both psilocybin and MDMA as Schedule 9 substances. These substances are regarded as:

‘substances which may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with the approval of Commonwealth or State or Territory Health Authorities’.^[20]

Under the PTG Act, authorisation can be given by the Secretary of the Ministry of Health for the manufacture, possession, use and supply of a Schedule 9 substance for medical or scientific research, or analytical, teaching or training, industrial or commercial purposes. However, NSW legislation exempts prohibited drugs listed in Schedule 1 of the Drug Misuse and Trafficking Act 1985 (NSW) (Drugs Act) from being authorised for use, despite the drugs being in Schedule 9 of the Standard. Both MDMA and psilocybin are Schedule 1 drugs.

The Drugs Act does provide for use by medical practitioners of other substances which are otherwise outside the law. The clinical use of psilocybin and MDMA is currently prohibited in NSW.

Legal status in Queensland

Psilocybin and MDMA are scheduled as ‘dangerous drugs’ in Queensland under the Drugs Misuse Regulation 1987 (Qld), sch 2. The supply of dangerous drugs is an offence under the Drugs Misuse Act 1986 (Qld). The Health (Drugs and Poisons) Regulation 1996 (Qld) provides that an endorsement is required for activities relevant to regulated poisons, including Schedule 9 drugs. The current legal status in Queensland means that treatment with MDMA and psilocybin is prohibited.

Legal status in Victoria

In Victoria, the Drugs, Poisons and Controlled Substances Act 1981 (Vic) (Act) and the Drugs Poisons and Controlled Substances Regulations 2017 (Vic) (Regulations) are relevant. Schedule 11 of the Act lists ‘drugs of dependence’. Both MDMA and psilocybin are on the list, meaning possession of either is an offence under s73 of the Act.

Section 13 of the Act sets out the persons authorised to possess drugs of dependence. The list includes podiatrists, dentists and nurses. However, because MDMA and psilocybin are Schedule 9 substances, s33A of the Act applies, which means that the only authorised persons are medical practitioners. The medical practitioner must make an application to the Secretary of the Department of Environment and Primary Industries in order to administer, supply or prescribe a Schedule 9 drug to a patient. At the time of writing (November 2021), no such application has been successful.

The Therapeutic Goods Administration scheme

Under Australia’s TGA there is a Special Access Scheme which is supposed to be a pathway allowing authorised prescribers access to ‘unapproved’ therapeutic goods. This scheme involves an application by a doctor for an individual patient on the basis that they have a treatment-resistant illness, such as major depression or PTSD, which has not responded to other medications. Theoretically, this would be a pathway for the prescribing of psilocybin and MDMA. However, as set out above, various state laws currently prevent this.

Mind Medicine Australia^[21] made a submission to the TGA in 2020^[22] to seek to have psilocybin and MDMA rescheduled from a Schedule 9 to a Schedule 8 substance. A Schedule 9 substance is a ‘Prohibited Substance’, whereas a Schedule 8 substance is a ‘Controlled Drug’ and can be prescribed. Examples of Schedule 8 substances are ketamine and morphine. In February 2021, the TGA declined to reschedule the substances, primarily citing the need for further research into the drugs. However, in October 2021, following further submissions from Mind Medicine Australia,^[23] the TGA announced it had commissioned an independent review of the therapeutic value, benefits and risks of MDMA and psylocibin for the treatment of key mental health disorders.^[24]

Interaction of laws – and the future

Under current state laws, it appears that a pathway in Victoria may be possible. If the TGA is prepared to reconsider the rescheduling of MDMA and psilocybin, this will make a material difference to the prospect of the Secretary of the Department of Environment and Primary Industries approving use of the substances.

There is a current groundswell of interest, internationally and in Australia, in psychedelic substances. The negative historical overlay is being replaced by sound medical research and a growing body of evidence that shows that, when these substances are prescribed and administered in a safe, supportive setting, they offer hope to people who suffer from treatment-resistant mental illnesses.

The authors would like to acknowledge the input and assistance of Greg Barns SC; David Hewitt, solicitor; and Peter Hunt AM, Chair of Mind Medicine Australia.

Ngaire Watson is a barrister and registered nurse who specialises in medical negligence litigation. Before studying law, she worked in acute care medical and surgical hospital settings, and then, after post-graduate training, as a mental health nurse and psychoanalyst. EMAIL [e-mail]. WEBSITE www.2selborne.com.au.

