Young distressed Australians put at ultra-high-risk of stigma by $33M pre-psychosis drug research
Updated: Oct 15, 2020
by Dr Martin Whitely
Led by prominent psychiatrist and former Australian of the year Patrick McGorry, youth mental health research organisation Orygen has secured $33 million from the US National Institutes for Health to breathe new life into McGorry’s three decade long quest to develop a reliable and safe way of identifying young people who are at 'imminent and high' risk of becoming psychotic.
Orygen will recruit approximately a thousand young people they judge to be at high risk of psychosis and will undertake ‘a range of assessments – clinical interviews, neurocognitive and neurophysiological assessments, brain imaging and genetics’.  The hope is that this $33 million will enable Orygen and McGorry - who began work on first episode psychosis in 1984 - to develop better ‘prediction models’ to enable the achievement of ‘a holy grail in this area - more effective preventative treatments tailored to individual patients’.
McGorry’s and Orygen’s vision of early intervention to prevent psychosis sounds like something we should all rally behind. Certainly our trusted national broadcaster, the ABC, seems to think so. For the last decade it has uncritically promoted McGorry and his preventative psychiatry approach. However, the devil is in the detail. Detail you simply don’t hear on the ABC.
In reality, McGorry’s grand plan involves intervening earlier than early, by medicating mildly disturbed young people who have never been psychotic. The hope is that this may prevent (or at least delay) some of them from later experiencing first-episode psychosis – which he dangerously conflates with full-blown schizophrenia.
Orygen’s new project - Trajectories and Predictors in the Clinical High Risk for Psychosis population: Australian Network of Clinics and international Partners - is part of a bigger $82 million US-led Accelerating Medicines [Schizophrenia Research] Partnership that includes drug companies as partners. According to McGorry, the overall aim is to ‘provide a pathway to a more targeted drug discovery, because that is what we really need to get much better outcomes for these illnesses’.
As detailed in Time magazine way back in 2006 - in an excellent article called Drugs before Diagnosis - McGorry has long believed that the use of psychiatric drugs is central to preventing mental illness, particularly psychosis and schizophrenia. Time detailed McGorry’s ‘full steam ahead, damn the torpedos’ determination to continue to experiment with antipsychotics as a means of preventing psychosis in mildly disturbed young people despite contradictory evidence.
McGorry’s hyper-confidence comes from his unshakable belief that, prior to the onset of psychosis, depression and other serious mental illnesses, there is a ‘prodromal phase’, and that intervening then will help save many the misery of full blown mental illness.
The Ultra-High-Risk label – Science or Ultra-Hyped-Rhetoric?
McGorry’s ‘stitch in time’ theories sound appealing. Surely you would intervene if you could prevent mental illness? The problem is you can’t. Despite spending tens of millions of dollars experimenting with thousands of young people over three decades, models for identifying and treating those who are ‘pre-psychotic’ simply do not work.
Clinicians cannot predict who will go on to become psychotic. The vast majority of people who are identified as being at ‘ultra-high-risk’ (or clinical high risk) of developing psychosis never become psychotic. Even on the odd occasion when ‘pre-psychotic’ individuals are correctly identified, the preventive measures on offer don’t have sustained benefits.
The harm from unnecessary drugging driven by the high false positive rate is not the only danger of McGorry’s ‘ultra-high-risk’ diagnosis. It is a stigmatising, alarming and completely misleading label. Ultra-high-risk implies that it is very likely that the young person will transition from distress to disease. This is simply not true.
Independent evidence found a conversion rate for those considered at ‘ultra-high-risk’ to first episode psychosis of 8%.
Even headspace (established by McGorry) has acknowledged that 82% to 90% of the people identified as being at ultra-high-risk of developing psychosis do not become psychotic within a year.
However, headspace and McGorry argue that the use of the term is justified because even at these low rates of conversion, ‘UHR clients are still at significantly higher risk of psychosis than the general population’.
Yes, anxious, distressed teenagers and young adults have a higher risk of future psychosis than their happier peers. But with a 90%+ false positive rate, the real ultra-high-risk is the near certainty of being incorrectly labelled as being ‘pre-psychotic’- a term Professor McGorry has used interchangeably with ‘prodromal’ and ‘ultra-high-risk’.
