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

Related Media

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Also, Professor McGorry wrote a piece for Science Digest in 2010, entitled “Schizophrenia Research” in which he stated, “The proposal to consider including the concept of the risk syndrome in the forthcoming revision of the DSM classification is innovative and timely. It has not come out of left field, however, and is based upon a series of conceptual and empirical foundations built over the past 15 years.”[15]

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

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

Later, when pushed on the issue, McGorry the great enthusiast, who had become McGorry the indifferent, went on to become McGorry the denier, denying his previous position. He was on the ABC World Today program of 12 May 2011. I had said that Professor McGorry was a leading international proponent of Psychosis Risk Syndrome as a new psychiatric disorder for inclusion in the next edition of DSM5. Professor McGorry responded by saying, “contrary to Mr Whitely’s statements, I haven’t been pushing for it to be included in DSM5. Now that hasn’t been my position. But it’s a new area of work. It’s only been studied for the last 15 years.”[17]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Others who have had plenty to say include Professor Allen Frances, the chief author of the DSM–IV, the current edition of the bible of psychiatry. He has been a fierce critic of Professor McGorry, although he is very charitable in what he says about McGorry’s intentions. He said “McGorry’s intentions are clearly noble, but so were Don Quixote’s. The kindly knight’s delusional good intentions and misguided interventions wreaked havoc and confusion at every turn.”[39] Professor Frances goes on to warn that Australia is really in danger of following him blindly down “an unknown path that is fraught with dangers”.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

[21] In response to my blog titled Australian of the Year Patrick McGorry’s call for early intervention to prevent Psychosis: A Stitch in Time or a Step too Far? (available at http://speedupsitstill.com/patrick-mcgorry-early-intervention-psychosis-stitch-time-stitch-up ) Professor McGorry wrote a blog titled Responding at the earliest opportunity to emerging mental illnesses http://www.patmcgorry.com.au/blog/pmcgorry/responding-earliest-opportunity-emerging-mental-illnesses

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

By Martin Whitely MLA

The off colour Australian colloquialism ‘you can’t polish a turd but you can cover it in glitter’ is a fitting analogy for the danger of legitimising ADHD as a diagnosable mental illness by developing treatment guidelines. However, treatment guidelines are being developed and the more conservative the treatment guidelines, the fewer children risk damage with the long-term administration of amphetamines.

That is why I welcome the release by the National Health and Medical Research Council (NHMRC) of the Australian ADHD Clinical Practice Points (CPPs) as a small but significant step in the right direction. (The CPPs available at http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/mh26_adhd_cpp_2012_120903.pdf )

Eventually ADHD will be regarded as an embarrassing footnote of history and society will collectively wonder how anyone ever thought it would be a good idea to give amphetamines to children. But in the meantime improvements like those in the ADHD CPPs, although modest, will hopefully see fewer children diagnosed and drugged.

That said, the CPPs are far from perfect. The statement that, “…stimulants might be considered for this age group (under 7 years)” leaves the door open for drugging very young children.[1] The manufacturers prescribing information for all stimulants state they should not be used in children under 6 years, since safety and efficacy in this age group have not been established.[2] Any clinician ignoring the manufacturers warning is inviting a future law suit for negligence.

The ADHD CPPs were developed as a stop gap replacement for the corrupted NHMRC 2009 Draft Australian Guidelines on Attention Deficit Hyperactivity Disorder which in turn replaced the deeply flawed 1997 NHMRC ADHD Guidelines that were rescinded in 2005.[3] The ADHD CPPs state the 2009 Draft Guidelines were “not approved by NHMRC” as “…undisclosed sponsorship may have affected the findings of a large number of publications (co-authored by Prof Joseph Biederman and Drs Thomas Spencer and Timothy Wilens) relied on for the Draft Guidelines”.(Page 4)

Undue drug company influence went much deeper than simply relying on corrupted research. While I am not suggesting they were individually corrupt; the majority of members of the guidelines development group had ties to ADHD drug manufacturers and were enthusiastic proponents of ADHD child drugging. (For more detail on the corrupted guidelines development process refer to Open book approach a good start for the new National ADHD Guidelines Committee)

It took six years of determined advocacy to expose the connections and prompt the intervention of Mental Health Minister Mark Butler. In contrast to the indifference and incompetence of previously responsible ministers Nicola Roxon and Tony Abbott, Minister Butler established the relatively conflict of interest free[4] and transparent ADHD CPPs development process.

Although the ADHD CPPS are described as being “based on expert consensus” it would probably have been more accurate if they were described as being “based on expert compromise”. This was an inevitable product of a committee which contained members with diametrically opposed views like ADHD sceptic, Professor Jon Jureidini, and ADHD prescribing enthusiast, Professor Michael Kohn. (see Where is the evidence to support ‘ADHD expert’ Prof Kohn’s claim that amphetamines aid brain development? ) As a result in several places the ADHD CPPs are contradictory.

Despite their limitations Mental Health Minister Mark Butler deserves credit for establishing the ADHD CPPs process. There was significant opportunity for public input with approximately 140 submissions spanning the divergent range of views on ADHD and resulting in significant differences between draft and final guidelines.[5]

One of the more notable improvements from the draft was the removal of the statement that “as with any medical intervention, the inability of parents to implement strategies may raise child protection concerns”.[6] This statement attracted widespread media attention and condemnation.[7]  On 23 November 2011 the NHMRC issued a media release denying that a failure to medicate may result in the intervention of child protection authorities.[8] This statement was welcome however it should never have been included in the draft ADHD CPPs in the first place.

Overall the final September 2012 ADHD CPPs represent a significant improvement on the November 2011 draft ADHD CPPs and a vast improvement on the corrupted 2009 Draft Australian Guidelines. Below I have listed both positive and negative features of the final ADHD CPPs.

Positive features of the final ADHD CPPs include the statements that:

• “The clinician should always be mindful of seeking a more meaningful explanation of the child/adolescent’s behaviour than simply labelling it as ADHD because it meets diagnostic criteria.” (Page 14)
• “ADHD is a description rather than an explanation of a pervasive, persistent, disabling pattern of inattentiveness, overactivity and/or impulsivity. A child/adolescent who meets diagnostic criteria for ADHD may not be always best served by making that diagnosis. For example, their behaviour could be understood as a reaction to specific cognitive difficulties or family/environmental circumstances.” (Page 6)
• Comment- A very good statement, however I would argue that a child is never best served by applying a one size fits all label that fails to explain their unique circumstances.

