First TGA gives non-clinically trialled or fully vetted cannabis ‘medicines’ a short cut, now they just give a pass to Psilocybine, because this drug users group demand it – Science and Evidence be Damned?
"Members agreed that there was little additional evidence presented in this application … As such, the main barrier to down-scheduling psilocybine was therefore still a lack of established therapeutic value.
"Members expressed several concerns, including the broadness of the indication included in the proposal (treatment-resistant mental illness), the lack of phase III trials, and the problems associated with the translation from a clinical trial setting to clinical practice.
"The Committee agreed that the risk of diversion is low in a controlled medical environment, but noted that, contrary to the assertions of the applicant, there are significant risks of diversion at other points in the supply chain. In addition, not dispensing from a pharmacy would bypass the real-time prescription monitoring system, hence limiting oversight and governance. "There remains no approved therapeutic product containing psilocybine anywhere in the world." TGA Board Minutes
The committee's advice for MDMA echoed these concerns. The committee also noted the Australian Medical Association's continued opposition to the down-scheduling. So, it was little surprise that the secret TGA decision-maker known as "the delegate" made the interim decision in October to keep the drugs prohibited.
For most drugs, that would be the end of the story — TGA insiders told Background Briefing it's uncommon for a final decision to diverge from the interim decision. But this time was different.
In the intervening months, Mind Medicine Australia doubled down on its campaign.
The group called for supporters to put in submissions opposing the TGA's interim decision, and more than 3,000 heeded the call. That's on top of the more than 13,000 public submissions the TGA had received before the interim decision.
The TGA delegate noted how few submissions came from actual psychiatrists or relevant organisations (submissions from the Royal Australian and New Zealand College of Psychiatrists and the Australian Psychological Society supported the interim decision not to down-schedule the drugs). The delegate said the submissions — largely corralled by MMA — were brief, and most failed to address any of the reservations expressed in its interim decision.
High-profile psychiatrist and Orygen CEO Patrick McGorry tweeted: "It is premature to allow psilocybin to be used beyond research trials. Can we be reassured that approval is not due to intense private lobbying/special pleading by a zealous private group?"
McGorry is conducting his own trial in the space, much like psychiatrist Nigel Strauss, who, despite long advocating for the potential of psychedelic therapy, felt the decision was premature.
"We're doing the research here, but it's early days still," said Professor Strauss. "And when you look around the world at all the research that's available, there hasn't been that much.
"I'm not really aware of what drove the TGA to make this change decision. All I can say, is that it's definitely not research because there hasn't been any great change … particularly in Australia.
Professor Strauss is concerned about how the decision was reached.
For complete story
Also see
- Cannabis as ‘Medicine?’: Pot Propaganda, Emotive Anecdote, Marketing Manipulation, and the Side Stepping of Science
- IS THE PSYCHEDELIC THERAPY BUBBLE ABOUT TO BURST?
Shane W. Varcoe