Judge for yourself if the Ultra-High-Risk diagnostic process is Nonsense or Science by CLICKING HERE and watching an excerpt from an Orygen training video that shows clinicians to diagnose young people at ‘ultra-high-risk’ of psychosis.
Blurring the boundary between first episode psychosis and schizophrenia
While working as a mental health advocate, I supported a number of young adults desperate to lose the schizophrenic diagnosis they had been given as a result of a single psychotic episode resulting from drug use. Yes, they wanted help, but they didn’t want a lifelong ‘sticky label’, or an imposed daily drug habit that messes further with their muddled emotions and developing brains and bodies.
McGorry and the partners in the Accelerating Medicines [Schizophrenia Research] Partnership are likely to make this more common. They dangerously blur the boundaries between single episode psychosis and full blown schizophrenia. Teenage and early adult psychosis is very often an isolated event caused by substance abuse or trauma. So not only do the vast majority of ultra-high-risk patients never experience first episode psychosis; most who do have a single psychotic episode, (or a few episodes) do not have schizophrenia.
But McGorry and Orygen minimise all these concerns and grossly exaggerate the miniscule progress achieved in their thirty-six years working in the field.
In a recent radio interview with a senior ABC journalist, Fran Kelly, McGorry said: We’ve already developed good psycho-social treatments for this stage of illness which are quite effective, but we do need safer and more effective biological therapies. I have been measuring bio markers of various kinds including imaging and a whole range of blood bio markers as well which we know are actually associated with the onset of the illness too.
McGorry’s statement invited the following three obvious follow up questions, but Kelly failed to ask any of them:
Most of those identified by you and Orygen in your prior research as being at ultra-high-risk never become psychotic. Isn’t it misleading to describe them as being at a ‘stage of illness’?
If as you claim, Orygen has already developed ‘good, effective psycho-social treatments’ for the ultra-high-risk group, why do these young people need drug treatment when less invasive and potentially harmful treatments exist?
Despite decades of well-funded research, there are no diagnostic biomarkers for any mainstream psychiatric disorder, but you appear to be saying you have found biomarkers that are indicative of schizophrenia in people who have never been psychotic. How can this be?
I believe that McGorry’s claims were bullshit, but as happens far too often an ABC journalist failed to challenge them, so we didn’t get the required detail.
Instead the ABC acted like McGorry and Orygen’s advertorial channel. Hardly behaviour we should accept from our generally respected, publicly funded broadcaster.
McGorry’s crusading mindset is unsuited to science
Even if continuing the search for drugs that prevent psychosis in mostly well mildly distressed young people was a good idea (and it isn't) McGorry doesn't have the open mind needed to conduct experimental science. While few doubt his good intentions, his reaction to peer-reviewed research that I led - Antidepressant prescribing and suicide/self harm by young Australians: Regulatory warnings, contradictory advice, and long-term trends - demonstrates that McGorry can't deal with evidence that doesn't fit his crusading agenda.
Our research analysed the Australian response to the 2004 and 2007 US Food and Drug Administration warnings that antidepressant use approximately doubled the risk of suicidal behaviour in young people (under 25) with depression and other psychiatric disorders. We described how, in the years after the warning, McGorry and other prominent Australian ‘suicide prevention experts’ led a backlash challenging the FDA warning, arguing that antidepressants reduce the risk of youth suicide.
We detailed that, since 2009, the per-capita use of antidepressants and the rate of suicide among young Australians has spiralled upwards sharply. This decade-long disturbing positive correlation is exactly what I predicted would occur nearly a decade ago, but McGorry and others continue to argue that antidepressants reduce the risk of suicide in young people.
Our paper pointed out significant shortcomings and omissions by McGorry and other ‘suicide prevention experts’ in their analysis of the relationship between youth suicide and antidepressant use. In June 2020, shortly after our paper was reported on in the Australian Financial Review – Suicide prevention experts may have got it horribly wrong - McGorry was interviewed by Patricia Karvelas on ABC Radio’s RN Drive program.