• “All children and adolescents can display active, impulsive and inattentive behaviour as part of normal development. This does not mean that they have a disorder, and important controversies exist about the use of ADHD as a diagnosis for children and adolescents.” (Page 10)
• “Parents/carers must be given information on the diagnosis and management plan, including any potential adverse effects of treatment in order to fully inform them and to have them make a decision regarding the treatment that is offered to their child.” (Page 16)
• Potential “adverse-effects” of stimulants identified in the ADHD CPPs include sleep disturbance, reduced appetite, abdominal pain, headaches, crying spells, repetitive movements, slowed growth (height and weight), restlessness, dizziness, anxiety, irritability cardiovascular effects such as tachycardia, palpitations and minor increases in blood pressure and psychosis or mania.  In addition the ADHD CPPS say where to report side-effects in Australia (to the TGA) and acknowledge that stimulants are Schedule 8 drugs because they can be addictive and are abused.  (Page 20)
• “Children/adolescents on stimulant medication require 3-6 monthly clinical assessment and review to ensure the management strategies remain appropriate and effective. Monitoring should include assessment of side effects and particularly psychological symptoms and plotting of growth parameters, pubertal development, heart rate and blood pressure.” (Page 8)
• “Not all children and adolescents with ADHD will require, or benefit from, pharmacological management.”  (Page 8)
• Comment- A double edged sword but nonetheless an improvement from previous guidelines that promoted the use of ADHD amphetamines as the first line treatment for all children diagnosed with ADHD.

• “Practical supports for families, such as respite care, parenting education and guidance and counselling, may be helpful or even a sufficient intervention perhaps obviating the need for specific treatment and psychological management of the child.” (Page 17)
• “When stimulant treatment is used it should only be continued if there is demonstrated benefit in the absence of unacceptable side effects. “ (Page 8).
• Comment- Again a double edged sword but an improvement from previous guidelines.

• “There is no one single known cause of ADHD….” (Page 10).
• Comment- Would have been more accurate to say there is no one single known cause of the inattentive and/or impulsive behaviours characterised as ADHD

• “….the effect of medication and behavioural or educational interventions on long-term outcomes such as academic and social and emotional outcomes, has not been established…..“ (Page 11) AND “Considering that there is insufficient evidence on the long-term outcomes and long-term adverse effects following use of stimulants, the continuing benefit from, and need for medication should be regularly assessed.” (Page 21)
• Comment- The limited long term evidence available indicates that children diagnosed with ADHD and never medicated do much better than children diagnosed with ADHD and medicated. Therefore the prudent ‘first do no harm’ step would be to never medicate or time limit the use of stimulants by children to a year. For more information on the long term effects of stimulants see One year on from the Raine Study ADHD Medication Review – Will the analysis of this unique long term data source continue and if so can we trust those doing the analysis?

• “….there are no specific treatments to ‘cure’ ADHD…..” (Page 16)
• “In the absence of another diagnosis, neuroleptics (anti-psychotics) have no role in the treatment of ADHD.” (Page 18)On the negative side the ADHD CPPs include the statements that:

• “The risk of not making a diagnosis is that the child/adolescent may not receive appropriate management and care.” (Page 12)
• Comment-This is one of the most disturbing statements in the CPPs. ADHD is a dumbed down label that does nothing to explain a child’s individual circumstances. It prevents understanding and invites a dangerous one size fits all treatment, stimulants, that mask behaviours without addressing any underlying problems. 

• “Regardless of whether the cause is explicable or not these symptoms impact so adversely on the child or adolescent and their family that the symptoms cannot be left untreated.” (Page 11)
• Comment- These first two statements may panic clinicians and parents in premature treatment with unnecessary and potentially dangerous drugs, i.e. amphetamines. The statements are inconsistent with the precautionary first do no harm principal of medicine. Understanding the cause of any problem is essential to identifying appropriate long term solutions.

• “Use of stimulant medications (methylphenidate and dexamphetamine sulphate) can reduce core ADHD symptoms and improve social skills and peer relations in children and adolescents diagnosed with ADHD in the short term (up to 3 years).” (Page 8)
• Comment- I agree that drugs will alter behaviour immediately and in some cases make boisterous, even annoying and in some cases traumatised children more compliant. However, achieving social control and compliance in that manner is a violation of the rights of the child and frequently covers up underlying serious problems including in some cases the traumatic effects of child abuse and neglect.

• “Both medication and combined medication and behavioural treatment have been shown to be more effective in treating ADHD symptoms than psychosocial or behavioural interventions alone.” (Page 19)
• Comment- Again I agree that drugs will alter behaviour immediately, however achieving compliant behaviour in the short term is not an appropriate way to measure child welfare. The only consideration that should matter is the long-term welfare of the child not the convenience of others. The limited long term evidence available indicates that children diagnosed with ADHD and never medicated do much better than children diagnosed with ADHD and medicated.

• “For young children (under 7 years) psychological, environmental and family interventions should, if possible, be trialed and evaluated before initiating pharmacological treatment. If all these other interventions have not been effective then stimulants might be considered for this age group in consultation with the parents or guardians and including when appropriate teachers or other carers.” (Page 9)
• Comment- This is the most concerning recommendation as it leaves the door open for drugging very young children. The manufacturers prescribing information for all stimulants state stimulants should not be used in children under 6 years, since safety and efficacy in this age group have not been established.[9]

• “It is rare that symptoms of ADHD occur in isolation. In the assessment of a child/adolescent with ADHD the specialist clinician should assess for other psychological, social, emotional and behavioural difficulties that might coexist with ADHD (comorbidities).” (Page 11)
• Comment – Psychological, social and emotional difficulties are often the causes of ADHD type behaviours. In these cases ADHD doesn’t coexist, rather the ADHD type behaviours are caused by psychological, social and emotional difficulties.

• “Children/adolescents with ADHD may have other mental health problems, such as depression, which may be associated with an increased risk of suicidal ideation. Conducting a mental health assessment, where indicated, can detect mental health problems and inform appropriate management.” (Page 15)
• Comment – Inviting multiple diagnoses invites poly-pharmacy in the minds of some medical practitioners. Antidepressants are not approved for use in young people as studies show they increase suicidality by approximately 80%.[10]

• “Assessment of response to treatment and periodic review of progress is facilitated by the use of questionnaires from parents/carers, teachers and if possible the child/adolescent using psychometrically sound, evidence-based checklists such as the Conners’ ADHD/DSM-IV Scales (CADS).” (Page 16)
• Comment- Please let’s all stop pretending the diagnosis of ADHD involves scientific testing. These so-called psychometrically sound, evidence-based checklists are no more than loosely defined behavioural tick-lists and are reminiscent of a Dolly Magazine find your perfect boyfriend tick-box questionnaire.

• “Heredity, genetic, neuro-imaging and neuro-psychological studies provide evidence for a biological basis for inattention and impulsiveness.” (Page 10)
• Comment- This is concerning for two reasons. Firstly it overstates the validity of this evidence. Secondly and most significantly even if a biological basis for ” for inattention and impulsiveness” is established this does not make a disease or disorder any more than other genetic variations like height or skin colour. Refer to The ‘Genetic basis of ADHD’ – much ado about nothing

• “Data from 2000 indicates the prevalence rate of ADHD symptoms among 6–17 year-olds in Australia is around 11%.” (Page 11)Related Media
•  Experts alarmed at new ADHD guidelines | News.com.au Sue Dunlevy, News Limited Network, October 03, 2012
• Comment- This is a massive overestimate of the proportion of children who would qualify for a DSMIV diagnosis as when conducting this research there was no assessment for impairment or requirement for children to display sustained ADHD in multiple settings. Nonetheless the garbage research continues to be quoted by the ADHD industry, the NHMRC and even Commonwealth Ministers.[11]

[1] Page 9 of the ADHD CPPs available at http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/mh26_adhd_cpp_2012_120903.pdf

