Today (Wednesday 13 July 2011) Mental Health Minister Mark Butler announced the membership of the committee responsible for developing new Australian guidelines on ADHD. Of the ten members invited to participate, two have significant conflicts of interest that should preclude their involvement. However, this compares very favorably to previous ADHD guideline development processes which have been dominated by pharmaceutical company allies who have relied on commercially compromised research.
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Rescinded 2009 draft Guidelines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.]
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.
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
Tags: ADHD guidelines, Australian ADHD Guidelines 1997, conflict of interest and ADHD, Daryl Efron, Jon Jureidini, Joseph Biederman, Learning and Attentional Disorders Society (LADS), Mark Butler, Michael Kohn, Michelle Toner, Minister Butler, NHMRC, Nicola Roxon, Roger Patterson, Tony Abbott