“Personalities, rhetoric and charisma are driving the direction of mental health rather than science and evidence.” (Martin Whitely MLA, Parliament of Western Australia, 25 September 2012)

Related Media

Sue Dunlevy, News Limited Sunday papers, 7 October 2012, Doubts cast on youth mental health program. Available at  http://www.news.com.au/national/doubts-cast-on-youth-mental-health-program/story-fndo4eg9-1226489760605

Also see Patrick McGorry’s ‘Ultra High Risk of Psychosis’ training DVD fails the common sense test http://speedupsitstill.com/patrick-mcgorrys-ultra-high-risk-psychosis-theory-fails-common-sense-test

MARTIN WHITELY (Trancript of speech in the Legislative Assembly, Parliament of Western Australia, 25 September 2012): I want to use this opportunity to talk about some very serious concerns I have about the direction of the mental health policy in Australia. My basic contention is that personalities, rhetoric and charisma are driving the direction of mental health rather than science and evidence.

In May 2011, the Gillard government announced that it would spend $2.2 billion on mental health initiatives over five years. The biggest program it announced expenditure on, costing $222.4 million and which would be matched by state governments, was for the rollout of 16 Early Psychosis Prevention and Intervention Centre sites nationally, which would have “the capacity to assist more than 11 000 Australians with, or at risk of developing, psychotic mental illness.”[1]

A month later, amid growing criticisms of the ability to help those at risk of becoming psychotic, Patrick McGorry, the chief architect of EPPIC services, told The Australian “EPPICs do not treat people with psychosis risk but only patients who have had their first psychotic episode…”[2]

That is in direct contravention to what was said in the May 2011 announcement. Since then the Minister for Mental Health and Ageing, Mark Butler, once in December 2011[3] and again in June 2012[4] indicated that EPPICs may not treat those perceived to be at ultra-high risk of becoming psychotic; which is in conflict with what he said in the May 2011 rollout.

Frankly, confusion reigns supreme. I asked a question in the May 2012 estimates process in the Western Australian Parliament about the functions of the planned Western Australian EPPIC services. The response that came back as supplementary information after the estimates process stated “The Early Psychosis Prevention and Intervention Centre (EPPIC) services are for young people with first episode early psychosis and for detecting those with ultra high risk of developing psychosis.”[5]

Members can see the confusion. The initial announcement was that they would be for the purpose of assessing those at ultra-high risk of developing psychosis. Then there was a backdown by both McGorry, the architect of EPPIC, and the mental health minister. Then the state government indicated that that was one of the chief functions.

How could the functions of the most expensive program that is being rolled out nationally be so confused? There are two reasons for this: first, because we have been let down by the politicians in Canberra on all sides—I am one of the rare critics in politics of what is happening—and, second, because we have been let down by the media. They have been inattentive to the detail of what is on offer.

The problem is that the politicians have let a handful of gurus relying on rhetoric, charisma and hype drive the direction of the mental health policy in Australia. They have accepted their overblown claims without scrutiny. The danger is that young Australians will suffer as a result.

Patrick McGorry is undoubtedly the biggest of those gurus. EPPIC is very much his baby. Patrick McGorry has two claims to fame. The first is obviously the fact that in 2010 he was made Australian of the Year. The second is that he is one of the world’s most prominent advocates of preventive psychiatry. The philosophy of preventive psychiatry is basically the idea that a stitch in time saves nine. In other words, if we get in pre-emptively before people become mentally ill, we can help them—we can prevent it.

He uses the language of early intervention when he is really (often talking about prevention and) not talking about early intervention. He is (often) not talking about getting people when they become psychotic; he is talking about getting in there prior to the advent of psychosis. The theory is that we can spot and stop psychosis and a range of mental illnesses before they happen. Intuitively, it seems like a reasonable theory. However, the independent evidence that is available shows that there are two problems with the theory.

First, we cannot predict with any accuracy who will become mentally ill. In the case of psychosis, the accuracy of predictions are somewhere between eight per cent and 36 per cent. Second, even when we do predict those who will go on to become psychotic, the interventions that are on offer simply do not help in the long term. There is little evidence of sustained benefits.

The problem that we are all saddled with is that Patrick McGorry has been unable to accept that his theory does not stand up to the evidence. He has been unable to accept that even when this theory has been rejected internationally. We should be doing a double take on what we are doing in Australia.

We can thank Professor McGorry for putting mental health on the political agenda in the lead-up to the 2010 election. His status as Australian of the Year allowed him to do that, but we cannot continue to blindly follow him where he tells us to go. Frankly, that is just what is happening.

In the lead-up to the 2010 election, as I said, mental health was on the agenda for the first time. Anybody who watched Insight on SBS in July 2010 would have noticed just how deferential the presenters and the politicians were to Patrick McGorry—in particular Peter Dutton on behalf of the Liberal Party and Mark Butler on behalf of the Labor Party. Peter Dutton went the furthest; he said “we’re going to roll out a national scheme based on advice by people like John Mendoza, Pat McGorry, Ian Hickey, David Crosby and others.”[6] He added that “early intervention is proven, without any doubt, to work”. Frankly, that is just complete and utter rubbish. The independent evidence shows us anything but that.

In fact, Patrick McGorry used an address to the National Press Club in the lead-up to the 2010 election to say that we had “twenty-first century solutions” that were just waiting to be implemented if only government would urgently fund these “proven approaches”.[7]

The rhetoric continued after the election. In March 2011 Professor McGorry was the co-author of a blueprint for mental health that significantly said — “EPPIC has the largest international evidence base of any mental health model of care, demonstrating not only their clinical effectiveness but also their financial and social return on investment. This is a mature model simply requiring implementation in Australia.”[8]

Frankly, the hype is not backed up by the evidence. In 2011 the Cochrane Collaboration, which is acknowledged internationally as one of the world’s most rigorous, systematic and comprehensive sources of independent, reliable medical information, found that there was “inconclusive evidence” that early intervention could prevent psychosis and that “there is a question of whether the gains are maintained”.[9] Professor McGorry responded by attacking the Cochrane review, saying it used flawed methodology.[10] As I pointed out, Cochrane is widely regarded as the gold standard for international research. ` Other evidence that the claims are not supported by the facts was provided by a Queensland psychiatric registrar and economist—he has dual training—Andrew Amos, who wrote an article in the June edition of the Australian and New Zealand Journal of Psychiatry entitled “Assessing the cost of early intervention in psychosis: A systemic review”.[11] He wrote about the methodology used in his study, saying that 11 articles were included in the review. He made reference to one that was co-authored by Patrick McGorry, writing, “one small case-control study with evidence of significant bias concluded annual early-intervention costs were one-third of treatment-as-usual costs.”

That is the only one that found positive outcomes. He said there was significant bias in that study. Andrew Amos’s paper concluded “the published literature does not support the contention that early intervention for psychosis reduces costs or achieves cost-effectiveness.”

We have to bear that against Professor McGorry’s claim that EPPIC is supported by “the largest international evidence base of any mental health model of care”.[12] It simply does not stack up.

The problem is that after the 2010 election, there was no independent review process. The mental health minister, Mark Butler, tried in a sense when he set up the Mental Health Expert Working Group, which included a number of mental health practitioners, including Professor McGorry and Ian Hickey, and Monsignor David Cappo, who was the vice-chair. For some unknown reason, those three gentlemen decided to step outside the process and produce their own blueprint for mental health. They termed themselves the Independent Mental Health Reform Group.

Basically, they produced a $3.5 billion, five-year wish list, which was completely devoid of evidence.[13] Mark Butler should have resisted it at that stage but the media pressure was enormous because there is an enormous cheer squad for this group. He should have ordered an independent review of the evidence underlying the claims that were made in that blueprint. Instead, he adopted so much of it, which led to the $2.2 billion announcement and the $222.4 million for EPPIC, being half of the total expenditure when it is supplemented by the states.

Soon after the debate started to change for Professor McGorry. In fact, science started to catch up with some of his claims last year when international debate about the inclusion of Attenuated Psychosis Syndrome (often called Psychosis Risk Syndrome) in DSM5 took place. The basic theory underlying Professor McGorry’s work and the proposed diagnosis of Attenuaed Psychosis Syndrome was that mental illness has a prodromal phase, and in that phase mental illnesses can be predicted, treated and prevented. There was very strong international backlash to that.

As a result of that, we saw a change in the attitude of Professor McGorry to the inclusion of Attenuated Psychosis Syndrome in DSM5. In May 2010 he was quoted in an article in in the Psychiatry Update entitled “DSM5 ‘risk syndrome’: a good start, should go further” as saying “The proposal for DSM5 to include a ‘risk syndrome’ reflecting an increased likelihood of mental illness is welcome but does not go far enough.”[14]

Also, Professor McGorry wrote a piece for Science Digest in 2010, entitled “Schizophrenia Research” in which he stated, “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.”[15]

It is a very strong endorsement saying it was based on 15 years of research. That was Professor McGorry, the great enthusiast for its inclusion in DSM5.