[2] Ritalin prescribing information says “Ritalin should not be used in children under 6 years, since safety and efficacy in this age group have not been established” see http://www.pharma.us.novartis.com/product/pi/pdf/ritalin_ritalin-sr.pdf   Concerta’s says “safety and efficacy has not been established in children less than six years old or elderly patients greater than 65 years of age” see http://www.concerta.net/sites/default/files/pdf/Prescribing_Info-short.pdf#zoom=56  Dexedrine’s (brand of dexamphetamine) says “Long-term effects of amphetamines in pediatric patients have not been well established. DEXEDRINE is not recommended for use in pediatric patients younger than 6 years of age with Attention Deficit Disorder with Hyperactivity” see http://www.dexedrine.com/docs/dexedrine_PI.pdf

[3] National Health and Medical Research Council, Attention Deficit Hyperactivity Disorder (ADHD), Canberra, 1997. http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/ch36.pdf

[4] Conflict of Interest details available at http://www.nhmrc.gov.au/guidelines/adhd-conflicts-interest

[5] For details of the effect of the submissions on the final ADHD CPPs see appendix D page 16 available at http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/mh26_adhd_cpp_appendices_120903_0.pdf

[6] National Health and Medical Research Council, Public Consultation on the Draft Clinical Practice Points on the Diagnosis, Assessment and Management of Attention Deficit Hyperactivity Disorder in Children and Adolescents, Australian Government, November 2011 p15. Available http://consultations.nhmrc.gov.au/open_public_consultations/a-d-h-d

[7] Sue Dunleavy, The Australian medicate ADHD kids or else parents told 21/11/2011 http://www.theaustralian.com.au/national-affairs/medicate-adhd-kids-or-else-parents-told/story-fn59niix-1226200652633

[8] 8. see http://www.nhmrc.gov.au/media/releases/2011/reassuring-parents-new-draft-adhd-clinical-practice-points-do-not-mandate-medica

[9] Ritalin prescribing information says “Ritalin should not be used in children under 6 years, since safety and efficacy in this age group have not been established” see http://www.pharma.us.novartis.com/product/pi/pdf/ritalin_ritalin-sr.pdf   Concerta’s says “safety and efficacy has not been established in children less than six years old or elderly patients greater than 65 years of age” see http://www.concerta.net/sites/default/files/pdf/Prescribing_Info-short.pdf#zoom=56  Dexedrine’s (brand of dexamphetamine) says “Long-term effects of amphetamines in pediatric patients have not been well established. DEXEDRINE is not recommended for use in pediatric patients younger than 6 years of age with Attention Deficit Disorder with Hyperactivity” see http://www.dexedrine.com/docs/dexedrine_PI.pdf

[10] See http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm096273.htm

[11] Draft ADHD Guidelines Released, Joint Media Release, 30 November 2009.  The Hon Nicola Roxon MP, Minister for Health and Ageing, National Health and Medical Research Council, and Royal Australasian College of Physicians.]

]]> http://speedupsitstill.com/2012/10/02/australian-adhd-clinical-practice-points-6-years-frustrated-advocacy-small-step-direction/feed/ 5 http://speedupsitstill.com/2012/02/01/backdown-better-access-cuts-and-rare-win-talking-therapies/ http://speedupsitstill.com/2012/02/01/backdown-better-access-cuts-and-rare-win-talking-therapies/#respond Wed, 01 Feb 2012 07:20:57 +0000 http://speedupsitstill.com/?p=2337 The decision by Australian Government Mental Health Minister Mark Butler to suspend proposed cuts to the “Better Access” program from a maximum of 16 visits to counselling services to 10 per year appears to be a welcome and rare win for talking therapies over drug therapies.

Minister Butler’s media release stated, “We recognise that reducing the number of rebatable sessions has caused some community concern and that the new services in our mental health package need to build further capacity before they are fully able to provide care and support to those with more complex needs. We will therefore reinstate the additional 6 services under ‘exceptional circumstances’ for a transitional period to 31 December 2012. The transitional period will provide sufficient time for our new mental health services to build capacity and effectively respond to people with more complex needs.” ( see http://www.health.gov.au/internet/ministers/publishing.nsf/Content/mr-yr12-mb-mb005.htm accessed 1 February 2012)

The back-down is only a temporary stay of execution (until 2013) and there is the potential  for the ‘exceptional circumstances’ to be so narrowly defined as to prevent people who need the extra 6 sessions getting access. However, it gives hope for those advocating the permanent protection of access to talking therapies. Alternatively it gives Minister Butler time to prove that the much vaunted ‘new mental health services… effectively respond to people with more complex needs.’

It is also, for the first time, an open process. We know from the start who is developing the guidelines and the details of their conflict of interest declaration. (see http://www.nhmrc.gov.au/guidelines/adhd-conflicts-interest ) Gillard Government Mental Health Minister Mark Butler deserves credit for this. Let us hope this creates a precedent for future commonwealth government medical guidelines and advisory committee processes.

Rescinded 2009 draft Guidelines

The new guidelines, due for release in October, will supersede the flawed draft ADHD guidelines developed by the Royal Australian College of Physicians (RACP) at a cost of $135,000. The RACP process begun in 2007 and was dominated by ADHD prescribing enthusiasts and dogged conflict of interest controversies. In November 2009 the commissioning body, the National Health and Medical Research Council (NHMRC), decided that because of the then uncompleted investigation into undisclosed drug company payments to three prominent US researchers, whose work was heavily relied on in the draft guidelines, the process should be halted. [1. NHMRC, ‘Draft Australian Guidelines on ADHD – NHMRC consideration deferred pending outcome of USA investigation’, NHMRC Noticeboard 2009. Available at http://www.nhmrc.gov.au/media/noticeboard/notice09/091130-adhd.htm (accessed 5 January 2010).]  On 2 July 2011 the Boston Globe reported that Harvard Professor’s Biederman, Spencer and Wilens, who were referenced 82, 46 and 32 times respectively in the draft guidelines, had been sanctioned by their employer after investigations into allegations of millions of dollars in hidden pharmaceutical company payments were completed. The most high profile of the three Professor Joseph Biederman is believed to be the worlds’ most frequently quoted researcher supporting the use of psychotropic drugs for ADHD.[2. http://www.esi-topics.com/add/interviews/JosephBiederman.html]

The Biederman (et al) scandal was not the only ‘conflict of interest’ controversy around the Draft National ADHD Guidelines. The guidelines committee was initially chaired by Dr Daryl Efron until his ADHD pharmaceutical company ties were exposed by the Daily Telegraph in April 2007. [3. ADHD guru quits over Ritalin link, Janet Fife-Yeomans, The Daily Telegraph 5 May 2007 http://www.dailytelegraph.com.au/news/sydney-nsw/adhd-guru-quits-over-ritalin-link/story-e6freuzi-1111113472188 ] Freedom of Information processes also revealed the vast majority, at least 70%, but probably 80% ‘of the original (guidelines committee) group members, including doctors, have declared receiving grants and air fares, hotels and overseas trips from companies making drugs to treat the disorder.’ [4. Janet Fife-Yeomans, ‘Guidelines panel linked to drug firms’, The Advertiser, 17 November 2008, Available at http://www.news.com.au/adelaidenow/story/0,22606,24660999-5006301,00.html (accessed 4 October 2009).] (for more detail see http://speedupsitstill.com/gillard-government-continues-turn-blind-eye-drug-company-money)

