A few weeks ago (March 14th), I described the outlandish process that led to the approval of the “dissociative anaesthetic” agent, esketamine as a nasal spray, for “treatment-resistant depression.” Since then, we’ve had the ADHD bandwagon, pushed by no less than a senator, arriving in town for what threatens to be a long stay. This week the Royal Australia and New Zealand College of Psychiatrists (RANZCP) hosted an hour-long Zoom meeting for 500 psychiatrists on the absolute latest of treatments for the untreatable; psychotomimetic drugs [psychedelics and hallucinogenics].
After intense lobbying by a registered charity called Mind Medicine Australia, and despite the RANZCP’s initial opposition, earlier this year the TGA approved the use of MDMA and psilocybin for use in PTSD and “treatment-resistant depression” respectively, when all else has failed. MDMA, an amphetamine derivative and party drug commonly known as ecstasy, is said to increase the sense of empathy, social acceptance and social connectedness. Psilocybin, the psychoactive chemical in “magic mushrooms,” is said to reduce anxiety and depression for some months after ingestion.
Starting in July, approved psychiatrists will be able to prescribe these drugs to be used in conjunction with psychotherapy. This is completely new: both chemicals were listed as Schedule 9, meaning prohibited except for approved clinical trials. They have now been rescheduled as S8, “controlled substances,” which can only be prescribed by psychiatrists. This was something of a surprise. On November 9th, 2021, a report commissioned by the TGA stated:
We conclude that MDMA and psilocybin may show promise in highly selected populations but only where these medicines are administered in closely clinically supervised settings and with intensive professional support.
The college was caught unawares by the decision and as July 1st is approaching rapidly has had to scramble to get ready. On April 27th, a national Zoom meeting, chaired by the college CEO and watched by over 500 psychiatrists, heard the president of the college and a professor who has been active in promoting the drugs discuss the state of play. I’m not aware that there has been such a roll-out of the big guns in the past fifty years.
After an introduction, the CEO talked about what the college planned to do to assist this “ground-breaking” move, mainly setting up a “hub” to act as a collection and distribution centre for information. Prof. Richard Harvey spoke at some length on the technicalities involved in being authorised to prescribe these drugs while the college president, A/Prof Vinay Lakra, was more concerned with training psychiatrists for their role in what is called “psychedelic assisted psychotherapy” (PAT).
Prof. Harvey emphasised that the psychotherapy component is the main form of treatment while the drugs are “tools” in that process, although there is “a little bit of lack of clarity over exactly what the TGA has said.” He continued:
The questions that remain very, very unclear, and there are a lot of very unclear questions in all of this, is whether the benefit derived from PAT versus psychological support during the course of treatment, just remains a little unclear as to where the benefits are coming from within this treatment process (at 9.30 in the video).
That is, there is no understanding of whether the drugs do anything or their effect is a non-specific placebo effect due to the extra support and close interest, along the lines of insulin treatment in the 1950s (see my comments on Harold Bourne, Substack, March 28th). Treatment would occur not in an ordinary ward (9.54) but in “a very carefully-put-together environment” using drugs sourced from approved manufacturers (of which there are none in Australia). Noting that the college did not support their rescheduling in March 2020 and again in May 2023, he said:
These are really experimental substances that need to be evaluated in a clinical trial process … lobbying of the TGA has resulted in them making a decision that wasn’t in line with recommendations we made … like it or not, that puts the onus on the college to provide support (14.05).
However, the PAT Steering Committee has assembled an “amazingly experienced group of psychiatrists, in PTSD, treatment resistant depression, psychotherapy and PAT.” They would be working on revising the RANZCP clinical memorandum that recommended against the drugs on the basis they were experimental, Prof. Harvey warned:
All psychiatrists know we have been victims of fads and fallacies in the past and we have gone down the pathway of pursuing treatment that appeared to be potentially beneficial but actually turned out to be significantly harmful, so we are being very careful in this, we really want to emphasize the importance of research continuing and building a research base … to establish from truly evidence-based perspective whether these are treatments that should be more widely used or not. We are very keen to avoid unintended consequences…” (22.50).
He raised the question of a national clinical registry to include data on all treated cases:
We hope we can encourage somebody to fund a registry to allow high quality data to be collected … the potential cost of these treatments is potentially extraordinary and how it’s going to be funded is very unclear … access to treatment would be very limited outside the major metropolitan areas… it is very, very staff intensive (which will) amplify existing workplace shortages … access to the funding for conventional psychotherapy is currently quite insufficient … this potentially gives an additional platform to leverage our advocacy activities (23.35 – 26.45) (in the context, that meant get more money).
Answering questions from 28.00 mins, the president was asked what specific training was required and was the college involved in approving training? Although he answered at length, the short answers were “Don’t know” and “No.” Asked about trainees in psychiatry being taught the various skills involved, he replied: “There are quite a few unknowns and in time we will have better answers to these issues” (30.30). The college “information hub” will collect and collate information over time “… as the treatment space evolves.” The next question, on treatment and dosages, was directed to Prof. Harvey, who said:
To be frank, providing specific guidance is really challenging in a rapidly emerging field where there is limited evidence and clarity on protocols, right dose, duration of treatment, the right form of psychotherapy. These are questions that the research has to answer (32.25) … There is a lot of unanswered questions here and a lot of opportunity for research … We expect that psychiatrists will have practical experience in a clinical trial setting (33.50) … The biggest unknown is the extent to which PAT is dependent on the type of psychotherapy … that’s going to be the tricky bit, going to be very difficult to issue very clear guidance about these things until we have more research evidence (35.20).