Then the heat started to go on. In June 2011, McGorry the great enthusiast, became McGorry the indifferent, when he wrote a blog on my website at my invitation. He wrote, “Personally, I am not concerned whether it (Attenuated Psychosis Syndrome) enters the DSM5 or not.”[16] So he began backing away from it.

Later, when pushed on the issue, McGorry the great enthusiast, who had become McGorry the indifferent, went on to become McGorry the denier, denying his previous position. He was on the ABC World Today program of 12 May 2011. I had said that Professor McGorry was a leading international proponent of Psychosis Risk Syndrome as a new psychiatric disorder for inclusion in the next edition of DSM5. Professor McGorry responded by saying, “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.”[17]

So if we take those three positions—the great enthusiast, the indifferent, the denier—and recap, in 2010 he described the proposal to put Attenuated Psychosis Syndrome in the DSM5 as “innovative and timely … has not come out of left field and is based upon a series of conceptual and empirical foundations built over the past 15 years.”

The heat goes on. In 2011 the response becomes, “I haven’t been pushing for it to be included in DSM5. Now that hasn’t been my position.… It’s only been studied for the last 15 years or so, so you know we haven’t got all the answers.”

Frankly, I was aware of the hypocrisy in that statement, but I did not actually make much of it at the time because Professor McGorry and I were engaged in some very productive discourse. I was very encouraged when in February 2012 in the Sydney Morning Herald, in an article entitled “About-turn on treatment of the young”, Professor McGorry acknowledged the widespread international concern, with the inclusion of psychosis risk syndrome in DSM5 and said that he now opposed it.[18] In fact I wrote a blog entitled “Patrick McGorry deserves praise for about-turn on Psychosis Risk Disorder”. I was very encouraged. I was prepared to forgive him the dishonesty and the inconsistency of his position.

It is important to understand why the idea of Psychosis Risk Disorder, Attenuated Psychosis Syndrome, was removed from DSM5. It was removed basically for three reasons, the first being the rate of false positives. It is an accurate diagnosis of between eight per cent In 2012 in the Medical Journal of Australia Professor David Castle a critic of the rollout of EPIC’s stated that the diagnosis was accurate in only 8% of cases. [19] In the same edition of the MJA McGorry’s close colleague Professor Alison Yung identified the conversion rate from UHR to first episode psychosis was 36%.[20] So, the false positive rate it is somewhere between a 64% per cent and a 92%.

The second was the idea that labelling someone as being pre-psychotic could be stigmatising and could be a self-fulfilling prophecy. The third concern was the inappropriate use of antipsychotics in people who had never been psychotic and are unlikely to go on and become psychotic.

As I said, when Professor McGorry seemingly abandoned supporting Psychosis Risk Disorder’s inclusion in DSM5, that was the high point of the trust that had developed between Professor McGorry and me. But I have to say that I now distrust him for two very clear reasons.

One is that he has acknowledged that it is a problem when other people do it but not a problem when he diagnoses it. He wrote in 2010 that “both of these concerns are valid”—the concern about extending the use of antipsychotic medication and the concerns about labelling and stigmatising people —”Both of these concerns are valid, though both can and have been addressed in our work and systems of care in Melbourne.”[21]

Basically he is saying; Look, nobody else is good enough to do it, but we are good enough to do it in our Melbourne-based system.

What really turned me around was when I got access to training DVD produced by Patrick McGorry’s Orygen Youth Health, which actually teaches mental health clinicians how to diagnose and treat Psychosis Risk Syndrome otherwise known as Attenuated Psychosis Syndrome.[22] This DVD is still for sale, even though Attenuated Psychosis Syndrome has been removed from DSM5 and even though Professor McGorry said he did not support its inclusion.

I encourage people to go to my blog and look at an excerpt from that DVD. There is a video blog there and members can look at an excerpt from the training DVD and see if it passes the commonsense test. Jon Jureidini, a professor of psychiatry at University of Adelaide, somebody who I have great respect for, looked at the training DVD and said that it is a great training tool, because it “demonstrates how not to carry out a psychiatric interview and interact with young people”—a damning comment. (see Patrick McGorry’s ‘Ultra High Risk of Psychosis’ training DVD fails the common sense test )

The diagnosis of Attenuated Psychosis Syndrome is a very controversial issue, but more controversial than that has been the role of the use antipsychotics in the treatment of people who are not psychotic, who are considered to be at risk of being psychotic. Again, Professor McGorry has spun his own position.

In 2010 in response to my blog, he wrote, “our clinical guidelines do not (and have never done so in the past) recommend the use of anti-psychotic medication as the first line or standard treatment for this Ultra High Risk group.”[23]

It is true in the sense that final endorsed clinical guidelines have never actually recommended it, but Professor McGorry has produced draft guidelines recommending their use and, for well over a decade, Professor McGorry has experimented with and it appears likely he continues to experiment with the pre-emptive prescription of psychotropics to adolescents.

Three examples of his earlier advocacy were that in 2006 in the Australian and New Zealand Journal of Psychiatry he proposed a clinical staging framework for psychosis and identified “atypical antipsychotic agents” as one of the “potential interventions” for individuals who are at “ultra-high risk” of developing first-episode psychosis.[24] In 2007 in an article in the British Medical Journal that he jointly authored he extolled the potential of pre-psychotic use of pharmacological interventions.[25] Again in the British Medical Journal in 2008, in an article entitled “Is early intervention in the major psychiatric disorders justified?” he wrote — “Early intervention … It should be as central in psychiatry as it is in cancer, diabetes, and cardiovascular disease … Several randomised controlled trials have shown that it is possible to delay the onset of fully fledged psychotic illness in young people at very high risk of early transition with either low dose antipsychotic drugs or cognitive behavioural therapy.”[26]

I easily found three instances when he advocated for it, which is in conflict with his December 2010 claim that he has not been an advocate.

After the pressure from the debate on the inclusion of Attenuated Psychosis Syndrome in DSM–5, Professor McGorry began to adjust his position. In December 2010 he wrote that, “Antipsychotic medications should not be considered unless there is a clear-cut and sustained progression to frank psychotic disorder meeting full DSM 4 criteria.”[27] He outlined that the only exception to the previous statement is when there has been a definite failure to respond to the first and second line interventions. That was written in late 2010 in response to some concerns I had raised with him.

In November 2010 in an article in The Weekend West titled “Mental health guru stumbles into public policy minefield”, a spokesman from Orygen Youth Health said on Professor McGorry’s behalf that antipsychotics are not recommended as a standard treatment and “there has been a substantial amount of research and we do change according to the research.”

All of that kept me happy at the time, as I thought Professor McGorry had realised that the research showed that antipsychotics are not a good way to treat people perceived to be at risk of becoming psychotic. The problem is that he continued to do research on this topic.

A 2011 article referred to the NEURAPRO-Q trial that was being conducted by Professor Patrick McGorry. Thirteen international critics lodged an appeal against the trial, saying that it was unethical because of the potential harms of the use of Seroquel, an antipsychotic, in this nonpsychotic group, the very high false positive rate of misdiagnosis, which I have talked about, and a number of other reasons.

The heat was on and in August 2011, Melbourne’s The Age quoted Professor McGorry as saying that the trial had been abandoned because of “feasibility issues recruiting participants”.[28] It seems he never gave up on his treasured theory. He has acknowledged, we have all this evidence that we should not use antipsychotics in this way, yet he continued to do this trial. I contend that if he cannot prove it in 15 years of trialling antipsychotics on people who are not psychotic and are never likely to become psychotic, why would he continue to do it?

That is not the only evidence. There are more reasons to be concerned that Professor McGorry has still not abandoned his favourite theory, which is that we can use psychotropic medication as a preventive measure and a way of immunising young people against future mental illness.

He has 10 million good reasons not to abandon this research—a grant that was provided to Professor McGorry and others. He is the principal investigator for a National Health and Medical Research Council grant for “Emerging mental disorders in young people: using clinical staging for prediction, prevention and early intervention”.[29] They received a $10 million grant from the NHMRC. He said “this money will allow us to continue our research into the causes of mental illness and help the one in four young people suffering a mental disorder.”[30]

This $10 million trial may include the testing of psychotropic drugs as a preventive measure—in other words, as an attempt to immunise people against getting future mental illness.

So, go back to the claim that Professor McGorry used in the lead-up to the 2010 election. He said that the Early Psychosis Prevention and Intervention Centre has “the largest international evidence base of any mental health model of care”.[31] If that were true, after 15 years of trialling, we would have a mature model and there would not have been these back-downs.

We also need to be concerned about some of the disease mongering that comes out of the mouth of Professor McGorry and his allies. In March 2010 on the ABC’s Lateline program he said, “4 million Australians have mental health problems in any given year… there are 1 million young Australians aged 12 to 25 with a mental disorder in any given year. … And 750,000 of them have no access to mental health care currently.”[32]

I was at an excellent conference in Perth in June, hosted by the Richmond Fellowship of Western Australia. Patrick McGorry cited a New Zealand study, from memory, and claimed that between the ages of 18 and 25 years, 50.1 per cent of people had a psychiatric disorder.[33] This is disease mongering. This is turning normality into disease. People who are ill and need treatment will be denied resources because we spread resources too thin.