Flawed 1997 National Guidelines

The 2009 draft guidelines were supposed to replace Australian National ADHD guidelines developed for the NHMRC in 1997. The 1997 guidelines were also developed by clinicians, mostly paediatricians, with ties to the pharmaceutical industry. They encouraged the widespread ‘off label’ prescribing of stimulants and other psychotropic drugs for ‘co-morbid disorders’, without any evidence base except for ‘reasonable theory’ derived from ‘clinical experience’. This helped facilitate the explosion of prescribing rates in the late 1990’s and into the new millennium by providing a justification for reckless, hypothesis-based prescribing by a relatively small number of self-appointed ‘ADHD experts’; primarily paediatricians with limited mental health training.[5. National Health and Medical Research Council, Attention Deficit Hyperactivity Disorder (ADHD), Canberra, 1997, pp. 32-38.]

2011 Committee

In comparison with either the 1997 or 2007 guideline development committees, the 2011 committee is relatively ‘conflict of interest’ free. At last this gives hope for true ‘evidence based – first do no harm’ approach.

The 2011 committee consists of:

Bruce Tonge (Chairperson) – Child and Adolescent Psychiatrist, Head of the Centre for Development Psychiatry at Monash Medical Centre.

Mark Dadds – Professor of Psychology, University of New South Wales.

John Dowden – Director of Therapeutic Guidelines Ltd.

Jon Jureidini – Professor of Psychiatry and Paediatrics, Adelaide University.

Michael Kohn – Paediatrician, Westmead Hospital Sydney.

Nicole Rinehart – Consulting Clinical Psychologist, Associate Professor, School of Psychology & Psychiatry, Monash University.

Margaret Vikingur representing LADS – Volunteer, Learning and Attentional Disorders Society, Perth.

Three others are expected to join the committee:

Vicky Anderson – Paediatric Neuropsychologist, University of Melbourne.

Kim Cornish – Developmental Neuroscientist, School of Psychology and Psychiatry, Monash University.

Professor Helen Milroy – Child and Adolescent Psychiatrist and Professor Aboriginal and Torres Strait Islander Health, University of Western Australia.

While a number of members of the committee have worked with or for pharmaceutical companies, for most these affiliations don’t relate directly to ADHD. However this can’t be said for Sydney’s Westmead Hospital paediatrician, Professor Michael Kohn, and the Perth based pharmaceutical company sponsored Learning and Attentional Disorders Society (LADS) who have a ‘consumer representative’ on the committee. Both Kohn and LADS have significant and direct conflicts of interest and should be excluded from the committee.

Professor Kohn’s quasi-religious faith in Ritalin

Professor Michael Kohn’s 2009 description of an article in Sydney’s Daily Telegraph detailing extreme reactions to ADHD medications reported to the TGA, such as psychotic episodes and suicidal ideation as “BLASPHEMING the use of Ritalin” indicates a near religious fervour for prescribing amphetamines like drugs to children.[7. Medicating our children, Reportage Online, 22 December 2009 http://www.reportageonline.com/2009/12/medicating-our-children/ Kohn’s comment was in response to We’re turning our children psychotic with ADHD medication, Kate Sikora, The Daily Telegraph October 13, 2009. http://www.dailytelegraph.com.au/lifestyle/body-soul/were-turning-our-children-psychotic/story-e6frf01r-1225786025127] This is not an isolated comment from Professor Kohn. (refer Where is the evidence to support ‘ADHD expert’ Prof Kohn’s claim that amphetamines aid brain development? )

Professor Kohn has significant financial connections to ADHD drug manufacturers Eli Lily and Janssen Cilag[7. M. Williams (et al), 2010. An ‘integrative neuroscience’ perspective on ADHD: linking cognition, emotion, brain and genetic measures with implications for clinical support.]  He was a member of Strattera Advisory Board for Elli Lilly and is currently undertaking publicly funded research on Strattera. He has received other financial support from both Janssen Cilag and Eli Lilly and been paid to prepare and deliver educational materials by Janssen Cilag. He has also received research support for ADHD studies from Brain Resource Ltd which has received funding from at least 13 different pharmaceutical companies.

Learning and Attentional Disorders Society (LADS)

LADS is partially funded by drug companies and has a long history of marketing of ADHD as having a biological cause best treated with ‘safe, effective medication’. [8. ‘LADS has accepted limited unrestricted grants from pharmaceutical companies.’ (Including Eli Lilly and Novartis.) See http://www.ladswa.com.au/page.php?id=6 (accessed 26 June 2009).] In 2003, on a Perth community television program Face the Facts, speaking on behalf of LADS, Michelle Toner and psychiatrist Dr Roger Patterson made some noteworthy statements.

Dr Patterson said: Dexamphetamine has the amphetamine name in it and this is what people are starting to worry about because they are giving them to children – or they are taking them themselves…let me dispel that, they are taking a medicinal form of amphetamine…this is not addictive stuff. In fact, I wish it was a little more addictive so that my younger patients would remember to take it rather than having to be reminded by their long-suffering parents.[9. Dr Roger Patterson interviewed on Face the Facts, video recording taken from Channel 31 Perth, 27 January 2003. 25]

Toner’s statements on the same TV program were even more notable. ‘In order to get a high equivalent to what people are taking [as] street speed, you would have to take close to 200 tablets. Children take 1 or 6 tablets a day and it is not addictive at all.’ [6. Michelle Toner interviewed on, Face the Facts, video recording taken from Channel 31 Perth, 27 January 2003. This information is also referred to in Ferguson and Rushworth, ‘ADHD – The Quick Fix’.] Two hundred of the standard 5 milligram dexamphetamine tablets would deliver a dose of 1 gram which would kill most people and a fair proportion of elephants as well. [10. ‘Individual patient response to amphetamines varies widely. While toxic symptoms occasionally occur as an idiosyncrasy at doses as low as 2mg, they are rare with doses of less than 15mg; 30mg can produce severe reactions, yet doses of 400 to 500mg are not necessarily fatal.’ GlaxoSmithKline’s Prescribing Information for Dexedrine (dextroamphetamine sulphate). Available at http://us.gsk.com/products/assets/us_dexedrine.pdf (accessed 26 June 2009).]

Also obviously ignorant of the effects of 1 gram of dexamphetamine, the interviewer went on to ask Toner: ‘Right, but if you do have ADHD and you take the medication, is it successful?’ Toner replied, ‘Oh yes…a lot of people discovered they had ADHD by accident. For example, truckies who needed uppers to keep them awake while they were driving across the Nullarbor suddenly found that they were driving a whole lot better…when they were taking dexies.’ Both Toner and Patterson remain on the professional advisory board of LADS.  [11. http://www.ladswa.com.au/page.php?id=9 ]

LADS have even encouraged the illegal diversion of ADHD amphetamines. In 1998 LADS was warned twice not to recommend the illegal use of a child’s ADHD stimulants by parents if they thought they had adult ADHD.[9. WA Stimulant Committee, Minutes of Meeting held on 4 August, 1998, obtained under Freedom of Information Act 1992] LADS have also publicly endorsed ADHD drugs in press releases prepared by public relations business in order to promote ADHD drugs. [12. Last Say Communications, ADHD – A Day of Calm – Dawn to Dusk: Long Lasting Medication to Provide Relief for Kids with ADHD, Media Release, 27 March 2007.]

