John Curtin Institute of Public Policy – Curtin Business School Attention Deficit Hyperactivity Disorder Policy, Practice and Regulatory Capture in Australia 1992–2012 Martin Paul Whitely This thesis is presented for the Degree of Doctor of Philosophy of Curtin University March 2014 Declaration To the best of my knowledge and belief this thesis contains no material previously published by any other person except where due acknowledgment has been made. This thesis contains no material which has been accepted for the award of any other degree or diploma in any university. Signature: …………………………………………. Date: ………………………... Abstract Like many first world nations, Australia has demonstrated an increasingly pharmaceuticalized response to Attention Deficit Hyperactivity Disorder (ADHD). Per capita rates of prescriptions of ADHD medications grew 277 percent between 1995 and 2010. However, there have been large and inconsistent intertemporal variations between state jurisdictions (shifting over time in relative terms). Most notably, in Western Australia (WA) in 2002 the child Pharmaceutical Benefits Scheme (PBS) per capita prescribing rate was 142 percent above the national average. However, after 2003, while in other states prescribing rates grew, they fell by 50 percent in WA, and by 2011 they were 11 percent below the national average. There has been significant academic, public and media interest not only about the growing and inconsistent prescribing rates, but also about concerns that conflicts of interests and ‘regulatory capture’ may have affected significant policy development and regulatory processes in relation to ADHD. Regulatory capture occurs if an entity that is supposed to advance the public interest instead acts to benefit commercial or industry interests in ways that are contrary to the public interest. The thesis draws heavily on the work of British sociologist John Abraham, who contends that regulatory capture is the most significant explanation of the process of pharmaceuticalization for many health conditions, including ADHD. Here key ADHD policy development processes are analysed to evaluate the extent of regulatory capture in Australian national and state jurisdictions. These include the development of national treatment guidelines and state-specific reviews of WA and New South Wales (NSW) prescribing practices. For the purposes of this thesis, the term ‘regulatory capture’ is taken to have a broad scope, encompassing capture of any or all of the actors, both government and non-government, which have the declared intention of protecting and enhancing the public good. Examples of non-government actors include professional organisations, researchers, and patient advocacy groups. The history of ADHD policy and regulation nationally from 1992 to 2012, in WA from 1993 to 2011 and in NSW from 2007 to 2011 is that regulatory capture occurred in the majority of policy development and regulatory processes. These ‘captured’ processes have been associated with subsequent ADHD child pharmaceuticalization. Conversely the only ADHD- critic dominated process identified occurred in WA in 2002 and was associated with subsequent ADHD child de-pharmaceuticalization. The findings of this thesis are consistent with Abraham’s assertion that regulatory capture is a significant driver of pharmaceuticalization. Acknowledgements First and foremost I wish to thank my supervisor, Professor John Phillimore, for his support and guidance. His prompt and comprehensive feedback has made completing this thesis possible. I also thank Professor Alan Fenna, Dr Alan Tapper, Dr Melissa Raven and Dr Ann Jones for their expert assistance. I am also grateful to my former constituents, the residents of the Western Australian state electorates of Bassendean and Roleystone, for providing me with the opportunity to influence some of the policy processes described in this thesis. Finally I wish to thank my family, Melinda, Shane and Patrick for their love, patience and support during the writing this thesis, and throughout my, at times, obsessive involvement in the policy processes described within it. Contents Preface 1 Chapter 1. Introduction: Regulatory Capture and Australian ADHD Child Prescribing 1.1 The significance of and need for the Study 4 1.2 The Research Questions 7 1.3 Working Hypothesis 7 1.4 Methodology 8 1.5 Structure of the Thesis Chapter 2. Literature Review - Competing perspectives on ADHD Pharmaceuticalization; Biomedicalism versus Medicalization and Regulatory Capture 2.1 The Controversies about ADHD 16 2.1.1 The validity of the diagnosis 16 2.1.2 The safety and efficacy of the pharmaceutical used to treat ADHD 21 2.1.2.1 ADHD Stimulants 21 2.1.2.2 Atomoxetine (Brand name Strattera) 22 2.1.3 ADHD and Drug Abuse 24 2.2 Pharmaceuticalization 26 2.2.1 Competing Explanations for ADHD Pharmaceuticalization 27 2.2.1.1 The Biomedicalisation viewpoint of ADHD Proponents 27 2.2.1.2 The Medicalisation perspective of ADHD critics 33 2.3 Injury versus Access Orientated Consumerism 42 2.4 Summary of ADHD proponent’s and ADHD critic’s positions 43 2.5 The Theory of Regulatory Capture 46 2.6 Abraham on Regulatory Capture and Pharmaceuticalization 52 2.7 What policies have been proposed for regulatory capture and the pharmaceutical industry? 