Karvelas - without an adequate introduction or any follow up questioning - asked McGorry what our study ‘claimed to show’. He failed to address any of the substantive issues we raised. Instead he replied: It wasn't really a study. It was more like you know a piece of propaganda and these people have been at it for years and years…there is some grain of truth in what these people are on about but they are on a mission and I was very surprised that that paper got published and I certainly was very surprised that AFR ran it. But every, 6 or 12 months we have this issue about drugging our kids coming up again it’s a very unsophisticated way to look at it… we actually go with evidence. We don’t go with polemic.
Our criticisms of the flawed evidence base McGorry and others used to justify their advice that antidepressants reduce the risk of youth suicidality was detailed, referenced, and peer reviewed. That is how scientific debate should occur. It is laughable that McGorry ended his answer with the claim that he goes with evidence and not the ‘polemic’, having begun it by dismissing the work of those who disagree with him (these people) as ‘propaganda’.
McGorry’s ‘propaganda’ dummy-spit reinforced my belief that he is wholly unsuited to dealing with evidence that contradicts his strongly held convictions. Likewise, the deferential tone Karvelas adopted in her interview increased my bewilderment at the strange compliant effect that McGorry seems to have on otherwise appropriately robust ABC journalists, like Patricia Karvelas and Fran Kelly.
Fortunately, the Australian Government were not as dismissive of our study as McGorry and Karvelas. Two days after their interview, the Sunday edition of the Sydney Morning Herald reported that the Morrison Government Minster for Heath Greg Hunt: has asked his department to review the results of an academic study linking the increase in youth suicide with a rise in antidepressants being prescribed to Australian children… A spokesman for Mr Hunt said the minister ‘is deeply concerned by the rate of depression and suicide among young Australians’ and that the TGA would review the Curtin study's findings ‘and, if necessary, take strong and appropriate action’.
A re-run of the DSM-5 Psychosis Risk Disorder Debate
The debate that is about to kick-off about the appropriateness of McGorry and Orygen’s involvement in this ultra-high-risk research is fundamentally a rerun of the global debate about whether Psychosis Risk Disorder should be formally recognised in the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) that was published in 2013. Early drafts of the DSM-5 included Psychosis Risk Disorder (otherwise known as Attenuated Psychosis Syndrome) based on the ultra-high-risk concept.
The planned inclusion received widespread international criticism led by Professor Allen Frances, the psychiatrist who led the development of the prior edition, DSM-IV published in 1994. Frances described Psychosis Risk Disorder as ‘the most ill-conceived and potentially harmful’ of all the proposals for insertion into DSM-5. Frances concluded, 'The whole concept of early intervention rests on three fundamental [flawed] pillars … 1) it would misidentify many teenagers who are not really at risk for psychosis; 2) the treatment they would most often receive (atypical antipsychotic medication) has no proven efficacy; but, 3) it does have definite dangerous complications.'
Frances was also scathing in his assessment of McGorry’s plans for the national roll out of his Early Psychosis Prevention and Intervention Centres (EPPIC) based on the Psychosis Risk Disorder concept writing; ‘McGorry’s intentions are clearly noble, but so were Don Quixote’s. The kindly knight’s delusional good intentions and misguided interventions wreaked havoc and confusion at every turn’. Frances warned that Australia is in danger of following McGorry blindly down ‘an unknown path that is fraught with dangers’.
Thankfully, in May 2011, the American Psychiatric Association’s DSM-5 task force revealed that the group had decided not to include Attenuated Psychosis Syndrome because of concerns that ’this diagnosis might result in inappropriate treatments’.
This was a big setback for McGorry. He had been a prominent advocate for its inclusion. In May 2010, before the backlash against Psychosis Risk Disorder got significant Australian media coverage, McGorry was quoted in an article in Psychiatry Update, titled DSMV [DSM-5] ‘risk syndrome’: a good start, should go further. McGorry said “the proposal for DSMV to include a ‘risk syndrome’ reflecting an increased likelihood of mental illness is welcome but does not go far enough”.
