Australia's first psychedelic therapy clinic opened this week, charging patients $24,000 for nine months of treatment.
But even the Melbourne clinic admits there are still many unknowns about the approach.
Since July, psychiatrists have been authorized to prescribe MDMA, commonly known as ecstasy, to treat post-traumatic stress disorder and psilocybin, found in magic mushrooms, to treat treatment-resistant depression. .
Australia became the first country in the world to legalize the medical use of psychedelic substances in February 2023, contrary to the previously stated position of the Therapeutic Goods Administration (TGA). In a commentary published in the Australian and New Zealand Journal of Psychiatry, some neuropsychologists and neuroscientists raised concerns that the decision was influenced by lobbying groups rather than health experts or evidence. He said he is doing so.
However, the decision allows Clarion Clinic to open its first dedicated facility to prescribe the drug, headed by Professor Suresh Sundram, a psychiatrist and head of Monash University's psychiatry department.
Sundrum said Clarion received more than 250 expressions of interest from patients in the first week. However, he acknowledged that while there is some clinical trial evidence to support TGA's decision, there are still gaps in medical understanding of the treatment.
“That said, there is still much we need to learn and understand about these drugs and how they work, what patients are suitable for them, and what conditions are suitable for this type of treatment. That is no exaggeration,” he said.
“We're taking a very cautious approach to this because of the lack of data mentioned earlier about who is eligible… There's still a lot we don't know.”
What is psychedelic therapy?
To receive treatment at Clarion Clinic, patients must meet a clinical diagnosis of post-traumatic stress disorder or treatment-resistant depression and have previously tried approved treatments without success. is necessary.
Patients complete an online medical screening and, if on medication, may need to be weaned from the medication before being prescribed either MDMA or psilocybin.
They then meet with Sundram and undergo a psychiatric and physical evaluation. If you are deemed eligible for treatment, you will be enrolled in the program.
The treatment begins with a preparatory session in which patients are asked about their thoughts about their disease and its treatment possibilities. I will explain the process of taking the medicine.
A dosing session will then take place. Patients arrive early in the morning, take their medication after induction, and spend a trial period (several hours, depending on the person and her two types of medication) with two therapists.
Once the medication wears off, the patient has a debriefing session with the therapist. They come back the next day for an integration session to further discuss the previous day's experiences and therapeutic insights.
Patients typically complete one psychotherapy session weekly for four weeks before the second dose.
“Everyone focuses on the dosing session, but in reality the dosing session is only two days long…Then the rest of the time over the first six months and then a total of nine months is devoted to psychotherapy,” Sundram he said.
“Drugs exist only to aid and facilitate treatment, and are not treatments themselves. They allow patients to reflect on and experience memories, problems, and issues that were not traditionally possible. It's a mechanism.”
unknown
Dr Richard Harvey, chair of the Royal Australian and New Zealand College of Psychiatrists' Steering Group on Psychedelic-Assisted Therapy, said the TGA's surprise announcement will create guidelines for psychiatrists to safely prescribe and deliver therapy. He said there were only five months left. What remains “fairly unknown and undefined territory”?
Mr Harvey said the evidence had not changed since the steering group conducted a systematic review of psychedelic treatments for TGA.
Harvey said the study found that more research is needed before the drug can be safely recommended.
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“Evidence of MDMA [in treating] PTSD has slightly better evidence than psilocybin for treatment-resistant depression. [amount of evidence to support it]” Harvey said.
Professor Susan Rossell, a cognitive neuropsychologist at Swinburne Mental Health Center, is the principal investigator of Australia's largest research trial into the effectiveness of psilocybin for treatment-resistant depression.
“What I'm really concerned about is psilocybin,” she said.
“The fact is that there is not enough evidence for psilocybin-based psychotherapy. It is growing and promising, but it is not as clear as it used to be. [evidence supporting] It's MDMA. ”
Rossell said that in thousands of cases around the world who received psilocybin-assisted psychotherapy for major depressive disorder, some people improved, others did not, and that psychedelic treatment was a last resort. He said they could experience anxiety about what to do next. About 10 to 20 percent of patients experience a “bad trip,” she says.
“It can actually cause post-traumatic stress disorder that wasn't there to begin with. This is one of the reasons I said about the safety of testing people. [is paramount] – We are really careful to keep vulnerable people out. ”
Psilocybin is not considered suitable for people with extensive trauma histories, she says.
Dr. Adam Bayes, a psychiatrist and psychedelic researcher at the Black Dog Institute, said the TGA's decision “provides an even stronger basis for further research and understanding of these drugs.” .
Bayes said the data is needed to answer “many unanswered questions” such as which patients are most likely to respond to treatment. Whether treatments can be combined. and the length of the effect.
Professor Bayes said the question of whether patients could take psilocybin while continuing their medication was important because trials would require patients to stop all medication, which is not possible for many people with severe depression. said.
It is hoped that patients treated with Clarion will be able to help answer some of these questions. Sundrum said patients entering the country will be asked to consent to the collection of assessment data, with the results potentially being published in scientific journals.
$24,000 price tag
Clarion Clinics says on its website that a complete treatment package can cost up to $24,000, but that amount may be reduced through Medicare.
The psychotherapy component accounts for about 85 percent of the cost, Sundrum said.
There is no subsidy by Medicare or the Pharmaceutical Benefits Scheme, but the clinic says that depending on individual circumstances, a quarter of the costs may be reimbursed through existing items such as psychiatric assessments and psychotherapy sessions. I am estimating.
Rossell said the high cost “suggests that…the lobbying groups were not seriously thinking about this” when they urged the TGA to approve the treatment.
““The drug benefit system will never schedule psychedelic-assisted psychotherapy until appropriate research is published,” she said.
Rossell said in the investigation that there are health economists who are tracking patients to tell PBS how much the trial has saved. “That's the kind of research we need to make it cheaper for people to live.”
Harvey said only a “relatively small number” of people have access to the current treatments provided by Clarion.
“But there are many other treatments that people can consider, and they should have considered before arriving at this option,” he says.
“It's not a first-line treatment for people with PTSD or treatment-resistant depression. People don't get the message, 'You've been diagnosed with PTSD – your treatment will cost $25,000.' It should not be ignored.”
