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Is the $3.5b Patrick McGorry endorsed ‘Independent Mental Health Reform Group’ blueprint for Australian Mental Health a prescription for more ‘psychiatric disorders’, youth suicides and an epidemic of iatrogenic (adverse prescription drug event) suffering?

First published May 2011

Former Australian of the Year, Professor Patrick McGorry, and to a lesser extent his close colleague Professor Ian Hickie, have dominated the long overdue debate about the future of mental health service delivery in Australia. Their claims of massive unmet need and proven 21st Century solutions are being accepted almost without question by the Gillard Government, the Abbott Opposition, the independents, the media and therefore the public.

 

In December 2010 Mental Health Minister Mark Butler, took the extraordinary step of sidelining the Australian College of Psychiatry and his own Mental Health Advisory Board and appointed Professors McGorry and Hickie as members of the Mental Health Expert Working Group. Minister Butler said ‘that the creation of the new, time limited, specialist group will allow for targeted advice to be provided directly to the Australian Government on how to achieve the most coordinated, cost-effective and lasting reforms for their investment in mental health care.’[1] 

 

For reasons that are not clear Professors McGorry and Hickie and fellow member of the Mental Health Expert Working Group, Monsignor David Cappo subsequently established the Independent Mental Health Reform Group. In March this year the Independent Mental Health Reform Group released its $3.5B blueprint for mental health.[2] 

So what is in Professor McGorry’s blueprint for Australian mental health for organisations run by him?

The blueprint outlines $3.5billion expenditure over 5 years on programs that are identified as mental health ‘best buys’. The most Centres (EPPIC). Australia’s only EPPIC clinic is run by Orygen Youth Health headed up by expensive ‘best buy’ at $910m is for the rollout of 20 new Early Psychosis Prevention Intervention Professor McGorry.[3] The blueprint states EPPIC has ‘the largest international evidence base of any mental health model of care demonstrating not only their clinical effectiveness but also their return on financial and social return on investment.’ Despite this bold claim there was no evidence in the blueprint of EPPIC’s cost effectiveness or of patient outcomes compared to other mental health services.

 

The second most expensive program is for the expansion of the national Headspace program to 90 service sites at a cost of $226m. Professors McGorry and Hickie are both board members of Headspace. Again there was no supporting evidence. In fact the entire blueprint is completely unreferenced. It is merely a $3.5billion consensus wish list of these supposedly independent mental health experts completely devoid of supporting verifiable evidence.

 

That is not to suggest Headspace and even EPPIC don’t provide some valuable interventions and that there may be some merit in the other programs identified. However, the blueprint falls far short of establishing the case that these programs are the best way to allocate an extra $3.5 billion of taxpayer’s funds.   

 

How ‘independent’ was the Independent Mental Health Reform Group that helped Professor McGorry develop the blueprint?

 

Professor McGorry and organisations he is influential in, have received considerable support from the pharmaceutical industry.  Professor McGorry individually ‘has received unrestricted research grant support from Janssen- Cilag, Eli Lilly, Bristol Myer Squibb, Astra-Zeneca, Pfizer, and Novartis. He has acted as a paid consultant for, and has received speaker’s fees and travel reimbursement from, all or most of these companies.‘[4] 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. [5]  Orygen Youth Health Research Centre receives support from numerous pharmaceutical companies.[6]

Professor Ian Hickie has received the grants totalling $411,000 from pharmaceutical companies including $10,000 from Roche Pharmaceuticals (1992); $30,000 from Bristol-Myers Squibb (1997); $40,000 from Bristol-Myers Squibb (1998-1999); $250,000 from Pfizer Australia (2009); $81,000 from Pfizer Australia (n.d.).[7]

Along with Professors McGorry and Hickie and Monsignor David Cappo the other members of the ‘independent’ group are Sebastian Rosenberg, John Moran and Mathew Hamilton. John Moran and Mathew Hamilton both work for Orygen and therefore are subordinates of Professor McGorry. Sebastian Rosenberg is the former CEO of the Mental Health Council and is currently a director of the mental health business ConNetica's whose website lists one of its ‘Private Sector Customers’ as Eli Lilly.[8]

Neither Professors McGorry or Hickie or any other member of the Independent Reform Group disclosed their pharmaceutical company connections in the blueprint. Neither did the blueprint identify as the mental health ‘best buys’ are based on service delivery models exclusive to organisations they control.

