Just weeks after Australia became the first country to approve the use of MDMA and psilocybin for treating mental health conditions, the decision has drawn sharp criticism from experts and stakeholders.
Published interviews and studies have cast doubt over the Therapeutic Goods Administration's (TGA) move to down-schedule these drugs for clinical use, amid claims there’s not enough evidence to support clinical use of psychedelic drugs.
A paper in Public Health Research & Practice revealed interviews conducted by Monash University that included a range of experts, from politicians to frontline researchers. All expressed concerns about the quality of existing evidence.
The paper highlighted methodological flaws like "poor blinding practices, small sample sizes, short durations, lack of comparison to existing treatments, and narrow populations not reflective of the general population."
Deputy director of the Neuromedicines Discovery Centre at Monash, Chris Langmead, underscored the need for more rigorous clinical trials.
"We still do need to do more clinical trials, bigger clinical trials, we need to do clinical trials that essentially monitor patients for longer to ensure that these medicines are safe and efficacious," Langmead stated.
Steve Kisely, a psychiatrist and public health physician, who co-authored an independent report for the TGA, said "the certainty of evidence was rated as low or very low" during the decision-making process. His paper criticised the TGA's decision as premature and ahead of the available scientific evidence.
Mind Medicine Australia's Peter Hunt countered that the decision was backed by data, with more than 13,000 submissions, 98% of which favoured rescheduling. Hunt claims the researchers have vested interests who stand to lose access to funding.
While the TGA acknowledged concerns over patient safety, it emphasised that the drugs could only be prescribed by specialised psychiatrists. The cost for a single course of psilocybin averages $25,000 and only three clinics in Australia are currently authorised to prescribe these medicines.
With multiple voices calling for a review of the TGA's decision, the debate underscores the complexities surrounding the emerging role of psychedelics in mental health treatment. Critics insist that robust, independent data collection and trials are crucial for justifying such a groundbreaking regulatory change.