Mental Health was a centrepiece of the federal budget, with an additional $2.2 billion being identified over five years for mental health initiatives, of which $419.7 million was split between the Early Psychosis Prevention and Intervention Centre (EPPIC), and Headspace.^[1] An additional $2.2 billion for mental health is a good thing and to the extent that people such as Professor Patrick McGorry, Professor Ian Hickie and Professor John Mendoza, have contributed to putting mental health on the agenda, they deserve praise. However, I am concerned that the devil is in the detail. My criticism is not about extra funding but about the lack of an evidence base for the decisions that have been made.

Politics not science drove the Gillard Government’s mental health response.

I suggest that this response was a political response to a political problem, not a public policy response based on thorough analysis of the evidence. I criticise not only the Gillard government but also the Abbott opposition, the independents and, indeed, the media. They have all allowed the mental health debate to be dominated by a tiny group—Patrick McGorry, Ian Hickie and John Mendoza.

I am not suggesting that those people do not have valuable contributions to make. However, I am saying that they are not the independent mental health spokespersons that they are portrayed to be in the media; they are players with vested interests.^[2] That has been missed by the media, the opposition, the federal government and even the independents in federal Parliament. Those three gentlemen are fantastic advocates and great political lobbyists, but I am not convinced that they have been asked enough tough questions about the programs they advocate for and control—particularly EPPIC and Headspace. I am concerned about the potential for off-label prescribing in expanded EPPIC and Headspace services, and the potential for this to do enormous harm to young people in Australia.

Before I talk about that, I will talk about the political process involved and highlight how unusual it was. The Minister for Mental Health and Ageing has the National Advisory Council on Mental Health to give him advice on strategic directions for mental health. The Minister for Mental Health and Ageing took the extraordinary step of sidelining the National Advisory Council and set up the Mental Health Expert Working Group.^[3] Three members of that group—Professor McGorry, Professor Ian Hickie and Monsignor David Cappo—left that group and produced their own $3.5 billion five-year blueprint for mental health under the banner of the Independent Mental Health Reform Group.^[4] It is interesting that both Professors McGorry and Hickie have extensive and longstanding commercial ties to the pharmaceutical industry, so I have some questions about the use of the term “independent”.

Extra EPPIC and Headspace funding may see increased ‘off label’ prescribing of SSRI Antidepressants to young people and more youth suicides.

The blueprint they came up with identified $226 million for Headspace, which ended up getting $197.3 million and $910 million for Early Psychosis Prevention and Intervention Centres, which received $222.4 million. The EPPIC funding is supposed to be matched by state governments. I suggest that state governments need to have a good think about whether they do that.

I am very concerned that we will see through Headspace and EPPIC an increase in the off-label prescription of selective serotonin reuptake inhibitor (SSRI) antidepressants, despite the clinical trial evidence that is accepted by the Therapeutic Goods Administration and the US Food and Drug Administration that using SSRI antidepressants leads to a significant increase in the prospects of young people under the age of 24 years being suicidal—an increase of 80 per cent. Regardless both Headspace and EPPIC advocate the use of SSRI antidepressants for all young people with moderate to severe depression.^[5]

This document titled, “Using SSRI Antidepressants to Treat Depression in Young People: What are the Issues and What is the Evidence?”^[6] was produced by Headspace in 2009 and has five authors, including Patrick McGorry. It concludes by stating —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.

Yet the body of the paper builds a compelling case for not using SSRI antidepressants. It acknowledges that the only SSRI that has positive outcomes in clinical trials is fluoxetine and that even those benefits seem to disappear the longer one looks at the evidence. The paper also highlights the fact that clinical trials indicate that compared to taking a placebo, SSRI antidepressants increase the probability of a young person being suicidal by 80 per cent.

One has to bear this in mind against the political process that was used to sell the need for expansions of Headspace services. It was done against the background of candlelight vigils that were coordinated through Get Up! to highlight concerns about youth suicide and create momentum for increased funding to youth-oriented mental health services. However, the very services that the federal government is funding prescribe against TGA and FDA recommendations and against the (suicidal behaviour) black box warnings that exist for SSRI antidepressants.