Why does Professor McGorry think that 4 million Australians will have a ‘psychiatric disorder’ requiring treatment in 2011 and what treatments does he propose?

In March 2010 when appearing on ABC’s Lateline, Professor McGorry said ‘4 million Australians have mental health problems in any given year. Only one third of them get access to treatment… there are 1 million young Australians aged 12 to 25 with a mental disorder in any given year. It's the peak period across a lifespan when mental disorders appear. And 750,000 of them have no access to mental health care currently.’[9] [10]

Public critics are rare, however not everyone accepts McGorry’s alarming claims. Adelaide University Professor of Psychiatry and Paediatrics and Head of the Department of Psychological Medicine at the Women’s and Children’s Hospital in Adelaide, Jon Jureidini, accused McGorry of disease-mongering when claiming 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]

Professor McGorry responded to Professor Jueridini’s criticisms writing ‘I have never argued that 1 million young Australians have serious mental illness’. However he added the ‘late intervention philosophy is associated with risk, preventable damage and stigma and for this reason access to appropriate, staged mental health care for young Australians with mild, moderate and serious mental ill-health is overwhelmingly supported by political parties and the health and social sectors (most recently expressed in a letter co-signed by 65 organisations). To argue that young Australians with mild to moderate mental ill-health do not need access to mental health care applies a standard to mental health that would not be acceptable in physical health. Imagine restricting access to health services to only Australians with severe physical ill-health and locking out all those with milder conditions with the admonition that they should just regard their distress as part of the human condition and suck it up!’[12]

Professor McGorry is of course correct in that there appears to be ‘overwhelming’ support by ‘by political parties and the health and social sectors’ for his calls for early intervention, however this is evidence of political rather than clinical or scientific success. There is undoubtedly unmet and mis-met mental health need but Professor Jueridini’s legitimate questions remain: In 2011 will more than one in seven Australian’s (4 million) have a ‘psychiatric disorder’ requiring a ‘mental health intervention’? Would these millions of Australian’s benefit from, or be stigmatised by being labeled ‘psychiatrically disordered’? And even more worryingly what are these potential interventions and will they do more harm than good? 

Why does Headspace and Professor McGorry advocate the ‘off label’ (unapproved) use of SSRI antidepressants in even ‘moderately depressed’ young people despite FDA and TGA warnings for the increased risk of suicidality?

 

A 2009 paper produced by Orygen Youth Health for Headspace and co-authored by Patrick McGorry titled ‘Using SSRI Antidepressants to Treat Depression in Young People: What are the Issues and What is the Evidence?’ correctly identifies that the US FDA has issued the highest possible ‘black box’ warning that the use of SSRI antidepressants increases the risk of suicidality in people under 24.[13] The warning was put on in 2005 after an analysis of clinical trials by the FDA found statistically significant increases of the risks of ‘suicidal ideation and suicidal behavior’ by about 80%, and of agitation and hostility by about 130%.[14]

 

Professor McGorry’s co-authored paper 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 than18 years’.[15] In addition the paper 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.’[16]

 

The body of the paper builds a compelling argument for avoiding the use of SSRI’s in young people. Despite this it concludes by recommending ‘In cases of (even) 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’.[17] The nearest thing to a rationale offered in the paper is that many young people who are depressed get no treatment and that it is better to do something than nothing.

 

Through the use of a variety of mechanisms including candle-light vigils Professor McGorry has mobilised well intentioned, vocal supporters including Get Up to highlight the tragedy of youth suicide to advocate for reform of mental health services for the young.[18] Yet Professor McGorry acknowledges and then ignores the clinical trial evidence and FDA and TGA advice on the relationship between SSRI antidepressants and youth suicidality.

 

If Australia were, as Professor McGorry frequently advocates, to follow ‘evidence based medicine’ on preventing the tragedy of youth suicide, we would not allow the use of SSRI’s on young people. However, if Australia follows Headspace and Professor McGorry’s advice on SSRI’s we risk there will be more, not fewer, candles at the next vigil.