LADS’ representative Margaret Vikingur is probably a very well intentioned individual, however, LADS acceptance of drug company money and its history should preclude it from membership of the committee. Failing LADS exclusion a counter-balancing voice from a ‘conflict of interest’ free support group should be included on the committee.

Minister Butler a vast improvement on ‘Roxon’s hypocrisy’ and ‘Do Nothing Abbott’

The above concerns aside, in comparison to the two previous ministers with responsibility for the development of national ADHD guidelines, Nicola Roxon and Tony Abbott, Mental Health Minister Mark Butler has made a good start.

When opposition health spokesperson Roxon called for the public release of conflict of interest declarations but refused to even release the names of guidelines committee members when she became the Health Minister. Her predecessor, Howard Government Health Minister Tony Abbott, was just as bad. He had the opportunity to prevent the problem when the original panel was appointed. He then had an opportunity to fix his original mistake when the conflict of interest issues were first revealed in 2007. Abbott expressed concern and then did next to nothing. (for more detail see http://speedupsitstill.com/gillard-government-continues-turn-blind-eye-drug-company-money )

Minister Butler has delivered an open process and ensured there is a range of views and expertise on the committee. It is hoped that the committee will produce cautious, evidence based, child friendly, rather than drug-company friendly, hypothesis based, guidelines. However it is just the start of the process and only time will tell. I will keep you posted.

Related Media

The Australian – Sue Dunleevy 13 July 2011 Attention deficit disorder guru’s in conflict of interest http://www.theaustralian.com.au/national-affairs/health/attention-deficit-disorder-gurus-in-conflict-of-interest/story-fn59nokw-1226093390142

The Monthly – Gail Bell 2011 The Rush to Diagnose ADHD http://www.themonthly.com.au/rush-diagnose-adhd-prescribing-behaviour-gail-bell-4013

The article states: ‘In a letter to co-workers yesterday, Biederman and Drs. Thomas Spencer and Timothy Wilens said the hospital and medical school “have determined that we violated certain requirements’’ of the institutions’ policies. They did not specify the nature of the violations. But in 2008, Senator Charles Grassley, an Iowa Republican, accused the three doctors of accepting millions of dollars in consulting fees from drug makers from 2000 to 2007, and of failing for years to report much of the income to university officials. Officials at Harvard and Massachusetts General released the letter to the Globe, but would not answer questions about the probe.‘ 

Although according to the Boston Globe ‘Biederman severed his industry ties soon after Massachusetts General and Harvard began their separate but coordinated investigations’ it appears he gets to keep the payments. However, the imposition of sanctions obviously confirms there was substance to the original allegations and should have serious implications for the Australian ADHD industry.

In November 2009 the National Health and Medical Research Council (NHMRC) decided that because of the then uncompleted investigation into undisclosed drug company payments to these three high profile US researchers the draft national ADHD guidelines had not been approved. The NHMRC later issued a press release stating that ‘If the US investigation remains unresolved by mid-2010, NHMRC will move to redevelop the draft guidelines’. [4. NHMRC, ‘Draft Australian Guidelines on ADHD – NHMRC consideration deferred pending outcome of USA investigation’, NHMRC Noticeboard 2009. Available at http://www.nhmrc.gov.au/media/noticeboard/notice09/091130-adhd.htm (accessed 5 January 2010).] Despite this the mid 2010 deadline passed without action.

This was very disappointing as the Biederman scandal was not the only ‘conflict of interest’ controversy around the Draft National ADHD Guidelines. The guidelines committee was initially chaired by Dr Daryl Efron until his ADHD pharmaceutical company ties were exposed by the Daily Telegraph in April 2007. [5. ADHD guru quits over Ritalin link, Janet Fife-Yeomans, The Daily Telegraph 5 May 2007 http://www.dailytelegraph.com.au/news/sydney-nsw/adhd-guru-quits-over-ritalin-link/story-e6freuzi-1111113472188 ] Dr Efron had been on the advisory boards of Novartis (Ritalin) and Eli Lilly (Strattera). Media exposure of Dr Efron’s pharmaceutical company ties prompted then Health Minister Tony Abbott’s intervention and Efron’s resignation as chair, but not from the committee.

Freedom of Information processes also revealed the vast majority, at least 70%, but probably 80% ‘of the original (guidelines committee) group members, including doctors, have declared receiving grants and air fares, hotels and overseas trips from companies making drugs to treat the disorder.’ [6. Janet Fife-Yeomans, ‘Guidelines panel linked to drug firms’, The Advertiser, 17 November 2008, Available at http://www.news.com.au/adelaidenow/story/0,22606,24660999-5006301,00.html (accessed 4 October 2009).]

The appointment of Australia’s first Mental Health Minister, Mark Butler, has brought fresh hope of a ‘conflict of interest’ free redevelopment of the national ADHD guidelines. Hopefully the sanctions on Bierderman, Spencer and Wilens along with the new evidence of significant long term harm from ADHD medications from the Raine Study will be the catalyst for decisive action.

For full detail, including a timeline, of the corrupted draft national ADHD guidelines see http://speedupsitstill.com/gillard-government-continues-turn-blind-eye-drug-company-money For more information on the Raine Study see http://speedupsitstill.com/raine-study-review-one-year-on For more information on the Biederman, Spencer and Wilens scandal see Harvard Docs Disciplined For Conflicts Of Interest // Pharmalot

LATE UPDATE: Todays’ Australian (5 July 2011) has reported that at last the flawed draft national guidelines are being redeveloped. Provided this is a ‘conflict of interest’ free process this is very welcome news. see http://www.theaustralian.com.au/news/nation/adhd-review-as-us-expert-faces-inquiry/story-e6frg6nf-1226087514583 When further information becomes available I will issue an update.

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. (9 August 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.

The continuing refusal of Gillard Government Health Minister Nicola Roxon to abandon flawed and compromised draft national ADHD guidelines is risking the health and wellbeing of tens of thousands of Australian children. It is now over a year since Federal Government Health Minister, Nicola Roxon, rejected advice from the NHMRC to abandon the draft guidelines because of concerns about undue influence by ADHD pharmaceutical manufacturers.

In 2007 when opposition health spokesperson, Nicola Roxon expressed concern about the potential for undue pharmaceutical company influence on these ‘incredibly important’ guidelines. However, upon becoming the Health Minister Nicola Roxon refused calls to abandon the controversial guidelines process and appoint a replacement ‘conflict of interest free’ committee.

Throughout 2009 Health Minister Roxon came under pressure from both sides of the ADHD debate. ADHD critics concerned about the potential of the draft national ADHD guidelines to further accelerate the growth in child prescribing rates lobbied Roxon to abandon the draft guidelines and seek advice from psychiatrists without ties to the pharmaceutical industry. ADHD industry insiders, including members of the committee who drafted the guidelines, wanted them released.

