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Medical Health Aged Care, Mental Health

Monash experts: TGA approval of psychedelic medicines for certain patients will take effect on 1 July 2023 – is Australia ready?

Monash University 4 mins read
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From 1 July  2023, the TGA has approved the use of medicines containing MDMA and psilocybin to be prescribed by authorised psychiatrists for people with certain mental health conditions. Under the changes, MDMA can be prescribed to treat post-traumatic stress disorder, and psilocybin can be prescribed to treat depression that is resistant to other treatments. 

The following experts are available to comment on the topic:

  • Professor Chris Langmead, Deputy Director of the Neuromedicines Discovery Centre, Monash Institute of Pharmaceutical Sciences

  • Dr Brea Kunstler, Research Fellow at BehaviourWorks Australia, Monash Sustainable Development Institute

  • Dr Melissa Hatty, Research Fellow at BehaviourWorks Australia, Monash Sustainable Development Institute

  • Dr Paul Liknaitzky, Head of Monash University's Clinical Psychedelic Lab within the Department of Psychiatry in the School of Clinical Sciences.

Professor Langmead is available for interviews on this topic up until 28 June.
Contact: M: +61 (0)417 959083 / E: chris.langmead@monash.edu 

  • How ready is Australia for this change, and what measures are in place to ensure these medicines are administered safely and effectively?

  • Why did the TGA make this decision in the first place?

  • How accessible will this be for patients who need it? 

  • What are the longer term opportunities at play for Australia?

  • Who are the major players in this space and what are they doing?

The following quotes can be attributed to Professor Chris Langmead:

“The TGA’s decision took many by surprise and, understandably, there have been questions from some regarding the timing of the decision. However, whether the sector likes it or not, Australia is now at the forefront of research in this field globally, and we need to seize the opportunity.

“Despite the profound prevalence of difficult-to-treat mental illness throughout the community, very few advancements in new safe and effective treatments have emerged over the last 50 years - this simply isn’t good enough. My hope is that the TGA’s decision will pave the way for the development of new safe, effective and widely accessible medicines to significantly improve the lives of those living with mental illness.”

Dr Brea Kunstler, Research Fellow at BehaviourWorks Australia, Monash Sustainable Development Institute

Dr Kunstler is happy to be contacted for print media and pre-records. 
Ph: M: + 61 405 366 124 / E: brea.kunstler@monash.edu

Dr Kunstler led an interview study before the TGA’s announcement that included interviews with 13 politicians and representatives of key organisations (e.g. medical peak bodies). The aim of the study was to explore their attitudes towards the use of psychedelics to treat mental health conditions in medically controlled environments (i.e. using psychedelics in a clinical environment with psychotherapy).

Themes emerging from the interviews, including;

  • The perceived need for more research

  • The impact negative stigma has on political decision making in this context

  • Types of messaging and communications strategies that can support attitude change

The following quotes can be attributed to Dr Kunstler:

“There is a sense of cautious optimism from key organisations that are impacted by this change, such as organisations who represent health workers. There are positive research findings backing the effects and safety of these medicines, but so much is still unknown regarding how the medications will be used in Australia, who will have access to them and how they will access them. These unknowns, amongst others, prevent key organisations from completely supporting the use of psychedelics clinically. 

“The decades-long accumulation of negative stigma surrounding the use of drugs, including MDMA and psilocybin, makes it very difficult for legislators and other decision makers to break the shackles and easily support the prescription of medicines containing these substances.

“Key organisations and politicians affected by the TGA’s decision want more information about psychedelics. They want credible and trustworthy information created using high-quality research evidence that is delivered by people with lived experience of treatment-resistant mental health conditions, and trusted entities such as doctors and scientists.”

Dr Melissa Hatty,Research Fellow at BehaviourWorks Australia, Monash Sustainable Development Institute 

Dr Hatty is happy to be contacted for print media. Ph: 0438568435, melissa.hatty@monash.edu

Before the TGA’s announcement, Melissa co-led a survey of 1719 Australian adults exploring their attitudes towards the use of psychedelics to treat mental health conditions in medically controlled environments (i.e. using psychedelics in a clinical environment with psychotherapy). She is happy to comment on:

  • Survey methodology 

  • Survey results and implications

The following quotes can be attributed to Dr Hatty:

“We surveyed 1719 Australian adults just before the TGA approved some psychedelics for clinical use in Australia. Respondents were more supportive of the use of psychedelics in clinical settings to treat mental health conditions than psychedelics used recreationally. 43 per cent agreed that psychedelics should be used in supervised clinical settings to treat mental health conditions.

“We surveyed 1719 Australian adults just before the TGA approved some psychedelics for clinical use in Australia. 38 per cent agreed that psychedelics show promise in treating mental health conditions in supervised clinical settings, and 59 per cent also wanted to see more research.

“People that had experienced a mental health condition themselves were more supportive of using psychedelic drugs to treat mental health conditions than people who had not experienced a mental health condition.

“People tended to be more supportive of psychedelic drugs to treat severe depression than mild depression.” 

Dr Paul Liknaitzky, Head of Monash University's Clinical Psychedelic Lab within the Department of Psychiatry in the School of Clinical Sciences.

Dr Liknaitzky is on US Eastern Time.
Contact: E: paul.liknaitzky@monash.edu 

· Psychedelics research in Australia

· What the TGA decision means

· Pros and cons of the decision

· Where to from here

The following quotes can be attributed to Dr Liknaitzky (via The Conversation): 

“Since the announcement, I’ve spoken with numerous clinicians and researchers working in psychedelic trials in Australia, and all have expressed mixed reactions to the TGA news. There’s excitement: about drug policy progress; about potential access for more people in need; about the prospect of being able to offer patients more suitable and tailored treatment without the constraints imposed by clinical trials and rigid protocols.

“And then there are concerns: that evidence remains inadequate, and moving to clinical service is premature; that incompetent or poorly equipped clinicians could flood the space; that treatment will be unaffordable for most; that formal oversight of training, treatment, and patient outcomes will be minimal or ill-informed.

“Many professionals working at the coalface are concerned that soon-to-be prescribers, therapists, and decision-makers probably don’t know that they don’t know about some of the essential elements of safe and effective psychedelic therapy.”

For more Monash media stories visit our news & events site: monash.edu/news

For any other topics on which you may be seeking expert comment, contact the Monash University Media Unit on +61 3 9903 4840 or media@monash.edu 

 

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