In Advancing Psychedelics, Australian Drug Regulator Ignored the Report of Its Own Researchers

Lead researcher Steve Kisely argues that regulatory bodies should decide whether to approve drugs based on scientific evidence, rather than public opinion.

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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.”

Panorama with close-up of girl's mouth with white pill on the tongue. Pill has text reading "HAPPY" on it.

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.

 

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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)

4 COMMENTS

  1. Psychiatry was always about putting the cart before the horse and promoting theories and hypothesis before evidence can be reviewed. After decades of using repurposed drugs and psychosurgery on helpless victims and getting poor long term outcomes- now comes the “promise of psychedelics” which will garner more research money and back to the 60’s new revolutionary breakthrough billable “treatments”- of course will poor long term outcomes.

    This is the business of “mental health” where the more done to the patient the worse they get and the more stuff can be done for the “treatment resistant” patients who are the remnants of all those decades of experimentation and treatments. Now the new era of psycho-stimulation medical implants and magic mushrooms.

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  2. It’s not publicly discussed, but amongst people who study the history of drug law reform in Australia, there’s an opinion that the TGA is sometimes more likely to be swayed by political pressure than scientific evidence. Make something enough of a problem for the sitting Federal Minister or Health, and the TGA will do something (often the bare minimum) that allows said minster to claim progress on the issue, while maintaining their “tough on drugs” posturing and conservative street-cred. (The ‘solution’ will also often be highly centralized and bureaucratic in a way that makes a lot of work for the TGA itself, but that’s a story for another day.)

    Some of us (myself included) think the Australian medicinal cannabis regime is another example of this, though this interpretation of these events is contested.

    All of this is complicated by the fact that, in my opinion, the TGA is a key part of the machinery of the war on drugs here, as their “independent” decisions on what goes on schedule 9 allows both federal and state governments to outsource responsibility when it suits them.

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  3. Something neglected to be mentioned in this blog, albeit this blog is not about the US, is that the mainstream medical doctors in the US are already handing psych drugs to people, without informed consent. Decades ago, I was inappropriately given a dangerous antidepressant, under the guise of a “safe smoking med.” No informed consent. And to this day, Wellbutrin is still NOT approved as a “safe smoking cessation med.”

    And just recently, a loved one wisely said no to a hospital doctor – not even a psychiatrist – who tried to give him … oh, I don’t remember what kind of drug it was … other than it isn’t one of the currently approved psych drug classes, but it was one of the illegal drug classes we were taught to say “no” to as a child.

    So in the US, the desperate psychiatric industry’s search for new “wonder drugs,” will result in these psychedelics being pushed on US citizens, by all doctors … and forced on people by the psychiatrists. IMHO, it’s a recipe for disaster for the American public.

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