Advocates have welcomed a surprise decision from Australia's drug regulator to approve two psychedelic drugs for mental health treatment, but some clinicians are concerned the decision may be premature.
Australia's Therapeutic Goods Administration (TGA) on Friday announced it had approved the prescribing of MDMA and psilocybin for the treatment mental health conditions.
Authorised psychiatrists will be able to prescribe the drugs as medicine, under strict conditions, from July 1.
MDMA, the active ingredient in party drugs such as ecstasy, will be able to be prescribed to some patients experiencing post-traumatic stress disorder (PTSD).
Psilocybin, a compound found in psychotropic "magic" mushrooms, will be listed as medicine for for treatment-resistant depression.
All other uses of psilocybin and MDMA will remain prohibited.
The decision comes off the back of years of lobbying from advocacy groups and clinical trials showing promise in the use of the drugs for treatment.
"I'm just very grateful to them … because there was no other solution for me," said Sydney woman Vanessa.
Vanessa's husband of 30 years, Franco, struggled with treatment-resistant depression before dying by suicide. About one-in-three people with depression are resistant to approved treatments.
"This enormous pain that he would talk about, that most of us who have never experienced mental [ill]-health in such a severe way would never comprehend," she said.
"The state of pain that they are in is just enormous.
"And I could see it in his eyes."
Vanessa presented her story to the TGA and Prime Minister Anthony Albanese, and said she now felt as though the decision "gives his life some meaning".
"I think the TGA can understand when somebody has tried everything that's available to them, to have the opportunity to try something different … I'm just very grateful," she said.
Her public appeals were part of her involvement with Mind Medicine Australia, which was involved in trying to find treatment for Franco.
The charity advocates for the use of psychedelics as treatment for mental health conditions and is responsible for the application to the TGA to reschedule MDMA and psilocybin. It has also faced some controversy, as a Four Corners investigation reported last year.
"For Australian to be the first country in the world to actually do this and actually lead in this field, it's very exciting because there's enormous opportunities," co-founder Tania de Jong said.
"There's enormous commercial opportunities and there's enormous opportunities to heal the millions of people who've been suffering, many people for decades."
Another group pushing to advance clinical trials and move towards the use of psychedelics in treating mental health is Psychedelic Research in Science and Medicine (PRISM).
Its chairman, Steve McDonald, developed PTSD after commanding infantry during the Somali civil war in 1993 and his subsequent job as a rescue helicopter pilot for five years in Queensland.
He was hospitalised due to his PTSD in 2003 and wasn't able to work for seven months. Years later, after becoming involved in PRISM, he said he tried MDMA "in an informal self-administered sense".
"And I found that it was very, very useful, more useful than any conventional treatment that I never had," he said.
Mr McDonald said the speed of the announcement came as somewhat of a surprise but "any movement towards making this medicine available for the mainstream is a good one".
But he said a number of issues needed resolving before the July 1 change, including how the treatments would be imported and the cost.
There are no TGA-approved medicines containing MDMA or psilocybin available in Australia. On Friday, the authority said the decision to allow treatment with unapproved therapies was made because for some patients, the benefits of being treated with these substances under a psychiatrist's supervision outweighed the risks.
Mr McDonald said training was another key issue, with only a "very small handful" of psychiatrists currently training as psychedelic therapists.
"We're trusting that the TGA will work with the industry and those who have the expertise to put all those pieces in place," he said.
'Serious reservations'
Suresh Sundram, head of Monash University's department of psychiatry, is involved in a number of studies looking at the use of psychedelics to treat mental health disorders.
A current study, investigating psilocybin's effects on generalised anxiety disorder, will be a world first.
Despite his interest in the field, the TGA's decision surprised him — he did not know why the authority changed its mind after earlier upholding a decision not to reschedule the drugs.
"It raises questions as to how the drugs are going to be used, it raises questions as to what the actual long-term outcomes associated with the use of these medicines are, it raises questions as to the conditions of how they're going to be prescribed," Professor Sundram said.
He said while current research showed "great potential" in the agents, more evidence was needed to inform safe prescription guidelines.
"It would be problematic if that was to be derailed in some way," he said.
He said his major concern was if the drugs were not administered appropriately, there would be backlash from the community.
University of New South Wales psychology professor Richard Bryant said he had "mixed feelings", but said the TGA giving attention to psychedelics was a good thing, based on early clinical results.
Studies looking at both MDMA and psilocybin have shown promising results in their use for treating mental health conditions.
"But I also have some serious reservations," Professor Bryant said.
"The science is basically telling us that psychedelics are worth investigating, but that they're definitely not ready for prime time."
Among his areas of study, Professor Bryant studies the assessment, cognitive processes and treatment of PTSD.
He said while clinical trials have shown promise, for example in the use of using MDMA to treat PTSD, "those trials have been rather weak in the way they've been designed".
He said the use of a placebo in the trials — "usually the gold standard in a drug trial" — was problematic, as MDMA had an immediate and powerful effect on patients.
"But what even worries me more is that none of the studies to date have actually investigated MDMA against the gold-standard treatments that we currently have," he said.
"We need to be testing something like MDMA against what we currently have. And until we really do that, I think it's a bit early to be saying we should be prescribing and treating PTSD with MDMA."