It is very upsetting that not only these statements are being made, but also the media is not questioning them. They are letting them go straight through to the keeper as though they are the absolute truth.

Professor McGorry has appropriated the language of early intervention, but in truth he is engaged in preventive psychiatry—preventive being pre-intervening; that is, stepping in and aggressively interfering with people who will probably never go on to be diseased.

In June 2012 in response to an article I wrote in The West Australian, Professor McGorry criticised me for describing him as a proponent of preventive psychiatry, but his own organisation, Orygen Youth Health Research Centre, registered EPPIC as a trademark in 2011. Part of its registration program listed Orygen as providing “education and training services”, including in the “field of youth-specific preventive psychiatry”.[34] They registered it in their trademark and then a year later criticised me for describing him as an advocate of preventive psychiatry.

One of his great debating tricks is to describe people such as me and those who work in the field, such as Jon Jureidini and others, as being proponents of “late intervention”.[35] We are not. We are arguing for early intervention. When people become psychotic or become mentally ill, we should get in there and intervene and help them. It is completely disingenuous of Professor McGorry to paint his opponents as being proponents of late intervention.

There are other things of concern. In July 2012 The Sunday Age in Melbourne published an article on a 2007 Orygen Youth Health antidepressant prescribing audit. The article highlighted the concern that antidepressants were being prescribed at Orygen “to a majority of depressed 15 to 25-year-olds before they had received adequate counselling”. It also found that “75 per cent of those diagnosed with depression were given the drugs too early”.[36]

Orygen’s own “Evidence Summary: Using SSRI Antidepressants to Treat Depression in Young People: What are the Issues and What is the Evidence?”, produced in 2009, builds a very compelling case for not using anti-depressants in young people, but then goes on to conclude that we should use them.[37] The only rationale that is offered—all the evidence is ignored—is that it is better to do something than nothing.

Am I alone? It is a relevant question. I am not an expert; I am a politician. I am probably the only politician who has stood and said, “We need to be concerned about this major investment in mental health in Australia.” I may be alone in politics, but I am not isolated within psychiatry. A range of very prominent psychiatrists are very critical of where we are going.

One of the most revealing things was that Psychiatry Update in October 2011 published a survey of psychiatrists in Australia. It revealed, “Almost 60% of psychiatrists think the Federal Government’s focus on EPPIC is inappropriate.”[38]

Others who have had plenty to say include Professor Allen Frances, the chief author of the DSM–IV, the current edition of the bible of psychiatry. He has been a fierce critic of Professor McGorry, although he is very charitable in what he says about McGorry’s intentions. He said “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.”[39] Professor Frances goes on to warn that Australia is really in danger of following him blindly down “an unknown path that is fraught with dangers”.

Another who has been critical is Professor George Patton, who told The Age that the Orygen antidepressant prescribing audit revealed how much we needed to look at the evidence base of these programs.[40] Clinical Professor David Castle, a very high profile psychiatrist from Melbourne, is also critical.[41] Professor Vaughan Carr from the University of New South Wales wrote an opinion piece that was very dismissive of Professor McGorry’s claims that this was the most cost-effective treatment. He described his claims as “a utopian fantasy” based on “published evidence that is not credible.”[42] [43]

I have run out of time. The message I want to put out there is that we need to go back to the evidence. I have met Patrick McGorry and I like him. He is a very charismatic individual and I think he is well intentioned, but that is not the point. The point is that we cannot have mental health policy driven by rhetoric; it needs to be driven by evidence.

Note: this transcript has contains endnotes and minor corrections not in the official Hansard record.

[1] National Mental Health Reform Statement by Hon. Nicola Roxon Minister, Hon. Jenny Macklin and the Hon. Mark Butler 10 May 2011 http://www.budget.gov.au/2011-12/content/ministerial_statements/health/download/ms_health.pdf

[2] Sue Dunlevy ‘Schism opens over ills of the mind’ The Australian June 16, 2011. http://www.theaustralian.com.au/news/features/schism-opens-over-ills-of-the-mind/story-e6frg6z6-1226075910650

[3] The Hon Mark Butler MP Minister for Mental Health and Ageing, Media Release 8 December 2011 More Early Psychosis Services for Young Australians. http://www.health.gov.au/internet/ministers/publishing.nsf/Content/B9CCE606D4092CE1CA257960000474FE/$File/MB222.pdf

[4] Mark Butler A bright future for mental health in Australia Ramp Up 8 Jun 2012 http://www.abc.net.au/rampup/articles/2012/06/08/3521451.htm

[5] Western Australian Legislative Assembly Hansard available at http://www.parliament.wa.gov.au/Hansard/hansard.nsf/0/57de02ae107600d148257a220046f171/$FILE/A38%20S1%2020120531%20p636b-639a.pdf

[6] Insight SBS television 27 July 2010 transcript available at http://news.sbs.com.au/insight/episode/index/id/272#transcript

[7] Address to the National Press Club Canberra by Prof. Patrick McGorry July 7, 2010

[8] Including, Connecting, Contributing: A Blueprint to Transform Mental Health and Social Participation in Australia, March 2011. Prepared by the Independent Mental Health Reform Group: Monsignor David Cappo, Professor Patrick McGorry, Professor Ian Hickie, Sebastian Rosenberg, John Moran, Matthew Hamilton http://sydney.edu.au/bmri/docs/260311-BLUEPRINT.pdf (accessed 26 April 2011)

[9] “There is emerging, but as yet inconclusive evidence, to suggest that people in the prodrome of psychosis can be helped by some interventions. There is some support for specialised early intervention services, but further trials would be desirable, and there is a question of whether gains are maintained. There is some support for phase-specific treatment focused on employment and family therapy, but again, this needs replicating with larger and longer trials.” Marshall M, Rathbone J. Early intervention for psychosis. Cochrane Database of Systematic Reviews 2011, Issue 6. Art. No.: CD004718. DOI: 10.1002/14651858.CD004718.pub3 June 15, 2011 http://summaries.cochrane.org/CD004718/early-intervention-for-psychosis

[10] Stark, J. 2011, August 21. Drug trial scrapped amid outcry. The Age. http://www.theage.com.au/national/drug-trial-scrapped-amid-outcry-20110820-1j3vy.html

[11] Andrew Amos Australia New Zealand Journal of Psychiatry – Assessing the cost of early intervention in psychosis: A systematic review 13 June 2012 http://anp.sagepub.com/content/46/8/719

[12] Including, Connecting, Contributing: A Blueprint to Transform Mental Health and Social Participation in Australia, March 2011. Prepared by the Independent Mental Health Reform Group: Monsignor David Cappo, Professor Patrick McGorry, Professor Ian Hickie, Sebastian Rosenberg, John Moran, Matthew Hamilton http://sydney.edu.au/bmri/docs/260311-BLUEPRINT.pdf (accessed 26 April 2011)

[13] Including, Connecting, Contributing: A Blueprint to Transform Mental Health and Social Participation in Australia, March 2011. Prepared by the Independent Mental Health Reform Group: Monsignor David Cappo, Professor Patrick McGorry, Professor Ian Hickie, Sebastian Rosenberg, John Moran, Matthew Hamilton A Blueprint to Transform Mental Health and Social Participation in Australia http://sydney.edu.au/bmri/docs/260311-BLUEPRINT.pdf (accessed 26 April 2011)

[14] Available at http://www.psychiatryupdate.com.au/news/DSM-V-risk-syndrome-a-good-start-should-go-further posted 20 May 2010 accessed 28 May 2011

[15] McGorry, P.D. Risk Syndromes, clinical staging and DSM V; New diagnostic infrastructure for early intervention in psychiatry, Schizophr, Res. (2010), doi;10.1016/j.schres.2010.03.016 http://www.ecnp-congress.eu/~/media/Files/ecnp/communication/talk-of-the-month/mcgorry/McGorry%20RIsk%20Syndrome%202010.pdf

[16] Professor Patrick McGorry June 2011 AUSTRALIA’S MENTAL HEALTH REFORM: AN OVERDUE INVESTMENT IN TIMELY INTERVENTION AND SOCIAL INCLUSION June 2011 available at www.speedupsitstill.com

[17] The World Today – Professor McGorry hits back at critics, 20 May 2011 www.abc.net.au/worldtoday/content/2011/s3222359.htm (accessed 28 May 2011)

[18] Amy Corderoy, About-turn on treatment of the Young,Sydney Morning Herald, February 20, 2012 http://www.smh.com.au/national/health/aboutturn-on-treatment-of-the-young-20120219-1th8a.html

[19] Professor David Castle, Medical Journal of Australia 21 May 2012 Is it appropriate to treat people at high-risk of psychosis before first onset — No Available at https://www.mja.com.au/journal/2012/196/9/it-appropriate-treat-people-high-risk-psychosis-first-onset-no http://www.bmj.com/cgi/content/full/337/aug04_1/a695 (accessed 3 August 2010)