Why did Professor McGorry’s experiment with the use of antipsychotics in non-psychotic adolescents and why does he advocate the recognition of controversial newly invented psychiatric disorders? 

Professor McGorry has a long history of advocating or experimenting with the ‘off label’ use of psychotropic drugs for moderate mental ‘illness’ and for hypothesised psychiatric disorders that are not officially recognised. He 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 American Psychiatric Associations clinically dominant Statistical Manual of Mental Disorders (DSM-V) due for publication in 2013.

Professor McGorry hypothesises that that there is ‘prodromal phase’ prior to the onset of a first psychotic episode. He acknowledges that ‘the false positive rate may exceed 50-60%’ nonetheless he led controversial research that trialled the use of the antipsychotic, Risperidone, on subjects without psychosis but that were suspected of being at risk of developing psychotic disorders such as schizophrenia.[19]

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.[20] [21] 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.[22] [23]

Dr Allen Frances the American Psychiatrist who led the 1994 revision of the current edition of the Diagnostic and Statistical Manual of Mental Disorders (DM-IV), is a fierce critic of Professor McGorry’s hypothesized Psychosis Risk Syndrome. With the benefit of hindsight Dr Frances 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.’[24]

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.”[25] 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’.[26]

Even one of Professor McGorry’s closest colleagues at the Orygen Youth Health Research Centre, Dr Alison Yung, has expressed strong opposition to the inclusion of Psychosis Risk Syndrome in DSM-V questioning; ‘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.’[27]

Professor McGorry still advocates for the inclusion of Psychosis Risk Syndrome in DSM-V however he recently distanced himself from the use of anti-psychotics on patients perceived to be at risk of psychosis. In response to earlier criticism including a blog I authored he wrote ‘Antipsychotic medications should not be considered unless there is a clear-cut and sustained progression to frank psychotic disorder meeting full DSM 4 criteria’ This appeared 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.

However, the statement in his December 2010 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.[28] Whilst it is true that Professor McGorry has never produced final endorsed clinical guidelines recommending the use of antipsychotics for his hypothesised ‘Ultra high risk group’ the facts are that for well over a decade Professor McGorry 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.[29] 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.

In a 2007 British Medical Journal article jointly authored by Professor McGorry began by quoting 1994 paper 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.’ Professor McGorry’s article’s opening comment followed; ‘Such sentiment underlines the aim of identifying people in the prodromal phase preceding a first psychotic episode.’[30] 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.’[31]

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 and continues to advocate for the official recognition of ‘Psychosis Risk Syndrome’ as a psychiatric disorder and to my knowledge has not ruled out further experimentation with antipsychotics for ‘PSR’. These are issues that need a clear resolution before there is any increased funding of Early Psychosis Prevention initiatives (i.e. EPPIC).

Where are other psychiatrists and the Royal Australian & New Zealand College of Psychiatry in the national mental health debate?

 

With the notable exception of Professor Jon Jueridini there has been little public criticism from within the Australian psychiatric profession of Professors McGorry’s plans for the future of Australian mental health. A number of psychiatrists I have spoken to are privately critical of Professor McGorry’s enthusiasm for biochemical interventions, however they are grateful that Patrick McGorry’s Australian of the year status has at least put mental health on the agenda and is likely to result in extra resources.

 

Whilst I am critical of the unquestioning acceptance of Professors McGorry and Hickie’s claims by politicians and the media it is not entirely their fault. Mental Health is a confusing and mysterious field clouded by personal and commercial agendas and politicians and the media have not been offered an alternative.

 

The Australian Psychiatric profession needs to start acting like a profession interested in cautious, first do no harm, ‘evidence based’ approaches to addressing unmet and mis-met mental health needs. The College of Psychiatry needs to stop being so timid. The Australian public needs a vigorous debate within the College of Psychiatry, the wider therapeutic community and the public to drive the future of Australian Mental Health. 

 

Isn’t it time to ask Professor McGorry a few tough questios?