Therefore I am very concerned that if this issue of SSRI antidepressant ‘off label’ prescribing is not addressed at both Headspace and EPPIC, we may see an increase in the number of candles at the next vigil.

Patrick McGorry on EPPIC - Contradictory and Confusing

My concerns about EPPIC are less straightforward. EPPIC is very much Professor McGorry’s baby and is based on the principle that early intervention can prevent later psychosis—the philosophy that a stitch in time saves nine. I support the philosophy of early intervention. Members who have listened to my speeches in the past will be bleeding from the ears hearing me plead for the need for early intervention so that we can identify kids’ real health, education and social needs. My concern is not that we do not need early intervention but what that early intervention will be.

At my invitation, Professor McGorry replied to my latest blog. We also had an exchange on The World Today program on ABC radio on 12 May in which I outlined my concerns, and on 20 May Professor McGorry responded. As I said, we are halfway through what I believe is going to be a constructive and cordial exchange. (we are meeting in late June)

However, I want to put on record my prime issue so there is absolutely no ambiguity about it. What we need from Professor McGorry, on behalf of EPPIC, is a very clear unambiguous statement about the circumstances under which antipsychotics will be prescribed at EPPIC, and we need a very clear statement about the future of Psychosis Risk Syndrome. I will not beat around the bush. To date, what Professor McGorry has said and written is confusing for those who follow it closely. It is confusing for one very clear reason: he has contradicted himself too often.

Specifically, I want to begin with the issue of psychosis risk syndrome, otherwise known as attenuated psychotic syndrome. Dr Allen Frances, the psychiatrist who led the redevelopment of DSM­IV, the bible of psychiatry, had some very unflattering things to say about psychosis risk syndrome. He said —“Psychosis Risk Syndrome” stands out as the most ill-conceived and potentially harmful …(Of all the proposals for insertion into DSM­5) — 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.” ^[7] They are the words of the man who led the redevelopment of DSM­IV. These are not the words of someone at the fringe of psychiatry. These are words from the very heart of psychiatry.

When I was on The World Today on 12 May I said that Professor McGorry is a leading international proponent of Psychosis Risk Syndrome a new psychiatric disorder for inclusion in the next edition of DSM­5. On the long version of the audio version on The World Today website, Professor McGorry said — Contrary to Mr Whitely’s statements, I haven’t been pushing for it —(That is, psychosis risk syndrome) — 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 or so, so you know we haven’t got all the answers … I’m certainly not saying that it should go into DSM­5.^[8]

So on two occasions in that interview he said that he was not advocating it should go into DSM­5. That is just plain wrong. I have an article that was published in Psychiatry update a year ago entitled “DSM­V ‘risk syndrome’: a good start, should go further”. ^[9] It begins by stating — The proposal for DSM­V to include a ‘risk syndrome’ reflecting an increased likelihood of mental illness is welcome but does not go far enough, according to Orygen Youth Health’s director Professor Patrick McGorry.

That is somebody else paraphrasing his words, so I went to the original source document, which is an article available in the Science Digest under “Schizophrenia Research”.^[10] It is written by Professor McGorry and the opening sentence states — 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.

That is absolutely clear-cut. I could build a case in greater detail but Professor McGorry has clearly advocated the inclusion of psychosis risk syndrome, otherwise known as attenuated psychosis syndrome in DSM­5. (Note; Far from rejecting the notion of Psychosis Risk Syndrome McGorry argues for the recognition of yet another disorder, General Distress Syndrome, for those with even less acute, ill-defined symptoms ).^[11]

In the same interview, Professor McGorry said — Medication should never be the first line of treatment in young people, we should always try to find psychological and simpler ways of treating youth mental health issues, that is where I agree with him (Martin Whitely) but where I part company is where he tried to I suppose confuse the issue by, I suppose, denying any value to these medications. They clearly do have value, the anti-psychotic medications, in people with clear­cut psychosis.