[20] Professor Alison Yung, Medical Journal of Australia 21 May 2012 Is it appropriate to treat people at high-risk of psychosis before first onset — Yes Available at https://www.mja.com.au/journal/2012/196/9/it-appropriate-treat-people-high-risk-psychosis-first-onset-yes

[21] In 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.patmcgorry.com.au/blog/pmcgorry/responding-earliest-opportunity-emerging-mental-illnesses

[22] Orygen Youth Health Centre, 2009, “Comprehensive Assessment of At Risk Mental State (CAARMS) Training DVD”, The PACE Clinic, Department of Psychiatry, University of Melbourne. see http://www.eppic.org.au/risk-mental-state accessed 3 September 2012

[23] Right of Reply – Patrick McGorry on Early Intervention for Psychosis December 11, 2010 refer http://speedupsitstill.com/reply-patrick-mcgorry-early-intervention-psychosis

[24] McGorry, P., Purcell, R., Hickie, I. B., Yung, A. R., Pantelis, C., & Jackson, H.J. (2006) Clinical staging of psychiatric disorders: a heuristic framework for choosing earlier safer and more effective interventions. Australian and New Zealand Journal of Psychiatry, 40:616-622. Note: A similar article is available online at http://www.mja.com.au/public/issues/187_07_011007/mcg10315_fm.html (accessed 26 April 2011)

[25] Yung, A.R. & McGorry, P.(2007) Prediction of psychosis: setting the stage, British Journal of Psychiatry, 191: s1-s8. http://bjp.rcpsych.org/cgi/content/full/191/51/s1 (accessed 7 December 2010)

[26] McGorry P.D. (2008) Is early intervention in the major psychiatric disorders justified? Yes, BMJ, 337:a695 http://www.bmj.com/cgi/content/full/337/aug04_1/a695 (accessed 3 August 2010)

[27] Right of Reply – Patrick McGorry on Early Intervention for Psychosis December 11, 2010 http://speedupsitstill.com/reply-patrick-mcgorry-early-intervention-psychosis

[28] “Professor McGorry insists the decision to scrap the trial was made in June and is unrelated to the complaint, which he said he was only alerted to just over a week ago. He maintained the trial received ethics approval in July last year but was abandoned due to “feasibility issues” with recruiting participants in European and American sites, which were to form the international arm of the study”.Stark, J. (2011, August 21). Drug trial scrapped amid outcry. The Age. http://www.theage.com.au/national/drug-trial-scrapped-amid-outcry-20110820-1j3vy.html

[29] Refer to http://www.nhmrc.gov.au/grants/research-funding-statistics-and-data/mental-health-0

[30] Professor Patrick McGorry Emerging Mental Disorders in Young People: Using Clinical Staging for Prediction, Prevention and Early Intervention.http://blogs.unimelb.edu.au/musse/?p=417 accessed 27 September 2009

[31] Including, Connecting, Contributing: A Blueprint to Transform Mental Health and Social Participation in Australia, March 2011. Prepared by the Independent Mental Health Reform Group: Monsignor David Cappo, Professor Patrick McGorry, Professor Ian Hickie, Sebastian Rosenberg, John Moran, Matthew Hamilton http://sydney.edu.au/bmri/docs/260311-BLUEPRINT.pdf (accessed 26 April 2011)

[32] ABC (11 March 2010) Mental health system in crisis: McGorry, Lateline, Australian Broadcasting Corporation. Reporter: Tony Jones http://www.abc.net.au/lateline/content/2010/s2843609.htm (accessed 26 April 2011)

[33] Professor Patrick McGorry wrote in a blog on 25 May 2011 “A recent New Zealand study has shown between 18 and 24 years that 50 per cent of young people will manifest diagnosable mental disorders, over half the time repeated episodes, which, far from being trivial or “normal”, will significantly affect their social, vocational and economic well-being at age 30.” See http://www.patmcgorry.com.au/blog/pmcgorry/government-has-thrown-black-dog-bone accessed 20 September 2012

[34] Details of the EPPIC trademark is available at http://www.trademarkify.com.au/trademark/1391532?i=EPPIC-ORYGEN_Research_Centre_ACN_ARBN_098_918_686#.T_OeZpEuh8E and the trademark for ‘E EPPIC’ that has been applied for is available at http://www.trademarkify.com.au/trademark/1447441?i=E_EPPIC-ORYGEN_Research_Centre_ACN_Street_MELBOURNE_VIC_3000_AUSTRALIA#.T_OfP5Euh8E

[35] Sweet, M. (17 August 2010) Patrick McGorry defends early intervention on youth mental health, Croakey: the Crikey Health Blog http://blogs.crikey.com.au/croakey/2010/08/17/patrick-mcgorry-defends-early-intervention-on-youth-mental-health/ (accessed 26 April 2011)

[36] Jill Stark, The Sunday Age, Youth mental health team too free with drugs: audit July 8, 2012 http://www.theage.com.au/national/youth-mental-health-team-too-free-with-drugs-audit-20120707-21o29.html

[37] In the U.S.A. a Black Box warning was put on in 2005 after an analysis of clinical trials by the FDA found statistically significant increases in the risks of ‘suicidal ideation and suicidal behavior’ by about 80%, and of agitation and hostility by about 130%. Headspace’s evidence summary also acknowledged that ‘no antidepressants (including any SSRIs) are currently approved by the Therapeutic Goods Administration (TGA) for the treatment of major depression in children and adolescents aged less than 18 years’. In addition the evidence summary acknowledges that research indicates that in terms of managing the symptoms of depression, ‘the only SSRI with consistent evidence of its effectiveness in young people is fluoxetine (Prozac)….The effectiveness of fluoxetine however is modest…Young people on fluoxetine do not appear to be functioning better in their daily lives at the end of the trials.’ Despite this, it concludes by recommending: ‘In cases of moderate to severe depression, SSRI medication may be considered within the context of comprehensive management of the patient, which includes regular careful monitoring for the emergence of suicidal ideation or behaviour’. Evidence Summary: Using SSRI Antidepressants to Treat Depression in Young People: What are the Issues and What is the Evidence? Headspace, Evidence Summary Writers Dr Sarah Hetrick, Dr Rosemary Purcell, Clinical Consultants Prof Patrick McGorry, Prof Alison Yung, Dr Andrew Chanen Copyright © 2009 Orygen Youth Health Research Centre http://www.headspace.org.au/core/Handlers/MediaHandler.ashx?mediaId=4896

[38] 6 October, 2011 Michael Slezak Psychiatry Update EPPIC disagreement over early intervention: poll http://www.psychiatryupdate.com.au/politics-practice-issues/eppic-disagreement-over-early-intervention–poll

[39] Australia’s Reckless Experiment In Early Intervention – prevention that will do more harm than good by Allen J. Frances, M.D. at http://www.psychologytoday.com/blog/dsm5-in-distress/201105/australias-reckless-experiment-in-early-intervention ]

[40] Professor George Patton quoted in the The Age, ”This paper illustrates how much we need to be looking at these new services (EPPIC) to determine the extent to which we’re following best clinical practice and to ask the questions, are we getting value for money out of these investments, and are we actually seeing better clinical outcomes?” Jill Stark, Youth mental health team too free with drugs: audit, The Sunday Age, July 8, 2012 http://www.theage.com.au/national/youth-mental-health-team-too-free-with-drugs-audit-20120707-21o29.html

[41] David Castle (St Vincents Melbourne) Medical Journal of Australia 21 May 2012- Is it appropriate to treat people at high risk of psychosis before first onset? NO

[42] Carr, Vaughan. (2010, July 10). Letter to the Editor, Mental health funding. The Australian. http://www.theaustralian.com.au/news/opinion/mental-health-funding/story-fn558imw-1225890005936

[43] Carr V. (8 July 2010) Mentally ill of all ages need services. The Australian. http://www.theaustralian.com.au/news/opinion/mentally-ill-of-all-ages-need-services/story-e6frg6zo-1225889141003 (accessed 30 April 2011)

Dr Frances is a former Chair of the Department of Psychiatry at Duke University. Whilst at Duke he led the American Psychiatric Association Task Force that revised the current edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). His attack on Australia’s blind acceptance of Professor Patrick McGorry’s model of early intervention comes from the very heart of heart of the psychiatric profession and can’t be ignored. Following Dr Frances’ blog is a response by Professor McGorry.

Australia’s Reckless Experiment In Early Intervention – prevention that will do more harm than good

by Allen J. Frances, M.D. in DSM5 in Distress

Patrick McGorry is a charismatic psychiatrist who has recently gained heroic status. First he was chosen to be Australia’s Man of the Year. Now, he has convinced the Australian government to spend more than $400 million over five years to fund his plan for a nationwide system of Early Psychosis Prevention and Intervention Centres. McGorry is the visionary prophet and pied piper of preventive psychiatry. His goal is to diagnose mental disorders early and treat them expectantly- before they can do their worst damage.