 

I think unquestioningly following Patrick McGorry’s prescription for Australian mental health risks more harm than good. I am particularly concerned that a Headspace and Patrick McGorry endorsed spike in the prescription of SSRI antidepressants to children and young people may cost lives. And I think Professors McGorry’s pharmaceutical company ties and obvious conflicts of interest in advocating for well over a $billion increased funding for EPPIC and Headspace need to be understood and considered.

 

Professor McGorry needs to show that his claim that four million Australian’s will suffer a mental health disorder warranting treatment this year is not disease-mongering. He needs to detail what these psychiatric disorder are and exactly what appropriate treatments would involve. And Professor McGorry needs to explain why the FDA and TGA are wrong and why giving SSRI’s to depressed children and adolescents doesn’t increase their chances of suicidality.

 

And Professor McGorry needs to explain why he experimented with antipsychotics on adolescents who had never been and by his own admission probably never will be psychotic. Professor McGorry also needs to explain why Dr Alan Frances and even his close ally Professor Alison Yung are wrong to be concerned that his push for the recognition of ‘Psychosis Risk Syndrome’ as a new psychiatric disorder may be all about promoting the use of antipsychotics and may lead to result an ‘iatrogenic health disaster’.

 

Perhaps Professor McGorry really does have insights that make him uniquely placed to design Australia’s 21st century mental health system. However, now that the Gillard Government is on the verge of committing massive resources to aspects of Professor McGorry’s mental health blueprint it is time the Canberra politicians, the media and the Australian psychiatric profession got beyond his former ‘Australian of the Year’ status and asked him a few hard questions?

 

[1] Advisory Group to Guide Mental Health Reforms, Pro Bono News Posted: Thursday, December 23, 2010 http://www.probonoaustralia.com.au/news/2010/12/advisory-group-guide-mental-health-reforms (accessed 26 April 2011)

[2] Including, Connecting, Contributing- A Blueprint to Transform Mental Health and Social  Participation in AustraliaMarch 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)

 

[3] Orygen Youth Health - Early Psychosis Prevention Intervention Centre website http://www.eppic.org.au/about-us (accessed 26 April 2011)

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

 

[5] McGorry was the former President and is the current Treasurer (http://www.iepa.org.au/ContentPage.aspx?pageID=40) of the “International Early Psychosis Association” which is funded by antipsychotic manufacturers Astra Zeneca, Lilly and Janssen-Cilag (http://www.iepa.org.au/2010/)

 

[6]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 receives support from AstraZeneca, Bristol Myer Squibb, Eli Lilly, and Janssen-Cilag. Orygen Youth Health, Research Centre – Other Funding http://rc.oyh.org.au/ResearchCentreStructure/otherfunding (accessed 3 August 2010)

 

[7] Cited in Ian Hickie, Curriculum Vitae, last updated 23 August 2009 http://sydney.edu.au/bmri/about/Hickie_CV.pdf (3 August 2010)  In addition Professor Hickie and colleagues created the ‘SPHERE: A National Depression Project’ (http://sydney.edu.au/bmri/about/Hickie_CV.pdf).  As was reported in The Australian Pfizer work in conjunction with SPHERE through a company called Lifeblood who are paid to review SPHERE. Through the use of SPHERE Pfizer have restored Zoloft to the number one antidepressant in Australia. (http://www.theaustralian.com.au/news/health-science/gp-jaunts-boosted-drug-sales/story-e6frg8y6-1225890003658)

 

[8] ConNetica's website http://connetica.com.au/about (accessed 26 April 2011)

[9] Mental health system in crisis: McGorry Lateline, Australian Broadcasting Corporation Broadcast: 11/03/2010 Reporter: Tony Jones http://www.abc.net.au/lateline/content/2010/s2843609.htm (accessed 26 April 2011)

[10] In a presentation on behalf of Beyond Blue Professor Ian Hickie claimed the 12 month prevalence of mental disorders for Australia men is 17.4% and woman 18.0%.   Responding to the challenge of brain and mind disorders in Australia Ian Hickie MD FRANZCP Professor of Psychiatry, Brain and Mind Research Institute, University of Sydney& Clinical Advisor, beyondblue: the national depression initiative http://www.gptt.com.au/Exam%20preparation%20CK%20Khong/Mental%20Health/Depression%20adults%20hickie_slides.pdf

 