I have never been critical of the on-label prescription of antipsychotics to people who have had a psychotic break. Professor McGorry is quite wrong in characterising me as saying that. But that is not of any great consequence because, after all, it just relates to me being misrepresented.

Another misrepresentation is of greater consequence because he contadicted EPPIC’s position when he said that — Medication should never be the first line of treatment in young people, we should always try to find psychological and simpler ways of treating people with youth mental health issues. EPPIC guidelines (at least in regard to the use of antidepressants in young people) clearly identified that all those presenting with a depressive episode of at least moderate severity should be commenced on an antidepressant.^[12] It does not even narrow it down to Fluoxetine, the one selective serotonin reuptake inhibitor identified as having some positive effects. It just says “antidepressant”.

That is not the only misrepresentation. Professor McGorry also claimed, in response to my blog^[13], that EPPIC followed the beyondblue guidelines with regard to the use of SSRI’s. That is not true. The beyondblue guidelines are far more cautious in its recommendations about the use of SSRIs or antidepressants.^[14] Professor McGorry is simply wrong to say that EPPIC follows the Beyondblue guidelines for the use of antidepressants.

I have a number of other concerns. (Especially the EPPIC guideline that states ‘All individuals with an ‘at risk’ mental state, e.g. siblings of  EPPIC clients, will be referred to PACE clinic for assessment. ^[15]) Unfortunately, I will run out of time but a major concern is with the use of antipsychotics in non-­psychotic teenagers by EPPIC. EPPIC’s target audience is young people between the ages of 15 to 24 years. Professor McGorry and EPPIC have to answer the following very simple question: under what circumstances, if any, will EPPIC either recommend or prescribe antipsychotics to patients who have not experienced psychosis?

EPPIC and Professor McGorry need to make their position clear because at the moment it is not clear. I mistakenly thought it was made clear in a previous blog that I had written when a spokesperson for Professor McGorry, Matthew Hamilton, made some quite promising statements that indicated that they were no longer proposing the use of antipsychotics for psychosis risk syndrome.^[16] Since then, we have seen some ambiguous and contradictory statements by Professor McGorry that have left that door open.^[17] We need to have a very clear answer from Professor McGorry on behalf of EPPIC as to when, if ever, antipsychotics will be used by those who have never been psychotic.

Clarrity at least is required, but in my opinion EPPIC and Headspace need to abandon prescribing antidepressants altogether to under 18′s and rule out the use of antipsychotics in non-psychotic young people. If they stick to ‘on label’ prescribing, we can be confident that the extra $419.7 M for EPPIC and Headspace will do more good than harm. This requires a change from experimental, hypothesis based, psychiatry to an evidence based, ’first do no harm’ mindset.

Update – Some progress has been made on the issues identified above see http://speedupsitstill.com/australian-16-june-2011

Coming Blogs – Mental health screening for three year olds and the budget cuts to psychology services: Are these a recipe for more dumbed down, psychiatric labelling and prescribing?

I ran out of time in the speech to outline all of my concerns with the mental health response in the 20011/12 federal budget. I am alarmed at the proposals for mental health screening of three year olds and despair at the cuts to support for psychological services, in order to fund GP mental health visits. Both of these measures have the potential to further promote the increasingly dominant dumbed down, ‘label and prescribe’ approach to mental health, however these are topics for another speech and blog.

