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Adopting the UNESCO Ethics Model to Critique Disease Mongering Barbara Postol

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Duquesne University Duquesne Scholarship Collection Electronic Theses and Dissertations Spring 1-1-2016 Adopting the UNESCO Ethics Model to Critique Disease Mongering Barbara Postol Follow this and additional works at: https://dsc.duq.edu/etd Recommended Citation Postol, B. (2016). Adopting the UNESCO Ethics Model to Critique Disease Mongering (Doctoral dissertation, Duquesne University). Retrieved from https://dsc.duq.edu/etd/1496 This One-year Embargo is brought to you for free and open access by Duquesne Scholarship Collection. It has been accepted for inclusion in Electronic Theses and Dissertations by an authorized administrator of Duquesne Scholarship Collection. ADOPTING THE UNESCO ETHICS MODEL TO CRITIQUE DISEASE MONGERING A Dissertation Submitted to the McAnulty College and Graduate School of Liberal Arts Duquesne University In partial fulfillment of the requirements for the degree of Doctor of Philosophy By Barbara A. Postol May 2016 Copyright by Barbara A. Postol 2016 ADOPTING THE UNESCO ETHICS MODEL TO CRITIQUE DISEASE MONGERING By Barbara A. Postol Approved April 5, 2016 ________________________________ ________________________________ Henk ten Have, MD, PhD Gerard Magill, PhD Director, Center for Healthcare Ethics Vernon F. Gallagher Chair for Professor of Healthcare Ethics Integration of Science, Theology, (Dissertation/Project Chair) Philosophy and Law Professor of Healthcare Ethics (Committee Member) ________________________________ ________________________________ Joris Gielen, PhD Henk ten Have, MD, PhD Assistant Professor of Healthcare Ethics Professor of Healthcare Ethics (Committee Member) (Center Director) ________________________________ James Swindal, PhD Dean, McAnulty College and Graduate School of Liberal Arts Professor and Dean of McAnulty College (Dean) iii ABSTRACT ADOPTING THE UNESCO ETHICS MODEL TO CRITIQUE DISEASE MONGERING By Barbara A. Postol May 2016 Dissertation supervised by Dr. Henk ten Have, MD, PhD The question this dissertation seeks to address is if the process of disease mongering can be ethically assessed. Chapter one provides a broad scope of the ethical challenge of disease mongering, UNESCO model framework, ADHD and PMDD. Chapter two examines disease mongering and its driving forces in detail. Chapter three provides an overview of the UNESCO model frameowork. Chapter four ethically examines disease mongering in conjunction with Attention Deficit Hyperactivity Disorder (ADHD). Chapter five examines disease mongering in association with Premenstrual Dysphoric Disorder (PMDD). Chapter six concludes that examined through the UNESCO model ethical framework disease mongering is occurring for both ADHD and PMDD, and provides remarks for the addressing this in the future. iv DEDICATION For you, Mom and in memory of you, Dad; thank you for everything. v ACKNOWLEDGEMENT Thank you to my dissertation director, Dr. Henk ten Have, for your invaluable guidance throughout the process of completing my dissertation, providing outstanding coursework, and for the opportunity to have worked as your Graduate Assistant. Thank you to Dr. Gerard Magill for both serving on my dissertation committee and for providing me with engaging coursework that challenged me throughout my doctoral program. Thank you to my committee member, Dr. Joris Gielen, for providing immediate oversight on my dissertation upon newly arriving at Duquesne. Last, but certainly not least, thank you to Ms. Glory Smith for her joyful spirit and for being my academic advisor, fellow Pittsburgher, and dear friend. Thank you all for helping me achieve success. vi TABLE OF CONTENTS Page Abstract .............................................................................................................................. iv Dedication ............................................................................................................................v Acknowledgement ............................................................................................................. vi Chapter One: Introduction 1.1 Background………………………………….………………………………………...1 1.2 Chapter 2………………………………………………………………………………4 1.3 Chapter 3………………………………………………………………………………6 1.4 Chapter 4………………………………………………………………………………8 1.5 Chapter 5…………………………………………………………………………...….9 1.6 Chapter 6…………………………………………………………………………..…10 Chapter Two: Disease mongering and the mechanisms that drive it 2.1 Disease Mongering………………………………………………………………..…13 2.2 Why disease mongering is problematic……………………………………………...19 2.3 Some examples of disease mongering………………………………………….……21 2.4 The impact of disease mongering on research and medicine………………………..26 2.4.1 Prescription Drug User Fee Act……………………………………………………27 2.4.2 The Bayh-Dole Act………………………………………………………………...28 2.4.3 Drug approval process………………………………………………………..