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I’ve often wondered….


Magic mushrooms and Ecstasy approved by the TGA


by Dr Emma Secomb


Did you like my salacious headline? I’ve been asked by a few people on the Range about the recently announced TGA (Therapeutic Goods Administration) changes to the Poisons Schedule listing of Psilocybin and MDMA from S9 (prohibited substances) to S8 (highly controlled substances).


In particular, I’ve been asked whether this means these substances are safe and effective, and how they might be made available to patients with mental illness.


This is a big deal. Since the ‘60s hallucinogens have been branded as dangerous recreational drugs through abuse by researchers, governments, and individuals. Genuine research into the potential of these substances to impact mental illness ground to a due to their prohibition.


Slowly, some hallucinogens have returned to respectability as therapeutic agents worthy of serious research, and the results of this early research for a range of difficult to treat mental health conditions is impressive.


The European Medicines Authority made a similar decision to allow authorised access to psilocybin and MDMA in 2016 following a Lancet publication on the use of Psilocybin in combination with psychotherapy for treatment-resistant depression.

Although only 12 patients were in this study the response was extraordinary; two thirds were depression free and the others experienced significant improvement in their symptoms. There were no significant adverse effects.


Many experienced a return of depressive symptoms within months but follow-up qualitative research also reported that the treatment had given them lasting hope for their futures. For an illness with an estimated mortality rate of 16/1000 in the 18-29yo cohort this is a massive step forward.


Trials of MDMA in conjunction with psychotherapy in treatment-resistant PTSD were equally compelling. It is important to note that these trials are relatively small, and there’s a great deal to unpack about who benefits and who doesn’t, and who might face an increased risk of harm as all research has been in neurotypical patients to date.


It’s also crucial to note these drugs have been given in the context of psychotherapy from qualified professionals with expertise in treatment of PTSD and major depression.


So what’s behind these results? What’s happening in people’s brains? These findings have opened a whole new area of research into the neuroscience of depression, PTSD, OCD, addiction, and existential distress associated with severe or terminal illness.


fMRI studies have shown that the degree of brain connectivity that occurs with PSI or MDMA treatment is enhanced markedly. Conversely, in both major depression and some forms of PTSD there can be marked reduction of activity in areas outside of the “Default Mode Network”.


Dutch researcher, Dr. Mendel Kaelen, uses a great metaphor to explain this theory. If the brain is described as a snow-covered hill, and thoughts as sled tracks down that hill, then it makes sense that the more a thought is repeated the deeper the rut will be and the more likely everything will “default” to this pathway over time.


This network of trails becomes the “Default Mode Network” of thought patterns for an individual, a large part of our concept of self identity and ego. If many of the thoughts are of trauma or negative self talk, then this may form the basis for PTSD and major depression.


PSI and MDMA may act like fresh snowfall, obliterating these tracks temporarily, and facilitating the generation of new and more healthier thought patterns with the guidance of a therapist.


The Australian law changes will come into effect on 1/7/23, and before PSI and MDMA therapy can be legally available to patients with treatment-resistant PTSD or depression psychiatrists will also need to seek approval to become an authorised prescriber and obtain a specific drug importation licence.


Production pathways will need to be generated to ensure safe and regulated supply outside of the illegal drug trade. Most importantly of all, we need to ensure the safety of patients undergoing these treatments.


Sadly, abuse of trust by some health practitioners is a reality we need to actively safeguard against in planning treatment protocols where patient autonomy is expected to be impaired temporarily. This will all take some time.


As a community we need to steward the use of these therapies wisely – continue research on a larger scale, ensure the safety of patients in therapy, work towards equitable treatment access routes, and be appropriately cautious about what we don’t yet know about these substances.


I’d like to acknowledge Michael Pollan’s excellent book, How to Change Your Mind, as well as Besel van der Kolk’s work The Body Keeps the Score – I highly recommend both if you’d like to learn more about the neuroscience of PTSD or emerging research into hallucinogens in severe mental illness.


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