Related Media

Minds at Risk: Choosing the Right Path for Adolescent Mental Health, Lisa Pryor, The Monthly July 2011 http://www.themonthly.com.au/choosing-right-path-adolescent-mental-health-minds-risk-lisa-pryor-3470

[2] Professor 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/) 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) 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 or speaker for most of these companies 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)

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). Professor Hickey received the following grants totalling $411,00 from pharmaceutical companies: $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.) Cited in Ian Hickie, Curriculum Vitae, last updated 23 August 2009 http://sydney.edu.au/bmri/about/Hickie_CV.pdf   (accessed 3 August 2010)

Professor Mendoza was co-author of the “Not for Service” report which was issued in 2005.  Apart from the Commonwealth Govt, the report was funded by unrestricted grants from AstraZeneca, Bristol-Myers Squibb, Eli Lilly Australia, GlaxoSmithKline, Medicines Australia, Pfizer Australia and Wyeth. (Not For Service: Experiences of Injustice and Despair in Mental Health Care in Australia, Mental Health Council of Australia, Canberra, 2005 http://www.hreoc.gov.au/disability_rights/notforservice/documents/NFS_Finaldoc.pdf (3 August 2010)). He is also a principle of ConNetica Consulting Pty Ltd, whilst they have very broad purposes such as providing a review, survey and planning service to government and not for profit organizations, including those involved in mental health. It currently lists Eli Lilly as one of its private sector clients (ConNetica Consulting, About Us http://connetica.com.au/about_us (accessed 3 August 2010))

[3] Advisory Group to Guide Mental Health Reforms (23 December 2010), Pro Bono News Advisory Group to Guide Mental Health Reforms (accessed 26 April 2011)

[4] 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 (accessed 26 April 2011)

[5] Hammad T.A. (16 August 2004). Review and evaluation of clinical data. Relationship between psychiatric drugs and pediatric suicidal behavior, Food and Drug Administration. pp. 42; 115. FDA Review and evaluation of clinical data (accessed 29 May 2008)

[6] 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  Headspace Evidence Summary (accessed 28 May 2011)

[7] Frances, A. (2010) DSM5 ‘Psychosis risk syndrome’—Far too risky, Psychology Today Psychosis risk syndrome—Far too risky

[8] 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)

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

[10] 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

[11] See  http://speedupsitstill.com/patrick-mcgorry-early-intervention-psychosis-stitch-time-stitch-up

[12] EPPIC guidelines state that all clients experiencing ‘a depressive episode of at least moderate severity should be commenced on an antidepressant.’ http://www.eppic.org.au/eppic-clinical-guidelines (accessed 28 May 2011)

[13] http://speedupsitstill.com/patrick-mcgorry%e2%80%99s-independent-mental-health-reform-group%e2%80%99s-3-5b-blueprint-australian-mental-health-forward-prescription-%e2%80%98psychiatric-disorders%e2%80%99-%e2%80%98off-label#more-1530

[14] In comparison to the EPPIC Guidelines which say that all clients experiencing ‘a depressive episode of at least moderate severity should be commenced on an antidepressant.’ the beyondblue clinical practice guidelines (page 55) state: ‘If symptoms are severe, or if symptoms are moderate to severe and psychological therapy has not been effective, is not available or is refused, prescription of the selective serotonin reuptake inhibitor (SSRI) antidepressant fluoxetine should be considered for reducing depression symptoms in the short term.’ http://beyondblue.org.au/index.aspx?link_id=6.1247 accessed 28 May 2011

[15] http://www.eppic.org.au/eppic-clinical-guidelines (accessed 28 May 2011)

[16] See http://speedupsitstill.com/patrick-mcgorry-reverses-support-psychosis-risk-syndrome-drugging

[17] In December 2010 Professor McGorry 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.’ He then immediately invalidated this statement by writing, ‘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.’ The term mental disorder itself is interesting as he is referring Psychosis Risk Syndrome which is not officially recognised as a legitimate psychiatric disorder and hopefully never will be. See http://speedupsitstill.com/reply-patrick-mcgorry-early-intervention-psychosis#more-1075

In December 2010 Minister for Mental Health & Ageing Mark Butler took the extraordinary step of sidelining his own National Advisory Council on Mental Health and appointing Professors McGorry and Hickie as members of a 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]

In the following blog I outline my concerns in relation to the blueprint including the:

• proposal to increase funding to Headspace by $226 million given the advocacy by Professor McGorry and Headspace of ‘off label’ prescribing of SSRI antidepressants to young people. This is despite clinical studies and FDA and TGA advice that the use of SSRI’s increases the risk of suicidal behaviour by young people.
• proposal to increase funding to EPPIC by $910 million given Professor McGorry advocacy of the recognition of Psychosis Risk Syndrome as a diagnosable psychiatric disorder. This is despite the concerns of numerous high profile psychiatrists including his close colleague Professor Alison Yung who questions; ‘ Is the agenda really to use antipsychotics?…the risk is that instead of getting maybe supportive therapy, they get antipsychotics and they will be diagnosed with the risk syndrome.
• lack of publicly accesible evidence of patient outcomes and the cost effectiveness of the mental health ‘best buys’ identified in the blueprint.
• alarmist claim by Professor McGorry that in 2011 four million Australian’s including 1 million young people will have a mental disorder requiring treatment.

Following my blog Professor McGorry takes up my invitation to exercise his right of reply.

So what is in the blueprint?

The blueprint outlines $3.5billion expenditure over 5 years on programs that are identified as mental health ‘best buys’. The most expensive ‘best buy’, at $910m, is for the rollout of 20 new Early Psychosis Prevention Intervention Centres (EPPIC). Australia’s only existing EPPIC clinic is run by Orygen Youth Health, headed up by Professor McGorry.^[3] The blueprint states that 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 is no evidence in the blueprint of EPPIC’s cost effectiveness or patient outcomes compared with outcomes from other mental health services.

The second priority identified is 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 is no supporting evidence. The blueprint is completely unreferenced. It is merely a $3.5billion consensus wish list of these ‘independent’ mental health experts, completely devoid of supporting verifiable evidence.

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

How ‘independent’ is the Independent Mental Health Reform Group that developed the blueprint?

Professor McGorry and several organisations he presides over have received considerable financial support from the pharmaceutical industry. In 2008, McGorry disclosed the sources but not the quantum of pharmaceutical company funds he has received in an article he wrote published by the British Medical Journal. To its’ credit the BMJ is one of the few journals that strictly enforces its’ disclosure policy. It stated McGorry, ‘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] 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 receives support from numerous pharmaceutical companies.^[6] In addition, McGorry is Treasurer and former President of the pharmaceutical industry funded International Early Psychosis Association.

Professor Ian Hickiehas received 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); and $81,000 from Pfizer Australia (n.d.).^[7]  Whilst it was not disclosed in the blueprint, Hickie does deserve some credit for disclosing in his online CV that he has received this funding from the pharmaceutical industry.

Along with Professors McGorry and Hickie and Monsignor David Cappo, the other members of the ‘independent’ group are Sebastian Rosenberg, John Moran and Matthew Hamilton. Moran and Hamilton both work for Orygen and therefore are subordinates of McGorry. Rosenberg is the former CEO of the Mental Health Council of Australia and is currently Head of the National Mental Health Policy Unit at Hickie’s Brain and Mind Research Institute^[8] and a director of the mental health business ConNetica, whose website lists one of its ‘Private Sector Customers’ as Eli Lilly.^[9]

Neither Professors McGorry nor Hickie nor any other member of the Independent Reform Group disclosed their pharmaceutical company connections in the blueprint. Neither did the blueprint identify which mental health ‘best buys’ are based on service delivery models exclusive to organisations they control. These potential conflicts of interest may have been known by the politicians controlling funding, however, it is apparent the media were either ignorant of, or disinterested in them and happily portray McGorry and Hickie as independent advocates.

Why does Professor McGorry think that 4 million Australians will have a ‘mental 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.’^[10][11]

Public critics of Professor McGorry are rare; however, not everyone accepts his alarming claims. Jon Jureidini, Adelaide University Professor of Psychiatry and Paediatrics, 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.’^[12]

Professor McGorry responded to Professor Jureidini’s criticisms, writing: ‘I have never argued that 1 million young Australians have serious mental illness’. However, he added: ‘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!’^[13]

Professor McGorry is of course correct 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 Jureidini’s legitimate questions remain. In 2011 will more than one in seven Australians (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 do Headspace and Professor McGorry advocate the ‘off label’ (unapproved) use of SSRI antidepressants in even ‘moderately depressed’ young people, despite FDA and TGA warnings about the increased risk of suicidality?