McGorry’s goal is certainly great. But its current achievement is simply impossible and Australia’s plans are patently premature. Early intervention to prevent psychosis requires first that there be an accurate tool to identify who will later become psychotic and who will not. Unfortunately, no such accurate tool exists. The false positive rate in selecting prepsychosis is at least about 60-70% in the very best of hands and may be as high as 90% in general practice. That’s right, folks, nine misidentified non patients for one accurately identified truly prepsychotic patient. Those are totally unacceptable odds.

What are the costs? McGorry does not recommend antipsychotic medications as a routine part of his prevention regimen. But experience teaches us that they will be overused despite having no proven efficacy and posing the risk of massive weight gain (and its consequent array of serious complications). The false positives will also suffer unnecessary stigma and worry and will undergo unnecessary and misdirected treatment. And surely there are many more productive ways to spend $400 million doing a better job of managing the mental health needs of those who have real and treatable psychiatric disorders.

Unfortunately, Mcgorry is a false prophet who’s visions are offered at least a few decades before their time. Australia, led astray by his impractical hopes, is about to embark on a vast and untried public health experiment that will almost surely cause more harm to its children than it prevents. Before embarking on this headlong and reckless rush, the following research steps need to be accomplished:

1) Developing a proven and reliable definition of “Psychosis Risk”

2) Learning how to use it in a way that reduces current outrageously high false positive rates to levels that are tolerable.

3) Demonstrating that the interventions chosen are indeed effective in preventing psychosis.

4) Determining the likely rate of antipsychotic use and how this influences the overall risk/benefit balance sheet of early intervention.

5) Studying the beneficial and harmful impacts of early diagnosis on stigma and self perception.

6) Comparing the marginal utility of a dollar spent trying to prevent an alleged future disorder vs a dollar spent treating an already clearly established one.

This is a research enterprise that will take many groups around the world many decades to complete. But it is an absolutely necessary precondition before spending $400 million on what is likely to be a failure. The Australian experiment will be flying blind on an airplane that is not at all ready to leave the ground. Doing prevention prematurely and poorly will give a good idea an unnecessary bad name.

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. Sad to say, Australia’s well intended impulse to protect its children will paradoxically put them at greater risk. Let’s applaud McGorry’s vision but not blindly follow him down an unknown path fraught with dangers.

AUSTRALIA’S MENTAL HEALTH REFORM: AN OVERDUE INVESTMENT IN TIMELY INTERVENTION AND SOCIAL INCLUSION

 By Professor Patrick McGorry

One has to wonder why Dr. Allen Francis, a retired former academic psychiatrist from the USA, would insert such an idiosyncratic, highly personalised critique of Australia’s Mental Health Reform into the blogosphere. Perhaps the title “DSM V in Distress” gives us a clue. A more accurate title may have been “Dr Allen Francis in Distress over DSM”. Dr. Francis was the chair of the previous (4^th) edition of the American Psychiatric Association’s classification system of mental disorders, the DSM. He is well known to be seriously unhappy with the way his successors are carrying out their task and has taken aim at one of their candidates for inclusion, the subthreshold stage of psychotic illness. In a quixotic adventure of his own, he has had a dramatic tilt at a windmill of quite a different kind; the mental health policy of another country. We have been caught in a reckless crossfire. Flattering to deceive, Dr. Francis seems to be totally unaware of the facts concerning recent progress in Australia. Here is the background to and the essential elements of Australia’s mental health reform package.

The Australian Context and The Facts of the Reforms

Mental health reform was a key element in the Australian Government’s Health and Hospitals Reform Commission, chaired by Dr. Christine Bennett, whose report was handed down in 2009. This process combed through the evidence base and selected 14 areas for action in mental health. Top of this list were new community based services for young people and the scaling up of the EPPIC model for first episode psychosis. Over the course of the next 12 months and through an election campaign, mental health reform received strong and unprecedented support from across the Australian community, all sides of politics and a uniquely cohesive mental health sector. The re-elected Labor government made a commitment to enact this reform in its second term and embarked on a further wave of community consultation. I was asked to join an Expert Working Group on Mental Health to advise the new Minister for Mental Health, the Hon. Mark Butler, along with many other leaders from the mental health and related sectors. The ultimate reform package however was decided upon by the government and has received unprecedented support from the mental health sector and the Australian community. The Mental Health Council of Australia, the peak body representing the sector nationally, is in full support. The reform covers many aspects of mental health care, not only youth and early intervention, and is the result of a national team effort, not naïve charisma, spin doctoring or a national snake oil scheme. To imply such is not only to reveal ignorance of the facts but is patronising and disrespectful to the Australian community, to the Government and indeed all sides of Australian politics, to the mental health sector, and to those most directly affected by mental ill health who desperately depend upon this investment.

Far from charisma-based reform, this is progress driven by unacceptable levels of unmet need and based upon the best available evidence. Its focus is spread across all stages of illness and the total investment adds up to $2.2bn over 5 years. The largest single allocation of over $500m is actually devoted to those with severe and enduring mental illness.

The $400m focused on youth mental health and early psychosis has little to do with prevention and nothing to do with the “psychosis risk” windmill that Dr Francis is attacking. It has everything to do with the fact that young people bear the major burden for onset of mental disorders with 75% of these appearing before the age of 25 years (25% before age 12 and 50% between 12 and 25). Young people also have the highest prevalence of any group yet the worst access to care by far. So it is treatment needs not prevention that is driving this aspect of our national reforms.

Approximately $200m is to be spent on Australia’s highly successful “headspace” initiative. This will mean that young Australians aged between 12 and 25 years will have access to 90 youth-friendly portals or one-stop shops where stigma-free and holistic mental health care will be available. Up to 100,000 young people will eventually benefit. Commenced in 2006 and currently operating successfully in 30 sites, this enhanced primary care model has started to lift the proportion of young people with diagnosable mental and substance use disorders who receive any kind of mental health care from the basement level of 25% (13% for young men). The type of help on offer ranges from information and support through specialised forms of counselling and psychological interventions and access to youth friendly GPs, and in some sites to psychiatrists as needed. All forms of mental ill-health are eligible and the model has no specific connection to psychosis or subthreshold psychosis/psychosis risk.

The $200m allocated to scale up the EPPIC model around Australia is to implement a model of care developed in Melbourne 20 years ago. It was a response to the fact that, even when young people developed clearcut psychotic illness, where the diagnosis of first episode psychosis was in no doubt, long treatment delays, often for years, occurred during which their lives and futures were seriously damaged. Furthermore when they did enter treatment it was provided in facilities geared to the needs of much older adults with severe and disabling illnesses. The result was poor engagement, poor recovery and secondary trauma in many cases. The EPPIC model, or versions thereof, has now been adopted successfully in hundreds of centres around the world, and across the board in several countries, including England, Canada, the Netherlands, and other parts of Western Europe, Asia and even in the State of Oregon in the USA. The International Early Psychosis Association has held 7 large and successful conferences all over the world and the field has generated large volumes of evidence and an international group of experienced experts in early psychosis.

Consequently, there is very good evidence now that EI for first episode psychosis is more humane, effective, and highly cost-effective. So Australia is hardly being reckless in belatedly implementing its own innovation, some 10 years after England and many other parts of the world have done so. This aeroplane took off years ago. Dr. Francis like other critics of early intervention in psychiatry seeks to confuse the treatment of first episode psychosis with efforts to intervene at an earlier stage, the so-called subthreshold stage or the “ultra-high risk” stage. The latter issue has nothing to do with the Australian reforms which are an overdue catch up/scale up effort in relation to EPPIC, and an essential and welcome response to huge levels of unmet need in the case of headspace and youth mental health more broadly. Finally, unlike in the US health care system, these models of care are guided by young people themselves and their families, not dominated by medication, and are heavily influenced and respectful of the value of psychosocial care, which in our system is covered within our system of universal health insurance.

 Psychosis Risk

Turning to the question of psychosis risk and the ultra-high risk (UHR) mental state that Prof Alison Yung and I described and operationalised over 15 years ago, this is an important frontier for mental health care. Personally, I am not concerned whether it enters the DSM V or not, and indeed believe that there may well be a better way via a much broader spectrum clinical staging approach to address the clinical needs of these young people (which I have described elsewhere (McGorry et al 2010)). There may be a better way through this strategy to resolve anxieties about “false positives” since other diagnostic outcomes are included with many advantages, especially in relation to risk benefit considerations. The young people who do meet the current UHR criteria we defined for the ultra-high risk (UHR) mental state are distressed by symptoms of anxiety, depression and low grade or subthreshold psychotic symptoms. Their ability to function at school or work is substantially impaired and they have cognitive impairments. They are seeking and in need of help and treatment and are certainly not “non-patients” by any measure. They also have 200-400 times the risk of the normal population of developing a sustained psychotic disorder. It is true that the around two thirds will not in fact follow this path. These figures are similar to but more pronounced than the level of risk that someone with impaired glucose tolerance possesses for developing frank diabetes. There is no sense that interventions such as information, diet and exercise should be withheld from such people. Why a double standard? Why cannot young people in need of care not be provided with information on the level of risk, the things they can do to reduce the risk and the care they need for their current problems. Especially when this appears to reduce the risk of psychosis? The evidence that my colleagues and I and other groups has assembled through our research clearly shows that antipsychotic medications are not necessary or indicated at this stage and that psychosocial treatments and even fish oil is sufficient as first line. The metanalysis of Preti et al (2010) shows that the transition rates to frank psychosis can be reduced from around 30% to 10% at least in the short term. Our own latest research also shows that the initial level of distress and functional impairment also improves greatly with conservative psychosocial care. These facts are enshrined in international clinical practice guidelines published in 2005. We haven’t changed our approach merely firmed it up with additional research.