The president was then asked who could provide the psychotherapy component. In a rambling and unfocused answer he indicated that the standard of skills involved was that of a clinical psychologist although there would be psychiatrists, non-clinical psychologists with 20yrs experience and even GPs who could provide “a certain amount of experience and skills.” At 40.25, he added: “There are some unknowns to it, we all need to live with a degree of uncertainty, if we can live with Covid, we should be able to manage uncertainty now…” Prof. Harvey, however, wanted all treatment to meet the standards of clinical drug trials to settle the question.
… as to whether this (PAT) is something that should be encouraged and validated or not … to ensure that people understand the magnitude of what they’re planning to get involved in … This is similar to a phase four clinical trial … you have a moral and clinical obligation to be collecting data and contributing … to a greater understanding of these treatments and whether they have merit or not (46.00).
At 47.30, Prof. Harvey noted that clinical trials on psylocibin excluded patients with even a family history of psychosis, mania, and those with records of violence or suicide attempts:
Many of the things we see commonly in people with PTSD are actually exclusion criteria … but whether this changes the outcomes for good or bad is unclear …
Psylocibin has only been tested on patients who have been taken off all psychotropic drugs. Both speakers agreed the college would not be providing specific training in this matter and it would be premature at this stage to set up an accreditation process as “The field isn’t established enough for anyone to know what an accreditation process should look like” (RH, at 53.00). In closing the president said “We are the only specialty that doesn’t run clinical registers … this might be an opportunity to establish a clinical registry because if we want to learn how this treatment works … then systematically collecting data is very important.”
In conclusion, the CEO said: “Being data-informed and evidence-based is exactly where the college positions itself … in terms of our vision of excellence and equity in going into new environments … the eyes are on Australia making this change ahead of other countries.” She is not a psychiatrist.
I have to say that sitting through this twice has been singularly unpleasant. My opinion is that there is no scientific basis whatsoever to this business. After decades of yelling from every rooftop in town that mental disorder is a “genetically-determined chemical imbalance of the brain,” psychiatrists have just done a 180 degree turn at full speed and announced that, yes, we’re right up to the minute in providing psychotherapy for major mental disorders. In case of any doubt on that point, in an article in 1976 entitled “It’s not all in your head,” the highly-influential American neuroscientist, Seymour S Kety, said: “There are now substantial indications that serious mental disorders derive from chemical, rather than psychological, imbalances.” Looks as though we’re racing ahead to 1975, while trying to work out on the run whether we should be doing it or not.
The psychiatric profession does not have a theory of mind or a model of mental disorder that tells them that this form of “treatment” is the proper way to go. As an institution, psychiatry has insufficient skills to practice intensive psychotherapy with seriously disturbed patients, although the most disturbed, and therefore the most in need will be excluded. Moreover, stopping all psychotropic drugs before the “treatment” is a potentially dangerous move as very few psychiatrists have any skills in tapering drugs. It also means that patients who were being slowly poisoned by polypharmacy will start to get better, so their “recovery” will be attributed to this latest miracle of modern psychiatry rather than to the fact that their “illness” was entirely iatrogenic.
In the name of an “evidence-based, data-informed psychiatry working toward excellence and equity,” what they are doing is foisting on the country a very large, uncontrolled, essentially unplanned and hugely expensive experiment with no model of mental disorder and no agreed protocol; treating mental problems that, until last week, were classed as “organic”; using drugs whose mode of action is unknown; administered by people who may never have seen drug-induced psychosis and whose training in psychotherapy is, shall we say, superficial.
This unplanned and rushed introduction of yet another hugely expensive fad will serve only to enrich the private sector while starving the mainstream of funds. Sure, there’s great excitement but if you go back to when insulin coma treatment and ECT and psychosurgery and all the other destructive “fads and fallacies” were being introduced, you will find exactly the same levels of excitement and blinding ignorance as was on display during the RANZCP meeting. Yes, some patients will like it, but we won’t know why it worked, while some will feel better for a while but then relapse. Certainly, some will go completely mad, because that’s why they’re called psychotomimetic drugs, and I expect that not a few will die, but that’s more or less how it is today anyway. Plus ça change, plus c’est la même chose.
Similarly, imagine if the government said “We’re going to build a nuclear power station near your place but the questions that remain very, very unclear, and there are a lot of very unclear questions in all of this as to whether this is something that should be encouraged and validated or not … The potential cost is potentially extraordinary and how it’s going to be funded is very unclear … To be frank, providing specific guidance is really challenging in a rapidly emerging field where there is limited evidence and clarity on protocols … The biggest unknown is the extent to which it is dependent on the type of engineering … that’s going to be the tricky bit, going to be very difficult to issue very clear guidance about these things until we have more research evidence …” (and yes, I know, they’ve just issued exactly those answers in relation to Australia’s decision to spend half a trillion dollars on nuclear submarines that haven’t yet been designed, to be delivered over the next 40 years in order to blockade our major trading partner).
Finally, the fact that 500 psychiatrists found time in their busy day to listen to this says something: Would 500 psychiatrists stop work to listen to a presentation on the rights and wrongs of involuntary treatment? Or on the implications of the Convention on the Rights of People with Disabilities, which says that nobody should be locked up? Or on the implications of placebo research on their use of ECT? No way. There’s no money in it.
This is not science. I can let you in on a secret: this is actually the script for a Monty Python skit that was rejected because it was too scary.