Months after Australia found itself at the global forefront of work to treat mental illness using psychedelic substances found in illicit drugs like ecstasy and magic mushrooms, those working in the field say confusion is rife.
A surprise decision by the country's drug regulator to approve the use of the substances, which caught even those working in the field unawares, came into effect on July 1.
Months after Australia found itself at the global forefront of work to treat mental illness using psychedelic substances found in illicit drugs like ecstasy and magic mushrooms, those working in the field say confusion is rife.
A surprise decision by the country's drug regulator to approve the use of the substances, which caught even those working in the field unawares, came into effect on July 1.
Since then, public interest in the use of MDMA and psilocybin to treat conditions like PTSD and treatment-resistant depression has grown while mental health practitioners try to navigate the unexpected change — with some flagging "serious reservations".
As issues around how treatment should be administered, who should be able to access the tightly-controlled substances and how much treatment should cost remain unclear, a body of medical and health practitioners has called for an urgent industry meeting to help iron out the problems.
Some say 'premature' decision has led to 'virtually unworkable' system
Anthony Bloch chairs the Australian Multidisciplinary Association for Psychedelic Practitioners (AMAPP), a 160-member organisation formed in the wake of the decision by the Therapeutic Goods Administration (TGA).
He said the group understood the TGA decision was "both unexpected and perhaps premature" given "the lack of adequate research up until now into psychedelic medicines".
But Dr Bloch said in light of the decision having been made, the group is calling for an urgent meeting to be held with the TGA, the Royal Australian and New Zealand College of Psychiatrists (RANZCP) and state health departments to help improve how things are working.
"The current regulatory system is virtually unworkable, overly cautious and cumbersome and needs to evolve with the help and input from those practitioners who have appropriate knowledge and experience working in the psychedelic field," he said.
The TGA said it was "always open to meet with stakeholders in order to help overcome points of confusion that may exist" and had met with stakeholders regarding the use of psilocybin and MDMA.
"The TGA welcomes an expression of interest to meet with any organisation should they wish to seek further discussion on these issues," they said.
RANZCP president Elizabeth Moore said guidance developed by the body regarding psychedelic-assisted therapy involved consultation with experts, "with patient safety as the primary concern and number one priority".
"Use of psychedelic-assisted therapy may carry its own unique risks that necessitate careful clinical judgement."
Dr Moore said the RANZCP was committed to safe practice and would meet with stakeholders as appropriate.
There is confusion about how treatment gets administered
For people who manage to access the treatment, the process is not a simple case of being handed a script.
Psychedelic-assisted treatment requires intensive preparation and supervision and trusting relationships with the mental health practitioners involved.
Experts say about 20 hours is the minimum requirement for a course of treatment.
Under the changes, only authorised prescribers — psychiatrists approved by the TGA — are able to access and administer MDMA and psilocybin.
Dr Bloch said he understood that less than 10 psychiatrists across Australia had been authorised as prescribers.
"While we understand the caution, limiting prescribers to that level of involvement in psychedelics does not add to safety, in our opinion," he said.
"All it does is completely restrict access."
He also said the level of involvement expected from the authorised prescribers was out of sync with the way mental health treatment worked on the ground.
According to the TGA, the authorised prescribers "must be directly involved in the immediate care of every patient undergoing treatment". That includes patient screening and consent, accessing the drugs for treatment and assessing the treatment.
Dr Bloch said the role supporting mental health practitioners could play in treatment was unclear, as were the settings for psychedelic-assisted therapy.
"Some state governments are now saying the clinics have to be inpatient facilities, while other state governments are saying they can just be day clinics," he said.
The research behind MDMA and psilocybin differs
Psychiatrist Nigel Strauss, who has been involved in psychedelic therapy for more than a decade, said the body of research behind the use of MDMA to treat PTSD is quite well established compared with the use of psilocybin to treat depression.
And he said the drugs worked differently.
"Psilocybin is a true psychedelic and I think there's a need for more research on who is suitable for this treatment, to discover outcomes and so forth," Dr Strauss said.
"Even though the TGA have announced that we can use it in treatment-resistant depression, I think there is some concern that there's still more to be learned about how we select people for this treatment, and how the treatment is carried out."
A Swinburne University study involving about 160 participants trialling the use of psilocybin for depression is about to begin.
Dr Strauss said such studies — the approval of which is separate to the TGA decision — were crucial to informing the use of the drug in one-on-one therapeutic settings.
"The results of that will tell us a lot about the effectiveness of the drug, but also to help to train a number of therapists," he said.
Public interest has geared up
Since the TGA's decision, public interest in psychedelic-assisted therapy (PAT) treatments has spiked.
One of the few psychiatrists authorised to prescribe the drugs, who wanted to remain anonymous, said they had a waiting list of 400 people interested in accessing the treatment.
"They won't all be eligible or ideal candidates — however, they are people who have tried every available mental health treatment and are interested in psychedelic-assisted therapy," they wrote.
Another practitioner said they received about 10 enquiries a week, with that figure jumping to about 30 "immediately after any news/Netflix special, etc".
Amid the increased interest is also a lack of understanding about the strict criteria that means many will not be eligible.
One practitioner reported that their client had told them that when they saw a psychiatrist the next month for their ADHD "they were going to ask … for a script of psilocybin so they could start microdosing".
The cost is still prohibitive for individuals
Given the intensive nature of psychedelic-assisted therapy, and the lack of subsidies in place for access to the drugs, the cost can run into thousands of dollars, making it too expensive for most people to access.
Dr Strauss said as well as the long-term goal of attracting a "meaningful" Medicare rebate, there were opportunities for other funding sources to help individuals access care as the use of the drugs becomes more established.
"Ideally, we want to see the Department of Veterans' Affairs, other first responder organisations starting to fund their members' PTSD treatments," he said
"We want to see private health insurers jumping in and realising that funding a person's treatment-resistant depression for a lifetime is more expensive than a psychedelic assisted therapy which may put them in remission for years, or longer, from a single treatment."
Further Reading
- Psychedelics: The New Panacea – Just Like Cannabis, it will Fix Everything, Won’t it?
- Psychedelics: The Hype, The Hope, The Harm? – Is the therapeutic potential of hallucinogens risky and overhyped?
- History repeating: A Roadmap to Address Common Problems in Psychedelic Science
- Problematic Psychedelics – Prescribing Harm? Researchers Warn of Major Threats to the Validity of Psychedelic Research
- We don’t want to run before we walk