It may be true and indeed it is already that untrained and unregulated practitioners in unregulated settings will still inappropriately prescribe for such patients. The best way to prevent this is to allow such patients to enter more specialised youth mental health settings especially where program and guideline fidelity to treatments can be audited. So while the UHR or psychosis risk concept was in no way a driver of the headspace and EPPIC reforms, the concerns that Dr. Francis expresses regarding the potential harms that may befall UHR patients, notably inappropriate medication and stigma will be much less likely. In the USA even without the UHR concept entering the DSMV and in the absence of any stream of care for early psychosis or youth mental health there is widespread inappropriate use of medication in such patients. This stage of illness will be a key focus for ongoing research to better define the range and sequence of interventions that will be safest and most helpful.

 Reform and Its Challenges

As Naomi Oreskes and Eric Conway illustrates in their compelling book “Merchants of Doubt”, evidence-based progress is not only hard won but can be undermined and delayed by the misuse of scientific arguments in support of vested interests of various kinds. She uses the examples of the link between cigarette smoking and cancer and also climate change. While not all resistance to change is so poorly motivated, vested interests and hidden agendas of other kinds can still delay the implementation of evidence based advances. Recognition of the barriers in the path of implementation of new knowledge has led to a whole new area of scientific endeavour known as implementation science and translational research. In Australia, the scaling up of an Australian innovation, early intervention for psychosis, has been delayed by this dynamic. It is not just a matter of reasonable scientific conservatism, since such reactions have not surfaced in relation to other aspects of reform in mental health over the past 20 years. With the Government’s recent budget announcements, we appear to have crossed a Rubicon in Australia, and the challenge is now high fidelity implementation strategies buttressed by rigorous health services research to measure the impact and outcomes of the reform. Early psychosis care with its vital focus on minimising treatment delays for first episode psychosis and guaranteeing holistic biopsychosocial care during the critical years post diagnosis is the best buy in mental health reform. The aeroplane left the ground 15 -20 years ago. EI for first episode psychosis is feasible now, not decades down the track as suggested by Dr. Francis. Far from labelling Australia as reckless, the Director of the National Institute for Mental Health (NIMH) in Washington DC, Dr. Tom Insel, recently stated at a national workshop on mental health research hosted by the NHMRC in Canberra, that Australia was a decade ahead of the US in research, clinical care and reform in early intervention for psychosis and other forms of mental ill-health in young people. We must ensure that the benefits of this progress to hundreds of thousands of Australians are not undermined by merchants of doubt with other agendas.

References:

McGorry PD, Nelson B, Goldstone S, Yung AR. Clinical staging: a heuristic and practical strategy for new research and better health and social outcomes for psychotic and related mood disorders. Can J Psychiatry. 2010;55(8):486-497.

McGorry P. Risk syndromes, clinical staging and DSM V: new diagnostic infrastructure for early intervention in psychiatry and schizophrenia. Schizophrenia Research. 2010; 120: 49 – 53.

Preti A, Cella M. Randomized-controlled trials in people at ultra high risk of psychosis: a review of treatment effectiveness. Schizophrenia Research. 2010;123(1):30-36.

Oreskes N. and Conway E.M. Merchants of Doubt. Bloomsbury Press. NewYork. 2010

Professor McGorry prepared his blog entry in response to criticism by me (Australian of the Year Patrick McGorry’s call for early intervention to prevent Psychosis: A Stitch in Time or a Step too Far?) and others of his past advocacy of antipsychotics as a measure to prevent psychosis and his support for the inclusion of a Psychosis Risk Syndrome in the next edition of the handbook of psychiatry, DSMV.

Following Professor McGorry’s blog is my response which details his past advocacy of the pre-psychosis use of antipsychotics, welcomes his recent change of heart but challenges him to join with his long term research partner, Dr Alison Yung, and oppose the inclusion of a Psychosis Risk Disorder in DSMV.

Responding at the earliest opportunity to emerging mental illnesses – by Patrick McGorry

6 December 2010 – 11:01am copied with permission from http://www.patmcgorry.com.au/blog/pmcgorry/responding-earliest-opportunity-emerging-mental-illnesses

One of the most important areas in mental health research is exploring how to delay or prevent the onset of severe mental illnesses such as psychotic illness, especially schizophrenia.   Twenty years ago this possibility was out of reach.  Now thanks to Australian-led research it is much closer.  Yet despite the great potential for this emerging field to avert distress, disability and death, it remains poorly understood within the community and recent progress is often actively misrepresented in the media and public discourse.  Such confusion and misrepresentation creates unnecessary public anxiety and risks weakening the imperative to provide safe forms of early intervention for those most in need.  I am writing this piece with the goal of clarifying the issues, the latest evidence and my own views which derive directly from the scientific evidence base and twenty years of clinical experience in this field.

Summary of key points

• Mental ill-health and a need for support, assessment and care, precedes the onset of psychotic symptoms in most people who develop a psychotic illness, especially schizophrenia.
• It is now possible to recognize in advance a set of symptoms which indicate a much greater risk for developing clearcut and severe psychotic illness.
• This enables safer and potentially more effective treatments to be offered prior to the onset of psychosis which aim to firstly respond to the immediate problems, symptoms and functional disability that has already manifested, and to secondly try to reduce the risk of progression to more severe forms of ill-health, particularly but not exclusively psychotic disorder.
• The support and interventions should be offered in a stepwise way, starting with personal support and information, supportive case management and problem-solving, moving onto trials of CBT and omega 3 fatty acids, all of which have a good risk benefit ratio.  Anti-depressants may also be considered if depression is severe and has not responded to CBT.
• Antipsychotic medications should not be considered unless there is a clearcut and sustained progression to frank psychotic disorder meeting full DSM 4 criteria.
• The only exception to the previous statement is where there has been a definite failure to respond to the first and second line interventions described above AND there is worsening and continuing disability, or significant risk of self-harm, suicide or harm to others arising directly from the mental disorder itself and its symptoms. In this situation, a trial of low dose antipsychotic medication for 6 weeks in the first instance may be appropriate, with careful monitoring for adverse events.
• All such care must be offered in stigma-free environments such as primary care or youth mental health settings and not in services designed for the care of the seriously mentally ill.
• Further research is required to define a clearer evidence base to guide stepwise decision making in the treatment of the pre-psychotic stage of early psychosis.

Psychosis can be devastating for individuals, their families and weakens our society.  Emerging in young people on the threshold of productive life, it poses a huge threat to health, career, personal fulfillment and even survival.   As a matter of equity, people who are experiencing psychosis or have a high risk of doing so should enjoy the same access to stigma-free quality care in a timely fashion just as is routinely the case with physical illnesses of comparable severity.

 Just as with heart disease and cancer, every reasonable effort should be made to avert as much distress, discomfort and long term collateral damage from psychosis as is possible. What that means in practice is identifying the earliest opportunities for detection and intervention and the safest and most effective means of preventing and treating emerging psychosis.  Our goal is to modify the impact and course of the illness, that is to preempt the disabling aspects.  Cure probably remains out of reach for most at this stage but substantially better recovery and long periods of freedom from illness are definitely attainable for the majority of people with psychosis.

 Psychosis tends to first emerge in adolescence or early adulthood. Over the last twenty years, it has been demonstrated that early detection, optimum treatment and support for recovery produce much better short and longer term outcomes for young people experiencing their first episode of psychosis.  This evidence also shows that these better outcomes are achieved with lower costs so that precious resources are freed up and can be used to strengthen and expand mental health and social services for other groups of people including those with persistent illness, children and the elderly.

Early detection and specialized care of young people with first episode psychosis and subsequently was initially the main international focus. Yet we have known for a long time that psychotic illness usually builds up over a period of time and is preceded by “prodromal” features, which distress, disable and attract concern and even stigma, yet do not yet manifest clearcut psychotic features such as delusions and hallucinations.  This held out the exciting possibility that we might be able to identify people who were “en route” to psychosis and not only provide care for their current problems but also intervene to reduce the risk of progression to more severe and clearcut psychosis.  

