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The Expansion of Newborn Screening in Israel: Ethical And THE EXPANSION OF NEWBORN SCREENING IN ISRAEL: ETHICAL AND SOCIAL DIMENSIONS By SHLOMIT ZUCKERMAN Submitted in partial fulfillment of the requirements For the degree of Doctor of Philosophy Department of Bioethics CASE WESTERN RESERVE UNIVERSITY August, 2009 CASE WESTERN RESERVE UNIVERSITY SCHOOL OF GRADUATE STUDIES We hereby approve the thesis/dissertation of Shlomit Zuckerman Candidate for the Doctor of Philosophy degree *. Eric Juengst, PhD (Chair of the committtee) Patricia Marshall, PhD Marvin Natowicz, MD PhD Jennifer Fishman, PhD Georgia Wiesner, MD July 8, 2009 *We also certify that written approval has been obtained for any proprietary material contained therein. TABLE OF CONTENTS Chapter 1: Introduction 7 Overview 7 Specific Aims and Research Questions 10 Conceptual Framework 12 Research Design and Methods 28 Human Subject Protection 43 Description of Dissertation Chapters 44 Study Timeline 46 Significance, Innovation, and Expectations 47 Study Limitations 51 Chapter 2: Background and Literature Review 54 Introduction 54 Data Collection Procedure 55 History and Controversy in the Development of Newborn Screening Programs 56 Recent Newborn Screening Debates 64 Benefit for the Baby, the family, and Society from Screening 68 Dealing with Uncertainty 70 Informed Consent for Newborn Screening 72 Newborn Screening Education 74 The Adoption of New Medical Technologies in Israel 76 1 Israel’s National Insurance Law and the Health Basket Committee 77 Genetic Screening in Israel 80 Newborn Screening in Israel 82 Chapter 3: Analysis of Newborn Screening Guideline Documents 85 Introduction 85 Data Collection Procedure 87 Data Analysis 88 Results 93 Discussion 96 Chapter 4: The Evolution of the Expanded Newborn Screening Program in Israel 109 Introduction 109 History of Newborn Screening in Israel 109 Pilot Testing and the Justification for Expansion 113 The Role of Advisory Committees in the Process of Expansion 115 Timing and Fundraising for Expansion 119 Structural Considerations: Centralization and Privatization of Newborn Screening in Israel 122 Criteria for Disease Selection 125 Determination, detection, and Reporting of “Screen Positive” Results 128 Parental Stress Following Receiving “Screen Positive” Results 134 2 Education and Public Awareness regarding Newborn Screening 135 The Inchoate Nature of Programmatic Policies and the various Interpretations of those Policies 142 Chapter 5: The Context of the Expanded Newborn Screening Program In Israel 149 Introduction Legal Basis of the Expanded Program 149 Economical Considerations in the Evolution of the Israeli Program 151 Disorganization, Informality, and Authoritative Biomedical Knowledge 154 The Political Context of the Expanded Israeli Program 157 The Social Context of the Routinization of Tandem Mass Spectrometry 159 Newborn Screening, Equity, and Sitgmatization 162 Benefit for the Baby, the family, and Society form Screening 163 Informed Consent for Screening and the Future Use of Bloodspots 167 American Influence on the Evolution of the Israeli Program 176 Chapter 6: Conclusion 188 Introduction 188 Challenges of the Israeli Program 189 3 Unique Characteristic of the Israeli Program: Significant American Influence 197 Concluding Remarks 200 Appendix 1 List of Candidate Conditions in Expanded Panel, 2009 206 Appendix 2 In-Depth Interview Guide 207 Appendix 3 Participant Observation Guide 210 Appendix 4 List of Candidate Conditions in Expanded Panel, 2007 212 Appendix 5 List of Candidate Conditions in Expanded Panel, 2008 213 Appendix 6 Interview Coding Guide 214 Appendix 7 Tables (see next page for individual listing) 225 References 241 4 LIST OF TABLES (APPENDIX 7) 1. Documents, Authors, and Scope of Guidelines 225 2. Criteria for Disease Selection 227 3. Ethical, Legal, and Social Considerations 230 4. Program Organization and Daily Functioning 233 5. Program Assessment 236 6. Research 239 5 LIST OF FIGURES AND ILLUSTRATIONS 1. Conceptual Framework 9 2. Study Design and Methods 26 3. Interview Guide: Sample Questions 31 6 Acknowledgements I would like to thank my committee members and the Department of Bioethics at Case Western Reserve University for the opportunity to write, the advising, and the assistance in submitting the complete dissertation. I would also like to thank the National Science Foundation for the dissertation improvement grant that assisted me in data collection and analysis, and the people of the expanded newborn screening program in Israel and their American colleagues. A special thanks to Sherri Broder for being my most devoted reader, my partner Dov Yelin, my parents David and Daphna Zuckerman for supporting me through the process, and, finally, to my daughter Aya, who made all this worthwhile. 