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Rescinded 2009 draft Guidelines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  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

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 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 (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

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.⁶ 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 Cilag⁷  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 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

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.’ ¹⁰ 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. ¹¹

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.  ¹²

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.¹³ LADS have also publicly endorsed ADHD drugs in press releases prepared by public relations business in order to promote ADHD drugs. ¹⁴

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 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

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

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 4} 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

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 7}.’ 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  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 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

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 University¹¹.  Biederman received research funds from 15 pharmaceutical companies and serves as a paid speaker or adviser to at least seven drug companies.’¹²

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 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

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  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  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

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

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  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

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

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

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

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  He has been a paid speaker for ADHD drug manufacturers Eli Lilly, Janssen Pharmaceuticals and Novartis Pharmaceuticals.²⁵  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 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

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  If both stimulants and Strattera fail to result in a ‘clinical response’ Clonidine can be ‘trialed’.²⁹ 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

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

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

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 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

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

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

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

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 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  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

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