Studies have shown that psychedelics could be a “game-changer” when it comes to mental health treatment — specifically in terms of treating depression and trauma. Regardless, the government’s medicines regulatory body has blocked a proposal that would loosen controls around the use of MDMA and psilocybin — the active component in ‘magic mushrooms’ — for psychological treatments.
Currently, MDMA and psilocybin are Schedule 9 drugs, meaning they are very difficult to access and getting hold of the proper credentials and documentation is virtually impossible. The proposal was seeking to change the classification of these drugs from Schedule 9 to Schedule 8, potentially allowing easier use of them for research and therapeutic aids.
Over the past few years, a mounting body of global research has continued to show that MDMA and hallucinogenic drugs like LSD and psilocybin have enormous potential for treating people with complex mental health issues like PTSD and treatment-resistant depression.
A 2016 US study found that a single dose of psilocybin in conjunction with a course of therapy could substantially reduce symptoms of depression and anxiety in 80% of chronic sufferers. These are conditions for which there is no cure but those same people reportedly permanently lower symptoms of depression and anxiety up to six months later.
The TGA explained its decision not to grant greater access to the drugs by citing concerns around lack of extensive clinical trials and potentially dangerous side effects.
“Psilocybin is an illicit drug with a high potential for misuse and an unknown safety
profile,” a spokesperson for the TGA wrote in an explanation of their decision.
“The medium and long-term effects of psilocybin-assisted psychotherapy are unknown, particularly in vulnerable populations, and the risk of developing psychosis may be high.”
MDMA was similarly described as having “a high potential for misuse in the Australian community, resulting in significant harms including seizures and deaths”.
Of the 575 responses considered for psilocybin, and 478 for MDMA, only 11 were fully against the rescheduling, though the TGA note that most were submissions from the public that failed to address relevant factors.
The TGA noted that the ruling does not affect access to either drug in clinical trial settings and indeed encouraged further work on them stating that “pending the outcome of current clinical research, the scheduling of psilocybin [and MDMA] could be reconsidered in future applications”.
The move comes as a blow to psychedelic therapeutic advocate group Mind Medicine Australia, who filed a formal proposal for the amendment of the current regulations. Mind Medicine now has less than four weeks to address the concerns of the TGA and re-mount their case for the rescheduling.
The Latch spoke with Peter Hunt, chairman and co-founder of Mind Medicine Australia, to find out more about the companies plans moving forward.
Examining the TGA’s decision, Hunt suggests there is an element of cultural bias at play with respected institutions not wanting to be seen to be in favour of stigmatised illicit substances. The TGA has relied heavily on the judgements of The Royal Australian and New Zealand College of Psychiatrists, which Hunt describes as “riddled with errors”.
“Rather than going underneath the statements to the clinical memorandum, and really analysing it, you’ve got a situation where people just take things at base.
“What we have to do, over the next four weeks, is pull this whole thing apart and go public with it.”
Hunt argues that the classification system is an illogical one to begin with. The Misuse of Drugs Act placed drugs like MDMA and psilocybin in the Schedule 9 category with no scientific evidence almost exactly 50 years ago. Organisations like his now have to prove that there is medical justification for the use of these chemicals while being stymied by restricted access to them.
While it might appear a setback for therapists looking to deliver these kinds of treatments and patients seeking access, Dr Stephen Bright, director of psychedelic research in science and medicine sees it as a scientific win.
“I think it’s great that Mind Medicine Australia has done this because the TGA has come back basically pointing out what needs to be done,” Bright explained.
“This presents an opportunity to identify what we need to do in Australia in terms of local research, in terms of international research, looking at the long term effects, demonstrating the safety of the drugs, developing clinical guidelines.”
Bright is not surprised by the TGA’s decision either. “The TGA is one of the world’s most conservative regulatory bodies,” he says. “There was no way that Australia was going to be the first country in the world to reschedule these drugs.”
While some clinical work has been done with small numbers of patients, larger tests still need to be conducted. There are currently studies underway in Australia and around the world but much of that work has been held up by COVID, particularly in the US. The TGA will likely need to see the results of those larger trials before it can be confident that these drugs do not represent a danger to the wider population.
Without trained therapists, clinical governance, or prescribing guidelines in place, “it would have been pretty risky,” Bright says. “Some of the risks here are very real and the TGA are risk-averse.”
Bright believes we are two to five years away from that stage in Australia. “Two years being very optimistic, five years, a little pessimistic,” he says.
For Hunt, the fight continues. He is driven by the need to get people the type of radical help they need when nothing else works.
“We have to keep going back and we have to keep educating,” he said. “There’s a whole bunch of people out there who are desperate and they need these therapies.”
“What they’re saying is that all those people who are suffering from treatment-resistant depression and treatment-resistant PTSD is that you can’t get access to these therapies, some of whom will actually take their lives.”
The decision made on Wednesday is only an interim decision giving the indication for which way the TGA are likely to move in. A final decision will be made on April 22 and anyone wishing to respond to the interim decision will have until March 5 to do so.