In October 2009 the National Health and Medical Research Council (NHMRC) effectively offered Roxon an ideal circuit breaker. They announced that because of an investigation involving undisclosed drug company payments to US researcher Dr Joseph Biederman, who was cited 82 times in the draft guidelines, the guidelines had not been approved. The NHMRC issued a press release stating that ‘if the US investigation remains unresolved by mid-2010, NHMRC will move to redevelop the draft guidelines’.[1. NHMRC, ‘Draft Australian Guidelines on ADHD – NHMRC consideration deferred pending outcome of USA investigation’, NHMRC Noticeboard 2009. Available at http://www.nhmrc.gov.au/media/noticeboard/notice09/091130-adhd.htm (accessed  3 December 2010)]

Surprisingly Minister Roxon rejected this opportunity to defuse the issue and in December 2009 pressured the NHMRC to release the guidelines. The public and the medical profession were left with the mixed message that according to the NHMRC the guidelines were draft and subject to withdrawal, but that Roxon was pleased they finally offered ‘more up-to-date information on ways to identify and care for those in our community who may be suffering from ADHD.’[2. Renee Viellaris, ‘Medication not first option to beat ADHD’, Courier-Mail, 1 December 2009.]

That was not the only inconsistency in the Commonwealth Government’s response. Minister Roxon, the Royal Australian College of Physicians and the NHMRC made the staggering claim in a joint press release that there were over 350,000 Australian children and adolescents with ADHD (over six times the number medicated in 2009).[3. The 350,000 figure is based on a flawed estimate that 11.2% of Australian children have ADHD from M. G. Sawyer, F. M. Arney et al., ‘The mental health of young people in “Australia: key findings from the child and adolescent component of the national survey of mental health and well-being’, Australian and New Zealand Journal of Psychiatry, 35:806-814, 2001.] [4. Statistics on number of patients on Attention Deficit Hyperactivity Disorder (ADHD) drugs in 2007 obtained on request from the Commonwealth Department of Health and Ageing. ] Yet in the same press release the ADHD guidelines committee chair Dr David Forbes stated ‘What’s important is that it is likely fewer children will be prescribed medication.[5. Draft ADHD Guidelines Released, Joint Media Release, 30 November 2009.  The Hon Nicola Roxon MP, Minister for Health and Ageing, National Health and Medical Research Council, and Royal Australasian College of Physicians.]

The draft guidelines, which were developed to replace guideline developed in 1997 and rescinded in 2005, have been dogged by controversy primarily because of allegations of bias amongst the guidelines committee members.

A Timeline of controversy around the guidelines follows:

31 December 2005- The National Health and Medical Research Council (NHMRC) rescinded the previous national ADHD guidelines and outsourced for $135,000 the development of new national guidelines for the diagnosis and treatment of ADHD to the pharmaceutical company sponsored Royal Australasian College of Physicians (RACP).[6. Health Minister Tony Abbott MHR, ADHD Review, media release,  2 May 2007.] [7. The RACP benefits from considerable sponsorship from drug manufacturers. For example, the RACP 2009 Annual Physicians Week Conference was sponsored by ADHD drug manufacturer Janseen-Cilag and had paid exhibitions by Eli Lilly and Novartis. On the RACP website, potential sponsors and exhibitors were encouraged to fund the RACP Conference with comments like ‘Sponsorship and Exhibition opportunities allow you to align the needs of your company to specific Congress events, whilst exposing your staff directly to your captive target markets [i.e. prescribers].’ The Royal Australasian College of Physicians, ‘Trade Exhibition and Sponsorship’, Physicians Week 2009. Available at http://www.physiciansweek.com/sponex.asp (accessed 12 August 2009).]

April /May2007- The guidelines committee was initially chaired by Dr Daryl Efron until his ADHD pharmaceutical company ties were exposed by the Daily Telegraph in April 2007. Dr Efron had been on the advisory boards of Novartis (Ritalin) and Eli Lilly (Strattera). Media exposure of Dr Efron’s pharmaceutical company ties prompted then Health Minister Tony Abbott’s intervention and Efron’s resignation as chair, but not from the committee.

The then Opposition Health Spokesperson and current Minister for Health, Nicola Roxon, expressed concern about protecting children from unnecessary prescribing.[8. ‘Call for policy on ADHD drugs’, Courier-Mail, 27 April 2007.]  Roxon called for the names and drug company connections of the guidelines review committee members to be made public; saying, ‘These guidelines are incredibly important and it is important there is public confidence in them. Given the controversy surrounding ADHD, releasing the names is the sensible option to help restore public confidence in the process.[9. Janet Fife-Yeomans, ‘Secrecy for ADHD doctors’, The Daily Telegraph, 30 June 2007.] Abbott rejected Roxon’s call for full disclosure. In addition to calling for full committee disclosure when in opposition, Roxon also called for an independent inquiry into ADHD ‘along the lines of one into ADHD in Western Australia’.[10. Fife-Yeomans and McDougall, ‘Call for ADHD drug inquiry’, Daily Telegraph, April 27 2007.]

November 2007- Rudd Labor won the federal election and Nicola Roxon became Minister of Health. Despite her calls for disclosure in opposition she failed to, and then later refused to disclose the names of the committee or their drug company connections. Roxon also completely ignored the WA experience.

July 2008- In a submission to the RACP guidelines committee I highlighted that the most frequently cited author in the first draft of the guidelines, Havard University Professor Dr Joseph Bierderman, was under investigationfor undisclosed pharmaceutical company payments. My submission stated: ‘On June 8 2008 the New York Times exposed how Dr Biederman was paid US$1.6 million in consulting fees from drug makers between 2000 and 2007 but did not disclose this income to his employer Harvard University[11. Gardiner Harris and Benedict Carey, ‘Researchers Fail to Reveal Full Drug Pay’. New York Times, 8 June 2008].  Biederman received research funds from 15 pharmaceutical companies and serves as a paid speaker or adviser to at least seven drug companies.’[12. ‘The Evolving Face of ADHD: From Adolescence to Adulthood—Clinical Implications’. Available at www.adhdhome.com (accessed 2 May 2008).]

19 August 2008- The first draft of the guidelines included the recommendation that ‘Federal, State and Territory funding allocations to schools need to be revised to enable schools to access funding for students diagnosed with ADHD’.[13. Royal Australasian College of Physicians, ‘Draft Australian Guidelines on Attention Deficit Hyperactivity Disorder (ADHD)’, p. 122.] Critics contended this would, if implemented, have provided a commission-based ADHD spotters’ fee to schools. After a letter from a group of fourteen researchers in education, disabilities and ADHD (led by Dr Linda Graham) to the Rudd government gained media coverage, this recommendation was dropped.[14. Justine Ferrari, ‘Alert over ADHD guidelines in schools’, The Australian, 19 August 2008.]