In addition, earlier in 2010 McGorry had written a journal article that concluded:
'The proposal to consider including the concept of the risk syndrome in the forthcoming revision of the DSM classification is innovative and timely. It has not come out of left field, however, and is based upon a series of conceptual and empirical foundations built over the past 15 years.'
However, a year later - after the announcement psychosis risk syndrome wasn’t going in the DSM-5 - McGorry made the astonishing claim that "Contrary to Mr Whitely's statements, I haven’t been pushing for it to be included in DSM5. Now that hasn’t been my position. But it’s a new area of work. It’s only been studied for the last 15 years".
The Drugs Don’t Work - but Never say Never.
About the same time as McGorry’s DSM-5 backflip, he made some reassuring comments that appeared to indicate he had been persuaded that using antipsychotics to prevent possible future psychosis was not justified.
However, months later it became obvious that McGorry’s determination to continue to experiment with antipsychotics in the belief that they may help prevent psychosis remained. In August 2011 The Sunday Age newspaper in an article titled Drug trial scrapped amid outcry reported how ‘Patrick McGorry has aborted a controversial trial of antipsychotic drugs on children as young as 15 who are ‘at risk’ of psychosis, amid complaints the study was unethical’.
The Sunday Age revealed that 13 researchers from Australia, Britain and America lodged a formal complaint calling for the NEURAPRO-Q trial not to go ahead. They were concerned that children who had not yet been diagnosed with a psychotic illness would be unnecessarily given drugs with potentially dangerous side effects.
McGorry told the Sunday Age the decision to scrap the trial was made in June 2011 and was unrelated to the complaint. He said the trial was abandoned due to ‘feasibility issues’ with recruiting participants in Europe and America. It was reported that McGorry ‘acknowledged the evidence suggested antipsychotics were not effective as a first-line treatment for the at-risk group’ but ‘he would consider a similar trial on patients for whom other treatments had failed’.
In April 2013 McGorry was the lead author of a paper detailing the results of a randomised controlled trial that commenced well before the NEURAPRO-Q trial was proposed. Surprisingly he and the other authors - including the current head of Orygen’s ultra-high risk for psychosis research program, Professor Barnaby Nelson - reported that transition rates from ultra-high-risk to psychosis where much lower than they expected and were marginally higher in those using antipsychotics compared to those taking placebo. But even this was not enough for them to accept that most people got better without treatment, or curb their enthusiasm for the idea that psychotropic drugs can prevent psychosis in mildly disturbed young people.
Despite the lack of supporting evidence McGorry’s and his allies unremitting belief that antipsychotics may help prevent psychosis has been influential internationally. Recent research published in the Australian and New Zealand Journal of Psychiatry revealed that the practice of using antipsychotics among those considered to be at elevated risk of psychosis (clinical high risk or ultra high risk) is ‘widely practiced’ in China but does not work.
The research first published in May 2020 followed the outcomes of 450 “individuals with a clinical high risk (CHR) of psychosis” for three years. Of these 319 were treated with antipsychotics and 141 were not. The researchers found: Patients who did not receive antipsychotics showed a lower conversion rate than those who did... In mild CHR cases, antipsychotic treatment was more likely to be associated with conversion to psychosis, compared with the no-antipsychotics group, with no such difference observed in severe CHR cases. Among those who received antipsychotics, monotherapy or low-dose treatment was associated with lower conversion rates.
The researchers concluded ‘administration of antipsychotics to CHR patients is potentially harmful with no preventive benefits’. This research should end the decades long push for antipsychotics to be used as a preventative treatment, although history suggests profitable ideas with bad patient outcomes can be stubbornly persistent (e.g. the use of antidepressants to reduce youth suicide).
Hey Pat leave those kids alone!
While the $33million Australian leg of the ongoing $82 million US-led Accelerating Medicines [Schizophrenia Research] Partnership doesn’t currently involve experimenting with drugs, it lays the groundwork, with approximately a thousand mildly distressed young Australians likely to be given the stigmatising ultra-high-risk label.
