In advancing psychedelic drugs for mental health treatment, Australia’s drug regulator ignored the advice of the researchers it had commissioned to investigate their use. That’s according to Steve Kisely, the head scientist tasked by Australia’s Therapeutic Goods Administration (TGA) with studying the drugs. Kisely’s report recommended against changing the status of the drugs, but the TGA did so anyway after receiving comments from the public criticizing its decision.
The Australian & New Zealand Journal of Psychiatry featured Kisely’s take on the situation.
“In the view of this author of the independent report to the TGA,” he writes, “the decision to down-schedule is ahead of the available scientific evidence especially as unresolved issues remain surrounding relapse, long-term safety and the challenges of conducting randomised controlled trials in this area.”
Kisely writes that MDMA and psilocybin had originally been Prohibited Substances (Schedule 9 drugs) in Australia—meaning that they had no known therapeutic use. However, as interest in using recreational, hallucinogenic drugs for psychiatric treatment has grown across the world, a powerful group known as Mind Medicine Australia lobbied for them to be reclassified to Schedule 8 drugs (drugs with known therapeutic use).
In 2020, after consulting with its expert committee, the Advisory Committee on Medicines Scheduling (ACMS), the TGA decided to keep the drugs as Schedule 9. This was consistent with the advice they received from the experts. However, public pressure led to them reconsidering the decision, and to them commissioning a report from independent experts, led by Kisely at the University of Queensland.
In their report, Kisely, Mark Connor, and Andrew Somogyi concluded that the evidence base for the drugs was of low quality, they did not beat current antidepressants for efficacy, and they may be associated with increased suicide risk. Kisely notes that expectancy effects could account for the benefits found in existing studies, particularly because the blind is typically broken in trials of psychedelic therapies. (Indeed, a recent study found that 94% of the people who received MDMA knew they received the drug, not the placebo, in a supposedly blinded study.)
Kisely’s report concluded that the drugs may show promise, but that reclassifying them at this time would be premature. The TGA initially accepted this outcome, but then suddenly reversed course and down-scheduled the drugs, as Mind Medicine Australia had asked.
According to Kisely, “this was a ‘delegate-only’ decision made without reference to the TGA’s own committee of experts, the ACMS, but influenced by approximately 3500 submissions, which on inspection seem to be largely individual opinion rather than expert advice.”
That is, the TGA changed the classification of psychedelic drugs not because it received scientific evidence that the drugs were safe and effective therapeutic agents—since the scientific experts actually recommended against it—but because of public pressure.
Kisely argues that regulatory bodies should start making decisions about whether to approve drugs based on scientific evidence, rather than public opinion.
Over the past few years, media hype has portrayed therapies using once-stigmatized hallucinogenic drugs as miracle cures for psychiatric problems, despite the lack of good research and the failure of clinical trials. Researchers have warned that these treatments pose a “significant risk to the public.”
In JAMA Psychiatry this year, researchers argued that more attention needs to be paid to the potential harms of psychedelic-assisted therapy. The risks include increased suicidality, “paradoxical” reactions to the drugs, and abuse by therapists.
Kisely, S. (2023). The down-scheduling of MDMA and psilocybin(e): Too fast and too soon. Australian & New Zealand Journal of Psychiatry, 57(7). https://doi.org/10.1177/00048674231174171 (Full Text)