17 November 2008- Freedom of Information processes reveal the vast majority, at least 70%, but probably 80% ‘of the original [guidelines committee] group members, including doctors, have declared receiving grants and air fares, hotels and overseas trips from companies making drugs to treat the disorder.’[15. Janet Fife-Yeomans, ‘Guidelines panel linked to drug firms’, The Advertiser, 17 November 2008, Available at http://www.news.com.au/adelaidenow/story/0,22606,24660999-5006301,00.html (accessed 4 October 2009).]  When this de-identified  information was reported in the media, it was reported that ‘the publicly-funded committee had threatened to quit if their names were revealed’.[16. Janet Fife-Yeomans, ‘Guidelines panel linked to drug firms’, The Advertiser, 17 November 2008, Available at http://www.news.com.au/adelaidenow/story/0,22606,24660999-5006301,00.html (accessed 4 October 2009).]  Adelaide psychiatrist and campaigner against ADHD prescribing, Dr Jon Jureidini, said many doctors had said no to drug company money and would have been well qualified to join the committee adding, ‘It is incredibly easy not to accept the money, you just decide not to do it.’[17. Janet Fife-Yeomans, ‘Guidelines panel linked to drug firms’, The Advertiser, 17 November 2008, Available at http://www.news.com.au/adelaidenow/story/0,22606,24660999-5006301,00.html (accessed 4 October 2009).]

27 November 2008- Following up on the media coverage, independent South Australian Senator Nick Xenophon asked for details of potential conflicts of interest. The requested details were not provided and the response was limited to; ‘Minister [Roxon] has been advised that the conflicts of interest declared by working party members are consistent with the normal range associated with clinician review committees of this nature.’[18. Commonwealth of Australia, Parliamentary Debates, Senate, 27 November 2008, p. 7540 (Senator Joe Ludwig on behalf of Hon Nicola Roxon, Minister for Health and Ageing).]

June 2009-  The draft guidelines document was completed with ‘the majority of the identified studies on ADHD medications’ being ‘sponsored, at least in part, by the manufacturers of the medications’.[19. Royal Australasian College of Physicians, ‘Draft Australian Guidelines on Attention Deficit Hyperactivity Disorder (ADHD)’, p. 82]  In addition two thirds of the 208 draft recommendations were made without any supporting scientific evidence. They were based entirely on reference group consensus and justified as ‘best practice based on clinical experience and expert opinion’.

October 2009-  The National Health and Medical Research Council (NHMRC) decide that because of an investigation involving undisclosed drug company payments to US researcher Dr Joseph Biederman, who was cited 82 times in the draft guidelines, the guidelines had not been approved. The NHMRC later issued a press release stating that ‘If the US investigation remains unresolved by mid-2010, NHMRC will move to redevelop the draft guidelines’.[20. NHMRC, ‘Draft Australian Guidelines on ADHD – NHMRC consideration deferred pending outcome of USA investigation’, NHMRC Noticeboard 2009. Available at http://www.nhmrc.gov.au/media/noticeboard/notice09/091130-adhd.htm (accessed 5 January 2010).]

23 November 2009- The Sydney Daily Telegraph reported the NHMRC decision to redevelop the guidelines and quoted a RACP spokesperson asserted that ‘the College was not aware of the US investigation (into Biederman) when drafting the guidelines’.[21. Kate Sikora, ‘ADHD guidelines pulled after payment scandal’, The Daily Telegraph, 23 November 2009.]

24 November 2009- The Australian reported that in conflict with the RACP spokespersons statement sixteen months earlier ‘(Martin Whitely) wrote to the panel in July last year, warning that its work had been tainted by Dr Biederman’s research’ and ‘raised similar concerns with Ms Roxon’s advisers in August last year’. [22. Nicola Berkovic, ‘Review of “tainted” ADHD guidelines’, The Australian, 24 November 2009.]

Note: Dr Biederman was not the only Harvard University researcher cited in the draft guidelines under investigation for undisclosed drug company payments. Two other Harvard researchers under investigation, Drs Timothy Wilens and Thomas Spencer, were cited thirty-two and forty-six times respectively.[23. Gardiner Harris, ‘3 Researchers at Harvard are named in subpoena’, The New York Times, 27 March 2009]

Another researcher cited either as the principal author or co-author on twenty-five occasions was Dr Laurence Greenhill. Dr Greenhill has worked as a paid consultant to Alza Corp., Bristol-Myers Squibb, Richwood and GlaxoSmithKline, Eli Lilly, McNeil Pharmaceutical, Novartis Pharmaceuticals and Solvay.[24. Greg Birnbaum and Douglas Montaro, ‘Shrinks for Sale. Analyze This: Docs get Drug Co. $$’, New York Sunday Post, 28 February 1999.]  He has been a paid speaker for ADHD drug manufacturers Eli Lilly, Janssen Pharmaceuticals and Novartis Pharmaceuticals.[25. Associated Press, ‘Study Warns of Ritalin Side Effects in Preschoolers’, 19 October 2006. Available at http://www.foxnews.com/story/0,2933,222559,00.html (accessed 25 July 2008). ]  When addressing an audience of 300 international psychiatrists at a conference in Melbourne in September 2006, Dr Greenhill misrepresented the FDA deliberations on the black box warning debate on stimulants.[26. International Association for Child and Adolescent Psychiatry and Allied Professions (IACAPAP) September 2006 Conference Melbourne Australia.] He portrayed the call for a black box warning for stimulants as coming from isolated clinicians rather than from the specially appointed FDA Drug Safety Advisory Panel. Dr Greenhill only revealed his extensive drug company connections when I asked him about them at the end of his presentation.

30 November 2009-  Minister Roxon rejected this opportunity to put the redevelopment of the guidelines in the hands of clinicians without commercial ties to the pharmaceutical industry and pressured the NHMRC to release the guidelines. Roxon, the NHMRC and the RACP issued a joint press release with Roxon praising the draft guidelines stating  ‘I am pleased that we can finally provide this more up to date information on ways to identify and care for those in our community who may be suffering from ADHD.’ Despite all the previously highlighted problems, the joint statement also said ‘The RACP has conducted a thorough and careful process to develop these draft Guidelines. They utilised a panel of independent experts to review the scientific evidence, and an independent scientific writer to prepare the draft document, with the work overseen by an expert working group.’[27. Draft ADHD Guidelines Released, Joint Media Release, 30 November 2009.  The Hon Nicola Roxon MP, Minister for Health and Ageing, National Health and Medical Research Council, and Royal Australasian College of Physicians.]

14 September 2010- The appointment of Australia’s first Mental Health Minister, Mark Butler, brought hope of a fresh ‘conflict of interest’ free redevelopment of the national ADHD guidelines. However it is unclear whether responsibility for the future of the draft guidelines remains with Roxon or has transferred to Butler.

The process is obviously discredited but what is wrong with the substance of the draft guidelines?