[11] The Age Julia MedewAugust 9, 2010 McGorry Misleading the parliament http://www.theage.com.au/national/mcgorry-misleading-the-public-20100808-11qes.html

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

[13] 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 http://www.headspace.org.au/core/Handlers/MediaHandler.ashx?mediaId=4896 (accessed 26 April 2011)

 

[14] Hammad TA (2004-08-116). "Review and evaluation of clinical data. Relationship between psychiatric drugs and pediatric suicidal behavior." (PDF). FDA. pp. 42; 115. http://www.fda.gov/OHRMS/DOCKETS/ac/04/briefing/2004-4065b1-10-TAB08-Hammads-Review.pdf. Retrieved 2008-05-29

[15] 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 http://www.headspace.org.au/core/Handlers/MediaHandler.ashx?mediaId=4896 (accessed 26 April 2011)

 

[16] 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 http://www.headspace.org.au/core/Handlers/MediaHandler.ashx?mediaId=4896 (accessed 26 April 2011)

 

[17] 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 http://www.headspace.org.au/core/Handlers/MediaHandler.ashx?mediaId=4896 (accessed 26 April 2011)

 

[18] The Age, GetUp! calls for urgent reform to mental health policy  Kate Hagan July 29, 2010 http://www.theage.com.au/victoria/getup-calls-for-urgent-reform-to-mental-health-policy-20100728-10w74.html#ixzz1Ka5lGSDj (accessed 26 April 2011)

 

[19] Williams, D (18 June 2006) Drugs Before Diagnosis? Time Magazine http://www.time.com/time/magazine/article/0,9171,1205408,00.html (accessed 18 November 2010) 

[20] Consumer Medicine Information: Risperidone http://www.racgp.org.au/cmi/jccrispe.pdf (accessed 3 August 2010)

[21] Webb, D. & Raven M. ‘McGorry’s ‘early intervention’ in mental health: a prescription for disaster’ Online Opinion (6 April 2010) http://www.onlineopinion.com.au/view.asp?article=10267 (accessed 18 November 2010)

[22] Adverse events information related to Risperidone obtained from the Therapeutic Goods Administration’s Public Case Detail reports

[23] As reporting is voluntary there is now way of knowing what proportion of actual adverse events gets reported. A 2008 study by Curtin University pharmacologist Con Berbatis indentified that only a tiny fraction (for general practitioners only 2 per cent) of adverse events are reported. (Con Berbatis, ‘Primary care and Pharmacy: 4. Large contributions to national adverse reaction reporting by pharmacists in Australia’, i2P E-Magazine, Issue 72, June 2008, p. 1)

[24] Frances, A in Whitely, M (2010) Speed Up and Sit Still: The Controversies of ADHD Diagnosis and Treatment p.18 UWA Publishing, Crawley, Western Australia

[25] Frances, A (2010) DSM5 ‘Psychosis Risk Syndrome’—Far Too Risky Psychology Today http://www.psychologytoday.com/blog/dsm5-in-distress/201003/dsm5-psychosis-risk-syndrome-far-too-risky

[26] Frances, A (2010) DSM5 ‘Psychosis Risk Syndrome’—Far Too Risky Psychology Today http://www.psychologytoday.com/blog/dsm5-in-distress/201003/dsm5-psychosis-risk-syndrome-far-too-risky

[27] Schizophrenia Research Forum, Live Discussion: Is the Risk Syndrome for Psychosis risky Business http://www.schizophreniaforum.org/for/live/transcript.asp?liveID=68 Posted 4 October 2009

 

[28] Refer http://speedupsitstill.com/reply-patrick-mcgorry-early-intervention-psychosis

[29]  Patrick D McGorry, Rosemary Purcell, Ian B Hickie, Alison R Yung, Christos Pantelis and Henry J Jackson. Clinical staging of psychiatric disorders: a heuristic framework for choosing earlier safer and more effective interventions. Australian and New Zealand Journal of Psychiatry 2006; 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 26April 2011)

[30] Alison R Yung and Patrick Mcgorry The British Journal of Psychiatry (2007) Prediction of psychosis: setting the stage http://bjp.rcpsych.org/cgi/content/full/191/51/s1 accessed 7 December 2010

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

 

Patrick McGorry’s - Right of Reply

first published on or about 4 May 2011

Martin Whitely suggests that the Independent Mental Health Reform Group's Blueprint may be a template for more psychiatric disorders, more off label prescribing and more youth suicide. In support of this improbable claim Mr. Whitely questions the integrity of the authors of the Blueprint, casts doubt about the wisdom of the Australian community's desire for major mental health reform and suggests that early intervention models headspace and EPPIC may do more harm than good. I therefore welcome the opportunity to respond to each of these themes.