A 2009 evidence summary produced by Orygen Youth Health for Headspace and overseen by Professor 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 Food and Drug Administration has issued the highest possible ‘black box’ warning that the use of SSRI antidepressants increases the risk of suicidality in people under 24.^[14] The 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%.^[15]

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’.^[16] 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.’^[17]

The body of the evidence summary builds a compelling argument for avoiding the use of SSRIs 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’.^[18] 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.^[19] Yet the Headspace evidence summary, which is effectively a guideline for the treatement of young Australians, 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 SSRIs by young people. However, if Australia follows Headspace and McGorry’s advice on SSRIs, we risk more, not fewer, candles at the next vigil.

Why has Professor McGorry experimented 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 Association’s clinically dominant Diagnostic and Statistical Manual of Mental Disorders (DSM-V) (the ‘bible’ of psychiatry) 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%’, but nonetheless he led controversial research that trialled the use of the antipsychotic risperidone (Risperdal®) on young people without psychosis who were suspected of being at risk of developing psychotic disorders such as schizophrenia.^[20]

Risperidone is one of the more commonly used ‘atypical’ (newer) antipsychotics and has a range of serious potential side effects including metabolic syndrome, and sudden cardiovascular death.^[21][22] 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.^[23][24]

Professor 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 the hypothesised psychosis risk syndrome. With the benefit of hindsight, 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.’.^[25]

Based on this experience, Professor 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.”^[26] Frances contends that up to 90% of those diagnosed with psychosis risk syndrome would never go on to develop psychosis, and concludes that the it is ‘the prescription for an iatrogenic [adverse effects resulting from treatment] public health disaster’.^[27]

Even one of Professor McGorry’s closest colleagues at the Orygen Youth Health Research Centre, Professor 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.’^[28]

Regardless Professor McGorry still advocates for the inclusion of psychosis risk syndrome in DSM-V. However, he recently distanced himself from the use of antipsychotics 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 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.^[29] 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 McGorry experimented with, and advocated, the pre-emptive prescription of antipsychotics to adolescents.

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.^[30] 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.

A 2007 British Medical Journal article jointly authored by Professor McGorry began by quoting a 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.’ McGorry’s article’s opening comment followed: ‘Such sentiment underlines the aim of identifying people in the prodromal phase preceding a first psychotic episode.’^[31] The 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.’^[32]

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. Despite being dircetly asked by me Professor McGorry has not ruled out further experimentation with antipsychotics for psychosis prevention, or the use of antipsychotics as a ‘second line treatment’ for ‘subthreshold psychosis’. These are issues that need a clear resolution before there is any increased funding of EPPIC.

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

With the notable exception of Professor Jon Jureidini and Professor Vaughan Carr^[33], there has been little public criticism from within the Australian psychiatric profession of Professor McGorry’s plans for the future of Australian mental health. A number of psychiatrists I have spoken to are privately critical of McGorry’s advocacy of ‘off label’ prescribing; however, they are grateful that McGorry’s Australian of the Year status has at last 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 attractive alternative – mainly because there are few simple solutions for complex problems.

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 Royal Australian & New Zealand College of Psychiatrists needs to stop being so timid. The Australian public needs a vigorous debate within the College, the psychiatric profession, the wider medical and therapeutic community and the public to drive the future of Australian mental health.

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

I think that unquestioningly following Professor McGorry’s prescription for Australian mental health risks more harm – more ‘psychiatric disorders’, youth suicides and an epidemic of iatrogenic (adverse prescription drug event) suffering – than good. I am particularly concerned that a McGorry endorsed and Headspace driven increase in the ‘off label’ prescription of SSRI antidepressants to children and young people may cost lives. And I think McGorry’s pharmaceutical company ties and obvious conflicts of interest in advocating for well over $1billion increased funding for EPPIC and Headspace need to be understood and considered.

