Experts question timing of psychedelics approval

Filip Vukasin

9/02/2023 4:59:00 PM

Researchers say people may benefit from psilocybin and MDMA treatments, but worry the approval has been rushed.

Psilocybin in a laboratory.
To be able to prescribe psilocybin and MDMA, psychiatrists will need to be approved by the TGA.

From 1 July this year, psilocybin and methylenedioxy-methamphetamine (MDMA) will be available for prescription by specifically authorised psychiatrists.
The Therapeutic Goods Administration (TGA) will permit prescribing of MDMA for the treatment of post-traumatic stress disorder (PTSD) and psilocybin for treatment-resistant depression as these are the only conditions where there is currently sufficient evidence for potential benefits.
Dr Cathy Andronis, Chair of RACGP Specific Interests Psychological Medicine, told newsGP the opportunity for patients to access innovative treatments for chronic, intractable and severe mental health conditions like PTSD is welcome, but said the timing is ‘unexpected’.
She also says there are clear concerns and caveats related to the new treatment.
‘Psychedelic-assisted psychotherapy is still in its infancy,’ Dr Andronis said.
‘Many studies worldwide are showing promising results, [but] the clear evidence to date is that the psychedelics themselves are only a small part of the whole treatment and the potential for misuse or mistreatment is significant.
‘The risks of rushing this through are immense.’
To prescribe, psychiatrists will need to be approved under the Authorised Prescriber Scheme by the TGA following approval by a human research ethics committee.
The Authorised Prescriber Scheme allows prescribing permissions to be granted under strict controls that ensure the safety of patients, including being used in a controlled medical setting.
Dr Paul Liknaitzky, Head of Clinical Psychedelic Research at Monash University, has personal experience in delivering psychedelic-assisted therapy and while he has seen the benefits, he too has highlighted caution regarding safety and timing.
‘I lead one of only a few sites in Australia that is already delivering psychedelic-assisted therapies to clinical patients. We have witnessed up-close the potential of our treatment to change people’s lives for the better,’ he said.
‘Yet the safety and effectiveness of psychedelic therapies depends on a unique set of professional competencies and considerations that are in scarce supply within mental healthcare.
‘For clinical psychedelic services to be sensible, safe and useful, considerable professional and public education will be needed and questions of affordability, eligibility, oversight and standards of care should be addressed.
‘With this schedule change coming in a matter of months, Australia has very little time to get across this.’
The TGA says patients may be vulnerable during psychedelic-assisted psychotherapy and in order to institute controls, psilocybin and MDMA will be listed as Schedule 8 (Controlled Drugs) medicines in the Poisons Standard.
For all other uses they will remain in Schedule 9 (Prohibited Substances) which largely restricts their supply to clinical trials. Their decision comes after extensive public consultation, a report from an expert panel and advice received from the Advisory Committee on Medicines Scheduling.
Professor Susan Rossell, a cognitive neuropsychologist and Professorial Research Fellow at Swinburne’s Centre for Mental Health, is the lead researcher on Australia’s largest research trial examining psilocybin for treatment-resistant depression.
She believes more research is required.
‘I have a significant degree of caution about this decision because these treatments are not well established at all for a sufficient level of broad-scale implementation. Substantial further research needs to be done,’ she said.

‘First, to confirm efficacy to international standards for all psychotropic medications and to understand which conditions are best treated and which formulations will best serve the patients and minimise risks.
‘We’ve got no data on long-term outcomes at all, so that worries me a lot, which is one of the reasons why I’m doing my very large study.’

Dr Andronis is also worried about the potential for harms.
‘The research is still in its infancy and therefore inconclusive about the best way to use these drugs and on whom,’ she said.
‘Results so far from most studies pertain to very carefully selected patients with many exclusions – for instance a family or personal history of psychosis and other comorbidities – so unless treatments are closely monitored by experienced psychiatrists, there is the potential for great harm and misuse with uncertain risks.’
The other issue Dr Andronis sees is the cost of psychedelics and resulting inequality.
‘Psychedelic-assisted psychotherapy is expensive as it often requires sessions lasting many hours with close monitoring. Our public mental health system is mostly crisis-focused and struggling with the basics,’ she said.
‘There is potential for further inequity with the most disadvantaged and needy least able to access good evidence psychedelic therapy.’
Professor Ashley Bush, a Senior Principal Research Fellow at The Florey Institute, explains this further.
‘The cost of the treatment is not yet determined but is likely to be expensive,’ he said.
‘Like medicinal cannabis products, which are also available for prescription under the Special Access Scheme, psilocybin and MDMA are likely to be more expensive than conventional psychiatric drug prescriptions.’
He says unlike medicinal cannabis products, the therapeutic use of psilocybin and MDMA will involve being dosed in a medical setting with the psychiatrist and other support staff on hand for up to eight hours.
Based on a study that the TGA noted for its decision, the therapist-training program was extensive and treatment rooms were specifically designed to provide a nonclinical, calming atmosphere.
‘While this study is very encouraging, to deliver a system of treatment of similar intensiveness in Australia, as contemplated by the TGA, will be costly over the price of the psilocybin itself,’ Professor Bush said.
‘Psychedelics are not yet on the Australian Register of Therapeutic Goods [ARTG] or the Pharmaceutical Benefits Scheme [PBS], so they attract no cost support from federal funds.’
The momentum for therapeutic psychedelics has gained traction worldwide in recent years.
The Global Drug Survey in 2021 contained 110,000 participants and reported 6500 people using ‘underground self-treatment with LSD, MDMA and psilocybin’.
In a 2020 article from the UK, scientists wrote about a ‘psychedelic revolution in psychiatry’ and called for a revisiting of the drugs, while Switzerland has allowed physicians to prescribe since 2014.
Australia’s CSIRO also started work on psychedelics in 2022 to improve existing drugs and develop new ones.
Dr Andronis says GPs will play a role in the upcoming rollout of psychedelic therapy.
‘GPs need to embrace consumer-led activism and lobbying. Rather than putting our heads in the sand, we need to discuss the risks and potential benefits with our patients,’ she said.
‘The lobbying worldwide for psychedelics is almost on a par with that for liberalised cannabis availability so we need to keep abreast of changes in this space and proactively address potential problems with our patients who may erroneously believe that because it is legal, even in restricted clinical settings, it must also be safe.
‘This encourages unsafe access and misuse.’
The TGA has posted a question and answer page about their decision here.
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