54 2.8 Summary 57 Chapter 3. ADHD and Imported Regulatory Capture 3.1 Defining ADHD 60 3.2 The American Psychiatric Association and Regulatory Capture 64 3.3 History of ADHD: the broadening of the diagnostic criteria 70 61 3.4 Further broadening of ADHD criteria in DSM-5 73 3.5 Regulatory Capture and International Drug Research 78 3.6 Oregon Health and Science University ADHD Drug Effectiveness Review Project 80 3.7 Imported Regulatory Capture Summary 81 Chapter 4. Statistics on Australian National and Western Australian and New South Wales ADHD prescribing rates 4.1 Sources of Data 83 4.2 National prescribing rates for ADHD medications 1992-2011 84 4.3 Western Australian inter-temporal statistics on ADHD child prescribing 88 4.3.1 Patient numbers growth from 1992 to 2002 92 4.3.2 Analysis of intertemporal trends in WA prescribing 93 4.4 A comparison of New South Wales and Western Australian inter-temporal statistics on ADHD prescribing 94 4.4.1 WA versus NSW Child Prescribing Rates 94 4.4.2 WA versus NSW Adult Prescribing Rates 96 4.5 - Summary of ADHD prescribing statistics 1992-2011 97 Chapter 5. National ADHD policy and regulation 5.1 Commonwealth Government Responsibilities in Regard to ADHD 99 5.2 Department of Health commissioned research into the prevalence of ADHD 101 5.3 The National Health and Medical Research Council 106 5.3.1 - The 1997 National Health and Medical Research Council National ADHD Treatment Guidelines 108 5.3.2 The 2009 NHMRC Draft National ADHD Treatment Guidelines 115 5.3.2.1 Timeline of controversy around the 2009 NHMRC Draft National ADHD Treatment Guidelines and Clinical Practice Points 116 5.3.3 - The 2012 Australian Clinical Practice Points for the Diagnosis and Treatment of ADHD in Children 129 5.3.4- Summary of the NHMRC’s involvement in ADHD policy processes 134 5.4 The Therapeutic Goods Authority 135 5.4.1 Licencing of Ritalin and Ritalin LA via the TGA 136 5.4.2 Licencing of Strattera by the Therapeutic Goods Administration 138 5.4.3 Post licencing monitoring of Strattera by the Therapeutic Goods Administration 140 5.4.4 Off Label Prescribing and the TGA 145 5.5 The Pharmaceutical Benefits Scheme 147 5.5.1 Case Study: The marketing of Strattera and subsidisation via the Pharmaceutical Benefits Scheme 148 5.5.2 Other evidence of Pharmaceutical Benefits Scheme Regulatory Capture 153 5.6 The effects of other Commonwealth Government policies on the economics of diagnosing and treating ADHD 153 5.7 Summary of the Australian Government experience of Pharmaceuticalization and Regulatory Capture 154 Chapter 6. Western Australian and New South Wales ADHD policy and Regulatory Capture 6.1 Western Australian State Government Responsibilities in Regard to ADHD 156 6.2 Timeline of significant events regarding the Western Australian Government’s response to ADHD 158 6.3 WA ADHD policy and politics 1994 -2001 159 6.3.1 Block Authorisation 160 6.3.2 Western Australian Stimulants Committee 161 6.3.3 The 1998 Western Australian Health Department convened International Panel on the Diagnosis and Treatment of ADHD 165 6.3.4 The 1999 Parliamentary Inquiry into a petition concerning Attention Deficit Hyperactivity Disorder 167 6.3.5 Training of Western Australian Paediatricians 171 6.4 WA ADHD policy and politics 2002-2012 174 6.4.1 Child Prescribing 176 6.4.2 Why did Western Australian adult prescribing rates continue to grow when child prescribing rates fell? 177 6.4.3 Limitations on Stimulant Dispensing 182 6.4.4 The 2004 WA Legislative Assembly Education and Health Standing Committee into ADHD 182 6.5 Amphetamine Abuse and ADHD Prescribing In Western Australia 186 6.6 Learning and Attentional Disorders Society a Western Australian ADHD Patient Support Group 189 6.7 The Raine Study: a unique Western Australian long-term data review of the safety and efficacy of ADHD psychostimulant use by children 193 6.8 Summary of Western Australia’s ADHD history 197 6.9 - New South Wales ADHD policy and regulatory history 198 6.9.1 ADHD in Children and Adolescents in New South Wales – 2007 Clinical Excellence Commission Prescribing Review 198 6.10 WA and NSW comparative history of regulation and prescribing rates 204 Chapter 7. Discussion, Conclusions and Recommendations 7.1 The Hypothesis 205 7.2 Pharmaceuticalization