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

And Professor McGorry needs to explain why he has experimented with antipsychotics on adolescents who had never been, and by his own admission probably never will be, psychotic. McGorry also needs to explain why Professor Allen Frances and even McGorry’s 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 an ‘iatrogenic health disaster’.

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

[2] 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)

[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. (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)

[5] McGorry is the former President and 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 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 ‘SPHERE: A National Depression Project’ (http://sydney.edu.au/bmri/about/Hickie_CV.pdf). As was reported in The Australian, Pfizer works in conjunction with SPHERE through a company called Lifeblood, which is based at Hickie’s Brain and Mind Research Institute. BMRI staff are paid to review SPHERE. According to Lifeblood, SPHERE ‘assisted in restoring the market share and growth of the Pfizer antidepressant Zoloft, restoring it to the No 1 product in this market’. Davies J. (10 July 2010) GP jaunts ‘boosted’ drug sales, The Australian. http://www.theaustralian.com.au/news/nation/gp-jaunts-boosted-drug-sales/story-e6frg6nf-1225890003658 (accessed 30 April 2011)

[8] Brain and Mind Research Institute website http://sydney.edu.au/bmri/research/mental-health-policy/index.php (accessed 30 April 2011)

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

[10] 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)

[11] In a presentation on behalf of beyondblue, 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

[12] Medew, J. (9August 2010)McGorry ‘misleading the public’, The Age http://www.theage.com.au/national/mcgorry-misleading-the-public-20100808-11qes.html

[13] 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)

[14] 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)

[15] Hammad T.A. (16 August 2004). Review and evaluation of clinical data. Relationship between psychiatric drugs and pediatric suicidal behavior, Food and Drug Administration. pp. 42; 115. http://www.fda.gov/OHRMS/DOCKETS/ac/04/briefing/2004-4065b1-10-TAB08-Hammads-Review.pdf (accessed 29 May 2008)

[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] 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)

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

[20] 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)  

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

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

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

[24] As reporting is voluntary, there is no 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, (2008), Primary care and Pharmacy: 4. Large contributions to national adverse reaction reporting by pharmacists in Australia, i2P E-Magazine, Issue 72, p. 1)

[25]Frances, A. (2010), in M. Whitely, Speed Up and Sit Still: The Controversies of ADHD Diagnosis and Treatment, p.18. UWA Publishing, Crawley, Western Australia. Also: Frances, A. (8 April 2010) Psychiatric diagnosis gone wild: The “epidemic” of childhood bipolar disorder, Psychiatric Times http://www.psychiatrictimes.com/bipolar-disorder/content/article/10168/1551005 (accessed 30 April 2011)

[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] 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

[28] Schizophrenia Research Forum (4 October 2009) Live Discussion: Is the risk syndrome for psychosis risky business http://www.schizophreniaforum.org/for/live/transcript.asp?liveID=68

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

[30] 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)

[31] 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)

[32] 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)

[33]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)

Right of Reply – Professor Patrick McGorry

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  

[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 – by Martin Whitely

I welcome Professor McGorry’s response and to the limited extent that it identifies the evidence base of the recommendations in the blueprint it is useful. I will examine in detail the evidence provided, however, 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 in the next edition of the DSM? 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 antidepressants- 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 $3.5 billion 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.

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 or any member of the Independent Mental Health Reform Group dishonestly ‘actively conceal’ their potential conflicts of interest. Rather, I am critical of them for not ‘actively disclosing’ potential conflicts of interest particularly when they badged themselves as an ‘independent’ and asked for $3,500,000,000 of taxpayer’s funds to be directed to programs, several of which they have significant influence over. I accept that senior decision makers would be aware at least of Professors McGorry and Hickies connections to EPPIC and Headspace but I am not so sure about the media and the public.  I became aware of Professor McGorry commercial ties to the pharmaceutical industry from a 2008 article in the British Medical Journal (BMJ). As is required by the BMJ Professor McGorry disclosed the sources but not the quantum of pharmaceutical company funding he had received.

