While TGA boss Professor John Skerritt maintains that the regulator was not swayed by any outside influences, he said one lobbying group went “over the top”.
The TGA’s decision to flip its stance on down-scheduling psilocybin and MDMA for therapeutic use was made after an extensive campaign from controversial charity Mind Medicine Australia.
According to ABC’s Background Briefing, outgoing TGA head Professor John Skerritt had to counsel staff about the charity’s aggressive lobbying on several occasions.
“I actually had to on several occasions say to staff, ‘Look, I know that they’re driving you crazy, put their approaches and the way they work to one side, think about the medical criteria and the scientific criteria and the regulatory issues only,’” he told ABC.
“And I also counselled Mind Medicine at some stages that they were perhaps working against their own case by frankly, being so aggressive.
“I lost count of the number of emails they would have sent staff here.”
The Medical Republic has experienced the full pestering force of Mind Medicine Australia firsthand, with reporters and editors bombarded by emails and phone calls requesting coverage.
The TGA’s final ruling on psychedelics came on February 3 this year, and completely walked back its interim ruling on the matter from October 2022.
Professor Patrick McGorry AM and his colleague Associate Professor Gillender Bedi write today for TMR about the profession’s concerns about the sudden approval. These include the reasons for the reversal, the nature of psychotherapy that will or should be offered in conjunction with the drug, and the extremely tight criteria that patients who have so far benefited have met, which are unlikely to be replicated in the real world.
Professor Skerritt emphasised that Mind Medicine Australia’s lobbying, while persistent, did not influence the final ruling.
Under the decision, Australians will be able to access both psilocybin and MDMA by authorised psychiatrists for treatment-resistant depression and PTSD respectively, beginning 1 July.
It’s the first time that any drug regulator has okayed the use of these drugs outside of clinical trials.
It is interesting to compare the reasoning for the interim decision not to move the psychedelics to Schedule 8 to the list of materials considered in making the final decision.
The TGA’s delegate – an undisclosed person appointed by a Department of Health secretary – listed just four new considered materials in the February 2023 notice that did not appear in the October 2022 interim decision.
The first two are the 3500 public submissions on psilocybin and the 6500 public submissions on MDMA made after the October 2022 decision.
According to the ABC, these were largely corralled by Mind Medicine Australia and did not come from psychiatrists or relevant organisations.
The third addition was a new study in the New England Journal of Medicine, which found psilocybin at a single dose of 25mg reduced depression significantly over a three-week period in an 80-person cohort.
Most intriguing, though, is the fourth new piece of material considered by the TGA delegate – a presentation by British neuropsychopharmacologist Professor David Nutt in late 2022.
Professor Nutt was flown out to Australia by Mind Medicine Australia to give a series of talks sponsored by medicinal mushroom company SuperFeast and vegan chocolate brand Pana Organic.
While in the country, he also gave an exclusive presentation to 130 TGA staff. It’s understood that the delegate was among this audience.
According to a TGA staff member who spoke to the ABC, it was “unusual” for a presentation like that to happen.
It’s now up to state and territory governments to decide whether to give effect to the recommended controls – i.e. restricting the use to authorised psychiatrists only, etc. – in the Poisons Standard through their own legislation.
The substances themselves will be recognised as Schedule 8 in each state and territory come July by default.