 

1. Integrity of the Blueprint's authors

 

Mr.Whitely raises numerous doubts about the integrity of the authors (and in particular of myself) – in terms of motive, independence and process. Specifically, Mr. Whitely questions what motivated the authors to convene to write the Blueprint in the first place, states that the authors have undisclosed conflicts of interest and suggests that we have made claims without being able to substantiate them with evidence. It is disappointing that Mr. Whitely should impute such bad faith to our group and should have been prompted to do so in the absence of supporting evidence. In terms of the issues of integrity that he raises:

The motive of the authors was to produce a credible investment action plan to advance mental health reform across the lifespan that could be adopted by Government (and by Opposition and Cross-Bench Parties). We felt that the momentum for mental health reform might temporarily stall in the absence of such a plan. We therefore convened a group to produce the Blueprint document and chose the name Independent Mental Health Reform Group to make it clear that our work reflected only the views of the six authors made no claims of wider representation or linkage to Government and/or other third parties. The suggestion that the authors are dishonestly trying to secure over $1b of public funding for projects (specifically headspace and EPPIC) to which they conceal their links is completely at variance with the truth. The target audience for this Blueprint (political leaders and public servants responsible for mental health policy) are unambiguously clear about my leadership role in EPPIC and the participation of Ian Hickie and myself on the headspace board. I have hosted both Julia Gillard and Tony Abbott at EPPIC, as well as Minister for Mental Health Mark Butler and a diverse range of current and past parliamentarians – including a visit last month by members of the House of Representatives Education and Employment Standing Committee. Likewise, officials from the Department of Health and Ageing have also visited our EPPIC service and both Ian Hickie and myself have longstanding relationships with political and public service leaders arising directly from our role with headspace. Furthermore the proposal we have made is that the public in other parts of Australia beyond the EPPIC service I lead should reap the considerable benefits of this model of care. There is no request or expectation of any personal benefit to me or any of my colleagues flowing from any Federal government decision to scale up the EPPIC model, as other countries have already done in response to my prior support and advocacy. Similarly, the implication that the content of the Blueprint may have been inappropriately influenced by the pharmaceutical industry is also false.

 

In my case, Mr. Whitely perversely uses my own declaration of previous pharmaceutical industry funding as supporting evidence for his claim that I am actively concealing this funding. To put this in context, pharmaceutical funding currently plays a very minor roll (less than 5%) in funding Orygen Youth Health Research Centre projects – all of which have been designed and conducted independently of pharmaceutical company input. Furthermore, its unclear which, if any, of the Blueprint's 30 recommendations would be core commercial concerns of any of the pharmaceutical companies – for example it is notable none of these recommendations call for the MBS listing of any drug.

2. Wisdom of the Australian community's desire for major mental health reform

 

Mr. Whitely acknowledges that the Australian public and elected representatives from all sides of politics accept that there is a major need to act on mental health reform. Mr. Whitely appears not to believe that this national consensus for action is the result of tens of thousands Australians sharing their stories of unmet serious mental distress to finally break through to our national conversation. Instead, Mr. Whitely chooses to believe it is more likely the product of a gullible public falling for some clever sophistry. Mr.Whitely appears to believe that the case for mental health reform remains unproven.

 

This is a disappointing approach from an elected representative. The facts are clear that access and quality in mental health care are well below the standards that exist in the rest of health care. National Mental Health survey data clearly backs this up and it is freely acknowledged by the department of health and ageing and the current government. Most of his peers and indeed all sides of politics have listened to the Australian community and concluded that it is time to act – it is unclear what new evidence he is waiting for before he joins them. It is notable that he has not chosen not to state in his article his own views about the appropriate level of expenditure on mental health care (an increase? a cut?) or where he feels resources should be directed.