In fairness to Professor Ian Hickie, whilst it was not disclosed in the blueprint, he does deserve credit for disclosing online via his CV that he has received $411,000 from various pharmaceutical companies. Whilst this was acknoweledged in my reference I should have acknowledged this self disclosure in the text of my blog when I originally wrote it (and I now have).

‘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 the drug manufacturers) and stuck to recommending and practising ‘on label’ prescribing.

Next week’s blog details how 2010 Australian of the Year Professor Patrick McGorry and his close colleagues have dominated the long overdue debate about the future of mental health services in Australia. It outlines how their claims of massive unmet need and proven 21^st century solutions have been accepted almost without question by the Gillard Government, the Abbott Opposition, the independents, the media and therefore the public.

In March Professor McGorry and fellow members of the Independent Mental Health Reform Group released their blueprint for the future of Australian mental health. The blueprint, Including, Connecting, Contributing: A Blueprint to Transform Mental Health and Social Participation in Australia, outlines $3.5b expenditure over 5 years on ‘transformational’ programs that are identified as mental health ‘best buys’.^[1] However, serious questions remain unasked, including:

• How ‘independent’ was the Independent Mental Health Reform Group, and why didn’t participants disclose any potential conflicts of interest?
• Why didn’t the blueprint identify that the most expensive ($910 million) ‘best buy’ is based on a service delivery model developed by Orygen Youth Health, which is headed up by Professor McGorry?^[2]
• Why was the supposedly ‘evidence based’ blueprint unreferenced and devoid of supporting verifiable evidence?
• What is the evidence of EPPIC’s outcomes compared to other mental health services and to support the claim in the blueprint that EPPIC has ‘the largest international evidence base of any mental health model of care’ ?
• Why does Professor McGorry believe four million Australians, including one million young people, will need treatment for a psychiatric disorder in 2011? And exactly what are these ‘disorders’ and what should the treatments involve?
• Has Professor McGorry finished experimenting with antipsychotics on adolescents, most of whom he admits would probably never have become psychotic?^[3]
• Why does Professor McGorry continue to advocate for the recognition of ‘Psychosis Risk Syndrome’ as a new psychiatric disorder when even his close colleague, Professor Alison Yung, asks ‘why the need for a specific risk syndrome diagnosis? Is the agenda really to use antipsychotics?’^[4]
• 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?^[5]
• When Professor McGorry ‘received unrestricted research grant support from Janssen-Cilag, Eli Lilly, Bristol Myer Squibb, Astra-Zeneca, Pfizer, and Novartis’ and ‘acted as a paid consultant for, and…received speaker’s fees and travel reimbursement from, all or most of these companies,‘ how much money did he get from each pharmaceutical company?^[6]

In next week’s blog I detail why I am most concerned with Professor McGorry and Headspace’s recommendation that SSRI antidepressants be used in even moderately depressed young people despite the clinical trial evidence and FDA and TGA warnings on the increased suicidality risk. Through the use of 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. However, if Australia follows Professor McGorry’s advice we risk there will be more, not fewer, candles at the next vigil.

Perhaps the answers to the questions above would reveal that Professor McGorry really does have insights that make him uniquely placed to design Australia’s 21^st century mental health system. However, it appears that the Gillard Government, at the urging of the Opposition, is on the verge of committing massive resources to Professor McGorry’s mental health blueprint without ever asking these questions. Isn’t it time the Canberra politicians and the media got beyond his former Australian of the Year status and asked him a few challenging questions?

Note: Professor McGorry has been provided with these questions and with early access to the full transcript of next week’s blog and has been offered the unedited right of reply on the day the full blog is published (Wednesday 4 May 2011)