7 The Expansion of Newborn Screening in Israel: Ethical and Social Dimensions Abstract by SHLOMIT ZUCKERMAN This dissertation is a bioethical study of the decision making involved in the recent expansion of newborn screening for genetic and metabolic disorders with the introduction of tandem mass spectrometry technology in Israel. It explores the ethical, social, and programmatic challenges posed by introducing new technology into a developing public health program. Newborn screening programs test infants in the first 24-48 hours of life to identify disorders while they are presymptomatic and preventive treatment is available. The number of tests performed and disorders screened for varies widely between programs, as do the methodologies used in testing. This study’s first aim is to locate the development of an expanded Israeli program in a broader social and international context by conducting a policy analysis of the evolution of newborn screening programs internationally. The study’s second goal is to analyze ethical, social, and policy issues in the formation and implementation of the expanded Israeli program based on in-depth interviews of program initiators and officials and practicing physicians in the field of newborn screening in Israel and internationally. Using social scientific theories regarding the social construction of medical knowledge, the concepts of medicalization and the technological imperative, this study examines the routinization of tandem mass spectrometry, and the influence of cultural quest for a “perfect baby” in Israeli society on the public perception of newborn screening and its expansion. I conclude that three issues have proved problematic in the development of the Israeli expanded newborn 8 screening program: the inchoate and contested nature of the policies that have emerged regarding basic programmatic aspects as practiced by different stakeholders; the insufficient evidence-base used to justify various programmatic aspects; the minimal involvement of the community in the process of decision making that shaped the program’s implementation. Finally, I demonstrate the significant influence of American newborn screening experience on various stages and aspects of the developing newborn screening program in Israel. 9 Chapter 1: Introduction Overview This study explores ethical and social dimensions of the expansion of newborn screening in Israel. Newborn screening is a term used to describe public health programs that test newborns for genetic and metabolic disorders in the first 24-48 hours of their life. Newborn screening programs allow for early detection of infants who have disorders that would cause irreversible clinical damage if not recognized at birth (Therrel, 2001). The objective of newborn screening is to identify disorders while they are presymptomatic and preventive treatment is available (Levy et al., 2000). The physical process of newborn screening starts with lancing a baby’s heel and then soaking several circles on a filter paper card with drops of the baby’s blood. Newborn screening programs have diverse approaches to education of parents and regarding the type of consent (or lack of consent) process that is used prior to obtaining the blood specimen. The blood is then air-dried at room temperature and delivered by courier or mail to the testing laboratory. A major concern in newborn screening is the age of the infant at the time of specimen collection; blood is typically obtained at 24-48 hours after birth, although this represents a compromise as it is ideal for the detection of some conditions and suboptimal for others. The number of tests done on the blood specimen and, therefore, the number of disorders that are screened for, varies widely between newborn screening programs, as do the methodologies used in the testing. The results of newborn screening are communicated by the laboratory staff to the medical home that, in turn, deliver the results to parents of newborns detected as screen-positive and refer them for further evaluation. Follow-up evaluation of a screen-positive baby involves additional 10 testing and, sometimes, immediate clinical evaluation as well, depending on the condition that the baby’s screening test was positive for. For babies whose follow-up testing reveals that they definitely have the disorder that was screened for (i.e., true positives), further evaluation and care is typically provided by clinical specialists in medical genetics or endocrinology at academic or tertiary care centers. The focus of this study is the development of the expanded newborn screening program in Israel; a program that was launched in May 2008. The conceptual framework consists of four components: 1) the social construction of medical knowledge as it relates to program parameters. among health
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