Problematic Psychedelics + ‘Vote for Therapy’ + TGA’s Clinical Bypass = ???

The recent decision by Australia’s Therapeutic Goods Administration (TGA) to allow psychiatrists to prescribe MDMA and psilocybin for certain mental health conditions has sparked both excitement and concern in the medical and research communities. While proponents hail it as a breakthrough for patients with treatment-resistant depression and PTSD, many experts warn that the move may be premature given significant limitations in the current evidence base for psychedelic therapies.

Methodological Concerns in Psychedelic Research

Several researchers have raised alarms about major methodological issues plaguing psychedelic studies that make conclusions about efficacy and safety uncertain. Michael van Elk and Eiko Fried of Leiden University outlined ten key problems that “threaten internal validity, external validity, construct validity, and statistical conclusion validity” of psychedelic research. These include:

Inability to properly blind participants and researchers
Lack of adequate control conditions
Small sample sizes
Selective reporting of positive results
Conflicts of interest among researchers
Overreliance on subjective outcome measures
Poor long-term follow-up

“These problems tend to co-occur in psychedelic studies, strongly limiting conclusions that can be drawn about the safety and efficacy of psychedelic therapy,” van Elk and Fried caution. They argue the field is at risk of “history repeating,” with inflated claims and premature adoption potentially leading to backlash as occurred in the 1960s.

Conflicts of Interest and Overhyped Claims

Other experts share similar concerns. Stuart Ritchie, a psychologist at King’s College London, notes the “over-exuberance” of some scientific advocates and conflicts of interest in the field, with many researchers being enthusiastic users of psychedelics themselves. “Reading the literature on psychedelics, you continually encounter concerns about the ‘over-exuberance’ of some scientific advocates of the drugs,” Ritchie writes.

He points out that even the most rigorous trials to date have been quite small and short-term. A widely publicised 2021 study in the New England Journal of Medicine comparing psilocybin to escitalopram for depression included just 59 participants. “We’re nowhere near reaching peak interest in psychedelics,” Ritchie observes. “With all the scientific research programmes, and all the companies vying with each other to create the bestselling psychedelic product, maybe there’s a chance some of the above uncertainties will be ironed out in the coming years.”

TGA’s Surprising Decision

Against this backdrop of limited evidence, the TGA’s decision to allow prescribing of psilocybin and MDMA has surprised many. The agency’s own advisory committee had recommended against rescheduling the drugs, citing “lack of established therapeutic value” and concerns about “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 Role of Lobbying

So what changed? The decision appears to have been heavily influenced by an intense lobbying campaign spearheaded by advocacy group Mind Medicine Australia, which rallied over 3,000 public submissions opposing the TGA’s initial decision to keep the drugs prohibited. However, the TGA delegate noted that few submissions came from psychiatrists or relevant medical organisations. Most were brief form letters that failed to address the scientific reservations expressed.

Concerns from the Medical Community

This has led some to question whether the TGA’s reversal was driven more by public pressure than by new evidence. Patrick McGorry, a prominent psychiatrist and CEO of youth mental health organisation Orygen, 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?”

Nigel Strauss, a psychiatrist conducting psychedelic research, echoed these concerns: “We’re doing the research here, but it’s early days still. 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.”

Parallels to Medical Cannabis

The situation draws parallels to the push for medical cannabis access in recent years. Critics argue that lobbying and public demand, rather than robust clinical evidence, drove policy changes that have outpaced scientific understanding. There are fears that a similar pattern may be unfolding with psychedelics.

Challenges and Questions Ahead

Importantly, allowing prescription access does not equate to proving therapeutic value or safety. As van Elk and Fried emphasise, much more rigorous research is needed to establish the true risks and benefits of psychedelic therapies. Large, well-controlled trials with long-term follow-up are essential.

In the meantime, the TGA’s decision raises challenging questions. How will psychiatrists navigate prescribing these powerful, mind-altering substances with such limited data to guide them? What safeguards will be in place to prevent misuse or adverse events? And does bypassing the usual clinical trial process set a concerning precedent for drug approval?

As the psychedelic renaissance gains momentum, maintaining scientific integrity and prioritising patient safety will be crucial. While these substances may hold promise, rushing to embrace them before the evidence is solid risks harming patients and undermining public trust. Careful, methodologically sound research – not hype or lobbying – should light the path forward.