3. Early intervention models headspace and EPPIC

Mr. Whitely only specifically mentions two investment recommendations contained in the Blueprint – the early intervention youth mental health models headspace and EPPIC. It is not clear why he has chosen just these two recommendations or what he thinks about the other 28 recommendations. For the record, the other 28 recommendations include family based interventions for children, social and economic participation supports for middle and older years Australians and a range of measures to improve accountability, innovation and practice across the mental health system.

 

Mr. Whitely wrongly concludes that because we wrote the Blueprint as an action plan rather than a referenced review of the evidence, that there is no evidence for our recommendations. It is based on the best available scientific evidence. In fact, we had already supplied much of that evidence to the policy making audience for the Blueprint over the previous months. The National Health and Hospitals Reform Commission chaired by Dr Christine Bennett reviewed all the evidence for the Rudd government and came up with very similar recommendations and carefully referenced their findings. Mr. Whitely surely is aware of the NHHRC’s unequivocal support for headspace and EPPIC. For example, cost-effectiveness data for Early Intervention in Psychosis (EPPIC or EPPIC derived models of care) indicate that:

- Health costs are less under EIP than under standard care. The first year health costs through providing the full EPPIC model to young people experiencing a first episode psychosis have been estimated to be $25,955 compared to $36,833 under standard care [1 – updated to 2009 prices]. Over the long term, mean annual costs under the EPPIC model are estimated to drop to approximately 1/3 of those under standard care [2].

- Employment costs are likely to be less under EIP than under standard care. Long term follow up of EPPIC clients indicates they are twice as likely to be currently in employment than people receiving standard mental health care [2].

- Suicide costs are likely to be less under EIP than under standard care. Most suicides associated with schizophrenia are thought to occur near the beginning of the illness [3]. A recent study suggested that the number of suicide attempts amongst this group in areas with EIP teams is one third that in areas without them [4].

- Homicide costs are likely to be less under EIP than under standard care. People with untreated psychosis are estimated to be ten times more likely to engage in acts of homicide than people with treated psychosis [5]. There is a significant association between homicide and the duration of untreated psychosis [6]. A core goal of EIP services is reducing the duration of untreated psychosis.

 

This cost-effectiveness data for the EPPIC model is significantly enhanced when including studies that focus specifically on clinical outcomes and functional recovery. Up to 85% of young people with vocational interventions achieve functional recovery, levels which are unprecedented. Furthermore, the recent independent evaluation of headspace was extremely positive, showing that headspace was meeting the goals set of it by the Australian Government.

 

Mr. Whitely raises concerns about the use of medication in headspace and EPPIC which are also unwarranted. There are acknowledged risks with medications of all kinds in healthcare so the risk benefit ratio always has to be the guide for timing and need for use of such interventions. In these programs the Centre for Excellence at Orygen Youth Health and headspace guides evidence based practice within these programs and care is strictly tailored to clinical practice guidelines which are published. We follow the International CPGs for early psychosis in EPPIC and beyondblue CPGs for the treatment of depression in young people recently published by beyondblue. Of course CPGs are guidelines and individual clinicians must make their own decisions in individual cases since every patient is different in some respects. There are also areas where the evidence is incomplete and clinicians need to act on the best available evidence recognising that further evidence is required through further research.

 

In closing I appreciate the opportunity to respond to Mr Whitely’s communications.

 

Patrick McGorry

AO MD PhD FRCP FRANZCP

Professor of Youth Mental Health

University of Melbourne

 

References

1. Mihalopoulos, C., P.D. McGorry, and R.C. Carter, Is phase-specific, community-oriented treatment of early psychosis an economically viable method of improving outcome? Acta Psychiatr Scand, 1999. 100(1): p. 47-55.

2. Mihalopoulos, C., et al., Is early intervention in psychosis cost-effective over the long term? Schizophr Bull, 2009. 35(5): p. 909-918.

3. Robinson, J., et al., Suicide attempt in first-episode psychosis: a 7.4 year follow-up study. Schizophr Res, 2010. 116(1): p. 1-8.