Stimulants as the Fist Line Treatment- The key recommendations of the draft guidelines encourage the use of stimulants, either methylphenidate or dexamphetamine, as the first line treatment with the substitution of one for the other in the case of adverse side effects or ineffectiveness. If children do ‘not respond to or are intolerant of stimulant medication’, the non-stimulant drug Strattera (with a black box warning for suicidal ideation) is recommended.[28. Royal Australasian College of Physicians, ‘Draft Australian Guidelines on Attention Deficit Hyperactivity Disorder (ADHD)’, p. xviii.]  If both stimulants and Strattera fail to result in a ‘clinical response’ Clonidine can be ‘trialed’.[29. Royal Australasian College of Physicians, ‘Draft Australian Guidelines on Attention Deficit Hyperactivity Disorder (ADHD)’, p. xviii.] This cascading use of medications does not stop to give children a chance to be drug free even if they are experiencing significant adverse drug reactions.

An example of this approach is the recommendation that if, as is common, ADHD stimulants cause tics or pre-existing tics become worse, the following treatment options can be followed: continue the ADHD medication alone; add an anti-tic medication; or trial another ADHD medication.[30. Royal Australasian College of Physicians, ‘Draft Australian Guidelines on Attention Deficit Hyperactivity Disorder (ADHD)’, p. xviii.]

Polypharmacy- The guidelines also encourage polypharmacy, by prescribing a range of psychotropic drugs to children, particularly for depression and bipolar disorder along with ADHD medications. This is despite the TGA insisting manufacturers of all selective serotonin reuptake inhibitors (SSRI) antidepressants include advice that their use by under-twenty-four-year-olds increases the risk of suicidality.[31. Julie-Anne Davies, ‘Probe into anti-depressants being conducted “in secret”’, The Australian, 1 November 2008.]

Similarly, the recommendation that methylphenidate be used as a second line treatment for children under six years of age, despite manufacturers’ guidelines recommending against it, exposes very young children to significant risks and prescribers to potential negligence claims.[32. Ritalin (R) LA: methylphenidate hydrochloride, Consumer Medicine Information, March 2007. Available at http://www.nps.org.au/__data/assets/pdf_file/0011/16004/nvcrtlla10307.pdf (accessed 29 June 2009).]

Drug Abuse- The conclusion that ‘the use of stimulant medication to treat people with ADHD does not increase the risk of developing substance use disorder’[33. Royal Australasian College of Physicians, ‘Draft Australian Guidelines on Attention Deficit Hyperactivity Disorder (ADHD)’, p. 8.] is completely inconsistent with the product warning for stimulants like the following one for Dexidrine a brand of dexamphetamine:

AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.  MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.[34. GlaxoSmithKline, Prescribing Information – Dexedrine (dextroamphetamine sulphate), July 2008.  http://www.gskus.com/products/assets/us_dexedrine.pdf (accessed 28 July 2009)]

Methylphenidate and dexamphetamine are controlled substances (Schedule 8 drugs) because they are drugs of addiction with a high potential for abuse. Again in my submission to the RACP and in a letter to Roxon, I provided details of the Western Australian experience of a huge fall in ADHD prescribing rates for children (60%+), which coincided with the massive fall in teenage amphetamine abuse rates (51%). Again this evidence was ignored.

Parents- The role and rights of parents and family in the draft guidelines are of particular concern. The recommendation that stimulants can be used even on preschoolers if ADHD symptoms are having a severe impact on ‘family/carers’ is a violation of the rights of the child.[35. Royal Australasian College of Physicians, ‘Draft Australian Guidelines on Attention Deficit Hyperactivity Disorder (ADHD)’, p. 8.]

Children must never be medicated for the benefit of third parties. Claims of improved family functioning or similar third party benefits must be ignored. The only consideration should be the long-term wellbeing of the individual child.

Prison Screening- The recommendation that ‘as ADHD and ADHD symptoms are common in individuals entering the justice system, screening for ADHD may be indicated in this population’ carries the risk of prisoners being supplied with divertable ADHD amphetamines.[36. Royal Australasian College of Physicians, ‘Draft Australian Guidelines on Attention Deficit Hyperactivity Disorder (ADHD)’,p. xxviii.]

Like two thirds of the 208 recommendations, this was based entirely on the consensus of the RACP panel with no supporting evidence.  The admission in the guidelines that ‘more research is needed to determine whether treatment of ADHD can reduce the risk of crime and recidivism’ further fuelled concerns that bias is the basis of the prison screening proposal.[37. Royal Australasian College of Physicians, ‘Draft Australian Guidelines on Attention Deficit Hyperactivity Disorder (ADHD)’,p. xxviii.]

Indigenous ADHD- The recommendation that ‘given the high rate of suicide in Australia’s Indigenous population and the association of impulsivity with suicidal ideation among Indigenous youth…there is an urgent need for culturally appropriate assessment of ADHD’ was also very controversial.[38. Royal Australasian College of Physicians, ‘Draft Australian Guidelines on Attention Deficit Hyperactivity Disorder (ADHD)’,p. 54] ADHD prescribing rates in non-metropolitan Aboriginal communities are generally below the Australian average. This must not change. The last thing that Aboriginal communities need is a source of cheap amphetamines.

Intellectual disability- Perhaps the most disturbing potential outcome of the guidelines affects people with intellectual disabilities. They are among the most vulnerable members of society. The recommendation that ‘in people with intellectual disability and ADHD, use of stimulant medication should be considered’ reflects an absurd expectation of ‘normal’ for children with intellectual disability.[39. Royal Australasian College of Physicians, ‘Draft Australian Guidelines on Attention Deficit Hyperactivity Disorder (ADHD)’,p. xxi.]  The ‘clear evidence of clinically significant impairment in social, academic or occupational functioning’ required for a DSM-IV diagnosis is a result of their intellectual impairment not ADHD.[40. American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, pp. 92–93]

Children and adults with intellectual disabilities need a safe, loving, interesting environment, not more labels and amphetamines.

Conclusion

Despite her position as Opposition Spokesperson for Health, Gillard Labor Government Health Minister Nicola Roxon has allowed the response to concerns about misdiagnosis and over-prescription to remain delegated to the RACP guidelines group. As a loyal member of the same political party as Roxon (Labor) I am particularly angry and frustrated by her hypocrisy and incompetent handling of this issue.

However, politicians of all persuasions including Roxon’s predecessor Howard Government Health Minister Tony Aboot have made the same mistake in seeking to address concerns about reckless ADHD prescription. They keep going back to the ADHD industry for advice and the industry inevitably promotes further prescribing.

The solution is simple. Mental Health Minister Butler should be given responsibility for the issue and then accept the NHMRC’s October 2009 decision and put the redevelopment of the guidelines in the hands of mental health professionals, primarily psychiatrists, who have no commercial ties to the pharmaceutical industry.

Update 13 July 2011- Action at Last: Mental Health Minister Mark Butler has set up a committe process to develop new National ADHD Guidelines see http://speedupsitstill.com/mental-health-minister-mark-butler-scores-8-10-open-book-approach-australian-national-adhd-guidelines-committee

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

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

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

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

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

‘Among all the problematic suggestions for DSM-V, the proposal for a “Psychosis Risk Syndrome” stands out as the most ill-conceived and potentially harmful… The whole concept of early intervention rests on three fundamental [flawed] pillars… 1) it would misidentify many teenagers who are not really at risk for psychosis; 2) the treatment they would most often receive (atypical antipsychotic medication) has no proven efficacy; but, 3) it does have definite dangerous complications.”^[9]

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

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

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

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

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

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

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

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

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

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

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