This challenge prompted a key breakthrough, developed originally by my colleague Prof Alison Yung and I in 1994, and elaborated since in many other overseas centres, which has enabled us to identify young people with high levels of risk of developing psychosis within the next year or so.  This was the reliable definition of the “Ultra High Risk” mental state which predicted progression to psychosis surprisingly accurately.  Young people in this “Ultra High Risk” group are already experiencing a range of mental health and social problems, are in need of care and actively seeking help.    They can typically be expected to have between a one in five to a one in two chance of progressing to a first episode of psychosis within 12 months (that is between two and four hundred times the rate within the general population).  They also are at risk of other persistent mental disorders in addition to psychosis.  But in addition to the potential risk, which is significant, they are in immediate need for care for distress and impairment that they are already experiencing.   What that care should consist of is being actively studied and clinical guidelines have been carefully developed based on the evidence and experience accumulated to date.

The Ultra High Risk criteria have been further studied internationally and have been proposed as a new category in the next edition of the DSMV manual, the US based system of diagnosis in psychiatry.  This proposal has been controversial, because of fears of extending antipsychotic medication more widely in the population and fears that labeling people as being at risk (even if already experiencing mental ill-health) may be harmful.   Both of these concerns are valid, though both can and have been addressed in our work and systems of care in Melbourne. 

 One obvious benefit of the ability to engage and monitor young people with a high risk of developing such a serious illness is obviously in reducing treatment delays once the threshold to first episode of psychosis has been reached and thereby to facilitate better outcomes. But aiming higher, can being offered access to care as a member of the Ultra High Risk group benefit a young person by prompting care responses that delay or prevent the onset of a first episode of psychosis?

This important question has been a subject that I and other colleagues, notably Alison Yung, have been researching over the last twenty years. As a result of this and other research – a total of 6 clinical trials now, we can now say that with appropriate intervention, it does appear to be possible to delay the onset of a first episode psychosis amongst members of the Ultra High Risk group. This finding, unimaginable twenty years ago, is highly encouraging as it gives grounds for optimism that further research may establish whether it is also possible to prevent the onset of a first episode psychosis within this group.  Several approaches to treatment that have been studied seem to be able to delay the progress to psychosis as well as alleviate the distressing and disabling symptoms that affect people at this stage of illness.

This week at the Seven^th International Early Psychosis Conference in Amsterdam, we launched the most recent version of the Australian Clinical Guidelines for Early Psychosis. These guidelines, which distill the very latest research evidence, specify that recommended interventions for this Ultra High Risk Group are a combination of Omega-3 fatty acids, Cognitive Behavioral Therapy and supportive counseling as well as, in some cases, medication for other diagnosed conditions that may be present (for example depression) as well as psycho-education for family members.

The guidelines explicitly state that anti-psychotic medication should not be considered as a first line treatment option for the Ultra High Risk group. Only in exceptional circumstances, where there is rapid worsening of psychotic symptoms combined with an elevated risk to the young person or others should consideration be given to the use of low dose anti-psychotic atypical medication. Even then, the use of anti-psychotic medication would normally not be justified.  The rationale for this is that safer treatment options should always be offered before those which carry increased adverse effects and risk.  This is a fundamental principle in medical care: “first do no harm”.  Only if the initial safer option fails should progress to the next level occur according to a “staging model” which we have explicitly developed and described in recent publications.  These guidelines restate and reinforce the earlier international guidelines produced by the IEPA in 2005 which my colleagues and wrote in a collaborative fashion with other international experts.   The evidence that has accumulated since that time strengthens the position taken in 2005 – there has been no reversal of that position.

This last point about the use of anti-psychotic medication within this group is very important as the stated position of myself and my colleagues about this issue is occasionally misreported or misrepresented. There is a clear distinction to be made between research trials and clinical guidelines, a distinction which is sometimes not made clear.   Our group in Melbourne has researched a number of potential interventions to reduce symptoms, disability and risk in the Ultra High Risk group,  including befriending, cognitive behaviour therapy, supportive case-management, family support, omega 3 fatty acids, lithium, anitdepressants and  low doses of anti-psychotic medication. All of this research has been approved by an independent ethics committee and all participants have of course provided fully informed consent to be involved.  This results have demonstrated that such not only supportive care, cognitive behaviour therapy and omega 3 fatty acids, but also low dose anti-psychotic medication may be effective in delaying the onset of first episode psychosis.

However, our clinical guidelines do not (and have never done so in the past) recommend the use of anti-psychotic medication as the first line or standard treatment for this Ultra High Risk group.  This is because other, safer interventions are equally effective in delaying the onset of psychosis and, despite the greatly elevated risk, it is equally true that most of the Ultra High Risk group will not experience a first episode of psychosis, so many could be receiving antipsychotic medications unnecessarily.  The key issue is timing and careful consideration of benefits versus risks in consultation with the patient and their family. The most promising initial combination so far is omega 3 fatty acids combined with cognitive-behavioural case-management; safe and effective as first line care.   We therefore believe that further research would be required before it could be known whether and in what circumstances, low dose anti-psychotic medication may have a role later in the sequence of treatment of the ultra high-risk group.  It may be for some patients, in the era of short duration of untreated psychosis, even when they have crossed the threshold to fully-fledged  psychosis, that antipsychotic medications may able to be avoided if expert psychosocial care is available.   This is something we are also researching.  

In summary we are trying to define the sequence of decision points for every patient based the balance between benefit and risk, not only for the present day but also for the future.  And not only for psychotic illness but for several other dimensions of mental ill-health.   This is a mainstream evidence based approach that is fully supported everywhere else in health care.  We need to see it embedded in mental health care too.

Martin Whitely’s response to Patrick McGorry’s Blog

Some welcome news but there is unfinished business- Psychosis Risk Syndrome and the DSMV

I wholeheartedly agree with Professor McGorry’s that the best way to prevent psychosis is ‘appropriate’ early intervention. However, I and other far more qualified critics have passionately disagreed with Professor McGorry’s past advocacy of antipsychotics as an ‘appropriate’ early intervention.

There is reason to be optimistic in the recent blog (copy above) prepared by Professor Patrick McGorry. His statement that ‘Antipsychotic medications should not be considered unless there is a clear-cut and sustained progression to frank psychotic disorder meeting full DSM 4 criteria’ is welcome. It appears to put an end to the debate about whether Professor McGorry currently advocates the use of antipsychotics on the hunch that adolescents will later become psychotic. While it is of some concern that the text immediately following the above statement leaves the door open to ‘off label’ psychosis risk prescribing, Professor McGorry’s is clearly less enthusiastic than he has been for broadening  the use of antipsychotics.^[1]

However, the statement in his blog that ‘our clinical guidelines do not (and have never done so in the past) recommend the use of anti-psychotic medication as the first line or standard treatment for this Ultra High Risk group’ has the potential to mislead. Casual readers may take this to mean that Professor McGorry and his allies have never advocated the use of antipsychotics in order to prevent psychosis.

As stated in my blog a fortnight ago ‘for over a decade Patrick McGorry has experimented with, or advocated, the prescription of antipsychotics to adolescents on the hunch that they may later become psychotic.’ Professor McGorry was the lead author of a 2006 article which as part of a proposed ‘clinical staging framework for psychosis’ identified ‘atypical antipsychotic agents’, as one of the ‘potential interventions’ for individuals who are at ‘ultra high risk (10% to 40%)’ of developing first episode psychosis.^[2] Whilst he has recently adjusted the ‘clinical staging framework’ he was still advocating antipsychotics as a potential pre-psychosis intervention at least as late as October 2007.^[3]

In addition a 2007 British Medical Journal article jointly authored by Dr Alison Yung and Professor McGorry began by quoting 1994 paper by Mrazek and Haggerty extolling the potential of pre-psychosis pharmacological interventions: ‘The best hope now for the prevention of schizophrenia lies with indicated preventive interventions targeted at individuals manifesting precursor signs and symptoms who have not yet met full criteria for diagnosis. The identification of individuals at this early stage, coupled with the introduction of pharmacological and psychosocial interventions, may prevent the development of the full-blown disorder.’

Dr Yung and Professor McGorry’s opening comment followed; ‘Such sentiment underlines the aim of identifying people in the prodromal phase preceding a first psychotic episode.’^[4] Their article went on to outline evidence supporting interventions including antipsychotics ‘to delay or even prevent onset of psychosis.’

Furthermore, in 2008, in the British Medical Journal, in an article titled ‘Is early intervention in the major psychiatric disorders justified? Yes’ Professor McGorry wrote; ‘Early intervention covers both early detection and the phase specific treatment of the earlier stages of illness with psychosocial and drug interventions. It should be as central in psychiatry as it is in cancer, diabetes, and cardiovascular disease….. Several randomised controlled trials have shown that it is possible to delay the onset of fully fledged psychotic illness in young people at very high risk of early transition with either low dose antipsychotic drugs or cognitive behavioural therapy.’ ^[5]

These are just a few of numerous similar statements which comment favourably or suggest the use of antipsychotics as part of the treatment for adolescents considered to be at ‘ultra high risk’ of developing psychosis.  Whether such comments constitute ‘advocacy’ is open to semantic debate however, Professor McGorry certainly favoured this highly controversial use.

