Researchers, politicians and medicos didn’t believe there was enough evidence to back the drugs for therapy. The TGA went ahead anyway.
Conducted in the weeks before the TGA green-lit psychedelics for mental illness, a new study puts into perspective just how shocking the decision was.
In February, Australia became a world leader in psychedelic therapy overnight when the TGA made the decision to down-schedule psilocybin and MDMA for therapeutics use in treatment-resistant depression and post-traumatic stress disorder respectively.
It was not only unexpected, but a complete 180-degree turn from the TGA’s interim ruling on the matter just four months previous.
A new study from Monash University, published today in Public Health Research & Practice, sheds light on the attitudes and views of an array of stakeholders in those intervening four months.
Researchers conducted in-depth interviews with a small group of politicians, medical and psychological peak body representatives, healthcare providers and advocates, a union and a body representing consumers.
The overarching theme was that stakeholders felt there was insufficient evidence to support using psychedelics to treat mental illnesses.
“All organisational representatives expressed concern regarding the quality of existing evidence, noting that insufficient evidence limits trust and, subsequently, prevents organisations from supporting the clinical use of psychedelics,” the Monash researchers wrote.
Participants were only asked to reflect on their general views on the use of psychedelics for mental health conditions, rather than the impending TGA rescheduling decision.
Researchers also noted that insufficiency can be subjective, and that what some might consider to be an “immature” evidence base, others would consider promising and sufficient.
The politicians interviewed consistently emphasised that the “negative stigma” surrounding psychedelics was a barrier to lending public support to the cause.
“There is still a stigma that comes from the decades-long war on drugs … and it’s those misconceptions or preconceptions that cloud the ability of legislators and decision makers to make clear and informed decisions in respect of … using psychedelic drugs for the treatment of mental health conditions,” study co-author Professor Christopher Langmead told The Medical Republic.
Because there has been a general unwillingness to discuss psychedelics as a mental health therapy, he said, members of the public have been left unclear on what the actual changes mean.
“Some people don’t fully appreciate that we’re talking about using drugs like psilocybin or MDMA in clinically supervised environments as an adjunct to psychotherapy,” Professor Langmead said.
“We’re not talking about people being given psychedelic drugs to take at home.”
Speaking outside of his capacity as a researcher, Professor Langmead said he was personally supportive of the TGA’s decision and that it was now incumbent on Australia to ensure that high standards are enforced.
“I’m a medicines development person … my aim is to think, ‘what does a medicine for a patient with a challenging mental health condition look like in 10 or 15 years’ time?’” he said.
“We’re using medicines [for mental illness] that are essentially based on 50-year-old science right now.
“A GP wouldn’t like to be talking to a patient about [50-year-old science] in the context of heart disease or cancer or diabetes.”
While more empirical research is needed, the Public Health Research & Practice study concluded, there is an even more pressing need for review-level research to inform effective messaging and challenge biases in the post-TGA decision Australian environment.
Almost immediately after the decision was made public, concerns were raised over the potential influence of lobbying group and charity Mind Medicine Australia, given that two of the four new pieces of evidence cited by the TGA in February were attributable to the group.
The TGA’s undisclosed decision-maker listed the thousands of public submissions in favour of deregulation – the majority of which were corralled by Mind Medicine Australia – and a presentation by British neuropsychopharmacologist Professor David Nutt, who was flown to Australia by the charity for a series of lectures.
The TGA has denied that Mind Medicine Australia’s lobbying was responsible for the outcome.