4. Melle, I., et al., Early detection of the first episode of schizophrenia and suicidal behavior. Am J Psychiatry, 2006. 163(5): p. 800-804.

5. Nielssen, O. and M. Large, Rates of homicide during the first episode of psychosis and after treatment: a systematic review and meta-analysis. Schizophr Bull, 2010. 36(4): p. 702-712.

6. Large M, Nielssen O. Evidence for a relationship between the duration of untreated psychosis and the proportion of psychotic homicides prior to treatment. Social Psychiatry and Psychiatric Epidemiology 2008, 43:37‐44;

 

 

The Last Word – Professor McGorry leaves key questions unanswered

 

 

I welcome Professor McGorry’s response and to the limited extent that it identifies the evidence base of the recommendations it is useful and I will examine in detail the evidence provided. However, the reality is it leaves most of the questions I raised unanswered. In particular I believe the key questions that must be answered before EPPIC and Headspace are considered for extra funding are;

1- EPPIC and the ‘off label” use of antipsychotics- Does Professor McGorry now agree with his colleague at EPPIC Prof Alison Yung and oppose the recognition of Psychosis Risk Syndrome? And if not, what is EPPIC’s position on the recognition of Psychosis Risk Syndrome (PSR)? And under what circumstances, if any, would Professor McGorry and EPPIC recommend the use of antipsychotics for the treatment of patients considered to be at risk of developing psychosis? Has Professor McGorry finished experimenting on young people with the use of antipsychotics for the treatment of Psychosis Risk Syndrome?

2- HEADSPACE and the ‘off label’ use of SSRI antipsychotics- Why do Professor McGorry and Headspace acknowledge and then ignore the clinical trial evidence, and FDA and TGA warnings, on the increased suicidality risk for young people using SSRI antidepressants and advocate the ‘off label’ use of SSRIs by even moderately depressed young people? Won’t this result in more, not less, youth suicide?

In response to specific comments in Professor McGorry’s right of reply I offer the following:

‘Mr. Whitely… casts doubt about the wisdom of the Australian community's desire for major mental health reform’ and ‘Mr.Whitely appears to believe that the case for mental health reform remains unproven. This is a disappointing approach from an elected representative…It is notable that he has not chosen not to state in his article his own views about the appropriate level of expenditure on mental health care (an increase? a cut?) or where he feels resources should be directed.’

I support a massive injection of funds into mental health but believe there are far too many unanswered questions to support the ‘best buys’ identified in Professor McGorry’s and the Independent Mental Health Reform Group’s $3.2billion blueprint. I believe as an elected representative it is not my job to go with the flow but rather to ask difficult questions and ensure taxpayers funds are spent on programs that help not harm.

…..In my case, Mr. Whitely perversely uses my own declaration of previous pharmaceutical industry funding as supporting evidence for his claim that I am actively concealing this funding.

I do not suggest that Professor McGorry ‘actively conceals’ his potential conflicts of interest but rather should ‘actively disclose’ particularly when part of a group badged as ‘independent’ and asking for $3,500,000,000 to be spent on programs they identify. It appears that unless Professor McGorry is required to disclose his pharmaceutical company funding ties he generally doesn’t. To the best of my knowledge the last time he disclosed commercial ties to the pharmaceutical industry was in 2008 article in the British Medical Journal his (BMJ). Professor McGorry disclosed the sources but not the quantum of pharmaceutical company funds he had received, as is required by the journal, which to its great credit enforces its disclosure policy.

Mr. Whitely only specifically mentions two investment recommendations contained in the Blueprint – the early intervention youth mental health models headspace and EPPIC…Mr. Whitely raises concerns about the use of medication in headspace and EPPIC which are also unwarranted… We follow the International CPGs for early psychosis in EPPIC and beyondblue CPGs for the treatment of depression in young people recently published by beyondblue.

As identified at 1 and 2 above I am very concerned that through the expansion of the EPPIC and Headspace networks we risk more ‘off label’ prescribing of antipsychotics and SSRI antidepressants to young people including children. I would be much more comfortable if EPPIC and Headspace followed the advice of the independent regulators i.e. the TGA and the FDA (and even perversely the drug manufacturers) and stuck to recommending and practising ‘on label’ prescribing.