One year on from the release of the corrupted National ADHD Guidelines

One year on from the release of the corrupted National ADHD Guidelines – The Gillard Government continues to turn a blind eye to drug company influence, ignore NHMRC advice, and expose Australian Children to unnecessary ADHD drugging.

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