Decision to make the previously illicit drugs available is dogged by suggestions the decision was rushed.
Psilocybin, the active ingredient in hallucinogenic mushrooms, has been cleared for regulated use in therapeutic settings in Australia.In a controversial move, Australia will become the world’s first country to allow the drugs psilocybin and MDMA to be prescribed by doctors to treat psychiatric conditions including depression and post-traumatic stress disorder. But many scientists are concerned that research has not yet conclusively shown that these drugs are safe or effective.
The TGA approval follows an application in March 2022 by Mind Medicine Australia, a non-profit group in Melbourne that advocates psychedelic therapy, for MDMA and psilocybin to be made available in therapeutic settings. In December 2021, the TGA had denied a 2020 application by the organization after a long consultation process involving an independent expert panel.
Rossell and her colleagues co-authored a report in May questioning why the TGA didn’t consult them, given their rare experience in Australia of administering psilocybin to treat depression. “Instead, it seems the TGA has yielded to pressure from the public and lobby groups to increase access to these experimental treatments, outside of clinical trials,” they wrote. “Sufficient levels of evidence have not yet been generated for broad-scale implementation to be justified.
“These are still investigational products,” says Tiffany Farchione, director of psychiatry at the FDA.Psychiatrists will prescribe the drugs using the TGA’s Authorised Prescriber Scheme, which allows registered psychiatrists to prescribe medicines that have yet to be formally included on Australia’s register of therapeutic goods.
Richard Harvey, who chairs the RANZCP’s Psychedelic-Assisted Therapy Steering Group has confidence in the protocols that the group has developed. And he says that Australian state and territory governments are likely to regulate licences for premises that offer psychedelic therapies or require permits for each patient.Harvey predicts that the roll-out of the therapy in Australia will be slow, given the cost and the complexity of delivering one-to-one psychedelic therapy.
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