Professor McGorry’s argues in his blog ‘that recent progress is often actively misrepresented in the media and public discourse. Such confusion and misrepresentation creates unnecessary public anxiety and risks weakening the imperative to provide safe forms of early intervention for those most in need.’ If there is confusion it is because Professor McGorry has never, even in his blog, unambiguously acknowledged he did favour the use of antipsychotics pre-psychosis and now (recent progress) he does not.

The closest Professor McGorry comes to acknowledging his previous position in his blog is when he states; ‘the use of anti-psychotic medication within this group is very important as the stated position of myself and my colleagues about this issue is occasionally misreported or misrepresented. There is a clear distinction to be made between research trials and clinical guidelines, a distinction which is sometimes not made clear.’

The articles cited above as evidence of Professor McGorry’s past advocacy of antipsychotics were all editorial pieces in which Professor McGorry summarised research and suggested appropriate treatment responses. They may not have been formally endorsed ‘clinical guidelines’ but to use that restricted criteria to imply that he has not previously advocated the use of antipsychotics is spin more suited to politics, the search for power, than science, the search for truth.

Nonetheless, Professor Mcgorry’s change of position is welcomed, however, there are two outstanding issues that require resolution. Specifically the issue of ‘off label’ pre-psychosis prescribing and the inclusion of Psychosis Risk Syndrome or Attenuated Psychosis Syndrome in DSMV. Professor McGorry leaves the door open to ‘off label’ prescribing and persists with his advocacy for the inclusion of a Psychosis Risk Syndrome in the DSMV.

In contrast his long term research partner Dr Alison Yung, presumably because of her long term exposure to the scientific evidence and the related medico-political processes, has changed her position. She is now suspicious enough to ask ‘So why the need for a specific (psychosis) risk syndrome diagnosis? Is the agenda really to use antipsychotics?’^[6]

I share Dr Yung’s suspicion.

Specifically Professor McGorry is a leading international advocate for the inclusion of Psychosis Risk Syndrome, otherwise known as Attenuated Psychotic Symptoms Syndrome, in the next edition of the clinically dominant Statistical Manual of Mental Disorders (DSM-V) due for publication in 2013. He acknowledges that ‘the false positive rate may exceed 50-60%’ nonetheless has justified the use of pre-psychosis drugs by arguing ‘all those identified are by definition seeking help and need some form of care’.^[1]

Criticism of his views on the use of pre-psychosis drugs have received limited publicity within Australia. However, in 2006 Time Magazine (Drugs before Diagnosis) stated ‘Calm and softly spoken, McGorry has a way of making the experimental use of antipsychotics seem like the only responsible course.’ Time outlined how Professor McGorry trialled the antipsychotic, Risperidone, on subjects without psychosis but that were suspected of being at risk of developing psychotic disorders such as schizophrenia.^[2]

Risperidone (also known as Risperdal) is one of the more commonly used antipsychotics and has a range of serious potential side effects including metabolic syndrome, and sudden cardiovascular death.^{[3] [4]} There have been more than 500 voluntary adverse event reports made to the TGA and these are just the tip of the iceberg as the vast majority of adverse events are never reported. ^{[5] [6]}

The results of Professor McGorry’s Risperidone trial were inconclusive; however Time describes McGorry’s determination to push on ‘full steam ahead – and damn the torpedoes.’^[7] And Professor McGorry did push ahead, but now many of his international colleagues in the psychiatric profession are pushing back.

Dr Allen Frances the American Psychiatrist who led the 1994 revision of the current edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) is a fierce critic of Psychosis Risk Syndrome. With the benefit of hindsight he regrets aspects of the 1994 revision for having triggered ‘three false epidemics. One for autistic disorder… another for the childhood diagnosis of Bi-Polar disorder and the third for the wild over-diagnosis of Attention Deficit Disorder.’^[8] Based on this experience Dr Frances warns of numerous problems with the drafting of the next edition DSM-V, recently writing that;

‘Among all the problematic suggestions for DSM-V, the proposal for a “Psychosis Risk Syndrome” stands out as the most ill-conceived and potentially harmful… 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.”^[9]

Dr Frances contends that up to 90% of those diagnosed with Psychosis Risk Syndrome would never go onto develop psychosis and concludes it is ‘the prescription for an iatrogenic [adverse effects resulting from treatment] public health disaster’.^[10]

Critics closer to home include Adelaide University Associate Professor, and Head of the Department of Psychological Medicine at the Women’s and Children’s Hospital in Adelaide, Dr Jon Jureidini, who in the August 2010 said that Professor McGorry had falsely claimed that 750,000 young Australians were ‘locked out’ of care they ‘desperately’ needed. ‘He’s taken the biggest possible figure you can come up with for people who might have any level of distress or unhappiness, which of course needs to be taken seriously and responded to, but he’s assuming they all require … a mental health intervention…It’s the way politicians operate. You look at figures and put a spin on it that suits your point of view. I don’t think that has a place in scientific conversations about the need for health interventions.’^[11]

Even one of Professor McGorry’s colleagues at the Orygen Youth Health Research Centre, Alison Yung, recently expressed strong opposition to the inclusion of Psychosis Risk Syndrome in DSM-IV stating;

‘I think the issue of antipsychotics is a crucial one. If someone meeting risk syndrome criteria also has depression and anxiety (the majority do), could they not be treated with psychological therapies such as cognitive behavioral therapy? So why the need for a specific risk syndrome diagnosis? Is the agenda really to use antipsychotics? …….I think there are concerns about validity, especially predictive validity, and this relates to potentially stigmatizing and unjustified treatment for some individuals as well as all the negative social effects of diagnosis. I think including the risk syndrome in the DSM-V is premature…….more people seek help, but the risk is that instead of getting maybe supportive therapy, they get antipsychotics and they will be diagnosed with the risk syndrome.’^[12]

Perhaps due to his Australian of the year status Professor McGorry is frequently quoted by the Australian media as an independent advocate for mental health reform. However he, and organisations he is influential in, have received support from the pharmaceutical industry.  Along with being treasurer and former president of the pharmaceutical industry funded International Early Psychosis Association,  McGorry is currently Director of Clinical Services at Orygen Youth Health Clinical Program and Executive Director of the Orygen Youth Health Research Centre. Orygen Youth Health Research Centre receives support from numerous pharmaceutical companies.^{[13] [14]} Professor McGorry individually has received unrestricted grants from Janssen-Cilag, Eli Lilly, Bristol Myer Squibb, Astra-Zeneca, Pfizer, and Novartis and has acted as a paid consultant for most of these companies.^[15]

Professor McGorry and his colleagues Professor John Mendoza and Professor Ian Hickie (who also recive support from the pharmaceutical industry) dominated the long overdue debate about mental health policy in the lead up to the August Federal election.^{[16] [17]} Anyone who watched Insight on SBS (27 July 2010) would have noticed how deferential the presenter, politicians and participants were to Patrick McGorry, and to a lesser extent John Mendoza. Their blessing was desperately being sought by Peter Dutton and Mark Butler on behalf of the Coalition and Labor respectively.

Most enamoured of Professor McGorry’s approach was Dutton who stated “Well, we’re going to roll out a national scheme based on advice by people like John Mendoza, Pat McGorry, Ian Hickey, David Crosby and others….early intervention is proven without any doubt to work.”^[18] Mendoza reciprocated Dutton’s admiration describing the Coalition’s approach as “streets ahead. It’s literally comparing an old clunker to a brand new motor vehicle.” Largely due to the advocacy of Professor McGorry and his allies Mental health was unquestionably a net positive for the Coalition in the election.

Professor McGorry is now pressuring the Gillard Government to match the Coalition’s 2010 election commitment of $440m to EPPIC (Early Psychosis Prevention and Intervention Centres)  like those run by Orygen Youth Health which is headed up by McGorry.^[19] These centres aim “to facilitate early identification and treatment of psychosis” and “reduce delays in initial treatment”.^[20] It is undeniable that early intervention in the form of identifying and addressing real problems must be supported. But the majority of Adolescents ‘seeking care’ and diagnosed with Psychosis risk Syndrome would not only suffer their original difficulties but posibly from the unnecessary administration of potentially harmful antipsychotics. Professor McGorry has justified this compromise of the Hippocratic obligation to ‘first do no harm’ by arguing the ‘real danger of lack of care overshadows the theoretical one of premature labelling and overtreatment.’^[21]

Irrespective of these concerns there is no doubt Professor McGorry is a fantastic salesman. He combines excessive pessimism about the widespread prevalence of mental illness and unmet need, with optimistic promises of ‘21^st Century’ solutions (which happen to have been developed by him and his allies) if only government will urgently fund these ‘proven approaches’.^[22]

Mental Health does deserve the national spotlight and we can be grateful that Patrick McGorry’s appointment as Australian of the Year put it on the agenda. But the public are entitled to and informed debate about exactly what is being advocated.

Access to appropriate early intervention in mental health is long overdue, however prescribing antipsychotics to adolescents on the outside chance that they may develop later psychosis, is a bit like killing a fly with a shotgum.