Dr Eli Kotler is a psychiatrist and psychodynamic psychotherapist. He is the Medical Director of Malvern Private Hospital, an adjunct Lecturer at Monash University and a Director at Mind Medicine Australia. Dr Kotler founded the Melbourne Neuropsychoanalytic Group and is the Principal Investigator in an upcoming MDMA-assisted therapy trial for PTSD (with Emyria).

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^[1] 3,4-Methyl​enedioxy​methamphetamine. Pharmaceutical-grade MDMA should not be confused with 'Ecstasy'; this is a recreational drug ostensibly containing MDMA, though in reality it often contains a mixture of ingredients.

^[2] US Department of Agriculture, The Mighty Fungi, <https://www.fs.fed.us/wildflowers/ethnobotany/Mind_and_Spirit/fungi.shtml>.

^[3] Lysergic acid diethylamide. See DJ Nutt, H de Wit, ‘Putting the MD back into MDMA’, Nature Medicine, Vol. 27, 2021, 950–1; J Fuentes et al, ‘Therapeutic Use of LSD in Psychiatry: A Systematic Review of Randomized-Controlled Clinical Trials’, Frontiers in Psychiatry, 21 January 2020 <https://www.frontiersin.org/articles/10.3389/fpsyt.2019.00943/full>.

^[4] LS Grof, Realms of the Human Unconscious: Observations from LSD Research, The Viking Press, 1975.

^[5] Multidisciplinary Association for Psychedelic Studies, ‘A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder’, 26 February 2018, 15 <https://mapscontent.s3-us-west-1.amazonaws.com/research-archive/mdma/mapp1/MAPS-2018-02-26-MDMA-MAPP1-Public-Blinded-Protocol-A1V1-26FEB2018.pdf>.

^[6] A Golub, AS Bennett and L Elliott, ‘Beyond America’s War on Drugs: Developing Public Policy to Navigate the Prevailing Pharmacological Revolution’, AIMS Public Health, Vol. 2, No. 1, 2015, 142–60.

^[7] A subtype of serotonin receptor in the brain. It has been suggested that these are a different class of serotonin receptor from those involved in the mechanism of action of antidepressants, which also alter the serotonin system, but in different ways.

^[8] L Eisenberg, ‘Mindlessness and Brainlessness in Psychiatry’, British Journal of Psychiatry, Vol. 148, 1986, 497–508.

^[9] Designated thus in the US to enhance public awareness of brain research.

^[10] RL Carhart-Harris and DJ Nutt, ‘Serotonin and brain function: a tale of two receptors’, Journal of Psychopharmacology, Vol. 31, No. 9, 2017, 1091–120.

^[11] See <https://mindmedicineaustralia.org.au/testimonials/>.

^[12] Grof, above note 4.

^[13] SD Muthukumaraswamy, A Forsyth and T Lumley, ‘Blinding and expectancy confounds in psychedelic randomized controlled trials’, Expert Review of Clinical Pharmacology, Vol. 14, No. 9, 2021, 1133–52.

^[14] L Jerome et al, ‘Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials’, Psychopharmacology, Vol. 237, No. 8, 2020, 2485–97. For an explanation of trial phases see <https://www.australianclinicaltrials.gov.au/what-clinical-trial/phases-clinical-trials>.

^[15] JM Mitchell et al, ‘MDMA-assisted therapy for severe PTSD: a randomized double-blind placebo controlled phase 3 study’, Nature Medicine, Vol. 27, 2021,1025–33.

^[16] RL Carhart-Harris et al,‘Trial of Psilocybin versus Escitalopram for depression‘, New England Journal of Medicine, 2021, Vol. 384, 1402–11. The primary end-point in this study was not met.

^[17] MW Johnson, A Garcia-Romeu and RR Griffiths, ‘Long-term follow-up of psilocybin facilitated smoking cessation’, American Journal of Drug and Alcohol Abuse, 2017, Vol. 43, No. 1, 55–60.

^[18] B Sessa, C Sakal, S O’Brien and D Nutt, ‘First study of safety and tolerability of 3,4 methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in patients with alcohol use disorder: preliminary data on the first four participants’, Journal of Psychopharmacology, Vol. 35, No. 4, 2021, 375–83.

^[19] S Ross et al, ‘Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial’, Journal of Psychopharmacology, Vol. 30, No. 12, 2016, 1165–80.

^[20] PTG Act, [8].

^[21] See <https://mindmedicineaustralia.org.au/>.

^[22] Ibid.

^[23] See <https://mindmedicineaustralia.org.au/submissions/>.

^[24] Commonwealth Department of Health, TGA, Independent Expert Panel on MDMA and psilocybin,

<https://www.tga.gov.au/independent-expert-panel-mdma-and-psilocybin>.