The bigger picture is of even greater concern. McGorry, Orygen and their international partners – which include numerous drug companies as active partners- are determined to have another go at pushing the ultra-high-risk/psychosis risk disorder label, and finding drugs to match.
There is no guarantee that young Australians won’t be the lab rats for future ultra-high-risk drug experimentation.
Surely three decades of failure is enough to accept that the concept is fundamentally flawed? McGorry is charismatic and a very effective lobbyist and self-promoter, but his ultra-high-risk concept is just another example of diagnostic over-reach from the extremes of psychiatry. It is facilitated in part by drug company dollars, and driven by the crusading zeal of hyper-confident clinicians – led by McGorry – who have forgotten their obligation to ‘first do no harm’.
McGorry’s wishful thinking and ultra-hyped-rhetoric must not continue to be confused with evidence. That will require more robust investigation of his claims, particularly at the ABC, which has for a decade now acted like his marketing arm.
His ’propaganda’ response to our research on the disturbing link between antidepressant and youth suicide demonstrates he can’t be trusted to respond appropriately to evidence he doesn’t like.
That is not how science should be done. Unbiased research and caution is required, especially when so many young lives are at stake!
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Youth mental health researchers awarded $33 million from US institute ABC Radio RN Breakfast. 16 September 2020. https://www.abc.net.au/radionational/programs/breakfast/youth-mental-health-researchers-awarded/12668472#:~:text=Youth%20mental%20health%20researchers%20awarded%20%2433%20million%20from%20US%20institute,-On%20RN%20Breakfast&text=The%20Australian%20youth%20mental%20health,Health%20in%20the%20United%20States  Orygen website. $33 Million grant for psychosis research sets Australian record for medical research funding. 16 September 2020. https://www.orygen.org.au/About/News-And-Events/2020/$33-million-grant-for-psychosis-research-sets-Aust  Orygen website. $33 Million grant for psychosis research sets Australian record for medical research funding. 16 September 2020. https://www.orygen.org.au/About/News-And-Events/2020/$33-million-grant-for-psychosis-research-sets-Aust  Fran Kelly interview with Professor Patrick McGorry. 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Risk Syndromes, clinical staging and DSM V; New diagnostic infrastructure for early intervention in psychiatry, Schizophrenia Research. 2010 http://www.ecnp-congress.eu/~/media/Files/ecnp/communication/talk-of-the-month/mcgorry/McGorry%20RIsk%20Syndrome%202010.pdf (accessed 13 June 2020)  The World Today – Professor McGorry hits back at critics, 20 May 2011 www.abc.net.au/worldtoday/content/2011/s3222359.htm (accessed 13 June 2020)  In October 2010 response to my blog titled Australian of the Year Patrick McGorry’s call for early intervention to prevent Psychosis: A Stitch in Time or a Step too Far? (available at http://speedupsitstill.com/patrick-mcgorry-early-intervention-psychosis-stitch-time-stitch-up ) Professor McGorry wrote a blog titled Responding at the earliest opportunity to emerging mental illnesses http://www.speedupsitstill.com/reply_patrick_mcgorry_early_intervention_psychosis/  Stark, J. Drug trial scrapped amid outcry. 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Australian and New Zealand Journal of Psychiatry. May 2020. https://journals.sagepub.com/doi/full/10.1177/0004867420917449 (accessed 15 August 2020)  ‘Accelerating Medicines Partnership [Schizophrenia Research] partners include Boehringer Ingelheim Pharmaceuticals, Inc.; Janssen Research & Development,; Otsuka Pharmaceutical Development & Commercialization, Inc. The Partnership steering committee includes representatives from each partner organizations and will provide detailed technical analyses of key scientific, policy, or informatics issues that arise during implementation.’ National Institute of Health website. Project Information page: Trajectories and Predictors in the Clinical High Risk for Psychosis population: Australian Network of Clinics and international Partners https://projectreporter.nih.gov/project_info_description.cfm?aid=10092863&icde=51660550&ddparam=&ddvalue=&ddsub=&cr=1&csb=default&cs=ASC&pball= (Accessed 30 September 2020)  Martin Whitely. 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