……28 2.4.4 The case of VIOXX……………………………………………………………..…31 2.4.5 Sponsored research……………………………………………….………..………32 vii 2.4.6 The Physician Payment and Sunshine Act………………………………………...33 2.4.7 The value of drug patents…………………………………………………………..35 2.5 Mechanisms of disease mongering…………………………………………………..36 2.5.1 Expansion of disease and creation of disease criteria…………………………...…37 2.5.2 Off-label drug use……………………………………………………………….…40 2.5.3 Diagnostic criteria manipulation………………………………………………..…41 2.5.4 Normal conditions branded as disease………………………………………….…42 2.5.5 Ghostwriting…………………………………………………………………….…43 2.5.6 Lax definition of disease………………………………………………………...…46 2.5.7 Construction of disease……………………………………………………….……47 2.5.7.1 Effects of medicalization……………………………...…………………………51 2.5.8 Business marketing procedures……………………………………………….……52 2.5.8.1 Direct to consumer marketing……………………………………………………54 2.5.8.2 Direct to physician marketing……………………………………………………60 2.5.8.2.1 The role of drug representatives……………………………………………….60 2.5.8.2.2 Detailing and Sampling………………………………………………………...62 2.5.8.2.3 Incentives to physicians……………………………………………………..…63 2.5.8.3 Indirect to physician marketing………………………………………………….64 2.5.8.4 The marketing of self-diagnosis…………………………………………………65 2.5.8.5 Marketing patients as consumers………………………………………………...66 2.6 A global phenomenon……………………………………………………………..…68 2.6.1 Neglected disease………………………………………………………………..…68 2.6.2 US medical model’s global reach…………………………………………….……70 viii 2.6.3 Access to drugs limited by patents………………………………………………..71 2.7 Conclusion………………………………………………………………………..…73 Chapter 3: An ethical framework for assessing disease mongering: the UNESCO model 3.0 Western Bioethics……………………………………………………………………75 3.1 Principlism……………………………………………………………………….…..75 3.1.1 Respect for Autonomy…………………………………………………………..…77 3.1.2 Principle of Nonmaleficence…………………………………………………….…78 3.1.3 Principle of Beneficence………………………………………………………...…78 3.1.4 Principle of Justice……………………………………………………………....…79 3.2 Criticism of principlism……………………………………………………………...80 3.3 Bioethics……………………………………………………………………………..83 3.3.1 Van Rensselaer Potter……………………………………………………………..84 3.4 Global bioethics……………………………………………………………………..90 3.4.1 Why a global model.................................................................................................91 3.5 The UNESCO model……………………………………………………….……….95 3.5.1 Background of UNESCO………………………………………………………….95 3.5.2 The Declaration…………………………………………………………………....98 3.5.2.1 History of Declaration……………………………………………………………98 3.5.2.2 Function of the Declaration……………………………………………………..99 3.5.2.3 Scope of the Declaration………………………………………….……………100 3.5.2.3 Aims of the Declaration……………………………………………………...…101 3.5.3 The articles…………………………………………………………………….…102 3.5.4 The principles………………………………………………………………….…104 ix 3.5.4.1 Article 3: The principle of respect for human dignity…………………….……104 3.5.4.2 Article 4: Benefit and Harm…………………………………………………….106 3.5.4.3 Article 5: Autonomy and individual responsibility………………………….....109 3.5.4.4 Article 6: Consent………………………………………………………………115 3.5.4.5 Article 8: Respect for human vulnerability and personal integrity……………..122 3.5.4.6 Article 10: Equality, justice, and equity……………………………………...…127 3.5.4.7 Non-discrimination and non-stigmatization……………………………………130 3.5.4.8 Article 14 on social responsibility and health………………………………..…132 3.5.4.9 Article 15: sharing of benefits………………………………………………..…133 3.5.4.10 Article 16: Protecting future generations……………………………..…….…135 3.6 Conclusion………………………………………………………………………….135 Chapter 4: Ethically assessing ADHD in the UNESCO framework 4.1 History of ADHD…………………………………………………...………………138 4.2 Critique of DSM criteria……………………………………………………………143 4.2.1 Criticism of DSM-5………………………………………………………………144 4.3 DSM-IV criteria of ADHD criteria comparison……………………………………146 4.4 DSM-5: ADHD……………………………………………………………….…… 146 4.4.1 Overview of ADHD………………………………………………………………146 4.4.2 Criteria for diagnosis……………………………………………………………...147 4.4.2.1 Inattention ADHD………………………………………………………………147 4.4.2.2 Hyperactivity or impulsivity type ADHD………………………………………148 4.4.2.3 Diagnostic features……………………………………………………...………150 4.4.2.4 Associated feature of ADHD………………………………………………...…151 x 4.4.2.5 Risk factors……………………………………………………………………151 4.4.2.6 Culture related components of ADHD…………………………………………153 4.4.2.7 Gender and ADHD……………………………………………………………..153 4.4.2.8 Consequences of ADHD…………………………………………………….…153 4.4.2.9 Differential diagnosis………………………………………………………..…154 4.4.2.10 Comorbidity………………………………………………………………...…155 4.5 Factors involved in diagnosing ADHD…………………………………………..…156 4.5.1 Clinical judgment…………………………………………………………………156 4.5.2 Components of a psychiatric diagnosis………………………………………..…156 4.5.3 Organic nature
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